Public tenders for consultant in Bethesda United States

Find all Consulting tenders in the world.
Finding business opportunities has never been easier.

Results for consulting. Make a new search!

Senior Consultant/Advisor for NINR

Department of Health and Human Services, National Institutes of Health | Published December 19, 2014  -  Deadline December 23, 2014
cpvs

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 and FAR Part 13, Simplified Acquisitions Procedures, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. Solicitation Number NIH-OD3611408, is being issued as a RFQ (request for quotes). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-79. The NAICS code for this requirement is 541690 and business size standard of $7.0M. The National Institute of Nursing Research (NINR) needs a Senior Consultant/Advisor to design and execute projects that define nursing research, career trajectory, review successful programs and their outcomes and identify future initiatives and marketing aspects of nursing research to the NIH nursing community and public at large. Deliverables include: Kick-off meeting (5 business days) Meet or converse via e-mail or phone with NINR Project Officer to review project activities,issues or concerns (Monthly) E-mail project status reports to NINR Project Officer (Quarterly) Provide results summaries and interpretations with tables and figures (As determined by NINR Project Team) Annual technical progress report (12 months) Summary of results report (Contract closeout) Final report (Contract closeout)

BIOINFORMATICS CONSULTANT

Department of Health and Human Services, National Institutes of Health | Published January 14, 2016  -  Deadline February 3, 2016
cpvs

The National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) intends to award a purchase order to M. S. Ring, LLC, 4011 Brookhill Road, Baltimore, MD 21215 for Bioinformatic Consultant to support clinical data management activities for a diverse array of clinical protocols. This requirement is to obtain bioinformatic consulting via a fee for service contract to support the NIDDK DIR in support of the NIDDK clinical research investigators by providing support of clinical data management activities across the diverse array of clinical protocols in this IC. The objective is to obtain consulting services to streamline DIR investigator's access to and implementation of clinical databases for new and on- going clinical research projects while ensuring the database systems utilized by investigators are compliant with NIH guidelines and federal regulatory requirements, where applicable. This contract requires that the vendor (contractor) be already familiar with the NIH and FDA guidelines and regulations for clinical data systems. The contractor should also be familiar with the key clinical data systems utilized by DIR investigators including, but not limited to TeleResults, REDCap, NICHD's Clinical Trials Database, and NHLBI's Crimson. Working knowledge of the NLM/CC BTRIS is also required. The anticipated service hours are estimated to not exceed more than 20 hours per week on an averaged basis for the year period this contract is to be approved. The services shall be rendered Monday-Friday, excluding Federal holidays. This requirement will enable the contractor to provide cost-efficient clinical data solutions to clinical investigators when initiating new clinical protocols, or transitioning data between data systems. Specific databases include BTRIS, REDCap, and the NICHD's CTDB. Knowledge and experience working with the NIH Clinical Center's CRIS medical records systems is required. The contractor must possess working knowledge of these systems as there is no staff available to provide the training in these systems under the funds obligated via this contract; any such work required to become familiar with these systems would be required to be independently undertaken at the contractor's personal expense and time. This contract is proposed to be offered to Dr. Michael Ring as he is already very trained and knowledgeable about these required systems. In addition, through his current and previous experience working with NIDDK's DIR investigators, he is already familiar with the varied study designs and data management requirements for many of the NIDDK clinical research protocols and will not require additional time to meet with investigators to assess current data management use and future needs. Duty Station: All services rendered shall be performed in support of NIDDK clinical research initiatives at the NIH Clinical Center on the National Institutes of Health's main campus in Bethesda, MD and other NIDDK study performance sites. The sole source determination is based on that Dr. Michael Ring possess a medical doctorate in order to be fully conversant with the clinical investigator's data management and system specification needs. Dr. Ring is qualified for this role, has the required knowledge and is already familiar with NIDDK DIR clinical protocols, providing a maximum efficiency for consultations with on-going and new projects. In compliance with Federal Acquisition Regulation (FAR) 13.106-1(b) Soliciting from a single source. This solicitation is not a Small Business Set-Aside. This notice of intent is not a request for competitive proposals, however; all responses received, before the closing date, of this announcement will be considered by the Government. A determination by the Government not to compete this proposed acquisition is based upon responses to this notice and is solely within the discretion of the Government. It is anticipated that the RFQ NICHD2016009 will be available fifteen (15) days after the publication date of this synopsis. Receipt of quotations will be due five (5) days after the release of the RFQ. All interested parties to this solicitation may request a copy of the RFQ package in writing to the attention of Ms. Verne Griffin at National Institute Child Health and Human Development (NICHD), 6100 Executive Blvd., Room 5C01, Rockville, MD 20815 or via email griffinv@nih.gov. All requests must contain offerors name, address, telephone number and fax number. Email addresses are encouraged but not mandatory. PLEASE NOTE: In order to receive an award, contractor must be registered and have valid certification in the System For Award Management (SAM) http://www.sam.gov

BIOINFORMATIC CONSULTANT

Department of Health and Human Services, National Institutes of Health | Published February 6, 2015  -  Deadline February 20, 2015
cpvs

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation number is NIHLM2015386 and is issued as a Request for Quotation (RFQ). The solicitation /contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2005-78. The North American Industrial Classification (NAICS) code 541711 with a size standard 500 employees. This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. The National Institutes of Health (NIH), National Institute of Digestive, Diabetes & Kidney Diseases (NIDDK) has a requirement to procure services including big data management and bioinformatics of next generation sequencing data analysis and software development. Specific requirements include the ability to analyze transcription or genomic data related to multiple model systems, including worm (C. elegans), fly, mouse and human. Professional Services Requirement: This fee for service contract is for services rendered to the NIDDK Division of lntramural Research in support of clinical research investigators to support clinical data management activities for a diverse array of clinical protocols. This requirement allows NIDDK to provide direct compensation for the professional consult services performed by offeror for currently operational clinical data information systems within the NIDDK Division of Intramural Research's clinical research program. This agreement is not intended to provide travel related expenses. The anticipated service hours are estimated to not exceed more than 20 hours per week on an averaged basis for the year period this contract is to be approved. The services will be rendered Monday - Friday, excluding Federal holidays. Tasks: The following represent key duties for consultant activities: Provide assistance with the application of computer technology to clinical research by assessing clinical data needs for unique clinical protocols, providing recommendations for cost efficient clinical data systems which will fulfill clinical data management requirements for these protocols; and provide technical expertise review to ensure customizable data solutions meet investigators' requirements for these data systems. Assist with the evaluation of various technical informatics systems to determine applicability for the support of research of specific clinical diseases in a clinical research setting. Provide technical support for NIDDK clinical databases. Train NIDDK clinical and technical support team to independently manage existing databases as appropriate. Coordinate necessary computerrelated activities with the NIDDK Computer Technology Branch as well as the staff supporting clinical database development for other applicable ICs. This task specifically requires knowledge of (1) the commercial, Teleresults system, (2) the Microsoft SQL Server environment, the NICHD's Clinical Trials Database (CTDB), (4) NIDDK's REDCap installation and (4 5) the specific configuration of these systems at NIDDK. Provide programming support for the Lab Grabber data retrieval, BTRIS and other data retrieval tools currently in use by NIDDK or that may be used in the future. Train NIDDK personnel to independently manage BTRIS and other clinical data query tools as appropriate. Maintain the current database source code and modify the database source code in consultation with the user base for applicable clinical databases. Deliverables: Upon request, the contractor will provide documentation of all work product, including, but not limited to, the following tasks: Provide technical support for NIDDK clinical databases. Provide programming support for the data retrieval tools currently in use by NIDDK. Generate research data reports. The contractor shall obtain project approvals prior to commencing new projects. All projects should specify the following: Scope of contractor's involvement with the project; Estimate of hours required to complete the specified scope; Secondary project approvals if the original number of project estimated hour total is exceeded Deliverables shall be established through written communication with NIDDK program office. Invoicing statements generated will need to be communicated to NIDDK program office to ensure prompt processing for invoice payment in addition to the invoice sent to the address specified in the awarded contract. The offeror must include a completed copy of the following provisions: 1) FAR Clause 52.212-1 Instructions to Offerors - Commercial items; 2) FAR Clause 52.212-2, Evaluation - Commercial Items. As stated in FAR Clause 52.212-2 (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be advantageous to the Government, price and other factors considered. The following factors will be used equally to evaluate offers: Technical Evaluation, Price, and Past Performance. Note on Government Issued Accountable Property: The contractor shall be issued government accountable property for the conduct of routine business functions within the scope of this contract. The contractor agrees to take on fiscal responsibility related to the loss, theft, or damage of any issued property. For any work which may require taking the accountable property off-site from the duty station, the contractor shall obtain a government property pass for the device(s). Additionally, the contractor agrees to complete required training, as applicable, for example, NIH privacy and security training (or refresher). Note: Past Performance Information: Vendors must submit a listing of the most recent contracts/awards (minimum of 3) which demonstrate similar work in nature to this Solicitation. Contracts/awards may include those entered with the Federal Government, state and local governments and commercial concerns. Include the following information for each contract or subcontract: 1. Name of Contracting Organization 2. Contract Number (for subcontracts provide the prime contract number and the subcontract number) 3. Contract Type 4. Total Contract Value 5. Description of Requirement 6. Contracting Officer's Name and Telephone Number 7. Program Manager's Name and Telephone Number 3) FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items; 4) FAR Clause 52.212-4, Contract Terms and Conditions - Commercial Items; 5) FAR Clause 52-212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items - Deviation for Simplified Acquisitions. The Dun and Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN) and the certification of business size shall be included. The clauses are available in full text at http://www.arnet.gov/far. PLEASE NOTE: In order to receive an award, contractor must be registered and have valid certification in the System For Award Management (SAM) http://www.sam.gov Interested vendors capable of providing the Government with the items specified in this synopsis should submit their quotation to the below address. Quotations will be due on or before February 20, 2015 at 11:00 a.m. EST. Offersors shall provide an original and one copy of your quotation. The quotation must reference Solicitation number NIHLM2015386. All responsible sources may submit a quotation, which if timely received, shall be considered by the agency. Quotations must be submitted in writing to the National Institutes of Health, National Library of Medicine, 6707 Democracy Blvd., II Democracy Plaza, Suite 700W, Bethesda, Maryland 20892, Attention: V. Lynn Griffin. Faxed copies will not be accepted.

AV CONSULTANT SERVICES

Department of Health and Human Services, National Institutes of Health | Published July 8, 2015  -  Deadline July 22, 2015
cpvs

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information contained in this notice. This procurement is being conducted under Simplified Acquisition Procedures in accordance with FAR Part 13.5. This solicitation document and incorporated provisions and clauses are those in effect through the June 8, 2015 Federal Acquisition Regulation revision, which includes the consolidation of all Federal Acquisition Circulars through 2005-82. This acquisition is a NOT a small business set-aside. The NAICS code is 519120, Libraries and Archives. This announcement constitutes the formal Request for Proposal (RFQ) and NO additional written solicitation will be issued. The resultant purchase order will be firm fixed price. It is anticipated that ONE AWARD will be made from this solicitation. The period of performance shall be on or around August 2015 to August 2016 with two successive one year option periods. It is the intent of the National Library of Medicine (NLM) to procure services of a qualified consultant to provide advice and recommendations on all aspects of digitizing audiovisuals in NLM's collections, including the technical requirements for a new purchase order to produce preservation master and derivative files and internal workflows for inspecting and processing the newly created files. Vendor shall furnish services, qualified personnel, material, equipment and/or facilities as needed to perform the work as stated on Statement of Work (SOW). ****The Statement of Work of this requirement is included below following the series of asterisks. All offers received within 15 days from the date of publication of this synopsis will be considered by NLM. NLM requires an electronic proposal to be submitted via the NLM electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov/nlm. Responses must be submitted via ONLY ONE .pdf document electronically as outlined here and must be received in the eCPS system by July 22, 2015 by 12:00 PM Eastern time, and must include pricing information and meet NLM's selection criteria. NLM Synopsis No. NIHLM2015472. For directions on using eCPS, go to https://ecps.nih.gov/nlm/home/howto and click on "How to Submit." NOTE: To submit your electronic proposal using eCPS, all offerors must have a valid NIH External Directory Account, which provides authentication and serves as a vehicle for secure transmission of documents and communication with the NLM. The NIH External Directory Account registration process may take up to 24 hours to become active. Submission of quotes by facsimile or e-mail are NOT accepted. Firms interested in responding to this notice must be able to provide the professional services required by NLM. The offeror shall include all information necessary to document and/or support the qualification criteria in one clearly marked section of its proposal. All responses from responsible sources will be considered. Inquiries regarding this procurement may be made via email to Keturah Busey, Contract Specialist keturah.busey@nih.gov no later than July 10, 2015 at 12:00 P.M. EST. Vendor shall comply with all applicable Federal, State and Local laws, executive orders, rules and regulations applicable to its performance under this order. Full text of clauses and provisions are available at Federal Acquisition Regulations (FAR). The following clauses and provisions shall apply to this acquisition and maybe obtained from the web site: FAR 52.212-1, Instructions to Offerors-Commercial Items (April 2014), FAR 52.212-2, Evaluation-Commercial Items (October 2014). Offerors are advised to provide with their offer a completed copy of the following provisions: FAR 52.212-3, Offeror Representations and Certifications- Commercial Items (March 2015)-With DUNS Number Addendum [52.204-6 (July 2013)]. The following FAR clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions-Commercial Items (May 2015)-With Addenda [Stop Work Order, FAR 52.242-15 (August 1989) and Year 2000 Compliance (July 1997)]; FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (May 2015), as well as the following clauses cited therein: FAR 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011); FAR 52.222-41, Service Contract Labor Standards (May 2014) FAR 52.232-18, Availability of Funds (April 1984); FAR 52.242-15, Stop Work Order (August 1989) with Alternate I (April 1984); FAR 52.242-17, Government Delay of Work (April 1984); and FAR 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration (July 2013). ************************************************************

Scientific Nurse Consultant

Department of Health and Human Services, National Institutes of Health | Published November 4, 2015  -  Deadline November 16, 2015
cpvs

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 and FAR Part 13, Simplified Acquisitions Procedures, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is NIH-OD3974052 and this is a request for proposal (RFP). (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-83. (iv) This is a small business set-aside and the associated NAICS code is 541611 and small business size standard is $15.M. (v) The contractor shall: •· Attend NINR symposiums and mentoring sessions •· Attend national and regional meetings of significant importance to nursing science •· Develop and present workshops for mid-career nurse scientists •· Review manuscripts, abstracts, research protocols and other material related to nursing science •· Coordinate NINR's Common Data Elements initiative, represent NINR on a task force, and write a subsequent manuscript on the topic (vi) The contractor shall provide documentation evidence of any and/or all work products, including, but not limited to, the following tasks: •· Work products and documents related to the review of manuscripts, abstracts, research protocols and other scientific material. •· Work products and documents related to providing administrative and technical support for outreach activities and programs for training and education in biomedical research. •· Workshop material for mid-career nurse scientists. •· Manuscript related to NINR's Common Data Elements initiative. •· Presentations of workshop material. PERIOD OF PERFORMANCE. The period of performance will be 12 months with the option to renew for two additional years. Education/Experience •· Master of Science in Nursing and Ph.D. in Nursing •· Published author in an area of nursing science •· A distinguished track record of contributions to nursing science •· History of Department of Health and Human Services grants funding •· Leadership and visionary capabilities in their scientific focus area(s) •· Strong oral and written communications, interpersonal and team building skills. •· Strong project management, program development and evaluation skills. •· Demonstrated leadership and customer service skills. 52.212-2 -- Evaluation -- Commercial Items. Evaluation -- Commercial Items (Oct 2014) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used toThe Government will make one award to the most responsive and responsible vendor that offers NIH the "best value" price and technical factors considered. Since this "best value" approach contains price/technical tradeoffs, award will not necessarily be made to the lowest price vendor or to the most technically qualified vendor. Note: Vendors that take exception to any term or condition of the RFP could make the offer unacceptable. Vendors do not have the option to respond to select requirements and must be able to provide all requirements to be considered for this engagement. The award may be made without discussions; therefore vendors are encouraged to submit proposals that are responsive and most advantageous. If NIH deems discussions necessary, NIH will conduct discussion only with those vendors determined to be within the competitive range for an efficient award. In this RFP, personnel qualifications and past performance are significantly more important than price. However, as proposals become more equal in technical merit, past performance will become more important. The evaluation factors are used by the technical evaluation committee when reviewing the technical proposals. The factors below are listed in the order of relative importance with weights assigned for evaluation purposes. No. Criterion Points 1. Personnel Qualifications Adequacy and feasibility of the proposed professional staff to represent and speak on NINR's behalf, including •· Nurse scientist with demonstrated ability to successfully evaluate research protocols, manuscripts and abstracts •· Scientist with demonstrated ability to receive HHS grant funding •· Demonstrated ability to implement the performance requirements described in this SOW •· History of Department of Health and Human Services grants funding •· Key personnel will have a minimum of qualifications and experiences as described in the Statement of Work 50 2. Past Performance •· Publications in peer-reviewed journals on a topic related to nursing science •· Prior support to NIH in a leadership capacity in an area related to nursing science 40 3. Price Proposal Evaluation 10 ADDITIONAL INFORMATION FOR PROPOSAL. •· Vendor will attend at least four national and/or regional meetings using NINR's travel support services. •· Travel expenses for eight trips to NINR in Bethesda, MD will be paid by the contractor and should be included in the price proposal. 52.212-4 -- Contract Terms and Conditions -- Commercial Items Contract Terms and Conditions -- Commercial Items (May 2015) Responses must be submitted no later than 10:00 AM Eastern Standard Time (EST), November 16, 2015 to Ms. Tonia Ellen at ellent@od.nih.gov. All information furnished must be in writing and must contain sufficient detail to allow the government to determine if it can meet the above specifications described herein. Please reference the announcement number on all correspondence.

Biostatistician Consulting Support Services

Department of Health and Human Services, National Institutes of Health | Published August 3, 2016  -  Deadline August 12, 2016
cpvs

Biostatistician Consulting Support Services  Competitive Combined Synopsis/Solicitation  HHS-NIH-NIDA-SSSA-CSS-16-473 INTRODUCTIONThis is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This acquisition is being conducted in accordance with the procedures of FAR Part 13--Simplified Acquisition Procedures and FAR Part 12--Acquisition of Commercial Items.The solicitation number is HHS-NIH-NIDA-SSSA-CSS-16-473 and the solicitation is issued as a request for proposal (RFP). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODEThe intended procurement is classified under NAICS code 541690 with a Size Standard of $14 Million. SET-ASIDE STATUSThis acquisition is 100% set aside for small businesses.ACQUISITION AUTHORITY This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures and FAR Part 12-Acquisition of Commercial Items, and IS NOT expected to exceed the simplified acquisition threshold.  The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-89 dated July 14, 2016. The resultant contract will include all applicable provisions and clauses in effect through this date. DESCRIPTION OF REQUIREMENT BackgroundThe National Institute of Neurological Disorders and Stroke (NINDS) Clinical Trials Unit (CTU) staff work with investigators at the NINDS Division of Intramural Research (DIR) in specific neurological and clinical research areas, including protocol development of interventional and non-interventional clinical research studies for neurological disorders and stroke. In addition to advising intramural investigators in the conception, development, implementation, and execution of clinical research studies and clinical trials, CTU interacts with the extramural Offices of Translational Research (OTR) and Clinical Research (OCR) to support the mission of NINDS. The CTU provides expertise to NINDS and investigators in the conception, design, implementation, execution, analysis, and reporting of clinical research. CTU staff advises the investigators and the Institute on clinical research methodology, research ethics, safety monitoring, clinical research data sharing, clinical trial reporting, and gender and minority tracking.For extramural research, NINDS awards grants and cooperative agreements to outside academic institutions, small business concerns and other organizations all over the U.S. and world to fund promising basic, translational, and clinical research projects. The NINDS Office of Translational Research (OTR) is committed to facilitate the translation of basic discoveries into the development of new therapeutic interventions through nonclinical development and early clinical investigation. NINDS seeks statistical advice given the institute's high priority in increasing the predictive value of non-clinical research, in order to ensure therapy projects are moving ahead to the clinic for the right reasons. For more information on the Office of Translational Research, Extramural program visit the website: http://www.ninds.nih.gov/funding/areas/translational_research/index.htmPurposeThe purpose of this acquisition is to procure biostatistics consulting services for the NINDS CTU and extramural research community. Scope of WorkThe Contractor shall provide the following Biostatistics Consulting Services:• Provide expert and strategic biostatistical technical support, guidance, education, and advice on advancing Government projects through nonclinical and clinical development.• Prepare and review statistical analysis plans, provide detailed specifications for analysis files, consistency checks, tables and figures; communicate with Government staff and investigators regarding statistical protocol design and data analysis issues. • Evaluate the design of Government proposed studies and milestones for sound statistical analysis methodology to ensure studies are sufficiently powered and controlled with experimental and statistical rigor to lend a high degree of confidence in the results.• Interpret and, as needed, perform analyses and assist in the writing of statistical sections of study reports. • Explain statistics in plain language and participates in educational activities when requested.• Provide feedback and recommendations of a biostatistics nature on projects through written documents, conference calls, and by email. Provide technical review and feedback of a biostatistics nature regarding project milestones, progress reports, development plans, study design, and data interpretation. • Interact with Federal staff and clinical trial investigators to facilitate discussions in support of Government research strategy with regards to statistical methods for clinical trials as the Government prepares protocol or grant applications. Level of EffortThe NIH estimates that the level of effort for this requirement shall be one (1) contractor employee on a part time basis for up to forty-five (45) hours per year. Key Personnel RequirementsThe Contractor employee working under this award shall be considered key personnel. Key Personnel requirements are as follows: • A PhD in a biostatistical discipline• At least 10 years biostatistical experience in the biotechnology or academic sector• At least 5 years demonstrated experience in:o Design and review of nonclinical animal research plans and/or analysis of nonclinical animal research results for IND-enabling studies or clinical studieso Design of clinical trial protocols, innovative and adaptive designs, review of statistical analysis plans, and validations plans.o Statistical interpretation of published results or critique of scientific proposalso Statistical support to non-clinical and/or clinical development efforts The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows:The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties. CollaborationIt is required that all contractors involved with the NINDS community work collaboratively with federal staff and other contractors towards the NINDS mission and other affected organizations and follow the direction of the Contracting Officer's Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer and creating and sharing documentation when required. Period of PerformanceThe period of performance shall be a one year base period plus four (4) one-year option periods as follows: Base Period: September 30, 2016 through September 29, 2017 Option Period 1: September 30, 2017 through September 29, 2018 Option Period 2: September 30, 2018 through September 29, 2019 Option Period 3: September 30, 2019 through September 29, 2020 Option Period 4: September 30, 2020 through September 29, 2021Place of PerformanceThe contractor shall provide services remotely from its own site. TravelUnder special circumstances, the consultant may be required to travel within the continuous United States to provide the services described in this statement of work. Travel reimbursement will be provided for such required travel. All travel arrangements must be made in accordance with Federal Travel Regulations and must be approved by the Contracting Officer's Representative prior to being finalized or invoiced. Contracting Officer's Representative-authorized travel shall not exceed $1,200.00 annually. Government Furnished Property/InformationNo Government furnished property shall be provided. Project related data will be provided to the contractor for performance of work efforts. All data provided to consultant must be treated as confidential and not be disclosed to any third party. Project data will be collected and stored by NINDS. NINDS will provide data as needed to the consultant each time it requests service. The consultant may store data up to 12 months after initially receiving it, after that time the consultant should either delete the data files and sanitize the computer using NIST SP 800-88 (current revision) or if information is still needed contact the COR for approval to store data longer.NINDS requires that the consultant's meet certain minimum requirements: All computers that are used by the consultant to perform work under this contract whether contractor furnished or government furnished will have to have:• Virus protection with regular automated scans• Up to date security patching• Two factor authentication• Encryption - FIPS 140-2 compliant encryption solution• Regular vulnerability scans and if the scan produces any high or medium results they need to be corrected - highs within 30 days and mediums within 90 days• Contractors will have to take NIH Security and Privacy Training annually http://irtsectraining.nih.gov/ • Consultant will have to sign the NIH non-disclosure agreement http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf• Report any lost or stolen NIH data to the NINDS ISSO within one hour of knowing of the lost or theft even if the data is on a contractor furnished computer. • Contractors must adhere to the NIH IT rules of behavior which can be found at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspxConfidential Treatment of Sensitive Information Consultant(s) must guarantee strict confidentiality of the information/data that is provided by the NINDS or by any other participant on a project to which the consultant is assigned. The NINDS has determined that the information/data that the consultant will be provided during the performance of the consulting contract is of a sensitive nature. Consultant(s) may only disclose the information/data generated for a particular project to other participants on that same project. These specific individuals will be identified when the consultant is assigned to a project. Disclosure of the information/data, in whole or in part, by the consultant to anyone else can only be made after the consultant receives prior written approval from the Contracting Officer. Whenever the consultant is uncertain with regard to the proper handling of information/data under the contract, the consultant shall obtain a written determination from the Contracting Officer.Contractor agrees that it will not use the Confidential Information for any purpose except as set forth within this SOW, unless such time as such Confidential Information becomes public information.Data Rights The NINDS shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations, briefings, work plans, created SOPs and all other deliverables. In addition, it includes any additional deliverables required by contract change. The definition of "unlimited rights" is contained in Federal Acquisition Regulation (FAR) 27.401, "Definitions." FAR clause 52.227-14, "Rights in Data-General," is hereby incorporated by reference and shall be made a part of any resulting contract/order. Non-Personal Service StatementContract employee performing services will be controlled, directed and supervised at all times by management personnel of the contractor. Actions of contractor employees may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulations (FAR). Contract TypeThe Government intends to issue one or more fixed price requirement contract(s) in reference to this requirement. Each contract shall include fixed hourly rates for each contract period. Only funding for the minimum level of effort is guaranteed, but funding may be obligated for additional hours up to the maximum level of effort specified in this solicitation. RESPONSE FORMAT Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The offeror must submit 1) a technical proposal and 2) a separate price proposal. The technical proposal should be prepared in reference to the evaluation criteria identified in this solicitation and may be up to thirty (30) single-sided pages. The price proposal must include fixed hourly rates for proposed consultant(s) for each contract period. Contractors must provide their Company Name, Dun & Bradstreet Number (DUNS), Taxpayer Identification Number (TIN), Business Size, Physical Address, and Point of Contact Information in their responses. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov."IMPORTANT NOTE TO OFFERORS: PLEASE ENSURE THAT YOUR RESPONSE MEETS THE FORMAT REQUIREMENTS AND SPECIFICALLY ADDRESSES EACH OF THE TECHNICAL EVALUATION CRITERION AND THE EVALUATION FOCUS THAT IS INDICATED FOR EACH CRITERION. PROPOSALS MUST INCLUDE BOTH A TECHNICAL DOCUMENT AND A SEPARATE PRICE PROPOSAL. CONTRACTORS NOT SUBMITTING BOTH A TECHINICAL PROPOSAL ADDRESSING THE EVALUATION CRITERIA AND A SEPARATE PRICE PROPOSAL SHALL NOT BE CONSIDERED.EVALUATION CRITERIAFAR clause 52.212-2, Evaluation - Commercial Items applies to this acquisition and the specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a contact resulting from this solicitation on the basis of best value in consideration of trade-off between technical factors and price/cost. Technical factors together shall be considered more important than price. The technical evaluation factors are as follows, in order of importance: Factor 1: Technical Capability (50 Points) The Contractor's proposal shall address each area of the statement of work requirements in sufficient detail to demonstrate a clear understanding of the statement of work and compliance with requirements. Factor 2: Key Personnel Qualifications (25 Points) Offerors proposals shall be evaluated for level of conformance to the key personnel qualifications identified in this statement of work. Offeror proposals must contain a resume/CV.Factor 3: Past Performance (25 Points) The Contractor shall provide a list of two (2) past performance references with knowledge of the contractor's relevant skills and experience related to the requirements outlined in this Statement of Work. References shall include the following information: a) Name of Organizationb) Description of Contractor's responsibilities as they relate to this SOWc) Contract Period of Performanced) Contact Name and Titlee) Telephone Number Past Performance shall be evaluated for relevance to the current requirement. Technical proposals will be evaluated using a summary adjectival rating based on total numerical score in accordance with the above and the following scale: Excellent (90 - 100)Very Good (80 - 89)Good (70 - 79)Fair (60 - 69)Poor (0-59) Award shall be made to the contractor offering the greatest value in consideration of both technical factors and price. Award shall not be considered for proposals evaluated to be "Poor." APPLICABLE CLAUSES AND PROVISIONSThe FAR clauses and provisions below shall apply to this solicitation. Please note that any clauses requiring fill-ins shall be completed at time of award.1. All Offerors MUST be actively registered in the System for Award Management (SAM) www.sam.gov. 2. The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items (April 2014), applies to this acquisition. 3. A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (March 2015), is required with any offer submitted. This requirement may be met by completion of the provision in the System for Award Management. 4. FAR clauses 52.212-4, Contract Terms and Conditions - Commercial Items (May 2015) and 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (October 2015) apply to this acquisition. 5. FAR clause 52.217-5 Evaluation of Options (July 1990) applies to this acquisition. 6. FAR clause 52.217-9 Option to Extend the Term of the Contract (March 200) applies to this acquisition. 7. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. 8. FAR clause 52.227-14 Rights in Data-General (May 2014) is applicable to this requirement.9. HHSAR clause 352.224-70 Privacy Act (December 18, 2015) is applicable to this requirement.10. HHSAR clause 352.237-75 Key Personnel (December 18, 2015) is applicable to this requirement. 11. The information security clauses included in Appendix A of this solicitation are applicable to this acquisition. In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." CONTRACTING OFFICER'S REPRESENTATIVEA Contracting Officer's Representative (COR) shall be assigned to the awarded contract. The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contractThe Government may unilaterally change the COR designation for this contract.CLOSING INFORMATIONResponses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. All responses must be received by the closing date of this announcement and must reference solicitation number HHS-NIH-NIDA-SSSA-CSS-16-473. Responses shall be submitted electronically via email to Lauren Phelps, Contract Specialist, at lauren.phelps@nih.gov.  

NINDS Biotechnology Products and Biologics Discovery and Development Consulting Services

Department of Health and Human Services, National Institutes of Health | Published March 13, 2015  -  Deadline April 13, 2015
cpvs

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The Solicitation Number for this acquisition is HHS-NIH-NIDA-(SSSA)-15-105 and is being issued as a Request for Proposal (RFP). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-80 effective March 2, 2015. This acquisition is a small business set aside. The North American Industry Classification System (NAICS) Code for this procurement is 541690 and the Small Business Size Standard is 14.0 million dollars; Other Scientific and Technical Consulting Services. STATEMENT OF OBJECTIVES The NIH is seeking senior-level, industry-experienced drug discovery and development consultants with expertise in the following specific disciplines to provide leadership and technical guidance on drug discovery and development projects in the Blueprint Neurotherapeutics Network and possibly other NIH neuroscience-focused drug discovery and development programs. • Biologics Regulatory Affairs Consultant • Biologics CMC Development Consultant STATEMENT OF WORK The Cooperative Research to Enable and Advance Translational Enterprises for Biotechnology Products and Biologics (CREATE Bio) projects are funded through a cooperative agreement award mechanism, a collaborative team is formed between the principal investigators (PI) group with NINDS program staff participation in guiding the project plan. The PI's team performs all of the experiments while NINDS role is to establish performance milestones for each project to facilitate go/no-go decision making and then monitor research progress and achievement of project milestones. Each consultant is expected to provide technical guidance and advice pertaining to their area of expertise on advancing discovery and development projects through nonclinical development and submission of an IND or BLA package, and in some cases, design of early clinical protocol and launch of a first in human clinical trial. Consulting services will be for biologics-focused projects from the Cooperative Translational Research program such as CREATE Bio, Intramural NINDS projects or any other NINDS program with similar needs as outlined in the scope of this statement of work. Consulting contracts will include as many areas of expertise as possible as outlined in this Statement of Work, and will reflect the NIH time commitment and needs for the specific areas of expertise. Consultants will be expected to provide feedback and guidance on projects to NINDS staff through written documents, conference calls, and by email. The consultants' major responsibility will be in offering review, guidance and advice on projects. They will be expected to offer technical review and feedback on project milestones, progress reports, or development plans, study design, and data interpretation. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects. On rare occasion, consultants may be asked to give oral presentations to NINDS staff or at an NINDS sponsored webinar, workshop or conference to provide training to investigators in their area of expertise. General Requirements Consultants will be asked to provide strategic and expert technical guidance for biotechnology products and biologic discovery and development projects. Consultants will serve as a resource to NINDS staff from the start of early discovery stage projects to structurally modify and optimize design characteristics of leads through IND-enabling activities necessary to advance potential development candidates through scale up and early phase clinical trials. Consulting advice and guidance shall be required to supplement NINDS program experience from the pre-application stage and then throughout the life of each project to review and monitor progress. Each project team is led by a PI and supported by NINDS staff with disease and therapy development expertise. The joint team establishes project milestones and monitors progress at least annually. The PIs conduct all of the research activities and report progress to NINDS. NINDS staff will interact directly with the PI and request assistance from consultants to review and provide expert advice on specific topics. Consultants shall directly advise NINDS staff, and in some cases communicate directly with the PI on team calls. The following attachments are provided to assist you in preparing your proposal responding to this solicitation. Attachment No. 1: Statement of Work Attachment No. 2: Invoice Instructions Attachment No. 3: Security Clauses

DRUG DISCOVERY AND DEVELOPMENT CONSULTING SERVICES

Department of Health and Human Services, National Institutes of Health | Published April 16, 2015  -  Deadline May 18, 2015
cpvs

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The Solicitation Number for this acquisition is HHS-NIH-NIDA-(SSSA)-CSS-15-106 and is being issued as a Request for Proposal (RFP). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-81 effective March 10, 2015. This acquisition is a small business set aside. The North American Industry Classification System (NAICS) Code for this procurement is 541690 and the Small Business Size Standard is 14.0 million dollars; Other Scientific and Technical Consulting Services. STATEMENT OF OBJECTIVES The NIH is seeking senior-level, industry-experienced drug discovery and development consultants with expertise in the following specific disciplines to provide leadership and technical guidance on drug discovery and development projects in the Blueprint Neurotherapeutics Network and possibly other NIH neuroscience-focused drug discovery and development programs. • Regulatory Affairs • Phase I Clinical Pharmacology • Business Development • Electrophysiology Assay Development • Medical Writing STATEMENT OF WORK Each consulting contract will be specific to one or more areas of expertise as outlined in this Statement of Work, and will reflect the NIH time commitment needs for the specific areas of expertise. Consultants hired under this requirement will not only make significant contributions to promising drug discovery and development projects that have been selected through a rigorous peer-review process, they will also help shape an innovative, high-profile program that may serve as a model for future NIH drug discovery efforts. Contract consultants will be expected to provide feedback and guidance on projects to the NIH and to Blueprint LDT members through conference calls and by email. Consultants may serve on an ad hoc basis or as members of LDTs. Consultants will be expected to offer input on project milestones, development strategy, study design, and data interpretation. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects. The BPN currently has projects in the exploratory through preclinical safety stages. Some projects will proceed to the IND and clinical trial stages. Project continuation will depend on the achievement of project-specific milestones and portfolio management. Since 2011, fifteen projects have entered the BPN, and five projects remain active. New projects are reviewed twice per year and the highest scoring projects may be incorporated into the program. General Requirements Consultants may serve on Blueprint LDTs, which require a regular time commitment of 3-10 hours per week, including meeting and preparation time. Each LDT meets for approximately 2 hours every 1-2 weeks by teleconference. Consultants may be asked to serve as co-chairs of LDTs. A consultant serving as an LDT co-chair shall facilitate LDT discussions, work with an NIH project manager by email and telephone to maintain and communicate the overall project strategy to other LDT members, and advise the PI on the preparation of milestone reports. Co-chairs for LDTs are selected based on breadth of expertise and previous experience serving in a comparable role. A teleconference call with all consultants is held twice per month to discuss programmatic issues of broad interest. The following attachments are provided to assist you in preparing your proposal responding to this solicitation. Attachment No. 1: Statement of Work Attachment No. 2: Invoice Instructions Attachment No. 3: Security Clauses

Regulatory Affairs Consulting Services for NINDS Biotechnology Products and Biologics

Department of Health and Human Services, National Institutes of Health | Published May 11, 2016  -  Deadline June 13, 2016
cpvs

Regulatory Affairs Consulting Services for NINDS Biotechnology Products & Biologics Competitive Combined Synopsis/Solicitation  HHS-NIH-NIDA-SSSA-CSS-16-287 INTRODUCTIONThis is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This acquisition is being conducted in accordance with the procedures of FAR Part 13--Simplified Acquisition Procedures, FAR Subpart 13.5--Test Program for Certain Commercial Items, and FAR Part 12--Acquisition of Commercial Items.The solicitation number is HHS-NIH-NIDA-SSSA-CSS-16-287 and the solicitation is issued as a request for proposal (RFP). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODEThe intended procurement is classified under NAICS code 541690 with a Size Standard of $14 Million. SET-ASIDE STATUSThis acquisition is unrestricted and available for full and open competition.ACQUISITION AUTHORITY This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, FAR Subpart 13.5--Test Program for Certain Commercial Items, and FAR Part 12-Acquisition of Commercial Items, and IS expected to exceed the simplified acquisition threshold. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-87-2 dated April 6, 2016. The resultant contract will include all applicable provisions and clauses in effect through this date.  DESCRIPTION OF REQUIREMENT BackgroundThe National Institute of Neurological Disorders and Stroke (NINDS) is a part of the National Institutes of Health (NIH), conducting research into the causes, treatment, and prevention of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. NINDS intramural labs are headed by federal employees who work for the Institute, primarily located in Bethesda, MD. For more information on the NINDS Intramural program visit the website http://dir1.ninds.nih.gov/ninds/Home.aspxFor extramural research, NINDS awards grants and cooperative agreements to outside academic institutions, small business concerns and other organizations all over the U.S. and world to fund promising basic, translational, and clinical research projects. Specifically, the NINDS Office of Translational Research (OTR) is committed to facilitate the translation of basic discoveries into the development of new therapeutic interventions through early nonclinical development and early clinical investigation. For more information about the Office of Translational Research visit the website http://www.ninds.nih.gov/funding/areas/translational_research/index.htmProjects that are funded through a cooperative agreement award mechanism are led by the principal investigators (PI) team with NINDS program staff participation in guiding the project plan. The PI's team performs all of the experiments while NINDS role is to establish performance milestones for each project to facilitate go/no-go decision making and then monitor research progress and achievement of project milestones. PurposeThe NINDS is seeking senior-level, industry-experienced discovery and development Biologics Regulatory Affairs consultants with expertise in biotechnology products and biologics to assist NINDS program staff to vet and advance only the most promising therapeutic biologics through the discovery and development pipeline. Both individual subject matter experts and multidisciplinary teams from consulting firms are encouraged to apply. The NIH anticipates possibly awarding multiple requirements-type consulting awards in reference to this requirement. Approximately two, and a maximum of three, awards are anticipated.Scope of WorkBiologics regulatory affairs consultant(s) shall provide the following services: • Advise NINDS staff on Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regulatory guidelines, regulations, and requirements pertaining to the early nonclinical and early clinical development of biologics• Review and assess data and project related proposals, and advise on study requirements to file an IND package for a range of potential biologics therapeutic modalities in nonclinical IND-enabling development - such as peptides, antibodies, recombinant proteins, oligonucleotides, cell and gene therapies - based on regulatory precedence and compliance to Common Technical Document (CTD) format requirements, including: o Review of administrative information (e.g. target product profiles, clinical protocols, and investigator information)o Review of animal pharmacology and toxicology study results to assess whether the product is expected to be reasonably safe for initial testing in humanso Determine if previous relevant human experience is available for similar biologics or research and report results from relevant clinical trials conducted both inside and outside of the US.o Review chemistry, manufacturing and control (CMC) nonclinical study plans and results pertaining to the composition, manufacturing, testing, stability and controls for a range of biologics to assess compliance to regulatory guidance. o Review clinical protocols and investigator information to assess adherence to investigational regulations and study protocols as it pertains to a biologic modality in each case. o Integrate regulatory guidance with research plans to advance translational research objectives. • Provide guidance to the preparation of pre-IND and IND Meetings or review FDA responses to recommend new course of action. • Review, identify and assess regulatory risks and gaps to IND-enabling research study plans and recommend solutions • Provide oral presentations in area of expertise as requested• Communicate effectively both orally and in writingEach consultant is expected to provide technical guidance and advice on advancing discovery and development projects through early nonclinical development and submission of an Investigational New Drug (IND) package, and in some cases, design of early clinical protocol and launch of a first in human clinical trial. Consulting services will be for NINDS biologics-focused projects or any other NIH program with similar needs as outlined in the scope of this statement of work. Consulting advice and guidance shall be required to supplement NINDS program experience from the pre-application stage and then throughout the life of each project to review and monitor progress. Consultants will serve as a resource to NINDS staff from the start of early discovery stage projects to structurally modify and optimize design characteristics of leads through IND-enabling activities necessary to advance potential development candidates through scale up, and early phase clinical trials. Consultants will be expected to provide feedback and guidance on projects to NINDS staff through written documents, conference calls, and by email. The consultants' major responsibility will be in offering review, guidance and advice on projects. They will be expected to offer technical review and feedback on project milestones, progress reports, or development plans, study design, and data interpretation. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects. On rare occasion, consultants may be asked to give oral presentations to NINDS staff or at an NINDS sponsored webinar, workshop or conference to provide training to investigators in their area of expertise. Consultants may be involved in multiple projects. Each project team is led by a PI and supported by NINDS staff with disease and therapy development expertise. The joint team establishes project milestones and monitors progress at least annually. The PIs conduct all of the research activities and report progress to NINDS. NINDS staff will interact directly with the PI and request assistance from consultants to review and provide expert advice on specific topics. Consultants shall directly advise NINDS staff, and in some cases communicate directly with the PI on team calls. Key Personnel RequirementsConsultant(s) working under this effort shall be considered key personnel. Key Personnel requirements are as follows: a) A minimum of an undergraduate degree in a relevant scientific discipline.b) A minimum of 10 years' experience in the biotechnology, pharmaceutical industry or regulatory industry. c) A minimum of 2 years hands-on and in-depth consulting experience in early nonclinical and early clinical development of biologics. The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows:The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty day notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.The individual(s) considered to be essential to the work being performed shall be identified in any award(s):CollaborationIt is required that all contractors involved with the NINDS community work collaboratively with federal staff and other contractors towards the NINDS mission and other affected organizations and follow the direction of the Contracting Officer's Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer and creating and sharing documentation when required. Level of EffortThe NIH estimates that individual consultants or multidisciplinary teams from consulting firms shall be able to perform the required services. More than one award may be made in relation to this requirement. The estimated level of effort for the overall five year contract is as follows: Overall Contract Requirements (Over 5 Years)    Minimum Quantity Maximum Quantity 30 Hours         900 Hours The minimum number of hours shall be guaranteed at time of award. The first task orders issued against the contracts awarded will be for the minimum number of hours (30). Additional hours up to the noted maximum may or may not be added to the award at the Government's discretion at the award's negotiated hourly rate. Additional hours shall be ordered via additional task orders against the awarded contracts. Annually, no more than 180 hours may be ordered. The overall contract requirements broken out by contract year are detailed below. Please note that requirements-type contracts do not contain option periods but may contain different pricing for each contract year. August 1, 2016 through July 31, 2017: Minimum of 30 hours up to 180 hours August 1, 2017 through July 31, 2018: Minimum of 0 hours up to 180 hours August 1, 2018 through July 31, 2019: Minimum of 0 hours up to 180 hours August 1, 2019 through July 31, 2020: Minimum of 0 hours up to 180 hours August 1, 2020 through July 31, 2021: Minimum of 0 hour up to 180 hoursOrdering and Receiving:The maximum quantity that the Government may order over the life of the IDIQ contract is detailed in the table below. The minimum quantity which may be ordered for the life of the contract is detailed in the same table. Overall Contract Requirements (Over 5 Years)    Minimum Quantity          Maximum Quantity 30 Hours                    900 Hours Orders issued under this contract may be placed in writing or via electronic mail (e-mail) by the authorized designee(s). The authorized designee(s) shall be identified at time of award. The Contractor representative(s) authorized to receive and accept orders shall be identified at time of award. All orders delivered under this contract must be verified by the authorized Federal designee(s). The authorized Federal designee shall formally document all work performed by the Contractor and the Contractor shall assist in this process. Period of PerformanceThis Requirements/Indefinite-Delivery Indefinite-Quantity requirement shall have a period of performance from August 1, 2016 through July 31, 2021. Hourly rates for each year within the period of performance may be separately priced. Should Offeror's propose different hourly rates for each year, please propose them for the following periods: August 1, 2016 through July 31, 2017August 1, 2017 through July 31, 2018 August 1, 2018 through July 31, 2019 August 1, 2019 through July 31, 2020August 1, 2020 through July 31, 2021 Place of PerformanceThe contractor shall provide services remotely from its own site. TravelUnder special circumstances, the consultant(s) may be asked to give presentations in their area of expertise to train program staff or investigators. Travel reimbursement will be provided for such presentations. The consultant shall make his/her own travel arrangements in coordination with the Contracting Officer's Representative (COR). Airplane tickets must be purchased from a US carrier at the coach/economy rate. The Government shall reimburse hotel costs for up to two nights per site visit, as well as food and incidental expenses at the Government per diem rate. All travel arrangements must be made in accordance with Federal Travel Regulations and must be approved by the Contracting Officer's Representative prior to being finalized or invoiced. Government Furnished PropertyNo Government Furnished Property shall be provided. Government Furnished InformationGovernment Furnished Information, including study data, shall be provided for the purposes of executing this requirement. Consultant(s) shall guarantee strict confidentiality of the information/data that it is provided by the NIH or by any other participant on a project to which the consultant is assigned. Confidentiality of Information Consultant(s) must guarantee strict confidentiality of the information/data that is provided by the NINDS or by any other participant on a project to which the consultant is assigned. Confidential information means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.Confidential information shall not be disclosed without the prior written consent of the individual, institution, or organization. Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor should obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication. Contracting Officer determinations will reflect the result of internal coordination with appropriate program and legal officials. Consultant(s) may only disclose the information/data generated for a particular project to other participants on that same project. These specific individuals will be identified when the consultant is assigned to a project. Disclosure of the information/data, in whole or in part, by the consultant to anyone else can only be made after the consultant receives prior written approval from the Contracting Officer. Whenever the consultant is uncertain with regard to the proper handling of information/data under the contract, the consultant shall obtain a written determination from the Contracting Officer. Contractor agrees that it will not use the Confidential Information for any purpose except as set forth within this SOW, unless such time as such Confidential Information becomes public information. Project data will be collected and stored by NINDS. NINDS will provide data as needed to the consultant each time it requests service. The consultant may store data up to 12 months after initially receiving it, after that time the consultant should either delete the data files and sanitize the computer using NIST SP 800-88 (current revision) or if information is still needed contact the Contracting Officer Representative and Contracting Officer for approval to store data longer. The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the "Disputes" clause. For information to be utilized under this contract, or a portion thereof, which is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act. Information Technology (IT) Security Requirements NINDS requires that the consultant's meet certain minimum IT Security Requirements: All computers that are used by the consultant to perform work under this contract whether contractor furnished or government furnished will have to have: • Virus protection with regular automated scans• Up to date security patching• Two factor authentication• Encryption - FIPS 140-2 compliant encryption solution• Regular vulnerability scans and if the scan produces any high or medium results they need to be correction the high within 30 days and the mediums within 90 days. • Contractors will have to take NIH Security and Privacy Training annually http://irtsectraining.nih.gov/.• Consultant will have to sign the NIH non-disclosure agreement https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf• Report any lost or stolen NIH data to Donna Stephenson, NINDS ISSO 301.496.0368 donna.stephenson@nih.gov within one hour (also notify the Contracting Officer Representative and Contracting Officer) of knowing of the lost or theft even if the data is on a contractor furnished computer. https://ocio.nih.gov/InfoSecurity/IncidentResponse/Pages/scroster.aspx• Contractors must adhere to the NIH IT rules of behavior which can be found at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx Please refer to Appendix A for a full list of the IT security requirements. Section 508 Compliance Section 508 of the Rehabilitation Act of 1973 requires that Federal agencies' electronic and information technology (EIT) is accessible to people with disabilities. The Federal Acquisition Regulations (FAR) Final Rule for Section 508 (EIT Accessibility) can be found at www.section508.gov and at the Access Board's Web site at https://www.access-board.gov/508.htm. Unless it is an "undue burden" or compliant products or services do not exist, the products must conform to Section 508. The contractor should state that they will comply with the requirements of Section 508 or cite a justifiable reason for an exception. NINDS may put contractor's presentation on its public website. Presentations (video and/or Powerpoint) must allow for individuals with disabilities to view them by following Section 508 accessibility standards from the United States Board 36 CFR Part 1194. Section 508 requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency. For example, presentations should not use color coding as the only means of conveying information, indicating an action, prompting a response, or distinguishing a visual element. In addition, all training and informational video and multimedia productions which support the agency's mission, regardless of format, that contain speech or other audio information necessary for the comprehension of the content, shall be open or closed captioned. Partially conforming presentations will be accepted from the contractor, since the COR will work with the contractor and the NINDS IT Web Team to make contractor's presentation fully compliant with Section 508. Data Rights The NINDS shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations, briefings, work plans, created SOPs and all other deliverables. In addition, it includes any additional deliverables required by contract change. The definition of "unlimited rights" is contained in Federal Acquisition Regulation (FAR) 27.401, "Definitions." FAR clause 52.227-14, "Rights in Data-General," is hereby incorporated by reference and shall be made a part of any resulting contract/order. Non-Personal Service StatementContract employee performing services will be controlled, directed and supervised at all times by management personnel of the contractor. Actions of contractor employees may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulations (FAR). Contract TypeThe Government intends to issue one or more fixed price requirement contract(s) in reference to this requirement. Each contract shall include fixed hourly rates for each contract period. Only funding for the minimum level of effort is guaranteed, but funding may be obligated for additional hours up to the maximum level of effort specified in this solicitation. Question and Answer PeriodInterested contractors may submit questions relating to this requirement. Questions shall be submitted to the contract specialist, Lauren Phelps via email at lauren.phelps@nih.gov by or before 05/17/2016 at 5:00 PM EST. Late questions shall not be accepted. Questions will be anonymized and answered and the answers will be provided as soon as possible after the question deadline via solicitation amendment. Should no questions be received, no amendment shall be posted. RESPONSE FORMAT Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The offeror must submit 1) a technical proposal and 2) a separate price proposal. The technical proposal should be prepared in reference to the evaluation criteria identified in this solicitation and may be up to forty (40) single-sided pages. The price proposal must include fixed hourly rates for proposed consultant(s) for each contract period. Contractors must provide their Company Name, Dun & Bradstreet Number (DUNS), Taxpayer Identification Number (TIN), Business Size, Physical Address, and Point of Contact Information in their responses. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov."IMPORTANT NOTE TO OFFERORS: PLEASE ENSURE THAT YOUR RESPONSE MEETS THE FORMAT REQUIREMENTS AND SPECIFICALLY ADDRESSES EACH OF THE TECHNICAL EVALUATION CRITERION AND THE EVALUATION FOCUS THAT IS INDICATED FOR EACH CRITERION. PROPOSALS MUST INCLUDE BOTH A TECHNICAL DOCUMENT AND A SEPARATE PRICE PROPOSAL. CONTRACTORS NOT SUBMITTING BOTH A TECHINICAL PROPOSAL ADDRESSING THE EVALUATION CRITERIA AND A SEPARATE PRICE PROPOSAL SHALL NOT BE CONSIDERED.EVALUATION CRITERIAFAR clause 52.212-2, Evaluation - Commercial Items applies to this acquisition and the specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a contact resulting from this solicitation on the basis of best value in consideration of trade-off between technical factors and price/cost. Technical factors together shall be considered more important than price. The technical evaluation factors are as follows, in order of importance: Factor 1: Technical Capability (35 Points)The Contractor's proposal shall address each area of the statement of work requirements in sufficient detail to demonstrate a clear understanding of the statement of work and compliance with requirements. Ability to effectively communicate will be particularly considered.Factor 2: Key Personnel Qualifications (10 Points)Offerors proposals shall be evaluated for level of conformance to the key personnel qualifications identified in this statement of work. Offeror proposals must contain a resume/CV and indicate the following minimum qualifications:a) A minimum of an undergraduate degree in a relevant scientific discipline.b) A minimum of 10 years' experience in the biotechnology, pharmaceutical industry or regulatory industry is required. c) A minimum of 2 years hands-on and in-depth consulting experience in early nonclinical and early clinical development of biologics. This is a Pass/Fail evaluation criterion. Offerors whose proposed personnel meet all of the minimum qualifications will received the full 10 points and offerors whose proposed personnel do not meet all of the minimum qualifications will receive 0 points for this criterion. Factor 3: Past PerformanceThe Contractor shall provide at least two (2) past performance references with knowledge of the contractor's relevant skills and experience related to the requirements outlined in this Statement of Work.References shall include the following information:a) Name of Organizationb) Description of Contractor's responsibilities as they relate to this SOWc) Contract Period of Performanced) Contact Name and Titlee) Telephone Numberf) E-mail addressPast Performance shall be evaluated as follows: Factor 3(a) -- Experience in Early Nonclinical Development and Approach to Providing Expert Review and Advice (35 Points)1. Contractor's past experience in early nonclinical development of different biologics leading to successful pre-IND meeting outcomes for clients and IND submissions to FDA (CDER and CBER). Contractor is expected to integrate regulatory guidance with research plans to span all aspects of nonclinical development to secure a successful IND package for different biologics. 2. Contractor's approach to providing expert review and advice for regulatory strategy development, early nonclinical product development planning, target product profile development, risk analysis, and regulatory submission strategy for different biologics - such as peptides, antibodies, recombinant proteins, oligonucleotides, cell and gene therapies. Factor 3(b) -- Experience in Enabling Early Clinical Development and Clinical Study Design (20 Points) 1. Contractor's past experience in enabling early clinical development and clinical study design considerations for biologics. 2. Contractor experience and knowledge to provide regulatory advice for advanced and/or novel potential biologics-based therapies. Technical proposals will be evaluated using a summary adjectival rating based on total numerical score in accordance with the above and the following scale: Excellent (90 - 100)Very Good (80 - 89)Good (70 - 79)Fair (60 - 69)Poor (0-59) The Government reserves the right to make one, more than one, or zero awards in reference to this solicitation. Should multiple awards be made, they will be made on the basis of best value in consideration of both technical factors and price. Multiple awards, if made in reference to this solicitation, shall be made in accordance with available budget up to a maximum of three awards. Awards shall be made to the contractors offering the greatest value in consideration of both technical factors and price. Award shall not be considered for proposals evaluated to be "Poor." APPLICABLE CLAUSES AND PROVISIONSThe FAR clauses and provisions below shall apply to this solicitation. Please note that any clauses requiring fill-ins shall be completed at time of award.1. All Offerors MUST be actively registered in the System for Award Management (SAM) www.sam.gov. 2. The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items (April 2014), applies to this acquisition. 3. A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (March 2015), is required with any offer submitted. This requirement may be met by completion of the provision in the System for Award Management. 4. FAR clauses 52.212-4, Contract Terms and Conditions - Commercial Items (May 2015) and 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (October 2015) apply to this acquisition. 5. FAR 52.216-18, Ordering (October 1995) is applicable to this acquisition. (a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from August 1, 2016 through July 31, 2021. (b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control. (c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule. 6. FAR 52.216-19, Order Limitations (October 1995) is applicable this acquisition. (a) Minimum order. Following the initial minimum order of quantity 30 Hours, when the Government requires supplies or services covered by this contract in a quantity of less than 10 Hours, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.(b) Maximum order. The Contractor is not obligated to honor-(1) Any order for a single item in excess of 150 Hours;(2) Any order for a combination of items in excess of 180 Hours; or(3) A series of orders from the same ordering office within thirty (30) days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within two (2) days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.7. FAR 52.216-21, Requirements (October 1995) is applicable to this acquisition. (a) This is a definite-quantity, indefinite-delivery contract for the supplies or services specified, and effective for the period stated, in the Schedule.(b) The Government shall order the quantity of supplies or services specified in the Schedule, and the Contractor shall furnish them when ordered. Delivery or performance shall be at locations designated in orders issued in accordance with the Ordering clause and the Schedule.(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.(d) Any order issued during the effective period of this contract and not completed within that time shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after September 30, 2021.8. FAR clause 52.217-5 Evaluation of Options (July 1990) applies to this acquisition. 9. FAR clause 52.217-9 Option to Extend the Term of the Contract (March 200) applies to this acquisition. 10. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. 11. FAR clause 52.227-14 Rights in Data-General (May 2014) is applicable to this requirement.12. HHSAR clause 352.224-70 Privacy Act (December 18, 2015) is applicable to this requirement.13. HHSAR clause 352.237-75 Key Personnel (December 18, 2015) is applicable to this requirement. 14. The information security clauses included in Appendix A of this solicitation are applicable to this acquisition. In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." CONTRACTOR PERFORMANCE EVALUATIONFinal Evaluation of Contractor performance will be prepared for the resulting contract in accordance with FAR Subpart 42.15. The final performance evaluation will be prepared at the time of completion of work. Final evaluation will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final. Copies of the evaluation, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions. Contractors may access evaluations through a secure Web site for review and comment at the following address: http://www.cpars.gov CONTRACTING OFFICER'S REPRESENTATIVEA Contracting Officer's Representative (COR) shall be assigned to the awarded contract. The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contractThe Government may unilaterally change the COR designation for this contract.CLOSING INFORMATIONResponses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. All responses must be received by the closing date of this announcement and must reference solicitation number HHS-NIH-NIDA-SSSA-CSS-16-287. Responses shall be submitted electronically via email to Lauren Phelps, Contract Specialist, at lauren.phelps@nih.gov.

CMC Development Consulting Services for NINDS Biotechnology Products and Biologics

Department of Health and Human Services, National Institutes of Health | Published May 11, 2016  -  Deadline June 13, 2016
cpvs

CMC Development Consulting Services for NINDS Biotechnology Products & Biologics Competitive Combined Synopsis/Solicitation  HHS-NIH-NIDA-SSSA-CSS-16-288 INTRODUCTIONThis is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This acquisition is being conducted in accordance with the procedures of FAR Part 13--Simplified Acquisition Procedures, FAR Subpart 13.5--Test Program for Certain Commercial Items, and FAR Part 12--Acquisition of Commercial Items.The solicitation number is HHS-NIH-NIDA-SSSA-CSS-16-288 and the solicitation is issued as a request for proposal (RFP). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODEThe intended procurement is classified under NAICS code 541690 with a Size Standard of $14Million. SET-ASIDE STATUSThis acquisition is unrestricted and available for full and open competition.ACQUISITION AUTHORITY  This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, FAR Subpart 13.5--Test Program for Certain Commercial Items, and FAR Part 12-Acquisition of Commercial Items, and IS expected to exceed the simplified acquisition threshold. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-87-2 dated April 6, 2016. The resultant contract will include all applicable provisions and clauses in effect through this date. DESCRIPTION OF REQUIREMENT BackgroundThe National Institute of Neurological Disorders and Stroke (NINDS) is a part of the National Institutes of Health (NIH), conducting research into the causes, treatment, and prevention of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. NINDS intramural labs are headed by federal employees who work for the Institute, primarily located in Bethesda, MD. For more information on the NINDS Intramural program visit the website http://dir1.ninds.nih.gov/ninds/Home.aspxFor extramural research, NINDS awards grants and cooperative agreements to outside academic institutions, small business concerns and other organizations all over the U.S. and world to fund promising basic, translational, and clinical research projects. Specifically, the NINDS Office of Translational Research (OTR) is committed to facilitate the translation of basic discoveries into the development of new therapeutic interventions through early nonclinical development and early clinical investigation. For more information about the Office of Translational Research visit the website http://www.ninds.nih.gov/funding/areas/translational_research/index.htmProjects that are funded through a cooperative agreement award mechanism are led by the principal investigators (PI) team with NINDS program staff participation in guiding the project plan. The PI's team performs all of the experiments while NINDS role is to establish performance milestones for each project to facilitate go/no-go decision making and then monitor research progress and achievement of project milestones. PurposeThe NINDS is seeking senior-level, industry-experienced Biologics Chemical Manufacturing and Controls (CMC) Development Consultants with expertise in biotechnology products and biologics to assist NINDS program staff to vet and advance only the most promising therapeutic biologics through the discovery and development pipeline. Both individual subject matter experts and multidisciplinary teams from consulting firms are encouraged to apply. The NIH anticipates possibly awarding multiple requirements-type consulting awards in reference to this requirement. Approximately two, and a maximum of three, awards are anticipated.Scope of WorkBiologics CMC development consultants shall provide the following services:• Provide guidance to NINDS staff on all CMC related requirements of early non clinical and early clinical development of biologics (such as peptides, antibodies, recombinant proteins, oligonucleotides, and cell and gene therapies) in accordance with the US regulatory and the ICH guidelines.• Review and comment on the adequacy of biologic manufacturing including scale-up, analytical method development, and process development (upstream and downstream processing) approaches proposed by investigators • Provide expert advice, risk and gap analysis to NINDS staff related to all CMC aspects such as proposed analytical strategy, QC release methods requirements, formulation development, stability testing, stage appropriate assay requirements such as potency and viral clearance• Provide guidance on delivery methods which may include complex formulations such as polymer, liposomes, and nanoparticles• Provide expert advice on master and working cell and viral bank development and testing• Provide oral presentations in area of expertise as required.• Communicate effectively both orally and in writing • Provide recommendations regarding global regulatory regulations and guidelines pertaining to the nonclinical and early clinical development of biologics. Each consultant is expected to provide technical guidance and advice on advancing early discovery and development projects through early nonclinical development and submission of an Investigational New Drug (IND) package, and in some cases, design of early clinical protocol and launch of a first in human clinical trial. Consulting services will be for NINDS biologics-focused projects or any other NIH program with similar needs as outlined in the scope of this statement of work.Consulting advice and guidance shall be required to supplement NINDS program experience from the pre-application stage and then throughout the life of each project to review and monitor progress. Consultants will serve as a resource to NINDS staff from the start of early discovery stage projects to structurally modify and optimize design characteristics of leads through IND-enabling activities necessary to advance potential development candidates through scale up, and early phase clinical trials.Consultants will be expected to provide feedback and guidance on projects to NINDS staff through written documents, conference calls, and by email. The consultants' major responsibility will be in offering review, guidance and advice on projects. They will be expected to offer technical review and feedback on project milestones, progress reports, or development plans, study design, and data interpretation. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects. On rare occasion, consultants may be asked to give oral presentations to NINDS staff or at an NINDS sponsored webinar, workshop or conference to provide training to investigators in their area of expertise.Consultants may be involved in multiple projects. Each project team is led by a PI and supported by NINDS staff with disease and therapy development expertise. The joint team establishes project milestones and monitors progress at least annually. The PIs conduct all of the research activities and report progress to NINDS. NINDS staff will interact directly with the PI and request assistance from consultants to review and provide expert advice on specific topics. Consultants shall directly advise NINDS staff, and in some cases communicate directly with the PI on team calls.Key Personnel RequirementsConsultant(s) working under this effort shall be considered key personnel. Key Personnel requirements are as follows: a) A PhD or equivalent in a biological science or chemistry degree or 5 years or more of equivalent industry experienceb) At least 10 years of CMC experience and biotechnology products and biologics experience The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows:The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty day notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.Individual(s) determined to be essential to the work being performed shall be identified in the award(s). CollaborationIt is required that all contractors involved with the NINDS community work collaboratively with federal staff and other contractors towards the NINDS mission and other affected organizations and follow the direction of the Contracting Officer's Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer and creating and sharing documentation when required. Level of EffortThe NIH estimates that individual consultants or multidisciplinary teams from consulting firms shall be able to perform the required services. More than one award may be made in relation to this requirement. The estimated level of effort for the overall five year contract is as follows:   Overall Contract Requirements (Over 5 Years) Minimum Quantity           Maximum Quantity 30 Hours                     900 Hours   The minimum number of hours shall be guaranteed at time of award. The first task orders issued against the contracts awarded will be for the minimum number of hours (30). Additional hours up to the noted maximum may or may not be added to the award at the Government's discretion at the award's negotiated hourly rate. Additional hours shall be ordered via additional task orders against the awarded contracts. Annually, no more than 180 hours may be ordered. The overall contract requirements broken out by contract year are detailed below. Please note that requirements-type contracts do not contain option periods but may contain different pricing for each contract year. August 1, 2016 through July 31, 2017: Minimum of 30 hours up to 180 hours August 1, 2017 through July 31, 2018: Minimum of 0 hours up to 180 hours August 1, 2018 through July 31, 2019: Minimum of 0 hours up to 180 hours August 1, 2019 through July 31, 2020: Minimum of 0 hours up to 180 hours August 1, 2020 through July 31, 2021: Minimum of 0 hour up to 180 hours Ordering and Receiving:The maximum quantity that the Government may order over the life of the IDIQ contract is detailed in the table below. The minimum quantity which may be ordered for the life of the contract is detailed in the same table.   Overall Contract Requirements (Over 5 Years) Minimum Quantity                Maximum Quantity 30 Hours                          900 Hours   Orders issued under this contract may be placed in writing or via electronic mail (e-mail) by the authorized designee(s). The authorized designee(s) shall be identified at time of award. The Contractor representative(s) authorized to receive and accept orders shall be identified at time of award. All orders delivered under this contract must be verified by the authorized Federal designee(s). The authorized Federal designee shall formally document all work performed by the Contractor and the Contractor shall assist in this process. Period of PerformanceThis Requirements/Indefinite-Delivery Indefinite-Quantity requirement shall have a period of performance from August 1, 2016 through July 31, 2021. Hourly rates for each year within the period of performance may be separately priced. Should Offeror's propose different hourly rates for each year, please propose them for the following periods: August 1, 2016 through July 31, 2017August 1, 2017 through July 31, 2018 August 1, 2018 through July 31, 2019 August 1, 2019 through July 31, 2020August 1, 2020 through July 31, 2021 Place of PerformanceThe contractor shall provide services remotely from its own site. TravelUnder special circumstances, the consultant(s) may be asked to give presentations in their area of expertise to train program staff or investigators. Travel reimbursement will be provided for such presentations. The consultant shall make his/her own travel arrangements in coordination with the Contracting Officer's Representative (COR). Airplane tickets must be purchased from a US carrier at the coach/economy rate. The Government shall reimburse hotel costs for up to two nights per site visit, as well as food and incidental expenses at the Government per diem rate. All travel arrangements must be made in accordance with Federal Travel Regulations and must be approved by the Contracting Officer's Representative prior to being finalized or invoiced. Government Furnished PropertyNo Government Furnished Property shall be provided. Government Furnished InformationGovernment Furnished Information, including study data, shall be provided for the purposes of executing this requirement. Consultant(s) shall guarantee strict confidentiality of the information/data that it is provided by the NIH or by any other participant on a project to which the consultant is assigned. Confidentiality of Information Consultant(s) must guarantee strict confidentiality of the information/data that is provided by the NINDS or by any other participant on a project to which the consultant is assigned. Confidential information means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.Confidential information shall not be disclosed without the prior written consent of the individual, institution, or organization. Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor should obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication. Contracting Officer determinations will reflect the result of internal coordination with appropriate program and legal officials. Consultant(s) may only disclose the information/data generated for a particular project to other participants on that same project. These specific individuals will be identified when the consultant is assigned to a project. Disclosure of the information/data, in whole or in part, by the consultant to anyone else can only be made after the consultant receives prior written approval from the Contracting Officer. Whenever the consultant is uncertain with regard to the proper handling of information/data under the contract, the consultant shall obtain a written determination from the Contracting Officer. Contractor agrees that it will not use the Confidential Information for any purpose except as set forth within this SOW, unless such time as such Confidential Information becomes public information. Project data will be collected and stored by NINDS. NINDS will provide data as needed to the consultant each time it requests service. The consultant may store data up to 12 months after initially receiving it, after that time the consultant should either delete the data files and sanitize the computer using NIST SP 800-88 (current revision) or if information is still needed contact the Contracting Officer Representative and Contracting Officer for approval to store data longer. The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the "Disputes" clause. For information to be utilized under this contract, or a portion thereof, which is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act. Information Technology (IT) Security Requirements NINDS requires that the consultant's meet certain minimum IT Security Requirements: All computers that are used by the consultant to perform work under this contract whether contractor furnished or government furnished will have to have: • Virus protection with regular automated scans• Up to date security patching• Two factor authentication• Encryption - FIPS 140-2 compliant encryption solution• Regular vulnerability scans and if the scan produces any high or medium results they need to be correction the high within 30 days and the mediums within 90 days. • Contractors will have to take NIH Security and Privacy Training annually http://irtsectraining.nih.gov/.• Consultant will have to sign the NIH non-disclosure agreement https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf• Report any lost or stolen NIH data to the NINDS Information Systems Security Officer within one hour (also notify the Contracting Officer Representative and Contracting Officer) of knowing of the lost or theft even if the data is on a contractor furnished computer. https://ocio.nih.gov/InfoSecurity/IncidentResponse/Pages/scroster.aspx• Contractors must adhere to the NIH IT rules of behavior which can be found at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx Please refer to Appendix A for a full list of the IT security requirements. Section 508 Compliance Section 508 of the Rehabilitation Act of 1973 requires that Federal agencies' electronic and information technology (EIT) is accessible to people with disabilities. The Federal Acquisition Regulations (FAR) Final Rule for Section 508 (EIT Accessibility) can be found at www.section508.gov and at the Access Board's Web site at https://www.access-board.gov/508.htm. Unless it is an "undue burden" or compliant products or services do not exist, the products must conform to Section 508. The contractor should state that they will comply with the requirements of Section 508 or cite a justifiable reason for an exception. NINDS may put contractor's presentation on its public website. Presentations (video and/or Powerpoint) must allow for individuals with disabilities to view them by following Section 508 accessibility standards from the United States Board 36 CFR Part 1194. Section 508 requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency. For example, presentations should not use color coding as the only means of conveying information, indicating an action, prompting a response, or distinguishing a visual element. In addition, all training and informational video and multimedia productions which support the agency's mission, regardless of format, that contain speech or other audio information necessary for the comprehension of the content, shall be open or closed captioned. Partially conforming presentations will be accepted from the contractor, since the COR will work with the contractor and the NINDS IT Web Team to make contractor's presentation fully compliant with Section 508. Data Rights The NINDS shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations, briefings, work plans, created SOPs and all other deliverables. In addition, it includes any additional deliverables required by contract change. The definition of "unlimited rights" is contained in Federal Acquisition Regulation (FAR) 27.401, "Definitions." FAR clause 52.227-14, "Rights in Data-General," is hereby incorporated by reference and shall be made a part of any resulting contract/order. Non-Personal Service StatementContract employee performing services will be controlled, directed and supervised at all times by management personnel of the contractor. Actions of contractor employees may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulations (FAR). Contract TypeThe Government intends to issue one or more fixed price requirement contract(s) in reference to this requirement. Each contract shall include fixed hourly rates for each contract period. Only funding for the minimum level of effort is guaranteed, but funding may be obligated for additional hours up to the maximum level of effort specified in this solicitation. Question and Answer PeriodInterested contractors may submit questions relating to this requirement. Questions shall be submitted to the contract specialist, Lauren Phelps via email at lauren.phelps@nih.gov by or before 05/17/2016 at 5:00 PM EST. Late questions shall not be accepted. Questions will be anonymized and answered and the answers will be provided as soon as possible after the question deadline via solicitation amendment. Should no questions be received, no amendment shall be posted. RESPONSE FORMAT Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The offeror must submit 1) a technical proposal and 2) a separate price proposal. The technical proposal should be prepared in reference to the evaluation criteria identified in this solicitation and may be up to forty (40) single-sided pages. The price proposal must include fixed hourly rates for proposed consultant(s) for each contract period. Contractors must provide their Company Name, Dun & Bradstreet Number (DUNS), Taxpayer Identification Number (TIN), Business Size, Physical Address, and Point of Contact Information in their responses. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov."IMPORTANT NOTE TO OFFERORS: PLEASE ENSURE THAT YOUR RESPONSE MEETS THE FORMAT REQUIREMENTS AND SPECIFICALLY ADDRESSES EACH OF THE TECHNICAL EVALUATION CRITERION AND THE EVALUATION FOCUS THAT IS INDICATED FOR EACH CRITERION. PROPOSALS MUST INCLUDE BOTH A TECHNICAL DOCUMENT AND A SEPARATE PRICE PROPOSAL. CONTRACTORS NOT SUBMITTING BOTH A TECHINICAL PROPOSAL ADDRESSING THE EVALUATION CRITERIA AND A SEPARATE PRICE PROPOSAL SHALL NOT BE CONSIDERED.EVALUATION CRITERIAFAR clause 52.212-2, Evaluation - Commercial Items applies to this acquisition and the specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a contact resulting from this solicitation on the basis of best value in consideration of trade-off between technical factors and price/cost. Technical factors together shall be considered more important than price. The technical evaluation factors are as follows, in order of importance: Factor 1: Technical Capability (35 Points)The Contractor's proposal shall address each area of the statement of work requirements in sufficient detail to demonstrate a clear understanding of the statement of work and compliance with requirements. Ability to effectively communicate will be particularly considered.Factor 2: Key Personnel Qualifications (10 Points)Offerors proposals shall be evaluated for level of conformance to the key personnel qualifications identified in this statement of work. Offeror proposals must contain a resume/CV and indicate the following minimum qualifications:a) A PhD or equivalent in a biological science or chemistry degree or 5 years or more of equivalent industry experienceb) At least 10 years of CMC experience and biotechnology products and biologics experience This is a Pass/Fail evaluation criterion. Offerors whose proposed personnel meet all of the minimum qualifications will received the full 10 points and offerors whose proposed personnel do not meet all of the minimum qualifications will receive 0 points for this criterion. Factor 3: Past PerformanceThe Contractor shall provide at least two (2) past performance references with knowledge of the contractor's relevant skills and experience related to the requirements outlined in this Statement of Work.References shall include the following information:a) Name of Organizationb) Description of Contractor's responsibilities as they relate to this SOWc) Contract Period of Performanced) Contact Name and Titlee) Telephone Numberf) E-mail addressPast Performance shall be evaluated as follows: Factor 3(a) -- Experience in Guiding Biotechnology and Biologic Discovery and Development Projects (35 Points)1. Consultants shall be evaluated for experience in providing expert advice for biotechnology and biologic discovery and development projects clients in the biopharmaceutical industry or academia. 2. Contractor's past experience in CMC strategy development and in providing guidance on CMC strategy development, technical due diligence, and proposing CMC related requirements to develop different biologic modalities in either nonclinical or clinical phase of development. 3. Experience with biotechnology products and biologic discovery for nervous system conditions is preferred. Factor 3(b) -- Experience in Regulatory Requirements of Nonclinical and Clinical CMC Development (20 Points) 1. Previous hands-on experience in the preparation and/or review of the CMC sections of pre-IND, IND and/or BLA for biologics.2. Demonstrate a good understanding of US regulatory requirements pertaining to nonclinical and clinical CMC development of different biologic modalities Technical proposals will be evaluated using a summary adjectival rating based on total numerical score in accordance with the above and the following scale: Excellent (90 - 100)Very Good (80 - 89)Good (70 - 79)Fair (60 - 69)Poor (0-59) The Government reserves the right to make one, more than one, or zero awards in reference to this solicitation. Should multiple awards be made, they will be made on the basis of best value in consideration of both technical factors and price. Multiple awards, if made in reference to this solicitation, shall be made in accordance with available budget up to a maximum of three awards. Awards shall be made to the contractors offering the greatest value in consideration of both technical factors and price. Award shall not be considered for proposals evaluated to be "Poor." APPLICABLE CLAUSES AND PROVISIONSThe FAR clauses and provisions below shall apply to this solicitation. Please note that any clauses requiring fill-ins shall be completed at time of award.1. All Offerors MUST be actively registered in the System for Award Management (SAM) www.sam.gov. 2. The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items (April 2014), applies to this acquisition. 3. A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (March 2015), is required with any offer submitted. This requirement may be met by completion of the provision in the System for Award Management. 4. FAR clauses 52.212-4, Contract Terms and Conditions - Commercial Items (May 2015) and 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (October 2015) apply to this acquisition. 5. FAR 52.216-18, Ordering (October 1995) is applicable to this acquisition. (a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from August 1, 2016 through July 31, 2021. (b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control. (c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule. 6. FAR 52.216-19, Order Limitations (October 1995) is applicable this acquisition. (a) Minimum order. Following the initial minimum order of quantity 30 Hours, when the Government requires supplies or services covered by this contract in a quantity of less than 10 Hours, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.(b) Maximum order. The Contractor is not obligated to honor-(1) Any order for a single item in excess of 150 Hours;(2) Any order for a combination of items in excess of 180 Hours; or(3) A series of orders from the same ordering office within thirty (30) days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within two (2) days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.7. FAR 52.216-21, Requirements (October 1995) is applicable to this acquisition. (a) This is a definite-quantity, indefinite-delivery contract for the supplies or services specified, and effective for the period stated, in the Schedule.(b) The Government shall order the quantity of supplies or services specified in the Schedule, and the Contractor shall furnish them when ordered. Delivery or performance shall be at locations designated in orders issued in accordance with the Ordering clause and the Schedule.(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.(d) Any order issued during the effective period of this contract and not completed within that time shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after September 30, 2021.8. FAR clause 52.217-5 Evaluation of Options (July 1990) applies to this acquisition. 9. FAR clause 52.217-9 Option to Extend the Term of the Contract (March 200) applies to this acquisition. 10. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. 11. FAR clause 52.227-14 Rights in Data-General (May 2014) is applicable to this requirement.12. HHSAR clause 352.224-70 Privacy Act (December 18, 2015) is applicable to this requirement.13. HHSAR clause 352.237-75 Key Personnel (December 18, 2015) is applicable to this requirement. 14. The information security clauses included in Appendix A of this solicitation are applicable to this acquisition. In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." CONTRACTOR PERFORMANCE EVALUATIONFinal Evaluation of Contractor performance will be prepared for the resulting contract in accordance with FAR Subpart 42.15. The final performance evaluation will be prepared at the time of completion of work. Final evaluation will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final. Copies of the evaluation, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions. Contractors may access evaluations through a secure Web site for review and comment at the following address: http://www.cpars.gov CONTRACTING OFFICER'S REPRESENTATIVEA Contracting Officer's Representative (COR) shall be assigned to the awarded contract. The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contractThe Government may unilaterally change the COR designation for this contract.CLOSING INFORMATIONResponses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. All responses must be received by the closing date of this announcement and must reference solicitation number HHS-NIH-NIDA-SSSA-CSS-16-288. Responses shall be submitted electronically via email to Lauren Phelps, Contract Specialist, at lauren.phelps@nih.gov.

Cardiology Consulting Support Services

Department of Health and Human Services, National Institutes of Health | Published November 16, 2017  -  Deadline November 24, 2017
cpvs

INTRODUCTIONThis is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is HHS-NIH-NIDA-SSSA-CSS-2018-002 and the solicitation is issued as a request for quotation (RFQ). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODEThe intended procurement is classified under NAICS code 541690 with a Size Standard of 500 Employees. SET-ASIDE STATUSThis acquisition is set aside for small business. ACQUISITION AUTHORITY This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 12-Acquisition of Commercial Items, and IS expected to exceed the simplified acquisition threshold. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-96, dated November 6, 2017. The resultant contract will include all applicable provisions and clauses in effect through this date.DESCRIPTION OF REQUIREMENT BackgroundThe Intramural Research Program (IRP) in the National Institute on Aging (NIA) is comprised ofnine scientific laboratories, the Translational Gerontology Branch, and ten core facilities. Theresearch program has three main focus areas: Neuroscience, Aging Biology and TranslationalGerontology. IRP scientists conduct research in many different disciplines that range from basicscience to clinical research and epidemiology. Medical problems, which typically affect olderpersons, are studied in depth using the tools of modern laboratory and clinical research, with atranslational perspective. The central focus of our research is understanding age-relatedchanges in physiology and the ability to adapt to environmental stress. This understanding isthen applied to developing insight about the pathophysiology of age-related diseases. Theprogram seeks to understand the changes associated with healthy aging and to define thecriteria for evaluating when changes should be considered pathologic and require treatment.Thus, in addition to study common age-related diseases, such as Alzheimer's Disease,Parkinson's Disease, stroke, atherosclerosis, osteoarthritis, diabetes and cancer, we alsoexplore the determinants of healthy aging as possible targets for interventions aimed atimproving health and quality of life in the older population at large. The National Institute on Aging (NIA) Intramural Research Program (IRP) program operates theBaltimore Longitudinal Study of Aging (BLSA), America's longest-running scientific study ofhuman aging which began in 1958. The focus of the study is to characterize how an individualages across the adult life span and individuals have been continually recruited for participationsince its initiation. The study measures and interprets data in a number of health subjects,including cardiovascular health. PurposeThe purpose of this requirement is to acquire consulting support services of an expert inclinical cardiovascular research to assist with coding, interpretation, and quality control ofscientific data on cardiovascular diseases generated by the clinical research program of the NIAfor the BLSA. Project RequirementsIndependently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the requirements stated below:The contractor shall provide the following cardiovascular consulting support services: • Provide coding, interpretation, data management, and quality control of resting electrocardiograms using the BLSA-modified Minnesota Coding System. Data and results shall be recorded using the NIA electronic reporting system. • Provide coding, interpretation, data management, and quality control of echocardiographs. Data and results shall be recorded in the Intellispace Cardiovascular reporting system owned and used by the NIA. • Provide coding, interpretation, data management, and quality control of carotid artery intimal medial thickness measurements. • Provide coding, interpretation, data management, and quality control of Pulse Wave Velocity measurements • Provide coding, interpretation, data management, and quality control of treadmill stress testing results using the BLSA-modified Minnesota coding system for ischemia, arrhythmia, and relevant electrocardiographic abnormalities using the NIA electronic reporting system. • Provide coding, interpretation, data management, and quality control for ambulatory Holter reports and ensure that data is efficiently imported into the BLSA study database. • Assist in oversight of the management and function of the NIA electronic cardiovascular test reporting system in cooperation with the NIA Information Technology department. • Provide weekly written progress reports to the Contracting Officer's Representative which describe all work completed during the specified period and present all work to be accomplished during the subsequent period. Reports shall identify any difficulties that arose in the performance of the required tasks during the specified period as well as how difficulties were resolved. Should any difficulties not have been resolved, the report shall provide an explanation and plans for full resolution. The contractor shall provide services at the following Government sites, as well as the contractor's site: 3001 S. Hanover Street Baltimore, MD 21225, and; 251 Bayview Boulevard, Suite 100 Baltimore, MD 21224 Level of EffortThe NIH estimates that the level of effort for this requirement shall be one (1) medical doctor on a part-time basis for up to 1,250 hours for the entire contract period. Government ResponsibilitiesThe Government will provide data necessary for performance of the required scope of work. The Government shall also provide desk space, computer, and software at the places of performance for use in performing the required scope of work. A laptop with VPN capabilities shall be provided for off-site work as approved by the Government. All data provided to the consultant by the Government must be treated as confidential and not be disclosed to any third party. All Government furnished property shall be safeguarded by the contractor and shall be managed by a NIA property administrator. Deliverables and Reporting RequirementsProvide weekly written electronic progress reports to the Contracting Officer's Representative which describe all work completed during the specified period and present all work to be accomplished during the subsequent period. Reports shall identify any difficulties that arose in the performance of the required tasks during the specified period as well as how difficulties were resolved. Should any difficulties not have been resolved, the report shall provide an explanation and plans for full resolution. Government Furnished Equipment/Facilities:The Government will provide scheduling support in arrangement of outpatient clinic rooms on an as needed basis. The Government will provide the contractor with a standard desk top computer along with necessary software. Contract employee will provide all necessary supplies for the various types of testing required. Supplies shall include tests, scoring manuals, test records, and response forms. Key PersonnelThe Contractor employee working under this award shall be considered key personnel. Key Personnel requirements are as follows: • Must be a licensed medical doctor with at least five (5) years of experience in cardiovascular research efforts. • Must have at least five (5) years of experience in the preparation of longitudinal research study data into SAS databases suitable for analysis by mixed model based approaches. • Must hold malpractice insurance which provides coverage through the base period of performance. Documentation of malpractice insurance coverage shall be required for all optional periods of performance, if exercised, as well.The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows:The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days' notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.It is required that all contractors involved with the NIA community work collaboratively with federal staff and other contractors towards the NIA mission and other affected organizations and follow the direction of the Contracting Officer's Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer and creating and sharing documentation when required. Period of PerformanceThe period of performance for this requirement shall be as follows:December 4, 2017 - December 3, 2018. Contract TypeThe Government intends to issue a firm fixed price contract.Data RightsThe NIA shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations, briefings, work plans, created SOPs and all other deliverables. In addition, it includes any additional deliverables required by contract change. The definition of "unlimited rights" is contained in Federal Acquisition Regulation (FAR) 27.401, "Definitions." FAR clause 52.227-14, "Rights in Data-General," is hereby incorporated by reference and shall be made a part of any resulting contract/order.OTHER CONSIDERATIONS TravelTravel is not expected or authorized for this requirement. No travel reimbursement shall be provided. Information Systems Security PlanThe contractor may have the ability to access federal information system(s). The information security policies and procedures are applicable to the requirement. Non-Personal Service StatementThe contract employee performing services will be controlled, directed and supervised at all times by management personnel of the contractor. Actions of contractor employees may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of the Federal employees, providing direct personal services to any Federal employee or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisitions Regulations (FAR).Contracting Officer's RepresentativeA Contracting Officer's Representative (COR) shall be assigned to the awarded contract. The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contractThe Government may unilaterally change the COR designation for this contract.APPLICABLE CLAUSES AND PROVISIONS All Offerors MUST be actively registered in the System for Award Management (SAM) www.sam.gov.The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items (JAN 2017), applies to this acquisition.FAR clause 52.212-2, Evaluation - Commercial Items (OCT 2014) applies to this acquisition.A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (JAN 2017), is required with any offer submitted. This requirement may be met by completion of the provision in the System for Award Management. FAR clauses 52.212-4, Contract Terms and Conditions - Commercial Items (JAN 2017) and 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (JAN 2017) apply to this acquisition. 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016) 52.209-9 Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) 52.219-8 Utilization of Small Business Concerns (Nov 2016) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (NOV 2011) (15 U.S.C 657f). 52.222-3 Convict Labor (June 2003).52.222-19 Child Labor-Cooperation with Authorities and Remedies (Oct 2016)52.222-21 Prohibition of Segregated Facilities (Apr 2015). 52.222-26 Equal Opportunity (Sept 2016).52.222-35 Equal Opportunity for Veterans (Oct 2015)52.222-36 Equal Opportunity for Workers with Disabilities (JUL 2014)52.222-37, Employment Reports on Veterans (FEB 2016)52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010)52.222-50 Combating Trafficking in Persons (March 2015)52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011)52.225-13 Restrictions on Certain Foreign Purchases (June 2008)52.232-33 Payment by Electronic Funds Transfer- System for Award Management (JUL 2013). Standard for Security Configurations, HHSAR 352.239-70, (January 2010)Standard for Encryption Language, HHSAR 352.239-71, (January 2010)Security Requirements for Federal Information Technology Resources, HHSAR 352.239-72, (January 2010) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. EVALUATION CRITERIAFAR clause 52.212-2, Evaluation - Commercial Items (OCT 2014) applies to this acquisition and the specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a contract resulting from this solicitation on the basis of best value, technical factors and price considered. Technical factors together shall be considered more important than price. Factor 1: Technical Capability The Contractor's proposal shall address each area of the statement of work requirements in sufficient detail to demonstrate a clear understanding of the statement of work and compliance with requirements. Factor 2: Key Personnel Qualifications Offerors proposals shall be evaluated for level of conformance to the key personnel qualifications identified in this statement of work. Offeror proposals must contain a resume/CV, as well as copies of current certifications relevant to the key personnel qualifications. Exceeding requirements shall be viewed favorably. Factor 3: Past Performance The Contractor shall provide a list of two (2) past performance references with knowledge of the contractor's relevant skills and experience related to the requirements outlined in this Statement of Work. References shall include the following information:a. Name of Organizationb. Description of Contractor's responsibilities as they relate to this SOWc. Contract Period of Performanced. Contact Name and Titlee. Telephone Numberf. E-mail address Past Performance shall be evaluated for relevance to the current requirement.Technical proposals will be evaluated using a summary adjectival rating in accordance with the following scale: ExcellentThe proposal has exceptional merit and reflects an excellent approach which will clearly result in the superior attainment of all requirements and objectives. This clearly achievable approach includes several advantageous characteristics of substance, and very few disadvantages, which can be expected to result in outstanding performance. The risk of unsuccessful performance is very low as the proposal provides solutions which are unquestionably feasible and practical. These solutions are further considered very low risk in that they are exceptionally clear andprecise, fully supported, and demonstrate a clear understanding of the requirements. Risk Level: Very Low GoodThe proposal demonstrates a sound approach which is expected to meet all requirements and objectives. This sound approach includes advantageous characteristics of substance, and few relatively minor disadvantages, which collectively can be expected to result in satisfactory performance. The risk of unsuccessful performance is low as the proposal contains solutions which are considered feasible and practical. These solutions are further considered to reflect low risk in that they are clear and precise, supported, and demonstrate an understanding of the requirements. Risk Level: Low AcceptableThe proposal demonstrates an approach which is capable of meeting all requirements and objectives. The approach includes both advantageous and disadvantageous characteristics of substance, where the advantages are not outweighed by the disadvantages. Collectively, the advantages and disadvantages are likely to result in acceptable performance. The risk of unsuccessful performance is moderate, as the proposal solutions are generally feasible and practical. These solutions may also be considered to reflect moderate risk in that they may be somewhat clear and precise, partially supported, and/or demonstrate a general understanding of the requirements. Risk Level: Neutral MarginalThe proposal demonstrates an approach which may not be capable of meeting all requirements and objectives. The approach has disadvantages of substance and advantages, which if they exist, are outweighed by the disadvantages. Collectively, the advantages and disadvantages present a low or questionable likelihood of resulting in satisfactory performance. The risk of unsuccessful performance is high as the proposal contains solutions which may not be feasible and practical. These solutions may also be considered to reflect high risk in that they lack clarity and precision, are generally unsupported, and/or do not demonstrate a complete understanding of the requirements. Risk Level: High UnacceptableThe proposal demonstrates an approach which, based on a very high risk, will very likely not be capable of meeting all requirements and objectives. This approach has several disadvantages of substance, and advantages which, if they exist, are outweighed by disadvantages. Collectively, the advantages and disadvantages are unlikely to result in satisfactory performance. The risk of unsuccessful performance is very high as the proposal contains solutions which are not feasible and practical. The solutions may also be considered to reflect very high risk in that they lack any clarity or precision. Risk Level: Very High RESPONSE FORMATResponses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The offeror must submit a technical response and a separate price quotation. The technical response should be prepared in reference to the evaluation criteria identified in this solicitation and shall not exceed 10 single-sided pages excluding any attachments (for example CV). The price quotation must include annual pricing for the base and option periods as well as the hourly rate used to calculate this pricing. Contractors must provide their Company Name, Dun & Bradstreet Number (DUNS), Taxpayer Identification Number (TIN), Business Size, Physical Address, and Point of Contact Information in their responses. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov."NoteResponses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision.CLOSING STATEMENTThe closing date for this solicitation is November 24, 2017 at 11:00am EST. All responses must be received by the closing date of this announcement and must reference solicitation number HHS-NIH-NIDA-SSSA-CSS-2018-002. Responses shall be submitted electronically via email to Jermaine Duncan, Contract Specialist, at jermaine.duncan@nih.gov.  

NONHUMAN PRIMATE CORE CELLULAR IMMUNOLOGY LABORATORY FOR AIDS VACCINE RESEARCH AND DEVELOPMENT

Department of Health and Human Services, National Institutes of Health | Published April 1, 2016  -  Deadline April 15, 2016
cpvs

IntroductionThe National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of AIDS has a requirement for the operation of the Nonhuman Primate Core Cellular Immunology Laboratory for AIDS Vaccine Research and Development. The current Nonhuman Primate Core Cellular Immunology Laboratory for AIDS Vaccine Research and Development contract (HHSN272201000028C) is held by Beth Israel Deaconess Hospital. DescriptionThe purpose of the proposed contract will be to support the development, conduct, and improvement of assays designed to evaluate and characterize the cellular immune responses of nonhuman primates that have been immunized with candidate HIV or SIV vaccines or infected with SIV, SHIV, or HIV in studies conducted at the NIAID SVEU contract sites or by NIH-supported investigators. The Contractor shall conduct, develop, acquire, improve, and implement assays to evaluate and characterize the cellular immune responses of nonhuman primates (NHPs) that have been immunized with candidate HIV or SIV vaccines or infected with SIV, SHIV, or HIV in studies conducted by the NIAID Simian Vaccine Evaluation Units (SVEUs) or by investigators supported by or collaborating with NIH. Specifically, the Contractor shall: 1) perform immunological analyses; 2) receive, store, catalog, track, and maintain an inventory of the specimens for evaluation; 3) manage and report study data; 4) perform project management activities related to contract activities; 5) conduct initial and final transition activities, as needed; and 6) perform option work described below, if required. The Contractor shall use state-of-the-art technologies, including ELISPOT, intracellular cytokine staining (ICS), flow cytometry, tetramer, and other assays to accomplish the technical objectives, and shall incorporate new and optimized technologies for assay development into contract activities when appropriate. Assays shall incorporate appropriate positive and negative controls to define background and dynamic range, and shall demonstrate reproducibility and consistency. The Contractor shall use GLP processes to conduct assays when directed by the Government. It is anticipated that one (1) cost reimbursement, level-of-effort (term) type contract will be awarded. The period of performance will be for one (1) year (Base Period) plus six (6) one year options (terms that may be exercised by the Government unilaterally), for a total possible performance period of 7 years, beginning on or about June 1, 2017. The performance requirement will be for the delivery of 6.0 full time equivalents (FTEs) per year for the base period (Year 1) and option periods (Year 2 through Year 7). Please note that the number of FTEs is inclusive of subcontractor and consultant effort. In addition, the Government may exercise options to accommodate unanticipated significant increases in demand as follows:(1) Options 7 through 20: Increased Level of Effort: The Government may exercise options for increased level of effort that may result from unanticipated increases in demand. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by1.0 Full Time Equivalents (FTEs) for each option exercised. These options may be exercised twice per year during Years 1 through 7. Please note that the number of FTEs is inclusive of subcontractor and consultant effort. The period of performance of an Option for Increased Level of Effort will not exceed the term of the Option year in which the Option is exercised. (2) Options 21 through 27: Increased Level of Effort: The Government may exercise options for increased level of effort that may result from unanticipated increases in demand. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 0.5 FTE for each option exercised. It is anticipated that only one option will be exercised per performance year. Please note that the number of FTEs is inclusive of subcontractor and consultant effort. The period of performance of an Option for Increased Level of Effort will not exceed the term of the Option year in which the Option is exercised. (3) Options 28 through 34: Increased Level of Effort: The Government may exercise options for increased level of effort that may result from unanticipated increases in demand for the conduct of cellular immunology assays. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 0.25 FTE for each option exercised. It is anticipated that only one option will be exercised per performance year. Please note that the number of FTEs is inclusive of subcontractor and consultant effort. The period of performance of an Option for Increased Level of Effort will not exceed the term of the Option year in which the Option is exercised. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about April 15, 2016, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. For this solicitation, the NIAID requires proposals to be submitted via two methods: (1) Disc (CD or DVD) and (2) Online via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. Submission of proposals by facsimile or e-mail is not acceptable. For directions on using eCPS, go to the website https://ecps.niaid.nih.gov and then click on "How to Submit."

ANATOMIC PATHOLOGY CONSULTATION

Other Defense Agencies, Defense Health Agency | Published December 5, 2014  -  Deadline December 15, 2014
cpvs

Synopsis: The Defense Health Agency (DHA) Contract Operations Division - National Capitol Region, Bethesda, MD, intends to issue a firm-fixed-price, sole source contract to Mayo Clinic, Mayo Medical Laboratories: Division of Anatomic Pathology, 3050 Superior Dr. NW, Rochester, MN 55901 to provide specialized laboratory and secondary pathology consultation services in support of the subspecialty pathology evaluation. This action contemplates a mechanism to provide access to subspecialty pathologists for case evaluation for Department of Defense, Military and Veteran Affairs patients with an anticipated period of performance of 01/01/15 - 12/31/15 with four one year options This procurement is being conducted in accordance with FAR Part 12.603 under streamlined solicitation for commercial items. Mayo Clinic, Mayo Medical Laboratories, of Rochester, MN is the only provider with the required skill set and proprietary rights that is capable of supporting this service. Mayo Medical Laboratories has collaborations with private medical diagnostic companies (Silicon Valley Biosystems, Liposcience, Sequenom, Prometheus, and A+G Pharmaceutical) to have access to their proprietary testing procedures. Of the greatest significance to pathology consultation is access to new proprietary genome interpretation testing to be able to utilize the newest advances in genomic science for detecting genetic mutations associated with pathological processes. Because Mayo offers the resources of its genome reference laboratory to these companies, they will give Mayo access to use the newest testing discoveries which are proprietary to the individual companies. Mayo's Division of Anatomic Pathology has over 50 board certified pathologists with sub specialty expertise in the following areas: Pulmonary Cardiovascular, Cardiovascular including lung transplant Autopsy Breast Medical renal Gynecologic Cytopathology Urologic Gastrointestinal Hematopathology Lymph node Dermatopathology Endocrine Nephrology Bone Soft Tissue Head and Neck Digital pathology Ophthalmic Molecular Neuropathology Solid Tumor Cytogenetics Endocrine Forensic Pathology The North American Industry Classification System (NAICS) for this requirement is 621511 and the size standard is $32.5M. All responsible sources may submit a response. A determination made by the Government to not compete this requirement will be based on responses to this notice and is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. A solicitation will not be issued. Interested firms may identify their interest in writing to the Government point of contact. All responses to this notice must be received no later than 10:00 AM EST, 15 December 2014. Telephone or facsimile inquiries are not acceptable in response to this notice. The point of contact for this action is Joseph Askerzada at joseph.a.askerzada.ctr@mail.mil. The Contracting Office Address is: Defense Health Agency (DHA) Contract Operations Division - National Capital Region, Bethesda, MD 20889-5000.

NIH DRUG DISCOVERY AND DEVELOPMENT CONSULTING SERVICES

Department of Health and Human Services, National Institutes of Health | Published February 23, 2016  -  Deadline May 15, 2016
cpvs

This is a solicitation for commercial services prepared in accordance with the format in Subpart 12.2, as supplemented with additional information included in this notice. The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-87 effective April 6, 2016. This acquisition will be processed under FAR Part 12, Simplified Acquisition Procedures (SAP), Acquisition of Commercial Items, and is set aside 100% for small businesses. The Solicitation Number for this acquisition is HHS-NIH-NIDA-SSSA-RFP-16-46 and is being issued as a Request for Proposal (RFP). The North American Industry Classification System (NAICS) Code for this procurement is 541690 and the Small Business Size Standard is $15.0 million dollars. BACKGROUND The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people's health and save lives. The National Institute of Neurological Disorders and Stroke (NINDS) is a part of the National Institutes of Health (NIH), conducting research into the causes, treatment, and prevention of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. The NIH Blueprint for Neuroscience Research, a consortium of 8 NIH Institutes and Centers that support neuroscience research, established the Blueprint Neurotherapeutics Network (BPN) as a pipeline between the typical endpoint of NIH-funded research and the beginning of industry drug development. The BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The program is intended for projects requiring medicinal chemistry optimization and contract research organization (CRO) support through phase I clinical testing. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by CROs. Bioactivity and efficacy studies are funded through an award to the PI; other research services are provided without cost to the PI through NIH contracts. Each consulting contract will be specific to one or more areas of expertise as outlined in the attached Statement of Work, and will reflect the NIH time commitment needs for the specific areas of expertise. Consultants hired under this requirement will not only make significant contributions to promising drug discovery and development projects that have been selected through a rigorous peer-review process, they will also help shape an innovative, high-profile program that may serve as a model for future NIH drug discovery efforts. Contract consultants will be expected to provide feedback and guidance on programs and projects to the NIH and to BPN LDT members through conference calls and by email. Consultants may serve on an ad hoc basis or as members of LDTs. Consultants will be expected to offer input on project milestones, development strategy, study design, and data interpretation. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects and programs. The BPN currently has projects in the exploratory through preclinical safety stages. Some projects will proceed to the Investigational New Drug (IND) and clinical trial stages. Project continuation will depend on the achievement of project-specific milestones and portfolio management. Since 2011, fifteen projects have entered the BPN, and five projects remain active. New projects are reviewed twice per year and the highest scoring projects may be incorporated into the program. STATEMENT OF OBJECTIVES The NIH is seeking senior-level, industry-experienced drug discovery and development consultants with expertise in the following specific disciplines to provide leadership and technical guidance on drug discovery and development projects in the Blueprint for Neuroscience Research (BPN) and possibly other NIH drug discovery and development projects and programs: • Bioactivity Assay• Drug Metabolism and Pharmacokinetics STATEMENT OF WORK Please see the attached statement of work for detailed requirements. PERIOD OF PERFORMANCE Base Year - June 1, 2016 through May 31, 2017Option Period One - June 1, 2017 through May 31, 2018Option Period Two - June 1, 2018 through May 31, 2019Option Period Three - June 1, 2019 through May 31, 2020Option Period Four - June 1, 2020 through May 31, 2021 LEVEL OF EFFORT The NIH estimates that it will require the following labor hours for each of the specific disciplines as follows: 1. Bioactivity Assay Year 1: Up to 800 hours Year 2: Up to 800 hours Year 3: Up to 800 hours Year 4: Up to 800 hours Year 5: Up to 800 hours 2. Drug Metabolism and Pharmacokinetics Year 1: Up to 800 hours Year 2: Up to 800 hours Year 3: Up to 800 hours Year 4: Up to 800 hours Year 5: Up to 800 hours ATTACHMENTS The following attachment is provided to assist you in preparing your proposal responding to this solicitation. Attachment No. 1: Statement of Work PAGE AND FORMATTING LIMITATIONS The Technical Proposal shall not exceed 50 single-sided pages or 25 double-sided pages. This page limitation does not include the cover sheet, abstract, table of contents, personnel, facilities, equipment and resources, other considerations, schedule, other support, and cost information. Appendices shall not exceed a total of 30 single-sided pages or 15 double-sided pages. Pages in excess of the limitation will be deleted and will be neither read nor evaluated. Each page of the technical proposal must be numbered sequentially. Offerors are encouraged to limit the overall size of the technical proposal, inclusive of appendices, attachments, etc. Type density and size must be 10 to 12 points. If constant spacing is used, 15 cpi (characters per inch) or fewer shall be used, whereas proportional spacing should provide an average of no more than 15 cpi. There must be no more than six lines of text within a vertical inch. Margins must be no less than ½ inch around, exclusive of headers and footers. The proposal must be signed by an official authorized to bind your organization and must stipulate that it is predicated upon all the terms and conditions of this RFP. One original and three (3) copies of your proposal shall be submitted to: National Institutes of HealthNational Institute on Drug AbuseStation Support Simplified Acquisition BranchAndriani Buck, Contract Specialist31 Center Drive, Suite 1B59Bethesda, MD 20892-7511. Proposals will be typewritten, paginated, reproduced on letter size paper, printed/copied double-sided, on at least 30 percent post consumer fiber paper, as required by FAR 4.302(b), and will be legible in all required copies. To expedite the proposal evaluation, all documents required for responding to the RFQ should be placed in the following order: I. COVER PAGEInclude RFP title, number, name of organization, DUNS No., identification of the proposal part, and indicate whether the proposal is an original or a copy. The solicitation number HHS-NIH-NIDA-SSSA-RFP-16-46 must be referenced on the cover page. II. TECHNICAL PROPOSALIt is recommended that the technical proposal consist of a cover page, a table of contents, and the information requested in the Technical Proposal Instructions and as specified in SECTION J, List of Attachments. Offers will be valid for 120 days unless a different period is specified by the offeror. MANDATORY EVALUATION FACTORS Mandatory Evaluation CriteriaThe solicitation contains the following mandatory qualification criteria specific to each discipline: 1. Bioactivity Assay Development• An advanced degree in a life science discipline is required. An advanced degree is defined as any postgraduate degree, doctorate or master's level including but not limited to a Ph.D., Pharm.D., M.D., M.S. • 10 years of experience in the pharmaceutical or other related industry is required• Experience working with multi-disciplinary drug development teams at a senior level in the pharmaceutical industry. A senior level position is generally at the highest level of an organization.• Experience with drug discovery and development for nervous system conditions is required. 2. Drug Metabolism and Pharmacokinetics• An advanced degree in a life/physical science discipline is required.• 10 years of experience in pharmacokinetics and drug metabolism of small molecules.• Experience providing DMPK project leadership in support of small molecule drug discovery programs and/or experience providing DMPK leadership to development teams. • Experience with drug discovery and development for nervous system conditions is required. The mandatory qualification criterion establishes conditions that must be met at the time of receipt of Technical Proposals by the Contracting Officer in order for your proposal to be considered any further for award. TECHNICAL EVALUATION ELEMENTS The evaluation factors are used by the technical evaluation committee when reviewing the technical proposals. Offerors proposals will be evaluated on the demonstrated experience and understanding of the project in relation to the specifications outlined in the solicitation and the statement of work.The acceptability of the technical portion of each contract proposal will be evaluated by a technical review committee. The committee will evaluate each proposal in strict conformity with the evaluation factors of the RFP, utilizing point scores and written critiques. The committee may suggest that the Contracting Officer request clarifying information from an offeror. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial prices are fair and reasonable and that discussions are not necessary. If award will be made without conducting discussions, offerors may be given the opportunity to clarify certain aspects of their proposal (e.g., the relevance of an offeror's past performance information and adverse past performance information to which the offeror has not previously had an opportunity to respond) or to resolve minor or clerical errors. The process described in FAR 15.101-1 will be employed, which permits the Government to make tradeoffs among cost or price and non-cost factors and to consider award to other than the lowest price offeror or other than the highest technically rated offeror. The NIDA reserves the right to make a single award, multiple awards, or no award at all to the RFP. In addition, the RFP may be amended or canceled as necessary to meet the NIDA requirements. Proposals will be scored based on the following three (3) technical evaluation criteria. Professional Experience in Drug Development -50 points Offerors shall be evaluated based on hands-on and management experience in drug discovery and development projects, explicitly applicable to the corresponding discipline description listed in the statement of work. Evaluations shall be based on demonstrated expertise and experience in executing and managing drug development tasks, particularly for nervous system conditions. Broad experience across the entire drug discovery and development process is especially desired. Reviewers shall consider the Offerors' years of experience, breadth of expertise, and track record in drug development projects that go through to the clinic. Examples of measures of success include preparation of successful IND, CTA, NDA, and MA applications, as well as publications, patents, and work on drugs brought to market. In addition, experiences showing use of expertise to identify or anticipate problems early, overcome technical or regulatory difficulties, distill complex situations, or demonstrate strong risk-assessment ability to make wise use of limited resources shall be considered as signs of a strong track record in drug development. Discipline specific experience requirements for Bioactivity Assay Development are as follows: • Demonstrated experience developing and implementing cell-based and biochemical assays for high throughput screening and safety screening• Demonstrated expertise in the application of assays in industrial pharmaceutical discovery and development; application of automated technologies and robotics relevant to pharmaceutical assays; and application of a diverse range of cellular techniques in pharmaceutical assays Education and Qualifications in Drug Development - 30 points Offerors shall be evaluated for a combination of advanced education, board certifications, and other advanced expertise explicitly applicable to the corresponding discipline description listed in the statement of work. Evaluations shall be based on the Offerors' in-depth understanding of the drug development process, including regulatory procedures and guidelines where relevant, especially in small molecule drug development for CNS indications. Experience with Collaborative Teams - 20 points Offerors shall be evaluated based on previous experience working with multi-disciplinary teams, especially teams with members from outside organizations and members at various management levels. Experiences such as team leadership, consulting, or service on strategic and advisory boards shall be considered as illustrations of collaborative work. Total Possible Points - 100 The Government will evaluate the Offerors on past performance based on the information provided in the proposal and the Government reserves the right to contact the parties provided as references in the Offerors proposal. In addition the Government may evaluate the Offeror based on information obtained from other sources known to the Government as to past performance of the Offeror. PAST PERFORMANCE FACTOR The Government may evaluate the offeror's past performance based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken. The Government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance. The Government will consider the currency and relevance of the information, source of the information, context of the data, and general trends in the offeror's performance. The lack of relevant a performance record may result in an unknown performance risk assessment, which will neither be used to the advantage nor disadvantage of the offeror. AWARD CRITERIAThe major evaluation factors for this solicitation include technical (which encompasses experience and past performance factors) and cost/price factors. Although technical factors are of paramount consideration in the award of the contract, cost/price is also important to the overall contract award decision. All evaluation factors other than cost or price, when combined, are significantly more important than cost/price. The Government intends to make an award(s) to that offeror whose proposal provides the best overall value to the Government. The evaluation will be based on the demonstrated capabilities of the prospective Contractors in relation to the needs of the project as set forth in the RFP. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of the RFP. Offerors must submit information sufficient to evaluate their proposals based on the detailed factors listed above. Offeror(s) cost/price proposal will be evaluated for reasonableness. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through cost and price analysis techniques as described in FAR 15.404. PROVISIONS AND CLAUSES It is anticipated that multiple firm fixed price type contracts will be awarded according to discipline. Any resultant contract shall include the clauses applicable to the selected offeror's organization and type of contract awarded as required by Public Law, Executive Order, or acquisition regulations in effect at the time of execution of the proposed contract. The following Provisions and Clauses apply: FAR 52.212-1 Instruction to Offerors-/Commercial Items (OCT 2015); FAR 52.212-2 Evaluation - Commercial Items (OCT 2014) (Additional Evaluation criteria set forth in the solicitation; FAR 212-3, Offeror Representations and Certifications - Commercial Items (NOV 2015); FAR 52.212-4 Contract Terms and Conditions Commercial Items (MAY 2015); FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive-Commercial Items (JAN 2016); FAR 52.217-8 Option To Extend Services (NOV 1999); FAR 52.217-9 Option to Extend the Term of the Contract, (MAR 2000); FAR 219-6 Notice of Total Small Business Set-Aside (NOV 2011); FAR 52.222-3 Convict Labor (JUN 2003); FAR 52.223-6 Drug Free Workplace (May 2001); FAR 52.227-14 Rights In Data - General (MAY 2014), FAR 52.228-5 Insurance - Working On a Government Installation (JAN 1997); and FAR 52.232-33 Payment by Electronic Funds Transfer - System for Award Management (JULY 2013). The Contractor shall comply with the following clauses, which are incorporated in this contract in full text, to implement provisions of law or Executive orders applicable to acquisitions of commercial items. 52.217-5 Evaluation of Options (JULY 1990) Except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).(End of clause)52.217-6 Option for Increased Quantity (MAR 1998)The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within the current period of performance. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree. (End of clause)52.217-8 Option to Extend Services, (NOV 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 60 days from the expiration of the contract. (End of clause) 52.217-9 Option to Extend the Term of the Contract, (MAR 2000) (a) The Government may extend the term of this contract by written notice to the Contractor within the current period of performance; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 60 months. (End of clause) FAR 52.222.17 Non-displacement of Qualified Workers (May 2014) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract in full text, to implement provisions of law or Executive orders applicable to acquisitions of commercial items. (End of clause) FAR 52.227-14 - Rights in Data - General (May 2014) Information Security is Applicable to this requirement and the following information is required for RFP preparedness. 1. SECURITY CATEGORIZATION OF FEDERAL INFORMATION AND INFORMATION SYSTEMS (FIPS 199 Assessment) a. Information Type: [ ] Administrative, Management and Support Information: [ x ] Mission Based Information: b. Security Categories and Levels (SCL) Confidentiality Level: [ ] Low [x ] Moderate [ ] HighIntegrity Level: [ ] Low [x ] Moderate [ ] HighAvailability Level: [ ] Low [x ] Moderate [ ] High Overall Level: [ ] Low [ x ] Moderate [ ] High This contract will entail the following position sensitivity levels: [ ] Level 6: Public Trust - High Risk. Contractor/subcontractor employees assigned to Level 6 positions shall undergo a Suitability Determination and Background Investigation (MBI). [ ] Level 5: Public Trust - Moderate Risk. Contractor/subcontractor employees assigned to Level 5 positions with no previous investigation and approval shall undergo a Suitability Determination and a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI). [x ] Level 1: Non-Sensitive. Contractor/subcontractor employees assigned to Level 1 positions shall undergo a Suitability Determination and National Check and Inquiry Investigation (NACI). Prospective Offeror Non-Disclosure Agreement[ x] Offerors WILL NOT require access to sensitive information in order to prepare an offer.[ ] Offerors WILL require access to sensitive information in order to prepare an offer.[ x] Systems Security Plan (SSP) is NOT required. SOLICITATION - STATEMENT OF WORK/REPORTS/DELIVERABLE PROVISIONS 1 ROSTER OF EMPLOYEES REQUIRING SUITABILITY INVESTIGATIONS The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the contract that will develop, have the ability to access, or host and/or maintain a Federalinformation system(s). The roster shall be submitted to the Contracting Officer'sRepresentative (COR), with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract.   1 REPORTING OF NEW AND DEPARTING EMPLOYEES The Contractor shall notify the Contracting Officer's Representative (COR) and Contracting Officer within five working days of staffing changes for positions that require suitability determinations as follows: 1 CONTRACTOR - EMPLOYEE NON-DISCLOSURE AGREEMENT(s) The contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information - Contractor Agreement" form for each contractor and subcontractor employee who may have access to non-public Department information under this contract. This form is located at:https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf SOLICITATION - SPECIAL CONTRACT REQUIREMENTS PROVISIONS 1 STANDARD FOR ENCRYPTION LANGUAGE, HHSAR 352.239-71, (January 2010) The Contractor shall use Federal Information processing Standard (FIPS) 140-2- compliant encryption (Security) Requirements for Cryptographic Module, as amended) to protect all instances of HHS sensitive information during storage and transmission. (Note: The Government has determined that HHS information under this contract is considered "sensitive" in accordance with FIPS 199, Standards for Security Categorization of Federal Information and Information Systems, dated February 2004). 1 SECURITY REQUIREMENT FOR FEDERAL INFORMATION TECHNOLOGY RESOURCES, HHSAR 352.239-72, (January 2010) Applicability. This clause applies whether the entire contract or order (hereafter "contract"), or portion thereof, includes information technology resources or services in which the Contractor has physical or logical (electronic) access to, or operates a Department of Health and Human Services (HHS) system containing, information that directly supports HHS' mission. The term "information technology (IT)", as used in this clause, includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services) and related resources. This clause does not apply to national security systems as defined in FISMA. 1 INFORMATION SECURITY TRAINING In addition to any training covered under paragraph (e) of HHSAR 352.239-72, the contractor shall comply with the below training: 1 PERSONNEL SECURITY RESPONSIBILITIES In addition to any personnel security responsibilities covered under HHSAR 52.239-72, the contractor shall comply with the below personnel security responsibilities: 1 LOSS AND/OR DISCLOSURE OF PERSONALLY IDENTIFIABLE INFORMATION (PII) - NOTIFICATION OF DATA BREACH The Contractor shall report all suspected or confirmed incidents involving the loss and/or disclosure of PII in electronic or physical form. Notification shall be made to the NIH Incident Response Team (IRT) via email (IRT@mail.nih.gov ) within one hour of discovering the incident. The Contractor shall follow up with IRT by completing and submitting one of the applicable two forms below within three (3) work days of incident discovery: INTELLECTUAL PROPERTY Consultants who contribute to the creation of new intellectual property will be named as inventors according to US or prevailing patent law. Accordingly, consultants must complete negotiations with the principal investigator's institution regarding assignment of rights and royalties distribution prior to advising on any activities. The consultant shall provide copies of all intellectual property agreements to the NIH COR, for documentation purposes. CONFIDENTIAL TREATMENT OF SENSITIVE INFORMATION The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government or by persons or entities applying to or accepted to the Blueprint Neurotherapeutics Network during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature. Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer. Contractor agrees that it will not use the Confidential Information for any purpose except as set forth within this SOW, unless such time as such Confidential Information becomes public information through the efforts of participants in the Blueprint Neurotherapeutics Network. NOTICE OF SMALL BUSINESS SET-ASIDE General. Offerors are solicited only from small business concerns. The procurement is to be awarded only to one or more such concerns, organizations, or individuals. This action is based on a determination by the Contracting Officer, alone or in conjunction with a representative of the Small Business Administration, that it is in the interest of maintaining or mobilizing the Nation's full productive capacity, or in the interest of war or national defense programs, or in the interest of assuring that a fair proportion of Government procurement is placed with small business concerns. Bids or proposals received from others will be considered non-responsive. Definitions. The term "small business concern" means a concern, including its affiliates, which is independently owned and operated, is not dominant in the field of operation in which it is bidding on Government contracts, and can further qualify under the size standards in this solicitation. In addition to meeting these criteria, a small business concern submitting an offer in his own name shall furnish, in the performing the contract, only end items manufactured or produced by small business concerns in the United States or its outlying areas, provided that this additional requirement does not apply in connection with construction or service contracts. COMMITMENT OF PUBLIC FUNDS The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with the proposed procurement. Any other commitment, either explicit or implied, is invalid. TRAVEL Travel Costs - Commercial Costs for lodging, meals, and incidental expenses incurred by Contractor personnel shall be considered to be reasonable and allowable to the extent they do not exceed on a daily basis the per diem rates set forth in the Federal Travel Regulations, General Services Administration (GSA). Therefore, if travel costs are applicable and proposed by offerors, please be advised that they shall be calculated using the per diem rate schedule as established by GSA. Reimbursement of travel costs under any contract awarded from this RFP shall be in accordance with FAR 31.205-46. Travel Policy One copy of the offeror's (and any proposed subcontractor's) written travel policy shall be included in the business proposal. If an offeror (or any proposed subcontractor) does not have a written travel policy, the offeror shall so state.ON-SITE CONTRACTOR ACCESS TO GOVERNMENT PROPERTYThe Contractor shall be held responsible for Government Property, regardless of dollar value, when: 1. The contract requires contractor personnel to be located on a Government site or installation;2. The property utilized by contractor personnel is incidental to the place of performance; and,3. The property used by the contractor remains accountable to the Government Responsibility includes physical presence, proper use and handling, normal maintenance, and reporting loss, damage or destruction. Responsibility for government property shared by two or more contractors or located in space shared by two or more contractors shall be determined and documented by the contractors involved. In cases where the parties cannot reach agreement on shared responsibility, the matter will be referred to the NIH Property Officer for resolution. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE a. Contractor Performance Evaluations Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually as follows on June 1st. Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final. Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions. b. Electronic Access to Contractor Performance Evaluations Contractors may access evaluations through a secure Web site for review and comment at the following address: http://www.cpars.gov CONTRACTING OFFICER REPRESENTATIVE The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract:To be specified prior to award The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract The Government may unilaterally change its COR designation. COMMUNICATIONS PRIOR TO CONTRACT AWARD Offerors shall direct all communications to the attention of the Contract Specialist cited herein. Communications with officials outside of the contracting office may compromise the competitiveness of this acquisition and result in cancellation of the requirement. CLOSING STATEMENT Interested Offerors may submit quotations electronically to this notice no later than 8:00 AM. (EST) May 15, 2016. Questions regarding this solicitation must be received in writing by this office no later than May 1, 2016. Responses to questions will be answered in an amendment to this posting. Offerors must submit a completed FAR 52.212-3. The quotation shall include fully-burdened hourly wage rates for the key personnel assigned to this requirement. The Government intends to make multiple awards based upon best value to the Government, technical and price factors considered. The anticipated award date for this requirement shall be on or before June 1, 2016. Facsimile submissions are not authorized and collect calls will not be accepted. Submit offers to Andriani Buck at the address listed herein. Please reference the solicitation number HHS-NIH-NIDA-SSSA-RFP-16-46 on your offer. Requests for information concerning this requirement are to be addressed to Andriani Buck via e-mail to andriani.buck@nih.gov prior to the date stated above.

Kuali COEUS Consulting Services

Other Defense Agencies, Uniformed Services University of the Health Sciences | Published August 30, 2015  -  Deadline September 8, 2015
cpvs

The Uniformed Services University of the Health Sciences (USU) is the Nation's federal health sciences university and is committed to excellence in military medicine and public health during peace and war. We provide the Nation with health professionals dedicated to career service in the Department of Defense and the United States Public Health Service and with scientists who serve the common good. We serve the uniformed services and the Nation as an outstanding academic health sciences center with a worldwide perspective for education, research, service, and consultation; we are unique in relating these activities to military medicine, disaster medicine, and military medical readiness. USU is located in Bethesda, MD on the grounds of the Naval Support Activity Bethesda. USU intends to negotiate on a sole source basis with Moderas, located in Schenectady, NY for Kuali COEUS consulting services These services will be procured in accordance with the procedures of FAR Part 12-Commercial Items and FAR Part 13-Simplified Acquisition Procedures. Sole source determination is made in accordance with: FAR Part 13.106-1 Soliciting Competition (b) Soliciting from a single source (1) For purchases not exceeding the simplified acquisition threshold, contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available. The mission of USU is to provide the highest quality education programs in the health sciences to those selected individuals who demonstrate dedication to a health profession career in the Uniformed Services. As such, it is essential USU provide the necessary training and equipment required for our students to become successful doctors and nurses and to be able to provide the best care possible for our soldiers and to support our research efforts. USU implemented Kuali COEUS in 2015 as a research management tool and replacement for the COEUS system. USU intends to procure software development services in support of the VPR use of Kuali COEUS. Moderas supported the migration of the COEUS system to Kuali COEUS in 2015. They possess the most current understanding of the system and the data structure. The company wrote the migration scripts necessary to move the data from COEUS to Kuali COEUS. Contracting with a different vendor will mean the new vendor will consume consulting hours examining the data, reporting tools and USU's implementation of the system. Selection of Moderas will enable USU to leverage current knowledge and limit redundant work resulting in a lower cost to continued development and implementation. As a result of their collaboration and support in configuring the current COEUS system, developing migration and reporting tools and providing implementation consulting, Moderas is the only source that can provide the requested services in the most advantageous way to the government. Thus we are treating this as a follow-on contract. This is not a request for quotes and a solicitation package will not be issued. Sources interested in responding to this requirement must be able to provide compelling evidence that they can provide the abovementioned requirement as specified. A determination by the government not to compete this proposed contractual action based upon responses received is solely within the discretion of the government. Responses must be received via email (carolyn.randolph@usuhs.edu) by 5:00 p.m. EST on September 8, 2015.

Expert Management Consulting Services

Department of Health and Human Services, National Institutes of Health | Published May 19, 2015  -  Deadline June 3, 2015
cpvs

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This solicitation is being issued as Request for Quotations (RFQ) NIHLM2015392. The resultant order will be a labor hour type contract. In accordance with FAR Parts 12 and 13, the National Institutes of Health (NIH) National Library of Medicine (NLM) intends to procure expert management consulting services. The North American Industry Classification System (NAICS) Code is 541611- Administrative Management and General Management Consulting Services. This acquisition is a Small Business Set-Aside. Background The overall objective of the NIH Business System (NBS) is to facilitate the scientific mission of the NIH and provide an administrative/scientific system that is cost effective and provides accurate and timely information. The scope of the NBS includes these business or "functional" areas: acquisition, travel, service and supply fund, management fund, supply, research and development contracting, property, and financial management. The NBS is designed, developed and tested as a fully integrated facility that supports these functional areas and interfaces with other major NIH and Departmental systems. "Best practices" i.e., those business processes determined to be most effective in the business community, were identified for the administrative areas at the NIH. Implementation will require configuration or changes to the upgraded system that will adopt and integrate these best practices. Functional teams under the direction of a NIH Program Director have been established to oversee this effort. Functional teams will engage in a variety of duties including the design and configuration of the system, establishing workflow for the business processes, maximizing inherent functionality available in the Oracle e-Business Suite Commercial-Off-The-Shelf (COTS) application, defining system interfaces, and participation in pre-deployment and deployment activities. Purpose and Objectives The Contract shall provide expert management consulting services related to training issues and other activities of NBS and the NIH community stakeholders. General Contractor Tasks Independently and not as an agent of the Government, the Contractor shall provide expert technical consulting services to the NBS. These services relate specifically to training issues and activities of NBS and the NIH community of stakeholders affected. The Contractor shall collaborate with the NBS Program Director, NIH Deputy Director for Management, the NBS Project Management Team (PMT), the system integrator, the IV&V contractor and the functional team members as well as other NIH stakeholders deemed appropriate by the NIH Program Director or Deputy Director for Management to ensure the success of the NBS upgrade to Oracle R12.2.3. The Contractor shall provide overall program and business management assistance to the NBS Program Management Office. These services include: planning; organizing and coordinating assigned projects and activities for the NBS. Specific tasks include, but are not limited to, assistance on the following: •· Developing and maintaining the balanced scorecard evaluation approach, with specific attention to the project monitoring level, for the NBS implementation phase. •· Developing and implementing a monitoring and review methodology specifically checking the System Integrator's adherence to the Project Plan, the proposed budget, and overall schedule. This methodology shall incorporate "earned value" calculations. •· Maintaining and monitoring a tracking chart that follows the schedule of NBS activities to be accomplished prior to the start of activities of the functional work teams. •· Performing policy and issue analyses for the NBS Project on a myriad of topics as identified by the NBS Program Director or Deputy Director for Management that could potentially be affected by the NBS Upgrade effort. Following these analyses, the Contractor shall develop appropriate policy documents/memoranda/reports/presentations for NBS and/or DDM review. Contract Deliverables Deliverables include but are not limited to: Regular written and/or verbal analyses and reports to the NBS Project Director, the Deputy Director for Management, NIH and as requested by the Director and Deputy Director, NIH. Monthly reports on all activities performed during the previous month. Reports as specified by the NBS Program Director in conjunction with the activities outlined above. The contractor shall review and report on integrated testing, i.e., the process of testing the integration of the modules that comprise a particular function and the integration of those functions with other NBS functions to carry out and perform activities that are consistent with NIH policies and guidance. Reporting requirements Monthly Progress Report-The Contractor shall provide monthly reports about the project's progress. These monthly progress reports shall be electronically submitted to the NLM designated COR via email by the 5th day of the following month. The monthly progress report should be a brief overview that outlines all progress in the past thirty (30) days and outlines anticipated progress during the next thirty (30) days. If the Contractor prepares a paper for refereed academic meetings or journals based on materials developed in conjunction with the contract, the Contractor is expected to cite the NLM contract. All instruments, publications, and presentations should be section 508 complaint. The Contractor shall deposit any future publications resulting from this work in PubMed Central (PMC) http://www.ncbi.nlm.nih.gov/pmc/. Period of Performance: The period of performance shall be August 25, 2015 to August 24, 2016 with two (2) additional 12 month option periods. Travel Use of contract funds for travel is prohibited. TECHNICAL EVALUATION FACTORS Technical factors are of paramount consideration in the award of the purchase order; however, price is also important to the overall award decision. All evaluation factors other than price, when combined, are significantly more important than cost. The Government can make tradeoffs among price and technical factors in determining which Offeror provides the best value by awarding to other than the lowest price Offeror or other than the highest technically rated Offeror. Offeror's are advised that an award will be made to that Offeror whose quote provides the best overall value to the Government. Technical Evaluation Criteria (Total 100 Points) In determining which quote represents the best value and results in the lowest overall price alternative (considering price, special features, administrative costs, etc.) to meet the Government's needs, the Government shall evaluate quotes using the following technical evaluation criteria, which are listed in the order of relative importance with weights assigned for evaluation processes: Personnel (40 Points) Key Personnel- 25 Points The Government will evaluate the resumes submitted for each of the proposed Key Personnel. The Government will evaluate the demonstrated experience, education, and training of each key person proposed to determine the breadth, depth, and quality of relevant experience, results and effectiveness of their work in achieving goals in performance of projects of similar size and complexity to this requirement. Key personnel should clearly demonstrate experience performed under projects similar in function, scope, and complexity. Technical Qualifications, Knowledge, Skills, and Certifications - 15 Points The Offeror will be evaluated on its demonstrated the ability to provide personnel with the skills necessary to perform the work as described within this Statement of work. These skills are inclusive of the Oracle R12 e-business suite. Technical Solution (30 Points) The Offeror will be evaluated on how well the technical proposal meets the NBS project objectives and addresses its approach to perform expert management consulting activities. This includes such items as planning the activities of its team(s), scheduling, organizing, and effective utilization of resources, controlling the execution of assigned activities, tasks, sub-tasks, monitoring progress, status reporting, assisting in resolving critical issues, and mitigating risks, Experience should clearly provide evidence and demonstrate work performed under projects similar in function, scope, and complexity as stated in the NBS Expert Management Consulting Support requirement. Management (15 Points) Cost Management -10 Points The Government will evaluate the contractor on their demonstrated ability to contain costs. This includes the effective use of labor categories and skill sets to accomplish tasks, minimizing overhead and management costs, and recommending and using tools or processes that would enable the project team to work in the most efficient manner. Service Level Quality Assurance- 5 Points The Government will evaluate the Offeror's technical approach as it relates to the Offeror's demonstrated ability to deliver quality support services. This means service support that meets best industry practices that meets with industry standard quality with a minimal level of defects. The Government will evaluate management plans that establish processes and methods to ensure the delivery of quality levels of service. The Government will evaluate the Offeror's Corporate Quality Assurance Plan for soundness of company policies and procedures for planning, implementing, and assessing the effectiveness of its project team. Past Performance (15 Points) Past Performance and Experience- 10 points The relevant past performance and experience of the Offeror and any proposed teaming partners will be evaluated to assess the Offeror's approach to recruiting, hiring, training, and retaining a fully qualified workforce, while minimizing turnover. The evaluation of this factor will include an evaluation of the quality of the Offeror's past products and services, its timeliness of performance, success in controlling costs, and the experience of its personnel. The Government prefers an Offeror who shows a trend of successful past performance and experience in: recruiting, hiring, and training staff, and managing service support activities. The evaluation shall include an assessment of the Offerors ability to successfully manage complex, time sensitive operations. Customer Satisfaction- 5 points A determination of customer satisfaction based upon information received from the Offeror's past customers. Questionnaires should be returned by the Offeror's customers. Offerors should not include its customer's questionnaires within its proposal. FEDERAL ACQUISITION REQULATION (FAR) CLAUSES The following provisions and clauses apply to this acquisition and are incorporated by reference. Full text may be found at https://www.acquisition.gov/Far FAR 52.212-1 Instructions to Offerors-Commercial Items FAR 52.212-2 Evaluation-Commercial Items FAR 52.212-3 Offeror Representations and Certifications-Commercial Items FAR 52.212-4 Contract Terms and Conditions-Commercial Items FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes and Executive orders FAR 52.227-14, Rights in Data - General All interested parties shall submit electronic responses to Reginald Brown at reginald.brown3@nih.gov. Responses must be received no later than 12:00 P.M. EST on Wednesday, June 3, 2015, and shall not exceed 10 single-sided pages in length, exclusive of the cover page and letter, table of contents, appendices, and resumes. Please reference solicitation number RFQ-NIHLM2015392 on all correspondence to this notice. Inquiries regarding this notice shall be submitted electronically to reginald.brown3@nih.gov and shall be received by 3 PM EST on Friday, May 22, 2015. The proposal submitted in response to this RFQ shall be prepared in two (2) parts and be clearly identified as a "Technical Proposal" and "Business Proposal." Proposals shall be in sufficient detail to permit proper evaluation, negotiation and/or acceptance thereof. The technical proposal must not contain reference to price; however, resource information (such as data concerning labor hours and categories, materials, subcontracts, etc.) must be contained in the technical proposal so that the Contractor's understanding of the Statement of Work may be evaluated. In order to receive an award, Contractors must have valid registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Application (ORCA) through the System of Award Management (SAM) www.sam.gov.

NIH Consulting Entrepreneur Services

Department of Health and Human Services, National Institutes of Health | Published November 18, 2014  -  Deadline December 10, 2014
cpvs

See Attachment for RFQ details.

MRI-Compatible Device and Radio Frequency Consulting Services

Department of Health and Human Services, National Institutes of Health | Published June 16, 2016  -  Deadline June 24, 2016
cpvs

INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Bogazici Universitesi, Guney Kampus Bebek Besiktas, Istanbul (Europe), 34342, Turkey, to procure the services of an experienced senior scientist in the field of medical device design and RF engineering that is required by the Cardiovascular Intervention Program (CIP) within NHLBI's Department of Intramural Research (DIR). BACKGROUND The National Heart, Lung, and Blood Institute's Cardiovascular Intervention Program is developing cardiovascular catheterization procedures to be conducted entirely under MRI guidance. Catheters are designed and built for novel pre-clinical and early-stage clinical catheter procedures. These catheter devices require an unusual combination of mechanical and electrical engineering skills to accomplish the clinical catheterization requirements as well as embedding radiofrequency (RF) antennas for visibility under MRI as well as avoiding hazardous heating of conductive structures during MRI. The laboratory needs an experienced senior scientist in the field of medical device design and RF engineering to develop new interventional devices addressing the above interventional MRI challenges, and implementing custom engineering and testing to allow FDA Investigational Device Exemption (IDE) approval. The laboratory includes a catheter fabrication facility including cleanroom, as well as a combined X-ray MRI clinical interventional suite. PURPOSE The purpose of this acquisition is to procure the services of an experienced senior scientist in the field of medical device design and RF engineering to develop new interventional devices addressing the above interventional MRI challenges, and implementing custom engineering and testing to allow FDA Investigational Device Exemption (IDE) approval. TASKS TO BE PERFORMED The contractor shall perform the following tasks: • Work with NHLBI Catheter Fabrication Staff to design, perform, analyze, and summarize all mechanical, in-vitro, and in-vivo tests for the TST-35 guidewire FDA Investigational Device Exemption.• Work with NHLBI Catheter Fabrication Staff to design, perform, analyze, and summarize all mechanical, in vitro, and in vivo tests for the Segmented Nitinol Guidewire FDA 510k application.• Assess and document service contracts for the facility.• Document existing suppliers for the facility.• Design clinical grade detachable hub active guidewire with following options: 128cm active guidewire (TST-35DH) otherwise unmodified from the current version (TST-35) 128cm active guidewire with 1.7m passive extension.• Design and manufacture 5 and 6Fr deflectable guiding catheter with inductively-coupled MRI markers. The guiding catheter should have a non-metallic braided shaft, at least 100 cm long, with 0.035" guidewire compatible inner lumen. The application is to cross congenital heart defects including ventricular septal defect. • Design and manufacture 4Fr long active needle with 0.035" guidewire compatible inner lumen. The active needle may have multiple coils to indicate insertion length under MRI.• Design and manufacture 10 Fr bidirectional steerable and MRI compatible volumetric intracardiac echo catheter prototypes during collaboration with Dr. Degertekin's Lab at Georgia Tech University.• Design and manufacture RF safe optical base transmission line for active MRI catheters during collaboration with Dr. Degertekin's Lab at Georgia Tech University. ANTICIPATED PERIOD OF PERFORMANCE Base Year: July 1, 2016 - June 30, 2017Option Year 1: July 1, 2017 - June 30, 2018Option Year 2: July 1, 2018 - June 30, 2019Option Year 3: July 1, 2019 - June 30, 2020 JUSTIFICATION The sole source determination is based on the fact that this is a follow-on to an existing contract and Bogazici Universitesi is currently providing an experienced senior scientist to assist with these services. Due to their specific experience and expertise with the projects outlined above, only Bogazici Universitesi would be able to complete any significant fraction of the work within the project interval. If another contractor were to take over, there would not only be a lapse in services in order to train the new contractor on the processes and procedures of the lab, but there would be an expensive and duplicative investment in analysis, training, and implementation. This loss of productivity and substantial duplication of costs is unacceptable to the Government. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b), soliciting from a single source (for purchases not exceeding the simplified acquisition threshold) and only one responsible source and no other supplies or services will satisfy agency requirements. ADDITIONAL INFORMATION Industry Classification (NAICS) Code is 541990, All Other Professional, Scientific, and Technical Services, and the Small Business Size Standard is $15.0 Million. The acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable (FAR Part 6.001). The resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-88 (June 15th, 2016). This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by June 24, 2016 at 9:00AM EST and must reference synopsis number NHLBI-CSB-(HL)-2016-176-KMA. Responses shall be submitted to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Room 6127, Bethesda, Maryland 20892-7902, Attention: Kevin Alvarez. Responses may be submitted electronically to kevin.alvarez@nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."

Identity and Access Management Consulting Services

Department of Health and Human Services, National Institutes of Health | Published February 23, 2016  -  Deadline March 1, 2016
cpvs

INTRODUCTION: THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), intends to negotiate and issue an award on a sole source noncompetitive basis to Sailpoint Technologies, Inc., 11305 Four Points Drive, Austin, TX, 78726-2367, to provide Identity and Access Management (IAM) software tool consulting services. BACKGROUND: The Information Technology Applications Center (ITAC) is a branch of the Office of Management of the National Heart, Lung, and Blood Institute (NHLBI). ITAC provides a full range of IT support services to the Institute including custom software development, customization and deployment of COTS products, management of the NHLBI IT infrastructure, and management of the Institute's IT Security policy. ITAC collaborates very closely with the NIH Center for Information Technology in many of its functions and serves a set of customers ranging from researchers in the Division of Intramural Research, to scientists managing a scientific grant portfolio, to personnel supporting the administrative aspects of the Institute's operations. To support the lifecycle management and governance of Identity and Access Management, NHLBI has selected the SailPoint IdentityIQ software tool (IAM tool). This tool will integrate to existing infrastructure such as Active Directory, SiteMinder, etc. Consulting services are required to plan the implementation of this software tool. PROCUREMENT: The contractor shall provide the following services: • Conduct planning sessions and best practices workshops for definition of the NHLBI setup • Provide knowledge transfer to the team identified by NHLBI on the software, system, integrations, and operations of the IAM system.• Provide expert technical consulting to the NHLBI development team to include any of the following:o Application on-boarding, including configuration of creation, correlation, and build map ruleso Extending reporting capabilities via custom reportingo Role mining and modeling assistance and configurationo Risk/SOD configuration and implementation consultingo Project/code reviewso Analysis and design activitieso Documentation reviewo Product version upgrades Planning and preparation Analysis of customer configuration Ongoing patch installationo Advanced configuration (workflow, rules, reports)o Mentoring and custom trainingo Performance management plan ANTICIPATED PERIOD OF PERFORMANCE: To be determined upon award. Estimated level of effort: 80 hours of consulting services JUSTIFICATION: The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research. The sole source determination is based on the fact that Sailpoint Technologies Inc. is the only vendor able to meet the requirements of the government. Due to the proprietary nature of the software and unique knowledge needed to provide these services, Sailpoint Technologieis Inc. is the only vendor capable to perform the requested services. REGULATORY AUTHORITY: This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b) Soliciting from a single source, only one responsible source and no other supplies or services will satisfy agency requirements. ADDITIONAL INFORMATION: Industry Classification (NAICS) Code is 541519, Other Computer Related Services and the Small Business Size Standard is $27,500,000. This acquisition is conducted in accordance with the procedures as prescribed in FAR Part 13-Simplified Acquisition Procedures and FAR Subpart 12.6. The solicitation document, the incorporated provisions and clauses are those in the Federal Acquisition Circular 2005-86, effective February 1, 2016. This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by March 1, 2016 at 4:00 p.m. EST. Responses must reference synopsis number HHS-NIH-NHLBI-CSB-HO-2016-071-CDB, may be submitted to the National, Heart, Lung and Blood Institute, Office of Acquisition, COAC Services Branch, 6701 Rockledge Drive, Rm 6207, Bethesda, Maryland 20892-7902, Attention: Chris Bocus. Response may be submitted electronically to chris.bocus@ nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."

Sleep Study Scoring and Interpretation Consulting Support Services

Department of Health and Human Services, National Institutes of Health | Published February 8, 2016  -  Deadline February 19, 2016
cpvs

Sleep Study Scoring and Interpretation Consulting Support Services Competitive Combined Synopsis/Solicitation  HHS-NIH-NIDA-SSSA-CSS-16-153 INTRODUCTIONThis is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This acquisition is being conducted in accordance with the procedures of FAR Part 13--Simplified Acquisition Procedures and FAR Part 12--Acquisition of Commercial Items.The solicitation number is HHS-NIH-NIDA-SSSA-CSS-16-153 and the solicitation is issued as a request for proposal (RFP). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODEThe intended procurement is classified under NAICS code 541690 with a Size Standard of $14 Million. SET-ASIDE STATUSThis acquisition is 100% set aside for small businesses. ACQUISITION AUTHORITY This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures and FAR Part 12-Acquisition of Commercial Items, and IS NOT expected to exceed the simplified acquisition threshold ($150,000.00). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-86-2, dated February 1, 2016. The resultant contract will include all applicable provisions and clauses in effect through this date. DESCRIPTION OF REQUIREMENT BackgroundThe National Institute of Neurological Disorders and Stroke (NINDS) is a part of the National Institutes of Health (NIH), conducting research into the causes, treatment, and prevention of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. The NINDS Sleep Laboratory is a part of the Electroencephalography (EEG) Section, which is part of the Office of the Clinical Director, NINDS. Its mission is two-fold: 1) to provide clinical diagnostic and therapeutic sleep studies to patients participating in research protocols at the NIH Clinical Center, and 2) to provide research support to intramural investigators in developing and carrying out research protocols related to sleep and sleep disorders, including protocol development, obtaining and interpreting sleep and EEG recordings, and designing appropriate testing protocols and outcomes.At least 40 million Americans each year suffer from chronic, long-term sleep disorders, and an additional 20 million experience occasional sleep problems. These disorders and the resulting sleep deprivation interfere with cognition, rehabilitation, work, driving, and social activities. They also account for an estimated $16 billion in medical costs each year, while the indirect costs due to lost productivity and other factors are probably much greater. In addition to primary sleep disorders, many neurologic, psychiatric and other medical diseases have associated sleep disturbances, many of which can be managed effectively once they are correctly diagnosed.PurposeThe purpose of this acquisition is to provide the NINDS EEG Section, under the Office of the Clinical Director, with professional consulting support services to assist in the analysis and interpretation of polysomnographic studies, as well as in providing technical expertise to assist intramural investigators with study design and outcome measures in the protocols investigating sleep or sleep disorders.Project RequirementsThe Contractor shall provide the following professional consulting support services: • Analyze and assist in overseeing the analysis of sleep staging, heart rate, respiratory status (including oxygen saturation rate), limb movements, arousal and unusual behaviors. • Interpret sleep study clinical findings; make clinical correlation and treatment plan recommendations. • Serve as a sleep medicine technical expert to the NIH/NINDS staff on study design and outcome measures. • Prepare, deliver, and track records of final sleep study interpretation for studies performed at the NIH Clinical Center by the NIH/NINDS staff. Reports shall be completed in the template provided by the Government (see sample report, attachment A). The Program Office and Contractor may discuss updates to the template during the award period of performance. Reports will be submitted to a NIH secure shared drive as a PDF within ten (10) days after study completion. • Provide activity status reports and assessment updates as needed to the EEG Section Chief. This includes a periodic summary of number of studies completed and hours required for completion, as well as discussions of technologist performance and other technical, clinical or performance issues on an as-needed basis. Level of EffortThe level of effort is estimated at one (1) contractor employee for 60 labor hours per contract period. Three (3) options for increased quantity in the amount of 20 labor hours each may be exercised during each contract period at the discretion of the Government as required. (Maximum of 120 labor hours per year).Offerors shall propose an hourly labor rate and also provide an extended price for the minimum 60 labor hours, and do the same for the three 20-hour options for increased quantity. Offerors shall propose in this format for each contract period. Key Personnel Requirements: The Contractor employee working under this award shall be considered key personnel. Key Personnel requirements are as follows: • The Contractor employee must have a Doctor of Medicine (MD) degree from an accredited University.• The Contractor Employee must be board certified in Sleep Medicine and Neurology.• The Contractor employee must have a current license to practice to medicine.• The Contractor employee must have a minimum of ten (10) years clinical experience in sleep medicine, specifically in the analysis and interpretation of sleep study findings using polysomnography and multiple sleep latency testing, including adult and pediatric studies, as well as therapeutic titration of in titration of ventilatory support devices. • The Contractor employee must have recent experience in research protocol development and outcome measures related to sleep and sleep disorders as demonstrated by inclusion as a co-author on at least 3 sleep-related publications within the last five years. The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 KEY PERSONNEL, (December 18, 2015): The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.Travel:Travel is not required or authorized for this requirement. No travel costs shall be accepted. The Contractor must be capable of working on site at the place of performance as needed. Collaboration:It is required that all contractors involved with the NINDS community work collaboratively with federal staff and other contractors towards the NINDS mission and other affected organizations and follow the direction of the Contracting Officer's Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer and creating and sharing documentation when required. Government Furnished Information/Property:The Government shall provide the contractor with facilities, equipment, and information necessary to perform the required tasks as well as mandatory annual on-line training per NIH Clinical Center requirements for badge and remote access privileges. Specifically, the Government will provide:• Workspace to the contractor when the contractor is on-site,• Laptop computer, • Grass-Telefactor polysomnographic system and its reading station • Nihon Kohden polysomnographic system and its reading station.• Data for analysis The Contractor shall secure and protect all Contractor-owned property and equipment brought into Government facilities during performance of work under this contract. The Government shall not be held liable for loss of or damage to Contractor-owned property or equipment brought into Government facilities. The Contractor shall remove any Contractor-owned property deemed inappropriate by the Government, for any reason, from the Government facility in which it is found.Confidential Treatment of Sensitive InformationThe Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature.The Contractor shall abide by the Privacy Act of 1974 (5 U.S.C. § 552a) and protect sensitive data which includes patient medical records, contract information, financial and budget records and IP addresses. Disclosure/download of information/data, in whole or in part, by the Contractor may only be made after the Contractor receives written approval from the Contracting Officer. Data shall not be downloaded to or stored on portable devices or outside systems without Government encryption. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer. Data RightsThe NINDS shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations, briefings, work plans, created SOPs and all other deliverables. In addition, it includes any additional deliverables required by contract change. The definition of "unlimited rights" is contained in Federal Acquisition Regulation (FAR) 27.401, "Definitions." FAR clause 52.227-14, "Rights in Data-General," is hereby incorporated by reference and shall be made a part of any resulting contract/order.Security Requirements:The Contractor must obtain approved access to the NIH campus and clinical research database and folder on the intramural NINDS server. The Contractor will utilize Government e-mail and computer systems. The Contractor will undergo a background check by the NIH Division of Personnel Security and Access (DPSAC) and upon successful completion be issued a Health and Human Services (HHS) Identification Badge. Please also see the attached Applicable Information Security Clauses. Period of Performance: The period of performance for this requirement shall be one (1) one-year base period and four (4) one-year option periods as follows:Base Period April 16, 2016 through April 15, 2017Option 1 April 16, 2017 through April 15, 2018Option 2 April 16, 2018 through April 15, 2019Option 3 April 16, 2019 through April 15, 2020Option 4 April 16, 2020 through April 15, 2021 Place of Performance: The place of performance shall be the NIH Main Campus, EEG Reading Room 7-3753 in the Neurodiagnostic Testing Area of the NIH Clinical Research Center, Building 10, 10 Center Drive, Bethesda, MD 20892-0001; and also via remote connection to the NIH Network and scientific data warehouses. It is expected that the Contractor will perform efforts at this address/ place of performance for use of Government-provided equipment and also for meetings as requested. Contract TypeA fixed price purchase order within the Simplified Acquisition threshold is anticipated. The order shall include options to extend the term of the contract as well as options for increased quantity. Question and Answer PeriodInterested contractors may submit questions relating to this requirement. Questions shall be submitted to the contract specialist, Lauren Phelps, via email at lauren.phelps@nih.gov by or before 02/10/2016 at 5:00 PM EST. Late questions shall not be accepted. Questions will be anonymized and answered and the answers will be provided as soon as possible after the question deadline via solicitation amendment. Should no questions be received, no amendment shall be posted. RESPONSE FORMAT Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The offeror must submit 1) a technical proposal with Resume/CV of proposed key personnel and 2) a separate price proposal. The technical proposal should be prepared in reference to the evaluation criteria identified in this solicitation and may be up to twenty-five single-sided pages, inclusive of the resume/CV. The price proposal must include the requirements listed above as well as associated pricing. The price proposal must include a fixed price for the annual 60 hour levels of effort, including the associated labor rate, as well as fixed prices for the annual options for increased quantity. The price proposal must quote fixed prices for all contract periods.Contractors must provide their Company Name, Dun & Bradstreet Number (DUNS), Taxpayer Identification Number (TIN), Business Size, Physical Address, and Point of Contact Information in their responses. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov."IMPORTANT NOTE TO OFFERORS: PLEASE ENSURE THAT YOUR RESPONSE MEETS THE FORMAT REQUIREMENTS AND SPECIFICALLY ADDRESSES EACH OF THE TECHNICAL EVALUATION CRITERION AND THE EVALUATION FOCUS THAT IS INDICATED FOR EACH CRITERION. PROPOSALS MUST INCLUDE BOTH A TECHNICAL DOCUMENT AND A SEPARATE PRICE PROPOSAL. CONTRACTORS NOT SUBMITTING BOTH A TECHINICAL PROPOSAL ADDRESSING THE EVALUATION CRITERIA AND A SEPARATE PRICE PROPOSAL SHALL NOT BE CONSIDERED.EVALUATION CRITERIA FAR clause 52.212-2, Evaluation - Commercial Items applies to this acquisition and the specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a contract resulting from this solicitation on the basis of best value, technical factors and price considered. Technical factors together shall be considered more important than price. The technical evaluation factors are as follows, in order of importance: 1) Factor 1: Technical Capability (50 Points) Offeror proposals shall address each area of the statement of work requirements in sufficient detail to demonstrate a clear understanding of the statement of work and compliance with requirements. The Offeror shall provide evidence of their capabilities in relation to technical analysis and clinical interpretation of sleep studies, treatment of sleep disorders, and ability to provide technical expertise regarding study design and outcome measures for research using sleep studies. The Offeror shall address its plan to prepare, submit, and track reports in accordance with the statement of work requirements. 2) Factor 2: Key Personnel Qualifications (MANDATORY PASS/FAIL FACTOR 25 Points/0 Points) Offeror proposals must contain a resume/CV. The resume/CV must indicate conformance to all key personnel qualifications listed in this solicitation. Offeror proposals meeting this requirement shall receive 25 points for this evaluation factor. Offeror proposals not indicating conformance to ALL key personnel qualifications listed in this solicitation shall receive 0 points for this factor. 3) Factor 3: Past Performance (25 Points) The Contractor shall provide a list of three (3) past performance references with knowledge of the contractor's relevant skills and experience related to the requirements outlined in this Statement of Work during the past five (5) years. Experience must be specific to assessing and interpreting sleep studies or research related to sleep and sleep disorders and shall include the following information for each reference listed: a. Name of Organizationb. Contract Typec. Total Contract Valued. Description of Contractor's responsibilities as they relate to this SOWe. Contract Period of Performancef. Contact Name and Titleg. Relationship to Contractorh. Telephone Numberi. E-mail address Past Performance shall be evaluated for relevance to the current requirement. APPLICABLE CLAUSES AND PROVISIONSThe following FAR clauses and provisions shall apply to this solicitation:1. All Offerors MUST be actively registered in the System for Award Management (SAM) www.sam.gov. 2. The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items (April 2014), applies to this acquisition. 3. FAR clause 52.212-2, Evaluation - Commercial Items (October 2014) applies to this acquisition. 4. A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (March 2015), is required with any offer submitted. This requirement may be met by completion of the provision in the System for Award Management. 5. FAR clauses 52.212-4, Contract Terms and Conditions - Commercial Items (May 2015) and 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (May 2015) apply to this acquisition. 6. HHSAR Clause 352.224-70, Privacy Act (January 2006) applies to this requirement.7. HHSAR 352.237-75 Key Personnel (December 2015) applies to this requirement. 8. The clauses included in the attached Additional Information Security Clauses apply to this acquisition. 9. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." CONTRACTOR PERFORMANCE EVALUATIONFinal Evaluation of Contractor performance will be prepared for the resulting contract in accordance with FAR Subpart 42.15. The final performance evaluation will be prepared at the time of completion of work. Final evaluation will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final. Copies of the evaluation, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions. Contractors may access evaluations through a secure Web site for review and comment at the following address: http://www.cpars.gov CONTRACTING OFFICER'S REPRESENTATIVEA Contracting Officer's Representative (COR) shall be assigned to this requirement at time of award. The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this purchase order; and (5) assisting in the resolution of technical problems encountered during performance.The Contracting Officer is the only person with authority to act as agent of the Government under this purchase order. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this purchase order; (5) otherwise change any terms and conditions of this purchase order; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in the purchase order.The Government may unilaterally change the COR designation for this purchase order. CLOSING INFORMATIONResponses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. All responses must be received by the closing date of this announcement and must reference solicitation number HHS-NIH-NIDA-SSSA-CSS-16-153. Responses shall be submitted electronically via email to Lauren Phelps, Contract Specialist, at lauren.phelps@nih.gov.