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International Audit ID/IQ

Department of Health and Human Services, Centers for Disease Control and Prevention | Published March 12, 2015
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Contract No. 200-2015-61862 has been awarded to Rumph and Associates, P.C. to provide International Audit Services to CDC's Global Health Programs. Services performed under this contract will include financial audits, forensic audits, program-specific audits, and special audits. This competitive 8(a) set-aside was synopsized under solicitation no. 2014-N-16659. This is a single-award Indefinite Delivery/Indefinite Quantity (ID/IQ) contract consisting of one period of sixty (60) months. The aggregate maximum value of all task orders shall not exceed $5,000,000.00.

MiSeq System Automated Generation of DNA Clonal Clusters

Department of Health and Human Services, Centers for Disease Control and Prevention | Published January 27, 2016  -  Deadline February 2, 2016
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THIS NOTICE IS FOR INFORMATIONAL PURPOSES ONLY.The Centers for Disease Control and Prevention (CDC), Center for Global Health contemplates award of a firm-fixed-price sole source purchase order to Illumina, Inc. at 5200 Illumina Way San Diego, CA 92122 for providing critical laboratory technology that possesses next generation DNA sequencing capabilities to assist with monitoring HIV drug resistance.This instrument will be used to meet the public health need of supporting surveillance of HIV drug resistance, specifically, in PEPFAE supported countries. With the scale-up of HIV antiretroviral therapy globally, countrywide HIVDR surveillance has to be conducted in order to monitor the effectiveness of HIV treatment programs. This instrument overcomes the bottleneck of the current technology by greatly increasing the capacity of sample size processing and HIVDR detection. Illumina, Inc. is the only vendor that is able to manufacture the reagents required for Miseq instruments.  No other vendor produces similar or compatible reagents that can be used in the MiSeq instrument. This acquisition will use sole source simplified procedures in accordance with FAR 13.106(b)(1). This requirement is not set aside for small businesses. CDC is not requesting competitive proposals and no solicitation is available. Interested parties who believe they possess the capabilities to satisfy this requirement should indicate their interest in writing and submit a capability statement demonstrating their ability to meet this requirement no later than 5:00 PM Eastern Standard Time, on February 02, 2016. Determination not to compete this proposed action based on responses to this notice is solely within the discretion of the Government. Respondents will assume all financial costs for preparing a response to this notice. The U.S. Government assumes no financial obligation for the preparation and distribution of prepared responses. Inquiries may be sent to Shelley E. Kreimer, Esq. via email at xky4@cdc.gov

Synthesis and Delivery of N-1 and N3-histidine adducts of sulfur mustard

Department of Health and Human Services, Centers for Disease Control and Prevention | Published February 2, 2016  -  Deadline February 9, 2016
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THIS NOTICE IS FOR INFORMATIONAL PURPOSES ONLY.The Centers for Disease Control and Prevention (CDC), Office of Noncommunicable Diseases, Injury and Environmental Health contemplates award of a firm-fixed-price sole source purchase order to the Netherlands Organisation for Applied Scientific Research (TNO) for providing the synthesis and delivery of four custom sulfur mustard-histidine adduct peptides. Specifically, the vendor will provide native and isotopically-labeled N1-histidine adduct of sulfur mustard and native isotopically-labeled N3-histidine adduct of sulfur mustard. These are custom synthetic peptides for the development of a sulfur mustard protein adduct method. The custom peptides require advanced chemistry to sythesize. These peptides are crucial for the detection of sulfur mustard exposure in humans.TNO is the only group that has successfully synthesized these peptides (Noort et al, Arch. Toxicol. 1997).  No other vendor has the unique materials (unadducted pure sulfur mustard) to synthesize this peptide or have the chemistry knowledge to make the peptide.  This acquisition will use sole source simplified procedures in accordance with FAR 13.106(b)(1). This requirement is not set aside for small businesses. CDC is not requesting competitive proposals and no solicitation is available. Interested parties who believe they possess the capabilities to satisfy this requirement should indicate their interest in writing and submit a capability statement demonstrating their ability to meet this requirement no later than 5:00 PM Eastern Standard Time, on February 09, 2016. Determination not to compete this proposed action based on responses to this notice is solely within the discretion of the Government. Respondents will assume all financial costs for preparing a response to this notice. The U.S. Government assumes no financial obligation for the preparation and distribution of prepared responses. Inquiries may be sent to Shelley E. Kreimer, Esq. via email at xky4@cdc.gov.

Fetal Bovine Serum

Department of Health and Human Services, Centers for Disease Control and Prevention | Published February 10, 2016  -  Deadline February 12, 2016
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THIS NOTICE IS FOR INFORMATIONAL PURPOSES ONLY.The Centers for Disease Control and Prevention (CDC), National Center for Emerging and Zoonotic Infectious Diseases contemplates award of a firm-fixed-price sole source purchase order to VWR, 100 Matsonford Road, Radnor, PA 19087 for the purchase of premium grade, gamma irradiated Fetal Bovine Serum. No other products were considered because extnesive correlation studies of many weeks would have to be performed to validate the use of a different serum product with all of our cell lines at significant cost. Using identical laboratory products including media, reagents, and plasticware are essential to preventing variability and inconsistencies in results. It is essential to use validated products to maintain the continuity of research products, reagent development, and consistency in laboratory results. The North American Industrial Classification Standards (NAICS) Code is 325414 with a small business size standard of 500 employees. This acquisition will use sole source simplified procedures in accordance with FAR 13.106(b)(1). This requirement is not set aside for small businesses. CDC is not requesting competitive proposals and no solicitation is available. Interested parties who believe they possess the capabilities to satisfy this requirement should indicate their interest in writing and submit a capability statement demonstrating their ability to meet this requirement no later than 12:00 PM Eastern Standard Time, on February 12, 2016. Determination not to compete this proposed action based on responses to this notice is solely within the discretion of the Government. Respondents will assume all financial costs for preparing a response to this notice. The U.S. Government assumes no financial obligation for the preparation and distribution of prepared responses. Inquiries may be sent to Patrick Winders via email at vxx6@cdc.gov  

PacBio2 Maintenance

Department of Health and Human Services, Centers for Disease Control and Prevention | Published February 10, 2016  -  Deadline February 12, 2016
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THIS NOTICE IS FOR INFORMATIONAL PURPOSES ONLY.The Centers for Disease Control and Prevention (CDC), National Center for Emerging and Zoonotic Infectious Diseases contemplates award of a firm-fixed-price sole source purchase order Pacific Biosciences, 1380 Willow Road, Menlo Park, CA 94025 for maintenance of the Pacific Biosciences RS DNA sequencer. The period of performance is expected to be 12 months. The services maintain the operational readiness of the critical laboratory instrument, and no other vendors were considered because the instrument is a highly specialized platform that can only be maintained by the original manufacturer. The North American Industrial Classification Standards (NAICS) Code is 811219 with a small business size standard of $20.5 million. This acquisition will use sole source simplified procedures in accordance with FAR 13.106(b)(1). This requirement is not set aside for small businesses. CDC is not requesting competitive proposals and no solicitation is available. Interested parties who believe they possess the capabilities to satisfy this requirement should indicate their interest in writing and submit a capability statement demonstrating their ability to meet this requirement no later than 12:00 PM Eastern Standard Time, on February 12, 2016. Determination not to compete this proposed action based on responses to this notice is solely within the discretion of the Government. Respondents will assume all financial costs for preparing a response to this notice. The U.S. Government assumes no financial obligation for the preparation and distribution of prepared responses. Inquiries may be sent to Patrick Winders via email at vxx6@cdc.gov

Bruker Maintenance

Department of Health and Human Services, Centers for Disease Control and Prevention | Published February 10, 2016  -  Deadline February 12, 2016
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THIS NOTICE IS FOR INFORMATIONAL PURPOSES ONLY.The Centers for Disease Control and Prevention (CDC), National Center for Emerging and Zoonotic Infectious Diseases contemplates award of a firm-fixed-price sole source purchase order to Bruker Deltonics for maintenance of the Maxis UHR-TOF and UT Extreme MALDI mass spectrometric equipment and software. The period of performance is expected to be 12 months.The services maintain the operational readiness of the critical laboratory instrument, and no other vendors support Bruker Daltonics instruments. Further, manufacturer provided repairs and services are required to ensure the instrument will perform at original specifications.The North American Industrial Classification Standards (NAICS) Code is 811219 with a small business size standard of $20.5 million. This acquisition will use sole source simplified procedures in accordance with FAR 13.106(b)(1). This requirement is not set aside for small businesses. CDC is not requesting competitive proposals and no solicitation is available. Interested parties who believe they possess the capabilities to satisfy this requirement should indicate their interest in writing and submit a capability statement demonstrating their ability to meet this requirement no later than 12:00 PM Eastern Standard Time, on February 12, 2016. Determination not to compete this proposed action based on responses to this notice is solely within the discretion of the Government. Respondents will assume all financial costs for preparing a response to this notice. The U.S. Government assumes no financial obligation for the preparation and distribution of prepared responses. Inquiries may be sent to Patrick Winders via email at vxx6@cdc.gov  

Operation of the Atlanta Job Corps Center

Department of Labor, Employment Training Administration | Published November 19, 2015  -  Deadline February 25, 2016
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On or about December 2015 the Department of Labor, Employment and Training Administration (DOL ETA) anticipates issuing a request for proposal (RFP) for the operation for the Turner Job Corps Center. Job Corps is a national residential and non-residential training and employment program administered by the United States Department of Labor to address multiple barriers to employment faced by disadvantaged youth, ages 16-24 years, throughout the United States. It is anticipated that the resultant contract will be a cost reimbursement, plus incentive fee type contract. The contract will have a 2-year base period, plus three (3) governmental unilateral renewal options for one (1) year each. A pre-proposal conference and site visit date will be posted in the RFP. The Atlanta Job Corps Center is located at 239 West Lake Avenue NW, Atlanta, GA 30314 and maintenance of the facility located at 3045 Roosevelt Highway College Park, GA 30349. The telephone number is (229)883-8500. It is recommended that potential Offerors download the RFP from the website: http://www.fbo.gov prior to attending the pre-proposal conference and site visit. All questions prior to and at the pre-proposal conference shall be submitted in writing. The successful contractor shall provide academic and career technical training, operate counseling and residential living programs and provide the following support services; Health and Wellness services, processing of student records, a discipline system, clothing issuances, and student mail and legal services. The contractor shall also provide overall Center management and administration as follows; contract and personnel management, staff training, financial management, procurement and property management, facility operations and maintenance, security and safety services, community relations and public information. The on-board strength (OBS) for the Atlanta Job Corps Center is students, with 0 residential males, 325 residential females, 42 non-residential males and 105 non-residential female students.

Pre-qualification for Security (CCTV - Access Control) Projects

United States Postal Service, Facilities Purchasing | Published December 23, 2014  -  Deadline January 27, 2015
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The United States Postal Service (USPS) is interested in pre-qualifying highly qualified suppliers for SECURITY (CCTV / ACCESS CONTROL) work within the United States (Areas I, II, and III). See attached map for Areas. PROPOSAL: Contractors will be required to submit a Qualification Statement/Package and a Management/Technical Plan. To be considered, a company must meet the following minimum requirements as shown in the Qualification Statement/Package: Background, Eligibility, Certification and Affirmation, Bonding Information, Financial Capability, and Safety The second part of the pre-qualification is the Management/Technical Plan which includes: Organizational chart for staff, with resumes and duties/responsibilities Project Management approach to reporting relationships between units/personnel with resumes A statement describing the company's safety program, i.e., responsibilities, reporting relationships and procedures Narrative on approach to procurement of subcontracts Narrative on Contractor Screening Requirements Construction Scheduling Capabilities Comparable Experience. The Postal Service is interested in selecting the MOST qualified companies. Meeting the minimum requirements established in the Contractor Qualification Statement/Package and Management/Technical Plan will NOT guarantee you will be pre-qualified. Only those companies that provide a superior Contractor Qualification Statement/Package and Management/Technical Plan will be pre-qualified. Pre-qualified contractors will be placed on a list for inclusion in future solicitations in this area with similar scopes of work. There is no guarantee that a specific number of solicitations will be issued to these pre-qualified contractors. PROJECT DESCRIPTION: The Contractor must provide all material, labor, tools, supplies, equipment, transportation, superintendence, temporary construction of every nature, and all other services and facilities necessary to complete the repair and alteration of a postal facility for the Postal Service, including all incidental work described in the contract documents. The construction cost and performance time for each individual solicitation/contract will vary. Scope of Work: All work is to be done in accordance with USPS approved plans and specifications. The full scope of work will vary for each solicitation. QUESTIONS SHOULD BE DIRECTED TO: Suzanne Bistline, Suzanne.w.bistline@usps.gov. Deadline for questions is noon on January 26, 2015. Contracting Office Address: 7540 E 53rd Place Room 281 Denver CO 80266-9505

Piccolo Express Chemistry Analyzer

Department of Health and Human Services, Centers for Disease Control and Prevention | Published February 8, 2016  -  Deadline February 11, 2016
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THIS NOTICE IS FOR INFORMATIONAL PURPOSES ONLY. The Centers for Disease Control and Prevention (CDC), Center for Global Health, Division of Parasitic Diseases and Malaria contemplates the award of a firm-fixed-price sole source purchase order to Fisher Healthcare at 9999 Veterans Memorial Drive, Houston TX 77038-2401 for providing Piccolo Xpress, a fully automated advanced diagnostic instrument that provides routine testing of blood samples in only twelve minutes, requiring only 100ul of sample. Abbott Point of Care is the exclusive US distributor of Piccolo Xpress, a fully automated advanced diagnostic instrument that provides routine testing of blood samples in 12 minutes, and requiring only 100ul of sample.  Fisher Healthcare is the preferred distributor of Abbot Point of Care products and the HHS strategic source for laboratory equipment, reagents, and supplies.  Abbot Point of Care does not sell the instrument directly, however they provide warranty, maintenance and consumable support to Fisher Healthcare to ensure continued instrument performance. The Piccolo Xpress point of care biochemistry analyser is a compact, portable, fully automated clinical chemistry system designed for on-site patient testing, which is vital for use in field conditions, where it will be used. The Piccolo analyzer is the only instrument able to perform routine multi-chemistry panels, using only 100ul of whole blood, serum or plasma, using patented 8-cm diameter single use plastic discs containing the liquid diluent and dry reagents. The Piccolo Xpress monitors the reagent reactions simultaneously using nine wavelengths, calculates the results from the absorbance data and reports the results. The Piccolo Xpress blood chemistry analyser self-calibrates with each run and the on-board continuous intelligent Quality Control (iQC™) monitors the analyser, reagent reactions and sample to ensure chemistry and instrument integrity. Results are delivered in approximately 12 minutes, enabling rapid diagnostic information at point of collection. The easy-to-use, maintenance-free system requires no special training to operate, making it uniquely suited for use in low-resource field settings. This acquisition will use sole source simplified procedures in accordance with FAR 13.106(b)(1). This requirement is not set aside for small businesses. CDC is not requesting competitive proposals and no solicitation is available. Interested parties who believe they possess the capabilities to satisfy this requirement should indicate their interest in writing and submit a capability statement demonstrating their ability to meet this requirement no later than 10:30 AM Eastern Standard Time, on February 11, 2016. Determination not to compete this proposed action based on responses to this notice is solely within the discretion of the Government. Respondents will assume all financial costs for preparing a response to this notice. The U.S. Government assumes no financial obligation for the preparation and distribution of prepared responses. Inquiries may be sent to Shelley E. Kreimer, Esq. via email at xky4@cdc.gov

CDC Roybal Shuttle Services

Department of Health and Human Services, Centers for Disease Control and Prevention | Published June 14, 2015  -  Deadline June 19, 2015
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SUBJECT: CDC Roybal Shuttle Services SOLICITATION NUMBER: 2015-Q-17280 RESPONSE DUE DATE/TIME: 19 June 2015/ Before 5:00 pm (1700) EASTERN TIME SECTION A - DESCRIPTION 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 a Request for Quote (RFQ). The associated North American Industrial Classification System (NAICS) code for this procurement is 485113 - Bus and Other Motor Vehicle Transit Systems with a Standard Size of $15,000,00.00 dollars. THIS IS A TOTAL SMALL BUSINESS SET-ASIDE. This is a RFQ for the procurement of Shuttle Services. The CDC's Transportation Services Office (TSO) has a requirement for shuttle services between the CDC Roybal Campus and a nearby off-site parking lot. The Government intends to award a Firm Fixed-Price contract as a result of this solicitation that will include the terms and conditions that are set forth herein. SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS B.1. DESCRIPTION OF SUPPLIES & SERVICES CLIN SUPPLIES/SERVICES QTY/UNIT UNIT PRICE EXTENDED PRICE 0001 Shuttle Services Period of Performance: 6 months from the date of Award 1 Job $______ $____________ OPTION 1 CLIN SUPPLIES/SERVICES QTY/UNIT UNIT PRICE EXTENDED PRICE 1001 Shuttle Services Period of Performance: 3 months from expiration of the base period 1 Job $______ $____________ OPTION 2 CLIN SUPPLIES/SERVICES QTY/UNIT UNIT PRICE EXTENDED PRICE 2001 Shuttle Services Period of Performance: 3 months from expiration of the Option period 1. 1 Job $______ $____________ TOTAL AGGREGATE AMOUNT: $ SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT Performance Work Statement Shuttle Services for the Centers for Disease Control and Prevention OSSAM/Transportation Services Office (TSO) 1.0 Introduction: The purpose of the inter-campus shuttle service is to provide CDC visitors and employees with transit services from the designated park and ride location external to the Roybal Campus. Shuttle services would be provided during core hours (6:30 a.m. to 6:30p.m.). The objective is to provide reliable, cost-effective, quality passenger service. 1.1 Background: The mission of the Centers for Disease Control and Prevention (CDC) is to promote health and quality of life by preventing and controlling disease, injury, and disability. These functions are the backbone of the CDC′s mission. Each of the CDC′s component organizations undertakes these activities in conducting its specific programs. The Transportation Services Office (TSO) supports this mission by providing exceptional customer service in the management of CDC's automotive fleet and parking services. In order to help CDC accomplish its mission, the Government requires a contractor to provide shuttle services for its employees to various CDC locations. TSO is undertaking initiatives to improve service delivery of services to internal and external customers and to increase efficiency of parking operations. A component of the initiative requires shuttle service to the transport CDC visitors, designated employees, and individuals identified with a Reasonable Accomodations (RA) to the Roybal Campus. The primary purpose of the shuttle is to support off-campus parking to relieve capacity issues resulting from additional personnel and guests assigned to the Roybal Campus due to the Ebola Response effort. The shuttle service will ensure that transportation to off-site park and ride location is available. The Contractor shall provide a shuttle services that is compliant with the American Disabilities Act (ADA). The Contractor shall transport employees to and from predetermined shuttle service pick-up points/locations. 1.2 Project Objectives: The contractor shall support the Parking Services section of TSO by providing shuttle services for CDC personnel and authorized visitors. • The Contractor shall provide shuttle service to visitors of the Clifton Road (Roybal) campus and CDC disabled employees that are approved for use of shuttle services as a reasonable accommodation. • The Contractor shall transport visitors and employees to/from a designated Park and Ride location (1800 Briarcliff Road Atlanta, GA. 30329) to specified locations at the CDC Roybal Campus (1600 Clifton Road, Atlanta GA 30329). • The Contractor shall act as an independent organization, and not as an agent of the government. A security clearance is required for all drivers hired under this contract. • Maintain radio communication at all times during the designated business hours . The Contractor shall, provide all labor, materials, and resources unless otherwise stipulated. 1.3 Scope: The scope of this task includes: 1.3.1.1 The shuttle service shall be available Monday through Friday from 7:00 a.m. to 6:00 p.m. 1.3.1.2 The Contractor drivers shall, at all times during the designated business hours, have radio communication. 1.3.1.3 Additionally, the Contractor shuttle drivers must check in with the dispatch officer at least every thirty (30) minutes to make sure the radios are still operational and that no requests for pick up has been missed when not already in service. 1.3.1.4 The Contractor shall respond to a radio call within ten (10) minutes of call. 1.3.1.5 The Contractor shall maintain a daily log of trips. The log intake form should include passenger's name, employment status (FTE, Contractor, guest), user ID (if applicable) time of pick up/return. 1.3.1.6 Ensure the radios are operational by testing battery and frequency. Ensure that no requests for pickup have been missed by contacting dispatch for pick up information. 1.3.1.7 Respond to radio calls and within ten (10) minutes of call for shuttle service 1.3.1.8 The Contract drivers must possess the necessary skills and qualifications to satisfactorily perform the requirements of this service. Drivers must obey all state, local, and CDC traffic laws and regulations. Drivers must possess a valid driver's license; possess good communication skills; have a driving record with no suspensions or revocations; have no criminal record and be drug free. 1.3.1.9 The Contractor shall always be polite, courteous, friendly, and attentive to the passengers needs and shall not engage in any behavior that is disruptive or disturbing to passengers. The drivers shall provide safe service at all times and not drive in a reckless manner, or endanger the lives of any passengers. 1.3.1.10 In the event that the shuttle vehicle is in an accident or is inoperable, another shuttle with a driver needs to be available within 4 hours of notification from the Project Officer. The contractor shall furnish the vehicle maintenance, drivers, fuel, liability insurance, and interstate permits for all vehicles. The contractor shall provide and the driver shall maintain a log of arrival and departure times as well as a count of the number of passengers using the shuttles for each day. If requested, this log will be delivered to the Project Officer on a quarterly basis. Monitoring of the contractor's performance will be conducted by passenger feedback and unannounced spot-checks by the Project Officer or his/her designee at least two (2) times monthly. All performance issues will be discussed with contractor for resolution, and/or corrective action, if necessary. 1.3.1.11 The shuttle drivers must possess the necessary skills and qualifications to satisfactorily perform the requirements of this contract. Drivers must obey all state, local, and CDC traffic laws and regulations. CDC will not reimburse the contractor for any traffic law violations. 1.3.1.12 The shuttle drivers shall be appropriately dressed, in company attire. The driver will maintain a neat, clean, and well-groomed appearance at all times. Drivers shall be in uniform while on duty. The color and style of the uniform shall be approved by the Project Officer. All personnel shall have an employee name tag and identity of the contractor located on the outer clothing which shall be visible at all times. 1.3.1.13 In addition, drivers shall always be courteous, polite and attentive to the passengers needs and shall not engage in any behavior that is disruptive or disturbing to the passengers. This means the driver must not use profanity, or make sexual or racial comments or gestures of any kind to any person while driving the shuttle. The driver shall not drive in a reckless manner, or endanger the lives of any passengers. The driver shall obey all traffic enforcement laws and traffic signs and signals at all times. The drivers must wear seat belts at all times while operating the shuttle. 1.3.1.14 The Contracting Officer may require the contractor to remove a driver from performing under this contract for the following reasons: (1) if the driver generates 3 complaints within a 30-day period (i.e., disruptive or disturbing behavior to the passengers, use of profanity, or making sexual or racial comments or gestures of any kind to any person). (2) if the driver is observed displaying unsafe driving habits, (3) if the driver is at fault in a serious accident, (4) if the driver otherwise fails to comply with the requirements of this contract. 1.3.1.15 The contractor, at its own expense, shall obtain and maintain all necessary permits, franchises, license, or other authorizations and certificates required for lawfully performing services under this contract. All contractor personnel engaged in the performance under this contract shall be required to possess certificates of training as required by the state, county, city or other local jurisdiction. The contractor shall make available to the Project Officer documentation of the certificates, training, licenses and permits no later than (10) days after award of the contract. The Project Officer will forward copies of the aforementioned documentation to the Contracting Officer. The Contractor shall provide the COR evidence that drivers do not exceed the maximum number of hours driven per week as established by Federal law. This evidence shall be in the form of the Contactor's driver's log for the specified drivers. 1.3.1.16 The contractor shall be fully insured with an insurance company licensed and qualified to do business in the State of Georgia. Insurance in the amount of at least $100,000 per person, and $300,000 per occurrence for death or bodily injury and $50,000 per occurrence for property damage or loss shall be procured and maintained during the entire period of performance under this contract. Tasks The Contractor shall stop at the designated park and ride location(s) and return to the Roybal Campus. The shuttle pick-up/drop off location predetermined by the Project Officer at the required intervals. This schedule and or locations may be adjusted based on demand and service level requirements. The timelines may be changed by the Project Officer for certain needs or events that periodically occur at the Roybal Campus. The duration of the special needs or events will not result in a major alteration of the timeline for more than three (3) consecutive calendar days per occurrence, or more than a cumulative total of twenty (20) calendar days per six (6) month period. The maximum wait time for employees at each building shall not exceed 10 minutes from designated pick/drop off locations. The Project Officer will provide the contractor with specific pickup times as identified by route. The contractor will comply with these times. Route: Single route service between 1800 Briarcliff Road and CDC Roybal Campus. Service hours (proposed): 7:00 am - 6:00pm  30 minute intervals (7:00a - 12:00p)  1 hour (12:00p - 3:00p)  30 minute (3:00p -6:00p) Pick up/drop off Locations: Building 19 (Visitor Center) and Building 16 (Level 4 Upper Deck) a. The Contractor shall stop at every shuttle pick-up location predetermined by the Project Officer at the required intervals. b. The Contractor shall: • Provide shuttles that accommodate up to 14 passengers • Ensure that all shuttles are equipped with a first aid kit, flashlight, and fire extinguisher • Ensure that all shuttles have a spare tire and are in excellent operating condition at all times. • Ensure that all shuttles have seat belts for each passenger • Meet High Vehicle standards (i.e., prior to first shuttle departing the vehicle will be washed and interior vacuumed daily, and kept in good operating/mechanical condition) • Provide timely, uninterrupted, dependable service (based upon the shuttle schedule) • Not smoke inside the vehicles • Not handle any packages placed on the shuttle. If any packages are left on the shuttle, the driver will notify the Security Officer and the Project Officer, for proper removal of the package • Not allow drivers to operate AM/FM radios while passengers are on the bus The Contractor shall operate the intra-campus shuttle Monday through Friday, from 6:30a.m. to 6:30p.m., excluding federal holidays (listed below). Federal holidays are: New Year's Day Labor Day Martin Luther King's Birthday Columbus Day President's Day Veteran's Day Memorial Day Thanksgiving Day Independence Day Christmas Day In the event CDC is closed due to inclement weather, national emergency or any other situation under which Government Employees are granted administrative leave, a determination will be made regarding contractor personnel on a case by case basis. Period of Performance: Base Period: 6 Months Approximately August 1 - December 31, 2015 (exact date to be determined) The Period of Performance is TBD. In addition, two (2) three-month option periods are included which may be exercised at any time before expiration of the previous period at the sole discretion of the Contracting Officer. Option Period 1: 3 Months. Dates to be determined. Option Period 2: 3 Months. Dates to be determined. Places of Performance: Roybal Campus Centers for Disease Control and Prevention 1600 Clifton Rd Atlanta, GA 30329 Park and Ride Location 1800 Briarcliff Road Atlanta, GA 30329 Quarterly Progress Reports: The contractor shall provide a monthly status report to contain, at a minimum, the following information: a brief description of requirements, accomplishments during the reporting period and significant events regarding the task order, deliverables submitted or progress on deliverable products, any current or anticipated problems and solutions proposed and a brief summary of activity planned for the next reporting period. Performance Matrix: Tasks Performance Standard Method of Measurement Acceptable Quality Level (AQL) Incentives / Disincentives Task 1: Shuttle Services Completeness, Accuracy User Feedback All data management systems contain accurate and reliable data CPARS Evaluation SECTION D - PACKING, MARKING AND SHIPPING D.1. All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. D.2. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. SECTION E - INSPECTION AND ACCEPTANCE E.1. The Project Officer will perform inspection and acceptance of the delivered supplies. E.2. Inspection and acceptance will be performed at the delivery location identified below. Acceptance is communicated in writing unless otherwise indicated in writing by the Contracting Officer or the Project Officer within 15 days of receipt. SECTION F - DELIVERIES OR PERFORMANCE NOT APPLICABLE SECTION G - CONTRACT ADMINISTRATION DATA G.1. GOVERNMENT REPRESENTATIVES G.1.1. Contracting Officer (CO) (Jul 1999) The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract. No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract. (End of Clause) G.2. INVOICE SUBMISSION G.2.1. Payment by Electronic Funds Transfer (Dec 2005) (a) The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract. FAR 52.232-33, Payment by Electronic Funds Transfer - Central Contractor Registration, in Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments. (b) In addition to Central Contractor Registration, the contractor shall make the designation by submitting the form titled "ACH Vendor/Miscellaneous Payment Enrollment Form" to the address indicated below. Note: The form is either attached to this contract (see Section L - List of Attachments) or may be obtained by contacting the Contracting Officer or the CDC Financial Management Office at (404) 718-8100. (c) In cases where the contractor has previously provided such designation, i.e., pursuant to a prior contract/order, and been enrolled in the program, the form is not required unless the designated financial institution has changed. (d) The completed form shall be mailed after award, but no later than 14 calendar days before an invoice is submitted, to the following address: The Centers for Disease Control and Prevention Financial Management Office (FMO) P.O. Box 15580 Atlanta, GA 30333 Or - Fax copy to: 404-638-5342 (End of Clause) G2.2. CDCAG001 - Invoice Submission (Mar 2006) (a) The Contractor may submit the original invoice/voucher via email: Email: FMOAPINV@CDC.GOV FINANCIAL MANAGEMENT OFFICE (c) In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Financial Management Office is the designated billing office for the purpose of determining the payment due date under FAR 32.904. (d) The Contractor shall include (as a minimum) the following information on each invoice: (1) Contractor's Name & Address (2) Contractor's Tax Identification Number (TIN) (3) Purchase Order/Contract Number and Task Order Number, if Appropriate (4) Invoice Number (5) Invoice Date (6) Contract Line Item Number and Description of Item (7) Quantity (8) Unit Price & Extended Amount for each line item (9) Shipping and Payment Terms (10) Total Amount of Invoice (11) Name, title and telephone number of person to be notified in the event of a defective invoice (12) Payment Address, if different from the information in (c)(1). (13) DUNS + 4 Number (End of Clause) SECTION H - SPECIAL CONTRACT REQUIREMENTS Not Applicable SECTION I - CONTRACT CLAUSES I.1. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2(FEB 1998) I.1.1. This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.acquisition.gov/comp/far/index.html. I.1.2. 52.212-1 Instructions to Offerors-Commercial Items (Feb 2012) I.1.3. 52.212-4 Contract Terms and Conditions-Commercial Items (Feb 2012) I.1.4 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items including subparagraphs (Feb 2012): 52.203-5 Covenant Against Contingent Fees (Apr 1984) 52.203-6 Restrictions on Subcontractor Sales to the Government (Sep 2006) 52.203-7 Anti-Kickback Procedures (Jul 1995) 52.219-6 Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644) 52.222-3 Convict Labor (Jun 2003) 52.222-19 Child Labor-Cooperation with Authorities and Remedies (Jul 2010) 52.222-21 Prohibition of Segregated Facilities (Feb 1999) 52.222-26 Equal Opportunity (Mar 2007) 52.222-36 Affirmative Action for Workers with Disabilities (Oct 2010) 52.222-54 Employment Eligibility Verification (Jan 2009) 52.225-1 Buy American Act-Supplies (Nov 2011) 52.225-13 Restrictions on Certain Foreign Purchases (June 2008) 52.232-33 Payment by Electronic Fund Transfer-System for Award Management (July 2013) 52.233-2 Service of Protest (Sep 2006) 52.233-3 Protest after Award (Aug 1996) 52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004) 52.243-1 Changes-Fixed Price (Aug 1987) I.1.7. 352.202-1 Definitions (Jan 2006) I.1.8. 352.203-70 Anti-lobbying (Jan 2006) I.1.9. 352.222-70 Contactor Cooperation in Equal Employment Opportunity Investigations (2010) I.1.10. 352.223-70 Safety and Health (Jan 2006) I.1.11. 352.239-70 Standard for Security Configurations (Jan 2010) I.1.12. 352.239-71 Standard for Encryption Language (Jan 2010) I.1.13. 352.239-72 Security Requirements for Federal Information Technology Resources (Jan 2010) I.1.14. 352.242-71 Tobacco-free Facilities (Jan 2006) 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 provision) FAR 52.217-8 Option to Extend Services 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 30 days of contract expiration. FAR 52.217-9 Option to Extend the Term of the Contract (a) The Government may extend the term of this contract by written notice to the Contractor within 15 calendar days before the last day of the period of performance; provided, that the Government gives the Contractor a preliminary written notice of its intent to extend at least 15 calendar 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 12 months. 52.212-2 Evaluation-Commercial Items (OCT 2014). (a) 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. Award will be made to the LOWEST PRICED TECHNICALLY ACCEPTABLE offeror. The following factors shall be used to evaluate offers: Technical Capability to meet the Requirements Price Past Performance Technical and past performance, when combined, are equally important to price (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. SECTION J - LIST OF ATTACHMENTS Not Applicable SECTION K - REPRESENTATION, CERTIFICATIONS AND OTHER STATEMENT OF OFFERORS K.1 Offer shall include a completed copy of the provision at FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items (See Section I). SECTION L - INSTRUCTIONS TO THE OFFERORS L.1. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-1(FEB 1998) L.1.1. Solicitation Provisions Incorporated by Reference (Feb 1998) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): http://www.acquisition.gov/comp/far/index.html. L.1.2. FAR clause, 52.212-1 Solicitation Provisions Incorporated by Reference (Feb 1998); [NAICS Code: 485113] L.1.3. The quote shall be submitted electronically via e-mail to the Contracting Officer at VWL8@CDC.GOV before 5:00 pm (1700) EASTERN TIME on 19 June 2015. L.1.4. QUESTIONS: ALL QUESTIONS shall be submitted electronically via e-mail to the Contracting Officer at VWL8@CDC.GOV before 5:00 pm (1700) EASTERN TIME on 16 June 2015. L.1.5. All email responses to this notice must identify the RFQ# in the subject line of the email. L.1.6. FAXED OR MAILED PROPOSALS AND/OR QUESTIONS WILL NOT BE CONSIDERED. SECTION M - CRITERIA FOR AWARD M.1. AWARD: M.1.1. This is an all or none procurement. Offerors must quote on all or none of the line items. M.1.2. Award will be made to the LOWEST-PRICED TECHNICALLY ACCEPTABLE offeror. The base plus all option period shall be evaluated M.1.3. CDC intends to make an award soon after the response date of this notice. And the Government intends to award without discussions. M.1.4. A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

Preventative Maintenance for FDA

Department of Health and Human Services, Food and Drug Administration | Published July 10, 2015  -  Deadline July 20, 2015
cpvs

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation number is FDA-SOL-1150390. This solicitation is issued as a Full and Open/Unrestricted, Request for Quote (RFQ), using the Simplified Acquisitions Procedures of FAR 13.5, Test Program for Certain Commercial Items. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2005-82, Effective 07 May 2015. The associated North American Industry Classification System (NAICS) Code is - 811219 - Other Electronic and Precision Equipment and Maintenance; Small Business Size Standard is $20.5 Million Dollars. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the following specifications below. Please submit all quotes to be valid until September 30, 2015. SUPPLIES OR SERVICES AND PRICES/COSTS The contractor shall fill out the following pricing sheet: CLIN Description Qty Unit of Issue Price 0001 Preventative Maintenance for a Q-Exactive LC-MS 1 EA $ 0002 Option Year 1 - Preventative Maintenance for Q-Exactive LC-MS 1 EA $ 0003 Option Year 2 - Preventative Maintenance for Q-Exactive LC-MS 1 EA $ Total Amount $ I. Background/Intro The Southeastern Regional Laboratory (SRL) needs to purchase a preventative maintenance and service contract for a Q-Exactive liquid chromatography mass spectrometer. The instrument must have annual preventative maintenance performed to remain in good working condition and a service contract to cover the cost of repair for services and parts out of warranty. The instrumentation listed must be serviced by a company or individual certified by the manufacturer of the instruments described and perform the duties detailed as salient characteristics. A reasonable, less than 72 hours, onsite response time of service engineer from initial contact is necessary to prevent loss of laboratory production. A loss of production 72 hours or greater could negatively impact deliverables to the Center for Tobacco Products (CTP) and adversely affect the regulatory decision making process. The preventative maintenance and service contract will include a base year with two optional years. II. Minimum Salient Characteristics All of the following are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated the Government. **Offerors shall address each of the salient characteristics in order to be considered.** The preventative maintenance/service contract must cover the following instrument components: Thermo Electron Instrument System Q-Exactive mass spectrometer UltiMate 3000 mobile phase pump UltiMate 3000 thermostatted column compartment UltiMate 3000 autosampler The preventative maintenance/service contract must meet the follow specifications on all instruments: • Unlimited on-site repair visits including engineer travel, labor and consumables. • Unlimited software updates and upgrades. • OEM parts and supplies, when possible, to ensure peak performance. • Unlimited hardware and software telephone support. • A minimum of one preventative maintenance visit per year. • Preventative maintenance must include necessary cleaning, adjustments, parts replacement and verification to ensure instrument is performing at a minimum of the installation specifications and documentation. • Onsite response time of 72 hours or less by a service engineer from initial phone call requesting service. • All instruments described must be serviced by a single company or individual certified by the manufacturer of each instrument. • Turbo pumps replacement must be included with service contract • The preventative maintenance and service contract will include a base year with two optional years. A. Special instructions The offeror shall include sufficient details on the technical specifications in order for a determination to be made as to whether the offeror meet all the technical requirements identified in the solicitation. Place(s) of Delivery: Food and Drug Administration Southeast Regional Laboratory (SRL) 60 8th Street Atlanta, GA 30309 Instrument can be serviced Monday - Friday between 9:00 am - 4 pm excluding Government holidays. The following FAR and HHSAR clauses apply to this acquisition. FAR clauses and provisions can be obtained at https://www.acquisition.gov/far/index.html. The provision at 52.212-1, Instructions to Offerors-Commercial Items (Apr 2014), applies to this acquisition with the following addenda to the provision. Period for Acceptance of Offers: The offeror agrees to hold the prices firm through September 30, 2015. The provision at 52.212-2, Evaluation-Commercial Items (Jan 1999), is applicable to this requirement. 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 to the responsible offeror whose proposal meets the specifications listed under Part 3 of this solicitation and is the lowest priced proposal received in response to this solicitation. Therefore, award will be made to offeror whose proposal is determined to be Lowest Price Technically Acceptable. A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Mar 2015), applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (May 2015), applies to this acquisition with the following addenda: Invoice Submission: A. The contractor shall submit one original copy of each invoice to the address specified below: Office of Financial Services Food and Drug Administration W032- Second Floor MAIL HUB 2145 10903 New Hampshire Avenue Bldg 32, Rm# 2162, Mail Hub 2145 Silver Spring MD 20993-0002 Attn: Vendor Payments (301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or applicable Far Clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (I) Name and address of the contractor; (II) Invoice Date and Invoice Number; (III) Purchase order/Award Number; (IV) Description, Quantity, Unit of Measure, Unit Price, and Extended Price Supplies Delivered or Services Performed, including: (a) Period of Performance for which costs are claimed; (b) Itemized travel costs, including origin and destination; and (c) Any other supporting information necessary to clarify questionable expenditures; (V) Shipping number and date of shipping, including the bill of lading number and weight of shipment if shipped on government bill of lading; (VI) Terms of any discount for prompt payment offered; (VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (VIII) Name, title and phone number of person to notify in event of defective invoice; (IX) Taxpayer Identification Number (TIN); (X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited; (XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award. C. QUESTIONS REGARDING INVOICES SHALL BE DIRECTED TO THE FDA AT THE TELEPHONE NUMBER PROVIDED ABOVE. The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items (May 2015), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition: (b) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). 52.222-21 Prohibition of Segregated Facilities (Feb 1999) 52.222-26 Equal Opportunity (Apr 2015) (E.O. 11246) 52.222-35 Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212) 52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513) 52.232-33 Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332) FAR 52.217-5 Evaluation of Options (July 1990) FAR 52.217-9 Option to Extend the term of the Contract (Mar 2000) The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.html 352.202-1 Definitions (Jan 2006) 352.203-70 Anti-lobbying (Jan 2006) 352.215-70 Late proposals and revisions (Jan 2006) 352.223-70 Safety and health (Jan 2006) 352.224-70 Privacy Act (Jan 2006) 352.228-7 Insurance--Liability to third persons (Dec 1991) 352.233-71 Litigation and claims (Jan 2006) 352.242-73 Withholding of contract payments (Jan 2006) 352.242-71 Tobacco-free Facilities (Jan 2006) 352.242-74 Final decisions on audit findings (Apr 1984) 352.270-1 Accessibility of meetings, conferences and seminars to persons with disabilities (Jan 2001) The supplies delivered hereunder shall be inspected and accepted at destination by the Contracting Officer's Representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. The COR name will be provided 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 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 contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. All responsible sources may submit a quote, which if timely received, shall be considered. The quote shall reference solicitation number FDA-SOL-1150390. The quotes are due by email to the point of contact listed below on or before July 20, 2015 by 1:00pm ET. Please contact Corina Genson at 240-402-5352 or email at Corina.Couch@fda.hhs.gov

Cigarette Paper Permeability Measurement Instrument for FDA

Department of Health and Human Services, Food and Drug Administration | Published March 15, 2016  -  Deadline March 22, 2016
cpvs

COMBINED SYNOPSIS/SOLICITATION FOR A CIGARETTE PAPER PERMEABILITY MEASUREMENT INSTRUMENT FOR FDA SOLICITATION NUMBER: FDA-SOL-1160787(2) This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation number is FDA-SOL-1160787(2). The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2005-85, Effective 04 Dec 2015.The associated North American Industry Classification System (NAICS) Code is - 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 Employees.The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the following specifications below. SUPPLIES OR SERVICES AND PRICES/COSTSThe contractor shall fill out the following pricing sheet:CLIN Description Qty Unitof Issue Price1 Cigarette Paper Permeability Measurement Instrument 1 Each $2 Installation and Travel Expense 1 Each $3 IQ/OQ Service 1 Each $4 Shipping Charges 1 Each $5 Optional Year 1 - Cigarette Paper Instrument Preventative Maintenance Service 1 Each $6 Optional Year 2 - Cigarette Paper Instrument Preventative Maintenance Service 1 Each $Total Amount $ STATEMENT OF WORK (SOW) I. BACKGROUND INFORMATION The Southeast Regional Laboratory (SRL) needs to purchase a Cigarette Paper Permeability measurement instrument for the purpose of developing and transferring methods in SRL to support regulatory work for the Center for Tobacco Products. This instrument will increase SRL Tobacco Group capabilities to analyze the permeability of cigarette paper as well as performing tests to market tobacco products. This instrument is designed to perform paper permeability analysis of cigarette paper, tipping paper, and plug wrap. Cigarette paper permeability testing is used by the tobacco industry as a quality control of their finish product. II. SALIENT CHARACTERISTICS All of the following are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the Project Advisory Group prior to purchase. **Offerors shall address each of the salient characteristics in order to be considered.** The system shall be a fully operational Paper Permeability Measurement instrument that will be used to analyze cigarette paper. The system shall have the following characteristics: • The instrument must be capable of performing paper permeability/Porosity as per CORESTA method No.40 and conform to ISO2965:2009 standard. • The instrument test piece holder must be capable of holding the cigarette paper without leaks. • The instrument test piece holder must be exchangeable to other sizes and at least include a rectangular test area of 2cm2. Different size holders must be included. • The instrument must be capable of providing accurate results within 2% and have a reproducibility of 2% above 10 CU (cm3 min-1 cm-2 at 1kPa) using the 2cm2 holder. For air porosity of less than 10 CU must be at least within 10% reproducible.• The instrument pressure range must be at least between 0-50 liter/minutes.• The instrument must measure permeability from 0 to 40,000 CU on the 2 cm2 clamp. • The instrument must include an integrated touch screen controller, keyboard or PC/monitor needed for operation and printer.• Training must be provided with the system installation. • The instrument installation must include IQ/OQ with documentation.• The instrument must be supplied with all necessary accessories to calibrate and run samples after installation.• The instrument power connection must be for a US power outlet with a voltage of 115V. • The system must be capable of performing the air permeability test by vacuum and positive pressure without the need to change parts or settings. It must change between methods by the computer operating system.• The instrument must be able to operate between temperature 18C to 33C and humidity of 20% to 80%.• The instrument must be benchtop size. • The system must include at least 1 year warranty that includes parts, travel and labor. Warranty All labor, replacement parts and components (excluding consumables) shall be guaranteed. III. PERIOD OF PERFORMANCE The period of performance shall be for a base period of twelve (12) months and two (2) twelve (12) month optional periods. IV. GOVERNMENT FURNISHED PROPERTY The Government shall provide visitor's access to the FDA facilities during the performance of the contract. A. Special instructionsThe offeror shall include sufficient details on the technical specifications in order for a determination to be made as to whether the offeror meet all the technical requirements identified in the solicitation. Place(s) of Delivery: Food and Drug Administration/SRL60 8th Street NEAtlanta, Ga. 30309 Hours of Operation: The Contractor will be responsible for delivering equipment between the hours of 9:00 am - 3:00 pm Monday thru Friday except Federal Holidays. The following FAR and HHSAR clauses apply to this acquisition. FAR clauses and provisions can be obtained at https://www.acquisition.gov/far/index.html. The provision at 52.212-1, Instructions to Offerors-Commercial Items (Apr 2014), applies to this acquisition with the following addenda to the provision. Period for Acceptance of Offers: The offeror agrees to hold the prices firm through September 30, 2015.The provision at 52.212-2, Evaluation-Commercial Items (Jan 1999), is applicable to this requirement. 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 to the responsible offeror whose proposal meets the specifications listed under Part 3 of this solicitation and is the lowest priced proposal received in response to this solicitation. Therefore, award will be made to offeror whose proposal is determined to be Lowest Price Technically Acceptable. A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Mar 2015), applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (May 2015), applies to this acquisition with the following addenda: Invoice Submission: A. The contractor shall submit one original copy of each invoice to the address specified below: Office of Financial ServicesFood and Drug AdministrationW032- Second FloorMAIL HUB 214510903 New Hampshire AvenueBldg 32, Rm# 2162, Mail Hub 2145Silver Spring MD 20993-0002Attn: Vendor Payments(301) 827-3742 or (866) 807-3742fdavendorpaymentsteam@fda.gov B. The contractor shall submit one electronic copy of the invoice to each of the recipients listed below: Project Officer: TBDEmail: Contract Specialist: Corina GensonEmail: Corina.Couch@fda.hhs.gov Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or applicable Far Clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (I) Name and address of the contractor; (II) Invoice Date and Invoice Number; (III) Purchase order/Award Number; (IV) Description, Quantity, Unit of Measure, Unit Price, and Extended Price Supplies Delivered or Services Performed, including: (a) Period of Performance for which costs are claimed; (b) Itemized travel costs, including origin and destination; and (c) Any other supporting information necessary to clarify questionable expenditures;(V) Shipping number and date of shipping, including the bill of lading number and weight of shipment if shipped on government bill of lading; (VI) Terms of any discount for prompt payment offered; (VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)(VIII) Name, title and phone number of person to notify in event of defective invoice; (IX) Taxpayer Identification Number (TIN);(X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;(XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award. C. QUESTIONS REGARDING INVOICES SHALL BE DIRECTED TO THE FDA AT THE TELEPHONE NUMBER PROVIDED ABOVE. The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items (Dec 2015), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition: (b) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513)52.232-33 Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332) FAR 52.222-41 Service Contract Labor Standards (May 2014)FAR 52.217-5 Evaluation of Options (July 1990)FAR 52.217-9 Option to Extend the term of the Contract (Mar 2000) The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.html 352.202-1 Definitions (Jan 2006)352.203-70 Anti-lobbying (Jan 2006)352.215-70 Late proposals and revisions (Jan 2006)352.223-70 Safety and health (Jan 2006)352.224-70 Privacy Act (Jan 2006)352.228-7 Insurance--Liability to third persons (Dec 1991)352.233-71 Litigation and claims (Jan 2006)352.242-73 Withholding of contract payments (Jan 2006)352.242-71 Tobacco-free Facilities (Jan 2006)352.242-74 Final decisions on audit findings (Apr 1984)352.270-1 Accessibility of meetings, conferences and seminars to persons with disabilities (Jan 2001) The supplies delivered hereunder shall be inspected and accepted at destination by the Contracting Officer's Representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. The COR name will be provided 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 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 contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. All responsible sources may submit a quote, which if timely received, shall be considered. The quote shall reference solicitation number FDA-SOL-1160787(2). The quotes are due by email to the point of contact listed below on or before March 22, 2016 by 1:00pm ET. Please contact Corina Genson at 240-402-5352 or email at Corina.Couch@fda.hhs.gov  

Cigarette Paper Instrument for FDA

Department of Health and Human Services, Food and Drug Administration | Published December 30, 2015  -  Deadline January 14, 2016
cpvs

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation number is FDA-SOL-1160787. This solicitation is issued as a Total Small Business Set, Request for Quote (RFQ). The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2005-85, Effective 04 Dec 2015. The associated North American Industry Classification System (NAICS) Code is - 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 Employees. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the following specifications below. SUPPLIES OR SERVICES AND PRICES/COSTS The contractor shall fill out the following pricing sheet: CLIN Description Qty Unit of Issue Price 0001 Cigarette Paper Instrument 1 Each $ 0002 Cigarette Paper Instrument Preventative Maintenance Service 12 Months $ 0003 Cigarette Paper Instrument Preventative Maintenance Service 12 Months Total Amount $ STATEMENT OF WORK (SOW) I. BACKGROUND INFORMATION The Southeast Regional Laboratory (SRL) needs to purchase a Cigarette Paper Permeability measurement instrument for the purpose of developing and transferring methods in SRL to support regulatory work for the Center for Tobacco Products. This instrument will increase SRL Tobacco Group capabilities to analyze the permeability of cigarette paper as well as performing tests to market tobacco products. This instrument is designed to perform paper permeability analysis of cigarette paper, tipping paper, and plug wrap. Cigarette paper permeability testing is used by the tobacco industry as a quality control of their finish product. II. SALIENT CHARACTERISTICS All of the following are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the Project Advisory Group prior to purchase. **Offerors shall address each of the salient characteristics in order to be considered.** The system shall be a fully operational Paper Permeability Measurement instrument that will be used to analyze cigarette paper. The system shall have the following characteristics: • The instrument must be capable of performing paper permeability/Porosity as per CORESTA method No.40 and conform to 1802965:2009 standard. • The instrument shall be able to perform the full range of permeability of papers used to manufacture cigarettes. Measuring range shall be approximate 2-65,000 ml/min with corresponding set of standards. • The instrument test piece holder must be capable of holding the cigarette paper without leaks. • The instrument test piece holder must be exchangeable to other sizes and at least include a rectangular test area of 2cm2. • The instrument must auto-calibrate across the measurement range. • The instrument must be capable of providing accurate results within 2% and have a reproducibility of 2% above 10 CU (cm3 min-1 cm·2 at 1kPa) using the 2cm2 holder. For air porosity of less than 10 CU must be at least within 10% reproducible. • the instrument must be able to measure the pressure difference to at least 0.001 kPa having a relative error of no more than 2%. • Must include a Pneumatic controller to regulate the air flow at a given but adjustable pressure difference between the two mating faces of the test piece holder. • Must be capable of measuring the air flow within an error not greater than 5%. • The instrument pressure range must be at least between 0-50 liter/minutes. • The instrument must measure permeability from 0 to 40,000 CU on the 2 cm2 clamp. • The instrument must include an integrated touch screen controller, keyboard or PC/monitor needed for operation and printer. • Vendor shall provide one day or less on-site training for up to 5 Analysts within 60 days after installation. • The instrument installation must include IQ/OQ with documentation. • The instrument must be supplied with all necessary accessories to calibrate and run samples after installation. • The instrument shall be supplied with a semi-automatic paper tractor; • thermal printer and printer paper. • The instrument power connection must be for a US power outlet with a voltage of 115V. • The system must be capable of performing the air permeability test by vacuum and positive pressure without the need to change parts or settings. It must change between methods by the computer operating system. • The instrument must be able to operate between temperature 18C to 33C • and humidity of 20% to 80%. • The instrument must be benchtop size. • The system must include at least a 1 year warranty that includes parts, travel and labor. • Contractor shall include in their proposal pricing for two (2) option years for preventative maintenance service upon expiration of manufacturer warranty, installation, travel expenses and shipping charges. Warranty All labor, replacement parts and components (excluding consumables) shall be guaranteed. III. PERIOD OF PERFORMANCE The period of performance shall be for a base period of twelve (12) months and two (2) twelve (12) month optional periods. Option periods shall include all work included in the base period. IV. GOVERNMENT FURNISHED PROPERTY The Government shall provide visitor's access to the FDA facilities during the performance of the contract. A. Special instructions The offeror shall include sufficient details on the technical specifications in order for a determination to be made as to whether the offeror meet all the technical requirements identified in the solicitation. Place(s) of Delivery: Food and Drug Administration/SRL 60 8th Street NE Atlanta, Ga. 30309 Hours of Operation: The Contractor will be responsible for delivering equipment between the hours of 9:00 am - 3:00 pm Monday thru Friday except Federal Holidays. The following FAR and HHSAR clauses apply to this acquisition. FAR clauses and provisions can be obtained at https://www.acquisition.gov/far/index.html. The provision at 52.212-1, Instructions to Offerors-Commercial Items (Apr 2014), applies to this acquisition with the following addenda to the provision. Period for Acceptance of Offers: The offeror agrees to hold the prices firm through September 30, 2015. The provision at 52.212-2, Evaluation-Commercial Items (Jan 1999), is applicable to this requirement. 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 to the responsible offeror whose proposal meets the specifications listed under Part 3 of this solicitation and is the lowest priced proposal received in response to this solicitation. Therefore, award will be made to offeror whose proposal is determined to be Lowest Price Technically Acceptable. A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Mar 2015), applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (May 2015), applies to this acquisition with the following addenda: Invoice Submission: A. The contractor shall submit one original copy of each invoice to the address specified below: Office of Financial Services Food and Drug Administration W032- Second Floor MAIL HUB 2145 10903 New Hampshire Avenue Bldg 32, Rm# 2162, Mail Hub 2145 Silver Spring MD 20993-0002 Attn: Vendor Payments (301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov B. The contractor shall submit one electronic copy of the invoice to each of the recipients listed below: Project Officer: TBD Email: Contract Specialist: Corina Genson Email: Corina.Couch@fda.hhs.gov Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or applicable Far Clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (I) Name and address of the contractor; (II) Invoice Date and Invoice Number; (III) Purchase order/Award Number; (IV) Description, Quantity, Unit of Measure, Unit Price, and Extended Price Supplies Delivered or Services Performed, including: (a) Period of Performance for which costs are claimed; (b) Itemized travel costs, including origin and destination; and (c) Any other supporting information necessary to clarify questionable expenditures; (V) Shipping number and date of shipping, including the bill of lading number and weight of shipment if shipped on government bill of lading; (VI) Terms of any discount for prompt payment offered; (VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (VIII) Name, title and phone number of person to notify in event of defective invoice; (IX) Taxpayer Identification Number (TIN); (X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited; (XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award. C. QUESTIONS REGARDING INVOICES SHALL BE DIRECTED TO THE FDA AT THE TELEPHONE NUMBER PROVIDED ABOVE. The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items (Dec 2015), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition: (b) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644 52.222-21 Prohibition of Segregated Facilities (Apr 2015) 52.222-26 Equal Opportunity (Apr 2015) (E.O. 11246) 52.222-35 Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212) 52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513) 52.232-33 Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) FAR 52.222-41 Service Contract Labor Standards (May 2014) FAR 52.217-5 Evaluation of Options (July 1990) FAR 52.217-9 Option to Extend the term of the Contract (Mar 2000) The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.html 352.202-1 Definitions (Jan 2006) 352.203-70 Anti-lobbying (Jan 2006) 352.215-70 Late proposals and revisions (Jan 2006) 352.223-70 Safety and health (Jan 2006) 352.224-70 Privacy Act (Jan 2006) 352.228-7 Insurance--Liability to third persons (Dec 1991) 352.233-71 Litigation and claims (Jan 2006) 352.242-73 Withholding of contract payments (Jan 2006) 352.242-71 Tobacco-free Facilities (Jan 2006) 352.242-74 Final decisions on audit findings (Apr 1984) 352.270-1 Accessibility of meetings, conferences and seminars to persons with disabilities (Jan 2001) The supplies delivered hereunder shall be inspected and accepted at destination by the Contracting Officer's Representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. The COR name will be provided 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 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 contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. All responsible sources may submit a quote, which if timely received, shall be considered. The quote shall reference solicitation number FDA-SOL-1160787. The quotes are due by email to the point of contact listed below on or before January 14, 2015 by 1:00pm ET. Please contact Corina Genson at 240-402-5352 or email at Corina.Couch@fda.hhs.gov

UHPLC-UV Mass Spec

Department of Health and Human Services, Food and Drug Administration | Published April 6, 2015  -  Deadline April 17, 2015
cpvs

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation number is FDA-SOL-1146767. This solicitation is issued as a Request for Quote (RFQ), using the Simplified Acquisitions Procedures of FAR 13.5, Test Program for Certain Commercial Items. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2005-80, dated March 02, 2015. The associated North American Industry Classification System (NAICS) Code is - 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 in number of employees. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the following specifications below. SUPPLIES OR SERVICES AND PRICES/COSTS The contractor shall fill out the following pricing sheet: CLIN Description Qty Unit of Issue Price 0001 Ultra-High Performance Liquid Chromatography (UHPLC) with single quadrupole mass detector (MS) and UV/Vis Spectrophotometer (PDA) detector 1 EA $ 0002 IQ/OQ/PQ 1 EA $ 0003 Shipping 1 EA $ 0004 Onsite Training and Installation 1 EA $ 0004 Option Year 1 - Post Warranty Preventative Maintenance 1 EA $ 0005 Option Year 2 - Post Warranty Preventative Maintenance 1 EA $ Total Amount $ I. Intro/Background The United States Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) has a requirement to purchase a Ultra-High Performance Liquid Chromatography (UHPLC) with single quadrupole mass detector (MS) and UV/Vis Spectrophotometer (PDA) detector. II. Objectives The FDA needs to purchase Ultra-High Performance Liquid Chromatography (UHPLC) with single quadrupole mass detector (MS) and UV/Vis Spectrophotometer (PDA) detector. It is needed to transfer and develop methods using UV detector and confirm the analyte of interest by a single quadrupole detector simultaneously. Additionally, the MS detector can be used for quantification purposes. III. Requirements All of the following are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the Government. A. General specifications: The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration. The entire system shall be warranted for parts and labor for 12 months from date of installation acceptance. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. Installation and operator familiarization should be included for both UHPLC and mass spectrometer modules. The vendor shall also provide pricing for an optional extended warranty/maintenance agreement for four additional years. ,However, this information shall not obligate FDA to purchase the extended warranty/maintenance agreement. The specific requirements for this optional service contract are: 1) Service contract coverage shall include trouble-shooting capabilities based on complete knowledge of the entire instrument, immediate access to certified replacement parts, and immediate access to improvements and new procedures provided by the original vendor and manufacturer. 2) Service shall be provided by service engineers who are trained and certified by the original manufacturer. Engineers shall have access to the manufacturer's latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures. 3) The contract shall enable the Project Officer to have access to the manufacturer's call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. 4) The offeror shall be able to guarantee that a service engineer will be scheduled to work with priority over non service contracted work. 5) The vendor shall provide all travel, labor and parts at no additional charge. There shall be at least one (1) scheduled maintenance visit per year of the contract. The vendor shall also include coverage for software and firmware updates. The vendor shall demonstrate and document upon installation that the item meets all performance specifications, including the mass spectrometer sensitivity specification (IQ/OQ/PQ). The instrument shall not be accepted until those performance specifications have been met. B. Salient Characteristics **Offerors shall address each of the salient characteristics in order to be considered.** 1. The system modules, including the mass detector, must be stackable due to space restriction in the laboratory. UHPLC cannot take more than 15 inch space width x 29 inches depth. 2. The system must come with all necessary modules to operate automatically: Auto-sampler with cooling capabilities, Column heating compartment, Detectors as mentioned below, assembly parts and Pumps. 3. Must work with a power connection of 120VAC. 4. Operating in a flow rate range between 0.01 to 2.000 mL/min. 5. The pump must handle at least four solvents (quaternary pump) 6. The software must include the System Suitability package. 7. System software must be capable of tracking column usage and condition automatically. 8. Maximum operating pressure of at least 15,000 psi. 9. Operational between the pH range of 2 to 12. 10. Integrated leak detection sensors. 11. Heating HPLC column compartment from 4C to 90C and include a solvent pre-heater. 12. One (1) Diode Array Detector (PDA) compatible with UHPLC. a. Must perform automated diagnostics at start-up. b. Collect UV spectra from 190nm to 500nm. c. Software must allow the handling of 3D data. Change chromatogram by manipulating the absorbance wavelength. d. Sampling rate up to 80 points/s. e. Optical resolution of at least 1.2nm f. Wavelength accuracy of at least +1nm. 13. One (1) Single Quadrupole Mass Spectrometer Detector. a. Must have atmospheric pressure ionization electrospray source. b. Mass calibration and resolution verification must be performed automatically. c. Must perform automated diagnostics at start-up. d. Must perform full scan and Select ion analysis. e. Mass Range: 30 to at least 1250 m/z f. Must have a fast Acquisition rate to obtain enough data points in the analyte peak for quantitation purposes. g. Mass accuracy of at least 0.2 Da h. Must switch polarity within 25 ms. i. Must have a resolution of at least 0.7Da j. Must come with all parts and software needed to operate. 14. One (1) monitor (minimum specification of at least 21 inch), computer, software and printer necessary to operate the UHPLC and mass spectrometer detector. 15. The instrument must be capable of quantitating the analyte of interest simultaneously in both detectors at PDA concentration level. Must be capable of producing a linear calibration curve in both detectors with one injection. 16. The instrument must have the capability of using each detector individually. 17. Must come with at least two columns. 18. The system must come with one year warranty that includes parts, labor, travel, support, etc. 19. Must include installation service, IQ/OQ and documentation. C. Delivery Addresses: US Food & Drug Administration Denver Laboratory (DEN-LAB) Denver Federal Center 60 8th Street, NE Atlanta, GA 30309 Supplies and Equipment shall be delivered Monday thru Friday 9:00am - 3:00pm. D. Clauses The following FAR and HHSAR clauses apply to this acquisition. FAR clauses and provisions can be obtained at https://www.acquisition.gov/far/index.html. The provision at 52.212-1, Instructions to Offerors-Commercial Items (Apr 2014), applies to this acquisition with the following addenda to the provision. Period for Acceptance of Offers: The offeror agrees to hold the prices firm through September 30, 2015. The provision at 52.212-2, Evaluation-Commercial Items (Jan 1999), is applicable to this requirement. 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 to the responsible offeror whose proposal meets the specifications listed under Part 3 of this solicitation and is the lowest priced proposal received in response to this solicitation. Therefore, award will be made to offeror whose proposal is determined to be Lowest Price Technically Acceptable. A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (May 2014), applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (Dec 2014), applies to this acquisition with the following addenda: Invoice Submission: A. The Contractor shall submit one original copy of each invoice to the address specified below: Office of Financial Services Food and Drug Administration W032- Second Floor MAIL HUB 2145 10903 New Hampshire Avenue Bldg 32, Rm# 2162, Mail Hub 2145 Silver Spring MD 20993-0002 Attn: Vendor Payments (301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or applicable Far Clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (I) Name and address of the contractor; (II) Invoice Date and Invoice Number; (III) Purchase order/Award Number; (IV) Description, Quantity, Unit of Measure, Unit Price, and Extended Price Supplies Delivered or Services Performed, including: (a) Period of Performance for which costs are claimed; (b) Itemized travel costs, including origin and destination; and (c) Any other supporting information necessary to clarify questionable expenditures; (V) Shipping number and date of shipping, including the bill of lading number and weight of shipment if shipped on government bill of lading; (VI) Terms of any discount for prompt payment offered; (VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (VIII) Name, title and phone number of person to notify in event of defective invoice; (IX) Taxpayer Identification Number (TIN); (X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited; (XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award. C. Questions regarding invoices shall be directed to the FDA at the telephone number provided above. The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items (Mar 2015), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition: • 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). • 52.222-21 Prohibition of Segregated Facilities (Feb 1999) • 52.222-26 Equal Opportunity (Mar 2007) (E.O. 11246) • 52.222-35 Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212) • 52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793) • 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513) • 52.232-33 Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332) FAR 52.217-5 Evaluation of Options (July 1990) FAR 52.217-9 Option to Extend the term of the Contract (Mar 2000) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.html • 352.202-1 Definitions (Jan 2006) • 352.203-70 Anti-lobbying (Jan 2006) • 352.215-70 Late proposals and revisions (Jan 2006) • 352.223-70 Safety and health (Jan 2006) • 352.224-70 Privacy Act (Jan 2006) • 352.228-7 Insurance--Liability to third persons (Dec 1991) • 352.233-71 Litigation and claims (Jan 2006) • 352.242-73 Withholding of contract payments (Jan 2006) • 352.242-71 Tobacco-free Facilities (Jan 2006) • 352.242-74 Final decisions on audit findings (Apr 1984) • 352.270-1 Accessibility of meetings, conferences and seminars to persons with disabilities (Jan 2001) The supplies delivered hereunder shall be inspected and accepted at destination by the Contracting Officer's Representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. The COR name will be provided 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 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 contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. All responsible sources may submit a quote, which if timely received, shall be considered. The quote shall reference solicitation number FDA-SOL-1146767. The quotes are due by email to the point of contact listed below on or before April 17, 2015 by 1:00pm ET. Please contact Corina Couch at (240) 402-5352 or email at Corina.Couch@fda.hhs.gov .

Brand Name or Equal to an Agilent 1290 Infinity UHPLC System

Department of Health and Human Services, Food and Drug Administration | Published April 8, 2015  -  Deadline April 17, 2015
cpvs

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation number is FDA-SOL-1145520. This solicitation is issued as a, Total Small Business Set Aside in accordance with the SBA Non-Manufacture Rule waiver dated January 1, 2015, Request for Quote (RFQ), using the Simplified Acquisitions Procedures of FAR 13.5, Test Program for Certain Commercial Items. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2005-80, Effective 02 Mar 2015. The associated North American Industry Classification System (NAICS) Code is - 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 in number of employees. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the following specifications below. Please submit all quotes to be valid until September 30, 2015. SUPPLIES OR SERVICES AND PRICES/COSTS The contractor shall fill out the following pricing sheet: CLIN Description Qty Unit of Issue Price 0001 Agilent 1290 Infinity UHPLC System 3 EA $ Total Amount $ I. Background/Intro The Mycotoxin Group in the Southeast Regional Laboratory (SRL) analyzes various grains, nuts and milk commodities for toxic metabolites produced by certain fungi that can infect and proliferate on various agricultural commodities in the field and/or during storage. SRL serves as the national servicing lab for all districts for domestic aflatoxin testing. The increase in sample load for FY15 is justification for the need a Ultra High Performance Liquid Chromatography (UHPLC) system to analyze large volume of samples in less time would greatly increase sample throughput and decrease sample turn-around times. The demand for multi-residue analyses would require the use of this UHPLC system since it employs a dual detection system for both fluorescence and diode array detection. II. Minimum Salient Characteristics All of the following system requirements are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the FCC prior to purchase. A. General Characteristics: Pump: • Active seal wash or equivalent; Must be available for handling of solvents containing salt buffers so that it ensures longer lifetime of the seal when using higher buffer concentrations. • SW Features; To ensure that all the HW advantages can be automatically controlled and handled in SW o Variable stroke o Solvent bottle filling status o Pressure limit • SW features-diagnostics: to ensure high instrument uptime o Leak Test o Pressure test o Records, log files o Pump solvent delivered • The pump must have a settable flow range wider than 0.001 - 5 ml/min, in ≤0.001 ml/min increments that ensures flexibility over the whole flow rate range - standard analytical HPLC to semi-preparative HPLC • Must have a flow precision/retention of ≤0.07% RSD or 0.005 min SD, whatever is greater (0.2 - 5.0 mL/min) • Compressibility must be user selectable based on the solvent in use so that it ensures precise flow rates and therefore also RT precision • Variable stroke or equivalent. Usually is a system comprising of two dual piston in series pumps with proprietary servo-controlled variable stroke drive, floating piston design and active inlet valve which allows for Precise pumping results in precise flow rate and therefore in excellent RT precision. • Integrated Solvent degasser which is a system comprised of integrated two-channel degasser so that Reproducible solvent properties are maintained Mulitcolumn: • The temperature range must be 4°C to 110°C, (minimum 20°C below ambient) • The temperature accuracy must be ± 0.05 ° C or better • Must contain Pre-column heating and post column cooling • Must contain a local handheld control module must be available with plot-, diagnosis-, and error handling capabilities. • The temperature stability must be ±0.05°C or better • It must offer at least 2 different heat exchanger volumesLeak detection and safe leak handling design must be incorporated in the module housing • Must offer an electronic column-identification module as standard for GLP documentation of column type, and major column parameters • Must be able to contain a maximum of 24 columns of 100 mm length or 12 columns of 300 mm length (including pre-columns) • Must have to ability to change valve drive • Software must be available on the local controller and on the data system for single point control of the thermostatted column compartment as well as other modules of the same family FLD: • The instrument must have in single wavelength mode a Raman signal-to-noise of >500:1, with Ex350 nm, Em397 nm and using the reference dark value at 450 nm standard flow cell • The instrument must have in single wavelength mode a Raman signal-to-noise of >3000:1, with Ex350 nm, Em397 nm and using the reference dark value at 450 nm standard flow cell • The detector must be able to acquire spectra (excitation and emission) during the analysis (no stop flow needed) • The lamp can be switched on directly before the analysis because it needs no warm up time Autosampler: • Must have sample cooler configuration by adding a thermostatting module to control the temperature of the sample in the vial/well-plate • The metering device must have the capability to be always flushed after injection • Must have dual needle feature with two independent injection needles and loops optionally available • Offer different choices of rotor seals • Must have an accuracy of 0.7% (10 uL, n=10) or better • SW feature: The instrument must provide extensive information for diagnostic purposes and built-in tests • Thermostat: o Temperature range must be settable from 4°C to 40°C in 1°C increments (with a max. temperature of 5°C below ambient) o Temperature accuracy must be ±2°C at set-point of 4°C UV Detector: • Short term noise - Signal noise must be with 10 mm Max-Light cartridge cell: Atlanta GA 30309 The system must be delivered during normal business hours (M-F, 8:00AM - 4:30 PM EST). The following FAR and HHSAR clauses apply to this acquisition. FAR clauses and provisions can be obtained at https://www.acquisition.gov/far/index.html. The provision at 52.212-1, Instructions to Offerors-Commercial Items (Apr 2014), applies to this acquisition with the following addenda to the provision. Period for Acceptance of Offers: The offeror agrees to hold the prices firm through September 30, 2015. The provision at 52.212-2, Evaluation-Commercial Items (Jan 1999), is applicable to this requirement. 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 to the responsible offeror whose proposal meets the specifications listed under Part 3 of this solicitation and is the lowest priced proposal received in response to this solicitation. Therefore, award will be made to offeror whose proposal is determined to be Lowest Price Technically Acceptable. A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (May 2014), applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (Dec 2014), applies to this acquisition with the following addenda: Invoice Submission: A. The contractor shall submit one original copy of each invoice to the address specified below: Office of Financial Services Food and Drug Administration W032- Second Floor MAIL HUB 2145 10903 New Hampshire Avenue Bldg 32, Rm# 2162, Mail Hub 2145 Silver Spring MD 20993-0002 Attn: Vendor Payments (301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or applicable Far Clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (I) Name and address of the contractor; (II) Invoice Date and Invoice Number; (III) Purchase order/Award Number; (IV) Description, Quantity, Unit of Measure, Unit Price, and Extended Price Supplies Delivered or Services Performed, including: (a) Period of Performance for which costs are claimed; (b) Itemized travel costs, including origin and destination; and (c) Any other supporting information necessary to clarify questionable expenditures; (V) Shipping number and date of shipping, including the bill of lading number and weight of shipment if shipped on government bill of lading; (VI) Terms of any discount for prompt payment offered; (VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (VIII) Name, title and phone number of person to notify in event of defective invoice; (IX) Taxpayer Identification Number (TIN); (X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited; (XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award. C. QUESTIONS REGARDING INVOICES SHALL BE DIRECTED TO THE FDA AT THE TELEPHONE NUMBER PROVIDED ABOVE. The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items (Mar 2015), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition: (b) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644 52.222-21 Prohibition of Segregated Facilities (Feb 1999) 52.222-26 Equal Opportunity (Mar 2007) (E.O. 11246) 52.222-35 Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212) 52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513) 52.232-33 Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332) FAR 52.211-6 -- Brand Name or Equal (Aug 1999) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.html 352.202-1 Definitions (Jan 2006) 352.203-70 Anti-lobbying (Jan 2006) 352.215-70 Late proposals and revisions (Jan 2006) 352.223-70 Safety and health (Jan 2006) 352.224-70 Privacy Act (Jan 2006) 352.228-7 Insurance--Liability to third persons (Dec 1991) 352.233-71 Litigation and claims (Jan 2006) 352.242-73 Withholding of contract payments (Jan 2006) 352.242-71 Tobacco-free Facilities (Jan 2006) 352.242-74 Final decisions on audit findings (Apr 1984) 352.270-1 Accessibility of meetings, conferences and seminars to persons with disabilities (Jan 2001) The supplies delivered hereunder shall be inspected and accepted at destination by the Contracting Officer's Representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. The COR name will be provided 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 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 contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. All responsible sources may submit a quote, which if timely received, shall be considered. The quote shall reference solicitation number 15-223-SOL-00053. The quotes are due by email to the point of contact listed below on or before April 17, 2015 by 1:00pm ET. Please contact Corina Couch at 240-402-5352 or email at Corina.Couch@fda.hhs.gov

Lab Reaserch Asistant Support Services

Department of Health and Human Services, Centers for Disease Control and Prevention | Published July 19, 2016  -  Deadline July 28, 2016
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Statement of WorkResearch Assistant SupportCDC/NCHHSTP/DHAP/Lab Branch I PROJECT IDENTIFICATION AND PURPOSE Effective and efficient diagnosis of HIV infection is a cornerstone of HIV prevention strategies. The DHAP Laboratory Branch has developed new assays for HIV diagnosis and incidence testing both independently and in collaboration with test manufacturers. Furthermore, the Laboratory branch has collaborated both within CDC and with external partners to evaluate new diagnostic/incidence technology currently in the pipeline for FDA approval (diagnostics assays) or implementation for HIV surveillance (incidence assays). The purpose of this project is to continue this work with new protocols and technology. II SCOPE OF WORK An experienced research assistant support is needed to perform the following tasks: 1. Process, catalogue and store human biological specimens including whole blood, serum, plasma and dried blood spots to be used for diagnostic assays.2. Explore alternative storage options for human biological specimens that eliminate the need for costly freezer storage and also maintain sample integrity.3. Perform a variety of serologic diagnostic assays including multi-analyte Bio-plex assays, EIAs, and rapid tests to evaluate test performance. 4. Construct and perform quality assurance of in house developed rapid HIV tests for diagnosis or incidence determination.5. Perform HIV Viral load assays such as the Roche or Abbott real-time assays.6. Calibrate and maintain laboratory instruments and equipment and documents for QMS related activities.7. Maintain experiment records, prepare and present oral and written reports within CDC, and help prepare results for manuscripts and presentations. The contractor key personnel must be very enthusiastic and have the appropriate technical expertise in the biological sciences to greatly enhance our investigations related to HIV diagnostic and incidence research. The key personnel is expected to have: • A minimum of 2 years of laboratory experience working with HIV diagnostic or incidence assay development or evaluation (this includes competency in assay design, format optimization and evaluation of HIV diagnostic or incidence rapid tests or Enzyme Immunoassays (EIAs) • Experience with multi-analyte equipment formats such as Bio-Plex/Luminex • Experience working human sample types such as whole blood, serum/plasma and dried blood spots • A working knowledge of HIV viral load platforms is desirable • Competence in the operation of all standard lab equipment (centrifuges, plate washers, plate readers, rapid test readers and Bio-plex instruments) Many of these activities involve cooperation and communication with other team or branch members within CDC and academic collaborators outside of CDC. The candidate should therefore be proficient in:• Microsoft Word, Powerpoint and Excel. The contractor key personnel shall perform tasks in 40 hours per week for 1 year with CDC personnel and shall adhere to administrative guidelines established in the contract and policy of the contractor company. III HOURS OF OPERATION The core hours of operation for the contractor shall be Monday through Friday. The work day shall consist of eight duty hours and a thirty-minute lunch period. As long as the eight duty hours are met, the start and end times may be adjusted by the program as deemed necessary to accommodate required support in the organization. However, the initial schedule shall be 8:00a.m.- 4:30p.m., excluding federal holidays (listed below) and weekends. *In case of government shutdown or closure for any reason, make-up time can be performed (no more than two hours per business day) to work on tasks affected by shutdown. Payment can be made for a shutdown period. Federal Holidays are: New Year's Day Labor DayMartin Luther King's B-day Columbus DayPresident's Day Veteran's DayMemorial Day Thanksgiving DayIndependence Day Christmas Day IV GOVERNMENT FURNISHED FACILITIES AND EQUIPMENT The Government shall provide a workspace area with computer access, telephone, fax and copy machines, and general office supplies (paper, pens, etc.) for the contractor's use in performing the required services at: 1600 Clifton RoadBuilding 17 Atlanta, GA 30329 Adequate parking is available on-site. V PROGRAM MANAGEMENT The Contractor shall ensure the quality of work performed by the research assistant associated with the performance of this procurement. The Contractor shall evaluate the entire scope of operations, and implement an effective quality control program. This includes providing up-front costs necessary for vaccinations, medical tests, blood draws, and any expected work related screening and items required for access to and work in the lab. The Contractor shall provide program management and supervision of services performed by research assistant to satisfy the requirements of this procurement. The Contractor shall manage any make-up time for days affected by Government shut down. The program management functions shall include the handling of all employment matters including health and leave benefits related to Contractor's employee/research assistant. The Contractor's employees shall adhere to government's policies and rules that are applicable to contractors and complete mandatory trainings as required in a timely manner. Neither the Contractor nor any of its employees shall disclose or cause to be disseminated, any information concerning government operations, including those performed by contractors for the government, which could result in or increase the likelihood of the possibility of a breach of security and/or failure to safeguard any restricted information that may come to the Contractor in connection with work under this procurement. VI PERIOD OF PERFORMANCE The period of performance shall be one year: 9/25/2016 - 9/24/2017. VII DELIVERABLES The Contractor shall submit monthly reports and invoices to the COR, and the Contracting Officer simultaneously. The monthly report will contain at a minimum, a summary statement of services, progress report and financial forecasting and budget information. This monthly report is a mandatory deliverable. Invoices will not be paid until a complete monthly report is received by the Contracting Officer and/or his/her designated representative. The Contracting Officer may return incomplete and/or inaccurate reports for correction prior to payment of invoices. Deliverables Frequency Process, catalogue and store human biological specimens 1000 specimens per month; 12,000 within the yearExplore alternative storage options for human biological specimens Conducts 5 literature searches per month; 60 per year; order approved alternative storage options and test biological specimens for viabilityPerform a variety of serologic diagnostic assays Perform 10,000 specimens per month using various serologic diagnostic assay equipmentPerform quality assurance of in house developed rapid HIV tests for diagnosis or incidence determination Perform 1,000 specimens quality assurance tests per monthPerform HIV Viral load assays Perform 5,000 specimens per month using automated processCalibrate and maintain laboratory instruments and equipment and documents for QMS related activities Perform daily on all lab instruments and equipment used and maintain documents for QMS relate activitiesMaintain experiment records Record experiment procedures daily - at least 365 entries per year VIII. KEY PERSONNEL The key personnel specified in this contract (Research assistant) is considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.No fromal soliciation will sent out. 

Digital Microscopes for FDA

Department of Health and Human Services, Food and Drug Administration | Published March 31, 2016  -  Deadline April 8, 2016
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COMBINED SYNOPSIS/SOLICITATION FOR A DIGITAL MICROSCOPE FOR FDA SOLICITATION NUMBER: FDA-SOL-1163241 This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation number is FDA-SOL-1163241. This solicitation is issued as a Total Small Business Set, Request for Quote (RFQ). The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2005-87-1, Effective 16 March 2016.The associated North American Industry Classification System (NAICS) Code is - 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 Employees.The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the following specifications below. SUPPLIES OR SERVICES AND PRICES/COSTSThe contractor shall fill out the following pricing sheet:CLIN Description Qty Unitof Issue Price1 VHX-5000 Digital Microscope 1 Each $2 Optional Item - VHX-5000 Digital Microscope 1 Each $Total Amount $ Items to be included with the Digital Microscope Unit: VHX-5100 Camera Unit Each $VHX-S550E Stand with Motorized XYZ Stage Each $VHX-A50E Console Manual for VHX-5000 Each $VHX-H4M 3D Software for VHX-5000 Each $VHX-Z00T VH Zoom Lens 0X-50X Each $VHX-J00T Lens Joint for VH-Z00M Each $VHX-Z20T VH ZOOM Lens 20X-200X Each $VHX-J20T Lens Joint for VH-Z20 Each $VHX-Z250T VH ZOOM Lens 250X-2500X Each $VHX-J250T Lens Joint for VH-Z250 Each $OP-51649 Polarized Light Adaptor Each $OP-32009 Anti-Halation Tip for VH-Z05 Each $VH-K20 Adjustable Illumination Adaptor for VH-Z20 Each $OP-87429 Polarization Adapter for Z20 pcs Each $OP-35414 Non-Contact Diffusion Ring for VH-Z20R Each $Shipping Each $ STATEMENT OF WORK (SOW) I. General Description of Need The Southeast Regional Laboratory - Filth Group has a need for Two (2) Digital Microscopes to aid in the identification and training of filth elements The required instrument will allow FDA's Office of Regulatory Affairs (ORA) and the Southeast Regional Laboratory's (SRL) Filth and Decomposition Laboratory to identify insects, hairs, animal tissue and other foreign materials through high resolution imaging. This instrumentation will also allow analysts to view items under the microscope on a large HD LCD monitor, tilt and rotate the camera stand to observe a specimen from various angles, greatly reducing or eliminating the need to manually manipulate fragile specimens. II. Salient Characteristics All of the following are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the Government. • The system must be portable with a detachable camera and lens which can be altered by only slight modification into a hand held wand which can be used to scan the surface of large or otherwise difficult specimens which are normally inappropriate for microscopic examination.• The system must combine the capabilities of a stereoscope, compound microscope, scanning electron microscope and measuring microscope in a single unit. **Offerors shall address each of the salient characteristics in order to be considered.** • Minimum 23" Full HD (1920 x 1080) LCD Monitor • High brightness LED light source, minimum rate of approx. 40,000 hours• Must be powered by 100-120V AC• Must have a CMOS camera capable of 50 frames per second and a multi-scan camera with up to 2,000 TV lines and excellent color reproducibility.• Must have a dedicated LCD display screen pre-installed with Windows 7 operating system that allows full accessibility to PC functionality, including the ability to install Microsoft Office and anti-virus software.• Must have viewer software with an unlimited number of copy licenses with the following functionality:• Simple data transfer from VHX to PC• Reproducibility of 3D images• HDR parameter adjustment• 2D measurement with engineering assist tools• One click consolidation of .csv data into excel file• The system interface must be available via LAN connection, CD-R/CD-RW/DVD drive, or 8 total USB ports (two 3.0 series A ports and six 2.0 series A ports).• The system must be capable of real-time depth composition to allow for instant observation of any object entirely in focus.• The system must be integrated with CMOS camera for rapid depth composition and 3D modeling features.• The system must include a free-angle stand that will tilt a total of 150° along with 360° rotation in the XY stage to allow observation of a target from various angles without having to manipulate the part by hand.• The system must have High Dynamic Range (HDR) function for 16-bit resolution color gradation.• The system must have image stitching capabilities to simultaneously overcome depth of field and field of view limitations as well as measure in all 3 dimensions. This capability must be fully automated with 20,000 x 20,000 pixel range, including 3D imagery and pattern recognition technology which leaves no stitching or pixelated lines over the image.• The system must have one-click measure capability where the user may program and register XY measurements on consistent parts, then automatically measure new samples with a single click. Multiple measurement files must be able to be consolidated into a single report.• The system must have automatic measurement capability where software is capable of identifying particles based on color, brightness, contrast and hue with user friendly editing and cropping tools to easily count and dimension particles.• The system must have a range of available lenses to enable magnification range of 0.1-5000x allowing operation as a stereoscope, compound microscope, measuring microscope and scanning electron microscope. • The system must have bright field, polarized/cross-polarized, diffused, variable angle, and differential interference contrast lighting options.• The system must have a camera and lens that can be detached from the stand and used in a hand held operation to view large samples that cannot fit on a traditional microscope stand.• The system must have measuring capability with accuracy of 6 micron over a 4" x 4" sample size, with auto edge extraction and navigation windows to eliminate user to user variability and make measurement much easier. Warranty All labor, replacement parts and components (excluding consumables) shall be guaranteed. III. Period of Performance The period of performance shall be for a base period of twelve (12) months and four (4) twelve (12) month optional periods. IV. Government Furnished Property The Government shall provide visitor's access to the FDA facilities during the performance of the contract. A. Special instructionsThe offeror shall include sufficient details on the technical specifications in order for a determination to be made as to whether the offeror meet all the technical requirements identified in the solicitation. Place(s) of Delivery: Food and Drug Administration/SRL60 8th Street NEAtlanta, Ga. 30309 Hours of Operation: The Contractor will be responsible for delivering equipment between the hours of 8:00 am - 4:00 pm Monday thru Friday except Federal Holidays.When vendor arrives on site to deliver and install equipment, they will need to check in with the Front Security Guards and provide proper identification. They will receive an "Escort Required" temporary badge, which must be worn at all times in the building and will need to stay with lab personnel during their visit. If vendors need to enter into the laboratory, safety glasses must be worn. When their work is complete, they will check out with the same Security Guards, turning in their temporary badge. Tobacco, of any form, is not permitted on Federal Property, in Federal Buildings or parking lots. The following FAR and HHSAR clauses apply to this acquisition. FAR clauses and provisions can be obtained at https://www.acquisition.gov/far/index.html. The provision at 52.212-1, Instructions to Offerors-Commercial Items (Apr 2014), applies to this acquisition with the following addenda to the provision. Period for Acceptance of Offers: The offeror agrees to hold the prices firm through September 30, 2016.The provision at 52.212-2, Evaluation-Commercial Items (Jan 1999), is applicable to this requirement. 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 to the responsible offeror whose proposal meets the specifications listed under Part 3 of this solicitation and is the lowest priced proposal received in response to this solicitation. Therefore, award will be made to offeror whose proposal is determined to be Lowest Price Technically Acceptable. A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Mar 2015), applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (May 2015), applies to this acquisition with the following addenda: Invoice Submission: A. The contractor shall submit one original copy of each invoice to the address specified below: Office of Financial ServicesFood and Drug AdministrationW032- Second FloorMAIL HUB 214510903 New Hampshire AvenueBldg 32, Rm# 2162, Mail Hub 2145Silver Spring MD 20993-0002Attn: Vendor Payments(301) 827-3742 or (866) 807-3742fdavendorpaymentsteam@fda.gov B. The contractor shall submit one electronic copy of the invoice to each of the recipients listed below: Project Officer: TBDEmail: Contract Specialist: Corina GensonEmail: Corina.Genson@fda.hhs.gov Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or applicable Far Clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (I) Name and address of the contractor; (II) Invoice Date and Invoice Number; (III) Purchase order/Award Number; (IV) Description, Quantity, Unit of Measure, Unit Price, and Extended Price Supplies Delivered or Services Performed, including: (a) Period of Performance for which costs are claimed; (b) Itemized travel costs, including origin and destination; and (c) Any other supporting information necessary to clarify questionable expenditures;(V) Shipping number and date of shipping, including the bill of lading number and weight of shipment if shipped on government bill of lading; (VI) Terms of any discount for prompt payment offered; (VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)(VIII) Name, title and phone number of person to notify in event of defective invoice; (IX) Taxpayer Identification Number (TIN);(X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;(XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award. C. QUESTIONS REGARDING INVOICES SHALL BE DIRECTED TO THE FDA AT THE TELEPHONE NUMBER PROVIDED ABOVE. The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items (Mar 2016), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition: (b) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 64452.222-21 Prohibition of Segregated Facilities (Apr 2015) 52.222-26 Equal Opportunity (Apr 2015) (E.O. 11246) 52.222-35 Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212)52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793)52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513)52.232-33 Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)FAR 52.222-41 Service Contract Labor Standards (May 2014)FAR 52.217-5 Evaluation of Options (July 1990)FAR 52.217-9 Option to Extend the term of the Contract (Mar 2000) The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.html 352.203-70 Anti-lobbying (Dec 2015)352.215-70 Late proposals and revisions (Dec 2015)352.223-70 Safety and health (Dec 2015)352.224-70 Privacy Act (Dec 2015)352.233-71 Litigation and claims (Dec 2015) The supplies delivered hereunder shall be inspected and accepted at destination by the Contracting Officer's Representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. The COR name will be provided 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 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 contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. All responsible sources may submit a quote, which if timely received, shall be considered. The quote shall reference solicitation number FDA-SOL-1163241. The quotes are due by email to the point of contact listed below on or before April 8, 2016 by 1:00pm ET. Please contact Corina Genson at 240-402-5352 or email at Corina.Genson@fda.hhs.gov  

Peptides & Aliquoting

Department of Health and Human Services, Centers for Disease Control and Prevention | Published August 13, 2015  -  Deadline August 21, 2015
cpvs

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Requirements (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation will not be issued. The solicitation number for this requirement is 2015_84920 and is hereby issued as a Request for Quote (RFQ) using FAR Subpart 13.1 Simplified Acquisition Procedures. The Centers for Disease Control and Prevention intends to award a firm-fixed-price contract for the following requirement, please either fill in the dollar amounts or provide a separate excel spreadsheet containing the same information including a list of line item number(s) and items, quantities, units of meansure, and options, if applicable: Your quote shall include the following: • Total Price for all CLINS (see Statement of Work) • Capabilities in accordance with the Statement of Work Delivery Date: 8/24/15 - 9/24/15 Delivery Address: 1600 Clifton Road, Roybal Lab, Bldg. 17, Atlanta, GA 30329-4018 Acceptance The quote format is at the discretion of the offeror. It is the offeror's responsibility to be familiar with the applicable clauses and provisions. Clauses and provisions may be accessed via the Internet at website http://farsite.hill.af.mil. This solicitation document and incorporated provisions and clauses are those in effect through the Federal Acquisition Circular (FAC) 2005-82 (effective 5/7/2015) This acquisition is set aside for small business under North American Industry Classification System (NAICS) code 334516 and small business size standard of 500 employees. A Firm-Fixed Price purchase order will be issued in writing to the successful offeror. To be eligible to receive an award resulting from this solicitation, contractor must be registered in the System for Award Management. To register apply via the Internet at http://www.sam.gov. For questions on registration contact Federal Service Desk at 866-606-8220. Include FAR 52.212-3, Offeror Representations and Certifications with Offer or indicate if it is available online at SAM.gov. No telephonic quotes will be processed. All questions must be received no later than 12:00 PM Eastern Standard Time on August 17, 2015. All responses must be received no later than 2:00 P.M., Eastern Standard Time on August 21, 2015. Please send any questions and quotes to Monica Shaw at vwk1@cdc.gov. FAR SOURCE TITLE AND DATE 52.204-13 System for Award Management Maintenance (July 2013) 52.204-18 Commercial and Government Entity Code Maintenance (Nov 2014) 52.212-4 Contract Terms and Conditions- Commercial Items (Dec 2014) 52.232-39 52.232-40 Unenforceability of Unauthorized Obligations (June 2013) Providing Accelerated Payments to Small Business Contractors (Dec 2013) FAR 52.252-2 --CLAUSES INCORPORATED BY REFERENCE (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these addres(es): Regulations URLs: (Click on the appropriate regulation.) http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm http://www.hhs.gov/policies/hhsar/subpart301-1.html NOTE: After selecting the appropriate regulation above, at the "table of Contents" page, conduct a search for the desired regulation reference using your browser's FIND function. When located, click on the regulation reference (hyperlink). 52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (May 2015) (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Dec 2014) (2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553). (3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 108-78 (19 U.S.C. 3805 note)). (b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: [Contracting Officer check as appropriate.] ___ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402). ___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509). ___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009). X (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note). ___ (5) [Reserved] ___ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). ___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). ___ (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Aug 2013) (31 U.S.C. 6101 note). ___ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313). ___ (10) [Reserved] ___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a). ___ (ii) Alternate I (Nov 2011) of 52.219-3. ___ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a). ___ (ii) Alternate I (Jan 2011) of 52.219-4. ___ (13) [Reserved] ___ (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644). ___ (ii) Alternate I (Nov 2011). ___ (iii) Alternate II (Nov 2011). ___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644). ___ (ii) Alternate I (Oct 1995) of 52.219-7. ___ (iii) Alternate II (Mar 2004) of 52.219-7. ___ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)). ___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2014) (15 U.S.C. 637 (d)(4)). ___ (ii) Alternate I (Oct 2001) of 52.219-9. ___ (iii) Alternate II (Oct 2001) of 52.219-9. ___ (iv) Alternate III (Oct 2014) of 52.219-9. ___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)). ___ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)). ___ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). ___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f). X (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)). ___ (23) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)). ___ (24) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)). X (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755). X (26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126). X (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015). X (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246). ___ (29) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212). X (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). ___ (31) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212). ___ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). X (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627). ___ (ii) Alternate I (Mar 2015) of 52.222-50, (22 U.S.C. chapter 78 and E.O. 13627). ___ (34) 52.222-54, Employment Eligibility Verification (Aug 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.) ___ (35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.) ___ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.) ___ (36) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514 ___ (ii) Alternate I (Jun 2014) of 52.223-13. ___ (37) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514). ___ (ii) Alternate I (Jun 2014) of 52.223-14. ___ (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b). ___ (39) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Jun 2014) (E.O.s 13423 and 13514). ___ (ii) Alternate I (Jun 2014) of 52.223-16. X (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513). ___ (41) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83). ___ (42) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43). X (ii) Alternate I (May 2014) of 52.225-3. ___ (iii) Alternate II (May 2014) of 52.225-3. ___ (iv) Alternate III (May 2014) of 52.225-3. ___ (43) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). X (44) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). ___ (45) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). ___ (46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). ___ (47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). ___ (48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)). ___ (49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). X (50) 52.232-33, Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332). ___ (51) 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332). ___ (52) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332). ___ (53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). ___ (54) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). ___ (ii) Alternate I (Apr 2003) of 52.247-64. (c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or executive orders applicable to acquisitions of commercial items: [Contracting Officer check as appropriate.] ___ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495) ___ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.). ___ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). ___ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67). ___ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). ___ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67). ___ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67). ___ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (E.O. 13658). ___ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). ___ (10) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)). (d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation. (1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract. (2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved. (3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law. (e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause- (i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509). (ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17. (iv) 52.222-21, Prohibition of Segregated Facilities (Apr 2015). (v) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246). (vi) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212). (vii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). (viii) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212). (ix) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40. (x) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67). (xi) ____ (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627). ___ (B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 E.O. 13627). (xii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.) (xiii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67) (xiv) 52.222-54, Employment Eligibility Verification (Aug 2013). (xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (E.O. 13658). (xvi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). (xvii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (xviii) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64. (2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations. (End of Clause) CDC100.0001 Needle Exchange (Jan 2014) No funds appropriated in the FY14 Appropriations Act and obligated to this contract may be used to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug. (End of clause) CDCAG001 - Invoice Submission (Mar 2006) (a) The Contractor shall submit the original contract invoice/voucher to the shown below: Mail: CDC Office of the Chief Financial Officer P.O. Box 15580 Atlanta, Ga. 30333 Or - The Contractor may submit the original invoice/voucher via facsimile or email: Fax: 404-638-5324 Email: FMOAPINV@CDC.GOV NOTE: Submit to only one (1) of the above locations. (b) The contractor shall submit one (1) copy of the invoice/voucher to the cognizant contracting office previously identified in this contract. These invoices/voucher copies shall be addressed to the attention of the Contracting Officer. (c) The Contractor is 1, is not 0 required to submit a copy of each invoice directly to the Project Officer concurrently with submission to the Contracting Officer. (d) In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Financial Management Office is the designated billing office for the purpose of determining the payment due date under FAR 32.904. (e) The Contractor shall include (as a minimum) the following information on each invoice: (1) Contractor's Name & Address (2) Contractor's Tax Identification Number (TIN) (3) Purchase Order/Contract Number and Task Order Number, if Appropriate (4) Invoice Number (5) Invoice Date (6) Contract Line Item Number and Description of Item (7) Quantity (8) Unit Price & Extended Amount for each line item (9) Shipping and Payment Terms (10) Total Amount of Invoice (11) Name, title and telephone number of person to be notified in the event of a defective invoice (12) Payment Address, if different from the information in (c)(1). (13) DUNS + 4 Number (End of Clause)

Peptides & Aliquoting

Department of Health and Human Services, Centers for Disease Control and Prevention | Published August 3, 2015  -  Deadline August 12, 2015
cpvs

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Requirements (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation will not be issued. The solicitation number for this requirement is 2015_84920 and is hereby issued as a Request for Quote (RFQ) using FAR Subpart 13.1 Simplified Acquisition Procedures. The Centers for Disease Control and Prevention intends to award a firm-fixed-price contract for the following requirement, please either fill in the dollar amounts or provide a separate excel spreadsheet containing the same information including a list of line item number(s) and items, quantities, units of meansure, and options, if applicable: Your quote shall include the following: • Total Price for all CLINS (see Statement of Work) • Capabilities in accordance with the Statement of Work Delivery Date: 8/17/15 - 9/17/15 Delivery Address: 1600 Clifton Road, Atlanta, GA 30329-4018 Acceptance The quote format is at the discretion of the offeror. It is the offeror's responsibility to be familiar with the applicable clauses and provisions. Clauses and provisions may be accessed via the Internet at website http://farsite.hill.af.mil. This solicitation document and incorporated provisions and clauses are those in effect through the Federal Acquisition Circular (FAC) 2005-82 (effective 5/7/2015) This acquisition is set aside for small business under North American Industry Classification System (NAICS) code 334516 and small business size standard of 500 employees. A Firm-Fixed Price purchase order will be issued in writing to the successful offeror. To be eligible to receive an award resulting from this solicitation, contractor must be registered in the System for Award Management. To register apply via the Internet at http://www.sam.gov. For questions on registration contact Federal Service Desk at 866-606-8220. Include FAR 52.212-3, Offeror Representations and Certifications with Offer or indicate if it is available online at SAM.gov. No telephonic quotes will be processed. All questions must be received no later than 12:00 PM Eastern Standard Time on August 7, 2015. All responses must be received no later than 2:00 P.M., Eastern Standard Time on August 12, 2015. Please send any questions and quotes to Monica Shaw at vwk1@cdc.gov. FAR SOURCE TITLE AND DATE 52.204-13 System for Award Management Maintenance (July 2013) 52.204-18 Commercial and Government Entity Code Maintenance (Nov 2014) 52.212-4 Contract Terms and Conditions- Commercial Items (Dec 2014) 52.232-39 52.232-40 Unenforceability of Unauthorized Obligations (June 2013) Providing Accelerated Payments to Small Business Contractors (Dec 2013) FAR 52.252-2 --CLAUSES INCORPORATED BY REFERENCE (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these addres(es): Regulations URLs: (Click on the appropriate regulation.) http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm http://www.hhs.gov/policies/hhsar/subpart301-1.html NOTE: After selecting the appropriate regulation above, at the "table of Contents" page, conduct a search for the desired regulation reference using your browser's FIND function. When located, click on the regulation reference (hyperlink). 52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (May 2015) (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Dec 2014) (2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553). (3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 108-78 (19 U.S.C. 3805 note)). (b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: [Contracting Officer check as appropriate.] ___ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402). ___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509). ___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009). X (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note). ___ (5) [Reserved] ___ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). ___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). ___ (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Aug 2013) (31 U.S.C. 6101 note). ___ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313). ___ (10) [Reserved] ___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a). ___ (ii) Alternate I (Nov 2011) of 52.219-3. ___ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a). ___ (ii) Alternate I (Jan 2011) of 52.219-4. ___ (13) [Reserved] ___ (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644). ___ (ii) Alternate I (Nov 2011). ___ (iii) Alternate II (Nov 2011). ___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644). ___ (ii) Alternate I (Oct 1995) of 52.219-7. ___ (iii) Alternate II (Mar 2004) of 52.219-7. ___ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)). ___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2014) (15 U.S.C. 637 (d)(4)). ___ (ii) Alternate I (Oct 2001) of 52.219-9. ___ (iii) Alternate II (Oct 2001) of 52.219-9. ___ (iv) Alternate III (Oct 2014) of 52.219-9. ___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)). ___ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)). ___ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). ___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f). X (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)). ___ (23) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)). ___ (24) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)). X (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755). X (26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126). X (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015). X (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246). ___ (29) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212). X (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). ___ (31) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212). ___ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). X (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627). ___ (ii) Alternate I (Mar 2015) of 52.222-50, (22 U.S.C. chapter 78 and E.O. 13627). ___ (34) 52.222-54, Employment Eligibility Verification (Aug 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.) ___ (35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.) ___ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.) ___ (36) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514 ___ (ii) Alternate I (Jun 2014) of 52.223-13. ___ (37) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514). ___ (ii) Alternate I (Jun 2014) of 52.223-14. ___ (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b). ___ (39) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Jun 2014) (E.O.s 13423 and 13514). ___ (ii) Alternate I (Jun 2014) of 52.223-16. X (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513). ___ (41) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83). ___ (42) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43). X (ii) Alternate I (May 2014) of 52.225-3. ___ (iii) Alternate II (May 2014) of 52.225-3. ___ (iv) Alternate III (May 2014) of 52.225-3. ___ (43) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). X (44) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). ___ (45) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). ___ (46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). ___ (47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). ___ (48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)). ___ (49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). X (50) 52.232-33, Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332). ___ (51) 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332). ___ (52) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332). ___ (53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). ___ (54) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). ___ (ii) Alternate I (Apr 2003) of 52.247-64. (c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or executive orders applicable to acquisitions of commercial items: [Contracting Officer check as appropriate.] ___ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495) ___ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.). ___ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). ___ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67). ___ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). ___ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67). ___ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67). ___ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (E.O. 13658). ___ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). ___ (10) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)). (d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation. (1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract. (2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved. (3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law. (e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause- (i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509). (ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17. (iv) 52.222-21, Prohibition of Segregated Facilities (Apr 2015). (v) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246). (vi) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212). (vii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). (viii) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212). (ix) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40. (x) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67). (xi) ____ (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627). ___ (B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 E.O. 13627). (xii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.) (xiii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67) (xiv) 52.222-54, Employment Eligibility Verification (Aug 2013). (xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (E.O. 13658). (xvi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). (xvii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (xviii) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64. (2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations. (End of Clause) CDC100.0001 Needle Exchange (Jan 2014) No funds appropriated in the FY14 Appropriations Act and obligated to this contract may be used to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug. (End of clause) CDCAG001 - Invoice Submission (Mar 2006) (a) The Contractor shall submit the original contract invoice/voucher to the shown below: Mail: CDC Office of the Chief Financial Officer P.O. Box 15580 Atlanta, Ga. 30333 Or - The Contractor may submit the original invoice/voucher via facsimile or email: Fax: 404-638-5324 Email: FMOAPINV@CDC.GOV NOTE: Submit to only one (1) of the above locations. (b) The contractor shall submit one (1) copy of the invoice/voucher to the cognizant contracting office previously identified in this contract. These invoices/voucher copies shall be addressed to the attention of the Contracting Officer. (c) The Contractor is 1, is not 0 required to submit a copy of each invoice directly to the Project Officer concurrently with submission to the Contracting Officer. (d) In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Financial Management Office is the designated billing office for the purpose of determining the payment due date under FAR 32.904. (e) The Contractor shall include (as a minimum) the following information on each invoice: (1) Contractor's Name & Address (2) Contractor's Tax Identification Number (TIN) (3) Purchase Order/Contract Number and Task Order Number, if Appropriate (4) Invoice Number (5) Invoice Date (6) Contract Line Item Number and Description of Item (7) Quantity (8) Unit Price & Extended Amount for each line item (9) Shipping and Payment Terms (10) Total Amount of Invoice (11) Name, title and telephone number of person to be notified in the event of a defective invoice (12) Payment Address, if different from the information in (c)(1). (13) DUNS + 4 Number (End of Clause)

Linear Smoking Machine

Department of Health and Human Services, Food and Drug Administration | Published February 23, 2015  -  Deadline March 10, 2015
cpvs

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation number is FDA-SOL-1145479. This solicitation is issued as a Request for Quote (RFQ), using the Simplified Acquisitions Procedures of FAR 13.5, Test Program for Certain Commercial Items. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2005-78, dated December 26, 2014. The associated North American Industry Classification System (NAICS) Code is - 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 in number of employees. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the following specifications below. SUPPLIES OR SERVICES AND PRICES/COSTS The contractor shall fill out the following pricing sheet: CLIN Description Qty Unit Price 0001 Linear Smoking Machine with required features 1 EA $________ 0002 Installation Operational Qualification Services 1 EA $________ 0003 Shipping 1 EA $________ 0004 Onsite Training and Installation 1 EA $________ 0005 Option Year 1 - Post Warranty Preventative Maintenance 1 EA $________ 0006 Option Year 2 - Post Warranty Preventative Maintenance 1 EA $________ 0007 Option Year 3 - Post Warranty Preventative Maintenance 1 EA $________ Total Amount $_______ I. Intro/Background The United States Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA)'s Southeast Regional Laboratory (SRL) has a requirement to purchase one (1) automatic linear smoking machine with attachments for impingers and carbon monoxide detection. II. Objectives The Southeast Regional Laboratory (SRL) needs to purchase an automatic linear smoking machine for the purpose of generating smoke residues that will be used in chemical analyses to support regulatory work for the Center for Tobacco Products. The requested instrument is needed to expand SRL's regulatory sample throughout and to add additional capabilities are not present on our existing smoking machines. Without this purchase, SRL will not be able to provide the anticipated regulatory support to the Center for Tobacco Products for chemical testing and new tobacco product submissions. III. Scope The request is for a twenty (20) port, automatic linear smoking machine with attachments for impingers and carbon monoxide detection. The unit is used to simulate human cigarette smoking under a variety of conditions and to collect smoke residues for further regulatory chemical analysis. IV. Requirements All of the following are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the Government. A. System specifications/ salient characteristics: The linear smoking machine system shall include the following components: • The linear smoking machine must be configurable to run on US 208-240 VAC electrical supply standards. • The linear smoking machine must be able to operate in a room with a maximum ceiling height of 89 inches. • The linear smoking machine must be supplied with all fitting and/or adapters to exhaust the smoke gases to a single (1) exhaust port of nominal internal diameter of 3.5 inches and external diameter of 3.75 inches. • All shipped components of the linear smoking machine must be able to fit through a doorway that is 33.5 inches wide and 77 inches tall. • The linear smoking machine shall have the ability to smoke twenty (20) cigarettes simultaneously with the ability to select different smoking regimes at each port. • The linear smoking machine must be able to smoke the following standard regimes used in regulatory testing: o ISO 3308 - Bell shaped profile, 35 mL puff volume, 2 second puff duration, 60 second puff frequency. o Canadian Intense - Bell shaped profile, 55 mL puff volume, 2 second duration, 30 second puff frequency. o Massachusetts Intense - Bell shaped profile, 45 mL puff volume, 2 second duration, 30 second puff frequency. • The linear smoking machine must have an automatic cigarette butt termination function that does not require the physical marking of cigarettes. • The linear smoking machine must have an automatic cigarette lighting function to minimize the user involvement in the lighting of cigarettes. • The linear smoking machine must have a smoke shield closure system that closes automatically once the smoking run has started. • The linear smoking machine shall be equipped with a system to detect leaks at each port. • The linear smoking machine must be supplied with an anemometer that can measure airflows of within the range of 160 to 300 millimeters/second with an accuracy of at least 10 millimeters/second. • The linear smoking machine shall be supplied with an anemometer and all necessary probes, fittings and attachments so that airflow measurement can be made at each of the twenty (20) cigarette ports. • If the anemometer is a self-contained unit that requires offsite, annual calibration, then the smoking machine must be supplied with a second anemometer and any necessary probes, cables or fittings to be used while the first is being calibrated. • The linear smoking machine shall be equipped with dual glass or Teflon impingers for each of the 20 smoking ports, including any racks and/or attachments needed on the smoking machine unit. • Each impinger set come equipped with all fittings, tubing and protection devices so that it can be used as-is for reactive carbonyl testing. • The linear smoking machine shall be equipped with twenty (20) Cambridge Filter Pad (CFP) holders, 1 for each of the 20 smoking ports. • The linear smoking machine shall have twenty (20) smoke collection bags, one for each port, so that online gas analysis can occur in the smoke bag. • The linear smoking machine must have an online, carbon monoxide (CO) detector so that CO levels can be measured for each of the twenty smoking ports. • The linear smoking machine must be supplied with all bags, tubing and fittings needed for CO gas calibrations. • The linear smoking machine shall come supplied with at least one (1) set of labyrinth seals per cigarette position for the following sizes: o 4.50 - 5.50 millimeters (mm), o 5.50 - 6.50 mm, o 6.50 - 7.50 mm, o 7.50 - 9.00 mm. • The linear smoking machine shall be controlled through a software interface that allows the user to select ISO3308, Canadian Intense and Massachusetts Intense smoke regimes as well as define customized smoke regimes for puff profiles, puff durations, puff volumes and puff numbers. • The linear smoking machine shall be controlled through a computer interface. If that interface is based on a Microsoft platform, then the underlying system must be at least Windows 7 or more recent operating system. • The linear smoking machine shall be supplied with all computers, monitors, user input devices, and a network capable laser printer. B. General Specifications The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. Installation and operator familiarization shall be included for the linear smoking machine system and all components. The vendor shall demonstrate upon installation that the item meets all performance specifications. The instrument will not be accepted until those performance specifications have been met. C. Service Maintenance Agreement: The system shall include a one (1) year full manufacturer's warranty on all parts, travel and labor, including software and hardware and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, computer, monitor, printer, and unlimited on-site service visits with a maximum 72-hour response time, factory-certified replacement parts, engineer labor and travel costs, software updates and notifications. In addition, the Government solicits three (3) 1-year Service and Maintenance Agreement Option Periods. The Service and Maintenance Agreement Option Periods shall meet the following technical requirements: - All manufacturer's required parts, consumables, supplies, labor and travel for repairs and maintenance are to be included. - Integrated service coverage for all of the modules that make up the analytical system. - Minimum of one (1) planned maintenance visit per year. - Maximum 72 hour response time to onsite repair requests. - Unlimited and priority telephone and e-mail access to instrument technical support. - All items utilized for repair and/or maintenance shall be new factory remanufactured OEM parts. - Service engineers shall be manufacturer certified and trained and have access to manufacturers' latest technical developments, repair procedures, application updates (including firmware and software) and planned maintenance procedures. - Pricing shall be inclusive of all labor, travel, parts, supplies, and other costs necessary to affect preventive maintenance and repairs and to otherwise accomplish all service herein. D. Training Services: Onsite training shall be provided at the installation location, for five people, on the operation and maintenance of the linear smoking machine, including software. Onsite training shall occur on a date determined by the COR during installation. Contractor will be given a minimum of 72 hours advance notice of requested date of training. E. Special instructions The contractor shall deliver and install Linear smoking machine that meets the above listed specifications, including equipment, software, essential documents and licenses. The contractor shall perform initial configuration of the system. The offeror shall include sufficient details on the technical specifications in order for a determination to be made as to whether the offeror meet all the technical requirements identified in the solicitation. Place of Delivery: US Food & Drug Administration ORA; Southeast Regional Laboratory 60 Eighth Street NE Atlanta, GA 30309 Delivery Period: Within sixty (60) days after contract award. Supplies and Equipment shall be delivered Monday - Friday between 9:00am - 3:00pm. The following FAR and HHSAR clauses apply to this acquisition. FAR clauses and provisions can be obtained at https://www.acquisition.gov/far/index.html. The provision at 52.212-1, Instructions to Offerors-Commercial Items (Apr 2014), applies to this acquisition with the following addenda to the provision. Period for Acceptance of Offers: The offeror agrees to hold the prices firm through September 30, 2015. The provision at 52.212-2, Evaluation-Commercial Items (Jan 1999), is applicable to this requirement. 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 to the responsible offeror whose proposal meets the specifications listed under Part 3 of this solicitation and is the lowest priced proposal received in response to this solicitation. Therefore, award will be made to offeror whose proposal is determined to be Lowest Price Technically Acceptable. A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (May 2014), applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (Dec 2014), applies to this acquisition with the following addenda: Invoice Submission: A. The Contractor shall submit one original copy of each invoice to the address specified below: Office of Financial Services Food and Drug Administration W032- Second Floor MAIL HUB 2145 10903 New Hampshire Avenue Bldg 32, Rm# 2162, Mail Hub 2145 Silver Spring MD 20993-0002 Attn: Vendor Payments (301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or applicable Far Clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (I) Name and address of the contractor; (II) Invoice Date and Invoice Number; (III) Purchase order/Award Number; (IV) Description, Quantity, Unit of Measure, Unit Price, and Extended Price Supplies Delivered or Services Performed, including: (a) Period of Performance for which costs are claimed; (b) Itemized travel costs, including origin and destination; and (c) Any other supporting information necessary to clarify questionable expenditures; (V) Shipping number and date of shipping, including the bill of lading number and weight of shipment if shipped on government bill of lading; (VI) Terms of any discount for prompt payment offered; (VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (VIII) Name, title and phone number of person to notify in event of defective invoice; (IX) Taxpayer Identification Number (TIN); (X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited; (XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award. C. QUESTIONS REGARDING INVOICES SHALL BE DIRECTED TO THE FDA AT THE TELEPHONE NUMBER PROVIDED ABOVE. The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items (Dec 2014), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition: (b) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). 52.222-21 Prohibition of Segregated Facilities (Feb 1999) 52.222-26 Equal Opportunity (Mar 2007) (E.O. 11246) 52.222-35 Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212) 52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513) 52.232-33 Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332) FAR 52.217-5 Evaluation of Options (July 1990) FAR 52.217-9 Option to Extend the term of the Contract (Mar 2000) FAR 52.232-18 Availability of Funds (APR 1984) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.html 352.202-1 Definitions (Jan 2006) 352.203-70 Anti-lobbying (Jan 2006) 352.215-70 Late proposals and revisions (Jan 2006) 352.223-70 Safety and health (Jan 2006) 352.224-70 Privacy Act (Jan 2006) 352.228-7 Insurance--Liability to third persons (Dec 1991) 352.233-71 Litigation and claims (Jan 2006) 352.242-73 Withholding of contract payments (Jan 2006) 352.242-71 Tobacco-free Facilities (Jan 2006) 352.242-74 Final decisions on audit findings (Apr 1984) 352.270-1 Accessibility of meetings, conferences and seminars to persons with disabilities (Jan 2001) The supplies delivered hereunder shall be inspected and accepted at destination by the Contracting Officer's Representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. The COR name will be provided 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 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 contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. All responsible sources may submit a quote, which if timely received, shall be considered. The quote shall reference solicitation number FDA-SOL-1145479. The quotes are due by email to the point of contact listed below on or before March 10, 2015 by 10:00am ET. Please contact Corina Couch at (240) 402-5352 or email at Corina.Couch@fda.hhs.gov .