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Medical Device Inspection Program

Department of Health and Human Services, Food and Drug Administration | Published March 23, 2015  -  Deadline April 6, 2015
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The Food and Drug Administration intends to award sole source contracts to State Agencies for the inspection of medical devices. The State Agencies must have the authority and capability required to gain access to private commercial establishments in order to conduct regulatory inspections in accordance with the Federal Food, Drug and Cosmetic Act. It is anticipated that awards will be made for a 12 month base contract period and one option year. The proposed contract actions are for services for which the Government intends to solicit and negotiate with only state organizations under the authority of 10 U.S.C. 2304(c)(5), authorized by statute. This notice is issued for informational purposes and not a request for competitive proposals. Any interested party should submit a statement of capabilities in sufficient detail to determine if the requirement of this synopsis can be met no later than 15 calendar days from this announcement. A determination by the Government not to compete the proposed contracts based on responses from this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. The solicitation will be available on or about April 6, 2015, on the FedBizOpps website at http://www.fbo.gov. Prospective offerors are responsible for downloading the solicitation and amendments. It is the offerors responsibility to monitor the FedBizOpps website for the release solicitations and amendments. Hard copies will be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. Responses to this notice must be sent via email to: yared.girmai@fda.hhs.gov. No phone calls will be accepted.

Federation of State Medical Boards (FSMB) Physician Data Center

Department of Health and Human Services, Program Support Center | Published April 6, 2016  -  Deadline April 7, 2016
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Pursuant to the authority of FAR 13.106-1(b)(1)(i), the Contracting Officer may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source is reasonably available. The Department of Health and Human Services (DHHS), Program Support Center (PSC), Acquisition Management Services (AMS), on behalf of the DHHS Office of Inspector General (OIG) Office of Investigations (OI) intends to sole source to: Federation of State Medical Boards (FSMB)400 Fuller Wiser RoadSuite 300Euless, TX 76039 The Office of Investigations (OI) is a federal law enforcement agency with statutory law enforcement authority. Within OI, the Exclusions Branch is responsible for investigating, imposing, and reporting exclusion actions taken under Section 1128 of the Social Security Act. The Exclusions Branch accomplishes its mission through receiving referral for consideration from a number of sources, including other Federal, State or local law enforcement; State professional licensing boards; and State Medicaid agencies. In connection with their mission, the Exclusions Branch requires a wide variety of data sources in order to complete their mission. The HHS Office of Inspector General, Office of Investigations (HHS/OIG/OI) requires access to a comprehensive reporting entity that offers medical licensing, credentialing and sanction history as an investigative resource for OI investigative analysts conducting exclusions investigations. The Federation of State Medical Boards (FSMB) Physician Data Center offers a central repository for disciplinary sanctions, licensure information and certification data by representing seventy state medical and osteopathic regulatory boards across the United States and provides comprehensive reports on that data. FSMB is a NCQA Certified Credentials Organization that provides the highest level of reporting of all NCQA certified entity. FSMB offers this comprehensive reporting with the appropriate NCQA certification that would uniquely assist investigative analysts in the Exclusions Branch within OI to more efficiently investigate exclusions actions under Section 1128. FSMB provides comprehensive data regarding disciplinary alerts for sanctioned physicians, comprehensive background information, and active and historic license information from seventy state medical and osteopathic boards across the United States our choices are limited down to solely this vendor. FSMB would provide OI the comprehensive data and reporting tools at the appropriate level with the appropriate credentials that are required in order to complete exclusions investigations. This is not a solicitation for competitive proposal. No solicitation document is available. All responsible sources that have determined that they can provide the same services may submit product information and a capabilities statement addressing their specific abilities regarding this requirement. The email subject line must reference OIG173127. All responses are due by April 7, 2016, 3:30PM Eastern Time and can be sent to Robert Bowman at Robert.Bowman@psc.hhs.gov. A determination by the Government not to compete this proposed contract base upon responses to this notice is solely within the discretion of the government.

Support for Patient Centered Medical Home (PCMH) Recognition Initiative

Department of Health and Human Services, Health Resources and Services Administration | Published July 27, 2015  -  Deadline August 27, 2015
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The Health Resources and Services Administration (HRSA) is seeking a nationally recognized certifying organization to provide services for patient centered medical home certifications/recognitions for HRSA funded health center practice sites. In addition, the contractor will provide educational and training services and technical assistance for HRSA funded health centers. This solicitation is for full and open competition with a period of performance of twelve months, with four twelve month option periods. The required services will be procured in accordance with FAR Part 15 - Contracting by Negotiation. This contract will acquire services from a nationally recognized certifying organization providing patient centered medical home certifications/recognitions for HRSA funded health center practice sites. In addition, the contract will provide educational and training services and technical assistance for HRSA funded health centers. All future information regarding this acquisition, including the solicitation and any amendments, will be distributed solely through the FedBizOpps website (www.fbo.gov). Copies of the solicitation document and its related documents, as appropriate, will be posted at this website. Interested parties are responsible for monitoring the FedBizOpps website to assure that they have the most up-to-date information regarding this acquisition. The Government will not reimburse interested parties for any costs associated with responding to this notice.

Medical Consultation Services

Department of Health and Human Services, Program Support Center | Published May 12, 2015  -  Deadline May 27, 2015
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Pursuant to the authority of FAR 13.106-1(b)(1)(i), the Contracting Officer may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source is reasonably available. The Department of Health and Human Services (DHHS), Program Support Center (PSC), Acquisition Management Services (AMS), on behalf of the Agency for Healthcare Research and Quality (AHRQ) intends to sole source to: Dr. Bernard Friedman 5750 Bou Avenue Unit 1616 Rockville, MD 20852-5629 AHRQ seeks to obtain expert consultation services to help develop healthcare resource methods and metrics; track clinical and other impacts of the Affordable Care Act insurance coverage expansion on hospitals; and produce policy relevant research. This work will include the following tasks: (1) build appropriate robust analytic databases in support of several analytic projects; (2) utilize appropriate rigorous analytic methods to test and evaluate the cost and clinical questions for each of the projects; (3) provide results in the form of tables and figures, as well as draft manuscripts that will be reviewed and edited with collaborators. Dr. Bernard Friedman is uniquely qualified to perform these services. In the past, Dr. Friedman has analyzed the responses of hospitals to changes in Medicare and regulatory programs, the supply of expensive hospital-based services such as organ transplants, hip replacement surgery, and intensive care services to adults and infants. His more current research addresses preventable hospital admissions, readmissions, the impacts of patient safety events, hospital care use, and cost in Medicare Advantage plans vs fee-for-service. He has tremendous expertise in the research of the Healthcare Cost and Utilization Project (HCUP) databases. Dr. Friedman is a unique and invaluable source to conduct complex analyses that address hospital costs for patient with multiple chronic conditions, to understand the hospital and patient costs for ambulatory sensitive conditions treated in U.S. hospitals, to analyze the impact of robotic technology on use and outcomes of radical prostatectomy and hysterectomy, to analyze readmissions for patients with septicemia, and to analyze readmissions following admission for treatment of asthma. Dr. Friedman's work in health economics has been published in many recognized books and peer-reviewed journals such as Review of Economics and Statistics, Medical Care, Health Services Research, Inquiry, Health Care Financing Review, American Journal of Managed Care and Health Affairs. This is not a solicitation for competitive proposal. No solicitation document is available. All responsible sources that have determined that they can provide the same services may submit product information and a capabilities statement that speaks to the services AHRQ is seeking in this proposed acquisition. The email subject line must reference AHR152120. All responses are due by May 27, 2015, 12:00 PM Eastern Time and can be sent to Anthony Adebayo at Anthony.Adebayo@psc.hhs.gov. A determination by the Government not to compete this proposed contract base upon responses to this notice is solely within the discretion of the Government.

Supplement on Patient Safety and Medical Liability: Demonstration Grants

Department of Health and Human Services, Program Support Center | Published November 14, 2014  -  Deadline December 1, 2014
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Pursuant to the authority of FAR 13.106-1(b)(1)(i), the Contracting Officer may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source is reasonably available. The Department of Health and Human Services (DHHS), Program Support Center (PSC), Acquisition Management Services (AMS), on behalf of the Agency for Healthcare Research and Quality (AHRQ) intends to sole source to: Health Research & Educational Trust - Health Services Research (HRET/HSR) 155 North Wacker, 4th Floor Chicago, IL 60606 In accordance with FAR 5.207(c), AHRQ's requirement is described as follows: (1) National Stock Number (NSN): N/A (2) Specification: AHRQ is seeking a journal supplement on patient safety and medical liability: demonstration grants for a period not to exceed 10 months. AHRQ's objective is to review, edit, and manage all aspects of editorial production for a special supplement of Health Services Research (HSR). HSR shall prepare a series of papers from demonstration grants that were funded under AHRQ's Patient Safety and Medical Liability Initiative. This supplement will focus on the outcomes and progress of the demonstration grantees, and will include commentaries and guest authors. (3) Manufacturer: Health Research & Educational Trust (4) Functional Description: HSR is the primary publication outlet for AcademyHealth, the professional association for health services research professionals. AHRQ is proposing to acquire a journal supplement with HSR. The purpose of this special supplement is to document and describe the key aspects of this groundbreaking federal initiative and the evaluation of that effort. It is critical that the outcomes of this report be communicated to potential users in the healthcare field through the professional journal as a relevant communication channel by using a journal that has a balanced perspective, relevant audience, and an established peer-review process with access to experienced experts. (5) Predominant material of manufacture: N/A (6) Quantity: electronically and/or printed resource - page limitation TBD for manuscripts (7) Unit of issue: page limitation TBD for manuscripts (8) Destination information: AHRQ 540 Gaither Road Rockville, MD 20850 (9) Delivery Schedule: N/A 10) Duration of the contract period: Period of performance shall not exceed 10 months from date of award. 11) Sustainable acquisition requirements: N/A 12) Description of Procedure: This is a presolicitation notice of intent to sole source. This is not a solicitation for competitive proposal. No solicitation document is available. The anticipated award date is no later than January 6, 2015. 13) Architect-Engineer Project: N/A 14) Trade Agreement Clauses: N/A 15) Sole Source Justification: The Department of Health and Human Services (DHHS), Program Support Center (PSC), Acquisition Management Services (AMS), on behalf of the Agency for Healthcare Research & Quality (AHRQ), intends to sole source to: Health Research & Educational Trust - Health Services Research (HRET/HSR) 155 North Wacker, 4th Floor Chicago, IL 60606 HSR is the primary publication outlet for AcademyHealth, the professional association for health services research professionals. AHRQ is proposing to acquire a journal supplement with HSR for many reasons which include the broad and relevant audience for this journal, and the quality of this publication's peer-review process. A special supplement with HSR offers the unprecedented opportunity to advance research findings from AHRQ's patient safety and medical liability demonstration grant program to the health services research community. This audience will be able to take these learnings and foster additional improvements in safety and the quality of health care delivery within the health services research field. Currently, research in this area has not been widely evident in the peer-reviewed literature and the rigor of HSR's review process will support the publication of strong papers and in turn, will further AHRQ's program activities and the field. HSR is also ranked among the top journals in the Institute for Scientific Information/ Thomson Scientific's "Health Care Sciences and Services" category of the Science Index, and in the "Health Policy and Services" category of the Social Sciences Index. Without a special supplement from HSR, the research findings of these grants are less likely to be prepared in a cohesive and impactful manner that enables AHRQ to provide the most comprehensive vehicle to disseminate research findings and advance federal program activities for public use. Because of its past accomplishments, experienced peer-review process for special supplements and access to the health care community, HSR is uniquely qualified to be a sole source contractor for the publication of a Special Supplement. Having identified such a source already, the contractor has an established process for producing a peer-reviewed journal supplement that would provide value to the Government and support AHRQ's research and program aims. 16) This is not a solicitation for competitive proposal. No solicitation document is available. All responsible sources that have determined that they can provide the same services may submit product information and a capabilities statement. The email subject line must reference AHR144815 Supplement on Patient Safety and Medical Liability: Demonstration Grants. All responses are due by December 1, 2014, 12:00 PM Eastern Time and can be sent to Sara Marrie at Sara.Marrie@psc.hhs.gov. A determination by the Government not to compete this proposed contract base upon responses to this notice is solely within the discretion of the government.

Outpatient treatment of Hansens Disease (HD) Medical Services

Department of Health and Human Services, Health Resources and Services Administration | Published December 13, 2012  -  Deadline February 1, 2013
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The National Hansen's Disease Programs (NHDP) has a full and open competition acquisition for outpatient treatment of Hansen's Disease (HD) Medical Services in locations where the disease is prevalent. The geographic areas are as follows: Boston MA; New York City NY; Miami FL; Chicago IL; State of Texas; Phoenix AZ; Seattle WA; San Diego CA; Los Angeles CA; San Francisco CA; and San Juan PR. The contractor shall provide all facilities, management, supervision, personnel, equipment and supplies. One contract is anticipated for each geographic location. Services to be provided include: patient assessment, diagnostic studies, treatment, consultant services (Ear, Nose & Throat (ENT), Occupational Therapy, Ophthalmology, Orthopedics, Orthotics, Physical Therapy, Podiatry) laboratory services, patient, professional, and community education. The period of performance will be for a base period of twelve (12) months with two (2) twelve (12) month option periods. This agency will consider proposals from all responsible sources. The RFP is anticipated to be available electronically on or about January 7, 2013 and can be downloaded by looking under the main menu at www.fbo.gov for RFP 13-258-SOL-00002. The closing date for receipt of proposals will approximately thirty (30) days after issuance/posting of the RFP. It is the offeror's responsibility to monitor the site for amendments to the solicitation. The NAICS code for this requirement is 622110. The RFP will allow time for questions to be posed. The contact person(s) for this acquisition is Henry Copeland, hcopeland@hrsa.gov and Diane Coger, dcoger@hrsa.gov. TELEPHONE REQUESTS OR QUESTIONS WILL NOT BE ACCEPTED AT THIS TIME.

Outpatient treatment of Hansens Disease (HD) Medical Services

Department of Health and Human Services, Health Resources and Services Administration | Published November 7, 2014
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" Post-Disaster Recovery for Communitys Public Health, Medical, and Social Services " - Intent to Sole Source

Department of Health and Human Services, Program Support Center | Published August 26, 2015  -  Deadline September 9, 2015
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Pursuant to the authority of FAR 6.302-1 The Department of Health and Human Services (DHHS), Program Support Center (PSC), Acquisition Management Services, on behalf of Department of Veterans Affair (VA), intends to negotiate on a sole source basis, a cost reimbursement order under the PSC Basic Ordering Agreement (BOA) with the National Academy of Sciences, for a study on " Post-Disaster Recovery for Community's Public Health, Medical and Social Services ". An ad hoc committee will conduct a study and issue a report on how to improve the short, intermediate and long-term health outcomes and public health impact for individuals in a community (as contrasted with communities of faith, identity, etc.). The committee will investigate and identify key activities that impact health and public health outcomes in a community recovering from a disaster, and develop recommendations for their implementation. In doing so, the committee will consider the determinants of health and how various activities could leverage those determinants to improve health in the post-disaster setting, including the needs of at-risk populations. The Institute of Medicine (IOM) is an independent, not for profit organization that works outside of government to provide unbiased and authoritative advice to decision makers and the public. Established in 1970, the IOM is the health arm of the National Academy of Sciences. For more than 140 years, the National Academies have been advising the nation on issues of science, technology, and medicine; ever since an 1863 Congressional charter signed by President Lincoln authorized this non-governmental institution to honor top scientists with membership and to serve the nation whenever called upon. The IOM's reputation as an unbiased source of information is crucial to its acceptance as an authority on questions of science, health, and medicine. The IOM's unique approach to studies ensures that sponsors such as the VA receive independent and authoritative advice. Checks and balances exist at every step to protect the integrity of the reports and to maintain public confidence in their findings. NAS has the unique ability to assemble the Nation's most eminent scholars and other experts, who are appointed by the President of the Academy to provide their expertise without compensation on committees and boards, which render advice and guidance of the highest quality and unparalleled objectivity to address national issues of high priority. The Institutes of Medicine (IOM) have extensive experience convening expert committees from a variety of fields to provide objective, credible, and scientific recommendations addressing key activities that impact health and public health outcomes in a community of place recovering from a disaster, and develop recommendations for their implementation. In doing so the committee will consider the determinants of health and how various activities could leverage those determinants to improve health in the post-disaster setting, including the needs of at-risk population. The IOM's selection of experts draws on nationally known experts in the field, selected for their extensive expertise and experience in the topics under study, with specific consideration of the overall balance of viewpoints on the committee. The IOM can secure the participation of experts whom it invites to serve. The National Academies work is made possible by 6,000 of the world's top scientists, engineers, and other professionals who volunteer their time without compensation to serve on committees and participate in activities. Accordingly, NAS is uniquely qualified to provide the measure of expertise, independence, objectivity and audience acceptance necessary to meet the program requirements. NAS stands alone in its level of expertise and capacity that is required to complete the proposed study on "Post-Disaster Recovery for Community's Public Health, Medical, and Social Services". The committee will do this by identifying (based in part on a literature review of domestic and international disasters) and recommending a series of recovery practices and novel programs most likely to impact overall community public health and contribute to resiliency for future incidents in the short-, intermediate and long-term period during disaster response and following incident stabilization. Specifically the committee will: • Examine existing guidance and frameworks, peer-reviewed literature, and case studies from post-disaster response and recovery operations; • Characterize and identify key determinants of pre- and post-disaster public health, medical and social services that may serve as indicators for the affected population's long-term recovery, from various perspectives amongst the different levels of government and non-government actors generally located within a community of place; • Ascertain which other sectors are responsible for, or have the organizational interest and capacity for, directly affecting the identified determinants, and identify opportunities for collaborative engagement or support amongst those sectors; • Identify practical guidance for recovery practices and programs for each sector that will benefit community post-disaster health and public health outcomes in the short- intermediate and long-term. • Consider how community needs may be integrated into health recovery efforts. • Consider any key determinants, differences and similarities in recovery between rural and urban communities; among household-income strata; among single-family, low-rise multifamily, and high-rise multifamily housing, among households receiving government assistance and unassisted households, etc. • Consider how long-term gains for health may be achieved through investments in community, housing, and other non-traditional health infrastructures. • Identify areas of research that should be explored to answer key questions about where to direct resources before, during and after an event occurs. • Disseminate the committee's findings in appropriate formats, including a written report in the public domain, presentation at professional meetings such as the Public Health Preparedness Summit, briefings for major stakeholders, and other such venues as deemed appropriate by the committee. A cost reimbursement order will be negotiated and awarded under the PSC Basic Ordering Agreement with the National Academy of Sciences. The anticipated period of performance shall be for eighteen (18) months from date of award. This is not a solicitation for competitive proposals. All responsible sources that have the requisite qualifications to perform the work above may submit a statement of capabilities via e-mail to shelley.namoski@psc.hhs.gov, which will be considered by the agency. The e-mail subject line must reference 15-PSC-NAS-248150 Capability Statement Submission. Responses must be double-spaced with 1" margins on all sides and use a standard font no smaller than 12 point. The statement of capabilities must include: 1.) Cover Letter/Capabilities Statement illustrating organization's technical capabilities and expertise, as it relates to the requirements presented in this notice. 2.) A list of at least 3-5 Past Performance references to include: a.) Description of previous work efforts; b.) Contract number; c.) Point of contact. The response must be sequentially numbered, beginning on the first page after the table of contents. Responses are due by September 9, 10:00 AM Eastern Day Light Savings Time. Responses received after the due date and time may not be considered. A determination by the Government not to compete this requirement based upon responses to this Notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive requirement.

Human Gene Editing: Scientific, Medical and Ethical Considerations. - INTENT TO SOLE SOURCE

Department of Health and Human Services, Program Support Center | Published August 20, 2015  -  Deadline September 4, 2015
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Pursuant to the authority of FAR 6.302-1 The Department of Health and Human Services (DHHS), Program Support Center (PSC), Acquisition Management Services (AMS), on behalf of the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Cellular, Tissue, and Gene Therapies (OCTGT) (FDA/CBER/OCTGT) intends to negotiate on a sole source basis, a cost reimbursement order under the PSC Basic Ordering Agreement (BOA) with the National Academy of Sciences, for a consensus report on "Human Gene Editing: Scientific, Medical and Ethical Considerations." The independence of the institution allows NAS the unique ability to work outside the framework of government to ensure independent, unbiased, objective, and non-partisan advice on matters. The core services involve collecting, analyzing, and sharing information and knowledge. Because of its expansive and distinguished membership, NAS is uniquely positioned to bring experts together to discuss high-profile issues enabling it to be responsive to a host of requests. Combined with its long history of delivering, objective assessments based on scientific evidence that is free of political and special-interest influence, NAS is the only qualified entity capable of carrying out this study. NAS has the unique ability to assemble the Nation's most eminent scholars and other experts, who are appointed by the President of the Academy to provide their expertise without compensation on committees and boards, which render advice and guidance of the highest quality and unparalleled objectivity to address national issues of high priority. Accordingly, NAS stands alone in its level of expertise and capablility that is required to convene a consensus panel and to provide the Government with a consensus report resulting from this panel;s discussion of the ethical, legal, and social policy issues related to Genome Editing of germline cells. The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. Researchers are developing methods that enable germline Genome Editing (GE) that involves the modification of specific genomic sequences in living germline cells to determine, change, or expand their function. Genome editing on germline cells would alter their genetic material and could result in heritable changes that can be passed from one generation to the next. If an Investigational New Drug application was submitted to FDA for clinical studies using one of the germline GE methods, FDA would have to either place the study on clinical hold or allow it to proceed within 30 days of its receipt. To further our mission as it relates to human subject protection and advancing public health, the FDA feels that an assessment of the ethical, legal, and social policy issues related to these novel methods should occur prior to reviewing any investigational new drug application for clinical studies related to them. FDA is requesting the National Academy of Sciences (NAS) and the National Academy of Medicine (NAM) to address this increasingly complex situation and undertake an in-depth study to examine the scientific underpinnings, clinical implications, and ethical, legal, and social aspects of the use of current and developing human genome editing technologies in biomedical research and medicine. The Contractor shall convene a consensus panel and to provide the Center for Biologics Evaluation and Research (CBER), Office of Cellular, Tissue, and Gene Therapies (OCTGT) (FDA/CBER/OCTGT) with a consensus report resulting from this panel's discussion of the ethical, legal, and social policy issues related to GE of germline cells. FDA will utilize this report in consideration of review of applications in this area. An ad hoc committee shall examine the issues surrounding the application of gene editing techniques in the human germline. The committee will address the following questions: 1. What is the state of science for the various approaches to gene editing?; 2. What is known about the efficacy and risks of gene editing in humans, and what research might help to increase its specificity and efficacy and reduce other risks?; 3. What are the potential clinical applications of the gene editing technologies and how should the risks and benefits of these applications be weighed for both current and future generations?; 4. What are the ethical, legal, and social implications of the use of this technology in humans?; 5. What should be the approach to, and characteristics of, oversight mechanisms for germline editing in humans?; 6. What principles and frameworks should be applied for determining which, if any, applications of gene editing in humans should or should not go forward? What safeguards should be in place to guard against misuse of gene editing techniques? The committee shall address these questions and prepare a report that contains its conclusions and recommendations. An ad hoc committee of approximately 12-15 experts shall be convened to review and assess the use of genome editing technologies for human germline modification. The committee will be selected based on nominations received and to ensure the presence of individuals with expertise in the relevant fields. This may include genetics, biomedical ethics, translational medicine, legal/regulatory issues, clinical and biomedical research, patients, behavioral and social aspects of effective communication, and genome engineering. Committee nominations shall be sought from a variety of sources, including the IOM and NAS membership and relevant IOM and NRC Boards and Forums, professional associations, and other relevant stakeholders. Care shall be taken to ensure that a variety of disciplines are represented. In addition, nominations shall be sought for speakers at the public meetings, including individuals from relevant federal agencies, professional associations, academic and clinical leaders, patient organizations, the public and other relevant stakeholders. Over the course of 12 months the committee shall meet 4 times and release a prepublication copy of a report to address the above issues. The first meeting shall include an in-depth discussion of the task and a public workshop. The workshop shall also include an opportunity for other interested parties to provide input to the committee. The second committee meeting shall include committee deliberations that will be informed in part by the discussions held during the workshop. The third and final meeting of the committee shall be used to finalize the recommendations and report text. Apart from the public workshop, these meetings shall be held primarily in closed session, but as needed, the committee shall host open sessions inviting in outside experts to provide further input. In addition the committee will meet, as needed, between meetings via conference calls. A cost reimbursement order will be negotiated and awarded under the PSC Basic Ordering Agreement with the National Academy of Sciences. The anticipated period of performance shall be for twelve (12) months from date of award. This is not a solicitation for competitive proposals. All responsible sources that have the requisite qualifications to perform the work above may submit a statement of capabilities via e-mail to shelley.namoski@psc.hhs.gov, which will be considered by the agency. The e-mail subject line must reference: 15-PSC-NAS0820215C apability Statement Submission. Responses must be double-spaced with 1" margins on all sides and use a standard font no smaller than 12 point. The statement of capabilities must include: 1.) Cover Letter/Capabilities Statement illustrating organization's technical capabilities and expertise, as it relates to the requirements presented in this notice. 2.) A list of at least 3-5 Past Performance references to include: a.) Description of previous work efforts; b.) Contract number; c.) Point of contact. The response must be sequentially numbered, beginning on the first page after the table of contents. Responses are due by September 4, 2015, 12:00 PM (NOON) Eastern Time. Responses received after the due date and time may not be considered. A determination by the Government not to compete this requirement based upon responses to this Notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive requirement. A cost reimbursement order will be negotiated and awarded under the PSC Basic Ordering Agreement with the National Academy of Sciences. The anticipated period of performance shall be for twenty-four (24) months from date of award. This is not a solicitation for competitive proposals. All responsible sources that have the requisite qualifications to perform the work above may submit a statement of capabilities via e-mail to shelley.namoski@psc.hhs.gov, which will be considered by the agency. The e-mail subject line must reference: 14-PSC-NAS091614 Capability Statement Submission. Responses must be double-spaced with 1" margins on all sides and use a standard font no smaller than 12 point. The statement of capabilities must include: 1.) Cover Letter/Capabilities Statement illustrating organization's technical capabilities and expertise, as it relates to the requirements presented in this notice. 2.) A list of at least 3-5 Past Performance references to include: a.) Description of previous work efforts; b.) Contract number; c.) Point of contact. The response must be sequentially numbered, beginning on the first page after the table of contents. Responses are due by September 23, 2014, 12:00 PM (NOON) Eastern Time. Responses received after the due date and time may not be considered. A determination by the Government not to compete this requirement based upon responses to this Notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive requirement. The long established status of the National Academy of Sciences (NAS) as a noncompetitive source of scientific research and policy advice to the Government derives from its creation by Congress in 1863 (36 U.S.C. Sec. 253). This special status and relationship with the Government was reconfirmed by Executive Order (E.O.) 2859, May 11, 1918, as amended by E.O. 10668, May 10, 1956. The noncompetitive status of the Academy was most recently formally affirmed in E.O. 12832 on January 19, 1993. This order cites the special relationship of the Academy to the Government and its unique capacity to marshal scientific expertise of the highest caliber in order to provide independent and objective science policy advice. Specifically, E.O. 12832 states that "4. When a department or agency of the executive branch of the Government determines that the Academy, because of its unique qualifications, is the only source that can provide the measure of expertise, independence, objectivity, and audience acceptance necessary to meet the department's or agency's program requirements, acquisition of services by the Academy may be obtained on a noncompetitive basis if otherwise in accordance with applicable law and regulations. "

Bio-hazardous Medical Pathological Waste (MPW) Boxes, Bags, and Ties

Department of Health and Human Services, National Institutes of Health | Published July 21, 2015  -  Deadline April 10, 2015
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Studies to Enhance FDA Communications Addressing Medical Countermeasures Prescription Drug Products

Department of Health and Human Services, Food and Drug Administration | Published June 21, 2016  -  Deadline July 20, 2016
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Extraction, Transformation and Loading (ETL) of the SEER Breast Cancer Data to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM)

Department of Health and Human Services, Program Support Center | Published June 18, 2015  -  Deadline July 2, 2015
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The U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute (NCI), Division of Cancer Control and Population Sciences (DCCPS), Surveillance Research Program (SRP), Surveillance Informatics Branch (SIB), plans to procure on a sole source basis a purchase order for the Extraction, Transformation and Loading (ETL) of the SEER Breast Cancer Data to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM), from Outcomes Insights, Inc., 2801 Townsgate Rd, Ste 330, Westlake Village, CA 91361. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541712 and the business size standard is 500. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type purchase order. The period of performance shall be a twelve (12) month base period from July 8, 2015 through July 7, 2016, with a twelve (12) month option period from July 8, 2016 through July 7, 2017. It has been determined there are no opportunities to acquire green products or services for this procurement. The Surveillance, Epidemiology, and End Results (SEER) Program is one of the premier cancer surveillance programs in the world being currently composed of population-based cancer registries covering 28% of the total US population reporting on 400,000 cancer cases annually. The information collected on each and every cancer patient in SEER include demographics, a description of their cancer, limited initial treatment information, and patient follow-up including cause of death for deceased patients. The main mission of the SEER Registries is to support research on the diagnosis, treatment and outcomes of cancer. With the increasing complexity of cancer care, as for example molecular target therapies and oral chemotherapy, more detailed information is being required for the SEER data to continue to be relevant and to advance cancer research. The Surveillance Research Program (SRP) is initiating several initiatives to enhance the existing SEER data to capture expanded types of data, as for example more complete and detailed treatment information, new biomarkers, other types of outcomes such a recurrence. As SEER obtains real time data from different sources and links to its database, it is important to investigate different standards for storage and processing of data and tools to create analytical files and facilitate analyses. Jigsaw software was developed for conducting research on electronic health data. Jigsaw creates analytical files, by allowing users to specify inclusion and exclusion criteria for the creation of entire studies, including the identification of a cohort, creation of baseline exposure variables and the creation of outcome variables. It does this using a common data model for the stored data, converting claims into unique visits, and storing the available information in pre-specified tables in a defined schema. Jigsaw generates variable labels, and a data dictionary, and sends the dataset out as a .csv file. It generates two files, a cohort file (one record per person) and an events file (multiple records per person which is good for things that happen multiple times like prescriptions, labs, and hospitalizations). It also includes a database of research algorithms that can be used to construct a study called the Jigsaw Algorithm Repository (JAR). The software understands temporal relationships between claims (before or after diagnosis), and uses vocabulary supported by NIH's National Library of Medicine (NLM) thesaurus. In other words, it allows researchers to design studies using the vocabulary of study design without having to express these ideas using the syntax of a programming language. The purpose of this requirement is to use and test the Jigsaw software in creating analytic data files from the SEER data linked to Electronic Medical Records (EMR). The far reaching goal is to facilitate the use and analyses of linked SEER-EMR data to advance cancer research. In order for the data to be used in Jigsaw, it first needs to be transformed into the Observational Medical Outcomes Partnership (OMOP) Common Data Model format. SEER data is being supplemented with different data sources to expand information on cancer patients by including information such as biomarkers, treatment, recurrence, etc. not currently captured. However, linked data are high volume and complex with many records per cancer patient stored in many different files and their analyses extremely difficult. In order to process and analyze the data, it needs to be cleaned, processed and transformed into analytical files. Jigsaw is the most comprehensive software that creates analytical files for EMR, claims and linked databases. Jigsaw is actually a study builder, so not only does it select a cohort, it also creates baseline exposure and outcome variables. Jigsaw generates variable labels, data dictionary, a cohort file (one record per person) and events file (multiple records per person which is the best way to deal and analyze longitudinal data). The data can be easily exported for analyses to other statistical packages. The bottleneck for the analyses of complex and high volume data such as claims data are the processing of the data. Purchase Order Requirements The contractor shall perform the following tasks: 1. Complete a draft ETL process for cancer data into the CDM v5 framework. • The contractor shall review all of the fields and propose (in collaboration with NCI) a list of SEER fields that need to be extracted, transformed, and loaded into the CDM o It is expected that this will include many, but not all of the existing fields. The primary focus will be on histology, dates of diagnosis, tumor-specific markers, dates of death, and selected staging variables. The focus will be on diagnoses starting in 2004 because there is more code consistency in the SEER data elements. • Using the list of identified SEER fields, the contractor shall determine the correct mappings (for example, the identification of the correct LOINC or SNOMED codes to map to each SEER field). • The contractor shall write software code to perform the actual conversion. This process will be iterative and shall continue until all selected fields are properly transformed. 2. The contractor shall provide detailed documentation to allow NCI and other organizations to repeat the transformation process (along with the code). • Provide all of the details needed to facilitate NCI and others in performing the conversion. o This will include any custom mappings that are needed to complete the process (for example, conversion of ICD-O-3 codes to SNOMED, mapping of SEER fields to LOINC fields, etc.). 3. The contractor shall process the ETL of the linked EMR data from the raw form to the OMOP CDM format. • The contractor shall design and write the software code to accomplish the ETL process to move the data from the raw form to the OMOP CDM format. • The contractor shall write the software code to accomplish the ETL and move all the data into the common data model. 4. The contractor shall support the installation and use of Jigsaw with both the SEER and the EMR data transformed into the OMOP CDM Format • The contractor shall identify the most efficient way to store the data, which will depend on the data use agreement and data storage requirements. • Once the dataset is appropriately stored, the contractor shall install the Jigsaw software on an appropriate server (preferably, Jigsaw will be stored on the same server as at least a portion of the data) • The contractor shall enable the NCI staff to use and test the Jigsaw software. One of the bottlenecks of analyses of complex and high volume health data is the creation of analytical files that could then be used with standard statistical software such as SAS, R, Stata, Excel and others. The creation of analytical files from claims is challenging and resource - intensive. The cohort of patients, codes and outcomes have to be identified from multiple data sources. Codes may vary from different sources and from year to years. Translating the data into the CMD v5 and loading the data into Jigsaw are in the best interest of the Surveillance Research Program. The translation of the data will provide methods that will facilitate the assessment and quality of the claims or EHR data being linked to SEER. The use of the Jigsaw to create analytical file for analyses will standardize the methodology for data creation and save resources, since in the past data creation was done ad hoc, by writing specific code for each data creation. Outcomes Insights, Inc. is uniquely situated to conduct the conversion of SEER to the Common Data Model due to their extensive experience with SEER and SEER Medicare data, their position as collaborators in the Observational Health Data Science and Informatics (OHDSI) organization that is responsible for maintaining and improving the Common Data Model, and their strong background in epidemiology and biostatistics. They are the developers of the Jigsaw software which uses the OMOP CMD framework to process, clean and organize the claims linked data and creates study data for analyses with minimal coding from users. Jigsaw is actually a study builder, so not only does it select a cohort, it also creates baseline exposure and outcome variables. Jigsaw generates variable labels, data dictionary, a cohort file (one record per person) and events file (multiple records per person which is the best way to deal and analyze longitudinal data). The data can be easily exported for analyses to other statistical packages. No other software is available with these specifications. Any efforts to identify the required skills and expertise through outside sources would pose additional costs to the government and delays in the project. Therefore, in the best interests of the government this contract should be awarded to Outcomes Insights, Inc. For the aforementioned reasons, Outcomes Insights, Inc. is the only known source for this procurement. This is not a solicitation for competitive quotations. However, if any interested party, especially small business, believes it can meet the above requirement, a capability statement, proposal, or quotation must be submitted and will be considered by the agency. The responses and any other information furnished must be typewritten and must contain information and material in sufficient detail to allow NCI to determine whether the party can fully meet NCI's requirement. Responses must be submitted via electronic mail to Megan.Kisamore@nih.gov, no later than 11:00 AM EST on July 2, 2015. Responses will not be accepted after the due date. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, Contractors must have a valid registration in Sam.gov including certification in the Central Contractor Registration and the Online Representations and Certifications Applications. No collect calls will be accepted. Please reference solicitation number N02PC52619-85 on all correspondence.

UPTODATE

Department of Health and Human Services, Food and Drug Administration | Published August 30, 2016  -  Deadline September 6, 2016
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The FDA Library routinely receives requests for an evidence based point of care decision resource tool to ensure the safety of the products FDA regulates. Medical Officer's (MO's) review an unlimited amount of data to answer safety concerns. When an adverse event is received, MO's need access to knowledge provided by expert medical specialists featuring depth and breadth of content that is peer reviewed. Typically, MO's need to obtain background rates of disease in multiple populations, risk factors for disease occurrence, and classification schemes for syndromes, diagnostic options, and latest treatments. This information forms the basis for the foundation of the interpretation of adverse events, and it is constantly changing as the volume of medical information increases exponentially. UpToDate, an online resource, brings all this information together in a rapidly accessible and integrated format. The subscription allows MO's to log on to UpToDate 24/7 to look up and verify information. Mobile app access is also available. The subscription service uses topic reviews that are referenced back to the original journal articles, which are written by physicians renowned in their specialty and peer reviewed by other physicians. The service is designed to assist medical professionals in their day-to-day practices.

UPTODATE Online Subscription

Department of Health and Human Services, Food and Drug Administration | Published March 21, 2016  -  Deadline April 4, 2016
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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; quotes are being requested and a written solicitation will not be issued. This synopsis is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.5 for the following, under simplified acquisition procedures. The Request for Quotation (RFQ) number is FDA-SOL-16-1161600. Provisions and clauses in effect through Federal Acquisition Circular 2005-86 are incorporated into this request. It is the contractor's responsibility to be familiar with the applicable clauses and provisions. The provisions and clauses may be accessed in full text at www.acquisition.gov/far. The NAICS code is 511120, Periodical Publishers. All qualified vendors are encouraged to respond.The purpose of this procurement is to establish a contract for an online subscription to UpToDate Medical Database (Brand Name or Equal) for one, 12-month base period. The online subscription shall support 106 medical officers of the FDA's Center for Biologics Evaluation and Research (CBER). The FDA requests responses from qualified sources capable of providing the end-users with a vast variety of medical information that is readily available for the medical officers to use for data analysis.

Autoantibody Microarray Analysis

Department of Health and Human Services, National Institutes of Health | Published July 27, 2015  -  Deadline August 10, 2015
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The National Institute of Allergy and Infectious Diseases (NIAID) in support of LIG intends to negotiate on an other than full and open competition for the following specialized service: Autoantibody Microarray Analysis with UT Southwestern Medical Center, 6001 Forest Park Rd/ND6.504, Dallas, TX 75390-8814. UT Southwestern Medical Center is the only provider for this service because of the protocol that needs to be followed for this experiment. Please see the attached Statement of Work for further details. This is not a request for proposal. All responsible sources may submit a response that will be considered. The Government reserves the right to make a decision whether to this requirement is available for competition. All responses shall be submitted no later than Monday, August 10, 2015 to Kemeley Torbert at email address torbertk@niaid.nih.gov.

Collaborative Study of Non-Contact Infrared Thermometers (NCITs) and Thermographic Cameras for Fever Screening

Department of Health and Human Services, Food and Drug Administration | Published August 7, 2015  -  Deadline August 21, 2015
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The FDA and Walter Reed Army Medical Center (WRAMC) will collaborate in the study of the accuracy and effectiveness of NCIT and IR Cameras in the detection of fever. They will use the WRAMC clinics to recruit patients for the studies. FDA will provide the IR devices used in this study and provide training for investigators working with the patients, and any special backdrops, etc. needed for the study.

384ST 30ul Tips

Department of the Navy, Bureau of Medicine and Surgery | Published June 14, 2016  -  Deadline June 28, 2016
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Thsi is a notice to intent request for competitive proposals. The Naval Medical Research Center/BMRD (NMRC/BMRD) intent to solicits a proposal and enter into contract that can provide item specified below. The NAICs for this action is 339113. Naval Medical Research Center required that all contractors doing business with the Acquisiton Office must be registered with Central Contractor Registry (CCR)/System for Award Management (SAM). For additional information and to register in SAM,  please access the following website: https://www.sam.gov/. In order to register with the SAM and to be elligible to receive and award from this acquisition office, all offerors must had a Dun & Bradstreet number maybe acquired free of charge by contacting Dun & Bradstreet on-line at: https://www,dnb.com/product/eupdate/requestOptions.html or by phone at (800) 333-0505. The following requirements are:Item #                                   Description                                       Qty.0001.      384ST 30ul Tips, Case of 50.    #11484-202                                       20 cs.

UV PLATE 96 WELL HALF AREA CS50; TIP NEPTN 200UL F LR S R PK960; TIP NPTN 100UL FL LR S PK960

Department of the Navy, Bureau of Medicine and Surgery | Published March 13, 2015  -  Deadline April 12, 2015
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This is to intent request for competitive proposals. The Naval Medical Research Center (NMRC) intent to solicits a proposal and enter into contract that can provide items listed below. The NAICs for this 325414. Naval Medical Research Center rquired that all contractor doing business with the Acquisition Office must be registered with System for Award Management (SAM). For additional information and to register in SAM, please access the following website: https://www.sam.gov/. In order to register with the SAM and to be elligible to receive and award from this acquisition office, all offerors must had a Dun & Bradstreet numbers may be acquired free fo charge by contacting Dun & Bradstreet online at https://www.dnb.com/product/eupdate/requestOptions.html or by phone at (800) 333-0505. The following requirements are: Item no. Cat.# Description Qty. 0001. 33501-012 UV Plate 96Well Half Area CS50 60 CS 0002. 89140-936 Tip Neptn 200UL F LR S R PK960 03 CS 0003. 89140-162 Tip Neptn 100UL F LR S PK960 03 CS 0004. Delivery Charge 01 EA.

Notice of Intent to Sole Source

Department of Health and Human Services, Program Support Center | Published August 28, 2015  -  Deadline September 11, 2015
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Pursuant to the authority of FAR 13.106-1(b)(1)(i), the Contracting Officer may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source is reasonably available. The Department of Health and Human Services (DHHS), Program Support Center (PSC), Acquisition Management Services (AMS), on behalf of the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to sole source to: University of Puerto Rico Medical Sciences Campus Box 365067 San Juan, PR 00936-5067 The contractor is to collaborate with International, Dominican Government, and local partners on the development of a curriculum and training materials related to Medication Assisted Treatment with Buprenorphine for PWIDs in the Dominican Republic. The goal of engaging PWIDs in MAT is to decrease the risk for infection or re-infection with HIV. SAMHSA requests a sole source contracting with Dr. Angel González and Dr. Salvador Santiago through the University of Puerto Rico Graduate, School of Public Health Medical Sciences Campus. This sole source is based on their expertise in Medical Assisted Treatment (MAT) with buprenorphine-naloxone to reduce HIV transmission among injecting drug users (IDU). They are both internationally recognized scholar in this area and they have experience delivering technical assistance to the Ministry of Health from the Dominican Republic. They both understand the situation on the ground in terms of knowledge gaps within the Dominican Republic health system and have significantly contributed as mentors and trainers not only in Puerto Rico but also in other countries. They are the best qualified individuals for this project and sole source contracting will allow for a timely implementation and assurance for meeting the project goals. Dr. Angel González and Dr. Salvador Santiago is a leader in the area of substance abuse prevention and treatment specifically with a focus on opioid medication interventions and a developer of culturally competent models of addiction therapy for individuals of Latin and Caribbean descent. Should alternate sources become available, we will reconsider at that time. This is not a solicitation for competitive proposal. No solicitation document is available. All responsible sources that have determined that they can provide the same services may submit product information and a capabilities statement that speaks to the services SAMHSA is seeking in this proposed acquisition. The email subject line must reference SAM159933. All responses are due by August 31, 2015, 12:00 PM Eastern Time and can be sent to Anthony Adebayo at Anthony.adebayo@psc.hhs.gov. A determination by the Government not to compete this proposed contract base upon responses to this notice is solely within the discretion of the Government.

Quantifying the Population Health and Economic Impact of the Ryan White HIV/AIDS Program

Department of Health and Human Services, Health Resources and Services Administration | Published April 27, 2016  -  Deadline May 11, 2016
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NEGOTIATED ACQUISITION FAR PART 15 - PRESOLICITATION SOLE SOURCE THIS IS A NOTICE OF INTENT ONLY - The Health Resources and Services Administration (HRSA) intends to negotiate, on a sole source basis, under authority of FAR 6.302-1, with Harvard Medical School/Massachusetts General Hospital, 55 Fruit Street Boston, MA 02114 to build on the Cost-Effectiveness of Prevention AIDS Complications (CEPAC) mathematical model, using the existing model framework and associated parameter inputs, and shall modify the model to assess the impact of the Ryan White HIV/AIDS Program. The parameter inputs for this adapted model shall be based on client-level data from the Ryan White HIV/AIDS Program Services Report (RSR), RWHAP expenditure data, and published data pertaining to HIV natural history, survival, and costs of care.A Justification & Approval (J&A) is on file and will be posted 14 days after contract award. Sole source determination is based on only one responsible source and no other services will satisfy agency requirements. The Harvard Medical School/Massachusetts General Hospital is the only organization that can provide the required services. The North American Industry Classification System (NAICS) code for this acquisition is 541990, and the size standard is $15 million. Interested persons may identify their interest by responding to the requirement within fifteen (15) days after the date of publication of this notice. A determination by the Government not to compete this proposed acquisition based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. No solicitation is available. For further information, please contact Chris Ganey in Room 14W26D, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, 301-443-0534 or cganey1@hrsa.gov.