SOLICITATION NOTICE
R -- “Human Gene Editing: Scientific, Medical and Ethical Considerations.” - INTENT TO SOLE SOURCE
- Notice Date
- 8/20/2015
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Program Support Center, Division of Acquisition Management, 12501 Ardennes Avenue, Suite 400, Rockville, Maryland, 20857, United States
- ZIP Code
- 20857
- Solicitation Number
- PSC-NAS-082015
- Point of Contact
- Michele Namoski, Phone: 301-443-3337
- E-Mail Address
-
SHELLEY.NAMOSKI@PSC.HHS.GOV
(SHELLEY.NAMOSKI@PSC.HHS.GOV)
- Small Business Set-Aside
- N/A
- Description
- 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. "
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