SOLICITATION NOTICE
R -- Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochodrial DNA Diseases.
- Notice Date
- 7/10/2014
- 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
- 14-PSC-NAS134440
- 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, on behalf of the of the Office of Cellular, Tissue, and Gene Therapy (OCTGT), Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA), 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 "Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial DNA Diseases". Researchers have developed methods for genetic modification of human eggs and embryos to prevent transmission of severe mitochondrial disease from women to their children. FDA believes that an assessment of the ethical and social policy issues related to these novel methods will be critical to its review of any Investigation New Drug Application (IND) proposing clinical studies that use such methods. FDA has determined that the Institute of Medicine (IOM) of the National Academy of Sciences is the only contractor capable of convening a consensus panel which would provide an appropriate, non-biased, open expert forum to discuss and assess ethical and policy issues raised by the recent development of novel methods for the prevention of transmission of mitochondrial disease from mother to child. 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 is well 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 the ethical and social policy issues raised by the recent development of novel methods for the prevention of transmission of mitochondrial disease from mother to child. The Institutes of Medicine (IOM) have extensive experience convening expert committees from a variety of fields to provide objective, credible, and scientific recommendations addressing extremely complex ethical and social policy issues, such as are the topics of this proposed study. The IOM's selection of experts draws on nationally known experts in the field, with specific consideration of the overall balance of viewpoints on the committee. Studies are undertaken by distinguished individuals selected for their extensive expertise and experience in the topics under study. 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. 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 fifteen (15) months from date of award. The Food and Drug Administration (FDA), regulates gene therapy products and human tissue, including reproductive tissue, intended for transfer into humans. An FDA Advisory Committee (AC) met on February 25 and 26, 2014 to discuss the science regarding assisted reproductive methods involving genetic modification of eggs and zygotes for the prevention of mitochondrial disease. Consistent with FDA's role in human subject protection, the AC discussion also focused on issues involving potential future clinical trials and on the risks for individual study participants and for any children that are born to women as a result of such studies. Although broader ethical and social policy issues were outside the scope of the FDA AC discussion, some of the written and oral public comments at the meeting focused on these issues. Specific issues that were raised at the meeting included: 1.) Whether manipulation of mitochondrial content should be considered germline modification, or viewed differently from modification of nuclear DNA, from a social and ethical perspective, 2.) Implications of manipulating mitochondrial content, not only in the children born to women as a result of participating in these studies, but also in descendants of any female children, 3.) The ethical issues that arise if a child is born with genetic material from three individuals, 4.) Ethical issues in providing "consent" or "permission" to accept risks on behalf of a child who does not exist. The purpose of this acquisition is to obtain the services of the National Academy of Sciences (NAS)/Institute of Medicine (IOM) to convene a consensus panel and to provide the FDA Center for Biologics Evaluation and Research (CBER), Office of Cellular, Tissue, and Gene Therapies (OCTGT) with a consensus report resulting from this panel's discussion of the ethical and social policy issues related to genetic modification of eggs and embryos to prevent transmission of mitochondrial disease. FDA will utilize this report in consideration of review of applications in this area. The following discussion questions should be addressed: 1.) Considering the ethical and social policy issues noted above, under what circumstances might clinical trials investigating the technology for the prevention of mitochondrial disease be conducted ethically? 2.) Whether, and how, the existence of alternative approaches (e.g., adoption, or egg donation) to prevent the transfer of mitochondrial disease from mother to child should factor into the assessment of allowing these trials to proceed. 3.) Whether specific measures and public oversight could address social and ethical concerns, or whether restrictions on one or more of these methods would be necessary for ethical or social policy reasons. 4.) Whether it is possible, or advisable, to establish controls under which the use of genetic engineering to prevent disease would be permitted without also authorizing genetic engineering to enhance desired traits. 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-NAS134440 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 July 25, 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.
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