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28 June 2012 Bioethics: Medical Countermeasures for Children
[Federal Register Volume 77, Number 125 (Thursday, June 28, 2012)] [Notices] [Pages 38631-38632] From the Federal Register Online via the Government Printing Office [www.gpo.gov] [FR Doc No: 2012-15841] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Request for Comments on Ethical Issues Associated with the Development of Medical Countermeasures for Children AGENCY: Department of Health and Human Services, Office of the Secretary, Presidential Commission for the Study of Bioethical Issues. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the ethical issues associated with the development of medical countermeasures for children, including ethical considerations surrounding clinical research with children, ethical considerations surrounding pediatric medical countermeasure research, and ethical considerations surrounding emergency access to and use of medical countermeasures. [[Page 38632]] DATES: To ensure consideration, comments must be received by August 27, 2012. Comments received after this date will be considered only as time permits. ADDRESSES: Individuals, groups, and organizations interested in commenting on this topic may submit comments by email to info@bioethics.gov or by mail to the following address: Public Commentary, Presidential Commission for the Study of Bioethical Issues, 1425 New York Avenue NW., Suite C-100, Washington, DC 20005. FOR FURTHER INFORMATION CONTACT: Hillary Wicai Viers, Communications Director, Presidential Commission for the Study of Bioethical Issues. Telephone: 202-233-3960. Email: hillary.viers@bioethics.gov. Additional information may be obtained at http://www.bioethics.gov. SUPPLEMENTARY INFORMATION: On November 24, 2009, the President established the Presidential Commission for the Study of Bioethical Issues (the Commission) to advise him on bioethical issues generated by novel and emerging research in biomedicine and related areas of science and technology. The Commission is charged to identify and promote policies and practices that ensure ethically responsible conduct of scientific research and healthcare delivery. Undertaking these duties, the Commission seeks to identify and examine specific bioethical, legal, and social issues related to potential scientific and technological advances; examine diverse perspectives and possibilities for international collaboration on these issues; and recommend legal, regulatory, or policy actions as appropriate. On January 6, 2012, HHS Secretary Kathleen Sebelius asked the Commission to ``conduct a thorough review of the ethical considerations of conducting clinical trials of medical countermeasures in children,'' including the ethical considerations of conducting a pre- and post- event pediatric study of Anthrax Vaccine Adsorbed (AVA) as a component of post-exposure prophylaxis, in order to address ``how best to obtain clinical data on medical countermeasures in children.'' Accordingly, the Commission is examining ethical issues surrounding the development of medical treatments to keep children safe in the event of a public health emergency. While significant progress has been made in the development of medical countermeasures for adults, the development of similar products for children has lagged, in part because of challenges in conducting safety and immunogenicity studies. In the 2011 report, ``Challenges in the Use of Anthrax Vaccine Adsorbed (AVA) in the Pediatric Population as a Component of Post-Exposure Prophylaxis,'' the National Biodefense Science Board recommended that the Department of Health and Human Services move forward with testing AVA before a public health emergency but only after the ethical considerations are adequately addressed and reviewed. The Commission is requesting public comment on the ethical issues associated with the development of medical countermeasures for children, including ethical considerations surrounding clinical research with children, ethical considerations surrounding pediatric medical countermeasure research, and ethical considerations surrounding emergency access to and use of medical countermeasures. To this end, the Commission is inviting interested parties to provide input and advice through written comments. The Commission is particularly interested in policies, practices, research, and perspectives on ethical issues associated with pre- and post-event studies testing the safety, dose, and/or immunogenicity of medical countermeasures for and with children. Among other issues, specifically:
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