[Federal Register Volume 77, Number 125 (Thursday, June 28, 2012)]
[Notices]
[Pages 38631-38632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-15841]


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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.

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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 
[email protected] 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: [email protected]. 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:
     How to conceptualize and consider risk and societal value 
when reviewing pediatric clinical research in general and for medical 
countermeasures in particular;
     the types of information, data, or facts needed to ensure 
evidence-based decision-making for conducting pediatric medical 
countermeasure research;
     possible criteria, if any, that might classify proposed 
studies testing medical countermeasures for pediatric use as minimal 
risk;
     ethical issues related to access to and allocation of 
medical countermeasures previously studied within pediatric populations 
in a public health emergency;
     scientific and public health strategies that could 
minimize the risk or ethical concerns associated with pediatric medical 
countermeasure research;
     strategies for communicating risk to prospective 
participants and their families; and
     the role communities play in the design and support of 
pediatric research and pediatric medical countermeasure research.
    Please address comments by email to [email protected], 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. Comments will be publicly available, 
including any personally identifiable or confidential business 
information that they contain. Trade secrets should not be submitted.

    Dated: June 15, 2012.
Lisa M. Lee,
Executive Director, Presidential Commission for the Study of Bioethical 
Issues.
[FR Doc. 2012-15841 Filed 6-27-12; 8:45 am]
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