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:
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 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. 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]
BILLING CODE 4154-06-P

 

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