[Federal Register Volume 79, Number 235 (Monday, December 8, 2014)]
[Notices]
[Page 72683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28617]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Request for Comments on Ethical Considerations and Implications 
of Public Health Emergency Response With a Focus on the Current Ebola 
Virus Disease Epidemic

AGENCY: Office of the Secretary, Presidential Commission for the Study 
of Bioethical Issues, Office of the Secretary, Department of Health and 
Human Services.

ACTION: Notice.

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SUMMARY: The Presidential Commission for the Study of Bioethical Issues 
is requesting public comment on ethical considerations and implications 
of public health emergency response with a focus on the current Ebola 
virus disease epidemic.

DATES: To ensure consideration, comments must be received by 5:00 p.m. 
EST on February 6, 2015. 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 
<a href="/cdn-cgi/l/email-protection#9bf2f5fdf4dbf9f2f4feeff3f2f8e8b5fcf4ed"><span class="__cf_email__" data-cfemail="234a4d454c63414a4c46574b4a40500d444c55">[email protected]</span></a> or by mail to the following address: Public 
Commentary, Presidential Commission for the Study of Bioethical Issues, 
1425 New York Ave. 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. E-Mail: <a href="/cdn-cgi/l/email-protection#ec848580808d9e95c29a85899e9fac8e8583899884858f9fc28b839a"><span class="__cf_email__" data-cfemail="fc949590909d8e85d28a95998e8fbc9e9593998894959f8fd29b938a">[email protected]</span></a>. 
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 with identifying and 
promoting policies and practices that ensure ethically responsible 
conduct of scientific research and health care 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.
    The Commission is considering three areas of ethical concern raised 
by public health emergency response with a focus on the current Ebola 
virus disease (EVD) epidemic. The first area concerns U.S. public 
policies that restrict association or movement (such as quarantine), 
which have recently been proposed and/or employed for health care 
workers and military personnel returning from countries affected by EVD 
in western Africa. The second area concerns the ethics of placebo-
controlled trials in the context of public health emergencies, and the 
EVD epidemic specifically, where the drug undergoing testing might be 
effective against the disease causing the emergency. The third area of 
concern is the ethical considerations relevant to collecting and 
storing biospecimens during a public health emergency, such as the EVD 
epidemic, and sharing these specimens and associated data 
internationally for future research. At its meeting on November 6, 
2014, the Commission heard from legal and medical experts in public 
health and infectious disease, and began its consideration of the 
complex ethical landscape of U.S. public health emergency response to 
the EVD epidemic.
    The Commission is interested in receiving comments from 
individuals, groups, and professional communities regarding the three 
areas of ethical concern outlined above. The Commission is particularly 
interested in receiving public commentary regarding the following 
issues in the context of public health emergency response generally and 
the EVD epidemic specifically:
    <bullet> Ethical and scientific standards for public health 
emergency response;
    <bullet> Ethical and scientific standards that guide the use of 
quarantine or other movement restrictions during public health 
emergencies;
    <bullet> The impact of quarantine or other movement restrictions on 
the availability or willingness of health workers to volunteer to 
contain the epidemic in disease-affected areas;
    <bullet> The impact of quarantine or other movement restrictions on 
public fear and anxiety about potential threats to public health;
    <bullet> How U.S. public policy and public health response to the 
current EVD epidemic might or should affect public attitudes to, and 
further U.S. policy and public health response to, other current and 
future public health issues and emergencies;
    <bullet> Ethical and scientific standards for placebo-controlled 
trials during public health emergencies;
    <bullet> Ethical and scientific standards for collection, storage, 
and international sharing of biospecimens and associated data during 
public health emergencies.
    To this end, the Commission is inviting interested parties to 
provide input and advice through written comments.
    Comments will be publicly available, including any personally 
identifiable or confidential business information that they contain. 
Trade secrets should not be submitted.

    Dated: November 20, 2014.
Lisa M. Lee,
Executive Director, Presidential Commission for the Study of Bioethical 
Issues.
[FR Doc. 2014-28617 Filed 12-5-14; 8:45 am]
BILLING CODE 4154-06-P


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