[Federal Register Volume 77, Number 59 (Tuesday, March 27, 2012)]
[Notices]
[Pages 18247-18248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7329]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Request for Comments on Issues of Privacy and Access With Regard 
to Human Genome Sequence Data

AGENCY: The 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 the ethical issues raised by the ready 
availability of large-scale human genome sequence data, with regard to 
privacy and data access and the balancing of individual and societal 
interests.

DATES: To assure consideration, comments must be received by May 25, 
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, The Presidential Commission for the Study of Bioethical 
Issues, 1425 New York Ave. NW., Suite C-100, Washington, DC 20005.

FOR FURTHER INFORMATION CONTACT: Cary Scheiderer, Senior Policy and 
Research Analyst, The Presidential Commission for the Study of 
Bioethical Issues, 1425 New York Avenue NW., Suite C-100, Washington, 
DC 20005. 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 (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 assure 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.
    The Commission is examining issues of privacy and access as 
pertains to large-scale human genome sequence data, including whole 
exome and whole genome data. As a result of the tremendous 
technological advances that have dramatically reduced the cost of 
sequencing, the science is at a point where relatively inexpensive, 
rapid sequencing of whole human genomes appears not only likely, but 
imminent. This prospect raises many questions for the scientific, 
medical, ethics, and patient communities related to how this 
information can and ought be collected, used, and governed. At the 
February 2012 meeting, the Commission decided to focus specifically on 
those questions related to privacy and data access and the balancing of 
individual and societal interests.
    The Commission will spend the next six months soliciting additional 
input from the scientific, ethics, and patient communities, as well as 
others, to help inform our deliberations of these important topics. The 
Commission will provide the President with a report of its findings and 
recommendations later this year.
    The Commission is particularly interested in policies, practices, 
research, and perspectives on issues of privacy and data access as they 
relate to the integration of large-scale human genome sequencing into 
research and clinical care. To this end, the Commission is inviting 
interested parties to provide input and advice through written 
comments.
    Among other issues, the Commission is interested in receiving 
comments on the implications of large-scale human genome sequencing for 
the privacy of individuals, research subjects, patients and their 
families; the views of those groups and medical professional 
communities about privacy, both as regards genomic information and 
evolving notions of privacy, as evidenced and influenced by social 
media; and models and mechanisms for protecting privacy, in both 
genetic/genomic databases and biobanks, but also in large databases of 
sensitive information. The Commission is further interested in 
receiving comments on issues related to balancing individual and 
societal interests with regard to the sharing of and access to large-
scale human genomic data; the views of patients and other stakeholders 
on who should have access to these data and who should control access; 
models and mechanisms for governing access to genomic information; the 
role of health information technology in providing and governing access 
to genomic data; and access to genetic/genomic

[[Page 18248]]

information by law enforcement entities.
    Please address comments by email to [email protected], or by mail 
to the following address: Public Commentary, The 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: March 21, 2012.
Wanda K. Jones,
Principal Deputy Secretary for Health, Department of Health and Human 
Services.
[FR Doc. 2012-7329 Filed 3-26-12; 8:45 am]
BILLING CODE 4154-06-P