[Federal Register Volume 79, Number 245 (Monday, December 22, 2014)]
[Notices]
[Page 76330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29915]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Draft Guidance on Disclosing Reasonably Foreseeable Risks in 
Research Evaluating Standards of Care

AGENCY: Department of Health and Human Services (HHS), Office of the 
Secretary, Office of the Assistant Secretary for Health, Office for 
Human Research Protections; Extension of Comment Period.

ACTION: Notice.

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SUMMARY: The Department of Health and Human Services (HHS), through the 
Office for Human Research Protections (OHRP) is extending the public 
comment period for a draft guidance document for the research community 
entitled ``Draft Guidance on Disclosing Reasonably Foreseeable Risks in 
Research Evaluating Standards of Care.'' The availability of that draft 
document was published in the Federal Register on October 24, 2014, 
Volume 79, Number 206, page 63629.

DATES: The comment period is extended by 30 days and thus will end on 
January 22, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Draft Guidance on Disclosing Reasonably 
Foreseeable Risks in Research Evaluating Standards of Care'' to the 
Division of Policy and Assurances, Office for Human Research 
Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Send 
one self-addressed adhesive label to assist that office in processing 
your request, or fax your request to 301-402-2071. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the draft guidance document.
    You may submit comments identified by docket ID number HHS-OPHS-
2014-0005 by one of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov. Enter the 
above docket ID number in the Enter Keyword or ID field and click on 
``Search.'' On the next page, click the ``Submit a Comment'' action and 
follow the instructions.
    Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions] 
to: Irene Stith-Coleman, Ph.D., Office for Human Research Protections, 
1101 Wootton Parkway, Suite 200, Rockville, MD 20852.
    Comments received, including any personal information, will be 
posted without change to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, Ph.D., Office for 
Human Research Protections, Department of Health and Human Services, 
1101 Wootton Parkway, Suite 200, Rockville, MD 20852; phone 240-453-
6900; email [email protected]

SUPPLEMENTARY INFORMATION: The notice of availability of the draft 
guidance document was published in the Federal Register on October 24, 
2014, Volume 79, Number 206, page 63629, with a deadline for comments 
of December 23, 2014. OHRP is specifically addressing what risks to 
subjects are presented by research evaluating or comparing risks 
associated with standards of care, and which of these risks are 
reasonably foreseeable and should be disclosed to prospective research 
subjects as part of their informed consent. OHRP is soliciting written 
comments from all interested parties, including, but not limited to, 
IRB members, IRB staff, institutional officials, research institutions, 
investigators, research subject advocacy groups, ethicists, the 
regulated community, and the public at large. Since the notice of 
availability and draft guidance documents were published, the 
Department has received requests to extend the comment period to allow 
sufficient time for a full review of the draft guidance document. OHRP 
is committed to affording the public a meaningful opportunity to 
comment on the draft guidance document and welcomes comments.

Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
document on OHRP's Web site at http://www.hhs.gov/ohrp/newsroom/rfc/index.html or on the Federal Rulemaking Portal at http://www.regulations.gov/.

    Dated: December 17, 2014.
Jerry Menikoff,
Director, Office for Human Research Protections.
[FR Doc. 2014-29915 Filed 12-19-14; 8:45 am]
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