[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Draft Guidance on Disclosing Reasonably Foreseeable Risks in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comment period for a draft guidance document for the research community
entitled ``Draft Guidance on Disclosing Reasonably Foreseeable Risks in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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Draft Guidance on Disclosing Reasonably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to the draft guidance document.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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