[Federal Register Volume 78, Number 166 (Tuesday, August 27, 2013)]
[Notices]
[Pages 52932-52933]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20822]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0847]
Guidance for Institutional Review Boards, Clinical Investigators,
and Sponsors: Institutional Review Board Responsibilities for Reviewing
the Qualifications of Investigators, Adequacy of Research Sites, and
the Determination of Whether an Investigational New Drug/
Investigational Device Exemption is Needed; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Guidance for IRBs, Clinical
Investigators, and Sponsors: IRB Responsibilities for Reviewing the
Qualifications of Investigators, Adequacy of Research Sites, and the
Determination of Whether an IND/IDE is Needed.'' The guidance announced
in this notice is intended to assist institutional review boards
(IRBs), clinical investigators, and sponsors involved in clinical
investigations of FDA-regulated products in fulfilling responsibilities
related to reviewing the qualifications of investigators and adequacy
of research sites, and determining whether an investigational new drug
(IND) application or investigational device exemption (IDE) is
required, to protect the rights and welfare of human subjects involved
in biomedical research.
DATES: Submit written or electronic comments on Agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 2201, Silver Spring, MD 20993-0002, 1-888-463-6332 or 301-796-
3400; or the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research, Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 1-800-835-4709 or 301-827-1800; or the Division of Small
Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave. Bldg. 66, Rm. 4621, Silver Spring, MD 20993, 1-800-
638-2041 or 301-796-7100. Send one self-addressed adhesive label to
assist the office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Doreen Kezer, Office of Good Clinical
Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 5170, Silver Spring, MD 20993-0002, 301-796-8340.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance entitled
``Guidance for IRBs, Clinical Investigators, and Sponsors: IRB
Responsibilities for Reviewing the Qualifications of Investigators,
Adequacy of Research Sites, and the
[[Page 52933]]
Determination of Whether an IND/IDE is Needed.'' This guidance is
intended to assist IRBs, clinical investigators, and sponsors involved
in clinical investigations of FDA-regulated products in determining
that the proposed research satisfies the criteria for approval
contained in 21 CFR 56.111, that ``[r]isks to subjects are minimized .
. . [and] reasonable in relation to anticipated benefits, if any, to
subjects . . .'' In particular, the guidance addresses the IRB's role
in reviewing: (1) The qualifications of clinical investigators, (2) the
adequacy of the research site, and (3) the determination of whether an
IND/IDE is required.
Many of the recommendations in this guidance have appeared in other
FDA guidance documents. FDA has compiled the recommendations from these
various sources into this guidance to ensure that all IRBs have access
to it. The guidance also explains how IRBs may efficiently fulfill
these important responsibilities.
To enhance protection of human subjects and reduce regulatory
burden, the Department of Health and Human Services, Office for Human
Research Protections (OHRP), and FDA have been actively working to
harmonize the Agencies' regulatory requirements and guidance for human
subject research. This guidance document was developed as a part of
these efforts and in consultation with OHRP.
In the Federal Register of November 20, 2012 (77 FR 69631), FDA
announced the availability of the draft guidance of the same title. FDA
received several comments on the draft guidance, and considered them in
preparing the final guidance. In the final guidance, FDA clarified that
IRBs, sponsors, and clinical investigators all have responsibility for
ensuring that the research complies with applicable laws and
regulations and that risks to subjects are minimized. FDA also made
changes to confirm that the recommendations in the guidance may be
fulfilled by any IRB, whether independent or affiliated with an
institution, and whether serving as a local IRB or as the central IRB,
and made editorial changes to improve clarity. The guidance announced
in this notice finalizes the draft guidance dated November 2012, and
replaces Question 56 in FDA's guidance entitled ``Institutional Review
Boards Frequently Asked Questions--Information Sheet--Guidance for
Institutional Review Boards and Clinical Investigators.'' \1\
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\1\ See http://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm#GeneralQuestions.
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The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
II. The Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). None of the collections of information
referenced in this guidance are new or represent material modifications
to previously approved collections of information. The collections of
information under 21 CFR part 312 have been approved under OMB control
number 0910-0014; the collections of information under 21 CFR part 812
have been approved under OMB control number 0910-0078; and the
collections of information under 21 CFR part 56 have been approved
under OMB control number 0910-0130.
III. Comments
Interested persons may submit either electronic comments regarding
this guidance to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.regulations.gov or http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219433.htm.
Dated: August 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20822 Filed 8-26-13; 8:45 am]
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