
[Federal Register Volume 78, Number 166 (Tuesday, August 27, 2013)]
[Notices]
[Pages 52932-52933]
From the Federal Register Online via the Government Printing 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]
BILLING CODE 4160-01-P


