Document ID: FDA-2012-D-0847-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for IRBs, Clinical Investigators, and Sponsors; Availability: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed
Posted Date: 2012-11-20T05:00Z

[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Notices]
[Pages 69631-69632]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28149]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0847]

Draft Guidance for IRBs, Clinical Investigators, and Sponsors: 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; 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availability of a draft guidance entitled ``Guidance for IRBs, Clinical 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 The draft guidance 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, adequacy of research sites, and the determination of 
whether an investigational new drug (IND) application or 
investigational device exemption (IDE) is needed in order to assure the 
protection of the rights and welfare of human subjects in clinical 
investigations.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by January 22, 2013.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Division of Drug Information, Center for Drug 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. 4622, 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 draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments 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. 5109, Silver Spring, MD 20993, 301-796-8524.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft 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.'' This guidance is intended to assist IRBs, clinical 
investigators, and sponsors involved in clinical investigations of FDA-
regulated

[[Page 69632]]

products in determining that the proposed research satisfies the 
criteria for approval contained in 21 CFR 56.111, that ``* * * the 
risks 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 investigators, (2) the adequacy of the research site, and (3) the 
determination of whether an IND/IDE is needed. When finalized, this 
guidance will supersede Question 56 in FDA's January 1998 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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    FDA is issuing this as a draft guidance. Although many of these 
recommendations have appeared in other FDA guidance documents, FDA has 
compiled the information here in order to assure that all IRBs are 
aware of and have access to it. The guidance also explains how IRBs may 
efficiently fulfill these important responsibilities.
    To enhance human subject protection and reduce regulatory burden, 
the Department of Health and Human Services (HHS) 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 addition, FDA 
acknowledges HHS's publication of the advanced notice of proposed 
rulemaking (ANPRM), ``Human Subjects Research Protections: Enhancing 
Protections for Research Subjects and Reducing Burden, Delay, and 
Ambiguity for Investigators,'' in the Federal Register of July 26, 2011 
(76 FR 44512). In the ANPRM, HHS sought comment on whether the Federal 
human subject protection regulations should be modified in a number of 
ways. In finalizing this draft guidance, ``IRB Responsibilities for 
Reviewing the Qualifications of Investigators, Adequacy of Research 
Sites, and the Determination of Whether an IND/IDE Is Needed,'' FDA 
intends to consider relevant public comments submitted in response to 
both the draft guidance and the ANPRM.
    The draft guidance is being issued consistent with FDA's Good 
Guidance Practices (GGPs) regulation (21 CFR 10.115). The draft 
guidance, when finalized, will represent 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 draft guidance includes information collections provisions 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520). 
The collections of information referenced in this guidance that are 
related to IRB recordkeeping requirements under 21 CFR 56.115 have been 
approved under OMB control number 0910-0130; the collections of 
information under 21 CFR Part 312 have been approved under OMB control 
number 0910-0014; and the collections of information under 21 CFR Part 
812 have been approved under OMB control number 0910-0078. In 
accordance with the PRA, prior to publication of any final guidance 
document, FDA intends to solicit public comment and obtain OMB approval 
for any information collections recommended in this guidance that are 
new or that would represent material modifications to these previously 
approved collections of information found in FDA regulations.

III. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm or http://www.regulations.gov.

    Dated: November 15, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28149 Filed 11-19-12; 8:45 am]
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