[Federal Register Volume 77, Number 38 (Monday, February 27, 2012)]
[Notices]
[Pages 11555-11556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4425]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0605]


Guidance for Institutional Review Boards, Clinical Investigators, 
and Sponsors: Institutional Review Board Continuing Review After 
Clinical Investigation Approval; 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 Continuing Review after Clinical 
Investigation Approval.'' The guidance announced in this document 
finalizes the draft guidance of the same title dated January 2010. This 
document also supersedes the Information Sheet, Continuing Review After 
Study Approval. The guidance is intended to assist institutional review 
boards (IRBs) in carrying out their continuing review responsibility by 
providing recommendations regarding the criteria, process, and 
frequency of continuing review to assure the protection of the rights 
and welfare of subjects in clinical investigations.

DATES: Submit either electronic or written comments at any time. Submit 
electronic comments 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. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research (CDER), 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 
(CBER), 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 (CDRH), Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, 
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.

FOR FURTHER INFORMATION CONTACT: Sara Goldkind, Office of Good Clinical 
Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 5129, Silver Spring, MD 20993-0002. 301-796-8342.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance entitled, 
``Guidance for IRBs, Clinical Investigators, and Sponsors: IRB 
Continuing Review after Clinical Investigation Approval.'' This 
guidance is intended to assist IRBs in carrying out their continuing 
review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing 
recommendations regarding the criteria, process, and frequency of 
continuing review to assure the protection of the rights and welfare of 
subjects in clinical investigations. The guidance should also help 
clinical investigators and sponsors better understand their 
responsibilities related to continuing review. This guidance supersedes 
the Information Sheet, ``Continuing Review After Study Approval'' 
(September 1998, Office of Health Affairs, Food and Drug 
Administration). To enhance human subject protection 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.
    In the Federal Register of January 13, 2010 (75 FR 1790), FDA 
announced the availability of the draft guidance of the same title, 
dated January 2010. FDA received numerous comments on the draft 
guidance. All comments received during the comment period and questions 
received by Agency staff related to implementation of the regulations 
have been carefully reviewed and, where appropriate, incorporated into 
the guidance. Changes from the draft guidance include more detailed 
discussion about what should be submitted to assist the IRB in 
conducting continuing review, clarification of recommendations 
regarding submission of study-wide information for multi-site studies, 
discussion of the circumstances in which expedited review procedures 
may be used for continuing review, and revised guidance about how 
continuing review dates should be determined. In addition, FDA's draft 
guidance, ``IRB Continuing Review after Clinical Investigation 
Approval'', did not address IRB approval of research with conditions. 
Subsequent to OHRP's issuance of its guidance, ``IRB Approval of 
Research with Conditions'' (November 2010), FDA received multiple 
inquiries and comments recommending that FDA adopt the same policy. In 
response to these comments, FDA is including a discussion of IRB 
approval of research with conditions in the guidance.
    This guidance is part of the Information Sheet Guidance Initiative, 
announced in the Federal Register of February 3, 2006 (71 FR 5861), 
which describes FDA's intention to update the process for developing, 
issuing, and making available guidances intended for IRBs, clinical 
investigators, and

[[Page 11556]]

sponsors. Known as ``Information Sheets,'' these guidances have 
provided recommendations to IRBs, clinical investigators, and sponsors 
to help them fulfill their responsibilities to protect human subjects 
who participate in research regulated by the FDA. The Information Sheet 
Guidance Initiative is intended to ensure that the Information Sheets 
are updated, consistent with the FDA's good guidance practices (GGPs). 
As part of the initiative, which will be ongoing, the Agency plans to 
rescind Information Sheets that are obsolete, revise and reissue 
guidances that address current issues, and develop new guidance 
documents as needed.
    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. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.regulations.gov or  http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm.

    Dated: February 21, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4425 Filed 2-24-12; 8:45 am]
BILLING CODE 4160-01-P