[Federal Register Volume 75, Number 8 (Wednesday, January 13, 2010)]
[Notices]
[Pages 1790-1791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-426]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Institutional Review Boards, Clinical 
Investigators, and Sponsors: IRB 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availability of a draft guidance entitled, ``Guidance for IRBs, 
Clinical Investigators, and Sponsors: IRB Continuing Review After 
Clinical Investigation Approval.'' The draft guidance announced in this 
notice 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. The draft guidance should also 
help clinical investigators and sponsors better understand their 
responsibilities related to continuing review.

[[Page 1791]]


DATES: Although comments on any guidance can be submitted at any time 
(see 21 CFR 10.115(g)(5)), to ensure that the agency considers a 
comment on this draft guidance before it begins work on the final 
version of the guidance, written or electronic comments on the draft 
guidance should be submitted by March 15, 2010. Submit written comments 
on the draft guidance to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to http://www.regulations.gov. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

ADDRESSES:  Submit written requests for single copies of this draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research (CDER), Food and Drug Administration, 10903 New 
Hampshire Ave., White Oak (WO) 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. (WO 
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.

FOR FURTHER INFORMATION CONTACT:  Sara Goldkind, Office of Good 
Clinical Practice (HF-34), Food and Drug Administration, 5600 Fishers 
Lane, rm. 16-85, Rockville, MD 20857, 301-827-3340.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft 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 draft guidance should also 
help clinical investigators and sponsors better understand their 
responsibilities related to continuing review. When finalized, this 
guidance will supersede 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 draft guidance document was developed as part of these 
efforts.
    FDA is issuing this as a draft guidance because it has been 
substantially revised in response to numerous questions about the 
continuing review process from the IRB and research communities. 
Changes include more detailed discussion about what should be submitted 
to assist the IRB in conducting continuing review, discussion of the 
circumstances in which expedited review procedures may be used for 
continuing review, and guidance about how continuing review dates 
should be determined.
    This draft 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 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 draft guidance is being issued consistent with FDA's 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 collection 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) 
(PRA). The collections of information referenced in this guidance that 
are related to IRB recordkeeping requirements under 21 CFR 56.115, 
which include the requirements for records of continuing review, have 
been approved under OMB Control No. 0910-0130; the collections of 
information in part 312 (21 CFR part 312) have been approved under OMB 
control number 0910-0014; and the collections of information in part 
812 (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 to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this draft 
guidance. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified 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.regulations.gov, or http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm

    Dated: January 7, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-426 Filed 1-12-10; 8:45 am]
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