[Federal Register Volume 72, Number 67 (Monday, April 9, 2007)]
[Notices]
[Pages 17562-17563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-6595]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0106]


Draft Guidance for Clinical Investigators, Sponsors, and 
Investigational Review Boards on Adverse Event Reporting--Improving 
Human Subject Protection; 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availability of a draft guidance for industry entitled ``Guidance for 
Clinical Investigators, Sponsors, and IRBs; Adverse Event Reporting--
Improving Human Subject Protection.'' This guidance is intended to 
assist the research community in interpreting requirements for 
submitting reports of unanticipated problems, including certain adverse 
events reports, to the Institutional Review Board (IRB). FDA developed 
this draft guidance in response to concerns raised by the IRB community 
that increasingly large volumes of individual adverse event reports are 
inhibiting rather than enhancing IRBs' ability to adequately protect 
human subjects. The guidance provides recommendations to IRBs, 
sponsors, and investigators on improving the usefulness of the adverse 
event information submitted to IRBs.

DATES:  Submit written or electronic comments on the draft guidance by 
June 8, 2007. General comments on agency guidance documents are welcome 
at any time.

[[Page 17563]]


ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Critical Path Programs (HF-18), Office of the 
Commissioner, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857. Send one self-addressed adhesive label to assist 
that office in processing your requests. Submit telephone requests to 
800-835-4709 or 301-827-1800. Submit written comments on the draft 
guidance to the Division of Dockets Management (HFA-305), Food and Drug 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.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Terrie L. Crescenzi, Office of 
Critical Path Programs (HF-18), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7864.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for clinical 
investigators, sponsors, and IRBs entitled ``Guidance for Clinical 
Investigators, Sponsors, and IRBs; Adverse Event Reporting--Improving 
Human Subject Protection.'' Under the regulations in 21 CFR part 50 
(Protection of Human Subjects), part 56 (21 CFR part 56) (Institutional 
Review Boards), part 312 (21 CFR part 312) (Investigational New Drug 
Application), and part 812 (21 CFR part 812) (Investigational Device 
Exemptions), an IRB must review and approve a clinical study before the 
study is initiated. Additionally, after an IRB's initial review and 
approval, an IRB must conduct continuing review of the study at 
intervals appropriate to the degree of risk presented by the study, at 
least annually. The primary purpose of both the initial review of a 
study and the periodic review of the conduct of the study is to assure 
the protection of the rights and welfare of human subjects. To assure 
the protection of the rights and welfare of human subjects during the 
conduct of a clinical study, an IRB must have information concerning 
unanticipated problems in the study and changes in the research 
activity. Such information may be important to the IRB's review. This 
draft guidance discusses adverse event reporting to IRBs by sponsors, 
and investigators, and emphasizes the greater value of well-analyzed 
adverse event data to an IRBs review. This draft guidance is being 
issued consistent with FDA's good guidance practices regulation (21 CFR 
10.115). The draft guidance, when finalized, will represent the 
agency's current thinking on adverse event reporting for the purpose of 
improving human subject protection. 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 refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in part 56 have been approved under OMB 
Control No. 0910-0130; the collections of information in part 312 have 
been approved under OMB Control No. 0910-0014; and the collections of 
information in part 812 have been approved under OMB Control No. 0910-
0078.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
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 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: April 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-6595 Filed 4-6-07; 8:45 am]
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