[Federal Register Volume 74, Number 10 (Thursday, January 15, 2009)]
[Pages 2599-2600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-683]



Food and Drug Administration

[Docket No. FDA-2007-D-0202] (formerly Docket No. 2007D-0106)

Guidance for Clinical Investigators, Sponsors, and Institutional 
Review Boards on Adverse Event Reporting--Improving Human Subject 
Protection; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``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 institutional review boards (IRBs). FDA 
developed this guidance in response to concerns raised by the IRB 
community that increasingly large volumes of individual, unanalyzed 
adverse event reports are inhibiting, rather than enhancing, the 
ability of IRBs 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. Elsewhere in this issue of the Federal Register, FDA is issuing 
the final rule entitled ``Institutional Review Boards; Registration 

DATES: Submit written or electronic comments on agency guidances at any 

ADDRESSES: Submit written requests for single copies of the 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. Send one self-addressed 
adhesive label to assist that office in processing your requests. 
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. Submit electronic comments to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Joseph Griffin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-2270, e-mail: 
[email protected].


I. Background

    FDA is announcing the availability of a guidance for clinical 
investigators, sponsors, and IRBs entitled ``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 ensure the protection of the rights and welfare of 
human subjects. To do its job, an IRB must be informed of any 
unanticipated problems in the study and any changes in the research 
activity. This guidance discusses adverse event reporting to IRBs by 
sponsors and investigators and emphasizes the value of well-analyzed 
adverse event data to an IRB review.
    A notice announcing the draft version of this guidance published in 
the Federal Register on April 9, 2007 (72 FR 17562). After carefully 
considering all received comments, the agency is finalizing that 
guidance. The draft and the final have relatively minor substantive 
differences. The recommendations section in the final

[[Page 2600]]

guidance is streamlined and re-organized to make the information 
clearer and more accessible, but there are no major policy differences. 
The final guidance also omits much of the background discussion about 
the origin and nature of the adverse event reporting problem that the 
guidance addresses because that information is tangential to the goals 
of the guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 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 number 0910-0130; the collections of information in part 312 
have been approved under OMB control number 0910-0014; and the 
collections of information in part 812 have been approved under OMB 
control number 0910-0078.
    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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: December 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-683 Filed 1-14-09; 8:45 am]