[Federal Register: April 9, 2007 (Volume 72, Number 67)]
[Notices]
[Page 17562-17563]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ap07-88]
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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Draft Guidance for Clinical Investigators, Sponsors, and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availability of a draft guidance for industry entitled ``Guidance for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this draft guidance in response to concerns raised by the IRB community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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Critical Path Programs (HF-18), Office of the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 Submit written comments on the draft
guidance to the Division of Dockets Management (HFA-305), Food and Drug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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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draft guidance document.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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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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