[Federal Register: July 29, 2008 (Volume 73, Number 146)]
[Notices]
[Page 43940-43941]
[DOCID:fr29jy08-63]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0406]

Draft Information Sheet Guidance for Sponsors, Clinical
Investigators, and Institutional Review Boards on Frequently Asked
Questions--Statement of Investigator (Form FDA 1572); 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 information sheet guidance entitled
``Information Sheet Guidance for Sponsors, Clinical Investigators, and
IRBs; Frequently Asked Questions--Statement of Investigator (Form FDA
1572).'' This guidance is intended to assist institutional review
boards (IRBs), clinical investigators, and sponsors involved in
clinical investigations of investigational drugs and biologics in
completing the Statement of Investigator form (Form FDA 1572). FDA
developed this draft information sheet guidance in response to numerous
questions from the research community regarding Form FDA 1572. This
draft information sheet guidance provides FDA's responses to the most
frequently asked questions.

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft
information sheet guidance by September 29, 2008.

ADDRESSES: Submit written comments on this draft information sheet
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
information sheet guidance document.

FOR FURTHER INFORMATION CONTACT:  Patricia M. Beers Block, Office of
Science and Health Coordination/Good Clinical Practice Program (HF-34),
Food and Drug Administration, 5600 Fishers Lane, Rockville MD 20857,
301-827-3340.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft information sheet
guidance for sponsors, clinical investigators, and IRBs entitled
``Frequently Asked Questions--Statement of Investigator (Form FDA
1572).'' This guidance is intended to assist IRBs, clinical
investigators, and sponsors involved in clinical investigations of
investigational drugs and biologics in complying with the requirement
that each investigator complete and sign a Form FDA 1572 before
participating in an investigation. It describes how to complete the
Statement of Investigator form (Form FDA 1572).
    FDA developed this draft information sheet guidance in response to
numerous questions from the research community regarding Form FDA 1572.
In this draft guidance, we provide answers to frequently asked
questions concerning the purpose of this form, when this form needs to
be completed and signed by the investigator, how to best complete the
various blocks within the form, and when the form might need to be
updated. In addition, we clarify questions related to the use of Form
FDA 1572 by clinical investigators participating in studies conducted
outside the United States that may or may not be under an
investigational new drug application.
    This information sheet 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 since the early 1980s. The Information
Sheet Guidance Initiative is intended to ensure that the Information
Sheets are 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
Information Sheet Guidances that address current issues, and develop
new Information Sheet Guidances as needed.
    This draft information sheet guidance is being issued consistent
with FDA's GGPs regulation (21 CFR 10.115). The draft information sheet
guidance, when finalized, will represent the agency's current thinking
on completing Form FDA 1572. 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 for Form FDA 1572 have been approved under
OMB Control No. 0910-0014.

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. The guidance and 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/oc/gcp/draft.html or http://
www.regulations.gov.

    Dated: July 21, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17305 Filed 7-28-08; 8:45 am]

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