[Federal Register Volume 73, Number 146 (Tuesday, July 29, 2008)]
[Notices]
[Pages 43940-43941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17305]


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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this draft guidance before it begins work on the final version of the 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:

[[Page 43941]]

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]
BILLING CODE 4160-01-S