[Federal Register Volume 75, Number 107 (Friday, June 4, 2010)]
[Notices]
[Pages 31794-31795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13420]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Information Sheet Guidance for Sponsors, Clinical Investigators, 
and IRBs; 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 an 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 sponsors, clinical 
investigators, and institutional review boards (IRBs) involved in 
clinical investigations of investigational drugs and biologics in 
completing the Statement of Investigator form (Form FDA 1572). FDA 
developed this information sheet guidance in response to numerous 
questions from the research community regarding Form FDA 1572. This 
information sheet guidance provides FDA's responses to the most 
frequently asked questions.

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

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Drug Information (HFD-240), 10903 New Hampshire Ave., 
Silver Spring, MD 20993 or to the Office of Communication, Training, 
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation 
and Research, Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448. Send one self-addressed adhesive label to 
assist the office in processing your requests. Submit electronic 
comments to http://www.regulations.gov. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the information sheet 
guidance document.

FOR FURTHER INFORMATION CONTACT: Joseph Salewski, Division of 
Scientific Investigations, Office of Compliance, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring MD 20993, 301-796-3395.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of an 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 
sponsors, clinical investigators, and IRBs 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. This guidance describes 
how to complete the Statement of Investigator form (Form FDA 1572).
    FDA developed this information sheet guidance in response to 
numerous questions from the research community regarding the Form FDA 
1572. In this 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 on February 3, 2006, in the Federal 
Register (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

[[Page 31795]]

new Information Sheet Guidances as needed.
    In the Federal Register of July 29, 2008 (73 FR 43940), FDA 
announced the availability of a draft version of the guidance entitled, 
``Draft Information Sheet Guidance for Sponsors, Clinical 
Investigators, and IRBs; Frequently Asked Questions--Statement of 
Investigator (Form FDA 1572).'' The July 2008 guidance gave interested 
persons an opportunity to submit comments through September 29, 2008. 
All comments received during the comment period have been carefully 
reviewed and, where appropriate, incorporated in the guidance. As a 
result of the public comments and editorial changes, the guidance is 
clearer than the draft version.
    This information sheet guidance is being issued consistent with 
FDA's GGPs regulation (21 CFR 10.115). The information sheet guidance 
represents the agency's current thinking on completing the 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 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) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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/Drugs/Guidance7ComplianceRegulatoryInformation/Guidances/default.htm or 
http://www.regulations.gov.

    Dated: May 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13420 Filed 6-3-10; 8:45 am]
BILLING CODE 4160-01-S