[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]
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