[Federal Register Volume 76, Number 100 (Tuesday, May 24, 2011)]
[Notices]
[Pages 30175-30176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-12623]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1999-D-0792] (Formerly FDA-1999-D-0792)


Draft Guidance for Clinical Investigators, Industry, and FDA 
Staff: Financial Disclosure by Clinical Investigators; 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availability of a draft guidance entitled ``Guidance for Clinical 
Investigators, Industry, and FDA Staff: Financial Disclosure by 
Clinical Investigators.'' This draft guidance is intended to assist 
clinical investigators, industry, and FDA staff in interpreting and 
complying with the regulations governing financial disclosure by 
clinical investigators. This guidance provides FDA's responses to the 
most frequently asked questions regarding financial disclosure by 
clinical investigators.

DATES: Although comments on any guidance can be submitted at any time 
(see 21 CFR 10.115(g)(5)), to ensure that the Agency considers a 
comment on this draft guidance before it begins work on the final 
version of the guidance, electronic or written comments on the draft 
guidance should be submitted by July 25, 2011. 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on the draft guidance to the Division of Dockets Management (HFA-305), 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://www.regulations.gov. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002 (1-
888-463-6332 or 301-796-3400); or the Office of Communication, Outreach 
and Development (HFM-40), Center for Biologics Evaluation and Research, 
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-
1448 (1-800-835-4709 or 301-827-1800); or the Division of Small 
Manufacturers, International, and Consumer Assistance, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, rm. 4622, Silver Spring, MD 20993 (1-800-
638-2041 or 301-796-7100). Send one self-addressed adhesive label to 
assist the office in processing your requests.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Marsha Melvin, Office of Good 
Clinical Practice, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, rm. 5170, Silver Spring, MD 20993-0002, 301-796-8345.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance entitled 
``Guidance for Clinical Investigators, Industry, and FDA Staff: 
Financial Disclosure by Clinical Investigators.'' This guidance is 
intended to assist clinical investigators, industry, and FDA staff in 
interpreting and complying with the regulations governing financial 
disclosure by clinical investigators, part 54 (21 CFR part 54), and to 
provide FDA's responses to the most frequently asked questions 
regarding financial disclosure by clinical investigators. When 
finalized, this guidance will supersede ``Guidance for Industry--
Financial Disclosure by Clinical Investigators'' (March 20, 2001, 
Center for Drug Evaluation and Research, Center for Biologics 
Evaluation and Research, and Center for Devices and Radiological 
Health).
    This guidance also responds to recommendations made by the Office 
of the Inspector General (OIG), Department of Health and Human 
Services, in their report entitled ``The Food and Drug Administration's 
Oversight of Clinical Investigators' Financial Information.'' \1\ The 
OIG's recommendations were intended to strengthen FDA's oversight

[[Page 30176]]

and review of clinical investigators' financial disclosures. 
Specifically, the draft guidance will describe: (1) The sponsor's 
responsibility to collect the financial disclosure information prior to 
an investigator participating in a study and ensure that all required 
forms and attachments are submitted in marketing applications; (2) what 
is meant by ``due diligence'' in obtaining financial disclosures from 
investigators; and (3) how FDA will review financial disclosure 
information. The guidance will also seek comment on the circumstances 
under which FDA should consider public release of financial disclosure 
information related to an approved marketing application.
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    \1\ OIG report OEI-05-07-00730 available at http://oig.hhs.gov/oei/reports/oei-05-07-00730.pdf. (FDA has verified the Web site 
address, but FDA is not responsible for any subsequent changes to 
the Web site after this document publishes in the Federal Register.)
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    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 this topic. 
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 54 and 21 CFR parts 312 and 812 have 
been approved under OMB control number 0910-0396; OMB control number 
0910-0014; and OMB control number 0910-0078.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments regarding this draft 
guidance document. 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 
http://www.regulations.gov or http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm.

    Dated: May 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-12623 Filed 5-23-11; 8:45 am]
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