[Federal Register Volume 78, Number 38 (Tuesday, February 26, 2013)]
[Notices]
[Pages 13070-13071]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04386]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1999-D-0742] (formerly 1999D-4396)


Guidance for Clinical Investigators, Industry, and Food and Drug 
Administration 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 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. This guidance provides FDA's responses to the most 
frequently asked questions regarding financial disclosure by clinical 
investigators. The guidance announced in this notice finalizes the 
draft guidance of the same title dated May 2011 and replaces the 
guidance entitled, ``Guidance for Industry: Financial Disclosure by 
Clinical Investigators,'' dated March 2001.

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

ADDRESSES: Submit written requests for single copies of the 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, suite 200N, 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. 4613, 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. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

[[Page 13071]]

    Submit electronic comments on the 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 document 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. This guidance provides FDA's 
responses to the most frequently asked questions regarding financial 
disclosure by clinical investigators.
    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 and 
review of clinical investigators' financial disclosures. Specifically, 
the guidance describes: (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. FDA also 
reiterates its policy on public release of individual clinical 
investigator financial disclosure information and states its intention 
to provide summary information about clinical investigator financial 
interests/arrangements in the new product reviews FDA posts for an 
approval decision.
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    \1\ OIG report OEI-05-07-00730 available at https://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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    In the Federal Register of May 24, 2011 (76 FR 30175), FDA 
announced the availability of the draft guidance of the same title 
dated May 2011. FDA received several comments on the draft guidance, 
and those comments were considered in preparing the final guidance. 
Changes include: Clarifications related to the terms ``due diligence,'' 
``covered clinical study,'' and ``material support;'' identification of 
a dependent child for purposes of part 54; and explanation of FDA's 
review of clinical investigator financial disclosure information. In 
addition, editorial changes were made to improve clarity. The guidance 
announced in this notice finalizes the draft guidance dated May 2011 
and replaces the guidance entitled, ``Guidance for Industry: Financial 
Disclosure by Clinical Investigators,'' dated March 2001.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents FDA'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. 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 in 21 CFR parts 54, 312, and 812 have been 
approved under OMB control numbers 0910-0396, 0910-0014, and 0910-0078.

III. Comments

    Interested persons may submit either electronic regarding this 
document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219433.htm or http://www.regulations.gov.

    Dated: February 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04386 Filed 2-25-13; 8:45 am]
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