2011-12623. Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled “Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.” This draft guidance is intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial disclosure by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guidance can be submitted at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers a comment on this draft guidance before it begins work on the final version of the guidance, electronic or written comments on the draft guidance should be submitted by July 25, 2011. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.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Submit written requests for single copies of this draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201,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Submit electronic comments on the draft guidance to http://www.regulations.gov.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 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.

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.

Footnotes

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.)