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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.


Fax written comments on the collection of information by May 22, 2009.


To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to All comments should be identified with the OMB control number 0910-0396. Also include the FDA docket number found in brackets in the heading of this document.

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Elizabeth Berbakos, Office of Information Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3792.

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In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Financial Disclosure by Clinical Investigators—(OMB Control Number 0910-0396)—Extension

Respondents are sponsors of marketing applications that contain clinical data from studies covered by the regulations. These sponsors represent pharmaceutical, biologic, and medical device firms. The applicant will incur reporting costs in order to comply with the final rule. Applicants will be required to submit, for example, the complete list of clinical investigators for each covered study, not employed by the applicant and/or sponsor of the covered study, and either certify to the absence of certain financial arrangements with clinical investigators or disclose the nature of those arrangements to FDA and the steps taken by the applicant or sponsor to minimize the potential for bias. The clinical investigator will have to supply information regarding financial interests or payments held in the sponsor of the covered study.

In the Federal Register of December 29, 2008 (73 FR 79493), FDA published a 60-day notice requesting public comment on the information collection provisions. Two comments were received, one comment expressed support for this information collection. The second comment raised several issues, first, the issue of the current cost the commenter incurs in the collection of Financial Disclosure and the estimate of substantial operating costs the commenter incurs in operating costs to support the collection of investigator financial information. FDA appreciates the comment and based on this new data, submitted by the commenter, will undertake a new evaluation whether there are capital costs or operating and maintenance costs associated with this collection of information. FDA also appreciates the comment concerning the definition of “clinical investigator” and will forward the comment to the FDA office responsible for this collection of information to consider in any future rulemaking. However, these definitions are codified in 21 CFR 54.2.

FDA also appreciates the comment regarding the use of Form FDA 1572 to minimize burden. However, 21 CFR 54.4 requires the use of Form FDA 3454 and Form FDA 3455. This comment will also be forwarded to the FDA office responsible for this collection of information to consider in any future rulemaking.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden1

21 CFR SectionNo. of RespondentsAnnual Frequency per ResponseTotal Annual ResponsesHours per ResponseTotal Hours
54.4(a)(1) and (a)(2)—Form FDA 34541,00011,00055,000
54.4(a)(3)—Form FDA 34551001100202,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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The sponsors of covered studies will be required to maintain complete records of compensation agreements with any compensation paid to nonemployee clinical investigators, including information showing any financial interests held by the clinical investigator, for a time period of 2 years after the date of approval of the applications. This time is consistent with the current recordkeeping requirements for other information related to marketing applications for human drugs, biologics, and medical devices. Currently, sponsors of covered studies must maintain many records with regard to clinical investigators, including protocol agreements and investigator resumes or curriculum vitae. FDA estimates than an average of 15 minutes will be required for each recordkeeper to add this record to clinical investigators' file.

Table 2.—Estimated Annual Recordkeeping Burden1

21 CFR SectionNo. of RecordkeepersAnnual Frequency per RecordkeepingTotal Annual RecordsHours per RecordTotal Hours
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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Dated: April 15, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

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[FR Doc. E9-9148 Filed 4-21-09; 8:45 am]