[Federal Register Volume 66, Number 60 (Wednesday, March 28, 2001)]
[Notices]
[Pages 16949-16950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-7564]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-4396]


Guidance for Industry on 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 ``Financial Disclosure by Clinical 
Investigators.'' FDA published a final rule requiring anyone who 
submits a marketing application for any drug, biologic, or device to 
submit certain information concerning the compensation to, and 
financial interests of, any clinical investigator conducting clinical 
studies covered by the rule. These requirements took effect on February 
2, 1999. This guidance is intended to provide clarification and respond 
to questions and comments concerning implementation of the final rule.

DATES: Submit written comments at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
entitled ``Financial Disclosure by Clinical Investigators'' to Mary C. 
Gross, Office of International and Constituency Relations (HF-24), Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send a 
self-addressed adhesive label to assist that office in processing your 
requests. Submit written comments on the guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mary C. Gross, Office of International 
and Constituency Relations (HF-24), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3450.

SUPPLEMENTARY INFORMATION:

I. Background

    The financial disclosure by clinical investigators regulations 
require that financial interests and arrangements of clinical 
investigators that could affect the reliability of data submitted to 
FDA are identified and disclosed by the applicant. This requirement 
applies to any clinical study submitted in a marketing application that 
the applicant or FDA relies on to establish that the

[[Page 16950]]

product is effective, and any study in which a single investigator 
makes a significant contribution to the demonstration of safety. 
Applicants are required to certify to the absences of certain financial 
interests of clinical investigators or to disclose those financial 
interests. If the applicant does not include certifications and/or 
disclosure or does not certify that it was not possible to obtain the 
information, the agency may refuse to file the application.

II. Discussion of Comments

    The agency has received 12 comments on the draft guidance which 
published in the Federal Register of October 26, 1999 (64 FR 57640). 
Some commenters asked whether use of Forms FDA 3454 and 3455 is 
mandatory. One comment asked how much information should be submitted 
when incomplete financial information is known. There were numerous 
commenters who asked whether information could be submitted through a 
questionnaire instead of through internal systems. Some commenters 
requested clarification on what FDA meant by the definition of 
``sponsor of the covered study.'' Comments were received on whether 
travel expenses for investigators should be tracked as significant 
payments of other sorts. Several commenters asked for clarification on 
FDA's definition of clinical investigator and subinvestigators. A few 
comments discussed the need to allow exemption for large scale efficacy 
studies from the covered clinical study definition. There were also 
comments requesting clarification on what FDA means by completion of 
the study and 1 year following completion of the study.

III. Status of the Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115; 65 FR 56468, September 19, 2000). 
This guidance document represents the agency's current thinking on 
financial disclosure by clinical investigators. 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 requirement of the applicable statutes and regulations.

IV. Electronic Access

    Persons interested in obtaining a copy of the guidance on the 
Internet may access the guidance at http://internet-dev.fda.gov/oc/guidance/finsumm.html or http://www.fda.gov/ohrms/dockets/default.htm.

V. Comments

    Interested persons may, at any time, submit written comments to the 
Dockets Management Branch (address above) regarding this guidance 
document. Two copies of any comments are to be submitted, except 
individuals may submit one copy. Comments should be identified with the 
docket number found in the brackets in the heading of this document. A 
copy of the document and received comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: March 20, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-7564 Filed 3-27-01; 8:45 am]
BILLING CODE 4160-01-S