[Federal Register Volume 64, Number 206 (Tuesday, October 26, 1999)]
[Notices]
[Pages 57640-57641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27840]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-4396]


Draft Guidance for Industry on Financial Disclosure by Clinical 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availability of the draft guidance entitled ``Financial Disclosure by 
Clinical Investigators.'' This draft guidance provides clarification, 
and responds to questions, concerning implementation of the final rule 
issued by FDA 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 final rule.
DATES: Submit written comments concerning this draft guidance by 
December 27, 1999.

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 20856. Send a 
self-addressed adhesive label to assist that office in processing your 
requests. Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 10-61, Rockville, MD 20852. See the Supplementary Information 
section of this document for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Mary C. Gross, Office of International 
and Constituency Relations (HF-24), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20856, 301-827-3450, FAX 301-827-1335.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Financial Disclosure by Clinical Investigators.'' This draft guidance 
is intended to provide clarification concerning implementation of the 
final rule issued by FDA 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 
final rule. The requirements of the final rule took effect on February 
2, 1999.
    The agency's regulations on financial disclosure by clinical 
investigators 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 
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 absence of certain financial interests 
of clinical investigators or to disclose those financial interests. If 
the applicant does not include a certification and/or disclosure or 
does not certify that it was not possible to obtain the information, 
the agency may refuse to file the application.
    The agency has received many questions concerning implementation of 
this final rule and has issued this draft guidance in the form of 
questions and answers in an effort to respond to these questions. FDA 
wishes to emphasize its commitment to work with sponsors as they begin 
their efforts to comply with the provisions of the rule.

II. Electronic Access

    Copies of this guidance are available on the Internet. The guidance 
is located at www.fda.gov/oc/guidance/financialdis.html.

III. Comments

    This draft document is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Dockets Management Branch (address above) written 
comments regarding this draft guidance document. Written comments may 
be submitted at any time, however, comments should be submitted by 
December 27, 1999, to ensure adequate consideration in preparation of 
the final

[[Page 57641]]

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: October 19, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-27840 Filed 10-25-99; 8:45 am]
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