[Federal Register: October 26, 1999 (Volume 64, Number 206)]
[Notices]
[Page 57640-57641]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26oc99-61]

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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Draft Guidance for Industry on Financial Disclosure by Clinical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availability of the draft guidance entitled ``Financial Disclosure by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 This draft guidance provides clarification,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DATES: Submit written comments concerning this draft guidance by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 Submit written comments on the draft guidance to the Dockets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section of this document for electronic access to the draft guidance.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 This draft guidance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]
BILLING CODE 4160-01-F