[Federal Register Volume 64, Number 229 (Tuesday, November 30, 1999)]
[Notices]
[Pages 66920-66921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30955]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-4959]
Guidance for Industry on the Disclosure of Materials Provided to
Advisory Committees in Connection with Open Advisory Committee Meetings
Convened by the Center for Drug Evaluation and Research Beginning on
January 1, 2000; 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 for industry entitled ``Disclosure of
Materials Provided to Advisory Committees in Connection with Open
Advisory Committee Meetings Convened by the Center for Drug Evaluation
and Research Beginning on January 1, 2000.'' This
[[Page 66921]]
document provides guidance for industry on how FDA interprets the
Federal Advisory Committee Act (FACA) with respect to the disclosure of
materials provided to advisory committees convened by the Center for
Drug Evaluation and Research (CDER).
DATES: Written comments may be submitted on the guidance document by
February 28, 2000. General comments on the agency guidance documents
are welcome at any time.
ADDRESSES: Copies of this guidance for industry are available on the
Internet at http://www.fda.gov/cder/guidance/index.htm. Submit written
requests for single copies of this guidance to the Drug Information
Branch (HFD-210), Center for Drug Evaluation and Research, Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one
self-addressed adhesive label to assist that office in processing your
requests. Submit written comments on this guidance to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Murray M. Lumpkin, Center for Drug
Evaluation and Research (HFD-2), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-5400.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
guidance for industry entitled ``Disclosure of Materials Provided to
Advisory Committees in Connection with Open Advisory Committee Meetings
Convened by the Center for Drug Evaluation and Research Beginning on
January 1, 2000.'' The document provides guidance on how FDA interprets
the FACA (5 U.S.C. App. 2) and Sec. 314.430 (21 CFR 314.430) with
respect to the disclosure of materials provided to advisory committees
and how FDA will exercise its discretion under Sec. 314.430(d)(1) in
connection with open advisory committee meetings convened by CDER
beginning on January 1, 2000.
FDA construes the FACA to require that, with respect to any open
advisory committee meeting convened pursuant to the FACA, whenever
practicable and subject to any applicable exemptions of the Freedom of
Information Act (FOIA) (5 U.S.C. 552), those materials that are
provided to the members of an advisory committee in connection with
that meeting must be made available for public inspection and copying
before or at the time of the advisory committee meeting. FDA interprets
Sec. 314.430 to be consistent with the FACA and therefore will exercise
its discretion under Sec. 314.430(d)(1) in a manner consistent with the
FACA and the FOIA as described in the previous sentence to make
available for public inspection and copying materials provided to the
members of an advisory committee in connection with open advisory
committee meetings convened by CDER, beginning on January 1, 2000.
FDA will issue further guidance on what sponsors may expect
concerning the disclosure of the materials they submit to advisory
committees in connection with open advisory committee meetings convened
by CDER beginning on January 1, 2000.
This level 1 guidance is being issued consistent with FDA's good
guidance practices (62 FR 8961, February 27, 1997). It is being
implemented immediately without prior public comment because the
guidance is needed to implement a court-approved settlement agreement.
However, the agency wishes to solicit comment from the public and is
providing a 90-day comment period and establishing a docket for the
receipt of comments.
The guidance represents the agency's current thinking on the
disclosure of materials provided to advisory committees in connection
with open advisory committee meetings convened by CDER beginning on
January 1, 2000. 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 statute, regulations, or both.
Interested persons may submit written comments on the guidance to
the Dockets Management Branch (address above). Two copies of any
comments are to be submitted, except that individuals may submit one
copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. The guidance 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: November 22, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-30955 Filed 11-29-99; 8:45 am]
BILLING CODE 4160-01-F
