[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