[Federal Register: November 2, 1998 (Volume 63, Number 211)]
[Notices]
[Page 58745-58746]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02no98-80]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0549]
Guidance for Industry on Advisory Committees: Implementing
Section 120 of the Food and Drug Administration Modernization Act of
1997; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Advisory Committees:
Implementing Section 120 of the Food and Drug Administration
Modernization Act of 1997.'' This document provides guidance for
industry on changes to the policies and procedures being used by the
Center for Drug Evaluation and Research (CDER) and Center for Biologics
Evaluation and Research (CBER) with regard to advisory committees as a
result of section 120 of the Food and Drug Administration Modernization
Act of 1997 (the Modernization Act).
DATES: Written comments on the guidance may be submitted by February 1,
1999. 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'' or ``http://
www.fda.gov/cber/guidelines.htm''. Submit written requests for single
copies 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.
Comments are to be identified with the docket number found in brackets
in the heading of this document. After the comment period, comments may
be submitted to one of the centers at the address below.
FOR FURTHER INFORMATION CONTACT:
Andrea C. Masciale, Center for Drug Evaluation and Research (HFD-
7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-594-5648, or
William Freas, Center for Biologics Evaluation and Research (HFM-
21), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD
20852, 301-827-0314.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
guidance for industry entitled ``Advisory Committees: Implementing
Section 120 of the Food and Drug Administration Modernization Act of
1997.'' Advisory committees provide independent advice and
recommendations to FDA on scientific and technical matters related to
the development and evaluation of products regulated by the agency.
CDER and CBER request advice from advisory committees on a variety of
matters, including various aspects of clinical investigations and
applications for marketing approval of drug products.
[[Page 58746]]
Although the committees provide recommendations to the agency, final
decisions are made by FDA.
On November 21, 1997, President Clinton signed the Modernization
Act. Section 120 of the Modernization Act amends section 505 of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) by
adding section 505(n), which pertains to advisory committees that
provide scientific advice and recommendations to the agency regarding
the clinical investigation of drugs and the approval for marketing of
drugs. Section 505(n) of the act includes provisions for: (1)
Additional members to be included in new advisory committees, (2) new
conflict of interest considerations, (3) education and training for new
committee members, (4) timely committee consideration of matters, and
(5) timely agency notification to affected persons of decisions on
matters considered by advisory committees. This guidance document
explains how CDER and CBER intend to change their policies and
procedures with regard to advisory committees to implement section 120
of the Modernization Act. Because CDER and CBER advisory committees are
organized according to general subject (e.g., blood products,
cardiovascular and renal drugs) and not according to the topic for
consideration by the committee (e.g., a clinical investigation of a
drug product, the content of a guidance document), CDER and CBER
generally use the same policies and procedures for all advisory
committees, regardless of the topic that will be considered by the
committee. Therefore, unless otherwise stated, the guidance applies to
CDER and CBER advisory committees regardless of the topic that will be
considered by the committee. This guidance document is being issued as
a level 1 guidance 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 the
Modernization Act. However, the agency wishes to solicit comments from
the public and is providing a 90-day comment period and establishing a
docket for the receipt of comments.
This guidance represents the agency's current thinking on the
advisory committee provisions of section 120 of the Modernization Act.
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, on or before January 4, 1999, submit
written comments on the guidance to the Dockets Management Branch
(address above). Two copies 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 may be seen in the office above between
9 a.m. and 4 p.m., Monday through Friday.
Dated: August 17, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-29186 Filed 10-30-98; 8:45 am]
BILLING CODE 4160-01-F