[Federal Register: October 2, 2002 (Volume 67, Number 191)]
[Notices]
[Page 61910-61911]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02oc02-102]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02D-0389]
Draft Guidance for Industry on Nonclinical Studies for
Development of Pharmaceutical Excipients; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Nonclinical
Studies for Development of Pharmaceutical Excipients.'' The draft
guidance document provides guidance concerning development of safety
profiles to support use of new excipients as components of drug or
biological products. It is intended for use by reviewers within both
the Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER) and by interested individuals
in industry. The goals of this document are to foster and expedite the
development of new excipients, communicate to industry current CDER and
CBER thoughts pertaining to safety data needed to support excipient
development, and increase uniformity within CDER and CBER on
expectations for the nonclinical development of excipients.
DATES: Submit written or electronic comments on the draft guidance by
December 31, 2002. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of this draft
guidance to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857 Office of Communication, Training, and
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and
Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist the office in processing your requests. The document may also be
obtained by mail by calling the CBER Voice Information System at 1-800-
835-4709 or 301-827-1800, or by fax by calling the FAX Information
System at 1-888-CBER-FAX or 301-827-3844. Send one self-addressed
adhesive label to assist that office in processing your requests.
Submit written comments on the guidance to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Robert E. Osterberg, Center for Drug
Evaluation and Research (HFD-024), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-5482, or Martin D. Green,
Center for Biologics Evaluation and Research (HFM-579), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
5349.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Nonclinical Studies for Development of Pharmaceutical
Excipients.'' Excipients are potential toxicants. It is important to
perform risk-benefit assessments on excipients for use in drug products
and to establish permissible limits for these compounds. These
activities necessitate the availability of safety data. Consequently,
there is a perception that development of new excipients is resource
intensive. With proper planning, however, it is often possible to
assess the toxicology of an excipient in a relatively efficient manner.
Moreover, CDER and CBER recognize that existing human data for some
excipients may substitute for nonclinical safety data, and use in
previously approved products or GRAS status as a food additive will
continue to receive consideration. This draft
[[Page 61911]]
guidance describes the nonclinical data that should be generated to
support the safety of an inactive ingredient in the amounts
administered if adequate, relevant prior human use cannot be
documented.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on nonclinical
studies for development of pharmaceutical excipients. 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 statutes and
regulations.
II. Comments
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 draft 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/
guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.
Dated: September 23, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-24985 Filed 10-1-02; 8:45 am]
BILLING CODE 4160-01-S