[Federal Register Volume 67, Number 191 (Wednesday, October 2, 2002)]
[Notices]
[Pages 61910-61911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24985]


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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Draft Guidance for Industry on Nonclinical Studies for 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.

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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availability of a draft guidance for industry entitled ``Nonclinical 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 The draft 
guidance document provides guidance concerning development of safety 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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