[Federal Register Volume 66, Number 102 (Friday, May 25, 2001)]
[Notices]
[Pages 28915-28916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13249]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-0087]


Guidance for Industry on IND Meetings for Human Drugs and 
Biologics; Chemistry, Manufacturing, and Controls Information; 
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 ``IND Meetings for 
Human Drugs and Biologics; Chemistry, Manufacturing, and Controls 
Information.'' This guidance provides recommendations to industry on 
formal meetings between sponsors of investigational new drug 
applications (INDs) and the Center for Drug Evaluation and Research 
(CDER) or the Center for Biologics Evaluation and Research (CBER) on 
chemistry, manufacturing, and controls (CMC) information.

DATES: Submit written comments on agency guidances at any time.

ADDRESSES: Submit written requests for single copies of this 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, or to the Office of Communication, Training, 
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation 
and Research, Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1488, FAX 1-888-CBER-FAX or 301-827-3844. Send one 
self-addressed adhesive label to assist the 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:
    Stephen K. Moore, Center for Drug Evaluation and Research (HFD-
501), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-6430;
or
    Robert A. Yetter, Center for Biologics and Research (HFM-10), Food 
and Drug Administration, Bldg. N29B, 8800 Rockville Pike, Bethesda, MD 
20892, 301-827-0373.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``IND Meetings for Human Drugs and Biologics; Chemistry, 
Manufacturing, and Controls Information.'' This guidance covers three 
kinds of meetings held at specific times between sponsors and the 
agency where CMC issues are discussed: (1) Pre-IND, (2) end-of-phase 2, 
and (3) pre-new drug application or prebiologics license application. 
These meetings are used to address questions and scientific issues that 
arise during the course of clinical investigations, aid in the 
resolution of problems, and facilitate evaluation of the drug. The 
meetings often coincide with critical points in the drug development 
and/or regulatory process. This guidance is intended to assist in 
making these meetings more efficient and effective by providing 
information on the: (1) Purpose, (2) meeting request, (3) information 
package, (4) format, and (5) focus of the meeting.
    In the Federal Register of February 4, 2000 (65 FR 5645), FDA 
announced the availability of a draft version of this guidance. The 
February 4, 2000, guidance gave interested persons an opportunity to 
submit comments through May 4, 2000. All comments received during the 
comment period have been carefully reviewed and incorporated in this 
revised guidance where appropriate. As a result of the public comment, 
the guidance is clearer and more concise than the draft version.
    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115; 65 FR 56468, September 
19, 2000). The guidance represents the agency's current thinking on IND 
meetings for human drugs and biologics; chemistry, manufacturing, and 
controls information. 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

[[Page 28916]]

such approach satisfies the requirements of the applicable statutes and 
regulations.

II. Comments

    Interested persons may, at any time, 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/ohrms/dockets/default.htm, or http://www.fda.gov/cber/guidelines.htm.

    Dated: May 17, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-13249 Filed 5-24-01; 8:45 am]
BILLING CODE 4160-01-S