[Federal Register Volume 65, Number 24 (Friday, February 4, 2000)]
[Notices]
[Pages 5645-5646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2436]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-0087]


Draft Guidance for Industry on IND Meetings for Human Drugs and 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availability of a draft guidance for

[[Page 5646]]

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 This draft 
guidance provides recommendations to industry on formal meetings 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

DATES:  Submit written comments on the draft guidance by May 4, 2000. 
General comments on agency guidance documents are welcome at any time.

ADDRESSES:  Copies of this draft guidance for industry are available on 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copies of the draft guidance to the Drug Information Branch (HFD-210), 
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, 1401 Rockville Pike, Rockville, 
MD 20852-1488, FAX: 888-CBERFAX or 301-827-3844. Send one self-
addressed adhesive label to assist the office in processing your 
requests. Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

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 Evaluation and Research 
(HFM-10), Bldg. N29B, 8800 Rockville Pike, Bethesda, MD 20892, 301-827-
0373.

SUPPLEMENTARY INFORMATION:  FDA is announcing the availability of a 
draft guidance for industry entitled ``IND Meetings for Human Drugs and 
Biologics; Chemistry, Manufacturing, and Controls Information.'' This 
draft guidance covers three kinds of meetings held between sponsors and 
the agency: (1) Pre-IND, (2) end-of-phase 2, and (3) pre-new drug 
application or pre-biologics license application. These meetings 
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 
draft guidance is intended to assist in making these meetings on CMC 
information 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.
    This Level 1 draft guidance is being issued consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). The draft 
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 such approach satisfies the requirements of the 
applicable statutes, regulations, or both.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance. 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.

    Dated: January 24, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-2436 Filed 2-3-00; 8:45 am]
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