[Federal Register Volume 64, Number 76 (Wednesday, April 21, 1999)]
[Notices]
[Pages 19543-19544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9769]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-0674]


Draft Guidance for Industry on IND's for Phase 2 and 3 Studies of 
Drugs, Including Specified Therapeutic Biotechnology-Derived Products; 
Chemistry, Manufacturing, and Controls Content and Format; 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availability of a draft guidance for industry entitled ``INDs for Phase 
2 and 3 Studies of Drugs, Including Specified Therapeutic 
Biotechnology-Derived Products; Chemistry, Manufacturing, and Controls 
Content and Format.'' This draft guidance is intended to provide 
recommendations to sponsors of investigational new drug applications 
(IND's) on the chemistry, manufacturing, and controls documentation 
(CMC), including microbiology documentation, that should be submitted 
for phase 2 and 3 of IND's. This draft guidance applies to human drugs 
and specified-biotechnology derived products.

DATES:  Written comments on the draft guidance document may be 
submitted by July 20, 1999. General comments on agency guidance 
documents are welcome at any time.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance for industry to the Drug Information Branch (HFD-210), Center 
for Drug Evaluation and Research, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, or 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 20852-1448. Send one self-addressed adhesive label 
to assist the office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft. 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comments on the draft guidance to the Dockets Management Branch (HFA-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: 
     Charles P. Hoiberg, Center for Drug Evaluation and Research (HFD-
810), Food and Drug

[[Page 19544]]

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2570, 
or
    Robert A. Yetter, Center for Biologics Evaluation and Research 
(HFM-10), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852, 301-827-0373.

SUPPLEMENTARY INFORMATION: 

I. Background

     FDA is announcing the availability of a draft guidance for 
industry entitled ``INDs for Phase 2 and 3 Studies of Drugs, Including 
Specified Therapeutic Biotechnology-Derived Products; Chemistry, 
Manufacturing, and Controls Content and Format.'' This draft guidance 
is intended to: (1) Facilitate drug discovery and development, (2) 
ensure that sufficient data will be submitted for the agency to assess 
the safety as well as the quality of the proposed clinical studies from 
the CMC and microbiology perspectives, and (3) expedite the entry of 
new drugs into the marketplace.
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). This draft 
guidance represents the agency's current thinking on CMC content and 
format of IND's for phase 2 and 3 studies of drugs, including specified 
therapeutic biotechnology-derived products. 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.

II. Comments

    Interested persons may submit written comments on the draft 
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 may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.

III. Electronic Access

    Copies of this draft guidance are available on the Internet at 
``http://www.fda.gov/cder/guidance/index.htm'' or ``http://www.fda.gov/
cber/guidelines.htm''.

    Dated: April 13, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-9769 Filed 4-20-99; 8:45 am]
BILLING CODE 4160-01-F