[Federal Register: May 20, 2003 (Volume 68, Number 97)]
[Page 27567-27568]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 99D-0674]

Guidance for Industry on INDs for Phase 2 and Phase 3 Studies; 
Chemistry, Manufacturing, and Controls Information; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``INDs for Phase 2 and 
Phase 3 Studies; Chemistry, Manufacturing, and Controls Information.'' 
This guidance is intended to provide recommendations to sponsors of 
investigational new drug applications (INDs) on the chemistry, 
manufacturing, and controls documentation (CMC), including microbiology 
documentation, that should be submitted for phase 2 and 3 studies 
conducted under INDs. The guidance applies to human drugs (as defined 
in the Federal Food, Drug, and Cosmetic Act). The guidance does not 
apply to botanical drug products, protein drugs derived from natural 
sources or produced by the use of biotechnology, or other biologics.

DATES: Submit written or electronic comments on agency guidances at any 

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. 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. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT: Charles Hoiberg, Center for Drug 
Evaluation and Research (HFD-800), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-5918.


I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``INDs for Phase 2 and Phase 3 Studies; Chemistry, 
Manufacturing, and Controls Information.'' The guidance is intended to: 
(1) Ensure that sufficient data will be submitted to the agency to 
assess from the CMC perspective the safety and quality of the proposed 
clinical studies; (2) expedite the entry of new drugs into the 
marketplace by clarifying the type, extent, and reporting of CMC 
information for phase 2 and 3 studies; and (3) facilitate drug 
discovery and development.
    In the Federal Register of April 21, 1999 (64 FR 19543), FDA 
announced the availability of a draft version of this guidance entitled 
``INDs for Phase 2 and 3 Studies of Drugs, Including Specified 
Therapeutic Biotechnology-Derived Products; Chemistry, Manufacturing, 
and Controls Content and Format.'' The April 1999 guidance gave 
interested persons an opportunity to submit comments through July 20, 
1999. All comments received during the comment period have been 
carefully reviewed and, where appropriate, incorporated in the 
guidance. The format of the guidance has been reorganized to include 
the relevant headings and to follow the order recommended for an 
application submitted in the ``Common Technical Document: Quality'' 
format (see the Quality section of the guidance entitled ``M4 
Organization of the Common Technical Document for the Registration of 
Pharmaceuticals for Human Use'' that FDA announced in the Federal 
Register on October 16, 2001 (66 FR 52634)). Additional information has 
been included to explain the difference between CMC safety information, 
which should be submitted in an information amendment, and 
corroborating information that can be submitted in an

[[Page 27568]]

annual report. As a result of the public comments and editorial 
changes, the guidance is clearer and more concise than the draft 
version. Furthermore, the scope of the guidance has been changed to 
exclude proteins and biologics. The agency is considering developing a 
separate guidance on INDs for these types of drugs.
    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in this guidance were approved under OMB 
Control No. 0910-0014.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on CMC content and format of INDs for phase 2 
and 3 studies of certain drugs. 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 to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the guidance. Submit a 
single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. The guidance and received comments may be 
seen 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 or http://www.fda.gov/ohrms/dockets/default.htm

    Dated: May 13, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-12545 Filed 5-19-03; 8:45 am]