[Federal Register: May 20, 2003 (Volume 68, Number 97)]
[Notices]
[Page 27567-27568]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20my03-78]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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
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. 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.
SUPPLEMENTARY INFORMATION:
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]
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