[Federal Register: December 20, 2004 (Volume 69, Number 243)]
[Notices]               
[Page 75987-75988]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20de04-93]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0524]

 
Draft Guidance for Industry on ANDAs: Pharmaceutical Solid 
Polymorphism; 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availability of a draft guidance for industry entitled ``ANDAs: 
Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and 
Controls Information.'' The draft guidance is intended to assist 
applicants with the submission of abbreviated new drug applications 
(ANDAs) when a drug substance exists in polymorphic forms.

DATES: Submit written or electronic comments on the draft guidance by 
March 21, 2005. General comments on

[[Page 75988]]

agency guidance documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 See the SUPPLEMENTARY INFORMATION section for electronic 

access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Andre Raw, Center for Drug Evaluation 
and Research (HFD-620), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-5758.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, 
Manufacturing, and Controls Information.'' This draft guidance 
provides: (1) A framework for making regulatory decisions on drug 
substance sameness in terms of polymorphic form, and (2) decision trees 
which provide a recommended course to monitor and control polymorphs in 
the drug substance and/or drug product when the drug substance exists 
in relevant polymorphic forms.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on 
pharmaceutical solid polymorphism. 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 Division of Dockets Management 
(see ADDRESSES) written or electronic 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 Division of Dockets Management 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 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
    Dated: December 11, 2004.

Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-27736 Filed 12-17-04; 8:45 am]

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