[Federal Register Volume 72, Number 130 (Monday, July 9, 2007)]
[Notices]
[Pages 37244-37245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-13171]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0524]


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 guidance for industry entitled ``ANDAs: 
Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and 
Controls Information.'' The 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 agency guidance 
documents 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 Division of Dockets Management (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: Andre Raw, Center for Drug Evaluation 
and Research (HFD-600), Food and Drug Administration, 7500 Standish 
Pl., Rockville, MD 20855, 240-276-9310.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, 
Manufacturing, and Controls

[[Page 37245]]

Information.'' This 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.
    On December 20, 2004 (69 FR 75987), the FDA announced the 
availability of the draft version of this guidance. The public comment 
period closed on March 21, 2005. A number of comments were received, 
which the agency considered carefully as it finalized the guidance and 
made appropriate changes. Most of the changes to the guidance were made 
to clarify statements in the draft guidance.
    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 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 regarding this document. 
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. Received comments may be seen 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://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: June 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-13171 Filed 7-6-07; 8:45 am]
BILLING CODE 4160-01-S