[Federal Register: August 29, 2005 (Volume 70, Number 166)]
[Notices]
[Page 51077]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29au05-65]
[[Page 51077]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0312]
Draft Guidance for Industry on Abbreviated New Drug Applications:
Impurities in Drug Products; 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availability of a draft guidance for industry entitled ``ANDAs:
Impurities in Drug Products; Chemistry, Manufacturing, and Controls
Information.'' This draft guidance provides recommendations on what
chemistry, manufacturing, and controls information sponsors should
include regarding reporting, identification, qualification, and setting
acceptance criteria for impurities that are classified as degradation
products in drug products when submitting an abbreviated new drug
application (ANDA) or supplement to support changes in drug substance
synthesis or process, formulation of the drug product, the
manufacturing process, or components of the container/closure system.
DATES: Submit written or electronic comments on the draft guidance by
November 28, 2005. General comments on 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Division of Dockets Management (HFA-305),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access to the draft guidance document.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: Devinder Gill, Center for Drug
Evaluation and Research (HFD-630), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-5845.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 5, 1999 (64 FR 516), FDA
published the draft guidance for industry on ``ANDAs: Impurities in
Drug Products.'' The draft guidance provided recommendations for
including information in ANDAs and ANDA supplements about the
reporting, identification, qualification of, and setting acceptance
criteria for degradation products in drug products that are
manufactured from drug substances produced by chemical synthesis.
FDA is announcing the availability of a revised draft guidance for
industry entitled ``ANDAs: Impurities in Drug Products,'' which revises
the January 5, 1999, draft guidance. The draft guidance is being
revised to update information on listing of degradation products,
setting acceptance criteria, and qualifying degradation products in
conformance with our current thinking and the revision of the
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH) guidance for
industry on ``Q3B(R) Impurities in New Drug Products,'' published in
November 2003. The draft guidance is also being revised to remove
sections of the guidance containing recommendations that are no longer
needed because they are addressed in the more recent Q3B(R).
This draft 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
collection of information in this draft guidance was approved under OMB
Control No. 0910-0001.
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 these
topics. 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
either 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: August 16, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-17150 Filed 8-26-05; 8:45 am]
BILLING CODE 4160-01-S