[Federal Register: June 1, 2006 (Volume 71, Number 105)]
[Notices]
[Page 31194-31195]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01jn06-73]
[[Page 31194]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 1985D-0243 (formerly 85D-0243), 1984D-0115 (formerly 84D-
0115), 1998D-0362 (formerly 98D-0362), 2003D-0061 (formerly 03D-0061),
2006D-0198, 1998D-0994 (formerly 98D-0994), 2003D-0571, 2000D-0186
(formerly 00D-0186), 1993D-0139 (formerly 93D-0139), 1996D-0010
(formerly 96D-0010), 1996D-0028 (formerly 96D-0028), 2001D-0361
(formerly 01D-0361), 2002D-0237 (formerly 02D-0237), 2002D-0231
(formerly 02D-0231), 1997D-0448 (formerly 97D-0448), 1998D-0374
(formerly 98D-0374), 2000D-1418 (formerly 00D-1418), 2005D-0021]
Guidance for Industry on Chemistry, Manufacturing, and Controls
Information; Withdrawal and Revision of Seven Guidances
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; withdrawal and revision.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal of five and the revision of two guidances for industry,
because some of the principles in these guidances are inconsistent with
the agency's initiative, Pharmaceutical Current Good Manufacturing
Practices (CGMPs) for the 21st Century (CGMP Initiative). Several of
the guidances listed in this notice are cross-Center guidances relating
to products regulated by the Center for Drug Evaluation and Research
(CDER), the Center for Biologics Evaluation and Research (CBER), and
the Center for Veterinary Medicine (CVM).
FOR FURTHER INFORMATION CONTACT:
For products regulated by CDER: Jon Clark, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, rm. 3550, Silver Spring, MD 20993-0002, 301-
796-2020.
For products regulated by CBER: Christopher Joneckis, Center for
Biologics Evaluation and Research (HFM-1), Food and Drug Administration
1401 Rockville Pike, suite 200N Rockville, MD 20852-1448, 301-435-5681.
For products regulated by CVM: Dennis Bensley, Center for
Veterinary Medicine (HFV-140), Food and Drug Administration, 7500
Standish Pl., MPN II, Rockville, MD 20855, 301-827-6956.
SUPPLEMENTARY INFORMATION: FDA is announcing the withdrawal of five and
the revision of two guidances for industry because of inconsistencies
with the agency's CGMP Initiative, announced by FDA on August 21, 2002.
FDA introduced the Initiative for a number of reasons: (1) To enhance
the CGMP, (2) to focus our resources and regulatory attention on those
aspects of manufacturing that pose the greatest risk to the quality of
the product, (3) to ensure that our work does not impede innovation in
manufacturing, and (4) to promote consistency in our regulatory
approach. A report on the outcome of the initiative and the recommended
steps for implementing a pharmaceutical quality regulatory system for
the future can be found on the FDA Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/
gmp/gmp2004/GMP--finalreport2004.htm.
Many of FDA's previously published guidances relating to chemistry,
manufacturing, and controls information were drafted prior to the CGMP
Initiative. FDA has begun a review of its guidances for their
consistency with the CGMP Initiative and is withdrawing five guidances
and revising two guidances as listed below. Several of the guidances
are cross-Center guidances.
CDER--Only Guidance for Withdrawal
Format and Content of the Chemistry, Manufacturing, and
Controls Section of an Application, February 1987.
CDER/CBER Guidances for Withdrawal
Submitting Documentation for the Stability of Human Drugs
and Biologics, February 1987.
Stability Testing of Drug Substances and Drug Products
(Draft), June 1998.
Drug Product: Chemistry, Manufacturing, and Controls
Information (Draft), January 2003.
Submission of Chemistry, Manufacturing and Controls
Information for Synthetic Peptides, November 1994.
CDER/CBER Guidances for Withdrawal; CVM Guidances for Revision
CDER and CBER are withdrawing the following two guidances from
their Web sites:
BACPAC I: Intermediates in Drug Substance Synthesis; Bulk
Actives Postapproval Changes: Chemistry, Manufacturing, and Controls
Documentation, February 2001.
Drug Substance: Chemistry, Manufacturing, and Controls
Information (draft), January 2004.
CVM made Level II revisions to the above two guidances to support
their continued use in CVM for the approval of new animal drugs (e.g.,
removed references to human drug and biological products). The revised
guidances are available on http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm. CVM is committed to
and supports the CGMP Initiative and may draft additional guidance that
supports the CGMP Initiative as it relates to new animal drugs.
We will continue to review our guidances for their consistency with
the CGMP Initiative and may withdraw or revise other guidances if they
do not reflect our current thinking or to align them with the concepts
of the CGMP Initiative, the Quality by Design Initiative, or Question-
based Reviews. We also plan to develop new guidances to support these
agency initiatives and to communicate guidance on submission of new
drug applications and abbreviated new drug applications.
In the meantime, we recommend that the human drug pharmaceutical
industry refer to the following International Conference on
Harmonisation's (ICH) documents, which are available on FDA's Web
sites, as alternate resources.
M4: Common Technical Document (CTD) for the Registration
of Pharmaceuticals for Human Use(CTD), October 2001.
M4: The CTD--Quality, August 2001.
Q1A(R2) Stability Testing of New Drug Substances and
Products, November 2003.
Q1B Photostability Testing of New Drug Substances and
Products, November 1996.
Q1C Stability Testing for New Dosage Forms, May 1997.
Q1D Bracketing and Matrixing Designs for Stability Testing
of New Drug Substances and Products, January 2003.
Q1E Evaluation of Stability Data, June 2004.
Q1F Stability Data Package for Registration Applications
in Climatic Zones III and IV, Revision 1, July 2004.
Q6A Specifications: Test Procedures and Acceptance
Criteria for New Drug Substances and New Drug Products: Chemical
Substances, December 2000.
Q6B Specifications: Test Procedures and Acceptance
Criteria for Biotechnological/Biological Products, August 1999.
Q7A Good Manufacturing Practice Guidance for Active
Pharmaceutical Ingredients, August 2001.
Q8 Pharmaceutical Development (Draft), February 2005.
The above list is not intended to be exhaustive. If questions arise
that are not covered in the ICH guidances, we recommend that
pharmaceutical manufacturers contact the appropriate review division.
[[Page 31195]]
Dated: May 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-8417 Filed 5-31-06; 8:45 am]
BILLING CODE 4160-01-S