[Federal Register Volume 71, Number 105 (Thursday, June 1, 2006)]
[Notices]
[Pages 31194-31195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-8417]



[[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://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://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.


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    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