Document ID: FDA-2012-N-0135-0001
Agency: fda
Document Type: Notice
Title: Compliance Policy Guides: Changes in Compendial Specifications and New Drug Application Supplements; Withdrawal
Posted Date: 2012-08-30T04:00Z

[Federal Register Volume 77, Number 169 (Thursday, August 30, 2012)]
[Notices]
[Page 52741]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-21415]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0135]

Compliance Policy Guide Sec. 420.300 Changes in Compendial 
Specifications and New Drug Application Supplements; Withdrawal of 
Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of Compliance Policy Guide (CPG) Sec. 420.300 Changes in 
Compendial Specifications and New Drug Application (NDA) Supplements. 
CPG Sec. 420.300 is included in FDA's Compliance Policy Guides Manual 
available on the Agency's Web site at http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm.

DATES: The withdrawal is effective August 30, 2012.

FOR FURTHER INFORMATION CONTACT:  Larry A. Ouderkirk, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-1585.

SUPPLEMENTARY INFORMATION: This CPG was originally issued on October 1, 
1980, in the Agency's Manual of Compliance Policy Guides. FDA is 
withdrawing CPG Sec. 420.300 because it is obsolete. Current guidance 
to FDA staff and industry regarding application requirement for changes 
in compendial specifications is provided in 21 CFR 314.70 and the 
Agency's Guidance for Industry: Changes to an Approved NDA or 
Abbreviated New Drug Application, which is available on the Internet at 
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM077097.pdf.

    Dated: August 16, 2012.
Dara A. Corrigan,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 2012-21415 Filed 8-29-12; 8:45 am]
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