Compliance Policy Guide Sec. 420.300 Changes in Compendial Specifications and New Drug Application Supplements; Withdrawal of Guidance, 52741 [2012-21415]

Download as PDF Federal Register / Vol. 77, No. 169 / Thursday, August 30, 2012 / Notices Dated: August 23, 2012. Ron A. Otten, Director, Office of Scientific Integrity (OSI), Office of the Associate Director for Science, Office of the Directors, Centers for Disease Control and Prevention. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2012–21312 Filed 8–29–12; 8:45 am] MDEpiNet 2012 Annual Meeting: The Medical Device Epidemiology Network as a Partnership for Building Global Medical Device Epidemiology and Surveillance Capabilities Food and Drug Administration [Docket No. FDA–2012–N–0360] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: Food and Drug Administration [Docket No. FDA–2012–N–0135] ACTION: Notice of public workshop; request for comments. 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. 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 https://www.fda.gov/ICECI/Compliance Manuals/CompliancePolicyGuidance Manual/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 FDA is withdrawing CPG Sec. 420.300 because it is obsolete.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 https://www.fda.gov/downloads/Drugs/ Guidance ComplianceRegulatoryInformation/ Guidances/UCM077097.pdf. SUMMARY: mstockstill on DSK4VPTVN1PROD with NOTICES Food and Drug Administration, HHS. Dated: August 16, 2012. Dara A. Corrigan, Associate Commissioner for Regulatory Affairs. [FR Doc. 2012–21415 Filed 8–29–12; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 17:07 Aug 29, 2012 Jkt 226001 The Food and Drug Administration (FDA) is announcing the following public workshop entitled ‘‘MDEpiNet 2012 Annual Meeting: The Medical Device Epidemiology Network as a Partnership for Building Global Medical Device Epidemiology and Surveillance Capabilities.’’ The topic to be discussed is setting strategic priorities and implementing an action plan for sustainable partnership toward improving regulatory science and the public health. DATES: The public workshop will be held on September 11, 2012, from 8 a.m. to 5 p.m. ADDRESSES: The public workshop will be held at the Greenbelt Marriott Hotel, 6400 Ivy Lane, Greenbelt, MD 20770, 301–441–3700. FOR FURTHER INFORMATION CONTACT: Danica Marinac-Dabic, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4110, Silver Spring, MD 20993, 301–796– 6689, email: Danica.MarinacDabic@fda.hhs.gov. SUMMARY: SUPPLEMENTARY INFORMATION: Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by 5 p.m., September 10, 2012. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. Onsite registration will not be available on the day of the workshop. If you need special accommodations due to a disability, please contact Joyce Raines, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4319, Silver Spring, MD 20993, 301–796–5709, email: joyce.raines@fda/hhs.gov; no later than September 5, 2012. To register for the public workshop, please visit FDA’s Medical Devices PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 52741 News & Events—Workshops & Conferences calendar at https:// www.fda.gov/MedicalDevices/ NewsEvents/WorkshopsConferences/ default.htm. (Select this public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. Those without Internet access should contact Danica Marinac-Dabic (see Contact Person) to register. Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Streaming Webcast of the Public Workshop: This public workshop will also be Webcast. Persons interested in viewing the Webcast must register online by 5 p.m., September 5, 2012. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after September 7, 2012. Comments: FDA is holding this public workshop to provide updates and obtain stakeholders’ input on the Medical Device Epidemiology Network (MDEpiNet) as a partnership for building global medical device epidemiology and surveillance capabilities. In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the workshop topics. The deadline for submitting comments related to this public workshop is October 9, 2012. Regardless of attendance at the meeting, interested persons may submit either written comments regarding this document to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 or electronic comments to https:// www.regulations.gov. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. In addition, when responding to specific questions as outlined in section II of this document, please identify the question you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. E:\FR\FM\30AUN1.SGM 30AUN1

Agencies

[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 https://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 
https://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]
BILLING CODE 4160-01-P
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