Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Health Promotion and Disease Prevention Research Centers, Special Interest Project Competitive Supplements (SIPS) (U48 Panels N-P), RFA-DP09-101SUPP09, Initial Review, 41145 [E9-19501]

Download as PDF mstockstill on DSKH9S0YB1PROD with NOTICES Federal Register / Vol. 74, No. 156 / Friday, August 14, 2009 / Notices harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area. In June 2009, the ICH Steering Committee agreed that a draft guidance entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 9: Tablet Friability General Chapter’’ should be made available for public comment. The draft guidance is the product of the Q4B Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Q4B Expert Working Group. The draft guidance provides the specific evaluation results from the ICH Q4B process for the Tablet Friability General Chapter harmonization proposal originating from the threeparty PDG. This draft guidance is in the form of an annex to the core ICH Q4B guidance. Once finalized, the annex will provide guidance to assist industry and regulators in the implementation of the specific topic evaluated by the ICH Q4B process. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). VerDate Nov<24>2008 16:27 Aug 13, 2009 Jkt 217001 The draft guidance, when finalized, will represent the agency’s current thinking on this topic. 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 on the draft guidance. 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 http:// www.regulations.gov, http:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, or http:// www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm. Dated: July 31, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–19528 Filed 8–13–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention (CDC) Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Health Promotion and Disease Prevention Research Centers, Special Interest Project Competitive Supplements (SIPS) (U48 Panels N–P), RFA–DP09– 101SUPP09, Initial Review Cancellation: The notice was originally published in the Federal Register on July 21, 2009 (Volume 74, Number 138] [page 35877]. The following panels are cancelled: N, O and P. Contact Person for More Information: Brenda Colley-Gilbert, Ph.D., Director, Extramural Research Program Office, CCCH, 4770 Buford Highway, MS K–92, PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 41145 Atlanta, GA 30341, Telephone (770) 488–6295. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E9–19501 Filed 8–13–09; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG–2008–0333] Delaware River and Bay Oil Spill Advisory Committee; Meeting Coast Guard, DHS. Notice of meeting. AGENCY: ACTION: SUMMARY: The Delaware River and Bay Oil Spill Advisory Committee (DRBOSAC) will meet in Lewes, DE to discuss various issues to improve oil spill prevention and response strategies for the Delaware River and Bay. This meeting will be open to the public. DATES: The Committee will meet on Wednesday, September 9, 2009, from 2 p.m. to 4 p.m. This meeting may close early if all business is finished. Written material, requests to make oral presentations, and requests to have a copy of your material distributed to each member of the committee should reach the Coast Guard on or before September 2, 2009. ADDRESSES: The Committee will meet at Virden Retreat Center, University of Delaware (the Harbor Room), 700 Pilottown Road, Lewes, DE 19958. Send written material and requests to make oral presentations to Gerald Conrad, Liaison to the Designated Federal Officer (DFO) of the DRBOSAC, Coast Guard Sector Delaware Bay, 1 Washington Ave., Philadelphia, PA 19147. This notice and any documents identified in the Supplementary Information section as being available in the docket may be viewed online, at http://www.regulations.gov, using docket number USCG–2008–0333. FOR FURTHER INFORMATION CONTACT: Gerald Conrad, Liaison to the DFO of the DRBOSAC, telephone 215–271– 4824. E:\FR\FM\14AUN1.SGM 14AUN1

Agencies

[Federal Register Volume 74, Number 156 (Friday, August 14, 2009)]
[Notices]
[Page 41145]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19501]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention (CDC)


Disease, Disability, and Injury Prevention and Control Special 
Emphasis Panel (SEP): Health Promotion and Disease Prevention Research 
Centers, Special Interest Project Competitive Supplements (SIPS) (U48 
Panels N-P), RFA-DP09-101SUPP09, Initial Review

    Cancellation: The notice was originally published in the Federal 
Register on July 21, 2009 (Volume 74, Number 138] [page 35877]. The 
following panels are cancelled: N, O and P.
    Contact Person for More Information: Brenda Colley-Gilbert, Ph.D., 
Director, Extramural Research Program Office, CCCH, 4770 Buford 
Highway, MS K-92, Atlanta, GA 30341, Telephone (770) 488-6295.
    The Director, Management Analysis and Services Office, has been 
delegated the authority to sign Federal Register notices pertaining to 
announcements of meetings and other committee management activities, 
for both CDC and the Agency for Toxic Substances and Disease Registry.

Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
[FR Doc. E9-19501 Filed 8-13-09; 8:45 am]
BILLING CODE 4163-18-P