Center for Scientific Review; Notice of Closed Meetings, 48080-48081 [E9-22587]

Download as PDF 48080 Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices Dated: September 14, 2009. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E9–22646 Filed 9–18–09; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0514] Guidance for Industry on End-of-Phase 2A Meetings; Availability AGENCY: Food and Drug Administration, HHS. mstockstill on DSKH9S0YB1PROD with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘End-of-Phase 2A Meetings.’’ This guidance provides information on end-of-phase 2A (EOP2A) meetings for sponsors of investigational new drug applications (INDs). The purpose of an EOP2A meeting is to facilitate interaction between FDA and sponsors who seek guidance related to clinical trial design employing clinical trial simulation and quantitative modeling of prior knowledge (e.g., drug, disease, placebo), designing trials for better dose response estimation and dose selection, and other related issues. This guidance is intended to further FDA initiatives directed at identifying opportunities to facilitate the development of innovative medical products and improve the quality of drug applications through early meetings with sponsors. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Jogarao Gobburu, Center for Drug VerDate Nov<24>2008 17:24 Sep 18, 2009 Jkt 217001 Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3186, Silver Spring, MD 20993–0002, 301– 796–2460. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Endof-Phase 2A Meetings.’’ This guidance will meet one of the performance goals agreed to under the September 27, 2007, reauthorization of the Prescription Drug User Fee Act (PDUFA IV). Under section XI of the PDUFA IV Performance Goals, Expediting Drug Development, FDA agreed to publish by the end of fiscal year 2008 a draft guidance on EOP2A meetings and to complete the final guidance within 1 year of the close of the public comment period (see https:// www.fda.gov/ForIndustry/UserFees/ PrescriptionDrugUserFee/ ucm119243.htm at section XI.A). FDA has a long-standing interest in defining dose or exposure-response relationships for the effectiveness and safety of new drugs. Accurate doseresponse information is important for understanding how patients should take drugs to maximize desirable effects and minimize undesirable effects. Dose selection for phase 2 and phase 3 studies is a challenge in many drug development programs and poor choice may lead to trial failure. Improving early dose selection may increase the likelihood of future trial success. FDA recognizes trial planning may be improved by clinical trial simulations that employ quantitative models of drug exposure-response, placebo effect, and disease progression. This guidance on EOP2A meetings is intended to encourage the best use of this science to facilitate the exploration of trial design alternatives to increase the likelihood for successful trials. In the Federal Register of September 26, 2008 (73 FR 55851), FDA announced the availability of a draft guidance of the same title. In response to public comments on the draft version, the guidance has been revised to clarify the following topics: (1) The type of information that should be submitted with the meeting request and the background package and (2) the role of the Office of New Drugs in preparing for and conducting EOP2A meetings. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on the roles of modelbased drug development together with early interaction between FDA and industry to improve late phase clinical PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 trial success. 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 regarding this document. 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. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 312 and the guidance on ‘‘Formal Meetings with Sponsors and Applicants for PDUFA Products’’ have been approved under OMB control numbers 0910–0014 and 0910–0429, respectively. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: September 16, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–22623 Filed 9–18–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections E:\FR\FM\21SEN1.SGM 21SEN1 Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. mstockstill on DSKH9S0YB1PROD with NOTICES Name of Committee: Center for Scientific Review Special Emphasis Panel, Childhood Obesity ARRA CR. Date: October 2, 2009. Time: 10 a.m. to 12 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Ann A. Jerkins, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6154, MSC 7892, Bethesda, MD 20892. 301–435– 4514. jerkins@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, Arthritis, Connective Tissue and Skin (ACTS), Small Business Applications. Date: October 7, 2009. Time: 8:30 a.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Aftab A. Ansari, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4108, MSC 7814, Bethesda, MD 20892. 301–594– 6376. ansaria@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: September 14, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–22587 Filed 9–18–09; 8:45 am] BILLING CODE 4140–01–M VerDate Nov<24>2008 17:24 Sep 18, 2009 Jkt 217001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; PCMB Member SEP. Date: September 30, 2009. Time: 9 a.m. to 10 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Barbara Whitmarsh, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2206, MSC 7890, Bethesda, MD 20892, (301) 435– 4511, whitmarshb@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflicts: GMPB. Date: October 2, 2009. Time: 12 p.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Patricia Greenwel, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2178, MSC 7818, Bethesda, MD 20892, 301–435– 1169, greenwep@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 48081 Dated: September 11, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–22435 Filed 9–18–09; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket Number NIOSH–187] Proposed Enhancements to Occupational Health Surveillance Data Collection Through the Healthcare Personnel Safety (HPS) Component of the National Healthcare Safety Network (NHSN) AGENCY: National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of public meeting and availability for public comment. SUMMARY: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following meeting and request for public comment on proposed enhancements to occupational health surveillance data collection through the Healthcare Personnel Safety (HPS) Component of the National Healthcare Safety Network (NHSN). Public Comment Period: Comments must be received by October 21, 2009. Public Meeting Date and Time: November 16, 2009, 1 p.m.–5 p.m. and November 17, 2009, 8 a.m.–5 p.m. Place: Sheraton Cincinnati Airport Hotel, 2826 Terminal Drive, Hebron, Kentucky 41048, (859) 371–6166. Purpose of Meeting: To obtain public comment on the content and conduct of enhancements to occupational health surveillance data collection through the Healthcare Personnel Safety (HPS) Component of the National Healthcare Safety Network (NHSN). Special emphasis will be placed on discussion of the content of the data collection forms. Status: The forum will include scientists and representatives from industry, labor, and other stakeholders, and is open to the public. Attendance is limited only by the space available. The meeting room will accommodate approximately 60 people. Interested parties should contact Ahmed Gomaa at agomaa@cdc.gov or (513) 841–4337, or E:\FR\FM\21SEN1.SGM 21SEN1

Agencies

[Federal Register Volume 74, Number 181 (Monday, September 21, 2009)]
[Notices]
[Pages 48080-48081]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22587]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of the following 
meetings.
    The meetings will be closed to the public in accordance with the 
provisions set forth in sections

[[Page 48081]]

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant 
applications and the discussions could disclose confidential trade 
secrets or commercial property such as patentable material, and 
personal information concerning individuals associated with the grant 
applications, the disclosure of which would constitute a clearly 
unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel, Childhood Obesity ARRA CR.
    Date: October 2, 2009.
    Time: 10 a.m. to 12 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 
Wisconsin Avenue, Bethesda, MD 20814.
    Contact Person: Ann A. Jerkins, PhD, Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 6154, MSC 7892, Bethesda, MD 20892. 301-435-
4514. jerkins@csr.nih.gov.
    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel, Arthritis, Connective Tissue and Skin (ACTS), Small Business 
Applications.
    Date: October 7, 2009.
    Time: 8:30 a.m. to 4 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Hilton Washington/Rockville, 1750 Rockville Pike, 
Rockville, MD 20852.
    Contact Person: Aftab A. Ansari, PhD, Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 4108, MSC 7814, Bethesda, MD 20892. 301-594-
6376. ansaria@csr.nih.gov.
    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.

(Catalogue of Federal Domestic Assistance Program Nos. 93.306, 
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, 
National Institutes of Health, HHS)

    Dated: September 14, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-22587 Filed 9-18-09; 8:45 am]
BILLING CODE 4140-01-M

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