Notice of Meeting, 60842 [05-20937]

Download as PDF 60842 Federal Register / Vol. 70, No. 201 / Wednesday, October 19, 2005 / Notices Dated: October 14, 2005. Karen V. Gregory, Assistant Secretary. [FR Doc. 05–20913 Filed 10–18–05; 8:45 am] Maryland 20850, Telephone (301) 4271554. Agenda items for this meeting are subject to change as priorities dictate. BILLING CODE 6730–01–P Dated: October 07, 2005. Carolyn M. Clancy, Director. [FR Doc. 05–20937 Filed 10–18–05; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4160–90–M Agency for Healthcare Research and Quality Notice of Meeting In accordance with section 10(d) of the Federal Advisory Committee Act (5 U.S.C., Appendix 2), announcement is made of a Health Care Policy and Research Special Emphasis Panel (SEP) meeting. A Special Emphasis Panel is a group of experts in fields related to health care research who are invited by the Agency for Healthcare Research and quality (AHRQ), and agree to be available, to conduct on an as needed basis, scientific reviews of applications for AHRQ support. Individual members of the Panel do not attend regularly scheduled meetings and do not serve for fixed terms or a long period of time. Rather, they are asked to participate in particular review meetings which require their type of expertise. Substantial segments of the upcoming SEP meeting listed below will be closed to the public in accordance with the Federal Advisory Committee Act, section 10(d) of 5 U.S.C., Appendix 2 and 5 U.S.C. 552b(c)(6). Grant applications for ‘‘The Centers for Education and Research on Therapeutics (CERTs),’’ are to be reviewed and discussed at this meeting. These discussions are likely to reveal personal information concerning individuals associated with the applications. This information is exempt from mandatory disclosure under the above-cited statutes. SEP Meeting on: The Centers for Education and Research on Therapeutics (CERTs). Date: November 2–3, 2005 (Open on November 2 from 8 a.m. to 8:15 a.m. and closed for the remainder of the meeting). Place: John M. Eisenberg Building, AHRQ Conference Center, 540 Gaither Road, Rockville, Maryland 20850. Contact Person: Anyone wishing to obtain a roster of members, agenda or minutes of the non-confidential portions of this meeting should contact Mrs. Bonnie Campbell, Committee Management Officer, Office of Extramural Research, Education and Priority Populations, AHRQ, 540 Gaither Road, Room 2038, Rockville, VerDate Aug<31>2005 14:50 Oct 18, 2005 Jkt 208001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003D–0367] Guidance for Industry on Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Frm 00059 Fmt 4703 FOR FURTHER INFORMATION CONTACT: Randy Levin, Center for Drug Evaluation and Research (HFD–001), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594– 5411, e-mail: levinr@cder.fda.gov, or Robert Yetter, Center for Biologics Evaluation and Research (HFM–25), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301–827–0373. SUPPLEMENTARY INFORMATION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format— Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.’’ This is one in a series of guidance documents on providing regulatory submissions to FDA in electronic format. This guidance discusses issues related to the electronic submission of new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), investigational new drug applications (INDs), master files, advertising material, and promotional labeling using the electronic common technical document (eCTD) specifications. The submission of these documents in electronic format should improve the agency’s efficiency in processing, archiving, and reviewing them. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or to the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research, Food and Drug PO 00000 Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist that office in processing your requests. Submit telephone requests to 800–835– 4709 or 301–827–1800. 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.fda.gov/dockets/ ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Sfmt 4703 I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.’’ This document provides guidance to industry regarding submission of marketing applications (NDAs, ANDAs, BLAs), INDs, and related submissions (master files, advertising, and promotional labeling) in electronic format based on the International Conference on Harmonisation eCTD specifications. In the Federal Register of August 29, 2003 (68 FR 52044), FDA made available a draft guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format— Human Pharmaceutical Product Applications and Related Submissions’’ and gave interested persons an opportunity to submit comments by October 28, 2003. The agency considered received comments as it finalized this guidance. 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 providing applications and related submissions in electronic format. 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 E:\FR\FM\19OCN1.SGM 19OCN1

Agencies

[Federal Register Volume 70, Number 201 (Wednesday, October 19, 2005)]
[Notices]
[Page 60842]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20937]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Notice of Meeting

    In accordance with section 10(d) of the Federal Advisory Committee 
Act (5 U.S.C., Appendix 2), announcement is made of a Health Care 
Policy and Research Special Emphasis Panel (SEP) meeting.
    A Special Emphasis Panel is a group of experts in fields related to 
health care research who are invited by the Agency for Healthcare 
Research and quality (AHRQ), and agree to be available, to conduct on 
an as needed basis, scientific reviews of applications for AHRQ 
support. Individual members of the Panel do not attend regularly 
scheduled meetings and do not serve for fixed terms or a long period of 
time. Rather, they are asked to participate in particular review 
meetings which require their type of expertise.
    Substantial segments of the upcoming SEP meeting listed below will 
be closed to the public in accordance with the Federal Advisory 
Committee Act, section 10(d) of 5 U.S.C., Appendix 2 and 5 U.S.C. 
552b(c)(6). Grant applications for ``The Centers for Education and 
Research on Therapeutics (CERTs),'' are to be reviewed and discussed at 
this meeting. These discussions are likely to reveal personal 
information concerning individuals associated with the applications. 
This information is exempt from mandatory disclosure under the above-
cited statutes.
    SEP Meeting on: The Centers for Education and Research on 
Therapeutics (CERTs).
    Date: November 2-3, 2005 (Open on November 2 from 8 a.m. to 8:15 
a.m. and closed for the remainder of the meeting).
    Place: John M. Eisenberg Building, AHRQ Conference Center, 540 
Gaither Road, Rockville, Maryland 20850.
    Contact Person: Anyone wishing to obtain a roster of members, 
agenda or minutes of the non-confidential portions of this meeting 
should contact Mrs. Bonnie Campbell, Committee Management Officer, 
Office of Extramural Research, Education and Priority Populations, 
AHRQ, 540 Gaither Road, Room 2038, Rockville, Maryland 20850, Telephone 
(301) 427-1554.
    Agenda items for this meeting are subject to change as priorities 
dictate.

    Dated: October 07, 2005.
Carolyn M. Clancy,
Director.
[FR Doc. 05-20937 Filed 10-18-05; 8:45 am]
BILLING CODE 4160-90-M

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