Advisory Committees; Filing of Closed Meeting Reports, 70336-70337 [E7-23986]

Download as PDF 70336 Federal Register / Vol. 72, No. 237 / Tuesday, December 11, 2007 / Notices in this time period to request written confirmation from these companies of their commitment to pay these fees; if companies do not agree to make this commitment, FDA will request that they withdraw their submission(s), and such submissions will not be reviewed. For further information, contact Wayne Amchin (see FOR FURTHER INFORMATION CONTACT). For information on how FDA will treat DTC television advertisement advisory review submissions not identified in response to the participation notice that are submitted after the 30-calendar-day time period for responding to that notice has elapsed, see sections II.A ‘‘Basis for the Fee’’ and II.B ‘‘Operating Reserves’’ of this document. Dated: December 5, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–24000 Filed 12–10–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. pwalker on PROD1PC71 with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on February 1, 2008, from 8 a.m. to 5 p.m. Location: Hilton Washington DC/ Silver Spring, Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD. The hotel phone number is 301–589–5200. Contact Person: Teresa Watkins, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827– 7001, FAX: 301–827–6776, e-mail: Teresa.Watkins@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512535. Please call the Information VerDate Aug<31>2005 19:12 Dec 10, 2007 Jkt 214001 Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss the efficacy and safety of new drug application (NDA) 22–054, INJECTAFER (ferric carboxymaltose injection), Luitpold Pharmaceuticals Incorporated, used for the treatment of iron deficiency anemia in patients with postpartum hemorrhage or heavy uterine bleeding. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before January 17, 2008. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 9, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by January 10, 2008. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Teresa Watkins at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/oc/advisory/ default.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: December 4, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7–24003 Filed 12–10–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committees; Filing of Closed Meeting Reports AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2007. ADDRESSES: Copies are available from the Dockets Management Branch (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 301–827–6860. FOR FURTHER INFORMATION CONTACT: Theresa L. Green, Committee Management Officer, Advisory Committee and Oversight Management Staff (HF–4), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1220. SUPPLEMENTARY INFORMATION: Under section 10(d) of the Federal Advisory Committee Act (5 U.S.C. app.1) and 21 CFR 14.60(d), FDA has filed with the Library of Congress the annual reports for the following FDA advisory committees that held closed meetings during the period October 1, 2006 through September 30, 2007: Center for Biologics Evaluation and Research: Cellular, Tissue and Gene Therapies E:\FR\FM\11DEN1.SGM 11DEN1 Federal Register / Vol. 72, No. 237 / Tuesday, December 11, 2007 / Notices Advisory Committee, Vaccines and Related Biological Products Advisory Committee, Center for Drugs Evaluation and Research: Antiviral Drugs Advisory Committee Center for Devices and Radiological Health: Medical Devices Advisory Committee (consisting of reports for Dental Products Panel; Circulatory Devices Panel) Annual Reports are available for public inspections between 9 a.m. and 4 p.m., Monday through Friday. (1) The Library of Congress, Madison Bldg., Newspaper and Current Periodical Reading Room, 101 Independence Ave. SE, rm. 133, Washington, DC; and (2) The Dockets Management Branch (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Dated: December 4, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7–23986 Filed 12–10–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY Bureau of Immigration and Customs Enforcement Agency Information Collection Activities: Extension of a Currently Approved Information Collection; Comment Request 60-Day Notice of Information Collection Under Review; Data Relating to Beneficiary of Private Bill, Form G– 79A. pwalker on PROD1PC71 with NOTICES ACTION: The Department of Homeland Security, Bureau of Immigration and Customs Enforcement (ICE) has submitted the following information collection request for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted for sixty days until February 11, 2008. Written comments and suggestions from the public and affected agencies concerning the collection of information should address one or more of the following four points: (1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; VerDate Aug<31>2005 19:12 Dec 10, 2007 Jkt 214001 (2) Evaluate the accuracy of the agencies estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology, e.g., permitting electronic submission of responses. Overview of this information collection: (1) Type of Information Collection: Extension of a currently approved collection. (2) Title of the Form/Collection: Data Relating to Beneficiary of Private Bill. (3) Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection: Form G–79A. Bureau of Immigration and Customs Enforcement. (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or Households. The information is needed to report on Private Bills to Congress when requested. (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: 100 responses at 1 hour per response. (6) An estimate of the total public burden (in hours) associated with the collection: 100 annual burden hours. Comments and/or questions; requests for a copy of the proposed information collection instrument, with instructions; or inquiries for additional information should be directed to: Lee Shirkey, Acting Chief, Records Management Branch; U.S. Immigration and Customs Enforcement, 425 I Street, NW., Room 1122, Washington, DC 20536; (202) 616– 2266. Dated: December 6, 2007. Lee Shirkey, Acting Branch Chief, Records Management Branch, Bureau of Immigration and Customs Enforcement, Department of Homeland Security. [FR Doc. E7–23979 Filed 12–10–07; 8:45 am] BILLING CODE 9111–28–P PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 70337 DEPARTMENT OF HOMELAND SECURITY Bureau of Immigration and Customs Enforcement Agency Information Collection Activities: Extension of a Currently Approved Information Collection, Comment Request Request OMB Emergency Approval and 60-Day Notice; Immigration Bond; Form I–352, OMB Control No. 1653–0022. ACTION: The Department of Homeland Security, Bureau of Immigration and Customs Enforcement has submitted the following information collection request for review and clearance in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted for sixty days until February 11, 2008. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information should address one or more of the following four points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection (1) Type of Information Collection: Extension of a currently approved information collection. (2) Title of the Form/Collection: Immigration Bond. (3) Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection: Form I–352. Bureau of Immigration and Customs Enforcement. E:\FR\FM\11DEN1.SGM 11DEN1

Agencies

[Federal Register Volume 72, Number 237 (Tuesday, December 11, 2007)]
[Notices]
[Pages 70336-70337]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23986]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Advisory Committees; Filing of Closed Meeting Reports

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that, as 
required by the Federal Advisory Committee Act, the agency has filed 
with the Library of Congress the annual reports of those FDA advisory 
committees that held closed meetings during fiscal year 2007.

ADDRESSES: Copies are available from the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, 301-827-6860.

FOR FURTHER INFORMATION CONTACT:  Theresa L. Green, Committee 
Management Officer, Advisory Committee and Oversight Management Staff 
(HF-4), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-1220.

SUPPLEMENTARY INFORMATION: Under section 10(d) of the Federal Advisory 
Committee Act (5 U.S.C. app.1) and 21 CFR 14.60(d), FDA has filed with 
the Library of Congress the annual reports for the following FDA 
advisory committees that held closed meetings during the period October 
1, 2006 through September 30, 2007:
Center for Biologics Evaluation and Research:
    Cellular, Tissue and Gene Therapies

[[Page 70337]]

Advisory Committee,
    Vaccines and Related Biological Products Advisory Committee,
Center for Drugs Evaluation and Research:
    Antiviral Drugs Advisory Committee
Center for Devices and Radiological Health:
    Medical Devices Advisory Committee (consisting of reports for 
Dental Products Panel; Circulatory Devices Panel)
    Annual Reports are available for public inspections between 9 a.m. 
and 4 p.m., Monday through Friday.
    (1) The Library of Congress, Madison Bldg., Newspaper and Current 
Periodical Reading Room, 101 Independence Ave. SE, rm. 133, Washington, 
DC; and (2) The Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

    Dated: December 4, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-23986 Filed 12-10-07; 8:45 am]
BILLING CODE 4160-01-S

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