National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 48760 [E9-23121]

Download as PDF srobinson on DSKHWCL6B1PROD with NOTICES 48760 Federal Register / Vol. 74, No. 184 / Thursday, September 24, 2009 / Notices appropriate advisory committee hot line/ phone line to learn about possible modifications before coming to the meeting. Agenda: On November 12 and 13, 2009, the Committee will discuss strategies and programs designed to communicate with the public about the risks and benefits of FDAregulated products so as to facilitate optimal use of these products. For more specific agenda topics, please visit the following Web site and scroll down to the appropriate advisory committee link (https:// www.fda.gov/AdvisoryCommittees/Calendar/ default.htm), or call the FDA Advisory Committee Information Line as detailed under ‘‘Contact Person’’. FDA intends to provide specific agenda topics at both these locations no later than 15 days before the meeting. 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/AdvisoryCommittees/Calendar/ default.htm. 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 November 4, 2009. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on November 12, 2009, and between approximately 10:30 a.m. and 11:30 a.m. on November 13, 2009. 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 November 4, 2009. 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 November 5, 2009. 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 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 Lee Zwanziger at least 7 days in advance of the meeting. VerDate Nov<24>2008 16:27 Sep 23, 2009 Jkt 217001 FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm111462.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: September 18, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–23001 Filed 9–23–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 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 meeting. The meeting 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: National Institute of Allergy and Infectious Diseases Special Emphasis Panel. ‘‘NIAID Science Education Awards.’’ Date: October 5, 2009. Time: 12 p.m. to 3 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge 6700, 6700B Rockledge Drive, Bethesda, MD 20817 (Telephone Conference Call). Contact Person: Jay Bruce Sundstrom, PhD, Scientific Review Official, Scientific Review Program, DEA/NIAID/NIH/DHHS, Room 2217, 6700B Rockledge Drvie, MSC–7616, Bethesda, MD 20892–7616, (301) 496–2550, sundstromj@niaid.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. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Frm 00052 Fmt 4703 Sfmt 4703 BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0444] Schmid Laboratories, Inc. et al.; Proposal To Withdraw Approval of Five New Drug Applications; Opportunity for a Hearing AGENCY: National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting PO 00000 Dated: September 18, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–23121 Filed 9–23–09; 8:45 am] Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity to request a hearing on the agency’s proposal to withdraw approval of five new drug applications (NDAs) from multiple sponsors. The basis for the proposal is that the sponsors have repeatedly failed to file required annual reports for these applications. DATES: Submit written requests for a hearing by October 26, 2009; submit data and information in support of the hearing request by November 23, 2009. ADDRESSES: Requests for a hearing, supporting data, and other comments are to be identified with Docket No. FDA–2009–N–0444 and submitted to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993–0002, 301– 796–3601. SUPPLEMENTARY INFORMATION: The holders of approved applications to market new drugs for human use are required to submit annual reports to FDA concerning each of their approved applications in accordance with § 314.81 (21 CFR 314.81). The holders of the approved applications listed in table 1 of this document have failed to submit the required annual reports and have not responded to the agency’s request by certified mail for submission of the reports. E:\FR\FM\24SEN1.SGM 24SEN1

Agencies

[Federal Register Volume 74, Number 184 (Thursday, September 24, 2009)]
[Notices]
[Page 48760]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23121]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Allergy and Infectious Diseases; Notice of 
Closed Meeting

    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 
meeting.
    The meeting 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: National Institute of Allergy and Infectious 
Diseases Special Emphasis Panel. ``NIAID Science Education Awards.''
    Date: October 5, 2009.
    Time: 12 p.m. to 3 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Rockledge 6700, 6700B 
Rockledge Drive, Bethesda, MD 20817 (Telephone Conference Call).
    Contact Person: Jay Bruce Sundstrom, PhD, Scientific Review 
Official, Scientific Review Program, DEA/NIAID/NIH/DHHS, Room 2217, 
6700B Rockledge Drvie, MSC-7616, Bethesda, MD 20892-7616, (301) 496-
2550, sundstromj@niaid.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. 93.855, 
Allergy, Immunology, and Transplantation Research; 93.856, 
Microbiology and Infectious Diseases Research, National Institutes 
of Health, HHS)

    Dated: September 18, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-23121 Filed 9-23-09; 8:45 am]
BILLING CODE 4140-01-P

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