Blood Products Advisory Committee; Notice of Meeting; Amendment, 110 [E8-31187]

Download as PDF 110 Federal Register / Vol. 74, No. 1 / Friday, January 2, 2009 / Notices V. 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. Revised comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at https://www.regulations.gov. Dated: December 16, 2008. Daniel G. Schultz, Director, Center for Devices and Radiological Health. [FR Doc. E8–31214 Filed 12–31–08; 8:45 am] BILLING CODE 4160–01–S 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. SUPPLEMENTARY INFORMATION: In the Federal Register of December 9, 2008, FDA announced that a meeting of the Blood Products Advisory Committee would be held on January 9, 2009. On page 74725, in the first column, in the 13th line of the Agenda portion of the document, after the phrase ‘‘Acid Constructs’’ the following has been added: ‘‘Included in the update will be an overview of the Center of Veterinary Medicine’s review of the new animal drug application pertaining to the genetically engineered animals producing milk that contains recombinant Antithrombin III and of the environmental assessment for that application.’’ This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. Dated: December 24, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–31187 Filed 12–29–08; 11:15 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0038] BILLING CODE 4160–01–S Blood Products Advisory Committee; Notice of Meeting; Amendment AGENCY: Food and Drug Administration, HHS mstockstill on PROD1PC66 with NOTICES ACTION: Notice. Food and Drug Administration The Food and Drug Administration (FDA) is announcing an amendment to the notice of the Blood Products Advisory Committee. This meeting was announced in the Federal Register of December 9, 2008 (73 FR 74725). The amendment is being made to reflect a change in the Agenda portion of the document. FOR FURTHER INFORMATION CONTACT: Contact Person: William Freas or Pearline K. Muckelvene, Center for Biologics Evaluation and Research (HFM–71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301–827–0314, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014519516. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal VerDate Aug<31>2005 16:23 Dec 31, 2008 DEPARTMENT OF HEALTH AND HUMAN SERVICES Jkt 217001 [Docket No. FDA–2008–N–0038] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. 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: Cardiovascular and Renal Drugs 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 3, 2009, from 8 a.m. to 5 p.m. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Location: Hilton Washington DC/ Silver Spring, Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD. The hotel phone number is 301–589–5200. Contact Person: Elaine Ferguson, 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, email: elaine.ferguson@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512533. Please call the Information 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 new drug application (NDA) 22–307, prasugrel hydrochloride film coated oral tablets, 5 milligrams (mg) and 10 mg, Eli Lilly and Company, for the proposed indication for use in acute coronary syndrome. 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 16, 2009. Oral presentations from the public will be scheduled between approximately 1 p.m. to 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, 2009. Time allotted for each presentation may be limited. If E:\FR\FM\02JAN1.SGM 02JAN1

Agencies

[Federal Register Volume 74, Number 1 (Friday, January 2, 2009)]
[Notices]
[Page 110]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-31187]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]


Blood Products Advisory Committee; Notice of Meeting; Amendment

AGENCY:  Food and Drug Administration, HHS

ACTION:  Notice.

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    The Food and Drug Administration (FDA) is announcing an amendment 
to the notice of the Blood Products Advisory Committee. This meeting 
was announced in the Federal Register of December 9, 2008 (73 FR 
74725). The amendment is being made to reflect a change in the Agenda 
portion of the document.

FOR FURTHER INFORMATION CONTACT: Contact Person: William Freas or 
Pearline K. Muckelvene, Center for Biologics Evaluation and Research 
(HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), code 
3014519516. Please call the Information 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.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 9, 2008, 
FDA announced that a meeting of the Blood Products Advisory Committee 
would be held on January 9, 2009. On page 74725, in the first column, 
in the 13th line of the Agenda portion of the document, after the 
phrase ``Acid Constructs'' the following has been added:
    ``Included in the update will be an overview of the Center of 
Veterinary Medicine's review of the new animal drug application 
pertaining to the genetically engineered animals producing milk that 
contains recombinant Antithrombin III and of the environmental 
assessment for that application.''
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: December 24, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-31187 Filed 12-29-08; 11:15 am]
BILLING CODE 4160-01-S

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