Request for Notification from Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative on the Blood Products Advisory Committee and Request for Nominations for a Nonvoting Industry Representative on the Blood Products Advisory Committee, 6186-6187 [E8-1815]

Download as PDF 6186 Federal Register / Vol. 73, No. 22 / Friday, February 1, 2008 / Notices Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number lll, Room C4–26– 05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. Dated: January 25, 2008. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E8–1810 Filed 1–31–08; 8:45 am] BILLING CODE 4120–01–P Executive Order, is responsible for evaluating the adequacy of current practices in programs, services and supports for persons with intellectual disabilities, and for reviewing legislative proposals that impact the quality of life experienced by citizens with intellectual disabilities and their families. Dated: January 25, 2008. Sally D. Atwater, Executive Director, President’s Committee for People with Intellectual Disabilities. [FR Doc. E8–1809 Filed 1–31–08; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families President’s Committee for People With Intellectual Disabilities; Notice of Quarterly Meeting AGENCY: President’s Committee for People with Intellectual Disabilities (PCPID); Administration for Children and Families; Department of Health and Human Services. ACTION: Notice of Quarterly Meeting. February 15, 2008, from 3:30 p.m. to 5:30 p.m. EST. The meeting will be conducted via conference call and will be open to the public using the dial-in information provided below. ADDRESSES: The conference call may be accessed on the date and time indicated by dialing 888–677–5720, passcode: 1397797. Agenda: PCPID will meet to finalize the 2007 Report to the President and to hear a briefing on the final report of the Ticket to Work and Work Incentives Advisory Panel. FOR FURTHER INFORMATION CONTACT: Sally D. Atwater, Executive Director, President’s Committee for People with Intellectual Disabilities, The Aerospace Center, Second Floor, West, 370 L’Enfant Promenade, SW., Washington, DC 20447. Telephone: 202–619–0634, Fax: 202–205–9591. E-mail: satwater@acf.hhs.gov. mstockstill on PROD1PC66 with NOTICES DATES: PCPID acts in an advisory capacity to the President and the Secretary of Health and Human Services on a broad range of topics relating to programs, services and supports for persons with intellectual disabilities. PCPID, by SUPPLEMENTARY INFORMATION: VerDate Aug<31>2005 18:22 Jan 31, 2008 Jkt 214001 Request for Notification from Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative on the Blood Products Advisory Committee and Request for Nominations for a Nonvoting Industry Representative on the Blood Products Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Blood Products Advisory Committee, Center for Biologics Evaluation and Research (CBER), notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for an upcoming vacancy on September 30, 2008, effective with this notice. DATES: Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating the interest to FDA by March 3, 2008, for vacancies listed in the notice. Concurrently, nomination material for prospective candidates should be sent to FDA by March 3, 2008. ADDRESSES: All letters of interest and nominations should be submitted in writing to Donald W. Jehn (see FOR FURTHER INFORMATION CONTACT). FOR FURTHER INFORMATION CONTACT: Donald W. Jehn, Division of Scientific Advisors and Consultants, Center for Biologics Evaluation and Research, PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 Food and Drug Administration (HFM– 71), 1401 Rockville Pike, Rockville, MD 20892, 301–827–1277, donald.jehn@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The agency requests nominations for a nonvoting industry representative to the Blood Products Advisory Committee. I. Function The Blood Products Advisory Committee reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood products derived from blood and serum or biotechnology which are intended for the use in the diagnosis, prevention, or treatment of human diseases, and, as required, any other product for which FDA has regulatory responsibility. The committee also advises the Commissioner of Food and Drugs (the Commissioner) on its findings regarding the safety, effectiveness, and labeling of the products, clinical and laboratory studies involving such products, the affirmation or revocation of biological product licenses, and on the quality and relevance of FDA’s research program which provides the scientific support for regulating these agents. II. Selection Procedure Any blood products industry, association, or organization interested in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document (see DATES). Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations and a list of all nominees along with their current resumes. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a primary and alternate candidate, within 60 days after the receipt of the FDA letter, and the primary candidate will serve as the nonvoting member to represent industry interests for the Blood Products Advisory Committee. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within 60 days, the Commissioner will select the nonvoting member to represent industry interests. III. Application Procedure Individuals may self nominate and/or an organization may nominate one or more individuals to serve as a nonvoting E:\FR\FM\01FEN1.SGM 01FEN1 Federal Register / Vol. 73, No. 22 / Friday, February 1, 2008 / Notices industry representative. A current curriculum vitae and the name of the committee of interest should be sent to the FDA contact person (see FOR FURTHER INFORMATION CONTACT) within 30 days (see DATES). FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the committee (persons who nominate themselves as nonvoting industry representatives will not participate in the selection process). FDA has a special interest in ensuring that women, minority groups, individuals with physical disabilities, and small businesses are adequately represented on its advisory committees, and therefore, encourages nominations for appropriately qualified candidates from these groups. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: January 24, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–1815 Filed 1–31–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. mstockstill on PROD1PC66 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: Vaccines and Related Biological Products 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 20, 2008, from 8:30 a.m. to approximately 4 p.m., and on February 21, 2008 from 8:30 a.m. to approximately 4:30 p.m. Location: Hilton Hotel DC North/ Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877. Contact Person: Christine Walsh or Denise Royster, Center for Biologics Evaluation and Research (HFM–71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, VerDate Aug<31>2005 18:22 Jan 31, 2008 Jkt 214001 301–827–0314, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512391. 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: On February 20, 2008, the committee will discuss and make recommendations on a rotavirus vaccine manufactured by GlaxoSmithKline Biologicals. On February 21, 2008, in the morning, the committee will discuss the selection of strains to be included in the influenza vaccine for the 2008— 2009 influenza season. In the afternoon, the committee will discuss clinical development of influenza vaccines for pandemic and pre-pandemic uses. 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 February 13, 2008. Oral presentations from the public will be scheduled between approximately 1 p.m. and 1:30 p.m. on February 20, 2008, and approximately 11:20 a.m. and 11:50 a.m. and 2:45 p.m. and 3:15 p.m. on February 21, 2008. 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 February 6, 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 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 6187 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 February 7, 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 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 Christine Walsh or Denise Royster 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: January 24, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–1889 Filed 1–31–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, February 22, 2008, 8 a.m. to February 22, 2008, 5 p.m., Holiday Inn Georgetown, 2101 Wisconsin Avenue, NW., Washington, DC 20007, which was published in the Federal Register on January 22, 2008, 73 FR 3733–3735. The meeting will be held February 21, 2008, 6 p.m. to February 22, 2008, 7 p.m. The meeting location remains the same. The meeting is closed to the public. Dated: January 25, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 08–435 Filed 1–31–08; 8:45 am] BILLING CODE 4140–01–M E:\FR\FM\01FEN1.SGM 01FEN1

Agencies

[Federal Register Volume 73, Number 22 (Friday, February 1, 2008)]
[Notices]
[Pages 6186-6187]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-1815]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Request for Notification from Industry Organizations Interested 
in Participating in the Selection Process for a Nonvoting Industry 
Representative on the Blood Products Advisory Committee and Request for 
Nominations for a Nonvoting Industry Representative on the Blood 
Products Advisory Committee

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is requesting that any 
industry organizations interested in participating in the selection of 
a nonvoting industry representative to serve on the Blood Products 
Advisory Committee, Center for Biologics Evaluation and Research 
(CBER), notify FDA in writing. A nominee may either be self-nominated 
or nominated by an organization to serve as a nonvoting industry 
representative. Nominations will be accepted for an upcoming vacancy on 
September 30, 2008, effective with this notice.

DATES:  Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests must send a letter stating the interest to FDA by March 3, 
2008, for vacancies listed in the notice. Concurrently, nomination 
material for prospective candidates should be sent to FDA by March 3, 
2008.

ADDRESSES:  All letters of interest and nominations should be submitted 
in writing to Donald W. Jehn (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT:  Donald W. Jehn, Division of 
Scientific Advisors and Consultants, Center for Biologics Evaluation 
and Research, Food and Drug Administration (HFM-71), 1401 Rockville 
Pike, Rockville, MD 20892, 301-827-1277, donald.jehn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The agency requests nominations for a 
nonvoting industry representative to the Blood Products Advisory 
Committee.

I. Function

    The Blood Products Advisory Committee reviews and evaluates 
available data concerning the safety, effectiveness, and appropriate 
use of blood products derived from blood and serum or biotechnology 
which are intended for the use in the diagnosis, prevention, or 
treatment of human diseases, and, as required, any other product for 
which FDA has regulatory responsibility. The committee also advises the 
Commissioner of Food and Drugs (the Commissioner) on its findings 
regarding the safety, effectiveness, and labeling of the products, 
clinical and laboratory studies involving such products, the 
affirmation or revocation of biological product licenses, and on the 
quality and relevance of FDA's research program which provides the 
scientific support for regulating these agents.

II. Selection Procedure

    Any blood products industry, association, or organization 
interested in the selection of an appropriate nonvoting member to 
represent industry interests should send a letter stating that interest 
to the FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days 
of publication of this document (see DATES). Within the subsequent 30 
days, FDA will send a letter to each organization that has expressed an 
interest, attaching a complete list of all such organizations and a 
list of all nominees along with their current resumes. The letter will 
also state that it is the responsibility of the interested 
organizations to confer with one another and to select a primary and 
alternate candidate, within 60 days after the receipt of the FDA 
letter, and the primary candidate will serve as the nonvoting member to 
represent industry interests for the Blood Products Advisory Committee. 
The interested organizations are not bound by the list of nominees in 
selecting a candidate. However, if no individual is selected within 60 
days, the Commissioner will select the nonvoting member to represent 
industry interests.

III. Application Procedure

    Individuals may self nominate and/or an organization may nominate 
one or more individuals to serve as a nonvoting

[[Page 6187]]

industry representative. A current curriculum vitae and the name of the 
committee of interest should be sent to the FDA contact person (see FOR 
FURTHER INFORMATION CONTACT) within 30 days (see DATES). FDA will 
forward all nominations to the organizations expressing interest in 
participating in the selection process for the committee (persons who 
nominate themselves as nonvoting industry representatives will not 
participate in the selection process).
    FDA has a special interest in ensuring that women, minority groups, 
individuals with physical disabilities, and small businesses are 
adequately represented on its advisory committees, and therefore, 
encourages nominations for appropriately qualified candidates from 
these groups.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: January 24, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-1815 Filed 1-31-08; 8:45 am]
BILLING CODE 4160-01-S

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