Blood Products Advisory Committee; Notice of Meeting, 11376-11377 [E9-5734]

Download as PDF 11376 Federal Register / Vol. 74, No. 50 / Tuesday, March 17, 2009 / Notices these delays have been due, in part, to ATS’s inability to pay its third party fulfillment houses, as well as its refusal to timely pay third party fulfillment houses with which it had disagreements. The proposed order contains provisions designed to prevent ATS from engaging in similar acts and practices in the future. Part I of the proposed order prohibits ATS from misrepresenting the time in which any rebate will be mailed and from failing to provide any rebate within the time specified, or if no time is specified, within thirty days. This provision also prohibits the company from misrepresenting any material terms of any rebate program, including the status of or reasons for any delay in providing any rebate. Parts II through V of the proposed order are standard reporting and compliance provisions. Part VI provides that the order will terminate after twenty (20) years, with certain exceptions. The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the agreement and proposed order or to modify in any way their terms. By direction of the Commission. Donald S. Clark Secretary [FR Doc. E9–5733 Filed 3–16–09: 8:45 am] [BILLING CODE 6750–01–S] DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: TANF Quarterly Financial Report, ACF–196. OMB No.: 0970–0247. Description: This information collection is authorized under Section 411(a)(3) of the Social Security Act. This request is for renewal of approval to use the Administration for Children and Families’ (ACF) 196 form for periodic financial reporting under the Temporary Assistance for Needy Families (TANF) program. Approval of this information collection expires on March 31, 2009. States participating in the TANF program are required by statute to report financial data on a quarterly basis. This form meets the legal standard and provides essential data on the use of Federal funds. Failure to collect the data would seriously compromise ACF’s ability to monitor program expenditures, estimate funding needs, and to prepare budget submissions required by Congress. Financial reporting under the TANF program is governed by 45 CFR part 265. Respondents: TANF Agencies. ANNUAL BURDEN ESTIMATES Number of respondents Number of responses per respondent Average burden hours per response ACF–196TT ..................................................................................................... ACF–196 .......................................................................................................... Estimated Total Annual Burden Hours: ........................................................... dwashington3 on PROD1PC60 with NOTICES Instrument 20 51 ........................ 4 4 ........................ 2 8 ........................ Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project. Fax: 202–395–6974. Attn: Desk Officer for the Administration for Children and Families. VerDate Nov<24>2008 13:44 Mar 16, 2009 Jkt 217001 Dated: March 11, 2009. Robert Sargis, Reports Clearance Officer. [FR Doc. E9–5641 Filed 3–16–09; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0664] Blood Products 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). At least one portion of the meeting will be closed to the public. Name of Committee: Blood Products Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 Total burden hours 160 1,632 1,792 Date and Time: The meeting will be held on April 1, 2009, from 8 a.m. to 6 p.m. and on April 2, 2009, from 8 a.m. to 4:45 p.m. Location: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD 20877, 301–977–8900. Contact Person: William Freas or Pearline K. Muckelvene, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike (HFM–71), 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. E:\FR\FM\17MRN1.SGM 17MRN1 dwashington3 on PROD1PC60 with NOTICES Federal Register / Vol. 74, No. 50 / Tuesday, March 17, 2009 / Notices Agenda: On April 1, 2009, the committee will hear updates on the following topics: National Biovigilance Data Collection and Analysis Program; a summary of the December 16 and 17, 2008, meeting of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability; and a summary of the September 12, 2008, FDA Workshop on Approaches to Minimize the Risk of Transfusion-Transmitted Babesiosis in the United States. The committee will then discuss blood donor screening and testing donors of human cells, tissues and cellular and tissue-based products (HCT/Ps) for hepatitis B virus infection by nucleic acid testing. In the afternoon, the committee will discuss potential testing strategies for Trypanosoma cruzi infection in blood donors. On April 2, 2009, the committee will discuss FDA’s current considerations on plasma obtained from a Whole Blood donor for further manufacturing use and in the afternoon will review the research programs in the Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, CBER Site Visit held on October 22, 2008. 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 2009 and scroll down to the appropriate advisory committee link. Procedure: On April 1, 2009, from 8 a.m. to 6 p.m. and on April 2, 2009, from 8 a.m. to 3:45 p.m, the meeting is open to the public. 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 March 25, 2009. Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12 noon and between approximately 4:15 p.m. and 4:45 p.m. on April 1, 2009, and between approximately 10:45 a.m. and 11:45 a.m. and between approximately 3:15 p.m. and 3:45 p.m. on April 2, 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 VerDate Nov<24>2008 13:44 Mar 16, 2009 Jkt 217001 participants, and an indication of the approximate time requested to make their presentation on or before March 23, 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 March 24, 2009. Closed Committee Deliberations: On April 2, 2009, between 4 p.m. and 4:45 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of intramural research programs and make recommendations regarding personnel staffing decisions. 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 William Freas or Pearline K. Muckelvene 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: March 10, 2009. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E9–5734 Filed 3–16–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF STATE [Public Notice 6545] DEPARTMENT OF HOMELAND SECURITY Certification Related to Implementation of The Western Hemisphere Travel Initiative Pursuant to the authorities vested in the Secretary of State and the Secretary of Homeland Security, including under section 7209(b)(1)(B) of the Intelligence PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 11377 Reform and Terrorism Prevention Act of 2004 (Pub. L. 108–458), as amended by section 546 of the Department of Homeland Security Appropriations Act, 2007 (Pub. L. 109–295), section 723 of the Implementing Recommendations of the 9/11 Commission Act of 2007 (Pub. L. 110–53), and section 545 of title V of Div. E of the Consolidated Appropriations Act of 2008 (Pub. L. 110–161), we hereby certify that (i) The National Institute of Standards and Technology certifies that the Departments of Homeland Security and State have selected a card architecture that meets or exceeds International Organization for Standardization (ISO) security standards and meets or exceeds best available practices for protection of personal identification documents: That the National Institute of Standards and Technology has also assisted the Departments of Homeland Security and State to incorporate into the architecture of the card the best available practices to prevent the unauthorized use of information on the card: That to facilitate efficient cross-border travel, the Departments of Homeland Security and State have, to the maximum extent possible, developed an architecture that is compatible with information technology systems and infrastructure used by United States Customs and Border Protection; (ii) The technology to be used by the United States for the passport card, and any subsequent change to that technology, has been shared with the governments of Canada and Mexico; (iii) An agreement has been reached with the United States Postal Service on the fee to be charged individuals for the passport card, and a detailed justification has been submitted to the Committees on Appropriations of the Senate and the House of Representatives; (iv) An alternative procedure has been developed for groups of children traveling across an international border under adult supervision with parental consent; (v) The necessary technological infrastructure to process the passport cards has been installed, and all employees at ports of entry have been properly trained in the use of the new technology; (vi) The passport card has been made available for the purpose of international travel by United States citizens through land and sea ports of entry between the United States and Canada, Mexico, the Caribbean and Bermuda; (vii) A single implementation date for sea and land borders has been established; and E:\FR\FM\17MRN1.SGM 17MRN1

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[Federal Register Volume 74, Number 50 (Tuesday, March 17, 2009)]
[Notices]
[Pages 11376-11377]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5734]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]


Blood Products 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). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Blood 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 April 1, 2009, from 8 
a.m. to 6 p.m. and on April 2, 2009, from 8 a.m. to 4:45 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 
620 Perry Pkwy., Gaithersburg, MD 20877, 301-977-8900.
    Contact Person: William Freas or Pearline K. Muckelvene, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
1401 Rockville Pike (HFM-71), 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.

[[Page 11377]]

    Agenda: On April 1, 2009, the committee will hear updates on the 
following topics: National Biovigilance Data Collection and Analysis 
Program; a summary of the December 16 and 17, 2008, meeting of the 
Department of Health and Human Services Advisory Committee on Blood 
Safety and Availability; and a summary of the September 12, 2008, FDA 
Workshop on Approaches to Minimize the Risk of Transfusion-Transmitted 
Babesiosis in the United States. The committee will then discuss blood 
donor screening and testing donors of human cells, tissues and cellular 
and tissue-based products (HCT/Ps) for hepatitis B virus infection by 
nucleic acid testing. In the afternoon, the committee will discuss 
potential testing strategies for Trypanosoma cruzi infection in blood 
donors. On April 2, 2009, the committee will discuss FDA's current 
considerations on plasma obtained from a Whole Blood donor for further 
manufacturing use and in the afternoon will review the research 
programs in the Laboratory of Molecular Virology, Division of Emerging 
and Transfusion Transmitted Diseases, CBER Site Visit held on October 
22, 2008.
    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 2009 and scroll down to the appropriate advisory committee 
link.
    Procedure: On April 1, 2009, from 8 a.m. to 6 p.m. and on April 2, 
2009, from 8 a.m. to 3:45 p.m, the meeting is open to the public. 
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 March 25, 2009. Oral 
presentations from the public will be scheduled between approximately 
11:30 a.m. and 12 noon and between approximately 4:15 p.m. and 4:45 
p.m. on April 1, 2009, and between approximately 10:45 a.m. and 11:45 
a.m. and between approximately 3:15 p.m. and 3:45 p.m. on April 2, 
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 
March 23, 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 March 24, 2009.
    Closed Committee Deliberations: On April 2, 2009, between 4 p.m. 
and 4:45 p.m., the meeting will be closed to permit discussion where 
disclosure would constitute a clearly unwarranted invasion of personal 
privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of 
intramural research programs and make recommendations regarding 
personnel staffing decisions.
    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 William Freas or 
Pearline K. Muckelvene 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: March 10, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-5734 Filed 3-16-09; 8:45 am]
BILLING CODE 4160-01-S

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