Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting, 19101-19102 [2011-8146]

Download as PDF Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Notices Act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective, (see DATES) (see sections 306(c)(1)(B), (c)(2)(A)(ii), and 201(dd) of the FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(ii), and 321(dd))). Any person with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise uses the services of Dr. Palazzo, in any capacity during Dr. Palazzo’s debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Dr. Palazzo provides services in any capacity to a person with an approved or pending drug product application during her period of debarment she will be subject to civil money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Dr. Palazzo during her period of debarment (section 306(c)(1)(B) of the FD&C Act. Any application by Dr. Palazzo for special termination of debarment under section 306(d)(4) of the FD&C Act should be identified with Docket No. FDA–2010–N–0450 and sent to the Division of Dockets Management (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20(j). Publicly available submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: March 28, 2011. Howard Sklamberg, Director, Office of Enforcement, Office of Regulatory Affairs. [FR Doc. 2011–8152 Filed 4–5–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration mstockstill on DSKH9S0YB1PROD with NOTICES [Docket No. FDA–2011–N–0002] Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative and Request for Nominations for a Nonvoting Industry Representative on an FDA Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Mar<15>2010 16:52 Apr 05, 2011 Jkt 223001 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 its Allergenic Products Advisory Committee notify FDA in writing. A nominee may either be selfnominated or nominated by an organization to serve as a nonvoting industry representative. Nomination will be accepted for current vacancies 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 May 6, 2011 for vacancies listed in the notice. Concurrently, nomination material for prospective candidates should be sent to FDA by May 6, 2011. ADDRESSES: All letters of interest and nominations should be submitted in writing to Gail Dapolito (see FOR FURTHER INFORMATION CONTACT). FOR FURTHER INFORMATION CONTACT: Gail Dapolito, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448, 301– 827–1289, FAX: 301–827–0294, e-mail: gail.dapolito@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background The Agency requests nominations for a nonvoting industry representative on the Allergenic Products Advisory Committee. The Allergenic Products Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to the regulation of allergenic products. This Committee has nine voting members. Members are asked to provide their expert scientific and technical advice to FDA to help make sound decisions on the safety, effectiveness, appropriate use, and labeling of allergenic biological products. II. Selection Procedure Any industry organization interested in participating 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. 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 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 19101 also state that it is the responsibility of the interested organizations to confer with one another and to select a candidate, within 60 days after the receipt of the FDA letter, to serve as the nonvoting member to represent industry interests for the Allergenic 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 of Food and Drugs 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 industry representative. A current curriculum vitae and the name of the committee of interest should be sent to the FDA contact person within the 30 days following nomination. 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. Specifically, in this document, nominations for nonvoting representatives of industry interests are encouraged from the allergenic product manufacturing industry. 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: March 31, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–8125 Filed 4–5–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: E:\FR\FM\06APN1.SGM 06APN1 19102 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Notices Name: Advisory Council on Blood Stem Cell Transplantation. Date and Times: May 11, 2011, 8 a.m. to 4:30 p.m. Place: Georgetown University Hotel and Conference Center, 3800 Reservoir Road, NW., Washington, DC 20057. Status: The meeting will be open to the public. Purpose: Pursuant to Public Law 109– 129, 42 U.S.C. 274k (section 379 of the Public Health Service Act, as amended), the Advisory Council on Blood Stem Cell Transplantation (ACBSCT) advises the Secretary of HHS and the Administrator, HRSA, on matters related to the activities of the C.W. Bill Young Cell Transplantation Program (Program) and the National Cord Blood Inventory (NCBI) Program. Agenda: The Council will hear reports from five ACBSCT Work Groups: Cord Blood Bank Collections, Realizing the Potential of Cord Blood, Scientific Factors Necessary to Define a Cord Blood Unit as High Quality, Cord Blood Thawing and Washing, and Access to Transplantation. The Council also will hear presentations and discussions on the following topics: Current State of Knowledge-Cord Blood Transplantation; National Marrow Donor Program (NMDP) Analysis of National Cord Blood Inventory (NCBI) and Non-NCBI Cord Blood Units; Adverse Event Reporting; Cord Blood Studies at the National Institutes of Health; and Report on NMDP Cord Blood Financial Summit. Agenda items are subject to change as priorities indicate. After the presentations and Council discussions, members of the public will have an opportunity to provide comments. Because of the Council’s full agenda and the timeframe in which to cover the agenda topics, public comment will be limited. All public comments will be included in the record of the ACBSCT meeting. Meeting summary notes will be made available on the HRSA’s Program Web site at http://bloodcell.transplant.hrsa.gov/ ABOUT/Advisory_Council/index.html. Those planning to attend are requested to register in advance and those wishing to make oral comments should so indicate. The draft meeting agenda and a registration form are available on the HRSA’s Program Web site at http:// bloodcell.transplant.hrsa.gov/ABOUT/ Advisory_Council/index.html. Registration also can be completed electronically at http://www.acbsct.com or submitted by facsimile to Lux Consulting Group, Inc., the logistical support contractor for the meeting, at fax number (301) 585–7741 ATTN: Deborah Jones. Individuals without access to the Internet who wish to register may call Deborah Jones at (301) 585–1261. FOR FURTHER INFORMATION CONTACT: Patricia Stroup, Executive Secretary, Healthcare Systems Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 12C–06, Rockville, Maryland 20857; telephone (301) 443–1127. Dated: March 29, 2011. Reva Harris, Acting Director, Division of Policy and Information Coordination. [FR Doc. 2011–8146 Filed 4–5–11; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; Short Follow-Up Questionnaire for the National Institutes of Health (NIH)–AARP Diet and Health Study (NCI) Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on February 4, 2011 (76 FR SUMMARY: Number of respondents Type of respondents mstockstill on DSKH9S0YB1PROD with NOTICES Senior Adults ................................................................................................... Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: VerDate Mar<15>2010 16:52 Apr 05, 2011 Jkt 223001 Frm 00074 Fmt 4703 Sfmt 4703 Frequency of response 485,909 (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the PO 00000 6485) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Short Follow-Up Questionnaire for the National Institutes of Health (NIH)AARP Diet and Health Study (NCI). Type of Information Collection Request: Extension. Need and Use of Information Collection: The purpose of this short 2page questionnaire is to obtain information on 18 different medical conditions, several medical procedures, and lifestyle characteristics from 485,909 participants of the NIH–AARP Diet and Health Study. The questionnaire will support the ongoing examination between cancer and nutritional exposures. A pilot mailing to 1,600 randomly selected NIH–AARP Diet and Health study participants confirmed the feasibility of the methodology and willingness of respondents to participate in this data collection effort. This questionnaire adheres to The Public Health Service Act, Section 412 (42 U.S.C. 285a–1) and Section 413 (42 U.S.C. 285a–2), which authorizes the Division of Cancer Epidemiology and Genetics of the National Cancer Institute (NCI) to establish and support programs for the detection, diagnosis, prevention and treatment of cancer; and to collect, identify, analyze and disseminate information on cancer research, diagnosis, prevention and treatment. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: U.S. adults (persons aged 50–85). The annual reporting burden is displayed in the table below. There are no Capital Costs, Operating Costs, and/ or Maintenance Costs to report. 1 Average Time per response (minutes/hour) 4/60 (0.067) Annual hour burden 32,394 information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the E:\FR\FM\06APN1.SGM 06APN1

Agencies

[Federal Register Volume 76, Number 66 (Wednesday, April 6, 2011)]
[Notices]
[Pages 19101-19102]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8146]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Advisory Council on Blood Stem Cell Transplantation; Notice of 
Meeting

    In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463), notice is hereby given of the following 
meeting:

[[Page 19102]]

    Name: Advisory Council on Blood Stem Cell Transplantation.
    Date and Times: May 11, 2011, 8 a.m. to 4:30 p.m.
    Place: Georgetown University Hotel and Conference Center, 3800 
Reservoir Road, NW., Washington, DC 20057.
    Status: The meeting will be open to the public.
    Purpose: Pursuant to Public Law 109-129, 42 U.S.C. 274k (section 
379 of the Public Health Service Act, as amended), the Advisory Council 
on Blood Stem Cell Transplantation (ACBSCT) advises the Secretary of 
HHS and the Administrator, HRSA, on matters related to the activities 
of the C.W. Bill Young Cell Transplantation Program (Program) and the 
National Cord Blood Inventory (NCBI) Program.
    Agenda: The Council will hear reports from five ACBSCT Work Groups: 
Cord Blood Bank Collections, Realizing the Potential of Cord Blood, 
Scientific Factors Necessary to Define a Cord Blood Unit as High 
Quality, Cord Blood Thawing and Washing, and Access to Transplantation. 
The Council also will hear presentations and discussions on the 
following topics: Current State of Knowledge-Cord Blood 
Transplantation; National Marrow Donor Program (NMDP) Analysis of 
National Cord Blood Inventory (NCBI) and Non-NCBI Cord Blood Units; 
Adverse Event Reporting; Cord Blood Studies at the National Institutes 
of Health; and Report on NMDP Cord Blood Financial Summit. Agenda items 
are subject to change as priorities indicate.
    After the presentations and Council discussions, members of the 
public will have an opportunity to provide comments. Because of the 
Council's full agenda and the timeframe in which to cover the agenda 
topics, public comment will be limited. All public comments will be 
included in the record of the ACBSCT meeting. Meeting summary notes 
will be made available on the HRSA's Program Web site at http://bloodcell.transplant.hrsa.gov/ABOUT/Advisory_Council/index.html.
    Those planning to attend are requested to register in advance and 
those wishing to make oral comments should so indicate. The draft 
meeting agenda and a registration form are available on the HRSA's 
Program Web site at http://bloodcell.transplant.hrsa.gov/ABOUT/Advisory_Council/index.html.
    Registration also can be completed electronically at http://www.acbsct.com or submitted by facsimile to Lux Consulting Group, Inc., 
the logistical support contractor for the meeting, at fax number (301) 
585-7741 ATTN: Deborah Jones. Individuals without access to the 
Internet who wish to register may call Deborah Jones at (301) 585-1261.

FOR FURTHER INFORMATION CONTACT: Patricia Stroup, Executive Secretary, 
Healthcare Systems Bureau, Health Resources and Services 
Administration, 5600 Fishers Lane, Room 12C-06, Rockville, Maryland 
20857; telephone (301) 443-1127.

    Dated: March 29, 2011.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2011-8146 Filed 4-5-11; 8:45 am]
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