Advisory Committee on Organ Transplantation; Request for Nominations for Voting Members, 111-112 [E8-31219]

Download as PDF Federal Register / Vol. 74, No. 1 / Friday, January 2, 2009 / Notices 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 January 12, 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 Elaine Ferguson 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 http://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: December 19, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–31217 Filed 12–31–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Organ Transplantation; Request for Nominations for Voting Members mstockstill on PROD1PC66 with NOTICES AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. SUMMARY: The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the Advisory Committee on Organ Transplantation (ACOT). The ACOT was established by the Amended Final Rule of the Organ Procurement and Transplantation Network (OPTN) (42 CFR Part 121) and, in accordance with Public Law 92–463, was chartered on September 1, 2000. DATES: The agency must receive nominations on or before February 2, 2009. ADDRESSES: All nominations should be submitted to the Executive Secretary, VerDate Aug<31>2005 16:23 Dec 31, 2008 Jkt 217001 Advisory Committee on Organ Transplantation, Healthcare Systems Bureau, HRSA, Parklawn Building, Room 12–105, 5600 Fishers Lane, Rockville, Maryland 20857. Federal Express, Airborne, UPS, etc., mail delivery should be addressed to Executive Secretary, Advisory Committee on Organ Transplantation, Healthcare Systems Bureau, HRSA, at the above address. FOR FURTHER INFORMATION CONTACT: Remy Aronoff, Executive Secretary, Advisory Committee on Organ Transplantation, at (301) 443–3300 or email Remy.Aronoff@hrsa.hhs.gov. SUPPLEMENTARY INFORMATION: As provided by 42 CFR 121.12 (64 FR 56661), the Secretary established the Advisory Committee on Organ Transplantation. The Committee is governed by the Federal Advisory Committee Act (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees. The ACOT advises the Secretary, acting through the Administrator, HRSA, on all aspects of organ procurement, allocation, and transplantation, and on other such matters that the Secretary determines. One of its principal functions is to advise the Secretary on ways to maximize Federal efforts to increase living and deceased organ donation nationally. Other matters that recently have been reviewed by the ACOT include: • Accreditation of all establishments required to be registered with the FDA as manufacturers of human cells, tissues, and cellular- and tissue-based products; • Concerns about U.S. citizens traveling abroad in order to receive organ transplants (also known as transplant tourism); • Collection of data on the long-term health status of living donors; • Organ Procurement and Transplantation Network development and distribution within the transplant community of a set of practice guidelines to be followed with respect to public solicitation of organ donors, both living and deceased; and • Standards of coverage for living donors relating to future adverse events. The ACOT consists of up to 25 members, including the Chair. Members and Chair shall be selected by the Secretary from individuals knowledgeable in such fields as organ donation, health care public policy, transplantation medicine and surgery, critical care medicine and other medical specialties involved in the identification PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 111 and referral of donors, non-physician transplant professions, nursing, epidemiology, immunology, law and bioethics, behavioral sciences, economics and statistics, as well as representatives of transplant candidates, transplant recipients, organ donors, and family members. To the extent practicable, Committee members should represent the minority, gender and geographic diversity of transplant candidates, transplant recipients, organ donors and family members served by the OPTN. In addition, the Director, Centers for Disease Control and Prevention; the Administrator, Centers for Medicare and Medicaid Services; the Commissioner, Food and Drug Administration; the Director, National Institutes of Health; and the Director, Agency for Healthcare Research and Quality (or the designees of such officials) serve as non-voting ex-officio members. Specifically, HRSA is requesting nominations for voting members of the ACOT representing: Health care public policy; transplantation medicine and surgery, including pediatric and heart/ lung transplantation; critical care medicine; nursing; epidemiology and applied statistics; immunology; law and bioethics; behavioral sciences; economics and econometrics; organ procurement organizations; transplant candidates/recipients; transplant/donor family members; and living donors. Nominees will be invited to serve a 4year term beginning after July 2009. HHS will consider nominations of all qualified individuals with a view to ensuring that the Advisory Committee includes the areas of subject matter expertise noted above. Individuals may nominate themselves or other individuals, and professional associations and organizations may nominate one or more qualified persons for membership on the ACOT. Nominations shall state that the nominee is willing to serve as a member of the ACOT and appears to have no conflict of interest that would preclude the ACOT membership. Potential candidates will be asked to provide detailed information concerning financial interests, consultancies, research grants, and/or contracts that might be affected by recommendations of the Committee to permit evaluation of possible sources of conflicts of interest. A nomination package should include the following information for each nominee: (1) A letter of nomination stating the name, affiliation, and contact information for the nominee, the basis for the nomination (i.e., what specific attributes, perspectives, and/or skills does the individual possess that would E:\FR\FM\02JAN1.SGM 02JAN1 112 Federal Register / Vol. 74, No. 1 / Friday, January 2, 2009 / Notices benefit the workings of ACOT), and the nominee’s field(s) of expertise; (2) a biographical sketch of the nominee and a copy of his/her curriculum vitae; and (3) the name, return address, and daytime telephone number at which the nominator can be contacted. The Department of Health and Human Services has special interest in assuring that women, minority groups, and the physically disabled are adequately represented on advisory committees; and therefore, extends particular encouragement to nominations for appropriately qualified female, minority, or disabled candidates. Dated: December 21, 2008. Elizabeth M. Duke, Administrator, HRSA. [FR Doc. E8–31219 Filed 12–31–08; 8:45 am] BILLING CODE 4165–15–P clinical research: Type of Information Collection Request: New. Need and Use of Information Collection: This study National Institutes of Health will assess the value of the training programs administered by the Office of Proposed Collection; Comment Clinical Research Training and Medical Request; the Impact of Clinical Education. The primary objective of the Research Training and Medical survey is to determine if training Education at the Clinical Center on programs have had an impact on Physician Careers in Academia and whether the trainees are performing Clinical Research clinical research, hold an academic appointment, have National Institutes of SUMMARY: In compliance with the Health funding sources as well as to requirement of Section 3506(c)(2)(A) of obtain information from the trainees as the Paperwork Reduction Act of 1995, to what part of the National Institutes of for opportunity for public comment on Health medical education program they proposed data collection projects, the feel could be improved upon, the Clinical Center, the National Institutes quality of the mentoring program, and of Health will publish periodic how their National Institutes of Health summaries of proposed projects to be training has contributed to their current submitted to the Office of Management clinical competence. Frequency of and Budget for review and approval. Proposed Collection: Title: The impact response: On occasion. Affected Public: of clinical research training and medical Physicians, dentists, medical students, dental students, nurses, and PhDs. The education at the Clinical Center on annual reporting burden is as follows: physician careers in academia and DEPARTMENT OF HEALTH AND HUMAN SERVICES Estimated number of responses per respondent Estimated number of respondents Type of respondents Average burden hours per response Estimated total annual burden hours requested 625 100 100 1 1 1 0.5 0.5 0.5 312.5 50 50 Total ........................................................................................ mstockstill on PROD1PC66 with NOTICES Doctoral Level ................................................................................ Students ......................................................................................... Nurses ............................................................................................ ............................ ............................ ............................ 362.5 There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. the data collection plans and instruments, contact Linda Wisniewski, Nurse Consultant, Office of Clinical Research Training and Medical Education, CC, NIH, Building 10, Room 1N252B, 9000 Rockville Pike, Bethesda, MD 20892 or 301–496–9425 or e-mail your request, including your address to: wisniewskil@cc.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Dated: December 24, 2008. Laura Lee, Project Clearance Liaison, Warren Grant Magnuson Clinical Center, National Institutes of Health. [FR Doc. E8–31240 Filed 12–31–08; 8:45 am] BILLING CODE 4140–01–P FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of VerDate Aug<31>2005 16:23 Dec 31, 2008 Jkt 217001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive E:\FR\FM\02JAN1.SGM 02JAN1

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[Federal Register Volume 74, Number 1 (Friday, January 2, 2009)]
[Notices]
[Pages 111-112]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-31219]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Advisory Committee on Organ Transplantation; Request for 
Nominations for Voting Members

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Health Resources and Services Administration (HRSA) is 
requesting nominations to fill vacancies on the Advisory Committee on 
Organ Transplantation (ACOT). The ACOT was established by the Amended 
Final Rule of the Organ Procurement and Transplantation Network (OPTN) 
(42 CFR Part 121) and, in accordance with Public Law 92-463, was 
chartered on September 1, 2000.

DATES: The agency must receive nominations on or before February 2, 
2009.

ADDRESSES: All nominations should be submitted to the Executive 
Secretary, Advisory Committee on Organ Transplantation, Healthcare 
Systems Bureau, HRSA, Parklawn Building, Room 12-105, 5600 Fishers 
Lane, Rockville, Maryland 20857. Federal Express, Airborne, UPS, etc., 
mail delivery should be addressed to Executive Secretary, Advisory 
Committee on Organ Transplantation, Healthcare Systems Bureau, HRSA, at 
the above address.

FOR FURTHER INFORMATION CONTACT: Remy Aronoff, Executive Secretary, 
Advisory Committee on Organ Transplantation, at (301) 443-3300 or e-
mail Remy.Aronoff@hrsa.hhs.gov.

SUPPLEMENTARY INFORMATION: As provided by 42 CFR 121.12 (64 FR 56661), 
the Secretary established the Advisory Committee on Organ 
Transplantation. The Committee is governed by the Federal Advisory 
Committee Act (5 U.S.C. Appendix 2), which sets forth standards for the 
formation and use of advisory committees.
    The ACOT advises the Secretary, acting through the Administrator, 
HRSA, on all aspects of organ procurement, allocation, and 
transplantation, and on other such matters that the Secretary 
determines. One of its principal functions is to advise the Secretary 
on ways to maximize Federal efforts to increase living and deceased 
organ donation nationally. Other matters that recently have been 
reviewed by the ACOT include:
     Accreditation of all establishments required to be 
registered with the FDA as manufacturers of human cells, tissues, and 
cellular- and tissue-based products;
     Concerns about U.S. citizens traveling abroad in order to 
receive organ transplants (also known as transplant tourism);
     Collection of data on the long-term health status of 
living donors;
     Organ Procurement and Transplantation Network development 
and distribution within the transplant community of a set of practice 
guidelines to be followed with respect to public solicitation of organ 
donors, both living and deceased; and
     Standards of coverage for living donors relating to future 
adverse events.
    The ACOT consists of up to 25 members, including the Chair. Members 
and Chair shall be selected by the Secretary from individuals 
knowledgeable in such fields as organ donation, health care public 
policy, transplantation medicine and surgery, critical care medicine 
and other medical specialties involved in the identification and 
referral of donors, non-physician transplant professions, nursing, 
epidemiology, immunology, law and bioethics, behavioral sciences, 
economics and statistics, as well as representatives of transplant 
candidates, transplant recipients, organ donors, and family members. To 
the extent practicable, Committee members should represent the 
minority, gender and geographic diversity of transplant candidates, 
transplant recipients, organ donors and family members served by the 
OPTN. In addition, the Director, Centers for Disease Control and 
Prevention; the Administrator, Centers for Medicare and Medicaid 
Services; the Commissioner, Food and Drug Administration; the Director, 
National Institutes of Health; and the Director, Agency for Healthcare 
Research and Quality (or the designees of such officials) serve as non-
voting ex-officio members.
    Specifically, HRSA is requesting nominations for voting members of 
the ACOT representing: Health care public policy; transplantation 
medicine and surgery, including pediatric and heart/lung 
transplantation; critical care medicine; nursing; epidemiology and 
applied statistics; immunology; law and bioethics; behavioral sciences; 
economics and econometrics; organ procurement organizations; transplant 
candidates/recipients; transplant/donor family members; and living 
donors. Nominees will be invited to serve a 4-year term beginning after 
July 2009.
    HHS will consider nominations of all qualified individuals with a 
view to ensuring that the Advisory Committee includes the areas of 
subject matter expertise noted above. Individuals may nominate 
themselves or other individuals, and professional associations and 
organizations may nominate one or more qualified persons for membership 
on the ACOT. Nominations shall state that the nominee is willing to 
serve as a member of the ACOT and appears to have no conflict of 
interest that would preclude the ACOT membership. Potential candidates 
will be asked to provide detailed information concerning financial 
interests, consultancies, research grants, and/or contracts that might 
be affected by recommendations of the Committee to permit evaluation of 
possible sources of conflicts of interest.
    A nomination package should include the following information for 
each nominee: (1) A letter of nomination stating the name, affiliation, 
and contact information for the nominee, the basis for the nomination 
(i.e., what specific attributes, perspectives, and/or skills does the 
individual possess that would

[[Page 112]]

benefit the workings of ACOT), and the nominee's field(s) of expertise; 
(2) a biographical sketch of the nominee and a copy of his/her 
curriculum vitae; and (3) the name, return address, and daytime 
telephone number at which the nominator can be contacted.
    The Department of Health and Human Services has special interest in 
assuring that women, minority groups, and the physically disabled are 
adequately represented on advisory committees; and therefore, extends 
particular encouragement to nominations for appropriately qualified 
female, minority, or disabled candidates.

    Dated: December 21, 2008.
Elizabeth M. Duke,
Administrator, HRSA.
 [FR Doc. E8-31219 Filed 12-31-08; 8:45 am]
BILLING CODE 4165-15-P