81 FR 3441 - Advisory Committee on Organ Transplantation Request for Nominations for Voting Members
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 81, Issue 13 (January 21, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 13 (January 21, 2016)
| Page Range | 3441-3442 | |
| FR Document | 2016-01126 |
[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)] [Notices] [Pages 3441-3442] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01126] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Organ TransplantationRequest for Nominations for Voting Members AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice of request for nominations. ----------------------------------------------------------------------- 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 a continuous basis. ADDRESSES: All nominations should be submitted to the Executive Secretary, ACOT, Healthcare Systems Bureau, HRSA, 5600 Fishers Lane, Room 08N182, 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, or via email to: [email protected] and [email protected]. FOR FURTHER INFORMATION CONTACT: Patricia A. Stroup, M.B.A., M.P.A., Executive Secretary, ACOT, at (301) 443-1127 or email [email protected]. SUPPLEMENTARY INFORMATION: As provided by 42 CFR 121.12, the Secretary established the ACOT. The ACOT 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 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 federal efforts to maximize the number of deceased donor organs made available for transplantation and to support the safety of living organ donation. The ACOT consists of up to 25 members, who are Special Government Employees, and 6 ex-officio, non-voting members. Members and the Chair shall be appointed by the Secretary from individuals knowledgeable in such fields as deceased and living 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, living organ donors, and family members of deceased and living organ donors. Members shall not serve while they are also serving on the OPTN Board of Directors. To the extent practicable, Committee members should represent minority, gender and geographic diversity of transplant candidates, transplant recipients, organ donors and family members served by the OPTN. The ex- officio, non-voting members shall include the Directors of the National Institutes of Health, the Centers for Disease Control and Prevention, and the Agency for Healthcare Research and Quality; the Administrator of the Centers for Medicare & Medicaid Services; the Commissioner of the Food and Drug Administration; and the Chair, Advisory Committee on Blood and Tissue and Safety Availability--or their designees. 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 up to a 4-year term. The Department of Health and Human Services (HHS) will consider nominations of all qualified individuals with a view to ensuring that the ACOT 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 ACOT 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 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, address, daytime telephone number, and email address at which the nominator can be contacted. HHS strives to ensure that the membership of HHS federal advisory committees is balanced in terms of [[Page 3442]] points of view represented, consistent with the committee's authorizing charter. Appointment to the ACOT shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic status. The Department encourages nominations of qualified candidates from all groups and locations. Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2016-01126 Filed 1-20-16; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices 3441
permit evaluation of possible sources of Public Law 92–463, was chartered on The ex-officio, non-voting members
conflicts of interest. In addition, September 1, 2000. shall include the Directors of the
nominees will be asked to provide DATES: The agency must receive National Institutes of Health, the
detailed information concerning any nominations on a continuous basis. Centers for Disease Control and
employment, governance, or financial ADDRESSES: All nominations should be Prevention, and the Agency for
affiliation with any donor centers, submitted to the Executive Secretary, Healthcare Research and Quality; the
recruitment organizations, transplant ACOT, Healthcare Systems Bureau, Administrator of the Centers for
centers, and/or cord blood banks. HRSA, 5600 Fishers Lane, Room Medicare & Medicaid Services; the
A nomination package should be sent 08N182, Rockville, Maryland 20857. Commissioner of the Food and Drug
in as hard copy, email communication, Federal Express, Airborne, UPS, etc., Administration; and the Chair, Advisory
or on compact disc. A nomination mail delivery should be addressed to Committee on Blood and Tissue and
package should include the following Executive Secretary, Advisory Safety Availability—or their designees.
information for each nominee: (1) A Committee on Organ Transplantation, Specifically, HRSA is requesting
letter of nomination stating the name, Healthcare Systems Bureau, HRSA, at nominations for voting members of the
affiliation, and contact information for the above address, or via email to: ACOT representing: Health care public
the nominee, the basis for the PStroup@hrsa.gov and PTongele@ policy; transplantation medicine and
nomination (i.e., what specific attributes hrsa.gov. surgery, including pediatric and heart/
recommend him/her for service in this lung transplantation; critical care
FOR FURTHER INFORMATION CONTACT: medicine; nursing; epidemiology and
capacity), and the nominee’s field(s) of
Patricia A. Stroup, M.B.A., M.P.A., applied statistics; immunology; law and
expertise; (2) a biographical sketch of
Executive Secretary, ACOT, at (301) bioethics; behavioral sciences;
the nominee and a copy of his/her
443–1127 or email PStroup@hrsa.gov. economics and econometrics; organ
curriculum vitae; and (3) the name,
SUPPLEMENTARY INFORMATION: As procurement organizations; transplant
return address, email address, and
daytime telephone number at which the provided by 42 CFR 121.12, the candidates/recipients; transplant/donor
nominator can be contacted. Secretary established the ACOT. The family members; and living donors.
HHS strives to ensure that the ACOT is governed by the Federal Nominees will be invited to serve up to
membership of HHS federal advisory Advisory Committee Act (5 U.S.C. a 4-year term.
committees is balanced in terms of Appendix 2), which sets forth standards The Department of Health and Human
points of view represented, consistent for the formation and use of advisory Services (HHS) will consider
with the committee’s authorizing statute committees. nominations of all qualified individuals
The ACOT advises the Secretary on with a view to ensuring that the ACOT
and charter. Appointment to the
all aspects of organ procurement, includes the areas of subject matter
ACBSCT shall be made without
allocation, and transplantation, and on expertise noted above. Individuals may
discrimination on the basis of age, race,
other such matters that the Secretary nominate themselves or other
ethnicity, gender, sexual orientation,
determines. One of its principal individuals, and professional
disability, and cultural, religious, or
functions is to advise the Secretary on associations and organizations may
socioeconomic status. The Department
federal efforts to maximize the number nominate one or more qualified persons
encourages nominations of qualified
of deceased donor organs made for membership on the ACOT.
candidates from all groups and
available for transplantation and to Nominations shall state that the
locations.
support the safety of living organ nominee is willing to serve as a member
Jackie Painter, donation. of the ACOT and appears to have no
Director, Division of the Executive Secretariat. The ACOT consists of up to 25 conflict of interest that would preclude
[FR Doc. 2016–01127 Filed 1–20–16; 8:45 am] members, who are Special Government the ACOT membership. Potential
BILLING CODE 4165–15–P
Employees, and 6 ex-officio, non-voting candidates will be asked to provide
members. Members and the Chair shall detailed information concerning
be appointed by the Secretary from financial interests, consultancies,
DEPARTMENT OF HEALTH AND individuals knowledgeable in such research grants, and/or contracts that
HUMAN SERVICES fields as deceased and living organ might be affected by recommendations
donation, health care public policy, of the ACOT to permit evaluation of
Health Resources and Services transplantation medicine and surgery, possible sources of conflicts of interest.
Administration critical care medicine and other medical A nomination package should include
specialties involved in the identification the following information for each
Advisory Committee on Organ and referral of donors, non-physician nominee:
TransplantationRequest for transplant professions, nursing, (1) A letter of nomination stating the
Nominations for Voting Members epidemiology, immunology, law and name, affiliation, and contact
AGENCY: Health Resources and Services bioethics, behavioral sciences, information for the nominee, the basis
Administration, HHS. economics and statistics, as well as for the nomination (i.e., what specific
ACTION: Notice of request for representatives of transplant candidates, attributes, perspectives, and/or skills
nominations. transplant recipients, living organ does the individual possess that would
donors, and family members of benefit the workings of ACOT), and the
SUMMARY: The Health Resources and deceased and living organ donors. nominee’s field(s) of expertise; (2) a
asabaliauskas on DSK9F6TC42PROD with NOTICES
Services Administration (HRSA) is Members shall not serve while they are biographical sketch of the nominee and
requesting nominations to fill vacancies also serving on the OPTN Board of a copy of his/her curriculum vitae; and
on the Advisory Committee on Organ Directors. To the extent practicable, (3) the name, address, daytime
Transplantation (ACOT). The ACOT Committee members should represent telephone number, and email address at
was established by the Amended Final minority, gender and geographic which the nominator can be contacted.
Rule of the Organ Procurement and diversity of transplant candidates, HHS strives to ensure that the
Transplantation Network (OPTN) (42 transplant recipients, organ donors and membership of HHS federal advisory
CFR part 121) and, in accordance with family members served by the OPTN. committees is balanced in terms of
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![3442 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices
points of view represented, consistent Executive Director, SACHRP, Office for administration, and biomedical ethics.
with the committee’s authorizing Human Research Protections, To qualify for consideration of
charter. Appointment to the ACOT shall Department of Health and Human appointment to the Committee, an
be made without discrimination on the Services, 1101 Wootton Parkway, Suite individual must possess demonstrated
basis of age, race, ethnicity, gender, 200; Rockville, MD 20852. Nominations experience and expertise in any of the
sexual orientation, disability, and will not be accepted by email or by several disciplines and fields pertinent
cultural, religious, or socioeconomic facsimile. to human subjects protection and/or
status. The Department encourages FOR FURTHER INFORMATION CONTACT: Julia clinical research, as well as the
nominations of qualified candidates Gorey, Executive Director, SACHRP, necessary time and dedication to devote
from all groups and locations. Office for Human Research Protections, to responsible membership on a
1101 Wootton Parkway, Suite 200, working federal advisory committee.
Jackie Painter, The individuals selected for
Director, Division of the Executive Secretariat. Rockville, MD 20852, telephone: 240–
453–8141. A copy of the Committee appointment to the Committee may be
[FR Doc. 2016–01126 Filed 1–20–16; 8:45 am]
charter and list of the current members invited to serve a term of up to four
BILLING CODE 4165–15–P years. Committee members receive a
can be obtained by accessing the
stipend and reimbursement for per diem
SACHRP Web site at www.hhs.gov/
and any travel expenses incurred for
DEPARTMENT OF HEALTH AND ohrp/sachrp, or requesting via email at
attending Committee meetings and/or
HUMAN SERVICES sachrp@osophs.dhhs.gov.
conducting other business in the
SUPPLEMENTARY INFORMATION: The
interest of the Committee. Interested
Solicitation of Nominations for Committee provides advice on matters applicants may self-nominate.
Membership on the Secretary’s pertaining to the continuance and Nominations may be retained and
Advisory Committee on Human improvement of functions within the considered for future vacancies.
Research Protections authority of HHS directed toward Nominations should be typewritten.
protections for human subjects in The following information should be
AGENCY: Office for Human Research research. Specifically, the Committee
Protections, Office of the Secretary, included in the package of material
provides advice relating to the submitted for each individual being
Office of the Assistant Secretary for responsible conduct of research
Health, Department of Health and nominated for consideration: (1) A letter
involving human subjects with of nomination that clearly states the
Human Services. particular emphasis on special name and affiliation of the nominee, the
ACTION: Notice. populations such as neonates and basis for the nomination (i.e., specific
children, prisoners, the decisionally attributes which qualify the nominee for
Authority: 42 U.S.C. 217a, Section 222 of impaired, pregnant women, embryos service in this capacity), and a statement
the Public Health Service Act, as amended. and fetuses, individuals and that the nominee is willing to serve as
The Committee is governed by the provisions populations in international studies,
of Public Law 92–463, as amended (5 U.S.C. a member of the Committee; (2) the
investigator conflicts of interest and nominator’s name, address, daytime
Appendix 2), which sets forth standards for
the formation and use of advisory populations in which there are telephone number and the home and/or
committees. individually identifiable samples, data work address, telephone number, and
or information. email address of the individual being
SUMMARY: The Office for Human In addition, the Committee is nominated; and (3) a current copy of the
Research Protections (OHRP), a program responsible for reviewing selected nominee’s curriculum vitae. Federal
office in the Office of the Assistant ongoing work and planned activities of employees should not be nominated for
Secretary for Health, Department of the OHRP and other offices/agencies consideration of appointment to this
Health and Human Services (HHS), is within HHS responsible for human Committee.
seeking four (4) nominations of subjects protection. These evaluations The Department makes every effort to
qualified candidates to be considered may include, but are not limited to, ensure that the membership of HHS
for appointment as members of the issues relating to the Notice of Proposed federal advisory committees is fairly
Secretary’s Advisory Committee on Rulemaking (NPRM) titled ‘‘Federal balanced in terms of points of view
Human Research Protections (SACHRP). Policy for the Protection of Human represented and the committee’s
SACHRP provides advice and Subjects’’ that appeared in the Federal function. Every effort is made to ensure
recommendations to the Secretary, HHS, Register on September 8, 2015, Vol 80, that individuals from a broad
through the Assistant Secretary for No 173:53933. In addition, SACHRP representation of geographic areas,
Health on issues pertaining to the may review matters pertaining to the women and men, ethnic and minority
continuance and improvement of assurance system, the application of groups, and the disabled are given
functions within the authority of HHS minimal research risk standards, the consideration for membership on HHS
directed toward protections for human granting of waivers, education programs federal advisory committees.
subjects in research. SACHRP was sponsored by OHRP, and the ongoing Appointment to this Committee shall be
established by the Secretary, HHS, on monitoring and oversight of made without discrimination on the
October 1, 2002. OHRP is seeking institutional review boards and the basis of age, race, ethnicity, gender,
nominations of four qualified institutions that sponsor research. sexual orientation, disability, and
candidates to fill positions on the Nominations: The OHRP is requesting cultural, religious, or socioeconomic
asabaliauskas on DSK9F6TC42PROD with NOTICES
Committee membership that will be nominations to fill four (4) positions for status.
vacated during the 2016 calendar year, voting members of SACHRP that will Individuals who are selected to be
including the position of Chair. become vacant in October 2016. considered for appointment will be
DATES: Nominations for membership on Nominations of potential candidates for required to provide detailed information
the Committee must be received no later consideration are being sought from a regarding their financial holdings,
than March 21, 2016. wide array of fields, including, but not consultancies, and research grants or
ADDRESSES: Nominations should be limited to: Public health and medicine, contracts. Disclosure of this information
mailed or delivered to Julia Gorey, behavioral and social sciences, health is necessary in order to determine if the
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Document Created: 2018-02-02 12:33:50
Document Modified: 2018-02-02 12:33:50
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of request for nominations. | |
| Dates | The agency must receive nominations on a continuous basis. | |
| Contact | Patricia A. Stroup, M.B.A., M.P.A., Executive Secretary, ACOT, at (301) 443-1127 or email [email protected] | |
| FR Citation | 81 FR 3441 |
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