80 FR 54299 - Nominations to the Presidential Advisory Council on HIV/AIDS

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 174 (September 9, 2015)

Page Range		54299-54300
FR Document		2015-22610

The Office of the Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Presidential Advisory Council on HIV/AIDS (PACHA). The PACHA is a federal advisory committee within the Department of Health and Human Services (HHS). Management support for the activities of this Council is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration for appointment as members of the PACHA. Members of the Council, including the Chair, are appointed by the Secretary. Members are invited to serve on the Council for up to four-year terms. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective prevention and care of HIV disease and AIDS. The functions of the Council are solely advisory in nature.

Federal Register, Volume 80 Issue 174 (Wednesday, September 9, 2015)

[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Pages 54299-54300]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-22610]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Nominations to the Presidential Advisory Council on HIV/AIDS

AGENCY: Department of Health and Human Services, Office of the 
Secretary, Office of the Assistant Secretary for Health.

ACTION: Notice.

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

SUMMARY: The Office of the Assistant Secretary for Health (OASH) is 
seeking nominations of qualified individuals to be considered for 
appointment as members of the Presidential Advisory Council on HIV/AIDS 
(PACHA). The PACHA is a federal advisory committee within the 
Department of Health and Human Services (HHS). Management support for 
the activities of this Council is the responsibility of the OASH. The 
qualified individuals will be nominated to the Secretary of Health and 
Human Services for consideration for appointment as members of the 
PACHA. Members of the Council, including the Chair, are appointed by 
the Secretary. Members are invited to serve on the Council for up to 
four-year terms. The Council was established to provide advice, 
information, and recommendations to the Secretary regarding programs 
and policies intended to promote effective prevention and care of HIV 
disease and AIDS. The functions of the Council are solely advisory in 
nature.

DATES: All nominations must be received no later than 5:00 p.m. (ET) on 
October 9, 2015 at the address listed below.

ADDRESSES: All nominations should be mailed or delivered to Ms. B. Kaye 
Hayes, Executive Director, PACHA, Department of Health and Human 
Services, Office of HIV/AIDS and Infectious Disease Policy, 200 
Independence Avenue SW., Room 443-H, Washington, DC 20201.

FOR FURTHER INFORMATION CONTACT: Ms. Caroline Talev, Public Health 
Analyst, Presidential Advisory Council on HIV/AIDS, Department of 
Health and Human Services, 200 Independence Avenue SW., Room 443-H, 
Hubert H. Humphrey Building, Washington, DC 20201; (202) 205-1178. More 
detailed information about PACHA can be obtained by accessing the 
Council's page at the AIDS.gov Web site at www.aids.gov/pacha.

SUPPLEMENTARY INFORMATION: PACHA was established by Executive Order 
12963, dated June 14, 1995, as amended by Executive Order 13009, dated 
June 14, 1996. The Council was established to provide advice, 
information, and recommendations to the Secretary regarding programs 
and policies intended to promote effective prevention and care of HIV 
disease and AIDS. The functions of the Council are solely advisory in 
nature.
    The Council consists of not more than 25 members. Council members 
are selected from prominent community leaders with particular expertise 
in, or knowledge of, matters concerning HIV and AIDS, public health, 
global health, philanthropy, marketing or business, as well as other 
national leaders held in high esteem from other sectors of society. 
Council members are appointed by the Secretary or designee, in 
consultation with the White House Office on National AIDS Policy. 
Pursuant to advance written agreement, Council members shall receive no 
stipend for the advisory service they render as members of PACHA. 
However, as authorized by law and in accordance with federal travel 
regulations, PACHA members may receive per diem and reimbursement for 
travel expenses incurred in relation to performing duties for the 
Council.
    This announcement is to solicit nominations of qualified candidates 
to fill current vacancies on the PACHA.
    Nominations: In accordance with the PACHA charter, persons 
nominated for appointment as members of the PACHA should be among 
prominent community leaders and authorities with particular expertise 
in, or knowledge of, matters concerning HIV and AIDS, public health, 
global health, philanthropy, marketing or business, as well as other 
national leaders held in high esteem from other sectors of society. The 
following information should be included in the package of material 
submitted for each individual being nominated for consideration of 
appointment:
     Name, return address, daytime telephone number, and 
affiliation(s) of

[[Page 54300]]

the individual being nominated, the basis for the individual's 
nomination, and a statement bearing an original signature of the 
nominated individual that, if appointed, he or she is willing to serve 
as a member of the Council;
     Name, return address, and daytime telephone number at 
which the nominator may be contacted. Nomina tions from organizations 
must identify a principal contact person; and a
     Copy of a current resume or curriculum vitae for the 
nominated individual.
    Individuals can nominate themselves for consideration of 
appointment to the Council. All nominations must include the required 
information. Incomplete nominations will not be processed for 
consideration. The letter from the nominator and certification of the 
nominated individual must bear original signatures; reproduced copies 
of these signatures are not acceptable.
    The Department is legally required to ensure that the membership of 
HHS federal advisory committees is fairly balanced in terms of points 
of view represented and the functions to be performed by the advisory 
committee. Every effort is made to ensure that the views of women, all 
ethnic and racial groups, and people with disabilities are represented 
on HHS federal advisory committees and, therefore, the Department 
encourages nominations of qualified candidates from these groups. The 
Department also encourages geographic diversity in the composition of 
the Council. Appointment to the Council shall be made without 
discrimination on the basis of age, race, ethnicity, gender, sexual 
orientation, disability, and cultural, religious, or socioeconomic 
status. The Standards of Ethical Conduct for Employees of the Executive 
Branch are applicable to individuals who are appointed as members of 
the Council. Individuals being considered for appointment as public 
voting members will be required to complete and submit a report of 
their financial holdings. An ethics review must be conducted to ensure 
that individuals appointed as members of PACHA are not involved in any 
activity that may pose a potential conflict of interest for the 
official duties that are to be performed.

    Dated: August 24, 2015.
B. Kaye Hayes,
Executive Director, Presidential Advisory Council on HIV/AIDS.
[FR Doc. 2015-22610 Filed 9-8-15; 8:45 am]
 BILLING CODE 4150-43-P

Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices 54299

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
Number of Total annual Average burden
Section of guidance/recordkeeping activity records per Total hours
recordkeepers records per recordkeeping
recordkeeper

4.1. and 6.4 SOPs for DMCs ....................................... 37 1 37 8 ............................ 296
4.4.3.2. DMC meeting records ..................................... 370 1 370 2 ............................ 740

Total ...................................................................... ........................ ........................ ........................ ............................... 1,036
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
Number of disclosures Total annual Average burden
Section of guidance/disclosure activity Total hours
respondents per disclosures per disclosure
respondent

4.4.1.2. Sponsor notification to the DMC regarding 1 1 1 0.25 (15 minutes) .. 0.25
waivers.
4.4.3.2. DMC reports of meeting minutes to the spon- 370 2 740 1 ............................ 740
sor.

Total ...................................................................... ........................ ........................ ........................ ............................... 740.25
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: September 3, 2015. prevention and care of HIV disease and selected from prominent community
Leslie Kux, AIDS. The functions of the Council are leaders with particular expertise in, or
Associate Commissioner for Policy. solely advisory in nature. knowledge of, matters concerning HIV
[FR Doc. 2015–22680 Filed 9–8–15; 8:45 am] DATES: All nominations must be and AIDS, public health, global health,
BILLING CODE 4164–01–P received no later than 5:00 p.m. (ET) on philanthropy, marketing or business, as
October 9, 2015 at the address listed well as other national leaders held in
below. high esteem from other sectors of
DEPARTMENT OF HEALTH AND society. Council members are appointed
ADDRESSES: All nominations should be
HUMAN SERVICES by the Secretary or designee, in
mailed or delivered to Ms. B. Kaye
consultation with the White House
Nominations to the Presidential Hayes, Executive Director, PACHA,
Office on National AIDS Policy.
Advisory Council on HIV/AIDS Department of Health and Human
Pursuant to advance written agreement,
Services, Office of HIV/AIDS and
AGENCY: Department of Health and Council members shall receive no
Infectious Disease Policy, 200
Human Services, Office of the Secretary, stipend for the advisory service they
Independence Avenue SW., Room 443–
Office of the Assistant Secretary for render as members of PACHA. However,
H, Washington, DC 20201.
Health. as authorized by law and in accordance
FOR FURTHER INFORMATION CONTACT: Ms. with federal travel regulations, PACHA
ACTION: Notice. Caroline Talev, Public Health Analyst, members may receive per diem and
SUMMARY: The Office of the Assistant Presidential Advisory Council on HIV/ reimbursement for travel expenses
Secretary for Health (OASH) is seeking AIDS, Department of Health and Human incurred in relation to performing duties
nominations of qualified individuals to Services, 200 Independence Avenue for the Council.
be considered for appointment as SW., Room 443–H, Hubert H. Humphrey This announcement is to solicit
members of the Presidential Advisory Building, Washington, DC 20201; (202) nominations of qualified candidates to
Council on HIV/AIDS (PACHA). The 205–1178. More detailed information fill current vacancies on the PACHA.
PACHA is a federal advisory committee about PACHA can be obtained by Nominations: In accordance with the
within the Department of Health and accessing the Council’s page at the PACHA charter, persons nominated for
Human Services (HHS). Management AIDS.gov Web site at www.aids.gov/ appointment as members of the PACHA
support for the activities of this Council pacha. should be among prominent community
is the responsibility of the OASH. The SUPPLEMENTARY INFORMATION: PACHA leaders and authorities with particular
qualified individuals will be nominated was established by Executive Order expertise in, or knowledge of, matters
to the Secretary of Health and Human 12963, dated June 14, 1995, as amended concerning HIV and AIDS, public
Services for consideration for by Executive Order 13009, dated June health, global health, philanthropy,
appointment as members of the PACHA. 14, 1996. The Council was established marketing or business, as well as other
Members of the Council, including the to provide advice, information, and national leaders held in high esteem
Chair, are appointed by the Secretary. recommendations to the Secretary from other sectors of society. The
Lhorne on DSK5TPTVN1PROD with NOTICES

Members are invited to serve on the regarding programs and policies following information should be
Council for up to four-year terms. The intended to promote effective included in the package of material
Council was established to provide prevention and care of HIV disease and submitted for each individual being
advice, information, and AIDS. The functions of the Council are nominated for consideration of
recommendations to the Secretary solely advisory in nature. appointment:
regarding programs and policies The Council consists of not more than • Name, return address, daytime
intended to promote effective 25 members. Council members are telephone number, and affiliation(s) of

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54300 Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices

the individual being nominated, the DEPARTMENT OF HEALTH AND September 2014 (https://
basis for the individual’s nomination, HUMAN SERVICES www.whitehouse.gov/sites/default/files/
and a statement bearing an original docs/carb_national_strategy.pdf) and
signature of the nominated individual National Institutes of Health addressed in the National Action Plan
that, if appointed, he or she is willing for Combating Antibiotic-Resistant
to serve as a member of the Council; Announcement of Public Consultation Bacteria released in March 2015
on Antimicrobial Resistance Rapid, (https://www.whitehouse.gov/sites/
• Name, return address, and daytime Point-of-Care Diagnostic Test
telephone number at which the default/files/docs/national_action_
Challenge plan_for_combating_antibotic-resistant_
nominator may be contacted.
Nominations from organizations must bacteria.pdf).
Authority: 15 U.S.C. 3719. In conformance to the above
identify a principal contact person; and
SUMMARY: The U.S. Department of documents, the NIH and BARDA are
a
Health and Human Services (HHS) sponsoring a prize competition, and the
• Copy of a current resume or intends to hold a prize competition in Food and Drug Administration (FDA)
curriculum vitae for the nominated which up to $20 million will be made and the Centers for Disease Control and
individual. available, subject to the availability of Prevention (CDC) are contributing
Individuals can nominate themselves funds, for the delivery of one or more technical and regulatory expertise to
for consideration of appointment to the successful rapid point-of-care develop the award evaluation process.
Council. All nominations must include diagnostics that may be used by health The aim of the prize competition is to
the required information. Incomplete care providers to identify bacterial incentivize the development of one or
nominations will not be processed for infections. The National Institutes of more in vitro diagnostic tests that would
consideration. The letter from the Health (NIH) and the Biomedical be of significant clinical and public
nominator and certification of the Advanced Research and Development health utility to combat the
nominated individual must bear original Authority (BARDA) are sponsoring the development and spread of antibiotic
signatures; reproduced copies of these prize competition and will convene a resistant bacteria. For example, such a
signatures are not acceptable. public consultation to seek comments diagnostic test could be used by health
regarding the technical criteria and care providers to identify bacterial
The Department is legally required to infections in patients to help guide their
performance characteristics of the
ensure that the membership of HHS decisions about the necessity of
diagnostic(s) for which the prize(s) will
federal advisory committees is fairly prescribing antibiotics, and if so, which
be offered.
balanced in terms of points of view antibiotics may be effective—thus
DATES: The public consultation will be
represented and the functions to be promoting antibiotic stewardship.
performed by the advisory committee. held on October 7, 2015, 8:30 a.m. to
3:30 p.m. PDT. Written comments can Another important diagnostic use could
Every effort is made to ensure that the be to facilitate clinical trials for new
views of women, all ethnic and racial be submitted to the https://
www.challenges.gov Web site for this antibacterial products by allowing for
groups, and people with disabilities are the enrichment of patient populations
represented on HHS federal advisory competition beginning on October 1 at
8:30 a.m. EDT to October 6, 2015 at 5:00 with specific infections, thus advancing
committees and, therefore, the the development of new antibacterial
Department encourages nominations of p.m. EDT.
agents. The prize-winning diagnostic(s)
qualified candidates from these groups. ADDRESSES: The public consultation
must exhibit a set of predefined
The Department also encourages will be held at the Marriott Marquis San
technical criteria and performance
geographic diversity in the composition Diego Marina, 333 West Harbor Drive,
characteristics based on the intended
of the Council. Appointment to the San Diego, California, 92101.
use(s).
Council shall be made without FOR FURTHER INFORMATION CONTACT: When exercising prize authority
discrimination on the basis of age, race, Robert W. Eisinger, Ph.D., National under the America COMPETES Act
ethnicity, gender, sexual orientation, Institutes of Health, Division of Program (http://www.gpo.gov/fdsys/pkg/PLAW–
disability, and cultural, religious, or Coordination, Planning, and Strategic 111publ358/html/PLAW–
socioeconomic status. The Standards of Initiatives, Telephone: 301–496–2229, 111publ358.htm), agencies are to
Ethical Conduct for Employees of the Email: Robert.eisinger@nih.gov. ‘‘consult widely both within and
Executive Branch are applicable to SUPPLEMENTARY INFORMATION: On outside the federal Government’’ when
individuals who are appointed as September 18, 2014, the President developing prize competitions. As such,
members of the Council. Individuals issued Executive Order 13676 on HHS is seeking input from the medical,
being considered for appointment as Combating Antibiotic-Resistant Bacteria public health, and scientific
public voting members will be required (https://www.whitehouse.gov/the-press- communities; the pharmaceutical and
to complete and submit a report of their office/2014/09/18/executive-order- medical diagnostic sectors; patients and
financial holdings. An ethics review combating-antibiotic-resistant-bacteria) other advocacy groups; and the public
must be conducted to ensure that and the Antimicrobial Resistance at-large in order to receive broad input
individuals appointed as members of Challenge was called for in the on the type(s) of diagnostic(s) that may
PACHA are not involved in any activity accompanying White House Fact Sheet be developed in an appropriate time
that may pose a potential conflict of https://www.whitehouse.gov/the-press- frame to be of significant utility in
interest for the official duties that are to office/2014/09/18/fact-sheet-obama- combating the development and spread
be performed. administration-takes-actions-combat- of antibiotic resistant bacteria.
Lhorne on DSK5TPTVN1PROD with NOTICES

antibiotic-resistan). The development HHS has previously issued a Request
Dated: August 24, 2015.
and use of rapid, point-of-care, and for Information (RFI) to obtain
B. Kaye Hayes, innovative diagnostic tests for comments on several topics as they
Executive Director, Presidential Advisory identification and characterization of pertain to a rapid, point-of-care
Council on HIV/AIDS. resistant bacteria was a goal identified diagnostic test(s) that could be
[FR Doc. 2015–22610 Filed 9–8–15; 8:45 am] in the National Strategy for Combating developed in an appropriate time frame
BILLING CODE 4150–43–P Antibiotic-Resistant Bacteria released in to be of significant clinical and public

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Document Created: 2015-12-15 09:52:57
Document Modified: 2015-12-15 09:52:57

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.
Dates		All nominations must be received no later than 5:00 p.m. (ET) on
Contact		Ms. Caroline Talev, Public Health Analyst, Presidential Advisory Council on HIV/AIDS, Department of Health and Human Services, 200 Independence Avenue SW., Room 443-H, Hubert H. Humphrey Building, Washington, DC 20201; (202) 205-1178. More detailed information about PACHA can be obtained by accessing the Council's page at the AIDS.gov Web site at www.aids.gov/pacha.
FR Citation		80 FR 54299