Nominations to the Presidential Advisory Council on HIV/AIDS, 54299-54300 [2015-22610]
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Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
54299
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Section of guidance/recordkeeping activity
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
4.1. and 6.4 SOPs for DMCs .......................................
4.4.3.2. DMC meeting records .....................................
37
370
1
1
37
370
8 ............................
2 ............................
296
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
disclosures
per
respondent
Number of
respondents
Section of guidance/disclosure activity
Total annual
disclosures
Average burden
per disclosure
Total hours
4.4.1.2. Sponsor notification to the DMC regarding
waivers.
4.4.3.2. DMC reports of meeting minutes to the sponsor.
1
1
1
0.25 (15 minutes) ..
0.25
370
2
740
1 ............................
740
Total ......................................................................
........................
........................
........................
...............................
740.25
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
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.
[FR Doc. 2015–22680 Filed 9–8–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Nominations to the Presidential
Advisory Council on HIV/AIDS
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health.
ACTION: Notice.
AGENCY:
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
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SUMMARY:
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14:19 Sep 08, 2015
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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.
ADDRESSES:
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
SUPPLEMENTARY INFORMATION:
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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
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09SEN1
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54300
Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
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.
Nominations 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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Announcement of Public Consultation
on Antimicrobial Resistance Rapid,
Point-of-Care Diagnostic Test
Challenge
Authority: 15 U.S.C. 3719.
The U.S. Department of
Health and Human Services (HHS)
intends to hold a prize competition in
which up to $20 million will be made
available, subject to the availability of
funds, for the delivery of one or more
successful rapid point-of-care
diagnostics that may be used by health
care providers to identify bacterial
infections. The National Institutes of
Health (NIH) and the Biomedical
Advanced Research and Development
Authority (BARDA) are sponsoring the
prize competition and will convene a
public consultation to seek comments
regarding the technical criteria and
performance characteristics of the
diagnostic(s) for which the prize(s) will
be offered.
DATES: The public consultation will be
held on October 7, 2015, 8:30 a.m. to
3:30 p.m. PDT. Written comments can
be submitted to the https://
www.challenges.gov Web site for this
competition beginning on October 1 at
8:30 a.m. EDT to October 6, 2015 at 5:00
p.m. EDT.
ADDRESSES: The public consultation
will be held at the Marriott Marquis San
Diego Marina, 333 West Harbor Drive,
San Diego, California, 92101.
FOR FURTHER INFORMATION CONTACT:
Robert W. Eisinger, Ph.D., National
Institutes of Health, Division of Program
Coordination, Planning, and Strategic
Initiatives, Telephone: 301–496–2229,
Email: Robert.eisinger@nih.gov.
SUPPLEMENTARY INFORMATION: On
September 18, 2014, the President
issued Executive Order 13676 on
Combating Antibiotic-Resistant Bacteria
(https://www.whitehouse.gov/the-pressoffice/2014/09/18/executive-ordercombating-antibiotic-resistant-bacteria)
and the Antimicrobial Resistance
Challenge was called for in the
accompanying White House Fact Sheet
https://www.whitehouse.gov/the-pressoffice/2014/09/18/fact-sheet-obamaadministration-takes-actions-combatantibiotic-resistan). The development
and use of rapid, point-of-care, and
innovative diagnostic tests for
identification and characterization of
resistant bacteria was a goal identified
in the National Strategy for Combating
Antibiotic-Resistant Bacteria released in
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September 2014 (https://
www.whitehouse.gov/sites/default/files/
docs/carb_national_strategy.pdf) and
addressed in the National Action Plan
for Combating Antibiotic-Resistant
Bacteria released in March 2015
(https://www.whitehouse.gov/sites/
default/files/docs/national_action_
plan_for_combating_antibotic-resistant_
bacteria.pdf).
In conformance to the above
documents, the NIH and BARDA are
sponsoring a prize competition, and the
Food and Drug Administration (FDA)
and the Centers for Disease Control and
Prevention (CDC) are contributing
technical and regulatory expertise to
develop the award evaluation process.
The aim of the prize competition is to
incentivize the development of one or
more in vitro diagnostic tests that would
be of significant clinical and public
health utility to combat the
development and spread of antibiotic
resistant bacteria. For example, such a
diagnostic test could be used by health
care providers to identify bacterial
infections in patients to help guide their
decisions about the necessity of
prescribing antibiotics, and if so, which
antibiotics may be effective—thus
promoting antibiotic stewardship.
Another important diagnostic use could
be to facilitate clinical trials for new
antibacterial products by allowing for
the enrichment of patient populations
with specific infections, thus advancing
the development of new antibacterial
agents. The prize-winning diagnostic(s)
must exhibit a set of predefined
technical criteria and performance
characteristics based on the intended
use(s).
When exercising prize authority
under the America COMPETES Act
(https://www.gpo.gov/fdsys/pkg/PLAW–
111publ358/html/PLAW–
111publ358.htm), agencies are to
‘‘consult widely both within and
outside the federal Government’’ when
developing prize competitions. As such,
HHS is seeking input from the medical,
public health, and scientific
communities; the pharmaceutical and
medical diagnostic sectors; patients and
other advocacy groups; and the public
at-large in order to receive broad input
on the type(s) of diagnostic(s) that may
be developed in an appropriate time
frame to be of significant utility in
combating the development and spread
of antibiotic resistant bacteria.
HHS has previously issued a Request
for Information (RFI) to obtain
comments on several topics as they
pertain to a rapid, point-of-care
diagnostic test(s) that could be
developed in an appropriate time frame
to be of significant clinical and public
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]]>Agencies
[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Pages 54299-54300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22610]
-----------------------------------------------------------------------
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]
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