Announcement of Public Consultation on Antimicrobial Resistance Rapid, Point-of-Care Diagnostic Test Challenge, 54300-54301 [2015-22690]
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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.
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identify a principal contact person; and
a
• Copy of a current resume or
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the required information. Incomplete
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consideration. The letter from the
nominator and certification of the
nominated individual must bear original
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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
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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,
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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
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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
E:\FR\FM\09SEN1.SGM
09SEN1
Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
Lhorne on DSK5TPTVN1PROD with NOTICES
health utility in combating the
development and spread of antibiotic
resistant bacteria. A prioritized list of 18
bacteria of highest concern can be found
in Table 3 of the National Action Plan
(https://www.whitehouse.gov/sites/
default/files/docs/national_action_
plan_for_combating_antibotic-resistant_
bacteria.pdf). Input received from the
RFI and during the public consultation
will be used by HHS to develop the
technical criteria and performance
characteristics of the diagnostic(s) for
which the prize(s) will be offered. The
design of the Challenge will take into
account previous guidance obtained in
the aforementioned National Strategy
and National Action Plan to combat
antibiotic resistant bacteria.
The agenda of the public consultation
meeting will be devoted to presentations
and discussions on the objectives and
criteria for the antimicrobial diagnostic
challenge competition. Presentations
will focus on the need for rapid
diagnostics to address antimicrobial
resistance; development and use of
rapid diagnostics for drug resistant
microorganisms; pathogen/resistance
markers identification versus
phenotypic susceptibility; antibiotic
stewardship in the clinical setting; and
regulatory perspectives on rapid
diagnostic development.
Any interested person may submit
written comments to be considered
during the public consultation to the
discussion board for this Challenge
accessible on https://
www.challenge.gov. This statement
should include your name, address,
telephone number and when applicable,
the business or professional affiliation.
Written comments can be submitted
from October 1, 2015 at 8:30 a.m. EDT
to October 6, 2015 at 5:00 p.m. EDT.
This web-based discussion board also
provides an open forum for discussion
of this prize competition. The online
community is open to the public and
will allow for a broad and interactive
discussion of the topics covered by this
public consultation. This platform will
allow users to submit ideas about a
desired diagnostic test and to comment
on the ideas that have been submitted
by others.
Dated: September 1, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2015–22690 Filed 9–8–15; 8:45 am]
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Jkt 235001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI
Omnibus R03 & R21 SEP–8.
Date: October 27–28, 2015.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Yisong Wang, Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical
Center Drive, Room 7W240, Rockville, MD
20850, 240–276–7157, yisong.wang@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI
Omnibus R03 & R21 SEP–11.
Date: October 29, 2015.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hilton Hotel Bethesda,
8120 Wisconsin Avenue, Bethesda, MD
20814.
Contact Person: Reed A. Graves, Ph.D.,
Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center
Drive, Room 7W264, Rockville, MD 20850,
240–276–6384, gravesr@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI
Omnibus R03 & R21 SEP–3.
Date: November 5–6, 2015.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Viatcheslav A.
Soldatenkov, MD, Ph.D., Scientific Review
Officer, Special Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
54301
Room 7W254, Bethesda, MD 20892, 240–
276–6378, soldatenkovv@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI
Omnibus R03 & R21 SEP–1.
Date: November 9–10, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hilton Hotel Bethesda,
8120 Wisconsin Avenue, Bethesda, MD
20814.
Contact Person: Zhiqiang Zou, MD, Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical
Center Drive, Room 7W242, Bethesda, MD
20892–8328, 240–276–6372, zouzhiq@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: September 3, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–22659 Filed 9–8–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Time-Sensitive
Obesity.
Date: September 30, 2015.
Time: 1 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\09SEN1.SGM
09SEN1
Agencies
[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Pages 54300-54301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22690]
-----------------------------------------------------------------------
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.
SUMMARY: 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-press-office/2014/09/18/executive-order-combating-antibiotic-resistant-bacteria) and the Antimicrobial
Resistance Challenge was called for in the accompanying White House
Fact Sheet https://www.whitehouse.gov/the-press-office/2014/09/18/fact-sheet-obama-administration-takes-actions-combat-antibiotic-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 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
[[Page 54301]]
health utility in combating the development and spread of antibiotic
resistant bacteria. A prioritized list of 18 bacteria of highest
concern can be found in Table 3 of the National Action Plan (https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf).
Input received from the RFI and during the public consultation will be
used by HHS to develop the technical criteria and performance
characteristics of the diagnostic(s) for which the prize(s) will be
offered. The design of the Challenge will take into account previous
guidance obtained in the aforementioned National Strategy and National
Action Plan to combat antibiotic resistant bacteria.
The agenda of the public consultation meeting will be devoted to
presentations and discussions on the objectives and criteria for the
antimicrobial diagnostic challenge competition. Presentations will
focus on the need for rapid diagnostics to address antimicrobial
resistance; development and use of rapid diagnostics for drug resistant
microorganisms; pathogen/resistance markers identification versus
phenotypic susceptibility; antibiotic stewardship in the clinical
setting; and regulatory perspectives on rapid diagnostic development.
Any interested person may submit written comments to be considered
during the public consultation to the discussion board for this
Challenge accessible on https://www.challenge.gov. This statement
should include your name, address, telephone number and when
applicable, the business or professional affiliation. Written comments
can be submitted from October 1, 2015 at 8:30 a.m. EDT to October 6,
2015 at 5:00 p.m. EDT.
This web-based discussion board also provides an open forum for
discussion of this prize competition. The online community is open to
the public and will allow for a broad and interactive discussion of the
topics covered by this public consultation. This platform will allow
users to submit ideas about a desired diagnostic test and to comment on
the ideas that have been submitted by others.
Dated: September 1, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2015-22690 Filed 9-8-15; 8:45 am]
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