80 FR 54300 - Announcement of Public Consultation on Antimicrobial Resistance Rapid, Point-of-Care Diagnostic Test Challenge
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 174 (September 9, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 174 (September 9, 2015)
| Page Range | 54300-54301 | |
| FR Document | 2015-22690 |
[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)] [Notices] [Pages 54300-54301] From the Federal Register Online [www.thefederalregister.org] [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: [email protected]. 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 (http://www.thefederalregister.org/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] BILLING CODE 4140-01-P
![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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![Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices 54301
health utility in combating the DEPARTMENT OF HEALTH AND Room 7W254, Bethesda, MD 20892, 240–
development and spread of antibiotic HUMAN SERVICES 276–6378, soldatenkovv@mail.nih.gov.
resistant bacteria. A prioritized list of 18 Name of Committee: National Cancer
bacteria of highest concern can be found National Institutes of Health Institute Special Emphasis Panel; NCI
Omnibus R03 & R21 SEP–1.
in Table 3 of the National Action Plan Date: November 9–10, 2015.
National Cancer Institute Notice of
(https://www.whitehouse.gov/sites/ Time: 8:00 a.m. to 5:00 p.m.
Closed Meetings
default/files/docs/national_action_ Agenda: To review and evaluate grant
plan_for_combating_antibotic-resistant_ Pursuant to section 10(d) of the applications.
bacteria.pdf). Input received from the Federal Advisory Committee Act, as Place: Doubletree Hilton Hotel Bethesda,
RFI and during the public consultation amended (5 U.S.C. App.), notice is 8120 Wisconsin Avenue, Bethesda, MD
hereby given of the following meetings. 20814.
will be used by HHS to develop the
The meetings will be closed to the Contact Person: Zhiqiang Zou, MD, Ph.D.,
technical criteria and performance Scientific Review Officer, Special Review
characteristics of the diagnostic(s) for public in accordance with the
Branch, Division of Extramural Activities,
which the prize(s) will be offered. The provisions set forth in sections National Cancer Institute, NIH, 9609 Medical
design of the Challenge will take into 552b(c)(4) and 552b(c)(6), title 5 U.S.C., Center Drive, Room 7W242, Bethesda, MD
account previous guidance obtained in as amended. The grant applications and 20892–8328, 240–276–6372, zouzhiq@
the aforementioned National Strategy the discussions could disclose mail.nih.gov.
confidential trade secrets or commercial (Catalogue of Federal Domestic Assistance
and National Action Plan to combat
property such as patentable material, Program Nos. 93.392, Cancer Construction;
antibiotic resistant bacteria.
and personal information concerning 93.393, Cancer Cause and Prevention
The agenda of the public consultation individuals associated with the grant Research; 93.394, Cancer Detection and
meeting will be devoted to presentations applications, the disclosure of which Diagnosis Research; 93.395, Cancer
and discussions on the objectives and would constitute a clearly unwarranted Treatment Research; 93.396, Cancer Biology
criteria for the antimicrobial diagnostic invasion of personal privacy. Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
challenge competition. Presentations Name of Committee: National Cancer Cancer Control, National Institutes of Health,
will focus on the need for rapid Institute Special Emphasis Panel; NCI HHS)
diagnostics to address antimicrobial Omnibus R03 & R21 SEP–8.
Date: October 27–28, 2015. Dated: September 3, 2015.
resistance; development and use of
Time: 8:00 a.m. to 6:00 p.m. Melanie J. Gray,
rapid diagnostics for drug resistant
Agenda: To review and evaluate grant Program Analyst, Office of Federal Advisory
microorganisms; pathogen/resistance
applications. Committee Policy.
markers identification versus Place: Hyatt Regency Bethesda, One [FR Doc. 2015–22659 Filed 9–8–15; 8:45 am]
phenotypic susceptibility; antibiotic Bethesda Metro Center, 7400 Wisconsin
BILLING CODE 4140–01–P
stewardship in the clinical setting; and Avenue, Bethesda, MD 20814.
regulatory perspectives on rapid Contact Person: Yisong Wang, Ph.D.,
diagnostic development. Scientific Review Officer, Special Review
Branch, Division of Extramural Activities, DEPARTMENT OF HEALTH AND
Any interested person may submit National Cancer Institute, NIH, 9609 Medical HUMAN SERVICES
written comments to be considered Center Drive, Room 7W240, Rockville, MD
during the public consultation to the 20850, 240–276–7157, yisong.wang@nih.gov. National Institutes of Health
discussion board for this Challenge Name of Committee: National Cancer
National Institute of Diabetes and
accessible on https:// Institute Special Emphasis Panel; NCI
Omnibus R03 & R21 SEP–11. Digestive and Kidney Diseases; Notice
www.challenge.gov. This statement of Closed Meetings
should include your name, address, Date: October 29, 2015.
Time: 8:00 a.m. to 6:00 p.m.
telephone number and when applicable, Agenda: To review and evaluate grant Pursuant to section 10(d) of the
the business or professional affiliation. applications. Federal Advisory Committee Act, as
Written comments can be submitted Place: Doubletree Hilton Hotel Bethesda, amended (5 U.S.C. App.), notice is
from October 1, 2015 at 8:30 a.m. EDT 8120 Wisconsin Avenue, Bethesda, MD hereby given of the following meetings.
to October 6, 2015 at 5:00 p.m. EDT. 20814. The meetings will be closed to the
Contact Person: Reed A. Graves, Ph.D.,
This web-based discussion board also Scientific Review Officer, Research
public in accordance with the
provides an open forum for discussion Technology and Contract Review Branch, provisions set forth in sections
of this prize competition. The online Division of Extramural Activities, National 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
community is open to the public and Cancer Institute, NIH, 9609 Medical Center as amended. The grant applications and
will allow for a broad and interactive Drive, Room 7W264, Rockville, MD 20850, the discussions could disclose
discussion of the topics covered by this 240–276–6384, gravesr@mail.nih.gov. confidential trade secrets or commercial
public consultation. This platform will Name of Committee: National Cancer property such as patentable material,
Institute Special Emphasis Panel; NCI and personal information concerning
allow users to submit ideas about a Omnibus R03 & R21 SEP–3.
desired diagnostic test and to comment individuals associated with the grant
Date: November 5–6, 2015. applications, the disclosure of which
on the ideas that have been submitted Time: 8:00 a.m. to 6:00 p.m. would constitute a clearly unwarranted
by others. Agenda: To review and evaluate grant
applications.
invasion of personal privacy.
Dated: September 1, 2015.
Lhorne on DSK5TPTVN1PROD with NOTICES
Place: Bethesda North Marriott Hotel & Name of Committee: National Institute of
Lawrence A. Tabak, Conference Center, 5701 Marinelli Road, Diabetes and Digestive and Kidney Diseases
Deputy Director, National Institutes of Health. Bethesda, MD 20852. Special Emphasis Panel; Time-Sensitive
[FR Doc. 2015–22690 Filed 9–8–15; 8:45 am] Contact Person: Viatcheslav A. Obesity.
Soldatenkov, MD, Ph.D., Scientific Review Date: September 30, 2015.
BILLING CODE 4140–01–P
Officer, Special Review Branch, Division of Time: 1 p.m. to 2:30 p.m.
Extramural Activities, National Cancer Agenda: To review and evaluate grant
Institute, NIH, 9609 Medical Center Drive, applications.
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Document Created: 2015-12-15 09:52:53
Document Modified: 2015-12-15 09:52:53
| 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 | |
| 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. | |
| Contact | Robert W. Eisinger, Ph.D., National Institutes of Health, Division of Program Coordination, Planning, and Strategic Initiatives, Telephone: 301-496-2229, Email: [email protected] | |
| FR Citation | 80 FR 54300 |
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