Announcement for Request for Comment for: Antimicrobial Resistance Rapid, Point-of-Care Diagnostic Test Challenge, 31402-31404 [2015-13113]

Download as PDF 31402 Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices including packaging grant announcements and application kits. Makes recommendations to the Director/NIDILRR regarding allocation of NIDILRR program funds for current and future budget years. Coordinate and collaborates with Office of Research Sciences program staff in the preparation of the annual spending plan and facilitate the implementation of the plan to ensure compliance with established departmental guidance. Provides administrative support in the monitoring of grants and cooperative agreements, and facilitates the administrative execution of interagency agreements. Administers NIDILRR evaluation activities to improve the effectiveness of NIDILRR’s research activities. This includes collaboration with NIDILRR’s senior management to define and facilitate the conduct of analyses of program and budget data as well as focused, special program evaluation activities. In its evaluation function, it coordinates with CPE to prepare planning and evaluation documents required by ACL, HHS, OMB and Congress. II. Delegations of Authority: All delegations and re-delegations of authority made to officials and employees of affected organizational components will continue in them or their successors pending further redelegations. III. Funds, Personnel and Equipment: Transfer of organizations and functions affected by this reorganization shall be accompanied in each instance by direct and support funds, positions, personnel, records, equipment, supplies and other resources. Dated: May 27, 2015. Sylvia M. Burwell, Secretary. [FR Doc. 2015–13351 Filed 6–1–15; 8:45 am] BILLING CODE 4150–04–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health asabaliauskas on DSK5VPTVN1PROD with NOTICES National Institute on Aging; Notice of Closed Meeting 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 meeting. The meeting 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 VerDate Sep<11>2014 17:26 Jun 01, 2015 Jkt 235001 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 on Aging Special Emphasis Panel; Mitochondrial ROS and Aging. Date: July 9, 2015. Time: 12:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, Suite 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Elaine Lewis, Ph.D., Scientific Review Branch, National Institute On Aging, Gateway Building, Suite 2C212, MSC–9205, 7201 Wisconsin Avenue, Bethesda, MD 20892, 301–402–7707, elainelewis@nia.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: May 27, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–13149 Filed 6–1–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Correction for Announcement of Requirements and Registration for: ‘‘Harnessing Insights From Other Disciplines To Advance Drug Abuse and Addiction Research’’ Challenge The National Institutes of Health (NIH) is correcting a notice previously published in the Federal Register on May 26, 2015 (80 FR 30084) and titled ‘‘Announcement of Requirements and Registration for: ‘‘Harnessing Insights From Other Disciplines To Advance Drug Abuse and Addiction Research’’ Challenge.’’ The notice announced a National Institute on Drug Abuse (NIDA) challenge soliciting ideas on how to adapt specialized knowledge from other disciplines to inform new directions and discoveries in drug abuse and addiction research. NIH is amending the submission date for the challenge from June 22, 2015 to June 30, 2015, the Judging period from June 23, 2015–July 17, 2015 to July 1, 2015–July 24, 2015, and winners announced date from July 30, 2015 to August 6, 2015. For further information about the Challenge, please contact Emily PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Einstein, Ph.D. Science Policy Branch, NIDA, Phone 301–443–6071, email: emily.einstein@nih.gov. Dated: May 27, 2015. Nora D. Volkow, Director, National Institute on Drug Abuse National Institutes of Health. [FR Doc. 2015–13348 Filed 6–1–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Announcement for Request for Comment for: 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 seek public comments regarding the technical criteria and performance characteristics of the diagnostic(s) for which the prize(s) will be offered. DATES: Submission Period begins June 2, 2015, 9:00 a.m. EST. Submission Period ends 5 p.m. EST July 17, 2015. ADDRESSES: Comments can be sent to https://www.challenge.gov. 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 SUMMARY: E:\FR\FM\02JNN1.SGM 02JNN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices 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, 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. At this time, HHS is seeking comments on the topics identified below as they pertain to a rapid, pointof-care diagnostic test(s) that could be developed in an appropriate time frame VerDate Sep<11>2014 17:26 Jun 01, 2015 Jkt 235001 to be of significant clinical and public 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). The comment period will be open for 45 days from the publication of this request for information (RFI). Input received during this 45-day comment period and during the subsequent 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. Comments can be submitted to the discussion board for this Challenge accessible on https://www.challenge.gov. 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 RFI. 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. Comments may include, but are not limited to, the following topic areas: 1. Purpose. The purpose(s) or function(s) a rapid, point-of-care in vitro diagnostic test that would be of significant utility to the clinical and public health communities in combating antibiotic resistance. Comments may reflect considerations about in vitro diagnostic tests that distinguish between bacterial and viral infections, or that identify specific bacterial pathogens and/or their drug susceptibility in patients. 2. Characterizing drug susceptibility. The development of an effective in vitro diagnostic test that can identify whether bacterial pathogens are resistant and/or sensitive to certain clinically relevant antibiotics, and thus would be of significant utility in combating antibiotic resistance. Examples may be provided. 3. Sample matrix. The development of an effective in vitro diagnostic test that identifies pathogens by testing human samples (e.g., blood, urine, sputum, tissue fluid, multiple or other sample specimens). Comments may include what type or types of samples would be most relevant in identifying pathogens and/or antibiotic susceptibility. PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 31403 4. Speed. The development of an effective in vitro diagnostic test that rapidly produces results. Comments may reflect considerations about what would be the maximum acceptable time-to-result for an in vitro diagnostic test to be of significant utility (i.e., from the time that a sample is collected from a patient to the time that the result is available to the healthcare provider). 5. Setting. The settings or venues in which the proposed point-of-care in vitro diagnostic test may be most needed for combating antibiotic resistance. 6. Ease-of-use. The development of an effective in vitro diagnostic test that is easy to use. Recognizing that diagnostics often require specialized equipment for sample storage, processing and/or analysis, comments also may include considerations about how such specialized equipment may affect an in vitro diagnostic test’s ease of use or otherwise limit its utility. Comments also may include considerations about the nature and extent of training that would be necessary to operate and obtain results from the proposed in vitro diagnostic test. 7. Diagnostic performance. The performance characteristics (e.g., sensitivity, specificity, positive predictive value, and negative predictive value) required of the proposed in vitro diagnostic test in order for it to have significant utility in combatting antibiotic resistance. 8. Tradeoffs. Any inherent tradeoffs associated with the performance characteristics/parameters described in connection with your previous comments and priority of the characteristics/parameters, if applicable. 9. Cost. The development of an effective in vitro diagnostic test that is not cost prohibitive for its intended purpose. Cost and cost considerations may include what price or price range would be desirable to support the widespread adoption of an in vitro diagnostic test that will be effective in combating antibiotic resistant bacteria. 10. Other characteristics. Additional characteristics of the proposed in vitro diagnostic test that would be of significant value. 11. Key technologies. The specific technologies or disciplines, current or nascent, which would lend themselves to the development of a successful in vitro diagnostic test including, for example, what special considerations, advantages, and disadvantages may be associated with each technology/ discipline. Comments on what timeframe would be considered reasonable for the development and licensure of a successful in vitro diagnostic test are also welcome. E:\FR\FM\02JNN1.SGM 02JNN1 31404 Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices 12. Interest. Major factors that may influence a person’s decision to compete in the prize competition described in this information request. 13. Use. Identification of who is likely to purchase and/or use the type of in vitro diagnostic tests being targeted by this prize competition and how or where such a purchaser or user is most likely to use the in vitro diagnostic test. Examples may be provided (e.g., patient/self-diagnosis, guiding prescriptive decisions, etc.). 14. Barriers. Major barriers that may impede development of the proposed in vitro diagnostic test (e.g., technical or research driven; financial or regulatory; infrastructure or resource based). Comments may reflect considerations about what potential solutions, if any, may be available to overcome such barriers and the level of difficulty associated with implementing any such solution in the U.S. and/or globally. Dated: May 26, 2015. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2015–13113 Filed 6–1–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings asabaliauskas on DSK5VPTVN1PROD with NOTICES 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: Center for Scientific Review Special Emphasis Panel; PAR–13– 080: Accelerating the Pace of Drug Abuse Research Using Existing Data. Date: June 16, 2015. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: George Vogler, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of VerDate Sep<11>2014 17:26 Jun 01, 2015 Jkt 235001 Health, 6701 Rockledge Drive, Room 3140, MSC 7770, Bethesda, MD 20892, (301) 237– 2693, voglergp@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Genes, Genomes, and Genetics Integrated Review Group; Molecular Genetics A Study Section. Date: June 22–23, 2015. Time: 8:30 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Renaissance M Street Hotel, 1143 New Hampshire Avenue NW., Washington, DC 20037. Contact Person: Michael M, Sveda, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1114, MSC 7890, Bethesda, MD 20892, 301–435– 3565, svedam@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA–RM– 14–007: Nucleomics Tools. Date: June 29, 2015. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW., Washington, DC 20015. Contact Person: Thomas Beres, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Dr. Rm. 5201, MSC 7840, Bethesda, MD 20892, 301–435–1175, berestm@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA–RM– 14–007: Nucleomics Tools. Date: June 29, 2015. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW., Washington, DC 20015. Contact Person: David Balasundaram, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5189, MSC 7840, Bethesda, MD 20892, 301–435– 1022, balasundaramd@csr.nih.gov. Name of Committee: Genes, Genomes, and Genetics Integrated Review Group; Genetics of Health and Disease Study Section. Date: June 29–30, 2015. Time: 8:30 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: Hotel Monaco Alexandria, 480 King Street, Alexandria, VA 22314. Contact Person: Cheryl M. Corsaro, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2204, MSC 7890, Bethesda, MD 20892, (301) 435– 1045, corsaroc@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Dated: May 27, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–13144 Filed 6–1–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood 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 Heart, Lung, and Blood Institute Special Emphasis Panel; Stem Cell-Derived Blood Products. Date: June 18, 2015. Time: 1:30 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Crystal City, 2399 Jefferson Davis Hwy., Arlington, VA 22202. Contact Person: Tony L. Creazzo, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7180, Bethesda, MD 20892–7924, 301–435– 0725, creazzotl@mail.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Stem Cell-Derived Blood Products. Date: June 18, 2015. Time: 12:30 p.m. to 1:30 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Crystal City, 2399 Jefferson Davis Hwy., Arlington, VA 22202. Contact Person: Tony L. Creazzo, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7180, Bethesda, MD 20892–7924, 301–435– 0725, creazzotl@mail.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Stem Cell-Derived Blood Products. Date: June 19, 2015. Time: 8:30 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Crystal City, 2399 Jefferson Davis Hwy., Arlington, VA 22202. E:\FR\FM\02JNN1.SGM 02JNN1

Agencies

[Federal Register Volume 80, Number 105 (Tuesday, June 2, 2015)]
[Notices]
[Pages 31402-31404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13113]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Announcement for Request for Comment for: 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 
seek public comments regarding the technical criteria and performance 
characteristics of the diagnostic(s) for which the prize(s) will be 
offered.

DATES: Submission Period begins June 2, 2015, 9:00 a.m. EST. Submission 
Period ends 5 p.m. EST July 17, 2015.

ADDRESSES: Comments can be sent to https://www.challenge.gov.

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

[[Page 31403]]

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, 
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.
    At this time, HHS is seeking comments on the topics identified 
below 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 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). 
The comment period will be open for 45 days from the publication of 
this request for information (RFI). Input received during this 45-day 
comment period and during the subsequent 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. Comments can be 
submitted to the discussion board for this Challenge accessible on 
https://www.challenge.gov.
    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 RFI. 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.
    Comments may include, but are not limited to, the following topic 
areas:
    1. Purpose. The purpose(s) or function(s) a rapid, point-of-care in 
vitro diagnostic test that would be of significant utility to the 
clinical and public health communities in combating antibiotic 
resistance. Comments may reflect considerations about in vitro 
diagnostic tests that distinguish between bacterial and viral 
infections, or that identify specific bacterial pathogens and/or their 
drug susceptibility in patients.
    2. Characterizing drug susceptibility. The development of an 
effective in vitro diagnostic test that can identify whether bacterial 
pathogens are resistant and/or sensitive to certain clinically relevant 
antibiotics, and thus would be of significant utility in combating 
antibiotic resistance. Examples may be provided.
    3. Sample matrix. The development of an effective in vitro 
diagnostic test that identifies pathogens by testing human samples 
(e.g., blood, urine, sputum, tissue fluid, multiple or other sample 
specimens). Comments may include what type or types of samples would be 
most relevant in identifying pathogens and/or antibiotic 
susceptibility.
    4. Speed. The development of an effective in vitro diagnostic test 
that rapidly produces results. Comments may reflect considerations 
about what would be the maximum acceptable time-to-result for an in 
vitro diagnostic test to be of significant utility (i.e., from the time 
that a sample is collected from a patient to the time that the result 
is available to the healthcare provider).
    5. Setting. The settings or venues in which the proposed point-of-
care in vitro diagnostic test may be most needed for combating 
antibiotic resistance.
    6. Ease-of-use. The development of an effective in vitro diagnostic 
test that is easy to use. Recognizing that diagnostics often require 
specialized equipment for sample storage, processing and/or analysis, 
comments also may include considerations about how such specialized 
equipment may affect an in vitro diagnostic test's ease of use or 
otherwise limit its utility. Comments also may include considerations 
about the nature and extent of training that would be necessary to 
operate and obtain results from the proposed in vitro diagnostic test.
    7. Diagnostic performance. The performance characteristics (e.g., 
sensitivity, specificity, positive predictive value, and negative 
predictive value) required of the proposed in vitro diagnostic test in 
order for it to have significant utility in combatting antibiotic 
resistance.
    8. Tradeoffs. Any inherent tradeoffs associated with the 
performance characteristics/parameters described in connection with 
your previous comments and priority of the characteristics/parameters, 
if applicable.
    9. Cost. The development of an effective in vitro diagnostic test 
that is not cost prohibitive for its intended purpose. Cost and cost 
considerations may include what price or price range would be desirable 
to support the widespread adoption of an in vitro diagnostic test that 
will be effective in combating antibiotic resistant bacteria.
    10. Other characteristics. Additional characteristics of the 
proposed in vitro diagnostic test that would be of significant value.
    11. Key technologies. The specific technologies or disciplines, 
current or nascent, which would lend themselves to the development of a 
successful in vitro diagnostic test including, for example, what 
special considerations, advantages, and disadvantages may be associated 
with each technology/discipline. Comments on what timeframe would be 
considered reasonable for the development and licensure of a successful 
in vitro diagnostic test are also welcome.

[[Page 31404]]

    12. Interest. Major factors that may influence a person's decision 
to compete in the prize competition described in this information 
request.
    13. Use. Identification of who is likely to purchase and/or use the 
type of in vitro diagnostic tests being targeted by this prize 
competition and how or where such a purchaser or user is most likely to 
use the in vitro diagnostic test. Examples may be provided (e.g., 
patient/self-diagnosis, guiding prescriptive decisions, etc.).
    14. Barriers. Major barriers that may impede development of the 
proposed in vitro diagnostic test (e.g., technical or research driven; 
financial or regulatory; infrastructure or resource based). Comments 
may reflect considerations about what potential solutions, if any, may 
be available to overcome such barriers and the level of difficulty 
associated with implementing any such solution in the U.S. and/or 
globally.

    Dated: May 26, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2015-13113 Filed 6-1-15; 8:45 am]
 BILLING CODE 4140-01-P
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