Notice of Correction for Announcement of Requirements and Registration for “Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test” Challenge, 20608-20609 [2017-08920]
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Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Mental Health
Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the 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/or proposals 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.
nlaroche on DSK30NT082PROD with NOTICES
Name of Committee: National Advisory
Mental Health Council.
Date: May 25, 2017.
Open: 9:00 a.m. to 12:15 p.m.
Agenda: Presentation of the NIMH
Director’s Report and discussion of NIMH
program.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
Closed: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
Contact Person: Jean G. Noronha, Ph.D.,
Director, Division of Extramural Activities,
National Institute of Mental Health, NIH,
Neuroscience Center, 6001 Executive Blvd.,
Room 6154, MSC 9609, Bethesda, MD 20892–
9609, 301–443–3367, jnoronha@mail.nih.gov.
Any member of the public interested in
presenting oral comments to the committee
may notify the Contact Person listed on this
notice at least 10 days in advance of the
meeting. Interested individuals and
representatives of organizations may submit
a letter of intent, a brief description of the
organization represented, and a short
description of the oral presentation. Only one
representative of an organization may be
allowed to present oral comments and if
accepted by the committee, presentations
may be limited to five minutes. Both printed
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14:29 May 02, 2017
Jkt 241001
and electronic copies are requested for the
record. In addition, any interested person
may file written comments with the
committee by forwarding their statement to
the Contact Person listed on this notice. The
statement should include the name, address,
telephone number and when applicable, the
business or professional affiliation of the
interested person.
Information is also available on the
Institute’s/Center’s home page:
www.nimh.nih.gov/about/advisory-boardsand-groups/namhc/index.shtml., where an
agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: April 28, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–08938 Filed 5–2–17; 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 ‘‘Antimicrobial
Resistance Rapid, Point-of-Need
Diagnostic Test’’ Challenge
The National Institutes of Health
(NIH) is correcting a notice previously
published in the Federal Register on
September 8, 2016 (81 FR 62150), titled
‘‘Announcement of Requirements and
Registration for ‘‘Antimicrobial
Resistance Rapid, Point-of-Need
Diagnostic Test’’ Challenge.’’ The notice
announced the Antimicrobial Resistance
Rapid, Point-of-Need challenge
competition that may result in the
awarding of $20 million dollars for the
successful development of new,
innovative, accurate, and cost-effective
in vitro diagnostic tests that would
rapidly inform clinical treatment
decisions and be of significant clinical
and public health utility to combat the
development and spread of antibiotic
resistant bacteria and improve antibiotic
stewardship.
The NIH is correcting and clarifying
several components of Step 2 of the
Challenge competition including:
(1) The letter of intent must be
submitted by August 3, 2018, at 11:59
p.m. ET, for all ‘‘Solvers’’ planning to
submit for the Step 2 (Delivery of
Prototype and Analytical Data) stage of
the competition.
(2) The prototype in vitro diagnostic
device is not to be provided with the
submission. The September 8, 2016,
PO 00000
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Fmt 4703
Sfmt 4703
announcement incorrectly stated that
the device was to be included as part of
the submission for Step 2.
(3) The Technical Evaluation Panel
will use the following 4 criteria for
evaluating the Step 2 submissions
including: (a) Innovation; (b) clinical
significance; (c) diagnostic performance
and feasibility; and (d) sample matrix/
setting and ease of use/throughput.
These criteria were defined in the
September 8, 2016, announcement;
however, the announcement incorrectly
stated that the Panel will evaluate the
solutions based on eight criteria.
(4) A description sufficiently detailed
and organized by sections for evaluation
in the technical review and
programmatic assessment of the
proposed solution in 15 pages or less
including the next 6 bullets, 8.5 x 11
inch page, 10-point or greater Arial,
Palatino Linotype, or Georgia font and
one inch margins including:
• A title of the proposed solution;
• A detailed description of the
proposed in vitro diagnostic, and the
development approach, challenges, and
risks;
• One section addressing each of the
4 criteria listed above;
• One section providing a summary
of the data, using the in vitro diagnostic
device and the Standard Operating
Procedures described in Appendix B,
generated with either clinical or
contrived samples compared to existing
standard techniques demonstrating the
performance characteristics (e.g., limits
of detection, sensitivity, specificity, and
other characteristics that demonstrate
test performance to support detection of
biomarkers or analytes). The September
8, 2016, announcement incorrectly
stated that diagnostic performance
characteristics included positive
predictive value and negative predictive
value;
• Photographs of the in vitro
diagnostic prototype device and a video
not to exceed 5 minutes (in accordance
with the NIH interim policy for
submitting a video as NIH application
materials https://grants.nih.gov/grants/
guide/notice-files/NOT-OD-12-141.html)
demonstrating the status of the
development and actual use of the
device in testing contrived or clinical
specimens;
• Address the NIH Human Subjects
Protections and Inclusion of Women,
Children, and Minorities policies, as
well as biohazards policies (https://
grants.nih.gov/grants/guide/notice-files/
NOT-OD-15-078.html), if applicable.
(5) An Appendix A, provide
additional data and tables to support the
data summary and performance claims
based on the use of the proposed
E:\FR\FM\03MYN1.SGM
03MYN1
nlaroche on DSK30NT082PROD with NOTICES
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Notices
solution testing clinical or contrived
samples in 15 pages or less.
(6) An Appendix B with the standard
operating procedures for the use of the
solution submitted for Step 2 of the
Challenge competition must be limited
to 10 pages or less in length. If a longer
Appendix is submitted, only the first 10
pages will be considered by the
Technical Evaluation Panel and the
Judging Panel.
(7) Submissions for Step 2 of the
Challenge competition can be submitted
to https://www.cccinnovationcenter.com/
challenges/antimicrobial-resistancediagnostic-challenge/ beginning June 1,
2018. Submissions received after the
deadline of September 4, 2018, at 11:59
p.m. ET will be disqualified and not
evaluated by the Technical Evaluation
Panel or Judging Panel.
(8) Solvers may submit corrections or
additional materials in support of their
Step 2 submissions so long as the NIH
receives the materials by the deadline of
September 4, 2018, at 11:59 p.m. ET.
Corrections or additional materials for
Step 2 will not be accepted or evaluated
by the Technical Evaluation Panel or
Judging Panel if they are received after
September 4, 2018, at 11:59 p.m. ET.
(9) The NIH will perform an initial
review of all submissions to ensure they
are complete and within the scope of
the Challenge competition. Submissions
that are incomplete will be
administratively disqualified and will
not be evaluated by the Technical
Evaluation Panel or the Judging Panel.
(10) A Solver may not be a federal
employee of HHS (or any component of
HHS) acting in their personal capacity.
(11) A Solver employed by a federal
agency or entity other than HHS (or any
component of HHS), should consult
with an agency Ethics Official to
determine whether the federal ethics
rules will limit or prohibit the
acceptance of a prize under this
challenge.
(12) The NIH and Assistant Secretary
for Preparedness and Response/
Biomedical Advanced Research and
Development Authority may determine
that based on the number of
submissions received for Step 2 that less
competitive submissions will not be
discussed by the Technical Evaluation
Panel during the Panel’s meeting.
(13) Members of the Technical
Evaluation Panel for Step 1 are not
eligible to participate in or contribute to
any proposal for Step 2 and Step 3 of
the Challenge competition.
(14) Any Solver is eligible for Step 2
of this Challenge competition. For
example, if a Step 1 ‘‘Solver’’ was not
identified as a semifinalist, he/she may
still submit for Step 2 of this
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14:29 May 02, 2017
Jkt 241001
competition and those who did not
submit a Step 1 proposal may still
submit a proposal for Step 2.
(15) All submissions for Step 2 and 3
must be in English.
For further information about the
Antimicrobial Resistance Diagnostic
Challenge competition, please contact
Robert W. Eisinger, Ph.D., NIH, 301–
496–2229 or by email Robert.eisinger@
nih.gov.
Dated: April 27, 2017.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2017–08920 Filed 5–2–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID FEMA–2007–0008]
National Advisory Council; Meeting
Federal Emergency
Management Agency, DHS.
ACTION: Committee management; notice
of Open Federal Advisory Committee
meeting.
AGENCY:
The Federal Emergency
Management Agency (FEMA) National
Advisory Council (NAC) will meet in
person on May 23–25, 2017 in Tampa,
FL. The meeting will be open to the
public.
SUMMARY:
The NAC will meet Tuesday,
May 23, 2017 from 8:00 a.m. to 5:00
p.m., Wednesday, May 24, 2017 from
8:30 a.m. to 5:00 p.m., and Thursday,
May 25, 2017 from 8:30 a.m. to 1:00
p.m. Eastern Daylight Time (EDT).
Please note that the meeting may close
early if the NAC has completed its
business.
DATES:
The meeting will be held at
The Barrymore Hotel Tampa Riverwalk
located at 111 W. Fortune St., Tampa,
FL 33602. It is recommended that
attendees register with FEMA prior to
the meeting by providing your name,
telephone number, email address, title,
and organization to the person listed in
ADDRESSES:
FOR FURTHER INFORMATION CONTACT
below.
For information on facilities or
services for individuals with disabilities
or to request special assistance at the
meeting, contact the person listed in FOR
FURTHER INFORMATION CONTACT below as
soon as possible.
To facilitate public participation,
members of the public are invited to
provide written comments on the issues
PO 00000
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20609
to be considered by the NAC listed in
the agenda. The ‘‘Agenda’’ section
below outlines these issues. The full
agenda and any related documents for
this meeting will be posted by Friday,
May 19 on the NAC Web site at https://
www.fema.gov/national-advisorycouncil. Written comments must be
submitted and received by 5:00 p.m.
EDT on May 12, 2017, identified by
Docket ID FEMA-2007–0008, and
submitted by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Email: FEMA-RULES@
fema.dhs.gov. Include the docket
number in the subject line of the
message.
• Fax: (540) 504–2331. Please include
a cover sheet addressing the fax to
ATTN: Deana Platt.
• Mail: Regulatory Affairs Division,
Office of Chief Counsel, FEMA, 500 C
Street SW., Room 8NE, Washington, DC
20472–3100.
Instructions: All submissions received
must include the words ‘‘Federal
Emergency Management Agency’’ and
the docket number for this action.
Comments received will be posted
without alteration at https://
www.regulations.gov, including any
personal information provided.
Docket: For access to the docket to
read comments received by the NAC, go
to https://www.regulations.gov, and
search for the Docket ID listed above.
A public comment period will be held
on Wednesday, May 24 from 1:30 p.m.
to 1:45 p.m. EDT. All speakers must
limit their comments to 5 minutes.
Comments should be addressed to the
NAC. Any comments not related to the
agenda topics will not be considered by
the NAC. To register to make remarks
during the public comment period,
contact the individual listed in FOR
FURTHER INFORMATION CONTACT by May
12, 2017. Please note that the public
comment period may end before the
time indicated, following the last call
for comments.
FOR FURTHER INFORMATION CONTACT:
Deana Platt, Designated Federal Officer,
Office of the National Advisory Council,
Federal Emergency Management
Agency, 500 C Street SW., Washington,
DC 20472–3184, telephone (202) 646–
2700, fax (540) 504–2331, and email
FEMA-NAC@fema.dhs.gov. The NAC
Web site is: https://www.fema.gov/
national-advisory-council.
SUPPLEMENTARY INFORMATION: Notice of
this meeting is given under the Federal
Advisory Committee Act, 5 U.S.C.
Appendix.
E:\FR\FM\03MYN1.SGM
03MYN1
]]>Agencies
[Federal Register Volume 82, Number 84 (Wednesday, May 3, 2017)]
[Notices]
[Pages 20608-20609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08920]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Notice of Correction for Announcement of Requirements and
Registration for ``Antimicrobial Resistance Rapid, Point-of-Need
Diagnostic Test'' Challenge
The National Institutes of Health (NIH) is correcting a notice
previously published in the Federal Register on September 8, 2016 (81
FR 62150), titled ``Announcement of Requirements and Registration for
``Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test''
Challenge.'' The notice announced the Antimicrobial Resistance Rapid,
Point-of-Need challenge competition that may result in the awarding of
$20 million dollars for the successful development of new, innovative,
accurate, and cost-effective in vitro diagnostic tests that would
rapidly inform clinical treatment decisions and be of significant
clinical and public health utility to combat the development and spread
of antibiotic resistant bacteria and improve antibiotic stewardship.
The NIH is correcting and clarifying several components of Step 2
of the Challenge competition including:
(1) The letter of intent must be submitted by August 3, 2018, at
11:59 p.m. ET, for all ``Solvers'' planning to submit for the Step 2
(Delivery of Prototype and Analytical Data) stage of the competition.
(2) The prototype in vitro diagnostic device is not to be provided
with the submission. The September 8, 2016, announcement incorrectly
stated that the device was to be included as part of the submission for
Step 2.
(3) The Technical Evaluation Panel will use the following 4
criteria for evaluating the Step 2 submissions including: (a)
Innovation; (b) clinical significance; (c) diagnostic performance and
feasibility; and (d) sample matrix/setting and ease of use/throughput.
These criteria were defined in the September 8, 2016, announcement;
however, the announcement incorrectly stated that the Panel will
evaluate the solutions based on eight criteria.
(4) A description sufficiently detailed and organized by sections
for evaluation in the technical review and programmatic assessment of
the proposed solution in 15 pages or less including the next 6 bullets,
8.5 x 11 inch page, 10-point or greater Arial, Palatino Linotype, or
Georgia font and one inch margins including:
A title of the proposed solution;
A detailed description of the proposed in vitro
diagnostic, and the development approach, challenges, and risks;
One section addressing each of the 4 criteria listed
above;
One section providing a summary of the data, using the in
vitro diagnostic device and the Standard Operating Procedures described
in Appendix B, generated with either clinical or contrived samples
compared to existing standard techniques demonstrating the performance
characteristics (e.g., limits of detection, sensitivity, specificity,
and other characteristics that demonstrate test performance to support
detection of biomarkers or analytes). The September 8, 2016,
announcement incorrectly stated that diagnostic performance
characteristics included positive predictive value and negative
predictive value;
Photographs of the in vitro diagnostic prototype device
and a video not to exceed 5 minutes (in accordance with the NIH interim
policy for submitting a video as NIH application materials https://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-141.html)
demonstrating the status of the development and actual use of the
device in testing contrived or clinical specimens;
Address the NIH Human Subjects Protections and Inclusion
of Women, Children, and Minorities policies, as well as biohazards
policies (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-078.html), if applicable.
(5) An Appendix A, provide additional data and tables to support
the data summary and performance claims based on the use of the
proposed
[[Page 20609]]
solution testing clinical or contrived samples in 15 pages or less.
(6) An Appendix B with the standard operating procedures for the
use of the solution submitted for Step 2 of the Challenge competition
must be limited to 10 pages or less in length. If a longer Appendix is
submitted, only the first 10 pages will be considered by the Technical
Evaluation Panel and the Judging Panel.
(7) Submissions for Step 2 of the Challenge competition can be
submitted to https://www.cccinnovationcenter.com/challenges/antimicrobial-resistance-diagnostic-challenge/ beginning June 1, 2018.
Submissions received after the deadline of September 4, 2018, at 11:59
p.m. ET will be disqualified and not evaluated by the Technical
Evaluation Panel or Judging Panel.
(8) Solvers may submit corrections or additional materials in
support of their Step 2 submissions so long as the NIH receives the
materials by the deadline of September 4, 2018, at 11:59 p.m. ET.
Corrections or additional materials for Step 2 will not be accepted or
evaluated by the Technical Evaluation Panel or Judging Panel if they
are received after September 4, 2018, at 11:59 p.m. ET.
(9) The NIH will perform an initial review of all submissions to
ensure they are complete and within the scope of the Challenge
competition. Submissions that are incomplete will be administratively
disqualified and will not be evaluated by the Technical Evaluation
Panel or the Judging Panel.
(10) A Solver may not be a federal employee of HHS (or any
component of HHS) acting in their personal capacity.
(11) A Solver employed by a federal agency or entity other than HHS
(or any component of HHS), should consult with an agency Ethics
Official to determine whether the federal ethics rules will limit or
prohibit the acceptance of a prize under this challenge.
(12) The NIH and Assistant Secretary for Preparedness and Response/
Biomedical Advanced Research and Development Authority may determine
that based on the number of submissions received for Step 2 that less
competitive submissions will not be discussed by the Technical
Evaluation Panel during the Panel's meeting.
(13) Members of the Technical Evaluation Panel for Step 1 are not
eligible to participate in or contribute to any proposal for Step 2 and
Step 3 of the Challenge competition.
(14) Any Solver is eligible for Step 2 of this Challenge
competition. For example, if a Step 1 ``Solver'' was not identified as
a semifinalist, he/she may still submit for Step 2 of this competition
and those who did not submit a Step 1 proposal may still submit a
proposal for Step 2.
(15) All submissions for Step 2 and 3 must be in English.
For further information about the Antimicrobial Resistance
Diagnostic Challenge competition, please contact Robert W. Eisinger,
Ph.D., NIH, 301-496-2229 or by email Robert.eisinger@nih.gov.
Dated: April 27, 2017.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2017-08920 Filed 5-2-17; 8:45 am]
BILLING CODE 4140-01-P
