Notice To Announce of Requirements and Registration for “Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test” Challenge, 464-466 [2019-00218]
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464
Federal Register / Vol. 84, No. 19 / Tuesday, January 29, 2019 / Notices
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Collaborative Applications: Behavioral
Genetics and Epidemiology.
Date: February 6, 2019.
Time: 8:45 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Melrose Hotel, 2430 Pennsylvania
Ave. NW, Washington, DC 20037.
Contact Person: Suzanne Ryan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3139,
MSC 7770, Bethesda, MD 20892, (301) 435–
1712, ryansj@csr.nih.gov.
This meeting notice is being published less
than 15 days in advance of the meeting due
to the partial Government shutdown of
December 2018.
(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)
Dated: January 18, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–00179 Filed 1–28–19; 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 Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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
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: Molecular, Cellular
and Developmental Neuroscience Integrated
Review Group; Cellular and Molecular
Biology of Glia Study Section.
Date: February 7–8, 2019.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Lorien Hotel & Spa, 1600 King
Street, Alexandria, VA 22314.
VerDate Sep<11>2014
16:14 Jan 28, 2019
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Contact Person: Linda MacArthur, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4187,
Bethesda, MD 20892, 301–537–9986,
macarthurlh@csr.nih.gov.
This meeting notice is being published less
than 15 days in advance of the meeting due
to the partial Government shutdown of
December 2018.
(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)
Dated: January 18, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–00187 Filed 1–28–19; 8:45 am]
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: January 18, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–00188 Filed 1–28–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice To Announce of Requirements
and Registration for ‘‘Antimicrobial
Resistance Rapid, Point-of-Need
Diagnostic Test’’ Challenge
AGENCY:
BILLING CODE 4140–01–P
National Institutes of Health,
HHS.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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
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: Immunology
Integrated Review Group; Transplantation,
Tolerance, and Tumor Immunology Study
Section.
Date: February 4–5, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Sir Francis Drake Hotel, 450 Powell
Street at Sutter, San Francisco, CA 94102.
Contact Person: Jin Huang, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4199,
MSC 7812, Bethesda, MD 20892, 301–435–
1230, jh377p@nih.gov.
This meeting notice is being published less
than 15 days in advance of the meeting due
to the partial Government shutdown of
December 2018.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research; 93.306, 93.333,
PO 00000
Frm 00014
Fmt 4703
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ACTION:
Notice.
The National Institutes of
Health (NIH) is supplementing and
amending a Notice previously published
in the Federal Register on September 8,
2016 titled ‘‘Announcement of
Requirements and Registration for
‘‘Antimicrobial Resistance Rapid, Pointof-Need Diagnostic Test’’ Challenge.’’
This Notice serves to provide additional
details to Step 2 Semi-finalists of the
submission requirements and review
criteria for Step 3 (Performance Testing
in CLIA-certified Laboratories) of this
Challenge.
DATES: On or before Monday, November
4, 2019, 11:59 p.m. ET: Step 3 Letter of
Intent is due. Only Step 2 Semi-finalists
are eligible to submit a Letter of Intent.
On or before Friday, January 3, 2020,
5:00 p.m. ET: The submissions from the
Step 2 Semi-finalists for Step 3 are due.
Submissions received after the deadline
of January 3, 2020, at 5:00 p.m. ET will
be disqualified and not evaluated by the
CLIA-certified laboratories, the
Technical Evaluation Panel, or Judging
Panel.
Important note: The Step 3
submission must be received by January
3, 2020. Plan to send the submission so
it arrives on or before January 3, 2020.
In effect, a post-mark date of January 3,
2020, is not sufficient; the submission
must be received by that date.
ADDRESSES: The Letter of Intent and
Step 3 submission must be submitted to
Capital Consulting Corporation no later
than the due dates cited above. The
letter of intent must be submitted on
https://www.cccinnovationcenter.com/
challenges/antimicrobial-resistancediagnostic-challenge/.
FOR FURTHER INFORMATION CONTACT:
Robert W. Eisinger, Ph.D., NIH, 301–
SUMMARY:
E:\FR\FM\29JAN1.SGM
29JAN1
Federal Register / Vol. 84, No. 19 / Tuesday, January 29, 2019 / Notices
496–2229 or by email Robert.eisinger@
nih.gov.
On
September 8, 2016, the National
Institutes of Health (NIH) published a
Notice in the Federal Register 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 may
result in the awarding of $20 million
dollars for the successful development
of new, innovative, accurate, and costeffective 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 Notice provided
information on submission
requirements for Step 3 of the Challenge
and indicated that additional details on
submission requirements for Step 3 will
be made available after the Step 2 Semifinalists are announced. This Notice
serves to provide additional details to
Step 2 Semi-finalists of the submission
requirements and review criteria for
Step 3 (Performance Testing in CLIAcertified Laboratories) of this Challenge.
The NIH is supplementing and
amending several components of Step 3
of the Challenge including:
(1) The letter of intent must be
submitted by Monday, November 4,
2019, at 11:59 p.m. ET, for all Step 2
Semi-finalists planning to submit for the
Step 3 (Performance Testing in CLIAcertified Laboratories) stage of the
Challenge. A list of Step 2 Semi-finalists
can be found at https://
www.cccinnovationcenter.com/
challenges/antimicrobial-resistancediagnostic-challenge/.
(2) The Technical Evaluation Panel
will use the following 4 criteria for
evaluating the Step 3 submissions and
the test results from the two CLIAcertified laboratories’ analysis of the
Step 3 prototype 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 in
vitro diagnostics (solution) based on six
criteria.
(3) Each solution will be tested by two
CLIA-certified laboratories against
standard FDA-approved in vitro assays
using a panel of reference (or wellcharacterized) pathogens, clinical
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:14 Jan 28, 2019
Jkt 247001
specimens, and/or contrived samples to
demonstrate usability, stated time to
result, appropriate analytical
sensitivity/specificity, as well as
confirmation of analytical performance
(e.g., limit of detection, interference,
inclusivity, reproducibility, etc.)
reported in the data submitted by the
Step 2 Semi-finalist.
(4) Step 2 Semi-finalists will submit:
a. Sufficient numbers of their
diagnostic tests based on the Step 2
solutions for independent testing by
both CLIA-certified laboratories, as well
as methodology/protocols to perform
diagnostic testing using the prototypes.
These materials must be received on or
before January 3, 2020, at 5:00 p.m. ET
by Capital Consulting Corporation, Suite
100, 11821 Parklawn Drive, Rockville,
MD 20852. At a future date, the NIH
will provide additional information
about the specific number of test kits
that each Step 2 Semi-finalist will need
to provide for CLIA-certified laboratory
testing. Submissions received after the
deadline of January 3, 2020, at 5:00 p.m.
ET will be disqualified and not
evaluated by the CLIA-certified
laboratories, the Technical Evaluation
Panel, or the Judging Panel.
b. A description sufficiently detailed
and organized by sections for evaluation
in the technical evaluation and
programmatic assessment of the
proposed solution in 10 pages or less
including the next 8 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 one-paragraph executive
summary that will be posted on the
Challenge website after the ‘‘Winners’’
are announced in July 2020. The
Executive Summary must not contain
any proprietary information since the
website is open to the public;
• A statement as to the source of
funds that were used to develop their
solution submitted for Step 3 of the
Challenge;
• A detailed description of the
proposed in vitro diagnostic and the
claims of performance using specific
types of biospecimens/samples;
• A description of any changes from
the original design (Step 2 solution)
must be documented and explained;
• One section providing a summary
of the data, using the in vitro diagnostic
device and the Standard Operating
Procedures described in Appendix A,
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
PO 00000
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465
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;
• A video not to exceed 15 minutes
demonstrating the status of the
development and actual use of the
device in testing contrived or clinical
specimens;
• A section addressing applicable
HHS Human Subjects Protections
regulations and NIH Inclusion of
Women, Children, and Minorities
policies, as well as biohazards policies
(https://grants.nih.gov/grants/guide/
notice-files?NOT-OD-12-141.html), if
applicable.
(5) An Appendix A with the standard
operating procedures for the use of the
solution submitted for Step 3 of the
Challenge must include all steps to
prepare test specimen/sample, perform
the assay, and interpret the results.
(6) An Appendix B provide additional
data and tables to support the data
summary and performance claims based
on the use of the proposed solution
testing clinical or contrived samples in
5 pages of less.
(7) Each Step 2-Semi-finalist may
submit corrections in support of their
Step 3 submission within the page
limitations cited above as long as
Capital Consulting Corporation receives
the materials by the deadline of January
3, 2020, at 5:00 p.m. ET. Corrections for
Step 3 will not be accepted or evaluated
by the CLIA-certified laboratories,
Technical Evaluation Panel, or Judging
Panel if they are received after January
3, 2020, at 5:00 p.m. ET.
(8) The NIH will perform an initial
review of all submissions to ensure they
are complete and within the scope of
the Challenge. Submissions that are
incomplete or outside of the scope of
the Challenge will be administratively
disqualified and will not be evaluated
by the CLIA-certified laboratories, the
Technical Evaluation Panel, or the
Judging Panel. Disqualified submissions
will not be returned to the Step 2 Semifinalist.
(9) 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 3 that less
competitive submissions will not be
discussed by the Technical Evaluation
Panel during the Panel’s meeting.
(10) Members of the Technical
Evaluation Panel for Step 1 or Step 2 are
not eligible to participate in or
E:\FR\FM\29JAN1.SGM
29JAN1
466
Federal Register / Vol. 84, No. 19 / Tuesday, January 29, 2019 / Notices
contribute to any proposal for Step 3 of
the Challenge.
(11) Only Step 2 Semi-finalists are
eligible for Step 3 of this Challenge.
(12) All submissions for Step 3 must
be in English.
(13) No submissions will be returned
to the submitters.
(14) The remainder of the provisions
from the September 8, 2016, Federal
Register Notice (81 FR 62150) not
amended here still apply.
DEPARTMENT OF HOMELAND
SECURITY
Dated: January 11, 2019.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
SUMMARY:
[FR Doc. 2019–00218 Filed 1–28–19; 8:45 am]
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16:14 Jan 28, 2019
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[Docket No. DHS–2018–0076]
Homeland Security Advisory Council
Office of Partnership and
Engagement (OPE), Department of
Homeland Security (DHS).
ACTION: Notice of open teleconference
federal advisory committee meeting;
cancellation.
AGENCY:
On December 27, 2018 (83 FR
66724–66725) the Department of
Homeland Security (DHS) published a
notice announcing that a meeting of the
Homeland Security Advisory Council
PO 00000
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(HSAC) was to take place on Thursday,
January 31, 2019 via teleconference. Due
to the lapse in appropriations for the
Department of Homeland Security, DHS
is cancelling the January 31, 2019
meeting.
FOR FURTHER INFORMATION CONTACT:
Mike Miron at HSAC@hq.dhs.gov or
202–447–3135.
SUPPLEMENTARY INFORMATION:
None.
Dated: January 23, 2019.
Matthew Hayden,
Deputy Assistant Secretary, Private Sector
Office.
[FR Doc. 2019–00258 Filed 1–28–19; 8:45 am]
BILLING CODE 9110–9B–P
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]]>Agencies
[Federal Register Volume 84, Number 19 (Tuesday, January 29, 2019)]
[Notices]
[Pages 464-466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00218]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Notice To Announce of Requirements and Registration for
``Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test''
Challenge
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institutes of Health (NIH) is supplementing and
amending a Notice previously published in the Federal Register on
September 8, 2016 titled ``Announcement of Requirements and
Registration for ``Antimicrobial Resistance Rapid, Point-of-Need
Diagnostic Test'' Challenge.'' This Notice serves to provide additional
details to Step 2 Semi-finalists of the submission requirements and
review criteria for Step 3 (Performance Testing in CLIA-certified
Laboratories) of this Challenge.
DATES: On or before Monday, November 4, 2019, 11:59 p.m. ET: Step 3
Letter of Intent is due. Only Step 2 Semi-finalists are eligible to
submit a Letter of Intent. On or before Friday, January 3, 2020, 5:00
p.m. ET: The submissions from the Step 2 Semi-finalists for Step 3 are
due. Submissions received after the deadline of January 3, 2020, at
5:00 p.m. ET will be disqualified and not evaluated by the CLIA-
certified laboratories, the Technical Evaluation Panel, or Judging
Panel.
Important note: The Step 3 submission must be received by January
3, 2020. Plan to send the submission so it arrives on or before January
3, 2020. In effect, a post-mark date of January 3, 2020, is not
sufficient; the submission must be received by that date.
ADDRESSES: The Letter of Intent and Step 3 submission must be submitted
to Capital Consulting Corporation no later than the due dates cited
above. The letter of intent must be submitted on https://www.cccinnovationcenter.com/challenges/antimicrobial-resistance-diagnostic-challenge/.
FOR FURTHER INFORMATION CONTACT: Robert W. Eisinger, Ph.D., NIH, 301-
[[Page 465]]
496-2229 or by email Robert.eisinger@nih.gov.
SUPPLEMENTARY INFORMATION: On September 8, 2016, the National
Institutes of Health (NIH) published a Notice in the Federal Register
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 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 Notice
provided information on submission requirements for Step 3 of the
Challenge and indicated that additional details on submission
requirements for Step 3 will be made available after the Step 2 Semi-
finalists are announced. This Notice serves to provide additional
details to Step 2 Semi-finalists of the submission requirements and
review criteria for Step 3 (Performance Testing in CLIA-certified
Laboratories) of this Challenge.
The NIH is supplementing and amending several components of Step 3
of the Challenge including:
(1) The letter of intent must be submitted by Monday, November 4,
2019, at 11:59 p.m. ET, for all Step 2 Semi-finalists planning to
submit for the Step 3 (Performance Testing in CLIA-certified
Laboratories) stage of the Challenge. A list of Step 2 Semi-finalists
can be found at https://www.cccinnovationcenter.com/challenges/antimicrobial-resistance-diagnostic-challenge/.
(2) The Technical Evaluation Panel will use the following 4
criteria for evaluating the Step 3 submissions and the test results
from the two CLIA-certified laboratories' analysis of the Step 3
prototype 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 in
vitro diagnostics (solution) based on six criteria.
(3) Each solution will be tested by two CLIA-certified laboratories
against standard FDA-approved in vitro assays using a panel of
reference (or well-characterized) pathogens, clinical specimens, and/or
contrived samples to demonstrate usability, stated time to result,
appropriate analytical sensitivity/specificity, as well as confirmation
of analytical performance (e.g., limit of detection, interference,
inclusivity, reproducibility, etc.) reported in the data submitted by
the Step 2 Semi-finalist.
(4) Step 2 Semi-finalists will submit:
a. Sufficient numbers of their diagnostic tests based on the Step 2
solutions for independent testing by both CLIA-certified laboratories,
as well as methodology/protocols to perform diagnostic testing using
the prototypes. These materials must be received on or before January
3, 2020, at 5:00 p.m. ET by Capital Consulting Corporation, Suite 100,
11821 Parklawn Drive, Rockville, MD 20852. At a future date, the NIH
will provide additional information about the specific number of test
kits that each Step 2 Semi-finalist will need to provide for CLIA-
certified laboratory testing. Submissions received after the deadline
of January 3, 2020, at 5:00 p.m. ET will be disqualified and not
evaluated by the CLIA-certified laboratories, the Technical Evaluation
Panel, or the Judging Panel.
b. A description sufficiently detailed and organized by sections
for evaluation in the technical evaluation and programmatic assessment
of the proposed solution in 10 pages or less including the next 8
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 one-paragraph executive summary that will be posted on
the Challenge website after the ``Winners'' are announced in July 2020.
The Executive Summary must not contain any proprietary information
since the website is open to the public;
A statement as to the source of funds that were used to
develop their solution submitted for Step 3 of the Challenge;
A detailed description of the proposed in vitro diagnostic
and the claims of performance using specific types of biospecimens/
samples;
A description of any changes from the original design
(Step 2 solution) must be documented and explained;
One section providing a summary of the data, using the in
vitro diagnostic device and the Standard Operating Procedures described
in Appendix A, 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;
A video not to exceed 15 minutes demonstrating the status
of the development and actual use of the device in testing contrived or
clinical specimens;
A section addressing applicable HHS Human Subjects
Protections regulations and NIH Inclusion of Women, Children, and
Minorities policies, as well as biohazards policies (https://grants.nih.gov/grants/guide/notice-files?NOT-OD-12-141.html), if
applicable.
(5) An Appendix A with the standard operating procedures for the
use of the solution submitted for Step 3 of the Challenge must include
all steps to prepare test specimen/sample, perform the assay, and
interpret the results.
(6) An Appendix B provide additional data and tables to support the
data summary and performance claims based on the use of the proposed
solution testing clinical or contrived samples in 5 pages of less.
(7) Each Step 2-Semi-finalist may submit corrections in support of
their Step 3 submission within the page limitations cited above as long
as Capital Consulting Corporation receives the materials by the
deadline of January 3, 2020, at 5:00 p.m. ET. Corrections for Step 3
will not be accepted or evaluated by the CLIA-certified laboratories,
Technical Evaluation Panel, or Judging Panel if they are received after
January 3, 2020, at 5:00 p.m. ET.
(8) The NIH will perform an initial review of all submissions to
ensure they are complete and within the scope of the Challenge.
Submissions that are incomplete or outside of the scope of the
Challenge will be administratively disqualified and will not be
evaluated by the CLIA-certified laboratories, the Technical Evaluation
Panel, or the Judging Panel. Disqualified submissions will not be
returned to the Step 2 Semi-finalist.
(9) 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 3 that less
competitive submissions will not be discussed by the Technical
Evaluation Panel during the Panel's meeting.
(10) Members of the Technical Evaluation Panel for Step 1 or Step 2
are not eligible to participate in or
[[Page 466]]
contribute to any proposal for Step 3 of the Challenge.
(11) Only Step 2 Semi-finalists are eligible for Step 3 of this
Challenge.
(12) All submissions for Step 3 must be in English.
(13) No submissions will be returned to the submitters.
(14) The remainder of the provisions from the September 8, 2016,
Federal Register Notice (81 FR 62150) not amended here still apply.
Dated: January 11, 2019.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2019-00218 Filed 1-28-19; 8:45 am]
BILLING CODE 4140-01-P
