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. 

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] 

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: 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, 

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: 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, 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 

http://www.cccinnovationcenter.com/ 

challenges/antimicrobial-resistancediagnostic-challenge/. 

FOR FURTHER INFORMATION CONTACT: 

Robert W. Eisinger, Ph.D., NIH, 301– 

Federal Register / Vol. 84, No. 19 / Tuesday, January 29, 2019 / Notices 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 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 http://

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 

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 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 

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. 

Dated: January 11, 2019. 

Lawrence A. Tabak, 

Deputy Director, National Institutes of Health. 

[FR Doc. 2019–00218 Filed 1–28–19; 8:45 am] 

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DEPARTMENT OF HOMELAND 

SECURITY 

[Docket No. DHS–2018–0076] 

Homeland Security Advisory Council 

AGENCY: Office of Partnership and 

Engagement (OPE), Department of 

Homeland Security (DHS). 

ACTION: Notice of open teleconference 

federal advisory committee meeting; 

cancellation. 

SUMMARY: 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 

(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] 

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