4106 Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 

1 50 U.S.C. 4558(c)(1). 

2 85 FR 18403 (Apr. 1, 2020). 

3 DHS Delegation 09052, Rev. 00.1 (Apr. 1, 2020); 

DHS Delegation Number 09052 Rev. 00 (Jan. 3, 

2017). 

massively paralleled multiplexed 

screening method using next generation 

sequencing (NGS). This method uses 

sample-specific barcoded indexes that 

detect both SARS–COV–2 virus and the 

host’s transcriptional response to 

infection simultaneously. By matching 

existing laboratory protocols for PCRbased sample processing, this assay is 

easily incorporated into existing CLIAcertified facilities. This testing approach 

provides the capability for testing tens 

of thousands of patient samples in a 

large bolus, allowing accurate and fastturnaround SARS-CoV–2 testing 

capacity at population scale, and 

permits massive scale monitoring of atrisk individuals with minimal 

processing delay. 

Potential Commercial Applications: 

Diagnostic test for detecting infectious 

organisms, including SARS-CoV–2. 

Competitive Advantages 

• Reduction in reagents needed to 

perform a test, reducing test cost and 

bottleneck of critical reagents used 

during nucleic acid amplification. 

• Simultaneously detect the pathogen 

and a host’s transcriptional response to 

infection by the pathogen. 

• Gene expression information from 

the donor can be used to predict disease 

severity. 

Development Stage: 

• Early stage. 

• Data from tests of human samples 

available. 

Inventors: Ozwaldo Alonso Lozoya 

(NIEHS), and Brian Papas (NIEHS). 

Intellectual Property: HHS Reference 

No. E–241–2020–0; U.S Provisional 

Patent Application 63/116,031 filed 

November 19, 2020. 

Licensing Contact: Vidita Choudhry, 

Ph.D.; 301–594–4095; vidita.choudhry@

nih.gov. This notice is made in 

accordance with 35 U.S.C. 209 and 37 

CFR part 404. 

Dated: January 8, 2021. 

Bruce D. Goldstein, 

Director, National Heart, Lung, and Blood 

Institute, Office of Technology Transfer and 

Development. 

[FR Doc. 2021–00825 Filed 1–14–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, 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/or contract 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. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel; Maternal and 

Pediatric HIV/AIDS Research. 

Date: March 12, 2021. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Child Health 

and Human Development, 6710B Rockledge 

Drive, Bethesda, MD 20817 (Video-Assisted 

Meeting). 

Contact Person: Luis E. Dettin, Ph.D., M.S., 

M.A., Scientific Review Officer, Scientific 

Review Branch, Eunice Kennedy Shriver 

National Institute of Child Health and 

Human Development, NIH, 6710B Rockledge 

Drive, Rm. 2131B, Bethesda, MD 20892, (301) 

827–8231, luis_dettin@nih.gov. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel; Centers to Advance 

Research in Endometriosis (CARE) (P01 

Clinical Trial Not Allowed). 

Date: March 16–17, 2021. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6710B 

Rockledge Drive, Rockledge Drive, Bethesda, 

MD 20817 (Video-Assisted Meeting). 

Contact Person: Derek J. McLean, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, NIH, 6710B Rockledge Drive, 

Rm. 2125B, Bethesda, MD 20892–7002, 

Derek.McLean@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.865, Research for Mothers 

and Children, National Institutes of Health, 

HHS) 

Dated: January 12, 2021. 

Ronald J. Livingston, Jr., 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–00918 Filed 1–14–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Docket ID FEMA–2020–0016] 

Meeting To Implement Pandemic 

Response Voluntary Agreement Under 

the Defense Production Act 

AGENCY: Federal Emergency 

Management Agency, Department of 

Homeland Security. 

ACTION: Announcement of meetings. 

SUMMARY: The Federal Emergency 

Management Agency (FEMA) held a 

series of meetings to implement the 

Voluntary Agreement for the 

Manufacture and Distribution of Critical 

Healthcare Resources Necessary to 

Respond to a Pandemic. 

DATES: The first meeting took place on 

Wednesday, January 6, 2021, from 2 to 

4 p.m. Eastern Time (ET). The second 

meeting took place on Thursday, 

January 7, 2021, from 2 to 4 p.m. ET. 

The third meeting took place on Friday, 

January 8, 2021, from 2 to 3:30 p.m. ET. 

FOR FURTHER INFORMATION CONTACT: 

Robert Glenn, Office of Business, 

Industry, Infrastructure Integration, via 

email at OB3I@fema.dhs.gov or via 

phone at (202) 212–1666. 

SUPPLEMENTARY INFORMATION: Notice of 

these meetings is provided as required 

by section 708(h)(8) of the Defense 

Production Act (DPA), 50 U.S.C. 

4558(h)(8), and consistent with 44 CFR 

part 332. 

The DPA authorizes the making of 

‘‘voluntary agreements and plans of 

action’’ with, among others, 

representatives of industry and business 

to help provide for the national 

defense.1 The President’s authority to 

facilitate voluntary agreements was 

delegated to the Secretary of Homeland 

Security with respect to responding to 

the spread of COVID–19 within the 

United States in Executive Order 

13911.2 The Secretary of Homeland 

Security has further delegated this 

authority to the FEMA Administrator.3

On August 17, 2020, after the 

appropriate consultations with the 

Attorney General and the Chairman of 

the Federal Trade Commission, FEMA 

completed and published in the Federal 

Register a ‘‘Voluntary Agreement for the 

Manufacture and Distribution of Critical 

Healthcare Resources Necessary to 

Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 4107 

4 85 FR 50035 (Aug. 17, 2020). The Attorney 

General, in consultation with the Chairman of the 

Federal Trade Commission, made the required 

finding that the purpose of the voluntary agreement 

may not reasonably be achieved through an 

agreement having less anticompetitive effects or 

without any voluntary agreement and published the 

finding in the Federal Register on the same day. 85 

FR 50049 (Aug. 17, 2020). 

5See 85 FR 78869 (Dec. 7, 2020). See also 85 FR 

79020 (Dec. 8, 2020). 

6See 50 U.S.C. 4558(h)(7). 

7 ‘‘[T]he individual designated by the President in 

subsection (c)(2) [of section 708 of the DPA] to 

administer the voluntary agreement, or plan of 

action.’’ 50 U.S.C. 4558(h)(7). 

8Under 50 U.S.C. 4558(h)(8), the Sponsor 

generally must publish in the Federal Register prior 

notice of any meeting held to carry out a voluntary 

agreement or plan of action. However, when the 

Sponsor finds that the matters to be discussed at 

such meeting fall within the purview of matters 

described in 5 U.S.C. 552b(c), notice of the meeting 

may instead be published in the Federal Register 

within ten days of the date of the meeting. See 50 

U.S.C. 4558(h)(8). 

Respond to a Pandemic’’ (Voluntary 

Agreement).4 Unless terminated prior to 

that date, the Voluntary Agreement is 

effective until August 17, 2025, and may 

be extended subject to additional 

approval by the Attorney General after 

consultation with the Chairman of the 

Federal Trade Commission. The 

Agreement may be used to prepare for 

or respond to any pandemic, including 

COVID–19, during that time. 

On December 7, 2020, the first plan of 

action under the Voluntary 

Agreement—the Plan of Action to 

Establish a National Strategy for the 

Manufacture, Allocation, and 

Distribution of Personal Protective 

Equipment (PPE) to Respond to COVID– 

19 (Plan of Action)—was finalized.5 The 

Plan of Action established several subcommittees under the Voluntary 

Agreement, focusing on different 

aspects of the Plan of Action. 

The meetings were chaired by the 

FEMA Administrator or his delegate, 

and attended by the Attorney General or 

his delegate and the Chairman of the 

Federal Trade Commission or his 

delegate. In implementing the Voluntary 

Agreement, FEMA adheres to all 

procedural requirements of 50 U.S.C. 

4558 and 44 CFR part 332. 

Meeting Objectives: The objectives of 

the meetings were to: 

(1) Establish priorities for COVID–19 

PPE under the Voluntary Agreement; 

(2) Identify tasks that should be 

completed under specific subcommittees; and 

(3) Identify information gaps and 

areas that merit sharing (from both 

FEMA to private sector and vice versa). 

Meetings Closed to the Public: By 

default, the DPA requires meetings held 

to implement a voluntary agreement or 

plan of action be open to the public.6

However, attendance may be limited if 

the Sponsor 7 of the voluntary 

agreement finds that the matter to be 

discussed at a meeting falls within the 

purview of matters described in 5 U.S.C. 

552b(c). The Sponsor of the Voluntary 

Agreement, the FEMA Administrator, 

found that these meetings to implement 

the Voluntary Agreement involved 

matters which fell within the purview of 

matters described in 5 U.S.C. 552b(c) 

and were therefore closed to the public.8

Specifically, the meetings to 

implement the Voluntary Agreement 

could have required participants to 

disclose trade secrets or commercial or 

financial information that is privileged 

or confidential. Disclosure of such 

information is a basis for closing 

meetings pursuant to 5 U.S.C. 

552b(c)(4). In addition, the success of 

the Voluntary Agreement depends 

wholly on the willing and enthusiastic 

participation of private sector 

participants. Failure to close these 

meetings could have had a strong 

chilling effect on participation by the 

private sector and caused a substantial 

risk that sensitive information would be 

prematurely released to the public, 

resulting in participants withdrawing 

their support from the Voluntary 

Agreement and thus significantly 

frustrating the implementation of the 

Voluntary Agreement. Frustration of an 

agency’s objective due to premature 

disclosure of information allows for the 

closure of a meeting to pursuant to 5 

U.S.C. 552b(c)(9)(B). 

Pete Gaynor, 

Administrator, Federal Emergency 

Management Agency. 

[FR Doc. 2021–00893 Filed 1–14–21; 8:45 am] 

BILLING CODE 9111–19–P 

DEPARTMENT OF HOMELAND 

SECURITY 

[Docket Number DHS–2021–0004] 

Agency Information Collection 

Activities: COVID–19 Contact Tracing, 

COVID–19 Contact Tracing Scripts, 

COVID–19 Contact Tracing Form 

AGENCY: Department of Homeland 

Security (DHS). 

ACTION: 60-day notice and request for 

comments; extension without change of 

a currently approved collection, 1601– 

0027. 

SUMMARY: The Department of Homeland 

Security, will submit the following 

Information Collection Request (ICR) to 

the Office of Management and Budget 

(OMB) for review and clearance in 

accordance with the Paperwork 

Reduction Act of 1995. 

DATES: Comments are encouraged and 

will be accepted until March 16, 2021. 

This process is conducted in accordance 

with 5 CFR 1320.1 

ADDRESSES: You may submit comments, 

identified by docket number Docket # 

DHS–1601–0027, at: 

Æ Federal eRulemaking Portal: http:// 

www.regulations.gov. Please follow the 

instructions for submitting comments. 

Instructions: All submissions received 

must include the agency name and 

docket number Docket # DHS–1601– 

0027. All comments received will be 

posted without change to http://

www.regulations.gov, including any 

personal information provided. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov. 

SUPPLEMENTARY INFORMATION: 

COVID–19 Contact Tracing 

information is necessary to support the 

President’s National Guidelines for all 

phases of Opening Up America Again. 

The Office of Management and Budget 

(OMB) M–20–23Memorandum for 

Heads of Executive Department requires 

employers to develop and implement 

policies and procedures for workforce 

contact tracing following an employee’s 

COVID–19 positive test. The M–20–23 

Memorandum requires symptomatic 

Federal employees and contractors to 

follow their Agency’s process if they are 

symptomatic or test positive for COVID– 

19. It specifies that the agency processes 

should protect the anonymity and 

privacy of Federal employees and 

contractors, to the extent possible, while 

disclosing only the information 

necessary for agencies to take 

appropriate actions of notifying 

potentially affected employees and 

cleaning the facility. Additionally, per 

the Centers for Disease Control and 

Prevention guidance entitled Get and 

Keep America Open, COVID–19 Contact 

Tracing is essential to reduce the spread 

of COVID–19. Furthermore, in response 

to the Coronavirus Pandemic, public 

health leaders are calling for 

communities around the country to 

ramp up capacity and implement a 

massive contact tracing effort to control 

spread of the Coronavirus. The response 

and recovery from the effect of COVID– 

19 will continue to present Federal 

agencies with unprecedented 

challenges, as well as opportunities for 

improvement, that require new 

processes and practices such as COVID– 

19 Contact Tracing to keep the 

workforce and the public safe. As DHS 

plans to reconstitute the workforce, it is