Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 32885 

1 42 U.S.C. 247d–6b, which states: ‘‘[t]he 

Homeland Security Secretary, in consultation with 

the Secretary and the heads of other agencies as 

appropriate, shall on an ongoing basis—(i) assess 

current and emerging threats of chemical, 

biological, radiological, and nuclear agents; and (ii) 

determine which of such agents present a material 

threat against the United States population 

sufficient to affect national security.’’ 

heightened risk of an enemy attack with 

agents of military combat, including 

firearms, projectiles, and explosive 

devices, that may cause major and 

imminently life-threatening combat 

casualties involving uncontrolled 

hemorrhage. 

On the basis of this determination, on 

July 9, 2018 the Secretary declared that 

circumstances exist justifying the 

authorization of emergency use of 

Freeze Dried Plasma (FDP) to treat 

uncontrolled hemorrhage due to agents 

of military combat (e.g., firearms, 

projectiles, and explosive devices) in 

emergency situations when plasma is 

not available for use or its use is not 

practical, pursuant to section 564 of the 

FD&C Act, subject to the terms of any 

authorization issued under that section. 

DATES: The declaration is effective July 

9, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Robert P. Kadlec, MD, MTM&H, MS, 

Assistant Secretary for Preparedness 

and Response, Office of the Secretary, 

Department of Health and Human 

Services, 200 Independence Avenue 

SW, Washington, DC 20201, Telephone 

(202) 205–2882 (this is not a toll free 

number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under Section 564 of the FD&C Act, 

the Commissioner of the Food and Drug 

Administration (FDA), acting under 

delegated authority from the Secretary 

of HHS, may issue an Emergency Use 

Authorization (EUA) authorizing (1) the 

emergency use of an unapproved drug, 

an unapproved or uncleared device, or 

an unlicensed biological product; or (2) 

an unapproved use of an approved drug, 

approved or cleared device, or licensed 

biological product. Before an EUA may 

be issued, the Secretary of HHS must 

declare that circumstances exist 

justifying the authorization based on 

one of four determinations: (1) A 

determination by the Secretary of 

Homeland Security that there is a 

domestic emergency, or a significant 

potential for a domestic emergency, 

involving a heightened risk of attack 

with a biological, chemical, radiological, 

or nuclear (‘‘CBRN’’) agent or agents; (2) 

the identification of a material threat by 

the Secretary of Homeland Security 

pursuant to section 319F–2 of the Public 

Health Service (PHS) Act 1 sufficient to 

affect national security or the health and 

security of United States citizens living 

abroad; (3) a determination by the 

Secretary of Defense that there is a 

military emergency, or a significant 

potential for a military emergency, 

involving a heightened risk to United 

States military forces, including 

personnel operating under the authority 

of title 10 or title 50, of attack with (i) 

a biological, chemical, radiological, or 

nuclear agent or agents; or (ii) an agent 

or agents that may cause, or are 

otherwise associated with, an 

imminently life-threatening and specific 

risk to United States military forces; or 

(4) a determination by the Secretary that 

there is a public health emergency, or a 

significant potential for a public health 

emergency, that affects, or has a 

significant potential to affect, national 

security or the health and security of 

United States citizens living abroad, and 

that involves a CBRN agent or agents, or 

a disease or condition that may be 

attributable to such agent or agents. 

Based on any of these four 

determinations, the Secretary of HHS 

may then declare that circumstances 

exist that justify the EUA, at which 

point the FDA Commissioner may issue 

an EUA if the criteria for issuance of an 

authorization under section 564 of the 

FD&C Act are met. The determination of 

a military emergency or significant 

potential for a military emergency by 

the Deputy Secretary of Defense, and the 

declaration that circumstances exist 

justifying emergency use of French FDP 

by the Secretary of HHS, as described 

below, enable the FDA Commissioner to 

issue an EUA for FDP in emergency 

situations when plasma is not available 

for use or its use is not practical for 

emergency use under section 564 of the 

FD&C Act. 

II. Determination of a Military 

Emergency or Significant Potential for a 

Military Emergency by the Deputy 

Secretary of Defense 

On June 7, 2018, Patrick M. 

Shanahan, Deputy Secretary of Defense, 

determined in accordance with section 

564(b)(1)(B) of the Federal Food, Drug 

and Cosmetic Act, 21 U.S.C. 360bbb– 

3(b)(1)(B), as delegated by the Secretary 

of Defense, that there is a military 

emergency or significant potential for a 

military emergency, involving a 

heightened risk to U.S. military forces of 

an attack with an agent or agents that 

may cause, or are otherwise associated 

with an imminently life-threatening and 

specific risk to those forces. The Deputy 

Secretary further stated that, more 

specifically, U.S. Forces are now 

deployed in multiple locations where 

they serve at heightened risk of an 

enemy attack with agents of military 

combat, including firearms, projectiles, 

and explosive devices, that may cause 

major and imminently life-threatening 

combat casualties involving 

uncontrolled hemorrhage. 

III. Declaration of the Secretary of 

Health and Human Services 

On July 9, 2018, on the basis of the 

Deputy Secretary of Defense’s 

determination that there is a military 

emergency or significant potential for a 

military emergency involving a 

heightened risk to U.S. military forces of 

an attack with an agent or agents that 

may cause, or are otherwise associated 

with an imminently life-threatening and 

specific risk to those forces, I declared 

that circumstances exist justifying the 

authorization of emergency use of FDP 

to treat uncontrolled hemorrhage due to 

agents of military combat (e.g., firearms, 

projectiles, and explosive devices) in 

emergency situations when plasma is 

not available for use or its use is not 

practical, pursuant to section 564 of the 

FD&C Act, subject to the terms of any 

authorization issued under that section. 

Notice of any EUAs issued by the 

FDA Commissioner pursuant to this 

determination and declaration will be 

provided promptly in the Federal 

Register as required under section 564 

of the FD&C Act. 

Alex M. Azar II, 

Secretary. 

[FR Doc. 2018–15152 Filed 7–13–18; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

[Docket No. USCBP–2018–0026] 

Commercial Customs Operations 

Advisory Committee (COAC) 

AGENCY: U.S. Customs and Border 

Protection (CBP), Department of 

Homeland Security (DHS). 

ACTION: Committee management; notice 

of Federal Advisory Committee meeting. 

SUMMARY: The Commercial Customs 

Operations Advisory Committee (COAC) 

will hold its public meeting on 

Wednesday, August 1, 2018 via 

webinar. The meeting will be open to 

the public. 

DATES: The COAC will meet on 

Wednesday, August 1, 2018 from 1:00 

p.m. to 4:00 p.m. EST. Please note that 


sradovich on DSK3GMQ082PROD with NOTICES
32886 Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 

the meeting may close early if the 

committee has completed its business. 

ADDRESSES: The meeting will be held 

via webinar. The webinar link and 

conference phone number will be 

provided to all registrants by 5:00 p.m. 

on July 31, 2018. For information on 

services for individuals with disabilities 

or to request special assistance at the 

meeting, contact Ms. Florence ConstantGibson, Office of Trade Relations, U.S. 

Customs & Border Protection, at (202) 

344–1440 as soon as possible. 

Pre-Registration: Members of the 

public who plan to attend the meeting, 

please register online at: https://

teregistration.cbp.gov/index.asp?w=137 

by 4 p.m. EST, July 31, 2018. Please feel 

free to share this information with other 

interested members of your organization 

or association. 

Members of the public who are preregistered to attend via webinar and 

later need to cancel, please do so by 

9:00 a.m. EST on August 1, 2018 

utilizing the following link: https://

teregistration.cbp.gov/ 

cancel.asp?w=137. 

To facilitate public participation, we 

are inviting public comment on the 

issues the committee will consider prior 

to the formulation of recommendations 

as listed in the Agenda section below. 

Comments must be submitted in 

writing no later than 5:00 p.m. EST on 

July 31, 2018, and must be identified by 

Docket No. USCBP–2018–0026, and 

may be submitted by one (1) of the 

following methods: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Email: tradeevents@dhs.gov. 

Include the docket number in the 

subject line of the message. 

• Fax: (202) 325–4290, Attention 

Florence Constant-Gibson. 

• Mail: Ms. Florence ConstantGibson, Office of Trade Relations, U.S. 

Customs and Border Protection, 1300 

Pennsylvania Avenue NW, Room 3.5A, 

Washington, DC 20229. 

Instructions: All submissions received 

must include the words ‘‘Department of 

Homeland Security’’ and the docket 

number (USCBP–2018–0026) for this 

action. Comments received will be 

posted without alteration at https://

www.regulations.gov. Please do not 

submit personal information to this 

docket. 

Docket: For access to the docket or to 

read background documents or 

comments, go to https://

www.regulations.gov and search for 

Docket Number USCBP–2018–0026. To 

submit a comment, click the ‘‘Comment 

Now!’’ button located on the top-right 

hand side of the docket page. 

There will be multiple public 

comment periods held during the 

meeting on August 1, 2018. Speakers are 

requested to limit their comments to 

two (2) minutes or less to facilitate 

greater participation. Contact the 

individual listed below to register as a 

speaker. Please note that the public 

comment period for speakers may end 

before the time indicated on the 

schedule that is posted on the CBP web 

page, https://www.cbp.gov/trade/ 

stakeholder-engagement/coac. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Florence Constant-Gibson, Office of 

Trade Relations, U.S. Customs and 

Border Protection, 1300 Pennsylvania 

Avenue NW, Room 3.5A, Washington, 

DC 20229; telephone (202) 344–1440; 

facsimile (202) 325–4290; or Mr. 

Bradley Hayes, Executive Director, 

Office of Trade Relations and 

Designated Federal Officer for COAC at 

(202) 344–1440. 

SUPPLEMENTARY INFORMATION: Notice of 

this meeting is given under the Federal 

Advisory Committee Act, 5 U.S.C. 

Appendix. The Commercial Customs 

Operations Advisory Committee (COAC) 

provides advice to the Secretary of 

Homeland Security, the Secretary of the 

Treasury, and the Commissioner of U.S. 

Customs and Border Protection (CBP) on 

matters pertaining to the commercial 

operations of CBP and related functions 

within the Department of Homeland 

Security and the Department of the 

Treasury. 

Agenda 

The Designated Federal Officer will 

introduce the newly appointed, reappointed, and alternate COAC 

members. The COAC will also hear from 

the following subcommittees on the 

topics listed below and then will 

review, deliberate, provide observations, 

and formulate recommendations on how 

to proceed: 

1. The Exports Subcommittee will 

discuss a path forward for its work and 

the work of the Export Manifest 

Working Group for the 15th Term 

COAC. There will also be an update on 

the automated export manifest pilots, 

and on progress in implementing a postdeparture filing pilot as part of the 

ocean pilot. 

2. The Trusted Trader Subcommittee 

will present an update from the 

C–TPAT Minimum Security Criteria 

Working Group on its recommendation 

regarding CBP’s plans to roll out new 

C–TPAT criteria. The subcommittee will 

also provide an update on the progress 

on the Trusted Trader Strategy and the 

formation of a new Trade Compliance 

Working Group. 

3. The Trade Modernization 

Subcommittee will discuss the progress 

of the Regulatory Reform Working 

Group’s efforts to identify and prioritize 

areas of regulations administered by 

CBP which can be reformed and the 

Foreign Trade Zone Regulations 

Working Group. In addition, the 

subcommittee will discuss the progress 

being made in the E-Commerce Working 

Group. 

4. The Trade Enforcement and 

Revenue Collection (TERC) 

Subcommittee will provide updates 

from the Anti-Dumping/Countervailing 

Duties (AD/CVD), Bond, Forced Labor 

and Intellectual Property Rights 

Working Groups and will also speak to 

the lessons learned from the risk-based 

bonding tabletop exercise. 

Meeting materials will be available by 

July 31, 2018 at: http://www.cbp.gov/ 

trade/stakeholder-engagement/coac/ 

coac-public-meetings. 

Dated: July 11, 2018. 

Bradley F. Hayes, 

Executive Director, Office of Trade Relations. 

[FR Doc. 2018–15107 Filed 7–13–18; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–7001–N–36] 

30-Day Notice of Proposed Information 

Collection: Human Trafficking Housing 

Partnership 

AGENCY: Office of the Chief Information 

Officer, HUD. 

ACTION: Notice. 

SUMMARY: HUD is seeking approval from 

the Office of Management and Budget 

(OMB) for the information collection 

described below. In accordance with the 

Paperwork Reduction Act, HUD is 

requesting comment from all interested 

parties on the proposed collection of 

information. The purpose of this notice 

is to allow for 30 days of public 

comment. 

DATES: Comments Due Date: August 15, 

2018. 

ADDRESSES: Interested persons are 

invited to submit comments regarding 

this proposal. Comments should refer to 

the proposal by name and/or OMB 

Control Number and should be sent to: 

HUD Desk Officer, Office of 

Management and Budget, New 

Executive Office Building, Washington, 

DC 20503; fax: 202–395–5806, Email: 

OIRA_Submission@omb.eop.gov. 

FOR FURTHER INFORMATION CONTACT: 

Anna P. Guido, Reports Management 


sradovich on DSK3GMQ082PROD with NOTICES