32884 Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 

Guidance for Industry and FDA Staff— 

Class II Special Controls Guidance 

Document: Automated Blood Cell 

Separator Device Operating by 

Centrifugal or Filtration Separation 

Principle 

OMB Control Number 0910–0594— 

Extension 

Under the Safe Medical Devices Act 

of 1990 (Pub. L. 101–629), FDA may 

establish special controls, including 

performance standards, postmarket 

surveillance, patient registries, 

guidelines, and other appropriate 

actions it believes necessary to provide 

reasonable assurance of the safety and 

effectiveness of the device. The special 

control guidance serves as the special 

control for the automated blood cell 

separator device operating by 

centrifugal or filtration separation 

principle intended for the routine 

collection of blood and blood 

components (§ 864.9245 (21 CFR 

864.9245)). 

For currently marketed products not 

approved under the premarket approval 

process, the manufacturer should file 

with FDA for 3 consecutive years an 

annual report on the anniversary date of 

the device reclassification from class III 

to class II or on the anniversary date of 

the 510(k) of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

360(k)) clearance. Any subsequent 

change to the device requiring the 

submission of a premarket notification 

in accordance with section 510(k) of the 

FD&C Act should be included in the 

annual report. Also, a manufacturer of a 

device determined to be substantially 

equivalent to the centrifugal or 

filtration-based automated cell separator 

device intended for the routine 

collection of blood and blood 

components should comply with the 

same general and special controls. 

The annual report should include, at 

a minimum, a summary of anticipated 

and unanticipated adverse events that 

have occurred and that are not required 

to be reported by manufacturers under 

Medical Device Reporting (MDR) (part 

803 (21 CFR part 803)). The reporting of 

adverse device events summarized in an 

annual report will alert FDA to trends 

or clusters of events that might be a 

safety issue otherwise unreported under 

the MDR regulation. The report should 

also include any subsequent change to 

the preamendments class III device 

requiring a 30-day notice in accordance 

with 21 CFR 814.39(f). 

Reclassification of this device from 

class III to class II relieves 

manufacturers of the burden of 

complying with the premarket approval 

requirements of section 515 of the FD&C 

Act (21 U.S.C. 360e) and may permit 

small potential competitors to enter the 

marketplace by reducing the burden. 

Although the special control guidance 

recommends that manufacturers of these 

devices file with FDA an annual report 

for 3 consecutive years, this would be 

less burdensome than the current 

postapproval requirements under 21 

CFR part 814, subpart E, including the 

submission of periodic reports under 21 

CFR 814.84. 

Collecting or transfusing facilities, the 

intended users of the device, and the 

device manufacturers have certain 

responsibilities under the Federal 

regulations. For example, collecting or 

transfusing facilities are required to 

maintain records of any reports of 

complaints of adverse reactions (21 CFR 

606.170), while the device manufacturer 

is responsible for conducting an 

investigation of each event that is 

reasonably known to the manufacturer 

and evaluating the cause of the event 

(§ 803.50(b) (21 CFR 803.50(b))). In 

addition, manufacturers of medical 

devices are required to submit to FDA 

individual adverse event reports of 

death, serious injury, and malfunctions 

(§ 803.50). 

In the special control guidance 

document, FDA recommends that 

manufacturers include in their three 

annual reports a summary of adverse 

reactions maintained by the collecting 

or transfusing facility or similar reports 

of adverse events collected. 

In the Federal Register of February 

22, 2018, (83 FR 7745), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. One comment was received 

but did not respond to any of the four 

information collection topics solicited 

and is therefore not discussed here. 

We estimate the burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Reporting activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 

Annual Report ...................................................................... 3 1 3 5 15 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on FDA records, there are 

approximately three manufacturers of 

automated blood cell separator devices. 

We estimate that the manufacturers will 

spend approximately 5 hours preparing 

and submitting the annual report. The 

total burden hours are reduced from 

previous collections due to a decrease in 

the number of manufacturers. 

Other burden hours required for 

§ 864.9245 are reported and approved 

under OMB control number 0910–0120 

(premarket notification submission 

510(k), 21 CFR part 807, subpart E), and 

OMB control number 0910–0437 (MDR, 

part 803). 

Dated: July 9, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15089 Filed 7–13–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Declaration Regarding Emergency Use 

of Treatment for Uncontrolled 

Hemorrhage Due to Agents of Military 

Combat 

AGENCY: Office of the Secretary, 

Department of Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: The Secretary of Health and 

Human Services (HHS) is issuing this 

notice pursuant to the Federal Food, 

Drug, and Cosmetic (FD&C) Act. On 

June 7, 2018, Patrick M. Shanahan, 

Deputy Secretary of Defense, 

determined in accordance with the 

Federal Food, Drug and Cosmetic Act, 

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. More specifically, 

U.S. Forces are now deployed in 

multiple locations where they serve at 


sradovich on DSK3GMQ082PROD with NOTICES
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