Federal Register / Vol. 85, No. 251 / Thursday, December 31, 2020 / Rules and Regulations 86835 

anticipate any impacts to the Medicare 

program, beneficiaries, or other 

stakeholders. 

There are three primary aspects of the 

provision that could affect its cost and 

the amount saved. The most immediate 

cost comes from the one-time 

implementation cost for the few EHR 

vendors that need to need to change 

their programming to use two standards; 

the NCPDP SCRIPT standard version 

2017071 for Part D ePA and the HIPAA 

standard for other contexts. Based on 

our conversations with EHR vendors, 

we believe that it will take the EHR 

vendors approximately 200 developing 

hours and 800 programming hours to 

enable the EHRs to utilize two 

standards. 

We also estimated what it will cost 

plan sponsors to implement this 

standard. After consulting with industry 

stakeholders, we have concluded that 

implementing or building to the SCRIPT 

standard can vary, but $6,500 is the 

approximate amount per plan and 

$100,000 is the approximate amount for 

the industry. We estimate that only 2 

percent of the 774 plans will have to 

make changes to their ePA process to 

implement the NCPDP SCRIPT standard 

version 2017071 ePA transactions, 

which gives us an approximate one time 

implementation cost of $100,000 (15 * 

$6,500). 

E. Alternatives Considered 

We considered requiring the adoption 

of the standard by January 1, 2021 to 

ensure that this important mandate was 

implemented quickly. However, we 

want to help ensure that plans have as 

much time to comply with the statutory 

mandate as possible. 

F. Accounting Statement and Table 

The following table summarizes 

overall costs for this rule. The cost 

comes from implementing the new 

standard. 

2022 2023 2024 2025 2026 

Total Costs ........................................................................... $100,000 ........................ ........................ ........................ ........................

Net Savings .......................................................................... ........................ ........................ ........................ ........................ ........................

List of Subjects in 42 CFR Part 423 

Administrative practice and 

procedure, Emergency medical services, 

Health facilities, Health maintenance 

organizations (HMO), Health 

professionals, Incorporation by 

reference, Medicare, Penalties, Privacy, 

Reporting and recordkeeping 

requirements. 

For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services amends 42 CFR part 

423 as set forth below: 

PART 423—VOLUNTARY MEDICARE 

PRESCRIPTION DRUG BENEFIT 

■ 1. The authority citation for part 423 

continues to read as follows: 

Authority: 42 U.S.C. 1302, 1306, 1395w– 

101 through 1395w–152, and 1395hh. 

■ 2. Section 423.160 is amended by 

adding paragraph (b)(8) to read as 

follows: 

§ 423.160 Standards for electronic 

prescribing. 

* * * * * 

(b) * * * 

(8) Electronic prior authorization. (i) 

Beginning January 1, 2021, Part D 

sponsors and prescribers may use the 

National Council for Prescription Drug 

Programs SCRIPT standard, 

Implementation Guide Version 2017071 

approved July 28, 2017 (incorporated by 

reference in paragraph (c)(1)(vii) of this 

section), to provide for the 

communication of a prescription or 

prescription-related information 

between prescribers and Part D sponsors 

for the following transactions: 

(A) PAInitiationRequest and 

PAInitiationResponse. 

(B) PARequest and PAResponse. 

(C) PAAppealRequest and 

PAAppealResponse. 

(D) PACancelRequest and 

PACancelResponse. 

(ii) Beginning January 1, 2022, Part D 

sponsors and prescribers must use the 

standard specified in paragraph (b)(8)(i) 

of this section for the transactions listed 

in paragraphs (b)(8)(i)(A) through (D) of 

this section. 

* * * * * 

Dated: February 6, 2020. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Dated: March 13, 2020. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

Editorial note: This document was 

received for publication by the Office of the 

Federal Register on December 23, 2020. 

[FR Doc. 2020–28877 Filed 12–29–20; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 328 

[Docket ID FEMA–2020–0018] 

RIN 1660–AB01 

Prioritization and Allocation of Certain 

Scarce and Critical Health and Medical 

Resources for Domestic Use 

AGENCY: Federal Emergency 

Management Agency, Department of 

Homeland Security (DHS). 

ACTION: Temporary final rule; extension 

of effective date with modifications. 

SUMMARY: In April, the Federal 

Emergency Management Agency 

(FEMA) issued a temporary final rule to 

allocate certain health and medical 

resources for domestic use, so that these 

resources may not be exported from the 

United States without explicit approval 

by FEMA. The rule covered five types 

of personal protective equipment (PPE), 

outlined below. While this rule remains 

in effect, and subject to certain 

exemptions stated below, no shipments 

of such designated materials may leave 

the United States without explicit 

approval by FEMA. In August, FEMA 

modified the types of PPE covered and 

extended the duration of the temporary 

rule. Through this action, FEMA again 

extends and modifies the temporary 

final rule designating the list of scarce 

and critical materials that cannot be 

exported from the United States without 

explicit approval by FEMA. 

DATES: Effective date: This rule is 

effective from December 31, 2020 until 

June 30, 2021. 

ADDRESSES: You may review the docket 

by searching for Docket ID FEMA–2020– 

0018, via the Federal eRulemaking 

Portal: http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Daniel McMasters, Program Analyst, 

Office of Policy and Program Analysis, 

202–709–0661, FEMA-DPA@

fema.dhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On April 10, 2020, FEMA published 

a temporary final rule in the Federal 

Register allocating certain health and 


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86836 Federal Register / Vol. 85, No. 251 / Thursday, December 31, 2020 / Rules and Regulations 

1 85 FR 20195 (Apr. 10, 2020). See also 85 FR 

22622 (Apr. 23, 2020) (correcting the date filed from 

‘‘4–8–20’’ to’’ 4–7–20’’). 

2 85 FR 22021 (Apr. 21, 2020). 

3 85 FR 48113 (Aug. 10, 2020). 

4Statement on the second meeting of the 

International Health Regulations (2005) Emergency 

Committee regarding the outbreak of novel 

coronavirus (2019–nCoV) (Jan. 30, 2020), available 

at https://www.who.int/news/item/30-01-2020- 

statement-on-the-second-meeting-of-theinternational-health-regulations-(2005)-emergencycommittee-regarding-the-outbreak-of-novelcoronavirus-(2019-ncov) (accessed December 2, 

2020). 

5HHS, ‘‘Determination that a Public Health 

Emergency Exists,’’ (Jan. 31, 2020) available at 

https://www.phe.gov/emergency/news/ 

healthactions/phe/Pages/2019-nCoV.aspx (accessed 

December 2, 2020). 

6 ‘‘Proclamation on Declaring a National 

Emergency Concerning the Novel Coronavirus 

Disease (COVID–19) Outbreak,’’ Mar. 13, 2020, 

available at https://www.whitehouse.gov/ 

presidential-actions/proclamation-declaringnational-emergency-concerning-novel-coronavirusdisease-covid-19-outbreak/ (accessed December 15, 

2020). 

7COVID–19 Emergency Declaration available at 

https://www.fema.gov/news-release/2020/03/13/ 

covid-19-emergency-declaration (accessed 

December 15, 2020). 

8See https://www.fema.gov/disasters/ (accessed 

December 15, 2020). 

9As of December 22, 2020, the United States has 

over 17.79 million reported cases and over 300,000 

deaths attributed to COVID–19. See https://

covid.cdc.gov/covid-data-tracker/#cases_

casesper100klast7days (accessed December 22, 

2020). As of December 7, 2020, the number of 

reported weekly cases and weekly deaths are 

forecast to increase. See https://covid.cdc.gov/ 

covid-data-tracker/#forecasting_weeklycases 

(accessed December 22, 2020) and https://

covid.cdc.gov/covid-data-tracker/#forecasting_

weeklydeaths (accessed December 22, 2020). 

10See https://www.cdc.gov/flu/prevent/vaccinesupply-distribution.htm (accessed December 15, 

2020). 

11See https://www.cdc.gov/coronavirus/2019- 

ncov/vaccines/different-vaccines.html (accessed 

December 22, 2020). 12See Memorandum on Allocating Certain Scarce 

or Threatened Health and Medical Resources to 

Domestic Use for the Secretary of Health and 

Human Services, the Secretary of Homeland 

Security, and the Administrator of the Federal 

Emergency Management Agency (Apr. 3, 2020), 

https://www.whitehouse.gov/presidential-actions/ 

memorandum-allocating-certain-scarce-threatenedhealth-medical-resources-domestic-use/ (accessed 

December 15 2020). 

medical resources for domestic use, so 

that these resources may not be 

exported from the United States without 

explicit approval by FEMA.1 The rule 

aids the response of the United States to 

the spread of Coronavirus Disease 2019 

(COVID–19) by ensuring that certain 

health and medical resources are 

appropriately allocated for domestic 

use. On April 21, 2020, FEMA 

published a notification of exemptions 

to the rule.2 With the continued goal of 

ensuring that these resources are 

appropriately allocated for domestic 

use, FEMA extended the date through 

which the allocation in the temporary 

final rule would be in effect, including 

the exemptions published on April 21, 

2020, and modified the list of covered 

materials under the rule to reflect 

domestic supply needs as of August 10, 

2020.3 FEMA is now further extending 

and modifying this rule to reflect 

current domestic supply needs of health 

and medical resources to promote the 

national defense. The temporary final 

rule, as extended and modified, will 

remain in effect until June 30, 2021, 

unless sooner modified or terminated by 

the Administrator. 

A. The Current COVID–19 Pandemic 

COVID–19 is a communicable disease 

caused by severe acute respiratory 

syndrome coronavirus 2 (SARS–CoV–2), 

that was first identified as the cause of 

an outbreak of respiratory illness that 

began in Wuhan, Hubei Province, 

People’s Republic of China. On January 

30, 2020, the Director-General of the 

World Health Organization (WHO) 

declared that the outbreak of COVID–19 

is a Public Health Emergency of 

International Concern under the 

International Health Regulations.4 The 

following day, the Secretary of Health 

and Human Services (HHS) declared 

COVID–19 a public health emergency 

under Section 319 of the Public Health 

Service (PHS) Act.5 On March 11, 2020, 

the WHO declared COVID–19 a 

pandemic. On March 13, 2020, the 

President issued a Proclamation on 

Declaring a National Emergency 

Concerning the Novel Coronavirus 

Disease (COVID–19) Outbreak under 

sections 201 and 301 of the National 

Emergencies Act, 50 U.S.C. 1601 et seq., 

and consistent with section 1135 of the 

Social Security Act, 42 U.S.C. 1320b–5.6

On March 13, 2020, the President 

declared a nationwide emergency under 

section 501(b) of the Robert T. Stafford 

Disaster Relief and Emergency 

Assistance Act, authorizing FEMA to 

provide assistance for emergency 

protective measures to respond to the 

COVID–19 pandemic.7 FEMA 

subsequently issued 57 major disaster 

declarations in response to COVID–19, 

including for every State, 5 territories, 

the Seminole Tribe of Florida, and the 

District of Columbia.8

Within the United States, widespread 

transmission of COVID–19 has occurred. 

Widespread transmission of COVID–19 

has resulted and will continue to result 

in large numbers of people needing 

medical care at the same time. Public 

health and healthcare systems have 

become overwhelmed in some areas, 

with elevated rates of hospitalizations 

and deaths, as well as elevated demand 

for PPE, including the PPE covered by 

this rule. Due to a surge in confirmed 

COVID–19 cases and hospitalizations in 

October, November, and December 

2020,9 domestic supply of the allocated 

PPE has not kept pace with demand and 

is not anticipated to do so. Additionally, 

given the high rate of influenza 

vaccination administrations in 2020,10

along with the recent developments in 

COVID–19 vaccines and vaccine trials,11

the projected domestic supply of 

syringes and hypodermic needles is not 

expected to meet demand. 

B. Legal Authorities 

FEMA is extending and modifying 

this temporary final rule as part of its 

response to the COVID–19 pandemic. 

The rule is issued pursuant to the 

following authorities, among others: 

• The Defense Production Act of 

1950, as amended (‘‘DPA’’ or ‘‘the Act’’), 

and specifically sections 101 and 704 of 

the Act, 50 U.S.C. 4511, 4554; 

• Executive Order 13909, 85 FR 

16227 (Mar. 23, 2020); 

• Executive Order 13911, 85 FR 

18403 (Apr. 1, 2020); 

• Department of Homeland Security 

(DHS) Delegations, including DHS 

Delegation Number 09052 Rev. 00, 

‘‘Delegation of Defense Production Act 

Authority to the Administrator of the 

Federal Emergency Management 

Agency’’ (Jan. 3, 2017) and DHS 

Delegation Number 09052 Rev. 00.1, 

‘‘Delegation of Defense Production Act 

Authority to the Administrator of the 

Federal Emergency Management 

Agency’’ (Apr. 1, 2020); and 

• The Presidential Memorandum on 

Allocating Certain Scarce or Threatened 

Health and Medical Resources to 

Domestic Use (Apr. 3, 2020).12

Under subsection 101(a) of the Act, 50 

U.S.C. 4511(a), the President may (1) 

require that performance under 

contracts or orders (other than contracts 

of employment) which the President 

deems necessary or appropriate to 

promote the national defense shall take 

priority over performance under any 

other contract or order, and, for the 

purpose of assuring such priority, 

require acceptance and performance of 

such contracts or orders in preference to 

other contracts or orders by any person 

he finds to be capable of their 

performance. The President may also (2) 

allocate materials, services, and 

facilities in such manner, upon such 

conditions, and to such extent as the 

President shall deem necessary or 

appropriate to promote the national 

defense. FEMA refers to these 

authorities as relating to ‘‘priority 

ratings’’ and ‘‘allocation,’’ respectively. 


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Federal Register / Vol. 85, No. 251 / Thursday, December 31, 2020 / Rules and Regulations 86837 

13Executive Order 13909 also delegated to the 

Secretary of Health and Human Services (HHS) 

authority under the DPA for the prioritization and 

allocation of health and medical resources to 

respond to the spread of COVID–19. Further, on 

March 23, 2020, the President signed Executive 

Order 13910, in which the President delegated to 

the Secretary of HHS the authority under section 

102 of the Act to prevent hoarding and price 

gouging with respect to health and medical 

resources necessary to respond to the spread of 

COVID–19. On March 25, 2020, the Secretary of 

Health and Human Services designated under 

section 102 of the Act 15 categories of health and 

medical resources as scarce materials or materials 

the supply of which would be threatened by 

accumulation in excess of the reasonable demands 

of business, personal, or home consumption, or for 

the purpose of resale at prices in excess of 

prevailing market prices (‘‘anti-hoarding 

designation’’). See 85 FR 17592 (Mar. 30, 2020). The 

Secretary of HHS later modified and extended this 

designation. See 85 FR 45895 (July 30, 2020). The 

anti-hoarding designation relates to domestic 

hoarding and price-gouging activity, and is 

conceptually distinct from, and serves different 

purposes than, this rulemaking. 

14The Executive Order also delegated to the 

Secretary of Homeland Security the authority under 

section 102 of the Act to prevent hoarding and price 

gouging with respect to such resources, and 

requires that before exercising the authority under 

section 102 of the Act, the Secretary of Homeland 

Security shall consult with the Secretary of Health 

and Human Services. 

15See 85 FR 20195 (Apr. 10, 2020). 

16See 85 FR 48113 (Aug. 10, 2020). 

17See 85 FR 28500 (May 13, 2020) (codified at 44 

CFR part 333). In that interim final rule, FEMA 

noted that although FEMA effectuated the April 

allocation order via a temporary rule that predated 

the interim final rule, FEMA retains authority to 

administer and enforce that allocation order 

according to its terms, and to issue future allocation 

orders consistent with the procedures announced in 

the interim final rule. See 85 FR at 28505. As noted 

above, in August, FEMA opted to extend the April 

allocation, with modifications, consistent with the 

form of the April order. FEMA does the same here. 

Under subsection 101(b) of the Act, 50 

U.S.C. 4511(b), the President may not 

use the aforementioned authorities to 

control the general distribution of any 

material in the civilian market unless 

the President finds (1) that such 

material is a scarce and critical material 

essential to the national defense, and (2) 

that the requirements of the national 

defense for such material cannot 

otherwise be met without creating a 

significant dislocation of the normal 

distribution of such material in the 

civilian market to such a degree as to 

create appreciable hardship. 

Under subsection 101(d) of the Act, 

50 U.S.C. 4511(d), the head of each 

Federal agency to which the President 

delegates authority under section 101 of 

the Act (1) shall issue, and annually 

review and update whenever 

appropriate, final rules, in accordance 

with 5 U.S.C. 553, that establish 

standards and procedures by which the 

priorities and allocations authority 

under section 101 is used to promote 

the national defense, under both 

emergency and nonemergency 

conditions; and (2) as appropriate and to 

the extent practicable, consult with the 

heads of other Federal agencies to 

develop a consistent and unified 

Federal priorities and allocations 

system. 

On March 18, 2020, the President 

signed Executive Order 13909, which 

(among other things) contained a 

finding that health and medical 

resources needed to respond to the 

spread of COVID–19, including personal 

protective equipment and ventilators, 

meet the criteria specified in section 

101(b) of the Act (50 U.S.C. 4511(b)).13

On March 27, 2020, the President 

signed Executive Order 13911, which 

(among other things) delegated to the 

Secretary of Homeland Security, the 

President’s authority under section 101 

of the Act with respect to health and 

medical resources needed to respond to 

the spread of COVID–19 within the 

United States. The Executive Order 

provides that the Secretary of Homeland 

Security may use the authority under 

section 101 of the Act to determine, in 

consultation with the heads of other 

executive departments and agencies as 

appropriate, the proper nationwide 

priorities and allocation of health and 

medical resources, including by 

controlling the distribution of such 

materials (including applicable services) 

in the civilian market, for responding to 

the spread of COVID–19 within the 

United States.14 The Secretary of 

Homeland Security has redelegated the 

Secretary’s DPA authorities to the 

FEMA Administrator. See DHS 

Delegation Number 09052, Rev. 00 (Jan. 

3, 2017) and DHS Delegation Number 

09052, Rev. 00.1 (Apr. 1, 2020). 

Additionally, on April 3, 2020, the 

President signed a Memorandum on 

Allocating Certain Scarce or Threatened 

Health and Medical Resources to 

Domestic Use (the Memorandum). The 

Memorandum reaffirmed the 

delegations and findings contained in 

Executive Orders 13909 and 13911, 

including that health and medical 

resources needed to respond to the 

spread of COVID–19, including personal 

protective equipment (PPE), meet the 

criteria specified in section 101(b) of the 

Act, i.e., that (1) such material is a 

scarce and critical material essential to 

the national defense, and (2) that the 

requirements of the national defense for 

such material cannot otherwise be met 

without creating a significant 

dislocation of the normal distribution of 

such material in the civilian market to 

such a degree as to create appreciable 

hardship. The Memorandum identified 

certain categories of PPE materials that 

the Secretary of HHS had previously 

designated as ‘‘scarce or threatened’’ for 

purposes of section 102 of the DPA, and 

further stated that to ensure that these 

materials remain in the United States for 

use in responding to the spread of 

COVID–19, it is the policy of the United 

States to prevent domestic brokers, 

distributors, and other intermediaries 

from diverting such PPE materials 

overseas. 

In furtherance of such policy, the 

President directed the Secretary of 

Homeland Security, through the FEMA 

Administrator, and in consultation with 

the Secretary of HHS, to use any and all 

authority available under section 101 of 

the Act to allocate to domestic use, as 

appropriate, the five types of PPE 

identified in the Memorandum. On 

April 10, 2020, FEMA executed this 

direction by issuing the allocation order 

as a temporary final rule pursuant to the 

Memorandum, and with the authority 

delegated to the Secretary of Homeland 

Security in E.O. 13911 and re-delegated 

to the FEMA Administrator.15 The 

temporary final rule was modified and 

extended on August 10, 2020, to ensure 

certain health and medical resources 

were appropriately allocated for 

domestic use.16

Finally, on May 13, 2020, FEMA 

published an interim final rule to 

establish standards and procedures by 

which the priorities and allocations 

authority under section 101 is used to 

promote the national defense, under 

both emergency and nonemergency 

conditions.17

As the COVID–19 pandemic 

continues in the United States, the 

FEMA Administrator, in consultation 

with other agencies as appropriate, has 

determined that FEMA must continue to 

allocate some materials contained in the 

August 10, 2020, temporary final rule 

for domestic use, and to incorporate 

other health and medical resources due 

to changes in domestic supply and 

demand, surges in the number of 

confirmed COVID–19 cases and deaths 

in the United States, forecasts 

anticipating the increased number of 

COVID–19 cases and deaths, the current 

and projected volume of influenza 

vaccination doses, and future COVID–19 

vaccination predictions. FEMA has 

determined, consistent with the 

Memorandum and FEMA’s authorities 

under section 101 of the DPA, that it is 

appropriate to designate, with 

modification, the PPE previously 

designated and to include syringes and 

hypodermic needles (whether 

distributed separately or attached 

together) to ensure domestic supply is 


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18 85 FR 22021 (Apr. 21, 2020). 

able to meet the continuing demand for 

these materials. In short, FEMA has 

determined that the original temporary 

final rule must be extended, and the list 

of covered materials under such rule 

must be modified. 

Consistent with the authority 

delegated to the Secretary of Homeland 

Security in E.O. 13911 and re-delegated 

to the FEMA Administrator, FEMA now 

issues this temporary final rule to 

extend and modify the allocation order. 

II. Provisions of the Temporary Final 

Rule 

Following consultation with the 

appropriate Federal agencies; pursuant 

to the President’s direction; and as an 

exercise of the Administrator’s priority 

order, allocation, and regulatory 

authorities under the Act, the 

Administrator has determined that the 

April 10, 2020, temporary final rule 

(‘‘covered materials’’) shall be extended 

temporarily, and that the list of scarce 

and critical materials identified in such 

temporary final rule shall be modified to 

reflect current domestic needs. The 

materials identified in this rule will 

continue to be allocated for domestic 

use and may not be exported from the 

United States without explicit approval 

by FEMA. See 44 CFR 328.102(a). 

The rule is necessary and appropriate 

to promote the national defense with 

respect to the covered materials because 

the domestic need for them exceeds the 

supply. Under this temporary final rule 

extension, before any shipments of such 

covered materials may leave the United 

States, U.S. Customs and Border 

Protection (CBP) will continue to detain 

the shipment temporarily, during which 

time FEMA will determine whether to 

return for domestic use, issue a rated 

order for, or allow the export of part or 

all of the shipment under section 101(a) 

of the Act, 50 U.S.C. 4511(a). FEMA will 

continue to make such a determination 

within a reasonable time of being 

notified of an intended shipment and 

will make all decisions consistent with 

promoting the national defense. See 44 

CFR 328.102(b). FEMA will work to 

review and make determinations 

quickly and will endeavor to minimize 

disruptions to the supply chain. 

In determining whether it is necessary 

or appropriate to promote the national 

defense to purchase covered materials, 

or allocate materials for domestic use, 

FEMA may continue to consult other 

agencies and will consider the totality of 

the circumstances, including the 

following factors: (1) The need to ensure 

that such items are appropriately 

allocated for domestic use; (2) 

minimization of disruption to the 

supply chain, both domestically and 

abroad; (3) the circumstances 

surrounding the distribution of the 

materials and potential hoarding or 

price-gouging concerns; (4) the quantity 

and quality of the materials; (5) 

humanitarian considerations; and (6) 

international relations and diplomatic 

considerations. 

This extension to the rule continues 

the eleven exemptions that the 

Administrator has determined to be 

necessary or appropriate to promote the 

national defense. See 44 CFR 

328.102(d). 

Specifically, the Administrator has 

determined that FEMA will not 

purchase covered materials from 

shipments made by or on behalf of U.S. 

manufacturers with continuous export 

agreements with customers in other 

countries since at least January 1, 2020, 

so long as at least 80 percent of such 

manufacturer’s domestic production of 

covered materials, on a per item basis, 

was distributed in the United States in 

the preceding 12 months. The 

Administrator decided that this 

exemption is necessary or appropriate to 

promote the national defense because it 

would limit the impact of this order on 

pre-existing commercial relationships, 

in recognition of the importance of these 

commercial relationships to the 

international supply chain, and for 

humanitarian reasons, in consideration 

of the global nature of the COVID–19 

pandemic. If FEMA determines that a 

shipment of covered materials falls 

within this exemption, such materials 

may be transferred out of the United 

States without further review by FEMA, 

provided that the Administrator may 

waive this exemption and fully review 

shipments of covered materials subject 

to this exemption for further action by 

FEMA, if the Administrator determines 

that doing so is necessary or appropriate 

to promote the national defense. FEMA 

may develop additional guidance 

regarding which exports are covered by 

this exemption and encourages 

manufacturers to contact FEMA with 

specific information regarding their 

status under this exemption. 

On April 21, 2020, FEMA published 

notification of 10 additional exemptions 

to the original temporary final rule.18

These exemptions will remain in effect 

for the new effective period of this rule, 

subject to the Administrator’s discretion 

to waive, modify, or terminate such 

exemptions at any time in the future. 

The Administrator has determined that 

it continues to be necessary and 

appropriate to promote the national 

defense to exempt these categories of 

covered materials from the requirements 

of 44 CFR 328.102(a) and (b). The 

Administrator may establish, in his 

discretion, additional exemptions that 

he determines are necessary or 

appropriate to promote the national 

defense and will announce any such 

exemptions by notice in the Federal 

Register. 

FEMA will continue to implement 

this rule with the cooperation and 

assistance of other U.S. Government 

agencies, including CBP, and will work 

with manufacturers, brokers, 

distributors, exporters, and shippers to 

ensure that the applicable requirements 

are carried out. Any covered materials 

intended for export may be detained by 

CBP while FEMA conducts its review of 

the shipment. FEMA will review the 

shipment and provide notification as 

soon as possible regarding the 

disposition of the covered materials 

under this order, provided that any 

goods that have been detained by CBP 

and are subsequently made subject to a 

DPA-rated order will be consigned to 

FEMA pending further distribution or 

agency direction. FEMA may provide 

additional guidance regarding the 

application of any exemptions to this 

temporary final rule, as appropriate. 

FEMA is modifying the original 

temporary final rule’s authority citation 

to include both DHS Delegation Number 

09052, Rev. 00 (Jan. 3, 2017) and DHS 

Delegation Number 09052, Rev. 00.1 

(Apr. 1, 2020), and to update the 

formatting of other citations previously 

included. FEMA is making a number of 

non-substantive revisions throughout 

part 328 to correct formatting errors and 

improve clarity and readability. FEMA 

is also modifying the original temporary 

final rule at § 328.101 to reflect the 

appropriate statutory language from 

section 101 of the Act. FEMA is further 

modifying § 328.103(a) to update the 

designation of covered materials under 

the rule. FEMA is further clarifying the 

types of PPE surgical masks subject to 

the allocation order and is adding 

specific syringes and hypodermic 

needles (whether distributed separately 

or attached together). The continued 

allocation of certain PPE materials 

reflects current domestic demand, as 

indicated by the number of open 

requests for such materials from State, 

local, Tribal, and territorial (SLTT) 

jurisdictions. Specifically— 

• FEMA is continuing the designation 

of Surgical N95 Filtering Facepiece 

Respirators as covered materials. 

Surgical N95 respirators for medical use 

are still subject to high demand within 

the United States, and supply is not 

expected to catch up with demand at 

this time given the current forecasts of 


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Federal Register / Vol. 85, No. 251 / Thursday, December 31, 2020 / Rules and Regulations 86839 

19The American Society for Testing and Materia 

(ASTM) F 1862 Standard Test Method for 

Resistance of Medical Face Masks to Penetration by 

Synthetic Blood (Horizontal Projection of Fixed 

Volume at a Known Velocity) is the test method 

used to evaluate the resistance of medical face 

masks to penetration by the impact of a small 

volume ((∼2 mL) of a high-velocity stream of 

synthetic blood. Medical face mask pass/fail 

determinations are based on visual detection of 

synthetic blood penetration. 

20The Consumer Protection Safety Commission 

(CPSC) CS 191–53 standard is the flammability 

standard for clothing textiles pursuant to 16 CFR 

part 1610. 

21The National Fire Protection Association 

(NFPA) Standard 702–1980 is the standard for 

classification of the flammability of wearing 

apparel. 

22UL (previously Underwriters Laboratories) is a 

global independent safety science company with 

expertise in innovating safety solutions. The UL 

2154 is the standard for safety fire tests of surgical 

fabrics. 

23ANSI/AAMI PB70 is the second edition of the 

standard for liquid barrier performance of 

protective apparel. 

24The American Society for Testing and Material 

(ASTM) F2407 is an umbrella document which 

describes testing for surgical gowns: Tear resistance, 

seam strength, lint generation, evaporative 

resistance, and water vapor transmission. 

25 ISO 7886–1:2017 specifies requirements and 

test methods for verifying the design of empty 

sterile single-use hypodermic syringes, with or 

without needle, made of plastic or other materials 

and intended for the aspiration and injection of 

fluids after filling by the end-users. 

26More information on CGMP processes can be 

found on the Food and Drug Administration (FDA) 

website, Facts About the Current Good 

Manufacturing Practices (CGMPs) (June 25, 2018), 

https://www.fda.gov/drugs/pharmaceutical-qualityresources/facts-about-current-good-manufacturingpractices-cgmps. 

27Public Law 106–430, 114 Stat. 1901 (Nov. 6, 

2000). 

28https://www.cdc.gov/flu/prevent/vaccinesupply-distribution.htm (accessed December 15, 

2020). As of November 27, 2020, 188 million doses 

of influenza vaccine had been distributed in the 

United States, the highest number of influenza 

doses distributed in the United States during a 

single influenza season. https://www.cdc.gov/flu/ 

fluvaxview/dashboard/vaccinationdistribution.html (accessed December 15, 2020). 

29https://www.cdc.gov/flu/prevent/vaccinesupply-historical.htm (accessed December 15, 

2020). 

30https://www.cdc.gov/flu/prevent/vaccinesupply-distribution.htm (accessed December 15, 

2020). 

31See https://www.cdc.gov/coronavirus/2019- 

ncov/vaccines/different-vaccines.html (accessed 

December 22, 2020). 

32https://www.gov.uk/government/news/ukmedicines-regulator-gives-approval-for-first-ukcovid-19-vaccine (accessed December 15, 2020) and 

https://www.canada.ca/en/health-canada/services/ 

drugs-health-products/covid19-industry/drugsvaccines-treatments/vaccines.html (accessed 

December 15, 2020). 

increases in confirmed cases and 

hospitalizations. 

• FEMA is continuing the designation 

of PPE surgical masks as covered 

materials due to the continued inability 

of domestic supply to meet current 

demands, with modification. In the 

original temporary final rule, FEMA 

designated ‘‘PPE surgical masks, 

including masks that cover the user’s 

nose and mouth and provide a physical 

barrier to fluids and particulate 

materials.’’ This temporary final rule 

clarifies the existing language regarding 

the PPE surgical masks subject to this 

order. As revised, 44 CFR 328.103(a)(2) 

now specifically designates PPE surgical 

masks as described by 21 CFR 878.4040, 

including masks that cover the user’s 

nose and mouth providing a physical 

barrier to fluids and particulate 

materials that meet fluid barrier 

protection standards pursuant to ASTM 

F 1862 19 and to Class I or Class II 

flammability tests under CPSC CS 191– 

53,20 NFPA Standard 702–1980,21 or UL 

2154 standards.22 As of December 9, 

2020, FEMA had open requests for over 

13 million surgical masks from SLTT 

jurisdictions. 

• FEMA is also continuing the 

designation of PPE nitrile gloves as 

covered materials with one minor edit 

to clarify the specific types of gloves 

subject to the order. There is still a 

significant shortage of nitrile gloves. As 

of December 9, 2020, FEMA had open 

requests for over 168 million nitrile 

gloves from SLTT jurisdictions. 

• FEMA is continuing the designation 

of Level 3 and 4 Surgical Gowns and 

Surgical Isolation Gowns that meet all of 

the requirements in ANSI/AAMI 

PB70 23 and ASTM F2407–06 24 and are 

classified by Surgical Gown Barrier 

Performance based on AAMI PB70. At 

this time, domestic supply is not 

meeting demand. As of December 9, 

2020, FEMA had open requests for over 

1.2 million of these gowns from SLTT 

jurisdictions. 

• FEMA is adding designations for 

specific syringes and hypodermic 

needles (whether distributed separately 

or attached together) to the covered 

materials list. The designated materials 

are piston syringes and hypodermic 

needles that are either: Piston syringes 

that allow for the controlled and precise 

flow of liquid as described by 21 CFR 

880.5860, that are compliant with ISO 

7886–1:2017,25 and use only Current 

Good Manufacturing Practice (CGMP) 

processes; 26 or hypodermic single 

lumen needles as described by 21 CFR 

880.5570 that have engineered sharps 

injury protections as described in the 

Needlestick Safety and Prevention 

Act.27 Due to the current high rate of 

influenza vaccine administration, in 

conjunction with the development of 

COVID–19 vaccines, the projected 

domestic supply of these materials is 

not anticipated to meet demand. As of 

the week of December 4, 2020, more 

than 189.4 million influenza vaccine 

doses had been distributed in the 

United States for this influenza season 28

compared to the 2019–2020 influenza 

season, where approximately 174.5 

million influenza vaccine doses were 

distributed for the entire season,29

representing an increase of over 14.9 

million vaccine doses so far in the 

2020–2021 influenza season. A record 

number of influenza vaccine doses is 

being produced and distributed this 

influenza season, and production and 

distribution will occur over a longer 

period of time as a result,30 further 

reducing the domestic supply of 

syringes. Additionally, as of December 

22, 2020, the United States has 

authorized for emergency use two 

COVID–19 vaccines, with multiple other 

vaccines in large clinical trials.31 As of 

December 16, 2020, the United Kingdom 

and Canada have also already approved 

the use of one vaccine for COVID–19.32

As vaccination efforts expand, FEMA 

anticipates that these materials will be 

in short supply. 

Consistent with the DPA and the 

original temporary final rule, FEMA 

may continue to conduct such 

investigations and issue such requests 

for information as may be necessary for 

the enforcement of the Act, including 

this rule. See 44 CFR 328.104(a); see 

also section 705 of the Act, 50 U.S.C. 

4555; Executive Order 13911, 85 FR 

18403 (Apr. 1, 2020). FEMA may seek 

an injunction or other order whenever, 

in the Administrator’s judgment, a 

person has engaged or is about to engage 

in any acts or practices which constitute 

or will constitute a violation of the Act 

or any rule or order issued thereunder. 

See 44 CFR 328.104(b); see also section 

706 of the Act, 50 U.S.C. 4556. In 

addition to an injunction, failure to 

comply fully with this rule is a crime 

punishable by a fine of not more than 

$10,000 or imprisonment for not more 

than one year, or both. See 44 CFR 

328.104(c); see also section 103 of the 

Act, 50 U.S.C. 4513. In addition, 

pursuant to 18 U.S.C. 554, whoever 

fraudulently or knowingly exports or 

sends from the United States, or 

attempts to export or send from the 

United States, any merchandise, article, 

or object contrary to any U.S. law or 

regulation, or receives, conceals, buys, 

sells, or in any manner facilitates the 

transportation, concealment, or sale of 

such merchandise, article, or object, 

prior to exportation, knowing the same 

to be intended for exportation contrary 

to any U.S. law or regulation, faces up 

to 10 years’ imprisonment, a fine, or 

both, if convicted. 

At any point in time, and to the extent 

consistent with United States policy, the 


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86840 Federal Register / Vol. 85, No. 251 / Thursday, December 31, 2020 / Rules and Regulations 

33https://www.who.int/emergencies/diseases/ 

novel-coronavirus-2019 (accessed December 15, 

2020). 

34https://covid.cdc.gov/covid-data-tracker/ 

#trends_dailytrendscases (accessed December 15, 

2020). 35https://covid19.who.int/ (accessed December 

15, 2020). The United States has over 16 million 

confirmed cases compared to over 9.9 million 

confirmed cases in India as of December 15, 2020. 

The United States has over 296,000 deaths from 

COVID–19 compared to over 181,000 deaths in 

Brazil from COVID–19 as of December 15, 2020. 

36https://covid.cdc.gov/covid-data-tracker/ 

#forecasting_weeklycases (accessed December 15, 

2020) and https://covid.cdc.gov/covid-data-tracker/ 

#forecasting_weeklydeaths (accessed December 15, 

2020). 

37A record number of influenza vaccine doses is 

being produced and distributed this influenza 

season, and production and distribution will occur 

over a longer period as a result. https://

www.cdc.gov/flu/prevent/vaccine-supplydistribution.htm (accessed December 15, 2020). As 

of December 22, 2020, the United States has 

authorized for emergency use two COVID–19 

vaccines, with multiple other vaccines in large 

clinical trials. https://www.cdc.gov/coronavirus/ 

2019-ncov/vaccines/different-vaccines.html 

(accessed December 22, 2020). 

FEMA Administrator may determine 

additional materials to be subject to this 

allocation order. Upon a determination 

under section 101(b) of the DPA that an 

additional material is a scarce and 

critical material essential for national 

defense, and that being allocated to 

domestic use under this allocation order 

is the only way to meet national defense 

requirements without significant 

disruption to the domestic markets, the 

Administrator will include these 

additional materials in this allocation 

order, and will provide notification of 

this decision through publication in the 

Federal Register. 

III. Regulatory Procedure and Analyses 

A. Temporary Final Rule With 

Immediate Effective Date 

Agency rulemaking is generally 

governed by the agency rulemaking 

provisions of the Administrative 

Procedure Act (APA). See 5 U.S.C. 553. 

Such provisions generally require that, 

unless the rule falls within one of a 

number of enumerated exceptions, or 

unless another statute exempts the 

rulemaking from the requirements of the 

APA, FEMA must publish a notice of 

proposed rulemaking in the Federal 

Register that provides interested 

persons an opportunity to submit 

written data, views, or arguments, prior 

to finalization of regulatory 

requirements. Section 553(b)(B) 

authorizes a department or agency to 

dispense with the prior notice and 

opportunity for public comment 

requirement when the agency, for ‘‘good 

cause,’’ finds that notice and public 

comment thereon are impracticable, 

unnecessary, or contrary to the public 

interest. 

This rule is exempt from the APA 

under section 709(a) of the Act, 50 

U.S.C. 4559(a). Instead, this rule is 

issued subject to the provisions of 

section 709(b). Pursuant to section 

709(b)(2) of the Act, the Administrator 

has concluded, based on the facts 

related to the COVID–19 pandemic, that, 

with respect to this temporary final rule, 

urgent and compelling circumstances 

continue to make compliance with the 

notice and comment requirements of 

section 709(b)(1) of the Act, 50 U.S.C. 

4559(b)(1), impracticable. The COVID– 

19 pandemic continues to grow 

worldwide. The World Health 

Organization reports over 71.5 million 

cases and over 1.6 million deaths in 220 

countries as of December 15, 2020.33

The severity of the pandemic has 

increased significantly in the United 

States in recent months, with surges of 

up to 244,007 new cases in a single 

day.34 The United States now leads the 

world in the total number of COVID–19 

cases and deaths 35 and the Centers for 

Disease Control and Prevention (CDC) 

estimates the number of confirmed cases 

and deaths in the United States will 

continue to increase.36 As a result of the 

surge in U.S. confirmed cases and 

deaths, demand for PPE used to treat 

patients with the disease has increased 

and the domestic supply has been 

unable to keep pace. As explained 

above, FEMA continues to have a high 

volume of open requests for the specific 

types of PPE listed in this allocation 

order and anticipates this volume will 

increase given the COVID–19 forecasts 

from the CDC. The historic increase in 

the number of influenza vaccine doses 

manufactured and distributed this 

influenza season combined with the 

authorization for emergency use of 

vaccines for COVID–19 and the demand 

for the same by those who wish to be 

vaccinated against the disease means 

the projected domestic supply of 

syringes and hypodermic needles will 

not meet demand in the upcoming 

months.37 If final regulations become 

necessary, an opportunity for public 

comment will be provided for not less 

than 30 days before such regulations 

become final, pursuant to section 

709(b)(2)(C) of the Act, 50 U.S.C. 

4559(b)(2)(C). 

Furthermore, the same facts that 

warrant waiver under section 709(b)(2) 

of the Act would constitute good cause 

for FEMA to determine, under the APA, 

that notice and public comment thereon 

are impractical, unnecessary, or 

contrary to the public interest, and that 

the temporary final rule should become 

effective immediately upon publication 

in the Federal Register. The exigent 

need for this rule is related to the 

COVID–19 pandemic. 

Although the Federal Government, 

along with State and local governments, 

have taken preventative and proactive 

measures to slow the spread of COVID– 

19, and to treat those affected, the 

current surge of confirmed COVID–19 

cases and deaths within the Nation’s 

communities is straining the Nation’s 

healthcare systems. It is imperative that 

health and medical resources needed to 

respond to the spread of COVID–19, 

including the PPE and other health and 

medical resources affected by this rule, 

continue to be allocated for domestic 

use as appropriate. Given the evolving 

nature of this pandemic, the current 

surge in confirmed COVID–19 cases and 

deaths, and the frequently changing 

supply of and demand for the health 

and medical resources needed to combat 

it, full public notice and comment 

proceedings are impracticable. As 

explained earlier in the preamble, the 

volume of requests for certain health 

and medical resources continues to 

outpace domestic supply. FEMA is 

continuously monitoring SLTT 

jurisdictions’ demand for these scarce 

and critical health and medical 

resources and is taking this immediate 

action to continue to ensure that such 

resources are appropriately allocated for 

domestic use to continue to combat the 

current surge of confirmed COVID–19 

cases and deaths, the forecasted increase 

in both, and the projected shortages of 

supplies to ensure the effective 

distribution of influenza vaccine doses 

and COVID–19 vaccine doses for those 

who wish to be vaccinated against these 

diseases. 

In short, given the national and 

international emergency caused by 

COVID–19 and the current surge of 

confirmed cases and deaths, FEMA 

finds that urgent and compelling 

circumstances have made it 

impracticable and contrary to the public 

health—and, by extension, the public 

interest—to delay these implementing 

regulations until a full public noticeand-comment process is completed. 

Based on current needs, this temporary 

final rule modification and extension is 

needed to appropriately allocate scarce 

and critical materials for domestic use. 

Specifically, FEMA seeks to continue 

designation of certain PPE materials 

with minor modifications based on 

current demand and to add other health 

and medical resources based on 

projected domestic supply not meeting 

demand. 

The measures described in this rule 

are being issued on a temporary basis. 

This temporary final rule with 


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modification remains in effect until June 

30, 2021, unless sooner modified or 

terminated by the Administrator. 

B. Executive Orders 12866 and 13563 

Executive Orders 12866 and 13563 

direct agencies to assess the costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, and public health and 

safety effects; distributive impacts; and 

equity). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, 

reducing costs, harmonizing rules, and 

promoting flexibility. Section 3(f) of 

Executive Order 12866 defines a 

‘‘significant regulatory action’’ as any 

regulatory action that is likely to result 

in a regulation that may (1) have an 

annual effect on the economy of $100 

million or more, or adversely affect in 

a material way a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

State, local, or Tribal governments or 

communities (also referred to as 

‘‘economically significant’’); (2) create a 

serious inconsistency or otherwise 

interfere with an action taken or 

planned by another agency; (3) 

materially altering the budgetary 

impacts of entitlement grants, user fees, 

or loan programs or the rights and 

obligations of recipients thereof; or (4) 

raise novel legal or policy issues arising 

out of legal mandates, the President’s 

priorities, or the principles set forth in 

the Executive Order. 

The Office of Management and Budget 

has designated this temporary final rule 

as an economically significant 

regulatory action. Given that the 

temporary final rule is a significant 

regulatory action, FEMA proceeds under 

the emergency provision of Executive 

Order 12866, section 6(a)(3)(D) based on 

the need for immediate action, as 

described above, to ensure these health 

and medical resources are appropriately 

allocated for domestic use. 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) 

generally requires that when an agency 

issues a proposed rule, or a final rule 

that the agency issues under 5 U.S.C. 

553 after being required by that section 

or any other law to publish a general 

notice of proposed rulemaking, the 

agency must prepare a regulatory 

flexibility analysis that meets the 

requirements of the RFA and publish 

such analysis in the Federal Register. 

5 U.S.C. 603, 604. 

This is neither a proposed rule, nor a 

final rule that the agency has issued 

under 5 U.S.C. 553 after being required 

by that section or any other law to 

publish a general notice of proposed 

rulemaking. This is a temporary final 

rule issued without a prior proposed 

rule, under the separate authority of the 

Defense Production Act of 1950. 

Accordingly, a regulatory flexibility 

analysis is not required. 

D. Unfunded Mandates Reform Act 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 

(Unfunded Mandates Act), 2 U.S.C. 

1532, requires that covered agencies 

prepare a budgetary impact statement 

before promulgating a rule that includes 

any Federal mandate that may result in 

the expenditure by State, local, and 

Tribal governments, in the aggregate, or 

by the private sector, of $100 million in 

1995 dollars, updated annually for 

inflation. If a budgetary impact 

statement is required, section 205 of the 

Unfunded Mandates Act also requires 

covered agencies to identify and 

consider a reasonable number of 

regulatory alternatives before 

promulgating a rule. DHS has 

determined that this rule is not expected 

to result in expenditures by State, local, 

and Tribal governments, or by the 

private sector, in that amount in any one 

year. This rule imposes no requirements 

on State, local, and Tribal governments 

and, therefore, cannot require them to 

expend any funds, let alone in excess of 

the threshold. To the extent that this 

rule affects the private sector, it only 

prohibits conduct, namely certain 

exports. It does not require any private 

sector expenditures within the meaning 

of the Unfunded Mandates Act. Further, 

the rule is excluded from the Unfunded 

Mandates Act under 2 U.S.C. 1532(a) 

and 1503(4) and (5). 

E. National Environmental Policy Act 

(NEPA) 

Under the National Environmental 

Policy Act of 1969 (NEPA), as amended, 

42 U.S.C. 4321 et seq., an agency must 

prepare an environmental assessment or 

environmental impact statement for any 

rulemaking that significantly affects the 

quality of the human environment. 

FEMA has determined that this 

rulemaking does not significantly affect 

the quality of the human environment 

and consequently has not prepared an 

environmental assessment or 

environmental impact statement. 

Rulemaking is a major Federal action 

subject to NEPA. Categorical exclusion 

A3 included in the list of exclusion 

categories at Department of Homeland 

Security Instruction Manual 023–01– 

001–01, Revision 01, Implementation of 

the National Environmental Policy Act, 

Appendix A, issued November 6, 2014, 

covers the promulgation of rules, 

issuance of rulings or interpretations, 

and the development and publication of 

policies, orders, directives, notices, 

procedures, manuals, and advisory 

circulars if they meet certain criteria 

provided in A3(a–f). This temporary 

final rule meets Categorical Exclusion 

A3(a), ‘‘Those of a strictly 

administrative or procedural nature’’. 

F. Executive Order 13132: Federalism 

This rule has been reviewed under 

Executive Order 13132, Federalism, 64 

FR 43255 (August 4, 1999). That 

Executive order imposes certain 

requirements on agencies formulating 

and implementing policies or 

regulations that preempt State law or 

that have federalism implications. DHS 

has determined that this temporary final 

rule will not have a substantial direct 

effect on the States, on the relationship 

between the National Government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. 

Furthermore, there are no provisions in 

this rule that impose direct compliance 

costs on State and local governments. 

Accordingly, DHS is not providing the 

additional analysis as the rule does not 

warrant additional analysis under 

Executive Order 13132. 

G. Congressional Review Act 

Under the Congressional Review Act 

(CRA), 5 U.S.C. 801–808, before a rule 

can take effect, the Federal agency 

promulgating the rule must: Submit to 

Congress and to the Government 

Accountability Office (GAO) a copy of 

the rule; a concise general statement 

relating to the rule, including whether it 

is a major rule; the proposed effective 

date of the rule; a copy of any costbenefit analysis; descriptions of the 

agency’s actions under the Regulatory 

Flexibility Act and the Unfunded 

Mandates Reform Act; and any other 

information or statements required by 

relevant Executive orders. 

FEMA has sent this rule to the 

Congress and to GAO pursuant to the 

CRA. The Office of Information and 

Regulatory affairs has determined that 

this rule is a ‘‘major rule’’ within the 

meaning of the CRA. As this rule 

contains FEMA’s finding for good cause 

that notice and public procedure are 

impracticable, unnecessary, or contrary 

to the public interest, there is not a 

required delay in the effective date. See 

5 U.S.C. 808. 


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List of Subjects in 44 CFR Part 328 

Administrative practice and 

procedure, Business and industry, 

Government contracts, Health or 

medical resource, Hoarding, 

Investigations, Materials, National 

defense, Scarce materials, Strategic and 

critical materials, Threatened materials. 

■ Accordingly, for the reasons set forth 

in the preamble, and effective from 

December 31, 2020 until June 30, 2021, 

chapter I of title 44 of the Code of 

Federal Regulations is amended by 

revising part 328 to read as follows: 

PART 328—COVID–19 ALLOCATION 

ORDERS AND PRIORITY ORDER 

REVIEW UNDER THE DEFENSE 

PRODUCTION ACT 

Sec. 

328.101 Basis and purpose. 

328.102 Requirements. 

328.103 Designation of covered materials. 

328.104 Investigations and injunctions; 

penalties. 

Authority: 50 U.S.C. 4511, et seq.; E.O. 

13909, 85 FR 16227; E.O. 13911, 85 FR 

18403; DHS Delegation Number 09052, Rev. 

00 (Jan. 3, 2017); DHS Delegation Number 

09052, Rev. 00.1 (Apr. 1, 2020); Presidential 

Memorandum on Allocating Certain Scarce 

or Threatened Health and Medical Resources 

to Domestic Use (Apr. 3, 2020). 

§ 328.101 Basis and purpose. 

(a) Basis. The rules in this part are 

issued pursuant to section 101 of the 

Defense Production Act of 1950, as 

amended, 50 U.S.C. 4511, and 

complementary authorities, including 

such authorities as are contained in 

subchapter III of chapter 55 of title 50, 

United States Code (50 U.S.C. 4554, 

4555, 4556, and 4559), which have been 

delegated to the Federal Emergency 

Management Agency (FEMA). 

(b) Purpose. The purpose of the rules 

in this part are to aid the response of the 

United States to the spread of COVID– 

19 by ensuring that scarce and critical 

health and medical resources are 

appropriately allocated for domestic 

use. 

§ 328.102 Requirements. 

(a) Allocation order and requirement 

for the Administrator’s approval. All 

shipments of covered materials, as 

designated in § 328.103, shall be 

allocated for domestic use, and may not 

be exported from the United States 

without explicit approval by FEMA. 

(b) Procedures. U.S. Customs and 

Border Protection (CBP), in coordination 

with such other officials as may be 

appropriate, will notify FEMA of an 

intended export of covered materials. 

CBP must temporarily detain any 

shipment of such covered materials, 

pending the Administrator’s 

determination whether to return for 

domestic use or issue a rated order for 

part or all of the shipment, pursuant to 

the Administrator’s delegated 

authorities. The Administrator will 

make such a determination within a 

reasonable timeframe after notification 

of an intended export. 

(c) Administrator’s determination. In 

making the determination described in 

paragraph (b) of this section, the 

Administrator may consult other 

agencies and will consider the totality of 

the circumstances, including the 

following factors: 

(1) The need to ensure that scarce or 

threatened items are appropriately 

allocated for domestic use; 

(2) Minimization of disruption to the 

supply chain, both domestically and 

abroad; 

(3) The circumstances surrounding 

the distribution of the materials and 

potential hoarding or price-gouging 

concerns; 

(4) The quantity and quality of the 

materials; 

(5) Humanitarian considerations; and 

(6) International relations and 

diplomatic considerations. 

(d) Exemption. (1) The Administrator 

has determined in the interest of 

promoting the national defense to 

generally allow the export of covered 

materials from shipments made by or on 

behalf of U.S. manufacturers with 

continuous export agreements with 

customers in other countries since at 

least January 1, 2020, so long as at least 

80 percent of such manufacturer’s 

domestic production of such covered 

materials, on a per item basis, was 

distributed in the United States in the 

preceding 12 months. If FEMA 

determines that a shipment of covered 

materials falls within the exemption in 

this paragraph (d), such materials may 

be exported without further review by 

FEMA, provided that the Administrator 

may waive the exemption in this 

paragraph (d) and fully review 

shipments of covered materials under 

paragraph (b) of this section, if the 

Administrator determines that doing so 

is necessary or appropriate to promote 

the national defense. FEMA will 

communicate to CBP regarding the 

application of the exemption in this 

paragraph (d) to shipments identified by 

CBP. 

(2) The Administrator may establish, 

in his or her discretion, additional 

exemptions that he or she determines 

necessary or appropriate to promote the 

national defense and will announce any 

such exemptions by notice in the 

Federal Register. 

(e) Exportations prohibited. The 

exportation of covered materials other 

than in accordance with this section is 

prohibited. 

§ 328.103 Designation of covered 

materials. 

(a) The Administrator has designated 

the following materials as ‘‘covered 

materials’’ under this part: 

(1) Surgical N95 Filtering Facepiece 

Respirators, including devices that are 

disposable half-face-piece non-powered 

air-purifying particulate respirators 

intended for use to cover the nose and 

mouth of the wearer to help reduce 

wearer exposure to pathogenic 

biological airborne particulates; 

(2) PPE surgical masks as described by 

21 CFR 878.4040, including masks that 

cover the user’s nose and mouth 

providing a physical barrier to fluids 

and particulate materials, that meet 

fluid barrier protection standards 

pursuant to— 

(i) ASTM F 1862; and 

(ii) Class I or Class II flammability 

tests under CPSC CS 191–53, NFPA 

Standard 702–1980, or UL 2154 

standards; 

(3) PPE nitrile gloves, specifically 

those defined at 21 CFR 880.6250 (exam 

gloves) and 878.4460 (surgical gloves) 

and such nitrile gloves intended for the 

same purposes; 

(4) Level 3 and 4 Surgical Gowns and 

Surgical Isolation Gowns that meet all of 

the requirements in ANSI/AAMI PB70 

and ASTM F2407–06 and are classified 

by Surgical Gown Barrier Performance 

based on AAMI PB70; and 

(5) Syringes and hypodermic needles 

(whether distributed separately or 

attached together) that are either: 

(i) Piston syringes that allow for the 

controlled and precise flow of liquid as 

described by 21 CFR 880.5860, that are 

compliant with ISO 7886–1:2017 and 

use only Current Good Manufacturing 

Practices (CGMP) processes; or 

(ii) Hypodermic single lumen needles 

that have engineered sharps injury 

protections as described in the 

Needlestick Safety and Prevention Act, 

Pub. L. 106–430, 114 Stat. 1901 (Nov. 6, 

2000). 

(b) Upon determination that 

additional items are scarce and 

necessary for national defense, and that 

consideration under the allocation order 

in this part is the only way to meet 

national defense requirements without 

significant disruption to the domestic 

markets, the Administrator may 

designate additional materials as 

‘‘covered materials’’ in the list provided 

in paragraph (a) of this section. The 

Administrator will publish notice of 


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Federal Register / Vol. 85, No. 251 / Thursday, December 31, 2020 / Rules and Regulations 86843 

these additional ‘‘covered materials’’ in 

the Federal Register. 

§ 328.104 Investigations and injunctions; 

penalties. 

(a) To administer or enforce this part, 

the Administrator may exercise the 

authorities available under section 705 

of the Defense Production Act of 1950, 

as amended, 50 U.S.C. 4555, including 

the conduct of investigations, requests 

for information or testimony, and 

inspections of records or premises. 

Before such authorities are utilized, the 

Administrator will determine the scope 

and purpose of the investigation, 

inspection, or inquiry, and be assured 

that no adequate and authoritative data 

are available from any Federal or other 

responsible agency. 

(b) Whenever, in the judgment of the 

Administrator, any person has engaged 

or is about to engage in any acts or 

practices that constitute or will 

constitute a violation of any provision of 

this part, or order issued thereunder, the 

Administrator may exercise the 

authorities available under section 706 

of the Defense Production Act of 1950, 

as amended, 50 U.S.C. 4556, including 

applying for a preliminary, permanent, 

or temporary injunction, restraining 

order, or other order to enforce 

compliance with this part. 

(c) Any person who willfully engages 

in violations of this part is subject to 

penalties available under section 103 of 

the Defense Production Act of 1950, as 

amended, 50 U.S.C. 4513, or other 

available authority. 

Pete Gaynor, 

Administrator, Federal Emergency 

Management Agency. 

[FR Doc. 2020–29060 Filed 12–30–20; 8:45 am] 

BILLING CODE 9111–19–P 

DEPARTMENT OF TRANSPORTATION 

Federal Motor Carrier Safety 

Administration 

49 CFR Part 389 

[Docket No. FMCSA–2016–0341] 

RIN 2126–AB96 

Rulemaking Procedures Update 

AGENCY: Federal Motor Carrier Safety 

Administration (FMCSA), DOT. 

ACTION: Final rule. 

SUMMARY: FMCSA amends its 

rulemaking procedures by revising the 

process for preparing and adopting rules 

and petitions. Also, the Agency adds 

new definitions, and makes general 

administrative corrections throughout 

its rulemaking procedures. These 

actions are authorized under the Fixing 

America’s Surface Transportation 

(FAST) Act and the Administrative 

Procedure Act (APA). 

DATES: This final rule is effective March 

1, 2021. 

Petitions for Reconsideration of this 

final rule must be submitted to the 

FMCSA Administrator no later than 

February 1, 2021. You may use today’s 

amended procedures below in 49 CFR 

389.35. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Steven J. LaFreniere, Regulatory 

Ombudsman, Federal Motor Carrier 

Safety Administration, 1200 New Jersey 

Avenue SE, Washington, DC 20590– 

0001, (202) 366–0596, 

steven.lafreniere@dot.gov. If you have 

questions on viewing or submitting 

material to the docket, contact Dockets 

Operations, (202) 366–9826. 

SUPPLEMENTARY INFORMATION: This final 

rule is organized as follows: 

I. Rulemaking Documents 

A. Availability of Rulemaking Documents 

B. Privacy Act 

II. Legal Basis for the Rulemaking 

III. Discussion of Proposed Rulemaking 

IV. Discussion of Comments and Responses 

V. International Impacts 

VI. Section-By-Section Analysis 

VII. Regulatory Analyses 

A. Executive Order 12866 Executive Order 

12866 (Regulatory Planning and Review, 

as Supplemented by E.O. 13563 and 

DOT Regulations) 

B. Executive Order 13771 Reducing 

Regulation and Controlling Regulatory 

Costs 

C. Regulatory Flexibility Act (Small 

Entities) 

D. Assistance for Small Entities 

E. Unfunded Mandates Reform Act of 1995 

F. Paperwork Reduction Act (Collection of 

Information) 

G. Executive Order 13132 (Federalism) 

H. Executive Order 12988 (Civil Justice 

Reform) 

I. Executive Order 13045 (Protection of 

Children) 

J. Executive Order 12630 (Taking of Private 

Property) 

K. Privacy 

L. Executive Order 12372 

(Intergovernmental Review) 

M. Executive Order 13211 (Energy Supply, 

Distribution, or Use) 

N. Executive Order 13175 (Indian Tribal 

Governments) 

O. National Technology Transfer and 

Advancement Act (Technical Standards) 

P. National Environmental Policy Act of 

1969 

Q. Executive Order 13783 (Promoting 

Energy Independence and Economic 

Growth) 

I. Rulemaking Documents 

A. Availability of Rulemaking 

Documents 

For access to docket FMCSA–2016– 

0341 to read background documents and 

comments received, go to http://

www.regulations.gov at any time, or to 

Dockets Operations at U.S. Department 

of Transportation, Room W12–140, 1200 

New Jersey Avenue SE, Washington, DC 

20590–0001, between 9 a.m. and 5 p.m., 

Monday through Friday, except Federal 

holidays. To be sure someone is there to 

help you, please call (202) 366–9317 or 

(202) 366–9826 before visiting Dockets 

Operations. 

B. Privacy Act 

In accordance with 5 U.S.C. 553(c), 

DOT solicits comments from the public 

to better inform its rulemaking process. 

DOT posts these comments, without 

edit, including any personal information 

the commenter provides, to 

www.regulations.gov, as described in 

the system of records notice (DOT/ALL– 

14 FDMS), which can be reviewed at 

www.dot.gov/privacy. 

II. Legal Basis for the Rulemaking 

The FAST Act requires FMCSA to 

address its rulemaking and petitions 

procedures. Specifically, section 5202 

provides requirements for the Agency to 

follow regarding the development of 

proposed rulemakings [49 U.S.C. 

31136(f)–(h)]. Section 5204 also directs 

the Agency to be more transparent to the 

public regarding how FMCSA 

prioritizes and defines petitions. 

The APA (5 U.S.C. 551–706) 

established procedures for all Federal 

agencies to use in developing rules and 

regulations. It also established the 

standards that allow the public to 

participate in a rulemaking as well as 

the opportunity to petition the Federal 

government for the issuance, 

amendment, or repeal of a rule. The 

APA authorizes changes to 49 CFR part 

389, beyond what is required by the 

FAST Act. 

DOT’s regulatory procedures, codified 

at 49 CFR part 5, also describe how 

persons may petition a departmental 

Operating Administration, like FMCSA, 

for a new rulemaking, an exemption 

from an existing rule, or a retrospective 

review. These departmental procedures 

apply unless a statute or an Operating 

Administration’s regulations or 

procedures provide alternate procedures 

for processing petitions. FMCSA’s 

procedures are housed in 49 CFR part 

389, and are the subject of this 

rulemaking. 


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