Prioritization and Allocation of Certain Scarce and Critical Health and Medical Resources for Domestic Use, 86835-86843 [2020-29060]

Agencies

• Federal Emergency Management Agency
• DEPARTMENT OF HOMELAND SECURITY

[Federal Register Volume 85, Number 251 (Thursday, December 31, 2020)]
[Rules and Regulations]
[Pages 86835-86843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-29060]


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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.

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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: https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Daniel McMasters, Program Analyst, 
Office of Policy and Program Analysis, 202-709-0661, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On April 10, 2020, FEMA published a temporary final rule in the 
Federal Register allocating certain health and

[[Page 86836]]

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.
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    \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).
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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\
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    \4\ Statement 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-the-international-health-regulations-(2005)-emergency-committee-
regarding-the-outbreak-of-novel-coronavirus-(2019-ncov) (accessed 
December 2, 2020).
    \5\ HHS, ``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-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/ (accessed December 15, 2020).
    \7\ COVID-19 Emergency Declaration available at https://www.fema.gov/news-release/2020/03/13/covid-19-emergency-declaration 
(accessed December 15, 2020).
    \8\ See https://www.fema.gov/disasters/ (accessed December 15, 
2020).
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    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.
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    \9\ As 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).
    \10\ See https://www.cdc.gov/flu/prevent/vaccine-supply-distribution.htm (accessed December 15, 2020).
    \11\ See https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html (accessed December 22, 2020).
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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\
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    \12\ See 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-threatened-health-medical-resources-domestic-use/ (accessed December 15 2020).
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    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.

[[Page 86837]]

    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\
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    \13\ Executive 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.
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    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).
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    \14\ The 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.
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    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\
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    \15\ See 85 FR 20195 (Apr. 10, 2020).
    \16\ See 85 FR 48113 (Aug. 10, 2020).
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    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\
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    \17\ See 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.
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    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

[[Page 86838]]

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.
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    \18\ 85 FR 22021 (Apr. 21, 2020).
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    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 Sec.  328.101 to 
reflect the appropriate statutory language from section 101 of the Act. 
FEMA is further modifying Sec.  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

[[Page 86839]]

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.
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    \19\ The 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.
    \20\ The Consumer Protection Safety Commission (CPSC) CS 191-53 
standard is the flammability standard for clothing textiles pursuant 
to 16 CFR part 1610.
    \21\ The National Fire Protection Association (NFPA) Standard 
702-1980 is the standard for classification of the flammability of 
wearing apparel.
    \22\ UL (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.
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     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.
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    \23\ ANSI/AAMI PB70 is the second edition of the standard for 
liquid barrier performance of protective apparel.
    \24\ The 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.
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     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.
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    \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.
    \26\ More 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-quality-resources/facts-about-current-good-manufacturing-practices-cgmps.
    \27\ Public Law 106-430, 114 Stat. 1901 (Nov. 6, 2000).
    \28\ https://www.cdc.gov/flu/prevent/vaccine-supply-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/vaccination-distribution.html 
(accessed December 15, 2020).
    \29\ https://www.cdc.gov/flu/prevent/vaccine-supply-historical.htm (accessed December 15, 2020).
    \30\ https://www.cdc.gov/flu/prevent/vaccine-supply-distribution.htm (accessed December 15, 2020).
    \31\ See https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html (accessed December 22, 2020).
    \32\ https://www.gov.uk/government/news/uk-medicines-regulator-gives-approval-for-first-uk-covid-19-vaccine (accessed December 15, 
2020) and https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/vaccines.html (accessed December 15, 2020).
---------------------------------------------------------------------------

    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

[[Page 86840]]

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).
---------------------------------------------------------------------------

    \33\ https://www.who.int/emergencies/diseases/novel-coronavirus-2019 (accessed December 15, 2020).
    \34\ https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases (accessed December 15, 2020).
    \35\ https://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.
    \36\ https://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).
    \37\ 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 as a result. https://www.cdc.gov/flu/prevent/vaccine-supply-distribution.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).
---------------------------------------------------------------------------

    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 notice-and-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

[[Page 86841]]

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 cost-benefit 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.

[[Page 86842]]

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.

0
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).


Sec.  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.


Sec.  328.102  Requirements.

    (a) Allocation order and requirement for the Administrator's 
approval. All shipments of covered materials, as designated in Sec.  
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.


Sec.  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

[[Page 86843]]

these additional ``covered materials'' in the Federal Register.


Sec.  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