Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use; Exemptions
| Published date | 21 April 2020 |
| Citation | 85 FR 22021 |
| Record Number | 2020-08542 |
| Section | Rules and Regulations |
| Court | Federal Emergency Management Agency |
22021
Federal Register / Vol. 85, No. 77 / Tuesday, April 21, 2020 / Rules and Regulations
one or more sources of two-factor
authentication credentials that will be
interoperable with their applications.
Additionally, an IFR provision, 21 CFR
1311.105, requires that a CSP providing
EPCS authentication credentials be
approved by the General Services
Administration Office of Technology
Strategy/Division of Identify
Management to conduct identity
proofing at Assurance Level 3 or above
of NIST SP 800–63–1 (i.e., Identity
Assurance Level 2 or above of NIST SP
800–63–3). DEA has received questions
asking for clarification of this
requirement. DEA is seeking comment
on this approach to identity proofing, as
well as any more comments about
whether clarification of the language
regarding CSP approval would be
helpful.
3. DEA emphasizes that institutional
practitioners are allowed, but not
required, to conduct identity proofing. If
an institutional practitioner decides to
have each practitioner obtain identity
proofing and the two-factor
authentication credential on his or her
own, as other individual practitioners
do, that is permissible under the rule.
DEA is seeking comment on this
approach to identity proofing by
institutional practitioners.
•DEA is also seeking comment on
the methods institutional practitioners
are using to validate the identity of
practitioners remotely. For example, are
institutions viewing practitioners’
driver’s licenses or other forms of
identification remotely using video?
4. The IFR requires that any setting of
or change to logical access controls
related to the issuance of controlled
substance prescriptions be defined as an
auditable event and that a record of the
changes be retained as part of the
internal audit trail. DEA is seeking
comment on this approach to logical
access control for individual
practitioners. In particular, DEA is
seeking comment on whether there are
any adjustments that DEA could make
to this requirement that would reduce
its burden on practitioners while still
protecting the integrity of EPCS.
5. As explained above, the IFR sets
requirements for how institutional
practitioners must establish logical
access control for their electronic
prescription applications. Among other
things, the IFR requires that at least two
individuals from the institution’s
credentialing office provide the part of
the institution that controls the
computer applications with the names
of practitioners authorized to issue
controlled substance prescriptions. The
entry of the data that grant access to
practitioners also requires the
involvement of at least two individuals,
one to enter the data and another to
approve the entry. The institutional
registrant is responsible for designating
and documenting individuals or roles
that can perform these functions. And a
practitioner’s access must be revoked
whenever any of the following occurs:
The institutional practitioner’s or,
where applicable, individual
practitioner’s DEA registration expires
without renewal, or is terminated,
revoked, or suspended; the practitioner
reports that a token or other factor
associated with the two-factor
authentication credential has been lost
or compromised; or the individual
practitioner is no longer authorized to
use the institutional practitioner’s
application. DEA is seeking comment on
this approach to logical access control
for institutional practitioners.
6. The IFR requires that security
events—auditable events that
compromise or could compromise the
integrity of the prescription records of
an electronic prescription application—
be reported to both the application’s
provider and DEA within one business
day. DEA is seeking comment from
EPCS application users on whether they
have experienced a security incident
and, if so, whether they have
experienced any difficulties reporting it.
7. DEA is generally seeking comment
on any aspects of the IFR or other EPCS
areas where further clarification would
be helpful. For example:
•What types of issues have
registrants encountered during the
adoption and implementation of EPCS
into their workflow, particularly where
a prescriber uses an electronic health
record (electronic medical record)?
•What types of devices are currently
being used to create, sign, transmit, and
process controlled substances
electronically? For example, are
practitioners using iOS or Android
mobile devices, Chromebooks, Windows
Laptop/Desktops, Mac OS, or others?
•Are there problems using two-factor
authentication due to the method used
to complete verification (e.g., prohibited
or limited cellular service, restriction on
external USB devices, offline system
access)?
•Has two-factor authentication
caused barriers to efficient workflows?
•Have staff workflows at long-term
and post-acute care facilities faced
barriers during the adoption and
implementation of EPCS?
8. Many institutions have
implemented biometrics as part of their
authentication credentialing for
electronic applications. DEA is seeking
comments in response to the following
questions:
•What types of biometric
authentication credentials are currently
being utilized (e.g., fingerprint, iris scan,
handprint)?
•How has the implementation of
biometrics, as an option for meeting the
two-factor authentication requirement,
benefited the EPCS program?
•Are there alternatives to biometrics
that could result in a greater adoption
rate for EPCS while continuing to meet
the authentication requirements? If so,
please describe the alternative(s) and
indicate how, specifically, it would be
an improvement on the authentication
requirements in the IFR.
9. Previous commenters have
expressed concern regarding failed
transmissions of electronic
prescriptions. DEA is seeking comment
in response to the following questions:
•Have any entities experienced
failed transmissions (e.g., an EPCS being
sent to the wrong pharmacy, an
incorrectly filled out EPCS, an EPCS
fails to send, the pharmacy does not
have the prescribed controlled
substance in stock, or the pharmacy
rejects the EPCS)?
•If any failed transmissions have
occurred, what alternative means of
submitting the prescription to the
pharmacy have been used?
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020–07085 Filed 4–20–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 328
[Docket ID FEMA–2020–0018]
Prioritization and Allocation of Certain
Scarce or Threatened Health and
Medical Resources for Domestic Use;
Exemptions
AGENCY
: Federal Emergency
Management Agency, DHS.
ACTION
: Notification of exemptions.
SUMMARY
: The Federal Emergency
Management Agency (FEMA)
announces exemptions from a
temporary final rule that FEMA
published in the Federal Register on
April 10, 2020.
DATES
: Applicability date: This
notification applies beginning on April
17, 2020.
ADDRESSES
: You may review the docket
by searching for Docket ID FEMA–2020–
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Federal Register / Vol. 85, No. 77 / Tuesday, April 21, 2020 / Rules and Regulations
1
See 85 FR 20195 (Apr. 10, 2020) (codified at 44
CFR part 328).
2
See 44 CFR 328.101.
3
50 U.S.C. 4501 et seq.
4
See 85 FR at 20196–20197.
5
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/.
6
44 CFR 328.102(a).
7
44 CFR 328.102(b).
8
Id.
9
44 CFR 328.102(c).
10
44 CFR 328.102(d)(1).
11
Id.
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
:
Background
On April 10, 2020, the Administrator
of the Federal Emergency Management
Agency Administrator (FEMA
Administrator or the Administrator)
published a temporary final rule (the
‘‘rule’’) to allocate certain scarce or
threatened materials for domestic use,
so that these materials 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 COVID–19 by ensuring
that certain scarce or threatened health
and medical resources are appropriately
allocated for domestic use.
2
The Administrator issued the rule
under the authority of the Defense
Production Act of 1950, as amended
(DPA),
3
and related executive orders
and delegations.
4
Most prominently, on
April 3, 2020, the President signed a
Memorandum on Allocating Certain
Scarce or Threatened Health and
Medical Resources to Domestic Use
(Memorandum).
5
In the Memorandum,
the President directed the Secretary of
Homeland Security, through the
Administrator, and in consultation with
the Secretary of Health and Human
Services (HHS), to use any and all
authority available under section 101 of
the DPA to allocate to domestic use, as
appropriate, five types of personal
protective equipment (PPE) materials
(covered materials).
Consistent with the Memorandum,
the rule provides that until August 10,
2020, and subject to certain exemptions,
no shipments of covered materials may
leave the United States without explicit
approval by FEMA.
6
The rule requires
U.S. Customs and Border Protection
(CBP), in coordination with such other
officials as may be appropriate, to notify
FEMA of an intended export of covered
materials.
7
CBP must temporarily detain
any shipment of such covered materials
pending the Administrator’s
determination whether to return for
domestic use, issue a rated order for, or
allow the export of part or all of the
shipment.
8
In making such
determination, the Administrator may
consult other agencies and will consider
the totality of the circumstances,
including: (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.
9
In addition to providing for the
determination described above, the rule
includes one exemption to the
requirement that covered materials not
leave the United States without explicit
approval by FEMA. In the interest of
promoting the national defense, the
Administrator determined 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.
10
If FEMA determines that a
shipment of covered materials falls
within this exemption, such materials
may be exported without further review
by FEMA, provided that the
Administrator may waive this
exemption and fully review shipments
of covered materials, if the
Administrator determines that doing so
is necessary or appropriate to promote
the national defense.
11
Pertinent to this notification, the rule
also provides that the Administrator
may establish, in his discretion,
additional exemptions that he
determines necessary or appropriate to
promote the national defense and will
announce any such exemptions by
notice in the Federal Register. This
notification announces such
exemptions.
Notice of Additional Exemptions
Pursuant to 44 CFR 328.102(d)(2),
section 101 of the DPA, and related
authorities, the Administrator has
determined that it is necessary and
appropriate in order to promote the
national defense to exempt certain
categories of covered materials from the
requirements of 44 CFR 328.102(a) and
(b). The Administrator may waive any of
these exemptions at any time and fully
review shipments of covered materials
under 44 CFR 328.102(b) if the
Administrator determines that doing so
is necessary or appropriate to promote
the national defense. In addition, if CBP
believes that any manufacturer, broker,
distributor, exporter, or shipper of any
covered materials is intentionally
modifying its shipments in a way to take
advantage of one or more of these
exemptions, diverting materials from
the United States market, or otherwise
trying to circumvent the FEMA review
requirements in 44 CFR 328.102(b)
through application of any of the
exemptions, CBP may detain a shipment
and forward information about that
shipment (including the basis for CBP’s
belief) to FEMA for determination.
For exemptions (2), (3), (4), (8), and
(9), below, FEMA will require a letter of
attestation to be submitted to FEMA via
CBP’s document imaging system and
placed on file with CBP, certifying to
FEMA the purpose of the shipment of
covered materials. The letter should be
submitted to CBP with other
documentation related to the shipment,
and contain the following information:
(1) A description of which
exemption(s) the exporter is claiming.
(2) Details regarding the shipment that
are sufficient for the CBP and FEMA
officials to determine whether the
shipment falls under the claimed
exemption(s).
(3) A statement that the provided
information is true and accurate to the
best of the exporter’s knowledge, and
that the exporter is aware that false
information is subject to prosecution
under the DPA, as outlined in the
allocation order.
Exporters who have concerns about
how to file this letter of attestation
should reach out to CBP to request
additional details.
The exemptions are as follows.
(1) Shipments to U.S.
Commonwealths and Territories,
Including Guam, American Samoa,
Puerto Rico, U.S. Virgin Islands, and the
Commonwealth of the Northern
Mariana Islands (Including Minor
Outlying Islands). The Administrator
issues this exemption to clarify that
shipments to U.S. territories are not
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Federal Register / Vol. 85, No. 77 / Tuesday, April 21, 2020 / Rules and Regulations
considered to be ‘‘exports’’ for purposes
of the implementation of the allocation
order. The Administrator believes that
this exemption is necessary to clarify
the scope of the original allocation order
and to ensure that scarce or threatened
items are allocated for the use of all
Americans, including Americans living
in U.S. territories. The Administrator
believes that ensuring widespread
access by Americans to covered
materials is necessary and appropriate
to promote the national defense and
consistent with the purposes of the
Presidential Memorandum and the
subsequent allocation order to provide
for the needs of all Americans.
(2) Exports of Covered Materials by
Non-profit or Non-governmental
Organizations that are Solely for
Donation to Foreign Charities or
Governments for Free Distribution (Not
Sale) at their Destination(s). The
Administrator believes that it is
necessary and appropriate to promote
the national defense to support the
efforts of domestic and international
non-profit and non-governmental
organizations (NGOs) responding to
COVID–19 around the world, in
response to the humanitarian concerns
that have arisen as a result of this global
pandemic, and consistent with the
position of the United States as a world
leader. A key element of national
defense is the ability of the United
States to convey international
leadership during times of crisis,
including the COVID–19 pandemic.
This includes our ability to exercise
moral leadership, help those in need,
and to remain stalwarts of the
international community. Denying
shipments of humanitarian goods would
undermine U.S. diplomacy and
messaging internationally, allowing
strategic competitors to take advantage
of our absence. The allocation order
recognizes the importance of
humanitarian considerations by
specifying it as an explicit factor to be
considered in making determinations
about whether to allow an export to
proceed or to utilize the purchase
domestically. This exemption creates a
limited definition of what constitutes a
humanitarian shipment for purpose of
the exemption by limiting the
exemption both on the exporter side (by
limiting it to non-profit organizations or
NGOs) and on the recipient side (foreign
governments or charities). Further, the
exemption is limited by specifying that
the goods must be shipped as donations
in kind and cannot be sold upon receipt.
This limited exemption will allow
FEMA to meet the goals of the allocation
order while prioritizing review of
commercial shipments most likely to be
needed for domestic use.
FEMA will require a letter of
attestation to be submitted to FEMA via
CBP’s document imaging system and
placed on file with CBP, certifying to
FEMA the purpose of the shipment of
covered materials.
(3) Intracompany Transfers of
Covered Materials by U.S. Companies
from Domestic Facilities to Company-
owned or Affiliated Foreign Facilities.
The Administrator recognizes the
international nature of many U.S.
companies, and believes that allowing
these companies to continue to produce
at a high level is crucial to the
functioning of the U.S. economy. One of
the factors specifically identified in the
allocation order as being critical for the
national defense is minimization of
disruption of the supply chain, both
domestically and abroad. The
Administrator believes that allowing
this exemption would minimize
disruption to the domestic supply
chain, while not causing a detrimental
shortage of covered materials to
Americans.
FEMA will require a letter of
attestation to be submitted to FEMA via
CBP’s document imaging system and
placed on file with CBP, certifying to
FEMA the purpose of the shipment of
covered materials.
(4) Shipments of Covered Materials
that are Exported Solely for Assembly in
Medical Kits and Diagnostic Testing Kits
Destined for U.S. Sale and Delivery. The
Administrator recognizes that, in many
circumstances, materials destined for
domestic use are assembled in other
countries, prior to being returned to the
United States for domestic distribution.
One of the factors specifically identified
in the allocation order as being critical
for the national defense is the
minimization of disruption of the
supply chain, both domestic and
abroad. The Administrator believes that
allowing the shipments of these kits is
important to allow for uninterrupted
continuation of existing supply chains,
and is the most expedient means to
ensure timely delivery and allocation of
these materials within the United States
to respond to the national emergency.
Relying on existing supply chains where
available and efficient will maximize
the ability for FEMA and CBP to focus
limited resources on areas where the
supplies are being shipped outside the
United States for final disposition. As
noted above, the Administrator believes
that ensuring widespread access by
Americans to covered materials is
necessary and appropriate to promote
the national defense and consistent with
the purposes of the Presidential
Memorandum, and the subsequent
allocation order, to provide for the
needs of Americans.
FEMA will require a letter of
attestation to be submitted to FEMA via
CBP’s document imaging system and
placed on file with CBP, certifying to
FEMA the purpose of the shipment of
covered materials.
(5) Sealed, Sterile Medical Kits and
Diagnostic Testing Kits Where Only a
Portion of the Kit is Made Up of One or
More Covered Materials That Cannot be
Easily Removed Without Damaging the
Kits. The Administrator believes that
detaining shipments containing these
kits, and subsequently attempting to
separate the covered materials from the
kits (potentially destroying the kits in
the process), is an inefficient use of
national defense resources. In addition,
ready-to-use sealed, sterile medical kits
are vital for the healthcare community
globally to continue to meet broader
urgent healthcare needs in the context
of the pandemic. Addressing the related
healthcare needs globally will enable
other countries to best respond to and
contain the pandemic, which will
advance the ability of the United States
Government to best contain the
pandemic within the United States. The
Administrator believes that refraining
from needlessly dismantling valuable
kits is necessary and appropriate to
promote the national defense and
consistent with the purposes of the
Presidential Memorandum, and the
subsequent allocation order, to provide
for the needs of Americans.
(6) Declared Diplomatic Shipments
from Foreign Embassies and Consulates
to their Home Countries. These May be
Shipped via Intermediaries (Logistics
Providers) but are Shipped from and
Consigned to Foreign Governments.
Pursuant to the diplomatic interests of
the United States, the Administrator
believes that it is necessary and
appropriate to promote the national
defense to allow diplomatic shipments
to proceed without interruption or
delay. One of the factors specifically
identified in the allocation order as
being critical for the national defense is
international relations and diplomatic
concerns. The Administrator believes
that stopping these types of shipments
would cause significant international
relations and domestic concerns, while
not providing significantly enhanced
access to covered materials for
Americans. In order to continue to foster
positive diplomatic relationships with
our partners and allies, the
Administrator has determined to
exempt diplomatic shipments from the
allocation order.
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Federal Register / Vol. 85, No. 77 / Tuesday, April 21, 2020 / Rules and Regulations
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, sec. 1 (Apr. 3,
2020), https://www.whitehouse.gov/presidential-
actions/memorandum-allocating-certain-scarce-
threatened-health-medical-resources-domestic-use/.
1
Public Health Emergency Declaration issued by
HHS Secretary, pursuant to Section 319 of the
Public Health Service Act, on January 31, 2020,
with retroactive effective date of January 27, 2020.
For more information, see https://www.phe.gov/
emergency/news/healthactions/phe/Pages/2019-
nCoV.aspx.
2
Due to the public health emergency posed by
COVID–19, the HHS Office for Civil Rights (OCR)
is exercising its enforcement discretion under the
conditions outlined herein. We believe that this
guidance is a statement of agency policy not subject
to the notice and comment requirements of the
Administrative Procedure Act (APA). 5 U.S.C.
553(b)(3)(A). OCR additionally finds that, even if
this guidance were subject to the public
participation provisions of the APA, prior notice
(7) Shipments to Overseas U.S.
Military Addresses, Foreign Service
Posts (e.g., Diplomatic Post Offices), and
Embassies. The Administrator believes
the intent of the Presidential
Memorandum is to protect Americans
by ensuring their access to covered
materials. The Administrator believes
this extends to all Americans, including
those serving our country overseas. For
this reason, the Administrator believes
that it is necessary and appropriate to
promote the national defense to allow
shipments of covered materials to be
shipped overseas to U.S. government
employees working abroad.
(8) In-Transit Merchandise:
Shipments in Transit through the
United States with a Foreign Shipper
and Consignee, Including Shipments
Temporarily Entered into a Warehouse
or Temporarily Admitted to a Foreign
Trade Zone. The April 3 Presidential
Memorandum states that ‘‘To ensure
that these scarce or threatened PPE
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 material overseas’’
(emphasis added).
12
The Administrator
believes that merchandise merely
passing through the United States is
outside the scope of the Presidential
Memorandum. In addition, the
Administrator believes that diversion of
these specific types of materials would
cause significant impacts to
international relations, diplomacy, and
global supply chains, each of which is
a factor that is specifically identified in
the allocation order as being necessary
and appropriate to promote the national
defense. Therefore, the Administrator is
explicitly exempting these shipments
from the enforcement of the allocation
order.
FEMA will require a letter of
attestation to be submitted to FEMA via
CBP’s document imaging system and
placed on file with CBP, certifying to
FEMA the purpose of the shipment of
covered materials.
(9) Shipments for Which the Final
Destination is Canada or Mexico. The
Administrator recognizes the important
role our closest neighbors play in the
national defense interests of the United
States. The integration of the economies
and supply chains among the United
States, Mexico, and Canada is robust.
Many critical sectors—including, for
example, food and agriculture;
communications and energy;
automotive and industrial; water and
wastewater management; and law
enforcement and first responders—cross
national boundaries. Negative impacts
to workers, including a lack of PPE, in
these and other critical sectors in
Canada and Mexico may cause
significant interruptions to the
corresponding supply chains in the
United States, and in turn, may disrupt
the large flow of cross-border trade with
our neighbors. In addition, the United
States maintains close economic and
diplomatic ties with these nations,
which would be negatively impacted by
the restriction of exports of covered
materials into these countries. In the
allocation order, the Administrator
specifically identified minimization of
disruption to the supply chain, both
domestically and abroad, and
international relations and diplomatic
considerations as key elements of
promoting the national defense. Each
would be negatively impacted by
slowing or halting the transportation of
covered materials across country lines
to Canada and Mexico. For these
reasons, the Administrator has
determined that this exemption is
necessary and appropriate to promote
the national defense.
FEMA will require a letter of
attestation stating that the items being
shipped are for use in and not for
transshipment through Canada or
Mexico, to be submitted to FEMA via
CBP’s document imaging system and
placed on file with CBP, certifying to
FEMA the purpose of the shipment of
covered materials.
(10) Shipments by or on behalf of the
U.S. Federal Government, including its
Military. The Administrator recognizes
that any shipment of covered materials
made by or on behalf of the Federal
Government, including its military, are
inherently necessary and appropriate to
promote the national defense, and so
should be exported without delay.
Peter T. Gaynor,
Administrator, Federal Emergency
Management Agency.
[FR Doc. 2020–08542 Filed 4–17–20; 4:15 pm]
BILLING CODE 9111–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
45 CFR Parts 160 and 164
Notification of Enforcement Discretion
for Telehealth Remote
Communications During the COVID–19
Nationwide Public Health Emergency
AGENCY
: Office of the Secretary, HHS.
ACTION
: Notification of enforcement
discretion.
SUMMARY
: This notification is to inform
the public that the Department of Health
and Human Services (HHS) is exercising
its discretion in how it applies the
Privacy, Security, and Breach
Notification Rules under the Health
Insurance Portability and
Accountability Act of 1996 (HIPAA). As
a matter of enforcement discretion, the
HHS Office for Civil Rights (OCR) will
not impose penalties for noncompliance
with the regulatory requirements under
the HIPAA rules against covered health
care providers in connection with the
good faith provision of telehealth during
the COVID–19 nationwide public health
emergency.
DATES
: The Notification of Enforcement
Discretion went into effect on March 17,
2020, and will remain in effect until the
Secretary of HHS declares that the
public health emergency no longer
exists, or upon the expiration date of the
declared public health emergency,
including any extensions, (as
determined by 42 U.S.C. 247d),
1
whichever occurs first.
FOR FURTHER INFORMATION CONTACT
:
Rachel Seeger at (202) 619–0403 or (800)
537–7697 (TDD).
SUPPLEMENTARY INFORMATION
:
I. Background
The Office for Civil Rights (OCR) at
the Department of Health and Human
Services (HHS) is responsible for
enforcing certain regulations issued
under the Health Insurance Portability
and Accountability Act of 1996
(HIPAA),
2
as amended by the Health
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