Authorizing Legislation: 42 CFR 71.55 Human Remains

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G. Executive Order 12988: Civil Justice
Reform
H. Executive Order 13132: Federalism
I. The Plain Language Act of 2010

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 71
[Docket No. CDC–2019–0063]

I. Public Participation

RIN 0920–AA72

On November 25, 2019, HHS/CDC
published a notice of proposed
rulemaking (NPRM) (84 FR 64808) to
amend 42 CFR part 71 (Foreign
Quarantine). The public was invited to
comment on these amendments. In the
NPRM, HHS/CDC specifically requested
public comment on the following:
• Proposed Definitions for ‘‘death
certificate,’’ ‘‘human remains,’’
‘‘importer,’’ and ‘‘leak-proof container.’’
• Whether other valid documents
should be accepted in lieu of a death
certificate.
• The applicability of 42 CFR 71.63 to
42 CFR 71.55.
• The costs to importers to support
inspections and respond to CDC
questions.
• Repackaging costs or decomposition
costs.
The public comment period for the
proposed rule ended on January 24,
2020, and HHS/CDC received three
comments from the public. A summary
of those comments and responses to
those comments are found at Section IV,
below.

Control of Communicable Diseases;
Importation of Human Remains
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Final rule.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), within
the Department of Health and Human
Services (HHS), is issuing this Final
Rule (FR) to amend two provisions
within its Foreign Quarantine
regulations to best protect the public
health of the United States. The
provisions in this Final Rule clarify
various safeguards to prevent the
importation and spread of
communicable diseases affecting human
health into the United States from
threats posed by human remains.
DATES: This rule is effective August 14,
2020. Direct written comments
regarding the Paperwork Reduction Act
(PRA) items contained in this document
by August 14, 2020.
FOR FURTHER INFORMATION CONTACT: For
information regarding this Final Rule:
Ashley C. Altenburger, J.D., Division of
Global Migration and Quarantine,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
H16–4, Atlanta, GA 30329. For
information regarding CDC operations
related to this Final Rule: ATTN:
Kendra Stauffer, D.V.M., Division of
Global Migration and Quarantine,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
V–18–2, Atlanta, GA 30329. Either
person may also be reached by
telephone 404–498–1600 or email
[email protected].
SUPPLEMENTARY INFORMATION:
SUMMARY:

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Table of Contents
I. Public Participation
II. Background
A. Legal authority
B. Regulatory History
III. Summary of the Final Rule
IV. Overview of Public Comment to the 2019
NPRM
V. Alternatives Considered
VI. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
B. Executive Order 13771
C. The Regulatory Flexibility Act
D. The Paperwork Reduction Act
E. Executive Order 12866
F. National Environmental Policy Act
(NEPA)

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II. Background
A. Legal Authority
The primary legal authorities
supporting this rulemaking are sections
361 and 362 of the Public Health
Service Act (42 U.S.C. 264 and 265).
Section 361 authorizes the Secretary 1 of
HHS to make and enforce such
regulations as in the Secretary’s
judgment are necessary to prevent the
introduction, transmission, or spread of
communicable diseases from foreign
countries into the states or possessions
of the United States or from one state or
possession into any other state or
possession. A detailed explanation of
these legal authorities was provided in
the NPRM published at 84 FR 64809.
1 42 U.S.C. 264 and 265 by their terms grant
authority to the U.S. Surgeon General. The
Reorganization Plan No. 3 of 1966 abolished the
Office of the Surgeon General and transferred the
Surgeon General’s functions to the Secretary of
Health, Education, and Welfare (now Secretary of
HHS). 31 FR 8855, 80 Stat. 1610 (Jun. 25, 1966). The
Secretary of Health, Education, and Welfare was redesignated the Secretary of Health and Human
Services by section 509(b) of Public Law No. 96–
88, 93 Stat. 695 (codified at 20 U.S.C. 3508(b)).
Although the Office of the Surgeon General was reestablished in 1987, the Secretary of HHS has
retained the authority for carrying out the functions
of the Surgeon General under 42 U.S.C. 264 and
265.

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B. Regulatory History
On November 25, 2019, HHS/CDC
published a Notice of Proposed
Rulemaking to update 42 CFR 71.50 and
42 CFR 71.55 within its Foreign
Quarantine regulations to address the
risk to public health from the
importation of human remains into the
United States. The provisions contained
within the proposal were designed to
enhance HHS/CDC’s ability to prevent
the importation and spread of
communicable diseases into the United
States and interstate by clarifying for the
public HHS/CDC’s capabilities and
current practices, while also making
them more transparent.
III. Summary of the Final Rule
To best reflect current practice, HHS/
CDC has renamed 42 CFR 71.55
‘‘Importation of Human Remains’’ to
clarify that our authority extends to
portions of the human body, and not
only to ‘‘dead bodies’’ as a whole, as
well as to highlight the difference in
documentation needed between human
remains imported for final resting
(under § 71.55) and human body parts
primarily imported for other reasons,
which may fall under § 71.54 ‘‘Import
regulations for infectious biological
agents, infectious substances, and
vectors.’’ Also for added clarity, HHS/
CDC has included four new definitions
under 42 CFR 71.50 Scope and
definitions, which is applicable to
importations under part 71 subpart F:
‘‘death certificate,’’ ‘‘human remains,’’
‘‘importer,’’ and ‘‘leak-proof container.’’
Updated 42 CFR 71.55(a), now states
that all human remains intended for
import into the United States and those
transiting through the United States en
route to a foreign destination must be
contained in a leak-proof container that
is packaged and shipped in accordance
with all applicable legal requirements.
This requirement will ensure that
individuals handling the packages of
human remains are not exposed to body
fluids that may contain an infectious
biological agent or embalming material,
regardless of whether the remains are
intended for importation or are in
transit through the United States.
Section 71.55(b) informs the public
that imports of human remains known
to contain or reasonably suspected of
containing an infectious biological agent
must abide by 42 CFR 71.54 to ensure
that all measures are taken to protect
U.S. public health. This includes
remains known to contain or reasonably
suspected of containing an infectious
biological agent that have not or cannot
be rendered noninfectious.

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Under § 71.55(c)(1)(i), to ensure that
human remains imported for final
resting enter only for the intended
purpose, we have included a
requirement that such remains be
consigned ‘‘directly’’ to a licensed
mortuary, cemetery, or crematory.
Section 71.55(c)(1)(ii), requires that
these remains (unless embalmed) must
also be accompanied by a death
certificate or, if the death certificate is
incomplete or missing, an importer
certification statement confirming that
the human remains are not known to
contain or stating why the human
remains are not reasonably suspected of
containing an infectious biological
agent. Such documentation ensures that
the human remains do not pose a threat
to public health because the decedent
succumbed to a communicable disease,
including a quarantinable
communicable disease.
Under § 71.55(c)(2)(i), if human
remains are imported for medical
examination or autopsy, the remains
must be consigned directly to an entity
authorized to perform such functions
under the laws of the applicable
jurisdiction prior to subsequent burial,
entombment, or cremation. By
‘‘authorized,’’ HHS/CDC includes
government entities that typically
perform medical examinations or
autopsies such as state or local coroners’
offices, as well as private entities
operating in compliance with the laws
of the relevant jurisdiction. Upon
completion of the medical examination
or autopsy, the human remains must be
immediately delivered to a licensed
mortuary, cemetery, or crematory that
will be responsible for final resting.
Section 71.55(c)(2)(ii), requires that
these remains (unless embalmed) be
accompanied by a death certificate or, if
the death certificate is incomplete or
missing, an importer certification
statement confirming that the human
remains are not known to contain or
stating why the human remains are not
reasonably suspected of containing an
infectious biological agent. Such
documentation ensures that the human
remains being imported do not pose a
threat to public health because the
decedent succumbed to a communicable
disease, including a quarantinable
communicable disease.
Section 71.55(c)(3) requires that,
unless embalmed, all ‘‘human remains’’
(as that term is defined) imported into
the United States for purposes other
than final resting or autopsy be
accompanied by an importer
certification statement confirming that
the human remains are not known to
contain or stating why the human
remains are not reasonably suspected of

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containing an infectious biological
agent. This language addresses the other
uses for human remains such as medical
training or anatomical display.
Finally, under § 71.55(d), the CDC
Director may suspend the entry or
importation of human remains under 42
CFR 71.63 if the Director determines
that such an action is necessary to
protect the public health. Such an
action may occur when (i) the import is
coming from a foreign country
designated by the CDC Director as a
place where a communicable disease
exists that could threaten U.S. public
health and (ii) the import increases the
risk of introducing or spreading the
communicable disease into the United
States. In the past, this provision has
only been invoked to temporarily
suspend wildlife reservoirs of zoonotic
disease and HHS/CDC does not
anticipate that this provision will be
invoked frequently absent a public
health emergency where such measures
would be needed to protect U.S. public
health.
As in the proposal, HHS/CDC notes
that certain federal partners, such as the
Department of Defense (DOD) and the
Department of State (DOS), may require
that human remains of military or
civilian personnel continue on to a
place of final resting outside of the
United States after the remains are
transported into the United States. Such
a transport will not be deemed an
‘‘import’’ under this Final Rule and
therefore will not be subject to the
requirement that remains be consigned
‘‘directly’’ to a licensed mortuary,
cemetery, or crematory, because the
remains are ‘‘transiting’’ through the
United States en route to final
destination. We note also that, under
this Final Rule, HHS/CDC will not
prevent human remains from transiting
through a U.S. port of entry en route to
another country, provided that the
remains are properly packaged in a leakproof container and in compliance with
applicable transportation requirements.
Upon consideration of the public
comments received, HHS/CDC did not
make any changes to the language
proposed to amend part 71 as set forth
in the November 2019 NPRM (84 FR
64808). Therefore, this regulation is
finalized as proposed.
IV. Overview of Public Comments to the
2019 NPRM
On November 25, 2019, HHS/CDC
published a Notice of Proposed
Rulemaking proposing to amend the
current foreign quarantine regulations
for the control of communicable
diseases. The NPRM included a 60-day
public comment period and during this

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time, HHS/CDC received three
comments from the public.
All comments received were in
support of this regulation. All three of
the commenters expressed that this
regulation is important for safeguarding
public health. In addition, one
commenter expressed that the updated
regulation ‘‘represent[s] an appropriate
response to complaints concerning
public health’’ and ‘‘the updated
definition and unambiguous recodification of these provisions are
simple enough for a (sic) someone
lacking education in medicine to
understand and can be adhered to by
almost anyone.’’ Furthermore, another
commenter expressed that ‘‘. . . these
new provisions would be a good idea to
amend, as they make the process of
bringing remains to the United States
safer [ . . . ] these additional safety nets
are needed, especially when regarding
public health.’’
HHS/CDC thanks the commenters for
their input on the proposed rule.
V. Alternatives Considered
As discussed in more detail above and
analyzed in VI(A), HHS/CDC amends
two provisions within its foreign
quarantine regulations (specifically, 42
CFR 71.50 and 71.55) to provide
additional clarity and safeguards to
address the risk to public health from
the importation of human remains into
the United States.
In addition to quantitatively analyzing
the economic impact of providing
additional clarity and safeguards to
address the public health risk from
importation of human remains relative
to the status quo baseline, HHS/CDC
also considered alternatives to this Final
Rule. HHS/CDC considered alternatives
that were both more and less
burdensome than the amendments to 42
CFR 71.50 and 71.55 described in this
Final Rule.
First, HHS/CDC considered whether a
leak-proof container was necessary for
importing human remains. If HHS/CDC
did not specify leak-proof containers for
importation, such an alternative would
be a potentially less burdensome
requirement than transport of human
remains in leak-proof containers. This
alternative may potentially reduce the
burden of airlines and importers.
However, the reduced burden is hard to
quantify because it is unclear whether
importers or airlines would change their
current practices if the less burdensome
alternative was chosen. HHS/CDC does
not believe this regulatory alternative
would significantly change the current
status quo baseline.
First, the reduced burden to airlines
of this alternative would probably be

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minor. The current requirements of the
four largest U.S. carriers to ship human
remains are already consistent with the
HHS/CDC’s leak-proof container
requirement. If HHS/CDC did not
specify that human remains be imported
in leak-proof containers, airlines may
choose to maintain their existing
requirements for transporting human
remains internationally in leak-proof
containers to avoid exposures to their
employees. The usage of leak-proof
containers may also be regulated under
the U.S. Department of Labor’s
Occupational Safety and Health
Administration’s requirements (refer to
29 CFR 1910.1030) after entry through
ports of entry.
In addition, importers (other than
colleges, hospitals, or laboratories) of
human remains for purposes other than
burial, entombment, or cremation may
already be subject to U.S. Department of
Transportation (DOT) packaging
requirements delineated in 49 CFR
173.199. These requirements are more
burdensome than HHS/CDC’s leak-proof
container requirement.
Another alternative would be to
require a more burdensome
requirement, such as a hermetically
sealed casket, to import all unembalmed human remains. This
alternative would increase importers’
burdens compared to the Final Rule.
The increased burden, however, is hard
to quantify because of limited data. The
cost of this alternative would be much
more expensive than the cost associated
with the status quo guidance and HHS/
CDC does not believe the marginal
improvement to public health would
justify the substantially increased cost
of requiring hermetically sealed caskets
to import all un-embalmed human
remains. For the purposes of this Final
Rule, HHS/CDC will apply an
established definition of embalming as
the (1) reduction of microorganisms
within the dead human body; (2)
retarding of organic decomposition, and
(3) restoring the deceased to a life-like
appearance.2
From a public health perspective,
embalming of human remains is
considered a mechanism to render the
remains noninfectious so they no longer
pose a risk of exposure to
communicable diseases. For some
diseases, such as Ebola virus disease,
embalming may pose a public health
risk to personnel performing the
embalming process because of the very
high risk of exposure to blood and other
2 The American Board of Funeral Services
Education, course content, 2001, and (3) Mayer, RG.
Embalming, History, Theory, and Practice, 5th
edition. 2012: McGraw-Hill Medical; ISBN 978–0–
07–174139–2.

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body fluids; for these diseases,
embalming is not recommended.
HHS/CDC documentation
requirements are consistent with
existing international agreements and
instruments governing the international
transportation of human remains as
noted in the DOS Foreign Affairs
Manual, 7 FAM 252(b).3 The
documentation requirements listed in
42 CFR 71.55(c) only apply to human
remains that are not embalmed. Since
the majority of human remains imported
for burial, entombment, or cremation are
embalmed, most importations would
not be affected by this codification of
current practice.
A less burdensome alternative would
be to also eliminate the documentation
requirements for un-embalmed human
remains. However, as noted in 7 FAM
258, DOS states that the consular
mortuary certificate is designed to
facilitate U.S. Customs Clearance. In
addition, DOS requests a certificate of
death, an affidavit by the local funeral
director, and a transit permit as required
by local laws to support exporting
human remains. It should be noted that
the documentation requested by DOS to
support the transportation of cremated
human remains (which are exempt from
HHS/CDC requirements) are similar to
the requested documentation for noncremated human remains.4 In general,
HHS/CDC would expect that death
certificates or the Affidavit of Foreign
Funeral Director and Transit Permit
would be created in the event of an
overseas death and would be available
for most human remains imported for
burial, entombment, or cremation.
However, it may be necessary to provide
either a (translated) death certificate or
to translate the Affidavit of Foreign
Funeral Director or Transit Permit.
Thus, the primary cost may be for
translation services for these documents
if human remains are imported from a
non-English-speaking country.
However, since the importation of most
human remains are already facilitated
by DOS consular offices, translated
documentation may already be provided
to U.S. consular offices in most cases.
Without the documentation required in
this Final Rule, it would not be possible
for HHS/CDC to confirm that
3 The international agreements and instruments
listed in 7 FAM 252(b) are (1) Council of Europe,
Agreement on The Transfer Of Corpses, Signed at
Strasbourg, October 26th, 1973; (2) Pan American
World Health Organization, XVII Pan American
Sanitary Conference, XVIII Regional Committee
Meeting, Resolution XXIX, adopted in Washington,
October 7th, 1966, International Transportation Of
Human Remains; and (3) International
Arrangements Concerning the Conveyance of
Corpses, Signed at Berlin, February 10, 1937.
4 Refer to 7 FAM 256.

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individuals did not die from a
quarantinable communicable disease or
otherwise pose a public health risk to
individuals exposed to their unembalmed remains. In the past, HHS/
CDC has not routinely had issues
obtaining these documents for imported,
un-embalmed human remains for burial,
entombment, or cremation, and did not
receive any public comments on the
cost or burden of producing such
documentation. HHS/CDC believes that
the costs associated with increased risk
of exposure to un-embalmed human
remains infected with communicable
diseases justify the expense for the
documentation requirements in new 42
CFR 71.55(c), once finalized, for unembalmed human remains.
A more burdensome documentation
requirement would be to require that all
importations of human remains (i.e.,
embalmed remains as well as unembalmed remains) comply with this
documentation requirement. However,
HHS/CDC does not believe that the
public health risks posed by embalmed
human remains (e.g., exposure to
embalming fluids) shipped in leak-proof
containers necessitate additional
documentation requirements for public
health purposes.
HHS/CDC also considered an
alternative in which different
requirements would apply to different
countries. However, since most human
remains that are imported to the United
States were U.S. citizens, permanent
residents, or their relatives, HHS/CDC
does not generally believe the risk of
exposure to communicable diseases is
likely to vary depending based on the
country from which human remains are
imported. HHS/CDC does address the
potential need to apply different
requirements to different countries in 42
CFR 71.55(d). The CDC Director may
suspend the entry or importation of
human remains under 42 CFR 71.63 if
the Director determines that such an
action is necessary to protect the public
health. Such an action may occur when
(i) the import is coming from a foreign
country designated by the CDC Director
as a place where a communicable
disease exists that could threaten U.S.
public health and (ii) the import
increases the risk of introducing or
spreading the communicable disease
into the United States. In the past, this
provision has only been invoked to
temporarily suspend wildlife reservoirs
of zoonotic disease such as suspension
of six genera of African rodents to
prevent further importation of
monkeypox virus during the 2003
monkeypox outbreak. The order was
later replaced by an interim Final Rule
on November 3, 2003 (42 CFR 71.56 and

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42 CFR 1240.63). HHS/CDC does not
anticipate that this provision will be
invoked frequently absent a public
health emergency where such measures
would be needed to protect U.S. public
health.
VI. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
Executive Orders 12866 ‘‘Regulatory
Planning and Review,’’ and 13563
‘‘Improving Regulation and Regulatory
Review,’’ 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, 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.

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Statement of Need
As discussed in more detail above,
HHS/CDC amends two provisions
within its foreign quarantine regulations
(specifically, 42 CFR 71.50 and 71.55) to
provide additional clarity and
safeguards to address the risk to public
health from the importation of human
remains into the United States. In recent
years, HHS/CDC has received an
increased number of notifications
regarding the importation of body parts
that are improperly packaged (e.g.,
contained in garbage bags or coolers
susceptible of leaking fluid) or that lack
proper documentation (e.g., importers
stating only that the remains are to be
used for ‘‘training.’’).5 6 In some cases,
importers have misrepresented the
contents of their shipped packages
containing human remains, and the
shipped containers with human remains
were subsequently found to be leaking.
HHS/CDC has two regulatory
provisions that control the safe
importation of human remains into the
United States:
• Under § 71.54, CDC requires an
import permit for the importation of a
whole body or body part that is known
to contain or reasonably suspected of
containing an infectious biological
agent.
• Under current § 71.55, CDC requires
that imported human remains be
cremated, or properly embalmed and
5 https://www.washingtonpost.com/news/
morning-mix/wp/2016/03/26/the-husband-andwife-duo-who-allegedly-dismembered-diseasedbodies-and-sold-them-for-profit/.
6 https://www.reuters.com/investigates/specialreport/usa-bodies-brokers/.

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placed in a hermetically sealed casket,
or accompanied by a permit issued by
the CDC Director if the cause of death
was a quarantinable communicable
disease.
Because both §§ 71.54 and 71.55 are
applicable to imported human remains,
U.S. Customs and Border Protection
agents often hold bodies and body parts
for several days at the port of entry until
a determination is made as to which
regulatory provision should apply.
While CDC has published guidance on
its website, it believes that further
rulemaking is needed to address these
concerns. Therefore, HHS/CDC is
formally amending its regulations to
codify current policy, to clarify roles
and responsibilities, and to better
inform importers what requirements
may apply, including when a permit
may be needed. These changes are not
intended to affect the operations of
other federal partners who have a role
in either the importation of human
remains or the regulation of such
imports.
The regulatory changes described in
the preamble and reported below are a
codification of current requirements
authorized under existing 42 CFR
71.32(b), 71.54, 71.55, and 71.63, and
described in guidance. Since this Final
Rule does not change the regulatory
baseline, HHS/CDC expects minimal
economic impacts on importers of
human remains, Department of
Homeland Security/Customs and Border
Protection/Transportation Security
Administration (DHS/CBP, DHS/TSA,),
HHS/CDC, Department of State (DOS),
airline or other industries that facilitate
the importation of human remains, or
state and local public health
departments (Ph.D.s).
HHS/CDC regulations are necessary to
correct the market failure in which
human remains are improperly
packaged (e.g. contained in garbage bags
or coolers susceptible of leaking fluid)
or that lack proper documentation that
could pose additional risk to
individuals in the event of an accidental
exposure. These changes should reduce
risks of exposure for other non-importer
stakeholders (e.g., carrier or vessel staff,
other travelers, TSA or CBP staff who
inspect cargo) to communicable
diseases. The container requirement
limits exposures to leaking fluids. The
documentation requirements ensure that
human remains that pose a public
health risk are accompanied with the
proper permit documentation under
existing 42 CFR 71.54 or, under 42 CFR
71.55(c)(1)(i) are consigned ‘‘directly’’ to
a licensed mortuary, cemetery, or
crematory. If human remains are
consigned directly to a licensed

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mortuary, cemetery, or crematory, the
human remains will be handled by
professionals with experience handling
human remains. Otherwise, the
documentation and container
requirements would limit others’
exposures to human remains or may
provide additional information (via the
documentation requirements) on
potential public health risks in the event
of an exposure.
The requirements specified under 42
CFR 71.55(a) conform with existing CDC
guidance that human remains should be
transported in a leak-proof container
that is packaged and shipped in
accordance with all applicable legal
requirements. For human remains for
which the cause of death was a
quarantinable communicable disease,
HHS/CDC requirements will change
from the more burdensome hermetically
sealed casket to the less burdensome
leak-proof container. These
requirements are also consistent with
requirements imposed by the four
largest U.S. carriers in 2019 for transport
of human remains (i.e., Delta, American,
United, and Southwest Airlines). In
practice, HHS/CDC is unaware of any
imported human remains of individuals
who died of a quarantinable disease in
the previous 15 years. HHS/CDC
eliminates specific requirements under
current § 71.55 that human remains of a
person who died of a quarantinable
communicable disease be ‘‘embalmed’’
and placed into a ‘‘hermetically sealed
casket’’ because this no longer reflects
current best practices and would
unnecessarily increase the burden on
importers.
The requirements under 42 CFR
71.55(b) simply refer to existing permit
requirements described in 42 CFR 71.54
for all imported human remains known
to contain or reasonably suspected of
containing an infectious biological
agent. There is no change to 42 CFR
71.54, simply clarification in 42 CFR
71.55(b) of when 42 CFR 71.54 should
apply to transport of human remains.
The requirements under 42 CFR 71.55(c)
clarify the documentation requirements
for un-embalmed human remains
imports that do not need permits
according to existing 42 CFR 71.54.
These documentation requirements are
consistent with existing practices in the
Department of State’s Foreign Affairs
Manual and consistent with other
agencies’ requirements for transporting
human remains to facilitate U.S.
Customs Clearance.
DOS works with U.S. residents to
process the required documentation for
importing human remains into the
United States for burial, entombment, or
cremation. Their requirements are

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reported in the current version of the
Foreign Affairs Manual (FAM). In 7
FAM 252(a)(3), DOS notes that CDC’s
authority is not limited to quarantinable
communicable diseases but extends to
the importation of remains of persons
who died of other communicable
diseases. Specifically, 7 FAM 252(a)(3)
states that ‘‘In general, U.S. public
health requirements will be satisfied if
the remains are shipped in a leak-proof
container and accompanied by the death
certificate or the consular mortuary
certificate, which must state that the
deceased did not die from a
quarantinable communicable disease. A
leak-proof container is one that is
puncture-resistant and sealed in a
manner to contain all contents and

prevent leakage of fluids during
handling, storage, transport, or
shipping. While additional restrictions
are not generally employed, CDC
reserves the right to do so on a case-bycase basis when necessary to prevent
the spread of disease.’’
This description is consistent with the
codification of requirements of human
remains for the purposes of burial,
entombment, or cremation under the
new 42 CFR 71.55, once effective, as
summarized above. Because this is a
codification of current practice, the
economic impact on importers of
human remains and DOS are expected
to be minimal. To estimate the cost to
DOS to update the FAM to include
references to 42 CFR 71.55, the cost was

estimated by assuming that 1 GS–14,
step 5 employee and one GS–15, step 5
employee each spend 40 hours (i.e., 80
hours in total) for any updates to cite
the language in 42 CFR 71.55. The
hourly wage rates for two employees
based in Washington-BaltimoreArlington, DC–MD–VA–WV–PA are
$62.23 (GS–14) and $73.20 (GS–15).7 To
account for the non-wage benefits, we
multiplied the wage cost by two to
result in a total cost estimate of $10,834.
The costs for CBP and CDC are expected
to be similar (Table 1), because this
change is a codification of current
practice. Thus, the expected one-time
costs associated with codification for all
three agencies can be estimated at
$31,906.

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TABLE 1—SUMMARY OF THE ONE-TIME COSTS IN 2018 USD TO UPDATE OFFICIAL DOCUMENTS FOR DEPARTMENT OF
STATE (DOS), CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC), AND CUSTOMS AND BORDER PROTECTION
(CBP) COSTS FROM THE CODIFICATION IN 42 CFR 71.55 OF THE REQUIREMENTS AUTHORIZED UNDER EXISTING 42
CFR 71.32(b), 71.54, AND 71.63
Hourly
wage rate 8

Multiplier
for non-wage
benefits and
overhead

Total

Agency

Cost components

DOS ..................
CDC ..................
CBP ...................

80 hours split between GS–14, step 5 and GS–15, step 5 levels ..............
80 hours split between GS–14, step 5 and GS–15, step 5 levels ..............
80 hours split between GS–14, step 5 and GS–15, step 5 levels ..............

$67.72
63.99
67.72

2
2
2

$10,834
10,238
10,834

Total ...........

.......................................................................................................................

........................

........................

31,906

Individuals importing human remains
for purposes other than burial,
entombment, or cremation, may be less
familiar with CDC requirements
authorized under existing 42 CFR
71.32(b) and 71.54. As a result,
importers of human remains for other
purposes may not be aware of the
requirement that human remains must
arrive in an appropriate, leak-proof
shipping container as specified under
new 42 CFR 71.55(a), once effective. In
addition, they may not be aware that,
unless human remains are embalmed
and therefore rendered noninfectious,
they must be accompanied by a death
certificate listing cause of death or that
if the death certificate is incomplete or
if cause of death is not listed, the human
remains must be accompanied by an
importer certification statement either
confirming that the human remains are
not known to contain or stating why the
human remains are not reasonably
suspected of containing an infectious
biological agent as specified under 42

CFR 71.55(c). In addition, importers
would need to apply for a permit under
existing 42 CFR 71.54 if they are unable
to demonstrate that human remains are
not reasonably suspected of containing
an infectious biological agent. Upon
publishing of this Final Rule, CDC will
update its website to ensure that
importers have access to the most up-todate information regarding packaging
and documentation requirements for
human remains.
The codification of existing
requirements should not result in an
additional regulatory burden and should
help reduce the costs by reducing
confusion regarding the requirements
for importing human remains for
purposes other than burial, entombment
or cremation. However, as an upper
bound cost estimate, we assumed that
one additional importer would apply for
a permit to import human remains every
other year after the Final Rule goes into
effect. When importers first apply for a
permit, the greatest expense is

associated with the need for DSAT to
perform an inspection of the importers’
facilities and to document their
findings. This process also requires time
for importers to support the inspection
and respond to questions from DSAT
subject matter experts. HHS/CDC
estimated the amount of time per
inspection to include about 20 hours of
staff time split between the GS–12, GS–
13, and GS–14 pay levels. To estimate
costs, HHS/CDC assumed the staff
would be compensated at step 5 as
summarized in Table 2. In addition to
hourly wages, non-wage benefits and
overhead costs were estimated by
multiplying the wage cost by two. The
average round trip airfare for flights
from Atlanta was estimated at $367
using data from the Bureau of
Transportation Statistics.9 The average
Federal per diem for lodging, meals, and
incidental expenses was estimated at
$158 per day for one day.10 Assuming
that inspections occur on average (0.5

7 U.S. Office of Personnel and Management.
https://www.opm.gov/policy-data-oversight/payleave/salaries-wages/2018/general-schedule/.
Accessed on March 27, 2019.
8 U.S. Office of Personnel and Management.
https://www.opm.gov/policy-data-oversight/pay-

leave/salaries-wages/2018/general-schedule/.
Accessed on March 27, 2019.
9 Bureau of Transportation Statistics. Average
Domestic Airfares (Atlanta, 2018 Q4). https://
transtats.bts.gov/AIRFARES/. Accessed on June 19,
2019.

10 FederalPay.org 2018 Federal Per Diem Rates.
(Average of 50 states). https://www.federalpay.org/
perdiem/2018. Accessed on June 19, 2019.

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Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Rules and Regulations
times per year, the annual cost would be
estimated at $1,518 per year.
In addition to CDC costs, importers
would have to spend time to support the
inspection and respond to CDC
questions. HHS/CDC did not receive
public comments on the costs to
importers to support such inspections.
HHS/CDC assumed the amount of time
required would be equivalent to CDC
staff time (i.e., about 20 hours) and that
the individual working on the

inspection would be compensated at a
rate equivalent to the national average
wage rate reported for individuals
working as Sales Representatives,
Wholesale and Manufacturing,
Technical and Scientific Products as
reported in the Bureau of Labor
Statistics’ May 2018 National
Occupational Employment and Wage
Estimates (Occupation code = 41–
4011).11 Their 2018 reported hourly
wage rate was $44.15. Assuming 0.5

42737

inspections per year and a multiplier of
2 to cover non-wage benefits and
overhead, the annual cost for importers
was estimated at $883 per year. In total,
the annual cost for increased
inspections for CDC ($1,518) and
importers ($883) was estimated at
$2,401. This should represent an upper
bound estimate as HHS/CDC does not
anticipate a large increase in inspections
as a result of this Final Rule.

TABLE 2—ESTIMATED ANNUAL CDC COST IN 2018 USD FOR INSPECTIONS OF THE FACILITIES FOR AN IMPORTER OF
HUMAN REMAINS FOR PURPOSES OTHER THAN FINAL RESTING
Number of
inspections
per year

Number
of staff

Type of CDC staff

Number of
hours spent per
inspection

Average
hourly wage
rate 12

Overhead
multiplier

Annual cost

GS–12 (step 5) ..................................
GS–13 (step 5) ..................................
GS–14 (step 5) ..................................

0.33
0.33
0.33

0.5
0.5
0.5

20
20
20

$41.85
49.76
58.80

2
2
2

$276
328
388

Total ............................................

........................

........................

..............................

........................

........................

993

Travel cost .........................................

Airfare 13 ........

367

158

525

Total (personnel + travel) ...........

........................

........................

........................

1,518

The total projected costs over a 10year time horizon for each government
agency and for importers can be
estimated using a 3% discount rate.

Hotel, food, lodging 14
..............................

........................

Table 3 summarizes the present value
and annualized value of costs over the
full 10-year period. In total, the
estimated cost is $46,977 over 10 years

or an annualized value of $5,507 per
year.

TABLE 3—PRESENT VALUE AND ANNUALIZED VALUE OF COSTS IN 2018 USD OVER 10 YEARS USING A 3% DISCOUNT
RATE FOR GOVERNMENT AGENCIES AND FOR IMPORTERS OF HUMAN REMAINS FOR PURPOSES OTHER THAN FINAL
RESTING

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Net present cost
over 10-year
horizon

Annualized cost
over 10-year
horizon

CDC .............................................................................................................................................................
CBP ..............................................................................................................................................................
DoS ..............................................................................................................................................................
Importers of human remains for other purposes .........................................................................................

$18,408
10,518
10,518
7,532

$2,158
1,233
1,233
883

Total ......................................................................................................................................................

46,977

5,507

In the past, imported human remains
for reasons other than burial,
entombment or cremation have arrived
in inappropriate (i.e., not leak-proof)
containers or without sufficient
documentation to determine whether
such remains may contain or be
reasonably suspected of containing an
infectious biological agent. This has led
to confusion at the port of entry and
detention of the human remains
pending an investigation. CDC reviewed

available importation records and
identified six human remains shipments
that required repackaging over the 5year period from 2014 to 2018. Of the
six shipments, four occurred between
November 2017 and the end of 2018.
These investigations required significant
effort to resolve. CDC involvement
usually includes scientific, legal, policy,
and leadership staff from CDC/DGMQ
and CDC/DSAT. In each of these cases,
CDC determined that a permit issued

according to existing 42 CFR 71.54
would be required when human
remains are reasonably suspected of
containing an infectious biological agent
if they are without adequate shipping
containers or proper documentation,
unless they are cremated, embalmed, or
otherwise rendered noninfectious per
the definition of ‘‘human remains.’’
Although the amount of time per
investigation event varies, on average,
each importation investigation was

11 Bureau of Labor Statistics, May 2018 National
Occupational Employment and Wage Estimates
(Occupation code = 41–4011). https://www.bls.gov/
oes/current/oes_nat.htm. Accessed on June 19,
2019.
12 U.S. Office of Personnel and Management.
https://www.opm.gov/policy-data-oversight/pay-

leave/salaries-wages/2018/general-schedule/.
Atlanta-Athens-Clarke county-Sandy Springs, GA–
AL Accessed on June 19, 2019.
13 Bureau of Transportation Statistics. Average
Domestic Airfares (Atlanta, 2018 Q4). https://
transtats.bts.gov/AIRFARES/. Accessed on June 19,
2019.

14 FederalPay.org 2018 Federal Per Diem Rates.
(Average of 50 states). https://www.federalpay.org/
perdiem/2018. Accessed on June 19, 2019.

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estimated to require approximately 600
hours of CDC staff time split between
the GS–13, GS–14, and GS–15 levels.
The time spent included conference
calls with the importer and CBP, legal
review, permit issuance under 42 CFR
71.54, if applicable, among other
activities (Table 4). The 2018 reported
hourly wage rates for GS–13, GS–14,
and GS–15 employees at step 5 are
$49.76, $58.80, and $69.17 per hour
respectively in the Atlanta, GA area.15 If
this amount of time is split evenly
across each level, the estimated cost per
investigation would be $35,546. This

amount can then be multiplied by 2 to
account for non-wage benefits and
overhead to estimate a total cost of
$71,092 per investigation.
In addition to CDC costs, CBP also
incurs costs to deal with each
investigation including time spent
communicating with CDC. The amount
of time spent by CBP is also significant
and conservatively estimated at 50% of
the time spent by CDC staff. The
estimated hourly wage rate for CBP
officers was estimated by assuming that
the workload would be split evenly
across employees at the GS–5, GS–9,
GS–11, and GS–12 levels with support

from GS–15 managers providing
additional coordination with CDC
senior staff. Thus, compensation was
split evenly across grades and each
grade was assumed to be compensated
at the step 5 level using the WashingtonBaltimore-Arlington hourly pay scale
(on average, $41.02 per hour).16 This
would result in a wage cost of $12,306.
After multiplying wages by 2 to account
for non-wage benefits and overtime, the
estimated CBP cost would be $24,614.
Adding the CBP and CDC costs, the total
cost per investigation event would be
$71,092 + $24,614 = $95,706.

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TABLE 4—BENEFITS (AVERTED COSTS) PER EVENT IN 2018 USD IN WHICH HUMAN REMAINS WITHOUT ADEQUATE DOCUMENTATION OR SHIPPING CONTAINERS ARE IMPORTED FOR PURPOSES OTHER THAN BURIAL, ENTOMBMENT, OR CREMATION AND ARE HELD AT THE PORT OF ENTRY PENDING AN INVESTIGATION
Hourly wage
rate 17

Multiplier
for non-wage
benefits and
overhead

Agency

Cost components

Total

CDC ..................

$59.24

2

$71,092

CBP ...................

600 hours split between GS–13, step 5; GS–14, step 5; and GS–15, step
5 levels.
300 hours at the GS–5, GS–9, GS–11, GS–12, and GS–15, step 5 level

41.02

2

24,614

Total ...........

.......................................................................................................................

........................

........................

95,706

In addition to costs to CDC and CBP,
importers of human remains for
purposes other than final resting might
not use leak-proof containers or fail to
provide import permits or importer
certification statement(s). When this
occurs, importers spend a considerable
amount of time communicating with
CDC and CBP about missing
documentation, searching for missing
documentation after those human
remains arrive at ports of entry, or
repackaging shipments at the importer’s
expense. This codification of
requirements authorized under 42 CFR
71.32(b), 71.54, and 71.55 pertaining to
the importation of human remains
should reduce confusion. Besides the
time spent on searching for
documentation and the cost of
repackaging, the human remains may
begin to decompose during the
investigation process, which would
affect the value of imports that may
otherwise be used for purposes other
than final resting. HHS/CDC does not
have any way to estimate time for
repackaging costs or decomposition
costs, and did not receive any public
comments on these costs. By reducing
confusion, some of these costs may be
averted when 42 CFR 71.55 goes into

effect. On the other hand, codification of
these requirements may increase the
costs of human remains for purposes
other than burial, entombment, or
cremation if such importations are
currently occurring without CBP or CDC
oversight.
The one-time costs of updating
communications materials and the costs
for an additional 0.5 importers per year
to undergo an inspection to verify their
ability to safely import human remains
for purposes other than final resting was
estimated to cost $46,977 over 10 years
(annualized cost: $5,507). These costs
can be compared to the benefits (averted
costs per investigation after human
remains are held at the port of entry
because they arrived in a container that
was not leak-proof or with improper
documentation ($95,706)). During
calendar years 2014–2018, there were
seven time-intensive investigations for
an average 1.4 investigations per year.
Among these events, one shipment of
human remains was re-exported. The
remaining six shipments all required
repackaging and were held by CBP for
between 2 days and 22 days (average
hold: 11.3 days). Of the seven total
investigations, six involved human
remains imported for purposes other

than final resting. One of these
shipments was re-exported and the
other five shipments of human remains
were cremated after being held by CBP.
Four of the seven investigations
occurred in 2018, demonstrating an
increasing trend in improperly imported
human remains.
A comparison can be made between
the estimated costs and potential
benefits (i.e., averted federal
government costs for an investigation).
This comparison suggests that even if
only one held importation requiring
investigation will be averted in the 10
years after the codification goes into
effect, the expected benefits (averted
costs) would exceed expected costs
assuming a discount rate of 3% per year.
To the extent that this Final Rule would
increase the number of inspections by
DSAT, the need to conduct
investigations should decrease
proportionately. This is because it is
assumed that the need for investigations
results from lack of awareness of
importation requirements for human
remains for purposes other than final
resting as authorized under existing 42
CFR 71.32(b), 71.54 and 71.55.
However, the inspection process itself
should allow importers to fully

15 U.S. Office of Personnel and Management.
https://www.opm.gov/policy-data-oversight/payleave/salaries-wages/2018/general-schedule/.
Accessed on March 27, 2019.

16 U.S. Office of Personnel and Management.
https://www.opm.gov/policy-data-oversight/payleave/salaries-wages/2018/general-schedule/.
Accessed on March 27, 2019.

17 U.S. Office of Personnel and Management.
https://www.opm.gov/policy-data-oversight/payleave/salaries-wages/2018/general-schedule/.
Accessed on March 27, 2019.

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understand their import requirements in
regard to shipping containers,
documentation, or permits.
In addition to the reduced costs
associated with imported human
remains for purposes other than burial,
entombment, or cremation arriving with
inadequate documentation or shipping
containers, there may be additional
savings for the small numbers of human
remains that arrive with insufficient
documentation for burial, entombment,
or cremation. During calendar years
2014 through 2018, CDC requested
additional documentation from seven
importers of human remains for burial,
entombment or cremation (average 1.4
events per year) and 9 importers of
human remains for purposes other than
final resting (1.8 events per year). In
contrast to the time-intensive
investigation events described above,
these events were usually resolved
quickly because death certificates listing
cause of death or importer certification
statements either confirming that the
human remains were not known to
contain or stating why the human
remains were not reasonably suspected
of containing an infectious biological
agent were provided relatively quickly.
However, delays still incur some
additional time costs that may be
averted if the requirements codified in
42 CFR 71.55 are better understood.
Finally, the language in 42 CFR
71.55(d) indicating that 42 CFR 71.63
may apply to imported human remains,
if the Director designates a foreign
country and determines that such an
action is necessary to protect the public
health, is cross-referencing an the
existing requirement in 42 CFR 71.63.
Since its enactment, CDC has applied 42
CFR 71.63 one time, on May 10, 2019,
to suspend entry of dogs from Egypt
after three dogs with canine rabies virus
variant were imported into the United
States within four years.18 However, the
suspension has not been in place long
enough to do a full economic analysis
and a suspension of imports for dogs
may not be analogous to a suspension of
imports for human remains in terms of
economic impact.
B. Executive Order 13771
Executive Order 13771 ‘‘Reducing
Regulation and Controlling Regulatory
Costs,’’ requires executive departments
and agencies to eliminate at least two
existing regulations for every new
significant regulation that imposes
18 CDC (May 10, 2019) Notice of Temporary
Suspension of Dogs Entering the United States
From Egypt. 84 FR 20628. https://
www.federalregister.gov/documents/2019/05/10/
2019-09654/notice-of-temporary-suspension-ofdogs-entering-the-united-states-from-egypt.

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costs. HHS/CDC has determined that
this rule imposes no more than de
minimis costs, and therefore not
considered a regulatory action.
C. The Regulatory Flexibility Act
HHS/CDC has analyzed the impacts of
the Final Rule under the Regulatory
Flexibility Act (5 U.S.C. 601–612).
Unless we certify that the Final Rule is
not expected to have a significant
economic impact on a substantial
number of small entities, the Regulatory
Flexibility Act (RFA), as amended by
the Small Business Regulatory
Enforcement Fairness Act (SBREFA),
requires agencies to analyze regulatory
options that would minimize any
significant economic impact of a rule on
small entities. Based on our analysis as
described above, we certify that this
Final Rule will not have a significant
economic impact on a substantial
number of small entities within the
meaning of the RFA.
This regulatory action is not a major
rule as defined by section 804 of the
Small Business Regulatory Enforcement
Fairness Act of 1996. This Final Rule
will not result in an annual effect on the
economy of $100,000,000 or more; a
major increase in cost or prices; or
significant adverse effects on
competition, employment, investment,
productivity, innovation, or on the
ability of United States-based
companies to compete with foreignbased companies in domestic and
export markets.
D. The Paperwork Reduction Act
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection requests titled Foreign
Quarantine Regulations (42 CFR part 71)
(OMB Control No. 0920–0134) and
0920–0199 Application for Permit to
Import Biological Agents and Vectors of
Human Disease into the United States
and Application for Permit to Import or
Transport Live Bats (42 CFR 71.54)
(expiration date 04/30/2021) to the
Office of Management and Budget
(OMB) for review and approval. CDC
previously published a Notice of
Proposed Rulemaking on November 25,
2019 to obtain comments from the
public and affected agencies. CDC
received no comments related to the
previous document. This document
serves to allow an additional 30 days for
public and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:

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42739

(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) Minimize the burden of the
collection of information on those who
are to respond, including, through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to [email protected]. Direct
written comments and/or suggestions
regarding the items contained in this
document to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of final rule publication.
HHS/CDC currently has approval to
collect certain information concerning
the importation of dead bodies under
two OMB Control Numbers: 0920–0134
Foreign Quarantine Regulations
(expiration date 03/31/2022) and 0920–
0199 Application for Permit to Import
Biological Agents and Vectors of Human
Disease into the United States and
Application for Permit to Import or
Transport Live Bats (42 CFR 71.54)
(expiration date 04/30/2021). This Final
Rule is updating one information
collection: 0920–0134. CDC invited
public comment on the burden to the
public outlined in the NPRM and did
not receive any comments.
Information Collections
(1) Foreign Quarantine Regulations
(42 CFR part 71) (OMB Control No.
0920–0134)—Nonmaterial/nonsubstantive change—National Center for
Emerging, and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Description
Section 361 of the Public Health
Service (PHS) Act (42 U.S.C. 264)
authorizes the Secretary of Health and

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Human Services to make and enforce
regulations necessary to prevent the
introduction, transmission, or spread of
communicable diseases from foreign
countries into the United States.
Legislation and existing regulations
governing foreign and interstate
quarantine activities (42 CFR parts 70
and 71) authorize CDC quarantine
officers and customs personnel to
inspect and undertake necessary control
measures in order to protect the public’s
health. Other inspection agencies assist
quarantine officers in public health risk
assessment and management of persons,
animals, and other importations of
public health importance, including
human remains. Human remains may
harbor communicable diseases, and if
not packaged and processed according
to accepted standards, may represent a
risk to handlers and the receiving
community.
Requiring a death certificate that
states the cause of death (or a specified
alternative document) and requiring
appropriate packaging of human
remains mitigates the introduction and
spread of communicable diseases into
the United States with a minimum of
recordkeeping and reporting as well as
a minimum of interference with trade
and travel. The death certificate will
only be required for those seeking to
import human remains that have not

been embalmed or otherwise rendered
noninfectious.
• At present, HHS/CDC has approval
from OMB to collect certain information
and impose recordkeeping requirements
related to foreign quarantine
responsibilities under OMB Control
Number 0920–0134 (expiration 03/31/
2022). HHS/CDC is proposing a nonsubstantive/nonmaterial change to:
• 42 CFR 71.55 Dead Bodies, 42 CFR
71.32(b)—Death certificates (No Form)
• 42 CFR 71.32 Statements or
documentation of non-infectiousness
(No Form)
Description of Respondents.
Respondents to this data collection are
individuals seeking to import human
remains into the United States.
There is no burden to respondents
other than the time taken to acquire a
death certificate for the human remains
being imported to the United States or
to produce documentation stating that
the human remains have been
embalmed or otherwise rendered noninfectious. However, death certificates
and embalming documentation are
routinely produced by mortuary
providers or hospitals after a death. DOS
also provides a consular mortuary
certificate that also commonly states the
cause of death for an individual who
dies abroad or, if the cause of death is
not known, can reference whether the
person died of a communicable disease.

HHS/CDC does not anticipate
significant additional administrative
burden in acquiring these documents.
With data provided by CBP, CDC is
updating the estimate of the number of
imports of human remains that will
require a death certificate from 20 to
150, and increasing by 1850 the estimate
of the number of human remains that
will require some statement or
documentation of non-infectiousness.
CDC believes this is a more accurate
estimate of the volume of imported
human remains imported into the
United States, and not an increase in
respondent burden. As stated above,
both of these documents are routinely
provided by mortuary services and do
not represent an increase in respondent
burden specifically for this rulemaking.
Additionally, as this Final Rule
clarifies the requirements for importing
human remains, HHS/CDC is also
renaming the provision. The associated
information collections will clearly
reference the title:
• 42 CFR 71.55 Importation of Human
Remains—Death Certificate (No Form).
• 42 CFR 71.32, 71.55 Statements or
documentation of non-infectiousness
(No Form).
Table 5 below presents the estimate of
annual burden (in hours) associated
with the reporting requirement under
this OMB control number, accounting
for the rule changes.

TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN 0920–0134
Regulatory provision or form name

Importers ....................................

42 CFR 71.55 Importation of Human
Remains—Death
Certificate
(No
Form).
42 CFR 71.32, 71.55 Statements or
documentation of non-infectiousness
(No Form).

Importer ......................................

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Number of
respondents

Type of respondent

The estimates are based on experience
to date with current recordkeeping and
reporting requirements of 42 CFR 71.55
Dead Bodies—Death Certificate (No
Form) and 42 CFR 71.32 Statements or
documentation of non-infectiousness,
are based on discussion with partners at
DOS and DHS.
(2) Application for Permit to Import
Biological Agents and Vectors of Human
Disease into the United States and
Application for Permit to Import or
Transport Live Bats (42 CFR 71.54)
(OMB Control No. 0920–0199) No
Change Requested–Center for
Preparedness and Response, Centers for
Disease Control and Prevention.

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Average
burden per
response
(in hours)

Total burden
hours

150

1

1

150

3850

1

5/60

321

CDC/DSAT administers OMB Control
No. 0920–0199 and did not make any
changes in information collection. Due
to DSAT’s experience with issuing CDC
import permits, DSAT does not expect
any additional burden from respondents
because respondents understand that
any material including human remains
that is reasonably suspected of
containing an infectious biological agent
requires submission of an application
for CDC import permit.
On an annual basis, DSAT usually
receives approximately 3 applications
for importing human remains that are
known to contain or reasonably
suspected of containing an infectious

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Number of
responses per
respondent

biological agent. DSAT performs
inspection of these requests to ensure
that the facility has the appropriate
biosafety conditions to receive these
materials. DSAT plans to use current
resources for processing any
applications received for importing
human remains that are known to
contain or reasonably suspected of
containing an infectious biological
agent.
E. Executive Order 12866
This rule is not being treated as a
significant regulatory action as defined
by Executive Order 12866. As such, it

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Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Rules and Regulations
has not been reviewed by the Office of
Management and Budget (OMB).
F. National Environmental Policy Act
(NEPA)
HHS/CDC has determined that the
amendments to 42 CFR part 71 will not
have a significant impact on the human
environment.
G. Executive Order 12988: Civil Justice
Reform
HHS/CDC has reviewed this rule
under Executive Order 12988 on Civil
Justice Reform and determines that this
Final Rule meets the standard in the
Executive Order.
H. Executive Order 13132: Federalism
Under Executive Order 13132, a
Federalism analysis is required if a
rulemaking has Federalism
implications, would limit or preempt
State or local law, or impose substantial
direct compliance costs on State or local
governments. Under such
circumstances, a Federal agency must
consult with State and local officials.
Federalism implications is defined as
having substantial direct effects on State
or local governments, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Under 42 U.S.C.
264(e), Federal public health regulations
promulgated under that section do not
preempt State or local public health
regulations, except in the event of a
conflict with the exercise of Federal
authority. Other than to restate this
statutory provision, this rulemaking
does not alter the relationship between
the Federal Government and State/local
governments as set forth in 42 U.S.C.
264. There are no provisions in these
regulations that impose direct
compliance costs on State and local
governments. Therefore, HHS/CDC
believes that the rule does not warrant
additional consultation under Executive
Order 13132.

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I. The Plain Language Act of 2010
Under the Plain Language Act of 2010
(Pub. L. 111–274, October 13, 2010),
Executive Departments and Agencies
are required to use plain language in all
proposed and Final Rules. Prior to
publication, this Final Rule was
reviewed by specialists in health
communication and education to ensure
the content and intention, as well as
substance, were clear and accurate.
HHS/CDC did not receive any public
comment concerning plain language.

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List of Subjects in 42 CFR Part 71
Burial, communicable diseases,
cremation, death certificate,
entombment, human remains, importer,
infectious biological agent, leak-proof
container, public health, quarantinable
communicable diseases.
For the reasons discussed in the
preamble, we amend 42 CFR part 71 as
follows:
PART 71—FOREIGN QUARANTINE
1. The authority citation for part 71
continues to read as follows:

■

Authority: Secs. 215 and 311 of the Public
Health Service (PHS) Act, as amended (42
U.S.C. 216, 243); secs. 361–369, PHS Act, as
amended (42 U.S.C. 264–272).

2. Amend § 71.50, paragraph (b), by
adding in alphabetical order definitions
for ‘‘Death certificate’’, ’’Human
remains’’, ‘‘Importer’’, and ‘‘Leak-proof
container’’ to read as follows:

■

§ 71.50

Scope and definitions.

*

*
*
*
*
(b) * * *
Death certificate means an official
government document that certifies that
a death has occurred and provides
identifying information about the
deceased, including (at a minimum)
name, age, and sex. The document must
also certify the time, place, and cause of
death (if known). If the official
government document is not written in
English, then it must be accompanied by
an English language translation of the
official government document, the
authenticity of which has been attested
to by a person licensed to perform acts
in legal affairs in the country where the
death occurred. In lieu of a death
certificate, a copy of the Consular
Mortuary Certificate and the Affidavit of
Foreign Funeral Director and Transit
Permit, shall together constitute
acceptable identification of human
remains.
*
*
*
*
*
Human remains means a deceased
human body or any portion of a
deceased human body, except:
(i) Clean, dry bones or bone
fragments; human hair; teeth; fingernails
or toenails; or
(ii) A deceased human body and
portions thereof that have already been
fully cremated prior to import; or
(iii) Human cells, tissues or cellular or
tissue-based products intended for
implantation, transplantation, infusion,
or transfer into a human recipient.
Importer means any person importing
or attempting to import an item
regulated under this subpart.
*
*
*
*
*

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42741

Leak-proof container means a
container that is puncture-resistant and
sealed in such a manner as to contain
all contents and prevent leakage of
fluids during handling, storage,
transport, or shipping, such as
(i) A double-layered plastic, punctureresistant body bag (i.e., two sealed body
bags, one inside the other);
(ii) A casket with an interior lining
certified by the manufacturer to be leakproof and puncture-resistant; or
(iii) A sealed metal body-transfer case.
*
*
*
*
*
■ 3. Revise § 71.55 to read as follows:
§ 71.55

Importation of human remains.

(a) Human remains imported into the
United States, or in transit within the
United States and not intended for
import, must be fully contained within
a leak-proof container that is packaged
and shipped in accordance with all
applicable legal requirements.
(b) The provisions of 42 CFR 71.54
shall apply to all imported human
remains known to contain or reasonably
suspected of containing an infectious
biological agent.
(c) Unless accompanied by a permit
issued under 42 CFR 71.54, human
remains imported into the United States
must meet one of the following
requirements:
(1) Human remains imported for
burial, entombment, or cremation must:
(i) Be consigned directly to a licensed
mortuary, cemetery, or crematory for
immediate and final preparation prior to
burial, entombment, or cremation; and
(ii) Unless embalmed, be
accompanied by a death certificate or, if
the death certificate is incomplete or
missing, an importer certification
statement confirming that the human
remains are not known to contain or
stating why the human remains are not
reasonably suspected of containing an
infectious biological agent.
(2) Human remains imported for
medical examination or autopsy must:
(i) Be consigned directly to an entity
authorized to perform such functions
under the laws of the applicable
jurisdiction prior to subsequent burial,
entombment, or cremation; and
(ii) Unless embalmed, be
accompanied by a death certificate or, if
the death certificate is incomplete or
missing, an importer certification
statement confirming that the human
remains are not known to contain or
stating why the human remains are not
reasonably suspected of containing an
infectious biological agent.
(3) Human remains imported for any
other purpose, unless embalmed, must
be accompanied by an importer

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Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Rules and Regulations

certification statement confirming that
the human remains are not known to
contain or stating why the human
remains are not reasonably suspected of
containing an infectious biological
agent.
(d) The Director may suspend the
importation of human remains under 42
CFR 71.63 if the Director designates the
foreign country and determines that
such an action is necessary to protect
the public health.
Dated: June 3, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
[FR Doc. 2020–12931 Filed 7–14–20; 8:45 am]
BILLING CODE 4163–18–P

FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Parts 73 and 76
[MB Docket Nos. 19–165, 17–105; FCC 20–
8; FRS 16923]

Electronic Delivery of Notices to
Broadcast Television Stations;
Modernization of Media Regulation
Initiative
Federal Communications
Commission.
ACTION: Final rule; announcement of
compliance date.
AGENCY:

In this document, the Federal
Communications Commission (FCC)
announces that the Office of
Management and Budget (OMB) has
approved non-substantive and nonmaterial changes to the information
collections associated with certain rule
amendments adopted in the Report and
Order, FCC 20–8, MB Docket Nos. 19–
165, 17–105 (Report and Order), to
modernize certain notice requirements
for cable operators and direct broadcast
satellite (DBS) providers. The
Commission also announces that
compliance with the revised rules is
required. This document is consistent
with Electronic Delivery of Notices to
Broadcast Television Stations,
published March 20, 2020, which stated
that the Commission would publish a
document in the Federal Register
announcing the compliance date for the
revised rules listed in the DATES section
below.
DATES: Compliance with the
amendments to 47 CFR 74.779, 76.54(e),
76.64(k), 76.66(d)(1)(vi), (d)(2)(ii), (v),
and (vi), (d)(3)(iv), (d)(5)(i), (f)(3) and
(4), and (h)(5), 76.1600(e), 76.1607,
76.1608, 76.1609, and 76.1617(a) and

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SUMMARY:

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(c), published March 20, 2020, at 85 FR
15999, is required as of July 31, 2020.
FOR FURTHER INFORMATION CONTACT:
Brendan Holland of the Media Bureau,
Industry Analysis Division, at (202)
418–2757 or [email protected].
SUPPLEMENTARY INFORMATION: This
document announces that OMB
approved the non-substantive and nonmaterial changes to the information
collection requirements in §§ 76.1607
and 76.1617(a) and (c) on March 19,
2020. OMB approved the nonsubstantive and non-material changes to
the information collection requirements
in §§ 76.54(e), 76.64(k), 76.66(d)(1)(vi),
(d)(2)(ii), (v), and (vi), (d)(3)(iv), (d)(5)(i),
(f)(3) and (4), and (h)(5), 76.1600(e),
76.1607, and 76.1608 on March 31,
2020, and the changes to § 76.1609 were
approved by OMB on April 13, 2020.
The remaining rule amendments
adopted in the Report and Order did not
contain new or modified information
collection requirements subject to OMB
approval under the Paperwork
Reduction Act.
The Commission publishes this
document as an announcement of the
compliance date of the revised rules. If
you have any comments on the burden
estimates listed below, or how the
Commission can improve the
collections and reduce any burdens
caused thereby, please contact Cathy
Williams, Federal Communications
Commission, Room 1–C823, 445 12th
Street SW, Washington, DC 20554,
regarding OMB Control Number 3060–
1273. Please include the applicable
OMB Control Number in your
correspondence. The Commission will
also accept your comments via email at
[email protected].
To request materials in accessible
formats for people with disabilities
(Braille, large print, electronic files,
audio format), send an email to fcc504@
fcc.gov or call the Consumer and
Governmental Affairs Bureau at (202)
418–0530 (voice).
Synopsis
As required by the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507),
the FCC is notifying the public that it
received final OMB approval for the
information collection requirements
contained in §§ 76.54(e), 76.64(k),
76.66(d)(1)(vi), (d)(2)(ii), (v), and (vi),
(d)(3)(iv), (d)(5)(i), (f)(3) and (4), and
(h)(5), 76.1600(e), 76.1607, 76.1608,
76.1609, and 76.1617(a) and (c). Under
5 CFR part 1320, an agency may not
conduct or sponsor a collection of
information unless it displays a current,
valid OMB Control Number.
No person shall be subject to any
penalty for failing to comply with a

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collection of information subject to the
Paperwork Reduction Act that does not
display a current, valid OMB Control
Number.
The foregoing is required by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13, October 1, 1995, and 44
U.S.C. 3507.
The total annual reporting burdens
and costs for the respondents are as
follows:
OMB Control Number: 3060–0311.
OMB Approval Date: March 31, 2020.
OMB Expiration Date: March 31,
2023.
Title: Section 76.54, Significantly
Viewed Signals; Method to be Followed
for Special Showings.
Form Number: N/A.
Respondents: Business or other forprofit entities.
Number of Respondents and
Responses: 500 respondents; 1,274
responses.
Estimated Time per Response: 1–15
hours (average).
Frequency of Response: On-occasion
reporting and third-party disclosure
requirements.
Total Annual Burden: 20,610 hours.
Total Annual Cost: $300,000.
Nature and Extent of Confidentiality:
There is no need for confidentiality with
this collection of information.
Privacy Act: No impact(s).
Needs and Uses: The information
collection requirements contained in 47
CFR 76.54(b) state significant viewing in
a cable television or satellite community
for signals not shown as significantly
viewed under 47 CFR 76.54(a) or (d)
may be demonstrated by an
independent professional audience
survey of over-the-air television homes
that covers at least two weekly periods
separated by at least thirty days but no
more than one of which shall be a week
between the months of April and
September. If two surveys are taken,
they shall include samples sufficient to
assure that the combined surveys result
in an average figure at least one
standard error above the required
viewing level.
The information collection
requirements contained in 47 CFR
76.54(c) are used to notify interested
parties, including licensees or
permittees of television broadcast
stations, about audience surveys that are
being conducted by an organization to
demonstrate that a particular broadcast
station is eligible for significantly
viewed status under the Commission’s
rules. The notifications provide
interested parties with an opportunity to
review survey methodologies and file
objections.
Lastly, 47 CFR 76.54(e) and (f), are
used to notify television broadcast

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