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DEPARTMENT OF HEALTH AND G. Executive Order 12988: Civil Justice B. Regulatory History HUMAN SERVICES Reform H. Executive Order 13132: Federalism On November 25, 2019, HHS/CDC 42 CFR Part 71 I. The Plain Language Act of 2010 published a Notice of Proposed Rulemaking to update 42 CFR 71.50 and I. Public Participation [Docket No. CDC–2019–0063] 42 CFR 71.55 within its Foreign RIN 0920–AA72 On November 25, 2019, HHS/CDC Quarantine regulations to address the published a notice of proposed risk to public health from the Control of Communicable Diseases; rulemaking (NPRM) (84 FR 64808) to importation of human remains into the Importation of Human Remains amend 42 CFR part 71 (Foreign United States. The provisions contained within the proposal were designed to AGENCY: Centers for Disease Control and Quarantine). The public was invited to Prevention (CDC), Department of Health comment on these amendments. In the enhance HHS/CDC’s ability to prevent and Human Services (HHS). NPRM, HHS/CDC specifically requested the importation and spread of public comment on the following: communicable diseases into the United ACTION: Final rule. • Proposed Definitions for ‘‘death States and interstate by clarifying for the SUMMARY: The Centers for Disease certificate,’’ ‘‘human remains,’’ public HHS/CDC’s capabilities and Control and Prevention (CDC), within ‘‘importer,’’ and ‘‘leak-proof container.’’ current practices, while also making the Department of Health and Human • Whether other valid documents them more transparent. Services (HHS), is issuing this Final should be accepted in lieu of a death III. Summary of the Final Rule Rule (FR) to amend two provisions certificate. within its Foreign Quarantine • The applicability of 42 CFR 71.63 to To best reflect current practice, HHS/ regulations to best protect the public 42 CFR 71.55. CDC has renamed 42 CFR 71.55 health of the United States. The ‘‘Importation of Human Remains’’ to • The costs to importers to support provisions in this Final Rule clarify clarify that our authority extends to inspections and respond to CDC various safeguards to prevent the portions of the human body, and not questions. importation and spread of • only to ‘‘dead bodies’’ as a whole, as communicable diseases affecting human Repackaging costs or decomposition well as to highlight the difference in health into the United States from costs. documentation needed between human threats posed by human remains. The public comment period for the remains imported for final resting DATES: This rule is effective August 14, proposed rule ended on January 24, (under § 71.55) and human body parts 2020. Direct written comments 2020, and HHS/CDC received three primarily imported for other reasons, regarding the Paperwork Reduction Act comments from the public. A summary which may fall under § 71.54 ‘‘Import (PRA) items contained in this document of those comments and responses to regulations for infectious biological by August 14, 2020. those comments are found at Section IV, agents, infectious substances, and below. FOR FURTHER INFORMATION CONTACT: For vectors.’’ Also for added clarity, HHS/ information regarding this Final Rule: II. Background CDC has included four new definitions Ashley C. Altenburger, J.D., Division of under 42 CFR 71.50 Scope and A. Legal Authority Global Migration and Quarantine, definitions, which is applicable to Centers for Disease Control and The primary legal authorities importations under part 71 subpart F: Prevention, 1600 Clifton Road NE, MS– supporting this rulemaking are sections ‘‘death certificate,’’ ‘‘human remains,’’ H16–4, Atlanta, GA 30329. For 361 and 362 of the Public Health ‘‘importer,’’ and ‘‘leak-proof container.’’ information regarding CDC operations Service Act (42 U.S.C. 264 and 265). Updated 42 CFR 71.55(a), now states related to this Final Rule: ATTN: Section 361 authorizes the Secretary 1 of that all human remains intended for Kendra Stauffer, D.V.M., Division of HHS to make and enforce such import into the United States and those Global Migration and Quarantine, regulations as in the Secretary’s transiting through the United States en Centers for Disease Control and judgment are necessary to prevent the route to a foreign destination must be Prevention, 1600 Clifton Road NE, MS– introduction, transmission, or spread of contained in a leak-proof container that V–18–2, Atlanta, GA 30329. Either communicable diseases from foreign is packaged and shipped in accordance person may also be reached by countries into the states or possessions with all applicable legal requirements. telephone 404–498–1600 or email of the United States or from one state or This requirement will ensure that [email protected]. possession into any other state or individuals handling the packages of SUPPLEMENTARY INFORMATION: possession. A detailed explanation of human remains are not exposed to body these legal authorities was provided in fluids that may contain an infectious Table of Contents the NPRM published at 84 FR 64809. biological agent or embalming material, I. Public Participation regardless of whether the remains are II. Background 1 42 U.S.C. 264 and 265 by their terms grant intended for importation or are in A. Legal authority authority to the U.S. Surgeon General. The transit through the United States. B. Regulatory History Reorganization Plan No. 3 of 1966 abolished the III. Summary of the Final Rule Office of the Surgeon General and transferred the Section 71.55(b) informs the public IV. Overview of Public Comment to the 2019 Surgeon General’s functions to the Secretary of that imports of human remains known NPRM Health, Education, and Welfare (now Secretary of to contain or reasonably suspected of V. Alternatives Considered HHS). 31 FR 8855, 80 Stat. 1610 (Jun. 25, 1966). The containing an infectious biological agent VI. Required Regulatory Analyses Secretary of Health, Education, and Welfare was re- designated the Secretary of Health and Human must abide by 42 CFR 71.54 to ensure A. Executive Orders 12866 and 13563 that all measures are taken to protect B. Executive Order 13771 Services by section 509(b) of Public Law No. 96– 88, 93 Stat. 695 (codified at 20 U.S.C. 3508(b)). U.S. public health. This includes C. The Regulatory Flexibility Act Although the Office of the Surgeon General was re- remains known to contain or reasonably D. The Paperwork Reduction Act established in 1987, the Secretary of HHS has E. Executive Order 12866 retained the authority for carrying out the functions suspected of containing an infectious F. National Environmental Policy Act of the Surgeon General under 42 U.S.C. 264 and biological agent that have not or cannot (NEPA) 265. be rendered noninfectious.

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Under § 71.55(c)(1)(i), to ensure that containing an infectious biological time, HHS/CDC received three human remains imported for final agent. This language addresses the other comments from the public. resting enter only for the intended uses for human remains such as medical All comments received were in purpose, we have included a training or anatomical display. support of this regulation. All three of requirement that such remains be Finally, under § 71.55(d), the CDC the commenters expressed that this consigned ‘‘directly’’ to a licensed Director may suspend the entry or regulation is important for safeguarding mortuary, cemetery, or crematory. importation of human remains under 42 public health. In addition, one Section 71.55(c)(1)(ii), requires that CFR 71.63 if the Director determines commenter expressed that the updated these remains (unless embalmed) must that such an action is necessary to regulation ‘‘represent[s] an appropriate also be accompanied by a death protect the public health. Such an response to complaints concerning certificate or, if the death certificate is action may occur when (i) the import is public health’’ and ‘‘the updated incomplete or missing, an importer coming from a foreign country definition and unambiguous re- certification statement confirming that designated by the CDC Director as a codification of these provisions are the human remains are not known to place where a communicable disease simple enough for a (sic) someone contain or stating why the human exists that could threaten U.S. public lacking education in medicine to remains are not reasonably suspected of health and (ii) the import increases the understand and can be adhered to by containing an infectious biological risk of introducing or spreading the almost anyone.’’ Furthermore, another agent. Such documentation ensures that communicable disease into the United commenter expressed that ‘‘. . . these the human remains do not pose a threat States. In the past, this provision has new provisions would be a good idea to to public health because the decedent only been invoked to temporarily amend, as they make the process of succumbed to a communicable disease, suspend wildlife reservoirs of zoonotic bringing remains to the United States including a quarantinable disease and HHS/CDC does not safer [ . . . ] these additional safety nets communicable disease. anticipate that this provision will be are needed, especially when regarding Under § 71.55(c)(2)(i), if human invoked frequently absent a public public health.’’ remains are imported for medical health emergency where such measures HHS/CDC thanks the commenters for examination or autopsy, the remains would be needed to protect U.S. public their input on the proposed rule. must be consigned directly to an entity health. V. Alternatives Considered authorized to perform such functions As in the proposal, HHS/CDC notes under the laws of the applicable that certain federal partners, such as the As discussed in more detail above and jurisdiction prior to subsequent burial, Department of Defense (DOD) and the analyzed in VI(A), HHS/CDC amends entombment, or cremation. By Department of State (DOS), may require two provisions within its foreign ‘‘authorized,’’ HHS/CDC includes that human remains of military or quarantine regulations (specifically, 42 government entities that typically civilian personnel continue on to a CFR 71.50 and 71.55) to provide perform medical examinations or place of final resting outside of the additional clarity and safeguards to autopsies such as state or local coroners’ United States after the remains are address the risk to public health from offices, as well as private entities transported into the United States. Such the importation of human remains into operating in compliance with the laws a transport will not be deemed an the United States. of the relevant jurisdiction. Upon ‘‘import’’ under this Final Rule and In addition to quantitatively analyzing completion of the medical examination therefore will not be subject to the the economic impact of providing or autopsy, the human remains must be requirement that remains be consigned additional clarity and safeguards to immediately delivered to a licensed ‘‘directly’’ to a licensed mortuary, address the public health risk from mortuary, cemetery, or crematory that cemetery, or crematory, because the importation of human remains relative will be responsible for final resting. remains are ‘‘transiting’’ through the to the status quo baseline, HHS/CDC Section 71.55(c)(2)(ii), requires that United States en route to final also considered alternatives to this Final these remains (unless embalmed) be destination. We note also that, under Rule. HHS/CDC considered alternatives accompanied by a death certificate or, if this Final Rule, HHS/CDC will not that were both more and less the death certificate is incomplete or prevent human remains from transiting burdensome than the amendments to 42 missing, an importer certification through a U.S. port of entry en route to CFR 71.50 and 71.55 described in this statement confirming that the human another country, provided that the Final Rule. remains are not known to contain or remains are properly packaged in a leak- First, HHS/CDC considered whether a stating why the human remains are not proof container and in compliance with leak-proof container was necessary for reasonably suspected of containing an applicable transportation requirements. importing human remains. If HHS/CDC infectious biological agent. Such Upon consideration of the public did not specify leak-proof containers for documentation ensures that the human comments received, HHS/CDC did not importation, such an alternative would remains being imported do not pose a make any changes to the language be a potentially less burdensome threat to public health because the proposed to amend part 71 as set forth requirement than transport of human decedent succumbed to a communicable in the November 2019 NPRM (84 FR remains in leak-proof containers. This disease, including a quarantinable 64808). Therefore, this regulation is alternative may potentially reduce the communicable disease. finalized as proposed. burden of airlines and importers. Section 71.55(c)(3) requires that, However, the reduced burden is hard to unless embalmed, all ‘‘human remains’’ IV. Overview of Public Comments to the quantify because it is unclear whether (as that term is defined) imported into 2019 NPRM importers or airlines would change their the United States for purposes other On November 25, 2019, HHS/CDC current practices if the less burdensome than final resting or autopsy be published a Notice of Proposed alternative was chosen. HHS/CDC does accompanied by an importer Rulemaking proposing to amend the not believe this regulatory alternative certification statement confirming that current foreign quarantine regulations would significantly change the current the human remains are not known to for the control of communicable status quo baseline. contain or stating why the human diseases. The NPRM included a 60-day First, the reduced burden to airlines remains are not reasonably suspected of public comment period and during this of this alternative would probably be

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minor. The current requirements of the body fluids; for these diseases, individuals did not die from a four largest U.S. carriers to ship human embalming is not recommended. quarantinable communicable disease or remains are already consistent with the HHS/CDC documentation otherwise pose a public health risk to HHS/CDC’s leak-proof container requirements are consistent with individuals exposed to their un- requirement. If HHS/CDC did not existing international agreements and embalmed remains. In the past, HHS/ specify that human remains be imported instruments governing the international CDC has not routinely had issues in leak-proof containers, airlines may transportation of human remains as obtaining these documents for imported, choose to maintain their existing noted in the DOS Foreign Affairs un-embalmed human remains for burial, requirements for transporting human Manual, 7 FAM 252(b).3 The entombment, or cremation, and did not remains internationally in leak-proof documentation requirements listed in receive any public comments on the containers to avoid exposures to their 42 CFR 71.55(c) only apply to human cost or burden of producing such employees. The usage of leak-proof remains that are not embalmed. Since documentation. HHS/CDC believes that containers may also be regulated under the majority of human remains imported the costs associated with increased risk the U.S. Department of Labor’s for burial, entombment, or cremation are of exposure to un-embalmed human Occupational Safety and Health embalmed, most importations would remains infected with communicable Administration’s requirements (refer to not be affected by this codification of diseases justify the expense for the 29 CFR 1910.1030) after entry through current practice. documentation requirements in new 42 ports of entry. A less burdensome alternative would CFR 71.55(c), once finalized, for un- In addition, importers (other than be to also eliminate the documentation embalmed human remains. colleges, hospitals, or laboratories) of requirements for un-embalmed human A more burdensome documentation human remains for purposes other than remains. However, as noted in 7 FAM requirement would be to require that all burial, entombment, or cremation may 258, DOS states that the consular importations of human remains (i.e., already be subject to U.S. Department of mortuary certificate is designed to embalmed remains as well as un- Transportation (DOT) packaging facilitate U.S. Customs Clearance. In embalmed remains) comply with this requirements delineated in 49 CFR addition, DOS requests a certificate of documentation requirement. However, 173.199. These requirements are more death, an affidavit by the local funeral HHS/CDC does not believe that the burdensome than HHS/CDC’s leak-proof director, and a transit permit as required public health risks posed by embalmed container requirement. by local laws to support exporting human remains (e.g., exposure to Another alternative would be to human remains. It should be noted that embalming fluids) shipped in leak-proof require a more burdensome the documentation requested by DOS to containers necessitate additional requirement, such as a hermetically support the transportation of cremated documentation requirements for public sealed casket, to import all un- human remains (which are exempt from health purposes. embalmed human remains. This HHS/CDC requirements) are similar to HHS/CDC also considered an alternative would increase importers’ the requested documentation for non- alternative in which different burdens compared to the Final Rule. cremated human remains.4 In general, requirements would apply to different The increased burden, however, is hard HHS/CDC would expect that death countries. However, since most human to quantify because of limited data. The certificates or the Affidavit of Foreign remains that are imported to the United cost of this alternative would be much Funeral Director and Transit Permit States were U.S. citizens, permanent more expensive than the cost associated would be created in the event of an residents, or their relatives, HHS/CDC with the status quo guidance and HHS/ overseas death and would be available does not generally believe the risk of CDC does not believe the marginal for most human remains imported for exposure to communicable diseases is improvement to public health would burial, entombment, or cremation. likely to vary depending based on the justify the substantially increased cost However, it may be necessary to provide country from which human remains are of requiring hermetically sealed caskets either a (translated) death certificate or imported. HHS/CDC does address the to import all un-embalmed human to translate the Affidavit of Foreign potential need to apply different remains. For the purposes of this Final Funeral Director or Transit Permit. requirements to different countries in 42 Rule, HHS/CDC will apply an Thus, the primary cost may be for CFR 71.55(d). The CDC Director may established definition of embalming as translation services for these documents suspend the entry or importation of the (1) reduction of microorganisms if human remains are imported from a human remains under 42 CFR 71.63 if within the dead human body; (2) non-English-speaking country. the Director determines that such an retarding of organic decomposition, and However, since the importation of most action is necessary to protect the public (3) restoring the deceased to a life-like human remains are already facilitated health. Such an action may occur when appearance.2 by DOS consular offices, translated (i) the import is coming from a foreign From a public health perspective, documentation may already be provided country designated by the CDC Director embalming of human remains is to U.S. consular offices in most cases. as a place where a communicable considered a mechanism to render the Without the documentation required in disease exists that could threaten U.S. remains noninfectious so they no longer this Final Rule, it would not be possible public health and (ii) the import pose a risk of exposure to for HHS/CDC to confirm that increases the risk of introducing or communicable diseases. For some spreading the communicable disease diseases, such as Ebola virus disease, 3 The international agreements and instruments into the United States. In the past, this embalming may pose a public health listed in 7 FAM 252(b) are (1) Council of Europe, provision has only been invoked to risk to personnel performing the Agreement on The Transfer Of Corpses, Signed at temporarily suspend wildlife reservoirs Strasbourg, October 26th, 1973; (2) Pan American embalming process because of the very World Health Organization, XVII Pan American of zoonotic disease such as suspension high risk of exposure to blood and other Sanitary Conference, XVIII Regional Committee of six genera of African rodents to Meeting, Resolution XXIX, adopted in Washington, prevent further importation of 2 The American Board of Funeral Services October 7th, 1966, International Transportation Of monkeypox virus during the 2003 Human Remains; and (3) International Education, course content, 2001, and (3) Mayer, RG. monkeypox outbreak. The order was Embalming, History, Theory, and Practice, 5th Arrangements Concerning the Conveyance of edition. 2012: McGraw-Hill Medical; ISBN 978–0– Corpses, Signed at Berlin, February 10, 1937. later replaced by an interim Final Rule 07–174139–2. 4 Refer to 7 FAM 256. on November 3, 2003 (42 CFR 71.56 and

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42 CFR 1240.63). HHS/CDC does not placed in a hermetically sealed casket, mortuary, cemetery, or crematory, the anticipate that this provision will be or accompanied by a permit issued by human remains will be handled by invoked frequently absent a public the CDC Director if the cause of death professionals with experience handling health emergency where such measures was a quarantinable communicable human remains. Otherwise, the would be needed to protect U.S. public disease. documentation and container health. Because both §§ 71.54 and 71.55 are requirements would limit others’ applicable to imported human remains, exposures to human remains or may VI. Required Regulatory Analyses U.S. Customs and Border Protection provide additional information (via the A. Executive Orders 12866 and 13563 agents often hold bodies and body parts documentation requirements) on for several days at the port of entry until potential public health risks in the event Executive Orders 12866 ‘‘Regulatory a determination is made as to which of an exposure. Planning and Review,’’ and 13563 regulatory provision should apply. The requirements specified under 42 ‘‘Improving Regulation and Regulatory While CDC has published guidance on CFR 71.55(a) conform with existing CDC Review,’’ direct agencies to assess the its website, it believes that further guidance that human remains should be costs and benefits of available regulatory rulemaking is needed to address these transported in a leak-proof container alternatives and, if regulation is concerns. Therefore, HHS/CDC is that is packaged and shipped in necessary, to select regulatory formally amending its regulations to accordance with all applicable legal approaches that maximize net benefits codify current policy, to clarify roles requirements. For human remains for (including potential economic, and responsibilities, and to better which the cause of death was a environmental, public health and safety inform importers what requirements quarantinable communicable disease, effects, distributive impacts, and may apply, including when a permit HHS/CDC requirements will change equity). Executive Order 13563 may be needed. These changes are not from the more burdensome hermetically emphasizes the importance of intended to affect the operations of sealed casket to the less burdensome quantifying both costs and benefits, other federal partners who have a role leak-proof container. These reducing costs, harmonizing rules, and in either the importation of human requirements are also consistent with promoting flexibility. remains or the regulation of such requirements imposed by the four Statement of Need imports. largest U.S. carriers in 2019 for transport The regulatory changes described in of human remains (i.e., Delta, American, As discussed in more detail above, the preamble and reported below are a United, and Southwest Airlines). In HHS/CDC amends two provisions codification of current requirements practice, HHS/CDC is unaware of any within its foreign quarantine regulations authorized under existing 42 CFR imported human remains of individuals (specifically, 42 CFR 71.50 and 71.55) to 71.32(b), 71.54, 71.55, and 71.63, and who died of a quarantinable disease in provide additional clarity and described in guidance. Since this Final the previous 15 years. HHS/CDC safeguards to address the risk to public Rule does not change the regulatory eliminates specific requirements under health from the importation of human baseline, HHS/CDC expects minimal current § 71.55 that human remains of a remains into the United States. In recent economic impacts on importers of person who died of a quarantinable years, HHS/CDC has received an human remains, Department of communicable disease be ‘‘embalmed’’ increased number of notifications Homeland Security/Customs and Border and placed into a ‘‘hermetically sealed regarding the importation of body parts Protection/Transportation Security casket’’ because this no longer reflects that are improperly packaged (e.g., Administration (DHS/CBP, DHS/TSA,), current best practices and would contained in garbage bags or coolers HHS/CDC, Department of State (DOS), unnecessarily increase the burden on susceptible of leaking fluid) or that lack airline or other industries that facilitate importers. proper documentation (e.g., importers the importation of human remains, or The requirements under 42 CFR stating only that the remains are to be state and local public health 71.55(b) simply refer to existing permit used for ‘‘training.’’).56 In some cases, departments (Ph.D.s). requirements described in 42 CFR 71.54 importers have misrepresented the HHS/CDC regulations are necessary to for all imported human remains known contents of their shipped packages correct the market failure in which to contain or reasonably suspected of containing human remains, and the human remains are improperly containing an infectious biological shipped containers with human remains packaged (e.g. contained in garbage bags agent. There is no change to 42 CFR were subsequently found to be leaking. or coolers susceptible of leaking fluid) 71.54, simply clarification in 42 CFR HHS/CDC has two regulatory or that lack proper documentation that 71.55(b) of when 42 CFR 71.54 should provisions that control the safe could pose additional risk to apply to transport of human remains. importation of human remains into the individuals in the event of an accidental The requirements under 42 CFR 71.55(c) United States: exposure. These changes should reduce clarify the documentation requirements • Under § 71.54, CDC requires an risks of exposure for other non-importer for un-embalmed human remains import permit for the importation of a stakeholders (e.g., carrier or vessel staff, imports that do not need permits whole body or body part that is known other travelers, TSA or CBP staff who according to existing 42 CFR 71.54. to contain or reasonably suspected of inspect cargo) to communicable These documentation requirements are containing an infectious biological diseases. The container requirement consistent with existing practices in the agent. limits exposures to leaking fluids. The Department of State’s Foreign Affairs • Under current § 71.55, CDC requires documentation requirements ensure that Manual and consistent with other that imported human remains be human remains that pose a public agencies’ requirements for transporting cremated, or properly embalmed and health risk are accompanied with the human remains to facilitate U.S. proper permit documentation under Customs Clearance. 5 https://www.washingtonpost.com/news/ existing 42 CFR 71.54 or, under 42 CFR DOS works with U.S. residents to morning-mix/wp/2016/03/26/the-husband-and- 71.55(c)(1)(i) are consigned ‘‘directly’’ to process the required documentation for wife-duo-who-allegedly-dismembered-diseased- bodies-and-sold-them-for-profit/. a licensed mortuary, cemetery, or importing human remains into the 6 https://www.reuters.com/investigates/special- crematory. If human remains are United States for burial, entombment, or report/usa-bodies-brokers/. consigned directly to a licensed cremation. Their requirements are

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reported in the current version of the prevent leakage of fluids during estimated by assuming that 1 GS–14, Foreign Affairs Manual (FAM). In 7 handling, storage, transport, or step 5 employee and one GS–15, step 5 FAM 252(a)(3), DOS notes that CDC’s shipping. While additional restrictions employee each spend 40 hours (i.e., 80 authority is not limited to quarantinable are not generally employed, CDC hours in total) for any updates to cite communicable diseases but extends to reserves the right to do so on a case-by- the language in 42 CFR 71.55. The the importation of remains of persons case basis when necessary to prevent hourly wage rates for two employees who died of other communicable the spread of disease.’’ based in Washington-Baltimore- diseases. Specifically, 7 FAM 252(a)(3) This description is consistent with the Arlington, DC–MD–VA–WV–PA are states that ‘‘In general, U.S. public codification of requirements of human $62.23 (GS–14) and $73.20 (GS–15).7 To health requirements will be satisfied if remains for the purposes of burial, account for the non-wage benefits, we the remains are shipped in a leak-proof entombment, or cremation under the multiplied the wage cost by two to container and accompanied by the death new 42 CFR 71.55, once effective, as result in a total cost estimate of $10,834. certificate or the consular mortuary summarized above. Because this is a The costs for CBP and CDC are expected certificate, which must state that the codification of current practice, the to be similar (Table 1), because this deceased did not die from a economic impact on importers of change is a codification of current quarantinable communicable disease. A human remains and DOS are expected practice. Thus, the expected one-time leak-proof container is one that is to be minimal. To estimate the cost to costs associated with codification for all puncture-resistant and sealed in a DOS to update the FAM to include three agencies can be estimated at manner to contain all contents and references to 42 CFR 71.55, the cost was $31,906.

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

Multiplier for non-wage Agency Cost components Hourly Total wage rate 8 benefits and overhead

DOS ...... 80 hours split between GS–14, step 5 and GS–15, step 5 levels ...... $67.72 2 $10,834 CDC ...... 80 hours split between GS–14, step 5 and GS–15, step 5 levels ...... 63.99 2 10,238 CBP ...... 80 hours split between GS–14, step 5 and GS–15, step 5 levels ...... 67.72 2 10,834

Total ...... 31,906

Individuals importing human remains CFR 71.55(c). In addition, importers associated with the need for DSAT to for purposes other than burial, would need to apply for a permit under perform an inspection of the importers’ entombment, or cremation, may be less existing 42 CFR 71.54 if they are unable facilities and to document their familiar with CDC requirements to demonstrate that human remains are findings. This process also requires time authorized under existing 42 CFR not reasonably suspected of containing for importers to support the inspection 71.32(b) and 71.54. As a result, an infectious biological agent. Upon and respond to questions from DSAT importers of human remains for other publishing of this Final Rule, CDC will subject matter experts. HHS/CDC purposes may not be aware of the update its website to ensure that estimated the amount of time per requirement that human remains must importers have access to the most up-to- inspection to include about 20 hours of arrive in an appropriate, leak-proof date information regarding packaging staff time split between the GS–12, GS– shipping container as specified under and documentation requirements for 13, and GS–14 pay levels. To estimate new 42 CFR 71.55(a), once effective. In human remains. costs, HHS/CDC assumed the staff addition, they may not be aware that, The codification of existing would be compensated at step 5 as unless human remains are embalmed requirements should not result in an summarized in Table 2. In addition to and therefore rendered noninfectious, additional regulatory burden and should hourly wages, non-wage benefits and they must be accompanied by a death help reduce the costs by reducing overhead costs were estimated by certificate listing cause of death or that confusion regarding the requirements multiplying the wage cost by two. The if the death certificate is incomplete or for importing human remains for average round trip airfare for flights if cause of death is not listed, the human purposes other than burial, entombment from Atlanta was estimated at $367 remains must be accompanied by an or cremation. However, as an upper using data from the Bureau of importer certification statement either bound cost estimate, we assumed that Transportation Statistics.9 The average confirming that the human remains are one additional importer would apply for not known to contain or stating why the a permit to import human remains every Federal per diem for lodging, meals, and human remains are not reasonably other year after the Final Rule goes into incidental expenses was estimated at 10 suspected of containing an infectious effect. When importers first apply for a $158 per day for one day. Assuming biological agent as specified under 42 permit, the greatest expense is that inspections occur on average (0.5

7 U.S. Office of Personnel and Management. leave/salaries-wages/2018/general-schedule/. 10 FederalPay.org 2018 Federal Per Diem Rates. https://www.opm.gov/policy-data-oversight/pay- Accessed on March 27, 2019. (Average of 50 states). https://www.federalpay.org/ leave/salaries-wages/2018/general-schedule/. 9 Bureau of Transportation Statistics. Average perdiem/2018. Accessed on June 19, 2019. Accessed on March 27, 2019. Domestic Airfares (Atlanta, 2018 Q4). https:// 8 U.S. Office of Personnel and Management. transtats.bts.gov/AIRFARES/. Accessed on June 19, https://www.opm.gov/policy-data-oversight/pay- 2019.

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times per year, the annual cost would be inspection would be compensated at a inspections per year and a multiplier of estimated at $1,518 per year. rate equivalent to the national average 2 to cover non-wage benefits and In addition to CDC costs, importers wage rate reported for individuals overhead, the annual cost for importers would have to spend time to support the working as Sales Representatives, was estimated at $883 per year. In total, inspection and respond to CDC Wholesale and Manufacturing, the annual cost for increased questions. HHS/CDC did not receive Technical and Scientific Products as inspections for CDC ($1,518) and public comments on the costs to reported in the Bureau of Labor importers ($883) was estimated at importers to support such inspections. Statistics’ May 2018 National $2,401. This should represent an upper HHS/CDC assumed the amount of time Occupational Employment and Wage bound estimate as HHS/CDC does not required would be equivalent to CDC Estimates (Occupation code = 41– anticipate a large increase in inspections staff time (i.e., about 20 hours) and that 4011).11 Their 2018 reported hourly as a result of this Final Rule. the individual working on the wage rate was $44.15. Assuming 0.5

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 Number of Average Number Overhead Annual cost Type of CDC staff of staff inspections hours spent per hourly wage multiplier per year inspection rate 12

GS–12 (step 5) ...... 0.33 0.5 20 $41.85 2 $276 GS–13 (step 5) ...... 0.33 0.5 20 49.76 2 328 GS–14 (step 5) ...... 0.33 0.5 20 58.80 2 388

Total ...... 993

Travel cost ...... Airfare 13 ...... 367 Hotel, food, lodging 14 158 525

Total (personnel + travel) ...... 1,518

The total projected costs over a 10- Table 3 summarizes the present value or an annualized value of $5,507 per year time horizon for each government and annualized value of costs over the year. agency and for importers can be full 10-year period. In total, the estimated using a 3% discount rate. estimated cost is $46,977 over 10 years

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

Net present cost Annualized cost over 10-year over 10-year horizon horizon

CDC ...... $18,408 $2,158 CBP ...... 10,518 1,233 DoS ...... 10,518 1,233 Importers of human remains for other purposes ...... 7,532 883

Total ...... 46,977 5,507

In the past, imported human remains available importation records and according to existing 42 CFR 71.54 for reasons other than burial, identified six human remains shipments would be required when human entombment or cremation have arrived that required repackaging over the 5- remains are reasonably suspected of in inappropriate (i.e., not leak-proof) year period from 2014 to 2018. Of the containing an infectious biological agent containers or without sufficient six shipments, four occurred between if they are without adequate shipping documentation to determine whether November 2017 and the end of 2018. containers or proper documentation, such remains may contain or be These investigations required significant unless they are cremated, embalmed, or reasonably suspected of containing an effort to resolve. CDC involvement otherwise rendered noninfectious per infectious biological agent. This has led usually includes scientific, legal, policy, the definition of ‘‘human remains.’’ to confusion at the port of entry and and leadership staff from CDC/DGMQ Although the amount of time per detention of the human remains and CDC/DSAT. In each of these cases, investigation event varies, on average, pending an investigation. CDC reviewed CDC determined that a permit issued each importation investigation was

11 Bureau of Labor Statistics, May 2018 National leave/salaries-wages/2018/general-schedule/. 14 FederalPay.org 2018 Federal Per Diem Rates. Occupational Employment and Wage Estimates Atlanta-Athens-Clarke county-Sandy Springs, GA– (Average of 50 states). https://www.federalpay.org/ (Occupation code = 41–4011). https://www.bls.gov/ AL Accessed on June 19, 2019. perdiem/2018. Accessed on June 19, 2019. oes/current/oes_nat.htm. Accessed on June 19, 13 Bureau of Transportation Statistics. Average 2019. Domestic Airfares (Atlanta, 2018 Q4). https:// 12 U.S. Office of Personnel and Management. transtats.bts.gov/AIRFARES/. Accessed on June 19, https://www.opm.gov/policy-data-oversight/pay- 2019.

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estimated to require approximately 600 amount can then be multiplied by 2 to from GS–15 managers providing hours of CDC staff time split between account for non-wage benefits and additional coordination with CDC the GS–13, GS–14, and GS–15 levels. overhead to estimate a total cost of senior staff. Thus, compensation was The time spent included conference $71,092 per investigation. split evenly across grades and each calls with the importer and CBP, legal In addition to CDC costs, CBP also grade was assumed to be compensated review, permit issuance under 42 CFR incurs costs to deal with each at the step 5 level using the Washington- 71.54, if applicable, among other investigation including time spent Baltimore-Arlington hourly pay scale activities (Table 4). The 2018 reported communicating with CDC. The amount (on average, $41.02 per hour).16 This of time spent by CBP is also significant hourly wage rates for GS–13, GS–14, would result in a wage cost of $12,306. and conservatively estimated at 50% of and GS–15 employees at step 5 are After multiplying wages by 2 to account the time spent by CDC staff. The $49.76, $58.80, and $69.17 per hour estimated hourly wage rate for CBP for non-wage benefits and overtime, the 15 respectively in the Atlanta, GA area. If officers was estimated by assuming that estimated CBP cost would be $24,614. this amount of time is split evenly the workload would be split evenly Adding the CBP and CDC costs, the total across each level, the estimated cost per across employees at the GS–5, GS–9, cost per investigation event would be investigation would be $35,546. This GS–11, and GS–12 levels with support $71,092 + $24,614 = $95,706.

TABLE 4—BENEFITS (AVERTED COSTS) PER EVENT IN 2018 USD IN WHICH HUMAN REMAINS WITHOUT ADEQUATE DOCU- MENTATION OR SHIPPING CONTAINERS ARE IMPORTED FOR PURPOSES OTHER THAN BURIAL, ENTOMBMENT, OR CRE- MATION AND ARE HELD AT THE PORT OF ENTRY PENDING AN INVESTIGATION

Multiplier for non-wage Agency Cost components Hourly wage Total rate 17 benefits and overhead

CDC ...... 600 hours split between GS–13, step 5; GS–14, step 5; and GS–15, step $59.24 2 $71,092 5 levels. CBP ...... 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, effect. On the other hand, codification of than final resting. One of these importers of human remains for these requirements may increase the shipments was re-exported and the purposes other than final resting might costs of human remains for purposes other five shipments of human remains not use leak-proof containers or fail to other than burial, entombment, or were cremated after being held by CBP. provide import permits or importer cremation if such importations are Four of the seven investigations certification statement(s). When this currently occurring without CBP or CDC occurred in 2018, demonstrating an occurs, importers spend a considerable oversight. increasing trend in improperly imported amount of time communicating with The one-time costs of updating human remains. CDC and CBP about missing communications materials and the costs A comparison can be made between documentation, searching for missing for an additional 0.5 importers per year the estimated costs and potential documentation after those human to undergo an inspection to verify their benefits (i.e., averted federal remains arrive at ports of entry, or ability to safely import human remains government costs for an investigation). repackaging shipments at the importer’s for purposes other than final resting was This comparison suggests that even if expense. This codification of estimated to cost $46,977 over 10 years only one held importation requiring requirements authorized under 42 CFR (annualized cost: $5,507). These costs investigation will be averted in the 10 71.32(b), 71.54, and 71.55 pertaining to can be compared to the benefits (averted years after the codification goes into the importation of human remains costs per investigation after human effect, the expected benefits (averted should reduce confusion. Besides the remains are held at the port of entry costs) would exceed expected costs time spent on searching for because they arrived in a container that assuming a discount rate of 3% per year. documentation and the cost of was not leak-proof or with improper To the extent that this Final Rule would repackaging, the human remains may documentation ($95,706)). During increase the number of inspections by begin to decompose during the calendar years 2014–2018, there were DSAT, the need to conduct investigation process, which would seven time-intensive investigations for investigations should decrease affect the value of imports that may an average 1.4 investigations per year. proportionately. This is because it is otherwise be used for purposes other Among these events, one shipment of assumed that the need for investigations than final resting. HHS/CDC does not human remains was re-exported. The results from lack of awareness of have any way to estimate time for remaining six shipments all required importation requirements for human repackaging costs or decomposition repackaging and were held by CBP for remains for purposes other than final costs, and did not receive any public between 2 days and 22 days (average resting as authorized under existing 42 comments on these costs. By reducing hold: 11.3 days). Of the seven total CFR 71.32(b), 71.54 and 71.55. confusion, some of these costs may be investigations, six involved human However, the inspection process itself averted when 42 CFR 71.55 goes into remains imported for purposes other should allow importers to fully

15 U.S. Office of Personnel and Management. 16 U.S. Office of Personnel and Management. 17 U.S. Office of Personnel and Management. https://www.opm.gov/policy-data-oversight/pay- https://www.opm.gov/policy-data-oversight/pay- https://www.opm.gov/policy-data-oversight/pay- leave/salaries-wages/2018/general-schedule/. leave/salaries-wages/2018/general-schedule/. leave/salaries-wages/2018/general-schedule/. Accessed on March 27, 2019. Accessed on March 27, 2019. Accessed on March 27, 2019.

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understand their import requirements in costs. HHS/CDC has determined that (a) Evaluate whether the proposed regard to shipping containers, this rule imposes no more than de collection of information is necessary documentation, or permits. minimis costs, and therefore not for the proper performance of the In addition to the reduced costs considered a regulatory action. functions of the agency, including associated with imported human whether the information will have C. The Regulatory Flexibility Act remains for purposes other than burial, practical utility; entombment, or cremation arriving with HHS/CDC has analyzed the impacts of (b) Evaluate the accuracy of the inadequate documentation or shipping the Final Rule under the Regulatory agencies estimate of the burden of the containers, there may be additional Flexibility Act (5 U.S.C. 601–612). proposed collection of information, savings for the small numbers of human Unless we certify that the Final Rule is including the validity of the remains that arrive with insufficient not expected to have a significant methodology and assumptions used; documentation for burial, entombment, economic impact on a substantial (c) Enhance the quality, utility, and or cremation. During calendar years number of small entities, the Regulatory clarity of the information to be 2014 through 2018, CDC requested Flexibility Act (RFA), as amended by collected; additional documentation from seven the Small Business Regulatory (d) Minimize the burden of the importers of human remains for burial, Enforcement Fairness Act (SBREFA), collection of information on those who entombment or cremation (average 1.4 requires agencies to analyze regulatory are to respond, including, through the events per year) and 9 importers of options that would minimize any use of appropriate automated, human remains for purposes other than significant economic impact of a rule on electronic, mechanical, or other final resting (1.8 events per year). In small entities. Based on our analysis as technological collection techniques or contrast to the time-intensive described above, we certify that this other forms of information technology, investigation events described above, Final Rule will not have a significant e.g., permitting electronic submission of these events were usually resolved economic impact on a substantial responses; and quickly because death certificates listing number of small entities within the (e) Assess information collection cause of death or importer certification meaning of the RFA. costs. statements either confirming that the This regulatory action is not a major To request additional information on human remains were not known to rule as defined by section 804 of the the proposed project or to obtain a copy contain or stating why the human Small Business Regulatory Enforcement of the information collection plan and remains were not reasonably suspected Fairness Act of 1996. This Final Rule instruments, call (404) 639–7570 or of containing an infectious biological will not result in an annual effect on the send an email to [email protected]. Direct agent were provided relatively quickly. economy of $100,000,000 or more; a written comments and/or suggestions However, delays still incur some major increase in cost or prices; or regarding the items contained in this additional time costs that may be significant adverse effects on document to the Attention: CDC Desk averted if the requirements codified in competition, employment, investment, Officer, Office of Management and 42 CFR 71.55 are better understood. productivity, innovation, or on the Budget, 725 17th Street NW, Finally, the language in 42 CFR ability of United States-based Washington, DC 20503 or by fax to (202) 71.55(d) indicating that 42 CFR 71.63 companies to compete with foreign- 395–5806. Provide written comments may apply to imported human remains, based companies in domestic and within 30 days of final rule publication. if the Director designates a foreign export markets. HHS/CDC currently has approval to country and determines that such an D. The Paperwork Reduction Act collect certain information concerning action is necessary to protect the public the importation of dead bodies under health, is cross-referencing an the In accordance with the Paperwork two OMB Control Numbers: 0920–0134 existing requirement in 42 CFR 71.63. Reduction Act of 1995, the Centers for Foreign Quarantine Regulations Since its enactment, CDC has applied 42 Disease Control and Prevention (CDC) (expiration date 03/31/2022) and 0920– CFR 71.63 one time, on May 10, 2019, has submitted the information 0199 Application for Permit to Import to suspend entry of dogs from Egypt collection requests titled Foreign Biological Agents and Vectors of Human after three dogs with canine rabies virus Quarantine Regulations (42 CFR part 71) Disease into the United States and variant were imported into the United (OMB Control No. 0920–0134) and Application for Permit to Import or States within four years.18 However, the 0920–0199 Application for Permit to Transport Live Bats (42 CFR 71.54) suspension has not been in place long Import Biological Agents and Vectors of (expiration date 04/30/2021). This Final enough to do a full economic analysis Human Disease into the United States Rule is updating one information and a suspension of imports for dogs and Application for Permit to Import or collection: 0920–0134. CDC invited may not be analogous to a suspension of Transport Live Bats (42 CFR 71.54) public comment on the burden to the imports for human remains in terms of (expiration date 04/30/2021) to the public outlined in the NPRM and did economic impact. Office of Management and Budget not receive any comments. (OMB) for review and approval. CDC B. Executive Order 13771 previously published a Notice of Information Collections Executive Order 13771 ‘‘Reducing Proposed Rulemaking on November 25, (1) Foreign Quarantine Regulations Regulation and Controlling Regulatory 2019 to obtain comments from the (42 CFR part 71) (OMB Control No. Costs,’’ requires executive departments public and affected agencies. CDC 0920–0134)—Nonmaterial/non- and agencies to eliminate at least two received no comments related to the substantive change—National Center for existing regulations for every new previous document. This document Emerging, and Zoonotic Infectious significant regulation that imposes serves to allow an additional 30 days for Diseases (NCEZID), Centers for Disease public and affected agency comments. Control and Prevention (CDC). 18 CDC (May 10, 2019) Notice of Temporary CDC will accept all comments for this Suspension of Dogs Entering the United States proposed information collection project. Description From Egypt. 84 FR 20628. https:// Section 361 of the Public Health www.federalregister.gov/documents/2019/05/10/ The Office of Management and Budget 2019-09654/notice-of-temporary-suspension-of- is particularly interested in comments Service (PHS) Act (42 U.S.C. 264) dogs-entering-the-united-states-from-egypt. that: authorizes the Secretary of Health and

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Human Services to make and enforce been embalmed or otherwise rendered HHS/CDC does not anticipate regulations necessary to prevent the noninfectious. significant additional administrative introduction, transmission, or spread of • At present, HHS/CDC has approval burden in acquiring these documents. communicable diseases from foreign from OMB to collect certain information With data provided by CBP, CDC is countries into the United States. and impose recordkeeping requirements updating the estimate of the number of Legislation and existing regulations related to foreign quarantine imports of human remains that will governing foreign and interstate responsibilities under OMB Control require a death certificate from 20 to quarantine activities (42 CFR parts 70 Number 0920–0134 (expiration 03/31/ 150, and increasing by 1850 the estimate and 71) authorize CDC quarantine 2022). HHS/CDC is proposing a non- of the number of human remains that officers and customs personnel to substantive/nonmaterial change to: will require some statement or • inspect and undertake necessary control 42 CFR 71.55 Dead Bodies, 42 CFR documentation of non-infectiousness. measures in order to protect the public’s 71.32(b)—Death certificates (No Form) CDC believes this is a more accurate • health. Other inspection agencies assist 42 CFR 71.32 Statements or estimate of the volume of imported quarantine officers in public health risk documentation of non-infectiousness human remains imported into the assessment and management of persons, (No Form) United States, and not an increase in animals, and other importations of Description of Respondents. respondent burden. As stated above, public health importance, including Respondents to this data collection are both of these documents are routinely human remains. Human remains may individuals seeking to import human provided by mortuary services and do harbor communicable diseases, and if remains into the United States. not represent an increase in respondent not packaged and processed according There is no burden to respondents burden specifically for this rulemaking. to accepted standards, may represent a other than the time taken to acquire a Additionally, as this Final Rule risk to handlers and the receiving death certificate for the human remains clarifies the requirements for importing being imported to the United States or human remains, HHS/CDC is also community. to produce documentation stating that renaming the provision. The associated Requiring a death certificate that the human remains have been information collections will clearly states the cause of death (or a specified embalmed or otherwise rendered non- reference the title: alternative document) and requiring infectious. However, death certificates • 42 CFR 71.55 Importation of Human appropriate packaging of human and embalming documentation are Remains—Death Certificate (No Form). remains mitigates the introduction and routinely produced by mortuary • 42 CFR 71.32, 71.55 Statements or spread of communicable diseases into providers or hospitals after a death. DOS documentation of non-infectiousness the United States with a minimum of also provides a consular mortuary (No Form). recordkeeping and reporting as well as certificate that also commonly states the Table 5 below presents the estimate of a minimum of interference with trade cause of death for an individual who annual burden (in hours) associated and travel. The death certificate will dies abroad or, if the cause of death is with the reporting requirement under only be required for those seeking to not known, can reference whether the this OMB control number, accounting import human remains that have not person died of a communicable disease. for the rule changes.

TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN 0920–0134

Average Number of Number of burden per Total burden Type of respondent Regulatory provision or form name respondents responses per response hours respondent (in hours)

Importers ...... 42 CFR 71.55 Importation of Human 150 1 1 150 Remains—Death Certificate (No Form). Importer ...... 42 CFR 71.32, 71.55 Statements or 3850 1 5/60 321 documentation of non-infectiousness (No Form).

The estimates are based on experience CDC/DSAT administers OMB Control biological agent. DSAT performs to date with current recordkeeping and No. 0920–0199 and did not make any inspection of these requests to ensure reporting requirements of 42 CFR 71.55 changes in information collection. Due that the facility has the appropriate Dead Bodies—Death Certificate (No to DSAT’s experience with issuing CDC biosafety conditions to receive these Form) and 42 CFR 71.32 Statements or import permits, DSAT does not expect materials. DSAT plans to use current documentation of non-infectiousness, any additional burden from respondents resources for processing any are based on discussion with partners at because respondents understand that applications received for importing DOS and DHS. any material including human remains human remains that are known to (2) Application for Permit to Import that is reasonably suspected of contain or reasonably suspected of Biological Agents and Vectors of Human containing an infectious biological agent containing an infectious biological Disease into the United States and requires submission of an application agent. Application for Permit to Import or for CDC import permit. E. Executive Order 12866 Transport Live Bats (42 CFR 71.54) On an annual basis, DSAT usually (OMB Control No. 0920–0199) No receives approximately 3 applications This rule is not being treated as a Change Requested–Center for for importing human remains that are significant regulatory action as defined Preparedness and Response, Centers for known to contain or reasonably by Executive Order 12866. As such, it Disease Control and Prevention. suspected of containing an infectious

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has not been reviewed by the Office of List of Subjects in 42 CFR Part 71 Leak-proof container means a Management and Budget (OMB). Burial, communicable diseases, container that is puncture-resistant and cremation, death certificate, sealed in such a manner as to contain F. National Environmental Policy Act all contents and prevent leakage of (NEPA) entombment, human remains, importer, infectious biological agent, leak-proof fluids during handling, storage, HHS/CDC has determined that the container, public health, quarantinable transport, or shipping, such as amendments to 42 CFR part 71 will not communicable diseases. (i) A double-layered plastic, puncture- resistant body bag (i.e., two sealed body have a significant impact on the human For the reasons discussed in the bags, one inside the other); environment. preamble, we amend 42 CFR part 71 as (ii) A casket with an interior lining follows: G. Executive Order 12988: Civil Justice certified by the manufacturer to be leak- Reform PART 71—FOREIGN QUARANTINE proof and puncture-resistant; or (iii) A sealed metal body-transfer case. HHS/CDC has reviewed this rule ■ 1. The authority citation for part 71 under Executive Order 12988 on Civil * * * * * continues to read as follows: Justice Reform and determines that this ■ 3. Revise § 71.55 to read as follows: Authority: Secs. 215 and 311 of the Public Final Rule meets the standard in the § 71.55 Importation of human remains. Executive Order. Health Service (PHS) Act, as amended (42 U.S.C. 216, 243); secs. 361–369, PHS Act, as (a) Human remains imported into the H. Executive Order 13132: Federalism amended (42 U.S.C. 264–272). United States, or in transit within the ■ 2. Amend § 71.50, paragraph (b), by United States and not intended for Under Executive Order 13132, a adding in alphabetical order definitions import, must be fully contained within Federalism analysis is required if a for ‘‘Death certificate’’, ’’Human a leak-proof container that is packaged rulemaking has Federalism remains’’, ‘‘Importer’’, and ‘‘Leak-proof and shipped in accordance with all implications, would limit or preempt container’’ to read as follows: applicable legal requirements. State or local law, or impose substantial (b) The provisions of 42 CFR 71.54 direct compliance costs on State or local § 71.50 Scope and definitions. shall apply to all imported human governments. Under such * * * * * remains known to contain or reasonably circumstances, a Federal agency must (b) * * * suspected of containing an infectious consult with State and local officials. Death certificate means an official biological agent. Federalism implications is defined as government document that certifies that (c) Unless accompanied by a permit having substantial direct effects on State a death has occurred and provides issued under 42 CFR 71.54, human or local governments, on the identifying information about the remains imported into the United States relationship between the national deceased, including (at a minimum) must meet one of the following government and the States, or on the name, age, and sex. The document must requirements: distribution of power and also certify the time, place, and cause of (1) Human remains imported for responsibilities among the various death (if known). If the official burial, entombment, or cremation must: levels of government. Under 42 U.S.C. government document is not written in (i) Be consigned directly to a licensed 264(e), Federal public health regulations English, then it must be accompanied by mortuary, cemetery, or crematory for promulgated under that section do not an English language translation of the immediate and final preparation prior to preempt State or local public health official government document, the burial, entombment, or cremation; and regulations, except in the event of a authenticity of which has been attested (ii) Unless embalmed, be conflict with the exercise of Federal to by a person licensed to perform acts accompanied by a death certificate or, if authority. Other than to restate this in legal affairs in the country where the the death certificate is incomplete or statutory provision, this rulemaking death occurred. In lieu of a death missing, an importer certification does not alter the relationship between certificate, a copy of the Consular statement confirming that the human the Federal Government and State/local Mortuary Certificate and the Affidavit of remains are not known to contain or governments as set forth in 42 U.S.C. Foreign Funeral Director and Transit stating why the human remains are not 264. There are no provisions in these Permit, shall together constitute reasonably suspected of containing an regulations that impose direct acceptable identification of human infectious biological agent. compliance costs on State and local remains. (2) Human remains imported for governments. Therefore, HHS/CDC * * * * * medical examination or autopsy must: believes that the rule does not warrant Human remains means a deceased (i) Be consigned directly to an entity additional consultation under Executive human body or any portion of a authorized to perform such functions Order 13132. deceased human body, except: under the laws of the applicable I. The Plain Language Act of 2010 (i) Clean, dry bones or bone jurisdiction prior to subsequent burial, fragments; human hair; teeth; fingernails entombment, or cremation; and Under the Plain Language Act of 2010 or toenails; or (ii) Unless embalmed, be (Pub. L. 111–274, October 13, 2010), (ii) A deceased human body and accompanied by a death certificate or, if Executive Departments and Agencies portions thereof that have already been the death certificate is incomplete or are required to use plain language in all fully cremated prior to import; or missing, an importer certification proposed and Final Rules. Prior to (iii) Human cells, tissues or cellular or statement confirming that the human publication, this Final Rule was tissue-based products intended for remains are not known to contain or reviewed by specialists in health implantation, transplantation, infusion, stating why the human remains are not communication and education to ensure or transfer into a human recipient. reasonably suspected of containing an the content and intention, as well as Importer means any person importing infectious biological agent. substance, were clear and accurate. or attempting to import an item (3) Human remains imported for any HHS/CDC did not receive any public regulated under this subpart. other purpose, unless embalmed, must comment concerning plain language. * * * * * be accompanied by an importer

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certification statement confirming that (c), published March 20, 2020, at 85 FR collection of information subject to the the human remains are not known to 15999, is required as of July 31, 2020. Paperwork Reduction Act that does not contain or stating why the human FOR FURTHER INFORMATION CONTACT: display a current, valid OMB Control remains are not reasonably suspected of Brendan Holland of the Media Bureau, Number. containing an infectious biological Industry Analysis Division, at (202) The foregoing is required by the agent. 418–2757 or [email protected]. Paperwork Reduction Act of 1995, Pub. (d) The Director may suspend the SUPPLEMENTARY INFORMATION: This L. 104–13, October 1, 1995, and 44 importation of human remains under 42 document announces that OMB U.S.C. 3507. CFR 71.63 if the Director designates the approved the non-substantive and non- The total annual reporting burdens foreign country and determines that material changes to the information and costs for the respondents are as such an action is necessary to protect collection requirements in §§ 76.1607 follows: the public health. OMB Control Number: 3060–0311. and 76.1617(a) and (c) on March 19, OMB Approval Date: March 31, 2020. Dated: June 3, 2020. 2020. OMB approved the non- OMB Expiration Date: March 31, Alex M. Azar II, substantive and non-material changes to 2023. Secretary, Department of Health and Human the information collection requirements Title: Section 76.54, Significantly Services. in §§ 76.54(e), 76.64(k), 76.66(d)(1)(vi), Viewed Signals; Method to be Followed [FR Doc. 2020–12931 Filed 7–14–20; 8:45 am] (d)(2)(ii), (v), and (vi), (d)(3)(iv), (d)(5)(i), for Special Showings. (f)(3) and (4), and (h)(5), 76.1600(e), BILLING CODE 4163–18–P Form Number: N/A. 76.1607, and 76.1608 on March 31, Respondents: Business or other for- 2020, and the changes to § 76.1609 were profit entities. approved by OMB on April 13, 2020. Number of Respondents and FEDERAL COMMUNICATIONS The remaining rule amendments Responses: 500 respondents; 1,274 COMMISSION adopted in the Report and Order did not responses. contain new or modified information Estimated Time per Response: 1–15 47 CFR Parts 73 and 76 collection requirements subject to OMB hours (average). approval under the Paperwork Frequency of Response: On-occasion [MB Docket Nos. 19–165, 17–105; FCC 20– Reduction Act. reporting and third-party disclosure 8; FRS 16923] The Commission publishes this requirements. document as an announcement of the Total Annual Burden: 20,610 hours. Electronic Delivery of Notices to compliance date of the revised rules. If Total Annual Cost: $300,000. Broadcast Television Stations; you have any comments on the burden Nature and Extent of Confidentiality: Modernization of Media Regulation estimates listed below, or how the There is no need for confidentiality with Initiative Commission can improve the this collection of information. Privacy Act: No impact(s). AGENCY: Federal Communications collections and reduce any burdens Needs and Uses: The information Commission. caused thereby, please contact Cathy Williams, Federal Communications collection requirements contained in 47 ACTION: Final rule; announcement of CFR 76.54(b) state significant viewing in compliance date. Commission, Room 1–C823, 445 12th Street SW, Washington, DC 20554, a cable television or satellite community for signals not shown as significantly SUMMARY: In this document, the Federal regarding OMB Control Number 3060– viewed under 47 CFR 76.54(a) or (d) Communications Commission (FCC) 1273. Please include the applicable may be demonstrated by an announces that the Office of OMB Control Number in your independent professional audience Management and Budget (OMB) has correspondence. The Commission will also accept your comments via email at survey of over-the-air television homes approved non-substantive and non- that covers at least two weekly periods material changes to the information [email protected]. To request materials in accessible separated by at least thirty days but no collections associated with certain rule more than one of which shall be a week amendments adopted in the Report and formats for people with disabilities (Braille, large print, electronic files, between the months of April and Order, FCC 20–8, MB Docket Nos. 19– September. If two surveys are taken, 165, 17–105 (Report and Order), to audio format), send an email to fcc504@ fcc.gov or call the Consumer and they shall include samples sufficient to modernize certain notice requirements assure that the combined surveys result for cable operators and direct broadcast Governmental Affairs Bureau at (202) 418–0530 (voice). in an average figure at least one satellite (DBS) providers. The standard error above the required Commission also announces that Synopsis viewing level. compliance with the revised rules is As required by the Paperwork The information collection required. This document is consistent Reduction Act of 1995 (44 U.S.C. 3507), requirements contained in 47 CFR with Electronic Delivery of Notices to the FCC is notifying the public that it 76.54(c) are used to notify interested Broadcast Television Stations, received final OMB approval for the parties, including licensees or published March 20, 2020, which stated information collection requirements permittees of television broadcast that the Commission would publish a contained in §§ 76.54(e), 76.64(k), stations, about audience surveys that are document in the Federal Register 76.66(d)(1)(vi), (d)(2)(ii), (v), and (vi), being conducted by an organization to announcing the compliance date for the (d)(3)(iv), (d)(5)(i), (f)(3) and (4), and demonstrate that a particular broadcast revised rules listed in the DATES section (h)(5), 76.1600(e), 76.1607, 76.1608, station is eligible for significantly below. 76.1609, and 76.1617(a) and (c). Under viewed status under the Commission’s DATES: Compliance with the 5 CFR part 1320, an agency may not rules. The notifications provide amendments to 47 CFR 74.779, 76.54(e), conduct or sponsor a collection of interested parties with an opportunity to 76.64(k), 76.66(d)(1)(vi), (d)(2)(ii), (v), information unless it displays a current, review survey methodologies and file and (vi), (d)(3)(iv), (d)(5)(i), (f)(3) and valid OMB Control Number. objections. (4), and (h)(5), 76.1600(e), 76.1607, No person shall be subject to any Lastly, 47 CFR 76.54(e) and (f), are 76.1608, 76.1609, and 76.1617(a) and penalty for failing to comply with a used to notify television broadcast

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