Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Final rule.
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.
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 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
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.
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
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.
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
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
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.
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 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
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.
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 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 re-codification 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.
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
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 un-embalmed 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.
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 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).
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 non-cremated human remains.
A more burdensome documentation requirement would be to require that all importations of human remains (
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
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.
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 (
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 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 (
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 (
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
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 (
Individuals importing human
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.
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 (
The
In the past, imported human remains for reasons other than burial, entombment or cremation have arrived in inappropriate (
Although the amount of time per investigation event varies, on average, each importation investigation was
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 Washington-Baltimore-Arlington hourly pay scale (on average, $41.02 per hour).
In
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 (
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.
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 costs. HHS/CDC has determined that this rule imposes no more than de minimis costs, and therefore not considered a regulatory action.
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 foreign-based companies in domestic and export markets.
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:
(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) 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
HHS/CDC currently has approval to collect certain information concerning the importation of dead bodies under two OMB Control Numbers: 0920-0134
(1) Foreign Quarantine Regulations (42 CFR part 71) (OMB Control No. 0920-0134)—Nonmaterial/non-substantive change—National Center for Emerging, and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
Section 361 of the Public Health Service (PHS) Act (42 U.S.C. 264) authorizes the Secretary of Health and
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 non-substantive/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)
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 non-infectious. 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.
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.
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 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.
This rule is not being treated as a significant regulatory action as defined by Executive Order 12866. As such, it
HHS/CDC has determined that the amendments to 42 CFR part 71 will not have a significant impact on the human environment.
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.
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.
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.
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:
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).
(b) * * *
(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.
(i) A double-layered plastic, puncture-resistant body bag (
(ii) A casket with an interior lining certified by the manufacturer to be leak-proof and puncture-resistant; or
(iii) A sealed metal body-transfer case.
(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
(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.