# Control of Communicable Diseases > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2016-18103 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** August 15, 2016 - **Citation:** 81 FR 54230 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Parts 70 and 71 [CDC Docket No. CDC-2016-0068] RIN 0920-AA63 Control of Communicable Diseases AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of Proposed Rulemaking (NPRM). SUMMARY: Through this Notice of Proposed Rulemaking (NPRM), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is amending its domestic (interstate) and foreign quarantine regulations to best protect the public health of the United States. These amendments are being proposed to aid public health responses to outbreaks of communicable diseases such as the largest recorded outbreak of Ebola virus disease (Ebola) in history, the recent outbreak of Middle East Respiratory Syndrome (MERS) in South Korea, and repeated outbreaks and responses to measles in the United States, as well as the ongoing threat of other new or re-emerging communicable diseases. The provisions contained herein provide additional clarity to various safeguards to prevent the importation and spread of communicable diseases affecting human health into the United States and interstate. DATES: Written or electronic comments on the NPRM must be received by October 14, 2016. Paperwork Reduction Act Public Comments: Submit written or electronic comments by October 14, 2016. Please see the Paperwork Reduction Act section for instructions on how to submit comments. ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-0068 or RIN 0920-AA63 by any of the following methods: • Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for submitting comments. • Mail: Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS E-03, Atlanta, GA 30329, ATTN: Quarantine NPRM. Instructions: All submissions received must include the agency name and docket number or Regulatory Information Number (RIN) for this rulemaking. All relevant comments received will be posted without change to http://www.regulations.gov , including any personal information provided. For access to the docket to read background documents or comments received, go to http://www.regulations.gov . Comments will also be available for public inspection from Monday through Friday, except for legal holidays, from 9 a.m. to 5 p.m., Eastern Time, at 1600 Clifton Road NE., Atlanta, Georgia 30329. Please call ahead to 404-498-1600 and ask for a representative from the Division of Global Migration and Quarantine (DGMQ) to schedule your visit. FOR FURTHER INFORMATION CONTACT: For information regarding this NPRM: Ashley A. Marrone, J.D., Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-E03, Atlanta, GA 30329. For information regarding CDC operations related to this NPRM: ATTN: Nicole J. Cohen, M.D., Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-E03, Atlanta, GA 30329. Either may also be reached by telephone 404-498-1600 or email travelrestrictions@cdc.gov . SUPPLEMENTARY INFORMATION: The NPRM is organized as follows: I. Executive Summary A. Purpose of the Action B. Summary of Major Provisions C. Summary of Costs and Benefits II. Public Participation III. Background A. Legal Authority B. Historical Background for This Rulemaking IV. Rationale for Notice of Proposed Rulemaking V. Ongoing Efforts With DHS/CBP To Improve Passenger Data Collection VI. Summary of Notice of Proposed Rulemaking A. Updates to Part 70 1. Section 70.1 General Definitions 2. Section 70.5 Requirements Relating to Travelers Under a Federal Order of Isolation, Quarantine, or Conditional Release 3. Section 70.6 Apprehension and Detention of Persons With Quarantinable Communicable Diseases 4. Section 70.10 Public Health Prevention Measures To Detect Communicable Disease 5. Section 70.11 Report of Death or Illness Onboard Aircraft Operated by Airline 6. Section 70.12 Medical Examinations 7. Section 70.13 Payment for Care and Treatment 8. Section 70.14 Requirements Relating to Issuance of a Federal Order for Quarantine, Isolation, or Conditional Release 9. Section 70.15 Mandatory Reassessment of a Federal Order for Quarantine, Isolation, or Conditional Release 10. Section 70.16 Medical Review of a Federal Order for Quarantine, Isolation, or Conditional Release 11. Section 70.17 Administrative Records Relating to a Federal Order for Quarantine, Isolation, or Conditional Release 12. Section 70.18 Agreements 13. Section 70.19 Penalties B. Updates to Part 71 1. Section 71.1 Definitions 2. Section 71.2 Penalties 3. Section 71.4 Requirements Relating to Collection, Storage, and Transmission of Airline Passenger, Crew, and Flight Information for Public Health Purposes 4. Section 71.5 Requirements Relating To Collection, Storage and Transmission of Vessel Passenger, Crew and Voyage Information for Public Health Purposes 5. Section 71.20 Public Health Prevention Measures To Detect Communicable Disease 6. Section 71.29 Administrative Records Relating to a Federal Order for Quarantine, Isolation, or Conditional Release 7. Section 71.30 Payment for Care and Treatment 8. Section 71.36 Medical Examinations 9. Section 71.37 Requirements Relating to Issuance of a Federal Order for Quarantine, Isolation, or Conditional Release 10. Section 71.38 Mandatory Reassessment of a Federal Order for Quarantine, Isolation, or Conditional Release 11. Section 71.39 Medical Review of a Federal Order for Quarantine, Isolation, or Conditional Release 12. Section 71.40 Agreements 13. Section 71.63 Suspension of Entry of Animals, Articles, or Things From Designated Foreign Countries and Places Into the United States VII. Alternatives Considered VIII. Required Regulatory Analyses A. Executive Orders 12866 and 13563 B. The Regulatory Flexibility Act C. Paperwork Reduction Act of 1995 D. National Environmental Policy Act (NEPA) E. E.O. 12988: Civil Justice Reform F. E.O. 13132: Federalism G. Plain Language Act of 2010 I. Executive Summary A. Purpose of the Action HHS/CDC has statutory authority (42 U.S.C. 264, 265) to promulgate regulations which protect U.S. public health from communicable diseases, including quarantinable communicable diseases as specified in Executive Order of the President. See Executive Order 13295 (April 4, 2003), as amended by Executive Order 13375 (April 1, 2005) and Executive Order 13674 (July 31, 2014). The need for this proposed rulemaking was reinforced during HHS/CDC's response to the largest outbreak of Ebola virus disease (Ebola) on record, followed by the recent outbreak of Middle East Respiratory Syndrome (MERS) in South Korea, both quarantinable communicable diseases, and repeated outbreaks and responses to measles, a non-quarantinable communicable disease of public health concern, in the United States. The provisions contained within this proposal will enhance HHS/CDC's ability to prevent the further importation and spread of communicable diseases into the United States and interstate by clarifying and providing greater transparency regarding its response capabilities and practices. B. Summary of Major Provisions Both the domestic and foreign portions of this NPRM include new proposed public health definitions; new proposed regulatory language codifying HHS/CDC's activities concerning implementation of non-invasive public health prevention measures ( i.e., traveler health screening) at U.S. ports and other U.S. locations ( i.e., railway stations, bus terminals); and proposed provisions for affording persons served with a Federal public health order ( e.g., isolation, quarantine) with due process, including requiring that HHS/CDC explain the reasons for issuing the order, administrative processes for appealing the order, and a mandatory reassessment of the order. In addition, the domestic portion of this NPRM also proposes reporting requirements for commercial passenger flights of death or illness to CDC; a provision allowing for implementation of travel restrictions and issuance of travel permits by CDC for individuals under Federal quarantine, isolation, or conditional release orders, or in response to a state or local request for assistance; and new regulatory language clarifying when an individual who is moving between U.S. states is “reasonably believed to be infected” with a quarantinable communicable disease in a “qualifying stage,” which determines whether such an individual may be apprehended or examined for potential infection with a quarantinable communicable disease. The foreign portion of this NPRM also proposes new regulatory authority permitting the CDC Director to prohibit the importation of animals or products that pose a threat to public health. HHS/CDC is also proposing to change the text of the current regulation to reflect modern terminology, technology, and plain language currently used by private industry, public health partners, and the public. The NPRM further authorizes expanded forms of public health monitoring, beyond an in-person visit by a public health officer, for individuals who are reasonably believed to be exposed to or infected with a quarantinable communicable disease and subject to a conditional release order. This would include monitoring through electronic and internet-based means, such as email and webcam application tools. Finally, while neither modifying nor authorizing additional criminal penalties for violations of quarantine rules and regulations, this NPRM updates regulatory language to align with existing criminal penalties set forth in statute. C. Summary of Costs and Benefits The regulatory impact analysis quantitatively addresses the costs and benefits associated with this NPRM. The economic impact analysis of this NPRM is subdivided into four sections. The first analysis is of proposed 42 CFR 70.1, 42 CFR 71.1/71.4/71.5 for which the primary costs for submitting passenger and crew information to HHS/CDC are incurred by airlines and vessel operators and the primary benefit is improved public health responsiveness to assess and provide post-exposure prophylaxis to travelers potentially exposed to communicable diseases of public health concern. The most likely estimates of annual costs to airlines, vessel operators, the United States government, and public health departments are low ($35,785, range $10,959 to $65,644) because the NPRM primarily codifies existing practice or improves alignment between existing regulatory text as well as the International Civil Aviation Organization (ICAO)'s guidelines for symptoms to report. The cost estimates in this NPRM are based on an anticipated small increase in the number of illness reports delivered by airlines and processed by HHS/CDC and increased costs for airlines and vessel operators to comply with HHS/CDC orders for traveler and crew contact data, to the extent that such information is readily available and already maintained. The cost estimate also includes an increase in costs for public health departments to contact more exposed travelers due to the availability of improved contact data. The best estimate of the annual quantified benefits of the NPRM are $117,376 (range $26,337 to $312,054) and mostly result from increased efficiencies for HHS/CDC and state and local public health departments to conduct contact investigations among travelers on an aircraft exposed to communicable diseases of public health concern, especially for measles and tuberculosis. To the extent that improved responsiveness of airlines to HHS/CDC traveler data orders may result from the implementation of the provisions proposed in this NPRM, HHS/CDC may become better able to respond to infectious diseases threats and (1) reduce case-loads during infectious disease outbreaks, (2) reduce public anxiety during disease outbreaks, (3) mitigate economic impacts on businesses as a consequence of reduced public anxiety, and (4) reduce the amount of personnel labor time to conduct large-scale contact investigations in response to a new infectious disease or one with larger scale public health and medical consequences like Ebola. The second analysis in this NPRM is of a number of provisions that aim to improve transparency of how HHS/CDC uses its regulatory authorities to protect public health. These changes are not intended to provide HHS/CDC with new regulatory authorities, but rather to clarify the agency's standard operating procedures and policies with regard to existing regulations in 42 CFR parts 70 and 71 including due process rights for individuals. HHS/CDC believes that such clarity is an important qualitative benefit of the provisions proposed in this NPRM, but it is not able to monetize this increase in clarity in a robust way. Although the provisions updated in this NPRM do not provide HHS/CDC with new regulatory authority, the 2014-16 Ebola Entry Risk Assessment program is used the demonstrate the economic impact of the implementation of activities associated with these authorities. The third analysis is of the proposed revisions to 42 CFR 70.13/71.30: Payment for Care and Treatment, which are not expected to lead to a change in HHS/CDC policy under which HHS/CDC may act as the payer of last resort for individuals subject to medical examination, quarantine, isolation, and conditional release under Federal orders. The primary benefit of codification is increased transparency around HHS/CDC policies to assist in paying for treatment for individuals under Federal orders. The analysis for these provisions is an examination in potential transfer payments between HHS/CDC and healthcare facilities that provide treatment to individuals under Federal orders. Because this analysis deals only with transfer payments between HHS/CDC, any marginal costs to HHS/CDC associated with a change in payments would correspond exactly to a benefit to healthcare facilities. In the absence of the NPRM, the only possible change to the current baseline is an unanticipated precedent-changing event, which would require an increase in payments from HHS/CDC to healthcare treatment facilities. The resulting extreme upper bound estimate of the provisions in the NPRM would be a benefit of $500,000 to HHS/CDC and a corresponding cost to healthcare facilities of $500,000. The fourth analysis is of the impact of the proposed 42 CFR 71.63: Suspension of entry of animals, articles, or things from designated foreign countries and places into the United States. In this NPRM, HHS/CDC is elucidating its authority to temporarily suspend entry of animals, articles or things from designated foreign countries and places into the United States. HHS/CDC cannot predict how often such authority may be used in the future or for what animal, article or thing. HHS/CDC previously exercised this authority on June 11, 2003, “when under 42 CFR 71.32(b), HHS/CDC implemented an immediate embargo on the importation of all rodents from Africa (order Rodentia).” This embargo was necessary to halt transmission of a monkeypox outbreak in the United States, which caused 71 cases (16 hospitalized). Most cases resulted from contact with prairie dogs after monkeypox had been transmitted from African rodents to prairie dogs as part of the U.S. pet trade. A simple economic impact analysis of this embargo is performed to demonstrate the costs and benefits of such actions, but HHS/CDC does not anticipate an increase in frequency of such actions based on the provisions included in this NPRM. The primary purpose of the analysis is to demonstrate potential costs and benefits using a realistic example. Based on this simple analysis, the annual cost associated with the embargo of African rodents is estimated to be around $19,000. An average of 959 rodents per year were imported in the three years preceding the embargo (2000-2002). In comparison a very conservative estimate of some of the cost of the monkeypox outbreak is $3.3 million inclusive of illness costs to persons contracting monkeypox in the United States, a portion of HHS/CDC and local and state health department monkeypox outbreak response costs, and a one-time cost to the U.S. domestic prairie dog market. Comparing the benefits associated with the avoidance of a re-introduction of the monkeypox virus to the United States with the annual costs to the African rodent import market, the benefits of the embargo are likely to greatly exceed the cost. The permanent restriction of African rodent imports to the United States was later codified in current 42 CFR 71.56. II. Public Participation Interested persons or organizations are invited to participate in this rulemaking by submitting written views, recommendations, and data on all aspects of the proposed rule. Comments received should reference a specific portion of the rule, and inclusion of any attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. HHS/CDC will carefully consider and address all comments submitted and may revise the content of the rule as appropriate at the final rulemaking stage. HHS/CDC will publish a final rule after the comment period that reflects any content changes made as a result of comments received. As emphasized in the text below, HHS/CDC would appreciate public comment on data collection and any privacy concerns associated with this process, public health prevention measures, contact tracing, medical review process, and the availability of assistance for individuals who are indigent. III. Background A. Legal Authority The primary legal authority supporting this rulemaking is sections 361 and 362 of the Public Health Service Act (42 U.S.C. 264, 265). Section 361, among other things, authorizes the Secretary 1 of HHS to make and enforce such regulations as in the Secretary's judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the states or possessions of the United States and from one state or possession into any other state or possession. Such regulations currently define communicable disease as an illness due to a specific infectious agent or its toxic products which arises through transmission of that agent or its products from an infected person or animal or a reservoir to a susceptible host, either directly or indirectly through an intermediate animal host, vector, or the inanimate environment. See 42 CFR 70.1, 71.1. Such regulations also define possession as a U.S. territory meaning any territory of the United States, including American Samoa, Guam, the Northern Mariana Islands, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands. See 42 CFR 70.1, 71.1. On August 16, 2000, the Secretary transferred the authority for interstate control of communicable disease, including the authority to apprehend, examine, detain, and conditionally release individuals moving from one state into another from the U.S. Food and Drug Administration (FDA) to CDC. This authority is implemented in 42 CFR part 70. FDA retained its concurrent regulatory authority under section 361 of the Public Health Service Act for purposes of regulating animals and other products that may transmit or spread communicable diseases interstate. Thus, both CDC and FDA may take actions under section 361 of the Public Health Service Act to prevent interstate spread of communicable diseases in regard to animals or products, though in practice such actions would be coordinated internally between these agencies. The Secretary took this action to consolidate regulations designed to control the spread of communicable diseases, thereby increasing the efficiency and effectiveness of both agencies. This rule is not intended to have any effect upon FDA's authority under section 361 of the Public Health Service Act. Authority for carrying out CDC's functions under sections 361-369 (42 U.S.C. 264-272) has been delegated to HHS/CDC's Division of Global Migration and Quarantine (DGMQ). Regulations that implement Federal quarantine authority are currently promulgated in 42 CFR parts 70 and 71. Part 71 contains regulations to prevent the introduction, transmission, and spread of communicable diseases into the states and territories of the United States, while part 70 contains regulations to prevent the introduction, transmission, or spread of communicable diseases from one state or U.S. territory into another. 1 42 U.S.C. 264 and 265 by their terms grant authority to the U.S. Surgeon General. The Reorganization Plan No. 3 of 1966 abolished the Office of the Surgeon General and transferred the Surgeon General's functions to the Secretary of Health, Education, and Welfare (now Secretary of HHS). 31 FR 8855, 80 Stat. 1610 (Jun. 25, 1966). The Secretary of Health, Education, and Welfare was re-designated the Secretary of Health and Human Services by section 509(b) of Public Law 96-88, 93 Stat. 695 (codified at 20 U.S.C. 3508(b)). Although the Office of the Surgeon General was re-established in 1987, the Secretary of HHS has retained her authorities under 42 U.S.C. 264, 265. Section 361 (42 U.S.C. 264) is divided into five subsections, (a)-(e). Section 361(a) (42 U.S.C. 264(a) states that the Secretary may make and enforce regulations as necessary to prevent the introduction, transmission, and spread of “communicable diseases” from foreign countries into the United States or from one state or possession (U.S. territory) into any other state or possession (U.S. territory). By its terms, subsection (a) does not seek to limit the types of communicable diseases for which regulations may be enacted, but rather applies to all communicable diseases that may impact human health. Section 361(a) (42 U.S.C. 264(a)) further authorizes the Secretary to promulgate and enforce a variety of public health regulations to prevent the spread of these communicable diseases including: Inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be sources of dangerous infection to human beings, and other measures. In contrast, section 361(b) (42 U.S.C. 264(b)) authorizes the “apprehension, detention, or conditional release” of individuals for the purpose of preventing the introduction, transmission, and spread of a limited subset of communicable diseases, specifically those communicable diseases specified in an Executive Order of the President, upon recommendation of the Secretary in consultation with the Surgeon General. HHS/CDC refers to this limited subset of communicable diseases as “quarantinable communicable diseases” because these are the communicable disease for which by statute quarantine, isolation, or conditional release are authorized. Section 361(c) (42 U.S.C. 264(c)) states that, except as provided in subsection (d), regulations regarding apprehension, detention, examination, or conditional release shall only be applicable to individuals coming into a state or U.S. territory from a foreign country or U.S. territory. 42 U.S.C. 264(c). Thus, subsection (c) provides the basis for the quarantine, isolation, or conditional release of individuals arriving into the United States from foreign countries for the purposes of preventing the introduction, transmission, and spread of quarantinable communicable diseases (as specified by Executive Order) while subsection (d) provides the statutory basis for interstate quarantine, isolation, and conditional release measures. Section 361(d)(2) (42 U.S.C. 264(d)(2)) imposes two main requirements on the interstate quarantine, isolation, or conditional release of individuals: (1) The qualifying-stage requirement; and (2) the requirement for an effect on interstate movement. Both of these requirements must be satisfied. Subsection (d) states that regulations may provide for the apprehension and examination of any individual “reasonably believed to be infected with a communicable disease in a qualifying stage.” 42 U.S.C. 264(d)(1). As defined by this subsection, a “qualifying stage” means that the communicable disease is in “a precommunicable stage, if the disease would be likely to cause a public health emergency if transmitted to other individuals” or “a communicable stage.” 42 U.S.C. 264(d)(2). The subsection further states that if upon examination any such individual is found to be infected, he or she may be detained for such time and in such manner as may be reasonably necessary. 42 U.S.C. 264(d)(1). In addition to the qualifying-stage requirement, this subsection further requires a reasonable belief that the individual: (A) Be moving or about to move from a state to another state; or (B) be a probable source of infection to individuals who, while infected with such disease in a qualifying stage, will be moving from a state to another state. 42 U.S.C. 264(d)(1). As provided for under section 361(b) (42 U.S.C. 264(b)), the Secretary's authority to allow for the apprehension, examination, detention, and conditional release of individuals is limited to those communicable diseases specified in an Executive Order of the President, i.e., “quarantinable communicable diseases.” These quarantinable communicable diseases currently include cholera, diphtheria, infectious tuberculosis (TB), plague, smallpox, yellow fever, and viral hemorrhagic fevers (such as Marburg, Ebola, Lassa fever, and Crimean-Congo), severe acute respiratory syndromes, 2 and influenza caused by novel or re-emergent influenza viruses that are causing or have the potential to cause a pandemic. Executive Order 13295 (April 4, 2003), as amended by Executive Order 13375 (April 1, 2005) and Executive Order 13674 (July 31, 2014). 2 The Executive Order defines severe acute respiratory syndromes as follows: “Severe acute respiratory syndromes, which are diseases that are associated with fever and signs and symptoms of pneumonia or other respiratory illness, are capable of being transmitted from person to person, and that either are causing, or have the potential to cause, a pandemic, or, upon infection, are highly likely to cause mortality or serious morbidity if not properly controlled. This subsection does not apply to influenza.” Lastly, section 361(e) (42 U.S.C. 264(e) states that nothing in this section nor in section 363 (42 U.S.C. 266) (a different section authorizing quarantine in time of war) nor in regulations promulgated under these sections, shall be construed as superseding any provision under state law (including in regulations and provisions established by political subdivisions of states), except to the extent that such provisions conflict with the exercise of Federal authority. Accordingly, by its plain language, section 361 (42 U.S.C. 264) does not preempt state or local public health laws or regulations, except in the event of a conflict with the exercise of Federal public health authority. In addition to section 361 (42 U.S.C. 264), HHS/CDC believes that the following Public Health Service Act sections are also relevant with respect to this rulemaking: Section 311 (42 U.S.C. 243), section 321 (42 U.S.C. 248), section 322 (42 U.S.C. 249), section 362 (42 U.S.C. 265), section 365 (42 U.S.C. 268), and sections 367-69 (42 U.S.C. 270-72). Section 311 authorizes the Secretary to accept state and local assistance in the enforcement of quarantine rules and regulations and to assist states and their political subdivisions in the control of communicable diseases. Section 321 provides for the selection, establishment, control, management, and operation of institutions, hospitals, and stations as may be necessary to carry out public health functions. Section 322 authorizes payment for the care and treatment, in a public or private facility, of individuals detained in accordance with quarantine laws. Section 362 authorizes (in accordance with regulations approved by the President 3 ) suspending the entry of imports into the United States based on the presence of a communicable disease in a foreign country or place. Section 365 provides that it shall be the duty of customs officers ( e.g., U.S. Customs and Border Protection officers) and of U.S. Coast Guard officers to aid in the enforcement of quarantine rules and regulations. Section 367 authorizes the application of certain sections of the Public Health Service Act and promulgated regulations (including penalties and forfeitures for violations of such sections and regulations) to air navigation and aircraft to such extent and upon such conditions as deemed necessary for safeguarding public health. 3 The functions of the President under sections 362 and 364(a) of the Public Health Service Act (42 U.S.C. 265 and 267(a)) have been assigned to the HHS Secretary. See Exec. Order 13295 (Apr. 4, 2003), as amended by Exec. Order 13375 (Apr. 1, 2005) and Exec. Order 13674 (July 31, 2014). As prescribed in section 368 (42 U.S.C. 271) and under 18 U.S.C. 3559 and 3571(c), criminal sanctions exist for violating regulations enacted under sections 361 and 362 (42 U.S.C. 264 and 265). 18 U.S.C. 3559 defines an offense (not otherwise classified by letter grade) as a “Class A misdemeanor” if the maximum term of imprisonment is “one year or less but more than six months.” 18 U.S.C. 3571 provides that individuals found guilty of an offense may be sentenced to a fine. Specifically, an individual may be fined “not more than the greatest of”—(1) the amount specified in the law setting forth the offense; or (2) for a misdemeanor resulting in death, not more than $250,000; or (3) for a Class A misdemeanor that does not result in death, not more than $100,000. Similarly, an organization, found guilty of an offense may be fined “not more than the greatest of”—(1) the amount specified in the law setting forth the offense; or (2) for a misdemeanor resulting in a death, not more than $500,000; or (3) for a Class A misdemeanor that does not result in death, not more than $200,000. 42 U.S.C. 271 sets forth statutory penalties of up to 1 year in jail and a fine of $1,000. Therefore, it is classified as a Class A misdemeanor under 18 U.S.C. 3559. Because the alternate fines set forth under 18 U.S.C. 3571 are greater than the $1,000 set forth under 42 U.S.C. 271 (which sets a maximum penalty of not more than $1,000 or one year of jail, or both for violation of quarantine laws), and because 42 U.S.C. 271 does not exempt its lower penalties from 18 U.S.C. 3571(e), HHS/CDC plans to codify the greater penalties of 18 U.S.C. 3571(b)(5) and (c)(5) and to remove the lower penalties as stated in 42 CFR 71.2 from the regulation. Lastly, section 369 (42 U.S.C. 272) provides that quarantine officers are authorized to take declarations and administer oaths in matters pertaining to the administration of quarantine laws and regulations of the United States. B. Historical Background for This Rulemaking On November 30, 2005, HHS/CDC published a notice of proposed rulemaking (70 FR 71892) proposing to update its existing foreign and interstate quarantine regulations to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the U.S. and from one State or U.S. territory into another. HHS/CDC received extensive comments on this proposed rulemaking. The 2005 proposed rule would have required airlines and vessels to request certain information from passengers and crew and to maintain data in an electronic database for 60 days following the culmination of the flight or voyage. The proposed rule would have also modified Federal regulations governing the apprehension, detention, examination, and conditional release of individuals reasonably believed to be infected with a quarantinable communicable disease. CDC received significant comment on the 2005 NPRM from industry that felt that the development of the passenger information data storage system was overly burdensome. HHS/CDC also received comments contending that its procedures for quarantine and isolation lacked clarity and, in some instances, were not sufficiently protective of the individual. For instance, the 2005 proposal used the term “provisional quarantine” to denote the time period during which an individual could be held pending the issuance of a written order for quarantine, isolation, or conditional release or confirmation that the individual was not infected with a quarantinable communicable disease. The 2005 proposal also stated that “provisional quarantine” could last up to 3 business days. CDC received public comments that the term “provisional quarantine” was inconsistent with public health practice and that relying on “business days” which by definition excludes weekends and holidays was inappropriate. In response, the current proposal does not use the term “provisional quarantine,” but rather uses the term “apprehension” which is a statutory term used in section 361 of the Public Health Service Act (42 U.S.C. 264(c) and (d)(1)), and is defined in this proposal as “the temporary taking into custody of an individual or group for purposes of determining whether Federal quarantine, isolation, or conditional release is warranted.” Furthermore, as explained in the preamble text explaining the use of the term “apprehension,” based on past experience, HHS/CDC believes that the service of a written order for quarantine, isolation, or conditional release can generally be accomplished within 24-48 hours of an apprehension. Moreover, while the 2005 proposal stated that individuals subject to an order for quarantine, isolation, or conditional release could “authorize a representative” for purposes of a medical review hearing, the proposal did not have any provision authorizing Federal appointment of such a representative for individuals who are indigent. Accordingly, in response to public comments criticizing the lack of such an appointment, the current proposal contains specific language authorizing the appointment of a “medical representative” for anyone who qualifies as “indigent.” Proposed definitions for “medical representative” and “indigent” are contained in this current proposal and HHS/CDC invites public comment on these proposed definitions as well as the proposed “apprehension” activities. HHS/CDC ultimately did not publish a final rule based on this 2005 proposal and since that time its views have been informed by the public health response to more recent communicable disease outbreaks, including Ebola, MERS, and continuing sporadic outbreaks of measles. Through the publication of today's NPRM, CDC is formally withdrawing the 2005 NPRM and submitting a new proposal for public comment. Notably, today's proposal does have some similarities with the 2005 proposal, for instance by proposing specific provisions governing the content of written Federal orders for quarantine, isolation, and conditional release, proposed procedures for administrative hearings to review these written Federal orders, and a specific provision governing the content and compiling of an administrative record. However, today's proposal is more limited in scope than the 2005 proposal and does not contain any provisions affecting Tribal lands, authorizing quarantine “in time of war,” or altering HHS/CDC practices in regard to “bills of health” or yellow fever vaccination centers. On December 26, 2012, HHS/CDC simultaneously published two direct final rules (DFR) and notices of proposed rulemaking (NPRM) to update the Scope and Definitions in both parts 70 (77 FR 75880 and 77 FR 75936) and 71 (77 FR 75885 and 77 FR 75939) to reflect modern terminology and plain language used globally by industry and public health partners. HHS/CDC did not receive significant adverse comment to either proposals and on February 25, 2013, published notices in the Federal Register confirming the effective dates of the DFRs (February 25, 2013) (78 FR 12621 and 78 FR 12622) and withdrawing the NPRMs from rulemaking (78 FR 12702). IV. Rationale for Notice of Proposed Rulemaking A timely and efficient public health response during an outbreak is critical to preventing the introduction, transmission or spread of communicable disease. Globally, there are several current and recurring communicable disease outbreaks imminently threatening human health and safety. Ebola, also known as Ebola hemorrhagic fever or Ebola virus disease, is a rare and deadly disease caused by infection with one of the Ebola virus strains. The 2014-2016 Ebola epidemic was unprecedented in its scope and complexity, and it triggered the largest public health response in CDC's history. Outbreaks begin when Ebola is transmitted from an infected animal to a human, and then from human to human. Animal species carrying viruses that are capable of infecting humans are known as reservoir hosts. 4 For Ebola, fruit bats are believed to be the reservoir. 5 6 However, it is unclear whether the first infected human in the outbreak was infected with Ebola directly from a bat, or whether a second, intermediate animal host, such as a nonhuman primate ( e.g., monkeys, gorillas, and chimpanzees) or duiker (a type of forest antelope), was involved. 7 8 The virus can be transmitted from animal to human via contact with bodily fluids of infected animals. In West Africa, it's not uncommon for people to come into contact with animals while hunting or preparing food. As of the date of publication of this NPRM, although progress has been made and vaccine trials are underway in West Africa, there is no approved vaccine for Ebola, nor is there specific approved antiviral treatment. 4 “Glossary of Epidemiology Terms.” Centers for Disease Control and Prevention Resource Library, 2014. Web, accessed 15 July 2014. 5 “Ebola Hemorrhagic Fever: Ebolavirus Ecology.” CDC.gov, 2014. Web, accessed 8 July 2014. 6 Vogel, Gretchen. “Are Bats Spreading Ebola Across Sub-Saharan Africa?” Science, 2014. Vol. 344: p.140 7 Bagcchi, Sanjeet. “Ebola haemorrhagic fever in west Africa.” The Lancet, 2014. Vol. 14: p.375 8 Baize, Sylvain, et al. “Emergence of Zaire Ebola Virus Disease in Guinea—Preliminary Report.” The New England Journal of Medicine, 2014 (NEJM.ORG). As of March 3, 2016, a total of 28,603 cases of Ebola and 11,301 deaths have been reported worldwide. 9 10 The majority of cases occurred in Guinea, Liberia and Sierra Leone, with smaller outbreaks in Nigeria and Mali, and cases exported to four other countries including the United States. Liberia was first declared free of Ebola virus transmission (as defined by zero cases for at least 42 days) by the World Health Organization (WHO) on May 9, 2015; Sierra Leone on November 7, 2015; and Guinea on December 29, 2015. On January 14, 2016, WHO officially declared all three countries that were hardest-hit (Guinea, Liberia, and Sierra Leone) to be free of Ebola virus transmission for the first time since the start of the epidemic more than two years ago. However, each of the three countries has experienced one or more clusters of Ebola cases after having initially been declared free of Ebola transmission, and WHO warns that new cases could still appear because the virus can be transmitted through sexual activity with some male Ebola survivors for as long as one year after infection, and that efforts are still needed to prevent and respond to any new outbreaks. 11 9 http://www.afro.who.int/en/media-centre/pressreleases/item/8252-end-of-ebola-transmission-in-guinea.html. 10 Case numbers obtained from the World Health Organization ( http://apps.who.int/ebola/ebola-situation-reports ). 11 http://www.afro.who.int/en/media-centre/pressreleases/item/8252-end-of-ebola-transmission-in-guinea.html . Before the 2014-2016 Ebola epidemic in West Africa, reports of Ebola exportation to other countries were rare, a fact generally attributed in part to the remote, rural locations of previous outbreaks. The establishment of Ebola transmission in 2014 in the capital cities of Guinea, Liberia and Sierra Leone, with large populations and international airports and other connections to international transportation networks, raised concerns about the potential for spread through international travel to other parts of the world. These concerns were validated by the recognition of at least eight exported cases, three of which resulted in additional spread and infection of 29 people. 12 12 Cases were exported to United States (2), United Kingdom, Nigeria, Mali (2), Senegal, Italy; further spread occurred in Nigeria, the United States and Mali. In October, 2014, after a case of Ebola was imported and identified in the United States from West Africa, resulting in two domestic cases and extensive contact investigations of travelers onboard aircraft and the larger community, questions were raised concerning whether HHS/CDC should strengthen the domestic response to Ebola by prohibiting travel to the United States from the three countries with widespread transmission. HHS/CDC projected that such a travel ban would cause greater harm than good to the public health response by hampering travel of responders and delivery of supplies into the region, and could paradoxically increase the risk of spread via potentially infected individuals engaging in travel through covert and circuitous travel routes. Instead, HHS/CDC recommended that public health authorities assume the responsibility for monitoring of all travelers arriving from countries with Ebola outbreaks. Because complete and timely contact information was not available for these travelers, in-person questioning at the arrival airport was required to gather such information. Therefore, in response to the imported Ebola case, as well as consideration of potential response activities, beginning October 11, 2014, HHS/CDC and the U.S. Department of Homeland Security (DHS) began a new enhanced entry risk assessment and management program at the five U.S. international airports that routinely received approximately 90 percent of travelers from Guinea, Liberia, and Sierra Leone: New York's John F. Kennedy, Washington-Dulles, Newark Liberty, Chicago-O'Hare, and Atlanta Hartsfield Jackson. 13 This operation of unprecedented magnitude required coordination of multiple U.S. Government agencies, as well as airport authorities and health departments in all U.S. states and territories. Travelers from Mali were later added on November 17, 2014, in response to an outbreak in that country; Mali's outbreak was short-lived, and enhanced entry risk assessment and management for travelers from Mali was discontinued on January 6, 2015. Following the declaration that the outbreak had ended in Liberia and the establishment of control measures in that country, on September 21, 2015, the United States discontinued enhanced entry risk assessment and management for travelers from Liberia. On November 7, 2015, WHO declared Sierra Leone free of Ebola virus transmission and enhanced entry risk assessment and management for travelers from Sierra Leone was discontinued on December 22, 2015. In addition, Guinea was declared free of Ebola virus transmission on December 29, 2015, and enhanced entry risk assessment and management for travelers from Guinea was discontinued on February, 19, 2016, thus bringing an end to the enhanced entry risk assessment and management program in the US. Between October 11, 2014 and February 19, 2016, enhanced entry risk assessment was conducted for approximately 38,000 travelers. 13 See 79 FR 63313 (October 23, 2014). A second relevant example of the importance of CDC improving the efficiency of it public health response is illustrated by CDC's response to two imported cases of MERS into the United States in 2014. While no additional transmissions occurred as a result of these importations, the subsequent investigation required the tracking and monitoring of more than 700 household, healthcare, community, and travel-related contacts, including almost 650 travelers onboard commercial aircraft. If the cost estimates in the RIA for the average cost per contact to CDC ($180) and to public health departments ($180) 14 are applied to these investigations (704 contacts), the total cost to evaluate MERS contacts would be approximately $250,000. However, this may underestimate the actual cost if state and local health departments deployed more resources per contact to locate MERS contacts more rapidly than would be the case for contact investigations for diseases more commonly reported in the United States ( e.g., tuberculosis). First identified and reported to cause severe acute respiratory infection in September 2012, MERS has caused infections worldwide, with at least 25 countries reporting cases to date. All reported cases have been directly or indirectly linked through travel or residence to nine countries: The Kingdom of Saudi Arabia (KSA), the United Arab Emirates (UAE), Qatar, Jordan, Oman, Kuwait, Yemen, Lebanon, and Iran. The majority of cases (~85%) have been reported from KSA, where there is strong evidence for ongoing, sporadic introductions from animals ( e.g., camels) to humans, followed by both healthcare-related and community human-to-human transmission. In May 2015, a case in a person who had travelled through several countries in the Arabian Peninsula and returned to the Republic of Korea started the largest outbreak of MERS outside of the Arabian Peninsula. The Korea outbreak resulted in 186 cases and 36 deaths. 14 Refer to the RIA for more details. A third and historically more common example is measles. Measles is a highly contagious, acute viral illness that can lead to serious complications such as pneumonia, encephalitis, and even death. Although not a quarantinable communicable disease, every case of measles in the United States is considered a public health emergency because of its extremely high transmissibility. As a result of high vaccination coverage, measles was declared eliminated (defined as interruption of year-round endemic transmission) from the United States in 2000; however, importations from other countries where measles remains endemic continue to occur, which can lead to clusters of measles cases in the United States in pockets of unvaccinated persons. Of note, an unprecedented outbreak that originated in late December 2014 in Orange County, California resulted in 125 cases; measles cases associated with this outbreak were reported in eight U.S. states, Mexico, and Canada. Between 2010 and 2014, HHS/CDC investigated 91 measles exposures on international or interstate flights, which required time-consuming and labor-intensive location and evaluation of more than 4700 individuals, resulting in the identification of 12 cases of onward transmission. 15 15 CDC. Measles Outbreak—California, December 2014-February 2015. Morb Mortal Wkly Rep. 2015; 64(06): 153-154. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6406a5.htm. Global public health authorities have clearly indicated, and evidence has shown, that Ebola, MERS, and measles could spread between countries, and a re-emergence after the current outbreaks are controlled is always a risk. Additionally, although public health responses to measles have become routine over the past decade, the recent unprecedented outbreak in a large U.S. tourist destination with high potential for onward travel by exposed individuals identified greater danger for measles becoming reestablished in the United States in communities with lower rates of immunization. These three examples demonstrate the need for a more timely, efficient, and complete public health response, so that CDC can better protect individuals and prevent the further importation and spread of communicable disease. This NPRM clarifies and provides greater transparency regarding the tools HHS/CDC uses to identify and respond quickly and effectively to prevent introduction and spread of these and other communicable diseases in the United States. Currently, these processes are governed by standard and internal operating procedures and policies, based upon broad statutory authorities. For instance, it is anticipated that explicit regulatory authority, as proposed in this notice of proposed rulemaking, may lead to quicker and more accurate illness reporting, which would enhance HHS/CDC's ability to evaluate an ill traveler and assess the public health risk. The current definition of “ill person” does not include the range of signs and symptoms for many of the quarantinable communicable diseases, including Ebola and MERS, nor does it allow for detection of new or emerging communicable diseases. Currently the broader range of signs and symptoms is already requested on a voluntary basis; however, the current regulations do not require mandatory reporting of ill persons as defined by this broader definition, thus requiring HHS/CDC to rely on the voluntary compliance of conveyance operators. Given the grave consequences for mortality and morbidity of introducing and spreading these diseases, a strengthening of this reporting requirement via mandatory reporting according to the revised definition of an ill person, as described in this NPRM, is essential. This is validated by several recent instances of individuals traveling interstate while symptomatic with MERS, Ebola, Lassa fever, and measles. Conducting contact investigations on interstate flights is labor-intensive and often inaccurate and untimely given the current quality of passenger data. This NPRM through proposed section 42 CFR 70.11 would improve HHS/CDC's ability to receive reports of symptomatic interstate travelers allowing for more efficient evaluation and enabling HHS/CDC to expedite its domestic response activities, ( e.g. distributing Passenger Locator Forms) to more quickly and efficiently locate and assess exposed travelers, and mitigate the spread of disease. The proposed updated definition of “ill person” also includes a provision for the CDC Director to revise the symptom definition as needed in response to a newly identified communicable disease; this will greatly enhance HHS/CDC's ability to respond rapidly to emerging public health threats. By expanding the current regulatory definition to include the requested symptoms, CDC is improving the sensitivity of the system that requires reporting of ill travelers on conveyances, allowing CDC to then make a determination of whether the illness may represent a communicable disease of public health concern. Since 2007, HHS/CDC has employed basic tools, such as public health travel restrictions list (“Do Not Board list”) to prevent travel by commercial airline of individuals infectious with communicable diseases that pose a public health threat to the traveling public. 16 During the 2014-2016 Ebola epidemic, HHS/CDC revised the criteria for use of Federal travel restrictions to address the need to prevent travel by persons potentially exposed to Ebola or other communicable diseases but not yet considered contagious. The updated criteria provided HHS/CDC with greater flexibility to control the movement of persons who pose a public health threat during travel and to apply Federal travel restrictions in support of outbreak control. In certain circumstances, HHS/CDC has allowed people contagious with or exposed to serious communicable diseases to travel interstate if this can be done in a manner that does not expose the public ( e.g., by private vehicle). However, the needs of the individual to engage in travel must be carefully weighed against the public health risk due to the potential lack of public health oversight, especially during travel over long distances or crossing multiple states. For this reason, during the 2014-2016 Ebola epidemic, HHS/CDC recommended against long-distance travel by private vehicle for people with certain types of exposures to Ebola. State and local public health authorities, relying on their own legal processes, enforced these recommendations by imposing their own movement restrictions on individuals potentially exposed to Ebola. While HHS/CDC could similarly impose movement restrictions for individuals reasonably believed to be infected with a quarantinable communicable disease through the issuance of a Federal order for isolation, quarantine, or conditional release, codifying in regulation a separate, formal process to issue interstate travel permits for individuals subject to controlled movement allows for greater transparency and public understanding of what actions HHS/CDC may take to condition an individual's travel on the observance of public health measures to assure the safety of other travelers and communities. 16 See Criteria for Requesting Federal Travel Restrictions for Public Health Purposes, Including for Viral Hemorrhagic Fevers, 80 FR 16,400 (Mar. 27, 2015). In the last century, 60% of newly identified infectious diseases in humans globally were zoonotic (transmitted from animals to humans). As mentioned above, evidence indicates that both MERS and Ebola are associated with animal reservoirs (camels and bats, respectively). It is possible any future outbreaks may be linked to animal sources for which an emergency ban on certain animals or cargo ( e.g., animal products) would be necessary to protect the public. In the past, HHS/CDC has issued import embargoes either through publication of an interim final rule ( e.g., 68 FR 62353 (Nov. 4, 2003) (imposing restrictions on African rodents)) or through issuance of an emergency order under the authority of 42 CFR 71.32(b) (allowing for the application of public health measures to arriving carriers and animals, articles, or things found onboard such arriving carriers) ( See http://www.cdc.gov/sars/media/civet-ban.html ). Codifying in regulation a provision explicitly relating to HHS/CDC's ability to impose an import embargo provides greater transparency and will greatly enhance HHS/CDC's ability to protect the public from ongoing hazardous importations. We note that while proposed § 71.63 serves to clarify CDC's authority to temporarily ban certain imports, this is not a new authority and will not alter current CDC practices. HHS/CDC will continue to coordinate in advance with other Federal agencies that have overlapping authority, as may be necessary to implement and enforce this provision. Finally, this NPRM contains due process provisions (requirements relating to administrative records, quarantine, isolation, conditional release, medical examination, and agreements; authorization for payment for medical care and treatment; and an explanation of applicable criminal penalties) which are intended to inform the U.S. public of what steps HHS/CDC might take to protect public health during an outbreak while safeguarding the rights of the individual. Although these processes have been implemented through internal standard operating procedures, these procedures have not been codified, explicitly set forth in regulation, and made publicly available until today. These provisions are needed to provide transparency and assure the traveling public and any individual potentially placed under a Federal public health order that HHS/CDC will protect their individual liberties. The provisions in this NPRM describe the regulatory activities that HHS/CDC may undertake to reduce and mitigate the risk of outbreaks of Ebola, MERS, measles, and other communicable diseases in the United States. Greater transparency and public understanding of its processes, authorities, and procedures, will allow HHS/CDC to respond more effectively to these public health emergencies. V. Ongoing Efforts With U.S Department of Homeland Security (DHS)/U.S. Customs and Border Protection (DHS/CBP) To Improve Passenger Data Collection CDC is currently working with DHS/CBP to update existing DHS/CBP regulations that will require the electronic collection and submission of additional passenger and crew contact information to the Advance Passenger Information System (APIS) which would streamline the collection of additional data to minimize the burden on airline operators and travelers. We also plan to work with DHS/U.S. Coast Guard (USCG) to develop a comparable electronic data collection mechanism for vessels and their passengers and crew. Therefore this NPRM also informs airline and vessel industry, as well as travelers that HHS/CDC is working with DHS on expanding the data elements currently required and collected via APIS ( e.g., seat or cabin number, primary and secondary phone numbers, address information, and email address) that would be reported to CBP regarding passengers and crew on applicable international flights and vessel voyages. These data and additional contact information collected by DHS would then be shared with HHS/CDC as necessary for use in public health contact tracing. We have included the chart below to reflect the data elements of public health interest that are collected under current CDC manifest order practice, which HHS/CDC seeks to codify through this regulation. 17 See 19 CFR 122.49a for a list of the elements CBP requires for inbound commercial air travel. Currently required data elements of public health interest DHS/CBP-APIS 17 CDC— manifest order Full name (last, first, and, if available, middle or others) X X Date of Birth X X Sex X X Country of Residence X X If a passport is required; passport number, passport country of issuance, and passport expiration date X X Travel document information X X Name of Airline X X Flight number X X City of departure X X Departure date X X City of arrival X X Arrival date X X Address while in the United States (number and street, city, state, and zip code), except that U.S. citizens and lawful permanent residents will provide address of permanent residence in the U.S. (number and street, city, state, and zip code; as applicable) ( 18 ) X Primary contact phone number to include country code X Secondary contact phone number to include country code X Email Address X Seat or Cabin Number X V. Summary of Notice of Proposed Rulemaking 18 Under APIS, address while in the United States (number and street, city, state, and zip code), except that this information is not required for U.S. citizens, lawful permanent residents, or persons who are in transit to a location outside the United States. A. Updates to Part 70 1. § 70.1 General Definitions Section 70.1 contains the definitions used in this NPRM. The NPRM proposes new or updated definitions to be consistent with modern quarantine concepts and current medical and public health principles and practice. Apprehension Under section 361(d)(1) of the PHS Act (42 U.S.C. 264(d)(1)), HHS/CDC may promulgate regulations that provide for the apprehension and examination of any individual reasonably believed to be infected with a quarantinable communicable disease in a qualifying stage. In addition, HHS/CDC must reasonably believe that the individual is moving or about to move between states or constitutes a probable source of infection to others who may be moving between states. Thus, HHS/CDC believes that it is important to define for the public what is meant by the term “apprehension.” Apprehension means the temporary taking into custody of an individual or group for purposes of determining whether quarantine, isolation, or conditional release is warranted. Although each instance is unique, an apprehension will typically occur at the request of a state or local health department or in other time-sensitive situations, such as at a U.S. port of entry, where it is necessary for HHS/CDC to take immediate action to protect public health. The factors that may give rise to an apprehension are discussed in detail in the preamble section discussing the definition of “reasonably believed to be infected, as applied to an individual.” When an apprehension occurs, the individual is not free to leave or discontinue his/her discussion with an HHS/CDC public health or quarantine officer. In some cases, an apprehension may last from twenty minutes to one to two hours if, for instance, based on a public health assessment, HHS/CDC is able to quickly rule out the presence of a quarantinable communicable disease. In certain circumstances, the individual may remain apprehended pending confirmation that he or she is not infected or not reasonably believed to be infected with a quarantinable communicable disease. If it is necessary to issue the individual a Federal order for quarantine, isolation, or conditional release, the individual will remain apprehended pending the service of the written order. The factors that may give rise to an order for quarantine, isolation, or conditional release are discussed in detail in the preamble section discussing the definition of “reasonably believed to be infected, as applied to an individual.” Based on past experience, HHS/CDC believes that a written Federal order may be served to an individual within 24-48 hours of an apprehension. These timeframes are merely offered as guidance and HHS/CDC believes that the facts and circumstances of each case will dictate the expected length of an apprehension. Generally, however, HHS/CDC does not expect that the typical public health apprehension will last longer than 72 hours. It is not HHS/CDC's intent through this definition to allow for extended apprehensions absent the issuance of a Federal order for quarantine, isolation, or conditional release. HHS/CDC requests public comment concerning the expected apprehension period (no longer than 72 hours), and whether there are any public concerns with the absence of a specific maximum apprehension period in the regulation. Communicable Period HHS/CDC is proposing to revise the definition of communicable period in part 70. As listed in the table above, under the new definition, communicable period would mean the period during which an infectious agent may be transmitted either directly or indirectly from an infected individual to another individual. Under section 361 (b) and (d) of the Public Health Service Act, to authorize the quarantine, isolation, or conditional release of any individual traveling interstate, HHS/CDC must reasonably believe that an individual is infected with a quarantinable communicable disease in a qualifying stage. 42 U.S.C. 264(b) and (d)(1). As defined by the statute, a “qualifying stage” means that the communicable disease is in “a precommunicable stage, if the disease would be likely to cause a public health emergency if transmitted to other individuals” or “a communicable stage.” Thus, HHS/CDC believes that it is necessary to provide a clear definition for what it means for an individual to be in the communicable stage of a communicable disease. HHS/CDC's proposed revised definition is consistent with how this term is commonly understood in the public health community. There are numerous resources to describe the communicability of specific diseases. CDC's Health Information for International Travel (also known as the Yellow Book) provides the public with general guidance regarding the expected length of communicability for many quarantinable communicable diseases. The most current version is available on CDC's Web site. For more information, please see http://wwwnc.cdc.gov/travel/yellowbook/2016/table-of-contents . Agreement HHS/CDC is proposing a definition for “agreement” which refers to an agreement entered into between the CDC and an individual expressing agreement between the parties that the individual will observe public health measures authorized under this part, as the CDC considers reasonably necessary to protect the public's health, including quarantine, isolation, conditional release, medical examination, hospitalization, vaccination, and treatment. An explanation of the reasons for why HHS/CDC is including a regulatory provision explicitly allowing for agreements is discussed in detail in the preamble section explaining proposed § 70.8. HHS/CDC believes that the proposed definition is consistent with public health practice and common usage. Contaminated Environment HHS/CDC is proposing to define a contaminated environment as meaning the presence of an infectious agent on a surface, including on inanimate articles, or in a substance, including food, water, or in the air. Exposure to a contaminated environment is one method through which an individual may become infected with a communicable disease. Thus, HHS/CDC believes that it is important to define this term for transparency and to enhance the public's understanding of HHS/CDC's practices. HHS/CDC believes that the term is being defined consistently with public health practice and common usage. Conditional Release HHS/CDC is proposing to define conditional release to mean “surveillance” as that term is proposed in 42 CFR 71.1 and update the definition to include public health supervision through in-person visits by a public health official (or designee), telephone, or through electronic or internet-based monitoring as that term is defined. Surveillance under § 71.1 is currently defined as temporary supervision by a public health official (or designee) of an individual or group, who may have been exposed to a quarantinable communicable disease, to determine the risk of disease spread. HHS/CDC is proposing to expand the definition of conditional release to clarify that it may include electronic or internet-based monitoring in addition to in-person visits by a public health official or telephone reporting by the individual under a conditional release order. A proposed definition for electronic or internet-based monitoring has been included as part of this proposal and is discussed below. In general, such monitoring may include electronic or internet-based systems, such as video chat and voice calls from computers, tablets and mobile devices. This language is intended to be broad and would apply to any new or existing technologies that would allow for the public health supervision and monitoring of an individual under a conditional release order. Electronic or Internet-Based Monitoring HHS/CDC has proposed a definition for “electronic or internet-based monitoring” that defines this term as referring to mechanisms or technologies allowing for the temporary public health supervision of an individual under conditional release, including electronic mail, SMS texts, video conference or webcam technologies, integrated voice-response systems, entry of information into a web-based forum, wearable tracking technologies, and other mechanisms or technologies as determined by the Director or supervising health authority. HHS/CDC specifically solicits comment regarding whether this proposed definition is sufficiently broad to apply to any new or existing technologies that would allow for the public health supervision and monitoring of an individual under a conditional release order. HHS/CDC also solicits comment regarding whether the proposed definition raises any privacy implications for an individual who is reasonably believed to be infected with a quarantinable communicable disease and who is subject to a conditional release order. Ill Person HHS/CDC is including a proposed definition of “ill person” under part 70 to facilitate identification of communicable diseases of public health concern. Changes in the ill person definition, including the revised temperature threshold and inclusion of persistent diarrhea and vomiting, are particularly aimed at improving HHS/CDC's ability to detect Ebola. The NPRM definition of “ill person” focuses on the signs and symptoms of communicable diseases of public health concern to ensure such diseases are recognized and reported. However, HHS/CDC is also including a provision in this NPRM to allow it to include additional signs and symptoms of illness in case our understanding of the recognizable symptoms of communicable diseases of public health concern, such as Ebola, may change or to respond to communicable diseases that may emerge as future concerns. Notice of such additional signs and symptoms will be published in the Federal Register . HHS/CDC has crafted the proposed definition of “ill person” in such a way that it should be understood by non-medically trained crewmembers and used to discern illnesses of public health interest that HHS/CDC would like to be made aware of according to 42 CFR 70.4 from those that it does not ( e.g., common cold), while more closely aligning the definition with the symptoms reporting guidelines published by ICAO in Note 1 to paragraph 8.15 of Annex 9 to the Convention on International Civil Aviation. To further assist flight crewmembers (and vessel crewmembers under part 71) in identifying individuals with a reportable illness, HHS/CDC provides the following in-depth explanations and examples of the communicable diseases that such signs and symptoms might indicate. Note that these explanations also apply to the definition of “ill person” under part 71. 1. Fever: This term means that the person has a measured temperature of 100.4 °F (38°C) or greater, feels warm to the touch, or gives a history of feeling feverish. While a measured temperature is the preferable and more accurate method to determine whether a person has a fever, it is not always possible to obtain. The measured temperature also may not reflect the presence of a recent fever, for example, if the individual has taken a fever-reducing medication. For these reasons, the revised “ill person” definition includes other methods that may be used by crewmembers as proxies for a measured temperature. If it is not feasible or advisable to touch the individual or if the individual does not disclose a history of feeling feverish, then, while not definitive, the observer should consider his/her appearance, such as having a flushed face, glassy eyes, or chills as possible indications of the presence of a fever. A self-reported history of feeling feverish is included in the event that the ill person has taken medication that would lower the measured temperature or if the fever fluctuates as part of the natural course of the disease. 2. Skin rash: This term means that the individual has areas on the skin with multiple red bumps; red, flat spots; or blister-like bumps filled with fluid or pus that are intact or partly crusted over. The rash may be discrete or may run together, and may include one area of the body, such as the face, or more than one area. The presence of skin rash, along with fever, may indicate that the traveler has measles, rubella (German measles), varicella (chickenpox), meningococcal disease, or smallpox. 3. Difficulty breathing: This term means that the individual is gasping for air, is unable to “catch” his/her breath, is breathing too fast and shallow to get enough air, or cannot control his/her own secretions. These symptoms may be apparent or self-reported if not obvious. Difficulty breathing, along with fever, may indicate a traveler has tuberculosis, diphtheria, influenza with pandemic potential, or a severe acute respiratory syndrome. 4. Persistent cough: This term means that the cough is frequent and severe enough that it catches the attention of the crewmember, or the individual or another passenger voices concern about it. Persistent cough, along with fever, may indicate the traveler has pertussis/whooping cough (vomiting may occur at the end of a coughing fit), tuberculosis, severe acute respiratory syndrome, or influenza with pandemic potential. 5. Decreased consciousness or confusion of recent onset: This term means that the individual is not fully aware of his/her surroundings or may be unusually difficult to awaken. The individual may appear to be confused or disoriented. Decreased consciousness, along with fever, may indicate the traveler has meningococcal disease, another serious neurological infection, or serious infection in another body system. 6. Bruising or bleeding (without previous injury): This term means that the person has noticeable and unusual bruising or bleeding from gums, ears, nose or areas on skin for which there is no obvious explanation. Unexplained bruising or bleeding, along with fever, may indicate the person has a hemorrhagic fever, such as Ebola, or plague. 7. Persistent diarrhea: This term means that the diarrhea is frequent and severe enough that the air crewmember notices, for example, that the person has been to the restroom numerous times, or the individual or another passenger voices concern about it. Persistent diarrhea may indicate the person has a foodborne or waterborne infection such as norovirus or cholera, or another serious communicable disease, such as Ebola. Many infections that cause persistent diarrhea can be spread easily from person to person, either directly or indirectly through food or water, and cause large outbreaks. 8. Persistent vomiting: This term means that the individual has vomited two or more times (not due to air or sea sickness) and either expresses concern to the air/vessel crew or comes to the attention of others onboard (air/vessel crew or passengers). Persistent vomiting may indicate the person has a foodborne or waterborne infection such as norovirus, or another serious communicable disease, such as Ebola. 9. Headache with stiff neck: This term means that the individual is self-reporting a headache accompanied by difficulty moving his/her neck. These symptoms may indicate that the individual has bacterial meningitis, such as meningococcal meningitis. Meningococcal meningitis has a high death rate and a significant proportion of survivors have residual impairments, such as deafness or injury to the brain. Individuals in close contact with ill persons with meningococcal disease are at elevated risk for contracting the disease. 10. Obviously unwell: HHS/CDC has included this description into the proposed definition of “ill person” as it is used in ICAO guidelines to aid crewmembers in the identification of symptoms of communicable disease. See Note 1 to paragraph 8.15 of Annex 9 to the Convention on International Civil Aviation. Indigent CDC conducts a mandatory reassessment 72 hours after the service of all Federal orders for quarantine, isolation, or conditional release. A medical review is part of the administrative appeals process whereby an individual under a Federal order may request a separate medical review of his/her case after the mandatory reassessment is complete. HHS/CDC is defining the term “indigent” for purposes of appointing a medical representative for indigent individuals placed under a Federal order of quarantine, isolation, or conditional release who request a medical review and appointment of a medical representative. An indigent individual is defined as one whose annual family income is below 150% of the applicable poverty guidelines updated periodically in the Federal Register by the U.S. Department of Health and Human Services under the authority of 42 U.S.C. 9902(2) or liquid assets totaling less than 15% of the applicable poverty guidelines if no income is earned. The poverty guidelines are updated periodically by HHS and are used for determining eligibility for a number of Federal, state, local, and private programs. The poverty guidelines for 2016 are published at 81 FR 4036 (Jan. 25, 2016). The medical review process is explained in more detail below. CDC specifically requests public comment on whether the use of this standard definition is an appropriate threshold to determine whether an individual cannot afford representation and therefore should be appointed a medical representative at the government's expense. Medical Examination Under section 361(d)(1) of the PHS Act (42 U.S.C. 264(d)(1)), HHS/CDC may promulgate and enforce regulations concerning the apprehension and examination of any individual reasonably believed to be infected with a quarantinable communicable disease in a qualifying stage who is, or is reasonably expected to be, moving or about to be moving between states or constitutes a probable source of infection to others who may be moving between states. Thus, HHS/CDC believes that it is important to define for the public what is meant by a medical examination. Under this NPRM, we define Medical examination to mean the assessment of an individual by an authorized health worker to determine the individual's health status and potential public health risk to others and may include the taking of a medical history, a physical examination, and the collection of human biological samples for laboratory testing. Medical examination may be authorized as part of a Federal order for quarantine, isolation, or conditional release. The process for ordering a medical examination is explained in more detail in the portion of the preamble discussing that substantive provision at § 70.12. Medical Representative HHS/CDC is providing an opportunity for any individual under a Federal order of quarantine, isolation, or conditional release to request a medical review. As part of this process, the individual under the Federal order may choose anyone to represent him/her at the medical review at his/her own expense or to represent himself/herself. However, in the case of an individual who is indigent and cannot afford his/her own representative, HHS/CDC will appoint at government expense a medical representative to assist the indigent individual with the presentation of evidence during the medical review. Appointments by HHS/CDC will be made only if the individual qualifies as an indigent, requests a medical review, and specifically requests the appointment of a medical representative. Again, individuals who do not qualify as indigent may choose to be represented by anyone at their own expense or to represent themselves at the medical review. Because HHS/CDC views the medical review process as a medical fact-finding, it has defined the “medical representative” in terms of the relevant medical qualifications. Medical representative means a physician, nurse practitioner, or similar medical professional qualified in the diagnosis and treatment of infectious diseases who is appointed by the HHS Secretary or CDC Director to assist an indigent individual under Federal quarantine, isolation, or conditional release with a medical review. The medical representative's role will be to assist the indigent individual with the examination of witnesses and the presentation of factual and scientific evidence during the medical review. The medical representative and the medical reviewer will not be the same individual. Individuals who do not qualify as indigent may choose to be represented by anyone at their own expense or to represent themselves at the medical review. Medical reviewer means a physician, nurse practitioner, or similar medical professional qualified in the diagnosis and treatment of infectious diseases who is appointed by the HHS Secretary or CDC Director to conduct a medical review. The medical reviewer may be an HHS or HHS/CDC employee, but only if the employee differs from the HHS/CDC official who issued the Federal order for quarantine, isolation, or conditional release. The medical reviewer's role will be to review the medical or other evidence presented, make medical or scientific findings of fact, and issue a recommendation to the CDC Director concerning whether the quarantine, isolation, or conditional release should be continued, rescinded, or modified. The medical reviewer and the medical representative will be different individuals. Non-Invasive The definition of non-invasive has been added to this NPRM to provide the public with reasonable assurances and expectations regarding what measures may be employed as part of a public health risk assessment or following reporting of an ill traveler. We define non-invasive as “procedures conducted by an authorized health worker or other individual with suitable training and includes the visual examination of the ear, nose, and mouth; temperature assessments using an ear, oral, or cutaneous or noncontact thermometer or thermal imaging; auscultation; external palpation; external measurement of blood pressure; and other procedures not involving the puncture or incision of the skin or insertion of an instrument or foreign material into the body or a body cavity, except the ear, nose, or mouth.” HHS/CDC specifically requests comment concerning this definition including whether the definition aligns with common perceptions of what constitutes non-invasive procedures that may be conducted outside of a traditional clinical setting. Precommunicable Stage Under section 361(d) of the Public Health Service Act, to authorize the quarantine, isolation, or conditional release of an individual traveling interstate, CDC must reasonably believe that the individual is infected with a communicable disease in a qualifying stage. 42 U.S.C. 264(d)(1). As defined by the statute, a “qualifying stage” means that the communicable disease is in “a precommunicable stage, if the disease would be likely to cause a public health emergency if transmitted to other individuals” or “a communicable stage.” Thus, HHS/CDC believes that it is necessary to define the precommunicable stage of a communicable disease to adequately inform the public of when quarantine, isolation, or conditional release may be authorized. HHS/CDC defines precommunicable stage to mean the stage beginning upon an individual's earliest opportunity for exposure to an infectious agent and ending upon the individual entering or reentering the communicable stage of the disease or, if the individual does not enter the communicable stage, the latest date at which the individual could reasonably be expected to have the potential to enter or reenter the communicable stage. For instance, a patient diagnosed with multidrug-resistant or extensively drug-resistant tuberculosis who is not currently infectious but has not been adequately treated for the disease and is thus considered to be at high risk of relapse to an infectious state would be in the “precommunicable stage” of the disease. For clarity, and to be consistent with statutory language, we have also updated the definition of “incubation period” to mean the time from the moment of exposure to an infectious agent that causes a communicable disease until signs and symptoms of the communicable disease appear in the individual or for a quarantinable communicable disease the precommunicable stage of the disease. While it is important that HHS/CDC maintain flexibility to evaluate each case individually regarding the length of quarantine, CDC's Health Information for International Travel (also known as the Yellow Book) provides the public with general guidance regarding the expected incubation period for many quarantinable communicable diseases. The most current version is available on CDC's Web site. For more information, please see http://wwwnc.cdc.gov/travel/yellowbook/2016/table-of-contents . Public Health Emergency Under section 361(d) of the Public Health Service Act, in order to authorize the quarantine, isolation, or conditional release of any individual traveling interstate, CDC must reasonably believe that an individual is infected with a communicable disease in a qualifying stage. 42 U.S.C. 264(d)(1). As defined by this subsection, a “qualifying stage” means that the communicable disease is in “a precommunicable stage, if the disease would be likely to cause a public health emergency if transmitted to other individuals” or “a communicable stage.” 42 U.S.C. 264(d)(2). While the phrase “public health emergency” also appears under section 319 of the Public Health Service Act (42 U.S.C. 247d(a)), the use of the same phrase in both sections 319 and 361(d)(2) are not necessarily synonymous. Accordingly, HHS/CDC felt it was important to define “public health emergency” as used under section 361(d)(2) to provide the public with a clear understanding of HHS/CDC's authority for interstate quarantine, isolation or conditional release. Public health emergency as used in this part means any communicable disease event as determined by the CDC Director with either documented or significant potential for regional, national, or international communicable disease spread or that is highly likely to cause death or serious illness if not properly controlled; or any communicable disease event described in a declaration by the Secretary pursuant to § 319(a) of the Public Health Service Act (42 U.S.C. 247d(a)); or any communicable disease event the occurrence of which is notified to the World Health Organization, in accordance with Articles 6 and 7 of the International Health Regulations, as one that may constitute a Public Health Emergency of International Concern; or any communicable disease event the occurrence of which is determined by the Director-General of the World Health Organization, in accordance with Article 12 of the International Health Regulations, to constitute a Public Health Emergency of International Concern; or any communicable disease event for which the Director-General of the World Health Organization, in accordance with Articles 15 or 16 of the International Health Regulations, has issued temporary or standing recommendations for purposes of preventing or promptly detecting the occurrence or reoccurrence of the communicable disease. HHS/CDC specifically requests public comment on this definition and its utility in identifying communicable diseases that “would be likely to cause a public health emergency if transmitted to other individuals” under 42 U.S.C. 264(d)(2)(B). Public Health Prevention Measures Under this NPRM, Public health prevention measures means the assessment of an individual through non-invasive procedures and other means, such as observation, questioning, review of travel documents, review of other available records to determine the individual's health status and potential public health risk to others ( i.e., passenger screening). HHS/CDC believes that this definition is consistent with how public health risk assessments are generally conducted at U.S. ports and other locations, including by HHS/CDC personnel. HHS/CDC is publishing this definition to describe its authority to conduct public health prevention measures and is not effecting a change in operations. Qualifying Stage Under this NPRM, “qualifying stage” means the communicable stage of a quarantinable communicable disease, or the precommunicable stage of the quarantinable communicable disease, but only if the quarantinable communicable disease would be likely to cause a public health emergency if transmitted to other individuals. This NPRM also separately defines “communicable stage” and “precommunicable stage.” HHS/CDC believes that these definitions are consistent with public health practice and the requirements of 42 U.S.C. 264(d)(2). Reasonably Believed To Be Infected, as Applied to Individuals HHS/CDC is including this definition in this NPRM for transparency and so that the public understands the factors taken into consideration when HHS/CDC makes a determination to issue a Federal order for quarantine, isolation, or conditional release. By adding this definition, HHS/CDC is not changing its operations, but rather is codifying and providing an explanation to the public. Under this NPRM, reasonably believed to be infected, as applied to an individual, means specific articulable facts upon which a public health officer could reasonably draw the inference that an individual has been exposed, either directly or indirectly, to the infectious agent that causes a quarantinable communicable disease, as through contact with an infected person or an infected person's bodily fluids, a contaminated environment, or through an intermediate host or vector, and that as a consequence of the exposure, the individual is or may be harboring in the body the infectious agent of that quarantinable communicable disease. HHS/CDC believes that this standard is consistent with the legal requirements of the statute, public health practice, and long-standing historical practice concerning the quarantine and isolation of individuals. The determination as to whether an individual is “reasonably believed to be infected,” as defined in this NPRM, with a quarantinable communicable disease in a qualifying stage is made on a case-by-case basis. Notwithstanding, the following illustrative examples are provided to help explain to the public when facts or circumstances may exist giving rise to a reasonable belief that an individual is infected with a quarantinable communicable disease in its qualifying stage. These include: Clinical manifestations in the individual consistent with those of a quarantinable communicable disease; suspected contact with cases or suspect cases of individuals infected with a quarantinable communicable disease in its communicable stage; host susceptibility to a quarantinable communicable disease combined with opportunity for exposure; travel to countries and places where transmission of a quarantinable communicable disease has likely occurred; reports of the individual exhibiting illness or symptoms consistent with those of a quarantinable communicable disease; or other evidence of possible infection, including exposure to the infectious agent that causes a quarantinable communicable disease. These factors are meant to be illustrative and provide only general guidance. HHS/CDC specifically solicits public comment regarding this definition, in particular, whether the definition aligns with established public health practice regarding the handling of individuals exposed to or infected with communicable diseases. 2. § 70.5 Requirements Relating to Travelers Under a Federal Order of Isolation, Quarantine, or Conditional Release This provision of the NPRM proposes to replace the previous § 70.5 Certain Communicable Diseases; special requirements that imposes an interstate travel permit requirement for persons in the communicable stage of cholera, plague, smallpox, typhus, or yellow fever. The existing provision also prohibits conveyance operators from “knowingly” accepting for transportation any individual in the communicable stage of any of the specified diseases or in violation of the terms of the travel permit. Under this NPRM, any individual under a Federal order, or agreement, of isolation, quarantine, or conditional release for a quarantinable communicable disease, as specified by Executive Order, may be prohibited from traveling in interstate traffic, unless the individual has received a written travel permit issued by HHS/CDC. The term “interstate traffic” is currently defined in HHS/CDC regulations at 42 CFR 70.1 and includes movement from a point of origin in any state or possession to a point of destination in any other state or possession. This provision also applies to an “agreement” for isolation, quarantine, or conditional release. An individual must retain the travel permit in his/her possession and comply with the conditions for travel set forth in the permit. If an individual is denied an application for a travel permit, the denial will be issued in writing. The letter of denial will include the reasons for the denial as well as detailed instructions on whom to contact for questions, including name, address, and telephone number, as well as how to submit an appeal. Individuals who wish to contest HHS/CDC's determination will have 10 calendar days after receiving the letter of denial to submit an appeal. The appeal must be submitted in writing to the CDC, stating the reasons for the appeal and showing that there is a genuine and material issue of fact in dispute. Individuals should include also the reference number listed in the notification letter they received. The appeal should be addressed to: Director, Division of Global Migration and Quarantine, ATTN: Travel Restriction and Intervention Activity, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS E-03, Atlanta, GA 30329. Appeals may also be faxed to HHS/CDC at (404) 718-2158 or emailed to travelrestrictions@cdc.gov . HHS/CDC will issue a written response to an appeal, which shall constitute final agency action. The appeal will be reviewed and decided upon by an HHS/CDC senior official who will be senior to the employee who issued the initial letter of denial. This appeal process is also applicable to revocations and suspensions of a travel permit. Conveyance operators are also prohibited from ”knowingly” transporting an individual under a Federal order, or agreement, of isolation, quarantine, or conditional release without a travel permit or someone who is in violation of the terms of a permit. This prohibition only applies in circumstances where the operator would be reasonably considered to know or have knowledge that the individual is under a public health order and requires a travel permit. For instance, if the operator has been informed directly by the CDC, or if DHS, upon the request of CDC, has placed the individual's name on a Federal public health travel restrictions list (“Do Not Board” (DNB) list)—which would only apply to aircraft operators. The provisions of this section may also be applied to individuals under a state or local order, or an agreement, (if operators are directly notified by authorities that an individual is under a state or local order) for quarantine, isolation, or conditional release, or to those individuals traveling entirely within a state and to intrastate conveyance operators at the request of a state or local health department or in the event of inadequate local control as determined by the CDC Director under 42 CFR 70.2. In the event that this provision is applied intrastate, CDC will work with the relevant state or local health department of jurisdiction to inform intrastate conveyance operators ( e.g., bus operators) on a case-by-case basis of the names of individuals subject to this restriction. The application of these provisions to intrastate travel is authorized under section 361(a) of the Public Health Service Act (42 U.S.C. 264(a)) to the extent that such measures are necessary to prevent the interstate spread of communicable diseases. Specifically, because the statute authorizes the promulgation of regulations that are necessary to “prevent” interstate spread of disease, HHS/CDC may regulate certain activities that occur entirely within a State if those activities present a risk of interstate disease spread, as would occur, for instance, in the event of inadequate local control. This approach is consistent with how courts have interpreted the scope of the Federal government's authority under the Commerce Clause to the U.S. Constitution. See United States v. Lopez, 514 U.S. 549, 558-559 (1995) (noting that the Commerce Clause authorizes the regulation of the instrumentalities of interstate commerce, or persons or things in interstate commerce, even though the threat to interstate commerce may come only from intrastate activities). This provision is also consistent with HHS/CDC's Interim U.S. Guidance for the Monitoring and Movement of Persons with Potential Ebola Virus Exposure, published during the 2014-2016 Ebola epidemic (a description of the guidance is available at http://www.cdc.gov/vhf/ebola/hcp/monitoring-and-movement-of-persons-with-exposure.html ). HHS/CDC specifically requests public comment on this proposed provision. HHS/CDC recognizes that the right to engage in travel within the United States is a privilege of national citizenship protected by the Privileges and Immunities Clause of the U.S. Constitution, as well as an aspect of liberty protected by the Due Process Clauses of the Fifth and Fourteenth Amendments. See Jones v. Helms, 452 U.S. 412, 418 (1981). However, this right is not unqualified and travel restrictions based on the threat posed by communicable diseases are valid. See Zemel v. Rusk, 381 U.S. 1, 15-16 (1965) (“The right to travel within the United States is of course also constitutionally protected . . . [b]ut that freedom does not mean that areas ravaged by flood, fire or pestilence cannot be quarantined when it can be demonstrated that unlimited travel to the area would directly and materially interfere with the safety and welfare of the area or the Nation as a whole.”). Furthermore, HHS/CDC will afford individuals subject to these travel restrictions with adequate due process through the previously mentioned written appeals process. This new regulatory provision also serves as an important complement to the public health “Do Not Board” (DNB) list. In June 2007, HHS/CDC and the Department of Homeland Security (DHS) developed a public health DNB list, enabling domestic and international public health officials to request that individuals with communicable diseases who meet specific criteria, including posing a public health threat to the traveling public, be restricted from boarding commercial aircraft arriving into, departing from, or traveling within the United States. See Criteria for Requesting Federal Travel Restrictions for Public Health Purposes, Including for Viral Hemorrhagic Fevers. Available at: https://www.Federalregister.gov/articles/2015/03/27/2015-07118/criteria-for-requesting-Federal-travel-restrictions-for-public-health-purposes-including-for-viral . The public health DNB list, which is administered by DHS with HHS/CDC's assistance, is primarily intended to supplement state and local public health measures to prevent individuals who are infectious or at risk of becoming infectious from boarding commercial aircraft. However, because use of the DNB list is limited to commercial aircrafts, the public health protections offered by the DNB list do not extend to vessels, or other forms of interstate transportation, such as trains and buses. Thus, this new provision allows for an enhanced HHS/CDC public health response to quarantinable communicable diseases by establishing a permitting process that restricts interstate travel to modes of conveyance that do not put the public at risk of exposure, and ensures that appropriate public health measures are in place. CDC specifically requests public comment on this provision. In particular, HHS/CDC requests comment on whether stakeholders have concerns regarding the requirement imposed on conveyance operators to not “knowingly” transport individuals under a Federal order and the feasibility of this requirement. HHS/CDC also requests public comment on the application of this provision to individuals under state/local order as well as individuals traveling entirely within a state. 3. § 70.6 Apprehension and Detention of Persons With Quarantinable Communicable Diseases Through this NPRM, HHS/CDC has proposed to change the text of this provision. We have modified “infected with a quarantinable communicable disease” to clarify, consistent with the statute's requirements, that the individual must be in the “qualifying stage” of a quarantinable communicable disease, which we also define. We did this to better align our regulations with the Public Health Service Act which authorizes the “apprehension and examination of any individual reasonably believed to be infected with a [quarantinable communicable] disease in its qualifying stage and (A) moving or about to move from a state to another state; or (B) to be a probable source of infection to individuals who, while infected with such disease in a qualifying stage, will be moving from a state to another state.” See 42 U.S.C. 264(d)(1)(2). The statute's requirement for interstate movement is reflected in the requirement in § 70.6 that HHS/CDC's custody of the individual be “for the purposes of preventing the interstate introduction, transmission, or spread of quarantinable communicable diseases.” 4. § 70.10 Public Health Prevention Measures To Detect Communicable Disease This provision is authorized by the Public Health Service Act. Section 361(a) of the PHS Act (42 U.S.C. 264(a)) authorizes the HHS Secretary to promulgate regulations to prevent the interstate introduction, transmission, and spread of communicable diseases. As previously mentioned, section 361(a) (42 U.S.C. 264(a)) applies broadly to communicable diseases generally and is not limited to those subset of communicable diseases referred to as “quarantinable communicable diseases” for which quarantine, isolation, or conditional release are authorized. Section 361(a) includes the authority to allow for a variety of public health measures in regard to communicable diseases including: Inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be sources of dangerous infection to human beings, and other measures to protect public health. Specifically, this list of public health actions does not involve taking persons into custody or require reasonable suspicion as a predicate to implementation. In contrast an “apprehension, detention, or conditional release” as used in section 361(b) involves custodial situations and requires, with regard to persons moving between states or U.S. territories, a reasonable belief that the individual is in the qualifying stage of a quarantinable communicable disease. In addition to being consistent with the requirements of section 361 of the Public Health Service Act, this provision is also consistent with constitutional principles and requirements. For instance, in the analogous situation of an airport security screening, it is well established that the Transportation Security Administration may conduct routine warrantless searches of all carry-on luggage without individualized suspicion because of the compelling government interest involved. See United States v. Doe, 61. F.3d 107, 110 (1st Cir. 1995) (“Routine security searches at airport checkpoints pass constitutional muster because the compelling public interest in curbing air piracy generally outweighs their limited intrusiveness.”); see also Russkai v. Pistole, 775 F.3d 61, 68 (1st Cir. 2014) (noting that transit security screenings are treated as “administrative” or “special needs” searches, which may be conducted, at least initially, without individualized suspicion, a warrant, or probable cause). HHS/CDC believes that the rationale for airport security screenings may be extended to other forms of transportation, e.g., trains and buses, because of the similar “administrative” or special governmental need in preventing interstate communicable disease spread. Public health risk assessments are limited to non-invasive means, as defined in this NPRM, which includes temperature assessments using an ear, oral, cutaneous, or noncontact thermometer, auscultation, external palpation, external measurement of blood pressure, as well as questioning of individuals and review of travel documents. HHS/CDC does not intend through this provision to engage in medical testing of individuals (as would typically occur in a hospital or other clinical setting) at ports of entry or other places where individuals may engage in travel or to collect human biological samples for subsequent laboratory testing. HHS/CDC's intent under this provision is to provide for mandatory public health risk assessment and management at ports or other locations where individuals may gather to engage in interstate traffic. However, as in other circumstances where individuals are screened, such as airport security screenings, an individual's willingness to be screened may be inferred from his or her queueing with other travelers who may be engaging in interstate travel. See United States v. Herzbrun, 723 F.2d 773, 775 (11th Cir. 1984) (holding that a passenger consents to an airport security search by presenting himself/herself for boarding and that such consent may not be revoked by simply walking away). Thus, in order to protect interstate travel from communicable disease threats, HHS/CDC intends for this section to apply broadly to all circumstances where individuals may queue with other travelers because certain communicable diseases may be spread from person to person under such circumstances. This includes circumstances where only a certain percentage of travelers may be intending to subsequently engage in interstate travel or, for instance, the individual traveler is intending to engage in foreign travel outside the country as opposed to domestic interstate travel because by queuing in line with others at the airport he or she may expose other travelers intending to engage in interstate travel. HHS/CDC specifically requests public comment on this proposed provision and whether the public has any concerns regarding the mandatory health screening of passengers using non-invasive means as defined in this proposed rule. During a public health risk assessment, if facts or circumstances are discovered that give rise to a reasonable belief that the individual is infected, as defined under this NPRM, with a quarantinable communicable disease in its qualifying stage, CDC may authorize the quarantine, isolation, or conditional release of the individual. Similarly, an individual's refusal to be screened may result in quarantine, isolation, or conditional release, but only if sufficient facts and circumstances otherwise exist giving rise to a reasonable belief that the individual is infected with a quarantinable communicable disease in its qualifying stage. Under section 311 of the PHS Act (42 U.S.C. 243), HHS/CDC may accept state and local assistance in the enforcement of Federal quarantine rules and regulations, though these entities are not obligated to provide such assistance. In appropriate cases, Federal law enforcement agencies may also be able to assist in the enforcement of Federal public health orders. Under section 365 of the PHS Act (42 U.S.C. 268) it shall be the duty of “customs officers” and “Coast Guard officers” to aid in the enforcement of Federal quarantine rules and regulations. “Customs officers” includes U.S. Customs and Border Protection (CBP) officers, U.S. Border Patrol agents, U.S. Immigration and Customs Enforcement (ICE) officers, and U.S. Coast Guard Commissioned, Warrant, and Petty Officers pursuant to 14 U.S.C. 143 and 19 U.S.C. 1401(i). This section also requires individuals undergoing a public health risk assessment to provide basic contact tracing information which would be used to locate and notify individuals of a potential exposure to a communicable disease. This information would include U.S. and foreign addresses, telephone numbers, email addresses, used to locate and notify an individual. This section would also require that individuals undergoing a public health risk assessment provide additional information that would be used to assess an individual's health status and make a determination as to whether the individual may pose a public health risk to others. This would include information concerning the individual's intended destination, health status, and history of travel to places where exposure to communicable disease may have occurred. HHS/CDC specifically requests public comment on this proposed provision to collect additional personal information from screened individuals for the purposes of contact tracing. On December 13, 2007, HHS/CDC published a notice of a new system of records (SORN) under the Privacy Act of 1974 that is relevant to the activities that would be carried out under a future rule related to collecting, retaining, and disseminating passenger and crew data for public health purposes (72 FR 70867). HHS/CDC accepted public comment on its proposed routine uses of this information at that time. As required under the Privacy Act, in its notice, HHS/CDC described the proposed system of records; the proposed routine uses, disclosures of system data, the benefits and need for this data, agency policies and procedures, restrictions on the use of this information, and, most important, HHS/CDC's safeguards to prevent unauthorized use. Data collected from travelers, ill persons, and individuals under Federal public health orders will be maintained in accordance with the Privacy Act and the system of records notice regardless of whether the individual is a U.S. citizen or foreign national. More information regarding the storage, maintenance, and routine uses of this information may be found at 72 FR 70867 (Dec. 13, 2007). HHS/CDC will make disclosures from the system of records only with the consent of the subject individual or in accordance with the Privacy Act or its Privacy Act system of records notice. As a matter of practice, HHS/CDC applies these same requirements and protections afforded by its Privacy Act system of records notice to non-U.S. persons whose personal information is collected and maintained in this system of records. 5. § 70.11 Report of Death or Illness Onboard Aircraft Operated by Airline This NPRM specifies that the pilot in command of an aircraft operating on behalf of an airline who conducts a commercial passenger flight in interstate traffic under a regular schedule, shall report as soon as practicable to the HHS/CDC the occurrence onboard of any deaths or ill persons among passengers or crew and take such measures as HHS/CDC may direct to prevent the potential spread of the communicable disease, provided that such measures do not affect the aircraft's airworthiness or safety of flight operations. While this provision specific to interstate travel is new to the regulation, the reporting of deaths or illnesses among passengers and crew has been a long-established practice for flights arriving into the United States. Between 2010 and 2015, per year on average, HHS/CDC received about 175 illness and 10 death reports on aircraft and about 220 illness reports and 115 death reports from vessels. In light of recent events, such as the outbreaks of Ebola, measles and MERS, and the possibility that symptomatic, infectious individuals may board interstate flights, HHS/CDC believes it important to introduce this section to ensure that domestic flights report directly to HHS/CDC. This proposed section of the rule applies to aircraft and does not apply to other forms of transportation, such as buses and trains, because air travel generally carries an especially high risk of rapid transmission and dispersal of communicable disease as air travelers are able to easily connect to other flights and move around the country in just a few hours. Furthermore, if a traveler developed symptoms of a serious communicable disease onboard a bus or train, it might be easier for the bus or train operator to segregate or remove the ill person than onboard an aircraft. CDC also believes that it is easier for a local public health authority to respond to reports of an ill person onboard a bus or train traveling through its jurisdiction, even if ultimately on an interstate journey, than it would be for the same authority to respond to reports of an ill person on an aircraft. Furthermore, if the requirement were extended to interstate buses and trains, HHS/CDC believes that implementing this provision would be overly burdensome. HHS/CDC further notes that it is making no changes to its existing regulatory requirement at 42 CFR 70.4 which states that the master of a vessel or person in charge of any conveyance engaged in interstate traffic on which a case or suspected case of communicable disease develops shall, as soon as practicable, notify the local health authority. Under this NPRM, the pilot in command of an aircraft operating on behalf of an airline who submits the ill person report to HHS/CDC will not be required to also submit a report to the local health authority. HHS/CDC will continue to share public health information with state and local health departments through electronic disease reporting networks such as the Epidemic Information Exchange (Epi-X), HHS/CDC's secure, web-based system. CDC may also notify local authorities via a Health Alert Notice (HAN), and when necessary, via phone calls, email, or other direct communication. If finalized as proposed, in implementing this provision, an airline should establish a notification system sufficient to ensure that any death or ill person, as defined, that is made known to the pilot in command is reported to CDC either through the quarantine station of jurisdiction for the destination airport or the CDC Emergency Operations Center (EOC), where possible, at least one hour before arrival. The EOC serves an important triage function within HHS/CDC and operates 24-hours a day. CDC's EOC also is capable of quickly contacting the relevant state and local health authority and quarantine station of jurisdiction as well as assembling the necessary subject-matter experts for purposes of conducting a public heath investigation. This proposed provision is intended to provide airlines with flexibility regarding the exact routing of reports of deaths or ill persons, as defined. Thus, this NPRM explicitly authorizes airlines to develop and adopt a notification system that relays information from the pilot in command to CDC's EOC through a designated official of the airline. This may be accomplished by the pilot-in-command making a report of a death or ill person to the U.S. Department of Transportation (DOT)'s Federal Aviation Administration (FAA) air traffic control (ATC) facility. In such cases, the DOT/FAA will notify the CDC's EOC via DOT/FAA's Domestic Events Network (DEN), of the report. However, ATC channels will not be used by CDC or airlines for any subsequent coordination regarding the public health response that follows the initial report, unless no other reasonable alternative exists. ATC channels are open radio frequencies whose primary purpose is ensuring the safe and efficient movement of aircraft in the National Airspace System, and any personal health information broadcast over them may be overhead by any person with the appropriate equipment. HHS/CDC believes that an airline is in the best position to develop a notification system, because airlines presumably already have such systems in place for reporting of deaths or illnesses under CDC's existing regulations in 42 CFR parts 70 and 71 and to the relevant authorities for international flights. HHS/CDC, in coordination with DOT/FAA, may issue additional guidance to airlines regarding recommended procedures for the domestic reporting to the CDC's EOC of any death or ill person made known to the pilot in command. HHS/CDC will consider the adoption and implementation by an airline of a notification system as a measure of an airline's compliance with this provision. 6. § 70.12 Medical Examinations Under section 361(d)(1) of the PHS Act (42 U.S.C. 264(d)(1)), HHS/CDC may promulgate and enforce regulations concerning the apprehension and examination of any individual reasonably believed to be infected with a quarantinable communicable disease in a qualifying stage e. In addition, HHS/CDC must reasonably believe that the individual is moving or about to move between states or constitutes a probable source of infection to others who may be moving between states. Statutory support for medical examinations may be found directly under 42 U.S.C. 264(d)(1) which authorizes regulations allowing the “apprehension and examination” of any individual reasonably believed to be infected with a quarantinable communicable disease in a qualifying stage. Thus, HHS/CDC believes it is important to make this process more transparent and explicit. Accordingly, HHS/CDC is clarifying that the requirement for a medical examination by an authorized health worker may be included as part of a Federal order for quarantine, isolation, or conditional release. We specifically request public comment on this proposed provision and whether there are any concerns regarding the proposed practice to issue Federal orders before a medical examination has taken place. HHS/CDC will promptly arrange for a medical examination to be conducted in circumstances where such an examination is necessary to confirm the presence or absence of infection with a quarantinable communicable disease. A medical examination will typically occur in a hospital setting and be performed by clinical staff that will have primary responsibility for the patient's medical care and treatment. HHS/CDC will consult with hospital staff regarding the public health management of the case. A medical examination may include the taking of a medical history, a physical examination, and taking of laboratory samples. The determination as to whether a medical examination may be necessary in any given circumstances is by its nature highly fact dependent. Notwithstanding, the following illustrative examples are provided to help explain to the public when facts or circumstances may exist giving rise to a need for a medical examination. These include the following circumstances: Clinical manifestations in the individual consistent with those of a quarantinable communicable disease; suspected contact with cases or suspect cases of individuals infected with a quarantinable communicable disease in its communicable stage; host susceptibility to a quarantinable communicable disease combined with opportunity for exposure; travel to countries and places where transmission of a quarantinable communicable disease has likely occurred; reports of the individual exhibiting illness or symptoms consistent with those of a quarantinable communicable disease; or other evidence of possible infection, including exposure to the infectious agent that causes a quarantinable communicable disease. These factors are meant to be illustrative and provide only general guidance. 7. § 70.13 Payment for Care and Treatment Under this proposed section, HHS/CDC may pay for the care and treatment of individuals subject to apprehension, medical examination, quarantine, isolation, and conditional release after the exhaustion of all third party payments. This section implements § 322 of the Public Health Service Act (42 U.S.C. 249) which authorizes HHS/CDC to provide for the care and treatment of individuals detained in accordance with quarantine laws. Payment for care and treatment under this section is in the CDC's sole discretion, subject to the availability of appropriations, and after all third-party payments have been exhausted. This section also authorizes payment for ambulance or other medical transportation services whenever the HHS/CDC considers such services to be a necessary part of an individual's care and treatment. HHS/CDC, in consultation with state and local health departments, may make advance arrangements with medical providers through a memorandum of agreement or other mechanisms regarding payment for the care and treatment of individuals subject to public health actions. Under this proposed section, HHS/CDC may assume responsibility for payment for the care and treatment of individuals subject to Federal apprehension, medical examination, quarantine, isolation, and conditional release. For individuals requiring hospitalization for other reasons, however, payment will not be made for costs incurred after it is determined that the individual does not have a quarantinable communicable disease because medical services beyond that point are no longer for the benefit of the public's health. We reemphasize that any payment by HHS/CDC under this section will be made only after all th [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2016-18103. Public record. Not legal advice.