Announcement

Collapse
No announcement yet.

News: CDC, HHS Final Rule on Medical Examination of Aliens

Collapse
X
Collapse

  • News: CDC, HHS Final Rule on Medical Examination of Aliens

    [Federal Register Volume 81, Number 16 (Tuesday, January 26, 2016)]
    [Rules and Regulations]
    [Pages 4191-4206]
    From the Federal Register Online via the Government Publishing Office www.gpo.gov
    [FR Doc No: 2016-01418]


    =======================================================================
    -----------------------------------------------------------------------

    DEPARTMENT OF HEALTH AND HUMAN SERVICES

    42 CFR Part 34

    [Docket No. CDC-2015-0045]
    RIN 0920-AA28


    Medical Examination of Aliens--Revisions to Medical Screening
    Process

    AGENCY: Centers for Disease Control and Prevention (CDC), U.S.
    Department of Health and Human Services (HHS).

    ACTION: Final rule.

    -----------------------------------------------------------------------

    SUMMARY: The Centers for Disease Control and Prevention (CDC), within
    the Department of Health and Human Services (HHS), is issuing this
    final rule (FR) to amend its regulations governing medical examinations
    that aliens must undergo before they may be admitted to the United
    States. Based on public comment received, HHS/CDC did not

    [[Page 4192]]

    make changes from the NPRM published on June 23, 2015. Accordingly,
    this FR will: Revise the definition of communicable disease of public
    health significance by removing chancroid, granuloma inguinale, and
    lymphogranuloma venereum as inadmissible health-related conditions for
    aliens seeking admission to the United States; update the notification
    of the health-related grounds of inadmissibility to include proof of
    vaccinations to align with existing requirements established by the
    Immigration and Nationality Act (INA); revise the definitions and
    evaluation criteria for mental disorders, drug abuse and drug
    addiction; clarify and revise the evaluation requirements for
    tuberculosis; clarify and revise the process for the HHS/CDC-appointed
    medical review board that convenes to reexamine the determination of a
    Class A medical condition based on an appeal; and update the titles and
    designations of federal agencies within the text of the regulation.

    DATES: This rule is effective March 28, 2016.

    FOR FURTHER INFORMATION CONTACT: Ashley A. Marrone, J.D., Division of
    Global Migration and Quarantine, Centers for Disease Control and
    Prevention, 1600 Clifton Road NE., MS E-03, Atlanta, Georgia 30329;
    telephone 1-404-498-1600.

    SUPPLEMENTARY INFORMATION: The Preamble to this FR is organized as
    follows:

    I. Public Participation
    II. Background
    a. Legal Authority
    b. Legislative and Regulatory History
    III. Summary of the 2008 Interim Final Rule (IFR) and the 2015
    Notice of Proposed Rulemaking (NPRM) Requirements
    IV. Summary and Response to Public Comment
    a. 2008 IFR
    b. 2015 NPRM
    V. Alternatives Considered
    VI. Required Regulatory Analyses
    a. Executive Orders 12866 and 13563
    b. The Regulatory Flexibility Act
    c. The Paperwork Reduction Act
    d. National Environmental Policy Act (NEPA)
    e. Executive Order 12988: Civil Justice Reform
    f. Executive Order 13132: Federalism
    g. The Plain Language Act of 2010
    VII. References

    I. Public Participation

    On October 6, 2008, HHS/CDC published an interim final rule (IFR)
    (73 FR 58047) to amend its regulations that govern medical examinations
    that aliens must undergo before they are admitted to the United States.
    HHS/CDC amended the definition of ``communicable disease of public
    health significance'' by adding (1) quarantinable diseases designated
    by Presidential Executive Order, and (2) those diseases that meet the
    criteria of a public health emergency of international concern which
    require notification to the World Health Organization (WHO) under the
    revised International Health Regulations (IHR) of 2005 (http://www.who.int/ihr/en/). These amendments to the definition of
    communicable disease of public health significance permitted a more
    flexible, risk-based approach to the medical examination, based on
    medical and epidemiologic factors. The IFR also updated the screening
    requirements for tuberculosis to be consistent with current medical
    knowledge and practice. The public was invited to comment on these
    amendments; the comment period ended December 5, 2008. On October 20,
    2008, HHS/CDC published correcting amendments (73 FR 62210) that
    corrected an omission in the IFR. This document clarified that an alien
    of any age in the United States who applies for adjustment of status to
    permanent resident shall not be required to have a chest x-ray
    examination unless their tuberculin skin test, or an equivalent test
    that shows an immune response to Mycobacterium tuberculosis, is
    positive. HHS/CDC received three comments to the IFR, two comments from
    the public and one comment from a professional organization. A summary
    of those comments and a response to those comments are found at Section
    IV, below.
    On June 23, 2015, HHS/CDC published a notice of proposed rulemaking
    (NPRM) (80 FR 35899) that proposed to amend its regulations to (1)
    revise the definition of communicable disease of public health
    significance by removing chancroid, granuloma inguinale, and
    lymphogranuloma venereum as inadmissible health-related conditions for
    aliens seeking admission to the United States; (2) update the
    notification of the health-related grounds of inadmissibility to
    include proof of vaccinations to align with existing requirements
    established by the Immigration and Nationality Act (INA) (8 U.S.C.A.
    1101 et seq.); (3) revise the definitions and evaluation criteria for
    mental disorders, drug abuse and drug addiction; (4) clarify and revise
    the evaluation requirements for tuberculosis; (5) clarify and revise
    the process for the HHS/CDC-appointed medical review board that
    convenes to reexamine the determination of a Class A medical condition
    based on an appeal; and (6) update the titles and designations of
    federal agencies within the text of the regulation. Specifically, HHS/
    CDC sought comment on:
    1. Whether infectious Hansen's disease (previously referred to in
    regulation as infectious leprosy), infectious syphilis and/or gonorrhea
    should be removed from the definition of communicable disease of public
    health significance;
    2. Whether the definition of communicable disease of public health
    significance and the scope of the medical examination should be revised
    as proposed in this regulation;
    3. Whether the statutory requirement that aliens demonstrate proof
    of vaccinations should be incorporated into the regulations as a
    notifiable medical condition. To further clarify this question, HHS/CDC
    did not request comment on the statutory language itself as HHS/CDC
    does not have the authority to alter statutory language. Rather, we
    were interested in comment on the advisability of incorporating
    statutory language into regulations;
    4. Whether the requirement that immigrants demonstrate proof of
    vaccination against vaccine-preventable diseases recommended by the
    Advisory Committee on Immunization Practices (ACIP) should be limited
    to only those vaccines for which a public health need exists at the
    time of immigration or adjustment of status. CDC has previously
    published criteria for determining whether a public health need exists
    at the time of immigration or adjustment of status. See 74 FR 58634
    (Nov. 13, 2009). HHS/CDC was not seeking comment on the criteria, but
    rather on the incorporation of this standard into the regulations;
    5. Whether the definitions and evaluation criteria for mental
    disorders, drug abuse and drug addiction should be revised as proposed
    in this regulation;
    6. Whether the requirements for evaluating the presence of
    tuberculosis in alien applicants should be clarified and revised as
    proposed in this regulation; and
    7. Whether the process for convening a medical review board and
    reexamination of an alien by a medical review board should be revised
    as proposed in this regulation.

    HHS/CDC received three public comments on the 2008 IFR and six comments
    on the 2015 NPRM, from individuals and associations. A summary of those
    comments and responses to those comments are found at Section IV,
    below.

    [[Page 4193]]

    II. Background

    A. Legal Authority

    HHS/CDC is amending the regulation under the authority of 42 U.S.C.
    252 and 8 U.S.C. 1182 and 1222.

    B. Legislative and Regulatory History

    Beginning in 1952, the language of the Immigration and Nationality
    Act (INA) mandated that, among other grounds for inadmissibility,
    aliens ``who are afflicted with any dangerous contagious disease'' are
    ineligible to receive a visa and therefore are excluded from admission
    into the United States. In 1990, Congress amended the INA by revising
    the classes of excludable aliens to provide that an alien who is
    determined (in accordance with regulation prescribed by the Secretary
    of Health and Human Services) to have a communicable disease of public
    health significance shall be excludable from the United States.
    Immigration Act of 1990, Public Law 101-649, section 601, 104 Stat.
    4978 January 23, 1990; INA section 212(a)(1)(A)(i), 8 U.S.C.
    1182(a)(1)(A)(i) (effective June 1, 1991). At the time of the 1990 INA
    amendments, the following specific communicable illnesses rendered an
    alien inadmissible: Active tuberculosis, infectious syphilis,
    gonorrhea, infectious leprosy, chancroid, lymphogranuloma venereum,
    granuloma inguinale, and human immunodeficiency virus (HIV) infection.
    HHS/CDC subsequently published a proposed rule that would have removed
    from the list all diseases except for active tuberculosis. 56 FR 2484
    (January 23, 1991). Based on the review and consideration of public
    comments received on this proposal, HHS published an interim final rule
    retaining all communicable diseases on the list and committed its
    initial proposal for further study. See 56 FR 25000 (May 31, 1991). On
    October 6, 2008, HHS/CDC published an Interim Final Rule (IFR)
    announcing a revised definition of communicable disease of public
    health significance and revised scope of the medical examination in 42
    CFR part 34. This IFR addressed concerns regarding emerging and
    reemerging diseases in alien populations who are bound for the United
    States. See 73 FR 58047 and 73 FR 62210.
    With the 2008 revision to 42 CFR part 34, the definition of
    communicable disease of public health significance was modified to
    include two disease categories: (1) Quarantinable diseases designated
    by Presidential Executive Order; and (2) a communicable disease that
    may pose a public health emergency of international concern in
    accordance with the International Health Regulations (IHR) of 2005,
    provided the disease meets specified criteria in addition to the list
    of specific illnesses. Specific illnesses remaining as a communicable
    disease of public health significance were active tuberculosis,
    infectious syphilis, gonorrhea, infectious Hansen's disease (previously
    referred to in regulation as infectious leprosy), chancroid,
    lymphogranuloma venereum, granuloma inguinale, and HIV infection.
    In response to a 2008 amendment to the INA, on July 2, 2009, HHS/
    CDC published a Notice of Proposed Rulemaking (NPRM) (74 FR 31798),
    which proposed two regulatory changes: (1) The removal of HIV infection
    from the definition of communicable disease of public health
    significance; and (2) removal of references to serologic testing for
    HIV from the scope of examinations. On November 2, 2009, HHS/CDC
    published a final rule, effective on January 4, 2010 (74 FR 56547),
    that removed HIV infection and testing for HIV infection from part 34
    regulations.

    III. Summary of the Final Rule

    HHS/CDC identified the need for this rulemaking through an annual
    retrospective review of its regulations. Executive Order 13563
    ``Improving Regulation and Regulatory Review'' requires Federal
    agencies to periodically review existing regulations to eliminate those
    regulations that are obsolete, unnecessary, burdensome, or
    counterproductive or revise regulations to increase their
    effectiveness, efficiency, and flexibility.
    Through this final rule, HHS/CDC will revise 42 CFR part 34 to
    reflect modern terminology and plain language commonly used in medicine
    and science by public health partners in the medical examination of
    aliens. Likewise, we are revising part 34 to include text that
    accurately reflects the statutory and administrative changes that have
    occurred within the Federal Government regarding agencies and/or
    departments responsible for this process. These revisions will ensure
    regulations that govern the medical examination of aliens are based
    upon accepted contemporary scientific principles as well as current
    medical practices.
    The following is a section-by-section summary of the changes to
    part 34:

    Section 34.1 Applicability

    HHS/CDC is replacing the acronym ``INS'' within 34.1(c) with
    ``DHS'' to best reflect the administrative changes that have occurred
    within the Federal Government regarding agencies and/or departments
    responsible for the medical examination of aliens.

    Section 34.2 Definitions

    In this final rule, HHS/CDC is revising the definitions of: CDC,
    Communicable disease of public health significance, Civil Surgeon,
    Class A medical notification, Class B medical notification, Director,
    Drug abuse, Drug addiction, Medical notification, Medical hold
    document, Medical officer, Mental disorder and Physical disorder.
    Additionally, HHS/CDC is adding definitions for DHS and HHS and
    removing the definition of INS.

    Section 34.2(a) CDC

    The definition of CDC is updated to reflect the current official
    title of the Agency: Centers for Disease Control and Prevention,
    Department of Health and Human Services. In doing so, we removed
    ``Public Health Services'' from the definition.

    Section 34.2(b) Communicable Disease of Public Health Significance

    This provision now defines communicable disease of public health
    significance as both a specific list of diseases and categories of
    diseases for which all aliens are inadmissible to the United States.
    This final rule removes three uncommon bacterial infections associated
    with genital ulcer disease: Chancroid, granuloma inguinale, and
    lymphogranuloma venereum, from the specific list of communicable
    disease of public health significance as provided for in 42 CFR
    34.2(b).

    Section 34.2(c) Civil Surgeon

    HHS/CDC has removed the specific language of ``District Director''
    and ``INS'' from the definition of civil surgeon to align with the
    specific language of the definition of civil surgeon as provided for in
    Department of Homeland Security (DHS) regulations in 8 CFR part 232.
    HHS/CDC is also removing ``with not less than 4 years' professional
    experience'' from the definition of civil surgeon. Through
    complimentary regulations promulgated by DHS at 8 CFR part 232, the
    requirement of 4 years' professional experience for civil surgeons will
    remain in effect. This change removes a redundancy found in HHS/CDC
    regulation and does not affect a substantive change in policy. HHS/CDC
    will continue to consult with the Department of Homeland Security
    (DHS)/United States Citizenship and Immigration Services (USCIS) as
    needed, regarding recommendations for

    [[Page 4194]]

    civil surgeon requirements. Therefore, the definition of civil surgeon
    means a physician designated by DHS to conduct medical examinations of
    aliens in the United States who are applying for adjustment of status
    to permanent residence or who are required by DHS to have a medical
    examination.

    Section 34.2(d) Class A Medical Notification

    HHS/CDC is amending the definition of Class A medical notification
    by incorporating statutory language requiring documentary proof of
    vaccination. This requirement is provided by section 341 of the Illegal
    Immigration Reform and Immigrant Responsibility Act of 1996 (IIRIRA)
    which amended Section 212 of the INA. Part 34 is updated to explicitly
    include the requirement for proof of vaccination as previously
    specified in the IIRIRA. See Public Law 104-208, Div. C, 110 Stat.
    3009-546. Lack of proof of vaccination will result in the issuance of a
    Class A medical notification. This additional language will not change
    current practices, but simply reflects updated statutory language.
    The definition also includes the vaccination exemption specifically
    provided in Section 212 of the INA for an adopted child who is 10 years
    of age or younger. This exemption is applicable if, prior to the
    admission of the child, an adoptive or prospective adoptive parent, who
    has sponsored the child for admission as an immediate relative, has
    executed an affidavit stating that the parent is aware of the
    vaccination requirement and will ensure that the child will be
    vaccinated within 30 days of the child's admission, or at the earliest
    time that is medically appropriate. Execution of this affidavit will
    prevent a Class A medical notification from being generated for lack of
    proof of vaccination. This additional language does not change current
    practices, but reflects updated statutory language.

    Section 34.2(f) Director

    The final rule updates the definition of Director to reflect the
    current official title of the CDC Director, as well as his/her
    delegation authorities.

    Section 34.2(g) DHS

    We are adding DHS to the definitions in order to best reflect the
    administrative changes that have occurred within the Federal Government
    regarding agencies and/or departments responsible for the medical
    examination of aliens.

    Section 34.2(h) Drug Abuse and Section 34.2(i) Drug Addiction

    HHS/CDC is revising the definitions of drug abuse and drug
    addiction to align with the definitions of ``substance use disorders''
    and ``substance-induced disorders,'' provided by the Diagnostic and
    Statistical Manual for Mental Disorders (DSM) published by the American
    Psychiatric Association (25). The DSM is the medical standard for the
    diagnosis of mental disorders and substance-related disorders and
    provides current diagnostic criteria based on the latest available
    evidence.

    Section 34.2(k) Medical Hold Document

    This final rule updates the definition of Medical hold document by
    replacing ``INS'' with ``DHS'', replacing ``Public Health Service''
    with ``HHS/CDC'' and replacing ``quarantine inspector'' with
    ``quarantine officer.''

    Section 34.2(l) Medical Notification

    The final rule amends the definition of medical notification by
    adding proof of vaccination requirements as already provided by section
    341 of the IIRIRA which amended Section 212 of the INA. This amendment
    updates part 34 to include the requirement for proof of vaccination
    that is currently specified in statute in the IIRIRA and for those
    ACIP-recommended vaccinations for which HHS/CDC determines, by applying
    criteria published in the Federal Register, a public health need exists
    at the time of immigration or adjustment of status. This is not a
    substantive change to the regulation, as it will not affect current
    practice.
    Based on this update, medical notification, according to the INA,
    means a medical examination document issued to a consular authority or
    DHS by a medical examiner that includes the following additional
    language: ``(2) Documentation of having received vaccination against
    ``vaccine-preventable diseases'' for an alien who seeks admission as an
    immigrant, or who seeks adjustment of status to one lawfully admitted
    for permanent residence, which shall include at least the following
    diseases: Mumps, measles, rubella, polio, tetanus and diphtheria
    toxoids, pertussis, Haemophilus influenza type B and hepatitis B, and
    any other vaccinations against vaccine-preventable diseases recommended
    by the ACIP for which HHS/CDC determines, by applying criteria
    published in the Federal Register, there is a public health need at the
    time of immigration or adjustment of status.''

    Section 34.2(m) Medical Officer

    The final rule removes ``of the Public Health Service Commissioned
    Corps'' from the definition of medical officer to reflect that a
    medical officer for these purposes is not required to be a member of
    the U.S. Public Health Service Commissioned Corps.

    Section 34.2(n) Mental Disorder and 34.2(p) Physical Disorder

    The final rule clarifies mental disorder as a currently accepted
    psychiatric diagnosis, as defined by the most recent edition of the DSM
    published by the American Psychiatric Association (17) or in another
    authoritative source as approved by the Director. This revision adds
    ``most recent'' to qualify the version of the DSM referenced in this
    definition and clarifies the intent of HHS/CDC that such diagnoses
    align with current science and medical practice. This update also
    allows for the possibility of other authoritative sources to be used in
    the future based on the most current medical science and in the event
    that the DSM is no longer the accepted authoritative source for
    determining a psychiatric diagnosis.
    The final rule defines physical disorder to mean a currently
    accepted medical diagnosis, as defined by the most recent edition of
    the Manual of the International Classification of Diseases, Injuries,
    and Causes of Death (ICD) published by the World Health Organization
    (26) or in another authoritative source as approved by the Director.
    HHS/CDC is adding ``most recent version'' to qualify the version of the
    ICD referenced in this definition and to be consistent with the current
    Section 212 of the INA. HHS/CDC also allows for the possibility of
    other authoritative sources to be used in the future based on the most
    current medical science and in the event that the ICD is no longer the
    accepted authoritative source for determining a physical diagnosis.

    c. Section 34.3 Scope of Examinations

    This section applies to those aliens who are required to undergo a
    medical examination for U.S. immigration purposes. The scope of the
    examination outlines those matters that relate to inadmissible health-
    related conditions and was revised in 2008 through an interim final
    rule. The 2008 interim final rule provided specific screening and
    testing requirements for those diseases that meet the current
    definition of communicable disease of public health significance in
    Sec. 34.2(b) of 42 CFR part 34. This final rule further updates this
    section to incorporate

    [[Page 4195]]

    statutory language requiring documentation for vaccine-preventable
    disease and HHS/CDC's understanding that ACIP vaccine recommendations
    should only be applied in an immigration context when a public health
    need exists.
    In 2009, HHS/CDC published a final notice in the Federal Register,
    adopting proposed criteria that HHS/CDC intended to use to determine
    which vaccines recommended by the ACIP for the general U.S. population
    should be required for immigrants seeking admission into the United
    States or seeking adjustment of status to that of an alien lawfully
    admitted for permanent residence based on public health needs (74 FR
    58634). These criteria became effective on December 14, 2009. Since
    then, HHS/CDC has relied on such criteria to determine which vaccines
    aliens must receive as part of the immigration medical screening
    process.
    The 2015 NPRM proposed to formally incorporate a reference to this
    criteria into this final rule. HHS/CDC did not receive public comment
    in opposition of the incorporation. Therefore, under this final rule,
    HHS/CDC has modified the regulatory text to reflect reference to these
    criteria where appropriate. We note that if there is a future need for
    HHS/CDC to reconsider these established criteria, HHS/CDC will solicit
    comments through publication in the Federal Register. In subsection
    (a)(2)(i), we have also inserted the word ``current'' in front of
    ``physical or mental disorder'' as stated in section 212 of INA.

    Specific Proposed Revisions to Section 34.3(a)

    The final rule revised Sec. 34.3(a)(2) to include proof of
    vaccination requirements as provided by section 341 of IIRIRA of 1996
    which amended Section 212 of the INA.

    Specific Proposed Revisions to Section 34.3(e)

    The final rule amends Sec. 34.3(e)(1) to clarify the scope of
    examination requirements that apply to anyone who is required by DHS to
    have a medical examination for the purpose of determining their
    admissibility. The final rule adds Sec. 34.3(e)(1)(v) ``Applicants
    required by DHS to have a medical examination in connection with the
    determination of their admissibility into the United States.''
    The final rule includes the following changes to provide
    consistency in the required evaluation for tuberculosis: Replace all
    references to ``chest x-ray'' in Sec. 34.3(e) with ``chest
    radiograph''; clarify that Sec. 34.3(e)(3)(ii) applies to aliens in
    the United States; and to remove the specific size of chest radiograph
    provided in Sec. 34.3(e)(5). These changes reflect current medical
    terminology and technical practice.
    The final rule amends Sec. 34.3(e)(2)(iii) by removing ``and HIV''
    to correct the typographical error in the current rule language and
    reflect that testing for HIV is no longer required. The requirement for
    serologic testing for syphilis will remain and the final rule includes
    language to allow the Director to test for other communicable diseases
    of public health significance (as defined) through technical
    instructions.
    The final rule amends Sec. Sec. 34.3(e)(3)(i) and 34.3(e)(3)(ii)
    to reflect the scope of currently available medical tests. The final
    rule replaces ``positive tuberculin reaction'' with ``positive test of
    immune response to Mycobacterium tuberculosis antigens'' in Sec. Sec.
    34.3(e)(3)(i) and 34.3(e)(3)(ii).
    To allow HHS/CDC discretion to apply appropriate medical screening
    procedures, the final rule amends Sec. Sec. 34.3(e)(3)(iii) and
    34.3(e)(3)(iv) regarding application of tests of immune response by
    adding ``as determined by the Director.''
    To allow for additional testing in medically appropriate
    circumstances, the final rule revises Sec. 34.3(e)(4) by removing
    ``subject to the chest radiograph requirement, and for whom the
    radiograph shows an abnormality suggestive of tuberculosis disease,''
    replaces ``shall'' with ``may,'' and adds ``based on medical
    evaluation.'' Thus, in the final rule, this revision reads: ``All
    applicants may be required to undergo additional testing for
    tuberculosis based on the results of the medical evaluation.''
    To reflect current practice and INA statutory language, the final
    rule amends Sec. 34.3(b)(2) by adding ``or other relevant records'' to
    ensure that all appropriate available medical documentation may be
    considered. Thus, in the final rule, this revision reads: ``For the
    examining physician to reach a determination or conclusion about the
    presence or absence of a physical or mental abnormality, disease, or
    disability, the scope of the examination shall include any laboratory
    or additional studies that are deemed necessary, either as a result of
    the physical examination or pertinent information elicited from the
    alien's medical history or other relevant records.''
    The final rule includes language under Sec. 34.3(f), transmission
    of records, to ensure that electronic submissions may be acceptable as
    provided by the Director. Finally, the final rule amends Sec.
    34.3(g)(4) by replacing ``excludable'' with ``inadmissible'' in Sec.
    34.3(g)(4) to reflect modern terminology.

    d. Section 34.4 Medical Notifications

    The final rule revises Sec. 34.4(b)(1)(ii) to include proof of
    vaccination requirements as provided by section 341 of the IIRIRA of
    1996 which amended Section 212 of the INA and references criteria
    established by HHS/CDC and published in the Federal Register to
    determine which vaccines recommended by the ACIP will be required for
    U.S. immigration.
    In addition, the final rule adds specific language regarding the
    exemption of vaccination requirements for an adopted child as provided
    in Section 212 of the INA.

    e. Section 38.7 Medical and Other Care; Death

    Under this section, the final rule replaces ``INS'' with ``DHS''
    and replaces ``Public Health Services'' with ``HHS'' to reflect modern
    agency titles and appropriate authorities relating to this provision.

    f. Section 34.8 Reexamination; Convening of Review Boards; Expert
    Witnesses, Reports

    The final rule revises this section to clarify the reexamination
    and review board's process and improve the expediency of the process.
    The revisions include removing the requirement that one medical officer
    must be a board-certified psychiatrist in cases where the alien's
    mental health is a basis for inadmissibility. The requirement for a
    board-certified psychiatrist is replaced with a requirement that the
    review board consist of at least one medical officer who is experienced
    in the diagnosis and treatment of the physical or mental disorder, or
    substance-related disorder for which the medical notification was made.
    Additionally, the final rule adds failure to present documented proof
    of having been vaccinated against vaccine preventable diseases as a
    basis for reexamination by the review board and adds clarifying
    language that the reexamination may be conducted, at the board's
    discretion, based on the written record.

    IV. Response to Public Comments

    A. Summary of Public Comments to the 2008 IFR

    On October 6, 2008, HHS/CDC published an interim final rule (IFR)
    (73 FR 58047) to amend its regulations that govern medical examinations
    that aliens must undergo before they are admitted to the United States.
    HHS/CDC

    [[Page 4196]]

    amended the definition of ``communicable disease of public health
    significance'' by adding (1) quarantinable diseases designated by
    Presidential Executive Order, and (2) those diseases that meet the
    criteria of a public health emergency of international concern which
    require notification to the World Health Organization (WHO) under the
    International Health Regulations of 2005. These amendments to the
    definition of ``communicable disease of public health significance''
    permitted a more flexible, risk-based approach to the medical
    examination, based on medical and epidemiologic factors. The IFR also
    updated the screening requirements for tuberculosis to be consistent
    with current medical knowledge and practice. The public was invited to
    comment on these amendments; the comment period ended December 5, 2008.
    On October 20, 2008, HHS/CDC published correcting amendments (73 FR
    62210) that corrected an omission in the IFR. The correcting amendments
    clarified that an alien of any age in the United States who applies for
    adjustment of status to permanent resident shall not be required to
    have a chest x-ray examination unless their tuberculin skin test, or an
    equivalent test that shows an immune response to Mycobacterium
    tuberculosis, is positive. HHS/CDC received three comments to the IFR,
    two comments from the public and one comment from a professional
    organization. A summary of those comments and a response to those
    comments are found below.
    One commenter urged HHS/CDC to remove HIV infection from the
    definition of communicable disease of public health significance,
    stating that HIV has specific methods of transmission and that the
    likelihood that an HIV positive individuals would present an unusual
    risk of disease is extremely low.
    Response: HHS/CDC thanks the commenter for this comment and notes
    that HHS/CDC removed HIV infection from the definition of communicable
    disease of public health significance by rulemaking in 2009. No changes
    were made to the final rule based on this comment.
    A second commenter expressed concern that HHS/CDC was creating a
    double standard; an alien in the United States with a newly identified
    disease would not be found inadmissible, but an alien overseas with the
    same disease would be found inadmissible. With this double standard,
    aliens overseas would be encouraged to avoid overseas medical
    examinations and find ways to illegally enter the United States. The
    commenter suggested that the best way to avoid this situation would be
    to apply the same standards to medical examinations performed overseas
    and those performed in the United States. Finally, the commenter
    suggested that part 34 should be revised to clearly differentiate
    between overseas medical examinations and those in the United States.
    Response: HHS/CDC notes that the final rule does make a distinction
    between the medical examinations performed for those aliens outside of
    the United States and those already in the United States applying for
    adjustment of status to that of a lawful permanent resident. The
    distinction applies only to additional screening requirements for
    certain communicable diseases of public health significance where these
    diseases exist and for which importation into the United States would
    pose a threat as determined by the risk-based approach criteria. We
    reemphasize that both groups are required to undergo medical screening
    and the requirements for both groups are outlined in the regulation. No
    changes were made to the final rule based on this comment.
    A third commenter expressed concern that the interim final rule did
    not include a provision to ensure that the public and the panel
    physicians are adequately notified of new and emerging diseases which
    could render individuals inadmissible and subject to an additional
    medical assessment. The commenter urged HHS to work closely with the
    Department of State to promptly notify the public of any health
    emergency or changes or additions to medical examinations through
    consular Web sites. Finally, the commenter was disappointed that HHS
    did not remove HIV infection as an inadmissible condition in this
    rulemaking.
    Response: HHS/CDC notes that the regulation does contain a
    provision that all applicable additional requirements for medical
    screening and testing will be posted at the following Internet address:
    http://www.cdc.gov/immigrantrefugeeh.../ti/index.html. HHS/CDC
    also works closely with the Department of State to ensure that all
    changes or additions to the medical examination are communicated to
    affected consular posts, panel physicians, and to the public. Finally,
    HHS/CDC removed HIV infection from the definition of communicable
    disease of public health significance by rulemaking in 2009. No changes
    were made to the final rule based on this comment.

    B. Summary of Public Comments to the 2015 NPRM

    HHS/CDC received 6 comments from the public on this NPRM. A summary
    of the comments is provided here.
    One commenter protested the proposal to remove the three STIs from
    the list of communicable diseases of public health significance. The
    commenter also disagreed with HHS/CDC's proposal to incorporate a more
    flexible, risk-based approach, based on medical and epidemiologic
    factors. The comment points to recent outbreaks of Ebola, Bird and
    Swine Flu and states that screening should be more vigilant, and that
    not having stricter screening risks an outbreak.
    Response: HHS/CDC thanks the commenter for this comment and notes
    that in the 2008 IFR, HHS/CDC amended the definition of communicable
    disease of public health significance by adding (1) quarantinable
    diseases designated by Presidential Executive Order, and (2) those
    diseases that meet the criteria of a public health emergency of
    international concern which require notification to the World Health
    Organization (WHO) under the International Health Regulations of 2005
    which allows for screening of diseases in these categories which
    includes viral hemorrhagic fevers (such as Ebola) and flu that can
    cause a pandemic (including Bird and Swine variants). The addition of
    these categories of diseases along with the risk based approach allows
    HHS/CDC the ability to rapidly respond to unanticipated emerging or re-
    emerging outbreaks of disease and provides the framework to be able to
    screen and test individuals during disease outbreaks. HHS/CDC is
    confident that these changes will improve the ability of the United
    States to prevent the introduction and spread of infectious diseases,
    and to protect public health of the United States. No changes were made
    to the final rule based on this comment.
    One commenter expressed concern about any disease coming off the
    list as these immigrants may be a public ward, and stated that
    individuals with HIV should not be allowed to immigrate to the United
    States. The commenter also noted that there was no comment period when
    HIV was removed from the list. The commenter also asks why unvaccinated
    children under ten should be allowed to immigrate to the United States.
    Finally, the commenter states that Ebola should be added to the list
    and that CDC should start thinking about other diseases to add to the
    definition of communicable diseases of public health significance.

    [[Page 4197]]

    Response: HHS/CDC thanks the commenter for this comment and notes
    that HHS/CDC removed HIV infection from the definition of communicable
    disease of public health significance by rulemaking in 2009. As part of
    this process, HHS/CDC issued a notice of proposed rulemaking which
    received over 20,000 comments; the majority of which were in favor of
    removing HIV infection from the list.
    Under the Immigration and Nationality Act (INA), children under 10
    years of age who are adopted by U.S. citizens are exempt from
    vaccination requirements prior to entry into the United States. These
    children must receive vaccinations in the United States within thirty
    days upon arrival. The above exception and requirements are based on
    statutory language provided in the INA and cannot be changed by HHS/CDC
    regulations. This exception does not apply to any other children
    seeking an immigrant visa or adjustment of status to lawful permanent
    resident in the United States.
    In the 2008 IFR, HHS/CDC amended the definition of ``communicable
    disease of public health significance'' by adding (1) quarantinable
    diseases designated by Presidential Executive Order, and (2) those
    diseases that meet the criteria of a public health emergency of
    international concern which require notification to the World Health
    Organization (WHO) under the International Health Regulations of 2005.
    This allows for screening of diseases in these categories to be
    conducted during outbreaks and responses. Ebola and other hemorrhagic
    viral fevers are included in the current list of quarantinable
    diseases, and therefore are considered in the list of communicable
    diseases of public health significance. No changes were made to the
    final rule based on this comment.
    One commenter stated that removing the STIs from the list of
    communicable diseases of public health significance may lead to
    decreased use of effective measures to prevent infection. This
    commenter stated that it is currently ``too risky to the public good to
    downgrade the urgency of these types of preventable diseases.'' The
    commenter continued by stating that there have been countless
    occurrences of ``plagues taking over nations and killing off much of
    the populations,'' and the commenter states that ``there are many
    diseases that have not even been introduced yet and it is important to
    continue the current procedure in order to ensure nothing new `plagues'
    the nation.''
    The same commenter stated that all aliens should be required to
    receive the same vaccinations that Americans receive. Additionally, the
    commenter submits that all immigrants should be revaccinated, as proof
    of vaccination from an immigrant's home country may not be reliable.
    The commenter also provides two standards for vaccination. They are as
    follows:
    (1) If immigrating to the United States for economic reasons, the
    alien's standard of health should be comparable to the average resident
    of the United States.
    (2) if immigrating to the United States for medical treatment
    otherwise unobtainable in the alien's home country, the alien must be
    insured to prevent burden to the U.S. taxpayer.
    Response: HHS/CDC notes that, according to the analysis provided in
    the notice of proposed rulemaking, the incidence and prevalence of
    these STIs is declining globally and so the potential for introduction
    and spread of these diseases to the U.S. population is considered to be
    low. By removing the three STIs which no longer pose a threat to public
    health, the medical examination will be able to focus on the other
    communicable diseases which are considered more serious risks to the
    United States. Removing these 3 STIs does not mean that persons will
    not be treated for these infections if the infections are found during
    the medical examination. Removing these 3 STIs means that persons who
    have these infections are no longer considered inadmissible to the
    United States. HHS/CDC has incorporated into its regulations the
    vaccination requirements that are included in statutory language
    provided in the Immigration and Nationality Act (INA). Please see the
    relevant text of the INA at http://www.uscis.gov/iframe/ilink/do...L/SLB/act.html. No changes were made to the final rule based on
    these comments.
    Two commenters raised similar concerns regarding a statement made
    by HHS/CDC in the preamble of the 2015 NPRM regarding the inconclusive
    correlation between male circumcision and HIV prevention. Both
    commenters expressed disdain over the ethical, legal and methodological
    issues surrounding male circumcision as it relates to communicable
    disease. One commenter stated that some men from traditionally non-
    circumcising cultures [e.g. Hispanic/Latino communities] may read the
    NPRM and feel compelled to have themselves, and male children,
    circumcised in the belief that it may help them gain admittance to the
    U.S. Finally, both commenters concluded that any reference to male
    circumcision should be removed from the regulation.
    Response: HHS/CDC thanks these commenters for their input. We note
    first that today's final rule does not contain any reference to male
    circumcision. Second, we clarify that whether a male is circumcised
    does not--and will not under today's final rule--have an effect on his
    medical examination or eventual admission into the United States. In
    the preamble language of the June 2015 NPRM, HHS/CDC stated: ``. . .
    HIV prevention strategies such as male circumcision may be playing a
    role, although definitive studies of this effect are still pending.''
    This statement was made in addition to several other hypotheses which
    supported the underlying fact that ``[D]eclining rates of these [STIs]
    are likely due to a variety of factors.'' Other factors considered and
    listed in the NPRM included: Improved living conditions, better
    sanitation (e.g., availability of soap and water), condom use,
    educational efforts, improved recognition by physicians and treatment
    based on clinical presentation of sexually transmitted infections,
    treatment of sexual partners, as well as increased antibiotic usage for
    treatment of other unrelated conditions. No changes were made to the
    final rule based on these comments.
    One commenter opposed the removal of the requirement that a board
    certified psychiatrist must be part of the review board for an alien
    seeking an appeal of mental disorder with associated harmful behavior.
    The commenter also supports updating the definitions of drug abuse,
    drug addiction and mental disorder to be made using current DSM
    standards and criteria. The commenter also indicated concerns about the
    policy behind the immigration medical examination and its likely
    discriminatory impact on those aliens with mental illness. The
    commenter further noted that the terms ``drug abuser'' and ``drug
    addict'' are obsolete and stigmatizing terms that require replacement
    in order to meet current scientific understanding of substance use
    disorders.
    Response: HHS/CDC thanks the commenter for the comments and support
    for updating the definitions of drug abuse, drug addiction and mental
    disorder to reflect current DSM standards and criteria. As acknowledged
    by the commenter, changes to the medical examination as it relates to
    mental illness, including revising the terms ``drug abuser'' and ``drug
    addict,'' would require statutory language changes to the INA.
    Regarding the comment about the requirement for a board certified
    psychiatrist to be a member of the

    [[Page 4198]]

    review board, HHS/CDC notes that nothing in the regulations prevent the
    review board from including a board certified psychiatrist in mental
    disorder cases. However, the change in the regulation allows for
    another qualified mental health specialist to be on the review board in
    the event a board certified psychiatrist is not readily available. This
    allows for the review board process to proceed without any unnecessary
    delay that may affect the alien's immigration process. No changes were
    made to the final rule based on this comment.

    V. Alternatives Considered

    This rulemaking is the result of HHS/CDC's annual retrospective
    regulatory review. Most of the amendments are administrative and will
    result in minor changes to current guidelines for overseas medical
    examinations required of persons seeking permanent entry to the United
    States. Therefore, alternatives to these administrative updates were
    not considered.
    However, as we stated in the proposed rule, when considering
    updates to the definition of communicable disease of public health
    significance, HHS/CDC looked at all of the specific diseases listed in
    the definition. As stated previously in the Preamble, in this
    rulemaking, HHS/CDC is revising the definition of communicable disease
    of public health significance by removing these three uncommon health
    conditions: Chancroid; granuloma inguinale; and lymphogranuloma
    venereum.
    We have decided not to remove infectious Hansen's disease
    (leprosy), gonorrhea, and/or infectious syphilis from the definition at
    this time. Our decision is based on epidemiological principles and
    current medical practice to assess these three diseases (infectious
    Hansen's disease, gonorrhea, and infectious syphilis). We believe that
    the medical examination provides the opportunity to screen for and
    treat these diseases, and, when identified in immigrants, provides a
    public health benefit to the United States as well as a health benefit
    to the individual. Further, while infection with these three diseases
    initially renders an alien inadmissible to the United States, treatment
    is available upon identification, and once appropriately treated,
    aliens with these conditions are no longer inadmissible. Continued
    screening for these three diseases during the medical examination
    provides an opportunity to identify and treat disease in alien
    populations and thus provide a measure of public health protection to
    the general U.S. population. HHS/CDC will continue to assess each of
    these remaining diseases as a communicable disease of public health
    significance through further scientific review.

    VI. Required Regulatory Analyses

    A. Executive Orders 12866 and 13563

    HHS/CDC has examined the impacts of the proposed rule under
    Executive Order 12866, Regulatory Planning and Review (58 FR 51735,
    October 4, 1993) and Executive Order 13563, Improving Regulation and
    Regulatory Review (76 FR 3821, January 21, 2011) (1, 2). Both Executive
    Orders direct agencies to evaluate any rule prior to promulgation to
    determine the regulatory impact in terms of costs and benefits to
    United States populations and businesses. Further, together, the two
    Executive Orders set the following requirements: Quantify costs and
    benefits where the new regulation creates a change in current practice;
    define qualitative costs and benefits; choose approaches that maximize
    benefits; support regulations that protect public health and safety;
    and minimize the impact of regulation. HHS/CDC has analyzed the rule as
    required by these Executive Orders and has determined that it is
    consistent with the principles set forth in the Executive Orders and
    the Regulatory Flexibility Act, as amended by the Small Business
    Regulatory Enforcement Fairness Act (SBREFA) and that the rule will
    create minimal impact (3, 4).
    This rule is not being treated as a significant regulatory action
    as defined by Executive Order 12866. As such, it has not been reviewed
    by the Office of Management and Budget (OMB).
    There are two main impacts of this rule. First, we have updated the
    current regulation to reflect modern terminology, plain language, and
    current practice. Because there is no change in the baseline from these
    updates, no costs can be associated with these administrative updates
    to align the regulation with current practice.
    Second, we have removed three sexually transmitted bacterial
    infections, chancroid, granuloma inguinale and lymphogranuloma
    venereum, from the definition of communicable disease of public health
    significance (5). In doing this, aliens seeking permanent entry to the
    United States (immigrants, refugees and asylees) will no longer be
    examined for these diseases during the mandatory medical examinations
    that are part of the process of admission to the United States. The
    impact of dropping this portion of the examination is likely to be
    minimal. On the positive side, the physicians administering the exam
    will be able to focus on other areas of patient health. On the negative
    side, there is the potential for a negligible increase in the numbers
    of disease cases entering the United States. However, as we explain
    subsequently, this impact is likely to be small. Further, the costs
    associated with the current disease burden in the United States are
    also very limited. Therefore, the potential introduction of a very
    small number of cases will not change the current cost structure
    associated with the current disease burden.
    As discussed in detail below, the three bacterial infections
    (chancroid, granuloma inguinale and lymphogranuloma venereum), are
    transmitted through sexual contact, have never been common in the
    United States and over the past two decades are observed to be
    increasingly rare throughout the world. Of the three conditions, only
    laboratory-diagnosed cases of chancroid are reportable in the United
    States, and since 2005 fewer than 30 chancroid cases annually were
    reported to CDC from the U.S. states and territories (6-23). While some
    U.S. cities (7) keep records of cases of granuloma inguinale and
    lymphogranuloma venereum, neither condition is included on the list of
    diseases reported to the CDC by clinicians and public health
    departments (6). Online searches and a few available publications
    indicate that both conditions most typically occur in tropical and
    impoverished settings (i.e., with limited access to water, hygiene);
    and both conditions have become increasingly uncommon over time. A
    review of the literature published during the past five years
    identified only a handful of case reports on granuloma inguinale, and
    the vast majority of these cases were cases outside the United States
    (12-17). Sporadic small outbreaks of lymphogranuloma venereum have
    occurred over the past 10 years in Europe and the United States (18-
    20). The numbers of lymphogranuloma venereum cases are small, have been
    almost exclusively among men who have sex with men, and numbers are not
    systematically collected for country populations (18-20).
    When HHS/CDC originally attempted to estimate the disease impact to
    calculate the cost associated with removing these three diseases, we
    tried to examine the disease rates in the regions or countries of
    origin of aliens seeking entry to the United States. In the most recent
    report from DHS, the Annual Yearbook of Immigration Statistics, DHS
    reports on the regions and countries of origin of aliens (24).
    Unfortunately, we have been unable to find disease data that correlates
    with

    [[Page 4199]]

    DHS population data for region of origination of aliens (24). Data on
    chancroid, granuloma inguinale and lymphogranuloma venereum are not
    systematically collected by any country outside of the United States
    either by specific countries or regions listed by DHS for aliens, or
    from the World Health Organization (WHO) (8, 22, 23). Ultimately, we
    were unable to correlate the originating regions of aliens entering the
    United States permanently (immigrants, refugees, and asylees) with the
    rates of the three diseases in the countries of origin.
    Potential for onward transmission of these infections to the U.S.
    population is deemed to be extremely low. While we do not have country
    or region-specific rates for these diseases, our review of the
    literature supports the supposition that the potential introduction of
    additional cases into the United States by aliens is likely to have a
    negligible impact on the U.S. population. These primarily tropical
    infections can be prevented through improved personal hygiene (11) and
    protected sex (use of a condom) (12). New infections can be effectively
    treated and cured with a short, uncomplicated course of antibiotic
    therapy.
    Economic analysis and cost results. HHS/CDC has determined that the
    costs associated with chancroid, granuloma inguinale and
    lymphogranuloma venereum are currently very low. Given the pattern of
    diminishing caseloads reported in the literature and available data (6-
    21), HHS/CDC projects that future costs will remain low. A more
    detailed analysis as required by E.O. 12866 and 13563 can be found in
    the docket for this NPRM. A summary follows below.
    Summary. There is no international disease incidence data available
    for chancroid, granuloma inguinale or lymphogranuloma venereum. There
    is some data available for numbers of cases of chancroid observed in
    the United States over a number of years (6) and DHS also provides data
    regarding the numbers of legal foreign residents in the United States
    (24). In the full analysis we used the chancroid data to estimate a
    range of costs to treat chancroid in the United States (6) at the
    highest and lowest caseloads observed. An estimated component for
    granuloma inguinale and lymphogranuloma venereum was added by
    assumption because of lack of either domestic or international data.
    The costs were then prorated to reflect the foreign population residing
    in the United States using DHS data (24).
    Cost estimates were derived for three alternatives titled Low,
    High, and Extreme. The Low and High alternatives were based on the
    lowest (most recent) and highest reported caseloads of chancroid (6).
    The Extreme alternative is six times the highest rate of chancroid ever
    reported in the United States. Finally, often chancroid, granuloma
    inguinale, and lymphogranuloma venereum are co-morbid with other STIs,
    e.g., HIV, syphilis, or gonorrhea (6, 8, 21). Therefore costs are
    estimated to both treat cases with or without co-morbidity.
    The results of the analysis are reported in Table 1. Because of a
    decreasing trend in reported cases, it is conservative to estimate the
    annualized burden of these diseases based on past reporting (i.e. the
    number of cases observed in the future are likely to continue
    decreasing). Further, it was assumed that all cases are detected and
    treated within the first year after arrival. As a result of these
    assumptions, monetized costs were unaffected by the choice of discount
    rate.
    The results are not economically significant, i.e. more than $100
    million of costs and benefits in a single year.

    Table 1--Annual Costs of Chancroid, Granuloma Inguinale, and Lymphogranuloma Venereum in Lawful Permanent
    Residents (LPRs): LOW, HIGH, and EXTREMELY HIGH Caseload Alternatives, in 2013 Dollars
    ----------------------------------------------------------------------------------------------------------------

    ----------------------------------------------------------------------------------------------------------------
    Alternatives
    ----------------------------------------------------------------------------------------------------------------
    Notes: (1) Per-case cost $263.51. LOW (less than 1 case a HIGH................... EXTREMELY HIGH.
    (2) Assumes LPRs are 0.4% of total year).
    population.
    LPR Total Annual Costs 50% $18.................... $2,122................. $12,731.
    comorbidity.
    LPR Total Annual Costs NO $33.................... $3,858................. $23,147.
    comorbidity.
    ----------------------------------------------------------------------------------------------------------------

    Estimated benefits of this rule. The benefits to this rule are also
    qualitative. Aliens as well as the panel physicians and civil surgeons
    inherently benefit from having current, up-to-date regulations with
    modern terminology that reflects modern practice and plain language.
    The physicians administering the exam will be able to devote more time
    and training to other, more common and/or more serious health issues.
    The proposed changes do not impose any additional costs on aliens,
    panel physicians, or civil surgeons.
    Comparison of costs and benefits. Given the potential impact of the
    rulemaking, we conclude that the benefits of the rule justify any
    costs. See Tables 2 and 3 below.

    Table 2--Summary of the Quantified and Non-Quantified Benefits and Costs for Updates to the Current Regulation
    That Reflect Modern Terminology, Plain Language, and Current Practice
    ----------------------------------------------------------------------------------------------------------------
    Primary Minimum Maximum Source citation (RIA,
    Category estimate estimate estimate preamble, etc.)
    ----------------------------------------------------------------------------------------------------------------
    BENEFITS
    ----------------------------------------------------------------------------------------------------------------
    Monetized benefits....................... $0 (7%) $0 (7%) $0 (7%) RIA.
    0 (3%) 0 (3%) 0 (3%)
    0 (0%) 0 (0%) 0 (0%)
    Annualized quantified, but unmonetized, None N/A N/A RIA.
    benefits.
    ---------------------------------------

    [[Page 4200]]


    Qualitative (unquantified benefits)...... Aliens as well as the panel RIA.
    physicians and civil surgeons
    inherently benefit from having
    current, up-to-date regulations with
    modern terminology that reflects
    modern practice and plain language.
    ----------------------------------------------------------------------------------------------------------------
    COSTS
    ----------------------------------------------------------------------------------------------------------------
    Annualized monetized costs (discount rate $0 (7%) $0 (7%) $0 (7%) RIA.
    in parenthesis).\a\ 0 (3%) 0 (3%) 0 (3%)
    0 (0%) 0 (0%) 0 (0%)
    Annualized quantified, but unmonetized, None N/A N/A RIA.
    costs.
    ---------------------------------------
    Qualitative (unquantified) costs......... None RIA.
    ----------------------------------------------------------------------------------------------------------------


    Table 3--Summary of the Quantified and Non-Quantified Benefits and Costs Removing Chancroid, Granuloma
    Inguinale, and Lymphogranuloma Venereum From the Definition of Communicable Disease of Public Health
    Significance
    ----------------------------------------------------------------------------------------------------------------
    Primary Minimum Maximum Source citation (RIA,
    Category estimate estimate estimate preamble, etc.)
    ----------------------------------------------------------------------------------------------------------------
    BENEFITS
    ----------------------------------------------------------------------------------------------------------------
    Monetized benefits....................... $0 (7%) $0 (7%) $0 (7%) RIA.
    0 (3%) 0 (3%) 0 (3%)
    0 (0%) 0 (0%) 0 (0%)
    Annualized quantified, but unmonetized, None N/A N/A RIA.
    benefits.
    ---------------------------------------
    Qualitative (unquantified benefits)...... The physicians administering the exam RIA.
    will be able to devote more time and
    training to other, more common and/or
    more serious health issues.
    ----------------------------------------------------------------------------------------------------------------
    COSTS
    ----------------------------------------------------------------------------------------------------------------
    Annualized monetized costs (discount rate $3,858 (7%) $3,858 (7%) $3,858 (7%) RIA.
    in parenthesis).\a\ \b\ 3,858 (3%) 3,858 (3%) 3,858 (3%)
    3,858 (0%) 18 (0%) 23,147 (0%)
    Annualized quantified, but unmonetized, None N/A N/A RIA.
    costs.
    ---------------------------------------
    Qualitative (unquantified) costs......... None RIA.
    ----------------------------------------------------------------------------------------------------------------
    \a\ All costs of the rule are annual.
    \b\ It was assumed that all cases occur within one year of arrival. Further, given the decreasing trend in
    reported cases in the United States, these estimates are likely to be conservative. As a result of these
    assumptions, the results do not change as a function of the discount rate.

    B. The Regulatory Flexibility Act

    Under the Regulatory Flexibility Act, as amended by the Small
    Business Regulatory Enforcement Fairness Act (SBREFA), agencies are
    required to analyze regulatory options to minimize significant economic
    impact of a rule on small businesses, small governmental units, and
    small not-for-profit organizations. We have analyzed the costs and
    benefits of the final rule, as required by Executive Order 12866, and a
    preliminary regulatory flexibility analysis that examines the potential
    economic effects of this rule on small entities, as required by the
    Regulatory Flexibility Act. Based on the cost benefit analysis, we
    expect the rule to have little or no economic impact on small entities.

    C. The Paperwork Reduction Act

    The Paperwork Reduction Act applies to the data collection
    requirements found in 42 CFR part 34. The U.S. Department of State is
    responsible for providing forms to panel physicians, and the Department
    of Homeland Security is responsible for providing forms to civil
    surgeons to document the medical examination and screening information
    for aliens. The Office of Management and Budget (OMB) approved this
    data collection under OMB Control No. 1405-0113, which will expire on
    September 30, 2017. We note also that the medical examination form that
    civil surgeons use is the I-693 and the OMB control number provided on
    the I-693 is 1615-0033 (expiration date 3/31/2017).

    [[Page 4201]]

    D. National Environmental Policy Act (NEPA)

    HHS/CDC has determined that the amendments to 42 CFR part 34 will
    not have a significant impact on the human environment.

    E. Executive Order 12988: Civil Justice Reform

    HHS/CDC has reviewed this rule under Executive Order 12988 on Civil
    Justice Reform and determines that this final rule meets the standard
    in the Executive Order.

    F. Executive Order 13132: Federalism

    Under Executive Order 13132, if the rule would limit or preempt
    State authorities, then a federalism analysis is required. The agency
    must consult with State and local officials to determine whether the
    rule would have a substantial direct effect on State or local
    Governments, as well as whether it would either preempt State law or
    impose a substantial direct cost of compliance on them.
    HHS/CDC has determined that this rule will not have sufficient
    federalism implications to warrant the preparation of a federalism
    summary impact statement.

    G. The Plain Language Act of 2010

    Under 63 FR 31883 (June 10, 1998), Executive Departments and
    Agencies are required to use plain language in all proposed and final
    rules. HHS/CDC has attempted to use plain language in this rulemaking
    to make our intentions and rationale clear. We received no public
    comment regarding plain language.

    VII. References

    1. The President. Presidential documents. Executive Order 12866 of
    September 30, 1993: Regulatory Planning and Review. Federal
    Register. Monday, October 4, 1993;58(190). http://www.archives.gov/federal-regi.../pdf/12866.pdf. Accessed September
    2015.
    2. The President. Presidential documents. Executive Order 13563 of
    January 18, 2011: Improving Regulation and Regulatory Review.
    Federal Register. Friday, January 21, 2011; 76(14). http://www.gpo.gov/fdsys/pkg/FR-2011.../2011-1385.pdf. Accessed
    September 2015.
    3. U.S. Small Business Administration. Regulatory Flexibility Act.
    http://www.sba.gov/advocacy/823. Accessed September 2015.
    4. Summary of the Unfunded Mandates Reform Act. 2 U.S.C. 1501 et
    seq. (1995). http://www2.epa.gov/laws-regulations...tes-reform-act. Accessed September 2015.
    5. Tom Lantos and Henry Hyde United States Global Leadership Against
    HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008,
    Public Law 110-293, section 305, 122 Stat. 2963 (July 30, 2008).
    6. CDC. CDC WONDER: Sexually Transmitted Disease Morbidity, 1984-
    2008. Available from: http://wonder.cdc.gov/std-v2008.html. Accessed
    September 2015.
    7. New York State Department of Health. Bureau of Sexually
    Transmitted Disease Prevention and Epidemiology. STD Statistical
    Abstract 2008. http://www.health.state.ny.us/statis.../docs/2008.pdf. Accessed September 2015.
    8. Steen, R. (2001). Eradicating chancroid. Bulletin of the World
    Health Organization 2001. 79: 818-826.
    9. Plummer, FA et al. (1983). Epidemiology of chancroid and
    Haemophilus ducreyi in Nairobi, Kenya. The Lancet. 2(8362): 1293-
    1295.
    10. Hawkes S. et al. (1995) Asymptomatic carriage of Haemophilus
    ducreyi confirmed by the polymerase chain reaction. Genitourinary
    Medicine. 71 (4): 224-227.
    11. O'Farrell, N. (1993) Soap and water prophylaxis for limiting
    genital ulcer disease and HIV-1 infection in men in sub-Saharan
    Africa. Genitourinary Medicine. 69 (4): 297-303.
    12. O'Farrell, N., & Moi, H. (2010) European guideline for the
    management of donovanosis, 2010. International Journal of STD &
    AIDS. 21:609-610.
    13. Richens, J. (2006) Donovanosis (Granuloma Inguinale). Sexually
    Transmitted Infections. 82(Suppl IV):iv21-iv22.
    14. Miller, P. Donovanosis: control or eradication? (2001) Office
    for Aboriginal and Torres Strait Islander Health.
    15. Vorvick, LJ., & Storck, S. (2009). Granuloma inguinale
    (Donovanosis). Medline Plus. http://www.nlm.nih.gov/medlineplus/e...cle/000636.htm. Accessed September 2015.
    16. Bowden FJ, on behalf of the National Donovanosis Eradication
    Advisory Committee. Donovanosis in Australia: going, going. . . .
    Sex Transm Infect 2005. 81:365-366.
    17. CDC. Treatment of Sexually Transmitted Diseases. Diseases
    characterized by genital ulcers--Granuloma inguinale (Donovanosis) (
    ). 2011. Available from: http://www.cdc.gov/std/treatment/201...tal-ulcers.htm. Accessed September 2015.
    18. CDC. Treatment of Sexually Transmitted Diseases. Diseases
    characterized by genital ulcers--Lymphogranuloma Venereum. 2011.
    Available from: http://www.cdc.gov/std/treatment/201...tal-ulcers.htm. Accessed September 2015.
    19. Martin-Iguacel, R., Llibre, J.M., Nielsen, H., Heras, E., Matas,
    L., Lugo, R., Clotet, B., Siera, G. (2010) Lymphogranuloma venereum
    proctocolitis: a silent endemic disease in men who have sex with men
    in industrialized countries. European Journal of Clinical Microbial
    Infectious Disease. 29:917-925.
    20. Blank, S., Schillinger, JA., Harbatkin, D. (2005) Comment:
    Lymphogranuloma venereum in the industrialized world. The Lancet.
    365: 1607-08.
    21. Johnson, LF., Coetzee, DJ., & Dorrington, RE. (2005). Sentinel
    surveillance of sexually transmitted infections in South Africa: a
    review. Sexually Transmitted Infections. 81: 287-293.
    22. WHO, Global incidence and incidence of selected curable sexually
    transmitted infections 2001. 2001. Available from: http://www.who.int/hiv/pub/sti/en/wh...ds_2001.02.pdf. Accessed
    September 2015.
    23. WHO, Global incidence and incidence of four curable sexually
    transmitted infections (STIs): New estimates from WHO. 2009.
    24. United States. Department of Homeland Security. Yearbook of
    Immigration Statistics: 2010. Washington, DC: U.S. Department of
    Homeland Security, Office of Immigration Statistics, 2011.
    25. American Psychiatric Association: Diagnostic and Statistical
    Manual of Mental Disorders, Fifth Edition, Arlington, VA, American
    Psychiatric Association, 2013.
    26. International Classification of Diseases (ICD), Tenth Revision,
    World Health Organization.

    List of Subjects in 42 CFR Part 34

    Aliens, Health care, Medical examination, Passports and visas,
    Public health, Scope of examination.

    For the reasons discussed in the preamble, the Centers for Disease
    Control and Prevention, Department of Health and Human Services revises
    42 CFR part 34 to read as follows:

    PART 34--MEDICAL EXAMINATION OF ALIENS

    Sec.
    34.1 Applicability.
    34.2 Definitions.
    34.3 Scope of examinations.
    34.4 Medical notifications.
    34.5 Postponement of medical examination.
    34.6 Applicability of Foreign Quarantine Regulations.
    34.7 Medical and other care; death.
    34.8 Reexamination; convening of review boards; expert witnesses;
    reports.

    Authority: 42 U.S.C. 252; 8 U.S.C. 1182 and 1222.


    Sec. 34.1 Applicability.

    The provisions of this part shall apply to the medical examination
    of:
    (a) Aliens applying for a visa at an embassy or consulate of the
    United States;
    (b) Aliens arriving in the United States;
    (c) Aliens required by DHS to have a medical examination in
    connection with the determination of their admissibility into the
    United States; and
    (d) Aliens applying for adjustment of status.

    [[Page 4202]]

    Sec. 34.2 Definitions.

    As used in this part, terms shall have the following meanings:
    (a) CDC. Centers for Disease Control and Prevention, Department of
    Health and Human Services, or an authorized representative acting on
    its behalf.
    (b) Communicable disease of public health significance. Any of the
    following diseases:
    (1) Communicable diseases as listed in a Presidential Executive
    Order, as provided under Section 361(b) of the Public Health Service
    Act. The current revised list of quarantinable communicable diseases is
    available at http://www.cdc.gov and http://www.archives.gov/federal-register.
    (2) Communicable diseases that may pose a public health emergency
    of international concern if it meets one or more of the factors listed
    in Sec. 34.3(d) and for which the Director has determined a threat
    exists for importation into the United States, and such disease may
    potentially affect the health of the American public. The determination
    will be made consistent with criteria established in Annex 2 of the
    International Health Regulations (http://www.who.int/csr/ihr/en/), as
    adopted by the Fifty-Eighth World Health Assembly in 2005, and as
    entered into effect in the United States in July 2007, subject to the
    U.S. Government's reservation and understandings:
    (i) Any of the communicable diseases for which a single case
    requires notification to the World Health Organization (WHO) as an
    event that may constitute a public health emergency of international
    concern, or
    (ii) Any other communicable disease the occurrence of which
    requires notification to the WHO as an event that may constitute a
    public health emergency of international concern. HHS/CDC's
    determinations will be announced by notice in the Federal Register.
    (3) Gonorrhea.
    (4) Hansen's disease, infectious.
    (5) Syphilis, infectious.
    (6) Tuberculosis, active.
    (c) Civil surgeon. A physician designated by DHS to conduct medical
    examinations of aliens in the United States who are applying for
    adjustment of status to permanent residence or who are required by DHS
    to have a medical examination.
    (d) Class A medical notification. Medical notification of:
    (1) A communicable disease of public health significance;
    (2) A failure to present documentation of having received
    vaccination against ``vaccine-preventable diseases'' for an alien who
    seeks admission as an immigrant, or who seeks adjustment of status to
    one lawfully admitted for permanent residence, which shall include at
    least the following diseases: Mumps, measles, rubella, polio, tetanus
    and diphtheria toxoids, pertussis, Haemophilus influenza type B and
    hepatitis B, and any other vaccinations recommended by the Advisory
    Committee for Immunization Practices (ACIP) for which HHS/CDC
    determines, by applying criteria published in the Federal Register,
    there is a public health need at the time of immigration or adjustment
    of status. Provided, however, that in no case shall a Class A medical
    notification be issued for an adopted child who is 10 years of age or
    younger if, prior to the admission of the child, an adoptive parent or
    prospective adoptive parent of the child, who has sponsored the child
    for admission as an immediate relative, has executed an affidavit
    stating that the parent is aware of the vaccination requirement and
    will ensure that, within 30 days of the child's admission, or at the
    earliest time that is medically appropriate, the child will receive the
    vaccinations identified in the requirement.
    (3)(i) A current physical or mental disorder and behavior
    associated with the disorder that may pose, or has posed, a threat to
    the property, safety, or welfare of the alien or others;
    (ii) A history of a physical or mental disorder and behavior
    associated with the disorder, which behavior has posed a threat to the
    property, safety, or welfare of the alien or others and which behavior
    is likely to recur or lead to other harmful behavior; or
    (4) Drug abuse or addiction.
    (e) Class B medical notification. Medical notification of a
    physical or mental health condition, disease, or disability serious in
    degree or permanent in nature.
    (f) DHS. U.S. Department of Homeland Security.
    (g) Director. The Director of the Centers for Disease Control and
    Prevention or a designee as approved by the Director or Secretary of
    Health and Human Services.
    (h) Drug abuse. ``Current substance use disorder or substance-
    induced disorder, mild'' as defined in the most recent edition of the
    Diagnostic and Statistical Manual for Mental Disorders (DSM) as
    published by the American Psychiatric Association, or by another
    authoritative source as determined by the Director, of a substance
    listed in Section 202 of the Controlled Substances Act, as amended (21
    U.S.C. 802).
    (i) Drug addiction. ``Current substance use disorder or substance-
    induced disorder, moderate or severe'' as defined in the most recent
    edition of the Diagnostic and Statistical Manual for Mental Disorders
    (DSM), as published by the American Psychiatric Association, or by
    another authoritative source as determined by the Director, of a
    substance listed in Section 202 of the Controlled Substances Act, as
    amended (21 U.S.C. 802).
    (j) Medical examiner. A panel physician, civil surgeon, or other
    physician designated by the Director to perform medical examinations of
    aliens.
    (k) Medical hold document. A document issued to DHS by a quarantine
    officer of HHS at a port of entry which defers the inspection for
    admission until the cause of the medical hold is resolved.
    (l) Medical notification. A medical examination document issued to
    a U.S. consular authority or DHS by a medical examiner, certifying the
    presence or absence of:
    (1) A communicable disease of public health significance;
    (2) Documentation of having received vaccination against ``vaccine-
    preventable diseases'' for an alien who seeks admission as an
    immigrant, or who seeks adjustment of status to one lawfully admitted
    for permanent residence, which shall include at least the following
    diseases: Mumps, measles, rubella, polio, tetanus and diphtheria
    toxoids, pertussis, Haemophilus influenza type B and hepatitis B, and
    any other vaccinations recommended by the Advisory Committee for
    Immunization Practices (ACIP) for which HHS/CDC determines, based upon
    criteria published in the Federal Register, there is a public health
    need at the time of immigration or adjustment of status. Provided,
    however, that in no case shall a Class A medical notification be issued
    for an adopted child who is 10 years of age or younger if, prior to the
    admission of the child, an adoptive parent or prospective adoptive
    parent of the child, who has sponsored the child for admission as an
    immediate relative, has executed an affidavit stating that the parent
    is aware of the vaccination requirement and will ensure that, within 30
    days of the child's admission, or at the earliest time that is
    medically appropriate, the child will receive the vaccinations
    identified in the requirement;
    (3)(i) A current physical or mental disorder and behavior
    associated with the disorder that may pose, or has posed, a threat to
    the property, safety, or welfare of the alien or others;

    [[Page 4203]]

    (ii) A history of a physical or mental disorder and behavior
    associated with the disorder, which behavior has posed a threat to the
    property, safety, or welfare of the alien or others and which behavior
    is likely to recur or lead to other harmful behavior;
    (4) Drug abuse or addiction; or
    (5) Any other physical or mental condition, disease, or disability
    serious in degree or permanent in nature.
    (m) Medical officer. A physician or other medical professional
    assigned by the Director to conduct physical and mental examinations of
    aliens on behalf of HHS/CDC.
    (n) Mental disorder. A currently accepted psychiatric diagnosis, as
    defined by the current edition of the Diagnostic and Statistical Manual
    of Mental Disorders published by the American Psychiatric Association
    or by another authoritative source as determined by the Director.
    (o) Panel physician. A physician selected by a United States
    embassy or consulate to conduct medical examinations of aliens applying
    for visas.
    (p) Physical disorder. A currently accepted medical diagnosis, as
    defined by the current edition of the Manual of the International
    Classification of Diseases, Injuries, and Causes of Death published by
    the World Health Organization or by another authoritative source as
    determined by the Director.


    Sec. 34.3 Scope of examinations.

    (a) General. In performing examinations, medical examiners shall
    consider those matters that relate to the following:
    (1) Communicable disease of public health significance;
    (2) Documentation of having received vaccination against ``vaccine-
    preventable diseases'' for an alien who seeks admission as an
    immigrant, or who seeks adjustment of status to one lawfully admitted
    for permanent residence, which shall include at least the following
    diseases: Mumps, measles, rubella, polio, tetanus and diphtheria
    toxoids, pertussis, Haemophilus influenza type B and hepatitis B, and
    any other vaccinations recommended by the Advisory Committee for
    Immunization Practices (ACIP) for which HHS/CDC determines there is a
    public health need at the time of immigration or adjustment of status.
    Provided, however, that in no case shall a Class A medical
    notification be issued for an adopted child who is 10 years of age or
    younger if, prior to the admission of the child, an adoptive parent or
    prospective adoptive parent of the child, who has sponsored the child
    for admission as an immediate relative, has executed an affidavit
    stating that the parent is aware of the vaccination requirement and
    will ensure that, within 30 days of the child's admission, or at the
    earliest time that is medically appropriate, the child will receive the
    vaccinations identified in the requirement;
    (3)(i) A current physical or mental disorder and behavior
    associated with the disorder that may pose, or has posed, a threat to
    the property, safety, or welfare of the alien or others;
    (ii) A history of a physical or mental disorder and behavior
    associated with the disorder, which behavior has posed a threat to the
    property, safety, or welfare of the alien or others and which behavior
    is likely to recur or lead to other harmful behavior;
    (4) Drug abuse or drug addiction; and
    (5) Any other physical or mental health condition, disease, or
    disability serious in degree or permanent in nature.
    (b) Scope of all medical examinations. (1) All medical examinations
    will include the following:
    (i) A general physical examination and medical history, evaluation
    for tuberculosis, and serologic testing for syphilis.
    (ii) A physical examination and medical history for diseases
    specified in Sec. Sec. 34.2(b)(1), and 34.2(b)(4) through 34.2(b)(10).
    (2) For the examining physician to reach a determination and
    conclusion about the presence or absence of a physical or mental
    abnormality, disease, or disability, the scope of the examination shall
    include any laboratory or additional studies that are deemed necessary,
    either as a result of the physical examination or pertinent information
    elicited from the alien's medical history or other relevant records.
    (c) Additional medical screening and testing for examinations
    performed outside the United States.
    (1) HHS/CDC may require additional medical screening and testing
    for medical examinations performed outside the United States for
    diseases specified in Sec. Sec. 34.2(b)(2) and 34.2(b)(3) by applying
    the risk-based medical and epidemiologic factors in paragraph (d)(2) of
    this section.
    (2) Such examinations shall be conducted in a defined population in
    a geographic region or area outside the United States as determined by
    HHS/CDC.
    (3) Additional medical screening and testing shall include a
    medical interview, physical examination, laboratory testing, radiologic
    exam, or other diagnostic procedure, as determined by HHS/CDC.
    (4) Additional medical screening and testing will continue until
    HHS/CDC determines such screening and testing is no longer warranted
    based on factors such as the following: Results of disease outbreak
    investigations and response efforts; effectiveness of containment and
    control measures; and the status of an applicable determination of
    public health emergency of international concern declared by the
    Director General of the WHO.
    (5) HHS/CDC will directly provide medical examiners information
    pertaining to all applicable additional requirements for medical
    screening and testing, and will post these at the following Internet
    addresses: http://www.cdc.gov/ncidod/dq/technica.htm and http://www.globalhealth.gov.
    (d) Risk-based approach. (1) HHS/CDC will use the medical and
    epidemiological factors listed in paragraph (d)(2) of this section to
    determine the following:
    (i) Whether a disease as specified in Sec. 34.2(b)(3)(ii) is a
    communicable disease of public health significance;
    (ii) Which diseases in Sec. 34.2(b)(2) and (3) merit additional
    screening and testing, and the geographic area in which HHS/CDC will
    require this screening.
    (2) Medical and epidemiological factors include the following: (i)
    The seriousness of the disease's public health impact;
    (ii) Whether the emergence of the disease was unusual or
    unexpected;
    (iii) The risk of the spread of the disease in the United States;
    (iv) The transmissibility and virulence of the disease;
    (v) The impact of the disease at the geographic location of medical
    screening; and
    (vi) Other specific pathogenic factors that would bear on a
    disease's ability to threaten the health security of the United States.
    (e) Persons subject to requirement for chest radiograph examination
    and serologic testing. (1) As provided in paragraph (e)(2) of this
    section, a chest radiograph examination and serologic testing for
    syphilis shall be required as part of the examination of the following:
    (i) Applicants for immigrant visas;
    (ii) Students, exchange visitors, and other applicants for non-
    immigrant visas required by a U.S. consular authority to have a medical
    examination;
    (iii) Applicants outside the United States who apply for refugee
    status;
    (iv) Applicants in the United States who apply for adjustment of
    their status

    [[Page 4204]]

    under the immigration statute and regulations.
    (v) Applicants required by DHS to have a medical examination in
    connection with determination of their admissibility into the United
    States.
    (2) Chest radiograph examination and serologic testing. Except as
    provided in paragraph (e)(2)(iv) of this section, applicants described
    in paragraph (e)(1) of this section shall be required to have the
    following:
    (i) For applicants 15 years of age and older, a chest radiograph
    examination;
    (ii) For applicants under 15 years of age, a chest radiograph
    examination if the applicant has symptoms of tuberculosis, a history of
    tuberculosis, or evidence of possible exposure to a transmissible
    tuberculosis case in a household or other enclosed environment for a
    prolonged period;
    (iii) For applicants 15 years of age and older, serologic testing
    for syphilis and other communicable diseases of public health
    significance as determined by the Director through technical
    instructions.
    (iv) Exceptions. Serologic testing for syphilis shall not be
    required if the alien is under the age of 15, unless there is reason to
    suspect infection with syphilis. An alien, regardless of age, in the
    United States, who applies for adjustment of status to lawful permanent
    resident, shall not be required to have a chest radiograph examination
    unless their tuberculin skin test, or an equivalent test for showing an
    immune response to Mycobacterium tuberculosis antigens, is positive.
    HHS/CDC may authorize exceptions to the requirement for a tuberculin
    skin test, an equivalent test for showing an immune response to
    Mycobacterium tuberculosis antigens, or chest radiograph examination
    for good cause, upon application approved by the Director.
    (3) Immune response to Mycobacterium tuberculosis antigens. (i) All
    aliens 2 years of age or older in the United States who apply for
    adjustment of status to permanent residents, under the immigration laws
    and regulations, or other aliens in the United States who are required
    by DHS to have a medical examination in connection with a determination
    of their admissibility, shall be required to have a tuberculin skin
    test or an equivalent test for showing an immune response to
    Mycobacterium tuberculosis antigens. Exceptions to this requirement may
    be authorized for good cause upon application approved by the Director.
    In the event of a positive test of immune response, a chest radiograph
    examination shall be required. If the chest radiograph is consistent
    with tuberculosis, the alien shall be referred to the local health
    authority for evaluation. Evidence of this evaluation shall be provided
    to the civil surgeon before a medical notification may be issued.
    (ii) Aliens in the United States less than 2 years of age shall be
    required to have a tuberculin skin test, or an equivalent, appropriate
    test to show an immune response to Mycobacterium tuberculosis antigens,
    if there is evidence of contact with a person known to have
    tuberculosis or other reason to suspect tuberculosis. In the event of a
    positive test of immune response, a chest radiograph examination shall
    be required. If the chest radiograph is consistent with tuberculosis,
    the alien shall be referred to the local health authority for
    evaluation. Evidence of this evaluation shall be provided to the civil
    surgeon before a medical notification may be issued.
    (iii) Aliens outside the United States required to have a medical
    examination shall be required to have a tuberculin skin test, or an
    equivalent, appropriate test to show an immune response to
    Mycobacterium tuberculosis antigens, and, if indicated, a chest
    radiograph.
    (iv) Aliens outside the United States required to have a medical
    examination shall be required to have a tuberculin skin test, or an
    equivalent, appropriate test to show an immune response to
    Mycobacterium tuberculosis antigens, and a chest radiograph, regardless
    of age, if he/she has symptoms of tuberculosis, a history of
    tuberculosis, or evidence of possible exposure to a transmissible
    tuberculosis case in a household or other enclosed environment for a
    prolonged period, as determined by the Director.
    (4) Additional testing requirements. All applicants may be required
    to undergo additional testing for tuberculosis based on the medical
    evaluation.
    (5) How and where performed. All chest radiograph images used in
    medical examinations performed under the regulations to this part shall
    be large enough to encompass the entire chest.
    (6) Chest x-ray, laboratory, and treatment reports. The chest
    radiograph reading and serologic test results for syphilis shall be
    included in the medical notification. When the medical examiner's
    conclusions are based on a study of more than one chest x-ray image,
    the medical notification shall include at least a summary statement of
    findings of the earlier images, followed by a complete reading of the
    last image, and dates and details of any laboratory tests and treatment
    for tuberculosis.
    (f) Procedure for transmitting records. For aliens issued immigrant
    visas, the medical notification and chest radiograph images, if any,
    shall be placed in a separate envelope, which shall be sealed. When
    more than one chest radiograph image is used as a basis for the
    examiner's conclusions, all images shall be included. Records may be
    transmitted by other means, as approved by the Director.
    (g) Failure to present records. When a determination of
    admissibility is to be made at the U.S. port of entry, a medical hold
    document shall be issued pending completion of any necessary
    examination procedures. A medical hold document may be issued for
    aliens who:
    (1) Are not in possession of a valid medical notification, if
    required;
    (2) Have a medical notification which is incomplete;
    (3) Have a medical notification which is not written in English;
    (4) Are suspected to have an inadmissible medical condition.
    (h) The Secretary of Homeland Security, after consultation with the
    Secretary of State and the Secretary of Health and Human Services, may
    in emergency circumstances permit the medical examination of refugees
    to be completed in the United States.
    (i) All medical examinations shall be carried out in accordance
    with such technical instructions for physicians conducting the medical
    examination of aliens as may be issued by the Director. Copies of such
    technical instructions are available upon request to the Director,
    Division of Global Migration and Quarantine, Mailstop E03, HHS/CDC,
    Atlanta GA 30333.


    Sec. 34.4 Medical notifications.

    (a) Medical examiners shall issue medical notifications of their
    findings of the presence or absence of Class A or Class B medical
    conditions. The presence of such condition must have been clearly
    established.
    (b) Class A medical notifications. (1) The medical examiner shall
    report his/her findings to the consular officer or DHS by Class A
    medical notification which lists the specific condition for which the
    alien may be inadmissible, if an alien is found to have:
    (i) A communicable disease of public health significance;
    (ii) A lack of documentation, or no waiver, for an alien who seeks
    admission as an immigrant, or who seeks adjustment of status to one
    lawfully admitted for permanent residence, of having received
    vaccination against vaccine-preventable diseases which shall include at
    least the

    [[Page 4205]]

    following diseases: Mumps, measles, rubella, polio, tetanus and
    diphtheria toxoids, pertussis, Haemophilus influenza type B and
    hepatitis B, and any other vaccinations recommended by the Advisory
    Committee for Immunization Practices (ACIP) for which HHS/CDC
    determines, by applying criteria published in the Federal Register,
    there is a public health need at the time of immigration or adjustment
    of status. Provided however, that a Class A medical notification shall
    in no case be issued for an adopted child who is 10 years of age or
    younger if, prior to the admission of the child, an adoptive parent or
    prospective adoptive parent of the child, who has sponsored the child
    for admission as an immediate relative, has executed an affidavit
    stating that the parent is aware of the vaccination requirement and
    will ensure that, within 30 days of the child's admission, or at the
    earliest time that is medically appropriate, the child will receive the
    vaccinations identified in the requirement;
    (iii)(A) A current physical or mental disorder, and behavior
    associated with the disorder that may pose, or has posed, a threat to
    the property, safety, or welfare of the alien or others; or
    (B) A history of a physical or mental disorder and behavior
    associated with the disorder, which behavior has posed a threat to the
    property, safety, or welfare of the alien or others and which behavior
    is likely to recur or lead to other harmful behavior;
    (iv) Drug abuse or drug addiction. Provided, however, that a Class
    A medical notification of a physical or mental disorder, and behavior
    associated with that disorder that may pose, or has posed, a threat to
    the property, safety, or welfare of the alien or others, shall in no
    case be issued with respect to an alien having only mental shortcomings
    due to ignorance, or suffering only from a condition attributable to
    remediable physical causes or of a temporary nature, caused by a toxin,
    medically prescribed drug, or disease.
    (2) The medical notification shall state the nature and extent of
    the abnormality; the degree to which the alien is incapable of normal
    physical activity; and the extent to which the condition is remediable.
    The medical examiner shall indicate the likelihood, that because of the
    condition, the applicant will require extensive medical care or
    institutionalization.
    (c) Class B medical notifications. (1) If an alien is found to have
    a physical or mental abnormality, disease, or disability serious in
    degree or permanent in nature amounting to a substantial departure from
    normal well-being, the medical examiner shall report his/her findings
    to the consular or DHS officer by Class B medical notification which
    lists the specific conditions found by the medical examiner. Provided,
    however, that a Class B medical notification shall in no case be issued
    with respect to an alien having only mental shortcomings due to
    ignorance, or suffering only from a condition attributable to
    remediable physical causes or of a temporary nature, caused by a toxin,
    medically prescribed drug, or disease.
    (2) The medical notification shall state the nature and extent of
    the abnormality, the degree to which the alien is incapable of normal
    physical activity, and the extent to which the condition is remediable.
    The medical examiner shall indicate the likelihood, that because of the
    condition, the applicant will require extensive medical care or
    institutionalization.
    (d) Other medical notifications. If as a result of the medical
    examination, the medical examiner does not find a Class A or Class B
    condition in an alien, the medical examiner shall so indicate on the
    medical notification form and shall report his findings to the consular
    or DHS officer.


    Sec. 34.5 Postponement of medical examination.

    Whenever, upon an examination, the medical examiner is unable to
    determine the physical or mental condition of an alien, completion of
    the medical examination shall be postponed for such observation and
    further examination of the alien as may be reasonably necessary to
    determine his/her physical or mental condition. The examination shall
    be postponed for aliens who have an acute infectious disease until the
    condition is resolved. The alien shall be referred for medical care as
    necessary.


    Sec. 34.6 Applicability of Foreign Quarantine Regulations.

    Aliens arriving at a port of the United States shall be subject to
    the applicable provisions of 42 CFR part 71, Foreign Quarantine, with
    respect to examination and quarantine measures.


    Sec. 34.7 Medical and other care; death.

    (a) An alien detained by or in the custody of DHS may be provided
    medical, surgical, psychiatric, or dental care by HHS through
    interagency agreements under which DHS shall reimburse HHS. Aliens
    found to be in need of emergency care in the course of medical
    examination shall be treated to the extent deemed practical by the
    attending physician and if considered to be in need of further care,
    may be referred to DHS along with the physician's recommendations
    concerning such further care.
    (b) In case of the death of an alien, the body shall be delivered
    to the consular or immigration authority concerned. If such death
    occurs in the United States, or in a territory or possession thereof,
    public burial shall be provided upon request of DHS and subject to its
    agreement to pay the burial expenses. Autopsies shall not be performed
    unless approved by DHS.


    Sec. 34.8 Reexamination; convening of review boards; expert
    witnesses; reports.

    (a) The Director shall convene a board of medical officers to
    reexamine an alien:
    (1) Upon the request of DHS for a reexamination by such a board; or
    (2) Upon an appeal to DHS by an alien who, having received a
    medical examination in connection with the determination of
    admissibility to the United States (including examination on arrival
    and adjustment of status as provided in the immigration laws and
    regulations) has been certified for a Class A condition.
    (b) The board shall reexamine an alien certified as:
    (1) Having a communicable disease of public health significance;
    (2) Lacking documentation of having received vaccination against
    ``vaccine-preventable diseases'' for an alien who seeks admission as an
    immigrant, or who seeks adjustment of status to one lawfully admitted
    for permanent residence, which shall include at least the following
    diseases: Mumps, measles, rubella, polio, tetanus and diphtheria
    toxoids, pertussis, Haemophilus influenza type B and hepatitis B, and
    any other vaccinations recommended by the Advisory Committee for
    Immunization Practices (ACIP) for which HHS/CDC determines, by applying
    criteria published in the Federal Register, there is a public health
    need at the time of immigration or adjustment of status. Provided,
    however, that in no case shall a Class A medical notification be issued
    for an adopted child who is 10 years of age or younger if, prior to the
    admission of the child, an adoptive or prospective adoptive parent, who
    has sponsored the child for admission as an immediate relative, has
    executed an affidavit stating that the parent is aware of the
    vaccination requirement and will ensure that the child will be
    vaccinated within 30 days of the child's admission, or at

    [[Page 4206]]

    the earliest time that is medically appropriate.
    (3)(i) Having a current physical or mental disorder and behavior
    associated with the disorder that may pose, or has posed, a threat to
    the property, safety, or welfare of the alien or others; or
    (ii) Having a history of a physical or mental disorder and behavior
    associated with the disorder, which behavior has posed a threat to the
    property, safety, or welfare of the alien or others and which behavior
    is likely to recur or lead to other harmful behavior; or
    (iii) Having drug abuse or drug addiction;
    (c) The board shall consist of the following:
    (1) In circumstances covered by paragraph (b)(1) of this section,
    the board shall consist of at least one medical officer who is
    experienced in the diagnosis and treatment of the communicable disease
    for which the medical notification has been made;
    (2) In circumstances covered by paragraph (b)(2) of this section,
    the board shall consist of at least one medical officer who is
    experienced in the diagnosis and treatment of the vaccine-preventable
    disease for which the medical notification has been made;
    (3) In circumstances covered by paragraph (b)(3) of this section,
    the board shall consist of at least one medical officer who is
    experienced in the diagnosis and treatment of the physical or mental
    disorder, or substance-related disorder for which medical notification
    has been made.
    (d) The decision of the majority of the board shall prevail,
    provided that at least two medical officers concur in the judgment of
    the board.
    (e) Reexamination shall include:
    (1) Review of all records submitted by the alien, other witnesses,
    or the board;
    (2) Use of any laboratory or additional studies which are deemed
    clinically necessary as a result of the physical examination or
    pertinent information elicited from the alien's medical history;
    (3) Consideration of statements regarding the alien's physical or
    mental condition made by a physician after his/her examination of the
    alien; and
    (4) A physical or psychiatric examination of the alien performed by
    the board, at the board's discretion;
    (f) An alien who is to be reexamined shall be notified of the
    reexamination not less than 5 days prior thereto.
    (g) The alien, at his/her own cost and expense, may introduce as
    witnesses before the board such physicians or medical experts as the
    board may in its discretion permit; provided that the alien shall be
    permitted to introduce at least one expert medical witness. If any
    witnesses offered are not permitted by the board to testify (either
    orally or through written testimony), the record of the proceedings
    shall show the reason for the denial of permission.
    (h) Witnesses before the board shall be given a reasonable
    opportunity to review the medical notification and other records
    involved in the reexamination and to present all relevant and material
    evidence orally or in writing until such time as the reexamination is
    declared by the board to be closed. During the course of the
    reexamination the alien's attorney or representative shall be permitted
    to question the alien and he/she, or the alien, shall be permitted to
    question any witnesses offered in the alien's behalf or any witnesses
    called by the board. If the alien does not have an attorney or
    representative, the board shall assist the alien in the presentation of
    his/her case to the end that all of the material and relevant facts may
    be considered.
    (i) Any proceedings under this section may, at the board's
    discretion, be conducted based on the written record, including through
    written questions and testimony.
    (j) The findings and conclusions of the board shall be based on its
    medical examination of the alien, if any, and on the evidence presented
    and made a part of the record of its proceedings.
    (k) The board shall report its findings and conclusions to DHS, and
    shall also give prompt notice thereof to the alien if his/her
    reexamination has been based on his/her appeal. The board's report to
    DHS shall specifically affirm, modify, or reject the findings and
    conclusions of prior examining medical officers.
    (l) The board shall issue its medical notification in accordance
    with the applicable provisions of this part if it finds that an alien
    it has reexamined has a Class A or Class B condition.
    (m) If the board finds that an alien it has reexamined does not
    have a Class A or Class B condition, it shall issue its medical
    notification in accordance with the applicable provisions of this part.
    (n) After submission of its report, the board shall not be
    reconvened, nor shall a new board be convened, in connection with the
    same application for admission or for adjustment of status, except upon
    the express authorization of the Director.

    Dated: January 12, 2016.
    Sylvia M. Burwell,
    Secretary.
    [FR Doc. 2016-01418 Filed 1-25-16; 8:45 am]
    BILLING CODE 4163-18-P
      Posting comments is disabled.

    Categories

    Collapse

    article_tags

    Collapse

    There are no tags yet.

    Latest Articles

    Collapse

    • News: USCIS Clarification of STEM OPT Extension Reporting Responsibilities and Training Obligations
      ImmigrationDaily

      If you are having difficulty viewing this document please click here.

      08-20-2018, 08:41 AM
    • News: CRS Report on The Trump Administration’s “Zero Tolerance” Immigration Enforcement Policy
      ImmigrationDaily
      ...
      08-16-2018, 04:49 PM
    • News: Justice Department Secures Denaturalization of Guardian Convicted of Sexual Abuse of a Minor
      ImmigrationDaily
      Justice Department Secures Denaturalization of Guardian Convicted of Sexual Abuse of a Minor Release Date: Aug. 15, 2018 RALEIGH, N.C. — On Aug. 8, Chief Judge James C. Dever III of the U.S. District Court for the Eastern District of North Carolina entered an order that revoked the naturalized U.S. citizenship of a child sex offender; restrained and enjoined him from claiming any rights, privileges, or advantages of U.S. citizenship; and ordered him to immediately surrender and deliver his Certificate of Naturalization and any other indicia of U.S. citizenship to federal authorities. “The Justice Department is committed to preserving the integrity of our nation’s immigration system and the propriety of the government’s adjudication of immigration benefits,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “We will aggr...
      08-16-2018, 02:04 PM
    • News: USCIS publishes Immigration Services Available for Those Affected by California Wildfires
      ImmigrationDaily
      Immigration Services Available for Those Affected by California Wildfires USCIS offers immigration services that may help people affected by unforeseen circumstances , including the California wildfires. The following services may be available on a discretionary basis upon request: Changing a nonimmigrant status or extending a nonimmigrant stay for an individual currently in the United States. If you don’t apply for the extension or change before your authorized period of admission expires, we may excuse the delay if it was due to extraordinary circumstances beyond your control; Re-parole of individuals previously granted parole by USCIS; Expedited processing of advance parole requests; Expedited adjudication of requests for off-campus employment authorization for F-1 s...
      08-15-2018, 02:51 PM
    • News: Re-Registration Period Now Open for Temporary Protected Status for Yemen
      ImmigrationDaily
      Re-Registration Period Now Open for Temporary Protected Status for Yemen Versión en español WASHINGTON — U.S. Citizenship and Immigration Services (USCIS) announced today that current beneficiaries of Temporary Protected Status (TPS) under Yemen’s designation who want to maintain their status through the extension date of March 3, 2020, must re-register between August 14, 2018, and October 15, 2018. Re-registration procedures, including how to renew employment authorization documents (EADs), have been published in the Federal Register and on uscis.gov/tps . All applicants must submit Form I-821, Application for Temporary Protected Status. Applicants may also request an EAD by submitting Form I-765, Application for Employment Authorization, at the time they file Form I-821, or separately at a later date. Like all USCIS forms, both forms are free for download from the USCIS website at uscis.gov/tps . USCIS will issue new EADs with a March 3, 2020, expiration date to eligible Yemen TPS beneficiaries who timely re-register and apply for EADs. Given the timeframes involved with processing TPS re-registration applications, however, we recognize that not all re-registrants will receive new EADs before their current EADs expire on Sept. 3, 2018. Accordingly, we have automatically extended the validity of EADs for 180 days, through March 2, 2019. ...
      08-14-2018, 01:19 PM
    • News: USCIS Accrual of Unlawful Presence and F, J, and M Nonimmigrants
      ImmigrationDaily
      ...
      08-13-2018, 11:25 AM
    Working...
    X