[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]


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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.

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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/immigrantrefugeehealth/exams/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/docView/SLB/HTML/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-register/executive-orders/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-2011-01-21/pdf/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/summary-unfunded-mandates-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/statistics/diseases/communicable/std/abstracts/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/ency/article/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/2010/genital-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/2010/genital-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/who_hiv_aids_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