Medical Examination of Aliens-Revisions to Medical Screening Process, 35899-35916 [2015-15236]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Proposed Rules]
[Pages 35899-35916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15236]


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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: Notice of proposed rulemaking.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), within 
the U.S. Department of Health and Human Services (HHS), is issuing this 
Notice of Proposed Rulemaking (NPRM) to amend its regulations governing 
medical examinations that aliens must undergo before they may be 
admitted to the United States. Specifically, HHS/CDC proposes to: 
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: Written comments must be received on or before August 24, 2015.

ADDRESSES: You may submit comments, identified by the Regulatory 
Information Number (RIN) 0920-AA28 or the Docket Number CDC-2015-0045 
in the heading of this document by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Division of Global Migration and Quarantine, Centers 
for Disease Control and Prevention, 1600 Clifton Road, NE., MS E-03, 
Atlanta, GA 30333, ATTN: Part 34.
     Hand Delivery/Courier: Division of Global Migration and 
Quarantine, Centers for Disease Control and Prevention, 1600 Clifton 
Road, NE., MS E-03, Atlanta, GA 30333, ATTN: Part 34.
     Viewing Comments: Comments may be viewed at 
www.regulations.gov, Docket Number CDC-2015-0045.
    Instructions: All submissions received must include the agency name 
and docket number or RIN for this rulemaking. All relevant comments 
received will be posted without change to https://www.regulations.gov, 
including any personal information provided.
    Docket: For access to the docket to read background documents or 
comments received or to download an electronic version of the NPRM, go 
to https://www.regulations.gov and refer to Docket Number CDC-2015-0045. 
Comments will be available for public inspection from Monday through 
Friday, except for legal holidays, from 9 a.m. until 5 p.m., Eastern 
Time, at 1600 Clifton Road NE., Atlanta, Georgia 30333. Please call 
ahead to 1-866-694-4867, and ask for a representative in the Division 
of Global Migration and Quarantine to schedule your visit.

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 30333; 
telephone 1-404-498-1600.

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

I. Public Participation
II. Legal Authority
III. Background
    A. Inadmissibility and the Medical Examination
    B. Applicability of part 34
    C. Legislative and Regulatory History
IV. Rationale for Proposed Regulatory Action
    A. Section 34.2 Definitions
    B. Section 34.3 Scope of Examinations
    C. Section 34.4 Medical Notifications
    D. Section 34.7 Medical and Other Care; Death
    E. Section 34.8 Reexamination; Convening of Review Boards; 
Expert Witnesses, Reports
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

    Interested persons are invited to participate in this rulemaking by

[[Page 35900]]

submitting written views, opinions, recommendations, and data. Comments 
received, including attachments and other supporting materials, are 
part of the public record and subject to public disclosure.
    Specifically, HHS/CDC seeks 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. Please note when considering this 
question that HHS/CDC is not requesting comment on the statutory 
language itself as HHS/CDC does not have the authority to alter 
statutory language. Rather, we are 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. CDC is 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 the convening of a medical review board 
and reexamination of an alien by a medical review board should be 
revised as proposed in this regulation.
    Do not include any information in your comment or supporting 
materials that you do not wish to be disclosed publicly.

II. Legal Authority

    HHS/CDC is proposing these revisions under the authority of 42 
U.S.C. 252 and 8 U.S.C. 1182 and 1222.

III. Background

A. Inadmissibility and the Medical Examination

    Under section 212(a)(1) of the Immigration and Nationality Act 
(INA) (8 U.S.C. 1182(a)(1)), any alien who is determined to have a 
communicable disease of public health significance is inadmissible to 
the United States. As a result of this statute, aliens outside of the 
United States who have a communicable disease of public health 
significance are ineligible to receive a visa for admission into the 
United States, absent the grant of a waiver. Aliens within the United 
States who have a communicable disease of public health significance 
are also ineligible to adjust their status to that of a lawful 
permanent resident, absent the grant of a waiver.
    In addition to other potential grounds of inadmissibility, an alien 
is inadmissible if he/she is determined: (1) To have a communicable 
disease of public health significance (as currently defined by 
regulations); (2) to pose, or has posed, a threat to the property, 
safety, or welfare of the alien or others; (3) to have had a history of 
behavior, which has posed a threat to the property, safety, or welfare 
of the alien or others and which is likely to recur or lead to other 
harmful behavior; or (4) to be a drug abuser or addict.
    At present, except for certain adopted children 10 years of age or 
younger, HHS/CDC requires any alien seeking admission as an immigrant 
or seeking adjustment of status to that of a lawful permanent resident, 
to present documentation of vaccination against all vaccine-preventable 
diseases explicitly listed in section 212(a)(1)(A)(ii) of the INA 
(mumps, measles, rubella, polio, tetanus and diphtheria toxoids, 
pertussis, Haemophilus influenzae type B, hepatitis B), and for all 
other vaccinations recommended by the Advisory Committee for 
Immunization Practices (ACIP) for which a public health need exists at 
the time of immigration or adjustment of status.
    To allow HHS/CDC to adapt vaccination requirements for U.S. 
immigrants based on public health needs, on April 8, 2009, HHS/CDC 
published a notice in the Federal Register (74 FR 15986) seeking public 
comment on 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. The 
proposed criteria are as follows: The vaccine must be an age-
appropriate vaccine as recommended by the ACIP for the general U.S. 
population, and at least one of the following: (i) The vaccine must 
protect against a disease that has the potential to cause an outbreak; 
or (ii) the vaccine must protect against a disease that has been 
eliminated in the United States or is in the process for elimination in 
the United States. HHS/CDC received public comment on these criteria 
and after review and consideration, published a final notice on 
November 13, 2009, adopting the proposed criteria (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 list of the 
ACIP vaccine recommendations for the U.S. general public can be found 
at https://www.cdc.gov/vaccines/hcp/acip-recs/, and the list 
of HHS/CDC required vaccines for immigration purposes can be found at 
https://www.cdc.gov/immigrantrefugeehealth/exams/ti/panel/vaccination-panel-technical-instructions.html#tbl1. As more vaccines become 
available, HHS/CDC will continue to apply these criteria to respond to 
the ACIP vaccination recommendations.
    Any changes to the list of required vaccines, which result from an 
application of these criteria, will be reflected in HHS/CDC's Technical 
Instructions, available to the public at https://www.cdc.gov/immigrantrefugeehealth/exams/ti/. While HHS/CDC is not 
seeking additional comment on these previously published vaccination 
criteria at this time, we are requesting comment on incorporating the 
reference to these criteria in this regulation. 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.
    The Secretary of Health and Human Services (HHS) is authorized to 
promulgate regulations establishing the requirements for the medical 
examination of aliens by sections 212(a)(1) and 232 of the INA and 
section 325 of the Public Health Service Act (42 U.S.C. 252). The 
regulations, administered by HHS/CDC, are promulgated at 42 CFR part 
34. Under

[[Page 35901]]

current 42 CFR part 34, an alien seeking permanent residence prior to 
arrival into the U.S. or through an adjustment of status while in the 
U.S., must undergo a medical examination to determine whether the alien 
is inadmissible on medical grounds.
    HHS/CDC issues Technical Instructions that provide the technical 
consultation and guidance to panel physicians and civil surgeons who 
conduct the medical examinations of aliens. Panel physicians, 
designated by the U.S. Department of State (DOS), perform medical 
examinations on those aliens living outside the United States who are 
seeking to immigrate to the United States. Civil surgeons, designated 
by the U.S. Citizenship and Immigration Services (USCIS) within the 
U.S. Department of Homeland Security (DHS), perform medical 
examinations for aliens who are already present in the United States 
and are seeking adjustment of status. The CDC Technical Instructions 
for Medical Examination of Aliens, including the most current updates 
that panel physicians and civil surgeons must follow in accordance with 
these regulations, are available to the public on the CDC Web site, 
located at the following Internet address: https://www.cdc.gov/immigrantrefugeehealth/exams/ti/.

B. Applicability of Part 34

    The provisions in 42 CFR part 34 apply to the medical examination 
of (1) aliens outside the United States who are applying for a visa at 
an embassy or consulate of the United States; (2) aliens arriving in 
the United States; (3) aliens required by DHS to have a medical 
examination in connection with determination of their admissibility 
into the United States; and (4) aliens who apply for adjustment of 
their immigration status to that of lawful permanent resident. While 42 
CFR part 34 can apply to individuals who wish to come to the United 
States to visit, such as leisure or business travelers, a medical 
examination is not routinely required as a condition for issuance of 
non-immigrant visas or entry into the United States.
    Annually, DHS admits more than 1 million aliens to reside 
permanently in this country (24). Foreign citizens who wish to live 
permanently in the United States must comply with U.S. immigration law 
and specific procedures for applying for an immigrant visa or 
adjustment of status. These applicants are also subject to the medical 
grounds of inadmissibility. The four main immigrant visa 
classifications are: (1) Immediate Relatives, that is, the spouse, 
child (unmarried and under 21 years of age) or parent of a U.S. citizen 
(a citizen must be at least 21 years old to file a petition for a 
parent); (2) Family-Based immigrants (adult sons or daughters of 
citizens, the siblings of citizens who are at least 21 years old, and 
the spouse, child, or adult sons or daughters of lawful permanent 
residents); (3) Employment-Based immigrants; and (4) Diversity 
immigrants who obtain by lottery the ability to seek an immigrant visa.
    Refugees and asylees may also apply to adjust to permanent resident 
status from inside the United States. INA section 209; 8 U.S.C. 1159. 
Section 101(a)(42)(A) of the INA generally defines refugees and asylees 
as persons who cannot return to their country because of persecution or 
the well-founded fear of persecution based on race, religion, 
nationality, membership in a particular social group, or political 
opinion. A refugee applicant is preliminarily approved for refugee 
status overseas, but is admitted as a refugee upon admission to the 
United States at a port of entry. An asylee applicant is approved for 
asylum from within the United States and is not required to undergo a 
medical examination as part of the application process until he/she 
seeks adjustment of status. See INA 208 and 8 CFR part 208. A refugee 
is subject to the medical grounds of inadmissibility and the medical 
examination requirements. A refugee is not subject to the vaccination 
requirements until he/she seeks adjustment of status. See INA section 
207; 8 U.S.C. 1157; 8 CFR part 207.
    An additional immigration category under the INA is Temporary 
Protected Status (TPS). This applies to persons who are in the United 
States lawfully, though temporarily, as a result of ongoing armed 
conflict, natural disasters, or certain other extraordinary and 
temporary conditions, and whose countries have been designated as TPS 
countries under INA section 244; 8 U.S.C. 1255a; 8 CFR part 244. TPS 
applicants are also subject to the medical grounds of inadmissibility.

C. Legislative and Regulatory History of Part 34

    Beginning in 1952, the language of the 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. 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), which proposed 
two regulatory changes: 1) The removal

[[Page 35902]]

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, that removed HIV 
infection and testing for HIV infection from part 34 regulations. 74 FR 
31798 and 73 FR 56547.
    Through today's NPRM, HHS/CDC is soliciting public comment on the 
definition of communicable disease of public health significance and 
the revised scope of medical examination which were initially 
promulgated as an interim final rule in 2008. Specifically, in addition 
to the previously updated language, HHS/CDC proposes to further revise 
the definition of communicable disease of public health significance by 
removing these three uncommon health conditions: chancroid; granuloma 
inguinale; and lymphogranuloma venereum. This definition is now 
proposed to include (1) quarantinable diseases designated by 
Presidential Executive Order; (2) a communicable disease that may pose 
a public health emergency of international concern in accordance with 
the IHR of 2005; and (3) gonorrhea, infectious Hansen's disease, 
infectious syphilis, and active tuberculosis.
    HHS/CDC is not proposing to remove active tuberculosis from the 
definition of a communicable disease of public health significance. At 
this time, HHS/CDC is not proposing to remove infectious leprosy, 
gonorrhea, or syphilis from the definition but is proposing to replace 
the term ``infectious leprosy'' with ``infectious Hansen's disease'' 
and to modify ``syphilis, infectious stage'' to simply ``syphilis, 
infectious'' to reflect modern terminology. HHS/CDC will accept public 
comment on whether these three diseases should remain or be removed 
from the definition of communicable disease of public health 
significance. HHS/CDC's rationale for maintaining these three diseases 
is that continuing to screen for and treat these diseases, when 
identified in aliens, provides a public health benefit to the United 
States as well as a personal 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 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.

IV. Rationale for Proposed Regulatory Action

    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 NPRM, HHS/CDC proposes to update 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 proposing to update part 34 so that the text 
accurately reflects the statutory and administrative changes that have 
occurred within the Federal Government regarding agencies and/or 
departments responsible for this process. These updates 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 analysis of the proposed 
changes for which HHS/CDC is seeking public comment:

A. 34.1 Applicability

    HHS/CDC is proposing to replace 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.

B. Section 34.2 Definitions

    Current section 34.2 entitled ``Definitions'' provides information 
regarding the intent of HHS/CDC regarding certain terms that are used 
in the regulation. While HHS/CDC is not proposing to revise all of the 
current terms and definitions, such as medical examiner, we welcome 
comment on the use of these terms and its definitions. HHS/CDC is 
proposing to revise the definitions section as specifically described 
below.
    HHS/CDC proposes to revise 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. To help guide the reader, we have 
provided a chart to indicate which text is proposed to change and is 
therefore subject to comments from the public.

  Current Definitions and Corresponding Proposed Changes in Definitions
                             within the NPRM
------------------------------------------------------------------------
                                          Corresponding, new, or updated
     Definitions in 42 CFR part 34            definition within NPRM
------------------------------------------------------------------------
CDC. Centers for Disease Control,        CDC. Centers for Disease
 Public Health Services, U.S.             Control and Prevention, U.S.
 Department of Health and Human           Department of Health and Human
 Services.                                Services.

[[Page 35903]]

 
Communicable disease of public health    Communicable disease of public
 significance. Any of the following       health significance. Any of
 diseases:                                the following diseases:
(1) Chancroid..........................  (1) Communicable diseases as
(2) Communicable diseases as listed in    listed in a Presidential
 a presidential Executive Order, as       Executive Order, as provided
 provided under Section 361(b) of the     under Section 361(b) of the
 Public Health Service Act. The current   Public Health Service Act. The
 revised list of quarantinable            current revised list of
 communicable diseases is available at    quarantinable communicable
 https://www.cdc.gov and https://           diseases is available at http:/
 www.archives.gov/federal-register.       /www.cdc.gov and https://
(3) Communicable diseases that may pose   www.archives.gov/federal-
 a public health emergency of             register.
 international concern if it meets one   (2) Communicable diseases that
 or more of the factors listed in in      may pose a public health
 Sec.   34.3(d) and for which the CDC     emergency of international
 Director has determined (A) a threat     concern if it meets one or
 exists for importation into the United   more of the factors listed in
 States, and (B) such disease may         in Sec.   34.3(d) and for
 potentially affect the health of the     which the CDC Director has
 American public. The determination       determined (A) a threat exists
 will be made consistent with criteria    for importation into the
 established in Annex 2 of the revised    United States, and (B) such
 International Health Regulations         disease may potentially affect
 (https://www.who.int/csr/ihr/en/), as     the health of the American
 adopted by the Fifty-Eighth World        public. The determination will
 Health Assembly in 2005, and as          be made consistent with
 entered into effect in the United        criteria established in Annex
 States in July, 2007. Subject to the     2 of the revised International
 U.S. Government's reservation and        Health Regulations (https://
 understandings:.                         www.who.int/csr/ihr/en/), as
(i) Any of the communicable diseases      adopted by the Fifty-Eighth
 for which a single case requires         World Health Assembly in 2005,
 notification to the World Health         and as entered into effect in
 Organization (WHO) as an event that      the United States in July,
 may constitute a public health           2007. Subject to the U.S.
 emergency of international concern,      Government's reservation and
 or,.                                     understandings:
(ii) Any other communicable disease the  (i) Any of the communicable
 occurrence of which requires             diseases for which a single
 notification to the WHO as an event      case requires notification to
 that may constitute a public health      the World Health Organization
 emergency of international concern.      (WHO) as an event that may
 HHS/CDC's determinations will be         constitute a public health
 announced by notice in the Federal       emergency of international
 Register.                                concern, or,
(4) Gonorrhea..........................  (ii) Any other communicable
(5) Granuloma inguinale................   disease the occurrence of
(6) Leprosy, infectious................   which requires notification to
(7) Lymphogranuloma venereum...........   the WHO as an event that may
(8) Syphilis, infectious stage.........   constitute a public health
(9) Tuberculosis, active...............   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.
Civil surgeon. A physician, with not     Civil surgeon. A physician
 less than 4 years' professional          selected by DHS to conduct
 experience, selected by the District     medical examinations of aliens
 Director of INS to conduct medical       in the United States who are
 examinations of aliens in the United     applying for adjustment of
 States who are applying for adjustment   status to permanent residence
 of status to permanent residence or      or who are required by DHS to
 who are required by the INS to have a    have a medical examination.
 medical examination.
Class A medical notification...........  Class A medical notification.
(1) A communicable disease of public     (1) A communicable disease of
 health significance;                     public health significance;
(2)(i) A physical or mental disorder     (2) A failure to present
 and behavior associated with the         documentation of having
 disorder that may pose, or has posed,    received vaccination against
 a threat to the property, safety, or     ``vaccine-preventable
 welfare of the alien or others;          diseases'' for an alien who
(ii) A history of a physical or mental    seeks admission as an
 disorder and behavior associated with    immigrant, or who seeks
 the disorder, which behavior has posed   adjustment of status to one
 a threat to the property, safety, or     lawfully admitted for
 welfare of the alien or others and       permanent residence, which
 which behavior is likely to recur or     shall include at least the
 lead to other harmful behavior; or.      following diseases: mumps,
(3) Drug abuse or addiction............   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 Advisory
                                          Committee on 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 disorder and
                                          behavior that may pose, or has
                                          posed, a threat to the
                                          property, safety, or welfare
                                          of the alien or others;
                                         (ii) A history of 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.
Class B medical notification. Medical    Class B medical notification.
 notification of a physical or mental     Medical notification of a
 health condition, disease, or            physical or mental health
 disability serious in degree or          condition, disease, or
 permanent in nature amounting to a       disability serious in degree
 substantial departure from normal well-  or permanent in nature.
 being.
                                         DHS. U.S. Department of
                                          Homeland Security.

[[Page 35904]]

 
Director. The Director of the Centers    Director. The Director, Centers
 for Disease Control.                     for Disease Control and
                                          Prevention, Department of
                                          Health and Human Services, or
                                          another authorized
                                          representative as approved by
                                          the CDC Director or the
                                          Secretary.
Drug abuse. The non-medical use of a     Drug abuse. Current substance
 substance listed in section 202 of the   use disorder or substance-
 Controlled Substances Act, as amended    induced disorder, mild, as
 (21 U.S.C. 802) which has not            defined in the current edition
 necessarily resulted in physical or      of the Diagnostic and
 psychological dependence.                Statistical Manual for Mental
                                          Disorders (DSM) published by
                                          the American Psychiatric
                                          Association, or in another
                                          authoritative source as
                                          approved by the Director, of a
                                          substance listed in Section
                                          202 of the Controlled
                                          Substances Act, as amended (21
                                          U.S.C. 802).
Drug addiction. The non-medical use of   Drug addiction. Current
 a substance listed in section 202 of     substance use disorder or
 the Controlled Substances Act, as        substance-induced disorder,
 amended (21 U.S.C. 802) which has        moderate or severe as defined
 resulted in physical or psychological    in the current edition of the
 dependence.                              Diagnostic and Statistical
                                          Manual for Mental Disorders
                                          (DSM) published by the
                                          American Psychiatric
                                          Association, or in another
                                          authoritative source as
                                          approved by the Director, of a
                                          substance listed in Section
                                          202 of the Controlled
                                          Substances Act, as amended (21
                                          U.S.C. 802).
                                         HHS. U.S. Department of Health
                                          and Human Services
INS. Immigration and Naturalization      Definition Removed.
 Service, U.S. Department of Justice.
Medical examiner. A panel physician,     No change.
 civil surgeon, or other physician
 designated by the Director to perform
 medical examination of aliens.
Medical hold document. A document        Medical hold document. A
 issued to the INS by a quarantine        document issued to DHS by a
 inspector of the Public Health Service   quarantine officer of HHS/CDC
 at a port of entry, which defers the     at a port of entry, which
 inspection for admission until the       defers the inspection for
 cause of the medical hold is resolved.   admission until the cause of
                                          the medical hold is resolved.
Medical notification. A document issued  Medical notification. A
 to a consular authority or the INS by    document issued to a consular
 a medical examiner, certifying the       authority or DHS by a medical
 presence or absence of:                  examiner, certifying the
(1) A communicable disease of public      presence or absence of:
 health significance;.                   (1) A communicable disease of
(2)(i) A physical or mental disorder      public health significance;
 and behavior associated with the        (2) Documentation of having
 disorder that may pose, or has posed,    received vaccination against
 a threat to the property, safety, or     ``vaccine-preventable
 welfare of the alien or others;.         diseases'' for an alien who
(ii) A history of a physical or mental    seeks admission as an
 disorder, which behavior has posed a     immigrant, or who seeks
 threat to the property, safety, or       adjustment of status to one
 welfare of the alien or others and       lawfully admitted for
 which behavior is likely to recur or     permanent residence, which
 lead to other harmful behavior;.         shall include at least the
(3) Drug abuse or addiction; or........   following diseases: mumps,
(4) Any other physical abnormality,       measles, rubella, polio,
 disease, or disability serious in        tetanus and diphtheria
 degree or permanent in nature            toxoids, pertussis,
 amounting to a substantial departure     Haemophilus influenza type B,
 from normal well-being.                  and hepatitis B, and any other
                                          vaccinations against vaccine-
                                          preventable diseases
                                          recommended by the Advisory
                                          Committee on 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 behavior that may
                                          pose, or has posed, a threat
                                          to the property, safety, or
                                          welfare of the alien or
                                          others;
                                         (ii) A history of a 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;
                                         (5) Any other physical or
                                          mental condition, disease or
                                          disability serious in degree
                                          or permanent in nature.
Medical officer. A physician of the      Medical officer. A physician
 Public Health Service Commissioned       assigned by the Director to
 Corps assigned by the Director to        conduct physical and mental
 conduct physical and mental              examinations of aliens on
 examinations of aliens.                  behalf of HHS/CDC.
Mental disorder. A currently accepted    Mental disorder. A currently
 psychiatric diagnosis, as defined by     accepted psychiatric
 the Diagnostic and Statistical Manual    diagnosis, as defined by the
 of Mental Disorders published by the     most recent version of the
 American Psychiatric Association, or     Diagnostic and Statistical
 by other authoritative sources.          Manual of Mental Disorders
                                          (DSM) published by the
                                          American Psychiatric
                                          Association, or by other
                                          authoritative sources as
                                          approved by the Director.
Panel physician. A physician selected    No change.
 by a United States embassy or
 consulate to conduct medical
 examinations of aliens applying for
 visas.
Physical disorder. A currently accepted  Physical disorder. A currently
 medical diagnosis, as defined by the     accepted medical diagnosis, as
 Manual of the International              defined by the most recent
 Classification of Diseases, Injuries,    version of the Manual of the
 and Causes of Death published by the     International Classification
 World Health Organization, or by other   of Diseases (ICD), Injuries,
 authoritative sources.                   and Causes of Death published
                                          by the World Health
                                          Organization, or by other
                                          authoritative sources as
                                          approved by the Director.
------------------------------------------------------------------------


[[Page 35905]]

Section 34.2(a) CDC
    We are proposing to update the definition of CDC 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 
are removing ``Public Health Services'' from the definition.
Section 34.2(b) Communicable Disease of Public Health Significance
    This provision 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. 
HHS/CDC is proposing to remove 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).
    HHS/CDC uses epidemiological principles and current medical 
practice to assess and revise the list of diseases defined as a 
communicable disease of public health significance. Guided by such 
principles and practice, HHS/CDC believes that these three sexually 
transmitted infections no longer pose such a significant threat to the 
general U.S. population, that aliens with these infections should not 
be denied admission to the United States. The three bacterial 
infections (chancroid, granuloma inguinale and lymphogranuloma 
venereum), all primarily transmitted through sexual contact, have never 
been common in the United States and over the past two decades have 
been observed to be increasingly rare throughout the world (6, 8). Of 
the three bacterial infections, only laboratory-diagnosed cases of 
chancroid are reportable conditions in the United States, and since 
2005 fewer than 30 chancroid cases annually were reported to CDC from 
the U.S. states and territories (6-22).
    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 HHS/CDC by clinicians and public 
health departments. 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 are 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). 
Additionally, cases of lymphogranuloma venereum are increasingly rare 
among women. Although sporadic small outbreaks of lymphogranuloma 
venereum have occurred over the past 10 years, these have been almost 
exclusively among men who have sex with men, with disease generally 
manifested as severe proctitis (inflammation of the anus or rectum) 
(18-20).
    Internationally, most countries do not track any of the three 
infections; however, the few publications and records available suggest 
case rates have declined worldwide over the past 50 years. Declining 
rates of these conditions are likely due to a variety of factors. 
Improved living conditions, better sanitation (e.g., availability of 
soap and water), condom use, and educational efforts are all believed 
to be important factors (6, 21-23) contributing to the decline in the 
incidence of these infections. Improved recognition by physicians and 
treatment based on clinical presentation of sexually transmitted 
infections, coupled with treatment of sexual partners, also appears to 
be important in their decline. Increased antibiotic usage for treatment 
of other unrelated conditions may have contributed to the declining 
incidence of these infections. Additionally, HIV prevention strategies 
such as male circumcision may be playing a role, although definitive 
studies of this effect are still pending.
    Given the low burden of these three infections globally, the 
potential introduction of additional cases into the United States by 
aliens is likely to have a negligible impact on the U.S. population for 
several reasons. As mentioned, these primarily tropical infections can 
be prevented through improved personal hygiene (11); protected sex (use 
of a condom); and treatment of sexual partners. Such infections can be 
effectively treated and cured with relatively uncomplicated courses of 
antibiotic therapy. None of the three infections is associated with 
excess mortality (premature death); and most cases do not lead to 
serious long term consequences, disability or excessive medical costs.
    After careful consideration of epidemiological principles and 
current medical practice, scientific evidence indicates that chancroid, 
granuloma inguinale, and lymphogranuloma venereum do not represent a 
significant risk for introduction, transmission, and spread from 
foreign countries to the United States population. Therefore, HHS/CDC 
proposes to remove these three diseases from the specific list of 
communicable disease of public health significance and is seeking 
public comment on this proposal.
Section 34.2(c) Civil Surgeon
    Civil Surgeon is currently defined as a ``physician, with not less 
than 4 years professional experience, selected by the District Director 
of INS 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 the INS to have a medical examination.'' HHS/CDC is 
proposing to remove 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 DHS 
regulations in 8 CFR part 232. HHS/CDC also proposes to remove ``with 
not less than 4 years' professional experience'' from the definition of 
civil surgeon. Through complimentary regulations promulgated by DHS at 
8 CFR 232, the requirement of 4 years' professional experience for 
civil surgeons will remain in effect. We are proposing this change 
because DHS is responsible for designating civil surgeons and should 
therefore have the discretion to determine the necessary prerequisites 
for that position. Thus, CDC is simply proposing to remove a redundancy 
found in its regulations and is not affecting a substantive change in 
policy. HHS/CDC will continue to consult with DHS/USCIS as needed, 
regarding recommendations for civil surgeon requirements. Therefore, 
HHS/CDC is proposing civil surgeon to mean 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 proposing to amend 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. HHS/CDC is proposing to 
update part 34 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

[[Page 35906]]

will not change current practices, but is a reflection of updated 
statutory language. As noted above, HHS/CDC is not authorized to change 
statutory requirements; thus, CDC is not requesting comment on the 
statutory language, but on the advisability of incorporating statutory 
language into regulations. Additionally, CDC seeks to incorporate and 
is requesting comment on its understanding that the statutory 
requirement for proof of vaccination in regard to ACIP-recommended 
vaccines only applies to those vaccines that are appropriate in an 
immigration context and for which a public health need exists at the 
time of immigration or adjustment of status.
    The proposed 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 
will not change current practices, but is a reflection of updated 
statutory language. Again, because HHS/CDC is not authorized to change 
statutory requirements, HHS/CDC is not requesting comment on the 
statutory language, but will accept comment on the advisability of 
incorporating statutory language into regulations. HHS/CDC believes 
that the inclusion of statutory language promotes greater transparency 
and a better understanding of immigration requirements. For further 
information, please visit: https://www.uscis.gov/ilink/docView/SLB/HTML/SLB/0-0-0-1/0-0-0-29/0-0-0-2006.html.
Section 34.2(f) Director
    We are proposing to update the definition of Director to reflect 
the current official title of the CDC Director, as well as his/her 
delegation authorities. Therefore, the definition of Director is 
proposed as: the Director, Centers for Disease Control and Prevention, 
Department of Health and Human Services, or another authorized 
representative as approved by the CDC Director or the Secretary.
Section 34.2(g) DHS
    We are proposing to add 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. The definition of DHS is 
proposed as: U.S. Department of Homeland Security.
Section 34.2(h) Drug Abuse and Section 34.2(i) Drug Addiction
    HHS/CDC is proposing to revise the definitions of drug abuse and 
drug addiction by aligning with the definitions of ''substance use 
disorders'' and ``substance-induced disorders,'' with the definitions 
provided by the Diagnostic and Statistical Manual for Mental Disorders 
(DSM) published by the American Psychiatric Association (25). HHS/CDC 
is taking this approach because the DSM is the medical standard for the 
diagnosis of mental disorders and substance-related disorders. The DSM 
provides current diagnostic criteria based on the latest available 
evidence. As such, HHS/CDC is proposing drug abuse and drug addiction 
to mean ``current substance use disorders or substance-induced 
disorders'' as defined in the current edition of the DSM, or in another 
authoritative source as approved by the Director, of a substance listed 
in Section 202 of the Controlled Substances Act, as amended (21 U.S.C. 
802). These proposed updated definitions are not a substantive change, 
as it is the current practice of HHS/CDC to use the definitions found 
in the DSM. In the unlikely event that another authoritative source 
becomes more appropriate than the DSM, HHS/CDC would issue a notice in 
the Federal Register, update our Web site, and list the source in our 
technical instructions. We would not pursue notice and comment 
rulemaking unless the reliance on a new source resulted in a 
substantive change in CDC operations or policy.
Section 34.2(k) Medical Hold Document
    HHS/CDC is proposing to update 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.'' HHS/CDC is proposing these changes to reflect 
the current Federal agency and position names and respective 
responsibilities and is not seeking public comment on these non-
substantive changes.
Section 34.2(l) Medical Notification
    The medical notification is a medical examination document issued 
to a consular authority or to DHS by a medical examiner following 
examination of an applicant for immigration for inadmissible 
conditions. HHS/CDC is proposing to amend 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. HHS/CDC is proposing this addition to update 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 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, 
is proposed to mean a medical examination document issued to a consular 
authority or the DHS by a medical examiner that will include 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 there is a public health 
need at the time of immigration or adjustment of status.''
Section 34.2(m) Medical Officer
    HHS/CDC is proposing to remove ``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. Removing 
this requirement will best protect public health by broadening the pool 
of medical professionals qualified and available to provide alien 
examination services since there are a limited number of physicians 
within the Public Health Service Commissioned Corps.

[[Page 35907]]

Section 34.2(n) Mental Disorder and 34.2(p) Physical Disorder
    HHS/CDC is proposing to clarify 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. HHS/CDC is 
proposing to add ``most recent'' to qualify the version of the DSM 
referenced in this definition and clarify the intent of CDC that such 
diagnoses align with current science and medical practice. HHS/CDC is 
also allowing for the possibility of other authoritative sources in 
order to rely on the most recent medical science.
    HHS/CDC is proposing 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 
proposing to add ``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 is also allowing for the possibility of 
other authoritative sources in order to rely on the most recent medical 
science. In the event that another authoritative source is determined 
to be more appropriate for immigration medical examination purposes, 
HHS/CDC will issue updated technical instructions. Again, these are not 
substantive changes to the regulation as they follow current HHS/CDC 
practice and protocol.

ii. Section 34.3 Scope of Examinations

    Current section 34.3 entitled ``Scope of Examinations'' 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 Section 34.2(b) of 42 CFR part 34. HHS/
CDC is proposing to further update this section to incorporate 
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 subsection (a)(2)(i), we are also proposing to insert 
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)
    HHS/CDC is proposing to revise 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. HHS/CDC is proposing this change 
as previously described in proposed changes to 34.2 Definitions.
Specific Proposed Revisions to Section 34.3(e)
    HHS/CDC is proposing to amend 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. HHS/CDC has added Sec.  34.3(e)(1)(v) ``Applicants 
required by the DHS to have a medical examination in connection with 
the determination of their admissibility into the United States.''
    HHS/CDC is proposing 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.
    HHS/CDC is proposing to amend 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 HHS/CDC 
has included language to allow the Director to test for other 
communicable diseases of public health significance (as defined) 
through technical instructions.
    HHS/CDC is proposing to amend Sec.  34.3(e)(3)(i) and (ii) to 
reflect the scope of currently available medical tests. HHS/CDC 
proposes to replace ``positive tuberculin reaction'' with ``positive 
test of immune response to Mycobacterium tuberculosis antigens'' in 
Sec.  34.3(e)(3)(i) and (ii).
    To allow HHS/CDC discretion to apply appropriate medical screening 
procedures, HHS/CDC is proposing to amend Sec.  34.3(e)(3)(iii) and 
(iv) regarding application of tests of immune response by adding ``as 
determined by the Director.''
    To allow for additional testing in medically appropriate 
circumstances, HHS/CDC is proposing to revise 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,'' replacing ``shall'' with ``may,'' and adding ``based on 
medical evaluation.'' HHS/CDC is proposing this revision to read: ``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, HHS/CDC is 
also proposing to amend Sec.  34.3(b)(2) by adding ``or other relevant 
records'' to ensure that all appropriate available medical 
documentation may be considered. HHS/CDC is proposing this revision to 
read: ``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.''
    HHS/CDC has included language under Sec.  34.3(f), transmission of 
records, to ensure that electronic submissions may be acceptable as 
provided by the Director. Finally, HHS/CDC is proposing to amend Sec.  
34.3(g)(4) by replacing ``excludable'' with ``inadmissible'' in Sec.  
34.3(g)(4) to reflect modern terminology.

iii. Section 34.4 Medical Notifications

    HHS/CDC proposes to revise 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 to reference criteria 
established by CDC and published in Federal Register Notices to 
determine which vaccines recommended by the ACIP will be required for 
U.S. immigration. In addition, HHS/CDC is proposing to add specific 
language regarding the exemption of vaccination requirements for an 
adopted child as provided in section 212 of the INA. Again, these 
changes are not substantive, but reflect current practice and statutory 
language.

iv. Section 38.7 Medical and Other Care; Death

    Under this section, HHS/CDC proposes to replace ``INS'' with 
``DHS'' and replace ``Public Health Services'' with ``HHS'' to reflect 
modern agency titles and appropriate authorities relating to this 
provision. Although HHS/CDC is not proposing to make any

[[Page 35908]]

substantive changes to Sec.  38.7, we will accept public comment on 
updating this section to reflect modern terminology.

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

    Review boards are convened by the Director to reexamine aliens at 
the request of DHS and upon appeal to DHS by an alien certified as 
having a Class A condition. HHS/CDC is proposing changes to this 
section to clarify the reexamination and review board's process and 
improve the expediency of the process. The proposed changes 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 will be 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, HHS/CDC is proposing to add failure to present documented 
proof of having been vaccinated against vaccine preventable diseases as 
a basis for reexamination by the review board and add clarifying 
language that the reexamination may be conducted, at the board's 
discretion, based on the written record.
    By removing the requirement that one medical officer must be a 
board-certified psychiatrist, HHS/CDC will be able to more easily and 
efficiently comprise the board of case-specific specialists. Removing 
the requirement for a board-certified psychiatrist also allows the 
agency to expedite the review board's convening in circumstances where 
a medical officer who is a board certified psychiatrist is unavailable. 
By tailoring the board to meet the needs of the alien, HHS/CDC will 
ensure that the alien has the attention of medical officers who are 
experienced in the diagnosis and treatment of their specific medical 
condition.

V. Alternatives Considered

    This rulemaking is the result of HHS/CDC's annual retrospective 
regulatory review. Most of the proposed changes 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, 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 proposes to 
revise the definition of communicable disease of public health 
significance by removing these three uncommon health conditions: 
chancroid; granuloma inguinale; and lymphogramuloma venereum. We 
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 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 proposed 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 proposed rule. First, we are 
proposing updates to the current regulation that 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 are proposing to remove 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 
extremely 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.
    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

[[Page 35909]]

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 the 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 the 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 EO 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 and 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. None of the 
results are economically significant, e.g., none of the results are 
more than $100 million a year in costs.

    Table 1--Annual Costs of Chancroid, Granuloma Inguinale, and Lymphogranuloma Venereum in Lawful Permanent
                 Residents: LOW, HIGH, and EXTREMELY HIGH Caseload Alternatives, in 2013 Dollars
----------------------------------------------------------------------------------------------------------------
                                                                               Alternatives
 Notes: (1) Per-case cost $263.51. (2) Assumes LPRs are --------------------------------------------------------
               0.4% of total population.                  LOW (less than 1
                                                            case a year)           HIGH          EXTREMELY HIGH
----------------------------------------------------------------------------------------------------------------
LPR Total Annual Costs 50% comorbidity.................                $18             $2,122            $12,731
LPR Total Annual Costs NO comorbidity..................                 33              3,858             23,147
----------------------------------------------------------------------------------------------------------------

    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.

[[Page 35910]]



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


     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
----------------------------------------------------------------------------------------------------------------
                                                                                               Source  citation
            Category              Primary  estimate    Minimum  estimate   Maximum  estimate    (RIA, preamble,
                                                                                                     etc.)
----------------------------------------------------------------------------------------------------------------
BENEFITS:
    Monetized benefits.........  NA (7%)............  NA (7%)...........  NA (7%)...........  RIA.
                                 NA (3%)............  NA (3%)...........  NA (3%)...........
                                 NA (0%)............  NA (0%)...........  NA (0%)...........
    Annualized quantified, but   None...............  N/A...............  N/A...............  RIA.
     unmonetized, benefits.
                                -------------------------------------------------------------
    Qualitative (unquantified       The physicians administering the exam will be able to     RIA.
     benefits).                   devote more time and training to other, more common and/or
                                                  more serious health issues.
                                -------------------------------------------------------------
COSTS:
    Annualized monetized costs   NA (7%)............  NA (7%)...........  NA (7%)...........  RIA.
     (discount rate in
     parenthesis) \a\.
                                 NA (3%)............  NA (3%)...........  NA (3%)...........
                                 $3,858 (0%)........  18 (0%)...........  $23,147 (0%)......
    Annualized quantified, but   None...............  N/A...............  N/A...............  RIA.
     unmonetized, costs.
                                -------------------------------------------------------------
    Qualitative (unquantified)                               None                             RIA.
     costs.
----------------------------------------------------------------------------------------------------------------
\a\ All costs of the rule are annual.

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 proposed rule on small businesses, small governmental 
units, and small not-for-profit organizations. We have analyzed the 
costs and benefits of this proposed 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 do expect this proposed 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.

D. National Environmental Policy Act (NEPA)

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

[[Page 35911]]

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 proposed rule meets the 
standard in the Executive Order.

F. Executive Order 13132: Federalism

    Under Executive Order 13132, if the proposed 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 proposed 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 proposing this 
rule to make our intentions and rationale clear and welcomes feedback 
from the public on our attempt to use plain language in this rule.

VIII. 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). https://www.archives.gov/federal-register/executive-orders/pdf/12866.pdf. Accessed February 
2014.
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). https://www.gpo.gov/fdsys/pkg/FR-2011-01-21/pdf/2011-1385.pdf. Accessed 
February 2014.
3. U. S. Small Business Administration. Regulatory Flexibility Act. 
https://www.sba.gov/advocacy/823. Accessed February 2014.
4. Summary of the Unfunded Mandates Reform Act. 2 U.S.C. 1501 et seq 
(1995). https://www2.epa.gov/laws-regulations/summary-unfunded-mandates-reform-act. Accessed February 2014.
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: https://wonder.cdc.gov/std-v2008.html. Accessed 
February 2014.
7. New York State Department of Health. Bureau of Sexually 
Transmitted Disease Prevention and Epidemiology. STD Statistical 
Abstract 2008. https://www.health.state.ny.us/statistics/diseases/communicable/std/abstracts/docs/2008.pdf Accessed February 2014.
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. https://www.nlm.nih.gov/medlineplus/ency/article/000636.htm. Accessed February 2014.
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: https://www.cdc.gov/std/treatment/2010/genital-ulcers.htm. Accessed February 2014.
18. CDC. Treatment of Sexually Transmitted Diseases. Diseases 
characterized by genital ulcers--Lymphogranuloma Venereum. 2011. 
Available from: https://www.cdc.gov/std/treatment/2010/genital-ulcers.htm. Accessed February 2014.
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. Available from: https://www.who.int/hiv/pub/sti/en/who_hiv_aids_2001.02.pdf. Accessed February 2014
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), Ninth 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 
proposes to amend 42 CFR part 34 as follows:

0
1. Revise 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.


Sec.  34.2  Definitions.

    As used in this part, terms shall have the following meanings:

[[Page 35912]]

    (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 https://www.cdc.gov and https://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) a threat 
exists for importation into the United States, and (B) 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 
revised International Health Regulations (https://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 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 the 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 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 addiction; or

[[Page 35913]]

    (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.  34.2(b)(1) and (b)(4) through (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.  34.2(b)(2) 
and (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: https://www.cdc.gov/ncidod/dq/technica.htm and https://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; and
    (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 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

[[Page 35914]]

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 the 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 old 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 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

[[Page 35915]]

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 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 
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

[[Page 35916]]

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:
    (i) 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;
    (ii) 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;
    (iii) 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 option, 
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: June 12, 2015.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2015-15236 Filed 6-22-15; 8:45 am]
 BILLING CODE 4150-28-P