[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: http://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Division of Global Migration and Quarantine, Centers
for Disease Control and Prevention, 1600 Clifton Road, NE., MS E-03,
Atlanta, GA 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 http://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 http://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 http://www.cdc.gov/vaccines/hcp/acip-recs/index.html, and the list
of HHS/CDC required vaccines for immigration purposes can be found at
http://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 http://www.cdc.gov/immigrantrefugeehealth/exams/ti/index.html. 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: http://www.cdc.gov/immigrantrefugeehealth/exams/ti/index.html.
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
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Corresponding, new, or updated
Definitions in 42 CFR part 34 definition within NPRM
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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
http://www.cdc.gov and http:// diseases is available at http:/
www.archives.gov/federal-register. /www.cdc.gov and http://
(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
(http://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 (http://
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: http://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). http://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). http://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.
http://www.sba.gov/advocacy/823. Accessed February 2014.
4. Summary of the Unfunded Mandates Reform Act. 2 U.S.C. 1501 et seq
(1995). http://www2.epa.gov/laws-regulations/summary-unfunded-mandates-reform-act. Accessed 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: http://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. http://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. http://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: http://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: http://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: http://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 http://www.cdc.gov and http://www.archives.gov/federal-register.
(2) Communicable diseases that may pose a public health emergency
of international concern if it meets one or more of the factors listed
in Sec. 34.3(d) and for which the Director has determined (A) 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 (http://www.who.int/csr/ihr/en/), as adopted by the Fifty-Eighth World Health Assembly in 2005, and
as entered into effect in the United States in July 2007, subject to
the U.S. Government's reservation and understandings:
(i) Any of the communicable diseases for which a single case
requires notification to the World Health Organization (WHO) as an
event that may constitute a public health emergency of international
concern, or
(ii) Any other communicable disease the occurrence of which
requires notification to the WHO as an event that may constitute a
public health emergency of international concern. HHS/CDC's
determinations will be announced by notice in the Federal Register.
(3) Gonorrhea.
(4) Hansen's disease, infectious.
(5) Syphilis, infectious.
(6) Tuberculosis, active.
(c) Civil surgeon. A physician designated by DHS to conduct medical
examinations of aliens in the United States who are applying for
adjustment of status to permanent residence or who are required by DHS
to have a medical examination.
(d) Class A medical notification. Medical notification of:
(1) A communicable disease of public health significance;
(2) A failure to present documentation of having received
vaccination against ``vaccine-preventable diseases'' for an alien who
seeks admission as an immigrant, or who seeks adjustment of status to
one lawfully admitted for permanent residence, which shall include at
least the following diseases: Mumps, measles, rubella, polio, tetanus
and diphtheria toxoids, pertussis, Haemophilus influenza type B and
hepatitis B, and any other vaccinations recommended by the Advisory
Committee for Immunization Practices (ACIP) for which 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: http://www.cdc.gov/ncidod/dq/technica.htm and http://www.globalhealth.gov.
(d) Risk-based approach. (1) HHS/CDC will use the medical and
epidemiological factors listed in paragraph (d)(2) of this section to
determine the following:
(i) Whether a disease as specified in Sec. 34.2(b)(3)(ii) is a
communicable disease of public health significance; 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