HHS FR removing HIV from examination

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Federal Register / Vol. 74, No. 210 / Monday, November 2, 2009 / Rules and Regulations
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
42 CFR Part 34
[Docket No. CDC–2009–0003]
RIN 0920–AA26

Medical Examination of Aliens—
Removal of Human Immunodeficiency
Virus (HIV) Infection From Definition of
Communicable Disease of Public
Health Significance
AGENCY: Centers for Disease Control and
Prevention (CDC), U.S. Department of
Health and Human Services (HHS)
ACTION: Final rule.
SUMMARY: Through this final rule, the
Centers for Disease Control and
Prevention (CDC), within the U.S.
Department of Health and Human
Services (HHS), is amending its
regulations to remove ‘‘Human
Immunodeficiency Virus (HIV)
infection’’ from the definition of
communicable disease of public health
significance and remove references to
‘‘HIV’’ from the scope of examinations
for aliens.
Prior to this final rule, aliens with
HIV infection were considered to have
a communicable disease of public
health significance and were thus
inadmissible to the United States per
the Immigration and Nationality Act
(INA). While HIV infection is a serious
health condition, it is not a
communicable disease that is a
significant public health risk for

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56547

introduction, transmission, and spread
to the U.S. population through casual
contact. As a result of this final rule,
aliens will no longer be inadmissible
into the United States based solely on
the ground they are infected with HIV,
and they will not be required to undergo
HIV testing as part of the required
medical examination for U.S.
immigration.
DATES: This final rule is effective
January 4, 2010.
FOR FURTHER INFORMATION CONTACT:
Stacy M. Howard, Division of Global
Migration and Quarantine, Centers for
Disease Control and Prevention, U.S.
Department of Health and Human
Services, 1600 Clifton Road, NE., MS
E–03, Atlanta, Georgia 30333; telephone
404–498–1600.
SUPPLEMENTARY INFORMATION: The
preamble to this final rule is organized
as follows:
I. Legal Authority
II. Background
A. Medical Examination and
Inadmissibility
B. Legislative and Regulatory History
C. Classes of Immigrants for Whom the
Regulation Applies
D. Global Context
III. Summary of NPRM
IV. Relation of this Final Rule to the July 2,
2009, Notice of Proposed Rulemaking
V. Overview of Public Comments
A. Comments on Removing HIV Infection
From the Definition of Communicable
Disease of Public Health Significance
B. Comments on Removing HIV Testing
From the Scope of Examinations
C. Comments on the Economic Impact
Analysis (EIA)
1. General Comments on the Cost Analysis
2. Comments on a Technical Review of the
EIA
D. Comments on Technical Correction
VI. Conclusions and the Final Rule
VII. Required Regulatory Analyses Under
Executive Order 12866
A. Objectives and Basis for the Action
B. Alternatives
C. Baseline and Incremental Analysis
D. Defining the Population Affected
E. Analysis of Impacts
1. Potential Benefits
2. Impact on Health Care Expenditures
3. Comparison With Congressional Budget
Office Analysis
4. Potential Fiscal Impacts
5. Onward Transmission
F. Summary of Impacts
G. Literature Cited
VIII. Final Regulatory Flexibility Analysis
IX. Other Administrative Requirements
A. The Unfunded Mandates Reform Act
B. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
C. Paperwork Reduction Act of 1995
D. Environmental Assessment
E. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments

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F. Executive Order 12630: Governmental
Actions and Interference With
Constitutionally Protected Property
Rights
G. Executive Order 13132: Federalism
H. Executive Order 13211: Energy Effects
I. National Technology Transfer and
Advancement Act
J. Assessment of Federal Regulations and
Policies on Families
K. Executive Order 12988: Civil Justice
Reform
L. Plain Language in Government Writing

I. Legal Authority
HHS/CDC is promulgating this rule
under the authority of 42 U.S.C. 252 and
8 U.S.C. 1182 and 1222.

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II. Background
A. Medical Examination and
Inadmissibility
Under section 212(a)(1) of the 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 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 on
the ground of inadmissibility. The
grounds of inadmissibility also apply to
most aliens who reside in the United
States and are seeking adjustment of
their status to that of a lawful
permanent resident.
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 Immigration
and Nationality Act (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.
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)
consular officers, perform medical
examinations on those refugees and/or
persons 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 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

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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/ncidod/dq/technica.htm.
B. Legislative and Regulatory History
Beginning in 1952, the language of the
INA mandated that 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
April 1986, prior to the recent
developments in medicine and
epidemiologic principles concerning
HIV infection, HHS published a
proposal in the Federal Register to
include acquired immunodeficiency
syndrome (AIDS) as a dangerous
contagious disease. See 51 FR 15354
(April 23, 1986). In June 1987, HHS
published a final rule adopting this
proposal. See 52 FR 21532 (June 8,
1987). Also during this time, HHS
separately published a proposed rule to
substitute HIV infection for AIDS on the
list of dangerous contagious diseases.
See 52 FR 21607 (June 8, 1987). While
this proposed rule was pending public
comment, Congress added HIV infection
to the list of dangerous contagious
diseases. Pub. L. 100–71, section 518,
101 Stat. 475 (July 11, 1987). In
response to the congressional mandate,
HHS issued final regulations to that
effect in August of that year. See 52 FR
32540 (August 28, 1987). Accordingly
and immediately, aliens infected with
HIV became ineligible to receive visas
and were excluded from admission into
the United States. See INA section
212(a)(6), 8 U.S.C. 1182(a)(6)(1988).
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 is 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). HHS/CDC
subsequently published a proposed rule
that would have removed from the list
all diseases, including HIV infection,
except for infectious tuberculosis. See
56 FR 2484 (January 23, 1991). Based on
public comments received on this
proposal, and after reconsideration of
the issues, HHS published an interim
final rule retaining all diseases on the
list, including HIV infection, and

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committed its initial proposal for further
study. See 56 FR 25000 (May 31, 1991).
Congress subsequently amended INA
section 212(a)(1) to specify that
‘‘infection with the etiologic agent for
acquired immune deficiency syndrome’’
is a communicable disease of public
health significance, thereby making
explicit in the INA that aliens with HIV
are ineligible for admission into the
United States. National Institutes of
Health Revitalization Act of 1993,
Public Law 103–43, section 2007, 107
Stat. 122 (June 10, 1993).
In summer 2008, Congress amended
the INA by striking ‘‘which shall
include infection with the etiologic
agent for acquired immune deficiency
syndrome,’’ thereby leaving to the
Secretary of HHS the discretion for
determining whether HIV infection
should remain in the definition of
communicable disease of public health
significance provided for in 42 CFR
34.2(b). [Tom Lantos and Henry Hyde
United States Global Leadership Against
HIV/AIDS, Tuberculosis, and Malaria
Reauthorization Act of 2008, Pub. L.
110–293, section 305, 122 Stat. 2963
(July 30, 2008)].
In a separate action 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 immigrant and
refugee populations who are bound for
the United States. See 73 FR 58047 and
73 FR 62210. With the 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 of 2005, provided the
disease meets specified criteria. Specific
illnesses remaining as a communicable
disease of public health significance
were active tuberculosis, infectious
syphilis, gonorrhea, infectious leprosy,
chancroid, lymphogranuloma
venereum, granuloma inguinale, and
HIV infection.
In response to the 2008 amendment to
the INA, on July 2, 2009, HHS/CDC
published a Notice of Proposed Rule
Making (NPRM), which proposed two
regulatory changes: (1) The removal of
HIV infection from the definition of
communicable disease of public health
significance; and (2) removal of

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III. Summary of NPRM

references to serologic testing for HIV
from the scope of examinations.

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C. Classes of Immigrants for Whom the
Regulation Applies
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; and (3)
aliens required by the U.S. Department
of Homeland Security (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 on a temporary basis, 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.
Aliens who are already in the United
States may apply to adjust to permanent
resident status pursuant to statutorilyeligible adjustment categories. See INA
§ 245; 8 U.S.C. 1255. Refugees and
aslyees may also apply to adjust to
permanent resident status from inside
the United States. See INA § 209; 8
U.S.C. 1159.
An alien seeking permanent
residence, whether through an
immigrant visa or asylee status, or
through an adjustment of status must
undergo a medical examination to
determine whether the alien is
inadmissible on medical grounds.
Aliens seeking admission as refugees
also undergo medical examinations
overseas. Overseas examinations are
conducted by panel physicians
designated by the Department of State.
Applicants for adjustment of status to
lawful permanent resident are required
to have a medical examination
conducted by a civil surgeon designated
by U.S. Citizenship and Immigration
Services within DHS.
D. Global Context
In 2004, the Joint United Nations
Programme on HIV/AIDS (UNAIDS) and
the International Organization for
Migration (IOM) issued the ‘‘UNAIDS/
IOM Statement on HIV/AIDS-related
travel restrictions’’ that provides
guidance to governments in regard to
addressing the public health, economic,
and human rights concerns involved in
HIV-related travel restrictions. This
document concludes that HIV-related
travel restrictions have no public health
justification.

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On July 2, 2009, HHS/CDC published
a notice of proposed rulemaking
(NPRM) to remove HIV infection from
the definition of communicable disease
of public health significance, as defined
in 42 CFR 34.2(b) and from the scope of
examinations in 42 CFR 34.3. See 74 FR
31798.
Section 34.2(b) Communicable Diseases
of Public Health Significance
Until this final rule, human
immunodeficiency virus (HIV) infection
was among those diseases listed in the
definition of communicable disease of
public health significance, as defined in
42 CFR part 34.2(b). As described in the
‘‘Legislative and Regulatory History’’
section above, Congress amended the
INA by striking ‘‘which shall include
infection with the etiologic agent for
acquired immune deficiency
syndrome,’’ thereby leaving to the
Secretary of HHS the discretion for
determining whether HIV infection
should remain in the definition of
communicable disease of public health
significance provided for in 42 CFR
34.2(b). In consideration of scientific
evidence, including epidemiologic
principles and current medical
knowledge regarding the mode of HIV
transmission, HHS/CDC proposed to
remove HIV infection from the
definition of communicable disease of
public health significance.
Section 34.3

Scope of Examinations

HHS/CDC also proposed to remove all
references to serologic testing for HIV
infection in 42 CFR 34.3, which is
entitled ‘‘Scope of examinations.’’ This
section applies to those aliens who are
required to undergo a medical
examination for U.S. immigration
purposes. The scope of examinations
outlines those matters that relate to the
inadmissible health-related conditions.
This section provides specific screening
and testing requirements for those
diseases that meet the definition of
communicable disease of public health
significance and directly relates to the
diseases listed in Section 34.2(b) of 42
CFR part 34. It does not provide specific
testing requirements for other healthrelated conditions that are not included
in the current definition of
communicable disease of public health
significance.
Therefore, HHS/CDC proposed to
remove the specific testing requirements
for HIV infection in 42 CFR 34.3.

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IV. Relation of This Final Rule to the
July 2, 2009, Notice of Proposed
Rulemaking
Through this final rule, HHS/CDC is
now removing HIV infection from the
definition of communicable disease of
public health significance and from the
scope of examinations. HHS/CDC
received over 20,000 public comments
on the NPRM, with the vast majority of
commenters in support of the proposed
changes, as written. HHS/CDC’s
evaluation of the comments did not lead
to changes between the NPRM and this
final rule. While HIV infection is a
serious health condition, scientific
evidence shows that it does not
represent a communicable disease that
is a significant risk for introduction,
transmission, and spread to the United
States population through casual
contact. An arriving alien with HIV
infection—or one adjusting status to that
of a legal permanent resident—does not
pose a public health risk to the general
population through casual contact.
Beginning on the effective date of this
final rule, HIV infection will no longer
be an inadmissible condition, and HIV
testing will no longer be required, for
those aliens who are required to
undergo a medical examination for U.S.
immigration purposes.
The specific illnesses that are now
listed in the definition of communicable
disease of public health significance are:
Active tuberculosis, infectious syphilis,
gonorrhea, infectious leprosy,
chancroid, lymphogranuloma
venereum, and granuloma inguinale.
The definition of communicable disease
of public health significance also
consists of (1) quarantinable diseases
designated by Presidential Executive
Order (E.O. 13295 as amended), and (2)
communicable diseases that could pose
a public health emergency of
international concern, in accordance
with the revised International Health
Regulations of 2005, provided the
disease meets specified criteria.
As a result of this final rule, HHS/
CDC has also revised the Technical
Instructions provided to panel
physicians and civil surgeons to reflect
the removal of the HIV testing
requirement. The revised Technical
Instructions will be immediately
available to the public on the HHS/CDC
Division of Global Migration and
Quarantine Web site, located at the
following Internet address: http://
www.cdc.gov/ncidod/dq/technica.htm.
HHS/CDC will continue to work with
DoS and DHS to ensure that panel
physicians and civil surgeons are aware
of the revision to the Technical
Instructions. DHS and DoS will

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determine the process for those
applicants with HIV infection who have
current applications pending.

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V. Overview of Public Comments
The public comment period for the
NPRM lasted for forty-five (45) days and
ended on August 17, 2009. HHS/CDC
received approximately 20,100
comments; of these, approximately
18,500 were largely similar ‘‘form’’
letters in favor of the proposed rule and
also several ‘‘form’’ letters against the
proposed rule. Comments were
submitted by individuals; advocacy
organizations; international and
national public health agencies;
immigration organizations; State and
local health departments; medical
associations; international, national and
local AIDS organizations; corporate
entities; various human rights; and other
organizations from across the globe.
Some comments were the collaborative
effort of multiple groups. The comments
will be permanently located in the
docket for this final rule and maintained
by HHS/CDC.
The sections below summarize and
discuss the comments in detail:
Comments on removing HIV infection
from the definition of communicable
disease of public health significance;
comments on removing HIV testing from
the scope of examinations; comments on
the Economic Impact Analysis (EIA);
and comments on technical correction.
Data on the numbers of comments
received in support of and opposed to
the rule are provided below for
informational purposes. However, these
data are not the determinative factor in
guiding public policy or in making these
policy changes.
A. Comments on Removing HIV
Infection From the Definition of
Communicable Disease of Public Health
Significance
Most commenters supported CDC’s
public health assessment that HIV
infection should be removed from the
definition of communicable disease of
public health significance as defined in
42 CFR 34.2(b) (approximately 19,500
comments were received in support of
CDC’s preliminary determination).
Many commenters stated that the
practice of excluding HIV-infected
visitors and immigrants from the United
States has no medical or public health
rationale. Most of these individuals and
organizations supported the language of
the NPRM stating that the scientific
evidence shows that HIV infection is not
a risk to the general population through
casual contact. Other comments
submitted by individuals supporting
equal rights and HIV advocacy groups

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urged HHS/CDC to adopt the NPRM
verbatim as a final rule that removes
HIV infection from the definition of
communicable disease of public health
significance as defined in 42 CFR
34.2(b). In response, HHS/CDC has
adopted the revisions to 42 CFR 34.2(b),
as proposed. HHS/CDC has taken this
action because based on scientific
evidence, HIV infection is not a threat
to the general population through casual
contact and is no longer considered a
significant public health risk given
advances in public health practices and
interventions for prevention and
control.
A number of commenters supported
the proposed rule for humanitarian
reasons, stating that the former
regulation (a) stigmatizes and
discriminates against HIV-infected
people, which include battered women
and children; the lesbian, gay, bisexual
and transgender (LGBT) community; or
other vulnerable or already stigmatized
populations; (b) separates loved ones;
(c) denies U.S. businesses and research
institutions access to talented workers;
(d) bars students and tourists from
accessing opportunities and supporting
our economy; and/or (e) violates human
rights by denying or interfering with the
rights to life, freedom of movement,
privacy, liberty and work. While HHS/
CDC acknowledges these assertions, its
mission is to protect public health and
base decisions upon solid scientific and
medical grounds. Therefore, there is no
public health benefit for retaining this
government-imposed barrier.
Several organizations and individuals
noted that preventing HIV-infected
travelers and/or immigrants from
entering the United States is also
counter to the nation’s longstanding
leadership in fighting the HIV/AIDS
epidemic internationally. These
commenters noted that no international
conference on HIV/AIDS has been held
in the United States since 1990 because
of the former regulations. In response,
HHS/CDC notes that with this final rule,
the United States will no longer be
included among the other countries that
maintain entry restrictions for HIVinfected individuals.
Many commenters suggested that the
former regulations undermine public
health efforts, including the fight against
HIV/AIDS, by keeping HIV-infected
researchers, advocates and experts from
entering the country and by preventing
HIV-infected immigrants from taking
their medications in an effort to conceal
their status from U.S. immigration
authorities. Some commenters indicated
that effective treatment of HIV infection
requires a continuous antiviral regimen,
and that interrupting antiviral

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medication can result in difficulty
treating the virus as well as higher viral
loads, which is also the most important
factor in transmissibility. In response,
HHS/CDC acknowledges these
humanitarian and medical
considerations. This final rule, based on
solid scientific and public health
practices, removes HIV as a condition
barring entry into the United States.
A number of commenters did not
support CDC’s assessment that HIV
infection should be removed from the
definition of communicable disease of
public health significance as defined in
42 CFR 34.2(b) (almost 600 comments).
Many commenters who opposed the
removal of HIV infection from the
definition of communicable disease of
public health significance cite financial
concerns. They suggested that neither
State health departments, Federal
government, nor individuals should
have to bear a significant financial
burden to pay costs associated with
treating HIV conditions in immigrants.
In addition, many submissions pointed
to the state of the economy and the
recent debate over the strength of the
health care system as a reason not to
admit HIV-infected persons. Some
commenters indicated that proof of
ability to pay for health care should be
required for HIV-infected immigrants,
noting that HIV is a chronic, life-long
infection, which is costly to monitor
and even more costly to effectively treat.
CDC acknowledges these concerns,
including those related to the potential
financial burden that may result from
this regulatory change. However, these
reasons are not part of the scientific
criteria used in determining whether
HIV infection should be included as a
defined communicable disease of public
health significance and as a basis for
admission to the United States. An
individual infected with HIV will not
pose a significant risk to the general
U.S. population since HIV infection
already exists as an endemic disease.
Data have shown that decrease in
transmission rates of HIV is directly
correlated with national prevention
efforts. CDC has and will continue to
work on a number of fronts to reduce
the impact of HIV across the nation by
enhancing access to available
prevention programs. These program
activities include expanding HIV testing
to increase knowledge of HIV status,
improving surveillance to identify the
leading edge of the epidemic, and
exploring innovative and promising
new prevention approaches.
Communities and public health partners
are working to tailor prevention efforts
to meet local needs, mobilize

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Federal Register / Vol. 74, No. 210 / Monday, November 2, 2009 / Rules and Regulations
communities, and expand the reach of
HIV prevention.
Some commenters noted that
changing the regulation at this current
time is ill advised, and several of the
commenters opposed to the proposed
rule requested that the waiver remain a
requirement for entry into the United
States. HHS/CDC acknowledges these
comments, but notes that the Part 34
regulations do not address the criteria
for a waiver of inadmissibility under
Section 212 of the INA.
A few commenters asked why the
U.S. government would put even one
person at risk of contracting HIV from
an immigrant. In response, as stated
previously, scientific evidence confirms
that HIV infection is not transmitted in
casual settings. An arriving alien with
HIV infection—or one adjusting status
to that of a legal permanent resident—
does not pose a public health risk to the
general population through casual
contact.
A few of these commenters, who did
not support the removal of HIV
infection as a condition of
inadmissibility, expressed concerns that
HIV infection should remain a
communicable disease of public health
significance or be accepted as a disease
of ‘‘public health significance,’’ and
cited morbidity and mortality rates of
HIV infection domestically and
internationally. HHS/CDC
acknowledges that HIV infection is a
serious illness and a major public health
concern both domestically and
internationally. However, HHS/CDC
notes that the purpose of the NPRM was
to determine whether HIV infection
should remain as a disease that bans
entry to the United States for
immigration purposes. HHS/CDC,
through this final rule, notes that HIV
infection will no longer be included in
the definition of communicable disease
of public health significance, because
scientific evidence suggests that it is not
transmitted through casual contact.
Other reasons cited by commenters
opposing the rule change include
various comments such as: (a) HIVinfected persons should be allowed in
for tourism but not for permanent
relocation; (b) allowing HIV-infected
immigrants into the country would
allow new strains of HIV to circulate in
the United States; (c) reporting
requirements for HIV infection seem to
indicate that HIV is a disease of public
health significance; and (d) removing
HIV infection from the disease list is
inconsistent with leaving other sexually
transmitted infections on the disease
list. In response, HHS/CDC
acknowledges these comments, however
as previously stated, the basis for this

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regulatory change is based on solid
scientific knowledge and current public
health practices. Additionally, HHS/
CDC is reviewing the other sexually
transmitted diseases on the disease list
to determine whether additional
revisions to Part 34 are warranted.
In summary, HHS/CDC appreciates all
the comments received on the proposed
change. After considering these
comments, CDC has determined that
HIV infection is not a communicable
disease that is a significant risk for
introduction and spread through casual
contact to the general U.S. population,
where HIV infection already exists as an
endemic disease. Thus, HHS/CDC
finalized the proposal to remove HIV
infection from the definition of
communicable disease of public health
significance.
B. Comments on Removing HIV Testing
From the Scope of Examinations
On the topic of removing HIV
infection from the scope of
examinations, some commenters stated
that mandatory testing for HIV infection
should no longer be required if they
meet all other conditions of
admissibility. These commenters also
noted that maintaining testing while
removing HIV infection from the
definition of communicable disease of
public health significance is legally and
procedurally problematic. HHS/CDC
maintains that it is appropriate to
remove HIV testing from the
immigration process, since HIV
infection has been removed as a
communicable disease of public health
significance. As previously stated, HHS/
CDC also notes that the regulations
found at 42 CFR part 34 regulations do
not specify testing for any illness that is
not included in the definition of
communicable disease of public health
significance.
Other commenters stated that
immigrants and refugees are not tested
for other expensive chronic diseases
(i.e., diabetes, heart disease, obesity)
and so, maintaining testing for HIV is
discriminatory and would fuel the
stigmatization of HIV-infected
individuals. In response, HHS/CDC
notes that testing for those chronic
diseases are not within the scope of Part
34 regulations since they neither fall
under the diseases listed in the INA for
the purpose of a medical examination
for U.S. immigration nor are they
defined as a communicable disease of
public health significance. HHS/CDC
notes that this regulatory change will
result in reducing stigma of HIVinfected persons.
Another group of commenters
maintained that any mention of

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serologic testing for HIV should be
removed from the regulation. These
comments stated that (1) the entry ban
for HIV infection amounted to
mandatory testing of all immigrants for
HIV, which should not be included in
routine medical screening of aliens
seeking admission into the United
States; (2) that people living with HIV
should be allowed to enter the United
States or adjust to permanent resident
status if they meet all other conditions
of admissibility; and (3) that when
tested, many immigrants do not receive
adequate counseling and in some cases
have their privacy violated. For these
reasons, these groups felt that testing for
HIV should be separate from the
immigration process.
In response, HHS/CDC acknowledges
these humanitarian concerns but notes
that HIV testing was required as a part
of the 42 CFR part 34 rule when HIV
infection was an inadmissible condition
based on the definition of
communicable disease of public health
significance. With this final rule, HIV
infection will no longer be contained in
this definition and HIV testing will not
be required as part of the medical
examination.
Some comments in support of the
proposed change to remove HIV
infection from the Part 34 regulations
also stressed the importance of HIV
testing for immigrants and refugees for
their own benefit and that of their
potential sexual partners (approximately
30 comments). Specifically, several
commenters said that testing for HIV
enables immigrants to receive
counseling and education related to
HIV/AIDS, including information on
treatment mechanisms and support
systems, as well as prevention. These
individuals and groups submit that
health care outcomes are improved
when testing is administered and access
to treatment is determined or planned
prior to arrival. Improved outcomes
mentioned due to HIV testing prior to
arrival included longer duration until
AIDS diagnosis, reduced onward HIV
transmission, reduced risk of active
tuberculosis infection, and increased
quality of life. In response, HHS/CDC
acknowledges that diagnosis and
linkage to high quality medical care in
the context of the required immigration
medical examination could positively
impact the health of persons with HIV
infection. HHS/CDC currently
recommends and funds routine HIV
screening in medical settings for all U.S.
residents, including immigrants in
contact with the health system.
Some individuals noted that in
September 2006, HHS/CDC
recommended that all persons age

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13–64 undergo testing at least once for
HIV. They suggested that keeping the
HIV testing requirement for would-be
immigrants would be consistent with
HHS/CDC existing policy, would help to
meet the HHS/CDC recommendation of
voluntary testing, and would ensure that
would-be permanent residents were
aware of their HIV status.
HHS/CDC appreciates these
comments and emphasizes the
importance of adolescents and adults
knowing their individual HIV status.
However, removing the requirement for
HIV testing at the time of the medical
examination for immigration purposes
will not prevent individuals from
knowing their status upon and after
arrival in the U.S. CDC has and will
continue to work on a number of fronts
to reduce the impact of HIV across the
nation by enhancing access to available
prevention programs. These program
activities include expanding HIV testing
to increase knowledge of HIV status,
improving surveillance to identify the
leading edge of the epidemic, and
exploring innovative and promising
new prevention approaches.
Communities and public health partners
are working to tailor prevention efforts
to meet local needs, mobilize
communities, and expand the reach of
HIV prevention. Further, Part 34
regulations do not specify testing for
any disease that is not included in the
definition of communicable disease of
public health significance. For example,
other recommended screening
procedures such as cholesterol tests,
Pap smears, mammograms, or other
diagnostic tests for the presence of
asymptomatic chronic health conditions
such as hepatitis B, are not conducted
as part of the required medical
examination. CDC recognizes that the
medical exam provides a unique
opportunity to both inform immigrants
of their health status and, if warranted,
link them with care. If, as a part of the
medical examination for immigration,
the panel physician detects a condition
that might warrant additional follow-up
or testing, CDC will continue to
encourage the panel physician to inform
the applicant about the condition and to
seek appropriate medical care and
counseling services. This would include
anyone with symptoms suggestive of
hepatitis, AIDS, or other chronic
infectious diseases that are not
inadmissible conditions.
Commenters also asked HHS/CDC to
clarify how local public health
departments and voluntary agencies
will be funded and equipped to provide
testing and counseling services to
immigrants potentially infected with
HIV if HIV testing is no longer included

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in the required medical examination for
U.S. immigration. In response, HHS/
CDC will continue to work closely with
its state and local partners in protecting
the public’s health. HHS/CDC currently
provides funding to State and local
health departments and communitybased organizations for outreach and
HIV counseling and testing programs.
Immigrants would be eligible for
services under these programs.
Some commenters suggested
alternatives such as listing HIV infection
as a Class B health condition or another
designation to justify testing for
immigrant applicants. In response,
HHS/CDC reiterates that Part 34
regulations do not specify testing unless
the illness is defined as a communicable
disease of public health significance.
In summary, CDC appreciates all the
comments received on the proposed
change. After considering these
comments, CDC has determined that
HIV testing will no longer be included
in the scope of examinations since HIV
has been removed from the definition of
communicable disease of public health
significance. Therefore, as stated above,
it is no longer necessary or appropriate
to maintain HIV in the scope of
examinations.
C. Comments on the Economic Impact
Analysis (EIA)
1. General Comments on the Cost
Analysis
HHS/CDC received a number of
comments from individuals and
organizations on the NPRM regarding
the cost estimates of admitting HIVinfected visitors and immigrants into
the United States (approximately 100).
Many of the commenters complimented
the quality of the economic impact
analysis and the level of transparency
provided regarding the methods and
assumptions.
A majority of the individuals and
organizations that provided comments
on the economic impact analysis
supported the removal of HIV infection
from the list of communicable diseases
as defined in 42 CFR 34.2(b), but
suggested that the estimates provided in
the NPRM overestimate the cost of the
proposed rule to the United States
taxpayer. Specifically, these individuals
and organizations expressed concerns
that the NPRM estimates did not
differentiate costs between public and
private payers; they noted that some
HIV-infected immigrants would secure
private insurance, some would pay outof-pocket, and some would go without
care or treatment. These commenters
also noted that there is no data available
to support the assumptions that HIV-

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infected immigrants will seek public
benefits. They stated that all immigrants
entering the United States must
document that they will not be a public
charge and immigrants do not have
access to entitlement benefits for five
years.
Many of these commenters also noted
that economic benefits of removing the
HIV ban were not included in the cost
analysis. Specifically, they noted that
health care expenditures are a large
portion of the United States economy.
Health care expenditures for treatment
of HIV infection contribute to the
United States economy and the creation
of jobs. Similarly, some of these
individuals and organizations suggested
that many HIV-infected immigrants will
provide revenue for the United States
through taxes, visa fees, and
contributions to Social Security and that
government-incurred expenses currently
used to enforce bans would be reduced.
Some commenters also noted that many
immigrants would bring unique sets of
skills and abilities, that can contribute
greatly to the United States workforce
and noted that these benefits were not
captured in the analysis.
For these reasons, these individuals
and organizations suggested that the
cost estimates presented in the NPRM
inflated the public costs of allowing
HIV-infected immigrants into the United
States. In other words, these
commenters suggested that the cost
estimates in the NPRM overestimate
public sector expenditures resulting
from this proposed rule. HHS/CDC
acknowledges these comments on the
health care expenditure estimates and
recognizes that the estimates in the
analysis do not consider all factors and
that there are some limitations to the
analysis.
Many of these individuals and
organizations suggested that the cost
estimates were high, but they also noted
that the assumptions upon which the
cost estimates were based were
reasonable for this economic analysis.
In response to these comments, HHS/
CDC notes that the analysis was not
restricted to impacts to the U.S.
Government. The HHS/CDC analysis is
an analysis of the health care sector
expenditures taken from a societal
perspective. That is, all health care costs
are included, regardless of who pays.
However, HHS/CDC also acknowledges
that the analysis is focused on the
impact to the health care sector.
HHS/CDC acknowledges that the
health care expenditures estimated in
the economic analysis may be small
relative to the total heath care sector in
the U.S. Nonetheless, Office of
Management and Budget (OMB)

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Circular A–4 on ‘‘Regulatory Analysis’’
(available at: http://
www.whitehouse.gov/OMB/circulars/
a004/a-4.pdf) directs agencies to assess
all relevant impacts whether they be
benefits, costs or distributional
(regardless of payer).
HHS/CDC also acknowledges that
allowing immigrants to enter and settle
in the United States benefits the
economy resulting from a number of
additional economic activities.
However, we are unable to quantify
those potential benefits directly related
to this rule.
Many organizations and individuals
also noted that immigrants infected with
HIV may consume fewer health care
resources than immigrants with other
chronic medical conditions. As such,
these commenters suggested that
including the cost model in the NPRM
reflected inconsistencies in United
States immigration policy. Specifically,
they noted that the costs of treating HIV
are raised as a concern in the proposed
rule, but the costs of treating immigrants
with other chronic conditions are not
considered when determining
immigrant status. In summary, they note
that if the costs of treating immigrants
with other significant health concerns
are not considered in determining
immigration policy, then HIV status
should not be a factor in setting
immigration policy.
HHS/CDC appreciates these
comments and acknowledges the points
made by these individuals and
organizations. However, HHS/CDC
conducted this cost analysis in
adherence to the Office of Management
and Budget (OMB) Circular A–4
requirements (available at: http://
www.whitehouse.gov/OMB/circulars/
a004/a-4.pdf).
Many of the individuals and
organizations in opposition to the
proposed rule often cited concerns that
the potential costs of the proposed rule
would result in an unacceptable,
increased burden to the United States
tax payers and to the United States
health care system.
HHS/CDC notes that the purpose of
the rulemaking was to determine
whether HIV infection should remain as
a communicable disease of public
health significance. Through this Final
Rule, HHS/CDC notes that HIV infection
will no longer be a communicable
disease of public health significance,
because scientific evidence suggests that
it is not transmitted through casual
contact. Furthermore, we found no
evidence to support the assertion that
the rule would impose an unacceptable,
increased burden on tax payers or the
U.S. health care system.

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One commenter noted that a
significant number of visa applicants are
the immediate relatives of U.S. citizens,
for whom there is no numerical
restriction. HHS/CDC acknowledges this
point, but also notes that most
immediate relatives of U.S. citizens are
eligible for waivers under existing
regulations. Much will depend on the
assumed age structure of family-related
immigration (i.e., immigrants who are
granted landed immigrant status on the
basis of uniting families) and how many
would have received a waiver absent
this regulatory change. However, HHS/
CDC has no reliable data measuring
existing demand (i.e., from family
members who are HIV-infected and who
will wish to immigrate here due to the
change in regulations).
Two reviewers noted CDC may have
overstated the costs of the proposed rule
through calculation or transcription
errors in the NPRM. HHS/CDC thanks
these reviewers for their careful review
of the analysis. HHS/CDC acknowledges
that there was a transcription error and
made the necessary edits in the analysis
for the final rule.
2. Comments on a Technical Review of
the EIA
In addition to the general comments
on the Economic Impact Analysis (EIA),
HHS/CDC also received a detailed
technical review of the EIA from
commenters. The comments received on
this review concluded that the HHS/
CDC cost assumptions were reasonable,
but possibly overstated. These reviewers
also indicated that a 5-year time horizon
for analysis was reasonable.
This technical review noted that
many of the economic benefits of
removing the HIV ban were not
included in the cost analysis. These
reviewers further noted that the costs
identified by HHS/CDC are health care
expenditures that may benefit rather
than harm the economy and suggest
using a multiplier to estimate these
economic benefits. One reviewer also
suggested that HHS/CDC wrongly
assumes that there will be no added
economic benefit from new HIVinfected immigrants. The reviewer also
contented that these immigrants would
contribute to the economy and so the
added health care expenditures CDC
outlined would in some part be offset.
Several reviewers also noted that the
costs estimated by the HHS/CDC model
were small in proportion to the overall
health care sector.
HHS/CDC acknowledges that data on
the average annual health care costs of
HIV treatment for immigrants are
limited and may be lower than the
estimates used in our analysis. We have

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added language which indicates that the
average annual medical costs for HIV
treatment in the Ryan White and
Medicaid Programs range from $15,738
to $17,790 per person. HHS/CDC also
acknowledges that we did not include a
quantitative estimate of the economic
benefits of removing HIV as an
inadmissible condition. We further
acknowledge that the health care
expenditures have a direct impact on
the health of individuals. However,
because no data exist to quantify these
potential indirect effects on the
economy, we have not estimated these
effects, either through direct
measurement or with the use of a
multiplier.
HHS/CDC acknowledges that the
health care expenditures estimated in
the economic analysis may be small
relative to the total heath care sector in
the U.S. Nonetheless, OMB’s Circular
A–4 directs agencies to assess all
relevant impacts whether they be
benefits, costs, or distributional
(regardless of payer).
One of the reviewers suggested that it
would be helpful if HHS/CDC explicitly
stated that the costs to be borne by the
federal government are a fraction of the
figure described as ‘‘costs’’ in the
NPRM. The reviewer also felt that it
would be helpful if HHS/CDC would
highlight that the CBO analysis states
that the government has already
identified a mechanism for offsetting the
costs through visa fees.
The reviewer also suggested that the
assumption that the prevalence of HIV
infection among those immigrating to
the U.S. will be the same as the
prevalence in the general population of
a particular region is questionable.
However, although the reviewer notes
the lack of reliable data may make this
assumption reasonable, the reviewer
believes that the assumption is a likely
overestimation.
This reviewer also suggested that the
assumption that there are a fixed
number of immigrants is a flawed
assumption because 40–47% of all
immigrants are not subject to numerical
caps. Therefore, immediate relatives
would not replace an immigrant who is
HIV negative. The reviewer finally states
that the assessment of the economic
impact of lifting the ban should also
take into account the economic benefits.
HHS/CDC thanks the reviewer for the
thoughtful and thorough examination of
the proposed rule and the economic
model. The reviewer is correct in the
statement that all of the costs are not
those to the government. Consistent
with OMB’s Circular A–4, the HHS/CDC
analysis is an analysis of the health care
sector costs taken from a societal

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perspective; that is, all health care costs
are included, regardless of payer.
HHS/CDC acknowledges the
uncertainty in the estimate of HIV
prevalence among immigrants who
change their status to legal permanent
residents, and the argument can be
made that the estimate of prevalence
should be higher or lower. Thus HHS/
CDC chose to use a range. Further, HHS/
CDC acknowledges that the range is
‘‘wide.’’ However, HHS/CDC believes
that the range provides an important
understanding of the limitations of the
available data.
The reviewer further commented that
the model fails to account for the
economic benefits that those immediate
family member immigrants would bring
to the U.S. economy. HHS/CDC notes
that the purpose of the HHS/CDC model
was to account for the direct impact to
the changes in policy to the health care
sector and not to account for ancillary
economic benefits. HHS/CDC also notes
that although it thoroughly and
carefully examined the direct effects of
the proposed rule change, there are
limitations to the analysis. Finally,
HHS/CDC points out that there is a limit
on the number of immigrants allowed
into the U.S. each year. Family-related
immigration is usually outside those
limits. Again, HHS/CDC acknowledges
that it has no reliable data measuring
the existing demand among families to
reunite with their loved ones. In
addition, HHS/CDC notes that this point
is probably only valid for an initial
period following the change in
regulations, where there would be a
catch-up phase.
D. Comments on Technical Correction
Two comments were received that
provided the following technical
correction: ‘‘In section II, Background,
part I (p. 31798), last sentence, the
proposed rule should state that the
grounds of inadmissibility for specific
health related grounds also pertain to
most aliens in the United States who are
applying for adjustment of their status
to that of lawful permanent resident.
There are few exceptions, e.g.,
applicants under INA 249, 8 U.S.C. 1259
(registry) or under INA 245, 8 U.S.C.
1255 (m) (U nonimmigrant status/U visa
holders) are exempt from the healthrelated grounds of inadmissibility at
INA 212(a)(1)(A), (8 U.S.C. 1182
(a)(1)(A))’’. CDC has accepted this
technical change and amended the
preamble text to reflect this.
VI. Conclusions and the Final Rule
Therefore, HHS/CDC amends 42 CFR
34 as follows: HIV infection is removed
from the definition of a communicable

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disease of public health significance as
defined in 42 CFR 34.2(b), and
references to HIV are removed from the
scope of examinations in 42 CFR 34.3.
As a result, beginning on the effective
date of this rule, HIV infection will no
longer be an inadmissible condition,
and HIV testing will no longer be
required for those aliens who are
required to undergo a medical
examination for U.S. immigration
purposes.
HHS/CDC has considered the
rationale for all the public comments on
the proposed rule. The vast majority of
comments support the NPRM as written,
with less than 3% of all commenters
opposed to the changes in the NPRM.
HHS/CDC believes that the positive
benefits of this regulatory change
outweigh the costs. After considering
public comments, as well as the most
recent scientific and public health data
available, HHS/CDC has decided to
promulgate the final regulation as
proposed in the NPRM.
HHS/CDC will revise the Technical
Instructions provided to panel
physicians and civil surgeons, as
needed, regarding the removal of
required HIV testing, and this
information will also be immediately
available to the public on the HHS/CDC
Division of Global Migration and
Quarantine Web site, located at the
following Internet address: http://
www.cdc.gov/ncidod/dq/technica.htm.
HHS/CDC will also work with DoS and
DHS to ensure that panel physicians
and civil surgeons respectively are
aware of the revision to the Technical
Instructions regarding the removal of
required HIV testing.
VII. Required Regulatory Analyses
Under Executive Order 12866
HHS/CDC has examined the impacts
of the proposed rule under Executive
Order 12866 and the Regulatory
Flexibility Act (5 U.S.C. 601–612), and
the Unfunded Mandates Reform Act
(Pub. L. 104–4). Executive Order 12866
directs agencies to assess all costs and
benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety,
and other advantages; distributive
impacts; and equity). The agency
believes that this final rule is an
economically significant action under
the Executive Order.
In the analysis that follows, we assess
the potential impacts of removing HIV
infection from the list of specific
communicable disease of public health
significance and removing the HIV

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testing requirement in the medical
examination for aliens who are applying
for adjustment of their status to that of
a lawful permanent resident.
A. Objectives and Basis for the Action
Prior to the enactment of the United
States Global Leadership Against HIV/
AIDS, Tuberculosis, and Malaria
Reauthorization Act of 2008, HHS/CDC
was required by statute to list HIV
infection as a ‘‘communicable disease of
public health significance.’’ Now that
the statute provides discretion, HHS/
CDC is taking this action to reflect
current scientific knowledge and public
health best practices, and to reduce
stigmatization of people who are HIVinfected. This final rule is not intended
to correct any market failure, but to
remove a government-imposed barrier
that does not provide a significant
public health benefit.
B. Alternatives
HHS/CDC examined three regulatory
approaches.
1. The first approach is to maintain
HIV infection on the list of
communicable disease of public health
significance, i.e., to keep the disease as
an inadmissible condition for entry into
the U.S. This means that visa applicants
seeking permanent residency would
continue to undergo testing for HIV
infection as part of the application
process. Those applicants testing
positive for HIV, if eligible, would still
be required to apply for and obtain a
waiver from DHS prior to coming to the
U.S. There are several disadvantages to
this approach. As stated previously,
while HIV infection is a serious health
condition, it does not represent a
communicable disease that is a
significant risk for introduction,
transmission, and spread to the U.S.
population through casual contact.
Currently, there are already roughly 1
million persons in the United Stated
living with HIV [1]. Thus, maintaining
HIV infection on the list of inadmissible
conditions for entry into the U.S. would
not result in significant public health
benefits. Further, this approach is not in
line with current international public
health practice. This approach
contributes toward the stigmatization of
HIV-infected persons. HHS/CDC did not
select this approach.
2. The second approach is to remove
HIV infection from the list of
communicable disease of public health
significance, i.e. remove it as a ground
of inadmissibility into the U.S., but
continue mandatory HIV testing for all
immigrant applicants similar to an
approach followed by some countries.
Under this approach, all those aliens

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who test positive for HIV infection
could be informed of their HIV status,
counseled regarding their condition, the
need for appropriate treatment, and the
steps that should be taken to minimize
the risk of onward transmission.
There are potential public health
benefits to a mandatory testing
approach. The medical examination
offers a unique opportunity to both
inform immigrants of their HIV status
and link them with care. Through
screening, HIV-infected aliens who are
potentially unaware of their HIV status
would become aware of their status and
could be linked with prevention, care
and treatment options in the United
States. Early diagnosis and treatment of
HIV-infected persons can increase life
expectancy and may improve the
quality of life. Additionally, knowing
one’s HIV status decreases the
likelihood of onward transmission [2,
3]. These public health benefits are the
basis for the HHS/CDC’s ‘‘Revised
Recommendations for HIV Testing of
Adults, Adolescents, and Pregnant
Women in Health-Care Settings,’’ which
states that the characteristics of HIV
infection are consistent with all
generally accepted criteria that justify
voluntary screening [4]. However,
mandatory HIV testing is limited to
certain infrequent cases such as blood
and organ donors.
There are also disadvantages to
continued mandatory testing if HIV
infection is removed from the definition
of communicable disease of public
health significance. Mandatory testing
for other serious health-related
conditions that are not inadmissible
health conditions, (e.g., infectious
diseases, such as hepatitis, malaria, and
West Nile virus and chronic conditions
such as diabetes and heart conditions),
are not required as part of this medical
examination. Thus, continued
mandatory HIV testing would
differentiate HIV infection from other
serious health-related conditions.
Second, although the purpose of the
medical examination is to identify
health conditions considered
inadmissible on public health grounds,
the results of examinations conducted
by panel physicians in the immigrant’s
home country might not be kept
confidential because of requirements in
the country of origin making it
necessary to report HIV results to local
authorities. These results may be
counter to HHS/CDC objectives of
reflecting current scientific knowledge
and public health best practices, and
reducing stigmatization of people who
are HIV-infected. Therefore, as
discussed below in the third approach,
HIV testing, consistent with CDC’s

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recommendations for general screening,
would be available.
3. The third approach is to remove
HIV infection from the definition of
communicable disease of public health
significance and as a requirement in the
medical examination. This means that
mandatory testing for HIV infection
would no longer be required and DHS
would allow HIV-infected persons to
enter into the U.S. (or to adjust to
permanent resident status) if they meet
all other conditions of admissibility.
This is the regulatory approach that
HHS/CDC selected. Along with this
approach, all immigrants, refugees and
status adjusters would still have the
opportunity to receive information
about HIV testing and to be tested in the
United States as recommended by the
CDC guidelines [4]. The discussion of
the potential impacts of the rule that
follow relate to this approach.
C. Baseline and Incremental Analysis
The baseline for this analysis assumes
no change in the current regulation. In
other words, all applicants for
admission into the U.S. as legal
permanent residents and those already
within the U.S. seeking adjustment to
permanent resident status are currently
tested for HIV infection during the
immigration medical examination.
Those who are HIV-infected and are not
granted a waiver by the Department of
Homeland Security are refused lawful
permanent resident status in the United
States.
Currently, refugees who are HIVinfected must be granted a waiver by the
Department of Homeland Security
before entering the U.S. Subsequently,
refugees infected with HIV who are
present in the U.S. and apply for
adjustment to permanent resident status
must be re-examined and granted
another waiver from DHS at that time
(i.e., the grant of waivers permits these
individuals to obtain refugee status, and
later, permanent resident status despite
being HIV-infected, which would
otherwise render them inadmissible).
We have not explicitly included groups
other than lawful permanent residents
(e.g. refugees) in our analysis, however,
because: (i) These persons, compared to
the other immigrants, enter the U.S.
under extraordinary circumstances; (ii)
the numbers are relatively small; and,
(iii) the proposed change in regulations
is not likely to have a significant impact
on the annual number of HIV-infected
refugees admitted to the U.S. and who
later become permanent residents
because such persons generally receive
a waiver of inadmissibility for HIV
infection under current procedures.
Thus, the numbers of admitted HIV-

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56555

infected refugees who are subsequently
granted permanent resident status are
likely to stay the same, regardless of
regulations in place. That is, the HIVinfected refugees-turned-permanent
residents are part of the baseline
scenario.
Furthermore, though this policy
would increase the total number of
people who may be eligible to be
admitted, we assume that the total
number of immigrants who are annually
admitted into the United States is fixed
over time. Thus, the incremental input
to the rule is a calculation of the
additional costs due to HIV-infected
immigrants above the costs of non-HIVinfected immigrants. In general, given
that the total number of immigrants is
not likely to change and the share of
HIV-infected immigrants is likely to be
relatively small, the rule will not likely
have an appreciable impact on the
economy in terms of wages,
productivity, or prices of goods and
services.
D. Defining the Population Affected
The affected population is defined as
the number of new HIV-infected lawful
permanent residents entering the United
States each year and those individuals
already in the United States seeking to
adjust their immigration status to that of
a lawful permanent resident. The
proposed changes in 42 CFR part 34:
Medical Examination of Aliens affects
all foreign nationals entering the U.S.
who are infected with HIV. Although
HIV testing is not routinely required for
entrance into the U.S. except for those
aliens who are seeking to become lawful
permanent residents, visitors who are
infected with HIV are currently required
to request waivers to obtain entrance.
With this final rule, the waiver process
will no longer be necessary. Data on the
number of waivers granted annually
based on HIV status are not available.
For example, in Fiscal Year 2007, the
Department of State reported that its
consular officers found 746 applicants
for immigration ineligible for admission
to the U.S. under the communicable
disease grounds of INA 212(a)(1)(A)(i).
The number of applicants who tested
positive for HIV infection is unknown.
This analysis is limited to aliens seeking
to become lawful permanent residents
who are required to have a medical
examination to determine admissibility.
Because applicants such as visitors and
refugees have historically had the
option of obtaining a waiver to enter
and remain in the U.S., these groups are
not included in this analysis.
Based on the estimated distribution of
HIV/AIDS cases in each of the regions
in the world and weighted by the

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number of immigrants entering the
United States from each region, we
estimate that approximately 4.06 (range
of 1.02 to 6.09) immigrants per 1,000

immigrants that would be likely to enter
the U.S. under the proposed rule would
be infected with HIV (see Table 1 for the
summary of regional estimates and

weights and Technical Appendix II,
Table 1: Summary of Model, HIVEcon,
Inputs and Assumptions for Primary,
Lower and Upper Bound Analyses [5]).

TABLE 1—REGIONAL POPULATION, IMMIGRATION AND HIV ESTIMATES USED TO CALCULATE THE WEIGHTED REGIONAL
RATE ESTIMATES
Legal
permanent
residents
(2007) [6]
Africa * ......................................................
Asia ..........................................................
Europe ......................................................
N. America ...............................................
Oceania ....................................................
S. America ...............................................
Total .........................................................

Estimate of HIV rate per 1,000 (based on
2006 regional population estimates [7]
and 2007 HIV regional estimates [8])
Primary

96,105
383,508
120,821
339,355
6,101
106,525
1,052,415

HIV positive Rate per 1,000 U.S. immigrants † .................................................

Low

Estimated number of
HIV-infected immigrants

High

Primary

Low

High

18.05
1.29
3.23
3.84
2.19
3.20
4.98

16.70
1.05
2.46
1.42
1.55
2.81
4.35

19.57
1.63
4.38
5.61
3.50
3.79
5.73

1,735
494
390
1,302
13
341
....................

1,605
403
297
481
9
300
....................

1,880
624
529
1,903
21
404
....................

4.06

‡ 2.94

‡ 5.09

4,275

3,096

5,361

dcolon on DSK2BSOYB1PROD with RULES

* In this case, Africa includes North Africa, the Middle East and Unknowns.
** Total number of adults and children living with HIV in the region (see Technical Appendix II for more detail [5]).
† Based on weighted regional estimates. The assumption is that prevalence of HIV amongst immigrants to the U.S. mirrors that of the immigrant’s native regions and is adjusted for the number of immigrants coming to the U.S. from each region.
‡ Note: these estimates represent the 5th and 95th percentiles based on regional weight estimates. Due to concern that immigrants may not be
representative of the typical country level estimates and thus may be outside the confidence interval, for purposes of this analyses we expanded
our confidence interval to 25% to 150% of the Primary estimate (i.e. 1.02 to 6.09 HIV+ immigrants per 1,000 immigrants).

The numbers of HIV/AIDS persons in
each region of the world were taken
from the 2007 AIDS Epidemic Update:
Global Overview issued by the Joint
United Nations Programme on HIV/
AIDS (UNAIDS)[8]. HHS/CDC used
regional data and rates that were
determined using the regional
population data from 2006 published by
the Population Division of the
Department of Economic and Social
Affairs of the United Nations Secretariat
[7]. After examining the immigration
data, by region, from the Yearbook of
Immigration Statistics: 2007 Immigrants
[6], we assigned regional weights
according to the number of aliens
coming to the United States from each
region.
The 2007 Immigration Statistics [6, 9]
indicate that 1,052,415 persons became
permanent residents in 2007.
Multiplying this number by our
prevalence estimate of 4.06 (range of
1.02 to 6.09) HIV-infected immigrants
per 1000 immigrants yields an estimated
4,275 (range of 1,073 to 6,409) HIVinfected immigrants who would enter
into the United States each year.
However, we note that there are
significant uncertainties in this estimate
since no specific data exist on the HIV
prevalence of persons seeking to
immigrate to the United States. We do
not have a basis to judge how these
immigrants who qualify for permanent
residence differ from the general
regional population in terms of HIV

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prevalence; thus, for the purposes of
this analysis we assumed that it would
be equivalent to the regional HIV
prevalence rates. We used regional HIV
prevalence rates rather than HIV rates
for specific countries to allow for year
to year variations in the number of
aliens entering the U.S. from specific
countries.
There are several possible reasons as
to why the proportion of HIV-infected
immigrants could be less or more than
the prevalence of HIV-infected persons
in the region of origin. For example, the
cost of adequate medical care in the U.S.
may make HIV-infected individuals
reluctant to immigrate to this country.
With the increase in the availability of
appropriate HIV treatments in many
parts of the world, adequate treatment is
often cheaper outside of the U.S.
Conversely, in regions or specific
countries where appropriate treatment
is less readily available, the portion of
HIV-infected immigrants from those
regions could be higher than the
prevalence of HIV-infected persons in
that region.
We used a range of 1.02 to 6.09 HIVinfected persons per 1,000 immigrants
based on 25% and 150% of the mean
weighted average—4.06 per 1,000
immigrants of the number of estimated
HIV-infected persons in each region but
weighted by the number of lawful
permanent residents who entered the
U.S. in 2007. This range yields a lower
bound estimate of 1,073 and an upper

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bound estimate of 6,409 HIV-infected
persons entering the United States
annually (see Technical Appendix II
[5]).
E. Analysis of Impacts
In this final rule, HHS/CDC is
removing HIV infection from the
definition of communicable disease of
public health significance contained in
42 CFR 34.2(b) and scope of
examination, 42 CFR 34.3 because HIV
infection does not represent a
communicable disease that is a
significant threat to the general U.S.
population. The rationale for
maintaining HIV infection as an
inadmissible condition is no longer
valid based on current medical
knowledge and public health practice,
scientific knowledge, and experience
which has informed us on the
characteristics of the virus, the modes of
transmission of HIV, and the effective
interventions to prevent further spread
of the virus. To the extent the final rule
will result in an increased number of
HIV-infected immigrants to the U.S.
each year, there will be quantifiable
impacts. We have made our best attempt
to capture the likely effects of the rule,
but there are significant uncertainties in
this estimation effort.
1. Potential Benefits
The benefits from this action are
difficult to quantify. Based on the
estimate above, this rule would allow
perhaps roughly 4,275 (range of 1,073 to

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dcolon on DSK2BSOYB1PROD with RULES

6,409) persons to enter the United States
annually who are otherwise admissible
but are denied admission solely based
on their HIV status. The rule will bring
family members together who had been
barred from entry, thus strengthening
families. Also, HIV-infected immigrants
with skills in high demand would be
permitted to enter the U.S. to seek
employment and contribute as
productive members of U.S. society.
Depending on the region of the world
from which a person emigrates,
admittance to the U.S. may afford
greater opportunity, better health care,
and education and training programs
than those available in the immigrant’s
home country. These HIV-infected
individuals, compared to those who do
not receive appropriate multi-drug antiretroviral therapy for HIV treatment,
could survive an additional 13 years,
with an average life expectancy of
approximately 29 years (to age 49 years)
[10]. This increased life expectancy
allows the opportunity for longer and
improved productivity.
Further, this final rule removing HIV
infection from the definition of
communicable disease of public health
significance and from the scope of
examinations will remove
stigmatization of HIV-infected people
who have long been denied entry into
the U.S. based only on a treatable and
preventable medical condition. This
proposed rule will bring the U.S. in line
with current science and international
standards of public health.
Though this rule is assumed to not
have an impact on the total number of
immigrants annually admitted as legal
permanent residents, we note that
immigration, in general, produces net
economic gains for the United
States.[11].
2. Impact on Health Care Expenditures
As previously noted, we have made
our best attempt to capture the likely
effects of the rule, but there are
significant uncertainties in this
estimation effort. HHS/CDC notes that
this analysis is an analysis of the health
care sector costs taken from a societal
perspective; that is, all health care costs
are included, regardless of payer. The
costs to be borne by the Federal
government are only a part of the total
costs described below.
As previously discussed, the
incremental impacts of the rule should
be a comparison between the arrival of
an HIV-infected immigrant and the
arrival of an HIV-negative immigrant.
Presumably, HIV-related health care
expenditures will be different, but there
are a variety of health expenditures that
the HIV-infected immigrant may not

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incur that other immigrants may incur
(e.g., certain types of cancer, diabetes,
heart disease). It is not clear that, over
the course of a lifetime, on net an HIVinfected immigrant would consume
more health care resources than other
immigrants. Furthermore, HIV treatment
yields benefits that off-set the
expenditures, including increased life
expectancy and productivity.
However, given that health care
expenditures associated with treatment
of HIV infection can be substantial and
may result in some fiscal impacts (as
discussed below), we developed a
model (HIVEcon) to estimate these
potential effects of the rule. A complete
description of the model including
assumptions, results and limitations is
available for examination [5]. The
spreadsheet model itself is also
available for download so that the
reader can determine the relative impact
of altering almost any input value,
individually or several simultaneously
[12].
The model, HIVEcon, examines the
treatment costs as estimated by
Schackman et al [13] associated with
newly identified persons infected with
HIV regardless of payer, following the
2004 standards of care. The annual
treatment cost is estimated to be $25,200
in 2004 dollars, with a range of $19,466
to $30,954. However, significant
advances in the treatment of HIV have
been made since 2004 [14], and are
likely to continue to be made. Thus, the
expenditure estimates could be
underestimated since as treatment
options increase, the benefits such as
quality of life and lifespan will increase
as will costs. However, these
expenditures may be overestimated
since it is not clear to what extent
immigrants will seek and receive even
the 2004 standard of care. Expenditures
may also be overestimates if only
including direct medical costs, as is
done for the Ryan White Block Grant
and Medicaid Programs, where average
annual costs range from $15,738 to
$17,790 per person.
The absolute lower bound estimate is
$19 million in the first year (decreasing
the prevalence rate to 1.02 HIV+
immigrants per 1,000 immigrants and
the average annual medical
expenditures to $19,466). The maximum
upper bound estimate is $173 million
(increasing the prevalence rate to 6.09
HIV-infected immigrants among 1,000
immigrants, and the average annual
medical expenses to $30,954 per
immigrant). In the HIVEcon model, in
Year Two following the change in
regulation, as the cumulative number of
HIV-infected immigrants almost
doubles, so will these annual health

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56557

expenditures. Likewise in the third year,
the expenditures will be equivalent to
three years’ worth of immigrants
(excluding those who have passed
away) and so on until the HIV-infected
immigrants reach their life expectancy
(e.g., in the model, an HIV-infected
person at age 30 has an average life
expectancy of 24.7 years).
3. Comparison With Congressional
Budget Office Analysis
The Congressional Budget Office
(CBO) estimated the cost to the federal
government of Section 305 of PL 110–
293 prior to the law’s enactment. The
analysis included increases in direct
spending related to provision of health
care and other benefits paid for by the
federal government. Specifically, those
benefits include Medicaid,
Supplemental Security Income, Food
Stamps, and nutritional programs. In
total, CBO estimated that providing
these benefits to HIV-infected
immigrants and their citizen children
will increase spending by less than
$500,000 in 2010 and $83 million over
the 2010–2018 period, primarily for
Medicaid.
The CBO analysis was done for the
purpose of estimating the impact of PL
110–293 on the federal budget. The
analysis for this final rule was done to
comply with Executive Order 12866,
which directs agencies to assess all costs
of available regulatory alternatives,
including, but not limited to, those costs
incurred by the federal government. The
economic analysis for this regulation
differs from the CBO analysis for PL
110–293 in four major areas: (1) The
CBO analysis assumed that the HIV
prevalence rate would be equal to half
of the weighted-average HIV prevalence
rate for the immigrants’ country of
origin, whereas this analysis assumed
that the HIV prevalence rate would be
equal to the weighted-average rate of the
immigrants’ region of origin; (2) the
number of immigrants was increased by
5% each year in the CBO analysis while
this analysis did not include growth in
the annual number; (3) the CBO analysis
only examined health care costs paid for
by Medicaid whereas this analysis
included all health care costs including
those paid for by the Ryan White
Program; and (4) the CBO analysis
included costs of federal disability and
nutrition benefits, whereas this analysis
did not include those costs.
By the year 2013, the number of HIVinfected immigrants entering the U.S.
projected by the CBO analysis is roughly
equivalent to that projected by this
analysis (analytical differences in
prevalence and growth rates cancel out).
By 2018, the number of HIV-infected

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immigrants projected by the CBO
analysis exceeds projections in this
analysis. The health care costs in this
analysis exceed that of CBO’s analysis
because the former included all federal
and nonfederal costs including those
costs paid for through the federallyfunded Ryan White Program. This
analysis did not include non-health care
costs.

the HIV-infected immigrants will be
eligible for assistance through this
program. However, given that the
estimated number of new HIV-infected
immigrants entering the United States as
a result of this rule is relatively small
compared to the total number of persons
currently assisted by the funding
(roughly half a million), the overall
impact on the program is likely small.

4. Potential Fiscal Impacts
As previously discussed, even if HIVrelated health restrictions are removed
as a barrier to admission for immigrants,
all immigrants still must meet other
admission requirements. In the United
States, under the Federal Personal
Responsibility Work and Opportunity
Reconciliation Act (PRWORA) of 1996,
most immigrants are not eligible to
receive means-tested public benefits for
five years after their entry into the U.S.
[15, 16]. Federal means-tested public
benefits include Supplemental Security
Income (SSI), cash Temporary
Assistance for Needy Families (TANF),
Medicaid, and food stamps [15, 17].
State and local means-tested benefits are
determined at the state or local level
and vary by jurisdiction. We have no
data to assume that HIV-infected
immigrants will seek, five years after
being admitted to the U.S., such benefits
at rates different from non HIV-infected
immigrants.
In addition, PRWORA placed other
limitations on aliens’ access to public
benefits, making them more difficult for
aliens to obtain. For example, the
income and resources of the sponsor of
a family-based immigrant or permanent
resident are deemed to be available to
that alien if he/she should apply for
certain means-tested public benefits.
See 8 U.S.C. 1631, 1632. Since a sponsor
must first prove to DHS that he/she is
able to provide support to the sponsored
alien at an annual income that is at least
125% above the federal poverty level
before the alien’s immigration
application will be approved, it is
unlikely that the alien will be able to
show that his/her available resources
fall beneath the low income eligibility
thresholds required for many meanstested public benefits. See INA section
213A(a)(1)(A).
However, some immigrants may be
eligible for certain assistance through
the Ryan White HIV/AIDS Program—a
federally-funded program that provides
HIV-related health services. Funds are
awarded to agencies located around the
country, which in turn deliver care to
eligible individuals. Since the program
is administered through different
grantees using different eligibility
criteria, it is difficult to assess the extent

5. Onward Transmission
Though difficult to quantify with
precision, there will likely be some
additional cases of HIV infection due to
onward transmission from HIV-infected
immigrants to others in the United
States who are not currently infected.
The costs associated with onward
transmission include:
• Shortened lifespan and reduction in
quality of life even with treatment,
• The health care costs associated
with treating HIV infection,
• The costs of social services when
individuals are unable to fully support
themselves because of their illness, and
• Decreased productivity when
individuals become too sick to work.
Because health care costs are
substantial and other costs listed above
are difficult to quantify, the analysis in
the HIVEcon model is limited to health
care costs associated with treatment of
HIV infection.
In the model, the number of estimated
HIV-infected cases due to onward
transmission (in Year t) is calculated as:
[(Number of HIV-infected immigrants
entering in Year t + Number of HIVinfected immigrants surviving from
previous years that survive to Year t +
additional persons previously infected
by onward transmission from HIVinfected immigrants that survive to Year
t) x onward transmission rate].
A 1.51% onward transmission rate
was used in the HIVEcon model to
represent the annual estimated number
of new infections caused by HIVinfected immigrants to the U.S., or
caused by U.S. person infected by HIVinfected immigrants (i.e., annually every
100 HIV-infected persons infect an
additional 1.51 persons). The most
recent estimate of average onward
transmission, when limited to sexual
transmission, in the United States is
3.02 per 100 HIV positive immigrants
[18]. In 2006, the overall rate for onward
transmission of HIV in the U.S. from all
causes, was 5 new infections per 100
HIV-infected persons [19]. Results from
published research indicate that
immigrants to the United States,
regardless of their race or ethnicity,
often have an initial better health profile
than native-born Americans across
diverse health behaviors and outcomes;

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however, this health advantage declines
as length of residence in the United
States and degree of acculturation
increase [20–26]. Specifically, studies of
HIV risk behavior among immigrant
populations, upon arrival in the U.S.,
indicate that these behaviors are
influenced by a number of factors
including the demographic
characteristics of the migrants
(especially sex, social class, relationship
status and education); the purpose of
immigration; the type and location of
their receiving community and the
existing supports; discrepancy between
pre-immigration expectations and postimmigration experiences; and
transnational movement between the
U.S. and their home countries [27–31].
These multiple factors result in
heterogeneity in HIV risk between
migrant communities, with some being
at lower, and others higher risk, than
their U.S. counterparts. There is no
evidence to suggest immigration to the
U.S. significantly affects HIV incidence
in this country in one direction or the
other. Thus, it is not unreasonable to
assume that onward transmission rates
amongst HIV-infected immigrants will
be lower than among HIV-infected
persons born in the U.S.
For this analysis, we assumed that the
onward transmission rate for
immigrants, and those that they infect,
would be fifty percent of the average
U.S. rate for sexual transmission (i.e.,
rate of onward transmission from HIVinfected immigrants is assumed, in the
baseline case, to be 1.51 per 100).
Because data supporting this
assumption are limited, this assumption
was tested in sensitivity analysis. We
used 0% transmission as our lower
bound estimate and a transmission rate
of 4.53 per 100 HIV-infected
immigrants, and those that they infect,
as our upper bound estimate. The upper
bound transmission rate is a fifty
percent increase in the average annual
onward transmission rate of 3.02%.
Assuming 4,275 HIV-infected
immigrants enter in the first year, there
will be 65 new HIV infections due to
onward transmission, assuming an
onward transmission rate of 1.51 per
100 HIV, with a range of 0 to 261
(assuming onward transmission of 0 and
4.53 per 100 HIV-infected immigrants,
respectively). These estimates imply
treatment costs, for those infected via
onward transmission only, in the first
year of $1.6 million in the primary
estimate and a range of $0 to $8.1
million [5].
For the purposes of calculating new
HIV infections associated with HIVinfected immigrants in the U.S.,
HIVEcon adds persons infected by HIV-

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Federal Register / Vol. 74, No. 210 / Monday, November 2, 2009 / Rules and Regulations
infected immigrants to the cohort of
projected HIV-infected immigrants. This
modeling technique represents the
chain of onward transmission after
initial transmission from an HIVinfected immigrant. Thus, in the next
year, though the cumulative number of
HIV-infected immigrants essentially
doubles, the number of new HIV cases
(as well as the associated treatment
costs) will be slightly more than double
the previous year.
This modeling approach assumes that
those people infected by HIV-infected
immigrants would never have become
infected with HIV were it not for the
arrival in the U.S. of HIV-infected
immigrants. This could be unrealistic
since U.S. persons who are infected by
HIV-infected immigrants may engage in
behaviors that lead them to activities
that expose them to HIV infections,

regardless of the source of infection. An
alternative interpretation may be that at
least some of the additional infections
are occurring earlier than they otherwise
would have. Thus, these shifts in the
timing of infection will increase the
total number of new cases in any one
year, but the true incremental impact
may be the implications of becoming
infected earlier.
Furthermore, the model treats the
onward transmission rate as fixed over
time. However, data show that onward
transmission has declined over time[19].
If we assume that transmission rates
will continue to decrease in the future,
it is possible that the model may
overestimate the number of HIVinfected individuals due to onward
transmission as we project impacts into
the future.

56559

F. Summary of Impacts
We have made our best attempt to
capture the likely effects of the rule, but
there are significant uncertainties in this
estimation effort. For example, the
HIVEcon model projects potential
impacts out to 50 years after the rules
go into effect. However, many of the key
inputs to the model may be significantly
different even ten years from now given
the rapid pace of change in HIV
treatment, HIV prevalence in other
countries, as well as potential changes
in the overall immigration policy. It may
not be inconceivable that there would
be an HIV vaccine in the next decade or
two. Given these and other
uncertainties, Table 2 provides a
summary of the potential effects of the
rule five years after implementation.

TABLE 2—SUMMARY OF IMPACTS (YEAR FIVE AFTER IMPLEMENTATION), ASSUMING THE AVERAGE AGE OF ENTRY IS 30
YEARS AND THE ANNUAL DISCOUNT RATE IS 3%
Primary estimate
(4.06 HIV+ immigrants per 1,000
immigrants)

Category

Low estimate
(1.02 HIV+ immigrants per 1,000
immigrants)

High estimate
(6.09 HIV+ immigrants per 1,000
immigrants)

BENEFITS
Total number of HIV–Positive Immigrants present in the U.S. at
year five who would not otherwise be able to immigrate.

15,755 ...........................................

3,956 .............................................

23,622

Qualitative ......................................

1. Will reduce stigmatization of HIV-infected people.
2. Will bring family members together who had been barred from entry, thus strengthening families.
3. Will permit HIV-infected immigrants with skills in high demand would be permitted to enter the U.S. to
seek employment and contribute as productive members of U.S. Society.
4. Compared to those who don’t receive appropriate multi-drug anti-retroviral therapy, survive an additional
13 years, with an average life expectancy of approximately 29 years (to age 49 years) [10]. This increased
life expectancy allows opportunity for longer and improved productivity.
COSTS

Total number of HIV–Positive
cases due to 1.51% onward
transmission connected with
U.S. Immigrants.
Annualized Monetized Health care
Expenditures from onward transmission.

676 ................................................

170 ................................................

1,014

$14 million ....................................

$4 million ......................................

$22 million.

Qualitative ......................................

1. Shortened lifespan and reduction in quality of life even with treatment.
2. Decreased productivity.
TRANSFERS

Annualized Monetized Health care
Expenditures.

$342 million ..................................

$86 million ....................................

$513 million.

Share for Federal Payers ..............

Depends upon assumptions of who pays annualized monetized medical costs; likely to be small given restrictions on Federal assistance to new immigrants.

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NOTES: Source of estimates see Figures 1, 3, and 4 in Technical Appendix II [5].

The primary benefit of this rule is that
each year an additional 4,275 (range of
1,073 to 6,409) immigrants who
otherwise qualify for entry but are

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denied based solely on HIV status will
now be able to enter the country.
Although we are unable to quantify all
of the benefits of this change in policy,

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we believe it will help reduce
stigmatization of HIV-infected people;
bring family members together who had
been barred from entry (thus

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strengthening families); and allow HIVinfected immigrants with skills in high
demand to enter the U.S. to seek
employment and contribute as
productive members of U.S. society, and
if they are able to obtain better health
care in the United States, to improve
health outcomes and productivity.
There are also ethical, humanitarian,
distributional, and international benefits
that are important but difficult to
quantify. [We note the words of
Executive Order 12866: ‘‘Costs and
benefits shall be understood to include
both quantifiable measures (to the
fullest extent that these can be usefully
estimated) and qualitative measures of
costs and benefits that are difficult to
quantify, but nevertheless essential to
consider.’’] We observe as well that in
the context of the U.S. HIV/AIDS
prevalence, currently estimated at
roughly 1 million persons [1] the 3,956
to 23,622 HIV-infected immigrants in
five years represents 0.4% to 2.4% of
the national total of persons living with
HIV/AIDS.
The main cost of this rule is the
potential for onward transmission to
U.S. residents who are not infected with
HIV. As we noted in the previous
discussion, however, our modeling
approach assumes that those people
infected by HIV-infected immigrants
would never have become infected with
HIV were it not for the arrival in the
U.S. of HIV-infected immigrants. This
assumption will in some cases be
unrealistic, because U.S. persons who
are infected by HIV-infected immigrants
may engage in behaviors that expose
them to HIV infections, regardless of the
source of infection. It is possible, of
course, that at least some of the
additional infections are occurring
earlier than they otherwise would have.
To the extent that this is so, the shifts
in the timing of infection will increase
the total number of new cases in any
one year, but the true incremental
impact may be the implications of
becoming infected earlier.
Furthermore, the model treats the
onward transmission rate as fixed over
time. However, data show that onward
transmission has declined over time
[19]. Even given these caveats, in the
context of the new U.S. incidence of
HIV, currently estimated at roughly
56,000 [32], the number of new onward
transmission cases due to the rule
change, 65 (ranging from 0 to 261) in
year one represent 0.1% (ranging from
0 to 0.5%) of the total new annual cases
of HIV in the U.S. (as described in
Section 5. Onward Transmission). The
monetized costs including the treatment
cost of the onward transmission cases,
are relatively modest. We add, however,

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that these monetized costs are
incomplete, because they do not include
the health costs in terms of reduction in
quality of life and longevity even with
treatment.
On the other hand, health care
expenditures for immigrants, although a
quantifiable and relevant impact of the
rule, are not really ‘‘costs’’ of the
rulemaking. Unlike in the case of
onward transmission, these immigrants
already have the disease and will now
be purchasing healthcare in the U.S.
that they would have purchased in their
home country (similar to spending on
other services such as housing or
education). However, since the
spending pattern may be systematically
different for HIV immigrants, we
quantify and report these effects as a
‘‘transfer’’ from the perspective of this
rulemaking—payments from immigrants
and/or their 3rd party payers to U.S.
providers of care. We estimate the
annual transfer payments to be $86
million to $513 million. The share of
these payments by Federal payers is
likely to be small given the restrictions
on Federal benefits to new immigrants.
Given these potential impacts, we
conclude that the benefits of the rule
justify its costs, and that while we do
not believe HIV is a ‘‘communicable
disease of public health significance’’
for the purposes of admissibility
determinations, the rule may be
economically significant.
G. Literature Cited
1. CDC, HIV prevalence estimates—United
States, 2006. MMWR Morb Mortal Wkly
Rep, 2008. 57(39): p. 1073–6.
2. Marks, G., N. Crepaz, and R.S. Janssen,
Estimating sexual transmission of HIV
from persons aware and unaware that
they are infected with the virus in the
USA. AIDS, 2006. 20(10): p. 1447–50.
3. Marks, G., et al., Meta-analysis of high-risk
sexual behavior in persons aware and
unaware they are infected with HIV in
the United States: implications for HIV
prevention programs. J Acquir Immune
Defic Syndr, 2005. 39(4): p. 446–53.
4. Branson, B.M., et al., Revised
recommendations for HIV testing of
adults, adolescents, and pregnant women
in health-care settings. MMWR Recomm
Rep, 2006. 55(RR–14): p. 1–17; quiz
CE1–4.
5. CDC, Technical Appendix II: HIVEcon:
Additional notes and data on model
inputs and outputs. 2009. Available
from: http://www.cdc.gov/ncidod/dq/
laws_regs/part34/hivecon-appendix.pdf.
6. DHS, Yearbook of Immigration Statistics:
2007 Immigrants. Table 3: Persons
Obtaining Legal Permanent Resident
Status by Region and Country of Birth:
Fiscal Years 1998 to 2007. 2007.
Available from: http://www.dhs.gov/
xlibrary/assets/statistics/yearbook/2007/
table03d.xls.

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7. UN, World Population Prospects: The 2006
Revision. Population Division of the
Department of Economic and Social
Affairs of the United Nations Secretariat.,
2007. Available from: http://www.un.org/
esa/population/publications/wpp2006/
wpp2006.htm.
8. UNAIDS, 2007 AIDS Epidemic Update.
WHO Library Cataloguing-in-Publication
Data: UNAIDS/07.27E/JC1322E, 2007.
Available from: http://data.unaids.org/
pub/EPISlides/2007/2007_epiupdate_en.
pdf.
9. DHS, Yearbook of Immigration Statistics:
2007 Immigrants. Table 8: Persons
Obtaining Legal Permanent Resident
Status by Gender, Age, Marital Status,
and Occupation: Fiscal Year 2007. 2007.
Available from: http://www.dhs.gov/
xlibrary/assets/statistics/yearbook/2007/
table08.xls.
10. Life expectancy of individuals on
combination antiretroviral therapy in
high-income countries: a collaborative
analysis of 14 cohort studies. Lancet,
2008. 372(9635): p. 293–9.
11. PDEII, et al., The New Americans:
Economic, Demographic, and Fiscal
Effects of Immigration. Panel on the
Demographic and Economic Impacts of
Immigration, National Research Council,
Commission on Behavioral and Social
Sciences and Education and Behavioral
and Social Sciences and Education, ed.
J.R. Smith and B. Edmonston. 1997:
National Academies Press.
12. Borse, R.H. and M.I. Meltzer, Technical
Appendix I: HIVEcon: A model to
estimate the economic costs of
immigrants who are HIV-positive. 2009.
Available from: http://www.cdc.gov/
ncidod/dq/laws_regs/part34/hivecon.
html.
13. Schackman, B.R., et al., The lifetime cost
of current human immunodeficiency
virus care in the United States. Med
Care, 2006. 44(11): p. 990–7.
14. PAGAA, Guidelines for the Use of
Antiretroviral Agents in HIV–1–Infected
Adults and Adolescents. DHHS Panel on
Antiretroviral Guidelines for Adults and
Adolescents (PAGAA)—A Working
Group of the Office of AIDS Research
Advisory Council (OARAC), 2008: p.
1–139. Available from: http://aidsinfo.
nih.gov/contentfiles/Adultand
AdolescentGL.pdf.
15. USCIS, Interoffice memorandum:
Consolidation of Policy Regarding USCIS
Form I–864, Affidavit of Support (AFM
Update AD06–20). 2006. Available from:
http://www.uscis.gov/files/pressrelease/
AffSuppAFM062706.pdf.
16. USDA, Public Law 104–193–Aug.22,
1996. 1996. Available from: http://
www.fns.usda.gov/snap/rules/
Legislation/pdfs/PL_104-193.pdf.
17. USCIS, A quick guide to public charge
and receipt to public benefits. U.S.
Department of Homeland Security, 1999.
Available from: http://www.uscis.gov/
files/article/Public.pdf.
18. Pinkerton, S.D., How many sexuallyacquired HIV infections in the USA are
due to acute-phase HIV transmission?
AIDS, 2007. 21(12): p. 1625–9.

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19. CDC, HIV/AIDS Transmission Rates in
the United States. CDC HIV/AIDS Facts,
2008. Available from: http://
www.cdc.gov/Hiv/topics/surveillance/
resources/factsheets/pdf/
transmission.pdf.
20. Lucas, J.W., D.J. Barr-Anderson, and R.S.
Kington, Health status, health insurance,
and health care utilization patterns of
immigrant Black men. Am J Public
Health, 2003. 93(10): p. 1740–7.
Available from: http://
www.ncbi.nlm.nih.gov/entrez/
query.fcgi?cmd=Retrieve&db=PubMed&
dopt=Citation&list_uids=14534231.
21. Kenya, S., et al., Effects of immigration
on selected health risk behaviors of
Black college students. J Am Coll Health,
2003. 52(3): p. 113–20. Available from:
http://www.ncbi.nlm.nih.gov/entrez/
query.fcgi?cmd=Retrieve&db=PubMed&
dopt=Citation&list_uids=14992296.
22. Newcomb, M.D., et al., Acculturation,
sexual risk taking, and HIV health
promotion among Latinas. Journal of
Counseling Psychology, 1998. 45: p.
454–467.
23. Hines, A.M. and R. Caetano, Alcohol and
AIDS-related sexual behavior among
Hispanics: acculturation and gender
differences. AIDS Educ Prev, 1998. 10(6):
p. 533–47. Available from: http://
www.ncbi.nlm.nih.gov/entrez/
query.fcgi?cmd=Retrieve&db=PubMed&
dopt=Citation&list_uids=9883288.
24. Shedlin, M.G., C.U. Decena, and D.
Oliver-Velez, Initial acculturation and
HIV risk among new Hispanic
immigrants. J Natl Med Assoc, 2005. 97(7
Suppl): p. 32S–37S. Available from:
http://www.ncbi.nlm.nih.gov/entrez/
query.fcgi?cmd=Retrieve&db=
PubMed&dopt=Citation&list_uids=
16080455.
25. Hoffman, S., et al., HIV and sexually
transmitted infection risk behaviors and
beliefs among Black West Indian
immigrants and US-born Blacks. Am J
Public Health, 2008. 98(11): p. 2042–50.
Available from: http://
www.ncbi.nlm.nih.gov/entrez/
query.fcgi?cmd=Retrieve&db=PubMed
&dopt=Citation&list_uids=18309140.
26. McDonald, J.A., J. Manlove, and E.N.
Ikramullah, Immigration measures and
reproductive health among Hispanic
youth: findings from the national
longitudinal survey of youth, 1997–2003.
J Adolesc Health, 2009. 44(1): p. 14–24.
Available from: http://
www.ncbi.nlm.nih.gov/entrez/
query.fcgi?cmd=Retrieve&db=PubMed
&dopt=Citation&list_uids=19101454.
27. Lassetter, J.H. and L.C. Callister, The
impact of migration on the health of
voluntary migrants in western societies.
J Transcult Nurs, 2009. 20(1): p. 93–104.
Available from: http://
www.ncbi.nlm.nih.gov/entrez/
query.fcgi?cmd=Retrieve&db=PubMed
&dopt=Citation&list_uids=18840884.
28. Shedlin, M.G., et al., Immigration and
HIV/AIDS in the New York Metropolitan
Area. J Urban Health, 2006. 83(1): p. 43–
58. Available from: http://
www.ncbi.nlm.nih.gov/entrez/

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query.fcgi?cmd=Retrieve&db=PubMed
&dopt=Citation&list_uids=16736354.
29. Harawa, N.T., et al., HIV prevalence
among foreign- and US-born clients of
public STD clinics. Am J Public Health,
2002. 92(12): p. 1958–63. Available from:
http://www.ncbi.nlm.nih.gov/entrez/
query.fcgi?cmd=Retrieve&db=PubMed
&dopt=Citation&list_uids=12453816.
30. Marin, B.V., et al., Acculturation and
gender differences in sexual attitudes
and behaviors: Hispanic vs non-Hispanic
white unmarried adults. Am J Public
Health, 1993. 83(12): p. 1759–61.
Available from: http://
www.ncbi.nlm.nih.gov/entrez/
query.fcgi?cmd=Retrieve&db=PubMed
&dopt=Citation&list_uids=8259813.
31. UNAIDS and IOM, Migration and AIDS.
Int Migr, 1998. 36(4): p. 445–68.
Available from: http://
www.ncbi.nlm.nih.gov/entrez/
query.fcgi?cmd=Retrieve&db=PubMed
&dopt=Citation&list_uids=12295093.
32. CDC, HIV Incidence. 2008 (accessed May
25, 2009). Available from: http://
www.cdc.gov/hiv/topics/surveillance/
incidence.htm.

VIII. Final Regulatory Flexibility
Analysis
HHS/CDC has considered the final
rule’s effects on small entities, as
required by the Regulatory Flexibility
Act (RFA) (5 U.S.C. 601 et seq., Pub. L.
96–354) as amended by the Small
Business Regulatory Enforcement
Fairness Act of 1996 (SBREFA) (Pub. L.
104–121). The RFA establishes, as a
principle of regulation, that agencies
should tailor regulatory and
informational requirements to the size
of the entities, consistent with the
objectives of a particular regulation and
applicable statutes.
The objective of this analysis was to
compare the benefits and the costs of a
change in legislation that currently
prohibits HIV-infected immigrants from
entering the United States. HHS/CDC
carefully considered several other
alternatives, but they were either not
logistically feasible or they were not
compatible with current U.S.
regulations. This analysis appears in the
‘alternatives’ section.
HHS/CDC certifies the rule will not
have a significant impact on a
substantial number of small entities as
defined in the statute.
IX. Other Administrative Requirements
A. The Unfunded Mandates Reform Act
HHS/CDC evaluated the rule
requirements for compliance with the
Unfunded Mandates Reform Act
(UMRA) of 1995. This rule does not
contain Federal mandates under the
regulatory provisions of Title II of the
UMRA for State, local, or Tribal
Governments, nor for the private sector.

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56561

The rule’s provisions will not affect
small Governments.
B. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
Executive Order 13045 requires HHS/
CDC to determine whether the rule is
economically significant. The Executive
Order further requires HHS to determine
whether the rule would create an
environmental health or safety risk
disproportionately affecting children.
HHS/CDC has determined that this rule
does not create an environmental health
or safety risk.
C. Paperwork Reduction Act of 1995
The Paperwork Reduction Act applies
to the data collection requirements
found in 42 CFR part 34. Currently,
aliens determined to have a
communicable disease of public health
significance may request a waiver from
DHS to enter the United States under
sections 212(d)(3)(a) and 212(g) of the
INA (8 U.S.C. 1182(d)(3)(a) and 1182(g)).
HHS/CDC has approval from the Office
of Management and Budget (OMB)
under OMB Control No. 0920–0006:
Statements in Support of Application
for Waiver of Inadmissibility under the
Immigration and Nationality Act
(expiration date December 31, 2011) to
collect data pertaining to the waiver;
CDC Form 4.422–1b. HHS/CDC will
discontinue the use of this form, for a
reduction of 67 burden hours for this
approved data collection.
D. Environmental Assessment
HHS has determined that provisions
to amend 42 CFR part 34.2(b) will not
have a significant impact on the human
environment.
E. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
Executive Order 13175, entitled
‘‘Consultation and Coordination with
Indian Tribal Governments’’ (65 FR
67249, September 9, 2000), requires
agencies to develop an accountable
process to ensure ‘‘meaningful and
timely input by tribal officials in the
development of regulatory policies that
have tribal implications.’’ The Executive
Order defines the phrase ‘‘policies that
have tribal implications’’ to include
regulations and other policy statements
or actions that have ‘‘substantial direct
effects on one or more Indian tribes, on
the relationship between the Federal
government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
government and Indian tribes.’’

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HHS/CDC has determined that
provisions to amend 42 CFR Part 34 will
not have tribal implications.
F. Executive Order 12630: Governmental
Actions and Interference With
Constitutionally Protected Property
Rights
Under Executive Order 12630, if the
contemplated rule would require a
Federal taking of private property, then
a takings analysis is required. Since the
rule does not require a Federal taking of
private property, the provisions in the
Executive Order are not applicable.
G. Executive Order 13132: Federalism
Under Executive Order 13132, if the
rule would limit or preempt State
authorities, then a Federalism analysis
is required. The agency must consult
with State and local officials to
determine whether the rule would have
a substantial direct effect on State or
local Governments, as well as whether
it would either preempt State law or
impose a substantial direct cost of
compliance on them.
HHS/CDC has determined that this
rule does not have sufficient federalism
implications to warrant the preparation
of a federalism summary impact
statement.

HHS/CDC has reviewed this rule
under Executive Order 12988, on Civil
Justice Reform and determines that this
rule meets the standard in the Executive
Order.
L. Plain Language in Government
Writing
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 did
not receive any comments seeking
clarity on language used in the NPRM.
HHS/CDC has attempted to use plain
language in promulgating this Final
Rule.
List of Subjects in 42 CFR Part 34
Aliens, Health care, Scope of
examination, Passports and visas, Public
health.
■ For the reasons stated in the preamble,
the Centers for Disease Control and
Prevention, within the U.S. Department
of Health and Human Services, is
amending 42 CFR part 34 as follows:
PART 34—MEDICAL EXAMINATION OF
ALIENS
1. The authority citation for Part 34
continues to read as follows:

■

H. Executive Order 13211: Energy
Effects

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

Executive Order 13211 requires HHS/
CDC to produce a statement of energy
effects if the rule is significant or
economically significant and likely to
have a significant adverse effect on the
supply, distribution, or use of energy.
HHS/CDC has determined that this rule
does not have that effect and that a
statement of energy is not required.

§ 34.2

I. National Technology Transfer and
Advancement Act

Title 5 U.S.C.A. 601 (note) requires
agencies to assess the impact of a
regulatory action to determine whether
such an action would affect family wellbeing. HHS/CDC has assessed the
impact of this regulation and has
determined that it would not negatively
affect family well-being.

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Scope of examinations.

*

J. Assessment of Federal Regulations
and Policies on Families

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[Amended]

2. Amend § 34.2 by removing
paragraph (b)(6) and redesignating
paragraphs (b)(7) through (10) as
paragraphs (6) through (9) respectively.
■ 3. Amend § 34.3 by revising
paragraphs (b)(1)(i), (e)(1) introductory
text, (e)(2)(iv), (e)(5), and (e)(6) to read
as follows:
■

§ 34.3

This act, 15 U.S.C. 272, requires the
adoption of technical standards
developed or adopted by voluntary
consensus standards bodies in rules
promulgated by HHS. No voluntary
consensus standards are applicable and
feasible with regard to this rule.

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K. Executive Order 12988: Civil Justice
Reform

*
*
*
*
(b) * * *
(1) * * *
(i) A general physical examination
and medical history, evaluation for
tuberculosis, and serologic testing for
syphilis.
*
*
*
*
*
(e) * * *
(1) As provided in paragraph (e)(2) of
this section, a chest x-ray examination
and serologic testing for syphilis shall
be required as part of the examination
of the following:
*
*
*
*
*
(2) * * *
(iv) Exceptions. Serologic testing for
syphilis shall not be required if the alien
is under the age of 15, unless there is

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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 x-ray
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 M. tuberculosis
antigens, or chest x-ray examination for
good cause, upon application approved
by the Director.
*
*
*
*
*
(5) How and where performed. All
chest x-ray images used in medical
examinations performed under the
regulations to this part shall be large
enough to encompass the entire chest
(approximately 14 x 17 inches; 35.6 x
32.2 cm).
(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.
*
*
*
*
*
Dated: October 22, 2009.
Kathleen Sebelius,
Secretary, Department of Health and Human
Services.
[FR Doc. E9–26337 Filed 10–30–09; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 648
[Docket No. 0907281181–91369–02]
RIN 0648–AX93

Fisheries of the Northeastern United
States; Modification to the Gulf of
Maine/Georges Bank Herring Midwater
Trawl Gear Letter of Authorization
AGENCY: National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Final rule.

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