[Federal Register Volume 74, Number 210 (Monday, November 2, 2009)]
[Rules and Regulations]
[Pages 56547-56562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-26337]


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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.

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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 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

[[Page 56548]]

    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.

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 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 
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

[[Page 56549]]

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

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 statutorily-eligible adjustment 
categories. See INA Sec.  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 Sec.  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.

III. Summary of NPRM

    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 
health-related 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.

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

[[Page 56550]]

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

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 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 
HIV-infected 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 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

[[Page 56551]]

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) HIV-infected 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 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 HIV-infected persons.
    Another group of commenters maintained that any mention of 
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

[[Page 56552]]

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 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 community-based 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 
HIV-infected 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 out-of-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-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)

[[Page 56553]]

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.
    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 HIV-infected 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 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

[[Page 56554]]

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 health-related 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 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 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 HIV-infected. 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

[[Page 56555]]

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 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 HIV-infected 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-infected refugees who are 
subsequently granted permanent resident status are likely to stay the 
same, regardless of regulations in place. That is, the HIV-infected 
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-HIV-infected 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

[[Page 56556]]

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Estimate of HIV rate per 1,000 (based     Estimated number of HIV-infected
                                                                  Legal     on 2006 regional population estimates                immigrants
                                                                permanent    [7] and 2007 HIV regional estimates  --------------------------------------
                                                                residents                    [8])
                                                                (2007) [6] ---------------------------------------   Primary        Low          High
                                                                              Primary        Low          High
--------------------------------------------------------------------------------------------------------------------------------------------------------
Africa *.....................................................       96,105        18.05        16.70        19.57        1,735        1,605        1,880
Asia.........................................................      383,508         1.29         1.05         1.63          494          403          624
Europe.......................................................      120,821         3.23         2.46         4.38          390          297          529
N. America...................................................      339,355         3.84         1.42         5.61        1,302          481        1,903
Oceania......................................................        6,101         2.19         1.55         3.50           13            9           21
S. America...................................................      106,525         3.20         2.81         3.79          341          300          404
Total........................................................    1,052,415         4.98         4.35         5.73  ...........  ...........  ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
HIV positive Rate per 1,000 U.S. immigrants [dagger].........  ...........         4.06     [Dagger]     [Dagger]        4,275        3,096        5,361
                                                                                                2.94         5.09
--------------------------------------------------------------------------------------------------------------------------------------------------------
* 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]).
[dagger] 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.
[Dagger] 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) HIV-infected 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 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 HIV-infected 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 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

[[Page 56557]]

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 anti-retroviral 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 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 HIV-infected 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 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 HIV-infected 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

[[Page 56558]]

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 federally-funded Ryan White 
Program. This analysis did not include non-health care costs.
4. Potential Fiscal Impacts
    As previously discussed, even if HIV-related 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 means-
tested 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 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.
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 HIV-infected 
immigrants surviving from previous years that survive to Year t + 
additional persons previously infected by onward transmission from HIV-
infected 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 HIV-
infected immigrants to the U.S., or caused by U.S. person infected by 
HIV-infected 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; 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 post-
immigration 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 HIV-infected 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 
HIV-infected immigrants in the U.S., HIVEcon adds persons infected by 
HIV-

[[Page 56559]]

infected immigrants to the cohort of projected HIV-infected immigrants. 
This modeling technique represents the chain of onward transmission 
after initial transmission from an HIV-infected 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 HIV-infected individuals due to onward transmission as we 
project impacts into the future.

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  Low estimate (1.02 HIV+    High estimate (6.09
               Category                  HIV+ immigrants per      immigrants per 1,000     HIV+ immigrants per
                                          1,000 immigrants)           immigrants)           1,000 immigrants)
----------------------------------------------------------------------------------------------------------------
                                                    BENEFITS
----------------------------------------------------------------------------------------------------------------
Total number of HIV-Positive           15,755.................  3,956..................  23,622
 Immigrants present in the U.S. at
 year five who would not otherwise be
 able to immigrate.
----------------------------------------------------------------------------------------------------------------
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     676....................  170....................  1,014
 due to 1.51% onward transmission
 connected with U.S. Immigrants.
Annualized Monetized Health care       $14 million............  $4 million.............  $22 million.
 Expenditures from onward
 transmission.
----------------------------------------------------------------------------------------------------------------
Qualitative..........................  1. Shortened lifespan and reduction in quality of life even with
                                        treatment.
                                       2. Decreased productivity.
----------------------------------------------------------------------------------------------------------------
                                                    TRANSFERS
----------------------------------------------------------------------------------------------------------------
Annualized Monetized Health care       $342 million...........  $86 million............  $513 million.
 Expenditures.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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 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, we believe it will help reduce 
stigmatization of HIV-infected people; bring family members together 
who had been barred from entry (thus

[[Page 56560]]

strengthening families); and allow HIV-infected 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, 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

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1997: National Academies Press.
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model to estimate the economic costs of immigrants who are HIV-
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immunodeficiency virus care in the United States. Med Care, 2006. 
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Infected Adults and Adolescents. DHHS Panel on Antiretroviral 
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the Office of AIDS Research Advisory Council (OARAC), 2008: p. 1-
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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.
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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.
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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.
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HIV health promotion among Latinas. Journal of Counseling 
Psychology, 1998. 45: p. 454-467.
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behavior among Hispanics: acculturation and gender differences. AIDS 
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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. 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.''

[[Page 56562]]

    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.

H. Executive Order 13211: Energy Effects

    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.

I. National Technology Transfer and Advancement Act

    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.

J. Assessment of Federal Regulations and Policies on Families

    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 well-being. HHS/CDC has assessed the impact of this regulation 
and has determined that it would not negatively affect family well-
being.

K. Executive Order 12988: Civil Justice Reform

    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.

0
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

0
1. The authority citation for Part 34 continues to read as follows:

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


Sec.  34.2  [Amended]

0
2. Amend Sec.  34.2 by removing paragraph (b)(6) and redesignating 
paragraphs (b)(7) through (10) as paragraphs (6) through (9) 
respectively.

0
3. Amend Sec.  34.3 by revising paragraphs (b)(1)(i), (e)(1) 
introductory text, (e)(2)(iv), (e)(5), and (e)(6) to read as follows:


Sec.  34.3  Scope of examinations.

* * * * *
    (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 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]
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