Medical Examination of Aliens-Removal of Human Immunodeficiency Virus (HIV) Infection From Definition of Communicable Disease of Public Health Significance, 56547-56562 [E9-26337]

Agencies

• Centers for Disease Control and Prevention
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 74, Number 210 (Monday, November 2, 2009)]
[Rules and Regulations]
[Pages 56547-56562]
From the Federal Register Online via the Government Printing 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: 
https://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: https://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: https://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: https://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: https://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