[Federal Register Volume 74, Number 126 (Thursday, July 2, 2009)]
[Proposed Rules]
[Pages 31798-31809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-15814]



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Part II





Department of Health and Human Services





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Centers for Disease Control and Prevention



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42 CFR Part 34



Medical Examination of Aliens--Removal of Human Immunodeficiency Virus 
(HIV) Infection From Definition of Communicable Disease of Public 
Health Significance; Proposed Rule

  Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / 
Proposed Rules  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

42 CFR Part 34

[Docket No. CDC-2008-0001]
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: Notice of Proposed Rulemaking (NPRM).

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SUMMARY: The Centers for Disease Control and Prevention (CDC), within 
the U.S. Department of Health and Human Services (HHS), is proposing to 
revise the Part 34 regulation to remove ``Human Immunodeficiency Virus 
(HIV) infection'' from the definition of ``communicable disease of 
public health significance.'' HHS/CDC is also proposing to remove 
references to ``HIV'' from the scope of examinations in its 
regulations. Aliens infected with a ``communicable disease of public 
health significance'' are inadmissible into the United States under the 
Immigration and Nationality Act (INA).
    The Tom Lantos and Henry Hyde United States Global Leadership 
Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 
(the July 2008 legislation reauthorizing the President's Emergency Plan 
for AIDS Relief (PEPFAR)) removed language from the INA which had 
previously mandated that HIV be on the list of diseases that can bar 
entry to the U.S. This legislative change allowed HHS/CDC to reassess 
whether HIV infection should be retained or removed from regulations 
based on sound public health science and current understanding of HIV 
epidemiology. There are other diseases, including sexually transmitted 
diseases, which CDC may remove from the definition of ``communicable 
disease of public health significance'' through future rulemaking after 
scientific review.
    While HIV infection is a serious health condition, it does not 
represent a communicable disease that is a significant threat for 
introduction, transmission, and spread to the U.S. population through 
casual contact. As a result of these proposed regulatory changes, 
aliens would no longer be inadmissible into the United States based 
solely on the grounds they are infected with HIV and they would no 
longer undergo HIV testing as part of the routine medical examination.

DATES: Written comments must be received on or before August 17, 2009. 
Comments received after August 17, 2009 will be considered to the 
extent possible.

ADDRESSES: You may submit written comments, identified by Docket No. 
CDC-2008-0001 to the following address: Division of Global Migration 
and Quarantine, Centers for Disease Control and Prevention, U.S. 
Department of Health and Human Services, Attn: Part 34 NPRM Comments, 
1600 Clifton Road, NE., MS E-03, Atlanta, Georgia 30333. You may also 
submit written comments electronically via the Internet at the 
following Address: http://regulations.gov, or via e-mail to 
[email protected].
    Comments will be available for public inspection from Monday 
through Friday, except for legal holidays, from 9 a.m. until 5 p.m., 
Eastern Time, at 1600 Clifton Road, NE., Atlanta, Georgia 30333. Please 
call ahead to 1-404-498-1600, and ask for a representative in the 
Division of Global Migration and Quarantine to schedule your visit.
    Comments will also be available for viewing at the following 
Internet address: http://www.cdc.gov//ncidod/dq. To download an 
electronic version of the NPRM, please go to the following Internet 
address: http://regulations.gov.

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 1-404-498-1600.

SUPPLEMENTARY INFORMATION:
    The NPRM is organized as follows:

I. Legal Authority
II. Background
    i. Inadmissibility and the Medical Examination
    ii. Legislative and Regulatory History
    iii. Immigration and Relevant Visa Categories
    iv. Current Scientific Knowledge for HIV Transmission
    v. Global Context
III. Summary of Proposed Changes to 42 CFR part 34
IV. Required Regulatory Analyses Under Executive Order 12866
V. Regulatory Flexibility Analysis
VI. Other Administrative Requirements

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

i. Inadmissibility and the Medical Examination

    Under section 212(a)(1) of the Immigration and Nationality Act 
(INA) (8 U.S.C. 1182(a)(1)), any alien who is determined to have a 
communicable disease of public health significance is inadmissible to 
the United States. Those aliens outside the United States with a 
communicable disease of public health significance (see below) are 
ineligible to receive a visa and ineligible for admission into the 
United States. The grounds of inadmissibility for specified health-
related grounds also pertain to aliens in the United States who are 
applying for adjustment of their status to that of a lawful permanent 
resident.
    In addition to other potential grounds of inadmissibility, aliens 
are inadmissible if they are determined: (1) To have a communicable 
disease of public health significance (as currently defined by 
regulations); (2) to have a physical or mental disorder and behavior 
associated with that disorder that may pose, or has posed, a threat to 
the property, safety, or welfare of the alien or others; (3) to have 
had a physical or mental disorder and a history of behavior associated 
with the disorder, which has posed a threat to the property, safety, or 
welfare of the alien or others and which is likely to recur or lead to 
other harmful behavior; or (4) to be a drug abuser or addict. Further, 
except for certain adopted children 10 years of age or younger, any 
alien who seeks admission as an immigrant, or seeks adjustment of their 
immigration status to that of a lawful permanent resident, is 
inadmissible if the alien fails to present documentation of having 
received vaccination against vaccine-preventable diseases, including 
mumps, measles, rubella, polio, tetanus and diphtheria toxoids, 
pertussis, Haemophilus influenzae type B, hepatitis B, and any other 
vaccination against vaccine-preventable disease recommended by the 
Advisory Committee for Immunization Practices (ACIP).
    Medical examinations, including a physical and mental evaluation, 
to determine whether an alien could have such a health-related 
condition, are authorized under section 232 of the INA. (8 U.S.C. 1222) 
Under sections 212(a)(1) and 232 of the INA, and section 325 of the 
Public Health Service Act (42 U.S.C. 252), the Secretary of

[[Page 31799]]

Health and Human Services (HHS) promulgates regulations establishing 
the requirements for the medical examination and lists the health-
related conditions that make aliens ineligible for admission into the 
United States. The regulations, administered by the HHS/Centers for 
Disease Control and Prevention (CDC), are promulgated at 42 CFR part 
34.
    The provisions in 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.
    On October 6, 2008, HHS/CDC revised 42 CFR part 34 to amend the 
definition of communicable disease of public health significance and 
revise the scope of the medical examination. This update addressed 
emerging and reemerging diseases in immigrant or refugee populations 
who are bound for the United States. See 73 FR 58047 and 73 FR 62210. 
The current definition of communicable disease of public health 
significance contained in 42 CFR 34.2(b) includes: active tuberculosis, 
infectious syphilis, gonorrhea, infectious leprosy, chancroid, 
lymphogranuloma venereum, granuloma inguinale, and HIV infection; 
quarantinable diseases designated by Presidential Executive Order; and 
a communicable disease that may pose a public health emergency of 
international concern in accordance with the International Health 
Regulations of 2005, provided it meets specified criteria.
    Panel physicians, designated by Department of State (DoS) consular 
officers, perform medical examinations on refugees and/or persons 
living outside of the United States who are seeking to immigrate to the 
United States, and civil surgeons, designated by U.S. Citizenship and 
Immigration Services within DHS, perform medical examinations for 
aliens who are already present in the United States seeking a change of 
status. Aliens determined to have a communicable disease of public 
health significance may request a waiver of inadmissibility to enter 
the United States under sections 207(c)(3), 212(d)(3)(A) and 212(g) of 
the INA (8 U.S.C. 1157(c)(3), 1182(d)(3)(A) and 1182(g)).
    HHS/CDC issues Technical Instructions and provides the technical 
consultation and guidance to panel physicians and civil surgeons who 
conduct the medical examinations of aliens. The CDC Technical 
Instructions for Medical Examination of Aliens, including the most 
current updates, which 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.

ii. Legislative and Regulatory History

    Beginning in 1952, the INA mandated that aliens ``who are afflicted 
with any dangerous contagious disease'' are ineligible to receive a 
visa and are to be excluded from admission into the United States. In 
April, 1986, prior to the recent developments in medicine and 
epidemiologic principles, HHS proposed to include acquired 
immunodeficiency syndrome (AIDS) as a dangerous contagious disease and 
in June, 1987 issued a final rule adopting the proposal. 51 FR 15354 
(April 23, 1986); 52 FR 21532 (June 8, 1987). Separately, HHS proposed 
to substitute HIV infection for AIDS on the list of dangerous 
contagious diseases since individuals who are so infected, but do not 
actually have AIDS, are also contagious. 52 FR 21607 (June 8, 1987). 
While the proposed rule was pending for public comment, Congress added 
HIV infection to the list of dangerous contagious diseases. Public Law 
100-71, section 518, 101 Stat. 475 (July 11, 1987). HHS issued final 
regulations in August of that year complying with the congressional 
mandate. 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 because of infection 
with a dangerous contagious disease. 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. 56 FR 2484 (January 23, 1991). 
Based on comments received and reconsideration of the issues, HHS 
published an interim final rule retaining all diseases on the list, 
including HIV infection, and committing its initial proposal for 
further study. 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 the summer of 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 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, Public Law 110-293, section 305, 122 Stat. 2963 (July 30, 
2008). In this Notice of Proposed Rulemaking, HHS/CDC is proposing this 
action to remove HIV infection from the definition of communicable 
disease of public health significance. While HIV infection is a serious 
health condition, it does not represent a communicable disease that is 
a significant threat for introduction, transmission, and spread to the 
United States population through casual contact. An arriving alien with 
HIV infection does not pose a public health risk to the general 
population through casual contact.

iii. Immigration to the U.S. and Relevant Visa Categories

    Annually, the U.S. Government admits more than 1,000,000 immigrants 
and refugees to reside permanently in this country.
    Foreign citizens who wish to live permanently in the United States 
must comply with U.S. immigration law and specific procedures for 
applying for an immigrant visa or adjustment of status. The four main 
immigrant visa classifications are: (1) Immediate

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relatives, that is, the spouse, child (unmarried and under 21 years of 
age) or parent of a U.S. citizen (a citizen must be at least 21 years 
old to file a petition for a parent); (2) Family-Based immigrants 
(adult sons or daughters of citizens, the siblings of citizens who are 
at least 21 years old, and the spouse, child, or adult sons or 
daughters of lawful permanent residents); (3) Employment-Based 
immigrants; and (4) immigrant visas available to ``Diversity'' 
immigrants who obtain by lottery the ability to seek one of these 
visas. The immigration of immediate relatives is not subject to 
numerical restrictions; thus, an immigrant visa is available to a 
qualified immediate relative upon approval of the citizen relative's 
visa petition. Each month, the U.S. Department of State (DoS) publishes 
a Visa Bulletin, indicating the availability of Family-Based, 
Employment-Based, and Diversity immigrant visas for the next month. The 
monthly Visa Bulletin is available on the Department of State's Web 
site (http://travel.state.gov).
    Aliens who are already in the United States may apply to adjust to 
permanent resident status pursuant to the family-based and employment-
based categories described above, as well as several other statutorily-
eligible adjustment categories. See INA section 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 section 209; 8 U.S.C. 
1159.
    An alien seeking permanent residence, whether through an immigrant 
or refugee visa or through an adjustment of status, must undergo a 
medical examination to determine whether the alien is inadmissible on 
medical grounds. 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. Under the proposed rule, testing 
for HIV infection would be eliminated from these medical examinations.
    Additionally, Temporary Protected Status (TPS) is another 
immigration mechanism for eligible aliens who are in the United States 
and whose countries have been designated for TPS due to ongoing armed 
conflict, natural disasters, or certain other extraordinary and 
temporary conditions. INA section 244; 8 U.S.C. 1255a; 8 CFR Part 244. 
TPS applicants are also subject to the medical grounds of 
inadmissibility. Currently, if a TPS applicant is infected with HIV, 
DHS requires that the applicant be granted a waiver of inadmissibility 
before TPS can be granted.
    Section 101(a)(42)(A) of the INA generally defines refugees as 
persons who cannot return to their country because of persecution or 
the well founded fear of persecution based on race, religion, 
nationality, membership in a particular social group, or political 
opinion. An applicant is preliminarily approved for refugee status 
overseas, but is admitted as a refugee upon admission to the U.S. at a 
port of entry. A refugee is also subject to the medical grounds of 
inadmissibility and the medical examination requirements. See INA 
section 207; 8 U.S.C. 1157; 8 CFR Part 207.

vi. Current Scientific Knowledge for HIV Transmission

    While HIV infection is a serious health condition, it does not 
represent a communicable disease that is a significant threat for 
introduction, transmission, and spread to the United States population 
through casual contact as is the case with other serious conditions 
such as tuberculosis. An arriving alien with HIV infection does not 
pose a public health risk to the general population through casual 
contact.
    CDC has determined that HIV infection is transmitted among 
individuals in the United States almost exclusively by the following 
mechanisms: Unprotected sexual intercourse with an HIV-infected person, 
sharing needles or syringes contaminated with HIV, and mother-to-child 
transmission of HIV before or during birth or through breast feeding. 
Additionally, HIV can be transmitted through transfusion of blood or 
blood products infected with HIV. However, there has been continuous 
screening for HIV in all donated blood since 1985. Therefore, the risk 
for HIV infection through transfusion is extremely low. The U.S. blood 
supply is considered among the safest in the world. Interventions have 
been successful at mitigating exposure to and transmission of HIV.

v. 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'' which 
provides guidance to governments regarding 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.
    There are a dozen countries that deny entry if a person has HIV. 
These countries are: Armenia, Brunei, Iraq, Libya, Moldova, Oman, 
Qatar, the Russian Federation, Saudi Arabia, South Korea, Sudan, and 
the United States.
    This proposed rule will remove the United States from the list of 
countries that continue to have entry restrictions for HIV-infected 
individuals.

III. Summary of Proposed Changes to 42 CFR Part 34

    This proposed rule removes HIV infection from the definition of 
communicable diseases of public health significance as defined in 42 
CFR 34.2(b) and scope of examinations in 42 CFR 34.3.

Section 34.2(b) Communicable Diseases of Public Health Significance

    This provision defines communicable disease of public health 
significance as both a specific list of diseases and categories of 
diseases for which all aliens are inadmissible to the United States. 
HHS/CDC is proposing to remove human immunodeficiency virus (HIV) 
infection from the specific list of communicable disease of public 
health significance as provided for in 42 CFR 34.2(b).
    As described above, inclusion of HIV in this definition is no 
longer statutorily mandated. As a result, the Secretary of HHS has the 
discretion to determine whether to leave HIV infection in the 
definition or remove it.
    In consideration of epidemiologic principles and current medical 
knowledge regarding the mode of HIV transmission, HHS/CDC is proposing 
to remove HIV infection from 42 CFR part 34 because HIV infection does 
not represent a communicable disease of public health significance. HIV 
is not a significant threat for introduction and spread through casual 
contact to the general U.S. population, where HIV infection already 
exists among the U.S. population as an endemic disease.
    Under current regulatory requirements, aliens who test positive for 
HIV infection can apply for a waiver from DHS and, if granted such a 
waiver, are allowed admission into the United States or to adjust 
status.
    Diseases transmissible through aerosol or respiratory droplets such 
as tuberculosis pose a much greater risk due to casual contact for 
introduction and spread in the U.S. population. While HIV infection 
continues to be a disease of public health concern throughout the 
world, HIV infection is preventable by avoiding high risk sexual

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contact or needle-sharing with HIV-infected persons. Interventions have 
been successful at mitigating exposure to and transmission of HIV.
    The rationale for maintaining HIV infection as an excludable 
condition is no longer valid based on current medical knowledge and 
practice, scientific knowledge, and experience which has informed us on 
characteristics of the virus, the modes of transmission of HIV, and 
interventions for prevention and further spread of the virus. Indeed, 
HIV infection is not spread by casual contact, through the air, or from 
food, water or other objects. An HIV-infected person in a common public 
setting will not place another individual at risk. HIV is a fragile 
virus and cannot live for very long outside the body. The virus is not 
transmitted by mosquitoes, or through day-to-day activities such as 
shaking hands, hugging, or a casual kiss. HIV infection cannot be 
acquired from a toilet seat, drinking fountain, doorknob, eating 
utensils, drinking glasses, food, or pets.

Section 34.3 Scope of Examinations

    HHS/CDC is also proposing 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 
current definition of communicable disease of public health 
significance and directly relates to the diseases list in Section 34.2 
(b) of 42 CFR Part 34. It does not provide specific testing 
requirements for other health-related conditions which are not included 
in the current definition of communicable disease of public health 
significance. Therefore, HHS/CDC is proposing to remove the specific 
testing requirements for HIV infection in 42 CFR 34.3.

IV. 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 proposed rule may be an economically significant action under the 
Executive Order.
    In the analysis that follows, we assess the potential impacts of 
removing HIV 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. We are seeking comments 
on this preliminary regulatory impact analysis, including the 
identification of potential data sources that would allow us to more 
appropriately characterize and estimate the impact of the proposed 
rule.

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 as a ``communicable 
disease of public health significance.'' Now that the statute provides 
discretion, HHS/CDC is proposing to take this action to reflect current 
scientific knowledge and public health best practices, and to reduce 
stigmatization of and discrimination against people who are HIV-
infected. This proposed rule is not intended to correct any market 
failure, but to remove a government-imposed barrier that does not 
appear to provide a significant public health benefit and is at odds 
with human rights considerations.

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 excludable 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 threat for 
introduction, transmission, and spread to the U.S. population through 
casual contact. Currently, there are already roughly 1 million persons 
in the United States living with HIV [1]. Thus, maintaining HIV 
infection on the list of excludable 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 continues discriminatory practices and 
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 diseases 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 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 a 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

[[Page 31802]]

mandatory HIV testing would differentiate HIV 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 exams 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. DHS would also 
know an applicant's HIV status (while not necessarily other serious 
health conditions) due to this information being included on medical 
notification form and could be used by DHS in evaluating the 
possibility of the alien becoming a public charge. 42 CFR 
34.3(b)(ii)(5). These results may be counter to HHS/CDC objectives of 
reflecting current scientific knowledge and public health best 
practices, and reducing stigmatization of and discrimination against 
people who are HIV-infected. Therefore, as discussed below in the 3rd 
approach, HIV testing, consistent with CDC's recommendations for 
general screening, would be available.
    Although the approach of removing HIV from the definition of 
communicable disease of public health significance but maintaining the 
mandatory testing component of the medical examination was not selected 
for this proposal, HHS/CDC welcomes public comment on the advantages 
and disadvantages of this or alternative approaches, such as (non-
mandatory) testing (i.e., opt out/opt in approach).
    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 
during the immigration medical exam. 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 refugees and TPS-turned permanent residents 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 the medical examination of aliens regulations 
affect 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. If this rule is 
finalized, that waiver process will no longer be necessary. Data on the 
number of waivers granted annually based on HIV status are not 
available but costs to obtain waivers are thought to be minimal. For 
example, in Fiscal Year 2007, the Department of State reported that its 
consular officers found 746 immigrants ineligible for admission to the 
U.S. under the communicable disease grounds of INA 212(a)(1)(A)(i). Of 
those immigrants 327 overcame the initial finding. What portion of 
those 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 visitors, refugees and TPS applicants 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 number of immigrants 
entering the United States from each region, we estimate that 
approximately 4.06 immigrants per 1000 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]).

[[Page 31803]]



    Table 1--Regional Population, Immigration and HIV Estimates Used To Calculate the Weighted Regional Rate
                                                    Estimates
----------------------------------------------------------------------------------------------------------------
                                                 Estimate of HIV rate per 1,000      Estimated number of HIV
                                                    (based on 2006 regional            infected immigrants
                                      Legal       population estimates [7] and  --------------------------------
                                    permanent     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        4.06   [Dagger]   [Dagger]      4,275      3,096     5,361
                   [dagger]                                     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 typcial 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 HIV-infected immigrants per 1000 
immigrants yields an estimated 4,275 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 whether 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 are seeking comments on these assumptions and data that 
would further allow us to refine our estimates.
    However, we also conducted sensitivity analyses to assess the 
impact of altering this assumption. 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 (high and low 
estimates) 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]). 
Because the impact of the proposed rule change is highly sensitive to 
HIV prevalence in aliens entering the U.S., we are seeking comment on 
these assumptions.

E. Benefits

    HHS/CDC is proposing to remove 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 excludable 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.
    The benefits from this action are difficult to quantify. Based on 
the estimate above, this rule would allow perhaps roughly 4,000 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

[[Page 31804]]

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 proposed rule to remove HIV infection from the list 
of communicable disease of public health significance and from the 
scope of examinations will remove stigmatization of and discrimination 
against 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 and human rights practice.
    Though this rule is assumed to not have an impact on the total 
number immigrants annually admitted as legal permanent residents, we 
note that immigration, in general, produces net economic gains for the 
United States. Overall, an NRC study estimated that immigrants, in 
general, create an annual economic impact of between $1 billion to $10 
billion [11].
    HHS/CDC welcomes comments on these and other benefits associated 
with the proposed regulatory change.

F. Costs

    To the extent the proposed 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. HHS/CDC encourages public comment on costs 
associated with this rulemaking and, in particular, additional 
information that would provide a basis for more robust qualitative 
discussion or quantitative estimates.
Impact on Health Care Expenditures
    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 
healthcare 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 
offset 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 comment [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 an 
underestimate since as treatment options increase, the benefits such as 
quality of life and lifespan will increase but so will costs. However, 
these expenditures may be overestimates since it is not clear to what 
extent immigrants will seek and receive even the 2004 standard of care.
    Therefore, assuming 0% onwards transmission from HIV-infected 
immigrants entering at an average age of 20 years, an average annual 
medical expenditures of $25,200 annually, an HIV prevalence rate among 
immigrants of 4.06 per 1,000, and a 3% annual discount rate, the 
primary estimate of the present value of lifetime medical costs for 
persons identified as HIV-infected in Year One is $94 million in the 
first year. 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+ 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 regulations, as the 
cumulative number of HIV-infected immigrants almost doubles, so will 
these 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).
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. This analysis 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

[[Page 31805]]

analysis (analytical differences in prevalence and growth rates cancel 
out). By 2018, the number of HIV-infected 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-healthcare costs.
    We are seeking comments on these assumptions and data that would 
further allow us to refine our estimates. We welcome comment on the 
estimated prevalence of HIV among those likely to immigrate based on, 
for example, humanitarian waivers or other sources of available data.
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 such 
benefits in the first place. 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 
Sec.  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 to what 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 are relatively small (around 4,000 
annually) 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.
Onward Transmission
    Though difficult to quantify with precision, there will likely be 
some additional cases of HIV 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

[[Page 31806]]

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-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 shows 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.

G. Summary of Impacts

    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 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      High  Estimate  (6.09
             Category                HIV+  immigrants  per      HIV+  immigrants  per     HIV+  immigrants  per
                                       1,000  immigrants)        1,000  immigrants)        1,000  immigrants)
----------------------------------------------------------------------------------------------------------------
                        HIV-POSITIVE IMMIGRANTS AT YEAR 5 (EXCLUDING ONWARD TRANSMISSION)
----------------------------------------------------------------------------------------------------------------
Total number of HIV-Positive       15,755...................  3,956...................  23,622.
 Immigrants present in the U.S.
----------------------------------------------------------------------------------------------------------------
Annualized Monetized Healthcare    $342 million.............  $86 million.............  $513 million.
 Expenditures.
----------------------------------------------------------------------------------------------------------------
Benefits (Qualitative)...........   1. Reduce stigmatization of and discrimination against HIV-infected people.
                                   2. 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.
----------------------------------------------------------------------------------------------------------------
                          HIV-POSITIVE CASES AT YEAR 5 DUE TO 1.51% ONWARD TRANSMISSION
----------------------------------------------------------------------------------------------------------------
Total number of HIV-Positive       676......................  170.....................  1,014.
 cases due to 1.51% onward
 transmission connected with U.S.
 Immigrants.
----------------------------------------------------------------------------------------------------------------
Annualized Monetized Healthcare    $96 million..............  $24 million.............  $145 million.
 Expenditures.
----------------------------------------------------------------------------------------------------------------
                                                    TRANSFERS
----------------------------------------------------------------------------------------------------------------
Federal Annualized Monetized.....     Depends upon assumptions of who pays annualized monetized medical costs.
----------------------------------------------------------------------------------------------------------------


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

    In the context of the U.S. HIV/AIDS prevalence, currently estimated 
at roughly 1 million persons [1] the 4,275 HIV-infected immigrants 
represents only 0.4% of the national total of persons living with HIV/
AIDS. In the context of the new U.S. incidence of HIV, currently 
estimated at roughly 56,000 [32], the onward transmission of 272 by 
year five represents only 0.5% of the new cases.
    In the primary estimate, the monetized costs, mainly the treatment 
cost of the onward transmission cases are relatively modest. In terms 
of health care expenditures for immigrants, by Year Five there will be 
a cumulative total of 15,755 HIV-infected immigrants living in the 
U.S., with another 676 cases occurring due to onward transmission 
(total: 16,431) (Table 2) These cases will incur $438 million of 
medical expenses in Year Five.
    We conclude 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

[[Page 31807]]

economically significant. However, due to all of the uncertainties 
previously discussed, we solicit comments on this tentative conclusion.

H. Literature Cited

    1. CDC, HIV prevalence estimates--United States, 2006. MMWR Morb 
Mortal Wkly Rep, 2008. 57(39): p. 1073-6.
    2. Marks, G., N. Crepaz, and R.S. Janssen, Estimating sexual 
transmission of HIV from persons aware and unaware that they are 
infected with the virus in the USA. AIDS, 2006. 20(10): p. 1447-50.
    3. Marks, G., et al., Meta-analysis of high-risk sexual behavior 
in persons aware and unaware they are infected with HIV in the 
United States: implications for HIV prevention programs. J Acquir 
Immune Defic Syndr, 2005. 39(4): p. 446-53.
    4. Branson, B.M., et al., Revised recommendations for HIV 
testing of adults, adolescents, and pregnant women in health-care 
settings. MMWR Recomm Rep, 2006. 55(RR-14): p. 1-17; quiz CE1-4.
    5. CDC, Technical Appendix II: HIVEcon: Additional notes and 
data on model inputs and outputs. 2009. Available from: http://www.cdc.gov/ncidod/dq.
    6. DHS, Yearbook of Immigration Statistics: 2007 Immigrants. 
Table 3: Persons Obtaining Legal Permanent Resident Status by Region 
and Country of Birth: Fiscal Years 1998 to 2007. 2007. Available 
from: http://www.dhs.gov/xlibrary/assets/statistics/yearbook/2007/table03d.xls.
    7. UN, World Population Prospects: The 2006 Revision. Population 
Division of the Department of Economic and Social Affairs of the 
United Nations Secretariat, 2007. Available from: http://www.un.org/esa/population/publications/wpp2006/wpp2006.htm.
    8. UNAIDS, 2007 AIDS Epidemic Update. WHO Library Cataloguing-
in-Publication Data: UNAIDS/07.27E/JC1322E, 2007. Available from: 
http://data.unaids.org/pub/EPISlides/2007/2007_epiupdate_en.pdf.
    9. DHS, Yearbook of Immigration Statistics: 2007 Immigrants. 
Table 8: Persons Obtaining Legal Permanent Resident Status by 
Gender, Age, Marital Status, and Occupation: Fiscal Year 2007. 2007. 
Available from: http://www.dhs.gov/xlibrary/assets/statistics/yearbook/2007/table08.xls.
    10. Life expectancy of individuals on combination antiretroviral 
therapy in high-income countries: a collaborative analysis of 14 
cohort studies. Lancet, 2008. 372(9635): p. 293-9.
    11. PDEII, et al., The New Americans: Economic, Demographic, and 
Fiscal Effects of Immigration. Panel on the Demographic and Economic 
Impacts of Immigration, National Research Council, Commission on 
Behavioral and Social Sciences and Education, ed. J.R. Smith and B. 
Edmonston. 1997: National Academies Press.
    12. Borse, R.H. and M.I. Meltzer, Technical Appendix I: HIVEcon: 
A model to estimate the economic costs of immigrants who are HIV-
positive. 2009. Available from: http://www.cdc.gov/ncidod/dq.
    13. Schackman, B.R., et al., The lifetime cost of current human 
immunodeficiency virus care in the United States. Med Care, 2006. 
44(11): p. 990-7.
    14. PAGAA, Guidelines for the Use of Antiretroviral Agents in 
HIV-1-Infected Adults and Adolescents. DHHS Panel on Antiretroviral 
Guidelines for Adults and Adolescents (PAGAA)--A Working Group of 
the Office of AIDS Research Advisory Council (OARAC), 2008: p. 1-
139. Available from: http://aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL.pdf.
    15. USCIS, Interoffice memorandum: Consolidation of Policy 
Regarding USCIS Form I-864, Affidavit of Support (AFM Update AD06-
20). 2006. Available from: http://www.uscis.gov/files/pressrelease/AffSuppAFM062706.pdf.
    16. USDA, Public Law 104-193-Aug.22, 1996. 1996. Available from: 
http://www.fns.usda.gov/snap/rules/Legislation/pdfs/PL_104-193.pdf.
    17. USCIS, A quick guide to public charge and receipt to public 
benefits. U.S. Department of Homeland Security, 1999. Available 
from: http://www.uscis.gov/files/article/Public.pdf.
    18. Pinkerton, S.D., How many sexually-acquired HIV infections 
in the USA are due to acute-phase HIV transmission? AIDS, 2007. 
21(12): p. 1625-9.
    19. CDC, HIV/AIDS Transmission Rates in the United States. CDC 
HIV/AIDS Facts, 2008. Available from: http://www.cdc.gov/Hiv/topics/surveillance/resources/factsheets/pdf/transmission.pdf.
    20. Lucas, J.W., D.J. Barr-Anderson, and R.S. Kington, Health 
status, health insurance, and health care utilization patterns of 
immigrant Black men. Am J Public Health, 2003. 93(10): p. 1740-7. 
Available from: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=14534231.
    21. Kenya, S., et al., Effects of immigration on selected health 
risk behaviors of Black college students. J Am Coll Health, 2003. 
52(3): p. 113-20. Available from: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=14992296.
    22. Newcomb, M.D., et al., Acculturation, sexual risk taking, 
and HIV health promotion among Latinas. Journal of Counseling 
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    23. Hines, A.M. and R. Caetano, Alcohol and AIDS-related sexual 
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Assoc, 2005. 97(7 Suppl): p. 32S-37S. Available from: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=16080455.
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    26. McDonald, J.A., J. Manlove, and E.N. Ikramullah, Immigration 
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    31. UNAIDS and IOM, Migration and AIDS. Int Migr, 1998. 36(4): 
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    32. CDC, HIV Incidence. 2008 (accessed May 25, 2009). Available 
from: http://www.cdc.gov/hiv/topics/surveillance/incidence.htm.

V. Regulatory Flexibility Analysis

    HHS/CDC has considered the proposed 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

[[Page 31808]]

logistically feasible or inconsistent with current public health 
practice. This analysis appears in the `Alternatives' section.
    HHS/CDC certifies the proposed rule will not have a significant 
impact on a substantial number of small entities as defined in the 
statute.

VI. 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 of general applicability is consistent with 
these principles.

 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 is the form that is required in support of a 
waiver of inadmissibility for HIV infection. If the proposed change is 
finalized, infection with HIV would no longer be grounds for an alien 
to apply for a waiver and HHS/CDC would discontinue the use of CDC form 
4.422-1b, for a reduction of 67 burden hours for this approved data 
collection.

D. Environmental Impact

    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.''
    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 proposed rule does not require a Federal taking of 
private property, the provisions in the Executive Order are not 
applicable.

 G. Federalism

    Under Executive Order 13132, if the proposed rule would limit or 
preempt State authorities, then a Federalism analysis is required. The 
agency must consult with State and local officials to determine whether 
the rule would have a substantial direct effect on State or local 
Governments, as well as whether it would either preempt State law or 
impose a substantial direct cost of compliance on them.
    HHS/CDC determines that this proposed 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 proposed 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 the 
proposed 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 the proposed 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 proposed action to determine whether such an action would affect 
family well-being. HHS/CDC has assessed the impact of this proposed 
regulation and determines 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 the proposed 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 has attempted to use plain language in promulgating the 
proposed rule and would welcome any comment from the public in this 
regard.

List of Subjects in 42 CFR 34

    Aliens, Health care, Scope of examination, Passports and visas, 
Public health.

    For the reasons stated in the preamble, the Centers for Disease 
Control and Prevention, within the U.S. Department of Health and Human 
Services, proposes to amend 42 CFR part 34 as follows:

PART 34--MEDICAL EXAMINATION OF ALIENS

    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]

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

[[Page 31809]]

    3. Amend Sec.  34.3 by revising paragraphs (b)(1)(i), (e)(1) 
introductory text, (e)(2)(iii), (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) * * *
    (iii) For applicants 15 years of age and older, serologic testing 
for syphilis.
    (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 Mycobacterium 
tuberculosis antigens, or chest x-ray examination for good cause, upon 
application approved by the Director.
* * * * *
    (5) How and where performed. All chest radiograph images used in 
medical examinations performed under the regulations to this part shall 
be large enough to encompass the entire chest (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: June 30, 2009.
Kathleen Sebelius,
Secretary.
[FR Doc. E9-15814 Filed 6-30-09; 4:15 pm]
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