31798 Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Proposed Rules 

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). 

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 

Part34HIVcomments@cdc.gov. 

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 

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

31800 Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Proposed Rules 

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 familybased 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-tochild 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 

Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Proposed Rules 31801 

contact or needle-sharing with HIVinfected 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 

31802 Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Proposed Rules 

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 HIVinfected and are not granted a waiver by 

the Department of Homeland Security 

are refused lawful permanent resident 

status in the United States. 

Currently, refugees who are HIVinfected must be granted a waiver by the 

Department of Homeland Security 

before entering the U.S. Subsequently, 

refugees infected with HIV who are 

present in the U.S. and apply for 

adjustment to permanent resident status 

must be re-examined and granted 

another waiver from DHS at that time 

(i.e., the grant of waivers permits these 

individuals to obtain refugee status, and 

later, permanent resident status despite 

being HIV-infected, which would 

otherwise render them inadmissible). 

We have not explicitly included 

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 HIVinfected refugees who are subsequently 

granted permanent resident status are 

likely to stay the same, regardless of 

regulations in place. That is, the HIVinfected refugees-turned-permanent 

residents are part of the baseline 

scenario. 

Furthermore, though this policy 

would increase the total number of 

people who may be eligible to be 

admitted, we assume that the total 

number of immigrants who are annually 

admitted into the United States is fixed 

over time. Thus, the incremental input 

to the rule is a calculation of the 

additional costs due to HIV-infected 

immigrants above the costs of non-HIVinfected immigrants. In general, given 

that the total number of immigrants is 

not likely to change and the share of 

HIV-infected immigrants is likely to be 

relatively small, the rule will not likely 

have an appreciable impact on the 

economy in terms of wages, 

productivity, or prices of goods and 

services. 

D. Defining the Population Affected 

The affected population is defined as 

the number of new HIV-infected lawful 

permanent residents entering the United 

States each year and those individuals 

already in the United States seeking to 

adjust their immigration status to that of 

a lawful permanent resident. The 

proposed changes in 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]). 

Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Proposed Rules 31803 

TABLE 1—REGIONAL POPULATION, IMMIGRATION AND HIV ESTIMATES USED TO CALCULATE THE WEIGHTED REGIONAL

RATE ESTIMATES

Legal 

permanent 

residents 

(2007) [6] 

Estimate of HIV rate per 1,000 

(based on 2006 regional 

population estimates [7] and 

2007 HIV regional estimates [8]) 

Estimated number of HIV 

infected immigrants 

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 ‡ 2.94 ‡ 5.09 4,275 3,096 5,361 

* In this case, Africa includes North Africa, the Middle East and Unknowns. 

** Total number of adults and children living with HIV in the region (see Technical Appendix II for more detail [5]). 

† Based on weighted regional estimates. The assumption is that prevalence of HIV amongst immigrants to the U.S. mirrors that of the immigrant’s native regions and is adjusted for the number of immigrants coming to the U.S. from each region. 

‡ Note: These estimates represent the 5th and 95th percentiles based on regional weight estimates. Due to concern that immigrants may not 

be representative of the 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 HIVinfected 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 

31804 Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Proposed Rules 

greater opportunity, better health care, 

and education and training programs 

than those available in the immigrant’s 

home country. These HIV-infected 

individuals, compared to those who do 

not receive appropriate multi-drug antiretroviral therapy for HIV treatment, 

could survive an additional 13 years, 

with an average life expectancy of 

approximately 29 years (to age 49 years) 

[10]. This increased life expectancy 

allows the opportunity for longer and 

improved productivity. 

Further, this 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 HIVinfected 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 HIVinfected 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 HIVinfected 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 weightedaverage HIV prevalence rate for the 

immigrants’ country of origin, whereas 

this analysis assumed that the HIV 

prevalence rate would be equal to the 

weighted-average rate of the immigrants’ 

region of origin; (2) the number of 

immigrants was increased by 5% each 

year in the CBO analysis while this 

analysis did not include growth in the 

annual number; (3) the CBO analysis 

only examined health care costs paid for 

by Medicaid whereas this analysis 

included all health care costs including 

those paid for by the Ryan White 

Program; and (4) the CBO analysis 

included costs of federal disability and 

nutrition benefits, whereas this analysis 

did not include those costs. 

By the year 2013, the number of HIVinfected immigrants entering the U.S. 

projected by the CBO analysis is roughly 

equivalent to that projected by this 

Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Proposed Rules 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 federallyfunded 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 HIVrelated health restrictions are removed 

as a barrier to admission for immigrants, 

all immigrants still must meet other 

admission requirements. In the United 

States, under the Federal Personal 

Responsibility Work and Opportunity 

Reconciliation Act (PRWORA) of 1996, 

most immigrants are not eligible to 

receive means-tested public benefits for 

five years after their entry into the U.S. 

[15, 16]. Federal means-tested public 

benefits include Supplemental Security 

Income (SSI), cash Temporary 

Assistance for Needy Families (TANF), 

Medicaid, and food stamps [15, 17]. 

State and local means-tested benefits are 

determined at the state or local level 

and vary by jurisdiction. We have no 

data to assume that HIV-infected 

immigrants will seek, five years after 

being admitted to the U.S., such benefits 

at rates different from non HIV-infected 

immigrants. 

In addition, PRWORA placed other 

limitations on aliens’ access to public 

benefits, making them more difficult for 

aliens to obtain such benefits in the first 

place. For example, the income and 

resources of the sponsor of a familybased immigrant or permanent resident 

are deemed to be available to that alien 

if he/she should apply for certain 

means-tested public benefits. See 8 

U.S.C. 1631, 1632. Since a sponsor must 

first prove to DHS that he/she is able to 

provide support to the sponsored alien 

at an annual income that is at least 

125% above the federal poverty level 

before the alien’s immigration 

application will be approved, it is 

unlikely that the alien will be able to 

show that his/her available resources 

fall beneath the low income eligibility 

thresholds required for many meanstested public benefits. See INA 

§ 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 HIVinfected immigrants surviving from 

previous years that survive to Year t + 

additional persons previously infected 

by onward transmission from HIVinfected immigrants that survive to Year 

t) × onward transmission rate]. 

A 1.51% onward transmission rate 

was used in the HIVEcon model to 

represent the annual estimated number 

of new infections caused by HIVinfected immigrants to the U.S., or 

caused by U.S. person infected by HIVinfected immigrants (i.e., annually every 

100 HIV-infected persons infect an 

additional 1.51 persons). The most 

recent estimate of average onward 

transmission, when limited to sexual 

transmission, in the United States is 

3.02 per 100 HIV positive immigrants 

[18]. In 2006, the overall rate for onward 

transmission of HIV in the U.S. from all 

causes, was 5 new infections per 100 

HIV-infected persons [19]. Results from 

published research indicate that 

immigrants to the United States, 

regardless of their race or ethnicity, 

often have an initial better health profile 

than native-born Americans across 

diverse health behaviors and outcomes; 

however, this health advantage declines 

as length of residence in the United 

States and degree of acculturation 

increase [20–26]. Specifically, studies of 

HIV risk behavior among immigrant 

populations, upon arrival in the U.S., 

indicate that these behaviors are 

influenced by a number of factors 

including the demographic 

characteristics of the migrants 

(especially sex, social class, relationship 

status and education); the purpose of 

immigration; the type and location of 

their receiving community and the 

existing supports; discrepancy between 

pre-immigration expectations and postimmigration experiences; and 

transnational movement between the 

U.S. and their home countries [27–31]. 

These multiple factors result in 

heterogeneity in HIV risk between 

migrant communities, with some being 

at lower, and others higher risk, than 

their U.S. counterparts. There is no 

evidence to suggest immigration to the 

U.S. significantly affects HIV incidence 

in this country in one direction or the 

other. Thus, it is not unreasonable to 

assume that onward transmission rates 

amongst HIV-infected immigrants will 

be lower than among HIV-infected 

persons born in the U.S. 

For this analysis, we assumed that the 

onward transmission rate for 

immigrants, and those that they infect, 

would be fifty percent of the average 

U.S. rate for sexual transmission (i.e., 

rate of onward transmission from HIVinfected immigrants is assumed, in the 

baseline case, to be 1.51 per 100). 

Because data supporting this 

assumption are limited, this assumption 

was tested in sensitivity analysis. We 

used 0% transmission as our lower 

bound estimate and a transmission rate 

of 4.53 per 100 HIV-infected 

immigrants, and those that they infect, 

as our upper bound estimate. The upper 

bound transmission rate is a fifty 

percent increase in the average annual 

onward transmission rate of 3.02%. 

Assuming 4,275 HIV-infected 

immigrants enter in the first year, there 

will be 65 new HIV infections due to 

onward transmission, assuming an 

31806 Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Proposed Rules 

onward transmission rate of 1.51 per 

100 HIV, with a range of 0 to 261 

(assuming onward transmission of 0 and 

4.53 per 100 HIV-infected immigrants, 

respectively). These estimates imply 

treatment costs, for those infected via 

onward transmission only, in the first 

year of $1.6 million in the primary 

estimate and a range of $0 to $8.1 

million [5]. 

For the purposes of calculating new 

HIV infections associated with HIVinfected immigrants in the U.S., 

HIVEcon adds persons infected by HIVinfected immigrants to the cohort of 

projected HIV-infected immigrants. This 

modeling technique represents the 

chain of onward transmission after 

initial transmission from an HIVinfected immigrant. Thus, in the next 

year, though the cumulative number of 

HIV-infected immigrants essentially 

doubles, the number of new HIV cases 

(as well as the associated treatment 

costs) will be slightly more than double 

the previous year. 

This modeling approach assumes that 

those people infected by HIV-infected 

immigrants would never have become 

infected with HIV were it not for the 

arrival in the U.S. of HIV-infected 

immigrants. This could be unrealistic 

since U.S. persons who are infected by 

HIV-infected immigrants may engage in 

behaviors that lead them to activities 

that expose them to HIV infections, 

regardless of the source of infection. An 

alternative interpretation may be that at 

least some of the additional infections 

are occurring earlier than they otherwise 

would have. Thus, these shifts in the 

timing of infection will increase the 

total number of new cases in any one 

year, but the true incremental impact 

may be the implications of becoming 

infected earlier. 

Furthermore, the model treats the 

onward transmission rate as fixed over 

time. However, data 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 HIVinfected 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% 

Category 

Primary 

Estimate 

(4.06 HIV+ 

immigrants 

per 1,000 

immigrants) 

Low 

Estimate 

(1.02 HIV+ 

immigrants 

per 1,000 

immigrants) 

High 

Estimate 

(6.09 HIV+ 

immigrants 

per 1,000 

immigrants) 

HIV-POSITIVE IMMIGRANTS AT YEAR 5 (EXCLUDING ONWARD TRANSMISSION) 

Total number of HIV-Positive Immigrants present in the U.S ............................................ 15,755 .............. 3,956 ................ 23,622. 

Annualized Monetized Healthcare Expenditures ................................................................ $342 million ...... $86 million ........ $513 million. 

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 cases due to 1.51% onward transmission connected with 

U.S. Immigrants.

676 ................... 170 ................... 1,014. 

Annualized Monetized Healthcare Expenditures ................................................................ $96 million ........ $24 million ........ $145 million. 

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 

Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Proposed Rules 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 highrisk 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 healthcare 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 highincome 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 sexuallyacquired 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 

Psychology, 1998. 45: p. 454–467. 

23. Hines, A.M. and R. Caetano, Alcohol 

and AIDS-related sexual behavior among 

Hispanics: acculturation and gender 

differences. AIDS Educ Prev, 1998. 10(6): p. 

533–47. Available from: http:// 

www.ncbi.nlm.nih.gov/entrez/ 

query.fcgi?cmd=Retrieve&db=PubMed&dopt=

Citation&list_uids=9883288. 

24. Shedlin, M.G., C.U. Decena, and D. 

Oliver-Velez, Initial acculturation and HIV 

risk among new Hispanic immigrants. J Natl 

Med Assoc, 2005. 97(7 Suppl): p. 32S–37S. 

Available from: http://www.ncbi.nlm.nih.gov

/entrez/query.fcgi?cmd=

Retrieve&db=PubMed&dopt=

Citation&list_uids=16080455. 

25. Hoffman, S., et al., HIV and sexually 

transmitted infection risk behaviors and 

beliefs among Black West Indian immigrants 

and US-born Blacks. Am J Public Health, 

2008. 98(11): p. 2042–50. Available from: 

http://www.ncbi.nlm.nih.gov/entrez/ 

query.fcgi?cmd=Retrieve&db=PubMed&dopt=

Citation&list_uids=18309140. 

26. McDonald, J.A., J. Manlove, and E.N. 

Ikramullah, Immigration measures and 

reproductive health among Hispanic youth: 

findings from the national longitudinal 

survey of youth, 1997–2003. J Adolesc 

Health, 2009. 44(1): p. 14–24. Available from: 

http://www.ncbi.nlm.nih.gov/entrez/ 

query.fcgi?cmd=Retrieve&db=PubMed&dopt=

Citation&list_uids=19101454. 

27. Lassetter, J.H. and L.C. Callister, The 

impact of migration on the health of 

voluntary migrants in western societies. J 

Transcult Nurs, 2009. 20(1): p. 93–104. 

Available from: http:// 

www.ncbi.nlm.nih.gov/entrez/ 

query.fcgi?cmd=Retrieve&db=PubMed&dopt=

Citation&list_uids=18840884. 

28. Shedlin, M.G., et al., Immigration and 

HIV/AIDS in the New York Metropolitan 

Area. J Urban Health, 2006. 83(1): p. 43–58. 

Available from: http:// 

www.ncbi.nlm.nih.gov/entrez/ 

query.fcgi?cmd=Retrieve&db=PubMed&dopt=

Citation&list_uids=16736354. 

29. Harawa, N.T., et al., HIV prevalence 

among foreign- and US-born clients of public 

STD clinics. Am J Public Health, 2002. 

92(12): p. 1958–63. Available from: http:// 

www.ncbi.nlm.nih.gov/entrez/ 

query.fcgi?cmd=Retrieve&db=PubMed&dopt=

Citation&list_uids=12453816. 

30. Marin, B.V., et al., Acculturation and 

gender differences in sexual attitudes and 

behaviors: Hispanic vs non-Hispanic white 

unmarried adults. Am J Public Health, 1993. 

83(12): p. 1759–61. Available from: http:// 

www.ncbi.nlm.nih.gov/entrez/ 

query.fcgi?cmd=Retrieve&db=PubMed&dopt=

Citation&list_uids=8259813. 

31. UNAIDS and IOM, Migration and 

AIDS. Int Migr, 1998. 36(4): p. 445–68. 

Available from: http:// 

www.ncbi.nlm.nih.gov/entrez/ 

query.fcgi?cmd=Retrieve&db=PubMed&dopt=

Citation&list_uids=12295093. 

32. CDC, HIV Incidence. 2008 (accessed 

May 25, 2009). Available from: http:// 

www.cdc.gov/hiv/topics/surveillance/

incidence.htm. 

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 

31808 Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Proposed Rules 

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 wellbeing. 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. 

§ 34.2 [Amended] 

2. Amend § 34.2 by removing 

paragraph (b)(6) and redesignating 

paragraphs (b)(7) through (10) (b)(6) 

through (9), respectively. 

Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Proposed Rules 31809 

3. Amend § 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: 

§ 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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