[Federal Register Volume 73, Number 194 (Monday, October 6, 2008)]
[Rules and Regulations]
[Pages 58047-58058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-23485]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

42 CFR Part 34

[Docket No. CDC-2008-0002]
RIN 0920-AA20


Medical Examination of Aliens--Revisions to Medical Screening 
Process

AGENCY: Centers for Disease Control and Prevention, U.S. Department of 
Health and Human Services.

ACTION: Interim final rule with comment period.

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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 amending its 
regulations that govern medical examinations that aliens must undergo 
before they may be admitted to the United States. HHS/CDC is amending 
the definition of communicable disease of public health significance. 
HHS/CDC is also amending the provisions that describe the scope of the 
medical examination for aliens by incorporating a more flexible, risk-
based approach, based on medical and epidemiologic factors. This 
approach will assist HHS/CDC in determining which diseases the medical 
screening, testing, and treatment of aliens should include in areas of 
the world that are experiencing unforeseen outbreaks of those diseases. 
In addition, HHS/CDC is updating the screening requirements for 
tuberculosis to be consistent with current medical knowledge and 
practice.
    These changes will reduce the health-security threat to the United 
States from emerging diseases without imposing an undue burden on 
either the aliens or the health-care system in U.S. resettlement 
communities.

DATES: The interim rule is effective on October 6, 2008. Interested 
parties must submit written comments on or before December 5, 2008. 
HHS/CDC will consider comments received after this period only to the 
extent practicable.

ADDRESSES: You may submit written comments, identified by Docket No. 
CDC-2008-0002, 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 Comments, 1600 
Clifton Road, NE., E03, Atlanta, GA 30333.
    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, GA 30333.
    Please call ahead to 1-866-694-4867, and ask for a representative 
in the Division of Global Migration and Quarantine to schedule your 
visit.
    Comments are also available for viewing at the following Internet 
addresses: http://www.cdc.gov/ncidod/dq and http://www.globalhealth.gov. You may submit written comments electronically 
via the Internet at the following address: http://www.regulations.gov, 
or via e-mail to <a href="/cdn-cgi/l/email-protection#3f6f5e4d4b0c0b4f4a5d53565c5c5052525a514b4c7f5c5b5c11585049"><span class="__cf_email__" data-cfemail="c494a5b6b0f7f0b4b1a6a8ada7a7aba9a9a1aab0b784a7a0a7eaa3abb2">[email protected]</span></a>.
    To download an electronic version of the rule, please go to the 
following Internet address: http://www.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., 
E03, Atlanta, GA 30333; telephone 404-498-1600.

SUPPLEMENTARY INFORMATION: The Preamble to this interim rule is 
organized as follows:

I. Legal Authority
II. Background
III. Summary of Changes to 42 CFR Part 34
IV. Revised Definition of Communicable Disease of Public Health 
Significance
V. Revised Scope of Medical Examination
VI. Updating Tuberculosis Screening Requirements
VII. Urgent Need for Regulatory Change
VIII. Analysis of Impacts
IX. Paperwork Reduction Act of 1995
X. References

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

    Under section 212(a)(1) of the Immigration and Nationality Act 
(INA) (8 U.S.C. 1182(a)(1)), any alien determined to have a specified 
health-related condition is inadmissible to the United States. Those 
aliens outside the United States with a specified health-related 
condition (see below) are ineligible to receive a visa and ineligible 
to be admitted into the United States. The grounds of inadmissibility 
for specified health-related conditions also pertain to aliens in the 
United States who are applying for adjustment of immigration status to 
that of a lawful permanent resident.
    Aliens are currently inadmissible into the United States if they 
have a communicable disease of public health significance, defined as 
follows: Active tuberculosis, infectious syphilis,

[[Page 58048]]

gonorrhea, infectious leprosy, chancroid, lymphogranuloma venereum, 
granuloma inguinale, and HIV infection.
    Medical examinations, including a physical and mental evaluation, 
to determine whether an alien may 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 (PHS) Act (42 U.S.C. 252), the Secretary of Health and 
Human Services promulgates regulations to establish the requirements 
for the medical examination and to list the health-related conditions 
that make aliens ineligible for entry into the United States. The 
regulations, administered by HHS/CDC, are promulgated at 42 FR part 34.
    As currently listed in Sec.  34.1, the provisions in this part 
apply to the medical examination of (1) aliens outside the United 
States who are applying for an immigrant visa at an embassy or 
consulate of the United States; (2) aliens arriving in the United 
States; (3) aliens required by the U.S. Department of Homeland Security 
(DHS) [formerly required by the Immigration and Naturalization Service 
(INS)] to have a medical examination in connection with the 
determination of their admissibility into the United States; and (4) 
applicants in the United States who apply for adjustment of their 
immigration status to that of permanent resident.
    Panel physicians, designated by consular officers of the U.S. 
Department of State, perform medical examinations abroad, and civil 
surgeons, designated by the U.S. Citizenship and Immigration Services, 
perform medical examinations for aliens who are already present in the 
United States. Aliens determined to have a communicable disease of 
public health significance may request a waiver 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)).
    Aliens are inadmissible if they are determined: (1) To have a 
communicable disease of public health significance; (2) to have a 
physical or mental disorder and behavior associated with the 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. In addition, except for certain 
adopted children 10 years of age or younger, any alien who seeks 
admission as an immigrant, or seeks adjustment of immigration status to 
legal permanent resident, is inadmissible if the alien fails to present 
documentation of having received vaccination against mumps, measles, 
rubella, polio, tetanus and diphtheria toxoids, pertussis, Haemophilus 
influenzae type B, hepatitis B and any other vaccination recommended by 
the Advisory Committee for Immunization Practices.
    Annually, the U.S. Government admits more than 1,000,000 immigrants 
and refugees to reside permanently in this country. The majority 
arrives from Asia, Africa and Central and South America, regions with 
recently reported outbreaks of emerging, infectious diseases, including 
yellow fever, dengue, Ebola and Marburg hemorrhagic fevers and the H5N1 
strain of highly pathogenic avian influenza. These regular outbreaks, 
many of which affect both urban and rural areas, and the movement of 
large population resettlements from these regions, highlight the 
serious threat to public health in the United States to which the 
Centers for Disease Control and Prevention (CDC) within the U.S. 
Department of Health and Human Services (HHS) has to respond on very 
short notice.
    In the recent past, the demographics of U.S.-bound refugees have 
shifted to populations that are at higher risk for communicable 
diseases. These newer groups of refugees have lower baseline rates of 
vaccination, higher rates of parasitic infections and more limited 
access to basic medical care and preventive health interventions before 
resettlement. Between 1996 and 2003, at least half of all arriving 
refugees were European. In 1998, 70 percent were European. Beginning in 
2003, however, the numbers of refugees from Europe rapidly declined. In 
2008, only three percent of all refugees arriving in the United States 
were European. At the same time, a larger proportion of refugees have 
come from countries with poorer economies, weaker health 
infrastructure, and limited access to basic medical care. As a result, 
these refugees have a higher incidence of major infectious diseases.
    This demographic shift is one of the most important factors that 
have led to the substantial increase in the number and nature of 
outbreaks of communicable diseases that have affected refugee 
resettlements. These new populations bring new diseases but the 
diseases for which individuals are inadmissible into the United States 
have remained much the same as at the end of the nineteenth century.
    The highest rates of tuberculosis among immigrants and refugees are 
for those born in sub-Saharan African and Southeast Asian countries, 
with rates of at least 250 cases per 100,000. By comparison, the rate 
in the United States is fewer than five cases per 100,000. Overall, 
approximately one-third of the world's population has the infection, 
and over 50 percent of TB cases in the United States are in foreign-
born residents.
    Panel physicians miss up to 67 per cent of tuberculosis (TB) cases 
based on the current scope of medical examination requirements. 
Implementation of these revisions to the regulations would ensure the 
methods for screening and testing TB used during the medical 
examination of aliens reflect the most current medical practice.
    The resettlement of these populations, many of which are coming 
from high-risk countries, is a strong argument for an immediate 
implementation of the changes in the list of communicable diseases of 
public health significance to reduce the potential of emerging disease 
threats in this higher-risk caseload. Urgent changes to this list are 
needed to prevent importing communicable diseases into our country. The 
current regulations do not address emerging and re-emerging diseases in 
immigrant or refugee populations. HHS is adding diseases to the 
communicable diseases of public health significance that better reflect 
the true threats that our Nation faces, including cholera, diphtheria, 
plague, smallpox, yellow fever, viral hemorrhagic fevers, and severe 
acute respiratory syndrome (SARS). These diseases currently exist in 
the list of quarantinable, communicable diseases defined by 
Presidential Executive Order, but do not appear on the list of 
communicable diseases of public-health significance. These diseases 
cause severe illness and death in regions of the world that are home to 
large numbers of immigrants and refugees bound for the United States.
    In addition, the revision to part 34 is consistent with relevant 
provisions of the revised International Health Regulations (2005), 
which came into force in July of 2007.
    HHS/CDC also issues technical instructions and provides technical 
consultation and guidance to panel physicians and civil surgeons who 
conduct the medical examinations of aliens. The HHS/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

[[Page 58049]]

available to the public on the HHS/CDC Web site, located at the 
following Internet address: http://www.cdc.gov/ncidod/dq/technica.htm. 
HHS/CDC will also post and maintain a list of all medical conditions 
and locations for which additional screening requirements are in effect 
pursuant to this rule. This list will be available at the same Internet 
address: http://www.cdc.gov/ncidod/dq/technica.htm, and http://www.globalhealth.gov.

III. Summary of Changes to 42 CFR Part 34

    HHS/CDC is amending the definition of a communicable disease of 
public health significance. Current communicable diseases of public 
health significance are: active tuberculosis, infectious syphilis, 
gonorrhea, infectious leprosy, chancroid, lymphogranuloma venereum, 
granuloma inguinale, and HIV infection.
    The definition of a communicable disease of public health 
significance in this rule remains as those diseases currently listed in 
Sec.  34.2(b), plus the addition of (1) quarantinable diseases 
designated by Presidential Executive Order, and (2) those diseases that 
meet the criteria of a public health emergency of international concern 
which require notification to the World Health Organization (WHO) under 
the revised International Health Regulations of 2005. A delay in 
implementing these updates to Part 34 poses a risk of further severe 
illness for refugees and immigrants as they move into receiving U.S. 
communities and presents American taxpayers with elevated medical 
costs. Updating the list of communicable diseases of public health 
significance will diminish complex and costly measures such as 
vaccination, chemoprophylaxis and isolation, and lessen illness and 
death among the affected migrating populations.
    The following is a section-by-section analysis of proposed changes:

Section 34.2 Definitions

    The revision updates the definition provided in Sec.  34.2(b) for a 
communicable disease of public health significance to include two new 
categories of disease. The first category, added as Sec.  34.2(b)(2), 
is the quarantinable, communicable diseases specified by the President 
in Executive Order, as provided under Section 361(b) of the Public 
Health Service Act. The second category, added as Sec.  34.2(b)(3), is 
any communicable disease that requires notification to the World Health 
Organization as an event that may constitute a public health emergency 
of international concern, pursuant to the revised International Health 
Regulations of 2005.

Section 34.3 Scope of Examinations

    HHS/CDC is publishing section 34.3 in its entirety for clarity, 
including republication of some provisions that are unchanged. HHS/CDC 
has revised section 34.3 to include screening and testing for the 
updated list of communicable diseases of public health significance, as 
defined in Sec.  34.2(b). HHS/CDC has also revised section 34.3 to 
require additional medical screening and testing using a more flexible 
risk-based approach for those medical examinations performed outside of 
the United States. HHS/CDC has also revised the specific requirements 
concerning the required evaluation for tuberculosis.
    The U.S. Department of Homeland Security (DHS) currently is the 
entity responsible for administering the immigration authority and 
functions previously administered by the Immigration and Naturalization 
Service (INS), which was within the U.S. Department of Justice. The 
revised rule text changes the reference to INS in existing Sec.  
34.3(b)(2)(i) to U.S. Department of Homeland Security in new Sec.  
34.3(e)(3)(i).

Specific Changes to the Scope of the Medical Examination, and the Risk-
Based Approach

    The title of Sec.  34.3(b) has changed to Scope of all medical 
examinations, and provides that all medical examinations will include a 
general physical examination and medical history, evaluation for 
tuberculosis, serologic testing for syphilis and HIV, and also a 
physical examination and medical history for diseases specified in 
Sec. Sec.  34.2(b)(1) and 34.2(b)(4) through 34.2(b)(10). The 
unindented paragraph currently at the end of Sec.  34.3(a) has been 
moved to Sec.  34.3(b)(2).
    The title of Sec.  34.3(c) has been changed to Additional medical 
screening and testing for examinations performed outside of the United 
States and provides that HHS/CDC may require additional screening and 
testing for medical examinations performed outside the United States 
for diseases specified in Sec. Sec.  34.2(b)(2) and 34.2(b)(3) by 
applying the risk-based medical and epidemiologic factors listed in 
Sec.  34.3(d)(2). It provides that such examinations shall be conducted 
in a defined population, in a geographic region or area outside the 
United States, for a period of time as determined by HHS/CDC. 
Additional medical screening and testing shall include a medical 
interview, physical examination, laboratory testing, radiologic exam, 
or other diagnostic testing as determined by HHS/CDC. Section 
34.3(c)(4) and (5) indicate that additional medical screening and 
testing will continue until HHS/CDC determines such activity is not 
necessary, based on medical and epidemiologic factors, and that HHS/CDC 
will provide medical examiners with information pertaining to all 
additional screening and testing requirements, and will also post the 
information on the HHS/CDC Web site.
    Section 34.3(d) is entitled Risk-based approach, and provides the 
medical and epidemiological factors that HHS/CDC will use to determine 
whether a disease as specified in Sec.  34.2(b)(3)(ii) is a 
communicable disease of public health significance, which diseases in 
Sec. Sec.  34.2(b)(2) and (b)(3) merit additional screening and 
testing, and the geographic area in which HHS/CDC will require this 
screening. These factors include the seriousness of the disease's 
public health impact; whether the emergence of the disease was unusual 
or unexpected; the risk of the spread of the disease to the United 
States; the transmissibility and virulence of the disease; the impact 
of the disease at the geographic location of medical screening; and 
other specific pathogenic factors that would bear on a disease's 
ability to threaten the health security of the United States.

Specific Changes to Tuberculosis Screening Requirements

    HHS/CDC has revised Sec.  34.3 to require testing for tuberculosis 
of children under the age of 15 years old when they have symptoms of 
tuberculosis, a history of tuberculosis, or possible exposure to a 
transmissible tuberculosis case in a household or other enclosed 
environment for a prolonged period. With regard to additional testing 
requirements for an applicant that has a radiograph that indicates an 
abnormality suggestive of tuberculosis disease, HHS/CDC has revised 
Sec.  34.3 to require additional testing for tuberculosis. Specific 
changes regarding the required evaluation for tuberculosis appear 
below.
    Section 34.3(b), entitled Persons subject to requirement for chest 
x-ray examination and serologic testing is now Sec.  34.3(e). The 
revision adds Sec.  34.3(e)(2)(ii) to include a chest x-ray examination 
for applicants under 15 years of age if they have symptoms of 
tuberculosis, a history of tuberculosis, or evidence of possible 
exposure to a transmissible tuberculosis case in a household or other 
enclosed

[[Page 58050]]

environment for a prolonged period. The paragraph describing 
requirements for tuberculin skin test (TST) examination is now Sec.  
34.3(e)(3), and has been renamed Immune response to Mycobacterium 
tuberculosis antigens to reflect updated, current equivalent tests that 
are increasingly used in clinical settings and may eventually be used 
as an alternative to the tuberculin skin test for refugee and immigrant 
screening. The Quantiferon-TB Gold (QFT-G) test is one recommended 
method for screening for tuberculosis in clinical practice in most 
circumstances instead of the TST. The incorporation of Immune Globulin 
Release Assays (IGRAs), which include QFT-G, is under consideration by 
CDC for screening for tuberculosis in aliens. This change will insure 
that current, updated medical technology will be used, as appropriate, 
by panel physicians and civil surgeons conducting the medical 
examinations. This section also includes the addition of Sec.  
34.3(e)(3)(iii) which requires a tuberculin skin test, or an equivalent 
test for showing an immune response to Mycobacterium tuberculosis 
antigens, for applicants outside of the United States who are required 
to have a medical examination and, if indicated, a chest x-ray 
examination, if the applicant is of sufficient age to be considered 
contagious.
    Section 34.3(e)(3)(iv) requires both a tuberculin skin test, or an 
equivalent test for showing an immune response to Mycobacterium 
tuberculosis antigens, and a chest x-ray examination for any applicant 
outside of the United States, regardless of age, if the applicant has 
symptoms of tuberculosis, a history of tuberculosis, or possible 
exposure to a transmissible tuberculosis case in a household or other 
enclosed environment for a prolonged period.
    Section 34.3(e)(4), entitled Additional testing requirements, 
indicates that all applicants subject to the chest x-ray examination 
and for whom the radiograph shows an abnormality suggestive of 
tuberculosis disease must undergo additional testing for tuberculosis. 
This change allows for the use of the most current testing procedures 
for tuberculosis disease.
    References to the Attorney General in existing Sec. Sec.  
34.3(b)(4) and (e) are changed to the Secretary of Homeland Security in 
new Sec. Sec.  34.3(e)(5) and (h) to reflect the creation of DHS in 
2003 and its assumption of applicable authorities and responsibilities. 
Reference to INS in existing Sec.  34.3(b)(2)(i) is changed to U.S. 
Department of Homeland Security in new Sec.  34.3(e)(3)(i). These 
ministerial corrections are the only amendments to these sections which 
are otherwise republished unchanged.

IV. Revised Definition of Communicable Disease of Public Health 
Significance

    As stated in Section 212(a)(1) of the INA, aliens are inadmissible 
into the United States if they are determined to have a specified 
health condition, which includes a communicable disease of public 
health significance. Currently, medical examinations require the 
screening of all aliens subject to these requirements for all listed 
communicable diseases of public health significance. Regulations have 
historically defined the term communicable disease of public health 
significance by listing specific diseases. The current definition in 42 
CFR 34.2(b) includes chancroid, gonorrhea, granuloma inguinale, human 
immunodeficiency virus (HIV) infection, infectious leprosy, 
lymphogranuloma venereum, infectious-stage syphilis, and active 
tuberculosis.
    Recent experience has demonstrated that a fixed list of diseases 
does not allow HHS/CDC the flexibility it needs to rapidly respond to 
unanticipated emerging or re-emerging outbreaks of disease. Rather, 
HHS/CDC requires an approach based on potential risks and consequences 
instead of a static list that does not reflect the potential for future 
outbreaks of novel diseases. National and international health agencies 
have recently developed guidelines for defining diseases of public 
health significance that threaten global health security and require an 
urgent response. This guidance provides the framework to update the 
list of communicable diseases of public health significance for the 
United States to screen and test aliens during disease outbreaks in 
real time.
    HHS/CDC is adding the following two disease categories to the 
current list of communicable diseases of public health significance:
    (1) Quarantinable, communicable diseases specified by Presidential 
Executive Order, as provided under Section 361(b) of the Public Health 
Service Act; and
    (2) Any communicable disease that requires notification to the 
World Health Organization as an event that may constitute a public 
health emergency of international concern, pursuant to the revised 
International Health Regulations of 2005.

Quarantinable Communicable Diseases Specified by Presidential Executive 
Order, as Provided Under Section 361(b) of the Public Health Service 
Act

    Section 361 of the Public Health Service Act authorizes the 
Secretary of HHS to enact rules and regulations for preventing the 
introduction, transmission, and spread of communicable diseases from 
foreign countries into the United States, and from one State or 
possession into another. Executive Order 13295 of April 4, 2003, as 
amended by Executive Order 13375 of April 1, 2005, contains the most 
recent list of quarantinable, communicable diseases, and includes the 
following: Cholera, yellow fever, plague, viral hemorrhagic fevers, 
diphtheria, infectious tuberculosis, smallpox, severe acute respiratory 
syndrome (SARS), and influenza caused by novel or re-emergent influenza 
viruses that are causing, or have the potential to cause, a pandemic 
(pandemic influenza). HHS/CDC is adding diseases listed by Presidential 
Executive Order to the definition of communicable diseases of public 
health significance, subject to screening and testing requirements 
outlined in the section on the scope of examinations.

Any Communicable Disease That Requires Notification to the World Health 
Organization as an Event That May Constitute a Public Health Emergency 
of International Concern, Pursuant to the Revised International Health 
Regulations of 2005

    In May 2005, the World Health Assembly adopted the revised 
International Health Regulations (IHR (2005)). These regulations 
entered into force for most of the Member States of the WHO in June 
2007 and for the U.S. in July 2007. The purpose and scope of the IHR 
(2005) are to prevent, protect against, control and provide a public 
health response to the international spread of disease, while 
minimizing interference with world travel and trade. Annex 2 of the IHR 
(2005) contains an algorithm for identifying a public health emergency 
of international concern, and can be located at the following Internet 
address: http://www.who.int/gb/ghs/pdf/IHR_IGWG2_ID4-en.pdf.
    The IHR (2005) define a public health emergency of international 
concern as an extraordinary event which is determined: (i) To 
constitute a public health risk to other [Member] States through the 
international spread of disease and (ii) to potentially require a 
coordinated international response. Under the IHR (2005), Member States 
must notify the World Health

[[Page 58051]]

Organization of any disease event that fulfills the criteria presented 
in the three categories of the algorithm in Annex 2. The definition in 
the revised part 34 rule text is intended to capture those diseases 
that require notification by any country to the WHO under the IHR 
(2005) and determined to be an event that may constitute a public 
health emergency of international concern. The revised part 34 rule 
text references IHR (2005) category (1), below, in Sec.  34.2(b)(3)(i), 
and categories (2) and (3), below, together in Sec.  34.2(b)(3)(ii).
(1) Diseases Listed in the IHR (2005) for Which a Single Case Requires 
Notification Through the Use of the IHR (2005) Algorithm
    Annex 2 of the IHR (2005) specifies that smallpox, poliomyelitis 
from wild-type poliovirus, pandemic influenza and severe acute 
respiratory syndrome (SARS) are diseases with serious public health 
impact, and that a single case, irrespective of context, requires 
immediate notification to the WHO. HHS/CDC is adding diseases listed in 
this category to the definition of a communicable disease of public 
health significance, subject to screening and testing requirements 
outlined in the section on the scope of examinations.
    The impact of the SARS outbreak demonstrates the importance of 
using the IHR (2005) algorithm to quickly detect and identify emerging 
and re-emerging pathogens in this category. SARS coronavirus is a 
droplet-spread illness that rapidly emerged as a global threat in 2003, 
caused more than 8,000 cases and 800 deaths, and required isolation and 
quarantine control measures. Although now contained, the disease (or 
one similar to it) could re-emerge at any time. The use of the IHR 
(2005) process for disease notification to the WHO will ensure the 
earliest possible protection of citizens in the United States through 
medical screening of a pathogen like SARS when the next outbreak 
occurs. Smallpox, which causes high mortality and morbidity, is another 
disease in this category. Because smallpox is now successfully 
eradicated, it poses an ongoing threat as a bioterrorism agent.
(2) Other Diseases Listed in the IHR (2005) for Which Notification Is 
Required Through the Use of the IHR (2005) Algorithm
    In addition to the single-case notification diseases, Annex 2 
indicates that an event that involves the following diseases shall 
always lead to the use of the IHR (2005) algorithm to determine whether 
the disease occurrence amounts to a public health emergency of 
international concern, because these diseases have demonstrated the 
ability to cause serious public health impact and to spread rapidly 
internationally:
--Cholera;
--Pneumonic plague;
--Yellow fever;
--Viral hemorrhagic fevers (Ebola, Lassa, Marburg);
--West Nile fever; and
--Other diseases that are of special national or regional concern (e.g. 
dengue fever, Rift Valley fever, and meningococcal disease).
    HHS/CDC is adding diseases listed in this category to the 
definition of a communicable disease of public health significance, 
subject to screening and testing requirements and risk-based factors 
outlined in the section on the scope of examinations.
    Ongoing threats in this category include Ebola hemorrhagic fever, a 
severe, often fatal disease, easily spread through close personal 
contact. An outbreak of Ebola in the Democratic Republic of the Congo, 
confirmed in September 2007, resulted in 26 laboratory-confirmed cases 
of illness as of October 2007. There have been a total of 264 suspected 
cases, and Ebola is believed to have killed up to 187 people over eight 
months. A subsequent outbreak of Ebola in the Republic of Uganda 
produced 149 suspect cases and killed 37 people. Cholera, which can 
cause severe diarrhea and death, also continues to be active. From 
August 2007 through November 2007, an outbreak spread throughout Iraq 
and caused over 4500 cases of illness and 23 deaths.
(3) Other Unspecified Diseases That Require Notification Through the 
Use of the IHR (2005) Algorithm
    Annex 2 also refers to any event of potential international health 
concern, including those of unknown causes or sources, and those that 
involve events or diseases, other than the IHR (2005) single-case 
notifiable and other specified notifiable diseases (listed in (1) and 
(2) above), that lead to use of the IHR (2005) algorithm. HHS/CDC is 
adding diseases listed in this category to the definition of a 
communicable disease of public health significance, subject to 
screening and testing requirements and risk-based factors outlined in 
the section on scope of examinations. Addition of this last category to 
the definition of diseases of public health significance allows HHS/CDC 
to respond rapidly to emerging disease threats in a way that adding 
specific diseases to a fixed list does not.
    Once HHS/CDC acknowledges an event from the IHR (2005) algorithm as 
a disease of public health significance, HHS/CDC will immediately 
advise the physicians who conduct medical examinations of the 
additional medical screening or testing required for the identified 
disease(s) via electronic notification, coordination with embassies, 
consulates and the International Organization for Migration, by 
publication on the HHS/CDC Web site, and publication of a notice in the 
Federal Register. HHS/CDC will also provide any required disease 
notifications to appropriate DOS bureaus. HHS/CDC will also maintain a 
current list of diseases and locations subject to additional medical 
screening and will update addenda to the Technical Instructions for 
Medical Examination of Aliens regarding these diseases, available to 
the public on the HHS/CDC Division of Global Migration and Quarantine 
Web site, located at the following Internet address: http://www.cdc.gov/ncidod/dq/technica.htm, and also at http://www.globalhealth.gov.
    The HHS/CDC Division of Global Migration and Quarantine is the 
current name of the former Division of Quarantine used in existing 
Sec.  34.3(f), and section 34.3(i) of the revised rule text uses the 
correct name. The section is otherwise republished unchanged.

V. Revised Scope of Medical Examination

    HHS/CDC is amending the scope of the medical examination in 42 CFR 
34.3 to allow greater agility to respond to significant outbreaks of 
communicable diseases of public health significance for applicants 
examined in geographic locations where these diseases exist, and for 
which importation into the United States would pose a threat. HHS/CDC 
believes a risk-based approach that uses medical and epidemiologic 
factors to detect additional diseases of public health significance 
provides a flexible, fair and practical means to address infectious 
disease threats among at-risk aliens without placing an undue burden on 
other applicants.
    Beginning on the effective date of this rule, HHS/CDC will also 
make a distinction between the medical examinations performed for 
aliens outside the United States, and those performed for aliens 
already in the United States who are applying for adjustment of status 
to that of permanent resident, in that the risk-based approach to 
detect additional diseases of public health significance will apply 
only to medical examinations outside the United States and only in 
those geographic areas where the risk is high. Applicants already 
within the United States who apply for adjustment

[[Page 58052]]

of immigration status will not be subject to additional screening or 
testing using the risk-based approach. Disease outbreaks in aliens who 
are within the United States primarily fall under the jurisdiction of 
state and local public health authorities. For both groups of aliens, 
those applying for status adjustment from within the United States and 
those applying for admission from outside the United States, the 
medical screening examination will continue to consist of a general 
physical examination and medical history, evaluation for tuberculosis, 
and serologic testing for syphilis and HIV. In addition, under the new 
risk-based approach, HHS/CDC may require aliens outside the United 
States applying for U.S. immigration to undergo additional screening 
and testing for specific communicable diseases of public health 
significance.

Quarantinable, Communicable Diseases Specified by Presidential 
Executive Order as Provided Under Section 361(b) of the Public Health 
Service Act

    Medical screening for these diseases will be achieved through 
physical examination and medical history. Accomplish HHS/CDC may 
require additional screening or testing for these diseases for aliens 
receiving medical examinations at the specific location or area where 
outbreaks of the disease or diseases may be occurring. This additional 
screening and testing will involve applying the defined risk-based 
approach by using medical and epidemiologic factors (shown below in 
this section.)
    This change addresses diseases in immigrant and refugee populations 
(and, in extreme cases, non-immigrant aliens) outside the United 
States, and ensures the lists of quarantinable diseases and 
inadmissible conditions remain consistent. Whenever this Executive 
Order is amended in the future to add additional diseases, HHS/CDC will 
be able to immediately begin testing and screening for these diseases.

Any Communicable Disease That Requires Notification to the World Health 
Organization as an Event That May Constitute a Public Health Emergency 
of International Concern, Pursuant to the Revised International Health 
Regulations of 2005

(1) Diseases Under the IHR (2005) for Which a Single Case Requires 
Notification to WHO as an Event That May Constitute a Public Health 
Emergency of International Concern
    HHS/CDC will consider all the diseases in this category, including 
diseases included by WHO in the future, as communicable diseases of 
public health significance and subject to medical screening through 
physical examination and medical history. HHS/CDC will also consider 
imposing additional screening and testing, as determined by the 
specific circumstances of the event, for diseases in this category that 
meet requirements of the risk-based approach composed of medical and 
epidemiologic factors (shown below in this section) and for which HHS/
CDC determines a threat exists for importation into the United States, 
and that may potentially affect the health of the American public.
(2) Other Diseases That Require Notification to WHO as an Event That 
May Constitute a Public Health Emergency of International Concern 
Through the Use of the IHR (2005) Algorithm (Includes Categories (2) 
and (3) of the IHR (2005) Algorithm Referenced Previously in Section 
IV--Revised Definition of a Communicable Disease of Public Health 
Significance)
    HHS/CDC will consider the diseases in this category as communicable 
diseases of public health significance and subject to medical screening 
through physical examination and medical history if they meet one or 
more of the risk-based criteria of medical and epidemiologic factors 
(shown below in this section), and HHS/CDC determines (1) a threat 
exists for importation into the United States, and (2) such diseases 
may potentially affect the health of the American public. HHS/CDC will 
also consider imposing additional screening and testing for diseases in 
this category, as determined by the specific circumstances of the 
event.

Risk-Based Approach of Medical and Epidemiologic Factors

    HHS/CDC will determine which diseases merit additional screening 
and testing, and the geographic area in which HHS/CDC will require this 
screening, by applying a risk-based approach that takes into account 
the following medical and epidemiologic factors: (a) The seriousness of 
the disease's public health impact; (b) whether the emergence of the 
disease was unusual or unexpected; (c) the risk of the spread of the 
disease to the United States; (d) the transmissibility and virulence of 
the disease; (e) the impact of the disease at the geographic location 
of medical screening; and (f) other, specific pathogenic factors that 
would bear on a disease's ability to threaten the health security of 
the United States. HHS/CDC will consider diseases identified through 
the International Health Regulations algorithm (other than diseases for 
which a single case requires notification) as communicable diseases of 
public health significance when they meet one or more of the criteria 
listed above, and for which HHS/CDC determines (A) a threat exists for 
importation into the United States, and (B) such diseases may 
potentially affect the health of the American public.
    This risk-based approach will facilitate a meaningful public health 
response to existing and emerging threats, without overwhelming the 
entire health system with needless testing. The changes to the scope of 
the examination will allow HHS/CDC to tailor testing requirements to 
those areas where the severity of communicable diseases of public 
health concern are actually affecting populations at the time of the 
medical examination.
    When HHS/CDC requires screening for additional communicable 
diseases of public health significance for applicants from specific 
geographic areas, HHS/CDC may require additional screening, including 
additional medical interviews, a physical examination, laboratory 
testing, radiologic exams, or other diagnostic procedures.
    Screening and testing for newly identified diseases as a part of 
the list of communicable diseases of public health significance will 
continue until HHS/CDC determines the particular situation does not 
warrant this designation, based on factors such as the results of 
disease investigations; response efforts; the effectiveness of 
containment and control measures; and the current determination or 
termination of the public health emergency of international concern by 
the Director General of the WHO.
    HHS/CDC will provide physicians the technical instructions 
regarding the required additional medical screening and testing to 
perform for a disease as part of the examination. In most instances, 
additional medical screening and testing may only consist of 
epidemiologic questions and further physical examination relating to 
the disease. HHS/CDC will also update the Technical Instructions for 
Medical Examination of Aliens, as needed, regarding the additional 
medical screening and testing protocol for a disease, and this 
information will also be immediately available to the public on the 
HHS/CDC Division of Global Migration and Quarantine Web site, located 
at the following Internet address: http://www.cdc.gov/ncidod/dq/technica.htm; and at http://www.globalhealth.gov. A listing of current 
documents regarding the

[[Page 58053]]

additional medical screening and testing protocol for specific diseases 
will also be available on the HHS/CDC Web site.

VI. Updating Tuberculosis Screening Requirements

    HHS/CDC is amending the medical examination rule for aliens by 
updating the screening requirements for tuberculosis, to be consistent 
with current medical knowledge and practice. HHS/CDC is amending 42 CFR 
34.3(b) by revising the requirement for a chest X-ray examination to 
include applicants under the age of fifteen years old, when there is 
reason to suspect tuberculosis infection. The practical effect of this 
change is to expand this testing protocol to alien applicant children 
under the age of 15, when medically appropriate. This change will allow 
HHS/CDC the flexibility to ensure the tuberculosis screening and 
testing methods used for medical examination of aliens are current and 
effective.
    HHS/CDC is amending Sec.  34.3(b)(1)(v) by adding the expanded 
tuberculin skin test requirement, or an equivalent test for showing an 
immune response to Mycobacterium tuberculosis antigens, to the 
exceptions that may be authorized for good cause upon application 
approved by the Director of CDC.
    HHS/CDC is amending Sec.  34.3(b)(2) to indicate that any alien 
applicant outside the United States shall have a tuberculin skin test 
or an equivalent test for showing an immune response to Mycobacterium 
tuberculosis antigens and, if indicated, a chest X-ray examination if 
the applicant is of sufficient age to be considered contagious. 
Additionally, any alien applicant outside the United States, regardless 
of age, shall have both a tuberculin skin test or an equivalent test 
for showing an immune response to Mycobacterium tuberculosis antigens, 
and a chest X-ray examination if the applicant has symptoms of 
tuberculosis disease, has a history of tuberculosis, or has exposure to 
a transmissible tuberculosis case in a household or other enclosed 
environment for a prolonged period. HHS/CDC is amending this section to 
make it consistent with current medical knowledge and practice.
    HHS/CDC is amending Sec.  34.3 by adding a new provision, entitled 
Additional Testing Requirements, with the following rule text: All 
applicants subject to the chest X-ray examination requirement and for 
whom the radiograph shows an abnormality suggestive of tuberculosis 
disease shall be required to undergo additional testing for 
tuberculosis disease.
    The current, outdated rule requires sputum smears for anyone with 
signs, or x-ray findings, suggestive of tuberculosis. Current medical 
guidelines require mycobacterial culture, which is three times as 
sensitive as a sputum smear for detecting active tuberculosis.
    HHS/CDC is also updating language in 34.3(e) and (f) to replace x-
ray film with x-ray image. This change is needed to reflect updated 
radiology technology such as CD-R and laser-printed x-ray formats. 
Language concerning chest x-rays being attached to the alien's visa in 
such a manner to be readily detached at the U.S. port of entry has also 
been deleted since x-rays are not required to be presented at the port 
of entry.

VII. Urgent Need for Regulatory Change

    The U.S. Department of State proposed 80,000 refugee admissions for 
Fiscal Year 2008 under the requirements of Section 207(e)(1)-(7) of the 
Immigration and Nationality Act. This is greater than a ten percent 
increase from FY 2007 projections. As of June 2008, approximately 
35,000 refugees have been resettled, and around 27,000 still expected 
by the end of September 2008. Major diseases of concern in these 
incoming refugee populations include multi-drug-resistant tuberculosis 
(MDR TB), measles, highly pathogenic avian influenza, and cholera. The 
potential for transmitting viral hemorrhagic fevers, such as Ebola and 
Marburg, also exists among some of the African populations being 
resettled. In addition, several vector-borne (animal-transmitted) 
diseases including chikungunya, dengue and, possibly, Rift Valley 
fever, are circulating in refugee camps with populations bound for the 
United States. Vectors (i.e. mosquitoes) prevalent in the United States 
are capable of widely spreading these diseases.
    Allowing serious diseases to enter into the United States can 
result in significant harm to both the American public and American 
business. The existing definition of communicable diseases of public 
health significance and the evaluation criteria for tuberculosis in the 
current regulation are outdated and no longer in keeping with current 
medical knowledge. Therefore, immediate changes are needed to improve 
the ability of the United States to prevent the introduction and spread 
of infectious diseases that are currently causing severe illness and 
death abroad. The scope of examination for medical screening is also 
outdated, and needs immediate changes to allow for medical screening by 
using a risk-based approach that considers medical and epidemiologic 
factors. The current regulations do not have a process for allowing 
HHS/CDC to adapt rapidly to new health threats, and they reference 
outdated public health practices that do not take advantage of the 
latest biomedical knowledge and epidemiologic data. Changes are needed 
now to reduce the potential for significant harm from emerging diseases 
and outbreaks of infectious diseases that currently threaten U.S. 
health security.
    Newly emerging communicable disease threats are arising with 
increased frequency because of multiple factors, such as increases in 
global travel and mobility, migration patterns, human susceptibility to 
novel infections, and microbial adaptation and mutation, as cited in 
the latest report of the U.S. Institute of Medicine on emergence of 
infectious diseases, Microbial Threats to Health: Emergence, Detection 
and Response, National Academies Press, 2003. Infectious disease 
outbreaks (e.g., SARS in 2003) or potential threats like pandemic 
influenza are evidence that virulent diseases with short incubation 
periods can be carried over a border before signs of illness can be 
observed. Additionally, when disease outbreaks occur in refugees or 
immigrants coming to the United States, public health control actions 
such as vaccination, treatment, chemoprophylaxis and isolation must be 
implemented immediately to prevent the importation of disease into the 
United States.
    Annually, approximately 1,000,000 immigrants and refugees enter the 
United States to reside here permanently. The majority arrive from 
Asia, Africa and Central and South America, regions with recently 
reported outbreaks of emerging infectious diseases, including yellow 
fever, dengue and the H5N1 strain of avian influenza. The 50,000-80,000 
refugees who resettle in the United States each year are the most 
vulnerable populations, as they often come from difficult environmental 
conditions with limited water, sanitation and health care. Living 
conditions for many refugees include poor to nonexistent health and 
public health infrastructure; thus, it is difficult to have adequate 
knowledge of their current and potential medical problems. In refugee 
camps, disease surveillance and laboratory resources are often limited, 
which increases the difficulty of maintaining good health and 
preventing outbreaks of infectious diseases. Historically, outbreaks of 
communicable diseases have occurred frequently in refugee camps. These 
regular outbreaks, and the inherent nature of large population 
resettlements, highlight the health threats to which

[[Page 58054]]

HHS/CDC has to respond on very short notice.
    The shift in the demographics of refugee and immigrant populations 
bound for the United States and consequent changes in their health 
risks mandate a change in the definition of a communicable disease of 
public health significance, because of the current uncertainty of 
global disease trends. This demographic shift is the single most 
important cause of the substantial increase in the number and nature of 
outbreaks of communicable diseases among immigrants who are resettling 
into the United States.
    HHS/CDC is unable to forecast constantly changing migration 
patterns, and thus must have the flexibility to respond swiftly as 
unpredictable, problematic health and humanitarian crises arise. The 
current definition of a communicable disease of public health 
significance does not adequately accommodate the demographic shifts 
that have dramatically altered the pattern of diseases among new 
arrivals in the United States.
    HHS/CDC has found that the origins of U.S.-bound populations are 
increasingly unpredictable, and these populations increasingly 
originate in areas with challenging and unpredictable communicable 
diseases of public health significance. Immigration statistics (http://www.dhs.gov/ximgtn/statistics) show more U.S.-bound refugees and 
immigrants now come from regions with a higher risk for communicable 
diseases. In recent years, the disease burden to the United States has 
increased as the proportion of refugees resettling from Africa and Asia 
has increased (http://www.state.gov/g/prm/refadm/rls/85970.htm). As an 
example, the proportion of refugees resettled to the United States from 
Africa have increased in the recent past. African refugee arrivals have 
averaged 16,000 per year since FY 2005. These newer groups of refugees 
have lower baseline rates of vaccination, higher rates of malaria and 
other parasitic infections (unfamiliar to most American clinicians), 
and very limited access to basic medical care and preventive health 
interventions before resettlement. Failure to address these conditions 
adequately because of the outdated definition of communicable diseases 
of public health significance has meant that HHS/CDC has had to respond 
to at least 25 outbreaks of disease among U.S.-bound refugees since 
2004.
    Major outbreaks of dangerous, communicable diseases around the 
world in 2007 included Ebola in the Democratic Republic of the Congo in 
September, and in Uganda in December; cholera in Iraq in August; yellow 
fever in Togo in February, and in Brazil and Paraguay in December; and 
85 animal-to-human cases of the highly pathogenic H5N1 strain of avian 
influenza throughout the year. These outbreaks have been of diseases 
that do not naturally occur in the United States, or occur rarely, 
which could result in disability and death in U.S.-bound immigrants and 
refugees and secondary spread in the communities in the United States 
that receive immigrants.
    The WHO classifies yellow fever as a disease that has demonstrated 
the ability to cause serious public health impact, and is a good 
example of a threat to the health security of the United States. The 
Ministry of Health in Togo reported an outbreak of yellow fever to the 
WHO that lasted from December 2006 through February 2007. Moreover, 
Sudan, Senegal, Mali, C[ocirc]te d'Ivoire, Burkina Faso, Guinea, 
Brazil, Peru, Paraguay, Bolivia and Argentina have also reported 
ongoing outbreaks of yellow fever to the WHO. In total, the WHO 
considers 46 countries, including 33 African countries and 11 countries 
in Central and South America, to be currently at risk of yellow fever. 
Substantial numbers of U.S.-bound immigrants and refugees originate 
from areas in which yellow fever is endemic, and therefore pose a risk 
of the importation of this disease. Since mosquitoes that spread yellow 
fever exist in the United States, and areas of our country experienced 
outbreaks of the disease throughout the nineteenth century, importation 
could potentially result in sustained transmission in this country. 
Yellow fever is not currently included in the specific disease list in 
the regulation, but HHS/CDC would be classify it as a communicable 
disease of public health significance under the newly proposed 
definition, because it is a quarantinable disease by Presidential 
Executive Order and a disease that requires notification to WHO as an 
event that may constitute a public health emergency of international 
concern under the IHR (2005).
    The examples below enumerate some of the most recent (and largely 
unpredictable) disease outbreaks encountered as refugees resettle into 
the United States:
--March 2007 to the present: Imported malaria outbreak in Burundian 
refugees from Tanzania. Over 40 cases of malaria have occurred as of 
October 2007 in more than 12 U.S. states, including 18 cases in 
children less than 10 years old, despite the administration of a pre-
departure drug treatment regimen. Single cases or small domestic 
outbreaks through mosquitoes are another potential risk from this 
outbreak.
--October 2007 to the present: at least 12 cases of cholera have been 
reported in several thousand U.S.-bound refugees from the Dadaab 
refugee camp in Kenya, which led to a temporary suspension of 
resettlement. This was the second outbreak of cholera in this camp in 
2007; an earlier outbreak affected more than 200 refugees in June 2007.
--July 2007 to the present: cholera in Mae La refugee camp in Thailand, 
with over 200 cases reported as of October 2007.
--April to June 2007: 288 cases of cholera were reported in Dadaab 
refugee camp in Kenya. These cases included four deaths and 
necessitated a five-day holding period for U.S.-bound refugees before 
travel.
--January to May 2007: A measles outbreak affected over 100 persons in 
Dadaab refugee camp in Kenya and showed unusual epidemiology: 43 
percent of cases were in persons 15 years of age and older (measles 
usually affects only children, and thus most vaccination campaigns only 
cover those under 5 years of age).
--November 2006 to May 2007: Rift Valley Fever in Kenya (including in 
the Dadaab camp), Somalia, and the United Republic of Tanzania, with 
over 300 deaths.
--October 2006: A case of polio reported in the Dadaab refugee camp in 
Kenya, in the first reported local transmission of wild poliovirus for 
over 20 years in Kenya; only quick action by HHS/CDC avoided the 
importation of wild poliovirus (WPV) into the United States. (The last 
indigenous case of WPV in the United States was in 1979, and the last 
imported case of WPV was in 1993.)
    Vector-borne diseases involve a pathogen transmitted from an 
infected individual or animal, usually by an insect or other arthropod 
such as a mosquito or tick. There are several vector-borne diseases 
that are circulating in areas with U.S.-bound immigrants and refugees, 
all of which could spread into the U.S. population. These include 
exotic illnesses like chikungunya, dengue, and possibly Rift Valley 
fever.

Pandemic Influenza

    The changes in the medical screening rules will also provide HHS/
CDC officials with the authority to screen applicants that are coming 
into the United States from areas affected by a possible pandemic 
influenza. The World Health Report 2007--A safer future: global public 
health security in the 21st

[[Page 58055]]

century, issued by the WHO, emphasizes the danger of an influenza 
pandemic. A pandemic strain of influenza would be far more contagious 
than SARS, since it spreads by coughing and sneezing, and is 
transmitted with a short incubation period that reduces the time for 
tracing the spread of disease and isolating patients. An influenza 
pandemic could extend the enormous health consequences seen with SARS 
in Asia and Canada to every corner of the world within a matter of 
months.
    Although HHS/CDC cannot predict the timing and exact strain, 
science and history suggest the world will suffer at least one 
influenza pandemic this century, which has the potential to have a 
rapid and immense impact on all segments of the U.S. population and our 
economy. In the 20th century, the greatest influenza pandemic occurred 
in 1918-1919, which caused an estimated 40-50 million deaths worldwide. 
A severe pandemic, as happened in 1918, could now have a much greater 
impact. When pandemic strains emerge, they sweep through nations with 
frightening velocity. The three pandemics of the 20th century each 
encircled the world within months of their emergence into humans. Based 
on the current speed and volume of international movement of people and 
animals, there is no reason to think the next pandemic would spread any 
slower.
    Although health care has improved in the past decades, the WHO is 
predicting that today an influenza pandemic could result in 2-7.4 
million deaths globally. \1\ The WHO estimates that if a pandemic virus 
emerged now, the spread of the disease would be rapid. Based on 
experiences with past pandemics, some experts have predicted an illness 
that could affect around 25 percent of the world's population--more 
than 1.5 billion people. Should these forecasts prove accurate, the 
impact an influenza pandemic would have on national and international 
public health, and on economic and political security, would be 
enormous. Even if the virus caused relatively mild symptoms, the 
economic and social disruption that would arise from sudden surges of 
illness in so many people--occurring almost simultaneously throughout 
the world--would be incalculable.\2\
---------------------------------------------------------------------------

    \1\ Pandemic influenza preparedness and mitigation in refugee 
and displaced populations, WHO guidelines for humanitarian agencies, 
May 2006.
    \2\ The World Health Report 2007--A safer future: global public 
health security in the 21st century, WHO, August 2007.
---------------------------------------------------------------------------

    Interpandemic (seasonal) influenza results in more than 200,000 
hospitalizations every year and causes an average of 36,000 deaths 
annually in the United States. Modeling studies suggest that, in the 
absence of effective control measures, a medium-level pandemic (in 
which 15 to 35 percent of the population of the United States develops 
influenza) could result in 89,000 to 207,000 deaths, between 314,000 
and 734,000 hospitalizations, 18 to 42 million outpatient visits, and 
20 to 47 million sick people. The associated economic impact in the 
United States alone could range between $71.3 and $166.5 billion.
    The H5N1 virus that is currently circulating in Asia, Africa and 
Europe provides an example of the immense potential impact of an 
emerging influenza virus. As of March 19, 2008, the H5N1 strain of 
influenza virus has killed over 63 percent of the 373 humans affected, 
and authorities fear the disease could mutate into a form that could 
pass quickly and efficiently from human to human, which could spark a 
global pandemic. The 14 countries that have reported laboratory-
confirmed human cases of H5N1 infection as of March 19, 2008, are 
Azerbaijan, The People's Republic of China, Djibouti, Thailand, Egypt, 
Vietnam, Cambodia, Indonesia, Laos, Nigeria, Pakistan, Burma, Turkey, 
and Iraq. Before the next pandemic virus becomes well-adapted to 
humans, there is an urgent need for the United States to be prepared to 
detect human cases, and to prevent a novel influenza virus from being 
imported to the United States. One of the most effective ways to 
protect the American population is the preventive medical screening of 
aliens which would thereby help avert the entry and importation of a 
pandemic strain, or at least delay its arrival.
    HHS/CDC is implementing these new provisions immediately because 
the United States needs to respond effectively to any potential 
emerging communicable disease. HHS/CDC is taking this immediate action 
because the existing definition of communicable diseases of public 
health significance and the scope of medical screening do not 
adequately reflect current threats or protect against the significant 
harm to the American public currently ongoing and future outbreaks 
represent. Changing our approach to identifying, screening and testing 
for communicable diseases of public health significance will greatly 
improve our ability to detect, treat, and mitigate the potential 
introduction into--and spread throughout our country--of newly emerging 
and re-emerging diseases.
    Under the provisions of the Administrative Procedure Act at 5 
U.S.C. 553(b)(3)(B) and (d)(3), HHS/CDC finds that good cause exists to 
waive prior notice and comment and a 30 day delay in effective date on 
this rule is impracticable and contrary to the public interest. It is 
critical, for the reasons stated above, that HHS/CDC act quickly to 
ensure appropriate response, now and in the immediate future, to urgent 
disease threats that could have significant consequences in the United 
States. As noted, CDC is eager to consider public comment and will 
revise the rule as appropriate after receiving and analyzing any 
comments submitted.

VIII. Analysis of Impacts

A. Review Under Executive Order 12866, the Regulatory Flexibility Act, 
and the Unfunded Mandates Act of 1995

    HHS/CDC has examined the impact of the Interim Final Rule under 
Executive Order 12866, the Regulatory Flexibility Act, and the Unfunded 
Mandates Reform Act (UMRA) of 1995.
    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.
    HHS/CDC commissioned an analysis of the rule, which is included in 
the docket. The analysis examined the increased costs to immigrants, 
refugees and other entities, and the benefits of additional screening 
in preventing the spread of disease in the U.S. population.
    Based on recent history of disease outbreaks worldwide, the 
analysis estimates an additional cost of $4 million per year to 
immigrants and refugees. Immigrants will bear the additional medical 
testing costs for themselves, and the U.S. government will bear the 
additional medical testing costs for refugees. The benefit to the U.S. 
population associated with reduced incidence of secondary infections is 
estimated to be $30 million.
    These estimates only reflect the costs and benefits based on recent 
history. The study examined the benefits and costs associated with a 
new or re-emerging disease separately, but did not include them in the 
annualized values because of the inherent inability to estimate the 
frequency of an unknowable event.
    Based on the analysis, HHS/CDC has determined that the rule is not 
economically significant, as defined under Executive Order 12866.
    HHS/CDC considered the proposed regulation's effects on small 
entities, as required by the Regulatory Flexibility Act, and certifies 
that the final rule will

[[Page 58056]]

not have a significant economic impact on small entities.
    HHS/CDC evaluated the rule requirements for compliance with the 
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. Finally, the rule's 
provisions will not affect small governments.

B. Environmental Impact

    HHS has determined that provisions that amend 42 CFR part 34 will 
not have a significant impact on the human environment.

C. Federalism

    In accordance with Executive Order 13132, HHS/CDC determines that 
this rule does not have sufficient federalism implications to warrant 
the preparation of a federalism summary impact statement.

D. Civil Justice Reform

    HHS/CDC has reviewed this rule under Executive Order 12988, on 
Civil Justice Reform. This rule (1) preempts all State and local laws 
and regulations that are inconsistent with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court to challenge this rule.

IX. Paperwork Reduction Act of 1995

    The Paperwork Reduction Act applies to the data collection 
requirements found in 42 CFR part 34. The U.S. Department of State 
(DoS) is responsible for providing forms to panel physicians to 
document the medical examination and screening information for aliens. 
The Office of Management and Budget (OMB) last approved this data 
collection under OMB Control No. 1405-0113, on September 30, 2007. DoS 
will update its information collection request to reflect the changes 
made to the forms by this Interim Final Rule.

X. References

    The following references are available at the following Internet 
address: http://www.who.int.

    1. Pandemic influenza preparedness and mitigation in refugee and 
displaced populations, WHO guidelines for humanitarian agencies, May 
2006.
    2. The World Health Report 2007--A safer future: global public 
health security in the 21st century, WHO, August 2007.

List of Subjects in 42 CFR Part 34

    Aliens, Health Care, Scope of Examination, Passports and Visas, 
Public Health.

0
For the reasons stated in the preamble, the Centers for Disease Control 
and Prevention (CDC), within the U.S. Department of Health and Human 
Services (HHS), is amending 42 CFR part 34 as follows:

PART 34--[AMENDED]

0
1. The authority citation for part 34 is amended to read as follows:

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


0
2. Amend Sec.  34.2 by revising paragraph (b) to read as follows:


Sec.  34.2  Definitions.

* * * * *
    (b) Communicable disease of public health significance. Any of the 
following diseases:
    (1) Chancroid.
    (2) Communicable diseases as listed in a Presidential Executive 
Order, as provided under Section 361(b) of the Public Health Service 
Act. The current revised list of quarantinable communicable diseases is 
available at http://www.cdc.gov and http://www.archives.gov/federal-register.
    (3) Communicable diseases that may pose a public health emergency 
of international concern if it meets one or more of the factors listed 
in Sec.  34.3(d) and for which the CDC Director has determined (A) a 
threat exists for importation into the United States, and (B) such 
disease may potentially affect the health of the American public. The 
determination will be made consistent with criteria established in 
Annex 2 of the revised International Health Regulations (http://www.who.int/csr/ihr/en/), as adopted by the Fifty-Eighth World Health 
Assembly in 2005, and as entered into effect in the United States in 
July, 2007, subject to the U.S. Government's reservation and 
understandings:
    (i) Any of the communicable diseases for which a single case 
requires notification to the World Health Organization (WHO) as an 
event that may constitute a public health emergency of international 
concern, or
    (ii) Any other communicable disease the occurrence of which 
requires notification to the WHO as an event that may constitute a 
public health emergency of international concern.
    HHS/CDC's determinations will be announced by notice in the Federal 
Register.
    (4) Gonorrhea.
    (5) Granuloma inguinale.
    (6) Human immunodeficiency virus (HIV) infection.
    (7) Leprosy, infectious.
    (8) Lymphogranuloma venereum.
    (9) Syphilis, infectious stage.
    (10) Tuberculosis, active.
* * * * *

0
3. Section 34.3 is revised to read as follows:


Sec.  34.3  Scope of examinations.

    (a) General. In performing examinations, medical examiners shall 
consider those matters that relate to the following:
    (1) A communicable disease of public health significance;
    (2)(i) A physical or mental disorder and behavior associated with 
the disorder that may pose, or has posed, a threat to the property, 
safety, or welfare of the alien or others;
    (ii) A history of a physical or mental disorder and behavior 
associated with the disorder, which behavior has posed a threat to the 
property, safety, or welfare of the alien or others and which behavior 
is likely to recur or lead to other harmful behavior;
    (3) Drug abuse or addiction; and
    (4) Any other physical abnormality, disease, or disability serious 
in degree or permanent in nature amounting to a substantial departure 
from normal well-being.
    (b) Scope of all medical examinations. (1) All medical examinations 
will include the following:
    (i) A general physical examination and medical history, evaluation 
for tuberculosis, and serologic testing for syphilis and HIV.
    (ii) A physical examination and medical history for diseases 
specified in Sec. Sec.  34.2(b)(1), and 34.2(b)(4) through 34.2(b)(10).
    (2) The scope of the examination shall include any laboratory or 
additional studies that are deemed necessary, either as a result of the 
physical examination or pertinent information elicited from the alien's 
medical history, for the examining physician to reach a conclusion 
about the presence or absence of a physical or mental abnormality, 
disease, or disability.
    (c) Additional medical screening and testing for examinations 
performed outside the United States. (1) HHS/CDC may require additional 
medical screening and testing for medical examinations performed 
outside the United States for diseases specified in Sec. Sec.  
34.2(b)(2) and 34.2(b)(3) by applying the risk-based medical and 
epidemiologic factors in paragraph (d)(2) of this section.
    (2) Such examinations shall be conducted in a defined population in 
a geographic region or area outside the United States as determined by 
HHS/CDC.

[[Page 58057]]

    (3) Additional medical screening and testing shall include a 
medical interview, physical examination, laboratory testing, radiologic 
exam, or other diagnostic procedure, as determined by HHS/CDC.
    (4) Additional medical screening and testing will continue until 
HHS/CDC determines such screening and testing is no longer warranted 
based on factors such as the following: Results of disease outbreak 
investigations and response efforts; effectiveness of containment and 
control measures; and the status of an applicable determination of 
public health emergency of international concern declared by the 
Director General of the WHO.
    (5) HHS/CDC will directly provide medical examiners information 
pertaining to all applicable additional requirements for medical 
screening and testing, and will post these at the following Internet 
addresses: http://www.cdc.gov/ncidod/dq/technica.htm and http://www.globalhealth.gov.
    (d) Risk-based approach. (1) HHS/CDC will use the medical and 
epidemiological factors listed in paragraph (d)(2) of this section to 
determine the following:
    (i) Whether a disease as specified in Sec.  34.2(b)(3)(ii) is a 
communicable disease of public health significance.
    (ii) Which diseases in Sec. Sec.  34.2(b)(2) and (b)(3) merit 
additional screening and testing, and the geographic area in which HHS/
CDC will require this screening.
    (2) Medical and epidemiological factors include the following:
    (i) The seriousness of the disease's public health impact;
    (ii) Whether the emergence of the disease was unusual or 
unexpected;
    (iii) The risk of the spread of the disease in the United States;
    (iv) The transmissibility and virulence of the disease;
    (v) The impact of the disease at the geographic location of medical 
screening; and
    (vi) Other specific pathogenic factors that would bear on a 
disease's ability to threaten the health security of the United States.
    (e) Persons subject to requirement for chest X-ray examination and 
serologic testing. (1) As provided in paragraph (e)(2) of this section, 
a chest X-ray examination, and serologic testing for syphilis and 
serologic testing for HIV shall be required as part of the examination 
of the following:
    (i) Applicants for immigrant visas;
    (ii) Students, exchange visitors, and other applicants for non-
immigrant visas required by a U.S. consular authority to have a medical 
examination;
    (iii) Applicants outside the United States who apply for refugee 
status;
    (iv) Applicants in the United States who apply for adjustment of 
their status under the immigration statute and regulations.
    (2) Chest X-ray examination and serologic testing. Except as 
provided in paragraph (e)(2)(iv) of this section, applicants described 
in paragraph (e)(1) of this section shall be required to have the 
following:
    (i) For applicants 15 years of age and older, a chest x-ray 
examination;
    (ii) For applicants under 15 years of age, a chest x-ray 
examination if the applicant has symptoms of tuberculosis, a history of 
tuberculosis, or evidence of possible exposure to a transmissible 
tuberculosis case in a household or other enclosed environment for a 
prolonged period;
    (iii) For applicants 15 years of age and older, serologic testing 
for syphilis and HIV.
    (iv) Exceptions. Serologic testing for syphilis and HIV shall not 
be required if the alien is under the age of 15, unless there is a 
reason to suspect infection with syphilis or HIV. 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.
    (3) Immune Response to Mycobacterium tuberculosis antigens. (i) All 
aliens 2 years of age or older in the United States who apply for 
adjustment of status to permanent residents, under the immigration laws 
and regulations, or other aliens in the United States who are required 
by the U.S. Department of Homeland Security to have a medical 
examination in connection with a determination of their admissibility, 
shall be required to have a tuberculin skin test or an equivalent test 
for showing an immune response to Mycobacterium tuberculosis antigens. 
Exceptions to this requirement may be authorized for good cause upon 
application approved by the Director. In the event of a positive 
tuberculin reaction, a chest X-ray examination shall be required. If 
the chest radiograph is consistent with tuberculosis, the alien shall 
be referred to the local health authority for evaluation. Evidence of 
this evaluation shall be provided to the civil surgeon before a medical 
notification may be issued.
    (ii) Aliens less than 2 years old shall be required to have a 
tuberculin skin test, or an equivalent, appropriate test to show an 
immune response to Mycobacterium tuberculosis antigens, if there is 
evidence of contact with a person known to have tuberculosis or other 
reason to suspect tuberculosis. In the event of a positive tuberculin 
reaction, a chest X-ray examination shall be required. If the chest 
radiograph is consistent with tuberculosis, the alien shall be referred 
to the local health authority for evaluation. Evidence of this 
evaluation shall be provided to the civil surgeon before a medical 
notification may be issued.
    (iii) Aliens outside the United States required to have a medical 
examination shall be required to have a tuberculin skin test, or an 
equivalent, appropriate test to show an immune response to 
Mycobacterium tuberculosis antigens, and, if indicated, a chest 
radiograph.
    (iv) Aliens outside the United States required to have a medical 
examination shall be required to have a tuberculin skin test, or an 
equivalent, appropriate test to show an immune response to 
Mycobacterium tuberculosis antigens, and a chest radiograph, regardless 
of age, if they have symptoms of tuberculosis, a history of 
tuberculosis, or evidence of possible exposure to a transmissible 
tuberculosis case in a household or other enclosed environment for a 
prolonged period.
    (4) Additional testing requirements. All applicants subject to the 
chest radiograph requirement, and for whom the radiograph shows an 
abnormality suggestive of tuberculosis disease, shall be required to 
undergo additional testing for tuberculosis.
    (5) How and where performed. All chest radiograph images used in 
medical examinations performed under the regulations in this Part shall 
be large enough to encompass the entire chest (approximately 14 by 17 
inches; 35.6x43.2 cm.). Serologic testing for HIV shall be a sensitive 
and specific test, confirmed when positive by a test such as the 
Western blot test or an equally reliable test. For aliens examined 
abroad, the serologic testing for HIV must be completed abroad, except 
that the Secretary of Homeland Security after consultation with the 
Secretary of State and the Secretary of Health and Human Services may 
in emergency circumstances permit serologic testing of refugees for HIV 
to be completed in the United States.
    (6) Chest X-ray, laboratory, and treatment reports. The chest 
radiograph reading and serologic test results for syphilis and HIV 
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

[[Page 58058]]

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.
    (f) Procedure for transmitting records. For aliens issued immigrant 
visas, the medical notification and chest X-ray images, if any, shall 
be placed in a separate envelope which shall be sealed. When more than 
one chest X-ray image is used as a basis for the examiner's 
conclusions, all images shall be included.
    (g) Failure to present records. When a determination of 
admissibility is to be made at the U.S. port of entry, a medical hold 
document shall be issued pending completion of any necessary 
examination procedures. A medical hold document may be issued for 
aliens who:
    (1) Are not in possession of a valid medical notification, if 
required;
    (2) Have a medical notification which is incomplete;
    (3) Have a medical notification which is not written in English;
    (4) Are suspected to have an excludable medical condition.
    (h) The Secretary of Homeland Security, after consultation with the 
Secretary of State and the Secretary of Health and Human Services, may 
in emergency circumstances permit the medical examination of refugees 
to be completed in the United States.
    (i) All medical examinations shall be carried out in accordance 
with such technical instructions for physicians conducting the medical 
examination of aliens as may be issued by the Director. Copies of such 
technical instructions are available upon request to the Director, 
Division of Global Migration and Quarantine, Mailstop E03, HHS/CDC, 
Atlanta GA 30333.

    Dated: June 25, 2008.
Michael O. Leavitt,
Secretary, Department of Health and Human Services.
 [FR Doc. E8-23485 Filed 10-3-08; 8:45 am]
BILLING CODE 4163-18-P


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