[Federal Register Volume 74, Number 218 (Friday, November 13, 2009)]
[Notices]
[Pages 58634-58638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-27317]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Criteria for Vaccination Requirements for U.S. Immigration 
Purposes

AGENCY: Centers for Disease Control and Prevention (CDC).

ACTION: Final notice of agency action.

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DATES: This agency action is effective December 14, 2009.

FOR FURTHER INFORMATION CONTACT: Ashley A. Marrone, J.D., U.S. 
Department of Health and Human Services, Centers for Disease Control 
and Prevention, Division of Global Migration and Quarantine, 1600 
Clifton Road, NE. (E03), Atlanta, GA 30333; Telephone, 404-498-1600.

SUMMARY: On April 8, 2009, the Centers for Disease Control and 
Prevention (CDC) published a notice in the Federal Register (74 FR 
15986) seeking public comment on proposed criteria that CDC intends to 
use to determine which vaccines recommended by the Advisory Committee 
on Immunization Practices (ACIP) for the general U.S. population should 
be required for immigrants seeking admission into the United States or 
seeking adjustment of status to that of an alien lawfully admitted for 
permanent residence. This final notice describes the criteria that CDC 
has adopted.
    At present, CDC requires all vaccinations against vaccine-
preventable diseases explicitly listed in section 212(a)(1)(A)(ii) of 
the Immigration and Nationality Act, as well as all vaccinations 
recommended by the ACIP for the general U.S. population. After the 
effective date of this notice, CDC will continue to require the 
vaccinations explicitly listed in section 212(a)(1)(A)(ii)--mumps, 
measles, rubella, polio, tetanus and diphtheria toxoids, pertussis, 
Haemophilus influenzae type B, and hepatitis B--and, for all other 
vaccinations recommended by ACIP for the general U.S. public, CDC will 
begin requiring only those for which there is a public health need at 
the time of immigration/change of status based on the following 
criteria:
    1. The vaccine must be an age-appropriate vaccine as recommended by 
the ACIP for the general U.S. population, and
    2. At least one of the following:
    a. The vaccine must protect against a disease that has the 
potential to cause an outbreak.\1\
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    \1\ For purposes of this Notice, ``outbreak'' means the 
occurrence of more cases of disease than could be anticipated in a 
given area or among a specific group of people over a particular 
period of time.
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    b. The vaccine must protect against a disease that has been 
eliminated in the United States or is in the process for elimination in 
the United States.\2\
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    \2\ ``Elimination'' is the reduction to zero of the incidence of 
infection caused by a specific agent in a defined geographic area as 
a result of deliberate efforts; continued measures to prevent re-
establishment of transmission are required.

SUPPLEMENTARY INFORMATION:

Background

    Under section 212(a)(1)(A)(ii) of the Immigration and Nationality 
Act (INA) (8 U.S.C. 1182(a)(1)(A)(ii)), any alien who seeks admission 
into the United States as an immigrant, or who seeks adjustment of 
status to the status of an alien lawfully admitted for permanent 
residence, is inadmissible into the United States if the alien is 
unable to present documentation of having received vaccination against 
``vaccine-preventable diseases, which shall include at least the 
following diseases: Mumps, measles, rubella, polio, tetanus and 
diphtheria toxoids, pertussis, Haemophilus influenzae type B, and 
hepatitis B, and any other vaccinations against vaccine-preventable 
diseases recommended by the Advisory Committee on Immunization 
Practices.'' Aliens subject to this provision may apply for a waiver in 
certain circumstances, e.g., if the vaccination is not medically 
appropriate or contrary to the alien's religious beliefs or moral 
convictions.
    Medical examinations, including an evaluation to determine whether 
an alien has received these vaccinations, are authorized under section 
232 of the INA (8 U.S.C. 1222). Under sections 212(a)(1) and 232 of the 
INA (8 U.S.C. 1182(a)(1), 1222), and section 325 of the Public Health 
Service Act (42 U.S.C. 252), the Department of Health and Human 
Services (HHS) publishes regulations establishing requirements for the 
medical examination. The Secretary of HHS has delegated the authority 
for administering these regulations to the Centers for Disease Control 
and Prevention (CDC). The regulations are codified in 42 CFR part 34. 
Panel physicians and civil surgeons, through contractual agreements and 
by designations with the Department of State (DOS) and the Department 
of Homeland Security (DHS), respectively, conduct the medical 
examinations in accordance with these regulations. CDC also publishes 
Technical Instructions (TIs) for the medical examinations, which must 
be followed by panel physicians and civil surgeons. The vaccinations 
required by the INA are listed in the Technical Instructions (see 
http://www.cdc.gov/ncidod/dq/technica.htm).
    Since 1996, when the vaccination requirement was added to the INA, 
CDC has required immigrants subject to the INA vaccination requirement 
to receive all vaccinations routinely recommended by the Advisory 
Committee on Immunization Practices (ACIP) for the general U.S. 
population. Vaccine development has evolved since 1996 and, in 
addition, a greater number of vaccines are recommended by ACIP than 
were recommended when the legislation was enacted. As a result, CDC is 
reassessing which of these vaccinations are appropriate for immigration 
purposes, taking into consideration both the context in which they are 
given as well as the interests of public health.
    To meet the threshold for consideration, a vaccine must first be an 
age-appropriate vaccine as recommended by the ACIP for the general U.S. 
population. After this determination is satisfied, the vaccine must 
protect against (1) a disease that has the potential to cause an 
outbreak, and/or (2) a disease that has been eliminated in the United 
States or is in the process for elimination in the United States. 
Outbreak is defined as the occurrence of more cases of disease than 
could be anticipated in a given area or among a specific group of 
people over a particular period of time. The determination of an 
outbreak may be made in a variety of scenarios. For example, an 
outbreak may be determined by comparing the current number of cases of 
disease with the background rate of the disease. The ``background 
rate'' of disease is the rate at which the disease usually occurs, at a 
particular time, in a particular population, or in a particular place. 
Therefore, the occurrence of a disease above the background rate, so 
that more people than usual or an unexpected group of people have 
become ill with the same disease in a given geographic area, or over a 
given period of time, could be viewed as an outbreak.
    In general, and as observed through previous experience, an 
outbreak is associated with a public health response (e.g., initiation 
of an investigation,

[[Page 58635]]

dissemination of prophylaxis, or public health messaging to change 
behavior).
    CDC will also consider whether the disease has been eliminated in 
the United States or is in the process for elimination in the United 
States. ``Elimination'' is the reduction to zero of the incidence of 
infection caused by a specific agent in a defined geographic area as a 
result of deliberate public health efforts; continued measures to 
prevent re-establishment of transmission are required.\3\ Therefore, if 
a vaccine is an age-appropriate vaccine as recommended by the ACIP for 
the general U.S. population, and the disease is in the process for 
elimination in the United States, it will be required for immigration 
purposes. The prevention of outbreaks and progress toward elimination 
represent two core public health goals. These criteria aim to prevent 
outbreaks and the re-introduction of vaccine-preventable diseases that 
have been eliminated or are in the process for elimination in the U.S. 
through the immunization of immigrants.
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    \3\ CDC. Dowdle WR. The Principles of Disease Elimination and 
Eradication. MMWR Supplement 1999; 48(SU01):23-7.
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    Congress mandated vaccinations for immigrants to decrease the 
public health threat from disease importation. Outbreak potential and 
absence of a vaccine-preventable disease in the United States (because 
of elimination or movement toward elimination through vaccination) are 
the critical public health concerns in determining which vaccines 
should be mandated for immigration to the United States. Evidence shows 
that disease importation contributes to many current vaccine-
preventable disease outbreaks in the United States, and is solely 
responsible for outbreaks of eliminated diseases. For example, close to 
90% of the measles cases reported in the U.S. during 2008 were either 
acquired abroad or linked to imported cases resulting in 7 outbreaks 
involving 135 persons.\4\ Some of these cases are attributable to 
traveling unvaccinated U.S. citizens. Such disease vulnerability among 
U.S. citizens is beyond the scope of this notice and should be 
addressed by states and other public health authorities. The INA 
immigrant vaccination mandate, however, provides a significant 
opportunity to reduce the potential of disease importation, in 
particular of those diseases (1) where a single case has the potential 
to spread widely or (2) to threaten reintroduction of an eliminated 
disease.
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    \4\ CDC. Update: Measles--United States, January-July 2008. 
MMWR, 22 August (2008) 57(33);893-896.
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    Disease prevention vigilance at the borders through imposition of 
vaccination mandates focused on those diseases of outbreak or 
elimination significance serves a critical role in the multi-layered 
public health response to vaccine-preventable diseases. State 
vaccination mandates for school attendance and availability of vaccines 
for children through public health programs add other layers to that 
public health response. Working together, these layers result in 
vibrant vaccination coverage that protects the health of our citizens, 
individually and as a whole.
    Further, it should be noted that given the existence of this multi-
layered public health system for assuring adequate vaccination of all 
Americans, determination that a vaccine should not be mandated at time 
of immigration or change in status is not relevant to and should not in 
any way be considered a factor in determining whether or not that 
vaccine should be required for school entry or otherwise mandated by a 
state or other public health entity. Immunization mandates at various 
times and places are a highly important and effective public health 
tool for preventing vaccine-preventable diseases.
    CDC has developed and accepted the criteria described in this 
Notice specifically for the required medical examination performed for 
U.S. immigration purposes. CDC stands behind all ACIP recommendations 
for the general U.S. population of which the immigrants will become 
part. CDC expects that such individuals will avail themselves of those 
vaccines not mandated for immigration as they make future wise medical 
decisions for themselves and encounter the other public health layers 
present to minimize vaccine-preventable diseases in our communities.

Implementation of Specific Vaccination Criteria

    ACIP recommendations serve multifactorial purposes, including 
optimizing individual health status, protecting the public health of 
the Nation, and providing technical guidance for State-based mandates 
for school, child care, employment, and other settings. However, to 
date, the ACIP recommendations for the general U.S. population have 
been applied to aliens seeking admission into the United States without 
further consideration of the public health impact and need of these 
immunizations at the time of the medical examination for immigration. 
CDC believes specific public health criteria that focus on preventing 
infectious diseases that can cause outbreaks or are in the process of 
elimination should be used to determine which ACIP-recommended 
vaccinations for the U.S. population are appropriate to mandate for 
aliens seeking admission into the United States or seeking to adjust 
their status to that of lawful permanent resident at the time of the 
medical examination.
    On April 8, 2009, CDC published a notice in the Federal Register 
seeking public comment on criteria CDC proposed to be used for these 
purposes. See 74 FR 15986. CDC proposed the following criteria:
    1. The vaccine must be an age-appropriate vaccine, as recommended 
by ACIP for the general U.S. population, and
    2. At least one of the following:
    a. The vaccine must protect against a disease that has the 
potential to cause an outbreak.\5\
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    \5\ For purposes of this Notice, ``outbreak'' means the 
occurrence of more cases of disease than could be anticipated in a 
given area or among a specific group of people over a particular 
period of time.
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    b. The vaccine must protect against a disease that has been 
eliminated in the United States, or is in the process for elimination 
in the United States.\6\
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    \6\ ``Elimination'' is the reduction to zero of the incidence of 
infection caused by a specific agent in a defined geographic area as 
a result of deliberate efforts; continued measures to prevent re-
establishment of transmission are required.
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    CDC received a total of forty (40) comments to the Federal Register 
notice, some of which contained multiple topics and some of which were 
the collaborative effort of multiple groups. Twenty-six comments were 
received regarding Human Papillomavirus (HPV) vaccine specifically, 
including two comments that suggested alternatives HHS/CDC could adopt 
if the HPV vaccine were not removed from the list as a result of the 
application of the adopted criteria. Twenty-four comments were received 
regarding HHS/CDC's current practice of requiring vaccines for the 
purpose of immigration. Nineteen comments were received that discussed 
the proposed criteria to be used in determining which vaccines 
recommended by ACIP for the U.S. population should be required for 
immigration purposes. Ten comments were received regarding the vaccine 
for the prevention of herpes zoster (zoster vaccine). Three comments 
were received regarding HHS/CDC's technical instructions. Finally, nine 
comments were received which were either outside the scope of the 
Notice or beyond the scope of HHS/CDC's mission. Below is

[[Page 58636]]

a summary of public comments received and CDC's responses to those 
comments.

I. Comments Regarding the Current Process

    One commenter noted that the current requirements work very well in 
practice and wondered what might be accomplished by a change.
    Response: The current process for determining which vaccines should 
be required does not take into consideration the purpose of the medical 
examination for U.S. immigration, i.e., to prevent the importation of 
infectious diseases of public health significance. The change to the 
current process will allow for the necessary flexibility to identify 
vaccines from a growing list of vaccines against vaccine-preventable 
diseases with highest public health impact (as defined in the criteria) 
at the time of the medical examination.
    Some commenters asserted that CDC's current practice of listing all 
ACIP vaccines in its technical instructions is too broad and 
inflexible, and likely to lead to unnecessary requirements that do not 
allow immigrant women to make an informed decision about whether to 
obtain certain recommended vaccines.
    Response: The issue of consent is not a subject of this notice. 
Congress has mandated (with opportunity for medical/religious/moral 
waiver) that particular vaccines be received by immigrants and that 
other vaccines also be received by them based on ACIP recommendations. 
Therefore, beyond application of waivers, immigrants do not have 
discretion to choose which mandated vaccines to receive.
    Some commenters wondered why certain vaccines are required for 
immigrants and not U.S. citizens. Other commenters incorrectly assumed 
that the Federal Register Notice and proposed criteria applied to 
refugees.
    Response: Vaccination requirements for aliens seeking admission 
into the United States are based on the Immigration and Nationality Act 
(INA). Section 212(a)(1)(A)(ii) of the INA requires any person who 
seeks admission as an immigrant, or who seeks adjustment of status to 
that of an alien lawfully admitted for permanent residence to document 
proof of vaccination of having received vaccination against certain 
vaccine-preventable diseases as listed in the statute or recommended by 
ACIP. The vaccine requirements provided in the INA do not apply to U.S. 
citizens. Additionally, the current vaccination requirements apply to 
refugees only when they apply to adjust their status to lawful 
permanent resident, typically one year after arrival into the United 
States.
    Several commenters expressed concern that the DHS waiver for moral 
convictions or religious reasons is an ineffective tool because waiving 
all vaccinations for an individual--instead of waiving particular 
vaccinations--results in a completely unvaccinated individual and, 
therefore, a threat to public health. Further, not all immigrants are 
aware that such a waiver exists, or it may not be an option for them 
because they previously received vaccines.
    Response: This issue is outside the scope of the request for 
comments--HHS does not issue waivers with respect to immigrant 
vaccination mandates. This is a function carried out by DHS under its 
regulations.

II. Comments Regarding the Proposed Criteria

    Some commenters agreed with the criteria and urged CDC to adopt 
them as proposed.
    Response: CDC has adopted the criteria as proposed. Application of 
criteria to ACIP recommendations will begin thirty (30) days after 
publication of this Notice.
    Some commenters expressed concern over the potential for an overly 
broad reading of proposed criterion 2b, which states: ``is in the 
process for elimination in the United States.'' These commenters 
suggested this text be narrowed to reflect an appropriate standard by 
which to evaluate the current and potential mandatory vaccinations for 
immigrants.
    Response: CDC follows an accepted definition for elimination of 
infections that states: ``Elimination is the reduction to zero of the 
incidence of infection caused by a specific agent in a defined 
geographic area as a result of deliberate efforts; continued measures 
to prevent re-establishment of transmission are required.'' \7\ Hence, 
in order to meet the criterion of an infection being in the process of 
elimination, deliberate efforts need to be in place for the elimination 
of infection, not merely the prevention of infection. CDC will rely on 
subject-matter experts, including national and international public 
health bodies such as the ACIP and the World Health Organization (WHO), 
to make such determinations. To date, only measles, polio, and rubella 
are considered to have been eliminated (or, in the case of polio, 
``eradicated'') in the United States.
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    \7\ CDC. Dowdle WR. The Principles of Disease Elimination and 
Eradication. MMWR Supplement 1999; 48(SU01):23-7.
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    One commenter raised concern that ``potential to cause an 
outbreak,'' as defined in the April 8, 2009 Federal Register Notice, is 
vague and overly broad and could be used to make a specious case that 
it encompasses noninfectious diseases. HPV, which can lead to cancer, 
is currently the most common sexually transmitted disease in the United 
States, which could be interpreted as being ``an outbreak.'' This 
commenter suggested that the definition of outbreak should be narrowed 
to include the spread of disease through the respiratory route or 
common public contact, and should also reference the difficulty of 
containing the spread due to unavoidable exposure.
    Response: CDC is adopting the language provided for in the Federal 
Register notice because it is widely established and accepted in public 
health. CDC recognizes that the mode of transmission itself does not 
define an outbreak potential. Similarly, as discussed in the Background 
section above, high prevalence in and of itself does not constitute an 
outbreak--in that it does not automatically mean there are ``more cases 
of disease than could be anticipated in a given area or among a 
specific group of people over a particular period of time'' per the 
applied definition of an outbreak. For endemic diseases, an outbreak 
occurs when the incidence rises above the normal expected level. While 
HPV is a common infection, the occurrence of more cases than expected 
(as defined by an outbreak, discussed above) is not met. Further, HPV 
has not been eliminated, nor is in the process of elimination, in the 
United States. Therefore, because HPV does not meet the adopted 
criteria, it will not be a required vaccine for immigrant and 
adjustment of status to permanent residence applicants.
    Some commenters rejected the proposed criteria and developed a list 
of vaccinations which should be required based upon their personal 
beliefs or practices.
    Response: Commenters should be aware that not all vaccination 
requirements are subject to change as a result of the adoption of these 
criteria. For example, vaccinations are not required for any alien for 
whom a civil surgeon, medical officer, or panel physician certifies 
that the vaccination would not be medically appropriate or for whom the 
vaccination requirement would be contrary to religious beliefs or moral 
convictions, in accordance with regulations promulgated by DHS. 
Further, commenters should be aware

[[Page 58637]]

that most adopted children 10 years of age or younger are not required 
to receive such vaccinations provided certain requirements are met. 
This includes a requirement that, prior to the admission of the child, 
an adoptive or prospective adoptive parent of the child who has 
sponsored the child for admission as an immediate relative must execute 
an affidavit stating that the parent is aware of the vaccination 
requirements and will ensure that the child receives the required 
vaccinations within 30 days of the child's admission, or earlier if 
medically appropriate.

III. Comments Regarding the HPV Vaccine

    CDC received numerous comments both advocating for and against 
inclusion of HPV vaccine.
    Response: CDC has applied the criteria and determined that once 
these criteria become effective December 14, 2009, the HPV vaccine will 
not be required for aliens seeking admission as an immigrant or seeking 
adjustment of status to that of an alien lawfully admitted for 
permanent residence. In reaching this decision, CDC applied the adopted 
criteria. Genital infection with HPV is an extremely common infection 
due to its efficient transmission via sexual intercourse. There are 
approximately 6 million incident infections occurring annually in the 
United States. Over half of sexually active men and women will develop 
HPV infection at some point in their lives and 15% of all Americans 
have current infection with HPV.\8\ Even more individuals will have 
been infected previously in their lives.
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    \8\ Dunne EF, Unger ER, Sternberg M, et al. Prevalence of HPV 
infection among females in the United States. JAMA 2007;297(8):813-
819.
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    Although millions of HPV infections occur annually, most are 
asymptomatic and resolve. About 10,000 cases of cervical cancer (the 
most important biologic outcome of HPV infection) develop annually in 
the United States. Because HPV infection is common in the general US 
population, is asymptomatic, and because it is not possible to 
distinguish infections which resolve spontaneously from those that 
result in cervical cancer, HPV is not the target of outbreak control. 
Rather a routine vaccination program is recommended to prevent 
infection. Similarly, HPV is not the target of a disease elimination 
campaign in the United States.
    Therefore, while HPV may be an age-appropriate vaccine for an 
immigrant applicant, HPV neither causes outbreaks nor is it associated 
with outbreaks (per explanation in the background section). Further, 
HPV has not been eliminated, nor is in the process of elimination, in 
the United States. Therefore, because HPV does not meet the adopted 
criteria, it will not be a required vaccine for immigrant and 
adjustment of status to permanent residence applicants.
    One commenter asked CDC to clarify if the phrase ``through 26 years 
of age,'' as written in the Technical Instructions for administration 
of the HPV vaccine, means ``past the age of 26 and up to 27,'' or ``up 
to the age of 26.''
    Response: CDC clarifies that ``through 26 years of age'' means past 
the age of 26 and up to the 27th birthday.

IV. Comments Regarding Alternative Approaches

    One commenter suggested that if, as a result of these published 
criteria, the HPV vaccine is not removed from the list of required 
vaccinations, aliens should be allowed to forego a required vaccination 
on the basis that it protects against a noninfectious disease. Further, 
that commenter asserted that there should be no charge or application 
for opting out of such vaccines, and the Attorney General should not 
have the discretion to deny aliens this option.
    Response: As indicated above, when the newly adopted criteria 
become effective (30 days after publication of this Notice), the HPV 
vaccine will no longer be required for immigration purposes. For those 
vaccines mandated for immigration, the only basis for opting out is 
receipt of a medical, religious, or moral convictions waiver. Whether 
or not the Attorney General has the authority to require a fee or 
application as part of a waiver process for vaccinations, is beyond the 
scope of this Notice.
    One commenter requested CDC to direct the ACIP to modify its 
recommendation to state that the HPV vaccination should not be mandated 
for immigrants.
    Response: The nature of an advisory committee is to provide its 
independent, unfettered expertise and advice to the agency, as 
described in the committee's administrative charter. The agency does 
not mandate that it receive any particular advice.
    One commenter urged CDC to direct the U.S. Citizenship and 
Immigration Services agency (USCIS) to suspend the HPV vaccination 
requirement for immigrants applying to adjust their immigration status 
or obtain visas for the United States.
    Response: HHS/CDC has no authority to direct component agencies 
within DHS to take action. However, HHS/CDC has determined that the HPV 
vaccine does not meet the necessary elements of the proposed criteria 
and will no longer be required for immigration purposes once the 
criteria become effective (30 days after publication of this notice).

V. Comments Regarding the Zoster Vaccine

    Several commenters opposed the requirement of Zoster vaccine based 
upon the proposed criteria, and further found the costs to immigrants 
and refugees for this vaccine to be prohibitive.
    Response: Upon application of the criteria adopted in this final 
notice, CDC has determined that Zoster vaccine will no longer be 
required for immigration purposes once the criteria become effective 
(30 days after publication of this notice). In reaching this decision, 
CDC applied the adopted criteria. Varicella Zoster Virus (VZV) is an 
exclusively human pathogen that infects approximately 98% of the adult 
population in the United States.\9\ Approximately 1 million new cases 
of Zoster occur in the United States annually and approximately one in 
three persons in the general population will develop zoster during 
their lifetime. These statistics alone indicate that VZV has neither 
been eliminated, nor is in the process of elimination in the United 
States.\10\ Further, Zoster neither causes outbreaks nor is it 
associated with outbreaks of varicella: Its high prevalence in the U.S. 
is in keeping with the background rate of the disease (i.e., no more 
people than usual, or an unexpected group of people, have become ill 
with VZV in a given geographic area in the U.S. over a given period of 
time). Therefore, because Zoster does not meet the criteria, it will 
not be a required vaccine for immigrant and adjustment of status to 
permanent residence applicants.
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    \9\ Kilgore PE, Kruszon-Moran D, Seward JF, et al. Varicella in 
Americans from NHANES III: implications for control through routine 
immunization. J Med Virol 2003;70 Suppl 1:S111-8.
    \10\ CDC. Prevention of herpes zoster: Recommendations of the 
Advisory Committee on Immunization Practices (ACIP). MMWR 
2008;57(No. RR-5):1-30.
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VI. Comments Regarding Technical Instructions

    One commenter requested that state immunization programs be 
notified of any change in vaccination requirements.
    Response: Any changes in the vaccination requirements for immigrant 
visa and adjustment of status applicants are posted on the CDC and DHS 
(USCIS) Web sites. Thus, they are available to the public and all 
organizations (e.g.,

[[Page 58638]]

civil surgeons, health departments) involved in vaccination issues.
    One commenter requested that the Technical Instructions be updated 
to reflect any change in vaccination requirements.
    Response: The Technical Instructions are routinely revised to 
reflect needed changes (e.g., addition of new vaccines). Two key 
changes to the Technical Instructions are based on the adoption of the 
criteria in this Federal Register Notice, i.e., that neither the HPV 
nor Zoster vaccines be required as part of the medical examination. 
These changes, which become effective 30 days after publication of this 
notice, will be reflected in the revised Technical Instructions posted 
on the CDC Web site at http://www.cdc.gov/ncidod/dq/technica.htm.
    One commenter suggested that the current Technical Instructions do 
not follow the ACIP recommendations and are confusing regarding the 
age-appropriate vaccinations and minimum intervals.
    Response: The current Technical Instructions are based on age-
appropriate vaccinations and minimum intervals of vaccine doses 
provided by the ACIP recommendations for the general population. The 
vaccine tables for children and adults based on the ACIP 
recommendations are located on CDC's Web site at the following Internet 
address: http://www.cdc.gov/vaccines/recs/schedules/.
    One commenter requested that the Technical Instructions be reviewed 
(if not written) by the National Center for Immunization and 
Respiratory Diseases (NCIRD) staff who are very familiar with 
immunizations.
    Response: The Technical Instructions are developed in coordination 
with numerous components of CDC, including NCIRD and other programs 
with expertise in immunization matters. Following their development, 
the Technical Instructions then undergo official agency clearance, 
which also includes review by relevant components of the agency. 
Ultimately, the Technical Instructions are published by CDC's Division 
of Global Migration and Quarantine (DGMQ), which is the component of 
CDC responsible for administering them for use by civil surgeons and 
panel physicians.

VII. Miscellaneous Comments

    One commenter called attention to the incorrect deadline for 
submission of comments which was originally posted in the Federal 
Register Notice.
    Response: CDC appreciates this comment and had already made changes 
to the original notice and published the corrected date on April 20, 
2009 in the Federal Register (74 FR 17966) to accurately reflect 30 
days after the April 8, 2009, publication.
    Another commenter urged the CDC to halt all immigration to the 
United States, thus making the vaccination issue moot.
    Response: Immigration laws are promulgated by the U.S. Congress and 
implemented by DHS. While CDC administers regulations describing 
medical examinations that aliens must undergo, as described above, CDC 
has no authority over immigration matters.
    Commenters requested that all people immigrating to the United 
States receive all available vaccinations to protect the U.S. public 
health.
    Response: The current vaccination requirements are based on the 
Immigration and Nationality Act, which requires any person who seeks an 
immigrant visa or who applies for adjustment of status to lawful 
permanent resident to have certain specified vaccines, as well as those 
recommended by ACIP. CDC has adopted criteria for determining which of 
the vaccinations recommended by ACIP are appropriate for the 
immigration population, in order to take into consideration the highest 
public health impact as defined in the criteria at the time of the 
medical examination for U.S. immigration.
    One commenter suggested that, rather than seek public comment on 
which vaccinations should be required for immigration purposes, CDC 
should focus on the connection between vaccines and autism.
    Response: HHS has a statutory obligation to describe medical 
examinations certain aliens must undergo. This responsibility has been 
delegated to CDC/DGMQ. This notice is being implemented under that 
authority. While HHS/CDC does work on the subject of autism, it is 
outside the scope of this notice.

VIII. Final Action

    After consideration of public comments received through this 
notice, as well as those received during an ACIP meeting held at CDC 
February 25-26, 2009, CDC is adopting the criteria as proposed and will 
begin applying the criteria to determine which vaccines recommended by 
ACIP for the general U.S. population will be required (in addition to 
those statutorily mandated) for immigrants in accordance with section 
212(a)(1)(A)(ii) of the Immigration and Nationality Act, 8 U.S.C. 
1182(a)(1)(A)(ii)). The current vaccine tables for children and adults 
based on the ACIP recommendations for the U.S. population are located 
on CDC's Web site at: http://www.cdc.gov/vaccines/recs/schedules/.
    The criteria that CDC is adopting today and will apply 30 days 
after publication of this notice are as follows:
    1. The vaccine must be an age-appropriate vaccine as recommended by 
the ACIP for the general U.S. population, and
    2. At least one of the following:
    a. The vaccine must protect against a disease that has the 
potential to cause an outbreak.\11\
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    \11\ For purposes of this Notice, an ``outbreak'' means the 
occurrence of more cases of disease than could be anticipated in a 
given area or among a specific group of people over a particular 
period of time.
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    b. The vaccine must protect against a disease that has been 
eliminated in the United States or is in the process for elimination in 
the United States.\12\
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    \12\ ``Elimination'' is the reduction to zero of the incidence 
of infection caused by a specific agent in a defined geographic area 
as a result of deliberate efforts; continued measures to prevent re-
establishment of transmission are required.
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    The updated vaccination requirements will be listed in the 
Technical Instructions (see http://www.cdc.gov/ncidod/dq/technica.htm) 
and will become effective 30 days after publication of this notice. CDC 
will continue to require the vaccinations explicitly referenced in 
section 212(a)(1)(A)(ii): Mumps, measles, rubella, polio, Tetanus and 
diphtheria toxoids, pertussis, Haemophilus influenzae type B and 
hepatitis B). All vaccines will remain subject to statutory waivers, if 
applicable. CDC will periodically review the list of vaccines 
recommended by ACIP for the general U.S. population to determine 
whether additional vaccinations fall within CDC's recommended criteria. 
Any changes to the list of required vaccines, which result from an 
application of these criteria, will be reflected in CDC's Technical 
Instructions, available to the public at http://www.cdc.gov/ncidod/dq/technica.htm). If there is a future need for CDC to reconsider these 
established criteria, CDC will solicit comments through publication in 
the Federal Register.

    Dated: November 6, 2009.
Anne Haddix,
Chief Policy Officer, CDC, OSI.
[FR Doc. E9-27317 Filed 11-12-09; 8:45 am]
BILLING CODE 4163-18-P