CDC-FR Notice eliminating HPV & Zoster vaccine (5/2010)

58634

Federal Register / Vol. 74, No. 218 / Friday, November 13, 2009 / Notices

Dated: November 6, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–27335 Filed 11–12–09; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Criteria for Vaccination Requirements
for U.S. Immigration Purposes

srobinson on DSKHWCL6B1PROD with NOTICES

AGENCY: Centers for Disease Control and
Prevention (CDC).
ACTION: Final notice of agency action.
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 vaccinepreventable 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:

VerDate Nov<24>2008

17:07 Nov 12, 2009

Jkt 220001

1. The vaccine must be an ageappropriate 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
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
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 ‘‘vaccinepreventable 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
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.
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 reestablishment of transmission are required.

PO 00000

Frm 00038

Fmt 4703

Sfmt 4703

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,

E:\FR\FM\13NON1.SGM

13NON1

srobinson on DSKHWCL6B1PROD with NOTICES

Federal Register / Vol. 74, No. 218 / Friday, November 13, 2009 / Notices
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 reintroduction of vaccine-preventable
diseases that have been eliminated or
are in the process for elimination in the
U.S. through the immunization of
immigrants.
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
3 CDC. Dowdle WR. The Principles of Disease
Elimination and Eradication. MMWR Supplement
1999; 48(SU01):23–7.
4 CDC. Update: Measles—United States, January–
July 2008. MMWR, 22 August (2008) 57(33);893–
896.

VerDate Nov<24>2008

17:07 Nov 12, 2009

Jkt 220001

widely or (2) to threaten reintroduction
of an eliminated disease.
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.

PO 00000

Frm 00039

Fmt 4703

Sfmt 4703

58635

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 ageappropriate 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
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
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
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.
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 reestablishment of transmission are required.

E:\FR\FM\13NON1.SGM

13NON1

58636

Federal Register / Vol. 74, No. 218 / Friday, November 13, 2009 / Notices

srobinson on DSKHWCL6B1PROD with NOTICES

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 vaccinepreventable 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

VerDate Nov<24>2008

17:07 Nov 12, 2009

Jkt 220001

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 subjectmatter 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
7 CDC. Dowdle WR. The Principles of Disease
Elimination and Eradication. MMWR Supplement
1999; 48(SU01):23–7.

PO 00000

Frm 00040

Fmt 4703

Sfmt 4703

polio, ‘‘eradicated’’) in the United
States.
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

E:\FR\FM\13NON1.SGM

13NON1

Federal Register / Vol. 74, No. 218 / Friday, November 13, 2009 / Notices

srobinson on DSKHWCL6B1PROD with NOTICES

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.
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 ageappropriate vaccine for an immigrant
applicant, HPV neither causes outbreaks
nor is it associated with outbreaks (per
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.

VerDate Nov<24>2008

17:07 Nov 12, 2009

Jkt 220001

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

PO 00000

Frm 00041

Fmt 4703

Sfmt 4703

58637

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.
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.,
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.

E:\FR\FM\13NON1.SGM

13NON1

58638

Federal Register / Vol. 74, No. 218 / Friday, November 13, 2009 / Notices

srobinson on DSKHWCL6B1PROD with NOTICES

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 ageappropriate vaccinations and minimum
intervals.
Response: The current Technical
Instructions are based on ageappropriate 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

VerDate Nov<24>2008

17:07 Nov 12, 2009

Jkt 220001

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.

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 ageappropriate 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
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
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.

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

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

PO 00000

Frm 00042

Fmt 4703

Sfmt 4703

BILLING CODE 4163–18–P

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.
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 reestablishment of transmission are required.

E:\FR\FM\13NON1.SGM

13NON1