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###### Department of Health and Human Services

###### Centers for Disease Control and Prevention

# AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

# ACTION:

Notice with comment period.

# SUMMARY:

                        The Centers for Disease Control and Prevention (CDC) is seeking public comment on a set of proposed criteria to be used in determining which vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) for the general United States 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. Under section 212 of the Immigration and Nationality Act (INA) (8 U.S.C. 1182), an alien who seeks admission as an immigrant, or who seeks adjustment of status to one lawfully admitted for permanent residence, must present documentation for having received vaccination for “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.” Because the INA explicitly requires vaccinations for some vaccine-preventable diseases (mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis,                         *Haemophilus influenzae*                         type B and hepatitis B), CDC will continue to require those vaccinations for immigrants seeking admission into the United States or seeking to adjust their status to that of legal permanent resident. CDC has developed specific criteria to determine which other vaccinations recommended by ACIP for the general population will be required for such immigrants. Through this notice, CDC proposes to begin use of 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.[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.

The evolution of vaccine development has progressed to include those targeting specific groups and chronic morbidity and mortality. Therefore, CDC is now developing specific criteria to be applied against each vaccine in lieu of requiring all ACIP recommended vaccines for immigration purposes. CDC has taken a scientific, evidence-based, public health approach in developing these criteria, and has considered the unique characteristics of the time and place of the medical screening process for U.S. immigration purposes.

Using specific scientific-based criteria to determine the relevant vaccines required for U.S. immigration purposes will ensure CDC decision-making regarding vaccination requirements is grounded in public health necessity and need in light of a growing list of vaccines for infectious and non-infectious diseases.

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 will publish a notice regarding implementation of the final criteria for determining which vaccines recommended by ACIP for the U.S. population will be required for immigrants in accordance with section 212(a)(1)(A)(ii) of the Immigration and Nationality Act, Section 212 (8 U.S.C. 1182(a)(1)(A)(ii)).

CDC will continue to work closely with the Department of Homeland Security and the Department of State in the implementation of the vaccination requirements for U.S. immigration purposes.

# DATES:

Written comments must be received on or before May 8, 2009. Comments received after April 8, 2009 will be considered to the extent possible.

# ADDRESSES:

You may submit written comments 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: Immigration Vaccination Requirements, 1600 Clifton Road, NE., MS E-03, Atlanta, Georgia, 30333.

                        You may also submit written comments via e-mail to                         *DGMQpubliccomments@cdc.gov*.                    

# FOR FURTHER INFORMATION CONTACT:

David M. McAdam, Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, 1600 Clifton Road, NE., MS E-03, Atlanta, Georgia 30333; telephone 404-498-1600.

# SUPPLEMENTARY INFORMATION:

## Background

                    Medical examinations for immigration purposes are authorized under section 232 of the Immigration and Nationality Act (INA) (8 U.S.C. 1222) Under sections 212(a)(1) and 232 of the INA (8 U.S.C. 1182(a)(1) and 1222), and section 325 of the Public Health Service Act (42 U.S.C. 252), the Department of Health and Human Services (HHS) establishes requirements for the medical examination. The Secretary of HHS has delegated this authority to the Centers for Disease Control and Prevention (CDC), and it is administered by CDC's Division of Global Migration and Quarantine (DGMQ). These requirements are codified in 42 CFR part 34, Medical Examination of Aliens. Panel physicians and civil surgeons, through contractual agreements and by designations with the Department of State and the Department of Homeland Security, respectively, conduct the medical examinations in accordance with these regulations and as provided for in Technical Instructions (TIs) issued by CDC/DGMQ. The vaccination requirements for U.S. immigration purposes are listed in the Technical Instructions (                    *see**http://www.cdc.gov/​ncidod/​dq/​technica.htm*).                

                    Under section 212(a)(1)(A)(ii) of the Immigration and Nationality Act (8 U.S.C. 1182(a)(1)(A)(ii)), an alien who seeks admission as an immigrant, or who seeks adjustment of status to one lawfully admitted for permanent residence, must present documentation for having received vaccination for “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                           ( print page 15987)                        vaccinations against vaccine-preventable diseases recommended by the Advisory Committee on Immunization Practices[(ACIP).]” The ACIP is a committee chartered under the Federal Advisory Committee Act (FACA). The ACIP makes vaccine recommendations for the U.S. population to the CDC Director, who, in accordance with FACA, is ultimately responsible for accepting, rejecting, or modifying those recommendations. Any immigrant or applicant applying for adjustment of status in the U.S., who is unable to present proof of vaccination, is inadmissible into the United States unless the immigrant or applicant receives the required vaccines or applies for and receives a statutory waiver. Such waivers may be issued if, for example, during the medical examination, the examiner determines that a vaccination is not medically appropriate.                

                    Since 1996, when the vaccination requirement was added to the INA, all vaccinations routinely                     *recommended*                     by ACIP for the U.S. population have been                     *required*                     for immigrants subject to the INA vaccination requirement. Although this vaccination requirement has been in effect since 1996, the continued evolution of vaccine development has led CDC to reassess the appropriateness for each recommended vaccine in the context of U.S. immigration in the interest of public health.                

## Implementation of Specific Vaccination Criteria

                    The ACIP recommendations regarding vaccines are extremely important for 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 have been applied to persons undergoing medical examination for U.S. immigration without consideration for the unique characteristics of such screening, which include the urgency of time in which the vaccination is required and the location of the individual immigrant, or group of immigrants, at the time of the medical examination. While the ACIP vaccination recommendations are appropriate for the general U.S. population, CDC is proposing specific criteria to determine which ACIP-recommended vaccines are appropriate as a requirement at the time and place of medical examination for immigration. For example, within these criteria, vaccinations will be administered to applicants if they are considered to be “age-appropriate” as recommended by ACIP for the general U.S. population (                    *i.e.*                     the applicant is within the ACIP-recommended age groups of the vaccine at the time of the examination). Once it is determined that a vaccine is age-appropriate, the vaccine will only be administered if it is determined to be appropriate in the immigration setting due to the potential of diseases to cause outbreaks and/or to be introduced into the United States, where they have been eliminated or are in the process of elimination. In contrast, all other ACIP recommended vaccines should be administered once the applicant is admitted to the United States according to CDC immunization schedule and State-based vaccination mandates.                

                    Therefore, CDC is proposing to implement the vaccination requirements provided for in section 212(a)(1)(A)(ii) of the INA as follows: Because section 212(a)(1)(A)(ii) explicitly requires vaccinations for listed vaccine-preventable diseases (mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis,                     *Haemophilus influenzae*                     type B and hepatitis B), CDC will continue to require those vaccinations for immigrants seeking admission into the United States or seeking to adjust their status to the status of legal permanent resident. CDC will use the criteria below for determining which additional vaccines recommended by ACIP for the general population will be required for such immigrants. All vaccines will remain subject to statutory waivers, if applicable. In addition, CDC will review the list of vaccines recommended by ACIP for the general U.S. population on a regular basis and apply the specific criteria to determine which additional vaccines will be required for U.S. immigration purposes.                

CDC proposes to use 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.[2] 

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.

Through the issuance of revised Technical Instructions and other standard operating procedures, CDC upon application of the criteria will notify the panel physicians and civil surgeons who conduct the medical examination of any changes to the vaccination requirements for U.S. immigration purposes.

Dated: April 1, 2009.

James D. Seligman,

Chief Information Officer, Centers for Disease Control and Prevention.

# Footnotes

1.                                 For purposes of this Notice, “potential to cause 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. In general, and as observed through previous experience, an outbreak is associated with a public health response.                        
        Back to Citation      

2.                             For purposes of this Notice, “potential to cause 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. In general, and as observed through previous experience, an outbreak is associated with a public health response.                    
        Back to Citation      

[FR Doc. E9-7934 Filed 4-7-09; 8:45 am]

BILLING CODE 4163-18-P