Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services (HHS).
Notice of proposed rulemaking.
The Centers for Disease Control and Prevention (CDC), within the U.S. Department of Health and Human Services (HHS), is issuing this Notice of Proposed Rulemaking (NPRM) to amend its regulations governing medical examinations that aliens must undergo before they may be admitted to the United States. Specifically, HHS/CDC proposes to: revise the definition of
Written comments must be received on or before August 24, 2015.
You may submit comments, identified by the Regulatory Information Number (RIN) 0920–AA28 or the Docket Number CDC–2015–0045 in the heading of this document by any of the following methods:
• Federal eRulemaking Portal:
• Mail: Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS E–03, Atlanta, GA 30333, ATTN: Part 34.
• Hand Delivery/Courier: Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS E–03, Atlanta, GA 30333, ATTN: Part 34.
• Viewing Comments: Comments may be viewed at
Ashley A. Marrone, J.D., Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS E–03, Atlanta, Georgia 30333; telephone 1–404–498–1600.
The Preamble to this NPRM is organized as follows:
Interested persons are invited to participate in this rulemaking by
Specifically, HHS/CDC seeks comment on:
(1) Whether infectious Hansen's disease (previously referred to in regulation as infectious leprosy), infectious syphilis and/or gonorrhea should be removed from the definition of communicable disease of public health significance.
(2) Whether the definition of communicable disease of public health significance and the scope of the medical examination should be revised as proposed in this regulation;
(3) Whether the statutory requirement that aliens demonstrate proof of vaccinations should be incorporated into the regulations as a notifiable medical condition. Please note when considering this question that HHS/CDC is not requesting comment on the statutory language itself as HHS/CDC does not have the authority to alter statutory language. Rather, we are interested in comment on the advisability of incorporating statutory language into regulations.
(4) Whether the requirement that immigrants demonstrate proof of vaccination against vaccine-preventable diseases recommended by the Advisory Committee on Immunization Practices (ACIP) should be limited to only those vaccines for which a public health need exists at the time of immigration or adjustment of status. CDC has previously published criteria for determining whether a public health need exists at the time of immigration or adjustment of status. CDC is not seeking comment on the criteria, but rather on the incorporation of this standard into the regulations.
(5) Whether the definitions and evaluation criteria for mental disorders, drug abuse and drug addiction should be revised as proposed in this regulation
(6) Whether the requirements for evaluating the presence of tuberculosis in alien applicants should be clarified and revised as proposed in this regulation and;
(7) Whether the process for the convening of a medical review board and reexamination of an alien by a medical review board should be revised as proposed in this regulation.
Do not include any information in your comment or supporting materials that you do not wish to be disclosed publicly.
HHS/CDC is proposing these revisions under the authority of 42 U.S.C. 252 and 8 U.S.C. 1182 and 1222.
Under section 212(a)(1) of the Immigration and Nationality Act (INA) (8 U.S.C. 1182(a)(1)), any alien who is determined to have a
In addition to other potential grounds of inadmissibility, an alien is inadmissible if he/she is determined: (1) To have a communicable disease of public health significance (as currently defined by regulations); (2) to pose, or has posed, a threat to the property, safety, or welfare of the alien or others; (3) to have had a history of behavior, 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.
At present, except for certain adopted children 10 years of age or younger, HHS/CDC requires any alien seeking admission as an immigrant or seeking adjustment of status to that of a lawful permanent resident, to present documentation of vaccination against all vaccine-preventable diseases explicitly listed in section 212(a)(1)(A)(ii) of the INA (mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis, Haemophilus influenzae type B, hepatitis B), and for all other vaccinations recommended by the Advisory Committee for Immunization Practices (ACIP) for which a public health need exists at the time of immigration or adjustment of status.
To allow HHS/CDC to adapt vaccination requirements for U.S. immigrants based on public health needs, on April 8, 2009, HHS/CDC published a notice in the
Any changes to the list of required vaccines, which result from an application of these criteria, will be reflected in HHS/CDC's Technical Instructions, available to the public at
The Secretary of Health and Human Services (HHS) is authorized to promulgate regulations establishing the requirements for the medical examination of aliens by sections 212(a)(1) and 232 of the INA and section 325 of the Public Health Service Act (42 U.S.C. 252). The regulations, administered by HHS/CDC, are promulgated at 42 CFR part 34. Under
HHS/CDC issues Technical Instructions that provide the technical consultation and guidance to panel physicians and civil surgeons who conduct the medical examinations of aliens. Panel physicians, designated by the U.S. Department of State (DOS), perform medical examinations on those aliens living outside the United States who are seeking to immigrate to the United States. Civil surgeons, designated by the U.S. Citizenship and Immigration Services (USCIS) within the U.S. Department of Homeland Security (DHS), perform medical examinations for aliens who are already present in the United States and are seeking adjustment of status. The
The provisions in 42 CFR part 34 apply to the medical examination of (1) aliens outside the United States who are applying for a visa at an embassy or consulate of the United States; (2) aliens arriving in the United States; (3) aliens required by DHS to have a medical examination in connection with determination of their admissibility into the United States; and (4) aliens who apply for adjustment of their immigration status to that of lawful permanent resident. While 42 CFR part 34 can apply to individuals who wish to come to the United States to visit, such as leisure or business travelers, a medical examination is not routinely required as a condition for issuance of non-immigrant visas or entry into the United States.
Annually, DHS admits more than 1 million aliens to reside permanently in this country (24). Foreign citizens who wish to live permanently in the United States must comply with U.S. immigration law and specific procedures for applying for an immigrant visa or adjustment of status. These applicants are also subject to the medical grounds of inadmissibility. The four main immigrant visa classifications are: (1) Immediate Relatives, that is, the spouse, child (unmarried and under 21 years of age) or parent of a U.S. citizen (a citizen must be at least 21 years old to file a petition for a parent); (2) Family-Based immigrants (adult sons or daughters of citizens, the siblings of citizens who are at least 21 years old, and the spouse, child, or adult sons or daughters of lawful permanent residents); (3) Employment-Based immigrants; and (4) Diversity immigrants who obtain by lottery the ability to seek an immigrant visa.
Refugees and asylees may also apply to adjust to permanent resident status from inside the United States. INA section 209; 8 U.S.C. 1159. Section 101(a)(42)(A) of the INA generally defines refugees and asylees as persons who cannot return to their country because of persecution or the well-founded fear of persecution based on race, religion, nationality, membership in a particular social group, or political opinion. A refugee applicant is preliminarily approved for refugee status overseas, but is admitted as a refugee upon admission to the United States at a port of entry. An asylee applicant is approved for asylum from within the United States and is not required to undergo a medical examination as part of the application process until he/she seeks adjustment of status.
An additional immigration category under the INA is Temporary Protected Status (TPS). This applies to persons who are in the United States lawfully, though temporarily, as a result of ongoing armed conflict, natural disasters, or certain other extraordinary and temporary conditions, and whose countries have been designated as TPS countries under INA section 244; 8 U.S.C. 1255a; 8 CFR part 244. TPS applicants are also subject to the medical grounds of inadmissibility.
Beginning in 1952, the language of the INA mandated that, among other grounds for inadmissibility, aliens “who are afflicted with any dangerous contagious disease” are ineligible to receive a visa and therefore are excluded from admission into the United States. In 1990, Congress amended the INA by revising the classes of excludable aliens to provide that an alien who is determined (in accordance with regulation prescribed by the Secretary of Health and Human Services) to have a
With the 2008 revision to 42 CFR part 34, the definition of
In response to a 2008 amendment to the INA, on July 2, 2009, HHS/CDC published a Notice of Proposed Rulemaking (NPRM), which proposed two regulatory changes: 1) The removal
Through today's NPRM, HHS/CDC is soliciting public comment on the definition of
HHS/CDC is not proposing to remove active tuberculosis from the definition of a communicable disease of public health significance. At this time, HHS/CDC is not proposing to remove infectious leprosy, gonorrhea, or syphilis from the definition but is proposing to replace the term “infectious leprosy” with “infectious Hansen's disease” and to modify “syphilis, infectious stage” to simply “syphilis, infectious” to reflect modern terminology. HHS/CDC will accept public comment on whether these three diseases should remain or be removed from the definition of
HHS/CDC identified the need for this rulemaking through an annual retrospective review of its regulations. Executive Order 13563 “Improving Regulation and Regulatory Review” requires Federal agencies to periodically review existing regulations to eliminate those regulations that are obsolete, unnecessary, burdensome, or counterproductive or revise regulations to increase their effectiveness, efficiency, and flexibility.
Through this NPRM, HHS/CDC proposes to update part 34 to reflect modern terminology and plain language commonly used in medicine and science by public health partners in the medical examination of aliens. Likewise, we are proposing to update part 34 so that the text accurately reflects the statutory and administrative changes that have occurred within the Federal Government regarding agencies and/or departments responsible for this process. These updates will ensure regulations that govern the medical examination of aliens are based upon accepted contemporary scientific principles as well as current medical practices.
The following is a section-by-section analysis of the proposed changes for which HHS/CDC is seeking public comment:
HHS/CDC is proposing to replace the acronym “INS” within 34.1(c) with “DHS” to best reflect the administrative changes that have occurred within the Federal Government regarding agencies and/or departments responsible for the medical examination of aliens.
Current section 34.2 entitled “Definitions” provides information regarding the intent of HHS/CDC regarding certain terms that are used in the regulation. While HHS/CDC is not proposing to revise all of the current terms and definitions, such as medical examiner, we welcome comment on the use of these terms and its definitions. HHS/CDC is proposing to revise the definitions section as specifically described below.
HHS/CDC proposes to revise the definitions of:
Additionally, HHS/CDC is adding definitions for
We are proposing to update the definition of
This provision defines
HHS/CDC uses epidemiological principles and current medical practice to assess and revise the list of diseases defined as a
While some U.S. cities (7) keep records of cases of granuloma inguinale and lymphogranuloma venereum, neither condition is included on the list of diseases reported to HHS/CDC by clinicians and public health departments. Online searches and a few available publications indicate that both conditions most typically occur in tropical and impoverished settings (
Internationally, most countries do not track any of the three infections; however, the few publications and records available suggest case rates have declined worldwide over the past 50 years. Declining rates of these conditions are likely due to a variety of factors. Improved living conditions, better sanitation (
Given the low burden of these three infections globally, the potential introduction of additional cases into the United States by aliens is likely to have a negligible impact on the U.S. population for several reasons. As mentioned, these primarily tropical infections can be prevented through improved personal hygiene (11); protected sex (use of a condom); and treatment of sexual partners. Such infections can be effectively treated and cured with relatively uncomplicated courses of antibiotic therapy. None of the three infections is associated with excess mortality (premature death); and most cases do not lead to serious long term consequences, disability or excessive medical costs.
After careful consideration of epidemiological principles and current medical practice, scientific evidence indicates that chancroid, granuloma inguinale, and lymphogranuloma venereum do not represent a significant risk for introduction, transmission, and spread from foreign countries to the United States population. Therefore, HHS/CDC proposes to remove these three diseases from the specific list of
HHS/CDC is proposing to amend the definition of Class A medical notification by incorporating statutory language requiring documentary proof of vaccination. This requirement is provided by section 341 of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996 (IIRIRA) which amended Section 212 of the INA. HHS/CDC is proposing to update part 34 to explicitly include the requirement for proof of vaccination as previously specified in the IIRIRA.
The proposed definition also includes the vaccination exemption specifically provided in Section 212 of the INA for an adopted child who is 10 years of age or younger. This exemption is applicable if, prior to the admission of the child, an adoptive or prospective adoptive parent, who has sponsored the child for admission as an immediate relative, has executed an affidavit stating that the parent is aware of the vaccination requirement and will ensure that the child will be vaccinated within 30 days of the child's admission, or at the earliest time that is medically appropriate. Execution of this affidavit will prevent a Class A medical notification from being generated for lack of proof of vaccination. This additional language will not change current practices, but is a reflection of updated statutory language. Again, because HHS/CDC is not authorized to change statutory requirements, HHS/CDC is not requesting comment on the statutory language, but will accept comment on the advisability of incorporating statutory language into regulations. HHS/CDC believes that the inclusion of statutory language promotes greater transparency and a better understanding of immigration requirements. For further information, please visit:
We are proposing to update the definition of
We are proposing to add
HHS/CDC is proposing to revise the definitions of
HHS/CDC is proposing to update the definition of
The
Based on this update,
HHS/CDC is proposing to remove “of the Public Health Service Commissioned Corps” from the definition of
HHS/CDC is proposing to clarify
HHS/CDC is proposing
Current section 34.3 entitled “Scope of Examinations” applies to those aliens who are required to undergo a medical examination for U.S. immigration purposes. The scope of the examination outlines those matters that relate to inadmissible health-related conditions and was revised in 2008 through an interim final rule. The 2008 interim final rule provided specific screening and testing requirements for those diseases that meet the current definition of
HHS/CDC is proposing to revise 34.3(a)(2) to include proof of vaccination requirements as provided by section 341 of IIRIRA of 1996 which amended Section 212 of the INA. HHS/CDC is proposing this change as previously described in proposed changes to 34.2 Definitions.
HHS/CDC is proposing to amend § 34.3(e)(1) to clarify the scope of examination requirements that apply to anyone who is required by DHS to have a medical examination for the purpose of determining their admissibility. HHS/CDC has added § 34.3(e)(1)(v) “Applicants required by the DHS to have a medical examination in connection with the determination of their admissibility into the United States.”
HHS/CDC is proposing the following changes to provide consistency in the required evaluation for tuberculosis: replace all references to “chest x-ray” in § 34.3(e) with “chest radiograph”; clarify that § 34.3(e)(3)(ii) applies to aliens in the United States; and to remove the specific size of chest radiograph provided in § 34.3(e)(5). These changes reflect current medical terminology and technical practice.
HHS/CDC is proposing to amend § 34.3(e)(2)(iii) by removing “and HIV” to correct the typographical error in the current rule language and reflect that testing for HIV is no longer required. The requirement for serologic testing for syphilis will remain and HHS/CDC has included language to allow the Director to test for other communicable diseases of public health significance (as defined) through technical instructions.
HHS/CDC is proposing to amend § 34.3(e)(3)(i) and (ii) to reflect the scope of currently available medical tests. HHS/CDC proposes to replace “positive tuberculin reaction” with “positive test of immune response to
To allow HHS/CDC discretion to apply appropriate medical screening procedures, HHS/CDC is proposing to amend § 34.3(e)(3)(iii) and (iv) regarding application of tests of immune response by adding “as determined by the Director.”
To allow for additional testing in medically appropriate circumstances, HHS/CDC is proposing to revise § 34.3(e)(4) by removing “subject to the chest radiograph requirement, and for whom the radiograph shows an abnormality suggestive of tuberculosis disease,” replacing “shall” with “may,” and adding “based on medical evaluation.” HHS/CDC is proposing this revision to read: “All applicants may be required to undergo additional testing for tuberculosis based on the results of the medical evaluation.”
To reflect current practice and INA statutory language, HHS/CDC is also proposing to amend § 34.3(b)(2) by adding “or other relevant records” to ensure that all appropriate available medical documentation may be considered. HHS/CDC is proposing this revision to read: “For the examining physician to reach a determination or conclusion about the presence or absence of a physical or mental abnormality, disease, or disability, 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 or other relevant records.”
HHS/CDC has included language under § 34.3(f), transmission of records, to ensure that electronic submissions may be acceptable as provided by the Director. Finally, HHS/CDC is proposing to amend § 34.3(g)(4) by replacing “excludable” with “inadmissible” in § 34.3(g)(4) to reflect modern terminology.
HHS/CDC proposes to revise § 34.4(b)(1)(ii) to include proof of vaccination requirements as provided by section 341 of the IIRIRA of 1996 which amended section 212 of the INA and to reference criteria established by CDC and published in
Under this section, HHS/CDC proposes to replace “INS” with “DHS” and replace “Public Health Services” with “HHS” to reflect modern agency titles and appropriate authorities relating to this provision. Although HHS/CDC is not proposing to make any
Review boards are convened by the Director to reexamine aliens at the request of DHS and upon appeal to DHS by an alien certified as having a Class A condition. HHS/CDC is proposing changes to this section to clarify the reexamination and review board's process and improve the expediency of the process. The proposed changes include removing the requirement that one medical officer must be a board-certified psychiatrist in cases where the alien's mental health is a basis for inadmissibility. The requirement for a board-certified psychiatrist will be replaced with a requirement that the review board consist of at least one medical officer who is experienced in the diagnosis and treatment of the physical or mental disorder, or substance-related disorder for which the medical notification was made. Additionally, HHS/CDC is proposing to add failure to present documented proof of having been vaccinated against vaccine preventable diseases as a basis for reexamination by the review board and add clarifying language that the reexamination may be conducted, at the board's discretion, based on the written record.
By removing the requirement that one medical officer must be a board-certified psychiatrist, HHS/CDC will be able to more easily and efficiently comprise the board of case-specific specialists. Removing the requirement for a board-certified psychiatrist also allows the agency to expedite the review board's convening in circumstances where a medical officer who is a board certified psychiatrist is unavailable. By tailoring the board to meet the needs of the alien, HHS/CDC will ensure that the alien has the attention of medical officers who are experienced in the diagnosis and treatment of their specific medical condition.
This rulemaking is the result of HHS/CDC's annual retrospective regulatory review. Most of the proposed changes are administrative and will result in minor changes to current guidelines for overseas medical examinations required of persons seeking permanent entry to the United States. Therefore, alternatives to these administrative updates were not considered. However, when considering updates to the definition of
HHS/CDC has examined the impacts of the proposed rule under Executive Order 12866, Regulatory Planning and Review (58 FR 51735, October 4, 1993) and Executive Order 13563, Improving Regulation and Regulatory Review, (76 FR 3821, January 21, 2011)(1,2). Both Executive Orders direct agencies to evaluate any rule prior to promulgation to determine the regulatory impact in terms of costs and benefits to United States populations and businesses. Further, together, the two Executive Orders set the following requirements: quantify costs and benefits where the new regulation creates a change in current practice; define qualitative costs and benefits; choose approaches that maximize benefits; support regulations that protect public health and safety; and minimize the impact of regulation. HHS/CDC has analyzed the rule as required by these Executive Orders and has determined that it is consistent with the principles set forth in the Executive Orders and the Regulatory Flexibility Act, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) and that the rule will create minimal impact (3,4).
This proposed rule is not being treated as a significant regulatory action as defined by Executive Order 12866. As such, it has not been reviewed by the Office of Management and Budget (OMB).
There are two main impacts of this proposed rule. First, we are proposing updates to the current regulation that reflect modern terminology, plain language, and current practice. Because there is no change in the baseline from these updates, no costs can be associated with these administrative updates to align the regulation with current practice.
Second, we are proposing to remove three sexually transmitted bacterial infections, chancroid, granuloma inguinale and lymphogranuloma venereum, from the definition of communicable disease of public health significance (5). In doing this, aliens seeking permanent entry to the United States (immigrants, refugees and asylees) will no longer be examined for these diseases during the mandatory medical examinations that are part of the process of admission to the United States. The impact of dropping this portion of the examination is likely to be minimal. On the positive side, the physicians administering the exam will be able to focus on other areas of patient health. On the negative side, there is the potential for a negligible increase in the numbers of disease cases entering the United States. However, as we explain subsequently, this impact is likely to be extremely small. Further, the costs associated with the current disease burden in the United States are also very limited. Therefore, the potential introduction of a very small number of cases will not change the current cost structure associated with the current disease burden.
The three bacterial infections (chancroid, granuloma inguinale and lymphogranuloma venereum), are transmitted through sexual contact, have never been common in the United States and over the past two decades are observed to be increasingly rare throughout the world. Of the three conditions, only laboratory-diagnosed cases of chancroid are reportable in the United States, and since 2005 fewer than 30 chancroid cases annually were reported to CDC from the U.S. states and territories (6–23). While some U.S. cities (7) keep records of cases of granuloma
When HHS/CDC originally attempted to estimate the disease impact to calculate the cost associated with removing these three diseases, we tried to examine the disease rates in the regions or countries of origin of aliens seeking entry to the United States. In the most recent report from the DHS, the Annual Yearbook of Immigration Statistics, DHS reports on the regions and countries of origin of aliens (24). Unfortunately, we have been unable to find disease data that correlates with the DHS population data for region of origination of aliens (24). Data on chancroid, granuloma inguinale and lymphogranuloma venereum are not systematically collected by any country outside of the United States either by specific countries or regions listed by DHS for aliens, or from the World Health Organization (WHO) (8, 22, 23). Ultimately, we were unable to correlate the originating regions of aliens entering the United States permanently (immigrants, refugees, and asylees) with the rates of the three diseases in the countries of origin.
Potential for onward transmission of these infections to the U.S. population is deemed to be extremely low. While we do not have country or region-specific rates for these diseases, our review of the literature supports the supposition that the potential introduction of additional cases into the United States by aliens is likely to have a negligible impact on the U.S. population. These primarily tropical infections can be prevented through improved personal hygiene (11) and protected sex (use of a condom) (12). New infections can be effectively treated and cured with a short, uncomplicated course of antibiotic therapy.
Cost estimates were derived for three alternatives titled Low, High, and Extreme. The Low and High alternatives were based on the lowest (most recent) and highest reported caseloads of chancroid (6). The Extreme alternative is six times the highest rate of chancroid ever reported in the United States. Finally, often chancroid, Granuloma Inguinale, and Lymphogranuloma Venereum are co-morbid with other STIs,
The results of the analysis are reported in Table 1. None of the results are economically significant,
Under the Regulatory Flexibility Act, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), agencies are required to analyze regulatory options to minimize significant economic impact of a proposed rule on small businesses, small governmental units, and small not-for-profit organizations. We have analyzed the costs and benefits of this proposed rule, as required by Executive Order 12866, and a preliminary regulatory flexibility analysis that examines the potential economic effects of this rule on small entities, as required by the Regulatory Flexibility Act. Based on the cost benefit analysis, we do expect this proposed rule to have little or no economic impact on small entities.
The Paperwork Reduction Act applies to the data collection requirements found in 42 CFR part 34. The U.S. Department of State is responsible for providing forms to panel physicians, and the Department of Homeland Security is responsible for providing forms to civil surgeons to document the medical examination and screening information for aliens. The Office of Management and Budget (OMB) approved this data collection under OMB Control No. 1405–0113, which will expire on September 30, 2017.
HHS/CDC has determined that the proposed amendments to 42 CFR part 34 will not have a significant impact on the human environment.
HHS/CDC has reviewed this rule under Executive Order 12988 on Civil Justice Reform and determines that this proposed rule meets the standard in the Executive Order.
Under Executive Order 13132, if the proposed rule would limit or preempt State authorities, then a federalism analysis is required. The agency must consult with State and local officials to determine whether the rule would have a substantial direct effect on State or local Governments, as well as whether it would either preempt State law or impose a substantial direct cost of compliance on them.
HHS/CDC has determined that this proposed rule will not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.
Under 63 FR 31883 (June 10, 1998), Executive Departments and Agencies are required to use plain language in all proposed and final rules. HHS/CDC has attempted to use plain language in proposing this rule to make our intentions and rationale clear and welcomes feedback from the public on our attempt to use plain language in this rule.
Aliens, Health care, Medical examination, Passports and visas, Public health, Scope of examination.
For the reasons discussed in the preamble, the Centers for Disease Control and Prevention, Department of Health and Human Services proposes to amend 42 CFR part 34 as follows:
42 U.S.C. 252; 8 U.S.C. 1182 and 1222.
The provisions of this part shall apply to the medical examination of:
(a) Aliens applying for a visa at an embassy or consulate of the United States;
(b) Aliens arriving in the United States;
(c) Aliens required by DHS to have a medical examination in connection with the determination of their admissibility into the United States; and
(d) Aliens applying for adjustment of status.
As used in this part, terms shall have the following meanings:
(a)
(b)
(1) 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
(2) Communicable diseases that may pose a public health emergency of international concern if it meets one or more of the factors listed in § 34.3(d) and for which the 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 (
(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
(3) Gonorrhea.
(4) Hansen's disease, infectious.
(5) Syphilis, infectious.
(6) Tuberculosis, active.
(c)
(d)
(1) A
(2) A failure to present documentation of having received vaccination against “vaccine-preventable diseases” for an alien who seeks admission as an immigrant, or who seeks adjustment of status to one lawfully admitted for permanent residence, which shall include at least the following diseases: Mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis,
(3)(i) A current 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; or
(4) Drug abuse or addiction.
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(1) A communicable disease of public health significance;
(2) Documentation of having received vaccination against “vaccine-preventable diseases” for an alien who seeks admission as an immigrant, or who seeks adjustment of status to one lawfully admitted for permanent residence, which shall include at least the following diseases: mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis,
(3)(i) A current 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;
(4) Drug abuse or addiction; or
(5) Any other physical or mental condition, disease, or disability serious in degree or permanent in nature.
(m)
(n)
(o)
(p)
(a)
(1) Communicable disease of public health significance;
(2) Documentation of having received vaccination against “vaccine-preventable diseases” for an alien who seeks admission as an immigrant, or who seeks adjustment of status to one lawfully admitted for permanent residence, which shall include at least the following diseases: mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis,
Provided, however, that in no case shall a Class A medical notification be issued for an adopted child who is 10 years of age or younger if, prior to the admission of the child, an adoptive parent or prospective adoptive parent of the child, who has sponsored the child for admission as an immediate relative, has executed an affidavit stating that the parent is aware of the vaccination requirement and will ensure that, within 30 days of the child's admission, or at the earliest time that is medically appropriate, the child will receive the vaccinations identified in the requirement;
(3)(i) A current 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;
(4) Drug abuse or drug addiction; and
(5) Any other physical or mental health condition, disease, or disability serious in degree or permanent in nature.
(b)
(1) All medical examinations will include the following:
(i) A general physical examination and medical history, evaluation for tuberculosis, and serologic testing for syphilis.
(ii) A physical examination and medical history for diseases specified in § 34.2(b)(1) and (b)(4) through (10).
(2) For the examining physician to reach a determination and conclusion about the presence or absence of a physical or mental abnormality, disease, or disability, 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 or other relevant records.
(c)
(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.
(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:
(d)
(i) Whether a disease as specified in § 34.2(b)(3)(ii) is a communicable disease of public health significance; and
(ii) Which diseases in § 34.2(b)(2) and (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)
(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.
(v) Applicants required by DHS to have a medical examination in connection with determination of their admissibility into the United States.
(2)
(i) For applicants 15 years of age and older, a chest radiograph examination;
(ii) For applicants under 15 years of age, a chest radiograph 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 other
(iv)
(3)
(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 DHS 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
(ii) Aliens in the United States 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
(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
(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
(4)
(5)
(6)
(f)
(g)
(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 inadmissible 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.
(a) Medical examiners shall issue medical notifications of their findings of the presence or absence of Class A or Class B medical conditions. The presence of such condition must have been clearly established.
(b)
(i) A
(ii) A lack of documentation, or no waiver, for an alien who seeks admission as an immigrant, or who seeks adjustment of status to one lawfully admitted for permanent residence, 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,
Provided however, that a Class A medical notification shall in no case be issued for an adopted child who is 10 years of age or younger if, prior to the admission of the child, an adoptive parent or prospective adoptive parent of the child, who has sponsored the child for admission as an immediate relative, has executed an affidavit stating that the parent is aware of the vaccination requirement and will ensure that, within 30 days of the child's admission, or at the earliest time that is medically appropriate, the child will receive the vaccinations identified in the requirement;
(iii)(A) A current 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; or
(B) 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;
(iv)
(2) The medical notification shall state the nature and extent of the abnormality; the degree to which the alien is incapable of normal physical activity; and the extent to which the condition is remediable. The medical examiner shall indicate the likelihood, that because of the condition, the applicant will require extensive medical care or institutionalization.
(c)
(2) The medical notification shall state the nature and extent of the abnormality, the degree to which the alien is incapable of normal physical activity, and the extent to which the condition is remediable. The medical examiner shall indicate the likelihood, that because of the condition, the applicant will require extensive medical care or institutionalization.
(d)
Whenever, upon an examination, the medical examiner is unable to determine the physical or mental condition of an alien, completion of the medical examination shall be postponed for such observation and further examination of the alien as may be reasonably necessary to determine his/her physical or mental condition. The examination shall be postponed for aliens who have an acute infectious disease until the condition is resolved. The alien shall be referred for medical care as necessary.
Aliens arriving at a port of the United States shall be subject to the applicable provisions of 42 CFR part 71, Foreign Quarantine, with respect to examination and quarantine measures.
(a) An alien detained by or in the custody of DHS may be provided medical, surgical, psychiatric, or dental care by HHS through interagency agreements under which DHS shall reimburse HHS. Aliens found to be in need of emergency care in the course of medical examination shall be treated to the extent deemed practical by the attending physician and if considered to be in need of further care, may be referred to DHS along with the physician's recommendations concerning such further care.
(b) In case of the death of an alien, the body shall be delivered to the consular or immigration authority concerned. If such death occurs in the United States, or in a territory or possession thereof, public burial shall be provided upon request of DHS and subject to its agreement to pay the burial expenses. Autopsies shall not be performed unless approved by DHS.
(a) The Director shall convene a board of medical officers to reexamine an alien:
(1) Upon the request of DHS for a reexamination by such a board; or
(2) Upon an appeal to DHS by an alien who, having received a medical examination in connection with the determination of admissibility to the United States (including examination on arrival and adjustment of status as provided in the immigration laws and regulations) has been certified for a Class A condition.
(b) The board shall reexamine an alien certified as:
(1) Having a communicable disease of public health significance;
(2) Lacking documentation of having received vaccination against “vaccine-preventable diseases” for an alien who seeks admission as an immigrant, or who seeks adjustment of status to one lawfully admitted for permanent residence, which shall include at least the following diseases: Mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis,
Provided, however, that in no case shall a Class A medical notification be issued for an adopted child who is 10 years of age or younger if, prior to the admission of the child, an adoptive or prospective adoptive parent, who has sponsored the child for admission as an immediate relative, has executed an affidavit stating that the parent is aware of the vaccination requirement and will ensure that the child will be vaccinated within 30 days of the child's admission, or at the earliest time that is medically appropriate.
(3)(i) Having a current 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; or
(ii) Having 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
(iii) Having drug abuse or drug addiction;
(c) The board shall consist of the following:
(i) In circumstances covered by paragraph (b)(1) of this section, the board shall consist of at least one medical officer who is experienced in the diagnosis and treatment of the communicable disease for which the medical notification has been made;
(ii) In circumstances covered by paragraph (b)(2) of this section, the board shall consist of at least one medical officer who is experienced in the diagnosis and treatment of the vaccine-preventable disease for which the medical notification has been made;
(iii) In circumstances covered by paragraph (b)(3) of this section, the board shall consist of at least one medical officer who is experienced in the diagnosis and treatment of the physical or mental disorder, or substance-related disorder for which medical notification has been made.
(d) The decision of the majority of the board shall prevail, provided that at least two medical officers concur in the judgment of the board.
(e) Reexamination shall include:
(1) Review of all records submitted by the alien, other witnesses, or the board;
(2) Use of any laboratory or additional studies which are deemed clinically necessary as a result of the physical examination or pertinent information elicited from the alien's medical history;
(3) Consideration of statements regarding the alien's physical or mental condition made by a physician after his/her examination of the alien; and
(4) A physical or psychiatric examination of the alien performed by the board, at the board's discretion.
(f) An alien who is to be reexamined shall be notified of the reexamination not less than 5 days prior thereto.
(g) The alien, at his/her own cost and expense, may introduce as witnesses before the board such physicians or medical experts as the board may in its discretion permit; provided that the alien shall be permitted to introduce at least one expert medical witness. If any witnesses offered are not permitted by the board to testify (either orally or through written testimony), the record of the proceedings shall show the reason for the denial of permission.
(h) Witnesses before the board shall be given a reasonable opportunity to review the medical notification and other records involved in the reexamination and to present all relevant and material evidence orally or in writing until such time as the reexamination is declared by the board to be closed. During the course of the reexamination the alien's attorney or representative shall be permitted to question the alien and he/she, or the alien, shall be permitted to question any witnesses offered in the alien's behalf or any witnesses called by the board. If the alien does not have an attorney or representative, the board shall assist the alien in the presentation of his/her case to the end that all of the material and relevant facts may be considered.
(i) Any proceedings under this section may, at the board's option, be conducted based on the written record, including through written questions and testimony.
(j) The findings and conclusions of the board shall be based on its medical examination of the alien, if any, and on the evidence presented and made a part of the record of its proceedings.
(k) The board shall report its findings and conclusions to DHS, and shall also give prompt notice thereof to the alien if his/her reexamination has been based on his/her appeal. The board's report to DHS shall specifically affirm, modify, or reject the findings and conclusions of prior examining medical officers.
(l) The board shall issue its medical notification in accordance with the applicable provisions of this part if it finds that an alien it has reexamined has a Class A or Class B condition.
(m) If the board finds that an alien it has reexamined does not have a Class A or Class B condition, it shall issue its medical notification in accordance with the applicable provisions of this part.
(n) After submission of its report, the board shall not be reconvened, nor shall a new board be convened, in connection with the same application for admission or for adjustment of status, except upon the express authorization of the Director.