Federal Register / Vol. 73, No. 194 / Monday, October 6, 2008 / Rules and Regulations 58047 

descriptions in AQS and detailed 

documentation and the schedule shall 

apply for those data which will or may 

influence the initial designation of areas 

for those NAAQS. EPA anticipates 

revising Table 1 as necessary to 

accommodate revised data submission 

schedules for new or revised NAAQS. 

TABLE 1—SCHEDULE FOR EXCEPTIONAL EVENT FLAGGING AND DOCUMENTATION SUBMISSION FOR DATA TO BE USED IN

DESIGNATIONS DECISIONS FOR NEW OR REVISED NAAQS 

NAAQS pollutant/standard/(level)/promulgation date 

Air quality data 

collected for calendar year 

Event flagging and initial 

description deadline 

Detailed documentation 

submission deadline 

PM2.5/24-Hr Standard (35 μg/m3) Promulgated October 17, 

2006.

2004–2006 October 1, 2007 a ................... April 15, 2008 a. 

Ozone/8-Hr Standard (0.075 ppb) Promulgated March 12, 

2008.

2005–2007 

2008 

December 31, 2008 b .............

March 12, 2009 b ....................

March 12, 2009 b. 

March 12, 2009 b. 

2009 January 8, 2010 b ................... January 8, 2010 b. 

aThese dates are unchanged from those published in the original rulemaking, and are shown in this table for informational purposes. b Indicates change from general schedule in 40 CFR 50.14. 

Note: EPA notes that the table of revised deadlines only applies to data EPA will use to establish the final initial designations for new or revised NAAQS. The general schedule applies for all other purposes, most notably, for data used by EPA for redesignations to attainment. 

* * * * * 

[FR Doc. E8–23520 Filed 10–3–08; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

42 CFR Part 34 

[Docket No. CDC–2008–0002] 

RIN 0920–AA20 

Medical Examination of Aliens— 

Revisions to Medical Screening 

Process 

AGENCY: Centers for Disease Control and 

Prevention, U.S. Department of Health 

and Human Services. 

ACTION: Interim final rule with comment 

period. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), within 

the U.S. Department of Health and 

Human Services (HHS), is amending its 

regulations that govern medical 

examinations that aliens must undergo 

before they may be admitted to the 

United States. HHS/CDC is amending 

the definition of communicable disease 

of public health significance. HHS/CDC 

is also amending the provisions that 

describe the scope of the medical 

examination for aliens by incorporating 

a more flexible, risk-based approach, 

based on medical and epidemiologic 

factors. This approach will assist HHS/ 

CDC in determining which diseases the 

medical screening, testing, and 

treatment of aliens should include in 

areas of the world that are experiencing 

unforeseen outbreaks of those diseases. 

In addition, HHS/CDC is updating the 

screening requirements for tuberculosis 

to be consistent with current medical 

knowledge and practice. 

These changes will reduce the healthsecurity threat to the United States from 

emerging diseases without imposing an 

undue burden on either the aliens or the 

health-care system in U.S. resettlement 

communities. 

DATES: The interim rule is effective on 

October 6, 2008. Interested parties must 

submit written comments on or before 

December 5, 2008. HHS/CDC will 

consider comments received after this 

period only to the extent practicable. 

ADDRESSES: You may submit written 

comments, identified by Docket No. 

CDC–2008–0002, to the following 

address: Division of Global Migration 

and Quarantine, Centers for Disease 

Control and Prevention, U.S. 

Department of Health and Human 

Services, ATTN: Part 34 Comments, 

1600 Clifton Road, NE., E03, Atlanta, 

GA 30333. 

Comments will be available for public 

inspection from Monday through 

Friday, except for legal holidays, from 9 

a.m. until 5 p.m., Eastern Time, at 1600 

Clifton Road, NE., Atlanta, GA 30333. 

Please call ahead to 1–866–694–4867, 

and ask for a representative in the 

Division of Global Migration and 

Quarantine to schedule your visit. 

Comments are also available for 

viewing at the following Internet 

addresses: http://www.cdc.gov/ncidod/ 

dq and http://www.globalhealth.gov. 

You may submit written comments 

electronically via the Internet at the 

following address: http:// 

www.regulations.gov, or via e-mail to 

Part34publiccomments@cdc.gov. 

To download an electronic version of 

the rule, please go to the following 

Internet address: http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION, CONTACT: 

Stacy M. Howard, Division of Global 

Migration and Quarantine, Centers for 

Disease Control and Prevention, U.S. 

Department of Health and Human 

Services, 1600 Clifton Road, NE., E03, 

Atlanta, GA 30333; telephone 404–498– 

1600. 

SUPPLEMENTARY INFORMATION: The 

Preamble to this interim rule is 

organized as follows: 

I. Legal Authority 

II. Background 

III. Summary of Changes to 42 CFR Part 34 

IV. Revised Definition of Communicable 

Disease of Public Health Significance 

V. Revised Scope of Medical Examination 

VI. Updating Tuberculosis Screening 

Requirements 

VII. Urgent Need for Regulatory Change 

VIII. Analysis of Impacts 

IX. Paperwork Reduction Act of 1995 

X. References 

I. Legal Authority 

HHS/CDC is promulgating this rule 

under the authority of 42 U.S.C. 252 and 

8 U.S.C. 1182 and 1222. 

II. Background 

Under section 212(a)(1) of the 

Immigration and Nationality Act (INA) 

(8 U.S.C. 1182(a)(1)), any alien 

determined to have a specified healthrelated condition is inadmissible to the 

United States. Those aliens outside the 

United States with a specified healthrelated condition (see below) are 

ineligible to receive a visa and ineligible 

to be admitted into the United States. 

The grounds of inadmissibility for 

specified health-related conditions also 

pertain to aliens in the United States 

who are applying for adjustment of 

immigration status to that of a lawful 

permanent resident. 

Aliens are currently inadmissible into 

the United States if they have a 

communicable disease of public health 

significance, defined as follows: Active 

tuberculosis, infectious syphilis, 

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58048 Federal Register / Vol. 73, No. 194 / Monday, October 6, 2008 / Rules and Regulations 

gonorrhea, infectious leprosy, 

chancroid, lymphogranuloma 

venereum, granuloma inguinale, and 

HIV infection. 

Medical examinations, including a 

physical and mental evaluation, to 

determine whether an alien may have 

such a health-related condition, are 

authorized under section 232 of the INA 

(8 U.S.C. 1222). Under sections 212(a)(1) 

and 232 of the INA, and section 325 of 

the Public Health Service (PHS) Act (42 

U.S.C. 252), the Secretary of Health and 

Human Services promulgates 

regulations to establish the requirements 

for the medical examination and to list 

the health-related conditions that make 

aliens ineligible for entry into the 

United States. The regulations, 

administered by HHS/CDC, are 

promulgated at 42 FR part 34. 

As currently listed in § 34.1, the 

provisions in this part apply to the 

medical examination of (1) aliens 

outside the United States who are 

applying for an immigrant visa at an 

embassy or consulate of the United 

States; (2) aliens arriving in the United 

States; (3) aliens required by the U.S. 

Department of Homeland Security 

(DHS) [formerly required by the 

Immigration and Naturalization Service 

(INS)] to have a medical examination in 

connection with the determination of 

their admissibility into the United 

States; and (4) applicants in the United 

States who apply for adjustment of their 

immigration status to that of permanent 

resident. 

Panel physicians, designated by 

consular officers of the U.S. Department 

of State, perform medical examinations 

abroad, and civil surgeons, designated 

by the U.S. Citizenship and Immigration 

Services, perform medical examinations 

for aliens who are already present in the 

United States. Aliens determined to 

have a communicable disease of public 

health significance may request a waiver 

to enter the United States under sections 

212(d)(3)(a) and 212(g) of the INA (8 

U.S.C. 1182(d)(3)(a) and 1182(g)). 

Aliens are inadmissible if they are 

determined: (1) To have a 

communicable disease of public health 

significance; (2) to have a physical or 

mental disorder and behavior associated 

with the disorder that may pose, or has 

posed, a threat to the property, safety, or 

welfare of the alien or others; (3) to have 

had a physical or mental disorder and 

a history of behavior associated with the 

disorder, which has posed a threat to 

the property, safety, or welfare of the 

alien or others and which is likely to 

recur or lead to other harmful behavior; 

or (4) to be a drug abuser or addict. In 

addition, except for certain adopted 

children 10 years of age or younger, any 

alien who seeks admission as an 

immigrant, or seeks adjustment of 

immigration status to legal permanent 

resident, is inadmissible if the alien fails 

to present documentation of having 

received vaccination against mumps, 

measles, rubella, polio, tetanus and 

diphtheria toxoids, pertussis, 

Haemophilus influenzae type B, 

hepatitis B and any other vaccination 

recommended by the Advisory 

Committee for Immunization Practices. 

Annually, the U.S. Government 

admits more than 1,000,000 immigrants 

and refugees to reside permanently in 

this country. The majority arrives from 

Asia, Africa and Central and South 

America, regions with recently reported 

outbreaks of emerging, infectious 

diseases, including yellow fever, 

dengue, Ebola and Marburg hemorrhagic 

fevers and the H5N1 strain of highly 

pathogenic avian influenza. These 

regular outbreaks, many of which affect 

both urban and rural areas, and the 

movement of large population 

resettlements from these regions, 

highlight the serious threat to public 

health in the United States to which the 

Centers for Disease Control and 

Prevention (CDC) within the U.S. 

Department of Health and Human 

Services (HHS) has to respond on very 

short notice. 

In the recent past, the demographics 

of U.S.-bound refugees have shifted to 

populations that are at higher risk for 

communicable diseases. These newer 

groups of refugees have lower baseline 

rates of vaccination, higher rates of 

parasitic infections and more limited 

access to basic medical care and 

preventive health interventions before 

resettlement. Between 1996 and 2003, at 

least half of all arriving refugees were 

European. In 1998, 70 percent were 

European. Beginning in 2003, however, 

the numbers of refugees from Europe 

rapidly declined. In 2008, only three 

percent of all refugees arriving in the 

United States were European. At the 

same time, a larger proportion of 

refugees have come from countries with 

poorer economies, weaker health 

infrastructure, and limited access to 

basic medical care. As a result, these 

refugees have a higher incidence of 

major infectious diseases. 

This demographic shift is one of the 

most important factors that have led to 

the substantial increase in the number 

and nature of outbreaks of 

communicable diseases that have 

affected refugee resettlements. These 

new populations bring new diseases but 

the diseases for which individuals are 

inadmissible into the United States have 

remained much the same as at the end 

of the nineteenth century. 

The highest rates of tuberculosis 

among immigrants and refugees are for 

those born in sub-Saharan African and 

Southeast Asian countries, with rates of 

at least 250 cases per 100,000. By 

comparison, the rate in the United 

States is fewer than five cases per 

100,000. Overall, approximately onethird of the world’s population has the 

infection, and over 50 percent of TB 

cases in the United States are in foreignborn residents. 

Panel physicians miss up to 67 per 

cent of tuberculosis (TB) cases based on 

the current scope of medical 

examination requirements. 

Implementation of these revisions to the 

regulations would ensure the methods 

for screening and testing TB used during 

the medical examination of aliens 

reflect the most current medical 

practice. 

The resettlement of these populations, 

many of which are coming from highrisk countries, is a strong argument for 

an immediate implementation of the 

changes in the list of communicable 

diseases of public health significance to 

reduce the potential of emerging disease 

threats in this higher-risk caseload. 

Urgent changes to this list are needed to 

prevent importing communicable 

diseases into our country. The current 

regulations do not address emerging and 

re-emerging diseases in immigrant or 

refugee populations. HHS is adding 

diseases to the communicable diseases 

of public health significance that better 

reflect the true threats that our Nation 

faces, including cholera, diphtheria, 

plague, smallpox, yellow fever, viral 

hemorrhagic fevers, and severe acute 

respiratory syndrome (SARS). These 

diseases currently exist in the list of 

quarantinable, communicable diseases 

defined by Presidential Executive Order, 

but do not appear on the list of 

communicable diseases of public-health 

significance. These diseases cause 

severe illness and death in regions of 

the world that are home to large 

numbers of immigrants and refugees 

bound for the United States. 

In addition, the revision to part 34 is 

consistent with relevant provisions of 

the revised International Health 

Regulations (2005), which came into 

force in July of 2007. 

HHS/CDC also issues technical 

instructions and provides technical 

consultation and guidance to panel 

physicians and civil surgeons who 

conduct the medical examinations of 

aliens. The HHS/CDC Technical 

Instructions for Medical Examination of 

Aliens, including the most current 

updates, which panel physicians and 

civil surgeons must follow in 

accordance with these regulations, are 

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available to the public on the HHS/CDC 

Web site, located at the following 

Internet address: http://www.cdc.gov/ 

ncidod/dq/technica.htm. HHS/CDC will 

also post and maintain a list of all 

medical conditions and locations for 

which additional screening 

requirements are in effect pursuant to 

this rule. This list will be available at 

the same Internet address: http:// 

www.cdc.gov/ncidod/dq/technica.htm, 

and http://www.globalhealth.gov. 

III. Summary of Changes to 42 CFR Part 

34 

HHS/CDC is amending the definition 

of a communicable disease of public 

health significance. Current 

communicable diseases of public health 

significance are: active tuberculosis, 

infectious syphilis, gonorrhea, 

infectious leprosy, chancroid, 

lymphogranuloma venereum, 

granuloma inguinale, and HIV infection. 

The definition of a communicable 

disease of public health significance in 

this rule remains as those diseases 

currently listed in § 34.2(b), plus the 

addition of (1) quarantinable diseases 

designated by Presidential Executive 

Order, and (2) those diseases that meet 

the criteria of a public health emergency 

of international concern which require 

notification to the World Health 

Organization (WHO) under the revised 

International Health Regulations of 

2005. A delay in implementing these 

updates to Part 34 poses a risk of further 

severe illness for refugees and 

immigrants as they move into receiving 

U.S. communities and presents 

American taxpayers with elevated 

medical costs. Updating the list of 

communicable diseases of public health 

significance will diminish complex and 

costly measures such as vaccination, 

chemoprophylaxis and isolation, and 

lessen illness and death among the 

affected migrating populations. 

The following is a section-by-section 

analysis of proposed changes: 

Section 34.2 Definitions 

The revision updates the definition 

provided in § 34.2(b) for a 

communicable disease of public health 

significance to include two new 

categories of disease. The first category, 

added as § 34.2(b)(2), is the 

quarantinable, communicable diseases 

specified by the President in Executive 

Order, as provided under Section 361(b) 

of the Public Health Service Act. The 

second category, added as § 34.2(b)(3), is 

any communicable disease that requires 

notification to the World Health 

Organization as an event that may 

constitute a public health emergency of 

international concern, pursuant to the 

revised International Health Regulations 

of 2005. 

Section 34.3 Scope of Examinations 

HHS/CDC is publishing section 34.3 

in its entirety for clarity, including 

republication of some provisions that 

are unchanged. HHS/CDC has revised 

section 34.3 to include screening and 

testing for the updated list of 

communicable diseases of public health 

significance, as defined in § 34.2(b). 

HHS/CDC has also revised section 34.3 

to require additional medical screening 

and testing using a more flexible riskbased approach for those medical 

examinations performed outside of the 

United States. HHS/CDC has also 

revised the specific requirements 

concerning the required evaluation for 

tuberculosis. 

The U.S. Department of Homeland 

Security (DHS) currently is the entity 

responsible for administering the 

immigration authority and functions 

previously administered by the 

Immigration and Naturalization Service 

(INS), which was within the U.S. 

Department of Justice. The revised rule 

text changes the reference to INS in 

existing § 34.3(b)(2)(i) to U.S. 

Department of Homeland Security in 

new § 34.3(e)(3)(i). 

Specific Changes to the Scope of the 

Medical Examination, and the RiskBased Approach 

The title of § 34.3(b) has changed to 

Scope of all medical examinations, and 

provides that all medical examinations 

will include a general physical 

examination and medical history, 

evaluation for tuberculosis, serologic 

testing for syphilis and HIV, and also a 

physical examination and medical 

history for diseases specified in 

§§ 34.2(b)(1) and 34.2(b)(4) through 

34.2(b)(10). The unindented paragraph 

currently at the end of § 34.3(a) has been 

moved to § 34.3(b)(2). 

The title of § 34.3(c) has been changed 

to Additional medical screening and 

testing for examinations performed 

outside of the United States and 

provides that HHS/CDC may require 

additional screening and testing for 

medical examinations performed 

outside the United States for diseases 

specified in §§ 34.2(b)(2) and 34.2(b)(3) 

by applying the risk-based medical and 

epidemiologic factors listed in 

§ 34.3(d)(2). It provides that such 

examinations shall be conducted in a 

defined population, in a geographic 

region or area outside the United States, 

for a period of time as determined by 

HHS/CDC. Additional medical 

screening and testing shall include a 

medical interview, physical 

examination, laboratory testing, 

radiologic exam, or other diagnostic 

testing as determined by HHS/CDC. 

Section 34.3(c)(4) and (5) indicate that 

additional medical screening and testing 

will continue until HHS/CDC 

determines such activity is not 

necessary, based on medical and 

epidemiologic factors, and that HHS/ 

CDC will provide medical examiners 

with information pertaining to all 

additional screening and testing 

requirements, and will also post the 

information on the HHS/CDC Web site. 

Section 34.3(d) is entitled Risk-based 

approach, and provides the medical and 

epidemiological factors that HHS/CDC 

will use to determine whether a disease 

as specified in § 34.2(b)(3)(ii) is a 

communicable disease of public health 

significance, which diseases in 

§§ 34.2(b)(2) and (b)(3) merit additional 

screening and testing, and the 

geographic area in which HHS/CDC will 

require this screening. These factors 

include the seriousness of the disease’s 

public health impact; whether the 

emergence of the disease was unusual or 

unexpected; the risk of the spread of the 

disease to the United States; the 

transmissibility and virulence of the 

disease; the impact of the disease at the 

geographic location of medical 

screening; and other specific pathogenic 

factors that would bear on a disease’s 

ability to threaten the health security of 

the United States. 

Specific Changes to Tuberculosis 

Screening Requirements 

HHS/CDC has revised § 34.3 to 

require testing for tuberculosis of 

children under the age of 15 years old 

when they have symptoms of 

tuberculosis, a history of tuberculosis, 

or possible exposure to a transmissible 

tuberculosis case in a household or 

other enclosed environment for a 

prolonged period. With regard to 

additional testing requirements for an 

applicant that has a radiograph that 

indicates an abnormality suggestive of 

tuberculosis disease, HHS/CDC has 

revised § 34.3 to require additional 

testing for tuberculosis. Specific 

changes regarding the required 

evaluation for tuberculosis appear 

below. 

Section 34.3(b), entitled Persons 

subject to requirement for chest x-ray 

examination and serologic testing is 

now § 34.3(e). The revision adds 

§ 34.3(e)(2)(ii) to include a chest x-ray 

examination for applicants under 15 

years of age if they have symptoms of 

tuberculosis, a history of tuberculosis, 

or evidence of possible exposure to a 

transmissible tuberculosis case in a 

household or other enclosed 

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environment for a prolonged period. 

The paragraph describing requirements 

for tuberculin skin test (TST) 

examination is now § 34.3(e)(3), and has 

been renamed Immune response to 

Mycobacterium tuberculosis antigens to 

reflect updated, current equivalent tests 

that are increasingly used in clinical 

settings and may eventually be used as 

an alternative to the tuberculin skin test 

for refugee and immigrant screening. 

The Quantiferon-TB Gold (QFT–G) test 

is one recommended method for 

screening for tuberculosis in clinical 

practice in most circumstances instead 

of the TST. The incorporation of 

Immune Globulin Release Assays 

(IGRAs), which include QFT–G, is 

under consideration by CDC for 

screening for tuberculosis in aliens. This 

change will insure that current, updated 

medical technology will be used, as 

appropriate, by panel physicians and 

civil surgeons conducting the medical 

examinations. This section also includes 

the addition of § 34.3(e)(3)(iii) which 

requires a tuberculin skin test, or an 

equivalent test for showing an immune 

response to Mycobacterium tuberculosis 

antigens, for applicants outside of the 

United States who are required to have 

a medical examination and, if indicated, 

a chest x-ray examination, if the 

applicant is of sufficient age to be 

considered contagious. 

Section 34.3(e)(3)(iv) requires both a 

tuberculin skin test, or an equivalent 

test for showing an immune response to 

Mycobacterium tuberculosis antigens, 

and a chest x-ray examination for any 

applicant outside of the United States, 

regardless of age, if the applicant has 

symptoms of tuberculosis, a history of 

tuberculosis, or possible exposure to a 

transmissible tuberculosis case in a 

household or other enclosed 

environment for a prolonged period. 

Section 34.3(e)(4), entitled Additional 

testing requirements, indicates that all 

applicants subject to the chest x-ray 

examination and for whom the 

radiograph shows an abnormality 

suggestive of tuberculosis disease must 

undergo additional testing for 

tuberculosis. This change allows for the 

use of the most current testing 

procedures for tuberculosis disease. 

References to the Attorney General in 

existing §§ 34.3(b)(4) and (e) are 

changed to the Secretary of Homeland 

Security in new §§ 34.3(e)(5) and (h) to 

reflect the creation of DHS in 2003 and 

its assumption of applicable authorities 

and responsibilities. Reference to INS in 

existing § 34.3(b)(2)(i) is changed to U.S. 

Department of Homeland Security in 

new § 34.3(e)(3)(i). These ministerial 

corrections are the only amendments to 

these sections which are otherwise 

republished unchanged. 

IV. Revised Definition of 

Communicable Disease of Public 

Health Significance 

As stated in Section 212(a)(1) of the 

INA, aliens are inadmissible into the 

United States if they are determined to 

have a specified health condition, 

which includes a communicable disease 

of public health significance. Currently, 

medical examinations require the 

screening of all aliens subject to these 

requirements for all listed 

communicable diseases of public health 

significance. Regulations have 

historically defined the term 

communicable disease of public health 

significance by listing specific diseases. 

The current definition in 42 CFR 34.2(b) 

includes chancroid, gonorrhea, 

granuloma inguinale, human 

immunodeficiency virus (HIV) 

infection, infectious leprosy, 

lymphogranuloma venereum, 

infectious-stage syphilis, and active 

tuberculosis. 

Recent experience has demonstrated 

that a fixed list of diseases does not 

allow HHS/CDC the flexibility it needs 

to rapidly respond to unanticipated 

emerging or re-emerging outbreaks of 

disease. Rather, HHS/CDC requires an 

approach based on potential risks and 

consequences instead of a static list that 

does not reflect the potential for future 

outbreaks of novel diseases. National 

and international health agencies have 

recently developed guidelines for 

defining diseases of public health 

significance that threaten global health 

security and require an urgent response. 

This guidance provides the framework 

to update the list of communicable 

diseases of public health significance for 

the United States to screen and test 

aliens during disease outbreaks in real 

time. 

HHS/CDC is adding the following two 

disease categories to the current list of 

communicable diseases of public health 

significance: 

(1) Quarantinable, communicable 

diseases specified by Presidential 

Executive Order, as provided under 

Section 361(b) of the Public Health 

Service Act; and 

(2) Any communicable disease that 

requires notification to the World 

Health Organization as an event that 

may constitute a public health 

emergency of international concern, 

pursuant to the revised International 

Health Regulations of 2005. 

Quarantinable Communicable Diseases 

Specified by Presidential Executive 

Order, as Provided Under Section 361(b) 

of the Public Health Service Act 

Section 361 of the Public Health 

Service Act authorizes the Secretary of 

HHS to enact rules and regulations for 

preventing the introduction, 

transmission, and spread of 

communicable diseases from foreign 

countries into the United States, and 

from one State or possession into 

another. Executive Order 13295 of April 

4, 2003, as amended by Executive Order 

13375 of April 1, 2005, contains the 

most recent list of quarantinable, 

communicable diseases, and includes 

the following: Cholera, yellow fever, 

plague, viral hemorrhagic fevers, 

diphtheria, infectious tuberculosis, 

smallpox, severe acute respiratory 

syndrome (SARS), and influenza caused 

by novel or re-emergent influenza 

viruses that are causing, or have the 

potential to cause, a pandemic 

(pandemic influenza). HHS/CDC is 

adding diseases listed by Presidential 

Executive Order to the definition of 

communicable diseases of public health 

significance, subject to screening and 

testing requirements outlined in the 

section on the scope of examinations. 

Any Communicable Disease That 

Requires Notification to the World 

Health Organization as an Event That 

May Constitute a Public Health 

Emergency of International Concern, 

Pursuant to the Revised International 

Health Regulations of 2005 

In May 2005, the World Health 

Assembly adopted the revised 

International Health Regulations (IHR 

(2005)). These regulations entered into 

force for most of the Member States of 

the WHO in June 2007 and for the U.S. 

in July 2007. The purpose and scope of 

the IHR (2005) are to prevent, protect 

against, control and provide a public 

health response to the international 

spread of disease, while minimizing 

interference with world travel and trade. 

Annex 2 of the IHR (2005) contains an 

algorithm for identifying a public health 

emergency of international concern, and 

can be located at the following Internet 

address: http://www.who.int/gb/ghs/

pdf/IHR_IGWG2_ID4-en.pdf. 

The IHR (2005) define a public health 

emergency of international concern as 

an extraordinary event which is 

determined: (i) To constitute a public 

health risk to other [Member] States 

through the international spread of 

disease and (ii) to potentially require a 

coordinated international response. 

Under the IHR (2005), Member States 

must notify the World Health 

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Organization of any disease event that 

fulfills the criteria presented in the three 

categories of the algorithm in Annex 2. 

The definition in the revised part 34 

rule text is intended to capture those 

diseases that require notification by any 

country to the WHO under the IHR 

(2005) and determined to be an event 

that may constitute a public health 

emergency of international concern. The 

revised part 34 rule text references IHR 

(2005) category (1), below, in 

§ 34.2(b)(3)(i), and categories (2) and (3), 

below, together in § 34.2(b)(3)(ii). 

(1) Diseases Listed in the IHR (2005) for 

Which a Single Case Requires 

Notification Through the Use of the IHR 

(2005) Algorithm 

Annex 2 of the IHR (2005) specifies 

that smallpox, poliomyelitis from wildtype poliovirus, pandemic influenza 

and severe acute respiratory syndrome 

(SARS) are diseases with serious public 

health impact, and that a single case, 

irrespective of context, requires 

immediate notification to the WHO. 

HHS/CDC is adding diseases listed in 

this category to the definition of a 

communicable disease of public health 

significance, subject to screening and 

testing requirements outlined in the 

section on the scope of examinations. 

The impact of the SARS outbreak 

demonstrates the importance of using 

the IHR (2005) algorithm to quickly 

detect and identify emerging and reemerging pathogens in this category. 

SARS coronavirus is a droplet-spread 

illness that rapidly emerged as a global 

threat in 2003, caused more than 8,000 

cases and 800 deaths, and required 

isolation and quarantine control 

measures. Although now contained, the 

disease (or one similar to it) could reemerge at any time. The use of the IHR 

(2005) process for disease notification to 

the WHO will ensure the earliest 

possible protection of citizens in the 

United States through medical screening 

of a pathogen like SARS when the next 

outbreak occurs. Smallpox, which 

causes high mortality and morbidity, is 

another disease in this category. 

Because smallpox is now successfully 

eradicated, it poses an ongoing threat as 

a bioterrorism agent. 

(2) Other Diseases Listed in the IHR 

(2005) for Which Notification Is 

Required Through the Use of the IHR 

(2005) Algorithm 

In addition to the single-case 

notification diseases, Annex 2 indicates 

that an event that involves the following 

diseases shall always lead to the use of 

the IHR (2005) algorithm to determine 

whether the disease occurrence amounts 

to a public health emergency of 

international concern, because these 

diseases have demonstrated the ability 

to cause serious public health impact 

and to spread rapidly internationally: 

—Cholera; 

—Pneumonic plague; 

—Yellow fever; 

—Viral hemorrhagic fevers (Ebola, 

Lassa, Marburg); 

—West Nile fever; and 

—Other diseases that are of special 

national or regional concern (e.g. 

dengue fever, Rift Valley fever, and 

meningococcal disease). 

HHS/CDC is adding diseases listed in 

this category to the definition of a 

communicable disease of public health 

significance, subject to screening and 

testing requirements and risk-based 

factors outlined in the section on the 

scope of examinations. 

Ongoing threats in this category 

include Ebola hemorrhagic fever, a 

severe, often fatal disease, easily spread 

through close personal contact. An 

outbreak of Ebola in the Democratic 

Republic of the Congo, confirmed in 

September 2007, resulted in 26 

laboratory-confirmed cases of illness as 

of October 2007. There have been a total 

of 264 suspected cases, and Ebola is 

believed to have killed up to 187 people 

over eight months. A subsequent 

outbreak of Ebola in the Republic of 

Uganda produced 149 suspect cases and 

killed 37 people. Cholera, which can 

cause severe diarrhea and death, also 

continues to be active. From August 

2007 through November 2007, an 

outbreak spread throughout Iraq and 

caused over 4500 cases of illness and 23 

deaths. 

(3) Other Unspecified Diseases That 

Require Notification Through the Use of 

the IHR (2005) Algorithm 

Annex 2 also refers to any event of 

potential international health concern, 

including those of unknown causes or 

sources, and those that involve events or 

diseases, other than the IHR (2005) 

single-case notifiable and other 

specified notifiable diseases (listed in 

(1) and (2) above), that lead to use of the 

IHR (2005) algorithm. HHS/CDC is 

adding diseases listed in this category to 

the definition of a communicable 

disease of public health significance, 

subject to screening and testing 

requirements and risk-based factors 

outlined in the section on scope of 

examinations. Addition of this last 

category to the definition of diseases of 

public health significance allows HHS/ 

CDC to respond rapidly to emerging 

disease threats in a way that adding 

specific diseases to a fixed list does not. 

Once HHS/CDC acknowledges an 

event from the IHR (2005) algorithm as 

a disease of public health significance, 

HHS/CDC will immediately advise the 

physicians who conduct medical 

examinations of the additional medical 

screening or testing required for the 

identified disease(s) via electronic 

notification, coordination with 

embassies, consulates and the 

International Organization for 

Migration, by publication on the HHS/ 

CDC Web site, and publication of a 

notice in the Federal Register. HHS/ 

CDC will also provide any required 

disease notifications to appropriate DOS 

bureaus. HHS/CDC will also maintain a 

current list of diseases and locations 

subject to additional medical screening 

and will update addenda to the 

Technical Instructions for Medical 

Examination of Aliens regarding these 

diseases, available to the public on the 

HHS/CDC Division of Global Migration 

and Quarantine Web site, located at the 

following Internet address: http:// 

www.cdc.gov/ncidod/dq/technica.htm, 

and also at http://www.globalhealth.gov. 

The HHS/CDC Division of Global 

Migration and Quarantine is the current 

name of the former Division of 

Quarantine used in existing § 34.3(f), 

and section 34.3(i) of the revised rule 

text uses the correct name. The section 

is otherwise republished unchanged. 

V. Revised Scope of Medical 

Examination 

HHS/CDC is amending the scope of 

the medical examination in 42 CFR 34.3 

to allow greater agility to respond to 

significant outbreaks of communicable 

diseases of public health significance for 

applicants examined in geographic 

locations where these diseases exist, 

and for which importation into the 

United States would pose a threat. HHS/ 

CDC believes a risk-based approach that 

uses medical and epidemiologic factors 

to detect additional diseases of public 

health significance provides a flexible, 

fair and practical means to address 

infectious disease threats among at-risk 

aliens without placing an undue burden 

on other applicants. 

Beginning on the effective date of this 

rule, HHS/CDC will also make a 

distinction between the medical 

examinations performed for aliens 

outside the United States, and those 

performed for aliens already in the 

United States who are applying for 

adjustment of status to that of 

permanent resident, in that the riskbased approach to detect additional 

diseases of public health significance 

will apply only to medical examinations 

outside the United States and only in 

those geographic areas where the risk is 

high. Applicants already within the 

United States who apply for adjustment 

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of immigration status will not be subject 

to additional screening or testing using 

the risk-based approach. Disease 

outbreaks in aliens who are within the 

United States primarily fall under the 

jurisdiction of state and local public 

health authorities. For both groups of 

aliens, those applying for status 

adjustment from within the United 

States and those applying for admission 

from outside the United States, the 

medical screening examination will 

continue to consist of a general physical 

examination and medical history, 

evaluation for tuberculosis, and 

serologic testing for syphilis and HIV. In 

addition, under the new risk-based 

approach, HHS/CDC may require aliens 

outside the United States applying for 

U.S. immigration to undergo additional 

screening and testing for specific 

communicable diseases of public health 

significance. 

Quarantinable, Communicable Diseases 

Specified by Presidential Executive 

Order as Provided Under Section 361(b) 

of the Public Health Service Act 

Medical screening for these diseases 

will be achieved through physical 

examination and medical history. 

Accomplish HHS/CDC may require 

additional screening or testing for these 

diseases for aliens receiving medical 

examinations at the specific location or 

area where outbreaks of the disease or 

diseases may be occurring. This 

additional screening and testing will 

involve applying the defined risk-based 

approach by using medical and 

epidemiologic factors (shown below in 

this section.) 

This change addresses diseases in 

immigrant and refugee populations 

(and, in extreme cases, non-immigrant 

aliens) outside the United States, and 

ensures the lists of quarantinable 

diseases and inadmissible conditions 

remain consistent. Whenever this 

Executive Order is amended in the 

future to add additional diseases, HHS/ 

CDC will be able to immediately begin 

testing and screening for these diseases. 

Any Communicable Disease That 

Requires Notification to the World 

Health Organization as an Event That 

May Constitute a Public Health 

Emergency of International Concern, 

Pursuant to the Revised International 

Health Regulations of 2005 

(1) Diseases Under the IHR (2005) for 

Which a Single Case Requires 

Notification to WHO as an Event That 

May Constitute a Public Health 

Emergency of International Concern 

HHS/CDC will consider all the 

diseases in this category, including 

diseases included by WHO in the future, 

as communicable diseases of public 

health significance and subject to 

medical screening through physical 

examination and medical history. HHS/ 

CDC will also consider imposing 

additional screening and testing, as 

determined by the specific 

circumstances of the event, for diseases 

in this category that meet requirements 

of the risk-based approach composed of 

medical and epidemiologic factors 

(shown below in this section) and for 

which HHS/CDC determines a threat 

exists for importation into the United 

States, and that may potentially affect 

the health of the American public. 

(2) Other Diseases That Require 

Notification to WHO as an Event That 

May Constitute a Public Health 

Emergency of International Concern 

Through the Use of the IHR (2005) 

Algorithm (Includes Categories (2) and 

(3) of the IHR (2005) Algorithm 

Referenced Previously in Section IV— 

Revised Definition of a Communicable 

Disease of Public Health Significance) 

HHS/CDC will consider the diseases 

in this category as communicable 

diseases of public health significance 

and subject to medical screening 

through physical examination and 

medical history if they meet one or more 

of the risk-based criteria of medical and 

epidemiologic factors (shown below in 

this section), and HHS/CDC determines 

(1) a threat exists for importation into 

the United States, and (2) such diseases 

may potentially affect the health of the 

American public. HHS/CDC will also 

consider imposing additional screening 

and testing for diseases in this category, 

as determined by the specific 

circumstances of the event. 

Risk-Based Approach of Medical and 

Epidemiologic Factors 

HHS/CDC will determine which 

diseases merit additional screening and 

testing, and the geographic area in 

which HHS/CDC will require this 

screening, by applying a risk-based 

approach that takes into account the 

following medical and epidemiologic 

factors: (a) The seriousness of the 

disease’s public health impact; (b) 

whether the emergence of the disease 

was unusual or unexpected; (c) the risk 

of the spread of the disease to the 

United States; (d) the transmissibility 

and virulence of the disease; (e) the 

impact of the disease at the geographic 

location of medical screening; and (f) 

other, specific pathogenic factors that 

would bear on a disease’s ability to 

threaten the health security of the 

United States. HHS/CDC will consider 

diseases identified through the 

International Health Regulations 

algorithm (other than diseases for which 

a single case requires notification) as 

communicable diseases of public health 

significance when they meet one or 

more of the criteria listed above, and for 

which HHS/CDC determines (A) a threat 

exists for importation into the United 

States, and (B) such diseases may 

potentially affect the health of the 

American public. 

This risk-based approach will 

facilitate a meaningful public health 

response to existing and emerging 

threats, without overwhelming the 

entire health system with needless 

testing. The changes to the scope of the 

examination will allow HHS/CDC to 

tailor testing requirements to those areas 

where the severity of communicable 

diseases of public health concern are 

actually affecting populations at the 

time of the medical examination. 

When HHS/CDC requires screening 

for additional communicable diseases of 

public health significance for applicants 

from specific geographic areas, HHS/ 

CDC may require additional screening, 

including additional medical 

interviews, a physical examination, 

laboratory testing, radiologic exams, or 

other diagnostic procedures. 

Screening and testing for newly 

identified diseases as a part of the list 

of communicable diseases of public 

health significance will continue until 

HHS/CDC determines the particular 

situation does not warrant this 

designation, based on factors such as the 

results of disease investigations; 

response efforts; the effectiveness of 

containment and control measures; and 

the current determination or 

termination of the public health 

emergency of international concern by 

the Director General of the WHO. 

HHS/CDC will provide physicians the 

technical instructions regarding the 

required additional medical screening 

and testing to perform for a disease as 

part of the examination. In most 

instances, additional medical screening 

and testing may only consist of 

epidemiologic questions and further 

physical examination relating to the 

disease. HHS/CDC will also update the 

Technical Instructions for Medical 

Examination of Aliens, as needed, 

regarding the additional medical 

screening and testing protocol for a 

disease, and this information will also 

be immediately available to the public 

on the HHS/CDC Division of Global 

Migration and Quarantine Web site, 

located at the following Internet 

address: http://www.cdc.gov/ncidod/dq/ 

technica.htm; and at http:// 

www.globalhealth.gov. A listing of 

current documents regarding the 

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Federal Register / Vol. 73, No. 194 / Monday, October 6, 2008 / Rules and Regulations 58053 

additional medical screening and testing 

protocol for specific diseases will also 

be available on the HHS/CDC Web site. 

VI. Updating Tuberculosis Screening 

Requirements 

HHS/CDC is amending the medical 

examination rule for aliens by updating 

the screening requirements for 

tuberculosis, to be consistent with 

current medical knowledge and 

practice. HHS/CDC is amending 42 CFR 

34.3(b) by revising the requirement for 

a chest X-ray examination to include 

applicants under the age of fifteen years 

old, when there is reason to suspect 

tuberculosis infection. The practical 

effect of this change is to expand this 

testing protocol to alien applicant 

children under the age of 15, when 

medically appropriate. This change will 

allow HHS/CDC the flexibility to ensure 

the tuberculosis screening and testing 

methods used for medical examination 

of aliens are current and effective. 

HHS/CDC is amending § 34.3(b)(1)(v) 

by adding the expanded tuberculin skin 

test requirement, or an equivalent test 

for showing an immune response to 

Mycobacterium tuberculosis antigens, to 

the exceptions that may be authorized 

for good cause upon application 

approved by the Director of CDC. 

HHS/CDC is amending § 34.3(b)(2) to 

indicate that any alien applicant outside 

the United States shall have a tuberculin 

skin test or an equivalent test for 

showing an immune response to 

Mycobacterium tuberculosis antigens 

and, if indicated, a chest X-ray 

examination if the applicant is of 

sufficient age to be considered 

contagious. Additionally, any alien 

applicant outside the United States, 

regardless of age, shall have both a 

tuberculin skin test or an equivalent test 

for showing an immune response to 

Mycobacterium tuberculosis antigens, 

and a chest X-ray examination if the 

applicant has symptoms of tuberculosis 

disease, has a history of tuberculosis, or 

has exposure to a transmissible 

tuberculosis case in a household or 

other enclosed environment for a 

prolonged period. HHS/CDC is 

amending this section to make it 

consistent with current medical 

knowledge and practice. 

HHS/CDC is amending § 34.3 by 

adding a new provision, entitled 

Additional Testing Requirements, with 

the following rule text: All applicants 

subject to the chest X-ray examination 

requirement and for whom the 

radiograph shows an abnormality 

suggestive of tuberculosis disease shall 

be required to undergo additional 

testing for tuberculosis disease. 

The current, outdated rule requires 

sputum smears for anyone with signs, or 

x-ray findings, suggestive of 

tuberculosis. Current medical guidelines 

require mycobacterial culture, which is 

three times as sensitive as a sputum 

smear for detecting active tuberculosis. 

HHS/CDC is also updating language 

in 34.3(e) and (f) to replace x-ray film 

with x-ray image. This change is needed 

to reflect updated radiology technology 

such as CD–R and laser-printed x-ray 

formats. Language concerning chest xrays being attached to the alien’s visa in 

such a manner to be readily detached at 

the U.S. port of entry has also been 

deleted since x-rays are not required to 

be presented at the port of entry. 

VII. Urgent Need for Regulatory Change 

The U.S. Department of State 

proposed 80,000 refugee admissions for 

Fiscal Year 2008 under the requirements 

of Section 207(e)(1)–(7) of the 

Immigration and Nationality Act. This is 

greater than a ten percent increase from 

FY 2007 projections. As of June 2008, 

approximately 35,000 refugees have 

been resettled, and around 27,000 still 

expected by the end of September 2008. 

Major diseases of concern in these 

incoming refugee populations include 

multi-drug-resistant tuberculosis (MDR 

TB), measles, highly pathogenic avian 

influenza, and cholera. The potential for 

transmitting viral hemorrhagic fevers, 

such as Ebola and Marburg, also exists 

among some of the African populations 

being resettled. In addition, several 

vector-borne (animal-transmitted) 

diseases including chikungunya, dengue 

and, possibly, Rift Valley fever, are 

circulating in refugee camps with 

populations bound for the United 

States. Vectors (i.e. mosquitoes) 

prevalent in the United States are 

capable of widely spreading these 

diseases. 

Allowing serious diseases to enter 

into the United States can result in 

significant harm to both the American 

public and American business. The 

existing definition of communicable 

diseases of public health significance 

and the evaluation criteria for 

tuberculosis in the current regulation 

are outdated and no longer in keeping 

with current medical knowledge. 

Therefore, immediate changes are 

needed to improve the ability of the 

United States to prevent the 

introduction and spread of infectious 

diseases that are currently causing 

severe illness and death abroad. The 

scope of examination for medical 

screening is also outdated, and needs 

immediate changes to allow for medical 

screening by using a risk-based 

approach that considers medical and 

epidemiologic factors. The current 

regulations do not have a process for 

allowing HHS/CDC to adapt rapidly to 

new health threats, and they reference 

outdated public health practices that do 

not take advantage of the latest 

biomedical knowledge and 

epidemiologic data. Changes are needed 

now to reduce the potential for 

significant harm from emerging diseases 

and outbreaks of infectious diseases that 

currently threaten U.S. health security. 

Newly emerging communicable 

disease threats are arising with 

increased frequency because of multiple 

factors, such as increases in global travel 

and mobility, migration patterns, human 

susceptibility to novel infections, and 

microbial adaptation and mutation, as 

cited in the latest report of the U.S. 

Institute of Medicine on emergence of 

infectious diseases, Microbial Threats to 

Health: Emergence, Detection and 

Response, National Academies Press, 

2003. Infectious disease outbreaks (e.g., 

SARS in 2003) or potential threats like 

pandemic influenza are evidence that 

virulent diseases with short incubation 

periods can be carried over a border 

before signs of illness can be observed. 

Additionally, when disease outbreaks 

occur in refugees or immigrants coming 

to the United States, public health 

control actions such as vaccination, 

treatment, chemoprophylaxis and 

isolation must be implemented 

immediately to prevent the importation 

of disease into the United States. 

Annually, approximately 1,000,000 

immigrants and refugees enter the 

United States to reside here 

permanently. The majority arrive from 

Asia, Africa and Central and South 

America, regions with recently reported 

outbreaks of emerging infectious 

diseases, including yellow fever, dengue 

and the H5N1 strain of avian influenza. 

The 50,000–80,000 refugees who resettle 

in the United States each year are the 

most vulnerable populations, as they 

often come from difficult environmental 

conditions with limited water, 

sanitation and health care. Living 

conditions for many refugees include 

poor to nonexistent health and public 

health infrastructure; thus, it is difficult 

to have adequate knowledge of their 

current and potential medical problems. 

In refugee camps, disease surveillance 

and laboratory resources are often 

limited, which increases the difficulty 

of maintaining good health and 

preventing outbreaks of infectious 

diseases. Historically, outbreaks of 

communicable diseases have occurred 

frequently in refugee camps. These 

regular outbreaks, and the inherent 

nature of large population resettlements, 

highlight the health threats to which 

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HHS/CDC has to respond on very short 

notice. 

The shift in the demographics of 

refugee and immigrant populations 

bound for the United States and 

consequent changes in their health risks 

mandate a change in the definition of a 

communicable disease of public health 

significance, because of the current 

uncertainty of global disease trends. 

This demographic shift is the single 

most important cause of the substantial 

increase in the number and nature of 

outbreaks of communicable diseases 

among immigrants who are resettling 

into the United States. 

HHS/CDC is unable to forecast 

constantly changing migration patterns, 

and thus must have the flexibility to 

respond swiftly as unpredictable, 

problematic health and humanitarian 

crises arise. The current definition of a 

communicable disease of public health 

significance does not adequately 

accommodate the demographic shifts 

that have dramatically altered the 

pattern of diseases among new arrivals 

in the United States. 

HHS/CDC has found that the origins 

of U.S.-bound populations are 

increasingly unpredictable, and these 

populations increasingly originate in 

areas with challenging and 

unpredictable communicable diseases of 

public health significance. Immigration 

statistics (http://www.dhs.gov/ximgtn/ 

statistics) show more U.S.-bound 

refugees and immigrants now come 

from regions with a higher risk for 

communicable diseases. In recent years, 

the disease burden to the United States 

has increased as the proportion of 

refugees resettling from Africa and Asia 

has increased (http://www.state.gov/g/ 

prm/refadm/rls/85970.htm). As an 

example, the proportion of refugees 

resettled to the United States from 

Africa have increased in the recent past. 

African refugee arrivals have averaged 

16,000 per year since FY 2005. These 

newer groups of refugees have lower 

baseline rates of vaccination, higher 

rates of malaria and other parasitic 

infections (unfamiliar to most American 

clinicians), and very limited access to 

basic medical care and preventive 

health interventions before resettlement. 

Failure to address these conditions 

adequately because of the outdated 

definition of communicable diseases of 

public health significance has meant 

that HHS/CDC has had to respond to at 

least 25 outbreaks of disease among 

U.S.-bound refugees since 2004. 

Major outbreaks of dangerous, 

communicable diseases around the 

world in 2007 included Ebola in the 

Democratic Republic of the Congo in 

September, and in Uganda in December; 

cholera in Iraq in August; yellow fever 

in Togo in February, and in Brazil and 

Paraguay in December; and 85 animalto-human cases of the highly pathogenic 

H5N1 strain of avian influenza 

throughout the year. These outbreaks 

have been of diseases that do not 

naturally occur in the United States, or 

occur rarely, which could result in 

disability and death in U.S.-bound 

immigrants and refugees and secondary 

spread in the communities in the United 

States that receive immigrants. 

The WHO classifies yellow fever as a 

disease that has demonstrated the 

ability to cause serious public health 

impact, and is a good example of a 

threat to the health security of the 

United States. The Ministry of Health in 

Togo reported an outbreak of yellow 

fever to the WHO that lasted from 

December 2006 through February 2007. 

Moreover, Sudan, Senegal, Mali, Coˆte 

d’Ivoire, Burkina Faso, Guinea, Brazil, 

Peru, Paraguay, Bolivia and Argentina 

have also reported ongoing outbreaks of 

yellow fever to the WHO. In total, the 

WHO considers 46 countries, including 

33 African countries and 11 countries in 

Central and South America, to be 

currently at risk of yellow fever. 

Substantial numbers of U.S.-bound 

immigrants and refugees originate from 

areas in which yellow fever is endemic, 

and therefore pose a risk of the 

importation of this disease. Since 

mosquitoes that spread yellow fever 

exist in the United States, and areas of 

our country experienced outbreaks of 

the disease throughout the nineteenth 

century, importation could potentially 

result in sustained transmission in this 

country. Yellow fever is not currently 

included in the specific disease list in 

the regulation, but HHS/CDC would be 

classify it as a communicable disease of 

public health significance under the 

newly proposed definition, because it is 

a quarantinable disease by Presidential 

Executive Order and a disease that 

requires notification to WHO as an 

event that may constitute a public 

health emergency of international 

concern under the IHR (2005). 

The examples below enumerate some 

of the most recent (and largely 

unpredictable) disease outbreaks 

encountered as refugees resettle into the 

United States: 

—March 2007 to the present: Imported 

malaria outbreak in Burundian 

refugees from Tanzania. Over 40 cases 

of malaria have occurred as of 

October 2007 in more than 12 U.S. 

states, including 18 cases in children 

less than 10 years old, despite the 

administration of a pre-departure drug 

treatment regimen. Single cases or 

small domestic outbreaks through 

mosquitoes are another potential risk 

from this outbreak. 

—October 2007 to the present: at least 

12 cases of cholera have been reported 

in several thousand U.S.-bound 

refugees from the Dadaab refugee 

camp in Kenya, which led to a 

temporary suspension of resettlement. 

This was the second outbreak of 

cholera in this camp in 2007; an 

earlier outbreak affected more than 

200 refugees in June 2007. 

—July 2007 to the present: cholera in 

Mae La refugee camp in Thailand, 

with over 200 cases reported as of 

October 2007. 

—April to June 2007: 288 cases of 

cholera were reported in Dadaab 

refugee camp in Kenya. These cases 

included four deaths and necessitated 

a five-day holding period for U.S.- 

bound refugees before travel. 

—January to May 2007: A measles 

outbreak affected over 100 persons in 

Dadaab refugee camp in Kenya and 

showed unusual epidemiology: 43 

percent of cases were in persons 15 

years of age and older (measles 

usually affects only children, and thus 

most vaccination campaigns only 

cover those under 5 years of age). 

—November 2006 to May 2007: Rift 

Valley Fever in Kenya (including in 

the Dadaab camp), Somalia, and the 

United Republic of Tanzania, with 

over 300 deaths. 

—October 2006: A case of polio reported 

in the Dadaab refugee camp in Kenya, 

in the first reported local transmission 

of wild poliovirus for over 20 years in 

Kenya; only quick action by HHS/ 

CDC avoided the importation of wild 

poliovirus (WPV) into the United 

States. (The last indigenous case of 

WPV in the United States was in 

1979, and the last imported case of 

WPV was in 1993.) 

Vector-borne diseases involve a 

pathogen transmitted from an infected 

individual or animal, usually by an 

insect or other arthropod such as a 

mosquito or tick. There are several 

vector-borne diseases that are 

circulating in areas with U.S.-bound 

immigrants and refugees, all of which 

could spread into the U.S. population. 

These include exotic illnesses like 

chikungunya, dengue, and possibly Rift 

Valley fever. 

Pandemic Influenza 

The changes in the medical screening 

rules will also provide HHS/CDC 

officials with the authority to screen 

applicants that are coming into the 

United States from areas affected by a 

possible pandemic influenza. The World 

Health Report 2007—A safer future: 

global public health security in the 21st 

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Federal Register / Vol. 73, No. 194 / Monday, October 6, 2008 / Rules and Regulations 58055 

1Pandemic influenza preparedness and 

mitigation in refugee and displaced populations, 

WHO guidelines for humanitarian agencies, May 

2006. 

2The World Health Report 2007—A safer future: 

global public health security in the 21st century, 

WHO, August 2007. 

century, issued by the WHO, 

emphasizes the danger of an influenza 

pandemic. A pandemic strain of 

influenza would be far more contagious 

than SARS, since it spreads by coughing 

and sneezing, and is transmitted with a 

short incubation period that reduces the 

time for tracing the spread of disease 

and isolating patients. An influenza 

pandemic could extend the enormous 

health consequences seen with SARS in 

Asia and Canada to every corner of the 

world within a matter of months. 

Although HHS/CDC cannot predict 

the timing and exact strain, science and 

history suggest the world will suffer at 

least one influenza pandemic this 

century, which has the potential to have 

a rapid and immense impact on all 

segments of the U.S. population and our 

economy. In the 20th century, the 

greatest influenza pandemic occurred in 

1918–1919, which caused an estimated 

40–50 million deaths worldwide. A 

severe pandemic, as happened in 1918, 

could now have a much greater impact. 

When pandemic strains emerge, they 

sweep through nations with frightening 

velocity. The three pandemics of the 

20th century each encircled the world 

within months of their emergence into 

humans. Based on the current speed and 

volume of international movement of 

people and animals, there is no reason 

to think the next pandemic would 

spread any slower. 

Although health care has improved in 

the past decades, the WHO is predicting 

that today an influenza pandemic could 

result in 2–7.4 million deaths globally. 1

The WHO estimates that if a pandemic 

virus emerged now, the spread of the 

disease would be rapid. Based on 

experiences with past pandemics, some 

experts have predicted an illness that 

could affect around 25 percent of the 

world’s population—more than 1.5 

billion people. Should these forecasts 

prove accurate, the impact an influenza 

pandemic would have on national and 

international public health, and on 

economic and political security, would 

be enormous. Even if the virus caused 

relatively mild symptoms, the economic 

and social disruption that would arise 

from sudden surges of illness in so 

many people—occurring almost 

simultaneously throughout the world— 

would be incalculable.2

Interpandemic (seasonal) influenza 

results in more than 200,000 

hospitalizations every year and causes 

an average of 36,000 deaths annually in 

the United States. Modeling studies 

suggest that, in the absence of effective 

control measures, a medium-level 

pandemic (in which 15 to 35 percent of 

the population of the United States 

develops influenza) could result in 

89,000 to 207,000 deaths, between 

314,000 and 734,000 hospitalizations, 

18 to 42 million outpatient visits, and 

20 to 47 million sick people. The 

associated economic impact in the 

United States alone could range 

between $71.3 and $166.5 billion. 

The H5N1 virus that is currently 

circulating in Asia, Africa and Europe 

provides an example of the immense 

potential impact of an emerging 

influenza virus. As of March 19, 2008, 

the H5N1 strain of influenza virus has 

killed over 63 percent of the 373 

humans affected, and authorities fear 

the disease could mutate into a form 

that could pass quickly and efficiently 

from human to human, which could 

spark a global pandemic. The 14 

countries that have reported laboratoryconfirmed human cases of H5N1 

infection as of March 19, 2008, are 

Azerbaijan, The People’s Republic of 

China, Djibouti, Thailand, Egypt, 

Vietnam, Cambodia, Indonesia, Laos, 

Nigeria, Pakistan, Burma, Turkey, and 

Iraq. Before the next pandemic virus 

becomes well-adapted to humans, there 

is an urgent need for the United States 

to be prepared to detect human cases, 

and to prevent a novel influenza virus 

from being imported to the United 

States. One of the most effective ways to 

protect the American population is the 

preventive medical screening of aliens 

which would thereby help avert the 

entry and importation of a pandemic 

strain, or at least delay its arrival. 

HHS/CDC is implementing these new 

provisions immediately because the 

United States needs to respond 

effectively to any potential emerging 

communicable disease. HHS/CDC is 

taking this immediate action because 

the existing definition of communicable 

diseases of public health significance 

and the scope of medical screening do 

not adequately reflect current threats or 

protect against the significant harm to 

the American public currently ongoing 

and future outbreaks represent. 

Changing our approach to identifying, 

screening and testing for communicable 

diseases of public health significance 

will greatly improve our ability to 

detect, treat, and mitigate the potential 

introduction into—and spread 

throughout our country—of newly 

emerging and re-emerging diseases. 

Under the provisions of the 

Administrative Procedure Act at 5 

U.S.C. 553(b)(3)(B) and (d)(3), HHS/CDC 

finds that good cause exists to waive 

prior notice and comment and a 30 day 

delay in effective date on this rule is 

impracticable and contrary to the public 

interest. It is critical, for the reasons 

stated above, that HHS/CDC act quickly 

to ensure appropriate response, now 

and in the immediate future, to urgent 

disease threats that could have 

significant consequences in the United 

States. As noted, CDC is eager to 

consider public comment and will 

revise the rule as appropriate after 

receiving and analyzing any comments 

submitted. 

VIII. Analysis of Impacts 

A. Review Under Executive Order 

12866, the Regulatory Flexibility Act, 

and the Unfunded Mandates Act of 

1995 

HHS/CDC has examined the impact of 

the Interim Final Rule under Executive 

Order 12866, the Regulatory Flexibility 

Act, and the Unfunded Mandates 

Reform Act (UMRA) of 1995. 

Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits. 

HHS/CDC commissioned an analysis 

of the rule, which is included in the 

docket. The analysis examined the 

increased costs to immigrants, refugees 

and other entities, and the benefits of 

additional screening in preventing the 

spread of disease in the U.S. population. 

Based on recent history of disease 

outbreaks worldwide, the analysis 

estimates an additional cost of $4 

million per year to immigrants and 

refugees. Immigrants will bear the 

additional medical testing costs for 

themselves, and the U.S. government 

will bear the additional medical testing 

costs for refugees. The benefit to the 

U.S. population associated with reduced 

incidence of secondary infections is 

estimated to be $30 million. 

These estimates only reflect the costs 

and benefits based on recent history. 

The study examined the benefits and 

costs associated with a new or reemerging disease separately, but did not 

include them in the annualized values 

because of the inherent inability to 

estimate the frequency of an 

unknowable event. 

Based on the analysis, HHS/CDC has 

determined that the rule is not 

economically significant, as defined 

under Executive Order 12866. 

HHS/CDC considered the proposed 

regulation’s effects on small entities, as 

required by the Regulatory Flexibility 

Act, and certifies that the final rule will 

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58056 Federal Register / Vol. 73, No. 194 / Monday, October 6, 2008 / Rules and Regulations 

not have a significant economic impact 

on small entities. 

HHS/CDC evaluated the rule 

requirements for compliance with the 

UMRA of 1995. This rule does not 

contain Federal mandates under the 

regulatory provisions of Title II of the 

UMRA for State, local or tribal 

governments, nor for the private sector. 

Finally, the rule’s provisions will not 

affect small governments. 

B. Environmental Impact 

HHS has determined that provisions 

that amend 42 CFR part 34 will not have 

a significant impact on the human 

environment. 

C. Federalism 

In accordance with Executive Order 

13132, HHS/CDC determines that this 

rule does not have sufficient federalism 

implications to warrant the preparation 

of a federalism summary impact 

statement. 

D. Civil Justice Reform 

HHS/CDC has reviewed this rule 

under Executive Order 12988, on Civil 

Justice Reform. This rule (1) preempts 

all State and local laws and regulations 

that are inconsistent with this rule; (2) 

has no retroactive effect; and (3) does 

not require administrative proceedings 

before parties may file suit in court to 

challenge this rule. 

IX. Paperwork Reduction Act of 1995 

The Paperwork Reduction Act applies 

to the data collection requirements 

found in 42 CFR part 34. The U.S. 

Department of State (DoS) is responsible 

for providing forms to panel physicians 

to document the medical examination 

and screening information for aliens. 

The Office of Management and Budget 

(OMB) last approved this data collection 

under OMB Control No. 1405–0113, on 

September 30, 2007. DoS will update its 

information collection request to reflect 

the changes made to the forms by this 

Interim Final Rule. 

X. References 

The following references are available 

at the following Internet address: 

http://www.who.int. 

1. Pandemic influenza preparedness and 

mitigation in refugee and displaced 

populations, WHO guidelines for 

humanitarian agencies, May 2006. 

2. The World Health Report 2007—A safer 

future: global public health security in the 

21st century, WHO, August 2007. 

List of Subjects in 42 CFR Part 34 

Aliens, Health Care, Scope of 

Examination, Passports and Visas, 

Public Health. 

■ For the reasons stated in the preamble, 

the Centers for Disease Control and 

Prevention (CDC), within the U.S. 

Department of Health and Human 

Services (HHS), is amending 42 CFR 

part 34 as follows: 

PART 34—[AMENDED] 

■ 1. The authority citation for part 34 is 

amended to read as follows: 

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

and 1222. 

■ 2. Amend § 34.2 by revising paragraph 

(b) to read as follows: 

§ 34.2 Definitions. 

* * * * * 

(b) Communicable disease of public 

health significance. Any of the 

following diseases: 

(1) Chancroid. 

(2) Communicable diseases as listed 

in a Presidential Executive Order, as 

provided under Section 361(b) of the 

Public Health Service Act. The current 

revised list of quarantinable 

communicable diseases is available at 

http://www.cdc.gov and http:// 

www.archives.gov/federal-register. 

(3) Communicable diseases that may 

pose a public health emergency of 

international concern if it meets one or 

more of the factors listed in § 34.3(d) 

and for which the CDC Director has 

determined (A) a threat exists for 

importation into the United States, and 

(B) such disease may potentially affect 

the health of the American public. The 

determination will be made consistent 

with criteria established in Annex 2 of 

the revised International Health 

Regulations (http://www.who.int/csr/ 

ihr/en/), as adopted by the Fifty-Eighth 

World Health Assembly in 2005, and as 

entered into effect in the United States 

in July, 2007, subject to the U.S. 

Government’s reservation and 

understandings: 

(i) Any of the communicable diseases 

for which a single case requires 

notification to the World Health 

Organization (WHO) as an event that 

may constitute a public health 

emergency of international concern, or 

(ii) Any other communicable disease 

the occurrence of which requires 

notification to the WHO as an event that 

may constitute a public health 

emergency of international concern. 

HHS/CDC’s determinations will be 

announced by notice in the Federal 

Register. 

(4) Gonorrhea. 

(5) Granuloma inguinale. 

(6) Human immunodeficiency virus 

(HIV) infection. 

(7) Leprosy, infectious. 

(8) Lymphogranuloma venereum. 

(9) Syphilis, infectious stage. 

(10) Tuberculosis, active. 

* * * * * 

■ 3. Section 34.3 is revised to read as 

follows: 

§ 34.3 Scope of examinations. 

(a) General. In performing 

examinations, medical examiners shall 

consider those matters that relate to the 

following: 

(1) A communicable disease of public 

health significance; 

(2)(i) A physical or mental disorder 

and behavior associated with the 

disorder that may pose, or has posed, a 

threat to the property, safety, or welfare 

of the alien or others; 

(ii) A history of a physical or mental 

disorder and behavior associated with 

the disorder, which behavior has posed 

a threat to the property, safety, or 

welfare of the alien or others and which 

behavior is likely to recur or lead to 

other harmful behavior; 

(3) Drug abuse or addiction; and 

(4) Any other physical abnormality, 

disease, or disability serious in degree 

or permanent in nature amounting to a 

substantial departure from normal wellbeing. 

(b) Scope of all medical examinations. 

(1) All medical examinations will 

include the following: 

(i) A general physical examination 

and medical history, evaluation for 

tuberculosis, and serologic testing for 

syphilis and HIV. 

(ii) A physical examination and 

medical history for diseases specified in 

§§ 34.2(b)(1), and 34.2(b)(4) through 

34.2(b)(10). 

(2) The scope of the examination shall 

include any laboratory or additional 

studies that are deemed necessary, 

either as a result of the physical 

examination or pertinent information 

elicited from the alien’s medical history, 

for the examining physician to reach a 

conclusion about the presence or 

absence of a physical or mental 

abnormality, disease, or disability. 

(c) Additional medical screening and 

testing for examinations performed 

outside the United States. (1) HHS/CDC 

may require additional medical 

screening and testing for medical 

examinations performed outside the 

United States for diseases specified in 

§§ 34.2(b)(2) and 34.2(b)(3) by applying 

the risk-based medical and 

epidemiologic factors in paragraph 

(d)(2) of this section. 

(2) Such examinations shall be 

conducted in a defined population in a 

geographic region or area outside the 

United States as determined by HHS/ 

CDC. 

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Federal Register / Vol. 73, No. 194 / Monday, October 6, 2008 / Rules and Regulations 58057 

(3) Additional medical screening and 

testing shall include a medical 

interview, physical examination, 

laboratory testing, radiologic exam, or 

other diagnostic procedure, as 

determined by HHS/CDC. 

(4) Additional medical screening and 

testing will continue until HHS/CDC 

determines such screening and testing is 

no longer warranted based on factors 

such as the following: Results of disease 

outbreak investigations and response 

efforts; effectiveness of containment and 

control measures; and the status of an 

applicable determination of public 

health emergency of international 

concern declared by the Director 

General of the WHO. 

(5) HHS/CDC will directly provide 

medical examiners information 

pertaining to all applicable additional 

requirements for medical screening and 

testing, and will post these at the 

following Internet addresses: http:// 

www.cdc.gov/ncidod/dq/technica.htm 

and http://www.globalhealth.gov. 

(d) Risk-based approach. (1) HHS/ 

CDC will use the medical and 

epidemiological factors listed in 

paragraph (d)(2) of this section to 

determine the following: 

(i) Whether a disease as specified in 

§ 34.2(b)(3)(ii) is a communicable 

disease of public health significance. 

(ii) Which diseases in §§ 34.2(b)(2) 

and (b)(3) merit additional screening 

and testing, and the geographic area in 

which HHS/CDC will require this 

screening. 

(2) Medical and epidemiological 

factors include the following: 

(i) The seriousness of the disease’s 

public health impact; 

(ii) Whether the emergence of the 

disease was unusual or unexpected; 

(iii) The risk of the spread of the 

disease in the United States; 

(iv) The transmissibility and virulence 

of the disease; 

(v) The impact of the disease at the 

geographic location of medical 

screening; and 

(vi) Other specific pathogenic factors 

that would bear on a disease’s ability to 

threaten the health security of the 

United States. 

(e) Persons subject to requirement for 

chest X-ray examination and serologic 

testing. (1) As provided in paragraph 

(e)(2) of this section, a chest X-ray 

examination, and serologic testing for 

syphilis and serologic testing for HIV 

shall be required as part of the 

examination of the following: 

(i) Applicants for immigrant visas; 

(ii) Students, exchange visitors, and 

other applicants for non-immigrant 

visas required by a U.S. consular 

authority to have a medical 

examination; 

(iii) Applicants outside the United 

States who apply for refugee status; 

(iv) Applicants in the United States 

who apply for adjustment of their status 

under the immigration statute and 

regulations. 

(2) Chest X-ray examination and 

serologic testing. Except as provided in 

paragraph (e)(2)(iv) of this section, 

applicants described in paragraph (e)(1) 

of this section shall be required to have 

the following: 

(i) For applicants 15 years of age and 

older, a chest x-ray examination; 

(ii) For applicants under 15 years of 

age, a chest x-ray examination if the 

applicant has symptoms of tuberculosis, 

a history of tuberculosis, or evidence of 

possible exposure to a transmissible 

tuberculosis case in a household or 

other enclosed environment for a 

prolonged period; 

(iii) For applicants 15 years of age and 

older, serologic testing for syphilis and 

HIV. 

(iv) Exceptions. Serologic testing for 

syphilis and HIV shall not be required 

if the alien is under the age of 15, unless 

there is a reason to suspect infection 

with syphilis or HIV. HHS/CDC may 

authorize exceptions to the requirement 

for a tuberculin skin test, an equivalent 

test for showing an immune response to 

Mycobacterium tuberculosis antigens, or 

chest X-ray examination for good cause, 

upon application approved by the 

Director. 

(3) Immune Response to 

Mycobacterium tuberculosis antigens. (i) 

All aliens 2 years of age or older in the 

United States who apply for adjustment 

of status to permanent residents, under 

the immigration laws and regulations, or 

other aliens in the United States who 

are required by the U.S. Department of 

Homeland Security to have a medical 

examination in connection with a 

determination of their admissibility, 

shall be required to have a tuberculin 

skin test or an equivalent test for 

showing an immune response to 

Mycobacterium tuberculosis antigens. 

Exceptions to this requirement may be 

authorized for good cause upon 

application approved by the Director. In 

the event of a positive tuberculin 

reaction, a chest X-ray examination 

shall be required. If the chest radiograph 

is consistent with tuberculosis, the alien 

shall be referred to the local health 

authority for evaluation. Evidence of 

this evaluation shall be provided to the 

civil surgeon before a medical 

notification may be issued. 

(ii) Aliens less than 2 years old shall 

be required to have a tuberculin skin 

test, or an equivalent, appropriate test to 

show an immune response to 

Mycobacterium tuberculosis antigens, if 

there is evidence of contact with a 

person known to have tuberculosis or 

other reason to suspect tuberculosis. In 

the event of a positive tuberculin 

reaction, a chest X-ray examination 

shall be required. If the chest radiograph 

is consistent with tuberculosis, the alien 

shall be referred to the local health 

authority for evaluation. Evidence of 

this evaluation shall be provided to the 

civil surgeon before a medical 

notification may be issued. 

(iii) Aliens outside the United States 

required to have a medical examination 

shall be required to have a tuberculin 

skin test, or an equivalent, appropriate 

test to show an immune response to 

Mycobacterium tuberculosis antigens, 

and, if indicated, a chest radiograph. 

(iv) Aliens outside the United States 

required to have a medical examination 

shall be required to have a tuberculin 

skin test, or an equivalent, appropriate 

test to show an immune response to 

Mycobacterium tuberculosis antigens, 

and a chest radiograph, regardless of 

age, if they have symptoms of 

tuberculosis, a history of tuberculosis, 

or evidence of possible exposure to a 

transmissible tuberculosis case in a 

household or other enclosed 

environment for a prolonged period. 

(4) Additional testing requirements. 

All applicants subject to the chest 

radiograph requirement, and for whom 

the radiograph shows an abnormality 

suggestive of tuberculosis disease, shall 

be required to undergo additional 

testing for tuberculosis. 

(5) How and where performed. All 

chest radiograph images used in 

medical examinations performed under 

the regulations in this Part shall be large 

enough to encompass the entire chest 

(approximately 14 by 17 inches; 

35.6x43.2 cm.). Serologic testing for HIV 

shall be a sensitive and specific test, 

confirmed when positive by a test such 

as the Western blot test or an equally 

reliable test. For aliens examined 

abroad, the serologic testing for HIV 

must be completed abroad, except that 

the Secretary of Homeland Security after 

consultation with the Secretary of State 

and the Secretary of Health and Human 

Services may in emergency 

circumstances permit serologic testing 

of refugees for HIV to be completed in 

the United States. 

(6) Chest X-ray, laboratory, and 

treatment reports. The chest radiograph 

reading and serologic test results for 

syphilis and HIV shall be included in 

the medical notification. When the 

medical examiner’s conclusions are 

based on a study of more than one chest 

X-ray image, the medical notification 

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58058 Federal Register / Vol. 73, No. 194 / Monday, October 6, 2008 / Rules and Regulations 

shall include at least a summary 

statement of findings of the earlier 

images, followed by a complete reading 

of the last image, and dates and details 

of any laboratory tests and treatment for 

tuberculosis. 

(f) Procedure for transmitting records. 

For aliens issued immigrant visas, the 

medical notification and chest X-ray 

images, if any, shall be placed in a 

separate envelope which shall be sealed. 

When more than one chest X-ray image 

is used as a basis for the examiner’s 

conclusions, all images shall be 

included. 

(g) Failure to present records. When a 

determination of admissibility is to be 

made at the U.S. port of entry, a medical 

hold document shall be issued pending 

completion of any necessary 

examination procedures. A medical 

hold document may be issued for aliens 

who: 

(1) Are not in possession of a valid 

medical notification, if required; 

(2) Have a medical notification which 

is incomplete; 

(3) Have a medical notification which 

is not written in English; 

(4) Are suspected to have an 

excludable medical condition. 

(h) The Secretary of Homeland 

Security, after consultation with the 

Secretary of State and the Secretary of 

Health and Human Services, may in 

emergency circumstances permit the 

medical examination of refugees to be 

completed in the United States. 

(i) All medical examinations shall be 

carried out in accordance with such 

technical instructions for physicians 

conducting the medical examination of 

aliens as may be issued by the Director. 

Copies of such technical instructions are 

available upon request to the Director, 

Division of Global Migration and 

Quarantine, Mailstop E03, HHS/CDC, 

Atlanta GA 30333. 

Dated: June 25, 2008. 

Michael O. Leavitt, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. E8–23485 Filed 10–3–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 622 

[Docket No. 040205043–4043–01] 

RIN 0648–XK40 

Fisheries of the Caribbean, Gulf of 

Mexico, and South Atlantic; Reef Fish 

Fishery of the Gulf of Mexico; 

Reopening of the 2008 Deepwater 

Grouper and Tilefish Commercial 

Fisheries 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; reopening. 

SUMMARY: NMFS reopens the 

commercial fishery for deepwater 

grouper (misty grouper, snowy grouper, 

yellowedge grouper, warsaw grouper, 

and speckled hind) and tilefishes in the 

exclusive economic zone (EEZ) of the 

Gulf of Mexico. NMFS previously 

determined that the quotas for these 

commercial fisheries would be reached 

by May 10, 2008. The latest estimates 

for deepwater grouper and tilefish 

landings indicate the quotas were not 

reached by that date. Consequently, 

NMFS will reopen these fisheries for 10 

days. The purpose of this action is to 

allow the fisheries to maximize harvest 

benefits and at the same time protect the 

deepwater grouper and tilefish 

resources. 

DATES: The reopening is effective 12:01 

a.m., local time, November 1, 2008, 

until 12:01 a.m., local time, on 

November 11, 2008. The fisheries will 

then be closed until 12:01 a.m., local 

time, January 1, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Susan Gerhart, telephone 727–824– 

5305, fax 727–824–5308, e-mail 

Susan.Gerhart@noaa.gov. 

SUPPLEMENTARY INFORMATION: The reef 

fish fishery of the Gulf of Mexico is 

managed under the Fishery 

Management Plan for the Reef Fish 

Resources of the Gulf of Mexico (FMP). 

The FMP was prepared by the Gulf of 

Mexico Fishery Management Council 

and is implemented under the authority 

of the Magnuson-Stevens Fishery 

Conservation and Management Act 

(Magnuson-Stevens Act) by regulations 

at 50 CFR part 622. Those regulations 

set the commercial quota for deepwater 

grouper in the Gulf of Mexico at 1.02 

million lb (463,636 kg) and for tilefish 

in the Gulf of Mexico at 440,000 lb 

(200,000 kg) for the current fishing year, 

January 1 through December 31, 2008. 

Under 50 CFR 622.43(a), NMFS is 

required to close the commercial fishery 

for a species or species group when the 

quota for that species or species group 

is reached, or is projected to be reached, 

by filing a notification to that effect with 

the Office of the Federal Register. 

NMFS projected the fisheries for 

deepwater grouper and tilefishes would 

reach their respective quotas on May 10, 

2008, and closed the fisheries on that 

date (73 FR 24883, May 6, 2008). Based 

on current statistics, NMFS has 

determined that only 89 percent of the 

available commercial quotas for 

deepwater grouper and tilefishes were 

landed. Based on 2008 daily landings 

rates and the pounds remaining on each 

quota (approximately 100,000 lb (45,359 

kg) for deepwater grouper and 46,000 lb 

(20,865 kg) for tilefishes), NMFS has 

determined these fisheries can reopen 

for 10 days. Accordingly, NMFS is 

reopening the commercial deepwater 

grouper and tilefish fisheries in the Gulf 

of Mexico EEZ from 12:01 a.m., local 

time, on November 1, 2008, until 12:01 

a.m., local time, on November 11, 2008. 

The fisheries will then be closed until 

12:01 a.m., local time, on January 1, 

2009. November 1 was chosen as the 

opening day based on feedback from the 

fishing industry and weather concerns. 

Many fishers indicated that this was the 

most productive time for the reopening. 

NMFS also chose to wait until after the 

peak of hurricane season to promote 

safety at sea, consistent with National 

Standard 10 of the Magnuson-Stevens 

Act. 

The operator of a vessel with a valid 

commercial vessel permit for Gulf reef 

fish may not fish for or possess 

deepwater grouper or tilefishes prior to 

12:01 a.m., local time, November 1, 

2008, and must have landed and 

bartered, traded, or sold such deepwater 

grouper or tilefishes prior to 12:01 a.m., 

local time, November 11, 2008. 

During the closure, the bag and 

possession limits specified in 50 CFR 

622.39(b) apply to all harvest or 

possession of deepwater grouper and 

tilefishes in or from the Gulf of Mexico 

EEZ, and the sale or purchase of 

deepwater grouper and tilefishes taken 

from the EEZ is prohibited. The 

prohibition on sale or purchase does not 

apply to sale or purchase of deepwater 

grouper or tilefishes that were 

harvested, landed ashore, and sold prior 

to 12:01 a.m., local time, November 11, 

2008, and were held in cold storage by 

a dealer or processor. Vessels with 

commercial quantities of Gulf reef fish 

on board are prohibited from retaining 

a recreational bag limit of Gulf reef fish. 

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