[Federal Register Volume 65, Number 159 (Wednesday, August 16, 2000)]
[Rules and Regulations]
[Pages 49906-49909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20719]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 70

Food and Drug Administration

21 CFR Part 1240

[Docket No. 00N-1317]


Control of Communicable Diseases; Apprehension and Detention of 
Persons With Specific Diseases; Transfer of Regulations

AGENCIES: Food and Drug Administration and Centers for Disease Control 
and Prevention, HHS.

ACTION: Final rule.

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SUMMARY:  The Secretary of Health and Human Service (the Secretary) is 
transferring a portion of the Food and Drug Administration (FDA) 
``Control of Communicable Diseases'' regulations to the Centers for 
Disease Control and Prevention (CDC). In general, these regulations 
provide the Secretary with the authority to apprehend, detain, or 
conditionally release individuals to prevent the spread of specified 
communicable diseases. The regulations implement the provisions of the 
Public Health Service Act (PHS Act) to prevent the introduction, 
transmission, or spread of communicable diseases from one State or 
possession into any other State or possession. CDC will have authority 
for interstate quarantine over persons, while FDA will retain 
regulatory authority over animals and other products that may transmit 
or spread communicable diseases. The Secretary is taking this action to 
consolidate regulations designed to control the spread of communicable 
diseases, thereby increasing the agencies' efficiency and 
effectiveness.

DATES: This rule is effective September 15, 2000.

ADDRESSES: Submit written comments on the information collection 
requirements to the Office of Information and Regulatory Affairs, 
Office of Management and Budget (OMB), New Executive Office Bldg., 725 
17th St. NW., rm. 10235, Washington, DC 20503, Attn: Desk Officer for 
CDC.

FOR FURTHER INFORMATION CONTACT:
    James E. Barrow, National Center for Infectious Diseases (E-03), 
Centers for Disease Control and Prevention, 1600 Clifton Rd. NE., 
Atlanta, GA 30333, 404-639-8107; or
    Captain Lawrence C. Edwards, Retail Food and Interstate Travel Team 
(HFS-627), Food and Drug Administration, 200 ``C'' St. SW.,

[[Page 49907]]

Washington DC 20204, 202-205-8280.

SUPPLEMENTARY INFORMATION:

I. Background

    Under sections 361 and 369 of the PHS Act, as amended, the 
Secretary issues and enforces regulations necessary to prevent the 
introduction, transmission, or spread of communicable diseases in the 
United States. FDA and CDC have been delegated regulatory 
responsibility under these provisions. The regulations contained in 
part 1240 (21 CFR part 1240), pertain to interstate control of 
communicable diseases and are currently administered by FDA. 
Regulations to prevent the introduction, transmission, or spread of 
communicable diseases from foreign countries into the United States are 
currently administered by CDC in 42 CFR part 71. The Secretary is 
taking this action to consolidate regulations designed to control the 
spread of communicable diseases, thereby increasing the agencies' 
efficiency and effectiveness.
    The Secretary is transferring regulatory authority contained in the 
following sections of 21 CFR part 1240 to CDC: Section 1240.3 
introductory text and paragraphs (b), (c), (e), (g), (h), (l), (n), and 
(p); Sec. 1240.30; and Subpart C--Restrictions on Travel of Persons 
(consisting of Secs. 1240.40, 1240.45, 1240.50, 1240.54, 1240.55, and 
1240.57). The transferred regulations will be sequentially renumbered 
in 42 CFR part 70. In addition, ``Director of the Centers for Disease 
Control and Prevention''has been inserted in new 42 CFR 70.2 in place 
of ``Commissioner of Food and Drugs,'' currently in 21 CFR 1240.30.
    Although regulatory authority with respect to interstate quarantine 
over persons in Secs. 1240.3, 1240.30, and 1240.45 is being transferred 
to CDC, FDA is retaining its regulatory authority in Secs. 1240.3, 
1240.30, and 1240.45 with respect to animals and other products that 
may transmit or spread communicable diseases, to ensure that FDA's 
Center for Food Safety and Applied Nutrition has the necessary 
authorities to prevent the spread of disease from any conveyance 
engaged in interstate travel or in the event of inadequate local 
control. Current Sec. 1240.45 is also being moved to 21 CFR part 1240, 
subpart B (Administrative Procedures), and subpart C is being removed 
and reserved. The Secretary is issuing this rule without publishing a 
general notice of proposed rulemaking because such a notice is not 
required for this rule of agency organization, procedure, or practice 
under 5 U.S.C. 553(b)(A).
    Table 1 reflects the actions the Secretary is taking:

                                 Table 1
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     Current 21 CFR Sections (FDA)          New 42 CFR Sections (CDC)
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1240.3 introductory text, and           70.1
 paragraphs (b), (c), (e), (g), (h),
 (l), (n), and (p) transferring and
 retaining.
1240.30 transferring and retaining....  70.2
1240.40 transferred to................  70.3
1240.45 transferring and retaining....  70.4
1240.50 transferred to................  70.5
1240.54 transferred to................  70.6
1240.55 transferred to................  70.7
1240.57 transferred to................  70.8
------------------------------------------------------------------------

    This transfer of authority does not affect other authority 
exercised by FDA under sections 361 and 369, or any other sections, of 
the PHS Act.

II. Environmental Impact

    FDA has determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required. In the 
absence of an applicable categorical exclusion, CDC conducted an 
environmental assessment of this transfer of authority in accordance 
with the Department of Health and Human Services administrative 
guidance and determined that the transfer presented no significant 
impact on the human environment.

III. Federalism

    Executive Order 13132 applies when agencies formulate or implement 
policies or regulations that preempt State law or that have federalism 
implications. Executive Order 13132 provides that agencies are to 
examine the constitutional and statutory authority supporting any 
action that would limit the policymaking discretion of the States and 
assess carefully the need for such actions. FDA and CDC have examined 
this rule and have determined that it does not preempt State law and it 
does not have a substantial direct effect on the States, on the 
relationship between the National Government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government. Rather, the Secretary is taking this action to consolidate 
regulations to control the spread of communicable diseases, thereby 
increasing the agencies' efficiency and effectiveness. Therefore, no 
further action is required by Executive Order 13132.

IV. Analysis of Impacts

    FDA and CDC have examined the impacts of this rule under Executive 
Order 12866. 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 (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). 
Executive Order 12866 classifies a rule as significant if it meets any 
one of a number of specified conditions, including having an annual 
effect on the economy of $100 million or more, or adversely affecting 
in a material way a sector of the economy, competition, or jobs, or if 
it raises novel legal or policy issues. The agencies find that this 
final rule, which transfers existing regulatory authority from one 
agency to the other, is not a significant rule as defined by Executive 
Order 12866. No analysis is required under the Regulatory Flexibility 
Act (5 U.S.C. 601-612) because the Secretary is issuing it without 
publishing a general notice of proposed rulemaking, as explained 
previously in this document.

V. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to

[[Page 49908]]

review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520). In the Federal Register of April 12, 2000 (65 FR 19772), 
CDC published a document entitled ``Proposed Data Collections Submitted 
for Public Comment and Recommendations'' to collect information under 
those regulations, and sought public comment for 60 days. The comment 
period closed on June 12, 2000. CDC will now prepare an information 
collection request for submission to OMB, and will publish another 
document in the Federal Register announcing submission of the request 
to OMB and soliciting that comments be submitted to OMB. CDC will 
publish an additional document in the Federal Register announcing OMB's 
decision to approve, modify, or disapprove the information collection 
provisions of this final rule. An agency may not conduct or sponsor, 
and a person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number.

List of Subjects

21 CFR Part 1240

    Communicable diseases, Public health, Travel restrictions, Water 
supply.

42 CFR Part 70

    Communicable diseases, Public health, Quarantine, Reporting and 
recordkeeping requirements, Travel restrictions.

    Therefore, under the Public Health Service Act, 21 CFR Chapter I 
and 42 CFR Chapter I are amended as follows:

21 CFR Chapter I

PART 1240--CONTROL OF COMMUNICABLE DISEASES

    1. The authority citation for 21 CFR part 1240 continues to read as 
follows:

    Authority: 42 U.S.C. 216, 243, 264, 271.


Sec. 1240.45  [Transferred from Subpart C to Subpart B]

    2. Section 1240.45 Report of disease is transferred from subpart C 
to subpart B.


Subpart C  [Removed and Reserved]

    3. Subpart C is removed and reserved.

42 CFR Chapter I

    4. Part 70 is added to subchapter F of Chapter I to read as 
follows:

PART 70--INTERSTATE QUARANTINE

Secs.
70.1  General definitions.
70.2  Measures in the event of inadequate local control.
70.3  All communicable diseases.
70.4  Report of disease.
70.5  Certain communicable diseases; special requirements.
70.6  Apprehension and detention of persons with specific diseases.
70.7  Responsibility with respect to minors, wards, and patients.
70.8  Members of military and naval forces.


    Authority: 42 U.S.C. 216, 243, 264, 271.


Sec. 70.1  General definitions.

    As used in this part, terms shall have the following meaning:
    (a) Communicable diseases means illnesses due to infectious agents 
or their toxic products, which may be transmitted from a reservoir to a 
susceptible host either directly as from an infected person or animal 
or indirectly through the agency of an intermediate plant or animal 
host, vector, or the inanimate environment.
    (b) Communicable period means the period or periods during which 
the etiologic agent may be transferred directly or indirectly from the 
body of the infected person or animal to the body of another.
    (c) Conveyance means any land or air carrier, or any vessel as 
defined in paragraph (h) of this section.
    (d) Incubation period means the period between the implanting of 
disease organisms in a susceptible person and the appearance of 
clinical manifestation of the disease.
    (e) Interstate traffic means: 
    (1) The movement of any conveyance or the transportation of persons 
or property, including any portion of such movement or transportation 
that is entirely within a State or possession--
    (i) From a point of origin in any State or possession to a point of 
destination in any other State or possession; or
    (ii) Between a point of origin and a point of destination in the 
same State or possession but through any other State, possession, or 
contiguous foreign country.
    (2) Interstate traffic does not include the following:
    (i) The movement of any conveyance which is solely for the purpose 
of unloading persons or property transported from a foreign country, or 
loading persons or property for transportation to a foreign country.
    (ii) The movement of any conveyance which is solely for the purpose 
of effecting its repair, reconstruction, rehabilitation, or storage.
    (f) Possession means any of the possessions of the United States, 
including Puerto Rico and the Virgin Islands.
    (g) State means any State, the District of Columbia, Puerto Rico, 
and the Virgin Islands.
    (h) Vessel means any passenger-carrying, cargo, or towing vessel 
exclusive of:
    (1) Fishing boats including those used for shell-fishing;
    (2) Tugs which operate only locally in specific harbors and 
adjacent waters;
    (3) Barges without means of self-propulsion;
    (4) Construction-equipment boats and dredges; and
    (5) Sand and gravel dredging and handling boats.


Sec. 70.2  Measures in the event of inadequate local control.

    Whenever the Director of the Centers for Disease Control and 
Prevention determines that the measures taken by health authorities of 
any State or possession (including political subdivisions thereof) are 
insufficient to prevent the spread of any of the communicable diseases 
from such State or possession to any other State or possession, he/she 
may take such measures to prevent such spread of the diseases as he/she 
deems reasonably necessary, including inspection, fumigation, 
disinfection, sanitation, pest extermination, and destruction of 
animals or articles believed to be sources of infection.


Sec. 70.3  All communicable diseases.

    A person who has a communicable disease in the communicable period 
shall not travel from one State or possession to another without a 
permit from the health officer of the State, possession, or locality of 
destination, if such permit is required under the law applicable to the 
place of destination. Stop-overs other than those necessary for 
transportation connections shall be considered as places of 
destination.


Sec. 70.4  Report of disease.

    The master of any vessel or person in charge of any conveyance 
engaged in interstate traffic, on which a case or suspected case of a 
communicable disease develops shall, as soon as practicable, notify the 
local health authority at the next port of call, station, or stop, and 
shall take such measures to prevent the spread of the disease as the 
local health authority directs.


Sec. 70.5  Certain communicable diseases; special requirements.

    The following provisions are applicable with respect to any person 
who is in the communicable period of cholera, plague, smallpox, typhus 
or yellow fever, or who, having been

[[Page 49909]]

exposed to any such disease, is in the incubation period thereof:
    (a) Requirements relating to travelers. (1) No such person shall 
travel from one State or possession to another, or on a conveyance 
engaged in interstate traffic, without a written permit of the Surgeon 
General or his/her authorized representative.
    (2) Application for a permit may be made directly to the Surgeon 
General or to his/her representative authorized to issue permits.
    (3) Upon receipt of an application, the Surgeon General or his/her 
authorized representative shall, taking into consideration the risk of 
introduction, transmission, or spread of the disease from one State or 
possession to another, reject it, or issue a permit that may be 
conditioned upon compliance with such precautionary measures as he/she 
shall prescribe.
    (4) A person to whom a permit has been issued shall retain it in 
his/her possession throughout the course of his/her authorized travel 
and comply with all conditions prescribed therein, including 
presentation of the permit to the operators of conveyances as required 
by its terms.
    (b) Requirements relating to operation of conveyances.(1) The 
operator of any conveyance engaged in interstate traffic shall not 
knowingly:
    (i) Accept for transportation any person who fails to present a 
permit as required by paragraph (a) of this section; or
    (ii) Transport any person in violation of conditions prescribed in 
his/her permit.
    (2) Whenever a person subject to the provisions of this section is 
transported on a conveyance engaged in interstate traffic, the operator 
thereof shall take such measures to prevent the spread of the disease, 
including submission of the conveyance to inspection, disinfection and 
the like, as an officer of the Public Health Service designated by the 
Surgeon General for such purposes deems reasonably necessary and 
directs.


Sec. 70.6  Apprehension and detention of persons with specific 
diseases.

    Regulations prescribed in this part are not applicable to the 
apprehension, detention, or conditional release of individuals except 
for the purpose of preventing the introduction, transmission, or spread 
of the following diseases: Anthrax, chancroid, cholera, dengue, 
diphtheria, granuloma inguinale, infectious encephalitis, favus, 
gonorrhea, leprosy, lymphogranuloma venereum, meningococcus meningitis, 
plague, poliomyelitis, psittacosis, relapsing fever, ringworm of the 
scalp, scarlet fever, streptococcic sore throat, smallpox, syphilis, 
trachoma, tuberculosis, typhoid fever, typhus, and yellow fever.


Sec. 70.7  Responsibility with respect to minors, wards, and patients.

    A parent, guardian, physician, nurse, or other such person shall 
not transport, or procure or furnish transportation for any minor child 
or ward, patient or other such person who is in the communicable period 
of a communicable disease, except in accordance with provisions of this 
part.


Sec. 70.8  Members of military and naval forces.

    The provisions of Secs. 70.3, 70.4, 70.5, 70.7, and this section 
shall not apply to members of the military or naval forces, and medical 
care or hospital beneficiaries of the Army, Navy, Veterans' 
Administration, or Public Health Service, when traveling under 
competent orders: Provided, That in the case of persons otherwise 
subject to the provisions of Sec. 70.5 the authority authorizing the 
travel requires precautions to prevent the possible transmission of 
infection to others during the travel period.

    Dated: August 8, 2000.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 00-20719 Filed 8-15-00; 8:45 am]
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