[Federal Register Volume 65, Number 148 (Tuesday, August 1, 2000)]
[Notices]
[Pages 46935-46936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19324]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30DAY-54-00]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-7090. Send written 
comments to CDC, Desk Officer; Human Resources and Housing Branch, New 
Executive Office Building, Room 10235; Washington, DC 20503. Written 
comments should be received within 30 days of this notice.

Proposed Projects

    Interstate Control of Communicable Diseases--New--The Food and Drug 
Administration (FDA) and Centers for Disease Control and Prevention 
(CDC) are planning to consolidate regulations related to controlling 
the spread of communicable diseases, thereby increasing their 
efficiency and effectiveness. Currently, the regulations contained in 
Part 1240 of Title 21, Code of Federal Regulations, which pertain to 
interstate control of communicable diseases, are administered by FDA. 
Regulations to prevent the introduction, transmission, or spread of 
communicable diseases from foreign countries into the United States are 
separately promulgated in Part 71 of Title 42, Code of Federal 
Regulations and are administered by the CDC. FDA is transferring to CDC 
certain sections of 21 CFR Part 1240 that relate to restrictions on 
interstate travel of any person who is in the communicable period of 
cholera, plague, smallpox, typhus, or yellow fever, or who, having been 
exposed to any such disease, is in the incubation period thereof.
    Of the regulations being transferred, 21 CFR 1240.50 (Certain 
communicable diseases; special requirements), contains a requirement 
for reporting certain information to the Federal government. 
Specifically, this regulation requires any person who is in the 
communicable period of cholera, plague, smallpox, typhus or yellow 
fever, or who, having been exposed to any such disease, is in the 
incubation period thereof, to apply for and receive a permit from the 
Surgeon General or his authorized representative in order to travel 
from one State or possession to another.
    Control of disease transmission within the States is considered to 
be the province of State and Local health authorities, with Federal 
assistance being sought by those authorities on a cooperative basis, 
without application of Federal regulations. The regulations formerly 
administered by FDA and being assumed by CDC were developed to 
facilitate Federal action in the event of large outbreaks of disease 
requiring a coordinated effort involving several States, or in the 
event of inadequate local control. While it is not known whether, or to 
what extent, situations may arise in which these regulations would be 
invoked, contingency planning for domestic emergency preparedness is 
not uncommon. Should this occur, the reporting and record keeping 
requirements contained in the regulations will be used by CDC to carry 
out quarantine responsibilities as required by law.
    Because of the uncertainty about whether a situation will ever 
arise precipitating CDC's enforcement of this rule, the following data 
collection burden estimate was prepared using the article Smallpox: An 
Attack Scenario, Tara O'Toole; Emerging Infectious Diseases, Vol. 5, 
No. 4, Jul-Aug 1999. This article describes the aftermath of a 
hypothetical domestic public health emergency situation involving 
smallpox virus. Of the potentially 15,000 persons infected with 
smallpox, the data collection assumes that one-fourth of these would 
apply for a permit to move from one state to another while in the 
communicable period of or having been exposed to smallpox, under the 
requirements set forth in 42 CFR 70.5. During such an event, it is 
assumed that an additional 2,000 persons not infected with smallpox 
may, as a precautionary measure, be required to obtain a State permit 
in order to move from one State to another, and that 8 States would be 
involved, under the requirements set forth in 42 CFR 70.3.
    Further, it is assumed that during such an event, the master of a 
vessel or person in charge of a conveyance may be required to notify a 
local health authority of as many as 1,500 suspected cases of 
communicable disease developed and/or observed during transit, 
involving as many as 20 State or local jurisdictions, under the 
requirements set forth in 42 CFR 70.4.
    In such a scenario, it would be likely that CDC would obtain for 
followup and analysis any information it requires to be delivered to a 
State or local health authority. Accordingly, an additional burden may 
be imposed upon said authority to copy and transmit that information. 
We assume that the burden would apply to 100% of the information 
submitted under both 42 CFR 70.3 and 42 CFR 70.4
    The annualized burden is estimated to be 3,600 hours.

[[Page 46936]]



----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      Burden per
              Regulation                       Respondent           applicants     responses per   Response (in
                                                                                     applicant       minutes)
----------------------------------------------------------------------------------------------------------------
42 CFR 70.3...........................  Traveler................           2,000               1           15/60
                                        Attending physician.....           2,000               1           15/60
42 CFR 70.3...........................  State Health Authority..               8             250            6/60
42 CFR 70.4...........................  The Master of a vessel             1,500               1           15/60
                                         or person in charge of
                                         a conveyance engaged in
                                         interstate traffic.
42 CFR 70.4...........................  State or local Health                 20              75            6/60
                                         authority.
41 CFR 70.5...........................  Traveler................           3,750               1           15/60
                                        Attending physician.....           3,750               1           15/60
----------------------------------------------------------------------------------------------------------------


    Dated: July 26, 2000.
Nancy Cheal,
Acting Associate Director for Policy, Planning, and Evaluation, Centers 
for Disease Control and Prevention (CDC).
[FR Doc. 00-19324 Filed 7-31-00; 8:45 am]
BILLING CODE 4163-18-P