[Federal Register Volume 69, Number 33 (Thursday, February 19, 2004)]
[Notices]
[Pages 7752-7753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3485]



[[Page 7752]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0049]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Control of Communicable Diseases; Restrictions on 
African Rodents, Prairie Dogs, and Certain Other Animals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
requirements establishing restrictions on the import, capture, 
transport, sale, barter, exchange, distribution, and release of African 
rodents, prairie dogs, and certain other animals.

DATES: Submit written or electronic comments on the collection of 
information by April 19, 2004.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Management Programs (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Control of Communicable Diseases; African Rodents and Other Animals 
That May Carry the Monkeypox Virus--21 CFR 1240.63 (OMB Control Number 
0910-0519)--Extension

    Under 21 CFR 1240.63(a)(2)(ii), an individual must submit a written 
request to seek permission to capture, offer to capture, 
transportation, offer to transport, sell, barter, or exchange, offer to 
sell, barter, or exchange, distribute, offer to distribute, and/or 
release into the environment any of the following animals:
    [sbull] Prairie dogs (Cynomys sp.),
    [sbull] African Tree squirrels (Heliosciurus sp.),
    [sbull] Rope squirrels (Funisciurus sp.),
    [sbull] African Dormice (Graphiurus sp.),
    [sbull] Gambian giant pouched rats (Cricetomys sp.),
    [sbull] Brush-tailed porcupines (Atherurus sp.),
    [sbull] Striped mice (Hybomys sp.), or
    Any other animal so prohibited by order of the Commissioner of Food 
and Drugs because of that animal's potential to transmit the monkeypox 
virus.
    The request cannot seek written permission to sell, barter, or 
exchange, or offer to sell, barter, or exchange, as a pet, the animals 
listed previously or any animal covered by an order by the Commissioner 
of Food and Drugs.
    The request must state the reasons why an exemption is needed, 
describe the animals involved, and explain why an exemption will not 
result in the spread of monkeypox within the United States.
    FDA estimates the burden of this collection of information as 
follows:

                                      ESTIMATED ANNUAL REPORTING BURDEN\1\
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                         No. of        Annual Frequency     Total No. of        Hours per
   CFR Section        Respondents        per Response        Responses           Response         Total Hours
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21 CFR                           120                  1                120                  4                480
 1240.63(a)(2)(ii
 )
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Total                                                                                                        480
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimates are based on our experience to date with the interim 
final rule. To estimate the number of respondents, we examined the 
number of requests we have received since the June 11, 2003, order. FDA 
has received approximately 65 requests in a 7-month period, and most 
requests involved requests to move an animal from one location to 
another. As the agency cannot predict how the monkeypox outbreak will 
be resolved, FDA will tentatively estimate that 120 respondents would 
be affected. Furthermore, based on FDA's experience with requests 
submitted thus far, and the parties submitting those requests, the 
agency estimates that each respondent will need 4 hours to complete its 
request for an exemption. Therefore, the total reporting burden

[[Page 7753]]

under 21 CFR 1240.63(a)(2)(ii) will be 480 hours (120 respondents x 4 
hours per response = 480 hours).

    Dated: February 10, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-3485 Filed 2-18-04; 8:45 am]
BILLING CODE 4160-01-S