[Federal Register: February 19, 2004 (Volume 69, Number 33)]
[Notices]
[Page 7752-7753]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19fe04-59]
[[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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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