[Federal Register Volume 72, Number 157 (Wednesday, August 15, 2007)]
[Notices]
[Pages 45819-45820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15939]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0073]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

[[Page 45820]]


DATES: Fax written comments on the collection of information by 
September 14, 2007.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to [email protected]. All comments 
should be identified with the OMB control number 0910-0519. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Control of Communicable Diseases; Restrictions on African Rodents, 
Prairie Dogs, and Certain Other Animals (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, transport, 
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:
     Prairie dogs (Cynomys sp.),
     African Tree squirrels (Heliosciurus sp.),
     Rope squirrels (Funisciurus sp.)
     African Dormice (Graphiurus sp.),
     Gambian giant pouched rats (Cricetomys sp.),
     Brush-tailed porcupines (Atherurus sp.),
     Striped mice (Hybomys sp.), or
    Any other animal so prohibited by order of the Commissioner of Food 
and Drugs (the Commissioner) 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.
    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.
    Our estimates are based on our current experience with the interim 
final rule. To estimate the number of respondents, we examined the 
number of requests we have received in fiscal year 2006. There were 122 
requests, submitted by 65 individuals, in that time, and this figure 
represents a minor increase over the previous estimate of 120 annual 
responses (See 69 FR 7752, February 19, 2004). As we cannot determine 
whether the latest data indicates a trend towards more requests or is 
an anomaly, we have elected to increase our estimate to 122 requests. 
We also have revised the estimated number of respondents to 65 
(compared to 120 in our previous estimate) and, as a result, adjusted 
the annual frequency per response to 1.88 (which represents 122 
responses/65 respondents; the actual result is 1.8769, which we have 
rounded up to 1.88).
    Furthermore, consistent with our earlier Paperwork Reduction Act 
submission, we will estimate that each respondent will need 4 hours to 
complete its request for an exemption. Therefore, the total reporting 
burden under 21 CFR 1240.63(a)(2)(ii)(A) and (B) will be 488 hours (122 
responses x 4 hours per response = 488 hours).
    In the Federal Register of March 13, 2007 (72 FR 11368), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
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1240.63(a)(2)(ii)                 65               1.88                122                  4               488
 (A) and (B)
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: August 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-15939 Filed 8-14-07; 8:45 am]
BILLING CODE 4160-01-S