[Federal Register Volume 69, Number 131 (Friday, July 9, 2004)]
[Notices]
[Pages 41501-41502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15658]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0049]


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.

DATES: Fax written comments on the collection of information by August 
9, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management 
Programs (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 Sec.  1240.63(a)(2)(ii) (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 may not 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 of the 
Commissioner.
    The request must state, among other things, 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:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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  21 CFR                          Annual Frequency       Total No.  of
  Section   No. of Respondents      per Response           Responses      Hours per Response      Total Hours
----------------------------------------------------------------------------------------------------------------
1240.63(a)        120                    1                  120                   4                 480
 (2)(ii)
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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 41502]]

under Sec.  1240.63(a)(2)(ii) will be 480 hours (120 respondents x 4 
hours per response = 480 hours).
    In the Federal Register of February 19, 2004 (69 FR 7752), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. We received nearly 700 comments on the interim 
final rule and the notice that invited public comment on the proposed 
collection of information. Over 140 of these comments were submitted 
after February 19, 2004 (the date on which we published the notice 
concerning the collection of information), but the majority of these 
later comments apparently interpreted that notice as another 
opportunity to comment on the interim final rule's merits rather than 
comment on the collection of information itself. This notice simply 
announces that we are seeking renewal of OMB's paperwork approval for 
the interim final rule and addresses those comments regarding the 
collection of information. It is not an issuance of a final rule and we 
are not seeking additional comments on the interim final rule.
    Of the few comments that may pertain to the collection of 
information, none agreed with the collection of information or the 
estimates themselves. Here we address the comments on the collection of 
information, not the comments on the substance of the rule itself.
    Some comments claimed that we take 2 1/2 to 4 months to process a 
permit request. Of these comments, some also claimed that the permit 
process was too burdensome because State agencies had to be involved. 
One comment claimed that the permit process requires a person to 
describe the benefits that would result if we granted the permit and 
indicated that it is sometimes difficult to show a benefit.
    We disagree with the comments for several reasons. First, we 
disagree with the claim that our permit process takes several months to 
complete. While permit requests vary in their complexity, and complex 
and incomplete requests may take more time to process, our records 
indicate that we respond to permit requests, on average, within 27 days 
(including weekends and holidays).
    Second, although a person seeking a permit must also comply with 
all State and local requirements related to the handling and transport 
of animals subject to the interim final rule, nothing in the interim 
final rule's permit provision requires a person to contact State 
agencies as part of FDA's permit process. We may consult State agencies 
about a particular permit request, but this consultation does not 
create an information collection burden on the person requesting the 
permit. Furthermore, the interim final rule does not require a person 
seeking a permit to describe the benefit that would result if we 
granted their request. The interim final rule does require a person to 
explain why an exemption will not result in the spread of monkeypox in 
the United States, and this explanation can be derived from the facts 
accompanying the permit request. For example, the description of the 
animals involved (species, absence of contact with infected animals, 
the animals' origin) may help explain why the animals involved do not 
present a risk of having the monkeypox virus. The description of the 
precautions taken may help explain why there is no risk of spreading 
the monkeypox virus. In other words, the interim final rule does not 
require a person to show that a ``benefit'' would result if we granted 
the permit, but it does seek information to help us assess the risk 
associated with the request.
    Other comments appeared to address the estimated number of 
respondents or our data. One comment stated that it believed the 
estimated number of respondents (i.e., persons who would request a 
permit) is too low, although it offered no different estimates itself. 
The comment further stated that there are people who are ignoring the 
rule or are unaware of the rule, but offered no estimates. Another 
comment declared ``there are major flaws with the data collection in 
this docket,'' but did not discuss the permit process or any specific 
estimate.
    As we explained in the February 19, 2004, notice, we based our 
estimates on our experience with the permit process, including the 
experience of those submitting permit requests. We have no reasonable 
basis for adjusting our estimates to reflect the possibility that 
persons are either intentionally or unintentionally failing to seek 
permits, and the comments offered none. Consequently, in the absence of 
any new data or conflicting estimates, we decline to revise our 
estimates.

    Dated: July 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-15658 Filed 7-8-04; 8:45 am]
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