[Federal Register Volume 75, Number 133 (Tuesday, July 13, 2010)]
[Notices]
[Pages 39948-39949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-16971]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0307]
Agency Information Collection Activities; Proposed Collection;
Comment Request; ``Antiparasitic Drug Survey''
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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on FDA's ``Antiparasitic Drug Survey.''
DATES: Submit either electronic or written comments on the collection
of information by September 13, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. 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: Denver Presley Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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 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.
``Antiparasitic Drug Survey'' (OMB Control Number 0910-NEW)
Resistance of parasites to one or more of the major classes of FDA
approved antiparasitic drugs is a documented problem in cattle, horses,
sheep, and goats in the United States. Further, FDA is aware that there
are differing scientific opinions on the impact of the use of multiple
antiparasitic drugs at the same time on the development of resistance
to these drugs. The results from this survey will assist FDA in
regulating antiparasitic drugs. FDA will also share their results with
the veterinary parasitology community.
FDA plans to survey scientists and veterinarians with expertise in
veterinary parasitology using a web-based tool. The questions in the
survey are designed to elicit expert opinions and clarify areas of
agreement and disagreement within the veterinary parasitology
community. The survey will query subjects on topics such as: (1)
Concurrent use of multiple antiparasitic drug products, (2) recommended
tests to detect and monitor for antiparasitic resistance, (3)
characteristics of combination antiparasitic drug products that may
either slow or enhance the selection for multi-drug resistant
parasites, and (4) regulatory considerations regarding combination
antiparasitic drugs.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Portion of No. of Annual Frequency Total Annual Hours per
Study respondents per response Responses Response Total Hours
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Pre-test 5 1 5 .33 1.65
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Survey 100 1 100 .33 .33
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Total 34.65
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 39949]]
FDA will conduct a pre-test of the survey with five respondents,
and it is estimated that it will take a respondent 20 minutes (0.33
hours) to complete the pre-test, for a total of 1.65 hours. One hundred
respondents will complete the survey. It is estimated that it will take
a respondent 20 minutes (0.33 hours) to complete the survey, for a
total of 33 hours. Thus, the total estimated annual reporting burden is
34.65 hours. FDA's burden estimate is based on prior experience with
consumer surveys that are similar.
Dated: July 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-16971 Filed 7-12-10; 8:45 am]
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