Document ID: FDA-2010-N-0307-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Antiparasitic Drug Survey
Posted Date: 2010-07-13T04:00Z

[Federal Register: July 13, 2010 (Volume 75, Number 133)]
[Notices]               
[Page 39948-39949]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jy10-81]                         

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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
----------------------------------------------------------------------------------------------------------------
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]
BILLING CODE 4160-01-S