Document ID: FDA-2010-N-0307-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Antiparasitic Drug and Resistance Survey
Posted Date: 2012-12-03T05:00Z

[Federal Register Volume 77, Number 232 (Monday, December 3, 2012)]
[Notices]
[Pages 71603-71604]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29094]

-----------------------------------------------------------------------

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 and Resistance Survey

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 and Resistance 
Survey.''

DATES: Submit either electronic or written comments on the collection 
of information by February 1, 2013.

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: Jonna Capezzuto, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-410B, 
Rockville, MD 20850, 301-796-3784, JonnaLynn.capezzuto@fda.hhs.gov.

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 and Resistance Survey--21 CFR Part 514.4 (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. The results from this survey 
will provide FDA information that can be used to make decisions about 
future approaches to antiparasitic drugs. FDA will make the results of 
the survey publicly available.
    FDA plans to survey members of veterinary professional 
organizations using an Internet-based survey instrument. The questions 
in the survey are designed to elicit professional opinions regarding 
the use of antiparasitic drugs and the awareness of antiparasitic drug 
resistance. The survey will query subjects on topics including: (1) 
Awareness of the issues related to antiparasitic resistance, (2) 
methods currently being used to detect and/or monitor for antiparasitic 
resistance, (3) management practices being used or recommended to 
manage or reduce antiparasitic resistance, and (4) labeling and 
marketing considerations for antiparasitic drugs.
    FDA published a 60-day notice in the Federal Register on July 13, 
2010 (75 FR 39948), requesting public comment on the proposed survey, 
and published a 30-day notice on May 23, 2011 (76 FR

[[Page 71604]]

29762), and submitted the Information Collection Request (ICR) package 
to OMB. FDA subsequently entered into study design and development 
discussions with OMB officials. OMB decided that FDA should resubmit 
the study with a new 60-day notice and begin a new ICR package. This 
document responds to that request. Substantial revisions to the scope 
and content of the survey were also made based on information presented 
at the Antiparasitic Drug Use and Resistance in Ruminants and Equines 
Public Meeting (77 FR 7588, February 13, 2012; Docket No. FDA-2012-N-
0102).
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
        Portion of study            Number of     responses per   Total annual   Average burden    Total hours
                                   respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Pre-test.......................               5               1               5              .5              2.5
Survey.........................             650               1             650              .5            325
                                --------------------------------------------------------------------------------
    Total......................  ..............  ..............  ..............  ..............            327.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA will conduct a pre-test of the survey with five respondents, 
and it is estimated that it will take 30 minutes (0.5 hour) to complete 
the pretest, for a total of 2.5 hours. We estimate that 650 respondents 
will complete the survey. It is estimated that it will take a 
respondent 30 minutes (0.5 hour) for a total of 325 hours. Thus, the 
total estimated annual reporting burden is 327.5 hours. FDA's burden 
estimate is based on prior experience with consumer surveys that are 
similar.

    Dated: November 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29094 Filed 11-30-12; 8:45 am]
BILLING CODE 4160-01-P