Document ID: FDA-2010-N-0307-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Antiparasitic Resistance and Combination New Animal Drugs Survey
Posted Date: 2011-05-23T04:00Z

[Federal Register Volume 76, Number 99 (Monday, May 23, 2011)]
[Notices]
[Pages 29762-29763]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12555]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0307]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Antiparasitic 
Resistance and Combination New Animal Drugs Survey

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 (the PRA).

DATES: Fax written comments on the collection of information by June 
22, 2011.

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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Antiparasitic Resistance and Combination New Animal Drugs 
Survey.'' Also include the FDA docket number found in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
juanmanuel.vilela@fda.hhs.gov.

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.

Antiparasitic Resistance and Combination New Animal Drugs 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 multidrug resistant parasites, 
and (4) regulatory considerations regarding combination antiparasitic 
drugs.
    In the Federal Register of July 13, 2010 (75 FR 39948), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received five comments (all from the 
same source).
    (Comment 1) The first comment stated that any conclusions drawn 
from a survey that includes a diversity of opinion and conjecture would 
not be appropriate or adequate to develop the Agency's position with 
respect to the regulation of antiparasitic drugs. The Agency should 
instead consult with appropriate experts in the field to develop an 
appropriate science-based strategy.
    (Center for Veterinary Medicine's (CVM's) Response) The proposed 
information collection is only one part of a strategy to compile 
scientific data on the subject of antiparasitic resistance and 
combinations. It is not the sole method by which the Agency will make 
any regulatory decisions. The other parts of the strategy include 
gathering information from scientific meetings, consultation with 
outside experts, and a comprehensive literature search and evaluation. 
The information collection allows the Agency to gauge the awareness of 
the issues and affords a broader audience with an opportunity to 
provide scientific information to the Agency about the current state of 
antiparasitic resistance, the use patterns of combinations of 
antiparasitic drugs, and measures being employed in the field to detect 
and curtail antiparasitic resistance.
    (Comment 2) The second comment requested that FDA publish the 
survey questions in the Federal Register for comment prior to 
finalizing them for the pretest and the actual survey.
    (CVM's Response) In accordance with the PRA and the requirements of 
OMB, FDA will publish the survey questions as part of a 30-day notice 
in the Federal Register, and the public will have the opportunity to 
comment.
    (Comment 3) The third comment requested that FDA comment on how FDA 
will decide who to survey.
    (CVM's Response) FDA will offer the Web-based survey to scientists 
and veterinarians with parasitology experience. Professional 
organizations that FDA will notify of the availability of the survey 
include the American Veterinary Medical Association, American Academy 
of Veterinary Pharmacology and Therapeutics, American College of 
Veterinary Internal Medicine, American Association of Veterinary 
Parasitologists, World Association for the Advancement of Veterinary 
Parasitology, American Association of Bovine Practitioners, American 
Association of Equine Practitioners, American Association of Small 
Ruminant Practitioners, and the Veterinary Information Network. 
Additional organizations may be invited as appropriate.
    (Comment 4) The fourth comment requested that FDA comment on who 
will review and compile the survey results.
    (CVM's Response) Veterinarians and other scientists from CVM will 
review and compile the survey results.
    (Comment 5) The fifth comment requested that FDA comment on how FDA 
plans to publish the results and how they will be made public.
    (CVM's Response) FDA plans to present a summary of the information 
collection at a scientific forum widely available to the veterinary 
parasitology community.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 29763]]

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                    Average burden
        Portion of study             Number of     responses per   Total annual    per  response    Total hours
                                    respondents     respondent       responses    (in hours) \2\
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Pretest.........................               5               1               5           20/60            1.65
Survey..........................             100               1             100           20/60           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.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
  minutes per response]/60''.

    FDA calculated the total annual responses by multiplying the number 
of respondents by the annual frequency. FDA calculated the total hours 
by multiplying the estimated hours per response (20 minutes = 0.33 
hours) by the number of respondents.

    Dated: May 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-12555 Filed 5-20-11; 8:45 am]
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