[Federal Register Volume 79, Number 128 (Thursday, July 3, 2014)]
[Notices]
[Pages 38037-38039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15648]


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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 Drug 
Use and Antiparasitic Resistance 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 August 
4, 2014.

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 emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Antiparasitic Drug Use and Antiparasitic Resistance Survey.'' 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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 Drug Use and Antiparasitic Resistance Survey--21 CFR 
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's Center for Veterinary Medicine (CVM) 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 drug resistance; (2) methods currently being used to 
detect and/or monitor for antiparasitic drug resistance; (3) management 
practices being used or recommended to manage or reduce antiparasitic 
drug resistance; and (4) labeling and marketing considerations for 
antiparasitic drugs.
    In the Federal Register of December 3, 2012 (77 FR 71603), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received several comments in response to 
the notice, which are discussed below.
    (Comment) The first comment stated that the collection is not 
necessary for the proper performance of FDA's functions.
    (CVM Response) We disagree. The mission of the Office of New Animal 
Drug Evaluation within CVM is to expeditiously approve safe and 
effective, properly labeled, quality manufactured new animal drugs 
through a science-based approach in a regulatory environment. This 
collection is necessary for the proper performance of FDA/CVM's mission 
because it will help us gather information that can be used to 
appropriately label antiparasitic drugs and, thereby, enhance the 
sustainability and continued availability of approved antiparasitic 
drugs.
    (Comment) Another comment stated that while assessing the current 
situation in the field is important, the information to be gained from 
the survey will have little practical utility because the data will be 
of opinions held by an extremely small sample size.
    (CVM Response) The target population for this survey is the subset 
of veterinarians and parasitologists who have a direct opportunity to 
observe and assess the antiparasitic resistance issues in the field. 
CVM understands that a part of the target population, namely

[[Page 38038]]

veterinarians with training and experience with large animals, are 
diminishing in numbers in some areas of the United States (https://www.avma.org/KB/Resources/Reference/Pages/Food-Supply-Veterinary-Medicine-Data-Maps.aspx). While a wider and more general sampling of 
veterinarians would provide a larger sample size, such sampling would 
then include those who have opinions on the topic of antiparasitic 
resistance but not direct experience with the animal populations of 
interest. CVM designed the survey with input from subject matter 
experts, statisticians, and epidemiologists to reach the largest and 
most representative sample of this target population. Sample size, as 
well as total survey error, was considered in the design.
    (Comment) One comment stated that there are numerous variables 
involved in the field; thus, measuring resistance by observational 
methods has questionable validity. Re-infection is a significant 
confounder which could mimic resistance. Resistance should be 
determined more scientifically, such as through a challenge model.
    (CVM Response) The survey is not designed to measure antiparasitic 
resistance but to collect information from clinical experts who 
diagnose and treat the relevant animal populations and to provide a 
basis to assist in the design of labeling for approved antiparasitic 
drug products and the design of educational outreach programs. Data 
from laboratory-based, experimental models is extremely important for 
characterizing antiparasitic resistance. For successful translational 
research, both ``bench'' research, such as challenge models, and 
research from clinical or field settings, such as collecting the 
observations of clinicians treating and monitoring real animal patients 
are needed (http://www.accessdata.fda.gov/scripts/animaldrugsatfda/details.cfm?dn=045-578).
    (Comment) One comment stated that many antiparasitic drugs are 
available as over-the-counter drugs. Inappropriate or inconsistent 
administration could produce a perceived resistance.
    (CVM Response) CVM has not designed the survey to estimate the 
prevalence of resistance and agrees with the comment that the survey 
should not be used to draw conclusions about potential causes of 
resistance. The collection of such data would require a multiyear, 
multisite study of parasite resistance and antiparasitic drug use in 
multiple species in diverse geographic regions throughout the country. 
Such a study would be prohibitively expensive and complicated and is 
outside the scope of this survey. However, the survey is appropriately 
designed to gauge the level of awareness and concern about 
antiparasitic drug resistance issues among veterinarians using drugs in 
different clinical practice and production settings, as well as among 
academic parasitologists and scientists involved in drug research and 
development. In addition, the survey is designed to investigate methods 
currently used by veterinarians to detect, monitor, and manage 
parasites and antiparasitic drug resistance.
    (Comment) Another comment suggested FDA's efforts regarding drug 
safety and efficacy are vital. The survey could potentially yield a 
small glimpse of conditions in the field; however, the information to 
be gathered seems to be an ill fit with postmarket surveillance as well 
as adverse event reporting.
    (CVM Response) We agree that the survey should not attempt to 
obtain the same data as that obtained through postmarket surveillance 
and adverse event reporting. The survey is not designed to yield data 
or reports of adverse drug reactions, lack of effectiveness, or product 
defects which is obtained as part of postmarket surveillance. 
Information regarding the current state of awareness and concern about 
antiparasitic drug resistance issues in the field is important because 
it will assist CVM in the enhancement of appropriate labeling for the 
safe and effective use of approved antiparasitic drug products. The 
survey is one tool in a comprehensive antiparasitic resistance 
management strategy within CVM aimed at facilitating collaboration with 
CVM stakeholders on the issues related to antiparasitic resistance.
    (Comment) Another comment stated that recommendations regarding the 
management or reduction of antiparasitic resistance are aspects of 
medical management and preventative herd health within the practice of 
veterinary medicine. Such recommendations are based upon veterinary 
expertise combined with several factors including animal owner 
capabilities, animal species and health, and the parasitic risks. The 
respondent questioned FDA's reasoning and intended regulatory use in 
gathering such information from responders, especially since such 
recommendations are available in scientific literature.
    (CVM Response) The proposed survey is not intended as a replacement 
for the review of scientific research in published literature or the 
recommendations of expert veterinary parasitologists. As announced for 
the ``Antiparasitic Drug Use and Resistance in Ruminants and Equines; 
Public Meeting; Request for Comments'' (77 FR 7588, February 13, 2012; 
Docket No. FDA-2012-N-0102), CVM is committed to accessing and 
highlighting current research associated with the development and 
management of antiparasitic resistance in the United States. The survey 
is not designed to lead to any new recommendations regarding the 
management or reduction of antiparasitic resistance or provide 
recommendations related to the practice of veterinary medicine, but 
rather obtain information regarding the awareness and use of a variety 
of available strategies for detecting, monitoring, and/or managing 
antiparasitic resistance. CVM will not use the survey to undermine 
efforts of other organizations to provide science-based recommendations 
regarding the management or reduction of antiparasitic resistance. 
Instead, information obtained from the survey will be used to ensure 
properly labeled, safe, and effective antiparasitic drugs are available 
to veterinarians. In doing so, CVM will be providing the best array of 
options for veterinarians to choose from as they serve their patients 
and will be fulfilling its mission to protect human and animal health.
    (Comment) Finally, one comment suggested that if a survey is to be 
done, it should be redesigned so that, while it may still gather 
opinions, it focuses on obtaining pertinent scientific information and 
more accurately targets respondents possessing the appropriate 
expertise on this particular subject. Also, that the incorporation of a 
scientific literature review may be beneficial in addressing some of 
the questions proposed.
    (CVM Response) CVM believes that there are other more appropriate 
ways to obtain specific scientific information regarding antiparasitic 
resistance, such as holding public meetings, directly consulting with 
experts in the field of veterinary parasitology, and reviewing 
published literature available on the subject. As previously discussed, 
this survey is designed specifically to obtain information on the 
levels of awareness and concern related to antiparasitic resistance 
issues among veterinarians, key stakeholders for CVM.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 38039]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                    No. of
       Portion of study             No. of       responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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Pre-test......................               7               1               7  .5..............             3.5
                                                                                (30 minutes)....
Survey........................             650               1             650  .5..............             325
                                                                                (30 minutes)....
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    Total.....................  ..............  ..............  ..............  ................           328.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    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 by the number of 
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respondents.

    Dated: June 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15648 Filed 7-2-14; 8:45 am]
BILLING CODE 4164-01-P