Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Antiparasitic Resistance and Combination New Animal Drugs Survey, 29762-29763 [2011-12555]
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29762
Federal Register / Vol. 76, No. 99 / Monday, May 23, 2011 / Notices
Annually, FDA projects about 30
communication studies using the
variety of test methods listed in table 1.
FDA is requesting this burden so as not
to restrict the Agency’s ability to gather
information on public sentiment for its
proposals in its regulatory and
communications programs.
Dated: May 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–12557 Filed 5–20–11; 8:45 am]
BILLING CODE 4160–01–P
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.
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
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:22 May 20, 2011
Jkt 223001
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 Webbased 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,
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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:
E:\FR\FM\23MYN1.SGM
23MYN1
29763
Federal Register / Vol. 76, No. 99 / Monday, May 23, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Portion of study
Total annual
responses
Average
burden per
response (in
hours) 2
Total hours
Pretest ................................................................................
Survey ................................................................................
5
100
1
1
5
100
20/60
20/60
1.65
33
Total ............................................................................
........................
........................
........................
........................
34.65
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
2 Burden
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]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0327]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Generic Clearance
for the Collection of Qualitative
Feedback on Agency Service Delivery
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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.
DATES: Fax written comments on the
collection of information by June 22,
2011.
SUMMARY:
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 ‘‘Generic Clearance for the
Collection of Qualitative Feedback on
Agency Service Delivery.’’ Also include
srobinson on DSK4SPTVN1PROD with NOTICES
ADDRESSES:
VerDate Mar<15>2010
16:22 May 20, 2011
Jkt 223001
the FDA 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–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.Capezzuto@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.
Generic Clearance for the Collection of
Qualitative Feedback on Agency
Service Delivery—(OMB Control
Number 0910—NEW)
The proposed information collection
activity provides a means to garner
qualitative customer and stakeholder
feedback in an efficient, timely manner,
in accordance with the Administration’s
commitment to improving service
delivery.
By qualitative feedback, we mean
information that provides useful
insights on perceptions and opinions,
but are not statistical surveys that yield
quantitative results that can be
generalized to the population of study.
This feedback will provide insights into
customer or stakeholder perceptions,
experiences, and expectations, provide
an early warning of issues with service,
or focus attention on areas where
communication, training, or changes in
operations might improve delivery of
products or services. These collections
will allow for ongoing, collaborative,
and actionable communications
between the Agency and its customers
and stakeholders. It will also allow
feedback to contribute directly to the
improvement of program management.
The solicitation of feedback will target
areas such as: Timeliness,
appropriateness, accuracy of
information, courtesy, efficiency of
service delivery, and resolution of
issues with service delivery. Responses
will be assessed to plan and inform
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
efforts to improve or maintain the
quality of service offered to the public.
If this information is not collected, vital
feedback from customers and
stakeholders on the Agency’s services
will be unavailable.
The Agency will only submit a
collection for approval under this
generic clearance if it meets the
following conditions:
• The collections are voluntary;
• The collections are low burden for
respondents (based on considerations of
total burden hours, total number of
respondents, or burden hours per
respondent) and are low cost for both
the respondents and the Federal
Government;
• The collections are
noncontroversial and do not raise issues
of concern to other Federal Agencies;
• Any collection is targeted to the
solicitation of opinions from
respondents who have experience with
the program or may have experience
with the program in the near future;
• Personally identifiable information
(PII) is collected only to the extent
necessary and is not retained;
• Information gathered is intended to
be used only internally for general
service improvement and program
management purposes and is not
intended for release outside of the
Agency (if released, the Agency must
indicate the qualitative nature of the
information);
• Information gathered will not be
used for the purpose of substantially
informing influential policy decisions;
and
• Information gathered will yield
qualitative information; the collections
will not be designed or expected to
yield statistically reliable results or used
as though the results are generalizable to
the population of study.
Feedback collected under this generic
clearance provides useful information,
but it does not yield data that can be
generalized to the overall population.
This type of generic clearance for
qualitative information will not be used
for quantitative information collections
that are designed to yield reliably
E:\FR\FM\23MYN1.SGM
23MYN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Portion of study Number of responses per Total annual per response Total hours
respondents respondent responses (in hours) \2\
----------------------------------------------------------------------------------------------------------------
Pretest......................... 5 1 5 20/60 1.65
Survey.......................... 100 1 100 20/60 33
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 34.65
----------------------------------------------------------------------------------------------------------------
\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]
BILLING CODE 4160-01-P
