Agency Information Collection Activities; Proposed Collection; Comment Request; “Antiparasitic Drug Survey”, 39948-39949 [2010-16971]
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39948
Federal Register / Vol. 75, No. 133 / Tuesday, July 13, 2010 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE—Continued
Number of
respondents
Total ..........................................................................................................
Dated: July 7, 2010.
Carol Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–17050 Filed 7–12–10; 8:45 am]
BILLING CODE 4163–18–P
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.
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 https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Number of
responses per
respondent
Avg. burden
per response
(in hrs)
........................
Form
........................
........................
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
Total burden
hours
18,010
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 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 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 BURDEN1
Portion of Study
No. of
respondents
jlentini on DSKJ8SOYB1PROD with NOTICES
Pre-test
Annual Frequency
per response
Total Annual
Responses
Hours per
Response
5
1
5
.33
1.65
100
Survey
1
100
.33
.33
Total
1 There
Total Hours
34.65
are no capital costs or operating and maintenance costs associated with this collection of information.
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16:44 Jul 12, 2010
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Federal Register / Vol. 75, No. 133 / Tuesday, July 13, 2010 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0337]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Special Protocol
Assessment
AGENCY:
Food and Drug Administration,
HHS.
jlentini on DSKJ8SOYB1PROD with NOTICES
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, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection in the
guidance for industry on special
protocol assessment.
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 https://
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
VerDate Mar<15>2010
16:44 Jul 12, 2010
Jkt 220001
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792, e-mail:
Elizabeth.Berbakos@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,
including each proposed extension of an
existing 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.
Guidance for Industry on Special
Protocol Assessment (OMB Control
Number 0910–0470)—Extension
The ‘‘Guidance for Industry on Special
Protocol Assessment’’ describes agency
procedures to evaluate issues related to
the adequacy (e.g., design, conduct,
analysis) of certain proposed studies.
The guidance describes procedures for
sponsors to request special protocol
assessment and for the agency to act on
such requests. The guidance provides
information on how the agency
interprets and applies provisions of the
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39949
Food and Drug Administration
Modernization Act of 1997 and the
specific Prescription Drug User Fee Act
of 1992 (PDUFA) goals for special
protocol assessment associated with the
development and review of PDUFA
products. The guidance describes two
collections of information: (1) The
submission of a notice of intent to
request special protocol assessment of a
carcinogenicity protocol, and (2) the
submission of a request for special
protocol assessment.
Notification of a Carcinogenicity
Protocol
As described in the guidance, a
sponsor interested in agency assessment
of a carcinogenicity protocol should
notify the appropriate division in FDA’s
Center for Drug Evaluation and Research
(CDER) or the Center for Biologics
Evaluation and Research (CBER) of an
intent to request special protocol
assessment at least 30 days prior to
submitting the request. With such
notification, the sponsor should submit
relevant background information so that
the agency may review reference
material related to carcinogenicity
protocol design prior to receiving the
carcinogenicity protocol.
Request for Special Protocol Assessment
The guidance asks that a request for
special protocol assessment be
submitted as an amendment to the
investigational new drug application
(IND) for the underlying product and
that it be submitted to the agency in
triplicate with Form FDA 1571 attached.
The guidance also suggests that the
sponsor submit the cover letter to a
request for special protocol assessment
via facsimile to the appropriate division
in CDER or CBER. Agency regulations
(21 CFR 312.23(d)) state that
information provided to the agency as
part of an IND is to be submitted in
triplicate and with the appropriate cover
form, Form FDA 1571. An IND is
submitted to FDA under existing
regulations in part 312 (21 CFR part
312), which specifies the information
that manufacturers must submit so that
FDA may properly evaluate the safety
and effectiveness of investigational
drugs and biological products. The
information collection requirements
resulting from the preparation and
submission of an IND under part 312
have been estimated by FDA and the
reporting and recordkeeping burden has
been approved by OMB under OMB
Control Number 0910–0014.
FDA suggests that the cover letter to
the request for special protocol
assessment be submitted via facsimile to
the appropriate division in CDER or
CBER to enable agency staff to prepare
for the arrival of the protocol for
E:\FR\FM\13JYN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 133 (Tuesday, July 13, 2010)]
[Notices]
[Pages 39948-39949]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-16971]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Survey 100 1 100 .33 .33
----------------------------------------------------------------------------------------------------------------
Total 34.65
----------------------------------------------------------------------------------------------------------------
\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
