Agency Information Collection Activities; Proposed Collection; Comment Request; Sample Collection Plan for Dogs Treated With SLENTROL, 43989-43990 [2010-18304]
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Federal Register / Vol. 75, No. 143 / Tuesday, July 27, 2010 / Notices
43989
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
RFP and Contract ............................................................................................
Emergency Funding Request ..........................................................................
Service Agreements ........................................................................................
Biennial Reports ..............................................................................................
Advance Planning Document ..........................................................................
Estimated Total Annual Burden Hours: ...........................................................
50
27
14
50
50
........................
1.54
1
1
1
1.84
........................
1.50
1
1
1.50
60
........................
Additional Information
Dated: July 22, 2010.
Robert Sargis,
Reports Clearance Officer.
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
the sample collection plan for dogs
treated with the drug SLENTROL.
DATES: Submit either electronic or
written comments on the collection of
information by September 27, 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, 301–396–
3793.
[FR Doc. 2010–18343 Filed 7–26–10; 8:45 am]
SUPPLEMENTARY INFORMATION:
SUMMARY:
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following:
Office of Management and Budget,
Paperwork Reduction Project, Fax:
202–395–7285, E-mail:
OIRA_SUBMISSION@OMB.EOP.GOV.
Attn: Desk Officer for the
Administration for Children and
Families.
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sroberts on DSKD5P82C1PROD with NOTICES
[Docket No. FDA–2010–N–0358]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Sample Collection
Plan for Dogs Treated With SLENTROL
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Mar<15>2010
17:49 Jul 26, 2010
Jkt 220001
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
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
Total burden
hours
115.50
27
14
75
5,520
5,751.50
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.
Sample Collection Plan for Dogs
Treated With SLENTROL—21 CFR
514.80 (OMB Control Number 0910–
NEW)
FDA’s Center for Veterinary Medicine
(CVM) is planning a pharmacogenomic
study to examine whether adverse drug
events (ADEs) experienced with
SLENTROL, an anti-obesity drug
approved for dogs, are associated with
genetic variations in the dogs treated.
Pharmacogenomics involves the use of
genome-wide analyses to identify genes
with altered expression or activation as
a result exposure to a drug. Preliminary
analysis by CVM has indicated potential
correlations between dog breeds and
some ADEs. The study would collect a
blood sample and buccal swab from
animals that have been treated with
SLENTROL and experienced specific
ADEs (i.e., reactors), and animals that
have been treated with SLENTROL and
that have not experienced ADEs (i.e.,
controls). The samples would be
analyzed by FDA using microarray
analysis and single nucleotide
polymorphism analysis to determine
possible genetic variations associated
with the ADEs reported. If this project
identifies definite genotype mutations
E:\FR\FM\27JYN1.SGM
27JYN1
43990
Federal Register / Vol. 75, No. 143 / Tuesday, July 27, 2010 / Notices
associated with drug response, CVM
would potentially have a scientific basis
for modifying recommendations with
regard to SLENTROL use.
To conduct the study, FDA would
seek the voluntary participation of
veterinarians in the private sector. FDA
would contact veterinarians who have
reported adverse events with
SLENTROL to FDA using a Form FDA
1932a, or veterinarians who have posted
adverse experiences with SLENTROL on
Internet Web sites or other public
forums with their contact information,
to ask them if they are willing to
participate in the study. If the
veterinarians are willing to participate,
and the owners of the animals consent,
FDA would provide the veterinarians
with a package that includes
instructions and materials for taking a
blood sample and buccal swab from the
animal, a postage paid envelope to
return the samples, and a brief ‘‘Sample
Collection’’ form to be filled out by the
veterinarian. The ‘‘Sample Collection’’
form collects information that includes
the date and type of sample taken,
information about the treated dog
(breed, age, gender and neuter status,
type of food), and information about
past SLENTROL use and adverse events
experienced. FDA anticipates that
participating veterinarians will take the
samples during routine office visits from
pet owners for their pets, and that pet
owners will not make a special trip to
the veterinarian for the purpose of
participation in the study. FDA’s goal is
to obtain at about 100 samples.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 U.S.C. 512/ Form FDA
3754
Annual Frequency
per Response
100
1 There
Total Annual
Responses
1
Hours per
Response
100
Total Hours
0.5
50
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 U.S.C. 512/ Form No.
No. of
Record-keepers
3754
sroberts on DSKD5P82C1PROD with NOTICES
1 There
Annual Frequency per
per Record-keeping
100
Total Annual
Records
1
Hours per
Record
100
Total Hours
0.5
50
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimates that it will take a
veterinarian approximately 30 minutes
to obtain the owner’s consent, take the
blood and buccal samples, and fill out
the ‘‘Sample Collection’’ form. This
includes the time necessary for a
veterinarian to read instructions for
taking samples, to search the animal’s
medical records to obtain information
necessary to complete the form, such as
the adverse events that occurred after
initiating SLENTROL treatment, and to
mail the samples and form to FDA. As
noted previously, FDA anticipates that
participating veterinarians will obtain
the samples during routine office visits
from the pet owner for their pet, and
therefore no reporting burden is
contained in this collection of
information with respect to the owners
of the animals involved in the study.
Regarding recordkeeping, it is the
customary and usual practice of
veterinarians to keep medical records
for their patients, and the agency
believes that the proposed collection of
information would not contain any
additional recordkeeping burdens.
However, FDA has estimated that an
additional 30 minutes of recordkeeping
will be necessary to maintain records
necessary to participate in the study.
VerDate Mar<15>2010
16:30 Jul 26, 2010
Jkt 220001
Dated: July 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–18304 Filed 7–26–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2010–N–0368]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Pet Event Tracking
Network—State, Federal Cooperation
to Prevent Spread of Pet Food Related
Diseases
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
the paperwork requirements for the
SUMMARY:
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
proposed Pet Event Tracking Network
(PETNet) cooperative Federal and State
initiative.
DATES: Submit either electronic or
written comments on the collection of
information by September 27, 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, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793, Denver.presley@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
E:\FR\FM\27JYN1.SGM
27JYN1
]]>Agencies
[Federal Register Volume 75, Number 143 (Tuesday, July 27, 2010)]
[Notices]
[Pages 43989-43990]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18304]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0358]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Sample Collection Plan for Dogs Treated With SLENTROL
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 the sample collection plan for dogs treated
with the drug SLENTROL.
DATES: Submit either electronic or written comments on the collection
of information by September 27, 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, 301-396-3793.
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.
Sample Collection Plan for Dogs Treated With SLENTROL--21 CFR 514.80
(OMB Control Number 0910-NEW)
FDA's Center for Veterinary Medicine (CVM) is planning a
pharmacogenomic study to examine whether adverse drug events (ADEs)
experienced with SLENTROL, an anti-obesity drug approved for dogs, are
associated with genetic variations in the dogs treated.
Pharmacogenomics involves the use of genome-wide analyses to identify
genes with altered expression or activation as a result exposure to a
drug. Preliminary analysis by CVM has indicated potential correlations
between dog breeds and some ADEs. The study would collect a blood
sample and buccal swab from animals that have been treated with
SLENTROL and experienced specific ADEs (i.e., reactors), and animals
that have been treated with SLENTROL and that have not experienced ADEs
(i.e., controls). The samples would be analyzed by FDA using microarray
analysis and single nucleotide polymorphism analysis to determine
possible genetic variations associated with the ADEs reported. If this
project identifies definite genotype mutations
[[Page 43990]]
associated with drug response, CVM would potentially have a scientific
basis for modifying recommendations with regard to SLENTROL use.
To conduct the study, FDA would seek the voluntary participation of
veterinarians in the private sector. FDA would contact veterinarians
who have reported adverse events with SLENTROL to FDA using a Form FDA
1932a, or veterinarians who have posted adverse experiences with
SLENTROL on Internet Web sites or other public forums with their
contact information, to ask them if they are willing to participate in
the study. If the veterinarians are willing to participate, and the
owners of the animals consent, FDA would provide the veterinarians with
a package that includes instructions and materials for taking a blood
sample and buccal swab from the animal, a postage paid envelope to
return the samples, and a brief ``Sample Collection'' form to be filled
out by the veterinarian. The ``Sample Collection'' form collects
information that includes the date and type of sample taken,
information about the treated dog (breed, age, gender and neuter
status, type of food), and information about past SLENTROL use and
adverse events experienced. FDA anticipates that participating
veterinarians will take the samples during routine office visits from
pet owners for their pets, and that pet owners will not make a special
trip to the veterinarian for the purpose of participation in the study.
FDA's goal is to obtain at about 100 samples.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 U.S.C. 512/ Form FDA Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
3754 100 1 100 0.5 50
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Record- Annual Frequency per Total Annual
21 U.S.C. 512/ Form No. keepers per Record-keeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
3754 100 1 100 0.5 50
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA's estimates that it will take a veterinarian approximately 30
minutes to obtain the owner's consent, take the blood and buccal
samples, and fill out the ``Sample Collection'' form. This includes the
time necessary for a veterinarian to read instructions for taking
samples, to search the animal's medical records to obtain information
necessary to complete the form, such as the adverse events that
occurred after initiating SLENTROL treatment, and to mail the samples
and form to FDA. As noted previously, FDA anticipates that
participating veterinarians will obtain the samples during routine
office visits from the pet owner for their pet, and therefore no
reporting burden is contained in this collection of information with
respect to the owners of the animals involved in the study.
Regarding recordkeeping, it is the customary and usual practice of
veterinarians to keep medical records for their patients, and the
agency believes that the proposed collection of information would not
contain any additional recordkeeping burdens. However, FDA has
estimated that an additional 30 minutes of recordkeeping will be
necessary to maintain records necessary to participate in the study.
Dated: July 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-18304 Filed 7-26-10; 8:45 am]
BILLING CODE 4160-01-S
