[Federal Register Volume 75, Number 143 (Tuesday, July 27, 2010)]
[Notices]
[Pages 43989-43990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-18304]
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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.
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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 http://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\
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No. of Annual Frequency Total Annual Hours per
21 U.S.C. 512/ Form FDA Respondents per Response Responses Response Total Hours
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3754 100 1 100 0.5 50
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
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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
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3754 100 1 100 0.5 50
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\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]
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