Document ID: FDA-2010-N-0358-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Sample Collection Plan for Dogs Treated With Slentrol
Posted Date: 2010-07-27T04:00Z

[Federal Register: July 27, 2010 (Volume 75, Number 143)]
[Notices]               
[Page 43989-43990]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jy10-99]                         

-----------------------------------------------------------------------

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 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              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