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Notice

Agency Information Collection Activities; Proposed Collection; Comment Request; Sample Collection Plan for Dogs Treated With SLENTROL

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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.

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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.

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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 Start Printed Page 43990associated 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

21 U.S.C. 512/ Form FDANo. of RespondentsAnnual Frequency per ResponseTotal Annual ResponsesHours per ResponseTotal Hours
375410011000.550
1 There 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-keepersAnnual Frequency per per Record-keepingTotal Annual RecordsHours per RecordTotal Hours
375410011000.550
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.

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Dated: July 21, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2010-18304 Filed 7-26-10; 8:45 am]

BILLING CODE 4160-01-S