Document ID: FDA-2008-N-0312-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Extralabel Drug Use in Animals
Posted Date: 2008-09-05T04:00Z

[Federal Register: September 5, 2008 (Volume 73, Number 173)]
[Notices]               
[Page 51821-51822]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05se08-55]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0312]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Extralabel Drug Use 
in Animals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by October 
6, 2008.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments 
should be identified with the OMB control number 0910-0325. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Extralabel Drug Use in Animals--21 CFR part 530 (OMB Control Number 
0910-0325)--Extension

    Under part 530 (21 CFR Part 530), a veterinarian is permitted to 
prescribe the extralabel use of approved new animal drugs. Section 
530.22 (b) of the implementing regulations permits FDA, if it finds 
there is a reasonable probability that the extralabel use of an animal 
drug may present a risk to the public health, to: (1) Establish a safe 
level for a residue from the extralabel use of the drug, and (2) 
require the development of an analytical method for the detection of 
residues above that established safe level. To date, FDA has not 
established a safe level for a residue from the extralabel use of any 
new animal drug and therefore has not required the development of 
analytical methodology. However, the agency believes that there may be 
instances when analytical methodology will be required. Thus, FDA is 
estimating the reporting burden based on two methods being required 
annually. The requirement to establish an analytical method may be 
fulfilled by any interested person. The agency believes that the 
sponsor of the drug will be willing to develop the method in most 
cases. Alternatively, FDA, the sponsor, and perhaps a third party may 
cooperatively arrange for method development. The respondents may be 
sponsors of new animal drugs, State, or Federal government, or 
individuals.
    In the Federal Register of June 3, 2008 (73 FR 31693), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    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 CFR Section     Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
530.22(b)                       2                     1                  2              4,160              8,320
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

[[Page 51822]]

    Dated: August 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-20578 Filed 9-4-08; 8:45 am]

BILLING CODE 4160-01-S