Document ID: FDA-2011-N-0555-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Extralabel Drug Use in Animals
Posted Date: 2011-11-16T05:00Z

[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Notices]
[Page 71039]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29477]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0555]

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 
December 16, 2011.

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) 395-7285, or emailed to oira_submission@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: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, (301) 796-7651, 
Juanmanuel.vilela@fda.hhs.gov.

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 530--(OMB Control Number 0910-
0325)--Extension

    The Animal Medicinal Drug Use Clarification Act of 1994 allows a 
veterinarian to prescribe the extralabel use of approved new animal 
drugs. Also, it permits FDA, if it finds that there is a reasonable 
probability that the extralabel use of an animal drug may present a 
risk to the public health, to establish a safe level for a residue from 
the extralabel use of the drug, and to require the development of an 
analytical method for the detection of residues above that established 
safe level. Although to date, we have not established a safe level for 
a residue from the extralabel use of any new animal drug, and 
therefore, have not required the development of analytical methodology, 
we believe that there may be instances when analytical methodology will 
be required. We are therefore 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. We believe 
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 and/or State 
Agencies, academia, or individuals.
    In the Federal Register of August 16, 2011 (76 FR 50736), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           No. of
                           21 CFR section                                 No. of       responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.

    Dated: November 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29477 Filed 11-15-11; 8:45 am]
BILLING CODE 4160-01-P