[Federal Register: September 28, 2005 (Volume 70, Number 187)]
[Page 56706-56707]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0148]

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.

[[Page 56707]]

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 
28, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1472.

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 No. 0910-

    Description: The Animal Medicinal Drug Use Clarification Act of 
1994 (AMDUCA) (Public Law 103-396) allows a veterinarian to prescribe 
the extralabel use of approved new animal drugs. Also, AMDUCA 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 an animal 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 government, or 
    In the Federal Register of May 3, 2005 (70 FR 22884), the agency 
published a 60-day notice requesting public comment on the collection 
of information. No comments were received.
    FDA estimates the burden of this collection of information as 

                                 Table 1.--Estimated Annual Reporting Burden\1\
                                          Annual Frequency     Total Annual        Hours per
  21 CFR Section    No. of 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.

    The Center for Veterinary Medicine (CVM) has not found 
circumstances to require the establishment of a safe level and 
subsequent development of an analytical methodology. However, CVM 
believes there will be instances when an analytical methodology will be 

    Dated: September 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19392 Filed 9-27-05; 8:45 am]