[Federal Register Volume 67, Number 93 (Tuesday, May 14, 2002)]
[Notices]
[Pages 34456-34457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-11934]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0589]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Extralabel Drug Use in Animals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Submit written comments on the collection of information by June 
13, 2002.

ADDRESSES: Submit written comments on the collection of information to 
Office of Information and Regulatory Affairs, OMB, New Executive Office 
Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attention: 
Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Resources Management (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 Number 
0910-0325)--Extension

    The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), 
(Public Law 103-396), amended the Federal Food, Drug, and Cosmetic Act 
to permit licensed veterinarians to prescribe extralabel use in animals 
of approved human and animal drugs. Regulations implementing provisions 
of AMDUCA are codified under part 530 (21 CFR part 530). A new 
provision under these regulations in Sec. 530.22(b), permits FDA to 
establish a safe level for extralabel use in animals of an approved 
human or animal drug when the agency determines there is reasonable 
probability that this use may present a risk to the public health. The 
extralabel use in animals of an approved human or animal drug that 
results in residues exceeding a safe level is considered an unsafe use 
of a drug. In conjunction with the establishment of a safe level, the 
new provision permits FDA to request development of an acceptable 
residue detection method for an analysis of residues above any safe 
level established under part 530. The sponsor may be willing to provide 
the methodology in some cases, while in others, FDA, the sponsor and 
perhaps a third party, (e.g., a State agency or a professional 
association), may negotiate a cooperative arrangement to develop the 
methodology. If no acceptable analytical method is developed, the 
agency would be permitted to prohibit extralabel use of the drug.
    In the Federal Register of January 28, 2002 (67 FR 3903), the 
agency requested comments on the collection of information. In 
response, FDA received one comment. The comment asked whether the 
proposed collection of information was necessary for the proper 
performance of FDA functions including whether the information would 
have practical utility. As detailed, FDA under this regulation is 
permitted to request development of an acceptable residue detection 
method for human or animal drugs used in an extralabel manner that 
could result in unsafe residues in edible products of the treated 
animal. If no acceptable analytical method is developed, FDA is 
permitted to prohibit extralabel use of the drug. Thus, this collection 
of information is necessary to permit licensed veterinarians to 
prescribe extralabel use of certain drugs.
    The respondents may be sponsors of new animal drug(s), State or 
Federal

[[Page 34457]]

Government, or individuals. FDA estimates the burden of this collection 
of information as follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                    Annual Frequency per
    21 CFR Section         No. of Respondents             Response           Total Annual Responses      Hours per Response            Total Hours
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530.22(b)                                     2                         1                         2                     4,160                     8,320
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\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 
required.

    Dated: May 3, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-11934 Filed 5-13-02; 8:45 am]
BILLING CODE 4160-01-S