[Federal Register Volume 67, Number 18 (Monday, January 28, 2002)]
[Notices]
[Pages 3903-3904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-2051]


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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 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, 
including each proposed extension for an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the reporting requirements for 
development of residue detection methodology for human or animal drugs 
prescribed for extralabel use in animals when the agency has determined 
there is reasonable probability this use may present a risk to public 
health due to residues exceeding a safe level.

DATES: Submit written or electronic comments on the collection of 
information by March 29, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http: // www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, rm. 16B-26; Rockville, MD 20857, 301-827-1472.

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, including 
each proposed extension of an existing 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 listed below. With respect to the following collection 
of information, FDA invites comments on: (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.

Extralabel Drug Use in Animals--21 CFR Part 530 (OMB Control No. 
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

[[Page 3904]]

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. The respondents may be sponsors of 
new animal drugs, State or Federal 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    Total Annual
 21 CFR Section  No. of Respondents         Response            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. Thus, we are estimating the reporting burden on one 
methodology being required annually.

    Dated: January 17, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-2051 Filed 1-25-02; 8:45 am]
BILLING CODE 4160-01-S