[Federal Register Volume 64, Number 39 (Monday, March 1, 1999)]
[Notices]
[Page 10002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4875]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0240]


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 
drug(s) prescribed for extra label use in animals, when the agency has 
determined their is reasonable probability this use may present a risk 
to public health due to residues exceeding a safe level.

DATES: Submit written comments on the collection of information byApril 
30, 1999.
ADDRESSES: 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, 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)

    Description: The Animal Medicinal Drug Use Clarification Act of 
1994 (AMDUCA), (Pub. L. 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, 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 the 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. The respondents may be sponsors of new animal drug(s), State 
or Federal government, or individuals.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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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 estimate of the time required for this reporting requirement is 
based on the agency's communication with industry. The agency 
recognizes that the time to develop residue detection methodology is 
highly variable and dependent upon the level of difficulty to a certain 
extent. Based on this information, FDA estimates that two methods of 
intermediate difficulty for one to two drugs per year would be 
developed.

    Dated: February 23, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-4875 Filed 2-26-99; 8:45 am]
BILLING CODE 4160-01-F