[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
