[Federal Register: January 6, 2005 (Volume 70, Number 4)]
[Notices]
[Page 1253-1254]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ja05-53]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0558]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Evaluating the Safety of Antimicrobial New Animal
Drugs With Regard to Their Microbiological Effects on Bacteria of Human
Health Concern
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 of 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
assessing the antimicrobial resistance concerns as part of the overall
preapproval safety evaluation of new animal drugs, focusing on the
effect of antimicrobial new animal drugs on bacteria of human health
concern.
DATES: Submit written or electronic comments on the collection of
information by March 7, 2005.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.fda.gov/dockets/ecomments. Submit written comments on the
collection of information to the Division of Dockets Management (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 Management
Programs (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 set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (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.
Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to
Their Microbiological Effects on Bacteria of Human Health Concern
Description: The guidance document discusses an approach for
assessing the safety of antimicrobial new animal drugs with regard to
their microbiological effects on bacteria of human health concern. In
particular, the guidance describes methodology that sponsors of
antimicrobial new animal drug applications for food-producing animals
may use to complete a qualitative antimicrobial resistance risk
assessment. This risk assessment should be submitted to FDA for the
purposes of evaluating the safety of the new animal drug to human
health. The guidance document outlines a process for integrating
relevant information into an overall estimate of risk and discusses
possible risk management strategies.
[[Page 1254]]
Table 1 of this document represents the estimated burden of meeting
the reporting requirements. The burden estimates for these information
collection requirements are based on information provided by the Office
of New Animal Drug Evaluation, Center for Veterinary Medicine. The
guidance document describes the type of information that should be
collected by the drug sponsor when completing the antimicrobial
resistance risk assessment. FDA will use the risk assessment and
supporting information to evaluate the safety of original (21 CFR
514.1) or supplemental (21 CFR 514.8) NADAs for antimicrobial drugs
intended for use in food-producing animals.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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21 CFR
514.1(b)(8) and No. of Annual Frequency Total Annual Hours per Total Hours
514.8(a)(2) Respondents per Response Responses Response
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Hazard 15 1 15 30 450
Identification
(initial scoping
of issues--
relevant
bacteria,
resistance
determinants,
food products;
preliminary data
gathering)
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Release 10 1 10 1,000 1,000
Assessment
(literature
review; review
of research
reports; data
development;
compilation, and
presentation)
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Exposure 10 1 10 8 80
Assessment
(identifying and
extracting
consumption
data; estimating
probability of
contamination on
food product)
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Consequence 10 1 10 4 40
Assessment
(review ranking
of human drug
importance
table)
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Risk Estimation 10 1 10 12 120
(integration of
risk components;
development of
potential
arguments as
basis for
overall risk
estimate)
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Risk Management 10 1 10 30 300
(discussion of
appropriate risk
management
activities)
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Total Burden 10,990
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA estimates that on an annual basis an average of 15 NADAs
(including original applications and major supplements) would be
subject to information collection under this guidance. This estimate is
based on the number of reviews completed between October 2003 and
October 2004. During that period, microbial food safety for
approximately 15 antimicrobial NADAs (including original and major
supplements) was evaluated. This estimate excludes NADAs for
antimicrobial drug combinations, generic drug applications (ANADAs),
and certain supplemental NADAs.
Dated: December 30, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-245 Filed 1-5-05; 8:45 am]
BILLING CODE 4160-01-S