[Federal Register: June 30, 2005 (Volume 70, Number 125)]
[Notices]
[Page 37859-37860]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jn05-101]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0558]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Evaluating the Safety
of Antimicrobial New Animal Drugs With Regard to Their Microbiological
Effects on Bacteria of Human Health Concerns
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 has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
1, 2005.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
rm. 4B-41, 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.
Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to
Their Microbiological Effects on Bacteria of Human Health Concern (OMB
Control Number 0910-0522)
In the Federal Register of January 6, 2005 (70 FR 1253), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received on this information
collection.
Description: This guidance 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.
Table 1 of this document represents the estimated burden of meeting
the reporting requirements. The burden
[[Page 37860]]
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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Annual Frequency Hours per
Antimicrobial Risk Assessments No. of Respondents of Response Total Annual Responses Response Total Hours
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Hazard Identification (initial scoping of 15 1 15 30 450
issues; relevant bacteria, resistance
determinants, food products; preliminary data
gathering)
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Release Assessment (literature review; review 10 1 10 1,000 10,000
of research reports; data development;
compilation, and presentation)
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Exposure Assessment (identifying and extracting 10 1 10 8 80
consumption data; estimating probability of
contamination on food product)
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Consequence Assessment (review ranking of human 10 1 10 4 40
drug importance table)
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Risk Estimation (integration of risk 10 1 10 12 120
components; development of potential arguments
as basis for overall risk estimate)
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Risk Management (discussion of appropriate risk 10 1 10 30 300
management activities)
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Total Burden .................. .................. ....................... .................. 10,990
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\1\There are no capital costs and 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: June 23, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12910 Filed 6-29-05; 8:45 am]
BILLING CODE 4160-01-S