[Federal Register Volume 70, Number 125 (Thursday, June 30, 2005)]
[Notices]
[Pages 37859-37860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-12910]


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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