[Federal Register Volume 70, Number 4 (Thursday, January 6, 2005)]
[Notices]
[Pages 1253-1254]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-245]


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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