[Federal Register Volume 68, Number 182 (Friday, September 19, 2003)]
[Notices]
[Pages 54906-54907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23941]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1998D-1146]


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 a 
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 (the PRA).

DATES: Fax written comments on the collection of information by October 
20, 2003.

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, or e-mail comments to 
[email protected].

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 Concerns

    This guidance document discusses a recommended approach for 
assessing the antimicrobial resistance concerns as part of the overall 
preapproval safety evaluation of new animal drugs, focusing on the 
microbiological effects on bacteria of human health concern. In 
particular, the guidance describes a methodology sponsors of 
antimicrobial new animal drug applications for food-producing animals 
may use to complete a qualitative antimicrobial resistance risk 
assessment. This risk assessment

[[Page 54907]]

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 new reporting requests. The burden estimates for these information 
collection requests 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) new animal drug applications 
(NADAs) for antimicrobial drugs intended for use in food-producing 
animals.
    In the Federal Register of September 13, 2002 (67 FR 58058), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received in response to that 
notice.
    FDA estimates the burden for this collection of information:

             TABLE 1.--ESTIMATED ANNUAL REPORTING BURDEN\1\
------------------------------------------------------------------------
   21 CFR
   Section                   Annual                       Hours
 514.1(b)(8)     No. of    Frequency    Total Annual       per     Total
     and      Respondents     per     [chyph]Responses  Response   Hours
 514.8(a)(2)                Response
------------------------------------------------------------------------
Hazard        5            1          5                 30        150
 Identificat
 ion
 (initial
 scoping of
 issues--
 relevant
 bacteria,
 resistance
 determinant
 s, food
 products;
 preliminary
 data
 gathering)
------------------------------------------------------------------------
Release       5            1          5                 1,000     5,000
 Assessment
 (literature
 review;
 review of
 research
 reports;
 data
 development
 ;
 compilation
 , and
 presentatio
 n)
------------------------------------------------------------------------
Exposure      5            1          5                 8         40
 Assessment
 (identifyin
 g and
 extracting
 consumption
 data;
 estimating
 probability
 of
 contaminati
 on on food
 product)
------------------------------------------------------------------------
Consequence   5            1          5                 4         20
 Assessment
 (review
 ranking of
 human drug
 importance
 table)
------------------------------------------------------------------------
Risk          5            1          5                 12        60
 Estimation
 (integratio
 n of risk
 components;
 development
 of
 potential
 arguments
 as basis
 for overall
 risk
 estimate)
------------------------------------------------------------------------
Risk          5            1          5                 30        150
 Management
 (discussion
 of
 appropriate
 risk
 management
 activities)
------------------------------------------------------------------------
Total Burden  ...........  .........  ................  ........  5,420
------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs
  associated with this collection of information.
\2\FDA estimates that on an annual basis an average of five NADAs
  (including original applications and major supplements) would be
  subject to information collection under this guidance. This estimate
  is based on a review of the number of major NADA approvals that
  occurred between October 1997 and October 2001. During that 4-year
  period, an average of five antimicrobial NADAs (including original and
  major supplements) was approved in food-producing animals per year.
  This estimate excludes NADAs for antimicrobial drug combinations,
  generic drug applications (abbreviated new animal drug applications),
  and certain supplemental NADAs.


    Dated: September 15, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-23941 Filed 9-18-03; 8:45 am]
BILLING CODE 4160-01-S