[Federal Register: September 19, 2003 (Volume 68, Number 182)]
[Notices]
[Page 54906-54907]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19se03-70]
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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
Fumie_Yokota@omb.eop.gov.
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\
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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
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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
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\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