[Federal Register Volume 67, Number 172 (Thursday, September 5, 2002)]
[Notices]
[Pages 56846-56848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-22637]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0383]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Veterinary Adverse Drug Reaction, Lack of 
Effectiveness, Product Defect Report

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 renewal of an existing collection of information, and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on reporting and recordkeeping requirements 
obligating holders of approved new animal drug applications (NADAs) and 
abbreviated new animal drug applications (ANADAs) to submit information 
on adverse drug reactions, lack of effectiveness and product defects.

DATES: Submit written or electronic comments on the collection of 
information by November 4, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http:// www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1061, 
5630 Fishers Lane, 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 Information 
Resources Management (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

[[Page 56847]]

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 renewal of an existing 
collection, 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: (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.
    Veterinary Adverse Drug Reaction, Lack of Effectivenss, Product 
Defect Report--21 CFR Part 510--(OMB Control Number 0910-0012)--
Extension
    Section 512(l) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360b(l)), and 21 CFR 510.300, 510.301, and 510.302 
require that applicants of approved NADAs submit within 15 working days 
of receipt, complete records of reports of certain adverse drug 
reactions and unusual failure of new animal drugs. Other reporting 
requirements of adverse reactions to these drugs must be reported 
annually or semiannually in a specific format. This continuous 
monitoring of approved new animal drugs, affords the primary means by 
which FDA obtains information regarding potential problems in safety 
and effectiveness of marketed animal drugs and potential manufacturing 
problems. Data already on file with FDA is not adequate because animal 
drug effects can change over time and less apparent effects may take 
years to manifest themselves. Reports are reviewed along with those 
previously submitted for a particular drug to determine if any change 
is needed in the product or labeling, such as package insert changes, 
dosage changes, additional warnings or contraindications, or product 
reformulation.
    Adverse reaction reports are required to be submitted by the drug 
manufacturer on FDA Forms 1932 or 1932a (voluntary reporting form), 
following complaints from animal owners or veterinarians. Likewise, 
product defects and lack of effectiveness complaints are submitted to 
FDA by the drug manufacturer following their own detection of a problem 
or complaints from product users or their veterinarians using forms FDA 
Forms 1932 and 1932a. Form FDA 2301 is available for the required 
transmittal of periodic reports and promotional material for new animal 
drugs. Respondents to this collection of information are applicants of 
approved NADAs.
    FDA estimates the burden for this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                                      Annual
                                                          No. of    Frequency    Total Annual      Hours   Total
           Form No                 21 CFR Section      Respondents     per     [chyph]Responses     per    Hours
                                                                     Response                    Response
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Form FDA 2301                  510.302(b)                  190       10.94          2,079           0.5    1,040
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Form FDA 1932                  510.302(b)                  190       96.76         18,385           1.0     100
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Form FDA 1932a                 510.302(b)                  100         1.0            100           1.0     100
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Total Burden Hours             ......................  ...........  .........  ................  ........  19,52
                                                                                                              5
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\1\ There are no capitol costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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                          No. of          Annual Frequency of      Total Annual        Hours per
  21 CFR Section       Recordkeepers         Recordkeeping       [chyph]Responses     Recodkeeper    Total Hours
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510.300(a) and            190                    13.16              2,079                10.35      21,518
 510.301(a)
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510.300(b) and            190                    94.74             18,385                 0.50       9,193
 510.301(b)
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Total Burden Hours  ..................  ......................  ..................  ..............  30,711
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\1\ There are no capitol costs or operating and maintenance costs associated with this collection of
  information.


[[Page 56848]]

    The estimate of the times required for record preparation and 
maintenance is based on agency communication with industry. Other 
information needed to calculate the total burden hours (i.e., adverse 
drug reaction, lack of effectiveness, and product defect reports) are 
derived from agency records and experience.

    Dated: August 29, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-22637 Filed 9-4-02; 8:45 am]
BILLING CODE 4160-01-S