[Federal Register Volume 68, Number 45 (Friday, March 7, 2003)]
[Notices]
[Pages 11117-11118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5355]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0383]


Agency Information Collection Activities; Submission for OMB 
Review; 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 that the 
proposed collection of information listed below 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: Submit written comments on the collection of information by 
April 7, 2003.

ADDRESSES: Submit written comments on the collection of information to 
Office of Information and Regulatory Affairs, OMB, New Executive Office 
Bldg., 725 17th St., NW., rm. 10235, Washington, DC, 20503, Attention: 
Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, rm. 16B-26, 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:

Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect 
Report--21 CFR Part 510 (OMB Control Number 0910-0012)--Extension

    In response to a 60-day notice that published in the Federal 
Register of September 5, 2002 (67 FR 56846), the agency received four 
sets of comments. Two sets of comments were from a pharmaceutical 
company and two were from individuals. A discussion of the comments 
with the Center for Veterinary Medicine's response follows:
    The two individual comments pertained to a complaint concerning a 
veterinary product and the elimination of antibacterial soaps. These 
comments are not germane to this collection of information.
    Four comments pertained to the interim final rule for records and 
reports (21 CFR 514.80) that published February 4, 2002 (67 FR 5046), 
which is not the subject of this Federal Register notice. The closing 
date for receiving comments on the interim final rule was April 5, 
2002. These comments were submitted on November 4, 2002 and thus, FDA 
will not respond. Further, the substance of these comments were 
submitted in response to the Interim Final Rule and will be addressed 
in the Final Rule for Records and Reports.
    Three comments asked FDA to increase the amount of time for 
investigating, gathering, and processing information and data for Form 
FDA 1932. One comment estimated that the burden estimate should be 
increased by as much as 1 to 1.75 hours for product defects. Another 
comment estimated that the burden estimate should be increased from 
0.25 to 1 hours. The third comment stated that it would take close to 2 
hours to investigate, collect, conduct quality control, and record the 
information.
    FDA will increase the burden for the Form FDA 1932 from 1 hour to 2 
hours. This will increase the total burden hours for the Form FDA 1932 
from 18,385 hours to 36,770 hours.
    Section 512(l) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360b(i)), 21 CFR 510.300, 510.301, and 510.302 require 
that applicants of approved NADA's submit within 15-working days of 
receipt, complete records of reports of certain

[[Page 11118]]

adverse drug reactions and unusual failure of new animal drugs. Other 
reporting requirements of adverse reactions to these drugs must be 
reported annually or semi-annually 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 
drug applications.
    FDA estimates the burden for this collection of information as 
follows:

                                                      Table 1.--Estimated Annual Reporting Burden1
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                                                                  No. of        Annual Frequency      Total Annual         Hours per
           Form No.                   21 CFR Section           Respondents        per Response         Responses           Response        Total  hours
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Form FDA 2301                   510.302(a)                                190              10.94               2,079               0.5             1,040
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Form FDA 1932                   510.302(b)                                190              96.76              18,385               2.0            36,770
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Form FDA 1932a (voluntary)      510.302(b)                                100               1.0                  100               1.0               100
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Total Burden Hours                                                                                                                                37,910
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\1\ There are no capital 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      Total annual         Hours per
 21 CFR Section    Recordkeepers     of Recordkeeping        response         Recordkeeper        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                30,711
 Hours
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    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: February 21, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-5355 Filed 3-6-03; 8:45 am]
BILLING CODE 4160-01-S