[Federal Register Volume 66, Number 214 (Monday, November 5, 2001)]
[Notices]
[Pages 55942-55943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27641]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0231]


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 
December 5, 2001.

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

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: 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 No. 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 new animal drug applications 
(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

[[Page 55943]]

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 FDA Forms 
1932 and 1932a . FDA Form 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 of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                                   Annual Frequency      Total Annual        Hours per
                  Form No.                    21 CFR Section  No. of Respondents     per Response          Responses         Response       Total Hours
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Form FDA 2301...............................      510.302(a)        190                  13.16            2,500                 0.5         1,250
Form FDA 1932...............................      510.302(b)        190                  94.74           18,000                 1.0        18,000
Form FDA 1932a (voluntary)..................      510.302(b)        100                   1.0               100                 1.0           100
  Total burden hours........................                                                                                               19,350
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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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                                                             Total Annual
   21 CFR            No. of           Annual Frequency       Response per         Hours per        Total Hours
   Section        Recordkeepers       per Recordkeeping      Recordkeeper       Recordkeeper
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510.300(a)           190                    13.16             2,500                 10.35         25,875
 and
 510.301(a)
510.300(b)           190                    94.74            18,000                  0.50          9,000
 and
 510.301(b)
  Total                                                                                           34,875
   burden
   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: October 29, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-27641 Filed 11-2-01; 8:45 am]
BILLING CODE 4160-01-S