[Federal Register Volume 66, Number 103 (Tuesday, May 29, 2001)]
[Notices]
[Pages 29141-29142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13298]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0231]


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 each proposed extension 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 July 30, 2001.

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, 5630 Fishers 
Lane, rm. 1061, 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 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 proposed reinstatement 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 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 (21 
U.S.C. 360b(l)), 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. 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 also 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 for this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                                        Annual
                  Form No.                     21 CFR Section        No. of        Frequency  per      Total Annual       Hours  per       Total Hours
                                                                   Respondents        Response          Responses         Response
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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

[[Page 29142]]

 
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
----------------------------------------------------------------------------------------------------------------
510.300(a)          190                  13.16            2,500                  10.35           25,875
 and
 510.301(a)
510.300(b)          190                  94.74            2,900                   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: May 18, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-13298 Filed 5-25-01; 8:45 am]
BILLING CODE 4160-01-S