Document ID: FDA-2009-N-0488-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Records and Reports Concerning Experience With Approved New Animal Drugs; Adverse Event Reports on Forms FDA 1932, 1932a, and 2301
Posted Date: 2010-01-19T05:00Z

[Federal Register Volume 75, Number 11 (Tuesday, January 19, 2010)]
[Notices]
[Pages 2865-2866]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-782]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0488]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Records and Reports 
Concerning Experience With Approved New Animal Drugs; Adverse Event 
Reports on Forms FDA 1932, 1932a, and 2301

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.

DATES: Fax written comments on the collection of information by 
February 18, 2010.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0284. 
Also include the FDA docket number found in brackets in the heading of 
this document

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr. Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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.

Records and Reports Concerning Experience With Approved New Animal 
Drugs; Adverse Event Reports on Forms FDA 1932, 1932a, and 2301 (OMB 
Control Number 0910-0284)--Extension

    Section 512(l) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360b(l) and Sec.  514.80 (21 CFR 514.80) of FDA 
regulations require applicants of approved new animal drug applications 
(NADAs) and abbreviated new animal drug applications (ANADAs) to report 
adverse drug experiences and product/manufacturing defects (see Sec.  
514.80(b)).
    This continuous monitoring of approved NADAs and ANADAs affords the 
primary means by which FDA obtains information regarding potential 
problems with the safety and efficacy of marketed approved new animal 
drugs as well as potential product/manufacturing problems. Post-
approval marketing surveillance is important because data previously 
submitted to FDA may not be adequate, as animal drug effects can change 
over time and less apparent effects may take years to manifest.
    Under Sec.  514.80(d), an applicant must report adverse drug 
experiences and product/manufacturing defects on Form FDA 1932, 
``Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product 
Defect Report.'' Periodic drug experience reports and special drug 
experience reports must be accompanied by a completed Form FDA 2301, 
``Transmittal of Periodic Reports and Promotional Material for New 
Animal Drugs'' (see Sec.  514.80(d)). Form FDA 1932a, ``Veterinary 
Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report'' 
allows for voluntary reporting of adverse drug experiences or product/
manufacturing defects.
    The electronic versions of Forms FDA 1932 and 1932a have been 
incorporated into the agency-wide information collection 
(MedWatch\Plus\Portal and Rational Questionnaire) that was announced 
for public comment in the Federal Register on October 23, 2008 (73 FR 
63153). MedWatch\Plus\ Portal and Rational Questionnaire is part of a 
new electronic system for collecting, submitting, and processing 
adverse event reports and other safety information for all FDA-
regulated products. In the Federal Register of May 20, 2009 (74 FR 
23721), FDA announced the submission for OMB review and clearance of 
the electronic data collection using MedWatch\Plus\ Portal and Rational 
Questionnaire.
    Burden hours for the electronic versions of these forms were 
included as part of the MedWatch\Plus\ Portal and Rationale 
Questionnaire information collection approved under OMB control number 
0910-0645. It is estimated that, during the first 3 years that the 
MedWatch\Plus\ Portal is in use, half of the reports will be submitted 
in paper format and half will be submitted electronically. In order to 
avoid double counting, an estimated 50 percent of total annual 
responses for FDA Form 1932 (404) and FDA Form 1932a (81.5) are counted 
here as part of OMB Control No. 0910-0284 for the paper versions of 
Forms FDA 1932 and 1932a, and an estimated 50 percent of the total 
annual responses (404) and (81.5) for Form FDA 1932 and FDA Form 1932a 
respectively, are counted as part of OMB Control No. 0910-0645 for the 
electronic reporting of these adverse reports using the MedWatch\Plus\ 
Portal.
    In the Federal Register of October 15, 2009 (74 FR 52967), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    In a separate 30-day notice, FDA requested public comment on data 
elements associated with revisions to Forms FDA 1932 and 1932a (both 
paper and electronic) under revised OMB Control No. 0910-0645 (November 
20, 2009, 74 FR 60265). The agency plans to give companies time to 
accommodate the revisions since the proposed revisions may require 
changes to validated databases. The agency plans to provide a 
transition period for respondents until September 30, 2010, during 
which the current FDA Form 1932 (version dated 01/2007-- approved under 
this OMB Control No. 0910-0284) will be accepted as well as the revised 
FDA Form 1932 approved under revised OMB Control No. 0910-0645. After 
the transition period, Form FDA 2301 will

[[Page 2866]]

continue to be counted as part of OMB Control No. 0910-0284.
    The reporting and recordkeeping burden estimates, including the 
total number of annual responses, are based on the submission of 
reports to the Division of Surveillance, Center for Veterinary 
Medicine. The annual frequency of responses was calculated as the total 
annual responses divided by the number of respondents.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                      No. of      Annual Frequency      Total Annual      Hours per
      21 CFR Section or Section  of the Act        FDA Form No.    Respondents      per Response          Responses        Response      Total Hours
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514.80(b)(1), (b)(2)(i), (b)(2)(ii), and (b)(3)          1932\2\          404                44.26             17,881             1             17,881
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Voluntary reporting FDA Form 1932a for the              1932a\2\           81.5               1                    81.5        1\3\                 81.5
 public
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514.80(b)(4)                                                2301           84                17.0               1,428            16             22,848
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514.80(b)(5)(i)                                             2301           84                 0.31                 26             2                 52
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514.80(b)(5)(ii)                                            2301           84                33.92              2,849             2              5,698
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514.80(b)(5)(iii)                                           2301          646                 0.08                 51.68          2                103
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Total hours                                                                                                                                     46,663.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Burden hours were determined as explained previously.
\3\ The hours per response for paper versions of Forms FDA 1932 and 1932a are assumed to be 1 hour. The hours per response for the electronic version of
  Form FDA 1932 is assumed to be 1 hour, while the electronic version of Form FDA 1932a is assumed to take .6 hours to complete the form and gather the
  required information as part of the MedWatch\Plus\ Portal information collection (see 74 FR 23721 at 23727).

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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 21 CFR        No. of         Annual Frequency
Section    Recordkeepers     per Recordkeeping    Total Annual  Records   Hours per  Record      Total Hours
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514.80(                646                 7.20                    4,651                 14             65,116.8
 e)\2\
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Section 514.80(e) covers all recordkeeping hours for all adverse event reporting.

    Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-782 Filed 1-15-10; 8:45 am]
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