
[Federal Register: October 15, 2009 (Volume 74, Number 198)]
[Notices]               
[Page 52967-52968]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15oc09-60]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Agency Information Collection Activities; Proposed Collection; 
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.

-----------------------------------------------------------------------

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 requirements for recordkeeping 
and reports concerning experience with approved new animal drugs. The 
information contained in the reports required by the regulation enables 
FDA to monitor the use of new animal drugs after approval and to ensure 
their continued safety and efficacy.

DATES: Submit written or electronic comments on the collection of 
information by December 14, 2009.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (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 Jr, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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 extension of an existing collection of information, 
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 these topics: (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.

Records and Reports Concerning Experience With Approved New Animal 
Drugs; Adverse Event Reports on Forms FDA 1932, 1932a, and 2301--21 CFR 
Section 514.80 (OMB No. 0910-0284)--Extension

    Sections 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. Postapproval 
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 of 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 number 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 number 0910-0645 for 
the electronic reporting of these adverse reports using the 
MedWatch\Plus\ Portal.
    The paper versions of Forms FDA 1932 and 1932a, as well as Form FDA

[[Page 52968]]

2301, will continue to be counted as part of OMB control number 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       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
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(1), (b)(2)(i), (b)(2)(ii), and (b)(3)           1932\2\          404                44.26             17,882.5          1             17,882.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Voluntary reporting FDA Form 1932a for the public        1932a\2\           81.5               1                    81.5       1\3\                 81.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(4)                                                 2301           84                17.0               1,428           16             22,848
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(5)(i)                                              2301           84                 0.31                 26            2                 52
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(5)(ii)                                             2301           84                33.92              2,849            2              5,698
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(5)(iii)                                            2301          646                 0.08                 49            2                 98
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Hours                                                                                                                                     46,660
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Burden hours were determined as explained above.
\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, May 20, 2009).


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
 21 CFR        No. of         Annual Frequency
Section    Recordkeepers     per Recordkeeping    Total Annual  Records   Hours per  Record      Total Hours
----------------------------------------------------------------------------------------------------------------
514.80(                646                 7.20                     4651                 14             65,116.8
 e)\2\
----------------------------------------------------------------------------------------------------------------
Total                                                                                                    1,541
----------------------------------------------------------------------------------------------------------------
\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: October 7, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24734 Filed 10-14-09; 8:45 am]

BILLING CODE 4160-01-S
