[Federal Register Volume 74, Number 223 (Friday, November 20, 2009)]
[Notices]
[Pages 60265-60276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-27956]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0556]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Records and Reports Concerning Experience With 
Approved New Animal Drugs; Proposed New Data Elements for Adverse Event 
Reports on Revised Forms FDA 1932 and 1932a

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 and 
to allow 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, specifically on 
new data elements to be used in revised versions of Forms FDA 1932 and 
1932a. The information contained in the reports required by this 
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 21, 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, Office of Management 
Programs (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3793.

SUPPLEMENTARY INFORMATION:

I. Background

    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 notice in the Federal Register concerning 
each proposed 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.

II. Records and Reports Concerning Experience With Approved New Animal 
Drugs; Proposed New Data Elements for Adverse Event Reports on Revised 
Forms FDA 1932 and 1932a; 21 CFR 514.80 (OMB Control No. 0910-0645)--
Revision

    Section 512(l) of the Federal Food, Drug and Cosmetic Act (the act) 
(21 U.S.C. 360b(l)) and Sec.  514.80(b) of FDA regulations (21 CFR 
514.80) require applicants of approved new animal drug applications 
(NADAs) and approved abbreviated new animal drug applications (ANADAs) 
to report adverse drug experiences and product/manufacturing defects.
    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 no longer be adequate, as animal drug effects can change 
over time and less apparent effects may take years to manifest.
    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.
    Collection of information using existing paper forms FDA 2301, 
1932, and 1932a is currently approved under OMB control number 0910-
0284, set to expire on January 31, 2010. FDA currently is seeking 
renewal of that information collection.
    FDA recently proposed to collect information using electronic 
versions of Forms FDA 1932 and 1932a as part of 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). The MedWatch\Plus\ Portal 
and Rational Questionnaire are components of a new electronic system 
for collecting, submitting, and processing adverse event reports and 
other safety information for all FDA-regulated products.
    In this 30-day notice, FDA is requesting public comment on data 
elements associated with revisions to forms FDA 1932 and 1932a (both 
paper and electronic) under revised OMB control number 0910-0645, 
described below. We will publish separately in the Federal Register a 
30-day notice to complete the renewal of OMB control number 0910-0284, 
the collection of information using existing paper forms FDA 2301, 
1932, and 1932a, to provide time for development of the revised FDA 
Forms 1932 and 1932a and their incorporation into the MedWatch OMB

[[Page 60266]]

control number 0910-0645. After these forms have been incorporated 
under MedWatch OMB control number 0910-0645, they will cease to exist 
under OMB control number 0910-0284. FDA Form 2301 will continue without 
revision under OMB control number 0910-0284.
    This 30-day notice lists the data elements associated with revised 
versions of both paper and electronic forms 1932 and 1932a under a 
revision to 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.
    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 hours per response for both paper and electronic versions 
of revised Forms FDA 1932 and 1932a are assumed to be the time it will 
take to gather the required information and complete each form. 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\
----------------------------------------------------------------------------------------------------------------
 21 CFR Section
 or  Section of    FDA Form No.       No. of      Annual Frequency    Total Annual    Hours per     Total Hours
     the Act                       Respondents      per Response       Responses       Response
----------------------------------------------------------------------------------------------------------------
514.80(b)(1),            1932\2\          404                44.264       17,882.5            1.5       26,824
 (b)(2)(i),
 (b)(2)(ii), and
 (b)(3); Paper
 Version
----------------------------------------------------------------------------------------------------------------
514.80(b)(1),           1932\2\,          404                44.264       17,882.5            1         17,882.5
 (b)(2)(i),
 (b)(2)(ii), and
 (b)(3);
 Electronic
 Version
----------------------------------------------------------------------------------------------------------------
Voluntary               1932a\3\           81.5               1               81.5            1             81.5
 reporting FDA
 Form 1932a for
 public; Paper
 Version
----------------------------------------------------------------------------------------------------------------
Voluntary               1932a\3\           81.5               1               81.5            0.6           48.9
 reporting FDA
 Form 1932a for
 public;
 Electronic
 Version
----------------------------------------------------------------------------------------------------------------
Total Hours                                                                                             44,836.9
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ FDA received 35,765 mandatory reports (Form FDA 1932) during 2007 from 808 respondents. Based on this
  experience, and taking into account the data element revisions, we estimate that CVM will receive 35,765
  mandatory reports from 808 respondents annually. We estimate that one half of the respondents (404) will use
  the paper form, while the other half (404) will submit electronically; that is, we will receive 17,882.5
  reports in paper form, and 17,882.5 reports electronically. We estimate the reporting burden for mandatory
  reporting to be: Paper form: 26,824 hours (404 respondents x 44.264 annual frequency of response x 1.5 hours
  [ap] 26,824 hours). Electronic form: 17,882.5 hours (404 respondents x 44.264 annual frequency of response x 1
  hour [ap] 17,882.5 hours).
\3\ FDA received 163 voluntary reports (Form FDA 1932a) during 2007. Based on this experience, and taking into
  account the data element revisions, we estimate that CVM will receive 163 voluntary reports from 163
  respondents annually. We estimate that one half of the respondents (81.5) will use the paper form, while the
  other half (81.5) will submit electronically; that is, we will receive 81.5 reports in paper form, and 81.5
  reports electronically. We estimate the reporting burden for voluntary reporting to be: Paper form: 81.5 hours
  (81.5 respondents x 1 annual frequency of response x 1 hour per report = 81.5 hours). Electronic form: 48.9
  hours (81.5 respondents x 1 annual frequency of response x 0.6 hours per report = 48.9 hours).


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                              No. of         Annual Frequency       Total Annual
                    21 CFR Section                        Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(e)\2\                                                           90                    55              4,949                0.5           2,475\3\
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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 recordkeeping hours for adverse event reporting on revised forms 1932 and 1932a.
\3\ The annual frequency of responses was calculated as the total annual responses divided by the number of respondents.

III. Revisions to Forms FDA 1932 and 1932a and Request for Comments

A. Background on Revisions

    Section 514.80(d) of FDA's regulations requires applicants of 
approved NADAs and ANADAs to report adverse drug experiences and 
product and manufacturing defects associated with their new animal drug 
products using Form FDA 1932. For voluntary reporting, Form FDA 1932a 
should be used instead.
    As part of FDA's ongoing effort to harmonize the agency's adverse 
event (AE) regulatory reporting requirements with those of other 
nations and streamline reporting for product and manufacturing defects, 
FDA is contemplating changes to the data elements reported on Forms FDA 
1932 and 1932a. Furthermore, the contemplated changes to Forms FDA 1932 
and 1932a are based on FDA's experience in determining the safety and 
effectiveness of product(s) and need for efficient data capture and 
entry.
    The contemplated changes to the AE reporting requirements for Form 
FDA 1932 are the product of discussions undertaken between the United 
States, Japan, and the European Union as part of the International 
Cooperation on Harmonisation of Technical Requirements for Registration 
of Veterinary Medicinal Products (VICH). FDA is considering revisions 
to Form FDA 1932 that would bring the AE reporting data elements on the 
form more in line with the data elements developed as a result of the 
VICH discussions.\1\ The agency also is

[[Page 60267]]

contemplating the inclusion of additional new data elements that would 
gather information specific only to FDA. Collecting this FDA-specific 
information is essential for the processing, review, and regulatory 
disposition of the electronic and paper reports. Inclusion of some of 
the new data elements is necessitated by the Rational Questionnaire.
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    \1\ FDA will implement all of the VICH data elements verbatim 
from the draft guidance document entitled ``Pharmacovigilance of 
Veterinary Medicinal Products Data Elements for Submission of 
Adverse Event Reports'' (VICH GL-42), in Form FDA 1932. VICH GL-42 
is currently under discussion at Step 6. This guidance is available 
on the Internet at http://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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    In addition, the agency is considering adding new data elements for 
product and manufacturing defect reports on Form FDA 1932 and 1932a. 
These changes are the product of internal FDA discussions and are 
intended to capture additional pertinent product and manufacturing 
defect information.

B. Proposed Revisions

1. Form FDA 1932
    This section describes data elements on the current Form FDA 1932, 
proposed new data elements, and data elements we propose to delete from 
the current form. These AE and product and manufacturing defect data 
elements will be collected electronically, through the MedWatch\Plus\ 
Portal and Rational Questionnaire (currently under development), and in 
the paper form.
    Table 3 of this document, entitled ``Data Elements for Form FDA 
1932,'' presents the data elements for the collection of animal drug 
adverse event reports and manufacturing and product defect reports. The 
data elements are listed in the column entitled ``Data Elements.'' The 
column entitled ``Current, New, or Deleted Data Element'' indicates 
whether the data element is currently being collected (Current)\2\, is 
a proposed new data element (New), or is a data element FDA proposes to 
delete (Deleted).
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    \2\ In general, the information being collected is the same, but 
the data element has been renamed or restructured to facilitate data 
collection.
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    As previously mentioned in this document, the agency has had 
discussions with VICH regarding the data elements to be collected for 
animal drug adverse events. As a result, the agency is proposing new 
data elements that have been negotiated with VICH. The column entitled 
``VICH-Negotiated or FDA-Proposed Data Element'' differentiates between 
VICH-negotiated and FDA-proposed data elements.
    The agency intends to allow the regulated industry to submit this 
information collection in three different submission/transmission 
formats. Industry will be able to submit these reports using a paper 
form, the Web-based Rational Questionnaire, or an electronic file 
through the FDA electronic Gateway-to-Gateway transmission. The column 
entitled ``Submission/Transmission Format'' presents the submission/
transmission format(s) that will be used with each particular data 
element.

                                    Table 3.--Data Elements for Form FDA 1932
----------------------------------------------------------------------------------------------------------------
                                                                                                 Submission/
                                                                                             Transmission Format
                                                                                                 (Paper Form,
                                                         Current, New, or   VICH-Negotiated    Electronic Web-
  Line No.                  Data Elements                  Deleted Data     or FDA-Proposed     based Rational
                                                             Element         Data Element       Questionnaire
                                                                                               (EWBRQ), and/or
                                                                                             Electronic Gateway-
                                                                                              to-Gateway (EGG))
----------------------------------------------------------------------------------------------------------------
1                                     United States-Only Specific Information, including:
----------------------------------------------------------------------------------------------------------------
2             Report Identifier (The Report Identifier  Current            FDA Proposed      All Formats
               is the FDA application or file number
               of the AER being sent.)
----------------------------------------------------------------------------------------------------------------
3             Domestic vs. Foreign Category (This is a  New                FDA Proposed      All Formats
               list of values describing whether the
               product is an FDA-approved product, a
               foreign-approved product, or other type
               of product, e.g., an unapproved drug.)
----------------------------------------------------------------------------------------------------------------
4                United States Pharmacovigilance Contact Person for the Applicant or Nonapplicant (This is the
                  person within the United States acting on behalf of the applicant or nonapplicant and is the
                   contact person for the FDA for any pharmacovigilance issues about the report.), including:
----------------------------------------------------------------------------------------------------------------
5             Title, First and Last Name                Current            FDA Proposed      All Formats
----------------------------------------------------------------------------------------------------------------
6             Telephone Number, Fax Number, and E-Mail  New                FDA Proposed      All Formats
               Address
----------------------------------------------------------------------------------------------------------------
7                    Message Sender Identifier (Name and contact information of person responsible for any
                  corresponding communications regarding the whole batch electronic transmission.), including:
----------------------------------------------------------------------------------------------------------------
8             Street Address, City, State/County, and   New                FDA Proposed      EGG Only
               Mail/Zip Code
----------------------------------------------------------------------------------------------------------------
9             Three-character Country Code (This is     New                FDA Proposed      EGG Only
               the list of country codes from the
               International Organization for
               Standardization (ISO) 3166 standard.)
----------------------------------------------------------------------------------------------------------------
10            First and Last Name                       New                FDA Proposed      EGG Only
----------------------------------------------------------------------------------------------------------------
11            Telephone Number, Fax Number, and E-Mail  New                FDA Proposed      EGG Only
               Address
----------------------------------------------------------------------------------------------------------------
12            Profile Identifier Code (This             New                FDA Proposed      EWBRQ and EGG Only
               information indicates the type of
               report contained in the electronic
               message.)
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[[Page 60268]]

 
13            Batch ID (This information identifies     New                FDA Proposed      EGG Only
               the reports in this batch as a whole
               electronic message.)
----------------------------------------------------------------------------------------------------------------
14            Message Date (This information indicates  New                FDA Proposed      EGG Only
               the date this batch report is created.)
----------------------------------------------------------------------------------------------------------------
15            Message Version Number & Release Number   New                FDA Proposed      EGG Only
               (This information indicates the Health
               Level Seven, Inc. (HL7) ``Message
               Version'' and ``Release Number'' on
               which this batch report electronic
               submission is based.)
----------------------------------------------------------------------------------------------------------------
16                                    Adverse Event Report (AER) Information, including:
----------------------------------------------------------------------------------------------------------------
17            Unique AER Identification Number (This    New                VICH Negotiated   All Formats
               globally unique AER identification
               number is created by and assigned by
               the applicant or nonapplicant.)
----------------------------------------------------------------------------------------------------------------
18            Original Receive Date (The original       Current            VICH Negotiated   All Formats
               receive date is the date on which the
               first full communication of the AER was
               received by the applicant or
               nonapplicant responsible for reporting
               the AER to the FDA.)
----------------------------------------------------------------------------------------------------------------
19            Date of Current Submission (This is the   Current            VICH Negotiated   All Formats
               date the current AER was submitted to
               the Regulatory Authority (RA).)
----------------------------------------------------------------------------------------------------------------
20                                                Type of Report, including:
----------------------------------------------------------------------------------------------------------------
21            Type of Submission (This is a list of     Current            VICH Negotiated   All Formats
               values describing the regulatory type
               of report being submitted to the RA,
               e.g., 15-day NADA/ANADA alert report, 3-
               day NADA/ANADA field alert report,
               followup report, nullification report,
               periodic drug experience report, and
               other report.)
----------------------------------------------------------------------------------------------------------------
22            Reason for Nullification Report (This is  Current            VICH Negotiated   All Formats
               a text description of why this AER is
               being nullified.)
----------------------------------------------------------------------------------------------------------------
23            Type of Information in Report (This is a  New                VICH Negotiated   All Formats
               list of values for the categorization
               of the type of information in the AER,
               e.g., spontaneous safety and lack of
               expected effectiveness information,
               clinical study safety information,
               product and manufacturing defect
               information, product and manufacturing
               defect with safety and lack of expected
               effectiveness information, and other
               type of information.)
----------------------------------------------------------------------------------------------------------------
24               Regulatory Authority (RA) Information (This is the RA to which this AE report (AER) is to be
                  initially submitted based on the RA that has authority to regulate the product.), including:
----------------------------------------------------------------------------------------------------------------
25            RA Name                                   Current            VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
26            Street Address, City, State/County, and   Current            VICH Negotiated   All Formats
               Mail/Zip Code
----------------------------------------------------------------------------------------------------------------
27            Three-character Country Code              Current            VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
28              Marketing Authorization Holder (MAH) information. (The MAH is the applicant or the nonapplicant
                                who is responsible for reporting the AER to the RA.), including:
----------------------------------------------------------------------------------------------------------------
29            Business Name                             Current            VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
30            Street Address, City, State/County, and   Current            VICH Negotiated   All Formats
               Mail/Zip Code
----------------------------------------------------------------------------------------------------------------
31            Three-character Country Code              Current            VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
32            Person Acting on Behalf of the MAH        .................  ................  ...................
               information, including:
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33            Title, First and Last Name                Current            VICH Negotiated   All Formats
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[[Page 60269]]

 
34            Telephone Number, Fax Number, and E-Mail  New                VICH Negotiated   All Formats
               Address
----------------------------------------------------------------------------------------------------------------
35             Primary Reporter's information (The primary reporter is the person or organization, as determined
                   by the MAH, which holds or provides the most pertinent information related to this AER.),
                                                           including:
----------------------------------------------------------------------------------------------------------------
36            First and Last Name                       Current            VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
37            Telephone and Fax Number                  Current            VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
38            E-Mail Address                            New                VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
39            Business Name                             Current            VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
40            Street Address, City, State/County, and   Current            VICH Negotiated   All Formats
               Mail/Zip Code
----------------------------------------------------------------------------------------------------------------
41            Three-character Country Code              Current            VICH Negotiated   All Formats
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42            Primary Reporter Category (This is a      New                VICH Negotiated   All Formats
               list of values describing the role/
               involvement of the primary reporter,
               e.g., animal owner, physician, et
               cetera.)
----------------------------------------------------------------------------------------------------------------
43             Other Reporter's information (The other reporter is the person or organization, determined by the
                        MAH, who also possesses pertinent information related to this AER.), including:
----------------------------------------------------------------------------------------------------------------
44            First and Last Name                       Current            VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
45            Telephone and Fax Number                  Current            VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
46            E-Mail Address                            New                VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
47            Business Name                             Current            VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
48            Street Address, City, State/County, and   Current            VICH Negotiated   All Formats
               Mail/Zip Code
----------------------------------------------------------------------------------------------------------------
49            Three-character Country Code              Current            VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
50            Other Reporter Category (This is a list   New                VICH Negotiated   All Formats
               of values describing the role/
               involvement of the other reporter,
               e.g., animal owner, physician, et
               cetera.)
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51                        Veterinary Medical Product (VMP) and Data Usage (for all VMPs), including:
----------------------------------------------------------------------------------------------------------------
52            Registered or Brand Name (This is the     Current            VICH Negotiated   All Formats
               name by which the product is presented
               by the MAH, also known as the
               Proprietary Name or Trade Name of the
               product.)
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53            Product Code (The product code is the     New                VICH Negotiated   All Formats
               National Drug Code (NDC) number for
               U.S. FDA-regulated products.)
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54            Registration Identifier (The              .................  VICH Negotiated   All Formats
               Registration Identifier is the code for
               where the VMP is approved, what RA is
               responsible for regulating VMP, and the
               registration number of the VMP.)
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55            ATCvet Code (ATCvet stands for Anatomic   New                VICH Negotiated   All Formats
               Therapeutic Chemical System for
               Veterinary Medicine. It is used for the
               classification of substances intended
               for therapeutic use and can serve as a
               tool for the classification of
               veterinary medicinal products. More
               information about the ATCvet code is
               available at http://www.whocc.no/atcvet/
               )
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56            Who Administered the VMP (This is a list  Current            VICH Negotiated   All Formats
               of values describing the person who
               administered the VMP(s) to the animal
               involved in the AE, e.g., veterinarian,
               animal owner, et cetera.)
----------------------------------------------------------------------------------------------------------------

[[Page 60270]]

 
57            Company or MAH (This is the name(s) of    Current            VICH Negotiated   All Formats
               the company or MAH that owns the VMP(s)
               involved in the AE.)
----------------------------------------------------------------------------------------------------------------
58            MAH Assessment (This is the assessment    Current            VICH Negotiated   All Formats
               by the MAH of the association between
               the use of the VMP and the AE.)
----------------------------------------------------------------------------------------------------------------
59            FDA, Office of Regulatory Affairs (ORA)   New                FDA Proposed      All Formats
               District Field Office (This is a list
               of values identifying the ORA District
               Field Office or local FDA residence
               post to which the product and
               manufacturing defect information was
               submitted. This field is used for
               product and manufacturing defect
               reports and if the report is both an AE
               and a product and manufacturing defect
               report.)
----------------------------------------------------------------------------------------------------------------
60            Use According to Label (This element      Current            VICH Negotiated   All Formats
               requests information regarding whether
               the VMP(s) was used according to its
               label.)
----------------------------------------------------------------------------------------------------------------
61            Explanation for Off-Label Use Code (This  New                VICH Negotiated   All Formats
               is the list of values describing how
               the VMP was used in an off-label
               (extralabel) manner.)
----------------------------------------------------------------------------------------------------------------
62                                         Active Ingredient information, including:
----------------------------------------------------------------------------------------------------------------
63            Active Ingredient(s) (These are the       Current            VICH Negotiated   All Formats
               names of the pharmaceutical substances
               that comprise the active component of
               the VMP.)
----------------------------------------------------------------------------------------------------------------
64            Strength and Strength Unit (Numerator     Current            VICH Negotiated   All Formats
               and Denominator) (Strength is the
               concentration of the active
               ingredient.)
----------------------------------------------------------------------------------------------------------------
65             Active Ingredient Code (The active       New                VICH Negotiated   All Formats
               ingredient code is the Unique
               Ingredient Identifier (UNII) code. The
               UNII code is generated by the joint FDA/
               United States Pharmacopeia (USP)
               Substance Registration System (SRS).)
----------------------------------------------------------------------------------------------------------------
66            Dosage Form (This is a selection for a    Current            VICH Negotiated   All Formats
               list of values for the labeled dosage
               form of the VMP(s).)
----------------------------------------------------------------------------------------------------------------
67                                              Dosing Information, including:
----------------------------------------------------------------------------------------------------------------
68            Date of First Exposure (Day, Month,       Current            VICH Negotiated   All Formats
               Year) (This is the date on which the
               animal was first treated with the VMP.)
----------------------------------------------------------------------------------------------------------------
69            Date of Last Exposure (Day, Month, Year)  Current            VICH Negotiated   All Formats
               (This is the date on which the animal
               was last treated with the VMP.)
----------------------------------------------------------------------------------------------------------------
70            Numeric Value and Unit for Interval of    Current            VICH Negotiated   All Formats
               Administration (This is the frequency
               of administration of the VMP(s).)
----------------------------------------------------------------------------------------------------------------
71            Numeric Value and Unit for Dose (This is  Current            VICH Negotiated   All Formats
               the actual quantity of the dose
               administered.)
----------------------------------------------------------------------------------------------------------------
72            Route of Exposure (This is a selection    Current            VICH Negotiated   All Formats
               from a list of values for the route by
               which the VMP was administered.)
----------------------------------------------------------------------------------------------------------------
73                                            Lot Number Information, including:
----------------------------------------------------------------------------------------------------------------
74            Lot Number (This is the lot number        Current            VICH Negotiated   All Formats
               associated with the VMP in this AER.)
----------------------------------------------------------------------------------------------------------------
75            Expiration Date (Day, Month, Year) (This  New                VICH Negotiated   All Formats
               is the expiration date associated with
               the lot number.)
----------------------------------------------------------------------------------------------------------------
76            Manufacturing Site Identifier Number      New                FDA Proposed      All Formats
               (This is the FDA Establishment Number
               (FEI Number) or the Data Universal
               Number System (D-U-N-S[reg] Number.)
----------------------------------------------------------------------------------------------------------------

[[Page 60271]]

 
77            Manufacturer's Identifier Type (This is   New                FDA Proposed      All Formats
               a list of values describing the type of
               manufacturing site identifier number,
               i.e., FEI Number or D-U-N-S[reg]
               Number.)
----------------------------------------------------------------------------------------------------------------
78            Manufacturing Date (Day, Month, Year)     New                FDA Proposed      All Formats
               (This is the date the VMP was
               manufactured.)
----------------------------------------------------------------------------------------------------------------
79            Number of Defective Units (This is the    New                FDA Proposed      All Formats
               number of defective units associated
               with this VMP.)
----------------------------------------------------------------------------------------------------------------
80            Number of Units Returned (This is the     New                FDA Proposed      All Formats
               number of defective units associated
               with this VMP returned to the applicant
               or nonapplicant.)
----------------------------------------------------------------------------------------------------------------
81                                           Adverse Event Information, including:
----------------------------------------------------------------------------------------------------------------
82            Attending Veterinarian's Assessment       Current            VICH Negotiated   All Formats
               (This is a list of values describing
               the assessment of the attending
               veterinarian regarding the association
               between the VMP(s) and the AE (other
               than human).)
----------------------------------------------------------------------------------------------------------------
83            Previous Exposure to the VMP (Was the     Current            VICH Negotiated   All Formats
               animal previously exposed to the
               VMP(s)?)
----------------------------------------------------------------------------------------------------------------
84            Previous AE to the VMP (Did the animal    Current            VICH Negotiated   All Formats
               have a previous AE to the VMP(s)?)
----------------------------------------------------------------------------------------------------------------
85            Duration and Time Units (This is the      Current            VICH Negotiated   All Formats
               length of time the AE lasted.)
----------------------------------------------------------------------------------------------------------------
86            Serious AE (Was the AE serious?)          Current            VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
87            Treatment of AE (Was the AE treated?)     Current            VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
88                                          Outcome to Date, including: (number of)
----------------------------------------------------------------------------------------------------------------
89            Recovered/Normal, Ongoing, Recovered      Current            VICH Negotiated   All Formats
               with Sequela, and Unknown
----------------------------------------------------------------------------------------------------------------
90             Euthanized                               New                VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
91             Died                                     Current            VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
92             Length of Time Between Exposure to       Current            VICH Negotiated   All Formats
               VMP(s) and Onset of AE (This is a list
               of values describing the length of time
               between the first exposure to the VMP
               and the onset of the AE.)
----------------------------------------------------------------------------------------------------------------
93            Date of Onset of AE (Day, Month, Year)    Current            VICH Negotiated   All Formats
               (This is the date of the first clinical
               manifestation of the AE.)
----------------------------------------------------------------------------------------------------------------
94            Adverse Clinical Manifestations (This is  Current            VICH Negotiated   All Formats
               a list of values describing the
               clinical signs that occurred during the
               AE.)
----------------------------------------------------------------------------------------------------------------
95            Narrative of AE (open text field) (This   Current            VICH Negotiated   All Formats
               is a detailed description of the case,
               regardless of the type of information
               contained in the report.)
----------------------------------------------------------------------------------------------------------------
96             Did the AE Abate After Stopping the      Current            VICH Negotiated   All Formats
               VMP?
----------------------------------------------------------------------------------------------------------------
97            Did the AE Reappear After Re-             Current            VICH Negotiated   All Formats
               Introduction of the VMP?
----------------------------------------------------------------------------------------------------------------
98                                                  Animal Data, including:
----------------------------------------------------------------------------------------------------------------
99            Species (This is a list of values         Current            VICH Negotiated   All Formats
               describing the species of the animal(s)
               involved in the AER.)
----------------------------------------------------------------------------------------------------------------

[[Page 60272]]

 
100           Breeds and Crossbreed Information (This   Current            VICH Negotiated   All Formats
               is a list of values describing the
               breed(s) of animal(s) involved in the
               AER.)
----------------------------------------------------------------------------------------------------------------
101           Gender (This is a list of values for the  Current            VICH Negotiated   All Formats
               selection of the gender(s) of animal(s)
               involved in the AER.)
----------------------------------------------------------------------------------------------------------------
102           Reproductive Status (This is a list of    Current            VICH Negotiated   All Formats
               values describing if the animal is
               intact, neutered, etc.)
----------------------------------------------------------------------------------------------------------------
103           Female Physiological Status. (This is a   Current            VICH Negotiated   All Formats
               list of values describing the animal's
               pregnancy and lactation status.)
----------------------------------------------------------------------------------------------------------------
104                                     Age (Measured, Estimated, Unknown), including:
----------------------------------------------------------------------------------------------------------------
105           Precision Value for Age (Measured,        New                VICH Negotiated   All Formats
               Estimated, Unknown Age. This is a list
               of values describing whether the age(s)
               provided are measured or estimated, or
               if age is not known.)
----------------------------------------------------------------------------------------------------------------
106            Minimum Age Value and Units.             Current            VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
107            Maximum Age Value and Units.             Current            VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
108                                                   Weight, including:
----------------------------------------------------------------------------------------------------------------
109           Precision Value for Weight (Measured,     New                VICH Negotiated   All Formats
               Estimated, Unknown Weights) (This is a
               list of values describing whether the
               weight(s) provided are measured or
               estimated, or if weight is not known.)
----------------------------------------------------------------------------------------------------------------
110           Minimum Weight                            Current            VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
111           Maximum Weight                            Current            VICH Negotiated   All Formats
----------------------------------------------------------------------------------------------------------------
112           Attending Veterinarian's Assessment of    Current            VICH Negotiated   All Formats
               Animal Health Status Prior to VMP.
               (This is a list of values describing
               the attending veterinarian's assessment
               of the health status of the animal(s)
               involved in the AE prior to their
               exposure to the VMP.)
----------------------------------------------------------------------------------------------------------------
113           Number of Animals Treated (This is the    Current            VICH Negotiated   All Formats
               number of animal(s) being directly
               treated by the VMP(s).)
----------------------------------------------------------------------------------------------------------------
114           Number of Animals Affected (This is the   Current            VICH Negotiated   All Formats
               total number of animals affected in the
               AER, whether by direct or indirect
               exposure.)
----------------------------------------------------------------------------------------------------------------
115                                           Supplemental Documents, including:
----------------------------------------------------------------------------------------------------------------
116           Attached Document (These are additional   Current            VICH Negotiated   All Formats
               documents containing information
               relevant to the AE, such as medical
               record, radiology, clinical chemistry
               reports, newspaper articles, and
               letters.)
----------------------------------------------------------------------------------------------------------------
117           Attached Document Filename (This is the   Current            VICH Negotiated   All Formats
               name of the document for paper
               documents or the electronic file for
               electronic transmissions.)
----------------------------------------------------------------------------------------------------------------
118           Attached Document Type (This is a list    Current            VICH Negotiated   All Formats
               of values describing the type of
               document that is attached, e.g.,
               necropsy report)
----------------------------------------------------------------------------------------------------------------
119                     The following data elements are being deleted from the information collection:
----------------------------------------------------------------------------------------------------------------
120           2c. Number of Days Between 2a and b:      Deleted            ................  ...................
----------------------------------------------------------------------------------------------------------------
121           11. Illness/reason for use of this drug   Deleted            ................  ...................
----------------------------------------------------------------------------------------------------------------

[[Page 60273]]

 
122           17. Did any new illness develop or did    Deleted            ................  ...................
               initial diagnosis change after suspect
               drug started?
----------------------------------------------------------------------------------------------------------------
123           25. Outcome of Reaction to Date - Died    Deleted            ................  ...................
----------------------------------------------------------------------------------------------------------------
124           26. When reaction appeared, treatment     Deleted            ................  ...................
               with suspect drug: has already been
               completed, discontinued, replaced with
               another drug; continued at altered
               dose, other (explain)--and the
               reaction: continued, stopped, recurred,
               or other (explain)
----------------------------------------------------------------------------------------------------------------
125           29. Had animal(s) previously reacted to   Deleted            ................  ...................
               other drugs?
----------------------------------------------------------------------------------------------------------------
126           30. Has the attending veterinarian seen   Deleted            ................  ...................
               similar reactions to this drug in any
               other animals?
----------------------------------------------------------------------------------------------------------------
127           32. Signature of individual responsible   Deleted            ................  ...................
               for accuracy of reported information
----------------------------------------------------------------------------------------------------------------

2. Form FDA 1932a
    This section describes data elements on the current Form FDA 1932a 
and the proposed new data elements. These AE and product and 
manufacturing defect data elements will be collected electronically, 
through the MedWatch\Plus\ Portal Rational Questionnaire, and in the 
paper form. All the data elements will be captured using the 
MedWatch\Plus\ Portal Rational Questionnaire or the paper form.
    Table 4 of this document, entitled ``Data Element Information 
Collection for Form FDA 1932a,'' presents the data elements the agency 
is proposing for the collection of animal drug adverse events reports 
and manufacturing and product problem reports for individuals who 
choose to report information voluntarily to FDA. The current and 
proposed new data elements are listed in the column entitled ``Data 
Elements.'' In general, the information being collected is the same, 
but the data element has been renamed or restructured to facilitate 
data collection. As stated previously in this document, the proposed 
changes are based on FDA's experience in determining the safety and 
effectiveness of product(s) and need for efficient data capture and 
entry.

    Table 4.--Data Element Information Collection for Form FDA 1932a
------------------------------------------------------------------------
                                                          Current or New
 Line No.                  Data Elements                   Data Element
------------------------------------------------------------------------
1          Individual Case Safety Report Number (FDA-     New
            Assigned Number)
------------------------------------------------------------------------
2          Date of Initial Report. (This is the date the  New
            sender sent the first report of the
            information.)
------------------------------------------------------------------------
3          Date Reported (This is the date of this        Current
            current report.)
------------------------------------------------------------------------
4          Submission Type (This is a list of values      New
            describing the type of submission, e.g.,
            Initial or Followup Report)
------------------------------------------------------------------------
5          Report Type (This is a list of values          New
            describing the type of information in the
            report, e.g., adverse event, product
            problem, or both)
------------------------------------------------------------------------
6          Manufacturer's Case Number. (The               Current
            manufacturer's case number is given to the
            sender by the manufacturer of the product if
            the sender contacted the manufacturer.)
------------------------------------------------------------------------
7           Sender Information (The sender is the person or organization
               which fills out the report and submits or transmits the
                             report to FDA.), including:
------------------------------------------------------------------------
8          Sender First and Last Name                     New
------------------------------------------------------------------------
9          Sender Street Address, City, State/Province,   New
            Postal/Zip Code, and Country
------------------------------------------------------------------------
10         Sender Primary and Other Telephone Number, E-  New
            Mail Address, and Fax Number
------------------------------------------------------------------------
11         Sender Category. (This is a list of values     New
            describing the role/involvement of the
            sender, e.g., animal owner, physician, etc.)
------------------------------------------------------------------------

[[Page 60274]]

 
12         Did the sender report to other sources?        New
------------------------------------------------------------------------
13         Sender also reported to other sources. (This   New
            is a list of values describing the sources
            to which the sender reported the AE or
            product problem, e.g., manufacturer,
            distributor, etc.)
------------------------------------------------------------------------
14         No identity disclosure (This data element      Current
            indicates whether the sender wants their
            identity disclosed to the manufacturer.)
------------------------------------------------------------------------
15         Preferred Method of Contact. (This is a list   New
            of values describing the preferred method of
            contacting the sender, e.g., telephone, e-
            mail.)
------------------------------------------------------------------------
16                Healthcare Professional Information, including:
------------------------------------------------------------------------
17         Healthcare Professional First and Last Name.   Current
------------------------------------------------------------------------
18         Healthcare Professional Street Address, City,  Current
            State/Province, and Postal/Zip Code
------------------------------------------------------------------------
19         Healthcare Professional Primary and Other      Current
            Phone Number
------------------------------------------------------------------------
20         Healthcare Professional e-mail address         New
------------------------------------------------------------------------
21         Healthcare Professional Country                New
------------------------------------------------------------------------
22         Owner's Information (This is the owner of the animal involved
                              in the case.), including:
------------------------------------------------------------------------
23         Owner First and Last Name.                     Current
------------------------------------------------------------------------
24         Owner Primary and Other Phone Number, and E-   New
            Mail Address
------------------------------------------------------------------------
25         Owner Street Address, City, State/Province,    New
            Postal/Zip Code, and Country
------------------------------------------------------------------------
26                              Product Information:
------------------------------------------------------------------------
27         Name of Suspected Product. (This is the name   Current
            of the product suspected of causing the AE
            or the product with the product problem.)
------------------------------------------------------------------------
28         Name of Manufacturer                           Current
------------------------------------------------------------------------
29         Lot Number                                     Current
------------------------------------------------------------------------
30         Expiration Date                                Current
------------------------------------------------------------------------
31         Diagnosis and/or Reason for Use of the         Current
            Product
------------------------------------------------------------------------
32         Product Use Information: Dose Administered     Current
            (amount of product administered), Interval
            of Administration (frequency of
            administration--every 12 hours or for 5
            days), and Route of Administration (oral,
            injection, topical, etc.).
------------------------------------------------------------------------
33         Dosage Form. (This is how the product was      Current
            supplied to the animal, e.g., chewable
            tablet, topical, injection)
------------------------------------------------------------------------
34         Date of First and Last Exposure. (This is the  Current
            date the product(s) was first administered
            and last administered to the animal.)
------------------------------------------------------------------------
35         Duration of Product Use (Number) and Units of  New
            Measurement. (This is the duration the
            product was given, e.g., 2 weeks.)
------------------------------------------------------------------------
36         Product Administered By (This is a list of     Current
            values describing who administered the
            product(s), e.g., veterinarian/veterinary
            staff, Owner)
------------------------------------------------------------------------
37         Concurrent Drugs Administered (Were            Current
            concurrent product(s) given to the
            animal(s)?)
------------------------------------------------------------------------
38         Concurrent Products Names. (This is the name   Current
            of all concurrent products involved in the
            case.)
------------------------------------------------------------------------
39                              Animal Information:
------------------------------------------------------------------------
40         Species. (This is a list of values for         Current
            selecting the species of the animal(s)
            involved in the case.)
------------------------------------------------------------------------
41         Breed and Crossbreed (This is the breed(s) of  Current
            animal(s) involved in the report.)
------------------------------------------------------------------------
42         Gender. (This a list of values for the         Current
            selection of the gender(s) of animal(s)
            involved in the AER.)
------------------------------------------------------------------------

[[Page 60275]]

 
43         Reproductive Status. (This is a list of        Current
            values describing whether the animal is
            intact, neutered, et cetera.)
------------------------------------------------------------------------
44         Age and Age Units                              Current
------------------------------------------------------------------------
45         Weight and Weight Units                        Current
------------------------------------------------------------------------
46         Overall Health Status When Suspected Product   Current
            Given. (This is a list of values describing
            the health status of the animal(s) involved
            in the AE prior to their exposure to the
            product(s).)
------------------------------------------------------------------------
47         Number of Animals Treated (This is the number  New
            of animal(s) being directly treated by the
            product(s).)
------------------------------------------------------------------------
48         Number of Animals Affected. (This is the       New
            total number of animals affected in the AER,
            whether by direct or indirect exposure.)
------------------------------------------------------------------------
49         Adverse Event Information:
------------------------------------------------------------------------
50         Veterinarian's Level of Suspicion that         Current
            Product Caused the AE. (This is a list of
            values describing the veterinarian's level
            of suspicion, e.g., high, medium, low, or
            unknown.)
------------------------------------------------------------------------
51         Treatment of AE. (This is a description of     Current
            how the AE was treated.)
------------------------------------------------------------------------
52         Did the AE Abate After Stopping the Product?   Current
------------------------------------------------------------------------
53         Did the AE Reappear After Reintroduction of    Current
            the product?
------------------------------------------------------------------------
54         Outcome. (This is a list of values describing  Current
            the overall animal health status after
            exposure to the product.)
------------------------------------------------------------------------
55         Length of Time Between Initial Exposure to     Current
            Suspected Product and Onset of AE, numeric
            value and units of measurement
------------------------------------------------------------------------
56         Length of Time Between Last Administration of  Current
            Suspected Product and Onset of AE, numeric
            value and units of measurement
------------------------------------------------------------------------
57         Date of Onset of AE. (This is the date that    New
            the first adverse clinical sign(s)
            occurred.)
------------------------------------------------------------------------
58         Date of Product Problem Discovery. (This is    New
            the date that the product problem was
            discovered.)
------------------------------------------------------------------------
59         When the AE Occurred, Treatment with           Current
            Suspected Product. (This is a list of values
            describing the use of the suspected product
            after the AE occurred)
------------------------------------------------------------------------
60                      Other Relevant Clinical Information:
------------------------------------------------------------------------
61         Concurrent Clinical Problem (Does the          Current
            animal(s) have concurrent clinical
            problems?)
------------------------------------------------------------------------
62         List Concurrent Clinical Problem(s)            Current
------------------------------------------------------------------------
63         AE/Product Problem (Long Narrative) (This is   Current
            a detailed description of the case.)
------------------------------------------------------------------------
64                            Supplemental Documents:
------------------------------------------------------------------------
65         Attached Document Name/File name (if           Current
            electronic) (This is the name of the
            document for paper documents or the name of
            the electronic file for electronic
            transmissions.)
------------------------------------------------------------------------
66         Attached Document Type (This is a list of      Current
            values describing the type of document that
            is attached, e.g., necropsy report)
------------------------------------------------------------------------
67         Attached Document(s) (These are additional     Current
            documents containing information relevant to
            the AE, e.g., medical record, radiology,
            clinical chemistry reports, newspaper
            articles, and letters.)
------------------------------------------------------------------------
68         Attached Document Description. (This is a      New
            description of the document.)
------------------------------------------------------------------------

C. Request for Comments

    FDA invites comments on all aspects of the revised collection of 
the data elements for Forms FDA 1932 and 1932a as set forth in section 
III.B of this notice, including whether such lists incorporate all data 
elements necessary to report an adverse event and a product or 
manufacturing defect, and whether certain data elements should be 
deleted or modified. Interested persons may submit to the Division of 
Dockets Management (see ADDRESSES) electronic or written comments 
regarding the proposed changes. Submit a single copy of electronic 
comments or two paper copies of any mailed comments, except that 
individuals may submit one paper copy. Comments are to be identified 
with the docket number found in

[[Page 60276]]

brackets in the heading of this document. Received comments may be seen 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: November 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27956 Filed 11-19-09; 8:45 am]
BILLING CODE 4160-01-S