Agency Information Collection Activities; Proposals, Submissions, and Approvals
Federal Register: November 20, 2009 (Volume 74, Number 223)
Notices
Page 60265-60276
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr20no09-78
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.
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:
-
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.
-
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\
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\
\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.
-
Revisions to Forms FDA 1932 and 1932a and Request for Comments
-
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.
\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.
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.
-
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).
\2\ In general, the information being collected is the same, but the data element has been renamed or restructured to facilitate data collection.
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.)
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:
33
Title, First and Last Name
Current
VICH Negotiated All Formats
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
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.)
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.)
53
Product Code (The product code is the
New
VICH Negotiated All Formats
National Drug Code (NDC) number for
U.S. FDA-regulated products.)
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.)
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/
)
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
................ ...................
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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.)
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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.)
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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.)
-
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
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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
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