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Notice: 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
Federal Register: November 20, 2009 (Volume 74, Number 223)
Page 60265-60276AGENCY: 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:
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
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.
---------------------------------------------------------------------------
\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.
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).
---------------------------------------------------------------------------
\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 ................ ...................
----------------------------------------------------------------------------------------------------------------
[[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
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