0910-0284 Revision by ADE Electronic Submission FR

UNITED STATES FOOD & DRUG ADMINISTRATION
Animal Drug Adverse Event Reporting and Recordkeeping
OMB Control No. 0910-0284
RIN 0910-AH51
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection request supports rulemaking. With regard to adverse events
and product/manufacturing defects associated with approved new animal drugs, section
512(l) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(l))
requires applicants with approved new animal drug applications (NADAs) and
abbreviated new animal drug applications (ANADAs) to establish and maintain records
and reports of data relating to experience with uses of such drug, or with respect to
animal feeds bearing or containing such drug, to facilitate a determination under section
512(e) as to whether there may be grounds for suspending or withdrawing approval of the
NADA or ANADA under section 512(e) or 512(m)(4). FDA is issuing this final rule to
amend our regulations under § 514.80 (21 CFR 514.80) to require electronic submission
of certain postmarketing safety reports for approved new animal drugs and to provide a
procedure for requesting a temporary waiver of the requirement. This action will
improve our systems for collecting and analyzing postmarketing safety reports. The
change will help us to more rapidly review postmarketing safety reports, identify
emerging safety problems, and disseminate safety information in support of our public
health mission. In addition, the amendments will facilitate international harmonization
and exchange of safety information.
The final rule requires electronic submission for the following reports for approved new
animal drugs: 3-day alert reports that applicants elect to submit directly to FDA’s Center
for Veterinary Medicine (CVM) in addition to the requirement they have to submit these
reports on paper Form FDA 1932 to the appropriate FDA District Office or local FDA
resident post; 15-day alert reports and followup reports; product/manufacturing defect
and adverse drug experience reports submitted by nonapplicants who elect to report
adverse drug experiences directly to CVM in addition to providing these reports to the
applicant; product/manufacturing defect and adverse drug experience reports (including
reports of previously not reported adverse drug experiences that occur in postapproval
studies) required to be submitted as part of the periodic drug experience report.
We therefore request OMB approval of the information collection provisions of the final
rule, as discussed in this supporting statement, including one-time recordkeeping burden
for creating new SOPs to submit the reports electronically and the one-time burden of
training employees to electronically submit postmarketing safety reports to CVM in
accordance with the new SOPs.

2. Purpose and Use of the Information Collection
The purpose of this information collection is to enable the submission and review of
certain postmarketing safety reports for approved new animal drugs. This rule does not
change the content of these postmarketing safety reports or the frequency of the reporting
requirements.
Section 514.80 requires applicants and nonapplicants to keep records of and report to us
data, studies, and other information concerning experience with new animal drugs for
each approved NADA and ANADA. Following complaints from animal owners or
veterinarians, or following their own detection of a problem, applicants or nonapplicants
are required to submit adverse event reports and product/manufacturing defect reports
under § 514.80(b)(1), (b)(2)(i) and (ii), (b)(3), and (b)(4)(iv)(A) and (C) on Form FDA
1932.
We review the records and reports required in § 514.80 to facilitate a determination under
section 512(e) of the FD&C Act as to whether there may be grounds for suspending or
withdrawing approval of the new animal drug.
The final rule also revises these requirements to allow applicants or nonapplicants to
request a temporary waiver from the electronic submission requirement for “good cause”
shown. Examples of circumstances that could constitute “good cause” for granting
waivers of the electronic submission requirement include crisis situations that impact an
applicant’s or nonapplicant’s ability to report electronically, such as natural disasters,
pandemics, and terrorism. The rule requires applicants and nonapplicants to submit a
waiver request to us in writing. The initial request, however, could be made by telephone
or email to CVM’s Division of Veterinary Product Safety, with prompt written followup
submitted as a letter to the application. We will use the information sent to us in a waiver
request to make a determination to allow a temporary waiver of the electronic submission
requirement.
The continuous monitoring of new animal drugs affords the primary means by which we
obtain information regarding problems with the safety and efficacy of marketed approved
new animal drugs, as well as product/manufacturing problems. Postapproval marketing
surveillance is important to ensure the continued safety and effectiveness of new animal
drugs. Drug effects can change over time and other effects may not manifest until years
after the approval.
Description of Respondents: Respondents to this collection of information are applicants
and nonapplicants. An applicant is defined as “a person or entity who owns or holds on
behalf of the owner the approval for an NADA (new animal drug application) or an
ANADA (abbreviated new animal drug application), and is responsible for compliance
with applicable provisions of the act and regulations.” (§ 514.3 (21 CFR 514.3)) In
addition, nonapplicants, defined in § 514.3 as “any person other than the applicant whose
name appears on the label and who is engaged in manufacturing, packing, distribution, or
labeling of the product,” may elect to submit adverse drug experience reports directly to

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us (§ 514.80(b)(3)). Respondents include individuals and the private sector (for-profit
businesses).
3. Use of Improved Information Technology and Burden Reduction
Currently, most submitters have chosen, voluntarily, to use electronic submission for the
reports affected by this final rule. As of 2016, approximately 99.7 percent of
postmarketing safety reports eligible for electronic submission were electronically
submitted. Thus, this final rule will affect a small proportion of these reports.
Electronic reports may be submitted through FDA’s Electronic Submission Gateway or
through the FDA-National Institutes of Health Safety Reporting Portal (Safety Reporting
Portal). The Electronic Submission Gateway allows applicants or nonapplicants to
submit postmarketing safety reports using the Health Level 7 (HL7) Individual Case
Safety Report (ICSR)standard that has been adopted worldwide by the International
Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary
Medicinal Products (VICH). In this final rule, we reaffirm our intention to continue to
rely on these VICH-recommended standards. We believe the continued use of VICH
standards will promote harmonization of safety reporting among regulatory agencies and
facilitate the international exchange of postmarketing safety information. Accordingly,
this final rule is consistent with our ongoing initiatives to encourage the widest possible
use of electronic submission and to promote international harmonization of safety
reporting for animal drug products through reliance on VICH standards. We anticipate
that the final rule will enhance industry’s global pharmacovigilance practices by allowing
it to use common data elements and transmission standards when submitting ICSRs to
multiple regulators. The Electronic Submission Gateway provides industry with
gateway-to-gateway access to transmit an HL7 ICSR message using the FDA electronic
submission standard. The Safety Reporting Portal provides applicants or nonapplicants a
means to submit individual postmarketing safety reports without having to make financial
investments in the technical infrastructure needed to access the Electronic Submission
Gateway. Any person who has internet access can use the Safety Reporting Portal to
submit reports through a user-friendly, interactive questionnaire available at
https://www.safetyreporting.hhs.gov/.
Burden for the electronic version of Forms FDA 1932 and 1932a is accounted for under
OMB control number 0910-0645. FDA anticipates over time that adverse event reporting
for small businesses will shift more and more to the electronic FDA Safety Reporting
Portal.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.

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5. Impact on Small Businesses or Other Small Entities
We estimate that ten percent 10% of respondents are small businesses. Although new
animal drug development is typically an activity completed by large drug firms, the
information collection required under 21 CFR 514.80 applies to small as well as large
companies. As noted, electronic reports may be submitted through FDA’s Electronic
Submission Gateway or through the Safety Reporting Portal. The Safety Reporting
Portal provides applicants or nonapplicants, which may be small businesses, a means to
submit individual postmarketing safety reports without having to make financial
investments in the technical infrastructure needed to access the Electronic Submission
Gateway. Any person who has internet access can use the Safety Reporting Portal to
submit reports through a user-friendly, interactive questionnaire available at
https://www.safetyreporting.hhs.gov/. For applicants or nonapplicants that submit a
small number of reports, the use of the web-based Safety Reporting Portal may be more
cost effective than implementing a system to send an HL7 ICSR message through the
FDA Electronic Submission Gateway.
Under the Regulatory Flexibility Act, CVM analyzes regulatory options that would
minimize any significant impact on small entities. FDA aids small businesses in
complying with its requirements through the agency’s Regional Small Business
Representatives and through the scientific and administrative staffs within the agency.
FDA has provided a Small Business Guide on the agency’s website at
http://www.fda.gov/ForIndustry/SmallBusinessAssistance/default.htm.
6. Consequences of Collecting the Information Less Frequently
Data collection schedule occurs occasionally and is consistent with statutory and
regulatory requirements. Less frequent data collection would hinder early detection of
such threats to the public health. New, unusual, and serious adverse events can appear at
any time due to the large distribution of the drug as compared to its use during the
preapproval clinical trials.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
The reporting requirements under 21 CFR 514.80 are inconsistent with 5 CFR 1320.5.
This section requires justification for requesting respondents to report more often than
quarterly. Pursuant to 21 CFR 514.80(b)(1), the applicant is required to submit product
and manufacturing defects that may result in serious adverse drug events within 3
working days of first becoming aware that a defect may exist. Pursuant to 21 CFR
514.80(b)(2)(i)-(ii), the applicant is required to submit initial and follow-up reports
within 15 working days. Pursuant to 21 CFR 514.80(b)(3), the non-applicant required to
report adverse drug experiences to the applicant within 3 working days of first receiving
the information or if reported to FDA within 15 working days. This short time for
reporting is necessary to inform us as soon as possible of any serious problems with a
drug product, so that we can take appropriate action.

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The maintenance period for keeping records is also inconsistent with 5 CFR 1320.6.
Pursuant to 21 CFR 514.80(e), the applicant and non-applicant must maintain records and
reports of all information for a period of 5 years after the date of submission. This
extended period is due to the potential for litigation, delayed recognition of adverse drug
experiences, long expiration dates, and needed for studies of delayed effects such as
carcinogenicity.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside
the Agency
As required by section 3506(c)(2)(B) of the Paperwork Reduction Act of 1995 (PRA), we
provided an opportunity for public comment on the information collection requirements
of the proposed rule that published in the Federal Register of February 14, 2018 (83 FR
6480). The comments we received and our responses are discussed in the final rule as
well as here:
(Comment 1) Comments from a drug manufacturing firm, as well as an individual,
generally support our efforts to require electronic submission of certain postmarketing
safety reports for approved new animal drugs. One comment recognizes that the
requirement of electronic submission would greatly benefit the Agency and animal health
by supporting quicker access to postmarketing safety information. Another comment
applauds our efforts to improve our systems for collecting and analyzing postmarketing
safety reports and to facilitate international harmonization and exchange of safety
information.
(Response 1) We appreciate the general support that the comments express. As noted in
section II.A., we expect this rule to expedite our access to safety information and provide
us data in a format that will support more efficient and comprehensive reviews. This will
enhance our ability to rapidly communicate information about suspected problems to
animal owners, veterinarians, consumers, and industry within the United States and
internationally in support of our public health mission.
(Comment 2) One comment states that, although in favor of electronically reporting 3day alerts to CVM in addition to reporting to the appropriate FDA District Office or local
resident post, until such time that this can be accomplished via a single mechanism (i.e.,
electronic reporting to both segments of the Agency simultaneously), this places an
undue burden on industry both in time and resources as this would require reporting
electronically to CVM while continuing to file paper Form FDA 1932 to District Offices
or local resident posts.
(Response 2) We currently require 3-day alert reports to be submitted to the appropriate
FDA District Office or local FDA resident post on paper. (See § 514.80(b)(1)) However,
if in addition to that report an applicant elects to submit a 3-day field alert report directly
to CVM (i.e., a “courtesy copy”), we proposed to require the applicant to submit that
additional copy of the report to CVM electronically. (See proposed 514.80(b)(1)) At this
time FDA District Offices do not have the technology to receive Form FDA 1932

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electronically, so we cannot mandate electronic reporting to FDA District Offices at this
time. In addition, the FDA District Offices and local FDA resident posts use a different
database for tracking such reports, and do not have direct access to the CVM Adverse
Drug Event (ADE) database (which receives ADE information in part from Form FDA
1932). We agree that development of a single mechanism to report 3-day alert reports via
electronic Form FDA 1932 to both the FDA District Office (or local FDA resident post)
and CVM is ideal, and we are interested in developing this capacity; however, this effort
is preliminary and investigatory at this time. As there is currently no requirement to
provide a “courtesy copy” of 3-day alert reports to CVM, the required electronic
submission of such copies would only burden those applicants that choose to provide
them despite any additional time and resources needed to do so. Therefore, in this final
rule, we are keeping the language of the final rule as proposed at § 514.80(b)(1).
(Comment 3) One comment notes that, since the implementation of electronic reporting
capability, postmarketing safety reports may be submitted to us via Extensible Markup
Language (XML), which is designed to store and transport data and be both humanreadable and machine-readable. Therefore, there is no official Form FDA 1932 version
of these reports to provide to an inspector during manufacturing site FDA inspections. In
addition, the comment continues, inspectors are not well versed in reading the XML
formats created from electronically submitted reports. The comment suggests that we
provide training to inspectors to help them better understand how to read the XML format
for case data or that we provide industry with guidance for an alternative form that could
be generated from the database that satisfies the inspectors’ needs during site inspections.
(Response 3) We recognize the comment’s concerns with regard to utility of the XML
format information during inspections. We appreciate the commenter’s interest in either
preparing more easily readable versions of electronically submitted reports for inspectors
or providing training to inspectors in reading the XML format of electronically submitted
reports. We intend to consider these suggestions so that inspectors are better able to
access the information they need during an inspection. However, the comment did not
request any changes to the language in proposed § 514.80(b)(1), nor do we see a reason
to make any changes based on the concerns and suggestions included in the comment.
(Comment 4) One comment notes that, while the proposed rule provides a procedure for
requesting a temporary waiver of the electronic submission requirement for “good cause”
(i.e., crisis situations that impact an applicant’s or nonapplicant’s ability to report
electronically, such as natural disasters, pandemics, and terrorism), the proposed rule
does not change the content, frequency, or timeline for submission of the postmarketing
safety reports to the Agency. The comment suggests that, when the Agency’s Electronic
Submission Gateway or Safety Reporting Portal is down, we should grant a temporary
waiver of the electronic submission requirement for a period of time (e.g., for the length
of time that the Agency website/portal is down.)
(Response 4) In the proposed rule, we described that an applicant or nonapplicant
experiencing technical difficulty that temporarily prevents use of the Electronic
Submission Gateway could, as a backup, electronically submit reports using the Safety

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Reporting Portal. An applicant or nonapplicant that relies on the Safety Reporting Portal
but experiences a short-term, temporary interruption of internet services could, as a
backup, electronically submit reports from any other computer with access to a working
internet connection. We anticipate that temporary waivers of the electronic submission
requirement will only be needed in rare circumstances such as natural disasters,
pandemics, etc. In addition, we discussed in the preamble that in the unlikely event that
the Agency experiences a prolonged system outage or other major technical problem, we
may require an applicant or nonapplicant to submit reports that would otherwise be
required to be submitted electronically to be submitted in an alternate format (most likely
on paper using Form FDA 1932 (83 FR 6480 at 6485). We are not waiving the required
content, frequency, or timeline for submission of the postmarketing safety reports to the
Agency; applicants and nonapplicants should be prepared to comply with an Agency
request for submission in an alternate format by maintaining the capability to submit
paper reports using Form FDA 1932 if needed. We are finalizing proposed 514.80(d)
without change.
9. Explanation of Any Payment or Gift to Respondents
There are no payments or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
In preparing this Supporting Statement, our FDA Privacy Office was consulted to ensure
appropriate handling of information collected. This Information Collection Request
(ICR) is collecting personally identifiable information (PII) in the context of the
individuals’ professional capacity. This affects certain reports submitted on Form FDA
1932. The PII submitted for Form FDA 1932 (Veterinary Adverse Drug Reaction, Lack
of Effectiveness, Product Defect Report) is name, company name, company address,
telephone number, fax number, and email address. This ICR involves reporting adverse
events and product/manufacturing defects associated with approved new animal drugs.
Although PII is collected, the collection is not subject to the Privacy Act of 1974 and the
particular notice and other requirements of the Act do not apply. Specifically, FDA does
not use name or any other personal identifier to routinely retrieve records from the
information collected. FDA also minimized the PII to be collected to protect the privacy
of the individuals.
We expect that regulatory information will contain trade secret and commercial
confidential information. As a result, all files are maintained in a secured area.
Confidentiality of the information submitted under these reporting requirements is
protected under 21 CFR 514.11. Only information that is releasable under the agency’s
regulations in 21 CFR part 20 would be released to the public. This information is also
safeguarded by section 301(j) of the FD&C Act and would be protected from disclosure
under the Freedom of Information Act (FOIA) under sections 552(a) and (b) (5 U.S.C.
552(a) and (b)). Further, under the terms of the Freedom of Information Act, the
veterinarian’s name, address, and phone number, and the owner’s name, etc., reported on
Form FDA 1932 cannot be made available to a public request. To the extent 21 CFR

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20.64 applies, we will honor the confidentiality of any data in investigation records
compiled for law enforcement purposes.
11. Justification for Sensitive Questions
This information does not contain questions pertaining to sex behavior, attitude, religious
beliefs, or any other matter commonly considered private or of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
21 CFR Section

Table 1.--Estimated Recurring Reporting Burden1
Form
No. of
No. of
Total
Average
FDA
Respondents
Responses
Annual
Burden
No.
per
Responses
per
Respondent
Response
1932
15
18
270
1

Electronic submission of
postmarketing safety
reports under
§ 514.80(b)(1), (b)(2)(i)
and (ii), (b)(3), and
(b)(4)(iv)(A) and (C)
Request for waiver,
N/A
1
1
1
§ 514.80(d)(2)
Total
271
1
There are no capital costs or operating and maintenance costs associated with this collection of
information.

Total
Hours

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Table 1 reflects the recurring reporting burden we estimate is associated with the
final rule. Consistent with section II.F. of the Final Regulatory Impact Analysis (FRIA),
we estimate that 15 firms submitted a paper Form FDA 1932 report from 2011 to 2015
and thus will be affected by the rule’s requirement to submit electronically. As stated in
the FRIA, we estimate that in 2016 CVM received 270 of the affected postmarketing
safety reports on paper. We calculate the number of responses per respondent as the total
annual responses divided by the number of respondents. We assume that, on average, it
will take 1 hour to submit electronic postmarketing safety reports for approved new
animal drugs, for a total of 270 hours. We base our estimate of 1 hour per report on our
experience with electronic postmarketing safety reporting. In the FRIA, we also estimate
the burdens associated with submission of waiver requests. We expect very few waiver
requests (see section II.F.2. of the FRIA), estimating that approximately one firm will
request a waiver annually under § 514.80(d)(2). We assume a waiver request takes 1
hour to prepare and submit. Together, this results in a total of 271 hours and 271
responses. We have also added 1 hour to the paper reporting collection to reflect the new
waiver request process under § 514.80(d)(2).

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270

1
271

Activity
Write New SOPs
Training
Total

Table 2.--Estimated One-Time Recordkeeping Burden1
No. of
No. of Records Total
Average
Total
Recordkeepers per
Annual
Burden per
Hours
Recordkeeper
Records
Recordkeeping
15
1
15
20
300
15
1
15
20
300
30
600

1

There are no capital costs or operating and maintenance costs associated with this collection of
information.

Table 2 reflects one-time recordkeeping burden we estimate is associated with the final
rule. This burden includes both the one-time burden of creating new SOPs to submit the
reports electronically and the one-time cost of training employees to electronically submit
postmarketing safety reports to CVM in accordance with the new SOPs. In section II.F.
of the FRIA, we estimated that approximately 15 firms will be affected by this rule. We
also estimated that it will take approximately 20 hours per firm to create new SOPs for
electronic submission of postmarketing safety reports and approximately 20 hours per
firm to complete the training of employees to electronically submit postmarketing safety
reports in accordance with the new SOPs. Together, this results in a total of 600 hours
and 30 records. We assume that there are no capital costs associated with firms
implementing this rule (i.e., applicants and nonapplicants in the pharmaceutical industry
already have the computer and internet capacity necessary to electronically submit
postmarketing safety reports).
12b. Annualized Cost Burden Estimate
Type of Respondent
Industry Compliance Officer

Total Burden
Hours
871

Hourly Wage Rate
$51.75

Total Respondent
Costs
$45,074.25

1

May 2018 National Industry-Specific Occupational Employment and Wage Estimates, Bureau of Labor
Statistics and including 30% for benefits (https://www.bls.gov/oes/current/naics4_325400.htm).

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
There are no capital, start-up, operating or maintenance costs associated with this
information collection.
14. Annualized Cost to the Federal Government
Costs to the Federal Government are absorbed through existing resource allocations.
15. Explanation for Program Changes or Adjustments
This rulemaking revises the information collection to require electronic reporting or the
granting of a waiver from the requirement. We have updated our mandatory reporting
element (IC element 1) to reflect estimates consistent with the final rule, which results in
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a decrease in both annual responses and burden hours in the amount of 1512. This is
because the currently approved estimate was shown to be too high by the FRIA for the
final rule. Ultimately, upon approval of the revision, the 270 responses and hours
attributable to mandatory electronic reporting will be captured under OMB Control No.
0910-0645, FDA’s Adverse Event Reporting System (which administers our MedWatch
Program), however the 1 request for waiver will be retained in this information
collection. We have also added a one-time recordkeeping burden in the amount of 30
responses and 30 burden hours to reflect implementation of the new requirements, but we
expect this burden to be realized upon the next renewal request for the information
collection (currently expires March 31, 2021). Cumulatively, these changes reflect a total
decrease of 1481 hours and 1481 responses annually.
16. Plans for Tabulation and Publication and Project Time Schedule
No statistical reporting, tabulation, or publication of the data are planned.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of the OMB Expiration Date is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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