0284 AER Animal Drugs SSA 2018 Ext

U.S. Food & Drug Administration
Animal Drug Adverse Event Reporting and Recordkeeping
OMB Control No. 0910-0284; Revision

SUPPORTING STATEMENT Part A: Justification

Terms of Clearance: Approved with the understanding that FDA is currently seeking public
comment on this collection and revisions may be made to the new electronic submission
instrument as part of the upcoming extension request.
In accordance with these terms, FDA has published both a 60- and 30-day notice in the Federal
Register specifically inviting public comment on the proposed collection instruments. This is
discussed more fully under Question 8 below. FDA also notes that current rulemaking is
underway (RIN 0910-AH51) to revise the underlying regulations associated with the information
collection. The rule does not change the content of the postmarketing reports already covered,
but rather, proposes to require that certain submissions be made in an electronic form. At the
same time, the rule also proposes a provision for temporary waiver of the requirement and
establishes procedures for respondents to request such a waiver. We believe electronic
submissions facilitate agency review of adverse experiences associated with animal drugs and
ultimately impose minimal burden on respondents to the information collection.
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA) regulations. 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).
Sections 571(e)(3) and 512(e)(2) of the FD&C Act (21 U.S.C. 360ccc(e)(3) and 360b(e)(2))
require that applicants with conditionally approved new animal drug applications (CNADAs)
maintain adequate records and make reports in accordance with a regulation or order issued
under section 512(l). Section 512(m)(5) of the FD&C Act requires an applicant for a license to
manufacture animal feeds bearing or containing new animal drugs to maintain adequate records
and make reports “as the Secretary may by general regulation, or by order with respect to such
application, prescribe on the basis of a finding that such records and reports are necessary in
order to enable the Secretary to determine” whether there may be grounds for suspending or
withdrawing approval of the new animal drug under section 512(e) or a license to manufacture
animal feeds bearing or containing new animal drugs under section 512(m)(4).

Finally, section 514.80 of our regulations (21 CFR 514.80) sets forth recordkeeping and
reporting requirements for applicants and nonapplicants of approved NADAs and ANADAs.
FDA revised its burden tables at Question 12 below to more clearly reflect that provisions
associated with section 510.301 of our regulations (21 CFR 510.301), setting forth recordkeeping
and reporting requirements for licensed medicated feed manufacturing facilities, are included in
this information collection. Specifically, individual rows were added to reflect burden for
activities associated with this particular requirement.
To assist respondents with the reporting provisions required by the regulations, we have
developed the following forms:
Forms FDA 1932 and 1932a – “Veterinary Adverse Drug Reaction, Lack of Effectiveness,
Product Defect Report” (paper-based and e-form); Forms FDA 2301 – “Transmittal of
Periodic Reports and Promotional Material New Animal Drugs”; and Form FDA 3744 (eform using eSubmitter “Antimicrobial Animal Drug Distribution Report.” Minor editorial
revisions to Form FDA 1932a clarify how to report adverse drug events associated with
compounded products using that form. Respondents already report adverse drug events
associated with compounded products using Form FDA 1932a. The clarifications include the
addition of a new question, "Is this a compounded product"; the addition of a new field to
allow the submitter to provide product strength, "Strength of Active Ingredient(s)"; modifying
the title of the existing field requesting the name of manufacturer, so that it reads, "Name of
Manufacturer or Compounding Pharmacy/Compounder of Suspected Product"; and a request
for contact information for the manufacturer or compounder.
We therefore request extension of OMB approval for the information collection provisions found
in the applicable regulations under 21 CFR Part 510 and 514 and the supporting collection
instruments.
2. Purpose and Use of the Information Collection
The information collection allows FDA to implement specified public health protection
provisions under the FD&C Act regarding approved new animal drugs. Respondents are those
submitting adverse experience reports consistent with the applicable laws and regulations.
3. Use of Improved Information Technology and Burden Reduction
Many of the applicants have automated systems for reports of adverse drug experiences to new
animal drugs. Under 21 CFR 514.80(d) applicants may electronically generate Form FDA 1932
or Form FDA 2301. CVM works domestically with the animal pharmaceutical industry and
internationally under VICH to develop methods and standards for electronic submission. Form
FDA 1932 and Form FDA 1932 may be electronically submitted via the FDA Safety Reporting
Portal. Form FDA 2301 may be electronically submitted to the agency via eSubmitter. 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. We estimate that 95%

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of the respondents will use electronic means to fulfill the agency’s requirement or request in the
next three years.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information. Electronic adverse event reporting for approved
new animal drugs (including mandatory reporting under § 514.80(b) and voluntary reporting) has
been approved under OMB control number 0910-0645. Reporting and recordkeeping associated
with the index of legally marketed unapproved new animal drugs for minor species (21 CFR part
516) is approved under OMB control number 0910-0620.
5. Impact on Small Businesses or Other Small Entities
Although new animal drug development is typically an activity completed by large drug firms,
the information collection required under 21 CFR 510.301 and 21 CFR 514.80 applies to all
respondents. However, FDA aids small businesses in complying with its requirements through
Regional Small Business Representatives and scientific and administrative staffs within the
agency. Also, a Small Business Guide is available on our website at:
www.fda.gov/ForIndustry/SmallBusinessAssistance/default.htm.
We estimate that 10% of the respondents are small businesses.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with statutory and regulatory requirements and
requires reporting on only an occasional basis. Regulations at 21 CFR 510.301 and 21 CFR
514.80 establish a reporting frequency underscoring the need to focus on potential problems
concerning the safety and effectiveness of new animal drugs. Less frequent collection hinders
early detection of public health threats intended to be covered by the regulations.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
The reporting requirements under 21 CFR 510.301(a) and (b), 21 CFR 514.80(b)(1), (b)(2)(i)(ii), (b)(3), and (e) are inconsistent with 5 CFR 1320.5. This section requires justification for
requesting respondents to report more often than quarterly. Under 21 CFR 510.301(a) and (b), a
licensed medicated feed manufacturer must submit certain information to us immediately and
other information to us within 15 days. 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 shorter reporting time is necessary to inform
FDA as soon as possible of serious problems associated with a regulated product so that
appropriate action may be taken to offset threats to the public health.

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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
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice in the Federal Register of
July 18, 2017 (82 FR 32829) inviting public comment for the information collection. In the
notice we specifically invited feedback regarding FDA reporting forms and have made revisions
as discussed previously in this supporting statement. At the same time, we made no other
revisions. We therefore retain our burden estimate but note that FDA remains open to improving
its forms and continually welcomes feedback including suggested revisions that might assist
respondents with the information collection.
9. Explanation of Any Payment or Gift to Respondents
There are no payments or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
During working hours, only FDA employees have access to the computer files and database on a
need to know basis. During duty and non-duty hours building security is provided through a
contract with a private protection agency. None of the provisions bar the release of the
confidential information if subpoenaed by a court of law. Confidentiality of the information
submitted under these reporting requirements is protected under 21 CFR 514.11 and under 21
CFR part 20. The unauthorized use of disclosure of the trade secrets required in applications is
specifically prohibited under the Section 310(j) of the Act. 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.
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
Description of respondents: Respondents to this collection of information are animal drug
manufacturers with approved NADAs, ANADAs, or CNADAs, as well as licensed commercial
feed mills and licensed mixer-feeders.
Information collection provisions found in the regulations include:

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21 CFR 510.301 – Recordkeeping; requires a licensed medicated feed manufacturer to keep
records concerning any mixup in the new animal drug or its labeling; any bacterial or significant
chemical, physical, or other change or deterioration in a drug; any failure of one or more
distributed batches of a drug to meet the specifications established for it; any unexpected side
effect, injury, toxicity, or sensitivity reaction or any unexpected incidence or severity thereof, and
any unusual failure of the new animal drug to exhibit its expected pharmacological activity.
21 CFR 514.80(e) – Recordkeeping; requires maintenance of records and files containing full
records of information pertinent to the safety or effectiveness of a new animal drug for a period of
5 years after the date of submission.
21 CFR 510.301(a) and (b) – Reporting; requires a licensed medicated feed manufacturer to
immediately report to us information concerning any mixup in the new animal drug or its labeling;
any bacterial or significant chemical, physical, or other change or deterioration in a drug; and any
failure of one or more distributed batches of a drug to meet the specifications established for it. A
licensed medicated feed manufacturer must report to us within 15 working days of receipt of
information concerning any unexpected side effect, injury, toxicity, or sensitivity reaction or any
unexpected incidence or severity thereof, and any unusual failure of the new animal drug to exhibit
its expected pharmacological activity.
21 CFR 514.80(b)(1) – Reporting; specifies information pertaining to product
defect/manufacturing defects that may result in serious adverse drug events is to be reported within
3 working days of first becoming aware that a defect may exist.
21 CFR 514.80(b)(2)(i) – Reporting; specifies requirement that initial reports of serious adverse
drug events and unexpected adverse drug events are to be submitted within 15 working days of first
receiving the information.
21 CFR 514.80(b)(2)(ii) – Reporting; specifies requirements for submitting follow-up reports to
the initial report of serious adverse drug events and unexpected adverse drug events.
21 CFR 514.80(b)(3) – Reporting; specifies requirements by nonapplicants to forward reports of
adverse drug events to the applicant within 3 working days of first receiving the information.
Nonapplicants may also elect to submit reports directly to FDA within 15 working days of first
receiving the information.
21 CFR 514.80(b)(4)(i)-(iv) – Reporting; specifies requirements for submitting 6 month periodic
drug experience reports for the first two years following approval and then yearly thereafter.
Specifies for yearly drug experience reports that applicants may petition FDA to change the date of
reporting and(or) the frequency of reporting. Specifies requirements for submitting distribution
data for each new animal drug product for quantities distributed domestically and quantities
exported; applicant and distributor current package labeling; nonclinical laboratory studies and
clinical data not previously submitted; and adverse drug experiences not previously submitted.
21 CFR 514.80(b)(5)(i) – Reporting; specifies requirements for submitting special drug
experience reports at different times or more frequently from those stated in 21 CFR 514.80.
21 CFR 514.80(b)(5)(ii) – Reporting; specifies requirements for submitting advertisements and
promotional labeling.

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21 CFR 514.80(b)(5)(iii) – Reporting; specifies requirements for submitting distributor
statements.

We estimate the burden of the collection of information as follows:
12 a. Annualized Hour Burden Estimate
Table 1 – Estimated Annual Reporting Burden1
21 CFR Part and/or Activity

Medicated feed reports;
§510.301(a) and (b)
Mandatory adverse event
reporting; 21 U.S.C.
360b(l); §514.80(b)(1);
(b)(2)(i) and (ii); (b)(3); and
(b)(4)(iv)(A)
Voluntary adverse event
reporting by veterinarians
and the general public
Periodic drug experience
reports; §514.80(b)(4)
Special drug experience
reports; §514.80(b)(5)(i)
Submission of
advertisements and
promotional labeling;
§514.80(b)(5)(ii)
Submission of distributor
statements,
§514.80(b)(5)(iii)
Total
1 There

FDA
Form

No. of
Respondents

No. of
Responses
per
Respondent

Total
Annual
Responses

Avg.
Burden per
Response

Total Hours

N/A

5

1

5

.25 (15
minutes)

1.25

1932

22

81

1,782

1

1,782

1932a

197

1

197

1

197

2301

200

8.11

1,622

16

25,952

2301

200

0.57

117

2

228

2301

200

20.12

4,024

2

8,048

2301

190

0.1

19

2

38
36,246.25

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

Table 2 – Estimated Annual Recordkeeping Burden1
21 CFR Part
and Activity

No. of
Recordkeepers

No. of Records
per Recordkeeper

Total
Annual
Records

Average Burden
per
Recordkeeping

Total
Hours

Recordkeeping; §510.3012

5

1

5

4

20

Recordkeeping; 21 U.S.C.
360b(l) and §514.80(e)3
Total

646.70

7.19

4,649.8

14

65,097
65,117

1There

are no capital costs or operating and maintenance costs associated with this collection of information.
estimate includes all recordkeeping by licensed medicated feed manufacturers under §510.301.
3This estimate includes all recordkeeping by applicants of approved NADAs, ANADAs, and CNADAs under §514.80(e).
2This

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We base our reporting and recordkeeping estimates on our experience with adverse event
reporting for approved new animal drugs and the number of reports received in the previous 3
years. Included in our estimate is recordkeeping burden for medicated feed adverse event reports
as part of our estimate of the recordkeeping burden of all mandatory adverse event reports for
new animal drugs. To improve the clarity of our estimates we have added a row to table 2, on
which we separately report our recordkeeping estimate for medicated feed adverse event reports
(20 hours).
12b. Annualized Cost Burden Estimate
Type of Respondent
Industry Compliance
Officer

Total Burden
Hours
101,363

Hourly Wage Rate
$47.60

Total Respondent
Costs
$4,825,487

1

May 2016 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
We characterized this request as a revision to clarify that provisions under 21 CFR 510.301 are
included in the collection. We revised the burden tables at Q.12 of this supporting statement
accordingly. Also, and as discussed previously in this supporting statement and in our Federal
Register notices, we made minor editorial revisions to the paper and electronic versions of Form
FDA 1932a to clarify how to report adverse drug events associated with compounded products.
We also made adjustments. Specifically, the collection reflects a nominal increase in the
estimated number of submissions by 7.8 responses consistent with our review of the collection.
At the same time, there is a 1.75 decrease in burden hours that we attribute to improvements in
the reporting instruments.
16. Plans for Tabulation and Publication and Project Time Schedule
Information is not to be published for statistical use.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of the OMB Expiration Date is appropriate.

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18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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