0659 SS Part A Final Rule 2016

Antimicrobial Animal Drug Distribution
Reports and Recordkeeping
OMB Control No. 0910-0659
RIN 0910-AG45
SUPPORTING STATEMENT
Terms of Clearance: None
A. Justification
1. Circumstances Making the Information Collection Necessary
Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105) (P.L. 110-316)
amended section 512 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
360b) to require that sponsors of applications for new animal drugs containing an antimicrobial
active ingredient submit an annual report to the Food and Drug Administration (FDA or “we”)
on the amount of each such ingredient in the drug that is sold or distributed for use in foodproducing animals, including information on any distributor-labeled product. The legislation
was enacted to address the problem of antimicrobial resistance and to help ensure that FDA has
the necessary information to examine safety concerns related to the use of antibiotics in foodproducing animals.
Each report required must specify (1) the amount of each antimicrobial active ingredient by
container size, strength, and dosage form; (2) quantities distributed domestically and quantities
exported; (3) a listing of the target animals, indications, and production classes that are specified
on the approved label of the product. The report must cover the period of the preceding calendar
year and include separate information for each month of the calendar year.
FDA has promulgated regulations at 21 CFR section 514 to support the information collection
requirements associated with ADUFA 105. The rulemaking revises the existing collection to
incorporate the sales and distribution data reporting requirements specific to antimicrobial new
animal drugs that were added to the FD&C Act by ADUFA 105. The rulemaking also requires
species-specific information to be included on Form FDA 3744. Finally, the recordkeeping
provision under the rulemaking remains unchanged.
We therefore request approval of the revised reporting requirements under 21 CFR 514.87, Form
FDA 3744 entitled, “Antimicrobial Animal Drug Distribution Report,” and the existing
recordkeeping provision regarding monthly distribution data.
This information collection is not related to the American Recovery and Reinvestment Act of
2009 (ARRA).

2. Purpose and Use of the Information Collection
We believe the revised reporting provisions under ADUFA 105 will improve our understanding
of antimicrobial animal drug sales intended for use in specific food-producing animal species,
and assist us in assessing antimicrobial sales trends in the major food-producing animal species
and examining how such trends may relate to antimicrobial resistance. Collection of information
on the amount of animal antimicrobials being distributed, including species-specific information,
is necessary to support ongoing efforts to encourage the judicious use of antimicrobials in foodproducing animals and helps ensure the continued availability of safe and effective
antimicrobials for animals and humans.
3. Use of Information Technology and Burden Reduction
FDA believes that respondents to the collection already possess the computers, software, and
equipment necessary to collect the required data and make reports. To facilitate reporting, we
have developed and instituted Form FDA 3744, which may be submitted both in paper format
and electronically.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. Together with data collected under the
National Animal Health Monitoring System (NAHMS) and the National Antimicrobial
Resistance Monitoring System (NARMS) programs administered by the United States
Department of Agriculture and the Centers for Disease Control respectively, the information
collection provides a comprehensive and science-based assessment of antimicrobial drug use and
resistance in animal agriculture.
5. Impact on Small Business or Other Small Entities
Although new animal drug development is typically an activity completed by larger drug firms,
the information collection provisions apply to small firms as well. FDA provides for small
business contacts in the Center for Veterinary Medicine (CVM), as well as other agency
components.
6. Consequences of Collecting the Information Less Frequently
Information collection is consistent with statutory requirements.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.

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8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agency
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(B)), FDA
solicited public comment on the information collection provisions in its proposed rule of May
20, 2015 (80 FR 28863). While some comments were received supporting our effort to eliminate
duplicative reporting, suggesting specific modifications and different approaches, questioning or
supporting the utility of the information, suggesting we wait for resolution of the current legal
disputes over disclosure of confidential commercial information, and suggesting we provide a
specific methodology for making species-specific sales estimates, no comments suggested that
we modify burden estimates.
All comments received in response to the proposed rulemaking may be found in the agency
docket, FDA-2012-N-0447, and are addressed in the agency’s final rule that published May 11,
2016 (81 FR 29129). As finalized, we believe the regulations under 21 CFR part 514.87 reflect
minimal reporting burden and satisfy the statutory requirements under ADUFA. We believe the
existing recordkeeping burden under 21 U.S.C. 360b(l)(3)(C) also reflects minimal burden to
respondents.
9. Explanation of Any Payment or Gifts to Respondents
There are no payments or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondent
Confidentiality of information submitted under the reporting requirements is protected under 21
CFR 514.11 where data access is restricted to FDA and physical security measures are
employed. Records that may be reviewed during FDA inspections are subject to FDA
regulations in 21 CFR Part 20. Confidential commercial information is protected from
disclosure under FOIA in accordance with section 552(a) and (b) (5 U.S.C. 552(a) and (b)) and
by part 20. To the extent that § 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 collection does not contain questions of a sensitive nature.
12a. Estimates of Hour Burden Including Annualized Hourly Costs
FDA estimates the burden associated with the information below. Our estimates are based on
review of agency data and in consideration of feedback during rulemaking. More detailed
information regarding our calculations may be found within the agency’s Final Regulatory
Impact Analysis (FRIA) under docket FDA-2012-N-0447.
Description of Respondents: Respondents to the information collection are animal drug
manufacturers (Sponsors).

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Table 1 – Estimated One-Time Reporting Burden1
21 CFR 514.87

No. of
Respondents

Administrative Review of the
Rule: Sponsors With Active
Applications
Administrative Review of the
Rule: Sponsors With Inactive
Applications
Report Species: Specific Estimate
of Percent of Products Distributed
Domestically
Total
1

Total
Annual
Responses
20

Avg.
Burden per
Response
24

Total
Hours

20

No. of
Responses per
Respondent
1

7

1

7

1

7

20

7.50

150

2

300

480

787

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

We base our estimate of the average burden per response on recent experience with the existing
antimicrobial animal drug distribution reports program. We base our estimate of the number of
respondents reported in tables 1 and 2 on a review of our records of sponsors with active and
inactive applications, which shows that in the past 3 years the number of sponsors has increased
from 26 to 27.
Table 1 shows an estimated one-time burden associated with the new reporting provisions of the
final rule. We expect current sponsors of approved or conditionally approved applications for
antimicrobial new animal drugs sold or distributed for use in food-producing animals will need
to review the provisions of the final rule and develop a compliance plan. As previously stated,
based on a review of our records, we estimate a total of 27 sponsors, where 20 sponsors hold
active (i.e., currently marketed) applications and 7 sponsors hold inactive applications, as
reflected in rows 1 and 2. We estimate that the 20 sponsors with active applications will take 24
hours to complete the review and develop a compliance plan. We expect that the seven sponsors
with inactive applications will take 1 hour to complete the review and will not need to develop a
compliance plan.
Further, we estimate that the 20 sponsors with 150 applications will each spend approximately 2
hours to consider and decide upon a method to calculate the species-specific information
required under § 514.87(c). This estimate is reflected in row 3.
Table 2 – Estimated Annual Reporting Burden1
Annual Reports Under
21 CFR 514.87

FDA
Form

No. of
Respondents
10

No. of
Responses per
Respondent
7.5

Total
Annual
Responses
75

Avg.
Burden per
Response
62

Sponsors with active
applications; paper
submission
Sponsors with active
applications; electronic
submission

3744

3744

10

7.5

75

52

4

Total
Hours
4,650

3,900

Annual Reports Under
21 CFR 514.87

FDA
Form

No. of
Respondents

Sponsors with inactive
applications; paper
submission
Sponsors with inactive
applications; electronic
submission
Total

3744

3744

1

4

No. of
Responses per
Respondent
26.5

Total
Annual
Responses
106

Avg.
Burden per
Response
2

3

35

105

2

Total
Hours
212

210

8,972

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

Table 2 shows the estimated annual reporting burden associated with the information collection.
While we expect new § 514.87(c) will require 3 burden hours resulting from including speciesspecific estimates, we believe 1 hour will be saved by eliminating the requirement for sponsors
to calculate the amount of antimicrobial active ingredients associated with their monthly product
sales and distribution data (§ 514.80(b)(4)(i)(A)). Consequently, we estimate that the 20
sponsors with active applications will each expend approximately 2 additional reporting hours
annually for new § 514.87. Under the final rule, we will continue to accept both paper and
electronic submissions and estimate half of the respondents will report electronically and the
other half by paper, as shown in rows 1 and 2.
While we estimate no increase in burden for the seven sponsors of inactive applications, we
similarly will accept both paper and electronic submissions. Accordingly we retain the currently
approved estimate under OMB Control No. 0910-0659 for these reporting burdens, as shown in
rows 3 and 4.
Table 3—Estimated Annual Recordkeeping Burden
21 U.S.C.
360b(l)(3)(C)

No. of
Respondents

Annual
Frequency of
Recordkeeping

Total Annual
Records

Hours per
Record

All Applicants

27

1

27

2

Total Hours

54

Table 3 shows the estimated recordkeeping associated with the information collection. While
specific recordkeeping requirements associated with new animal drugs are included under OMB
Control Nos. 0910-0284 (periodic drug reports) and 0910-0139 (dosage form and distribution
date), here we include burden associated with distribution data as required under 21 U.S.C.
360b(l)(3)(C) (monthly data regarding antimicrobial active ingredient). We believe the
recordkeeping burden associated with this particular data element to be no more than 2 hours as
shown in table 3. Although we have not changed our burden estimate associated with this
recordkeeping, we have increased the number of respondents by one.

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12b. Annualized Cost Burden
The total annualized cost burden is estimated to be $419,709 as calculated below.
Table 4 – Annualized Cost Burden
Type of Respondent

Total Burden Hours

Hourly Wage
Total Respondent
Rate
Cost
8,972
$46.50 / hr²
$417,198

Animal Drug Manufacturer /Sponsor
(Reporting)
Animal Drug Manufacturer/
Sponsor (Recordkeeping)
Total

54

$46.50 / hr²

$2,511
$419,709

² Buraeu of Labor Statistics Occupation employment and wages, May 2011, by occupation, for all industries
(http://www.bls.gov). Wage ($46.50) includes mean hourly wage of $33.22 for Standard Occupational Classification 15-0000,
computer and mathematics occupations, all industries; we add 40% to account for benefits.
13. Estimate of Other Total Cost Burden to Respondents and Recordkeepers
We estimate no other cost burden to respondents.
14. Annualized Cost to the Federal Government
There will be a total of four FDA personnel working on this project; three FTEs at the GS-12
level (average annual salary $84,855 x 3 = $254,565) and one FTE at the GS-13 level (average
annual salary $100,904). We therefore calculate the annualized cost to the Federal government
to be $355,469 ($254,565 + $100,904).
15. Explanation of Program Changes or Adjustments
The information collection includes a one-time burden of 787 hours and 177 responses to reflect
current rulemaking. Upon its next request for renewal of the information collection the agency
expects this burden to have been realized. Meanwhile, the annual reporting burden reflects a
nominal adjustment of 330 fewer hours with 37 additional responses. Finally, the agency has
adjusted the recordkeeping burden to include one additional recordkeeper, consistent with the
number of respondents submitting reports and resulting in an additional 2 hours of burden.
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 is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submission
There are no exceptions to the certification.
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