0620 ss 7-23-20

United States Food and Drug Administration
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
OMB Control No. 0910-0620
SUPPORTING STATEMENT

Part A: Justification:
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, us or we) regulations
that implement section 572 of the Minor Use Minor Species (MUMS) Animal Health Act of 2004.
The MUMS Act is made up of three sections (571, 572, and 573) and it establishes new regulatory
procedures intended to make more medications legally available to veterinarians and animal
owners for the treatment of minor animal species as well as uncommon diseases in major animal
species. Section 572 of the legislation provides for a public index listing of legally-marketed
unapproved new animal drugs for minor species animals. The drugs in this index are only
indicated for use in non-food minor species or for use in early non-food life stages of foodproducing minor species. This regulation, among other things, specifies the procedures for
requesting eligibility and addition to the index as well as the annual reporting requirements for
index holders.
We therefore request OMB extension of our regulations related to public index listing of legallymarketed unapproved new animal drugs for minor species animals found in 21 CFR Part 516 as
discussed in this supporting statement.
2. Purpose and Use of the Information Collection
Foreign drug companies provide the FDA with the name and address of a permanent U.S. resident
agent to represent them at the time they establish their initial index file. Such information, or any
changes in such information, is submitted in writing to the FDA/Center for Veterinary Medicine
(CVM), Office of Minor Use and Minor Species Animal Drug Development (OMUMS), as
specified in section 516.119.
Drug companies may request, in writing, a meeting with FDA to discuss the requirements for
indexing under section 516.121 as well as an informal conference to dispute an action taken by
FDA regarding a request for indexing, as specified in section 516.123.
Section 516.125 provides for investigational use of new animal drugs intended for indexing.
Requests for determination of index eligibility and, if determined eligible, subsequent requests for
addition to the index, including a written report, are prepared by drug companies and submitted to
OMUMS, as specified in sections 516.129 and 516.145. Based on the criteria provided in the
MUMS Act and in this regulation, OMUMS will grant or deny such requests for each drug owner
and their specific drug, dosage form, and intended use. These two collections of information from
each drug owner are required only once for each specific drug/dosage form/intended use. A
description of the written report required in section 516.145 can be found under section 516.143.
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Under section 516.141 are provisions for drug companies to nominate a qualified expert panel as
well as the panel’s recordkeeping requirements. This section also calls for the submission of a
written conflict of interest statement to FDA by each proposed panel member.
Index holders may modify their index listing (section 516.161) or change drug ownership (section
516.163) by notifying OMUMS in writing.
Records and reports, as specified in section 516.165, are prepared by holders of indexed drugs and
are submitted to OMUMS. One of these requirements is an annual written drug experience report.
These reports are used by OMUMS to monitor possible drug-related adverse events.
3. Use of Improved Information Technology and Burden Reduction
We encourage the electronic submission of data and will consider any such electronic submission
which will be more efficient for industry and facilitate review by the Agency. Currently 50% of
submissions are electronic.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
Because many new animal drugs for minor uses and minor species traditionally come from
smaller drug companies, we expect the MUMS Act to have a beneficial impact on small business.
The collection of information outlined in this regulation is commensurate with what is required by
the MUMS Act and poses no greater burden to small business than it does to large pharmaceutical
firms. A small business coordinator has been established on the Commissioner’s staff to ensure
that small businesses have an adequate opportunity to express their concerns and to keep our
management apprised of how its regulatory decisions may impact the small business community.
Furthermore, we encourage sponsors, whether small or large businesses, to meet with us to discuss
questions concerning submissions
6. Consequences of Collecting the Information Less Frequently
Periodic drug experience reports, as proposed in section 516.165, are submitted to OMUMS
annually. This frequency is the same as is currently required for approved drugs under 21 CFR
514.80(b)(4). FDA reviews the records and reports required in this section to facilitate a
determination under section 572(f) of the Federal Food, Drug and Cosmetic Act (21 U.S.C.
360ccc-1) as to whether there may be grounds for removing a drug from the index.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
FDA published a 60-day notice for public comment in the Federal Register of January 7, 2020 (85
FR 714). Although one comment was received, it was not responsive to the four collection of
information topics solicited.
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9. Explanation of Any Payment or Gift to Respondents
There are no incentives, payments or gifts associated with this information collection.
10. Assurance of Confidentiality Provided to Respondents
This ICR collects personally identifiable information (PII) or information of a personal nature. The
PII collected within the proprietary index file may include point of contact information for the
requestor drug company; point of contact information for the veterinarian and/or pet owner that
reported the adverse event; and, CVs and conflict of interest information, which may include
personal financial information, for proposed outside expert panel members.
FDA further determined this information 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.
In preparing this Supporting Statement, FDA staff consulted with the FDA Privacy Office to
ensure appropriate handling of information collected. FDA minimized the PII to be collected to
protect the privacy of the individuals.
11. Justification for Sensitive Questions
The collection of information does not involve sensitive questions.
12. Estimates of Annualized Burden Hours and Cost
12a. Annualized Hour Burden Estimate
Table 1.--Estimated Annual Reporting Burden1
21 CFR Section

516.119; requires a foreign drug
company to submit and update
the name and address of a
permanent U.S. resident agent.
516.121; written request for a
meeting with FDA to discuss the
requirements for indexing a new
animal drug.
516.123; written request for an
informal conference and a
requestor’s written response to
an FDA initial decision denying
a request.
516.125; correspondence and
information associated with
investigational use of new
animal drugs intended for
indexing.

No. of
Respondents

No. of Responses
per Respondent

Total
Annual
Responses

Average
Burden per
Response

Total
Hours

5

1

5

1

5

30

2

60

4

240

3

1

3

8

24

2

3

6

20

120

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516.129; content and format of a
30
2
60
20
1,200
request for determination of
eligibility for indexing.
516.141; information to be
20
1
20
16
320
submitted to FDA by a requestor
seeking to establish a qualified
expert panel.
516.143; content and format of
20
1
20
120
2,400
the written report of the qualified
expert panel.
516.145; content and format of a
20
1
20
20
400
request for addition to the Index.
516.161; content and format of a
3
1
3
4
12
request for modification of an
indexed drug.
516.163; information to be
1
1
1
2
2
contained in a request to FDA to
transfer ownership of a drug's
index file to another person.
516.165; requires drug
10
10
100
5
500
experience reports and
distributor statements to be
submitted to FDA.
Total
5,223
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There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Recordkeeping Burden1
21 CFR Section

No. of
Recordkeepers

No. of Records
per
Recordkeeper

Total
Annual
Records

Average
Burden per
Recordkeepi
ng

Total
Hours

516.141, requires the qualified
30
2
60
.5
30
expert panel leader to maintain a
(30 min.)
copy of the written report and all
notes or minutes relating to panel
deliberations that are submitted
to the requestor for 2 years after
the report is submitted.
516.165, requires the holder of
10
2
20
1
20
an indexed drug to maintain
records of all information
pertinent to the safety or
effectiveness of the indexed
drug, from foreign and domestic
sources.
Total
50
1
There are no capital costs or operating and maintenance costs associated with this collection of
information.
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12b. Annualized Cost Burden Estimate
Type of Respondent
Industry Compliance
Officer1
Clerical Worker2
Total
1,2

Total Burden Hours
5,223

Hourly Wage Rate
$45.32

50

$22.00

Total Respondent Costs
$236,706.36
$1,100
$237,806.36

May 2018 National Industry-Specific Occupational Employment and Wage Estimates, Bureau of Labor Statistics
and including 30% for benefits

13. Estimates of Other Total Annual Costs to Respondents/Recordkeepers or Capital Costs
There are no capital, start-up, operating, or maintenance costs associated with this
information collection.
14. Annualized Cost to the Federal Government
We estimate the cost to the Federal government to respond to the current level of requests for
eligibility for indexing and for addition to the Index, as well as submission of periodic drug
experience reports, is approximately $151,454.50. This estimate is based on the salary of an FTE
at the GS-14/Step 4 level in the locality pay area of Washington-Baltimore-Arlington in 2020
($133,447 /year), plus one quarter of an FTE at the GS-11/Step 1 level in the locality pay area of
Washington-Baltimore-Arlington in 2020 ($72,030/year) (0.25 FTE x $72,030 = $18,007.50).
Thus, the total cost is estimated to be $151,454.50 ($133,447+ $18,007.50).
15. Explanation for Program Changes or Adjustments*
Our estimated burden for the information collection reflects an overall increase of 401 reporting
hours. We attribute this adjustment, generally, to an increase in the number of submissions we
received over the last few years. We also reduced our burden hour estimate for drug experience
reports and distributor statements under 21 CFR 516.165 from 8 hours per submission to 5 hours
per submission based on our experience with this type of reporting.
16. Plans for Tabulation and Publication and Project Time Schedule
Section 572(a) of the FD&C Act requires us to establish an index of legally marketed unapproved
new animal drugs for minor species, which we make available on ourwebsite at
www.fda.gov/animal-veterinary/minor-useminor-species/index-legally-marketed-unapprovednew-animal-drugs-minor-species. We have no plans to tabulate and publish other information
from this information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
We are not seeking approval to not display the expiration date for OMB approval of the
information collection.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.
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