0620 ss 7-26-2017 final-1

FOOD AND DRUG ADMINISTRATION
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
OMB Control No. 0910-0620
SUPPORTING STATEMENT
Terms of Clearance: None.
A. Justification
1. Circumstances Making the Collection of Information Necessary
The Minor Use and Minor Species Animal Health Act of 2004 (the MUMS Act) (Pub. L.
108-282) added section 572 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 360ccc-1), which authorizes FDA to establish new regulatory
procedures intended to make more medications legally available to veterinarians and
animal owners for the treatment of minor animal species (species other than cattle,
horses, swine, chickens, turkeys, dogs, and cats). In enacting the MUMS Act, Congress
sought to encourage the development of these new animal drugs. Congress recognized
that the markets for drugs intended to treat these species, diseases, or conditions are so
small that there are often insufficient economic incentives to motivate drug companies to
develop data to support approvals. Further, Congress recognized that some minor species
populations are too small or their management systems too diverse to make it practical to
conduct traditional studies to demonstrate safety and effectiveness of animal drugs for
such uses. As a result of these limitations, drug companies have generally not been
willing or able to collect data to support legal marketing of drugs for these species,
diseases, or conditions. Consequently, Congress enacted the MUMS Act to provide
incentives to develop new animal drugs for minor species, while still ensuring
appropriate safeguards for animal and human health.
Section 572 of the FD&C Act provides for a public index listing of legally marketed
unapproved new animal drugs for minor species. FDA regulations in part 516 (21 CFR
part 516) specify, among other things, the criteria and procedures for requesting
eligibility for indexing and for requesting addition to the Index, as well as the annual
reporting requirements for index holders. The administrative procedures and criteria for
indexing a new animal drug for use in a minor species are set forth in 21 CFR 516.111
through 516.171. Section 516.165 sets forth the annual reporting requirements for index
holders. FDA needs the information to determine: 1) the eligibility of a new animal drug
for indexing; 2) that a qualified expert panel proposed to review certain information
regarding the new animal drug meets the selection criteria listed in the regulations; 3)
whether the agency agrees with the recommendation of a qualified expert panel that a
drug be added to the Index; and, 4) whether there may be grounds for removing a drug
from the Index.

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We request extension of OMB approval of the reporting and recordkeeping requirements
contained in the following citations:
21 CFR 516.119 – Reporting
Requires a foreign drug company to submit to FDA the name and address of a permanent
U.S. resident agent, and provide notification of changes in such agents or changes of
address of agents within 60 days of the effective date of such changes.
21 CFR 516.121 – Reporting
Specifies information to be contained in a written request for a meeting with FDA to
discuss the requirements for indexing a new animal drug.
21 CFR 516.123 – Reporting
Specifies information to be contained in a written request for an informal conference and
a requestor’s written response to an FDA initial decision denying a request.
21 CFR 516.125 – Reporting
Specifies the requirements for correspondence and information associated with
investigational use of new animal drugs intended for indexing.
21 CFR 516.129 – Reporting
Specifies the content and format of a request for determination of eligibility for indexing.
21 CFR 516.141 – Reporting
Specifies information to be submitted to FDA by a requestor seeking to establish a
qualified expert panel.
21 CFR 516.143 – Reporting
Specifies the content and format of the written report of the qualified expert panel.
21 CFR 516.145 – Reporting
Specifies the content and format of a request for addition to the Index.
21 CFR 516.161 – Reporting
Specifies the content and format of a request for modification of an indexed drug.

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21 CFR 516.163 – Reporting
Specifies information to be contained in a request to FDA to transfer ownership of a
drug's index file to another person.
21 CFR 516.165 – Reporting
Requires drug experience reports and distributor statements to be submitted to FDA.
21 CFR 516.141 – Recordkeeping
Requires the qualified expert panel leader to maintain a 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.
21 CFR 516.165 – Recordkeeping
Requires the holder of an indexed drug to maintain records of all information pertinent to
the safety or effectiveness of the indexed drug, from foreign and domestic sources.
2. Purpose and Use of the Information Collection
The information collected in requests for determination of eligibility for indexing and in
requests for addition to the Index, as well as the annual reporting requirements for index
holders is submitted to the Office of Minor Use and Minor Species Animal Drug
Development (OMUMS). The information is used by OMUMS to determine: the
eligibility of a new animal drug for indexing; that a qualified expert panel proposed to
review certain information regarding the new animal drug meets the selection criteria
listed in the regulations; and, whether the agency agrees with the recommendation of a
qualified expert panel that a drug be added to the Index. The information collected in
annual written drug experience reports is used by OMUMS to monitor possible drugrelated adverse events. OMUMS reviews the records and reports required in 21 CFR
516.165 to facilitate a determination under section 572(f) of the FD&C Act as to whether
there may be grounds for removing a drug from the Index.
3. Use of Improved Information Technology and Burden Reduction
The regulations in part 516 do not specifically prescribe the use of automated, electronic,
mechanical, or other technological techniques or other forms of information technology
as necessary for use by firms. Companies are free to use whatever forms of information
technology may best assist them in fulfilling the agency’s submission requirements,
retaining the appropriate records, and making them available to regulatory officials. We
estimate that approximately 50% of requests for determination of eligibility for indexing
and requests for addition to the Index will be submitted electronically in the next three
years. We estimate that about 50% of respondents will keep some of the required records
electronically in the next three years.

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4. Efforts to Identify Duplication and Use of Similar Information
The information collected in requests for eligibility for indexing and for addition to the
Index, as well as the annual reporting requirements for index holders, is unique to each
new animal drug requestor and their specific drug, dosage form, and intended use.
Because FDA is the only Federal agency with the authority to maintain a public index
listing of legally marketed unapproved new animal drugs for minor species, there is no
likelihood of duplication by other Federal agencies.
5. Impact on Small Businesses or Other Small Entities
We estimate that approximately 5 of the affected firms are small businesses. Because
many new animal drugs for minor uses and minor species traditionally come from
smaller drug companies, we believe the MUMS Act and our regulations in part 516 have
a beneficial impact on small business. The collection of information outlined in part 516
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. We aid small businesses in
complying with our requirements through our Regional Small Business Representatives
and through our scientific and administrative staffs. We have provided a Small Business
Guide on our website at http://www.fda.gov/oc/industry/. Furthermore, we encourage
animal drug companies, whether small or large businesses, to meet with us to discuss
questions concerning submissions.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. New animal drug requestors will not be allowed to
make their drug legally available to veterinarians and animal owners for the treatment of
minor animal species if the information is not submitted. Periodic drug experience
reports are submitted to OMUMS annually (21 CFR 516.165). This reporting frequency
is the same as is currently required for approved drugs under 21 CFR 514.80(b)(4). The
reporting frequency is dictated by the need to identify potential problems concerning the
safety and effectiveness of new animal drugs. Less frequent data collection would hinder
early detection of threats to human and animal health.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), we published a 60-day notice for public comment
in the Federal Register of December 21, 2016 (81 FR 93689). One comment was
received, but was not responsive to the information collection topics solicited.

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9. Explanation of Any Payment or Gift to Respondents
We do not provide any payments or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
We expect that requests for eligibility for indexing and for addition to the Index, as well
as the periodic drug experience reports submitted by index holders, will contain trade
secret and confidential commercial information. Confidentiality of data and information
in an index file is provided for in 21 CFR 516.171. As a result, all files are maintained in
a secured area. A security controlled document file room, locked files, drawers and doors
are required for in-house protection. Unused documents are destroyed by shredding.
This protection is continued after a drug is added to index. 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)).
11. Justification for Sensitive Questions
This information collection does not involve any questions that are of a personally
sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection of information as follows:
Table 1.--Estimated Annual Reporting Burden
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.

No. of
Respondents
2

No. of
Responses per
Respondent
1

Total
Annual
Responses
2

30

2

60

5

Average
Burden per
Response

Total
Hours
1

2

4

240

21 CFR Section

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.
516.129; content and
format of a request for
determination of
eligibility for indexing.
516.141; information
to be submitted to FDA
by a requestor seeking
to establish a qualified
expert panel.
516.143; content and
format of the written
report of the qualified
expert panel.
516.145; content and
format of a request for
addition to the Index.
516.161; content and
format of a request for
modification of an
indexed drug.
516.163; information
to be contained in a
request to FDA to
transfer ownership of a
drug's index file to
another person.
516.165; requires drug
experience reports and
distributor statements
to be submitted to
FDA.
Total

No. of
Respondents
3

No. of
Responses per
Respondent
1

Total
Annual
Responses
3

2

3

30

Average
Burden per
Response

Total
Hours
8

24

6

20

120

2

60

20

1,200

20

1

20

16

320

20

1

20

120

2,400

20

1

20

20

400

1

1

1

4

4

1

1

1

2

2

10

2

20

8

160

4,872

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Table 2.--Estimated Annual Recordkeeping Burden
21 CFR Section

No. of
Recordkeepers

516.141, requires
the qualified expert
panel leader to
maintain a 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 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

Total
Annual
Records
60

Average Burden
per Recordkeeping

Total
Hours

30

No. of Records
per
Recordkeeper
2

0.5
(30 minutes)

30

10

2

20

1

20

50

We based our estimates in tables 1 and 2 on our experience with the MUMS indexing
program and the requests for eligibility for indexing and for addition to the Index, as well as
the periodic drug experience reports submitted during the past three years.
12b. Annualized Cost Burden Estimate
Type of Respondent
Industry Compliance
Officer1
Clerical Worker2
Total

Total Burden
Hours
4872

Hourly Wage
Rate
$43.24

50

$19.93

Total Respondent
Costs
$210,665.28
$996.50
$211,661.78

1,2
May 2015 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 and/or Recordkeepers/Capital
Costs
There are no capital, start-up, operating, or maintenance costs associated with this
information collection.

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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 $139,851. This estimate is based on the salary
of an FTE at the GS-14/Step 4 level in the locality pay area of Washington-BaltimoreArlington in 2017 ($123,223/year), plus one quarter of an FTE at the GS-11/Step 1 level
in the locality pay area of Washington-Baltimore-Arlington in 2017 ($66,510/year) (0.25
FTE x $66,510 = $16,628). Thus, the total cost is estimated to be $139,851 ($123,223+
$16,628).
15. Explanation for Program Changes or Adjustments
The burden remains unchanged for the information collection. However, we have revised
the IC list appearing at www.reginfo.gov by consolidating the previously itemized
regulatory provisions into reporting and recordkeeping categories. We believe this will
assist the reader by more easily identifying the summary of cumulative fluctuations for
the collection. At the same time, readers may still view estimated burden associated with
individual provisions by referring to the agency’s 60-day and 30-day notices and in the
burden tables found in Q.12: Estimates of Annualized Burden Hours and Costs of this
supporting statement.
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 our
website at
https://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorS
pecies/ucm125452.htm. 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 an exemption from displaying the expiration date for OMB approval.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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