Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Minor Use and Minor Species

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Published

June 29, 2023

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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<title>Federal Register, Volume 88 Issue 124 (Thursday, June 29, 2023)</title>
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[Federal Register Volume 88, Number 124 (Thursday, June 29, 2023)]
[Notices]
[Pages 42080-42082]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-13853]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2474]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; New Animal Drugs for
Minor Use and Minor Species

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by July 31, 2023.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0605. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
<a href="/cdn-cgi/l/email-protection#7d2d2f3c2e091c1b1b3d1b191c5315150e531a120b"><span class="__cf_email__" data-cfemail="653537243611040303250301044b0d0d164b020a13">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

New Animal Drugs for Minor Use and Minor Species

OMB Control Number 0910-0605--Revision

This information collection supports FDA regulations that implement
sections 572 and 573 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360ccc-1 and 21 U.S.C. 360ccc-2) which establish an
index of legally marketed unapproved new animal drugs for minor species
and requirements for the designation of minor use or minor species new
animal drugs, respectively. Agency regulations are codified in part 516
(21 CFR part 516) and include recordkeeping and reporting requirements.
The purpose of these regulations is to encourage the development of
these new animal drugs, while still ensuring appropriate safeguards for
animal and human health. The general provisions in part 516, subpart A,
set forth its purpose, scope, and applicable definitions.
Our regulations in part 516, subpart B, provide for designation
status for Minor Use and Minor Species (MUMS) drugs prior to their
approval or conditional approval. MUMS-drug designation makes the
sponsor eligible for incentives to support the approval or conditional
approval of the designated use and is completely optional for drug
sponsors. The regulations describe how to apply for designation, what
needs to be submitted, and other information pertaining to this option.
Sponsors of designated new animal drugs are required to demonstrate due
diligence toward approval or conditional approval through submission of
annual reports documenting their progress for each designated use. We
use this information to allow for determining eligibility for
designation and the associated incentives and benefits, including a 7-
year period of exclusive marketing rights, as provided by section 573
of the FD&C Act. It enables us to process requests for MUMS-drug
designation, requests to amend MUMS-drug designation, changes in
sponsorship, termination of MUMS-drug designation, requirements for
annual reports from sponsors, and provisions for insufficient
quantities of MUMS-designated drugs.
Regulations in part 516, subpart C, are intended to make more
medications legally available to veterinarians and animal owners for
the treatment of minor animal species. In some cases, a minor species
drug is intended for use in species that are too rare or too varied to
be the subject of adequate and well-controlled studies in support of a
drug approval. In such cases, FDA may add the drug to the public index
listing of legally marketed unapproved new animal drugs for minor
species animals (Index), as provided for by section 572 of the FD&C
Act. Within limitations established by the statute, such indexing
provides a basis for legally marketing an unapproved new animal drug
intended for use in a minor species. Our regulations in part 516,
subpart C, 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 holders of an
index listing. The administrative procedures and criteria for indexing
a new animal drug for use in a minor species, as well as modifications
and removal of a drug from the Index are also set forth. FDA uses the
information for the activities described above.
In the Federal Register of August 1, 2022 (87 FR 46961), FDA
published a 60-day notice requesting public

[[Page 42081]]

comment on the information collection requirements related to
designation status for MUMS drugs. No comments were received. We are
revising the information collection to add the information collection
requirements associated with the index listing of legally marketed
unapproved new animal drugs for minor species, for efficiency of Agency
operations.
Description of Respondents: The respondents to this information
collection are pharmaceutical companies that sponsor new animal drugs
for designation or requesters wishing to add a new animal drug to the
Index.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
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Number of Average burden
21 CFR section; activity Number of responses per Total annual per response Total hours
respondents respondent responses \2\ (hours) \3\
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Designated New Animal Drugs for Minor Use and Minor Species, Part 516, Subpart B
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516.20, 516.26, 516.27, 516.29, 26 ~2.65 69 4 276
516.30, and 516.36; Reporting
burden associated with drug
designation requests and
termination of designation.....
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Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, Part 516, Subpart C
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516.119, 516.121, 516.123, 30 ~10.33 310 ~16.954 5,256
516.125, 516.141, 516.143,
516.145; 516.161, 516.163, and
516.165; Reporting burden
associated with requests for
index listing and modifying
indexed drugs..................
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Total....................... .............. .............. .............. .............. 5,532
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Decimal rounded.
\3\ Rounded up.

Burden we attribute to reporting activities is assumed to be
distributed among the individual elements and averaged among
respondents. Our estimate of the burden per disclosure (4 and 16.954
hours, respectively) reflect what we believe is the average burden
based on the reporting required by the information collection.

Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
21 CFR section, activity Number of records per Total annual Average burden per Total hours
recordkeepers recordkeeper records recordkeeping
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Designated New Animal Drugs for Minor Use and Minor Species, Part 516, Subpart B
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One-time recordkeeping 474 1 474 0.68 (~41 minutes) 323
burden associated with \3\.
reading and understanding
the rule \2\.
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Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, Part 516, Subpart C
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516.141 and 516.165; 40 2 80 0.625 (37.5 50
recordkeeping associated minutes).
with panel deliberations
and the information
pertinent to the safety and
effectiveness from foreign
sources.
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Total................... .............. .............. .............. .................. 373
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Direct Final Rule, ``Defining `Small Number of Animals' for Minor Use Determination; Periodic Reassessment''
(September 15, 2022; 87 FR 56583). Preliminary Regulatory Impact Analysis (<a href="https://www.regulations.gov/document/FDA-2022-N-1128-0007">https://www.regulations.gov/document/FDA-2022-N-1128-0007</a>).
\3\ Rounded up.

Burden we attribute to recordkeeping activities for the indexing
provisions is assumed to be distributed among the individual elements
and averaged among respondents. Our estimate of the burden per record
(0.625 hours) reflects what we believe is the average burden based on
the recordkeeping required by the information collection.
For efficiency of Agency operations, we are consolidating the
related information collection activities currently approved in OMB
control numbers 0910-0605 and 0910-0620 into a single collection
request. The burden estimates reflect our current experience with the
information collection and requests received by respondents over the
past 3 years. We also include burden that may be attributable to
rulemaking (RIN 0910-A146), which became effective on December 14,
2022. Although the rulemaking revised the definition of ``small number
of animals,'' for purposes of determining whether a particular intended
use of a drug in a major species qualifies as a minor use, we believe
only nominal adjustments in burden associated with designation status
for MUMS drugs may result, other than a one-time recordkeeping burden.
In addition, upon review of the previous information collection
submission related to

[[Page 42082]]

indexing, we include burden associated with recordkeeping to address a
data-entry error in the RISC/ORIA Combined Information System (ROCIS
system). Cumulatively, these changes and adjustments reflect an overall
increase of 5,905 hours and a corresponding increase of 864 responses,
annually, to the information collection.

Dated: June 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13853 Filed 6-28-23; 8:45 am]
BILLING CODE 4164-01-P

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