[Federal Register Volume 88, Number 124 (Thursday, June 29, 2023)]
[Notices]
[Pages 42080-42082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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..................
                                 -------------------------------------------------------------------------------
    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.
                             -----------------------------------------------------------------------------------
    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 (https://www.regulations.gov/document/FDA-2022-N-1128-0007).
\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


