[Federal Register Volume 88, Number 4 (Friday, January 6, 2023)]
[Notices]
[Pages 1076-1077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00015]



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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; Designated 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) 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 February 6, 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.

Reporting Associated With Designated New Animal Drugs for Minor Use and 
Minor Species--21 CFR Part 516

OMB Control Number 0910-0605--Extension

    The Federal Food, Drug, and Cosmetic Act authorizes FDA to 
implement 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 (21 U.S.C. 360ccc). This statutory authority provides 
incentives designed to help pharmaceutical companies overcome the 
financial burdens they face in providing limited-demand animal drugs. 
These incentives are only available to sponsors who have had their 
drugs designated by FDA under section 573 of the Minor Use and Minor 
Species Animal Health Act of 2004 (Pub. L. 108-282) (MUMS Act). Minor 
use drugs are drugs for use in major species (cattle, horses, swine, 
chickens, turkeys, dogs, and cats) that are needed for diseases that 
occur in only a small number of animals either because they occur 
infrequently or in limited geographic areas. Minor species are all 
animals other than the major species, for example, zoo animals, 
ornamental fish, parrots, ferrets, and guinea pigs. Some animals of 
agricultural importance are also minor species. These include animals 
such as sheep, goats, catfish, and honeybees.
    MUMS-drug designation is completely optional for drug sponsors. The 
associated reporting only applies to those sponsors who request and are 
subsequently granted MUMS-drug designation status. Our regulations in 
21 CFR part 516 specify the criteria and procedures for requesting 
MUMS-drug designation as well as the annual reporting requirements for 
MUMS designees. Sponsors use FDA's ``eSubmitter'' system to fill out a 
series of system generated screens to submit their request and annual 
report electronically. To access the ``eSubmitter'' system, sponsors 
will use a previously established account. Additional information about 
this system is available on our website at: https://www.fda.gov/industry/fda-esubmitter.
    Description of Respondents: The respondents to this information 
collection are pharmaceutical companies that sponsor new animal drugs.
    In the Federal Register of August 1, 2022 (87 FR 46961), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
    21 CFR section; activity         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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516.20; content and format of                  5               2              10              16             160
 MUMS-drug designation request..
516.26; requirements for                       3               1               3               2               6
 amending MUMS-drug designation.
516.27; change in sponsorship of               1               1               1               1               1
 MUMS-drug designation..........
516.29; termination of MUMS-drug               2               1               2               1               2
 designation....................
516.30; requirements of annual                26               2              52               2             104
 reports from sponsor(s) of MUMS-
 designated drugs...............
516.36; consequences for                       1               1               1               3               3
 insufficient quantities of MUMS-
 designated drugs...............
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  Total.........................  ..............  ..............  ..............  ..............             276
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The information collection reflects an overall adjustment decrease 
of 88 responses and 1,086 burden hours. Upon further review since 
publication of the 60-day notice, we determined that the number of 
respondents for new designation requests decreased (from 15 to 5 
respondents) due to changes in industry, while the number of 
respondents for annual reports increased (from 15 to 26 respondents), 
due to an increase in the number of sponsors holding active MUMS 
designations since the last renewal of this collection. We also 
decreased the

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number of responses per respondent for both the new designation request 
and the annual report (from five to two), based on our experience over 
the last 3 years.

    Dated: January 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00015 Filed 1-5-23; 8:45 am]
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