Notice2023-00015
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Designated New Animal Drugs for Minor Use and Minor Species
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 6, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 4 (Friday, January 6, 2023)</title>
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[Federal Register Volume 88, Number 4 (Friday, January 6, 2023)]
[Notices]
[Pages 1076-1077]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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#98c8cad9cbecf9fefed8fefcf9b6f0f0ebb6fff7ee"><span class="__cf_email__" data-cfemail="f0a0a2b1a384919696b0969491de989883de979f86">[email 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.
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: <a href="https://www.fda.gov/industry/fda-esubmitter">https://www.fda.gov/industry/fda-esubmitter</a>.
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]
BILLING CODE 4164-01-P
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