Document ID: FDA-2016-N-2474-0007
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Designated New Animal Drugs for Minor Use and Minor Species
Posted Date: 2022-08-01T04:00Z

[Federal Register Volume 87, Number 146 (Monday, August 1, 2022)]
[Notices]
[Pages 46961-46962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16387]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Designated New Animal Drugs for Minor Use and Minor 
Species

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the reporting associated with 
regulations specifying the criteria and procedures for minor uses and 
minor species (MUMS) new animal drug designation requests.

DATES: Either electronic or written comments on the collection of 
information must be submitted by September 30, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 30, 2022. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-2474 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Designated New Animal Drugs for 
Minor Use and Minor Species.'' Received comments, those filed in a 
timely manner (see ADDRESSES), will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests

[[Page 46962]]

or requirements that members of the public submit reports, keep 
records, or provide information to a third party. Section 3506(c)(2)(A) 
of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to 
provide a 60-day notice in the Federal Register concerning each 
proposed collection of information, including each proposed extension 
of an existing collection of information, before submitting the 
collection to OMB for approval. To comply with this requirement, FDA is 
publishing notice of the proposed collection of information set forth 
in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 (FD&C 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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
    21 CFR section; activity         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
516.20; content and format of                 15               5              75              16           1,200
 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                15               5              75               2             150
 reports from sponsor(s) of MUMS-
 designated drugs...............
516.36; consequences for                       1               1               1               3               3
 insufficient quantities of MUMS-
 designated drugs...............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,362
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: July 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16387 Filed 7-29-22; 8:45 am]
BILLING CODE 4164-01-P