Document ID: FDA-2016-N-2474-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Reporting
Associated With Designated New Animal Drugs for Minor Use and Minor
Speciess
Posted Date: 2019-12-11T05:00Z

[Federal Register Volume 84, Number 238 (Wednesday, December 11, 2019)]
[Notices]
[Pages 67745-67746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26682]

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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; Reporting Associated 
With 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: Fax written comments on the collection of information by January 
10, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0605. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@fda.hhs.gov.

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 Minor Use and Minor Species (MUMS) Act (Pub. L. 108-282) 
amended the Federal Food, Drug, and Cosmetic Act to authorize FDA to 
establish new 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. This legislation 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 whose drugs are ``MUMS-designated'' by FDA. Minor 
use drugs are drugs for use in major species (e.g., 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 (e.g., 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. Participation in the MUMS program is 
completely optional for drug sponsors, so the associated reporting only 
applies to those sponsors who request and are subsequently granted 
``MUMS designation.''
    Our regulations in 21 CFR part 516 specify the criteria and 
procedures for requesting MUMS designation as well as the annual 
reporting requirements for MUMS designees. Section 516.20 provides 
requirements on the content and format of a request for MUMS-drug 
designation; Sec.  516.26 provides requirements for amending MUMS-drug 
designation; Sec.  516.27 provides for change in sponsorship of MUMS-
drug designation; Sec.  516.29 provides for termination of MUMS-drug 
designation; Sec.  516.30 contains the requirements for annual reports 
from sponsor(s) of MUMS-designated drugs; and Sec.  516.36 sets forth 
consequences for insufficient quantities of MUMS-designated drugs.
    Description of Respondents: The respondents to this information 
collection are pharmaceutical companies that sponsor new animal drugs.
    In the Federal Register of June 12, 2019 (84 FR 27333), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of

[[Page 67746]]

information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                     Table 1--Estimated Annual Reporting \1\
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                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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516.20; content and format of                 15               5              75              16           1,200
 MUMS request...................
516.26; requirements for                       3               1               3               2               6
 amending MUMS designation......
516.27; change in sponsorship...               1               1               1               1               1
516.29; termination of MUMS                    2               1               2               1               2
 designation....................
516.30; requirements of annual                15               5              75               2             150
 reports........................
516.36; insufficient quantities.               1               1               1               3               3
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................  ..............  ..............  ..............  ..............           1,362
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimate for this reporting requirement was derived in 
our Office of Minor Use and Minor Species Animal Drug Development by 
extrapolating the investigational new animal drug/new animal drug 
application reporting requirements for similar actions by this same 
segment of the regulated industry and from previous interactions with 
the minor use/minor species community, and has not changed since the 
last OMB approval.

    Dated: December 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26682 Filed 12-10-19; 8:45 am]
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