Document ID: FDA-2016-N-2474-0002
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
Species
Posted Date: 2016-12-22T05:00Z

[Federal Register Volume 81, Number 246 (Thursday, December 22, 2016)]
[Notices]
[Pages 93941-93942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30770]

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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 
23, 2017.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed

[[Page 93942]]

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) Animal Health Act of 2004 
(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 (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. 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 (21 CFR 
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 August 22, 2016 (81 FR 56658), 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                        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
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    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.

    Dated: December 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30770 Filed 12-21-16; 8:45 am]
 BILLING CODE 4164-01-P