[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Notices]
[Pages 71623-71624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28598]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0716]


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: Fax written comments on the collection of information by 
December 30, 2013.

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 [email protected]. 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, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [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.

Designated New Animal Drugs for Minor Use and Minor Species; 21 CFR 
Part 516--(OMB Control Number 0910-0605)--Extension

    Description: The Minor Use and Minor Species Animal Health Act of 
2004 (MUMS) (Pub. L. 108-282) amended the Federal Food, Drug, and 
Cosmetic Act (the FD&C 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 paperwork only 
applies to those sponsors who request and are subsequently granted 
``MUMS designation.'' The rule specifies 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 (21 CFR 
516.26) provides requirements for amending MUMS-drug designation; 
provisions for change in sponsorship of MUMS-drug designation can be 
found under Sec.  516.27 (21 CFR 516.27); under Sec.  516.29 (21 CFR 
516.29) are provisions for termination of MUMS-drug designation; under 
Sec.  516.30 (21 CFR 516.30) are requirements for annual reports from 
sponsor(s) of MUMS-designated drugs; and under Sec.  516.36 (21 CFR 
516.36) are provisions for insufficient quantities of MUMS-designated 
drugs.
    Description of Respondents: Pharmaceutical companies that sponsor 
new animal drugs.
    In the Federal Register of July 2, 2013 (78 FR 39734), 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              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                 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

[[Page 71624]]

 
516.29; Termination of MUMS                    2               1               2               1               2
 designation....................
516.30; Requirements for 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 current 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: November 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28598 Filed 11-27-13; 8:45 am]
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