[Federal Register Volume 78, Number 127 (Tuesday, July 2, 2013)]
[Notices]
[Pages 39734-39736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-15792]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 paperwork associated with 
designation under the Minor Use and Minor Species (MUMS) Act.

DATES: Submit either electronic or written comments on the collection 
of information by September 3, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug

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Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All 
comments should be identified with the docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, 301-796-5733, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 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.

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 (MUMS) Animal Health 
Act of 2004 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.
    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            1200
 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 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.


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    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: June 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-15792 Filed 7-1-13; 8:45 am]
BILLING CODE 4160-01-P