[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]
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