[Federal Register Volume 75, Number 138 (Tuesday, July 20, 2010)]
[Notices]
[Pages 42094-42095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17609]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0356]
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) Animal Health
Act of 2004.
DATES: Submit either electronic or written comments on the collection
of information by September 20, 2010.
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 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: Denver Presley Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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,
[[Page 42095]]
when appropriate, and other forms of information technology.
Designated New Animal Drugs for Minor Use and Minor Species--21 CFR
Part 516 (OMB Control No. 0910-0605)--Extension
The Minor Use and Minor Species (MUMS) Animal Health Act of 2004
amended the Federal Food, Drug, and Cosmetic Act (the 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.
Under part 516 (21 CFR part 516), Sec. 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 provisions for change in sponsorship
of MUMS-drug designation, Sec. 516.29 provides provisions for
termination of MUMS-drug designation, Sec. 516.30 provides
requirements for annual reports from sponsor(s) of MUMS-designated
drugs, and Sec. 516.36 provides provisions for insufficient quantities
of MUMS-designated drugs. Respondents are 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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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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516.20 15 5 75 16 1,200
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516.26 3 1 3 2 6
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516.27 1 1 1 1 1
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516.29 2 1 2 1 2
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516.30 15 5 75 2 150
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516.36 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
FDA's Office of Minor Use and Minor Species Animal Drug Development by
extrapolating the current investigational new animal drug (INAD) and
new animal drug (NAD) 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: July 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-17609 Filed 7-19-10; 8:45 am]
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