[Federal Register Volume 75, Number 187 (Tuesday, September 28, 2010)]
[Notices]
[Pages 59721-59722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24273]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0356]
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 October
28, 2010.
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 e-mailed 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: Denver Presley Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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; (OMB
Control Number 0910-0605)--Extension
The Minor Use and Minor Species (MUMS) Animal Health Act of 2004
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
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.
In the Federal Register of July 20, 2010 (75 FR 42094), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. In response, FDA received
[[Page 59722]]
one comment that was not responsive to the comment request on the
information collection provision.
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
our Office of Minor Use and Minor Species Animal Drug Development by
extrapolating the current investigational new animal drug (INAD)/new
animal drug application (NADA) 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: September 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24273 Filed 9-27-10; 8:45 am]
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