Document ID: FDA-2010-N-0356-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Designated New Animal Drugs for Minor Use and Minor Species
Posted Date: 2010-09-28T04:00Z

[Federal Register: September 28, 2010 (Volume 75, Number 187)]
[Notices]               
[Page 59721-59722]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28se10-75]                         

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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 oira_submission@omb.eop.gov. 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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