Document ID: FDA-2010-N-0356-0001
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: 2010-07-20T04:00Z

[Federal Register: July 20, 2010 (Volume 75, Number 138)]
[Notices]               
[Page 42094-42095]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jy10-56]                         

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents       per  Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
516.20                            15                  5                 75                 16              1,200
----------------------------------------------------------------------------------------------------------------
516.26                             3                  1                  3                  2                  6
----------------------------------------------------------------------------------------------------------------
516.27                             1                  1                  1                  1                  1
----------------------------------------------------------------------------------------------------------------
516.29                             2                  1                  2                  1                  2
----------------------------------------------------------------------------------------------------------------
516.30                            15                  5                 75                  2                150
----------------------------------------------------------------------------------------------------------------
516.36                             1                  1                  1                  3                  3
----------------------------------------------------------------------------------------------------------------
Total              .................  .................  .................  .................              1,362
----------------------------------------------------------------------------------------------------------------
\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]
BILLING CODE 4160-01-S