Document ID: FDA-2010-N-0597-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection;
Comment Request; Index of Legally Marketed Unapproved New Animal
Drugs for Minor Species; Extension
Posted Date: 2014-04-07T04:00Z

[Federal Register Volume 79, Number 66 (Monday, April 7, 2014)]
[Notices]
[Pages 19094-19096]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07708]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0597]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Index of Legally Marketed Unapproved New Animal Drugs 
for Minor Species; Extension

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 burden hours associated 
with indexing of legal marketed unapproved new animal drugs for minor 
species.

DATES: Submit either electronic or written comments on the collection 
of information by June 6, 2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget

[[Page 19095]]

(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.

Index of Legally Marketed Unapproved New Animal Drugs for Minor Species 
21 CFR Part 516 (OMB Control Number 0910-0620)--Extension

    Description: The Minor Use and Minor Species Animal Health Act of 
2004 (MUMS Act) 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 (species 
other than cattle, horses, swine, chickens, turkeys, dogs, and cats), 
as well as uncommon diseases in major animal species.
    The MUMS Act created three new sections to the FD&C Act (sections 
571, 572, and 573), and this final rule implements section 572, which 
provides for an index of legally marketed unapproved new animal drugs 
for minor species. Participation in any part of the MUMS program is 
optional so the associated paperwork only applies to those who choose 
to participate. The final rule specifies, among other things, the 
criteria and procedures for requesting eligibility for indexing and for 
requesting addition to the index as well as the annual reporting 
requirements for index holders.
    Under subpart C of part 516, Sec.  516.119 provides requirements 
for naming a permanent resident U.S. agent by foreign drug companies, 
and Sec.  516.121 provides for informational meetings with FDA. Section 
516.123 provides requirements for requesting informal conferences 
regarding Agency administrative actions and Sec.  516.125 provides for 
investigational use of new animal drugs intended for indexing. 
Provisions for requesting a determination of eligibility for indexing 
can be found under Sec.  516.129 and provisions for subsequent requests 
for addition to the index can be found under Sec.  516.145. A 
description of the written report required in Sec.  516.145 can be 
found under Sec.  516.143. Under Sec.  516.141 are provisions for drug 
companies to nominate a qualified expert panel as well as the panel's 
recordkeeping requirements. This section also calls for the submission 
of a written conflict of interest statement to FDA by each proposed 
panel member. Index holders are able to modify their index listing 
under Sec.  516.161 or change drug ownership under Sec.  516.163. 
Requirements for records and reports are under Sec.  516.165.
    Description of Respondents: Pharmaceutical companies that sponsor 
new animal drugs. FDA estimates the burden for this collection of 
information as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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516.119.........................               2               1               2               1               2
516.121.........................              30               2              60               4             240
516.123.........................               3               1               3               8              24
516.125.........................               2               3               6              20             120
516.129.........................              30               2              60              20            1200
516.141.........................              20               1              20              16             320
516.143.........................              20               1              20             120            2400
516.145.........................              20               1              20              20             400
516.161.........................               1               1               1               4               4
516.163.........................               1               1               1               2               2
516.165.........................              10               2              20               8             160
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    Total.......................  ..............  ..............  ..............  ..............           4,872
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\1\ There is no capital or operating and maintenance cost associated with this collection of information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                    Number of                        Average
         21 CFR section             Number of      records per    Total annual     burden per      Total hours
                                  recordkeepers   recordkeeper       records      recordkeeping
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516.141........................              30               2              60         \2\ 0.5             30
516.165........................              10               2              20               1             20
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    Total......................  ..............  ..............  ..............  ..............             50
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\1\ There is no capital or operating and maintenance cost associated with this collection of information.
\2\ 30 minutes.

[[Page 19096]]

    Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07708 Filed 4-4-14; 8:45 am]
BILLING CODE 4160-01-P