Document ID: FDA-2010-N-0597-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Index of Legally
Marketed Unapproved New Animal Drugs for Minor Species
Posted Date: 2014-06-20T04:00Z

[Federal Register Volume 79, Number 119 (Friday, June 20, 2014)]
[Notices]
[Pages 35357-35358]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14473]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Index of Legally 
Marketed Unapproved New Animal Drugs for 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 July 
21, 2014.

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 emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0620. 
Also include the FDA 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, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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.

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 of the 
FD&C Act (21 U.S.C. 360ccc-1), 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.
    In the Federal Register of April 7, 2014 (79 FR 19094), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 35358]]

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
         21 CFR Section              Number of     responses per   Total annual   Average burden    Total Hours
                                    respondents     respondent       responses     per 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 burden
         21 CFR Section              Number of      records per    Total annual         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.

    Dated: June 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14473 Filed 6-19-14; 8:45 am]
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