Document ID: FDA-2010-N-0597-0011
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: 2020-04-30T04:00Z

[Federal Register Volume 85, Number 84 (Thursday, April 30, 2020)]
[Notices]
[Pages 23969-23970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09170]

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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: Submit written comments (including recommendations) on the 
collection of information by June 1, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0620. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
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

    The Minor Use and Minor Species Animal Health Act of 2004 (the MUMS 
Act) (Pub. L. 108-282) added section 572 of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 360ccc-1), which authorizes 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). In enacting the MUMS Act, Congress 
sought to encourage the development of these new animal drugs. Congress 
recognized that the markets for drugs intended to treat these species 
are so small that there are often insufficient economic incentives to 
motivate drug companies to develop data to support approvals. Further, 
Congress recognized that some minor species populations are too small 
or their management systems too diverse to make it practical to conduct 
traditional studies to demonstrate safety and effectiveness of animal 
drugs for such uses.
    As a result of these limitations, drug companies have generally not 
been willing or able to collect data to support legal marketing of 
drugs for these species. Consequently, Congress enacted the MUMS Act to 
provide incentives to develop new animal drugs for minor species, while 
still ensuring appropriate safeguards for animal and human health. 
Section 572 of the FD&C Act provides for a public index listing of 
legally marketed unapproved new animal drugs for minor species. FDA 
regulations in part 516 (21 CFR part 516) specify, 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. The administrative procedures and 
criteria for indexing a new animal drug for use in a minor species are 
set forth in Sec. Sec.  516.111 through 516.171 (21 CFR 516.111 through 
516.171). Section 516.165 sets forth the annual reporting requirements 
for index holders. FDA needs the information to determine: (1) The 
eligibility of a new animal drug for indexing; (2) that a qualified 
expert panel proposed to review certain information regarding the new 
animal drug meets the selection criteria listed in the regulations; (3) 
whether the Agency agrees with the recommendation of a qualified expert 
panel that a drug be added to the index; and (4) whether there may be 
grounds for removing a drug from the index.
    In the Federal Register of January 7, 2020 (85 FR 714), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although one comment was received, it was 
not responsive to the four collection of information topics solicited.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 23970]]

                                 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; requires a foreign drug               5               1               5               1               5
 company to submit and update
 the name and address of a
 permanent U.S. resident agent..
516.121; written request for a                30               2              60               4             240
 meeting with FDA to discuss the
 requirements for indexing a new
 animal drug....................
516.123; written request for an                3               1               3               8              24
 informal conference and a
 requestor's written response to
 an FDA initial decision denying
 a request......................
516.125; correspondence and                    2               3               6              20             120
 information associated with
 investigational use of new
 animal drugs intended for
 indexing.......................
516.129; content and format of a              30               2              60              20           1,200
 request for determination of
 eligibility for indexing.......
516.141; information to be                    20               1              20              16             320
 submitted to FDA by a requestor
 seeking to establish a
 qualified expert panel.........
516.143; content and format of                20               1              20             120           2,400
 the written report of the
 qualified expert panel.........
516.145; content and format of a              20               1              20              20             400
 request for addition to the
 index..........................
516.161; content and format of a               3               1               3               4              12
 request for modification of an
 indexed drug...................
516.163; information to be                     1               1               1               2               2
 contained in a request to FDA
 to transfer ownership of a
 drug's index file to another
 person.........................
516.165; requires drug                        10              10             100               5             500
 experience reports and
 distributor statements to be
 submitted to FDA...............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           5,223
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                  Number of
                21 CFR Section                    Number of      records per    Total annual        Average burden per recordkeeping        Total hours
                                                recordkeepers   recordkeeper       records
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516.141, requires the qualified expert panel               30               2              60  0.5......................................              30
 leader to maintain a copy of the written                                                      (30 minutes).............................
 report and all notes or minutes relating to
 panel deliberations that are submitted to
 the requestor for 2 years after the report
 is submitted.
516.165, requires the holder of an indexed                 10               2              20  1........................................              20
 drug to maintain records of all information
 pertinent to the safety or effectiveness of
 the indexed drug, from foreign and domestic
 sources.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................              50
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We based our estimates in tables 1 and 2 on our experience with the 
MUMS indexing program and the requests for eligibility for indexing and 
for addition to the index, as well as the periodic drug experience 
reports submitted during the past 3 years.
    Our estimated burden for the information collection reflects an 
overall increase of 351 reporting hours and a corresponding increase of 
85 responses. We attribute this adjustment, generally, to an increase 
in the number of submissions we received over the last few years. We 
also reduced our burden hour estimate for drug experience reports and 
distributor statements under Sec.  516.165 from 8 hours per submission 
to 5 hours per submission based on our experience with this type of 
reporting.

    Dated: April 23, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-09170 Filed 4-29-20; 8:45 am]
BILLING CODE 4164-01-P