Document ID: FDA-2010-N-0597-0007
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: 2017-07-20T04:00Z

[Federal Register Volume 82, Number 138 (Thursday, July 20, 2017)]
[Notices]
[Pages 33507-33509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15206]

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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 August 
21, 2017.

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.

[[Page 33508]]

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726.

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 (the 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, diseases, or conditions 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, diseases, or conditions. 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 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 December 21, 2016 (81 FR 93689), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment, which was outside 
the scope of the comment requests in the notice.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
        21 CFR section             Number of       responses per   Total annual   Average burden    Total hours
                                  respondents       respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
516.119--requires a foreign                    2               1               2               1               2
 drug company to submit and
 update the name and address
 of a permanent U.S. resident
 agent.......................
516.121--written request for                  30               2              60               4             240
 a meeting with FDA to
 discuss the requirements for
 indexing a new animal drug..
516.123--written request for                   3               1               3               8              24
 an 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                   30               2              60              20           1,200
 of a 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                   20               1              20             120           2,400
 of the written report of the
 qualified expert panel......
516.145--content and format                   20               1              20              20             400
 of a request for addition to
 the Index...................
516.161--content and format                    1               1               1               4               4
 of a 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               2              20               8             160
 experience reports and
 distributor statements to be
 submitted to FDA............
                              ----------------------------------------------------------------------------------
    Total....................  .................  ..............  ..............  ..............           4,872
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

[[Page 33509]]

                               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
----------------------------------------------------------------------------------------------------------------
516.141--requires the                         30               2              60             *.5              30
 qualified expert panel
 leader to maintain a copy of
 the written 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                  10               2              20               1              20
 of an indexed drug to
 maintain records of all
 information pertinent to the
 safety or effectiveness of
 the indexed drug, from
 foreign and domestic sources
                              ----------------------------------------------------------------------------------
    Total....................  .................  ..............  ..............  ..............              50
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
*30 minutes.

    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. The burden has not changed 
since the last OMB approval.

    Dated: July 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15206 Filed 7-19-17; 8:45 am]
 BILLING CODE 4164-01-P