[Federal Register Volume 85, Number 4 (Tuesday, January 7, 2020)]
[Notices]
[Pages 714-716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00042]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 information collection provisions of 
our regulations related to public index listing of legally marketed 
unapproved new animal drugs for minor species of animals.

DATES: Submit either electronic or written comments on the collection 
of information by March 9, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before March 9, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 9, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2010-N-0597 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Index of Legally Marketed 
Unapproved New Animal Drugs for Minor Species.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the

[[Page 715]]

docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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, 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

    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 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. 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.
    FDA estimates the burden of this collection of information as 
follows:

                                  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; 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..........................

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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...............
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    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      Number of records     Total annual
              21 CFR section                 recordkeepers     per recordkeeper       records        Average burden per recordkeeping     Total hours
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516.141, requires the qualified expert                    30                  2                 60  0.5 (30 minutes).................                 30
 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 of an                        10                  2                 20  1................................                 20
 indexed drug to maintain records of all
 information pertinent to the safety or
 effectiveness of the indexed drug, from
 foreign and domestic sources.
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    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: January 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00042 Filed 1-6-20; 8:45 am]
 BILLING CODE 4164-01-P