[Federal Register Volume 84, Number 113 (Wednesday, June 12, 2019)]
[Notices]
[Pages 27333-27335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12316]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2474]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Reporting Associated With Designated New Animal Drugs 
for Minor Use and 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

[[Page 27334]]

to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the reporting associated with designation 
under the Minor Use and Minor Species Animal Health Act of 2004 (MUMS 
Act).

DATES: Submit either electronic or written comments on the collection 
of information by August 12, 2019.

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 August 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of August 12, 2019. 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-2016-N-2474 for ``Reporting Associated With Designated New Animal 
Drugs for Minor Use and 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.gpo.gov/fdsys/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 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: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
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 
(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.

Reporting Associated With Designated New Animal Drugs for Minor Use and 
Minor Species--21 CFR Part 516

OMB Control Number 0910-0605--Extension

    The MUMS Act (Pub. L. 108-282) amended the Federal Food, Drug, and 
Cosmetic 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 as well as 
uncommon diseases in major animal species. This legislation provides 
incentives designed to help pharmaceutical companies overcome the 
financial burdens they face in providing limited-demand animal

[[Page 27335]]

drugs. These incentives are only available to sponsors whose drugs are 
``MUMS-designated'' by FDA. Minor use drugs are drugs for use in major 
species (e.g., cattle, horses, swine, chickens, turkeys, dogs, and 
cats) that are needed for diseases that occur in only a small number of 
animals either because they occur infrequently or in limited geographic 
areas. Minor species are all animals other than the major species 
(e.g., zoo animals, ornamental fish, parrots, ferrets, and guinea 
pigs). Some animals of agricultural importance are also minor species. 
These include animals such as sheep, goats, catfish, and honeybees. 
Participation in the MUMS program is completely optional for drug 
sponsors, so the associated reporting only applies to those sponsors 
who request and are subsequently granted ``MUMS designation.''
    Our regulations in 21 CFR part 516 specify the criteria and 
procedures for requesting MUMS designation as well as the annual 
reporting requirements for MUMS designees. Section 516.20 provides 
requirements on the content and format of a request for MUMS-drug 
designation; Sec.  516.26 provides requirements for amending MUMS-drug 
designation; Sec.  516.27 provides for change in sponsorship of MUMS-
drug designation; Sec.  516.29 provides for termination of MUMS-drug 
designation; Sec.  516.30 contains the requirements for annual reports 
from sponsor(s) of MUMS-designated drugs; and Sec.  516.36 sets forth 
consequences for insufficient quantities of MUMS-designated drugs.
    Description of Respondents: The respondents to this information 
collection are pharmaceutical companies that sponsor new animal drugs.
    FDA estimates the burden of this collection of information as 
follows:

                                      Table 1--Estimated Annual Reporting 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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516.20; content and format of                 15               5              75              16           1,200
 MUMS request...................
516.26; requirements for                       3               1               3               2               6
 amending MUMS designation......
516.27; change in sponsorship...               1               1               1               1               1
516.29; termination of MUMS                    2               1               2               1               2
 designation....................
516.30; requirements of annual                15               5              75               2             150
 reports........................
516.36; insufficient quantities.               1               1               1               3               3
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    Total.......................  ..............  ..............  ..............  ..............           1,362
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimate for this reporting requirement was derived in 
our Office of Minor Use and Minor Species Animal Drug Development by 
extrapolating the investigational new animal drug/new animal drug 
application reporting requirements for similar actions by this same 
segment of the regulated industry and from previous interactions with 
the minor use/minor species community, and has not changed since the 
last OMB approval.

    Dated: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12316 Filed 6-11-19; 8:45 am]
 BILLING CODE 4164-01-P


