[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
[email protected].
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
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,362
----------------------------------------------------------------------------------------------------------------
\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