[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