Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application, 66280-66282 [2018-27812]
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66280
Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Notices
amozie on DSK3GDR082PROD with NOTICES1
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product, ADLYXIN
(lixisenatide) indicated as an adjunct to
diet and exercise to improve glycemic
control in adults with type 2 diabetes
mellitus. Subsequent to this approval,
the USPTO received a patent term
restoration application for ADLYXIN
(U.S. Patent No. RE45313) from ZP
Holding SPV K/S and the USPTO
requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter dated
October 16, 2017, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
ADLYXIN represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
ADLYXIN is 5,500 days. Of this time,
5,133 days occurred during the testing
phase of the regulatory review period,
while 367 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: July 8, 2001.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
July 8, 2001.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b)of the FD&C Act: July 27, 2015.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
ADLYXIN (NDA 208471) was initially
submitted on July 27, 2015.
3. The date the application was
approved: July 27, 2016. FDA has
verified the applicant’s claim that NDA
208471 was approved on July 27, 2016.
VerDate Sep<11>2014
20:07 Dec 21, 2018
Jkt 247001
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,826 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: December 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–27805 Filed 12–21–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4428]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medicated Feed
Mill License Application
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
Frm 00044
Fmt 4703
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
SUMMARY:
PO 00000
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 medicated
feed mill licensing system.
DATES: Submit either electronic or
written comments on the collection of
information by February 25, 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 February 25,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 25, 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.
Sfmt 4703
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
E:\FR\FM\26DEN1.SGM
26DEN1
Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Notices
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–
2018–N–4428 for ‘‘Medicated Feed Mill
License Application.’’ 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/201523389.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:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10 a.m.–12 p.m.,
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
66281
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.
Medicated Feed Mill License
Application—21 CFR Part 515—OMB
Control Number 0910–0337—Extension
Feed manufacturers that seek to
manufacture feed using Category II,
Type A medicated articles or
manufacture certain liquid and freechoice feed, using Category I, Type A
medicated articles that must follow
proprietary formulas or specifications
are required to obtain a facility license
under section 512 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360b). Our regulations in part
515 (21 CFR part 515) establish the
procedures associated with applying for
a facility license. We require that a
manufacturer seeking a facility license
submit a completed medicated feed mill
license application using Form FDA
3448 (21 CFR 515.10(b)). We use the
information submitted to establish that
the applicant has made the certifications
required by section 512 of the FD&C
Act, to register the mill, and to schedule
a pre-approval inspection.
We require the submission of a
supplemental medicated feed mill
license application for a change in
facility ownership or a change in facility
address (§ 515.11(b)). If a licensed
facility is no longer manufacturing
medicated animal feed under § 515.23, a
manufacturer may request voluntary
revocation of a medicated feed mill
license. An applicant also has the right
to file a request for hearing under
§ 515.30(c) to give reasons why a
medicated feed mill license should not
be refused or revoked.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
amozie on DSK3GDR082PROD with NOTICES1
21 CFR section and activity
Medicated Feed Mill License Application using Form FDA
3448 (515.10(b)).
Supplemental Feed Mill License Application using Form
FDA 3448 (515.11(b)).
Voluntary Revocation of Medicated Feed Mill License
(515.23).
VerDate Sep<11>2014
20:07 Dec 21, 2018
Jkt 247001
PO 00000
Frm 00045
Fmt 4703
Number of
responses per
respondent
Total annual
responses
14
1
14
54
1
54
29
1
29
Sfmt 4703
E:\FR\FM\26DEN1.SGM
26DEN1
Average
burden per
response
0.25 (15 minutes).
0.25 (15 minutes).
0.25 (15 minutes).
Total hours
4
14
7
66282
Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses per
respondent
Number of
respondents
21 CFR section and activity
Average
burden per
response
Total annual
responses
Total hours
Filing a Request for a Hearing on Medicated Feed Mill License (515.30(c)).
1
1
1
4 ....................
4
Total ..............................................................................
........................
........................
........................
........................
29
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section and activity
Maintenance of Records for Approved Labeling for Each
‘‘Type B’’ and ‘‘Type C’’ Feed (510.305).
1 There
837
Total annual
records
1
837
Average
burden per
recordkeeping
0.03 (2 minutes).
Total hours
25
are no capital costs or operating and maintenance costs associated with this collection of information.
These estimates are based on our
experience with medicated feed mill
license applications. We estimate that
we will receive 14 medicated feed mill
license applications, 54 supplemental
applications, 29 requests for voluntary
revocation, and that these submissions
will take approximately 15 minutes per
response, as shown in table 1, rows 1
through 3. We estimate that preparing a
request for a hearing under § 515.30(c)
takes approximately 4 hours, as shown
in table 1, row 4. In table 2, we estimate
that 837 licensees will keep the records
required by 21 CFR 510.305 expending
a total of 25 hours annually.
Our estimated burden for the
information collection reflects an
overall decrease of 2 hours and a
corresponding decrease of 56 responses/
records. We attribute this adjustment to
a net decrease in the number of
submissions we received over the last
few years.
Dated: December 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–27812 Filed 12–21–18; 8:45 am]
BILLING CODE 4164–01–P
amozie on DSK3GDR082PROD with NOTICES1
Number of
records per
recordkeeper
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–3001]
Modified Risk Tobacco Product
Applications for IQOS System With
Marlboro Heatsticks, IQOS System
With Marlboro Smooth Menthol
Heatsticks, and IQOS System With
Marlboro Fresh Menthol Heatsticks
Submitted by Philip Morris Products
S.A.; Closing of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; closing of comment
period.
The Food and Drug
Administration (FDA) is announcing a
closing date for the period for public
comment on modified risk tobacco
product applications (MRTPAs)
submitted by Philip Morris Products
S.A. for its IQOS system products. FDA
recently received amendments to these
MRTPAs and has made them available
for public comment.
DATES: Submit either electronic or
written comments by February 11, 2019
to ensure FDA considers your comment
before completing its review of the
applications.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
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
VerDate Sep<11>2014
20:07 Dec 21, 2018
Jkt 247001
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
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–
2017–D–3001 for ‘‘Modified Risk
Tobacco Product Applications for IQOS
system with Marlboro Heatsticks, IQOS
system with Marlboro Smooth Menthol
Heatsticks, and IQOS system with
Marlboro Fresh Menthol Heatsticks
submitted by Philip Morris Products
E:\FR\FM\26DEN1.SGM
26DEN1
]]>Agencies
[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Notices]
[Pages 66280-66282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27812]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4428]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medicated Feed Mill License Application
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
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the medicated feed mill licensing system.
DATES: Submit either electronic or written comments on the collection
of information by February 25, 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 February 25, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 25, 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
[[Page 66281]]
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-2018-N-4428 for ``Medicated Feed Mill License Application.''
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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
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.
Medicated Feed Mill License Application--21 CFR Part 515--OMB Control
Number 0910-0337--Extension
Feed manufacturers that seek to manufacture feed using Category II,
Type A medicated articles or manufacture certain liquid and free-choice
feed, using Category I, Type A medicated articles that must follow
proprietary formulas or specifications are required to obtain a
facility license under section 512 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360b). Our regulations in part 515
(21 CFR part 515) establish the procedures associated with applying for
a facility license. We require that a manufacturer seeking a facility
license submit a completed medicated feed mill license application
using Form FDA 3448 (21 CFR 515.10(b)). We use the information
submitted to establish that the applicant has made the certifications
required by section 512 of the FD&C Act, to register the mill, and to
schedule a pre-approval inspection.
We require the submission of a supplemental medicated feed mill
license application for a change in facility ownership or a change in
facility address (Sec. 515.11(b)). If a licensed facility is no longer
manufacturing medicated animal feed under Sec. 515.23, a manufacturer
may request voluntary revocation of a medicated feed mill license. An
applicant also has the right to file a request for hearing under Sec.
515.30(c) to give reasons why a medicated feed mill license should not
be refused or revoked.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section and activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Medicated Feed Mill License 14 1 14 0.25 (15 4
Application using Form FDA minutes).
3448 (515.10(b)).
Supplemental Feed Mill License 54 1 54 0.25 (15 14
Application using Form FDA minutes).
3448 (515.11(b)).
Voluntary Revocation of 29 1 29 0.25 (15 7
Medicated Feed Mill License minutes).
(515.23).
[[Page 66282]]
Filing a Request for a Hearing 1 1 1 4............... 4
on Medicated Feed Mill
License (515.30(c)).
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 29
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section and activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Maintenance of Records for 837 1 837 0.03 (2 minutes) 25
Approved Labeling for Each
``Type B'' and ``Type C''
Feed (510.305).
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
These estimates are based on our experience with medicated feed
mill license applications. We estimate that we will receive 14
medicated feed mill license applications, 54 supplemental applications,
29 requests for voluntary revocation, and that these submissions will
take approximately 15 minutes per response, as shown in table 1, rows 1
through 3. We estimate that preparing a request for a hearing under
Sec. 515.30(c) takes approximately 4 hours, as shown in table 1, row
4. In table 2, we estimate that 837 licensees will keep the records
required by 21 CFR 510.305 expending a total of 25 hours annually.
Our estimated burden for the information collection reflects an
overall decrease of 2 hours and a corresponding decrease of 56
responses/records. We attribute this adjustment to a net decrease in
the number of submissions we received over the last few years.
Dated: December 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27812 Filed 12-21-18; 8:45 am]
BILLING CODE 4164-01-P
