Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application, 12509-12511 [2016-05214]
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Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Rosemary Addy, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6430,
Silver Spring, MD 20993–0002, 301–
796–1640; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
Lhorne on DSK5TPTVN1PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Pediatric Study Plans: Content of and
Process for Submitting Initial Pediatric
Study Plans and Amended Initial
Pediatric Study Plans.’’ The purpose of
this draft guidance is to assist sponsors
in the submission of an iPSP and any
amendments to an iPSP. Specifically,
this guidance addresses FDA’s current
thinking regarding the requirement for
sponsors to submit an iPSP under
section 505B of the FD&C Act (21 U.S.C.
355c) as amended by FDASIA.
This guidance revises the draft
guidance entitled ‘‘Pediatric Study
Plans: Content of and Process for
Submitting Initial Pediatric Study Plans
and Amended Pediatric Study Plans’’
issued July 15, 2013 (78 FR 42085).
Changes made in this draft guidance
were based largely on public comments
received by FDA on the 2013 draft
guidance.
The following topics are addressed in
this draft guidance: (1) Who must
submit an iPSP; (2) when an iPSP must
be submitted; (3) what should be
included in an iPSP; (4) what should be
included in a requested amendment to
an iPSP; (5) the relationship of an
agreed iPSP to the requirement to
submit a pediatric study plan with a
marketing application; (6) what is meant
by a non-agreed iPSP; and (7) processes
for reaching agreement with FDA on a
non-agreed iPSP. This draft guidance
also includes a revised template that
should be used for submission of an
iPSP.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on the content of and process for
submitting iPSPs and amended iPSPs. It
does not establish any rights for any
VerDate Sep<11>2014
15:08 Mar 08, 2016
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12509
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
II. The Paperwork Reduction Act of
1995
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medicated Feed
Mill License Application
This draft guidance includes
information collection provisions that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information referenced in this draft
guidance that are related to the burden
on the submission of investigational
new drug applications are covered
under 21 CFR part 312, including plans
for pediatric studies under 21 CFR
312.47(b)(1)(iv) and waiver requests
under 21 CFR 312.10, and have been
approved under OMB control number
0910–0014. The collections of
information referenced in this draft
guidance that are related to the burden
on the submission of new drug
applications are covered under 21 CFR
part 314, including pediatric use
information under 21 CFR 314.50(d)(7)
and waiver requests under 21 CFR
314.90, and have been approved under
OMB control number 0910–0001. The
collections of information referenced in
this draft guidance that are related to the
burden on the submission of biologics
license applications are covered under
21 CFR part 601, including pediatric use
information and waiver requests under
21 CFR 601.27, and have been approved
under OMB control number 0910–0338.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–05223 Filed 3–8–16; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
Food and Drug Administration
[Docket No. FDA–2009–N–0511]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (the 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 collection of
information associated with Medicated
Feed Mill License Applications.
DATES: Submit either electronic or
written comments on the collection of
information by May 9, 2016.
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
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’’).
E:\FR\FM\09MRN1.SGM
09MRN1
12510
Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices
Lhorne on DSK5TPTVN1PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2009–N–0511 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Medicated Feed Mill License
Application.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002,
PRAStaff@fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
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 5157—OMB
Control Number 0910–0337—Revision
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 (the 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 have
made minor editorial revisions to Form
FDA 3448, including the addition of a
dedicated field for the submitter’s email
address in the contact information
section. We estimate that the revisions
will not change the amount of time
necessary to complete the form.
We require the submission of a
supplemental medicated feed mill
license application for a change in
facility ownership or a change in facility
address (21 CFR 515.11(b)). If a licensed
facility is no longer manufacturing
medicated animal feed under 21 CFR
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 21 CFR 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
21 CFR section and activity
Medicated Feed Mill License Application Using Form
FDA 3448 (515.10(b)).
VerDate Sep<11>2014
15:08 Mar 08, 2016
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Frm 00065
Number of
responses per
respondent
20
Fmt 4703
Total annual
responses
1
Sfmt 4703
E:\FR\FM\09MRN1.SGM
20
Average burden
per response
0.25 (15 minutes)
09MRN1
Total hours
5
Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices
12511
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses per
respondent
Number of
respondents
21 CFR section and activity
Total annual
responses
Average burden
per response
Total hours
Supplemental Feed Mill License Application Using
Form FDA 3448 (515.11(b)).
Voluntary Revocation of Medicated Feed Mill License
(515.23).
Filing a Request for a Hearing on Medicated Feed Mill
License (515.30(c)).
40
1
40
0.25 (15 minutes)
10
40
1
40
0.25 (15 minutes)
10
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
Maintenance of Records for Approved Labeling for
Each ‘‘Type B’’ and ‘‘Type C’’ Feed (510.305).
1 There
890
1
SUMMARY:
Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
DATES:
[FR Doc. 2016–05214 Filed 3–8–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0610]
Mass Spectrometry in the Clinic:
Regulatory Considerations
Surrounding Validation of Liquid
Chromatography-Mass Spectrometry
Based Devices; Public Workshop;
Request for Comments
AGENCY:
Average
burden per
recordkeeping
Total annual
records
890
0.03 (2 minutes)
Total hours
26.7
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 20 medicated feed mill
license applications, 40 supplemental
applications, 40 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 21 CFR
515.30(c) takes approximately 4 hours,
as shown in table 1, row 4. In table 2,
we estimate that 890 licensees will keep
the records required by 21 CFR 510.305
expending a total of 26.7 hours
annually.
Lhorne on DSK5TPTVN1PROD with NOTICES
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR section and activity
Food and Drug Administration,
HHS.
The public workshop will be
held on May 2, 2016, from 8:30 a.m. to
5 p.m. Submit either electronic or
written comments on the public
workshop by April 20, 2016.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Rm. 1503 (The Great Room), Silver
Spring, MD 20993. Entrance for the
public meeting participants (non-FDA
employees) is through Building 1, where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows:
Electronic Submissions
Notice of public workshop;
request for comments.
ACTION:
VerDate Sep<11>2014
The Food and Drug
Administration (FDA) is announcing the
following public workshop entitled
‘‘Mass Spectrometry in the Clinic:
Regulatory Considerations Surrounding
Validation of Liquid ChromatographyMass Spectrometry Based Devices.’’ The
topics to be discussed are the specific
analytical and clinical study designs
and considerations for validation and
use of liquid chromatography/massspectrometry (LC/MS)-based in vitro
diagnostic devices (IVDs) in the clinical
laboratory. The primary focus will be on
the validation considerations with
protein- and peptide-based LC/MS
devices.
15:08 Mar 08, 2016
Jkt 238001
Submit electronic comments in the
following way:
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
• 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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
E:\FR\FM\09MRN1.SGM
09MRN1
]]>Agencies
[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12509-12511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05214]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0511]
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, we) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 collection of information
associated with Medicated Feed Mill License Applications.
DATES: Submit either electronic or written comments on the collection
of information by May 9, 2016.
ADDRESSES: You may submit comments as follows:
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'').
[[Page 12510]]
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2009-N-0511 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medicated Feed Mill License
Application.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Division of Dockets
Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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 5157--OMB Control
Number 0910-0337--Revision
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 (the 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 have made minor
editorial revisions to Form FDA 3448, including the addition of a
dedicated field for the submitter's email address in the contact
information section. We estimate that the revisions will not change the
amount of time necessary to complete the form.
We require the submission of a supplemental medicated feed mill
license application for a change in facility ownership or a change in
facility address (21 CFR 515.11(b)). If a licensed facility is no
longer manufacturing medicated animal feed under 21 CFR 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 21 CFR 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 per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medicated Feed Mill License Application Using 20 1 20 0.25 (15 minutes)...................... 5
Form FDA 3448 (515.10(b)).
[[Page 12511]]
Supplemental Feed Mill License Application 40 1 40 0.25 (15 minutes)...................... 10
Using Form FDA 3448 (515.11(b)).
Voluntary Revocation of Medicated Feed Mill 40 1 40 0.25 (15 minutes)...................... 10
License (515.23).
Filing a Request for a Hearing on Medicated 1 1 1 4...................................... 4
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
21 CFR section and activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of Records for Approved Labeling 890 1 890 0.03 (2 minutes)....................... 26.7
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 20
medicated feed mill license applications, 40 supplemental applications,
40 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 21
CFR 515.30(c) takes approximately 4 hours, as shown in table 1, row 4.
In table 2, we estimate that 890 licensees will keep the records
required by 21 CFR 510.305 expending a total of 26.7 hours annually.
Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05214 Filed 3-8-16; 8:45 am]
BILLING CODE 4164-01-P
