Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medicated Feed Mill License Application, 34398-34399 [2019-15284]
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34398
Federal Register / Vol. 84, No. 138 / Thursday, July 18, 2019 / Notices
Since the last OMB approval, our
estimated annual reporting burden for
the information collection reflects an
increase due to an increase in the
number of submissions we have
received.
Dated: July 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15283 Filed 7–17–19; 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; Submission for Office of
Management and Budget Review;
Comment Request; Medicated Feed
Mill License Application
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 19,
2019.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0337. Also
include the FDA docket number found
in brackets in the heading of this
document.
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–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
ADDRESSES:
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 (§ 515.10(b) (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) (21 CFR 515.11(b))).
If a licensed facility is no longer
manufacturing medicated animal feed
under § 515.23 (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
§ 515.30(c) (21 CFR 515.30(c)) to give
reasons why a medicated feed mill
license should not be refused or
revoked.
In the Federal Register of December
26, 2018 (83 FR 66280), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
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).
Filing a Request for a Hearing on Medicated
Feed Mill License (515.30(c)).
Total .............................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section and activity
Average
burden per
response
Total annual
responses
Total hours
14
1
14
0.25 (15 minutes) ...........
4
54
1
54
0.25 (15 minutes) ...........
14
29
1
29
0.25 (15 minutes) ...........
7
1
1
1
4 .....................................
4
........................
........................
........................
........................................
29
are no capital costs or operating and maintenance costs associated with this collection of information.
khammond on DSKBBV9HB2PROD with NOTICES
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
Number of
records per
recordkeeper
837
1
Total annual
records
837
Average burden
per recordkeeping
0.03 (2 minutes) .............
are no capital costs or operating and maintenance costs associated with this collection of information.
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17:56 Jul 17, 2019
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Total hours
25
Federal Register / Vol. 84, No. 138 / Thursday, July 18, 2019 / Notices
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: July 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15284 Filed 7–17–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0893]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Center for Devices
and Radiological Health Appeals
Processes
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 19,
2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
khammond on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:56 Jul 17, 2019
Jkt 247001
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0738. Also
include the FDA docket number found
in brackets in the heading of this
document.
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Center for Devices and Radiological
Health Appeals Processes
OMB Control Number 0910–0738—
Extension
The guidance document entitled
‘‘Guidance for Industry and Food and
Drug Administration Staff; Center for
Devices and Radiological Health
Appeals Processes’’ 1 describes the
processes available to outside
stakeholders to request additional
review of decisions or actions by Center
for Devices and Radiological Health
(CDRH) employees. FDA is seeking
approval for the reporting burden
associated with requests for additional
review of decisions and actions by
CDRH employees as described in the
guidance.
Individuals outside of FDA who
disagree with a decision or action taken
by CDRH and wish to have it reviewed
or reconsidered have several processes
for resolution from which to choose,
including requests for supervisory
review of an action, petitions, and
hearings. Of these, by far the most
commonly used is a request for
supervisory review under § 10.75 (21
CFR 10.75) (‘‘10.75 appeal’’). Section
517A of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
360g–1), added by section 603 of the
Food and Drug Administration Safety
and Innovation Act, includes
requirements pertaining to the process
1 https://www.fda.gov/ucm/groups/fdagov-public/
@fdagov-meddev-gen/documents/document/
ucm284670.pdf.
PO 00000
Frm 00068
Fmt 4703
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34399
and timelines for 10.75 appeals of
‘‘significant decisions’’ regarding 510(k)
premarket notifications, applications for
premarket approvals (PMAs), and
applications for investigational device
exemptions (IDEs).
A request for review under § 10.75
should be based on the information that
was already present in the
administrative file at the time of the
decision that is being reviewed as
provided in § 10.75(d). Section 517A of
the FD&C Act refers to significant
decisions regarding the information in
the administrative file for premarket
notification (section 510(k) of the FD&C
Act (21 U.S.C. 360(k))), PMA (section
515 (21 U.S.C. 360e)), and IDE (section
520(g) (21 U.S.C. 360j(g))) submissions
that is collected under existing
regulations that specify the information
manufacturers must submit so that FDA
may properly evaluate the safety and
effectiveness of medical devices. The
information collections associated with
these regulations are currently approved
by the OMB as follows: The collections
of information in 21 CFR part 807,
subpart E (premarket notification) have
been approved under OMB control
number 0910–0120; the collections of
information in 21 CFR part 814
(premarket approval) have been
approved under OMB control number
0910–0231; and the collections of
information in 21 CFR part 812
(investigational device exemption) have
been approved under OMB control
number 0910–0078.
While CDRH already possesses in the
administrative file the information that
would form the basis of a decision on
a matter under appeal, the submission
of particular information regarding the
request itself and the data and
information relied on by the requestor
in the appeal would facilitate timely
resolution of the decision under review.
The guidance describes the collection of
information not expressly specified
under existing regulations such as the
submission of the request for review,
minor clarifications as part of the
request, and supporting information.
In the Federal Register of March 8,
2019 (84 FR 8530), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\18JYN1.SGM
18JYN1
]]>Agencies
[Federal Register Volume 84, Number 138 (Thursday, July 18, 2019)]
[Notices]
[Pages 34398-34399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15284]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4428]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medicated Feed Mill
License Application
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
19, 2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0337.
Also include the FDA docket number found in brackets in the heading of
this document.
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, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 (Sec. 515.10(b) (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) (21 CFR 515.11(b))). If a licensed
facility is no longer manufacturing medicated animal feed under Sec.
515.23 (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 Sec. 515.30(c) (21 CFR 515.30(c)) to
give reasons why a medicated feed mill license should not be refused or
revoked.
In the Federal Register of December 26, 2018 (83 FR 66280), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates 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 14 1 14 0.25 (15 minutes)........................... 4
using Form FDA 3448 (515.10(b)).
Supplemental Feed Mill License Application 54 1 54 0.25 (15 minutes)........................... 14
using Form FDA 3448 (515.11(b)).
Voluntary Revocation of Medicated Feed 29 1 29 0.25 (15 minutes)........................... 7
Mill License (515.23).
Filing a Request for a Hearing on 1 1 1 4........................................... 4
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
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 837 1 837 0.03 (2 minutes)............................ 25
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.
[[Page 34399]]
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: July 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15284 Filed 7-17-19; 8:45 am]
BILLING CODE 4164-01-P
