Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance, 28853-28854 [2013-11697]
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Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Notices
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.
Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins
Prohibited in Ruminant Feed-21 CFR
589.2000(e)(1)(iv)—(OMB Control
Number 0910–0339)—Extension
This information collection was
established because epidemiological
evidence gathered in the United
Kingdom suggested that bovine
spongiform encephalopathy (BSE), a
progressively degenerative central
nervous system disease, is spread to
ruminant animals by feeding protein
derived from ruminants infected with
BSE. This regulation places general
requirements on persons that
manufacture, blend, process, and
distribute products that contain or may
contain protein derived from
mammalian tissue, and feeds made from
such products.
Specifically, this regulation requires
renderers, feed manufacturers, and
others involved in feed and feed
ingredient manufacturing and
distribution to maintain written
procedures specifying the cleanout
procedures or other means, and
specifying the procedures for separating
products that contain or may contain
protein derived from mammalian tissue
from all other protein products from the
time of receipt until the time of
shipment. These written procedures are
intended to help the firm formalize their
processes, and then to help inspection
personnel confirm that the firm is
operating in compliance with the
regulation. Inspection personnel will
evaluate the written procedure, and
confirm it is being followed when they
are conducting an inspection.
These written procedures must be
maintained as long as the facility is
operating in a manner that necessitates
the record, and if the facility makes
changes to an applicable procedure or
process the record must be updated.
Written procedures required by this
section shall be made available for
inspection and copying by the Food and
Drug Administration.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Maintaining written procedures (§ 589.2000 (e)(1)(iv)) ........
1
400
Total annual
records
1
Average
burden per
recordkeeping
400
14
Total hours
5600
There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
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
information collection requirements for
postmarket surveillance of medical
devices.
[FR Doc. 2013–11633 Filed 5–15–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Submit either electronic or
written comments on the collection of
information by July 15, 2013.
DATES:
Food and Drug Administration
[Docket No. FDA–2013–N–0557]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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
SUMMARY:
VerDate Mar<15>2010
18:13 May 15, 2013
Jkt 229001
Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
ADDRESSES:
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Postmarket
Surveillance
tkelley on DSK3SPTVN1PROD with NOTICES
Number of
records per
recordkeeper
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@fda.hhs.gov.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\16MYN1.SGM
16MYN1
28854
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Notices
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.
Postmarket Surveillance—21 CFR Part
822 (OMB Control Number 0910–
0449)—Extension
Section 522 of the Federal Food, Drug
and Cosmetic Act (21 U.S.C. 360l)
authorizes the FDA to require a
manufacturers to conduct postmarket
surveillance (PS) of any device that
meets the criteria set forth in the statute.
The PS regulation establishes
procedures that FDA uses to approve
and disapprove PS plans. The regulation
provides instructions to manufacturers
so they know what information is
required in a PS plan submission. FDA
reviews PS plan submissions in
accordance with part 822 (21 CFR part
822) in §§ 822.15 through 822.19 of the
regulation, which describe the grounds
for approving or disapproving a PS plan.
In addition, the PS regulation provides
instructions to manufacturers to submit
interim and final reports in accordance
with § 822.38. Respondents to this
collection of information are those
manufacturers who require postmarket
surveillance of their products.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity/21 CFR section
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
Postmarket surveillance submission (§§ 822.9 and 822.10)
Changes to PS plan after approval (§ 822.21) ....................
Changes to PS plan for a device that is no longer marketed (§ 822.28) ................................................................
Waiver (§ 822.29) .................................................................
Exemption request (§ 822.30) ..............................................
Periodic reports (§ 822.38) ...................................................
131
15
1
1
131
15
120
40
15,720
600
80
1
16
131
1
1
1
3
80
1
16
393
8
40
40
40
640
40
640
15,720
Total ..............................................................................
........................
........................
........................
........................
33,360
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Explanation of Reporting Burden
Estimate: The burden captured in table
1 of this document is based on the data
available in FDA’s internal tracking
system. Sections 822.26, 822.27, and
822.34 do not constitute information
collection subject to review under the
PRA because it entails ‘‘no burden other
than that necessary to identify the
respondent, the date, the respondent’s
address, and the nature of the
instrument’’ (5 CFR 1320.3(h)(1)).
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity/21 CFR section
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total
hours
Manufacturer records (§ 822.31) ..........................................
Investigator records (§ 822.32) ............................................
131
393
1
1
131
393
20
5
2,620
1,965
Total ..............................................................................
........................
........................
........................
........................
4,585
tkelley on DSK3SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Explanation of Recordkeeping Burden
Estimate: FDA expects that at least some
of the manufacturers will be able to
satisfy the PS requirement using
information or data they already have.
For purposes of calculating burden,
however, FDA has assumed that each PS
order can only be satisfied by a 3-year
clinically-based surveillance plan, using
three investigators. These estimates are
based on FDA’s knowledge and
experience with postmarket
surveillance.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: May 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
ACTION:
[FR Doc. 2013–11697 Filed 5–15–13; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
18:13 May 15, 2013
Jkt 229001
Food and Drug Administration
[Docket No. FDA–2013–N–0545]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Infant Formula
Requirements
AGENCY:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on our proposed collection of
SUMMARY:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
certain information. 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 invites comments on
the information collection provisions of
our infant formula regulations,
including infant formula labeling,
quality control procedures, notification
requirements, and recordkeeping.
Submit either electronic or
written comments on the collection of
information by July 15, 2013.
DATES:
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]]>Agencies
[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Notices]
[Pages 28853-28854]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11697]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0557]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Postmarket Surveillance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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 information collection
requirements for postmarket surveillance of medical devices.
DATES: Submit either electronic or written comments on the collection
of information by July 15, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
daniel.gittleson@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
[[Page 28854]]
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.
Postmarket Surveillance--21 CFR Part 822 (OMB Control Number 0910-
0449)--Extension
Section 522 of the Federal Food, Drug and Cosmetic Act (21 U.S.C.
360l) authorizes the FDA to require a manufacturers to conduct
postmarket surveillance (PS) of any device that meets the criteria set
forth in the statute. The PS regulation establishes procedures that FDA
uses to approve and disapprove PS plans. The regulation provides
instructions to manufacturers so they know what information is required
in a PS plan submission. FDA reviews PS plan submissions in accordance
with part 822 (21 CFR part 822) in Sec. Sec. 822.15 through 822.19 of
the regulation, which describe the grounds for approving or
disapproving a PS plan. In addition, the PS regulation provides
instructions to manufacturers to submit interim and final reports in
accordance with Sec. 822.38. Respondents to this collection of
information are those manufacturers who require postmarket surveillance
of their products.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Postmarket surveillance 131 1 131 120 15,720
submission (Sec. Sec. 822.9
and 822.10)....................
Changes to PS plan after 15 1 15 40 600
approval (Sec. 822.21).......
Changes to PS plan for a device 80 1 80 8 640
that is no longer marketed
(Sec. 822.28)................
Waiver (Sec. 822.29).......... 1 1 1 40 40
Exemption request (Sec. 16 1 16 40 640
822.30)........................
Periodic reports (Sec. 822.38) 131 3 393 40 15,720
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 33,360
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Explanation of Reporting Burden Estimate: The burden captured in
table 1 of this document is based on the data available in FDA's
internal tracking system. Sections 822.26, 822.27, and 822.34 do not
constitute information collection subject to review under the PRA
because it entails ``no burden other than that necessary to identify
the respondent, the date, the respondent's address, and the nature of
the instrument'' (5 CFR 1320.3(h)(1)).
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity/21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Manufacturer records (Sec. 131 1 131 20 2,620
822.31)........................
Investigator records (Sec. 393 1 393 5 1,965
822.32)........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 4,585
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Explanation of Recordkeeping Burden Estimate: FDA expects that at
least some of the manufacturers will be able to satisfy the PS
requirement using information or data they already have. For purposes
of calculating burden, however, FDA has assumed that each PS order can
only be satisfied by a 3-year clinically-based surveillance plan, using
three investigators. These estimates are based on FDA's knowledge and
experience with postmarket surveillance.
Dated: May 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11697 Filed 5-15-13; 8:45 am]
BILLING CODE 4160-01-P
