Agency Information Collection Activities; Proposed Collection; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices, 78445-78446 [2014-30511]
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Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices
TABLE 2—COMPLIANCE DECISIONS FY 2013
Compliance decision
Number
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Official Action Indicated ...........................................................................................................................................
Voluntary Action Indicated .......................................................................................................................................
No Action Indicated .................................................................................................................................................
Pending Final Decision ............................................................................................................................................
Because FDA only expects firms who
do not have major deficiencies or
observations to be willing to submit
their audit reports to FDA under the
Voluntary Audit Report Submission
Program, FDA only expects to receive
audit reports that would have been
classified by FDA as No Action
Indicated (NAI).
Assuming that the percentage
breakdown of compliance decisions for
all inspections conducted in FY 2013
can be extrapolated and applied to
audits of manufacturers certified under
ISO 13485:2003 by Health Canada, FDA
can estimate the number of Canadian
establishments that would have had an
inspection classified as an NAI. Because
45 percent of all compliance decisions
resulted in an NAI decision, FDA
estimates that 1,546 of the facilities
certified under ISO 13485:2003 by
Health Canada (45 percent of the total
3,436 facilities) would have had an
inspection classified as an NAI.
Because FDA expects that the vast
majority of manufacturers who will
participate in the Voluntary Audit
Report Submission Program will be
manufacturers certified by Health
Canada under ISO 13485:2003, FDA
expects the number of reports to be
submitted from manufacturers certified
by regulatory systems established by
other founding GHTF members to be
minimal. For purposes of calculating the
reporting burden, FDA estimates that
approximately 10 percent of total audit
reports submitted under this program
will be from these other manufacturers.
Because 90 percent of the audit reports
are expected to be submitted by
manufacturers certified by Health
Canada (approximately 1,500 audit
reports), the total number of audit
reports FDA expects to receive in a year
is approximately 1,700 audit reports.
FDA estimates from past experience
with the Electronic Submission Gateway
system, WebTrader, that the first year to
set up the account and to receive the
verification certificate takes
approximately 40 hours. This burden
may be minimized if the respondent
already has an established account in
WebTrader for other electronic
submissions to FDA, but FDA is
assuming that all respondents to this
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new pilot program will be setting up a
WebTrader account for the first time in
the first year. For subsequent years, the
burden hours are estimated at 1 hour to
renew the yearly required verification
certification.
FDA further estimates that the
gathering, scanning, and submission of
the audit reports, certificates, and
related correspondence would take
approximately 2 hours utilizing the
eSubmitter system.
Therefore, the first year will include
40 hours for the WebTrader system plus
2 hours for the eSubmitter submission
process, resulting in 42 hours per
response for the first year. For
subsequent years, it is estimated that
only 1 hour will be necessary for the
WebTrader system plus the 2 hours for
the eSubmitter submission process,
resulting in 3 hours per response each
year thereafter.
There are operating and maintenance
costs associated with this information
collection. The costs are $30 per year to
establish and maintain the Electronic
Submission Gateway verification
certificate.
This guidance also refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by OMB under the
PRA. The collections of information in
21 CFR part 820 have been approved
under OMB control number 0910–0073,
and the collections of information for
the Inspection by Accredited Persons
Program have been approved under
OMB control number 0910–0569.
Dated: December 23, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–30513 Filed 12–29–14; 8:45 am]
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Approximate
percentage
169
902
1083
249
7
38
45
10
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0672]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prominent and
Conspicuous Mark of Manufacturers
on Single-Use Devices
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
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
reprocessed, single-use device labeling.
DATES: Submit either electronic or
written comments on the collection of
information by March 2, 2015.
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUMMARY:
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
SUPPLEMENTARY INFORMATION:
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78446
Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices
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.
Prominent and Conspicuous Mark of
Manufacturers On Single-Use Devices—
(OMB Control Number 0910–0577)—
Extension
Section 502 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 352), among other things,
establishes requirements that the label
or labeling of a medical device must
meet so that it is not misbranded and
subject to regulatory action. Section 301
of the Medical Device User Fee and
Modernization Act of 2002 (Pub. L. 107–
250) amended section 502 of the FD&C
Act to add section 502(u) to require
devices (both new and reprocessed) to
bear prominently and conspicuously the
name of the manufacturer, a generally
recognized abbreviation of such name,
or a unique and generally recognized
symbol identifying the manufacturer.
Section 2(c) of the Medical Device
User Fee Stabilization Act of 2005 (Pub.
L. 109–43) amends section 502(u) of the
FD&C Act by limiting the provision to
reprocessed single-use devices (SUDs)
and the manufacturers who reprocess
them. Under the amended provision, if
the original SUD or an attachment to it
prominently and conspicuously bears
the name of the manufacturer, then the
reprocessor of the SUD is required to
identify itself by name, abbreviation, or
symbol in a prominent and conspicuous
manner on the device or attachment to
the device. If the original SUD does not
prominently and conspicuously bear the
name of the manufacturer, the
manufacturer who reprocesses the SUD
for reuse may identify itself using a
detachable label that is intended to be
affixed to the patient record.
The requirements of section 502(u) of
the FD&C Act impose a minimal burden
on industry. This section of the FD&C
Act only requires the manufacturer,
packer, or distributor of a device to
include their name and address on the
labeling of a device. This information is
readily available to the establishment
and easily supplied. From its
registration and premarket submission
database, FDA estimates that there are
67 establishments that distribute
approximately 427 reprocessed SUDs.
Each response is anticipated to take 0.1
hours (6 minutes) resulting in a total
burden to industry of 43 hours.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 2
Number of
disclosures
per
respondent
Number of
respondents
Type of respondent
Average
burden per
disclosure
Total annual
disclosures
Total hours
Establishments listing less than 10
SUDs.
Establishments listing 10 or more
SUDs.
58
2
116
0.1 (6 minutes) .................................
12
9
34
306
0.1 (6 minutes) .................................
31
Total ...........................................
........................
........................
........................
...........................................................
43
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
2 Numbers
Dated: December 23, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–30511 Filed 12–29–14; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1027]
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Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Infant Formula Recall Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Infant Formula Recall Regulations’’ has
SUMMARY:
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been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
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.
On
October 27, 2014, the Agency submitted
a proposed collection of information
entitled ‘‘Infant Formula Recall
Regulations’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 79, Number 249 (Tuesday, December 30, 2014)]
[Notices]
[Pages 78445-78446]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30511]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0672]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Prominent and Conspicuous Mark of Manufacturers on
Single-Use Devices
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 reprocessed, single-use device
labeling.
DATES: Submit either electronic or written comments on the collection
of information by March 2, 2015.
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: 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
[[Page 78446]]
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.
Prominent and Conspicuous Mark of Manufacturers On Single-Use Devices--
(OMB Control Number 0910-0577)--Extension
Section 502 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 352), among other things, establishes requirements that
the label or labeling of a medical device must meet so that it is not
misbranded and subject to regulatory action. Section 301 of the Medical
Device User Fee and Modernization Act of 2002 (Pub. L. 107-250) amended
section 502 of the FD&C Act to add section 502(u) to require devices
(both new and reprocessed) to bear prominently and conspicuously the
name of the manufacturer, a generally recognized abbreviation of such
name, or a unique and generally recognized symbol identifying the
manufacturer.
Section 2(c) of the Medical Device User Fee Stabilization Act of
2005 (Pub. L. 109-43) amends section 502(u) of the FD&C Act by limiting
the provision to reprocessed single-use devices (SUDs) and the
manufacturers who reprocess them. Under the amended provision, if the
original SUD or an attachment to it prominently and conspicuously bears
the name of the manufacturer, then the reprocessor of the SUD is
required to identify itself by name, abbreviation, or symbol in a
prominent and conspicuous manner on the device or attachment to the
device. If the original SUD does not prominently and conspicuously bear
the name of the manufacturer, the manufacturer who reprocesses the SUD
for reuse may identify itself using a detachable label that is intended
to be affixed to the patient record.
The requirements of section 502(u) of the FD&C Act impose a minimal
burden on industry. This section of the FD&C Act only requires the
manufacturer, packer, or distributor of a device to include their name
and address on the labeling of a device. This information is readily
available to the establishment and easily supplied. From its
registration and premarket submission database, FDA estimates that
there are 67 establishments that distribute approximately 427
reprocessed SUDs. Each response is anticipated to take 0.1 hours (6
minutes) resulting in a total burden to industry of 43 hours.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\ \2\
----------------------------------------------------------------------------------------------------------------
Number of
Type of respondent Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
Establishments listing less 58 2 116 0.1 (6 minutes). 12
than 10 SUDs.
Establishments listing 10 or 9 34 306 0.1 (6 minutes). 31
more SUDs.
------------------------------------------------ ---------------
Total..................... .............. .............. .............. ................ 43
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Numbers have been rounded.
Dated: December 23, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30511 Filed 12-29-14; 8:45 am]
BILLING CODE 4164-01-P
