Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices, 20498-20499 [2015-08749]
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Federal Register / Vol. 80, No. 73 / Thursday, April 16, 2015 / Notices
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–08684 Filed 4–15–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0672]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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
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 May 18,
2015.
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0577. Also
include the FDA 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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
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.
In the Federal Register of December
30, 2014 (79 FR 78445), 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 THIRD-PARTY DISCLOSURE BURDEN 1 2
Number of
disclosures
per respondent
Number of
respondents
Type of respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
tkelley on DSK3SPTVN1PROD with NOTICES
Establishments listing fewer than 10 SUDs .......................
Establishments listing 10 or more SUDs ............................
58
9
2
34
116
306
0.1 (6 minutes)
0.1 (6 minutes)
12
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
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Federal Register / Vol. 80, No. 73 / Thursday, April 16, 2015 / Notices
Dated: April 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–08749 Filed 4–15–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0449]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Sun Protection
Factor Labeling and Testing
Requirements and Drug Facts Labeling
for Over-the-Counter Sunscreen Drug
Products
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
Sun Protection Factor (SPF) labeling
and testing requirements for over-thecounter (OTC) sunscreen products
containing specified ingredients and
marketed without approved
applications, and on compliance with
Drug Facts labeling requirements for all
OTC sunscreen products.
DATES: Submit either electronic or
written comments on the collection of
information by June 15, 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.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:48 Apr 15, 2015
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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.
SUPPLEMENTARY INFORMATION:
SPF Labeling and Testing Requirements
for OTC Sunscreen Products Containing
Specified Active Ingredients and
Marketed Without Approved
Applications, and Drug Facts Labeling
for All OTC Sunscreen Products—21
CFR 201.327(a)(1) and (i), 21 CFR
201.66(c) and (d) (OMB Control Number
0910–0717)—Extension
In the Federal Register of June 17,
2011 (76 FR 35620) we published a final
rule establishing labeling and
effectiveness testing requirements for
certain OTC sunscreen products
containing specified active ingredients
without approved applications (2011
sunscreen final rule; § 201.327 (21 CFR
201.327)). In addition to establishing
testing requirements, this sunscreen
final rule lifts the delay of
implementation of the prior 1999
sunscreen final rule (published May 21,
1999, at 64 FR 27666 and stayed
December 31, 2001, 66 FR 67485) from
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20499
complying with the 1999 labeling final
rule (published March 17, 1999, 64 FR
13254) in which we amended our
regulations governing requirements for
human drug products to establish
standardized format and content
requirements for the labeling of all
marketed OTC drug products in part 201
(21 CFR part 201). Specifically, the 1999
labeling final rule added new § 201.66
to part 201. Section 201.66 sets content
and format requirements for the Drug
Facts portion of labels on OTC drug
products. We specifically exempted
OTC sunscreen products from
complying with the 1999 labeling final
rule until we lifted the stay of the 1999
sunscreen final rule. The 2011
sunscreen final rule became effective
December 17, 2012, for sunscreen
products with annual sales of $25,000 or
more and December 17, 2013, for
sunscreen products with annual sales of
less than $25,000 when we published an
extension date notice on May 11, 2012
(77 FR 27591).
SPF Labeling and Testing for OTC
Sunscreens Containing Specified Active
Ingredients and Marketed Without
Approved Applications
In the Federal Register of June 17,
2011 (76 FR 35678), we published a 60day notice requesting public comment
on the proposed collection of
information in regard to SPF labeling
and testing requirements for OTC
sunscreen products containing specified
ingredients and marketed without
approved applications. In that notice,
we stated that § 201.327 (a)(1) requires
the principal display panel (PDP)
labeling of a sunscreen covered by the
2011 final rule to include the SPF value
determined by conducting the SPF test
outlined in § 201.327(i). Therefore, this
provision results in information
collection with a third-party disclosure
burden for manufacturers of OTC
sunscreens covered by the rule. We
determined that products need only
complete the testing and labeling
required by the rule one time, and then
continue to utilize the resultant labeling
(third-party disclosure) going forward
without additional burden. This onetime testing would need to be
conducted within the first 3 years after
publication of the 2011 final rule for all
OTC sunscreens covered by that rule.
We determined that the third-party
disclosure burden by manufacturers of
OTC sunscreens covered by the rule was
based on an estimate: (1) Of the time for
reviewing instructions, searching
existing data sources, gathering and
maintaining the data needed, and
completing and reviewing each
collection of information; (2) on the
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]]>Agencies
[Federal Register Volume 80, Number 73 (Thursday, April 16, 2015)]
[Notices]
[Pages 20498-20499]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08749]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0672]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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 May 18,
2015.
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 oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0577.
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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.
In the Federal Register of December 30, 2014 (79 FR 78445), 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 Third-Party Disclosure Burden \1\ \2\
----------------------------------------------------------------------------------------------------------------
Number of
Type of respondent Number of disclosures per Total annual Average burden per Total hours
respondents respondent disclosures disclosure
----------------------------------------------------------------------------------------------------------------
Establishments listing fewer 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.
[[Page 20499]]
Dated: April 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08749 Filed 4-15-15; 8:45 am]
BILLING CODE 4164-01-P
