Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 57560-57561 [2014-22807]
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Federal Register / Vol. 79, No. 186 / Thursday, September 25, 2014 / Notices
represent the Agency’s current thinking
on the policy clarification for certain
fluoroscopic equipment requirements. It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Policy Clarification for Fluoroscopic
Equipment Requirements’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number 1806 to identify the
guidance you are requesting.
Dated: September 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to currently
approved collections of information
found in FDA regulations. These
collections of information 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 in
21 CFR part 807, subpart E are currently
approved under OMB control number
0910–0120, and the collections of
information in 21 CFR part 1020 have
been approved under OMB control
number 0910–0025.
AGENCY:
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2014–M–0326, FDA–
2013–M–1324, FDA–2013–M–1693, FDA–
2014–M–0069, FDA–2014–M–0166, FDA–
2014–M–0167, FDA–2014–M–0224, and
FDA–2014–M–0254]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
(PMAs) that have been approved. This
list is intended to inform the public of
the availability of safety and
effectiveness summaries of approved
PMAs through the Internet and the
Agency’s Division of Dockets
Management.
SUMMARY:
Submit written requests for
copies of summaries of safety and
effectiveness data to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Please cite the appropriate docket
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Nicole Wolanski, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring,
MD 20993–0002, 301–796–6570.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2014–22806 Filed 9–24–14; 8:45 am]
ACTION:
number as listed in table 1 when
submitting a written request. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the summaries of
safety and effectiveness.
I. Background
In accordance with sections 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the FD&C
Act. The 30-day period for requesting
reconsideration of an FDA action under
§ 10.33(b) (21 CFR 10.33(b)) for notices
announcing approval of a PMA begins
on the day the notice is placed on the
Internet. Section 10.33(b) provides that
FDA may, for good cause, extend this
30-day period. Reconsideration of a
denial or withdrawal of approval of a
PMA may be sought only by the
applicant; in these cases, the 30-day
period will begin when the applicant is
notified by FDA in writing of its
decision.
The regulations provide that FDA
publish a quarterly list of available
safety and effectiveness summaries of
PMA approvals and denials that were
announced during that quarter. The
following is a list of approved PMAs for
which summaries of safety and
effectiveness were placed on the
Internet from January 1, 2014, through
March 31, 2014, and includes one
denial action during this period. The list
provides the manufacturer’s name, the
product’s generic name or the trade
name, and the approval date.
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1,
2014, THROUGH MARCH 31, 2014
Applicant
Trade name
Date of action
P070023, FDA–2013–M–1324 ..................
P110016/S008, FDA–2013–M–1693 .........
mstockstill on DSK4VPTVN1PROD with NOTICES
PMA No., Docket No.
Fzio Med, Inc .....................
St. Jude Medical, Inc .........
Oxiplex®/SP Gel .....................................
Therapy Cool Flex Ablation Catheter ......
P130004, FDA–2014–M–0069 ..................
P130021, FDA–2014–M–0166 ..................
Ocular Therapeutics, Inc ...
Medtronic CoreValve LLC
ReSure® Sealant ....................................
Medtronic CoreValveTM System .............
P100040/S012, FDA–2014–M–0167 .........
Medtronic Vascular ............
P120005/S002, FDA–2014–M–0224 .........
Dexcom, Inc ......................
Valiant Thoracic Stent Graft with
Captivia Delivery System.
Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System.
Denied October 21, 2013.
Approved December 18,
2013.
Approved January 8, 2014.
Approved January 17,
2014.
Approved January 22,
2014.
Approved February 3,
2014.
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Federal Register / Vol. 79, No. 186 / Thursday, September 25, 2014 / Notices
57561
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1,
2014, THROUGH MARCH 31, 2014—Continued
PMA No., Docket No.
Applicant
Trade name
Date of action
P090031, FDA–2014–M–0254 ..................
Anika Therapeutics, Inc .....
P130015, FDA–2013–M–0326 ..................
Roche Diagnostics Operations, Inc.
MONOVISCTM Injectable Intra-articular
Device.
Elecsys® HBeAg Immunoassay and
Elecsys® PreciControl HBeAg.
Approved February 25,
2014.
Approved March 14, 2014.
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/MedicalDevices/
ProductsandMedicalProcedures/
DeviceApprovalsandClearances/
PMAApprovals/default.htm.
Dated: September 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–22807 Filed 9–24–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-day
Comment Request; Generic Clearance
for the Collection of Qualitative
Feedback on Agency Service Delivery
(NICHD)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on Thursday, July
3, 2014, Vol. 79, No. 128, page 38047–
38049 and allowed 60-days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. The Eunice Kennedy Shriver
National Institute of Child Health and
Human Development (NICHD), National
Institutes of Health, may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
DATES: Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
ADDRESSES: Direct Comments to Omb:
Written comments and/or suggestions
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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regarding the item(s) contained in this
notice, especially regarding the
estimated public burden and associated
response time, should be directed to the:
Office of Management and Budget,
Office of Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: NIH
Desk Officer.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Dr. Sarah L. Glavin, Project
Clearance Liaison, Office of Science
Policy, Analysis and Communication,
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, National Institutes of
Health, 31 Center Drive, Room 2A18,
Bethesda, Maryland 20892, or call a
non-toll free number (301) 496–1877 or
Email your request, including your
address to glavins@mail.nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION:
Proposed Collection: Generic
Clearance for the Collection of
Qualitative Feedback on Agency Service
Delivery (NICHD), 0925–0643,
Expiration Date 10/31/2014,
EXTENSION, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development (NICHD), National
Institutes of Health (NIH).
Need and Use of Information
Collection: There are no changes being
requested for this submission. The
proposed information collection activity
provides a means to garner qualitative
customer and stakeholder feedback in
an efficient, timely manner, in
accordance with the Administration’s
commitment to improving service
delivery. By qualitative feedback we
mean information that provides useful
insights on perceptions and opinions,
but are not statistical surveys that yield
quantitative results that can be
generalized to the population of study.
This feedback will provide information
about the NICHD’s customer or
stakeholder perceptions, experiences
and expectations, provide an early
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warning of issues with service, or focus
attention on areas where
communication, training or changes in
operations might improve delivery of
products or services. These collections
will allow for ongoing, collaborative and
actionable communications between the
NICHD and its customers and
stakeholders. It will also allow feedback
to contribute directly to the
improvement of program management.
The solicitation of feedback will target
areas such as: timeliness,
appropriateness, accuracy of
information, courtesy, efficiency of
service delivery, and resolution of
issues with service delivery. Responses
will be assessed to plan and inform
efforts to improve or maintain the
quality of service offered to the public.
If this information is not collected, vital
feedback from customers and
stakeholders on the NICHD’s services
will be unavailable.
The NICHD will only submit a
collection for approval under this
generic clearance if it meets the
following conditions:
• The collections are voluntary;
• The collections are low-burden for
respondents (based on considerations of
total burden hours, total number of
respondents, or burden-hours per
respondent) and are low-cost for both
the respondents and the Federal
Government;
• The collections are noncontroversial and do not raise issues of
concern to other Federal agencies;
• Any collection is targeted to the
solicitation of opinions from
respondents who have experience with
the program or may have experience
with the program in the near future;
• Personally identifiable information
(PII) is collected only to the extent
necessary and is not retained;
• Information gathered will be used
only internally for general service
improvement and program management
purposes and is not intended for release
outside of the agency;
• Information gathered will not be
used for the purpose of substantially
informing influential policy decisions;
and
• Information gathered will yield
qualitative information; the collections
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]]>Agencies
[Federal Register Volume 79, Number 186 (Thursday, September 25, 2014)]
[Notices]
[Pages 57560-57561]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22807]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2014-M-0326, FDA-2013-M-1324, FDA-2013-M-1693, FDA-
2014-M-0069, FDA-2014-M-0166, FDA-2014-M-0167, FDA-2014-M-0224, and
FDA-2014-M-0254]
Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the Internet and the
Agency's Division of Dockets Management.
ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness data to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Please cite the appropriate docket number as listed in table
1 when submitting a written request. See the SUPPLEMENTARY INFORMATION
section for electronic access to the summaries of safety and
effectiveness.
FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with sections 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the FD&C Act. The
30-day period for requesting reconsideration of an FDA action under
Sec. 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a
PMA begins on the day the notice is placed on the Internet. Section
10.33(b) provides that FDA may, for good cause, extend this 30-day
period. Reconsideration of a denial or withdrawal of approval of a PMA
may be sought only by the applicant; in these cases, the 30-day period
will begin when the applicant is notified by FDA in writing of its
decision.
The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from January 1, 2014, through March 31,
2014, and includes one denial action during this period. The list
provides the manufacturer's name, the product's generic name or the
trade name, and the approval date.
Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From January 1, 2014,
Through March 31, 2014
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Date of action
----------------------------------------------------------------------------------------------------------------
P070023, FDA-2013-M-1324............. Fzio Med, Inc.......... Oxiplex[reg]/SP Gel.... Denied October 21,
2013.
P110016/S008, FDA-2013-M-1693........ St. Jude Medical, Inc.. Therapy Cool Flex Approved December 18,
Ablation Catheter. 2013.
P130004, FDA-2014-M-0069............. Ocular Therapeutics, ReSure[reg] Sealant.... Approved January 8,
Inc. 2014.
P130021, FDA-2014-M-0166............. Medtronic CoreValve LLC Medtronic CoreValveTM Approved January 17,
System. 2014.
P100040/S012, FDA-2014-M-0167........ Medtronic Vascular..... Valiant Thoracic Stent Approved January 22,
Graft with Captivia 2014.
Delivery System.
P120005/S002, FDA-2014-M-0224........ Dexcom, Inc............ Dexcom G4 PLATINUM Approved February 3,
(Pediatric) Continuous 2014.
Glucose Monitoring
System.
[[Page 57561]]
P090031, FDA-2014-M-0254............. Anika Therapeutics, Inc MONOVISCTM Injectable Approved February 25,
Intra-articular Device. 2014.
P130015, FDA-2013-M-0326............. Roche Diagnostics Elecsys[reg] HBeAg Approved March 14,
Operations, Inc. Immunoassay and 2014.
Elecsys[reg]
PreciControl HBeAg.
----------------------------------------------------------------------------------------------------------------
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.
Dated: September 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22807 Filed 9-24-14; 8:45 am]
BILLING CODE 4164-01-P
