Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 57560-57561 [2014-22807]

Download as PDF 57560 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 http:// 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 Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the Internet.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 http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at http://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 Paperwork Reduction Act of 1995 This draft guidance refers to currently approved collections of information found in FDA regulations.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 http://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. VerDate Sep<11>2014 17:25 Sep 24, 2014 Jkt 232001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\25SEN1.SGM 25SEN1 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 http:// 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: VerDate Sep<11>2014 17:25 Sep 24, 2014 Jkt 232001 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 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 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 E:\FR\FM\25SEN1.SGM 25SEN1

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]


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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 
http://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