Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 60704-60705 [2012-24479]

Download as PDF 60704 Federal Register / Vol. 77, No. 193 / Thursday, October 4, 2012 / Notices emcdonald on DSK67QTVN1PROD with NOTICES received before the close of the comment period on the following Web site as soon as possible after they have been received: https:// www.regulations.gov. Follow the search instructions on that Web site to view public comments. Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1–800–743–3951. I. Background Organ Procurement Organizations (OPOs) are not-for-profit organizations that are responsible for the procurement, preservation, and transport of transplantable organs to transplant centers throughout the country. Qualified OPOs are designated by the Centers for Medicare & Medicaid Services (CMS) to recover or procure organs in CMS-defined exclusive geographic service areas, pursuant to section 371(b)(1) of the Public Health Service Act (42 U.S.C. 273(b)(1) and our regulations at 42 CFR § 486.306. Once an OPO has been designated for an area, hospitals in that area that participate in Medicare and Medicaid are required to work with that OPO in providing organs for transplant, pursuant to section 1138(a)(1)(C) of the Social Security Act (the Act) and our regulations at 42 CFR 482.45. Section 1138(a)(1)(A)(iii) of the Act provides that a hospital must notify the designated OPO (for the service area in which it is located) of potential organ donors. Under section 1138(a)(1)(C) of the Act, every participating hospital must have an agreement to identify potential donors only with its designated OPO. However, section 1138(a)(2)(A) of the Act provides that a hospital may obtain a waiver of the above requirements from the Secretary under certain specified conditions. A waiver allows the hospital to have an agreement with an OPO other than the one initially designated by CMS, if the hospital meets certain conditions specified in section 1138(a)(2)(A) of the Act. In addition, the Secretary may review additional criteria described in section 1138(a)(2)(B) of the Act to evaluate the hospital’s request for a waiver. Section 1138(a)(2)(A) of the Act states that in granting a waiver, the Secretary must determine that the waiver—(1) is VerDate Mar<15>2010 15:21 Oct 03, 2012 Jkt 229001 expected to increase organ donations; and (2) will ensure equitable treatment of patients referred for transplants within the service area served by the designated OPO and within the service area served by the OPO with which the hospital seeks to enter into an agreement under the waiver. In making a waiver determination, section 1138(a)(2)(B) of the Act provides that the Secretary may consider, among other factors: (1) Cost-effectiveness; (2) improvements in quality; (3) whether there has been any change in a hospital’s designated OPO due to the changes made in definitions for metropolitan statistical areas; and (4) the length and continuity of a hospital’s relationship with an OPO other than the hospital’s designated OPO. Under section 1138(a)(2)(D) of the Act, the Secretary is required to publish a notice of any waiver application received from a hospital within 30 days of receiving the application, and to offer interested parties an opportunity to comment in writing during the 60-day period beginning on the publication date in the Federal Register. The criteria that the Secretary uses to evaluate the waiver in these cases are the same as those described above under sections 1138(a)(2)(A) and (B) of the Act and have been incorporated into the regulations at § 486.308(e) and (f). II. Waiver Request Procedures In October 1995, we issued a Program Memorandum (Transmittal No. A–95– 11) detailing the waiver process and discussing the information hospitals must provide in requesting a waiver. We indicated that upon receipt of a waiver request, we would publish a Federal Register notice to solicit public comments, as required by section 1138(a)(2)(D) of the Act. According to these requirements, we will review the request and comments received. During the review process, we may consult on an as-needed basis with the Health Resources and Services Administration’s Division of Transplantation, the United Network for Organ Sharing, and our regional offices. If necessary, we may request additional clarifying information from the applying hospital or others. We will then make a final determination on the waiver request and notify the hospital and the designated and requested OPOs. III. Hospital Waiver Request As permitted by § 486.308(e), the following hospital has requested a waiver in order to enter into an agreement with a designated OPO other than the OPO designated for the service area in which the hospital is located: PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 Quitman County Hospital, LLC. of Marks, Mississippi, is requesting a waiver to work with: Mississippi Organ Recovery Agency, 4400 Lakeland Drive, Flowood, MS 39232. The Hospital’s Designated OPO is: Mid-South Transplant Foundation, Inc., 8001 Centerview Parkway, Suite 302, Memphis, TN 38018. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; Program No. 93.774, Medicare— Supplementary Medical Insurance, and Program No. 93.778, Medical Assistance Program) Dated: September 28, 2012. Marilyn Tavenner, Acting Administrator and Chief Operating Officer, Centers for Medicare & Medicaid Services. [FR Doc. 2012–24496 Filed 10–3–12; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2012–M–0371, FDA– 2012–M–0372, FDA–2012–M–0373, FDA– 2012–M–0390, FDA–2012–M–0407, FDA– 2012–M–0562, and FDA–2012–M–0638] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: 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. 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 of this document 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 SUMMARY: E:\FR\FM\04OCN1.SGM 04OCN1 Federal Register / Vol. 77, No. 193 / Thursday, October 4, 2012 / Notices 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 § 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. 60705 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 April 1, 2012, through June 30, 2012. There were no denial actions 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 APRIL 1, 2012, THROUGH JUNE 30, 2012 PMA No., Docket No. Applicant Trade name P020018/S040, FDA–2012– M–0371. P110029, FDA–2012–M–0372 Cook, Inc ................................ P110004, FDA–2012–M–0407 P110035, FDA–2012–M–0373 P090015, FDA–2012–M–0390 P110010/S001, FDA–2012– M–0562. Medinol Ltd. ........................... Boston Scientific Corp ........... Leica Biosystems ................... Boston Scientific Corp ........... P090026, FDA–2012–M–0638 Beckman Coulter, Inc ............ Zenith® Fenestrated AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent). ARCHITECT HBsAg Qualitative, ARCHITECT HBsAg Qualitative Confirmatory, ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent, ARCHITECT HBsAg Qualitative Calibrators, and ARCHITECT HBsAg Qualitative Controls. PresillionTM plus CoCr Coronary Stent on RX System ......... EpicTM Vascular Self-Expanding Stent System ..................... BONDTM ORACLETM HER2 IHC System .............................. PROMUS® ElementTM Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (MonorailTM and Overthe-Wire). Access® Hybritech® p2PSA on the Access Immunoassay Systems. Abbot Laboratories ................ property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. II. Electronic Access Persons with access to the Internet may obtain the documents at https:// www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ DeviceApprovalsandClearances/ PMAApprovals/default.htm. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Minority Institutional Training. Date: October 25, 2012. Time: 3:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Chang Sook Kim, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7179, Bethesda, MD 20892–7924, 301–435– 0287, carolko@mail.nih.gov. Dated: September 28, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–24479 Filed 10–3–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health emcdonald on DSK67QTVN1PROD with NOTICES National Heart, Lung, and Blood Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial VerDate Mar<15>2010 15:21 Oct 03, 2012 Jkt 229001 Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; NHLBI Program Project for Triglyceride Metabolism. Date: October 26, 2012. Time: 8:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Conference Room 9091, Bethesda, MD 20892. Contact Person: Melissa E Nagelin, Ph.D., Scientific Review Officer, Office of Scientific PO 00000 Frm 00035 Fmt 4703 Sfmt 9990 Approval date April 4, 2012. April 12, 2012. April 12, 2012. April 13, 2012. April 18, 2012. June 1, 2012. June 14, 2012. Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Rm. 7202, Bethesda, MD 20892, 301–435–0297, nagelinmh2@nhlbi.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; NHLBI SBIR Phase II Contract Review. Date: October 26, 2012. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: YingYing Li-Smerin, Ph.D., MD, Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7184, Bethesda, MD 20892– 7924, 301–435–0277, lismerin@nhlbi.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: September 28, 2012. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2012–24417 Filed 10–3–12; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\04OCN1.SGM 04OCN1

Agencies

[Federal Register Volume 77, Number 193 (Thursday, October 4, 2012)]
[Notices]
[Pages 60704-60705]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24479]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2012-M-0371, FDA-2012-M-0372, FDA-2012-M-0373, FDA-
2012-M-0390, FDA-2012-M-0407, FDA-2012-M-0562, and FDA-2012-M-0638]

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 of this document 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

[[Page 60705]]

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 April 1, 2012, through June 30, 2012.
There were no denial actions 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 April 1, 2012, Through
June 30, 2012
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P020018/S040, FDA-2012-M-0371..... Cook, Inc............ Zenith[supreg] Fenestrated April 4, 2012.
AAA Endovascular Graft
(with the adjunctive
Zenith Alignment Stent).
P110029, FDA-2012-M-0372.......... Abbot Laboratories... ARCHITECT HBsAg April 12, 2012.
Qualitative, ARCHITECT
HBsAg Qualitative
Confirmatory, ARCHITECT
HBsAg Qualitative
Confirmatory Manual
Diluent, ARCHITECT HBsAg
Qualitative Calibrators,
and ARCHITECT HBsAg
Qualitative Controls.
P110004, FDA-2012-M-0407.......... Medinol Ltd.......... Presillion\TM\ plus CoCr April 12, 2012.
Coronary Stent on RX
System.
P110035, FDA-2012-M-0373.......... Boston Scientific Epic\TM\ Vascular Self- April 13, 2012.
Corp. Expanding Stent System.
P090015, FDA-2012-M-0390.......... Leica Biosystems..... BOND\TM\ ORACLE\TM\ HER2 April 18, 2012.
IHC System.
P110010/S001, FDA-2012-M-0562..... Boston Scientific PROMUS[supreg] Element\TM\ June 1, 2012.
Corp. Plus Everolimus-Eluting
Platinum Chromium
Coronary Stent System
(Monorail\TM\ and Over-
the-Wire).
P090026, FDA-2012-M-0638.......... Beckman Coulter, Inc. Access[supreg] June 14, 2012.
Hybritech[supreg] p2PSA
on the Access Immunoassay
Systems.
----------------------------------------------------------------------------------------------------------------

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 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-24479 Filed 10-3-12; 8:45 am]
BILLING CODE 4160-01-P

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