Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 58488-58489 [2015-24625]

Download as PDF 58488 Federal Register / Vol. 80, No. 188 / Tuesday, September 29, 2015 / Notices not to submit an evaluation because the field testing of a plant containing a new protein is conducted in such a way (e.g., on such a small scale, or in such isolated conditions, etc.) that crosspollination with traditional crops or commingling of plant material is not likely to be an issue. Also, other developers may have previously communicated with us about the food safety of a new plant protein, for example, when the same protein was expressed in a different crop. For purposes of this extension request, we are re-evaluating our estimate of the annual number of responses that we expect to receive in the next 3 years. We received 12 NPCs during the 5-year period from 2005 through 2009, for an average of 2.4 NPCs per year. However, during the last extension period, we saw a decrease in the number of NPCs submitted by developers, with no NPCs submitted in 2010 through 2014. More recently, we received four NPCs in the first 4 months of 2015. Based on an approximate average from the years 2005 through 2009, and our experience in 2015, we are revising our estimate of the annual number of NPCs submitted by developers to be six or fewer. The early food safety evaluation for new proteins includes six main data components. Four of these data components are easily and quickly obtainable, having to do with the identity and source of the protein. We estimate that completing these data components will take about 4 hours per NPC. We estimate the reporting burden for the first four data components to be 24 hours (4 hours × 6 responses). Two data components ask for original data to be generated. One data component consists of a bioinformatics analysis which can be performed using publicly available databases. The other data component involves ‘‘wet’’ lab work to assess the new protein’s stability and the resistance of the protein to enzymatic degradation using appropriate in vitro assays (protein digestibility study). The paperwork burden of these two data components consists of the time it takes the company to assemble the information on these two data components and include it in a NPC. We estimate that completing these data components will take about 16 hours per NPC. We estimate the reporting burden for the two other data components to be 96 hours (16 hours × 6 responses). Thus, we estimate the total annual hour burden for this collection of information to be 120 hours. Dated: September 23, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–24620 Filed 9–28–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2014–M–2375, FDA– 2015–M–0909, FDA–2015–M–0199, FDA– 2015–M–0200, FDA–2015–M–0201, FDA– 2015–M–0228, FDA–2015–M–0266, FDA– 2015–M–0267, FDA–2015–M–0431, FDA– 2015–M–0502, FDA–2015–M–0690, FDA– 2015–M–0738, FDA–2015–M–0910] 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 SUMMARY: 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: Melissa Torres, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993–0002, 301–796–5576. 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. 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, 2015, through March 31, 2015. 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 JANUARY 1, 2015, THROUGH MARCH 31, 2015 asabaliauskas on DSK5VPTVN1PROD with NOTICES PMA No., Docket No. Applicant Trade name P980040/S049, FDA–2014–M–2375 ........ Abbott Medical Optics, Inc. ..................... P140010, FDA–2015–M–0199 ................. Medtronic, Inc. ........................................ P130019, FDA–2015–M–0201 ................. P130025, FDA–2015–M–0200 ................. P060001/S020, FDA–2015–M–0228 ........ EnteroMedics, Inc. .................................. Koning Corp. ........................................... ev3, Inc. .................................................. H140001, FDA–2015–M–0267 ................. ABIOMED, Inc. ........................................ TECNIS® multifocal 1-piece intraocular lens. IN.PACTTM AdmiralTM Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter. Maestro® Rechargeable System ............ Koning Breast CT (Model CBCT 1000) .. ´ ´ ProtegeTM GPS Self-Expanding Peripheral Stent System. Impella RP System ................................. VerDate Sep<11>2014 17:54 Sep 28, 2015 Jkt 235001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\29SEN1.SGM 29SEN1 Approval date 12/17/2014 12/30/2014 1/14/2015 1/14/2015 1/21/2015 1/23/2015 58489 Federal Register / Vol. 80, No. 188 / Tuesday, September 29, 2015 / Notices TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1, 2015, THROUGH MARCH 31, 2015—Continued PMA No., Docket No. Applicant Trade name P140017, FDA–2015–M–0266 ................. Medtronic, Inc. ........................................ P130023, FDA–2015–M–0431 ................. P010047/S036, FDA–2015–M–0502 ........ P140018, FDA–2015–M–0690 ................. H130001, FDA–2015–M–0909 ................. Cohera Medical, Inc. ............................... NeoMend, Inc. ......................................... Covidien, LLC ......................................... Biologics Consulting Group, Inc. ............ P110024, FDA–2015–M–0738 ................. P130013, FDA–2015–M–0910 ................. Advanced Circulatory Systems, Inc. ....... Boston Scientific Corp. ........................... MelodyTM Transcatheter Pulmonary Valve (TPV) and EnsembleTM Transcatheter Valve Delivery System. TissuGlu® Surgical Adhesive .................. ProGelTM Pleural Air Leak Sealant ........ VenaSealTM Closure System .................. Lixelle Beta 2-microglobulin Apheresis Column. ResQCPRTM System .............................. WATCHMANTM Left Atrial Appendage (LAA) Closure Technology. 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 23, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–24625 Filed 9–28–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0229] Issuance of Priority Review Voucher; Rare Pediatric Disease Product AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that Xuriden (uridine triacetate), manufactured by Wellstat Therapeutics Corp., meets the criteria for a priority review voucher. FOR FURTHER INFORMATION CONTACT: Larry Bauer, Rare Diseases Program, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–4842, FAX: 301–796–9858, larry.bauer@fda.hhs.gov. asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:54 Sep 28, 2015 Jkt 235001 FDA is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by FDASIA, FDA will award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that Xuriden (uridine triacetate), manufactured by Wellstat Therapeutics Corp., meets the criteria for a priority review voucher. Uridine triacetate is a pyrimidine analog for uridine replacement. Xuriden is indicated for the treatment of hereditary orotic aciduria. Hereditary orotic aciduria is caused by a deficiency in the activity of the pyrimidine pathway enzyme uridine 5′-monophosphate synthase. The disorder is generally characterized by anemia and/or other hematological manifestations, excessive urinary excretion of orotic acid, failure to thrive, and developmental delay. For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/ForIndustry/ DevelopingProductsforRareDiseases Conditions/RarePediatricDiseasePriority VoucherProgram/default.htm. For further information about Xuriden (uridine triacetate), go to the Drugs@ FDA Web site at https://www.accessdata. fda.gov/scripts/cder/drugsatfda/ index.cfm. SUPPLEMENTARY INFORMATION: Dated: September 24, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–24640 Filed 9–28–15; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 Approval date 1/27/2015 2/3/2015 2/13/2015 2/20/2015 3/5/2015 3/6/2015 3/13/2015 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–3393] Determination That ORTHO EVRA (Norelgestromin/Ethinyl Estradiol) Transdermal System, 0.15 Milligrams/ 24 Hours Norelgestromin and 0.035 Milligrams/24 Hours Ethinyl Estradiol, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that ORTHO EVRA (norelgestromin/ethinyl estradiol) Transdermal System, 0.15 milligrams (mg)/24 hours (hr) norelgestromin and 0.035 mg/24hr ethinyl estradiol was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Ayako Sato, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993–0002, 240–402–4191, Ayako.Sato@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain SUMMARY: E:\FR\FM\29SEN1.SGM 29SEN1

Agencies

[Federal Register Volume 80, Number 188 (Tuesday, September 29, 2015)]
[Notices]
[Pages 58488-58489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24625]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-M-2375, FDA-2015-M-0909, FDA-2015-M-0199, FDA-
2015-M-0200, FDA-2015-M-0201, FDA-2015-M-0228, FDA-2015-M-0266, FDA-
2015-M-0267, FDA-2015-M-0431, FDA-2015-M-0502, FDA-2015-M-0690, FDA-
2015-M-0738, FDA-2015-M-0910]

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: Melissa Torres, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-5576.

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, 2015, through March 31,
2015. 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 January 1, 2015,
Through March 31, 2015
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P980040/S049, FDA-2014-M-2375....... Abbott Medical Optics, Inc.. TECNIS[supreg] multifocal 1- 12/17/2014
piece intraocular lens.
P140010, FDA-2015-M-0199............ Medtronic, Inc.............. IN.PACTTM AdmiralTM 12/30/2014
Paclitaxel-coated
Percutaneous Transluminal
Angioplasty Balloon
Catheter.
P130019, FDA-2015-M-0201............ EnteroMedics, Inc........... Maestro[supreg] Rechargeable 1/14/2015
System.
P130025, FDA-2015-M-0200............ Koning Corp................. Koning Breast CT (Model CBCT 1/14/2015
1000).
P060001/S020, FDA-2015-M-0228....... ev3, Inc.................... Prot[eacute]g[eacute]TM GPS 1/21/2015
Self-Expanding Peripheral
Stent System.
H140001, FDA-2015-M-0267............ ABIOMED, Inc................ Impella RP System........... 1/23/2015

[[Page 58489]]

P140017, FDA-2015-M-0266............ Medtronic, Inc.............. MelodyTM Transcatheter 1/27/2015
Pulmonary Valve (TPV) and
EnsembleTM Transcatheter
Valve Delivery System.
P130023, FDA-2015-M-0431............ Cohera Medical, Inc......... TissuGlu[supreg] Surgical 2/3/2015
Adhesive.
P010047/S036, FDA-2015-M-0502....... NeoMend, Inc................ ProGelTM Pleural Air Leak 2/13/2015
Sealant.
P140018, FDA-2015-M-0690............ Covidien, LLC............... VenaSealTM Closure System... 2/20/2015
H130001, FDA-2015-M-0909............ Biologics Consulting Group, Lixelle Beta 2-microglobulin 3/5/2015
Inc.. Apheresis Column.
P110024, FDA-2015-M-0738............ Advanced Circulatory ResQCPRTM System............ 3/6/2015
Systems, Inc..
P130013, FDA-2015-M-0910............ Boston Scientific Corp...... WATCHMANTM Left Atrial 3/13/2015
Appendage (LAA) Closure
Technology.
----------------------------------------------------------------------------------------------------------------

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 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24625 Filed 9-28-15; 8:45 am]
BILLING CODE 4164-01-P

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