Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 22527 

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, http://www.fda.gov/

BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/

default.htm, or http://

www.regulations.gov. 

Dated: April 16, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–09303 Filed 4–21–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2014–M–1452, FDA– 

2014–M–1596, FDA–2014–M–1597, FDA– 

2014–M–1599, FDA–2014–M–1735, FDA– 

2014–M–1736, FDA–2014–M–2042, FDA– 

2014–M–2246, FDA–2014–M–2248, and 

FDA–2014–M–2376] 

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 

§ 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 October 1, 2014, through 

December 31, 2014. 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 OCTOBER 1, 

2014, THROUGH DECEMBER 31, 2014 

PMA No., Docket No. Applicant Trade name Approval date 

P040037/S060, FDA–2014–M–1452 ............... W.L. Gore & Associates, Inc.GORE VIABAHN Endoprosthesis, GORE 

VIABAHN Endoprosthesis with Heparin.

September 19, 2014. 

P070015/S122, FDA–2014–M–1596 ............... Abbott Vascular, Inc ... XIENCE V® and XIENCE nano® Everolimus 

Eluting Coronary Stent System.

October 3, 2014. 

P110019/S066, FDA–2014–M–1596 ............... Abbott Vascular, Inc ... XIENCE PRIME® and XIENCE PRIME LL 

Everlimus Eluting Coronary Stent System.

October 3, 2014. 

P130024, FDA–2014–M–1597 ......................... Lutonix, Inc ................. Lutonix 035 Drug Coated Balloon PTA Catheter.October 9, 2014. 

P110023/S007, FDA–2014–M–1599 ............... ev3, Inc ....................... EverFlexTM Self-Expanding Peripheral Stent 

System.

October 10, 2014. 

P120005/S018, FDA–2014–M–1735 ............... Dexcom, Inc ............... Dexcom G4TM PLATINUM Continuous Glucose Monitoring System.October 21, 2014. 

P130026, FDA–2014–M–1736 ......................... St. Jude Medical ........ TactiCath Quartz® Catheter and 

TactiSysQuartz® Equipment.

October 24, 2014. 

P120011, FDA–2014–M–2042 ......................... Ideal Implant, Inc ........ IDEAL IMPLANT® Saline-filled Breast Implant November 14, 2014. 

P130007, FDA–2014–M–2246 ......................... Animas Corp .............. Animas Vibe System ....................................... November 25, 2014. 

P140020, FDA–2014–M–2248 ......................... Myriad Genetic Laboratories, Inc.BRACAnalysis CDxTM .................................... December 19, 2014. 

P020012/S009, FDA–2014–M–2376 ............... Suneva Medical, Inc ... Bellafill ............................................................. December 23, 2014. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
22528 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 

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: April 16, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–09298 Filed 4–21–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–E–0131] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; COMETRIQ 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

COMETRIQ and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

ADDRESSES: Submit electronic 

comments to http://

www.regulations.gov. Submit written 

petitions (two copies are required) and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

Submit petitions electronically to 

http://www.regulations.gov at Docket 

No. FDA–2013–S–0610. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of 

Management, Food and Drug 

Administration, 10001 New Hampshire 

Ave., Hillandale Campus, Rm. 3180, 

Silver Spring, MD 20993, 301–796– 

7900. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

and the Generic Animal Drug and Patent 

Term Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug product, animal drug product, 

medical device, food additive, or color 

additive) was subject to regulatory 

review by FDA before the item was 

marketed. Under these acts, a product’s 

regulatory review period forms the basis 

for determining the amount of extension 

an applicant may receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of USPTO may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product COMETRIQ 

(cabozanitinib (S)-maleate). COMETRIQ 

is indicated for the treatment of patients 

with progressive, metastatic medullary 

thyroid cancer. Subsequent to this 

approval, the USPTO received a patent 

term restoration application for 

COMETRIQ (U.S. Patent No. 7,579,473) 

from Exelixis, Incorporated, and the 

USPTO requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

March 27, 2014, FDA advised the 

USPTO that this human drug product 

had undergone a regulatory review 

period and that the approval of 

COMETRIQ represented the first 

permitted commercial marketing or use 

of the product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

FDA has determined that the 

applicable regulatory review period for 

COMETRIQ is 2,698 days. Of this time, 

2,513 days occurred during the testing 

phase of the regulatory review period, 

while 185 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 355(i)) became effective: July 13, 

2005. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on July 13, 2005. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: May 29, 2012. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

COMETRIQ (NDA 203756) was 

submitted on May 29, 2012. 

3. The date the application was 

approved: November 29, 2012. FDA has 

verified the applicant’s claim that NDA 

203756 was approved on November 29, 

2012. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 688 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) either 

electronic or written comments and ask 

for a redetermination by June 22, 2015. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

October 19, 2015. To meet its burden, 

the petition must contain sufficient facts 

to merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments and written or electronic 

petitions. 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. If you submit a written 

petition, two copies are required. A 

petition submitted electronically must 

be submitted to http://

www.regulations.gov, Docket No. FDA– 

2013–S–0610. Comments and petitions 

that have not been made publicly 

available on http://www.regulations.gov 

may be viewed in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: April 16, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–09302 Filed 4–21–15; 8:45 am] 

BILLING CODE 4164–01–P 


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