80 FR 25298 - Determination of Regulatory Review Period for Purposes of Patent Extension; RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 85 (May 4, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 85 (May 4, 2015)
| Page Range | 25298-25299 | |
| FR Document | 2015-10338 |
[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)] [Notices] [Pages 25298-25299] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-10338] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-E-0785] Determination of Regulatory Review Period for Purposes of Patent Extension; RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for the RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM 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 medical device. 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 medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is [[Page 25299]] granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (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 medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B). FDA has approved for marketing the medical device RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM is indicated for the endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating atherosclerotic ulcers in the descending thoracic aorta in patients having appropriate anatomy. Subsequent to this approval, the USPTO received a patent term restoration application for the RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (U.S. Patent No. 8,062,345 B2) from Bolton Medical Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated March 18, 2014, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of the RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM 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 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM is 2,852 days. Of this time, 2,529 days occurred during the testing phase of the regulatory review period, while 323 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: December 2, 2004. The applicant claims that the investigational device exemption (IDE) required under section 520(g) of the FD&C Act for human tests to begin became effective on December 3, 2004. However, FDA records indicate that the IDE was determined substantially complete for clinical studies to have begun on December 2, 2004, which represents the IDE effective date. 2. The date an application was initially submitted with respect to the device under section 515 of the FD&C Act (21 U.S.C. 360e): November 4, 2011. FDA has verified the applicant's claim that the premarket approval application (PMA) for the RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (PMA P110038) was initially submitted November 4, 2011. 3. The date the application was approved: September 21, 2012. FDA has verified the applicant's claim that PMA P110038 was approved on September 21, 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 225 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 July 6, 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 November 2, 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 28, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-10338 Filed 5-1-15; 8:45 am] BILLING CODE 4164-01-P
![25298 Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices
Leroy A. Richardson, DEPARTMENT OF HEALTH AND occurring in the administration of CCDF
Chief, Information Collection Review Office, HUMAN SERVICES grant funds once every three years.
Office of Scientific Integrity, Office of the The Office of Child Care (OCC) is
Associate Director for Science, Office of the Administration for Children and completing the third 3-year cycle of case
Director, Centers for Disease Control and Families record reviews to meet the requirements
Prevention. for reporting under IPIA. The current
[FR Doc. 2015–10286 Filed 5–1–15; 8:45 am] Submission for OMB Review; forms and instructions expire
BILLING CODE 4163–18–P
Comment Request September 30, 2015. OCC is submitting
the information collection for renewal
Title: Child Care Development Fund,
clearance with minor changes.
CCDF; Reporting Improper Payments;
Responders will now have additional
Instructions for States.
guidance and clarification in the
OMB No.: 0970–0323. instructions and errors have been
Description: Section 2 of the Improper corrected. New language incorporates
Payments Act of 2002 provides for requirements from the 2014 Child Care
estimates and reports of improper and Development Fund Block Grant Act
payments by Federal agencies. Subpart passed in November 2014.
K of 45 CFR, part 98 will require States Respondents: State grantees, the
to prepare and submit a report of errors District of Columbia, and Puerto Rico
ANNUAL BURDEN ESTIMATES
Number of Average burden
Number of Total burden
Instrument responses per hours per
respondents hours
respondent response
Sampling Decisions and Fieldwork Preparation Plan ................. 17 1 106 1,802
Record Review Worksheet .......................................................... 17 276 6.33 29,700.36
State Improper Authorizations for Payment Report .................... 17 1 639 10,863
Corrective Action Plan ................................................................. 8 1 156 1,248
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND Lane, Rm. 1061, Rockville, MD 20852.
Hours: 43,613.36. HUMAN SERVICES Submit petitions electronically to http://
Additional Information: Copies of the www.regulations.gov at Docket No.
Food and Drug Administration FDA–2013–S–0610.
proposed collection may be obtained by
writing to the Administration for [Docket No. FDA–2013–E–0785] FOR FURTHER INFORMATION CONTACT:
Children and Families, Office of Beverly Friedman, Office of
Determination of Regulatory Review Management, Food and Drug
Planning, Research and Evaluation, 370
Period for Purposes of Patent Administration, 10001 New Hampshire
L’Enfant Promenade SW., Washington,
Extension; RELAY THORACIC STENT– Ave., Hillandale Campus, Rm. 3180,
DC 20447, Attn: ACF Reports Clearance Silver Spring, MD 20993, 301–796–
Officer. All requests should be GRAFT WITH PLUS DELIVERY
SYSTEM 7900.
identified by the title of the information
SUPPLEMENTARY INFORMATION: The Drug
collection. Email address: AGENCY: Food and Drug Administration,
infocollection@acf.hhs.gov. Price Competition and Patent Term
HHS.
Restoration Act of 1984 (Pub. L. 98–417)
OMB Comment: OMB is required to ACTION: Notice. and the Generic Animal Drug and Patent
make a decision concerning the Term Restoration Act (Pub. L. 100–670)
collection of information between 30 SUMMARY: The Food and Drug
generally provide that a patent may be
and 60 days after publication of this Administration (FDA) has determined
extended for a period of up to 5 years
the regulatory review period for the
document in the Federal Register. so long as the patented item (human
RELAY THORACIC STENT–GRAFT
Therefore, a comment is best assured of drug product, animal drug product,
WITH PLUS DELIVERY SYSTEM and is
having its full effect if OMB receives it medical device, food additive, or color
publishing this notice of that
within 30 days of publication. Written additive) was subject to regulatory
determination as required by law. FDA
comments and recommendations for the review by FDA before the item was
has made the determination because of
proposed information collection should marketed. Under these acts, a product’s
the submission of an application to the
be sent directly to the following: Office regulatory review period forms the basis
Director of the U.S. Patent and
of Management and Budget, Paperwork for determining the amount of extension
Trademark Office (USPTO), Department
Reduction Project, Email: OIRA_ an applicant may receive.
of Commerce, for the extension of a A regulatory review period consists of
SUBMISSION@OMB.EOP.GOV. Attn: patent which claims that medical two periods of time: A testing phase and
Desk Officer for the Administration for device.
mstockstill on DSK4VPTVN1PROD with NOTICES
an approval phase. For medical devices,
Children and Families.
ADDRESSES: Submit electronic the testing phase begins with a clinical
Robert Sargis, comments to http:// investigation of the device and runs
Reports Clearance Officer. www.regulations.gov. Submit written until the approval phase begins. The
[FR Doc. 2015–10296 Filed 5–1–15; 8:45 am]
petitions (two copies are required) and approval phase starts with the initial
written comments to the Division of submission of an application to market
BILLING CODE 4184–01–P
Dockets Management (HFA–305), Food the device and continues until
and Drug Administration, 5630 Fishers permission to market the device is
VerDate Sep<11>2014 19:40 May 01, 2015 Jkt 235001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\04MYN1.SGM 04MYN1](https://thefederalregister.org/doc/80_FR_25383/page/1.svg)
![Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices 25299
granted. Although only a portion of a 2. The date an application was DEPARTMENT OF HEALTH AND
regulatory review period may count initially submitted with respect to the HUMAN SERVICES
toward the actual amount of extension device under section 515 of the FD&C
that the Director of USPTO may award Act (21 U.S.C. 360e): November 4, 2011. Food and Drug Administration
(half the testing phase must be FDA has verified the applicant’s claim [Docket Nos. FDA–2013–E–1299 and FDA–
subtracted as well as any time that may that the premarket approval application 2013–E–1302]
have occurred before the patent was (PMA) for the RELAY THORACIC
issued), FDA’s determination of the STENT–GRAFT WITH PLUS DELIVERY Determination of Regulatory Review
length of a regulatory review period for SYSTEM (PMA P110038) was initially Period for Purposes of Patent
a medical device will include all of the submitted November 4, 2011. Extension; CAMERON HEALTH S–ICD
testing phase and approval phase as SYSTEM
3. The date the application was
specified in 35 U.S.C. 156(g)(3)(B).
approved: September 21, 2012. FDA has AGENCY: Food and Drug Administration,
FDA has approved for marketing the
verified the applicant’s claim that PMA HHS.
medical device RELAY THORACIC
P110038 was approved on September ACTION: Notice.
STENT–GRAFT WITH PLUS DELIVERY
21, 2012.
SYSTEM. RELAY THORACIC STENT– SUMMARY: The Food and Drug
GRAFT WITH PLUS DELIVERY This determination of the regulatory
review period establishes the maximum Administration (FDA) has determined
SYSTEM is indicated for the the regulatory review period for
endovascular repair of fusiform potential length of a patent extension.
CAMERON HEALTH S–ICD SYSTEM
aneurysms and saccular aneurysms/ However, the USPTO applies several
and is publishing this notice of that
penetrating atherosclerotic ulcers in the statutory limitations in its calculations
determination as required by law. FDA
descending thoracic aorta in patients of the actual period for patent extension.
has made the determination because of
having appropriate anatomy. In its application for patent extension,
the submission of applications to the
Subsequent to this approval, the USPTO this applicant seeks 225 days of patent
Director of the U.S. Patent and
received a patent term restoration term extension. Trademark Office (USPTO), Department
application for the RELAY THORACIC Anyone with knowledge that any of of Commerce, for the extension of a
STENT–GRAFT WITH PLUS DELIVERY the dates as published are incorrect may patent which claims that medical
SYSTEM (U.S. Patent No. 8,062,345 B2) submit to the Division of Dockets device.
from Bolton Medical Inc., and the Management (see ADDRESSES) either
USPTO requested FDA’s assistance in ADDRESSES: Submit electronic
electronic or written comments and ask comments to http://
determining this patent’s eligibility for for a redetermination by July 6, 2015.
patent term restoration. In a letter dated www.regulations.gov. Submit written
Furthermore, any interested person may petitions (two copies are required) and
March 18, 2014, FDA advised the
petition FDA for a determination written comments to the Division of
USPTO that this medical device had
regarding whether the applicant for Dockets Management (HFA–305), Food
undergone a regulatory review period
extension acted with due diligence and Drug Administration, 5630 Fishers
and that the approval of the RELAY
during the regulatory review period by Lane, Rm. 1061, Rockville, MD 20852.
THORACIC STENT–GRAFT WITH
November 2, 2015. To meet its burden, Submit petitions electronically to
PLUS DELIVERY SYSTEM represented
the first permitted commercial the petition must contain sufficient facts http://www.regulations.gov at Docket
marketing or use of the product. to merit an FDA investigation. (See H. No. FDA–2013–S–0610.
Thereafter, the USPTO requested that Rept. 857, part 1, 98th Cong., 2d sess., FOR FURTHER INFORMATION CONTACT:
FDA determine the product’s regulatory pp. 41–42, 1984.) Petitions should be in Beverly Friedman, Office of
review period. the format specified in 21 CFR 10.30. Management, Center for Drug
FDA has determined that the Interested persons may submit to the Evaluation and Research, Food and
applicable regulatory review period for Division of Dockets Management (see Drug Administration, 10001 New
RELAY THORACIC STENT–GRAFT ADDRESSES) electronic or written Hampshire Ave., Hillandale Building,
WITH PLUS DELIVERY SYSTEM is comments and written or electronic Rm. 3180, Silver Spring, MD 20993–
2,852 days. Of this time, 2,529 days petitions. It is only necessary to send 0002, 301–796–7900.
occurred during the testing phase of the one set of comments. Identify comments SUPPLEMENTARY INFORMATION: The Drug
regulatory review period, while 323 with the docket number found in Price Competition and Patent Term
days occurred during the approval brackets in the heading of this Restoration Act of 1984 (Pub. L. 98–417)
phase. These periods of time were document. If you submit a written and the Generic Animal Drug and Patent
derived from the following dates: petition, two copies are required. A Term Restoration Act (Pub. L. 100–670)
1. The date an exemption under petition submitted electronically must generally provide that a patent may be
section 520(g) of the Federal Food, Drug, be submitted to http:// extended for a period of up to 5 years
and Cosmetic Act (the FD&C Act) (21 www.regulations.gov, Docket No. FDA– so long as the patented item (human
U.S.C. 360j(g)) involving this device 2013–S–0610. Comments and petitions drug product, animal drug product,
became effective: December 2, 2004. The that have not been made publicly medical device, food additive, or color
applicant claims that the investigational available on http://www.regulations.gov additive) was subject to regulatory
device exemption (IDE) required under may be viewed in the Division of review by FDA before the item was
mstockstill on DSK4VPTVN1PROD with NOTICES
section 520(g) of the FD&C Act for Dockets Management between 9 a.m. marketed. Under these acts, a product’s
human tests to begin became effective and 4 p.m., Monday through Friday. regulatory review period forms the basis
on December 3, 2004. However, FDA Dated: April 28, 2015. for determining the amount of extension
records indicate that the IDE was an applicant may receive.
Leslie Kux,
determined substantially complete for A regulatory review period consists of
clinical studies to have begun on Associate Commissioner for Policy. two periods of time: A testing phase and
December 2, 2004, which represents the [FR Doc. 2015–10338 Filed 5–1–15; 8:45 am] an approval phase. For medical devices,
IDE effective date. BILLING CODE 4164–01–P the testing phase begins with a clinical
VerDate Sep<11>2014 19:40 May 01, 2015 Jkt 235001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\04MYN1.SGM 04MYN1](https://thefederalregister.org/doc/80_FR_25383/page/2.svg)
Document Created: 2018-02-21 10:22:30
Document Modified: 2018-02-21 10:22:30
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| FR Citation | 80 FR 25298 |
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