Determination of Regulatory Review Period for Purposes of Patent Extension; HVAD ROTARY BLOOD PUMP, 26275-26276 [2015-11001]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices 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: August 12, 2002. The applicant claims February 13, 2002, as the date the investigational new animal drug application (INAD) became effective. However, FDA records indicate that the INAD effective date was August 12, 2002, which was the date a major health or environmental effects test is begun or the date on which the Agency acknowledges the filing of a notice of claimed investigational exemption for a new animal drug, whichever is earlier. 2. The date the application was initially submitted with respect to the animal drug product under section 512 of the FD&C Act (21 U.S.C. 360b): August 2, 2012. The applicant claims July 20, 2012, as the date the new animal drug Application (NADA) for OVUGEL RE42072 (NADA 141–339) was initially submitted. However, FDA records indicate that NADA 141–339 was submitted on August 2, 2012. 3. The date the application was approved: September 18, 2012. FDA has verified the applicant’s claim that NADA 141–339 was approved on September 18, 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 applications for patent extension, this applicant seeks 331 or 1,826 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 3, 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 VerDate Sep<11>2014 18:07 May 06, 2015 Jkt 235001 petition, two copies are required. A petition submitted electronically must be submitted to https:// www.regulations.gov, Docket No. FDA– 2013–S–0610. Comments and petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 1, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–11003 Filed 5–6–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–E–1652] Determination of Regulatory Review Period for Purposes of Patent Extension; HVAD ROTARY BLOOD PUMP AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for HVAD ROTARY BLOOD PUMP 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. SUMMARY: Submit electronic comments to https:// 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 https://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. ADDRESSES: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) SUPPLEMENTARY INFORMATION: PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 26275 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 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 HVAD ROTARY BLOOD PUMP. HVAD ROTARY BLOOD PUMP is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory endstage left ventricular heart failure. Subsequent to this approval, the USPTO received a patent term restoration application for HVAD ROTARY BLOOD PUMP (U.S. Patent No. 6,234,772) from HeartWare, 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 HVAD ROTARY BLOOD PUMP 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 HVAD ROTARY BLOOD PUMP is 1,667 days. Of this time, 973 days occurred during the testing phase of the regulatory review period, while 694 days occurred during the approval phase. These periods of time were derived from the following dates: E:\FR\FM\07MYN1.SGM 07MYN1 mstockstill on DSK4VPTVN1PROD with NOTICES 26276 Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices 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: April 30, 2008. FDA has verified the applicant’s claim that the date the investigational device exemption required under section 520(g) of the FD&C act for human tests to begin became effective April 30, 2008. 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): December 28, 2010. The applicant claims December 23, 2010, as the date the premarket approval application (PMA) for HVAD ROTARY BLOOD PUMP (PMA P100047) was initially submitted. However, FDA records indicate that PMA P100047 was submitted on December 28, 2010. 3. The date the application was approved: November 20, 2012. FDA has verified the applicant’s claim that PMA P100047 was approved on November 20, 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 818 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 3, 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 https:// www.regulations.gov, Docket No. FDA– 2013–S–0610. Comments and petitions that have not been made publicly VerDate Sep<11>2014 18:07 May 06, 2015 Jkt 235001 available on https://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: May 1, 2015. Leslie Kux, Associate Commissioner for Policy. [Docket No. FDA–2014–E–0100] [FR Doc. 2015–11001 Filed 5–6–15; 8:45 am] BILLING CODE 4164–01–P Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; SIGNIFOR AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0878] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Notification for a New Dietary Ingredient AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ‘‘Premarket Notification for a New Dietary Ingredient’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: On February 27, 2015, the Agency submitted a proposed collection of information entitled, ‘‘Premarket Notification for a New Dietary Ingredient’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0330. The approval expires on March 31, 2018. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. SUPPLEMENTARY INFORMATION: Dated: May 4, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–10997 Filed 5–6–15; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for SIGNIFOR 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 https:// 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 https://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. SUMMARY: 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 SUPPLEMENTARY INFORMATION: E:\FR\FM\07MYN1.SGM 07MYN1

Agencies

[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26275-26276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11001]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-1652]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; HVAD ROTARY BLOOD PUMP

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for HVAD ROTARY BLOOD PUMP 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 https://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 https://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 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 HVAD ROTARY BLOOD 
PUMP. HVAD ROTARY BLOOD PUMP is indicated for use as a bridge to 
cardiac transplantation in patients who are at risk of death from 
refractory end-stage left ventricular heart failure. Subsequent to this 
approval, the USPTO received a patent term restoration application for 
HVAD ROTARY BLOOD PUMP (U.S. Patent No. 6,234,772) from HeartWare, 
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 HVAD 
ROTARY BLOOD PUMP 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 
HVAD ROTARY BLOOD PUMP is 1,667 days. Of this time, 973 days occurred 
during the testing phase of the regulatory review period, while 694 
days occurred during the approval phase. These periods of time were 
derived from the following dates:

[[Page 26276]]

    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: April 30, 2008. FDA has verified the 
applicant's claim that the date the investigational device exemption 
required under section 520(g) of the FD&C act for human tests to begin 
became effective April 30, 2008.
    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): 
December 28, 2010. The applicant claims December 23, 2010, as the date 
the premarket approval application (PMA) for HVAD ROTARY BLOOD PUMP 
(PMA P100047) was initially submitted. However, FDA records indicate 
that PMA P100047 was submitted on December 28, 2010.
    3. The date the application was approved: November 20, 2012. FDA 
has verified the applicant's claim that PMA P100047 was approved on 
November 20, 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 818 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 3, 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 
https://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and 
petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11001 Filed 5-6-15; 8:45 am]
 BILLING CODE 4164-01-P
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