82 FR 49029 - Determination of Regulatory Review Period for Purposes of Patent Extension; Inspire Upper Airway Stimulation System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 203 (October 23, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 203 (October 23, 2017)
| Page Range | 49029-49031 | |
| FR Document | 2017-22897 |
[Federal Register Volume 82, Number 203 (Monday, October 23, 2017)] [Notices] [Pages 49029-49031] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-22897] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-E-3529] Determination of Regulatory Review Period for Purposes of Patent Extension; Inspire Upper Airway Stimulation System AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Inspire Upper Airway Stimulation System (Inspire UAS 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. DATES: Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by December 22, 2017. 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 April 23, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 22, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 22, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: [[Page 49030]] Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2015-E-3529 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; INSPIRE UAS SYSTEM.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with Sec. 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600. SUPPLEMENTARY INFORMATION: I. Background 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 INSPIRE UAS SYSTEM. INSPIRE UAS SYSTEM is indicated for treatment of a subset of patients with moderate to severe obstructive sleep apnea (apnea- hypopnea index of greater than or equal to 20 and less than or equal to 65). Subsequent to this approval, the USPTO received a patent term restoration application for INSPIRE UAS SYSTEM (U.S. Patent No. 6,021,352) from Inspire Medical Systems, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 30, 2015, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of INSPIRE UAS 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. II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for INSPIRE UAS SYSTEM is 2,002 days. Of this time, 1,653 days occurred during the testing phase of the regulatory review period, while 349 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: November 7, 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 on November 7, 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): May 17, 2013. The applicant claims May 1, 2013, as the date the premarket approval application (PMA) for INSPIRE UAS SYSTEM (PMA P130008) was initially submitted. However, FDA records indicate that the PMA submitted May 1, 2013 was incomplete. The completed PMA was then submitted on May 17, 2013, which is considered to be the initially submitted date. 3. The date the application was approved: April 30, 2014. FDA has verified the applicant's claim that PMA P130008 was approved on April 30, 2014. 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 1,184 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in Sec. 60.30 (21 CFR 60.30), any interested person may [[Page 49031]] petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES), must be filed in accordance with Sec. 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (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. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: October 17, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-22897 Filed 10-20-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 203 / Monday, October 23, 2017 / Notices 49029
Patent No. 7,288,097 from Abbott III. Petitions patent which claims that medical
Vascular Inc., and U.S. Patent No. Anyone with knowledge that any of device.
7,464,712, from The Trustees of the dates as published are incorrect may DATES: Anyone with knowledge that any
Columbia University in the City of New submit either electronic or written of the dates as published (in the
York), and the USPTO requested FDA’s comments and, under 21 CFR 60.24, ask SUPPLEMENTARY INFORMATION section) are
assistance in determining the patents’ for a redetermination (see DATES). incorrect may submit either electronic
eligibility for patent term restoration. In Furthermore, as specified in § 60.30 (21 or written comments and ask for a
a letter dated November 2, 2015, FDA CFR 60.30), any interested person may redetermination by December 22, 2017.
advised the USPTO that this medical petition FDA for a determination Furthermore, any interested person may
device had undergone a regulatory regarding whether the applicant for petition FDA for a determination
review period and that the approval of extension acted with due diligence regarding whether the applicant for
MITRACLIP CDS represented the first during the regulatory review period. To extension acted with due diligence
permitted commercial marketing or use meet its burden, the petition must during the regulatory review period by
of the product. Thereafter, the USPTO comply with all the requirements of April 23, 2018. See ‘‘Petitions’’ in the
requested that FDA determine the § 60.30, including but not limited to: SUPPLEMENTARY INFORMATION section for
product’s regulatory review period. Must be timely (see DATES), must be more information.
II. Determination of Regulatory Review filed in accordance with § 10.20, must
ADDRESSES: You may submit comments
Period contain sufficient facts to merit an FDA
as follows. Please note that late,
investigation, and must certify that a
FDA has determined that the untimely filed comments will not be
true and complete copy of the petition
applicable regulatory review period for considered. Electronic comments must
has been served upon the patent
MITRACLIP CDS is 3,846 days. Of this be submitted on or before December 22,
applicant. (See H. Rept. 857, part 1, 98th
time, 2,515 days occurred during the 2017. The https://www.regulations.gov
Cong., 2d sess., pp. 41–42, 1984.)
testing phase of the regulatory review electronic filing system will accept
Petitions should be in the format
period, while 1,331 days occurred comments until midnight Eastern Time
specified in 21 CFR 10.30.
during the approval phase. These at the end of December 22, 2017.
Submit petitions electronically to
periods of time were derived from the Comments received by mail/hand
https://www.regulations.gov at Docket
following dates: delivery/courier (for written/paper
No. FDA–2013–S–0610. Submit written
submissions) will be considered timely
1. The date an exemption under petitions (two copies are required) to the
if they are postmarked or the delivery
section 520(g) of the Federal Food, Drug, Dockets Management Staff (HFA–305),
service acceptance receipt is on or
and Cosmetic Act (the FD&C Act) (21 Food and Drug Administration, 5630
before that date.
U.S.C. 360j(g)) involving this device Fishers Lane, Rm. 1061, Rockville, MD
became effective: April 16, 2003. FDA 20852. Electronic Submissions
has verified the applicants’ claims that Dated: October 17, 2017. Submit electronic comments in the
the date the investigational device Leslie Kux, following way:
exemption required under section
520(g) of the FD&C Act for human tests
Associate Commissioner for Policy. • Federal eRulemaking Portal:
to begin became effective was April 16, [FR Doc. 2017–22895 Filed 10–20–17; 8:45 am] https://www.regulations.gov. Follow the
2003. BILLING CODE 4164–01–P instructions for submitting comments.
Comments submitted electronically,
2. The date an application was including attachments, to https://
initially submitted with respect to the DEPARTMENT OF HEALTH AND www.regulations.gov will be posted to
device under section 515 of the FD&C HUMAN SERVICES the docket unchanged. Because your
Act (21 U.S.C. 360e): March 4, 2010. comment will be made public, you are
The applicants claim March 30, 2009, as Food and Drug Administration solely responsible for ensuring that your
the date the premarket approval comment does not include any
application (PMA) for MITRACLIP CDS [Docket No. FDA–2015–E–3529] confidential information that you or a
(PMA P100009) was initially submitted. third party may not wish to be posted,
However, FDA records indicate that the Determination of Regulatory Review such as medical information, your or
PMA submitted on March 30, 2009, was Period for Purposes of Patent anyone else’s Social Security number, or
incomplete. The complete PMA was Extension; Inspire Upper Airway confidential business information, such
submitted on March 4, 2010, which is Stimulation System as a manufacturing process. Please note
considered to be the PMA initially that if you include your name, contact
submitted date. AGENCY: Food and Drug Administration,
HHS. information, or other information that
3. The date the application was identifies you in the body of your
ACTION: Notice.
approved: October 24, 2013. FDA has comments, that information will be
verified the applicants’ claims that PMA SUMMARY: The Food and Drug posted on https://www.regulations.gov.
P100009 was approved on October 24, Administration (FDA or the Agency) has • If you want to submit a comment
2013. determined the regulatory review period with confidential information that you
This determination of the regulatory for Inspire Upper Airway Stimulation do not wish to be made available to the
review period establishes the maximum System (Inspire UAS System) and is public, submit the comment as a
ethrower on DSK3G9T082PROD with NOTICES
potential length of a patent extension. publishing this notice of that written/paper submission and in the
However, the USPTO applies several determination as required by law. FDA manner detailed (see ‘‘Written/Paper
statutory limitations in its calculations has made the determination because of Submissions’’ and ‘‘Instructions’’).
of the actual period for patent extension. the submission of an application to the
Written/Paper Submissions
In the applications for patent extension, Director of the U.S. Patent and
the applicants seek 1,827 days or 1,721 Trademark Office (USPTO), Department Submit written/paper submissions as
days of patent term extension. of Commerce, for the extension of a follows:
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![Federal Register / Vol. 82, No. 203 / Monday, October 23, 2017 / Notices 49031
petition FDA for a determination extension acted with due diligence Instructions: All submissions received
regarding whether the applicant for during the regulatory review period by must include the Docket Nos. FDA–
extension acted with due diligence April 23, 2018. See ‘‘Petitions’’ in the 2015–E–2660, FDA–2015–E–2662,
during the regulatory review period. To SUPPLEMENTARY INFORMATION section for FDA–2015–E–2722, and FDA–2015–E–
meet its burden, the petition must be more information. 2965 for ‘‘Determination of Regulatory
timely (see DATES), must be filed in ADDRESSES: You may submit comments Review Period for Purposes of Patent
accordance with § 10.20, must contain as follows. Please note that late, Extension; OBIZUR.’’ Received
sufficient facts to merit an FDA untimely filed comments will not be comments, those filed in a timely
investigation, and must certify that a considered. Electronic comments must manner (see ADDRESSES), will be placed
true and complete copy of the petition be submitted on or before December 22, in the docket and, except for those
has been served upon the patent 2017. The https://www.regulations.gov submitted as ‘‘Confidential
applicant. (See H. Rept. 857, part 1, 98th electronic filing system will accept Submissions,’’ publicly viewable at
Cong., 2d sess., pp. 41–42, 1984.) comments until midnight Eastern Time https://www.regulations.gov or at the
Petitions should be in the format at the end of December 22, 2017. Dockets Management Staff between 9
specified in 21 CFR 10.30. Comments received by mail/hand a.m. and 4 p.m., Monday through
Submit petitions electronically to delivery/courier (for written/paper Friday.
https://www.regulations.gov at Docket submissions) will be considered timely • Confidential Submissions—To
No. FDA–2013–S–0610. Submit written if they are postmarked or the delivery submit a comment with confidential
petitions (two copies are required) to the service acceptance receipt is on or information that you do not wish to be
Dockets Management Staff (HFA–305), before that date. made publicly available, submit your
Food and Drug Administration, 5630 comments only as a written/paper
Fishers Lane, Rm. 1061, Rockville, MD Electronic Submissions submission. You should submit two
20852. Submit electronic comments in the copies total. One copy will include the
Dated: October 17, 2017. following way: information you claim to be confidential
Leslie Kux, • Federal eRulemaking Portal: with a heading or cover note that states
https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
Associate Commissioner for Policy.
instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
[FR Doc. 2017–22897 Filed 10–20–17; 8:45 am]
Comments submitted electronically, Agency will review this copy, including
BILLING CODE 4164–01–P the claimed confidential information, in
including attachments, to https://
www.regulations.gov will be posted to its consideration of comments. The
the docket unchanged. Because your second copy, which will have the
DEPARTMENT OF HEALTH AND
comment will be made public, you are claimed confidential information
HUMAN SERVICES
solely responsible for ensuring that your redacted/blacked out, will be available
Food and Drug Administration comment does not include any for public viewing and posted on
confidential information that you or a https://www.regulations.gov. Submit
[Docket Nos. FDA–2015–E–2660, FDA– third party may not wish to be posted, both copies to the Dockets Management
2015–E–2662, FDA–2015–E–2722, and FDA– Staff. If you do not wish your name and
such as medical information, your or
2015–E–2965] contact information to be made publicly
anyone else’s Social Security number, or
confidential business information, such available, you can provide this
Determination of Regulatory Review
as a manufacturing process. Please note information on the cover sheet and not
Period for Purposes of Patent
that if you include your name, contact in the body of your comments and you
Extension; OBIZUR
information, or other information that must identify this information as
AGENCY: Food and Drug Administration, identifies you in the body of your ‘‘confidential.’’ Any information marked
HHS. comments, that information will be as ‘‘confidential’’ will not be disclosed
ACTION: Notice. posted on https://www.regulations.gov. except in accordance with § 10.20 (21
• If you want to submit a comment CFR 10.20) and other applicable
SUMMARY: The Food and Drug with confidential information that you disclosure law. For more information
Administration (FDA or the Agency) has do not wish to be made available to the about FDA’s posting of comments to
determined the regulatory review period public, submit the comment as a public dockets, see 80 FR 56469,
for OBIZUR and is publishing this written/paper submission and in the September 18, 2015, or access the
notice of that determination as required manner detailed (see ‘‘Written/Paper information at: https://www.gpo.gov/
by law. FDA has made the Submissions’’ and ‘‘Instructions’’). fdsys/pkg/FR-2015-09-18/pdf/2015-
determination because of the 23389.pdf.
submission of applications to the Written/Paper Submissions Docket: For access to the docket to
Director of the U.S. Patent and Submit written/paper submissions as read background documents or the
Trademark Office (USPTO), Department follows: electronic and written/paper comments
of Commerce, for the extension of a • Mail/Hand delivery/Courier (for received, go to https://
patent which claims that human written/paper submissions): Dockets www.regulations.gov and insert the
biological product. Management Staff (HFA–305), Food and docket number, found in brackets in the
DATES: Anyone with knowledge that any Drug Administration, 5630 Fishers heading of this document, into the
of the dates as published (in the Lane, Rm. 1061, Rockville, MD 20852. ‘‘Search’’ box and follow the prompts
ethrower on DSK3G9T082PROD with NOTICES
SUPPLEMENTARY INFORMATION section) are • For written/paper comments and/or go to the Dockets Management
incorrect may submit either electronic submitted to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061,
or written comments and ask for a Staff, FDA will post your comment, as Rockville, MD 20852.
redetermination by December 22, 2017. well as any attachments, except for FOR FURTHER INFORMATION CONTACT:
Furthermore, any interested person may information submitted, marked and Beverly Friedman, Office of Regulatory
petition FDA for a determination identified, as confidential, if submitted Policy, Food and Drug Administration,
regarding whether the applicant for as detailed in ‘‘Instructions.’’ 10903 New Hampshire Ave., Bldg. 51,
VerDate Sep<11>2014 20:08 Oct 20, 2017 Jkt 244001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\23OCN1.SGM 23OCN1](https://thefederalregister.org/doc/82_FR_49232/page/3.svg)
Document Created: 2017-10-21 02:35:42
Document Modified: 2017-10-21 02:35:42
| 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. | |
| Dates | Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by December 22, 2017. 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 April 23, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. | |
| Contact | Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600. | |
| FR Citation | 82 FR 49029 |
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