82 FR 56250 - Determination of Regulatory Review Period for Purposes of Patent Extension; Senza Spinal Cord Stimulation System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 227 (November 28, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 227 (November 28, 2017)
| Page Range | 56250-56252 | |
| FR Document | 2017-25684 |
[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)] [Notices] [Pages 56250-56252] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25684] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2016-E-1195 and FDA-2016-E-1534] Determination of Regulatory Review Period for Purposes of Patent Extension; Senza Spinal Cord 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 Senza Spinal Cord Stimulation System and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 January 29, 2018. 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 May 29, 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 January 29, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 29, 2018. 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: 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 Nos. FDA-2016-E-1195 and FDA-2016-E-1534 for Determination of Regulatory Review Period for Purposes of Patent Extension; SENZA SPINAL CORD STIMULATION 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. [[Page 56251]] 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 Senza Spinal Cord Stimulation System. Senza Spinal Cord Stimulation System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: Failed back surgery syndrome, intractable low back pain, and leg pain. Subsequent to this approval, the USPTO received patent term restoration applications for Senza Spinal Cord Stimulation System (U.S. Patent Nos. 8,712,533 and 8,768,472) from Nevro Corporation, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated July 12, 2016, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of SENZA Spinal Cord Stimulation 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 Senza Spinal Cord Stimulation System is 1,136 days. Of this time, 820 days occurred during the testing phase of the regulatory review period, while 316 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: March 30, 2012. FDA has verified the applicant's claim that the date the investigational device exemption (IDE) required under section 520(g) of the FD&C Act for human tests to begin became effective was March 30, 2012. 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): June 27, 2014. FDA has verified the applicant's claim that the premarket approval application (PMA) for SENZA SPINAL CORD STIMULATION SYSTEM (PMA P130022) was initially submitted June 27, 2014. 3. The date the application was approved: May 8, 2015. FDA has verified the applicant's claim that PMA P130022 was approved on May 8, 2015. 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 312 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 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 comply with all the requirements of Sec. 60.30, including but not limited to: 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. [[Page 56252]] Dated: November 22, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-25684 Filed 11-27-17; 8:45 am] BILLING CODE 4164-01-P
![56250 Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices
different types of premarket warning label does not constitute a delivery/courier (for written/paper
submissions for devices intended for ‘‘collection of information’’ under the submissions) will be considered timely
use in pediatric populations. PRA. Rather, the labeling statements are if they are postmarked or the delivery
‘‘public disclosure(s) of information service acceptance receipt is on or
II. Significance of Guidance
originally supplied by the Federal before that date.
This guidance is being issued government to the recipient for the
consistent with FDA’s good guidance Electronic Submissions
purpose of disclosure to the public.’’ (5
practices regulation (21 CFR 10.115). CFR 1320.3(c)(2).) Submit electronic comments in the
The guidance represents the current following way:
Dated: November 21, 2017.
thinking of FDA on pediatric • Federal eRulemaking Portal:
information for x-ray imaging device Leslie Kux,
https://www.regulations.gov. Follow the
510(k)s. It does not establish any rights Associate Commissioner for Policy.
instructions for submitting comments.
for any person and is not binding on [FR Doc. 2017–25632 Filed 11–27–17; 8:45 am]
Comments submitted electronically,
FDA or the public. You can use an BILLING CODE 4164–01–P
including attachments, to https://
alternative approach if it satisfies the www.regulations.gov will be posted to
requirements of the applicable statutes the docket unchanged. Because your
and regulations. This guidance is not DEPARTMENT OF HEALTH AND
comment will be made public, you are
subject to Executive Order 12866. HUMAN SERVICES
solely responsible for ensuring that your
III. Electronic Access Food and Drug Administration comment does not include any
Persons interested in obtaining a copy confidential information that you or a
[Docket Nos. FDA–2016–E–1195 and FDA– third party may not wish to be posted,
of the guidance may do so by 2016–E–1534]
downloading an electronic copy from such as medical information, your or
the internet. A search capability for all anyone else’s Social Security number, or
Determination of Regulatory Review
Center for Devices and Radiological confidential business information, such
Period for Purposes of Patent
Health guidance documents is available as a manufacturing process. Please note
Extension; Senza Spinal Cord
at http://www.fda.gov/MedicalDevices/ that if you include your name, contact
Stimulation System
DeviceRegulationandGuidance/ information, or other information that
GuidanceDocuments/default.htm. This AGENCY: Food and Drug Administration, identifies you in the body of your
guidance document is also available at HHS. comments, that information will be
https://www.regulations.gov. Persons ACTION: Notice. posted on https://www.regulations.gov.
unable to download an electronic copy • If you want to submit a comment
SUMMARY: The Food and Drug with confidential information that you
of ‘‘Pediatric Information for X-ray
Administration (FDA or the Agency) has do not wish to be made available to the
Imaging Device Premarket
determined the regulatory review period public, submit the comment as a
Notifications’’ may send an email
for Senza Spinal Cord Stimulation written/paper submission and in the
request to CDRH-Guidance@fda.hhs.gov
System and is publishing this notice of manner detailed (see ‘‘Written/Paper
to receive an electronic copy of the
that determination as required by law. Submissions’’ and ‘‘Instructions’’).
document. Please use the document
FDA has made the determination
number 1771 to identify the guidance Written/Paper Submissions
because of the submission of
you are requesting.
applications to the Director of the U.S. Submit written/paper submissions as
IV. Paperwork Reduction Act of 1995 Patent and Trademark Office (USPTO), follows:
This guidance refers to previously Department of Commerce, for the • Mail/Hand delivery/Courier (for
approved collections of information extension of a patent which claims that written/paper submissions): Dockets
found in FDA regulations and guidance medical device. Management Staff (HFA–305), Food and
documents. These collections of DATES: Anyone with knowledge that any Drug Administration, 5630 Fishers
information are subject to review by the of the dates as published (in the Lane, Rm. 1061, Rockville, MD 20852.
Office of Management and Budget SUPPLEMENTARY INFORMATION section) are • For written/paper comments
(OMB) under the Paperwork Reduction incorrect may submit either electronic submitted to the Dockets Management
Act of 1995 (PRA) (44 U.S.C. 3501– or written comments and ask for a Staff, FDA will post your comment, as
3520). The collections of information in redetermination by January 29, 2018. well as any attachments, except for
21 CFR part 807, subpart E have been Furthermore, any interested person may information submitted, marked and
approved under OMB control number petition FDA for a determination identified, as confidential, if submitted
0910–0120; the collections of regarding whether the applicant for as detailed in ‘‘Instructions.’’
information in 21 CFR part 801 have extension acted with due diligence Instructions: All submissions received
been approved under OMB control during the regulatory review period by must include the Docket Nos. FDA–
number 0910–0485; and the collections May 29, 2018. See ‘‘Petitions’’ in the 2016–E–1195 and FDA–2016–E–1534
of information in 21 CFR parts 1002, SUPPLEMENTARY INFORMATION section for for Determination of Regulatory Review
1010, 1020, 1030, 1040, and 1050 have more information. Period for Purposes of Patent Extension;
been approved under OMB control ADDRESSES: You may submit comments SENZA SPINAL CORD STIMULATION
number 0910–0025. The collections of as follows. Please note that late, SYSTEM. Received comments, those
information in the guidance document untimely filed comments will not be filed in a timely manner (see
ethrower on DSK3G9T082PROD with NOTICES
‘‘Requests for Feedback on Medical considered. Electronic comments must ADDRESSES), will be placed in the docket
Device Submissions: The Pre- be submitted on or before January 29, and, except for those submitted as
Submission Program and Meetings with 2018. The https://www.regulations.gov ‘‘Confidential Submissions,’’ publicly
Food and Drug Administration Staff’’ electronic filing system will accept viewable at https://www.regulations.gov
have been approved under OMB control comments until midnight Eastern Time or at the Dockets Management Staff
number 0910–0756. In addition, FDA at the end of January 29, 2018. between 9 a.m. and 4 p.m., Monday
concludes that the Indications for Use Comments received by mail/hand through Friday.
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![56252 Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices
Dated: November 22, 2017. instructions for submitting comments. its consideration of comments. The
Leslie Kux, Comments submitted electronically, second copy, which will have the
Associate Commissioner for Policy. including attachments, to https:// claimed confidential information
[FR Doc. 2017–25684 Filed 11–27–17; 8:45 am] www.regulations.gov will be posted to redacted/blacked out, will be available
BILLING CODE 4164–01–P the docket unchanged. Because your for public viewing and posted on
comment will be made public, you are https://www.regulations.gov. Submit
solely responsible for ensuring that your both copies to the Dockets Management
DEPARTMENT OF HEALTH AND comment does not include any Staff. If you do not wish your name and
HUMAN SERVICES confidential information that you or a contact information to be made publicly
third party may not wish to be posted, available, you can provide this
Food and Drug Administration such as medical information, your or information on the cover sheet and not
[Docket No. FDA–2016–E–1237] anyone else’s Social Security number, or in the body of your comments and you
confidential business information, such must identify this information as
Determination of Regulatory Review as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
Period for Purposes of Patent that if you include your name, contact as ‘‘confidential’’ will not be disclosed
Extension; SAVAYSA information, or other information that except in accordance with § 10.20 (21
identifies you in the body of your CFR 10.20) and other applicable
AGENCY: Food and Drug Administration, comments, that information will be disclosure law. For more information
HHS. posted on https://www.regulations.gov. about FDA’s posting of comments to
ACTION: Notice. • If you want to submit a comment public dockets, see 80 FR 56469,
with confidential information that you September 18, 2015, or access the
SUMMARY: The Food and Drug do not wish to be made available to the
Administration (FDA or the Agency) has information at: https://www.gpo.gov/
public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
determined the regulatory review period
written/paper submission and in the 23389.pdf.
for SAVAYSA and is publishing this
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
notice of that determination as required
Submissions’’ and ‘‘Instructions’’). read background documents or the
by law. FDA has made the
determination because of the Written/Paper Submissions electronic and written/paper comments
submission of an application to the received, go to https://
Submit written/paper submissions as
Director of the U.S. Patent and www.regulations.gov and insert the
follows:
Trademark Office (USPTO), Department docket number, found in brackets in the
• Mail/Hand delivery/Courier (for
of Commerce, for the extension of a heading of this document, into the
written/paper submissions): Dockets
patent which claims that human drug ‘‘Search’’ box and follow the prompts
Management Staff (HFA–305), Food and
product. and/or go to the Dockets Management
Drug Administration, 5630 Fishers
Staff, 5630 Fishers Lane, Rm. 1061,
DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments Rockville, MD 20852.
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT:
incorrect may submit either electronic Staff, FDA will post your comment, as Beverly Friedman, Office of Regulatory
or written comments and ask for a well as any attachments, except for Policy, Food and Drug Administration,
redetermination by January 29, 2018. information submitted, marked and 10903 New Hampshire Ave., Bldg. 51,
Furthermore, any interested person may identified, as confidential, if submitted Rm. 6250, Silver Spring, MD 20993,
petition FDA for a determination as detailed in ‘‘Instructions.’’ 301–796–3600.
regarding whether the applicant for Instructions: All submissions received SUPPLEMENTARY INFORMATION:
extension acted with due diligence must include the Docket No. FDA–
2016–E–1237 for ‘‘Determination of I. Background
during the regulatory review period by
May 29, 2018. See ‘‘Petitions’’ in the Regulatory Review Period for Purposes The Drug Price Competition and
SUPPLEMENTARY INFORMATION section for of Patent Extension; SAVAYSA.’’ Patent Term Restoration Act of 1984
more information. Received comments, those filed in a (Pub. L. 98–417) and the Generic
ADDRESSES: You may submit comments timely manner (see ADDRESSES), will be Animal Drug and Patent Term
as follows. Please note that late, placed in the docket and, except for Restoration Act (Pub. L. 100–670)
untimely filed comments will not be those submitted as ‘‘Confidential generally provide that a patent may be
considered. Electronic comments must Submissions,’’ publicly viewable at extended for a period of up to 5 years
be submitted on or before January 29, https://www.regulations.gov or at the so long as the patented item (human
2018. The https://www.regulations.gov Dockets Management Staff between 9 drug product, animal drug product,
electronic filing system will accept a.m. and 4 p.m., Monday through medical device, food additive, or color
comments until midnight Eastern Time Friday. additive) was subject to regulatory
at the end of January 29, 2018. • Confidential Submissions—To review by FDA before the item was
Comments received by mail/hand submit a comment with confidential marketed. Under these acts, a product’s
delivery/courier (for written/paper information that you do not wish to be regulatory review period forms the basis
submissions) will be considered timely made publicly available, submit your for determining the amount of extension
if they are postmarked or the delivery comments only as a written/paper an applicant may receive.
service acceptance receipt is on or submission. You should submit two A regulatory review period consists of
ethrower on DSK3G9T082PROD with NOTICES
before that date. copies total. One copy will include the two periods of time: A testing phase and
information you claim to be confidential an approval phase. For human drug
Electronic Submissions with a heading or cover note that states products, the testing phase begins when
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS the exemption to permit the clinical
following way: CONFIDENTIAL INFORMATION.’’ The investigations of the drug becomes
• Federal eRulemaking Portal: Agency will review this copy, including effective and runs until the approval
https://www.regulations.gov. Follow the the claimed confidential information, in phase begins. The approval phase starts
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Document Created: 2017-11-28 01:50:45
Document Modified: 2017-11-28 01:50:45
| 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 January 29, 2018. 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 May 29, 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 56250 |
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