83 FR 54360 - Determination of Regulatory Review Period for Purposes of Patent Extension; RAINDROP NEAR VISION INLAY
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 209 (October 29, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 209 (October 29, 2018)
| Page Range | 54360-54362 | |
| FR Document | 2018-23527 |
[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)] [Notices] [Pages 54360-54362] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23527] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-E-4181] Determination of Regulatory Review Period for Purposes of Patent Extension; RAINDROP NEAR VISION INLAY 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 RAINDROP NEAR VISION INLAY 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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by December 28, 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 April 29, 2019. 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 28, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 28, 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 No. FDA-2017-E-4181 for ``Determination of [[Page 54361]] Regulatory Review Period for Purposes of Patent Extension; RAINDROP NEAR VISION INLAY.'' 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 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 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 RAINDROP NEAR VISION INLAY. RAINDROP NEAR VISION INLAY is indicated for intrastromal implantation to improve near vision in the non-dominant eye of phakic, presbyopic patients, 41 to 65 years of age, who have manifest refractive spherical equivalent of +1.00 diopters (D) to -0.50 D with less than or equal to 0.75 D of refractive cylinder, who do not require correction for clear distance vision, but who do require near correction of +1.50 D to +2.50 D of reading add. Subsequent to this approval, the USPTO received a patent term restoration application for RAINDROP NEAR VISION INLAY (U.S. Patent No. 8,057,541) from ReVision Optics, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated September 20, 2017, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of RAINDROP NEAR VISION INLAY 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 RAINDROP NEAR VISION INLAY is 2,354 days. Of this time, 2,074 days occurred during the testing phase of the regulatory review period, while 280 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 (FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: January 20, 2010. 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 was January 20, 2010. 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): September 24, 2015. The applicant claims March 25, 2014, as the date the premarket approval application (PMA) for RAINDROP NEAR VISION INLAY (PMA P150034) was initially submitted. However, FDA records indicate that PMA P150034 was completely submitted on September 24, 2015. 3. The date the application was approved: June 29, 2016. FDA has verified the applicant's claim that PMA P150034 was approved on June 29, 2016. 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 828 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 [[Page 54362]] 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 23, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-23527 Filed 10-26-18; 8:45 am] BILLING CODE P
![54360 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices
evaluate the potential benefits and risks Agency is not responsible for providing April 29, 2019. See ‘‘Petitions’’ in the
while considering issues such as access to electrical outlets. SUPPLEMENTARY INFORMATION section for
medication compliance, patient FDA welcomes the attendance of the more information.
perspective, and appropriate study public at its advisory committee ADDRESSES: You may submit comments
controls. meetings and will make every effort to as follows. Please note that late,
FDA intends to make background accommodate persons with disabilities. untimely filed comments will not be
material available to the public no later If you require accommodations due to a considered. Electronic comments must
than 2 business days before the meeting. disability, please contact Artair Mallett be submitted on or before December 28,
If FDA is unable to post the background at artair.mallett@fda.hhs.gov or 301– 2018. The https://www.regulations.gov
material on its website prior to the 796–9638 at least 7 days in advance of electronic filing system will accept
meeting, the background material will the meeting. comments until 11:59 p.m. Eastern Time
be made publicly available at the FDA is committed to the orderly at the end of December 28, 2018.
location of the advisory committee conduct of its advisory committee Comments received by mail/hand
meeting, and the background material meetings. Please visit our website at delivery/courier (for written/paper
will be posted on FDA’s website after https://www.fda.gov/ submissions) will be considered timely
the meeting. Background material is AdvisoryCommittees/AboutAdvis if they are postmarked or the delivery
available at https://www.fda.gov/ oryCommittees/ucm111462.htm for service acceptance receipt is on or
AdvisoryCommittees/Calendar/ procedures on public conduct during before that date.
default.htm. Scroll down to the advisory committee meetings.
Notice of this meeting is given under Electronic Submissions
appropriate advisory committee meeting
link. the Federal Advisory Committee Act (5 Submit electronic comments in the
Procedure: FDA will work with U.S.C. app. 2). following way:
affected industry, professional Dated: October 24, 2018.
• Federal eRulemaking Portal:
organizations, and societies with an https://www.regulations.gov. Follow the
Leslie Kux,
interest in medical devices designed to instructions for submitting comments.
Associate Commissioner for Policy. Comments submitted electronically,
treat hypertension, as well as members [FR Doc. 2018–23577 Filed 10–26–18; 8:45 am]
of those groups who wish to make a including attachments, to https://
presentation separate from the general
BILLING CODE 4164–01–P www.regulations.gov will be posted to
open public hearing; time slots are the docket unchanged. Because your
available on December 5, 2018. comment will be made public, you are
DEPARTMENT OF HEALTH AND solely responsible for ensuring that your
Representatives from industry, HUMAN SERVICES
professional organizations and societies comment does not include any
interested in making formal confidential information that you or a
Food and Drug Administration
presentations to the committee should third party may not wish to be posted,
notify the contact person on or before
[Docket No. FDA–2017–E–4181] such as medical information, your or
November 13, 2018. anyone else’s Social Security number, or
Determination of Regulatory Review confidential business information, such
Interested persons may present data, Period for Purposes of Patent
information, or views, orally or in as a manufacturing process. Please note
Extension; RAINDROP NEAR VISION that if you include your name, contact
writing, on issues pending before the INLAY
committee. Written submissions may be information, or other information that
made to the contact person on or before AGENCY: Food and Drug Administration, identifies you in the body of your
November 21, 2018. Oral presentations HHS. comments, that information will be
from the public will be scheduled on ACTION: Notice. posted on https://www.regulations.gov.
• If you want to submit a comment
December 4 and 5, between
SUMMARY: The Food and Drug with confidential information that you
approximately 1 p.m. and 2 p.m. Those
Administration (FDA or the Agency) has do not wish to be made available to the
individuals interested in making formal
determined the regulatory review period public, submit the comment as a
oral presentations should notify the
for RAINDROP NEAR VISION INLAY written/paper submission and in the
contact person and submit a brief
and is publishing this notice of that manner detailed (see ‘‘Written/Paper
statement of the general nature of the
determination as required by law. FDA Submissions’’ and ‘‘Instructions’’).
evidence or arguments they wish to
present, the names and addresses of has made the determination because of Written/Paper Submissions
proposed participants, and an the submission of an application to the
Director of the U.S. Patent and Submit written/paper submissions as
indication of the approximate time follows:
Trademark Office (USPTO), Department
requested to make their presentation on • Mail/Hand delivery/Courier (for
or before November 13, 2018. Time of Commerce, for the extension of a
written/paper submissions): Dockets
allotted for each presentation may be patent which claims that medical
Management Staff (HFA–305), Food and
limited. If the number of registrants device.
Drug Administration, 5630 Fishers
requesting to speak is greater than can DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852.
be reasonably accommodated during the of the dates as published (see the • For written/paper comments
scheduled open public hearing session, SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management
FDA may conduct a lottery to determine incorrect may submit either electronic Staff, FDA will post your comment, as
amozie on DSK3GDR082PROD with NOTICES1
the speakers for the scheduled open or written comments and ask for a well as any attachments, except for
public hearing session. The contact redetermination by December 28, 2018. information submitted, marked and
person will notify interested persons Furthermore, any interested person may identified, as confidential, if submitted
regarding their request to speak by petition FDA for a determination as detailed in ‘‘Instructions.’’
November 14, 2018. regarding whether the applicant for Instructions: All submissions received
Persons attending FDA’s advisory extension acted with due diligence must include the Docket No. FDA–
committee meetings are advised that the during the regulatory review period by 2017–E–4181 for ‘‘Determination of
VerDate Sep<11>2014 17:48 Oct 26, 2018 Jkt 247001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\29OCN1.SGM 29OCN1](https://thefederalregister.org/doc/83_FR_54569/page/1.svg)
![54362 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices
filed in accordance with § 10.20, must DATES: Electronic or written comments • Confidential Submissions—To
contain sufficient facts to merit an FDA on the application may be submitted submit a comment with confidential
investigation, and must certify that a beginning October 29, 2018. FDA will information that you do not wish to be
true and complete copy of the petition establish a closing date for the comment made publicly available, submit your
has been served upon the patent period as described in section I. comments only as a written/paper
applicant. (See H. Rept. 857, part 1, 98th ADDRESSES: You may submit comments submission. You should submit two
Cong., 2d sess., pp. 41–42, 1984.) as follows: copies total. One copy will include the
Petitions should be in the format information you claim to be confidential
specified in 21 CFR 10.30. Electronic Submissions with a heading or cover note that states
Submit petitions electronically to Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
https://www.regulations.gov at Docket following way: CONFIDENTIAL INFORMATION.’’ The
No. FDA–2013–S–0610. Submit written • Federal eRulemaking Portal: Agency will review this copy, including
petitions (two copies are required) to the https://www.regulations.gov. Follow the the claimed confidential information, in
Dockets Management Staff (HFA–305), instructions for submitting comments. its consideration of comments. The
Food and Drug Administration, 5630 Comments submitted electronically, second copy, which will have the
Fishers Lane, Rm. 1061, Rockville, MD including attachments, to https:// claimed confidential information
20852. www.regulations.gov will be posted to redacted/blacked out, will be available
Dated: October 23, 2018. the docket unchanged. Because your for public viewing and posted on
comment will be made public, you are https://www.regulations.gov. Submit
Leslie Kux,
solely responsible for ensuring that your both copies to the Dockets Management
Associate Commissioner for Policy.
comment does not include any Staff. If you do not wish your name and
[FR Doc. 2018–23527 Filed 10–26–18; 8:45 am] contact information to be made publicly
confidential information that you or a
BILLING CODE P
third party may not wish to be posted, available, you can provide this
such as medical information, your or information on the cover sheet and not
anyone else’s Social Security number, or in the body of your comments and you
DEPARTMENT OF HEALTH AND must identify this information as
HUMAN SERVICES confidential business information, such
as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
Food and Drug Administration that if you include your name, contact as ‘‘confidential’’ will not be disclosed
information, or other information that except in accordance with 21 CFR 10.20
identifies you in the body of your and other applicable disclosure law. For
[Docket No. FDA–2014–N–1051] more information about FDA’s posting
comments, that information will be
posted on https://www.regulations.gov. of comments to public dockets, see 80
Modified Risk Tobacco Product
Applications for Snus Products • If you want to submit a comment FR 56469, September 18, 2015, or access
with confidential information that you the information at: https://www.gpo.gov/
Submitted by Swedish Match North
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
America Inc.; Reopening of the
public, submit the comment as a 23389.pdf.
Comment Period
written/paper submission and in the Docket: For access to the docket to
AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper read the electronic and written/paper
HHS. Submissions’’ and ‘‘Instructions’’). comments received, go to https://
Notice; reopening of the
ACTION:
www.regulations.gov and insert the
Written/Paper Submissions docket number, found in brackets in the
comment period.
Submit written/paper submissions as heading of this document, into the
SUMMARY: The Food and Drug follows: ‘‘Search’’ box and follow the prompts
Administration (FDA or the Agency) is • Mail/Hand delivery/Courier (for and/or go to the Dockets Management
reopening the period for public written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
comment on modified risk tobacco Management Staff (HFA–305), Food and Rockville, MD 20852.
product applications (MRTPAs) for Drug Administration, 5630 Fishers FOR FURTHER INFORMATION CONTACT: Paul
specific General Snus products Lane, Rm. 1061, Rockville, MD 20852. Hart, Center for Tobacco Products, Food
submitted by Swedish Match North • For written/paper comments and Drug Administration, 10903 New
America Inc. and announcing the submitted to the Dockets Management Hampshire Ave., Bldg. 71, Rm. G335,
availability for public comment of a Staff, FDA will post your comment, as Silver Spring, MD 20993–0002, 1–877–
recently received amendment to the well as any attachments, except for 287–1373, email: AskCTP@fda.hhs.gov.
MRTPAs. The original notice of information submitted, marked and SUPPLEMENTARY INFORMATION:
availability for the applications identified, as confidential, if submitted
appeared in the Federal Register of as detailed in ‘‘Instructions.’’ I. Background
August 27, 2014. In that notice, FDA Instructions: All submissions received In the Federal Register of August 27,
requested comments on the originally must include the Docket No. FDA– 2014 (79 FR 51183), FDA published a
filed MRTPAs that are posted on https:// 2014–N–1051 for ‘‘Modified Risk notice of availability for MRTPAs
www.regulations.gov and FDA’s Tobacco Product Applications for Snus submitted by Swedish Match North
website. In the Federal Register of July Products Submitted by Swedish Match America Inc. and gave the public 180
31, 2015, FDA issued a notice to reopen North America Inc.’’ Received days to comment on the applications.
amozie on DSK3GDR082PROD with NOTICES1
and extended the comment period for comments will be placed in the docket FDA subsequently published a notice in
comments on amendments to the and, except for those submitted as the Federal Register of July 31, 2015 (80
MRTPAs. That comment period closed ‘‘Confidential Submissions,’’ publicly FR 45661), to reopen and extend the
on August 31, 2015. FDA is now viewable at https://www.regulations.gov comment period to allow for comment
reopening the comment period to seek or at the Dockets Management Staff on amendments to the applications. The
comment specifically on a recent between 9 a.m. and 4 p.m., Monday comment period closed on August 31,
amendment to the MRTPAs. through Friday. 2015. On December 14, 2016, FDA
VerDate Sep<11>2014 17:48 Oct 26, 2018 Jkt 247001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\29OCN1.SGM 29OCN1](https://thefederalregister.org/doc/83_FR_54569/page/3.svg)
Document Created: 2018-10-27 01:08:57
Document Modified: 2018-10-27 01:08:57
| 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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by December 28, 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 April 29, 2019. 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 | 83 FR 54360 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR