83 FR 5778 - Determination of Regulatory Review Period for Purposes of Patent Extension; KAMRA INLAY
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 28 (February 9, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 28 (February 9, 2018)
| Page Range | 5778-5780 | |
| FR Document | 2018-02582 |
[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)] [Notices] [Pages 5778-5780] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02582] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-1271] Determination of Regulatory Review Period for Purposes of Patent Extension; KAMRA 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 KAMRA 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 (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 10, 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 August 8, 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 April 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 10, 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-2016-E-1271 for ``Determination of Regulatory Review Period for Purposes [[Page 5779]] of Patent Extension; KAMRA 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 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 KAMRA INLAY. KAMRA INLAY is indicated for intrastromal corneal implantation to improve near vision by extending the depth of focus in the non-dominant eye of phakic, presbyopic patients between the ages of 45 and 60 years old who have cycloplegic refractive spherical equivalent of +0.50 diopters (D) to-0.75 D with less than or equal to 0.75 D of refractive cylinder, who do not require glasses or contact lenses for clear distance vision, and who require near correction of +1.00 D to +2.50 D of reading add. Subsequent to this approval, the USPTO received a patent term restoration application for KAMRA INLAY (U.S. Patent No. 8,460,374) from AcuFocus, Inc., and the USPTO requested FDA's assistance in determining this patent's 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 KAMRA 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 KAMRA INLAY is 2,347 days. Of this time, 1,541 days occurred during the testing phase of the regulatory review period, while 806 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 14, 2008. 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 November 14, 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): February 1, 2013. The applicant claims December 7, 2012, as the date the premarket approval application (PMA) for KAMRA INLAY (PMA P120023) was initially submitted. However, FDA records indicate that PMA P120023 was submitted on February 1, 2013. 3. The date the application was approved: April 17, 2015. FDA has verified the applicant's claim that PMA P120023 was approved on April 17, 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 application for patent extension, this applicant seeks 676 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 [[Page 5780]] 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: February 5, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-02582 Filed 2-8-18; 8:45 am] BILLING CODE 4164-01-P
![5778 Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices
for patent term restoration. In a letter meet its burden, the petition must SUPPLEMENTARY INFORMATION section for
dated August 31, 2016, FDA advised the comply with all the requirements of more information.
USPTO that this human biological § 60.30, including but not limited to: ADDRESSES: You may submit comments
product had undergone a regulatory Must be timely (see DATES), must be as follows. Please note that late,
review period and that the approval of filed in accordance with § 10.20, must untimely filed comments will not be
STRENSIQ represented the first contain sufficient facts to merit an FDA considered. Electronic comments must
permitted commercial marketing or use investigation, and must certify that a be submitted on or before April 10,
of the product. Thereafter, the USPTO true and complete copy of the petition 2018. The https://www.regulations.gov
requested that FDA determine the has been served upon the patent electronic filing system will accept
product’s regulatory review period. applicant. (See H. Rept. 857, part 1, 98th comments until midnight Eastern Time
II. Determination of Regulatory Review Cong., 2d sess., pp. 41–42, 1984.) at the end of April 10, 2018. Comments
Period Petitions should be in the format received by mail/hand delivery/courier
specified in 21 CFR 10.30. (for written/paper submissions) will be
FDA has determined that the Submit petitions electronically to considered timely if they are
applicable regulatory review period for https://www.regulations.gov at Docket postmarked or the delivery service
STRENSIQ is 2,670 days. Of this time, No. FDA–2013–S–0610. Submit written acceptance receipt is on or before that
2,365 days occurred during the testing petitions (two copies are required) to the date.
phase of the regulatory review period, Dockets Management Staff (HFA–305),
while 305 days occurred during the Electronic Submissions
Food and Drug Administration, 5630
approval phase. These periods of time Fishers Lane, Rm. 1061, Rockville, MD Submit electronic comments in the
were derived from the following dates: 20852. following way:
1. The date an exemption under • Federal eRulemaking Portal:
section 505(i) of the Federal Food, Drug, Dated: February 5, 2018.
https://www.regulations.gov. Follow the
and Cosmetic Act (21 U.S.C. 355(i)) Leslie Kux, instructions for submitting comments.
became effective: July 3, 2008. The Associate Commissioner for Policy. Comments submitted electronically,
applicant claims July 4, 2008, as the [FR Doc. 2018–02588 Filed 2–8–18; 8:45 am] including attachments, to https://
date the investigational new drug BILLING CODE 4164–01–P www.regulations.gov will be posted to
application (IND) became effective. the docket unchanged. Because your
However, FDA records indicate that the comment will be made public, you are
IND effective date was July 3, 2008, DEPARTMENT OF HEALTH AND solely responsible for ensuring that your
which was 30 days after FDA receipt of HUMAN SERVICES comment does not include any
the IND. confidential information that you or a
2. The date the application was Food and Drug Administration third party may not wish to be posted,
initially submitted with respect to the such as medical information, your or
human biological product under section [Docket No. FDA–2016–E–1271] anyone else’s Social Security number, or
351 of the Public Health Service Act (42 confidential business information, such
U.S.C. 262): December 23, 2014. FDA Determination of Regulatory Review as a manufacturing process. Please note
has verified the applicant’s claim that Period for Purposes of Patent that if you include your name, contact
the biologics license application (BLA) Extension; KAMRA INLAY information, or other information that
for STRENSIQ (BLA 125513) was AGENCY: Food and Drug Administration, identifies you in the body of your
initially submitted on December 23, HHS. comments, that information will be
2014. posted on https://www.regulations.gov.
ACTION: Notice.
3. The date the application was • If you want to submit a comment
approved: October 23, 2015. FDA has SUMMARY: The Food and Drug with confidential information that you
verified the applicant’s claim that BLA Administration (FDA or the Agency) has do not wish to be made available to the
125513 was approved on October 23, determined the regulatory review period public, submit the comment as a
2015. for KAMRA INLAY and is publishing written/paper submission and in the
This determination of the regulatory this notice of that determination as manner detailed (see ‘‘Written/Paper
review period establishes the maximum required by law. FDA has made the Submissions’’ and ‘‘Instructions’’).
potential length of a patent extension. determination because of the
However, the USPTO applies several Written/Paper Submissions
submission of an application to the
statutory limitations in its calculations Director of the U.S. Patent and Submit written/paper submissions as
of the actual period for patent extension. Trademark Office (USPTO), Department follows:
In its application for patent extension, of Commerce, for the extension of a • Mail/Hand delivery/Courier (for
this applicant seeks 1,109 days of patent patent which claims that medical written/paper submissions): Dockets
term extension. device. Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
III. Petitions DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852.
Anyone with knowledge that any of of the dates as published (in the • For written/paper comments
the dates as published are incorrect may SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management
submit either electronic or written incorrect may submit either electronic Staff, FDA will post your comment, as
comments and, under 21 CFR 60.24, ask or written comments and ask for a
sradovich on DSK3GMQ082PROD with NOTICES
well as any attachments, except for
for a redetermination (see DATES). redetermination by April 10, 2018. information submitted, marked and
Furthermore, as specified in § 60.30 (21 Furthermore, any interested person may identified, as confidential, if submitted
CFR 60.30), any interested person may petition FDA for a determination as detailed in ‘‘Instructions.’’
petition FDA for a determination regarding whether the applicant for Instructions: All submissions received
regarding whether the applicant for extension acted with due diligence must include the Docket No. FDA–
extension acted with due diligence during the regulatory review period by 2016–E–1271 for ‘‘Determination of
during the regulatory review period. To August 8, 2018. See ‘‘Petitions’’ in the Regulatory Review Period for Purposes
VerDate Sep<11>2014 16:57 Feb 08, 2018 Jkt 244001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\09FEN1.SGM 09FEN1](https://thefederalregister.org/doc/83_FR_5806/page/1.svg)
![5780 Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices
contain sufficient facts to merit an FDA be submitted on or before April 10, https://www.regulations.gov or at the
investigation, and must certify that a 2018. The https://www.regulations.gov Dockets Management Staff between 9
true and complete copy of the petition electronic filing system will accept a.m. and 4 p.m., Monday through
has been served upon the patent comments until midnight Eastern Time Friday.
applicant. (See H. Rept. 857, part 1, 98th at the end of April 10, 2018. Comments • Confidential Submissions—To
Cong., 2d sess., pp. 41–42, 1984.) received by mail/hand delivery/courier submit a comment with confidential
Petitions should be in the format (for written/paper submissions) will be information that you do not wish to be
specified in 21 CFR 10.30. considered timely if they are made publicly available, submit your
Submit petitions electronically to postmarked or the delivery service comments only as a written/paper
https://www.regulations.gov at Docket acceptance receipt is on or before that submission. You should submit two
No. FDA–2013–S–0610. Submit written date. copies total. One copy will include the
petitions (two copies are required) to the information you claim to be confidential
Dockets Management Staff (HFA–305), Electronic Submissions
with a heading or cover note that states
Food and Drug Administration, 5630 Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Fishers Lane, Rm. 1061, Rockville, MD following way: CONFIDENTIAL INFORMATION.’’ The
20852. • Federal eRulemaking Portal: Agency will review this copy, including
https://www.regulations.gov. Follow the the claimed confidential information, in
Dated: February 5, 2018.
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. 2018–02582 Filed 2–8–18; 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–1289] 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; ODOMZO information, or other information that except in accordance with § 10.20 (21
AGENCY: Food and Drug Administration, identifies you in the body of your CFR 10.20) and other applicable
HHS. comments, that information will be disclosure law. For more information
ACTION: Notice. posted on https://www.regulations.gov. about FDA’s posting of comments to
• If you want to submit a comment public dockets, see 80 FR 56469,
SUMMARY: The Food and Drug with confidential information that you September 18, 2015, or access the
Administration (FDA or the Agency) has do not wish to be made available to the information at: https://www.gpo.gov/
determined the regulatory review period public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
for ODOMZO and is publishing this written/paper submission and in the 23389.pdf.
notice of that determination as required manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
by law. FDA has made the Submissions’’ and ‘‘Instructions’’). read background documents or the
determination because of the Written/Paper Submissions electronic and written/paper comments
submission of an application to the received, go to https://
Director of the U.S. Patent and Submit written/paper submissions as
www.regulations.gov and insert the
Trademark Office (USPTO), Department follows:
• Mail/Hand delivery/Courier (for docket number, found in brackets in the
of Commerce, for the extension of a heading of this document, into the
patent which claims that human drug written/paper submissions): Dockets
Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts
product. and/or go to the Dockets Management
Drug Administration, 5630 Fishers
DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061,
of the dates as published (in the • For written/paper comments Rockville, MD 20852.
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 April 10, 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–
during the regulatory review period by 2016–E–1289 for ‘‘Determination of I. Background
sradovich on DSK3GMQ082PROD with NOTICES
August 8, 2018. See ‘‘Petitions’’ in the Regulatory Review Period for Purposes The Drug Price Competition and
SUPPLEMENTARY INFORMATION section for of Patent Extension; ODOMZO.’’ 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
VerDate Sep<11>2014 16:57 Feb 08, 2018 Jkt 244001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\09FEN1.SGM 09FEN1](https://thefederalregister.org/doc/83_FR_5806/page/3.svg)
Document Created: 2018-02-09 00:11:56
Document Modified: 2018-02-09 00:11:56
| 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 April 10, 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 August 8, 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 | 83 FR 5778 |
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