Determination of Regulatory Review Period for Purposes of Patent Extension; CYTALUX, 89458-89460 [2023-28507]

Download as PDF 89458 Federal Register / Vol. 88, No. 247 / Wednesday, December 27, 2023 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 • Ph+ CML in CP with the T315I mutation. Subsequent to this approval, the USPTO received a patent term restoration application for SCEMBLIX (U.S. Patent No. 8,829,195) from Novartis AG, and the USPTO requested FDA’s assistance in determining the patent’s eligibility for patent term restoration. In a letter dated January 10, 2023, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of SCEMBLIX 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 SCEMBLIX is 2,845 days. Of this time, 2,717 days occurred during the testing phase of the regulatory review period, while 128 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: January 16, 2014. The applicant claims December 17, 2013, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was January 16, 2014, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: June 24, 2021. FDA has verified the applicant’s claim that the new drug application (NDA) for SCEMBLIX (NDA 215358) was initially submitted on June 24, 2021. 3. The date the application was approved: October 29, 2021. FDA has verified the applicant’s claim that NDA 215358 was approved on October 29, 2021. 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 899 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). VerDate Sep<11>2014 19:00 Dec 26, 2023 Jkt 262001 Furthermore, as specified in § 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 § 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with § 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: December 21, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–28519 Filed 12–26–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–E–0926] Determination of Regulatory Review Period for Purposes of Patent Extension; CYTALUX AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CYTALUX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. DATES: Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic or written comments and ask for a redetermination by February 26, 2024. Furthermore, any interested person may SUMMARY: PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by June 24, 2024. 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. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of February 26, 2024. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received 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– E:\FR\FM\27DEN1.SGM 27DEN1 ddrumheller on DSK120RN23PROD with NOTICES1 Federal Register / Vol. 88, No. 247 / Wednesday, December 27, 2023 / Notices 2022–E–0926 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; CYTALUX.’’ 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, 240–402–7500. • 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 § 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500. 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: VerDate Sep<11>2014 19:00 Dec 26, 2023 Jkt 262001 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 or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, 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 human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved for marketing the human drug product, CYTALUX (pafolacianine), which is indicated in adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions. Subsequent to this approval, the USPTO received a patent term restoration application for CYTALUX (U.S. Patent No. 9,061,057) from Purdue Research Foundation, and the USPTO requested FDA’s assistance in determining the patent’s eligibility for patent term restoration. In a letter dated September 21, 2022, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of CYTALUX represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. PO 00000 Frm 00098 Fmt 4703 Sfmt 4703 89459 II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for CYTALUX is 2,610 days. Of this time, 2,274 days occurred during the testing phase of the regulatory review period, while 336 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: October 9, 2014. The applicant claims September 5, 2014, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was October 9, 2014, which was the first date after receipt of the IND that the investigational studies were allowed to proceed. 2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: December 29, 2020. FDA has verified the applicant’s claim that the new drug application (NDA) for CYTALUX (NDA 214907) was initially submitted on December 29, 2020. 3. The date the application was approved: November 29, 2021. FDA has verified the applicant’s claim that NDA 214907 was approved on November 29, 2021. 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 825 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 § 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 § 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with § 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 E:\FR\FM\27DEN1.SGM 27DEN1 89460 Federal Register / Vol. 88, No. 247 / Wednesday, December 27, 2023 / Notices 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: December 21, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–28507 Filed 12–26–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–F–5500] Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use); Chromium Propionate; Correction AGENCY: Food and Drug Administration, HHS Notification of petition; correction. ACTION: The Food and Drug Administration is correcting a notice entitled ‘‘Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use)’’ that appeared in the Federal Register of July 27, 2023. The document announced that we filed a petition, submitted by Kemin Industries, Inc., proposing that the food additive regulations be amended to provide for the safe use of chromium propionate to be used as a source of chromium in turkey feed. The document was published with an incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Wasima Wahid, Center for Veterinary Medicine (HFV–221), Food and Drug Administration, 12225 Wilkins Ave., Rockville, MD 20852, 240–402–5857, wasima.wahid@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of Thursday, July 27, 2023 (88 FR 48406) in FR Doc. 2023– 15913, the following correction is made: On page 48406, in the first column, in the header of the document, ‘‘Docket No. FDA–2023–F–2415’’ is corrected to read ‘‘Docket No. FDA–2023–F–5500’’. ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: Dated: December 21, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–28512 Filed 12–26–23; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 19:00 Dec 26, 2023 Jkt 262001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Nursing Research; Notice of Closed Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Nursing Research Special Emphasis Panel; NRRC Member Conflict Meeting. Date: February 2, 2024. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Nursing Research, 6701 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Nisan Bhattacharyya, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute of Nursing Research, NIH, 6701 Democracy Boulevard, Suite 668, Bethesda, MD 20892, 301–451– 2405, nisan.bhattacharyya@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.361, Nursing Research, National Institutes of Health, HHS) Dated: December 21, 2023. Victoria E. Townsend, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–28566 Filed 12–26–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose PO 00000 Frm 00099 Fmt 4703 Sfmt 4703 confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; Initiation of NIDCD Hearing and Balance Translational Application. Date: January 22, 2024. Time: 1:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting). Contact Person: Shiguang Yang, DVM, Ph.D., Scientific Review Officer, Division of Extramural Activities, NIDCD, NIH, 6001 Executive Blvd., Room 8349 Bethesda, MD 20892, 301–496–8683, yangshi@ nidcd.nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; Review of NIDCD Research Grant Applications for Translating Basic Research in Voice, Speech, and Language into Clinical Tools. Date: January 29, 2024. Time: 2:30 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting). Contact Person: Sonia Elena Nanescu, Ph.D., Scientific Review Officer, Division of Extramural Activities, NIDCD, NIH, 6001 Executive Blvd., Suite 8300, Bethesda, MD 20892, (301) 496–8683, sonia.nanescu@ nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; NIDCD Clinical Research Center Grant (P50) Review. Date: January 31, 2024. Time: 1:30 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting). Contact Person: Kausik Ray, Ph.D., Scientific Review Officer, National Institute on Deafness and Other Communication Disorders, National Institutes of Health, 6001 Executive Blvd., Rockville, MD 20852, 301– 402–3587, rayk@nidcd.nih.gov. Name of Committee: Communication Disorders Review Committee Date: February 1–2, 2024. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Delta Hotels by Marriott at Anaheim-Garden Grove, Anaheim, CA 92840. Contact Person: Katherine Shim, Ph.D., Scientific Review Officer, Division of E:\FR\FM\27DEN1.SGM 27DEN1

Agencies

[Federal Register Volume 88, Number 247 (Wednesday, December 27, 2023)]
[Notices]
[Pages 89458-89460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28507]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-E-0926]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; CYTALUX

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 CYTALUX and is publishing 
this notice of that determination as required by law. FDA has made the 
determination because of the submission of an application to the 
Director of the U.S. Patent and Trademark Office (USPTO), Department of 
Commerce, for the extension of a patent which claims that human drug 
product.

DATES: Anyone with knowledge that any of the dates as published (see 
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic 
or written comments and ask for a redetermination by February 26, 2024. 
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 June 24, 2024. 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. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 26, 2024. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received 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-

[[Page 89459]]

2022-E-0926 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; CYTALUX.'' 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.

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 or biologic product, animal drug product, medical device, 
food additive, or color additive) was subject to regulatory review by 
FDA before the item was marketed. Under these acts, a product's 
regulatory review period forms the basis for determining the amount of 
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a 
testing phase and an approval phase. For human drug products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the drug becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human drug product and 
continues until FDA grants permission to market the drug product. 
Although only a portion of a regulatory review period may count toward 
the actual amount of extension that the Director of USPTO may award 
(for example, 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 human 
drug product will include all of the testing phase and approval phase 
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, CYTALUX 
(pafolacianine), which is indicated in adult patients with ovarian 
cancer as an adjunct for intraoperative identification of malignant 
lesions. Subsequent to this approval, the USPTO received a patent term 
restoration application for CYTALUX (U.S. Patent No. 9,061,057) from 
Purdue Research Foundation, and the USPTO requested FDA's assistance in 
determining the patent's eligibility for patent term restoration. In a 
letter dated September 21, 2022, FDA advised the USPTO that this human 
drug product had undergone a regulatory review period and that the 
approval of CYTALUX 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 
CYTALUX is 2,610 days. Of this time, 2,274 days occurred during the 
testing phase of the regulatory review period, while 336 days occurred 
during the approval phase. These periods of time were derived from the 
following dates:
    1. The date an exemption under section 505(i) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: 
October 9, 2014. The applicant claims September 5, 2014, as the date 
the investigational new drug application (IND) became effective. 
However, FDA records indicate that the IND effective date was October 
9, 2014, which was the first date after receipt of the IND that the 
investigational studies were allowed to proceed.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505 of the FD&C Act: December 29, 
2020. FDA has verified the applicant's claim that the new drug 
application (NDA) for CYTALUX (NDA 214907) was initially submitted on 
December 29, 2020.
    3. The date the application was approved: November 29, 2021. FDA 
has verified the applicant's claim that NDA 214907 was approved on 
November 29, 2021.
    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 825 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

[[Page 89460]]

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: December 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28507 Filed 12-26-23; 8:45 am]
BILLING CODE 4164-01-P
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