Determination of Regulatory Review Period for Purposes of Patent Extension; Detectnet, 30133-30135 [2023-09891]

Download as PDF Federal Register / Vol. 88, No. 90 / Wednesday, May 10, 2023 / Notices 30133 TABLE 1—SUMMARY OF PROPOSED DATA FIELD CHANGES TO FORM FDA 3926—Continued Current field: Includes proposed changes to: Becoming new field: With accompanying instruction to: 5: Treatment Information. Add ‘‘(including rationale for dose)’’. Add ‘‘(e.g., assessment criteria/ procedure(s) for monitoring and frequency)’’. Add ‘‘(e.g., criteria for adjusting dose if dose reduction or escalation is planned, criteria for stopping the treatment),’’. Add ‘‘(e.g., concomitant medication)’’. Add ‘‘You may choose to attach an Investigator Brochure, scientific publication(s), or other supporting documents, if needed.’’. Field 6 .......................................... None .................... Add a box option for ‘‘Request for Withdrawal’’ under ‘‘Summary of Expanded Access Use (treatment completed)’’. 9. Contents of Submission ........... None .................... Add ‘‘When a waiver is requested in this manner, the physician does not receive notice from FDA indicating that the waiver is granted.’’. Field 10.b.: Request for Authorization to Use Alternative IRB Review Procedures. None .................... Add ‘‘Information on where and how to submit this form is available at Expanded Access— How to Submit’’. Insert a statement ‘‘Information on where and how to submit this form is available at Expanded Access—How to Submit a Request (Forms)’’ under ‘‘Signature of Physician’’ after Field 11. Field 11: Certification Statement and Signature of the Physician. Provide treatment information, including the investigational drug’s name and the name of the entity supplying the drug (generally the manufacturer), the applicable FDA review division (if known), and a concise statement regarding the treatment plan. This includes the planned dose, route and schedule of administration of the investigational drug (including rationale for dose), planned duration of treatment, monitoring procedures (e.g., assessment criteria/procedure(s) for monitoring and frequency), planned modifications to the treatment plan in the event of toxicity (e.g., criteria for adjusting dose if dose reduction or escalation is planned, criteria for stopping the treatment), and other relevant information (e.g., concomitant medication). The information should be entered within the space provided. You may choose to attach an Investigator Brochure, scientific publication(s), or other supporting documents, if needed. Field 9: Contents of Submission (Follow-up/Additional Submissions Only). Request for Withdrawal: A submission describing the intent to withdraw an effective IND (21 CFR 312.38). Select this box to request under 21 CFR 56.105, authorization to obtain concurrence by the IRB chairperson or by a designated IRB member, instead of at a convened IRB meeting, before the treatment use begins, in order to comply with FDA’s requirements for IRB review and approval. When a waiver is requested in this manner, the physician does not receive notice from FDA indicating that the waiver is granted. Field 11: Certification Statement and Signature of the Physician Information on where and how to submit this form is available at Expanded Access—How to Submit. Information on where and how to submit this form is available at Expanded Access—How to Submit a Request (Forms). lotter on DSK11XQN23PROD with NOTICES1 [General Instruction?]. b Request for Withdrawal. [General Instruction?] ................... We retain the currently approved burden estimate of 13,910 responses and 255,326 hours annually for the information collection. We anticipate no adjustment as a result of the proposed form updates and have posted a draft of revised Form FDA 3926 to the docket, available for public inspection through https://www.regulations.gov. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: May 5, 2023. Lauren K. Roth, Associate Commissioner for Policy. AGENCY: [FR Doc. 2023–09982 Filed 5–9–23; 8:45 am] SUMMARY: BILLING CODE 4164–01–P VerDate Sep<11>2014 17:49 May 09, 2023 Jkt 259001 Food and Drug Administration [Docket No. FDA–2022–E–0675] Determination of Regulatory Review Period for Purposes of Patent Extension; Detectnet Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Detectnet 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 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 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. Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic or written comments and ask for a redetermination by July 10, 2023. 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 November 6, 2023. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, DATES: E:\FR\FM\10MYN1.SGM 10MYN1 30134 Federal Register / Vol. 88, No. 90 / Wednesday, May 10, 2023 / Notices 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 July 10, 2023. Comments received by mail/hand delivery/courier (for written/ paper submissions) will be considered timely if they are received on or before that date. lotter on DSK11XQN23PROD with NOTICES1 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– 2022–E–0675 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; Detectnet.’’ 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 VerDate Sep<11>2014 17:49 May 09, 2023 Jkt 259001 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: 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 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 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 Detectnet (copper Cu-64 dotatate). Detectnet is a radioactive diagnostic agent indicated for use with positron emission tomography for localization of somatostatin receptor positive neuroendocrine tumors in adult patients. Subsequent to this approval, the USPTO received a patent term restoration application for Detectnet (U.S. Patent No. 10,383,961) from Somscan APS, and the USPTO requested FDA’s assistance in determining the patent’s eligibility for patent term restoration. In a letter dated June 13, 2022, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of Detectnet 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 Detectnet is 989 days. Of this time, 744 days occurred during the testing phase of the regulatory review period, while 245 days occurred during the approval phase. These periods of time were derived from the following dates: E:\FR\FM\10MYN1.SGM 10MYN1 Federal Register / Vol. 88, No. 90 / Wednesday, May 10, 2023 / Notices lotter on DSK11XQN23PROD with NOTICES1 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: December 21, 2017. The applicant claims November 28, 2017, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was December 21, 2017, 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: January 3, 2020. FDA has verified the applicant’s claim that the new drug application (NDA) for Detectnet (NDA 213227) was initially submitted on January 3, 2020. 3. The date the application was approved: September 3, 2020. FDA has verified the applicant’s claim that NDA 213227 was approved on September 3, 2020. 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 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 § 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. VerDate Sep<11>2014 17:49 May 09, 2023 Jkt 259001 30135 Dated: May 4, 2023. Lauren K. Roth, Associate Commissioner for Policy. Silver Spring, MD 20993–0002, 301– 796–0311 (this is not a toll-free number). [FR Doc. 2023–09891 Filed 5–9–23; 8:45 am] SUPPLEMENTARY INFORMATION: BILLING CODE 4164–01–P I. Background DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0973] Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID–19; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Thermo Fisher Scientific Inc., for the OmniPATH COVID–19 Total Antibody ELISA Test; Detect, Inc., for the Detect Covid–19 Test; and Cepheid, for the Xpert Xpress SARS–CoV–2/Flu/RSV. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by each Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document. DATES: The Authorization for the Thermo Fisher Scientific Inc.’s OmniPATH COVID–19 Total Antibody ELISA Test is revoked as of April 13, 2023. The Authorization for the Detect, Inc.’s Detect Covid–19 Test is revoked as of April 14, 2023. The Authorization for the Cepheid’s Xpert Xpress SARS– CoV–2/Flu/RSV is revoked as of April 17, 2023. ADDRESSES: Submit written requests for a single copy of the revocations to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request or include a fax number to which the revocations may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the revocations. FOR FURTHER INFORMATION CONTACT: Kim Sapsford-Medintz, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3216, SUMMARY: PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 Section 564 of the FD&C Act (21 U.S.C. 360bbb–3) as amended by the Project BioShield Act of 2004 (Pub. L. 108–276) and the Pandemic and AllHazards Preparedness Reauthorization Act of 2013 (Pub. L. 113–5) allows FDA to strengthen the public health protections against biological, chemical, radiological, or nuclear agent or agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. On October 2, 2020, FDA issued the Authorization to Thermo Fisher Scientific Inc., for the OmniPATH COVID–19 Total Antibody ELISA Test, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on April 23, 2021 (86 FR 21749), as required by section 564(h)(1) of the FD&C Act. On October 28, 2021, FDA issued the Authorization to Detect, Inc., for the Detect Covid–19 Test, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on March 22, 2022 (87 FR 16198), as required by section 564(h)(1) of the FD&C Act. On September 24, 2020, FDA issued the Authorization to Cepheid, for the Xpert Xpress SARS–CoV–2/Flu/RSV, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on April 23, 2021 (86 FR 21751), as required by section 564(h)(1) of the FD&C Act. Subsequent updates to the Authorizations were made available on FDA’s website. The authorization of a device for emergency use under section 564 of the FD&C Act may, pursuant to section 564(g)(2) of the FD&C Act, be revoked when the criteria under section 564(c) of the FD&C Act for issuance of such authorization are no longer met (section 564(g)(2)(B) of the FD&C Act), or other circumstances make such revocation appropriate to protect the public health or safety (section 564(g)(2)(C) of the FD&C Act). II. Authorization Revocation Requests In a request received by FDA on April 10, 2023, Thermo Fisher Scientific Inc., requested the withdrawal of, and on April 13, 2023, FDA revoked, the Authorization for the Thermo Fisher Scientific Inc.’s OmniPATH COVID–19 E:\FR\FM\10MYN1.SGM 10MYN1

Agencies

[Federal Register Volume 88, Number 90 (Wednesday, May 10, 2023)]
[Notices]
[Pages 30133-30135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09891]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-E-0675]


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

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 Detectnet 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 must submit either electronic 
or written comments and ask for a redetermination by July 10, 2023. 
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 November 6, 2023. See 
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more 
information.

ADDRESSES: You may submit comments as follows. Please note that late,

[[Page 30134]]

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 July 10, 2023. 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-2022-E-0675 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; Detectnet.'' 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 Detectnet 
(copper Cu-64 dotatate). Detectnet is a radioactive diagnostic agent 
indicated for use with positron emission tomography for localization of 
somatostatin receptor positive neuroendocrine tumors in adult patients. 
Subsequent to this approval, the USPTO received a patent term 
restoration application for Detectnet (U.S. Patent No. 10,383,961) from 
Somscan APS, and the USPTO requested FDA's assistance in determining 
the patent's eligibility for patent term restoration. In a letter dated 
June 13, 2022, FDA advised the USPTO that this human drug product had 
undergone a regulatory review period and that the approval of Detectnet 
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 
Detectnet is 989 days. Of this time, 744 days occurred during the 
testing phase of the regulatory review period, while 245 days occurred 
during the approval phase. These periods of time were derived from the 
following dates:

[[Page 30135]]

    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: 
December 21, 2017. The applicant claims November 28, 2017, as the date 
the investigational new drug application (IND) became effective. 
However, FDA records indicate that the IND effective date was December 
21, 2017, 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: January 3, 
2020. FDA has verified the applicant's claim that the new drug 
application (NDA) for Detectnet (NDA 213227) was initially submitted on 
January 3, 2020.
    3. The date the application was approved: September 3, 2020. FDA 
has verified the applicant's claim that NDA 213227 was approved on 
September 3, 2020.
    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 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.

    Dated: May 4, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09891 Filed 5-9-23; 8:45 am]
BILLING CODE 4164-01-P
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