Determination of Regulatory Review Period for Purposes of Patent Extension; Rybrevant, 14505-14507 [2024-03961]

Download as PDF 14505 Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Notices were approved under an emergency approval for 6-months and included a new requirement for Tribes or Tribal organizations to provide that charging fees and recovering costs will not be permitted. Comments due within 30 days of publication. OMB must make a decision about the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. DATES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review-Open for Public Comments’’ or by using the search function. You can also obtain copies of the proposed collection of information by emailing infocollection@ acf.hhs.gov. Identify all emailed ADDRESSES: requests by the title of the information collection. SUPPLEMENTARY INFORMATION: Description: The final rule within 45 CFR part 309, published in the Federal Register on March 30, 2004 at 69 FR 16638, contains a regulatory reporting requirement that, in order to receive funding for a Tribal IV–D program, a Tribe or Tribal organization must submit a plan describing how the Tribe or Tribal organization meets or plans to meet the objectives of section 455(f) of the Social Security Act, including establishing paternity; establishing, modifying, and enforcing support orders; and locating noncustodial parents. The plan is required for all Tribes requesting funding; however, once a Tribe has met the requirements to operate a comprehensive program, a new plan is not required annually unless a Tribe makes changes to its title IV–D program. If a Tribe or Tribal organization intends to make any substantial or material changes, a Tribal IV–D plan amendment must be submitted for approval. Tribes and Tribal organizations must have an approved plan and submit any required Burden Estimates The following burden estimates include new burden associated with the change in requirement, as well as existing burden under OMB #: 0970– 0218. Total number of responses per respondent (over three years) Total number of respondents Instrument plan amendments in order to receive funding to operate a Tribal IV–D program. Through an emergency approval request, OCSS included a new requirement for Tribes and Tribal organizations to provide that charging fees and recovering costs will not be permitted. This is due to the Final Rule on the Elimination of the Non-Federal Share published on February 12, 2024 (see 89 FR 9784). Tribes and Tribal organizations that charge fees and recover cost must submit a plan amendment demonstrating compliance with the proposed new requirement, in accordance with 45 CFR 309.35(d). This is a one-time submission. Only three Tribal child support programs report data on the collection of fees and recovered costs. This request is to extend approval with no changes. Respondents: Tribes and Tribal Organizations. Burden hours per response Total burden hours (over three years) Annual burden hours 45 CFR 309—New Plan .................................................... 45 CFR 309—Plan Amendment ........................................ 45 CFR 309—Plan Amendment—Charging fees and recovering .......................................................................... 10 60 3 *2 480 105 14,400 18,900 4,800 6,300 3 1 3 9 3 Estimated Burden Hours and Costs ........................... ........................ .......................... ........................ 33,309 11,103 * This estimate is based on an average number of about 2 amendments submitted per year per Tribe, but that does vary annually and by Tribe. Authority: Title IV–D of the Social Security Act; 45 CFR 309. Mary C. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2024–03968 Filed 2–26–24; 8:45 am] BILLING CODE 4184–41–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration lotter on DSK11XQN23PROD with NOTICES1 [Docket No. FDA–2022–E–2217] Determination of Regulatory Review Period for Purposes of Patent Extension; Rybrevant AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Sep<11>2014 16:53 Feb 26, 2024 Jkt 262001 The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Rybrevant 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 biological 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 April 29, 2024. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for SUMMARY: PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 extension acted with due diligence during the regulatory review period by August 26, 2024. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. 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 April 29, 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. ADDRESSES: Electronic Submissions Submit electronic comments in the following way: E:\FR\FM\27FEN1.SGM 27FEN1 14506 Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Notices lotter on DSK11XQN23PROD with NOTICES1 • 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–2217 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; RYBREVANT.’’ 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 VerDate Sep<11>2014 16:53 Feb 26, 2024 Jkt 262001 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 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 biological products, the testing phase begins when the exemption to permit PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological 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 biological 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 biologic product Rybrevant (amivantamab-vmjw). Rybrevant is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinumbased chemotherapy. Subsequent to this approval, the USPTO received a patent term restoration application for Rybrevant (U.S. Patent No. 9,593,164) from Janssen Biotech, Inc., and the USPTO requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated September 21, 2022, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of Rybrevant 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 Rybrevant is 1,284 days. Of this time, 1,105 days occurred during the testing phase of the regulatory review period, while 179 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 (21 U.S.C. 355(i)) became effective: November 16, 2017. The applicant claims November 19, 2017, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was November 16, 2017, which was the first date after E:\FR\FM\27FEN1.SGM 27FEN1 Federal Register / Vol. 89, No. 39 / Tuesday, February 27, 2024 / Notices 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 biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): November 24, 2020. FDA has verified the applicant’s claim that the biologics license application (BLA) for Rybrevant (BLA B761210) was initially submitted on November 24, 2020. 3. The date the application was approved: May 21, 2021. FDA has verified the applicant’s claim that BLA B761210 was approved on May 21, 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 546 days of patent term extension. lotter on DSK11XQN23PROD with NOTICES1 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. Dated: February 22, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–03961 Filed 2–26–24; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 16:53 Feb 26, 2024 Jkt 262001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Ryan White HIV/AIDS Program Core Medical Services Waiver Form, OMB No. 0906– 0065—Revision Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this ICR should be received no later than April 29, 2024. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14N39, 5600 Fishers Lane, Rockville, Maryland 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call Joella Roland, the HRSA Information Collection Clearance Officer, at (301) 443–3983. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the ICR title for reference. Information Collection Request Title: Ryan White HIV/AIDS Program Core Medical Services Waiver Form, OMB No. 0915–0065—Revision Abstract: In accordance with sections 2604(c), 2612(b), and 2651(c) of the Public Health Service Act, recipients are required to spend not less than 75 percent of funds on core medical services for individuals with HIV identified and eligible under the statute, after reserving permissible amounts for administrative and clinical quality management (CQM) costs. The statute also grants the Secretary of Health and Human Services authority to waive this requirement for a Ryan White HIV/AIDS Program (RWHAP) Part A, B, or C recipient if certain requirements are SUMMARY: PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 14507 met, and a waiver request is submitted to HRSA for approval. As currently implemented by HRSA, to be approved, (1) core medical services must be available and accessible to all individuals identified and eligible for the RWHAP in the recipient’s service area within 30 days. This access must be without regard to payer source, and without the need to spend at least 75 percent of funds remaining from the recipient’s RWHAP award after statutorily permissible amounts for administrative and CQM costs are reserved; (2) the recipient must ensure there are no AIDS Drug Assistance Program (ADAP) waiting lists in their service area; and (3) a public process to obtain input on the waiver request must have occurred. This process must seek input from impacted communities including clients and RWHAP-funded core medical services providers on the availability of core medical services, and the decision to request the waiver. The public process may be a part of the same one used by recipients to seek input on community needs as part of the annual priority setting and resource allocation, comprehensive planning, statewide coordinated statement of need, public planning, and/or needs assessment processes. RWHAP Parts A, B, and C core medical services waiver requests must include funds awarded under the Minority AIDS Initiative. Core medical services waivers are effective for a 1year period. The process for RWHAP Parts A, B, and C grant recipients to request a waiver of the minimum expenditure amount requirements for core medical services is outlined in Policy Notice 21– 01, Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure Requirement. HRSA proposes to modify the onepage form to include the proposed percentages of HIV service dollars allocated to core medical and support services. Under the proposed changes, a field will be added to the form to capture the proposed percentages. This information will inform HRSA whether recipients are able to meet the statutory requirements in sections 2604(c), 2612(b), and 2651(c) of the Public Health Service Act and will clarify what proposed portion of funds will be allocated to core medical and support services. Minor changes will also be made to the form to increase readability. Summary of Proposed Changes: Sections 2604(c), 2612(b), and 2651(c) of the Public Health Service Act requires recipients to spend not less than 75 percent of funds on core medical services after reserving statutorily E:\FR\FM\27FEN1.SGM 27FEN1

Agencies

[Federal Register Volume 89, Number 39 (Tuesday, February 27, 2024)]
[Notices]
[Pages 14505-14507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03961]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-E-2217]


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

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 Rybrevant 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 
biological 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 April 29, 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 August 26, 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 April 29, 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:

[[Page 14506]]

     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-2217 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; RYBREVANT.'' 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 biological products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the biological product becomes effective and runs 
until the approval phase begins. The approval phase starts with the 
initial submission of an application to market the human biological 
product and continues until FDA grants permission to market the 
biological 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 biological 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 biologic product Rybrevant 
(amivantamab-vmjw). Rybrevant is indicated for the treatment of adult 
patients with locally advanced or metastatic non-small cell lung cancer 
with epidermal growth factor receptor exon 20 insertion mutations, as 
detected by an FDA-approved test, whose disease has progressed on or 
after platinum-based chemotherapy. Subsequent to this approval, the 
USPTO received a patent term restoration application for Rybrevant 
(U.S. Patent No. 9,593,164) from Janssen Biotech, Inc., and the USPTO 
requested FDA's assistance in determining this patent's eligibility for 
patent term restoration. In a letter dated September 21, 2022, FDA 
advised the USPTO that this human biological product had undergone a 
regulatory review period and that the approval of Rybrevant 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 
Rybrevant is 1,284 days. Of this time, 1,105 days occurred during the 
testing phase of the regulatory review period, while 179 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 (21 U.S.C. 355(i)) became effective: November 
16, 2017. The applicant claims November 19, 2017, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was November 16, 2017, 
which was the first date after

[[Page 14507]]

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 biological product under section 351 of the Public Health 
Service Act (42 U.S.C. 262): November 24, 2020. FDA has verified the 
applicant's claim that the biologics license application (BLA) for 
Rybrevant (BLA B761210) was initially submitted on November 24, 2020.
    3. The date the application was approved: May 21, 2021. FDA has 
verified the applicant's claim that BLA B761210 was approved on May 21, 
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 546 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: February 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-03961 Filed 2-26-24; 8:45 am]
BILLING CODE 4164-01-P
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