Electronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Supporting Electronic Common Technical Document Version 4.0, 75545-75546 [2024-20897]

Download as PDF Federal Register / Vol. 89, No. 179 / Monday, September 16, 2024 / Notices lotter on DSK11XQN23PROD with NOTICES1 cancer with disease progression following at least one line of endocrine therapy. Subsequent to this approval, the USPTO received patent term restoration applications for ORSERDU (U.S. Patent Nos. 7,612,114 and 8,399,520 filed by Eisai R&D Management Co., Ltd., and U.S. Patent Nos. 10,071,066 and 10,420,734, filed by Duke University), and the USPTO requested FDA’s assistance in determining the patents’ eligibility for patent term restoration. In a letter dated January 30, 2024, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of ORSERDU 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 ORSERDU is 2,965 days. Of this time, 2,740 days occurred during the testing phase of the regulatory review period, while 225 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: December 17, 2014. FDA has verified the applicants’ claims that the date the investigational new drug application became effective was on December 17, 2014. 2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: June 17, 2022. FDA has verified the applicants’ claims that the new drug application (NDA) for ORSERDU (NDA 217639) was initially submitted on June 17, 2022. 3. The date the application was approved: January 27, 2023. FDA has verified the applicants’ claims that NDA 217639 was approved on January 27, 2023. 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 the applications for patent extension, the applicants seek 724 days, 841 days, or 1,595 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 VerDate Sep<11>2014 17:23 Sep 13, 2024 Jkt 262001 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: September 4, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–20893 Filed 9–13–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–1216] Electronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Supporting Electronic Common Technical Document Version 4.0 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration’s (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing support for Electronic Common Technical Document (eCTD) Version 4.0 (v4.0)based electronic submissions. DATES: Support for eCTDv4.0 electronic submissions begins September 16, 2024. FDA will also continue to support eCTDv3.2.2 electronic submissions. Submit either electronic or written comments at any time. SUMMARY: PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 ADDRESSES: 75545 You may submit comments as follows: 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 ‘‘Instruction.’’ Instructions: All submissions received must include the Docket No. FDA– 2018–D–1216 for ‘‘Electronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Supporting Electronic Common Technical Document Version 4.0.’’ Received comments 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 E:\FR\FM\16SEN1.SGM 16SEN1 lotter on DSK11XQN23PROD with NOTICES1 75546 Federal Register / Vol. 89, No. 179 / Monday, September 16, 2024 / Notices made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.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: Jonathan Resnick, Center for Drug Evaluation and Research, Food and Drug Administration, Jonathan.Resnick@fda.hhs.gov; or James Myers, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: According to the guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications’’ (available at https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/providing-regulatorysubmissions-electronic-format-certainhuman-pharmaceutical-productapplications), submissions subject to section 745A(a) of the Federal Food, VerDate Sep<11>2014 17:23 Sep 13, 2024 Jkt 262001 Drug, and Cosmetic Act (21 U.S.C. 379k–1(a)) must be submitted in eCTD format using the version of eCTD currently supported by FDA unless such submission is exempt from the electronic submission requirements or if FDA has granted a waiver. The version of eCTD currently supported by FDA is specified in the FDA Data Standards Catalog (available at https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents/datastandards-catalog). FDA plans to update the FDA Data Standards Catalog to add eCTDv4.0 upon publication of this notice. FDA will support both eCTDv3.2.2 and eCTDv4.0 submissions before eventually only supporting eCTDv4.0 submissions. FDA will provide advance notice of when the Agency will begin supporting electronic submission only in eCTDv4.0. Specifications for eCTDv3.2.2 and v4.0 are available on FDA’s eCTD web page (available at: https://www.fda.gov/ drugs/electronic-regulatory-submissionand-review/electronic-commontechnical-document-ectd). Dated: September 10, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–20897 Filed 9–13–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2023–E–3240, FDA– 2023–E–3259, and FDA–2023–E–3260] Determination of Regulatory Review Period for Purposes of Patent Extension; REZZAYO AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for REZZAYO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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. SUMMARY: 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 DATES: PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 redetermination by November 15, 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 March 17, 2025. 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 November 15, 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.’’ E:\FR\FM\16SEN1.SGM 16SEN1

Agencies

[Federal Register Volume 89, Number 179 (Monday, September 16, 2024)]
[Notices]
[Pages 75545-75546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20897]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1216]


Electronic Common Technical Document; Data Standards; Center for 
Drug Evaluation and Research and Center for Biologics Evaluation and 
Research Supporting Electronic Common Technical Document Version 4.0

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for 
Drug Evaluation and Research and Center for Biologics Evaluation and 
Research are announcing support for Electronic Common Technical 
Document (eCTD) Version 4.0 (v4.0)-based electronic submissions.

DATES: Support for eCTDv4.0 electronic submissions begins September 16, 
2024. FDA will also continue to support eCTDv3.2.2 electronic 
submissions. Submit either electronic or written comments at any time.

ADDRESSES: You may submit comments as follows:

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 ``Instruction.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-D-1216 for ``Electronic Common Technical Document; Data 
Standards; Center for Drug Evaluation and Research and Center for 
Biologics Evaluation and Research Supporting Electronic Common 
Technical Document Version 4.0.'' Received comments 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

[[Page 75546]]

made publicly available, submit your comments only as a written/paper 
submission. You should submit two copies total. One copy will include 
the information you claim to be confidential with a heading or cover 
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' 
The Agency will review this copy, including the claimed confidential 
information, in its consideration of comments. The second copy, which 
will have the claimed confidential information redacted/blacked out, 
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management 
Staff. If you do not wish your name and contact information to be made 
publicly available, you can provide this information on the cover sheet 
and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.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: Jonathan Resnick, Center for Drug 
Evaluation and Research, Food and Drug Administration, 
[email protected]; or James Myers, Center for Biologics 
Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 
7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: According to the guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
Certain Human Pharmaceutical Product Applications and Related 
Submissions Using the eCTD Specifications'' (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-certain-human-pharmaceutical-product-applications), submissions subject to section 
745A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379k-
1(a)) must be submitted in eCTD format using the version of eCTD 
currently supported by FDA unless such submission is exempt from the 
electronic submission requirements or if FDA has granted a waiver. The 
version of eCTD currently supported by FDA is specified in the FDA Data 
Standards Catalog (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-standards-catalog). FDA 
plans to update the FDA Data Standards Catalog to add eCTDv4.0 upon 
publication of this notice. FDA will support both eCTDv3.2.2 and 
eCTDv4.0 submissions before eventually only supporting eCTDv4.0 
submissions. FDA will provide advance notice of when the Agency will 
begin supporting electronic submission only in eCTDv4.0. Specifications 
for eCTDv3.2.2 and v4.0 are available on FDA's eCTD web page (available 
at: https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd).

    Dated: September 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20897 Filed 9-13-24; 8:45 am]
BILLING CODE 4164-01-P

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