Training Program for Regulatory Project Managers; Information Available to Industry, 11302-11303 [2024-03039]

Download as PDF 11302 Federal Register / Vol. 89, No. 31 / Wednesday, February 14, 2024 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B). FDA has approved for marketing the medical device OCS HEART SYSTEM. OCS HEART SYSTEM is indicated for the preservation of donor-after-braindeath hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation (e.g., >4 hours of crossclamp time). Subsequent to this approval, the USPTO received a patent term restoration application for the OCS HEART SYSTEM (U.S. Patent No. 7,651,835) from TransMedics, Inc., and the USPTO requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated September 28, 2022, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of the OCS HEART SYSTEM 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 the OCS HEART SYSTEM is 5,518 days. Of this time, 4,535 days occurred during the testing phase of the regulatory review period, while 983 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: July 28, 2006. FDA has verified the applicant’s claim that the date the investigational device exemption for human tests to begin, as required under section 520(g) of the FD&C Act, became effective July 28, 2006. 2. The date an application was initially submitted with respect to the device under section 515 of the FD&C Act (21 U.S.C. 360e): December 26, 2018. FDA has verified the applicant’s claim that the premarket approval application (PMA) for the OCS HEART SYSTEM (PMA P180051) was initially submitted December 26, 2018. 3. The date the application was approved: September 3, 2021. FDA has verified the applicant’s claim that PMA VerDate Sep<11>2014 17:50 Feb 13, 2024 Jkt 262001 P180051 was approved on September 3, 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 1,826 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. Dated: February 9, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–03028 Filed 2–13–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0179] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration’s (FDA or the Agency) Center for Drug Evaluation and Research SUMMARY: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER. DATES: Pharmaceutical companies may send proposed agendas to the Agency by April 15, 2024. FOR FURTHER INFORMATION CONTACT: Dan Brum, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5480, Silver Spring, MD 20993–0002, 301–796–0578, Dan.Brum@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background An important part of CDER’s commitment to make safe and effective drugs available to all Americans is optimizing the efficiency and quality of the drug review process. To support this goal, CDER has initiated various training and development programs to promote high performance in its regulatory project management staff. CDER seeks to enhance review efficiency and review quality by providing the staff with a better understanding of the pharmaceutical industry and its operations. To this end, CDER is continuing its training program to give regulatory project managers the opportunity to tour pharmaceutical facilities. The goals are to provide the following: (1) firsthand exposure to industry’s drug development processes and (2) a venue for sharing information about project management procedures (but not drug-specific information) with industry representatives. II. The Site Tours Program In this program, which generally lasts a few days, small groups of CDER regulatory project managers, often including a senior level regulatory project manager, can observe operations of pharmaceutical manufacturing and/or packaging facilities, pathology/ toxicology laboratories, and regulatory affairs operations. Neither this tour nor any part of the program is intended as a mechanism to inspect, assess, judge, or perform a regulatory function, but is meant rather to improve mutual understanding and to provide an avenue for open dialogue. During the Site Tours Program, regulatory project managers will also participate in daily workshops with their industry counterparts, focusing on selective regulatory issues important to both CDER staff and industry. The primary objective of the E:\FR\FM\14FEN1.SGM 14FEN1 Federal Register / Vol. 89, No. 31 / Wednesday, February 14, 2024 / Notices daily workshops is to learn about the team approach to drug development, including drug discovery, nonclinical and clinical evaluation, postmarketing activities, and regulatory submission operations. The overall benefit to regulatory project managers will be exposure to project management, team techniques, and processes employed by the pharmaceutical industry. By participating in this program, the regulatory project manager will grow professionally by gaining a better understanding of industry processes and procedures. III. Site Selection All travel expenses associated with the Site Tours Program will be the responsibility of CDER; therefore, selection will be based on the availability of funds and resources for each fiscal year. Selection will also be based on firms having a favorable facility status as determined by FDA’s Office of Regulatory Affairs District Offices in the firms’ respective regions. Firms that want to learn more about this training opportunity or that are interested in offering a site tour should respond by sending a proposed agenda by email directly to Dan Brum (see DATES and FOR FURTHER INFORMATION CONTACT). Dated: February 9, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–03039 Filed 2–13–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–E–0762] Determination of Regulatory Review Period for Purposes of Patent Extension; ORGAN CARE SYSTEM LIVER AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ORGAN CARE SYSTEM LIVER (OCS LIVER) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device. ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:50 Feb 13, 2024 Jkt 262001 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 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 August 12, 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 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. DATES: 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 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 11303 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–0762 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; OCS LIVER.’’ 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. E:\FR\FM\14FEN1.SGM 14FEN1

Agencies

[Federal Register Volume 89, Number 31 (Wednesday, February 14, 2024)]
[Notices]
[Pages 11302-11303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03039]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0179]


Training Program for Regulatory Project Managers; Information 
Available to Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration's (FDA or the Agency) Center 
for Drug Evaluation and Research (CDER) is announcing the continuation 
of the Regulatory Project Management Site Tours and Regulatory 
Interaction Program (the Site Tours Program). The purpose of this 
document is to invite pharmaceutical companies interested in 
participating in this program to contact CDER.

DATES: Pharmaceutical companies may send proposed agendas to the Agency 
by April 15, 2024.

FOR FURTHER INFORMATION CONTACT: Dan Brum, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 5480, Silver Spring, MD 20993-0002, 301-796-0578, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    An important part of CDER's commitment to make safe and effective 
drugs available to all Americans is optimizing the efficiency and 
quality of the drug review process. To support this goal, CDER has 
initiated various training and development programs to promote high 
performance in its regulatory project management staff. CDER seeks to 
enhance review efficiency and review quality by providing the staff 
with a better understanding of the pharmaceutical industry and its 
operations. To this end, CDER is continuing its training program to 
give regulatory project managers the opportunity to tour pharmaceutical 
facilities. The goals are to provide the following: (1) firsthand 
exposure to industry's drug development processes and (2) a venue for 
sharing information about project management procedures (but not drug-
specific information) with industry representatives.

II. The Site Tours Program

    In this program, which generally lasts a few days, small groups of 
CDER regulatory project managers, often including a senior level 
regulatory project manager, can observe operations of pharmaceutical 
manufacturing and/or packaging facilities, pathology/toxicology 
laboratories, and regulatory affairs operations. Neither this tour nor 
any part of the program is intended as a mechanism to inspect, assess, 
judge, or perform a regulatory function, but is meant rather to improve 
mutual understanding and to provide an avenue for open dialogue. During 
the Site Tours Program, regulatory project managers will also 
participate in daily workshops with their industry counterparts, 
focusing on selective regulatory issues important to both CDER staff 
and industry. The primary objective of the

[[Page 11303]]

daily workshops is to learn about the team approach to drug 
development, including drug discovery, nonclinical and clinical 
evaluation, postmarketing activities, and regulatory submission 
operations. The overall benefit to regulatory project managers will be 
exposure to project management, team techniques, and processes employed 
by the pharmaceutical industry. By participating in this program, the 
regulatory project manager will grow professionally by gaining a better 
understanding of industry processes and procedures.

III. Site Selection

    All travel expenses associated with the Site Tours Program will be 
the responsibility of CDER; therefore, selection will be based on the 
availability of funds and resources for each fiscal year. Selection 
will also be based on firms having a favorable facility status as 
determined by FDA's Office of Regulatory Affairs District Offices in 
the firms' respective regions. Firms that want to learn more about this 
training opportunity or that are interested in offering a site tour 
should respond by sending a proposed agenda by email directly to Dan 
Brum (see DATES and FOR FURTHER INFORMATION CONTACT).

    Dated: February 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-03039 Filed 2-13-24; 8:45 am]
BILLING CODE 4164-01-P

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