Source: https://regulations.justia.com/regulations/fedreg/2018/02/12/2018-02791.html
Timestamp: 2019-02-16 19:39:50
Document Index: 728251044

Matched Legal Cases: ['§ 10', 'art 1', '§ 10', '§ 60', '§ 60', '§ 10', 'art 1']

Determination of Regulatory Review Period for Purposes of Patent Extension; IMBRUVICA, 6028-6030 [2018-02791] :: Food And Drug Administration :: Department Of Health And Human Services :: Regulation Tracker :: Justia
Justia Regulation Tracker Department Of Health And Human Services Food And Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; IMBRUVICA, 6028-6030 [2018-02791]
Determination of Regulatory Review Period for Purposes of Patent Extension; IMBRUVICA, 6028-6030 [2018-02791]
Download as PDF 6028 Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices 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 6, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–02767 Filed 2–9–18; 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’s) 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 13, 2018. 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: daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: 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 VerDate Sep<11>2014 19:23 Feb 09, 2018 Jkt 244001 primary goal, CDER has initiated various training and development programs to promote high performance in its regulatory project management staff. CDER seeks to significantly 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, over a 2- to 3-day period, small groups (five or less) of regulatory project managers, 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 daily workshops is to learn about the team approach to drug development, including drug discovery, preclinical evaluation, tracking mechanisms, 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 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 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 6, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–02793 Filed 2–9–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–E–2373] Determination of Regulatory Review Period for Purposes of Patent Extension; IMBRUVICA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IMBRUVICA 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 (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 13, 2018. 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. Electronic comments must be submitted on or before April 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 13, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Furthermore, any interested person may petition FDA for a determination regarding whether the SUMMARY: E:\FR\FM\12FEN1.SGM 12FEN1 Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices applicant for extension acted with due diligence during the regulatory review period by August 13, 2018. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. 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’’). daltland on DSKBBV9HB2PROD with NOTICES 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– 2014–E–2373 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; IMBRUVICA.’’ 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. VerDate Sep<11>2014 19:23 Feb 09, 2018 Jkt 244001 • 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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. 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 product, animal drug product, medical device, food additive, or color additive) was subject to regulatory PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 6029 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 IMBRUVICA (ibrutinib). IMBRUVICA is indicated for treatment of patients with mantle cell lymphoma who have received at least one prior therapy. This indication is based on overall response rate. An improvement in survival of diseaserelated symptoms has not been established. Subsequent to this approval, the USPTO received a patent term restoration application for IMBRUVICA (U.S. Patent No. 8,008,309) from Pharmacyclics, Inc., and the USPTO requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated October 20, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of IMBRUVICA 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 IMBRUVICA is 1,865 days. Of this time, 1,726 days occurred during the testing phase of the regulatory review period, while 139 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 (the FD&C Act) (21 E:\FR\FM\12FEN1.SGM 12FEN1 6030 Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices U.S.C. 355(i)) became effective: October 7, 2008. The applicant claims September 8, 2008, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was October 7, 2008, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: June 28, 2013. FDA has verified the applicant’s claim that the new drug application (NDA) for IMBRUVICA (NDA 205552) was initially submitted on June 28, 2013. 3. The date the application was approved: November 13, 2013. FDA has verified the applicant’s claim that NDA 205552 was approved on November 13, 2013. 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 320 days of patent term extension. daltland on DSKBBV9HB2PROD with NOTICES 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 19:23 Feb 09, 2018 Jkt 244001 Dated: February 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–02791 Filed 2–9–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–5897] Packaging, Storage, and Disposal Options To Enhance Opioid Safety— Exploring the Path Forward; Public Workshop; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Notice of public workshop; extension of comment period. ACTION: The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice announcing the public workshop entitled ‘‘Packaging, Storage, and Disposal Options To Enhance Opioid Safety—Exploring the Path Forward’’ that appeared in the Federal Register on October 31, 2017, and was held on December 11–12, 2017. That notice requested comments by February 12, 2018; FDA is extending the comment period until March 16, 2018, in response to requests for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the public workshop ‘‘Packaging, Storage, and Disposal Options To Enhance Opioid Safety— Exploring the Path Forward’’ published October 31, 2017 (82 FR 50429). Submit either electronic or written comments by March 16, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before March 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of March 16, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 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– 2017–N–5897 for ‘‘Packaging, Storage, and Disposal Options To Enhance Opioid Safety—Exploring the Path Forward; Public Workshop; Request for Comments.’’ 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. • 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 E:\FR\FM\12FEN1.SGM 12FEN1
[Pages 6028-6030]
[FR Doc No: 2018-02791]
[Docket No. FDA-2014-E-2373]
Extension; IMBRUVICA
determined the regulatory review period for IMBRUVICA and is publishing
DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
13, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section
must be submitted on or before April 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 13, 2018. Comments received
acceptance receipt is on or before that date. Furthermore, any
interested person may petition FDA for a determination regarding
[[Page 6029]]
applicant for extension acted with due diligence during the regulatory
review period by August 13, 2018. See ``Petitions'' in the
FDA-2014-E-2373 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; IMBRUVICA.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
FDA has approved for marketing the human drug product IMBRUVICA
(ibrutinib). IMBRUVICA is indicated for treatment of patients with
mantle cell lymphoma who have received at least one prior therapy. This
indication is based on overall response rate. An improvement in
survival of disease-related symptoms has not been established.
restoration application for IMBRUVICA (U.S. Patent No. 8,008,309) from
Pharmacyclics, Inc., and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated October 20, 2015, FDA advised the USPTO that this human
approval of IMBRUVICA represented the first permitted commercial
IMBRUVICA is 1,865 days. Of this time, 1,726 days occurred during the
testing phase of the regulatory review period, while 139 days occurred
Drug, and Cosmetic Act (the FD&C Act) (21
[[Page 6030]]
U.S.C. 355(i)) became effective: October 7, 2008. The applicant claims
September 8, 2008, as the date the investigational new drug application
(IND) became effective. However, FDA records indicate that the IND
effective date was October 7, 2008, which was 30 days after FDA receipt
of the IND.
the human drug product under section 505(b) of the FD&C Act: June 28,
2013. FDA has verified the applicant's claim that the new drug
application (NDA) for IMBRUVICA (NDA 205552) was initially submitted on
3. The date the application was approved: November 13, 2013. FDA
has verified the applicant's claim that NDA 205552 was approved on
this applicant seeks 320 days of patent term extension.
[FR Doc. 2018-02791 Filed 2-9-18; 8:45 am]