83 FR 6583 - Determination of Regulatory Review Period for Purposes of Patent Extension; JARDIANCE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 31 (February 14, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 31 (February 14, 2018)
| Page Range | 6583-6585 | |
| FR Document | 2018-02992 |
[Federal Register Volume 83, Number 31 (Wednesday, February 14, 2018)] [Notices] [Pages 6583-6585] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02992] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-E-2576] Determination of Regulatory Review Period for Purposes of Patent Extension; JARDIANCE AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) has determined the regulatory review period for JARDIANCE 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 16, 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 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 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. 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 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''). [[Page 6584]] 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-2015-E-2576 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; JARDIANCE.'' 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. 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.thefederalregister.org/fdsys/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. 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 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 JARDIANCE (empagliflozin). JARDIANCE is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Subsequent to this approval, the USPTO received a patent term restoration application for JARDIANCE (U.S. Patent No. 7,579,449) from Boehringer Ingelheim International GmbH, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 15, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of JARDIANCE 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 JARDIANCE is 2,275 days. Of this time, 1,760 days occurred during the testing phase of the regulatory review period, while 515 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 U.S.C. 355(i)) became effective: May 11, 2008. The applicant claims May 10, 2008, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was May 11, 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: March 5, 2013. FDA has verified the applicant's claim that the new drug application (NDA) for JARDIANCE (NDA 204629) was initially submitted on March 5, 2013. 3. The date the application was approved: August 1, 2014. FDA has verified the applicant's claim that NDA 204629 was approved on August 1, 2014. 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 1,001 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 [[Page 6585]] 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 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-02992 Filed 2-13-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 31 / Wednesday, February 14, 2018 / Notices 6583
research, drug development, and workshop (https:// of Commerce, for the extension of a
regulatory review. Small population healthpolicy.duke.edu/events/ patent which claims that human drug
sizes, possible limited scientific innovative-tools-and-statistical- product.
understanding of the disease of interest, methods-treatment-development-rare-
DATES: Anyone with knowledge that any
and a lack of market incentives often disease-settings). Persons interested in
of the dates as published (in the
preclude more traditional clinical trial viewing the live webcast must register
SUPPLEMENTARY INFORMATION section) are
or analytical approaches from being online before 5 p.m. EDT on March 18,
pursued. To help collaboratively incorrect may submit either electronic
2018 (see Registration). Early
address these barriers, FDA is working or written comments and ask for a
registration is recommended because
with stakeholders to solicit feedback on redetermination by April 16, 2018. See
webcast connections are limited.
promising designs and methodologies ‘‘Petitions’’ in the SUPPLEMENTARY
Organizations are requested to register
INFORMATION section for more
for use in the development of rare all participants, but to view using one
disease treatments that can form the information.
connection per location whenever
basis of formal guidance documents. possible. Webcast participants will be ADDRESSES: You may submit comments
II. Topics for Discussion at the Public sent technical system requirements in as follows. Please note that late,
Workshop advance of the event. Prior to joining the untimely filed comments will not be
streaming webcast of the public considered. Electronic comments must
During the public workshop, speakers workshop, it is recommended that you be submitted on or before April 16,
and participants will discuss a range of review these technical system 2018. The https://www.regulations.gov
tools and methods that can be used in requirements. electronic filing system will accept
the development of treatments for rare Transcripts: Please be advised that comments until midnight Eastern Time
diseases and small patient populations. transcripts will not be available. at the end of April 16, 2018. Comments
The meeting will include both Other Issues for Consideration: A 1- received by mail/hand delivery/courier
presentations by panelists and hour lunch break is scheduled, but food (for written/paper submissions) will be
dedicated time for questions and will not be provided. There are multiple considered timely if they are
comments from attendees. Topics will restaurants within walking distance of postmarked or the delivery service
include: Master protocols, use of the DoubleTree by Hilton Hotel, 8727 acceptance receipt is on or before that
external controls in single-arm trials, Colesville Rd., Silver Spring, MD 20910. date. Furthermore, any interested
analytical tools for trials with multiple All event materials will be provided person may petition FDA for a
or novel endpoints, and best practices to registered attendees via email prior to determination regarding whether the
for leveraging Bayesian statistics and the workshop and will be publicly applicant for extension acted with due
adaptive study designs. available at the Duke-Margolis Center diligence during the regulatory review
III. Participating in the Public for Health Policy website (https:// period by August 13, 2018. See
Workshop healthpolicy.duke.edu/events/ ‘‘Petitions’’ in the SUPPLEMENTARY
Registration: To register for the public innovative-tools-and-statistical- INFORMATION section for more
workshop, visit the following website: methods-treatment-development-rare- information.
https://healthpolicy.duke.edu/events/ disease-settings).
Electronic Submissions
innovative-tools-and-statistical- Dated: February 7, 2018.
methods-treatment-development-rare- Leslie Kux, Submit electronic comments in the
disease-settings. If you are unable to following way:
Associate Commissioner for Policy.
attend the meeting in person, you can • Federal eRulemaking Portal:
[FR Doc. 2018–02990 Filed 2–13–18; 8:45 am]
register to view a live webcast of the https://www.regulations.gov. Follow the
BILLING CODE 4164–01–P
meeting. There will be no onsite instructions for submitting comments.
registration. Please provide complete Comments submitted electronically,
contact information for each attendee, DEPARTMENT OF HEALTH AND including attachments, to https://
including name, title, affiliation, HUMAN SERVICES www.regulations.gov will be posted to
address, email, and telephone. the docket unchanged. Because your
Registration is free and based on Food and Drug Administration comment will be made public, you are
space availability, with priority given to solely responsible for ensuring that your
[Docket No. FDA–2015–E–2576] comment does not include any
early registrants. Persons interested in
attending this public workshop must confidential information that you or a
Determination of Regulatory Review third party may not wish to be posted,
register by 5 p.m. EDT on Thursday, Period for Purposes of Patent
March 15, 2018. Early registration is such as medical information, your or
Extension; JARDIANCE anyone else’s Social Security number, or
recommended because seating is
limited; therefore, FDA may limit the AGENCY: Food and Drug Administration, confidential business information, such
number of participants from each HHS. as a manufacturing process. Please note
organization. ACTION: Notice. that if you include your name, contact
If you need special accommodations information, or other information that
due to a disability, please contact Sarah SUMMARY: The Food and Drug identifies you in the body of your
Supsiri at the Duke-Margolis Center for Administration (FDA or Agency) has comments, that information will be
Health Policy (phone: 202–791–9561, determined the regulatory review period posted on https://www.regulations.gov.
daltland on DSKBBV9HB2PROD with NOTICES
email: sarah.supsiri@duke.edu) no later for JARDIANCE and is publishing this • If you want to submit a comment
than March 12, 2018. notice of that determination as required with confidential information that you
Streaming webcast of the public by law. FDA has made the do not wish to be made available to the
workshop: This public workshop will determination because of the public, submit the comment as a
also be webcast. Archived video footage submission of an application to the written/paper submission and in the
will also be available at the Duke- Director of the U.S. Patent and manner detailed (see ‘‘Written/Paper
Margolis website following the Trademark Office (USPTO), Department Submissions’’ and ‘‘Instructions’’).
VerDate Sep<11>2014 22:07 Feb 13, 2018 Jkt 244001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\14FEN1.SGM 14FEN1](https://thefederalregister.org/doc/83_FR_6614/page/1.svg)
![Federal Register / Vol. 83, No. 31 / Wednesday, February 14, 2018 / Notices 6585
during the regulatory review period. To DATES: Comments on this ICR should be determining eligibility of applicants,
meet its burden, the petition must received no later than March 16, 2018. making loans, and collecting monies
comply with all the requirements of ADDRESSES: Submit your comments, owed by borrowers on their outstanding
§ 60.30, including but not limited to: including the ICR Title, to the desk loans. The Deferment Form (Deferment-
Must be timely (see DATES), must be officer for HRSA, either by email to HRSA Form 519), provides the schools
filed in accordance with § 10.20, must OIRA_submission@omb.eop.gov or by with documentation of a borrower’s
contain sufficient facts to merit an FDA fax to 202–395–5806. deferment status, as detailed for the
investigation, and must certify that a FOR FURTHER INFORMATION CONTACT: To HPSL Program under 42 CFR part
true and complete copy of the petition request a copy of the clearance requests 57.210 and for NSL under 42 CFR part
has been served upon the patent submitted to OMB for review, email Lisa 57.310. The Annual Operating Report
applicant. (See H. Rept. 857, part 1, 98th Wright-Solomon, the HRSA Information (AOR–HRSA Form 501), provides HHS
Cong., 2d sess., pp. 41–42, 1984.) Collection Clearance Officer at with information from participating
Petitions should be in the format paperwork@hrsa.gov or call (301) 443– schools (including schools that are no
specified in 21 CFR 10.30. 1984. longer disbursing loans but are required
Submit petitions electronically to SUPPLEMENTARY INFORMATION: When to report and maintain program records,
https://www.regulations.gov at Docket submitting comments or requesting student records, and repayment records
No. FDA–2013–S–0610. Submit written information, please include the until all student loans are repaid in full
petitions (two copies are required) to the information request collection title for and all monies due to the Federal
Dockets Management Staff (HFA–305), reference. Government are returned) relating to
Food and Drug Administration, 5630 Information Collection Request Title: HPSL and NSL Program operations and
Fishers Lane, Rm. 1061, Rockville, MD Health Professions Student Loan (HPSL) financial activities. Moreover, the HPSL
20852. Program and Nursing Student Loan and NSL Program requirements are
Dated: February 8, 2018. (NSL) Program Administrative essential for assuring that borrowers are
Leslie Kux, Requirements (Regulations and Policy). aware of their rights and
OMB No. 0915-0047-Revision. responsibilities, academic institutions
Associate Commissioner for Policy.
Abstract: The HPSL Program, as have accurate records of the history and
[FR Doc. 2018–02992 Filed 2–13–18; 8:45 am]
authorized by Public Health Service status of each loan account in order to
BILLING CODE 4164–01–P (PHS) Act Sections 721–722 and 725– pursue aggressive collection efforts to
735, provides long-term, low-interest reduce default rates, and that academic
loans to students attending schools of institutions maintain adequate records
DEPARTMENT OF HEALTH AND medicine, osteopathic medicine, for audit and assessment purposes to
HUMAN SERVICES dentistry, veterinary medicine, help HHS safeguard federal funds
Health Resources and Services optometry, podiatric medicine, and expended through the Federal Capital
Administration pharmacy. The NSL Program, as Contribution (FCC). Academic
authorized by PHS Act Sections 835– institutions are free to use improved
Agency Information Collection 842, provides long-term, low-interest information technology to manage the
Activities: Submission to OMB for loans to students who attend eligible information required by the regulations.
Review and Approval; Public Comment schools of nursing in programs leading
to a diploma and degrees in nursing, Likely Respondents: Financial Aid
Request; Information Collection Directors working at institutions
Request Title: Health Professions including an associate degree, a
baccalaureate degree, or graduate degree participating in the HPSL and NSL
Student Loan (HPSL) Program and Programs.
Nursing Student Loan (NSL) Program in nursing. It also contains a number of
Administrative Requirements recordkeeping and reporting Burden Statement: Burden in this
(Regulations and Policy). OMB No. requirements for academic institutions context means the time expended by
0915-0047-Revision and loan applicants. The applicable persons to generate, maintain, retain,
regulations for these programs under 42 disclose or provide the information
AGENCY: Health Resources and Services CFR part 57 implement and detail the requested. This includes the time
Administration (HRSA), Department of various statutory requirements (see needed to review instructions; to
Health and Human Services (HHS). chart below). In an effort to consolidate develop, acquire, install and utilize
ACTION: Notice. information collection requests and technology and systems for the purpose
achieve greater programmatic efficiency, of collecting, validating and verifying
SUMMARY: In compliance with of the HRSA is incorporating the Deferment information, processing and
Paperwork Reduction Act of 1995, Form (Deferment-HRSA Form 519) and maintaining information, and disclosing
HRSA has submitted an Information the Annual Operating Report (AOR– and providing information; to train
Collection Request (ICR) to the Office of HRSA Form 501) both formerly personnel and to be able to respond to
Management and Budget (OMB) for incorporated under OMB No. 0915– a collection of information; to search
review and approval. Comments 0044, into this information collection data sources; to complete and review
submitted during the first public review request. As a result, the OMB No. 0915– the collection of information; and to
of this ICR will be provided to OMB. 0044 package will be discontinued. transmit or otherwise disclose the
OMB will accept further comments from Need and Proposed Use of the information. The total annual burden
the public during the review and Information: Participating HPSL and hours estimated for this ICR are
daltland on DSKBBV9HB2PROD with NOTICES
approval period. NSL schools are responsible for summarized in the table below.
VerDate Sep<11>2014 22:07 Feb 13, 2018 Jkt 244001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\14FEN1.SGM 14FEN1](https://thefederalregister.org/doc/83_FR_6614/page/3.svg)
Document Created: 2018-02-14 03:59:37
Document Modified: 2018-02-14 03:59:37
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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 16, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more 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. | |
| FR Citation | 83 FR 6583 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR