82 FR 56246 - Determination of Regulatory Review Period for Purposes of Patent Extension; YONDELIS
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 227 (November 28, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 227 (November 28, 2017)
| Page Range | 56246-56248 | |
| FR Document | 2017-25683 |
[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)] [Notices] [Pages 56246-56248] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25683] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-2374] Determination of Regulatory Review Period for Purposes of Patent Extension; YONDELIS 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 YONDELIS and is publishing this notice of that determination as required [[Page 56247]] 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 January 29, 2018. 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 May 29, 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 January 29, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 29, 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. 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.'' Instructions: All submissions received must include the Docket No. FDA-2016-E-2374 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; YONDELIS.'' 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 YONDELIS (trabectedin). YONDELIS is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen. Subsequent to this approval, the USPTO [[Page 56248]] received a patent term restoration application for YONDELIS (U.S. Patent No. 7,420,051) from Pharma Mar, S.A., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated August 25, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of YONDELIS 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 YONDELIS is 7,107 days. Of this time, 6,773 days occurred during the testing phase of the regulatory review period, while 334 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 10, 1996. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on May 10, 1996. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: November 24, 2014. FDA has verified the applicant's claim that the new drug application (NDA) for YONDELIS (NDA 207953) was initially submitted on November 24, 2014. 3. The date the application was approved: October 23, 2015. FDA has verified the applicant's claim that NDA 207953 was approved on October 23, 2015. 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 1,471 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: November 22, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-25683 Filed 11-27-17; 8:45 am] BILLING CODE 4164-01-P
![56246 Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices
‘‘Weighing the Evidence: Variant internal and external experts in If you need special accommodations
Classification and Interpretation in precision oncology to discuss how due to a disability, please contact Peggy
Precision Oncology.’’ The purpose of genetic sequencing data is best Roney, Center for Devices and
the public workshop is to engage implemented in patient management so Radiological Health, Food and Drug
stakeholders and solicit input from that innovative regulatory strategies can Administration, 10903 New Hampshire
experts in oncology precision medicine be advanced to support the Ave., Bldg. 32, Rm. 5231, Silver Spring,
on how to best weigh and evaluate development of safe and effective MD 20993–0002, 301–796–5671, email:
evidence for classification and precision-based drugs and devices for Peggy.Roney@fda.hhs.gov no later than
interpretation of sequencing results for marketing. January 10, 2018.
precision oncology. Streaming Webcast of the Public
II. Topics for Discussion
DATES: The public workshop will be Workshop: This public workshop will
held on January 29, 2018, from 8:30 a.m. Topics for discussion at the public also be webcast. The webcast link will
to 5 p.m. See the SUPPLEMENTARY workshop include: be available on the registration Web
INFORMATION section for registration date • An overview of the state of the page after January 10, 2018.
and information. science for sequence variant Organizations are requested to view
ADDRESSES: The public workshop will classification in oncology and its using one connection per location.
be held at FDA’s White Oak Campus, practical use in treating patients; If you have never attended a Connect
10903 New Hampshire Ave., Bldg. 31, • The level of evidence required for Pro event before, test your connection at
Rm. 1503 (the Great Room), Silver reporting variants and/or guiding https://collaboration.fda.gov/common/
Spring, MD 20993–0002. Entrance for patient treatment; help/en/support/meeting_test.htm. To
the public workshop participants (non- • Best practices for the use of public/ get a quick overview of the Connect Pro
FDA employees) is through Building 1 private databases for variant program, visit https://www.adobe.com/
where routine security check classification and interpretation in go/connectpro_overview. FDA has
procedures will be performed. For oncology; and verified the Web site addresses in this
parking and security information, please • Future directions for data sharing, document, as of the date this document
refer to https://www.fda.gov/AboutFDA/ standardization, and establishing publishes in the Federal Register, but
WorkingatFDA/BuildingsandFacilities/ consistency in precision oncology. Web sites are subject to change over
WhiteOakCampusInformation/ The workshop will include a series of time.
ucm241740.htm. brief presentations to provide Transcripts: Please be advised that as
FOR FURTHER INFORMATION CONTACT: information to frame the main topics soon as a transcript of the public
Hisani Madison, Food and Drug and interactive discussions via several workshop is available, it will be
Administration, Center for Devices and panel sessions. Following the accessible at https://
Radiological Health, 10903 New presentations, there will be a moderated www.regulations.gov. It may be viewed
Hampshire Ave., Bldg. 66, Rm. 5547, discussion where speakers and at the Dockets Management Staff, Food
Silver Spring, MD 20993, 240–402– additional panelists may be asked to and Drug Administration, 5630 Fishers
6581, hisani.madison@fda.hhs.gov. provide their individual perspectives. Lane, Rm. 1061, Rockville, MD 20852. A
link to the transcript will also be
SUPPLEMENTARY INFORMATION: III. Participating in the Public available on the internet at https://
I. Background Workshop www.fda.gov/MedicalDevices/
The goal of precision oncology is to Registration: To register for the public NewsEvents/WorkshopsConferences/
use a cancer patient’s genetic data to workshop, please visit FDA’s Medical default.htm. (Select this public
help determine which therapeutic(s) Devices News & Events—Workshops & workshop from the posted events list.).
might be most effective in treating their Conferences calendar at https:// Dated: November 21, 2017.
disease. Next generation sequencing is www.fda.gov/MedicalDevices/ Leslie Kux,
increasingly employed in oncology NewsEvents/WorkshopsConferences/ Associate Commissioner for Policy.
because the technology can be used to default.htm. (Select this public
[FR Doc. 2017–25584 Filed 11–27–17; 8:45 am]
screen a large number of mutations workshop from the posted events list.)
BILLING CODE 4164–01–P
simultaneously to optimize and Please provide complete contact
personalize patient care. The increasing information for each attendee, including
number of reported mutations may lead name, title, affiliation, address, email, DEPARTMENT OF HEALTH AND
to uncertainty for clinicians in the and telephone. HUMAN SERVICES
interpretation and prioritization of the Registration is free and based on
variants with respect to the clinical space availability, with priority given to Food and Drug Administration
significance and optimal course of early registrants. Persons interested in
attending this public workshop must [Docket No. FDA–2016–E–2374]
action, respectively.
In January 2017, the Association for register by January 19, 2018, by 4 p.m.
Determination of Regulatory Review
Molecular Pathology, the American Eastern Time. Early registration is
Period for Purposes of Patent
Society of Clinical Oncology, and the recommended because seating is
Extension; YONDELIS
College of American Pathologists limited; therefore, FDA may limit the
published a joint consensus number of participants from each AGENCY: Food and Drug Administration,
recommendation for standards and organization. Registrants will receive HHS.
ethrower on DSK3G9T082PROD with NOTICES
guidelines for the interpretation and confirmation when they have been ACTION: Notice.
reporting of sequence variants in cancer. accepted. If time and space permit,
However, the implementation of these onsite registration on the day of the SUMMARY: The Food and Drug
recommendations is not consistently public workshop will be provided Administration (FDA or the Agency) has
applied across all stakeholders. FDA is beginning at 8 a.m. We will let determined the regulatory review period
holding this public workshop to engage registrants know if registration closes for YONDELIS and is publishing this
stakeholders and solicit input from before the day of the public workshop. notice of that determination as required
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![56248 Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices
received a patent term restoration during the regulatory review period. To support such indications. Both new
application for YONDELIS (U.S. Patent meet its burden, the petition must devices and modifications of existing x-
No. 7,420,051) from Pharma Mar, S.A., comply with all the requirements of ray imaging devices that require
and the USPTO requested FDA’s § 60.30, including but not limited to: submission of a new premarket
assistance in determining this patent’s Must be timely (see DATES), must be notification are included within the
eligibility for patent term restoration. In filed in accordance with § 10.20, must scope of this guidance document,
a letter dated August 25, 2016, FDA contain sufficient facts to merit an FDA regardless of whether the device is a
advised the USPTO that this human investigation, and must certify that a complete x-ray imaging system, a
drug product had undergone a true and complete copy of the petition component part of an x-ray imaging
regulatory review period and that the has been served upon the patent device, or an accessory (e.g., detectors
approval of YONDELIS represented the applicant. (See H. Rept. 857, part 1, 98th and software).
first permitted commercial marketing or Cong., 2d sess., pp. 41–42, 1984.) DATES: The announcement of the
use of the product. Thereafter, the Petitions should be in the format guidance is published in the Federal
USPTO requested that FDA determine specified in 21 CFR 10.30. Register on November 28, 2017.
the product’s regulatory review period. Submit petitions electronically to ADDRESSES: You may submit either
II. Determination of Regulatory Review https://www.regulations.gov at Docket electronic or written comments on
Period No. FDA–2013–S–0610. Submit written Agency guidances at any time as
petitions (two copies are required) to the follows:
FDA has determined that the Dockets Management Staff (HFA–305),
applicable regulatory review period for Food and Drug Administration, 5630 Electronic Submissions
YONDELIS is 7,107 days. Of this time, Fishers Lane, Rm. 1061, Rockville, MD
6,773 days occurred during the testing Submit electronic comments in the
20852. following way:
phase of the regulatory review period,
while 334 days occurred during the Dated: November 22, 2017. • Federal eRulemaking Portal:
approval phase. These periods of time Leslie Kux, https://www.regulations.gov. Follow the
were derived from the following dates: Associate Commissioner for Policy. instructions for submitting comments.
1. The date an exemption under [FR Doc. 2017–25683 Filed 11–27–17; 8:45 am] Comments submitted electronically,
section 505(i) of the Federal Food, Drug, BILLING CODE 4164–01–P
including attachments, to https://
and Cosmetic Act (the FD&C Act) (21 www.regulations.gov will be posted to
U.S.C. 355(i)) became effective: May 10, the docket unchanged. Because your
1996. FDA has verified the applicant’s DEPARTMENT OF HEALTH AND comment will be made public, you are
claim that the date the investigational HUMAN SERVICES solely responsible for ensuring that your
new drug application became effective comment does not include any
was on May 10, 1996. Food and Drug Administration confidential information that you or a
2. The date the application was third party may not wish to be posted,
[Docket No. FDA–2012–D–0384]
initially submitted with respect to the such as medical information, your or
human drug product under section Pediatric Information for X-Ray anyone else’s Social Security number, or
505(b) of the FD&C Act: November 24, Imaging Device Premarket confidential business information, such
2014. FDA has verified the applicant’s Notifications; Guidance for Industry as a manufacturing process. Please note
claim that the new drug application and Food and Drug Administration that if you include your name, contact
(NDA) for YONDELIS (NDA 207953) Staff; Availability information, or other information that
was initially submitted on November identifies you in the body of your
24, 2014. AGENCY: Food and Drug Administration, comments, that information will be
3. The date the application was HHS. posted on https://www.regulations.gov.
approved: October 23, 2015. FDA has ACTION: Notice of availability. • If you want to submit a comment
verified the applicant’s claim that NDA with confidential information that you
207953 was approved on October 23, SUMMARY: The Food and Drug do not wish to be made available to the
2015. Administration (FDA or Agency) is public, submit the comment as a
This determination of the regulatory announcing the availability of the written/paper submission and in the
review period establishes the maximum guidance entitled ‘‘Pediatric Information manner detailed (see ‘‘Written/Paper
potential length of a patent extension. for X-ray Imaging Device Premarket Submissions’’ and ‘‘Instructions’’).
However, the USPTO applies several Notifications.’’ This guidance document
outlines FDA’s current thinking on Written/Paper Submissions
statutory limitations in its calculations
of the actual period for patent extension. information that should be provided in Submit written/paper submissions as
In its application for patent extension, premarket notification submissions for follows:
this applicant seeks 1,471 days of patent x-ray imaging devices that are indicated • Mail/Hand delivery/Courier (for
term extension. for pediatric populations or general use written/paper submissions): Dockets
x-ray imaging devices for which Management Staff (HFA–305), Food and
III. Petitions considerable pediatric application is Drug Administration, 5630 Fishers
Anyone with knowledge that any of anticipated. FDA intends for this Lane, Rm. 1061, Rockville, MD 20852.
the dates as published are incorrect may guidance to minimize uncertainty • For written/paper comments
submit either electronic or written during the premarket review process of submitted to the Dockets Management
ethrower on DSK3G9T082PROD with NOTICES
comments and, under 21 CFR 60.24, ask premarket notification submissions for Staff, FDA will post your comment, as
for a redetermination (see DATES). x-ray imaging devices for pediatric use well as any attachments, except for
Furthermore, as specified in § 60.30 (21 to encourage the inclusion of pediatric information submitted, marked and
CFR 60.30), any interested person may indications for use for x-ray imaging identified, as confidential, if submitted
petition FDA for a determination device premarket notification as detailed in ‘‘Instructions.’’
regarding whether the applicant for submissions and to provide Instructions: All submissions received
extension acted with due diligence recommendations on information to must include the Docket No. FDA–
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Document Created: 2017-11-28 01:50:58
Document Modified: 2017-11-28 01:50:58
| 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 January 29, 2018. 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 May 29, 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 | 82 FR 56246 |
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