83 FR 8088 - Determination of Regulatory Review Period for Purposes of Patent Extension; ZYDELIG-New Drug Application 206545
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 37 (February 23, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 37 (February 23, 2018)
| Page Range | 8088-8089 | |
| FR Document | 2018-03701 |
[Federal Register Volume 83, Number 37 (Friday, February 23, 2018)] [Notices] [Pages 8088-8089] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03701] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2015-E-2602; FDA-2015-E-2615] Determination of Regulatory Review Period for Purposes of Patent Extension; ZYDELIG--New Drug Application 206545 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 ZYDELIG based on new drug application (NDA) 206545 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. 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 24, 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 August 22, 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 24, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 24, 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 Nos. FDA-2015-E-2602 and FDA-2015-E-2615 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; ZYDELIG-NDA 206545.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the dockets 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 [[Page 8089]] 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 ZYDELIG (idelalisib). As approved in both NDA 206545 and NDA 205858, ZYDELIG is indicated for treatment of patients with: Relapsed chronic lymphocytic leukemia in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. Relapsed follicular B-cell non-Hodgkin lymphoma (FL) in patients who have received at least two prior systemic therapies. Relapsed small lymphocytic lymphoma (SLL) in patients who have received at least two prior systemic therapies. Accelerated approval was granted for FL and SLL based on overall response rate. Improvement in patient survival or disease related symptoms has not been established. Continued approval for these indications may be contingent upon verification of clinical benefit in confirmatory trials. Subsequent to the approvals, the USPTO received patent term restoration applications for ZYDELIG (U.S. Patent Nos. RE44599 and RE44638) from ICOS Corporation, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated November 4, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approvals of ZYDELIG under NDA 206545 and NDA 205858 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 ZYDELIG is 2,247 days. Of this time, 2,017 days occurred during the testing phase of the regulatory review period, while 230 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 30, 2008. FDA has verified the applicant's claim that the date the investigational new drug application (IND) became effective was on May 30, 2008. This is the same IND and the same date FDA determined as the beginning of the regulatory review period for ZYDELIG approved under NDA 205858. The regulatory review period for ZYDELIG approved under NDA 205858 is publishing in this issue of the Federal Register. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: December 6, 2013. FDA has verified the applicant's claims that the NDA for ZYDELIG (NDA 206545) was initially submitted on December 6, 2013. 3. The date the application was approved: July 23, 2014. FDA has verified the applicant's claims that NDA 206545 was approved on July 23, 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 applications for patent extension, this applicant seeks 494 days or 708 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: February 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03701 Filed 2-22-18; 8:45 am] BILLING CODE 4164-01-P
![8088 Federal Register / Vol. 83, No. 37 / Friday, February 23, 2018 / Notices
The reporting form tables and a website: https://www.acl.gov/about-acl/ AoA estimates the burden of this
crosswalk from the old data collection public-input. collection and entering the additional
to the new may be viewed at the ACL report information as follows:
Average
Number
Number of burden per Total burden
Instrument responses per
respondents response hours
respondent (in hours)
Annual State Ombudsman Report .................................................................. 52 1 223.6 11,628.6
Dated: February 16, 2018. 2018. The https://www.regulations.gov Instructions: All submissions received
Mary Lazare, electronic filing system will accept must include the Docket Nos. FDA–
Administrator and Assistant Secretary for comments until midnight Eastern Time 2015–E–2602 and FDA–2015–E–2615
Aging. at the end of April 24, 2018. Comments for ‘‘Determination of Regulatory
[FR Doc. 2018–03767 Filed 2–22–18; 8:45 am] received by mail/hand delivery/courier Review Period for Purposes of Patent
BILLING CODE 4154–01–P (for written/paper submissions) will be Extension; ZYDELIG–NDA 206545.’’
considered timely if they are Received comments, those filed in a
postmarked or the delivery service timely manner (see ADDRESSES), will be
DEPARTMENT OF HEALTH AND acceptance receipt is on or before that placed in the dockets and, except for
HUMAN SERVICES date. those submitted as ‘‘Confidential
Electronic Submissions Submissions,’’ publicly viewable at
Food and Drug Administration https://www.regulations.gov or at the
Submit electronic comments in the Dockets Management Staff between 9
[Docket Nos. FDA–2015–E–2602; FDA–
following way: a.m. and 4 p.m., Monday through
2015–E–2615]
• Federal eRulemaking Portal: Friday.
Determination of Regulatory Review https://www.regulations.gov. Follow the • Confidential Submissions—To
Period for Purposes of Patent instructions for submitting comments. submit a comment with confidential
Extension; ZYDELIG—New Drug Comments submitted electronically, information that you do not wish to be
Application 206545 including attachments, to https:// made publicly available, submit your
www.regulations.gov will be posted to comments only as a written/paper
AGENCY: Food and Drug Administration, the docket unchanged. Because your submission. You should submit two
HHS. comment will be made public, you are copies total. One copy will include the
ACTION: Notice. solely responsible for ensuring that your information you claim to be confidential
comment does not include any with a heading or cover note that states
SUMMARY: The Food and Drug confidential information that you or a
Administration (FDA or the Agency) has ‘‘THIS DOCUMENT CONTAINS
third party may not wish to be posted, CONFIDENTIAL INFORMATION.’’ The
determined the regulatory review period such as medical information, your or
for ZYDELIG based on new drug Agency will review this copy, including
anyone else’s Social Security number, or the claimed confidential information, in
application (NDA) 206545 and is confidential business information, such
publishing this notice of that its consideration of comments. The
as a manufacturing process. Please note
determination as required by law. FDA second copy, which will have the
that if you include your name, contact
has made the determination because of claimed confidential information
information, or other information that
the submission of applications to the redacted/blacked out, will be available
identifies you in the body of your
Director of the U.S. Patent and for public viewing and posted on
comments, that information will be
Trademark Office (USPTO), Department https://www.regulations.gov. Submit
posted on https://www.regulations.gov.
of Commerce, for the extension of a • If you want to submit a comment both copies to the Dockets Management
patent which claims that human drug with confidential information that you Staff. If you do not wish your name and
product. do not wish to be made available to the contact information to be made publicly
public, submit the comment as a available, you can provide this
DATES: Anyone with knowledge that any information on the cover sheet and not
of the dates as published (in the written/paper submission and in the
manner detailed (see ‘‘Written/Paper in the body of your comments and you
SUPPLEMENTARY INFORMATION section) are must identify this information as
incorrect may submit either electronic Submissions’’ and ‘‘Instructions’’).
‘‘confidential.’’ Any information marked
or written comments and ask for a Written/Paper Submissions as ‘‘confidential’’ will not be disclosed
redetermination by April 24, 2018. Submit written/paper submissions as except in accordance with § 10.20 (21
Furthermore, any interested person may follows: CFR 10.20) and other applicable
petition FDA for a determination • Mail/Hand delivery/Courier (for disclosure law. For more information
regarding whether the applicant for written/paper submissions): Dockets about FDA’s posting of comments to
extension acted with due diligence Management Staff (HFA–305), Food and public dockets, see 80 FR 56469,
during the regulatory review period by Drug Administration, 5630 Fishers September 18, 2015, or access the
August 22, 2018. See ‘‘Petitions’’ in the Lane, Rm. 1061, Rockville, MD 20852. information at: https://www.gpo.gov/
daltland on DSKBBV9HB2PROD with NOTICES
SUPPLEMENTARY INFORMATION section for • For written/paper comments fdsys/pkg/FR-2015-09-18/pdf/2015-
more information. submitted to the Dockets Management 23389.pdf.
ADDRESSES: You may submit comments Staff, FDA will post your comment, as Docket: For access to the docket to
as follows. Please note that late, well as any attachments, except for read background documents or the
untimely filed comments will not be information submitted, marked and electronic and written/paper comments
considered. Electronic comments must identified, as confidential, if submitted received, go to https://
be submitted on or before April 24, as detailed in ‘‘Instructions.’’ www.regulations.gov and insert the
VerDate Sep<11>2014 18:52 Feb 22, 2018 Jkt 244001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\23FEN1.SGM 23FEN1](https://thefederalregister.org/doc/83_FR_8125/page/1.svg)
![Federal Register / Vol. 83, No. 37 / Friday, February 23, 2018 / Notices 8089
docket number, found in brackets in the who have received at least two prior verified the applicant’s claims that NDA
heading of this document, into the systemic therapies. 206545 was approved on July 23, 2014.
‘‘Search’’ box and follow the prompts • Relapsed small lymphocytic This determination of the regulatory
and/or go to the Dockets Management lymphoma (SLL) in patients who have review period establishes the maximum
Staff, 5630 Fishers Lane, Rm. 1061, received at least two prior systemic potential length of a patent extension.
Rockville, MD 20852. therapies. However, the USPTO applies several
FOR FURTHER INFORMATION CONTACT:
Accelerated approval was granted for statutory limitations in its calculations
Beverly Friedman, Office of Regulatory FL and SLL based on overall response of the actual period for patent extension.
Policy, Food and Drug Administration, rate. Improvement in patient survival or In its applications for patent extension,
10903 New Hampshire Ave., Bldg. 51, disease related symptoms has not been this applicant seeks 494 days or 708
Rm. 6250, Silver Spring, MD 20993, established. Continued approval for days of patent term extension.
301–796–3600. these indications may be contingent
upon verification of clinical benefit in III. Petitions
SUPPLEMENTARY INFORMATION: confirmatory trials. Anyone with knowledge that any of
I. Background Subsequent to the approvals, the the dates as published are incorrect may
USPTO received patent term restoration submit either electronic or written
The Drug Price Competition and applications for ZYDELIG (U.S. Patent comments and, under 21 CFR 60.24, ask
Patent Term Restoration Act of 1984 Nos. RE44599 and RE44638) from ICOS for a redetermination (see DATES).
(Pub. L. 98–417) and the Generic Corporation, and the USPTO requested Furthermore, as specified in § 60.30 (21
Animal Drug and Patent Term FDA’s assistance in determining the CFR 60.30), any interested person may
Restoration Act (Pub. L. 100–670) patents’ eligibility for patent term petition FDA for a determination
generally provide that a patent may be restoration. In a letter dated November regarding whether the applicant for
extended for a period of up to 5 years 4, 2015, FDA advised the USPTO that extension acted with due diligence
so long as the patented item (human this human drug product had undergone during the regulatory review period. To
drug product, animal drug product, a regulatory review period and that the meet its burden, the petition must
medical device, food additive, or color approvals of ZYDELIG under NDA comply with all the requirements of
additive) was subject to regulatory 206545 and NDA 205858 represented § 60.30, including but not limited to:
review by FDA before the item was the first permitted commercial must be timely (see DATES), must be
marketed. Under these acts, a product’s marketing or use of the product. filed in accordance with § 10.20, must
regulatory review period forms the basis Thereafter, the USPTO requested that contain sufficient facts to merit an FDA
for determining the amount of extension FDA determine the product’s regulatory investigation, and must certify that a
an applicant may receive. review period. true and complete copy of the petition
A regulatory review period consists of has been served upon the patent
two periods of time: A testing phase and II. Determination of Regulatory Review
applicant. (See H. Rept. 857, part 1, 98th
an approval phase. For human drug Period
Cong., 2d sess., pp. 41–42, 1984.)
products, the testing phase begins when FDA has determined that the Petitions should be in the format
the exemption to permit the clinical applicable regulatory review period for specified in 21 CFR 10.30.
investigations of the drug becomes ZYDELIG is 2,247 days. Of this time, Submit petitions electronically to
effective and runs until the approval 2,017 days occurred during the testing https://www.regulations.gov at Docket
phase begins. The approval phase starts phase of the regulatory review period, No. FDA–2013–S–0610. Submit written
with the initial submission of an while 230 days occurred during the petitions (two copies are required) to the
application to market the human drug approval phase. These periods of time Dockets Management Staff (HFA–305),
product and continues until FDA grants were derived from the following dates: Food and Drug Administration, 5630
permission to market the drug product. 1. The date an exemption under Fishers Lane, Rm. 1061, Rockville, MD
Although only a portion of a regulatory section 505(i) of the Federal Food, Drug, 20852.
review period may count toward the and Cosmetic Act (the FD&C Act) (21 Dated: February 16, 2018.
actual amount of extension that the U.S.C. 355(i)) became effective: May 30,
Director of USPTO may award (for Leslie Kux,
2008. FDA has verified the applicant’s
example, half the testing phase must be Associate Commissioner for Policy.
claim that the date the investigational
subtracted as well as any time that may new drug application (IND) became [FR Doc. 2018–03701 Filed 2–22–18; 8:45 am]
have occurred before the patent was effective was on May 30, 2008. This is BILLING CODE 4164–01–P
issued), FDA’s determination of the the same IND and the same date FDA
length of a regulatory review period for determined as the beginning of the
a human drug product will include all regulatory review period for ZYDELIG DEPARTMENT OF HEALTH AND
of the testing phase and approval phase approved under NDA 205858. The HUMAN SERVICES
as specified in 35 U.S.C. 156(g)(1)(B). regulatory review period for ZYDELIG Food and Drug Administration
FDA has approved for marketing the approved under NDA 205858 is
human drug product ZYDELIG publishing in this issue of the Federal [Docket No. FDA–2018–N–0478]
(idelalisib). As approved in both NDA Register.
206545 and NDA 205858, ZYDELIG is 2. The date the application was Sebela Ireland, Ltd. et al.; Withdrawal
indicated for treatment of patients with: initially submitted with respect to the of Approval of 24 Abbreviated New
• Relapsed chronic lymphocytic human drug product under section Drug Applications
daltland on DSKBBV9HB2PROD with NOTICES
leukemia in combination with 505(b) of the FD&C Act: December 6, AGENCY: Food and Drug Administration,
rituximab, in patients for whom 2013. FDA has verified the applicant’s HHS.
rituximab alone would be considered claims that the NDA for ZYDELIG (NDA ACTION: Notice.
appropriate therapy due to other co- 206545) was initially submitted on
morbidities. December 6, 2013. SUMMARY: The Food and Drug
• Relapsed follicular B-cell non- 3. The date the application was Administration (FDA or Agency) is
Hodgkin lymphoma (FL) in patients approved: July 23, 2014. FDA has withdrawing approval of 24 abbreviated
VerDate Sep<11>2014 18:52 Feb 22, 2018 Jkt 244001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\23FEN1.SGM 23FEN1](https://thefederalregister.org/doc/83_FR_8125/page/2.svg)
Document Created: 2018-02-23 01:32:39
Document Modified: 2018-02-23 01:32:39
| 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 24, 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 August 22, 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 8088 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR