83 FR 6861 - Determination of Regulatory Review Period for Purposes of Patent Extension; ZYDELIG-New Drug Application 205858
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 32 (February 15, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 32 (February 15, 2018)
| Page Range | 6861-6863 | |
| FR Document | 2018-03134 |
[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)] [Notices] [Pages 6861-6863] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03134] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2015-E-2604 and FDA-2015-E-2619] Determination of Regulatory Review Period for Purposes of Patent Extension; ZYDELIG--New Drug Application 205858 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) 205858 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 and that NDA. DATES: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 16, 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 14, 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. 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-2604 and FDA-2015-E-2619 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; ZYDELIG--NDA 205858.'' 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 [[Page 6862]] 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 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 based on NDA 205858 is 2,247 days. Of this time, 1,931 days occurred during the testing phase of the regulatory review period, while 316 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 (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 206545. The regulatory review period for ZYDELIG approved under NDA 206545 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: September 11, 2013. FDA has verified the applicant's claim that NDA 205858 for ZYDELIG was initially submitted on September 11, 2013. 3. The date the application was approved: July 23, 2014. FDA has verified the applicant's claim that NDA 205858 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 application for patent extension, this applicant seeks 537 days or 751 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), [[Page 6863]] Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: February 9, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03134 Filed 2-14-18; 8:45 am] BILLING CODE 4164-01-P
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2. The date the application was DEPARTMENT OF HEALTH AND the docket unchanged. Because your
initially submitted with respect to the HUMAN SERVICES comment will be made public, you are
human drug product under section solely responsible for ensuring that your
505(b) of the FD&C Act: September 25, Food and Drug Administration comment does not include any
2012. The applicant claims September [Docket Nos. FDA–2015–E–2604 and FDA– confidential information that you or a
24, 2012, as the date the NDA for 2015–E–2619] third party may not wish to be posted,
FETZIMA was initially submitted. such as medical information, your or
However, FDA records indicate that Determination of Regulatory Review anyone else’s Social Security number, or
new drug application (NDA) 204168 Period for Purposes of Patent confidential business information, such
Extension; ZYDELIG—New Drug as a manufacturing process. Please note
was submitted on September 25, 2012.
Application 205858 that if you include your name, contact
3. The date the application was information, or other information that
approved: July 25, 2013. FDA has AGENCY: Food and Drug Administration, identifies you in the body of your
verified the applicant’s claim that NDA HHS. comments, that information will be
204168 was approved on July 25, 2013. ACTION: Notice. posted on https://www.regulations.gov.
This determination of the regulatory • If you want to submit a comment
SUMMARY: The Food and Drug
review period establishes the maximum with confidential information that you
Administration (FDA or the Agency) has
potential length of a patent extension. do not wish to be made available to the
determined the regulatory review period
public, submit the comment as a
However, the USPTO applies several for ZYDELIG based on new drug
written/paper submission and in the
statutory limitations in its calculations application (NDA) 205858 and is
manner detailed (see ‘‘Written/Paper
of the actual period for patent extension. publishing this notice of that
Submissions’’ and ‘‘Instructions’’).
In its application for patent extension, determination as required by law. FDA
this applicant seeks 954 days of patent has made the determination because of Written/Paper Submissions
term extension. the submission of applications to the Submit written/paper submissions as
Director of the U.S. Patent and follows:
III. Petitions Trademark Office (USPTO), Department • Mail/Hand delivery/Courier (for
of Commerce, for the extension of a written/paper submissions): Dockets
Anyone with knowledge that any of
patent which claims that human drug Management Staff (HFA–305), Food and
the dates as published are incorrect may
product and that NDA. Drug Administration, 5630 Fishers
submit either electronic or written
DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852.
comments and ask for a redetermination
of the dates as published (see the • For written/paper comments
(see DATES). Furthermore, as specified in submitted to the Dockets Management
SUPPLEMENTARY INFORMATION section) are
§ 60.30 (21 CFR 60.30), any interested incorrect may submit either electronic Staff, FDA will post your comment, as
person may petition FDA for a or written comments and ask for a well as any attachments, except for
determination regarding whether the redetermination by April 16, 2018. information submitted, marked and
applicant for extension acted with due Furthermore, any interested person may identified, as confidential, if submitted
diligence during the regulatory review petition FDA for a determination as detailed in ‘‘Instructions.’’
period. To meet its burden, the petition regarding whether the applicant for Instructions: All submissions received
must comply with all the requirements extension acted with due diligence must include the Docket Nos. FDA–
of § 60.30, including but not limited to: during the regulatory review period by 2015–E–2604 and FDA–2015–E–2619
Must be timely (see DATES), must be August 14, 2018. See ‘‘Petitions’’ in the for ‘‘Determination of Regulatory
filed in accordance with § 10.20, must SUPPLEMENTARY INFORMATION section for Review Period for Purposes of Patent
contain sufficient facts to merit an FDA more information. Extension; ZYDELIG—NDA 205858.’’
investigation, and must certify that a ADDRESSES: You may submit comments Received comments, those filed in a
true and complete copy of the petition as follows. Please note that late, timely manner (see ADDRESSES), will be
has been served upon the patent untimely filed comments will not be placed in the docket and, except for
applicant. (See H. Rept. 857, part 1, 98th considered. Electronic comments must those submitted as ‘‘Confidential
Cong., 2d sess., pp. 41–42, 1984.) be submitted on or before April 16, Submissions,’’ publicly viewable at
Petitions should be in the format 2018. The https://www.regulations.gov https://www.regulations.gov or at the
specified in 21 CFR 10.30. electronic filing system will accept Dockets Management Staff between 9
comments until midnight Eastern Time a.m. and 4 p.m., Monday through
Submit petitions electronically to Friday.
at the end of April 16, 2018. Comments
https://www.regulations.gov at Docket
received by mail/hand delivery/courier • Confidential Submissions—To
No. FDA–2013–S–0610. Submit written submit a comment with confidential
(for written/paper submissions) will be
petitions (two copies are required) to the considered timely if they are information that you do not wish to be
Dockets Management Staff (HFA–305), postmarked or the delivery service made publicly available, submit your
Food and Drug Administration, 5630 acceptance receipt is on or before that comments only as a written/paper
Fishers Lane, Rm. 1061, Rockville, MD date. submission. You should submit two
20852. copies total. One copy will include the
Electronic Submissions information you claim to be confidential
Dated: February 9, 2018.
with a heading or cover note that states
sradovich on DSK3GMQ082PROD with NOTICES
Submit electronic comments in the
Leslie Kux,
following way: ‘‘THIS DOCUMENT CONTAINS
Associate Commissioner for Policy. • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
[FR Doc. 2018–03129 Filed 2–14–18; 8:45 am] https://www.regulations.gov. Follow the Agency will review this copy, including
BILLING CODE 4164–01–P instructions for submitting comments. the claimed confidential information, in
Comments submitted electronically, its consideration of comments. The
including attachments, to https:// second copy, which will have the
www.regulations.gov will be posted to claimed confidential information
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![Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices 6863
Food and Drug Administration, 5630 third party may not wish to be posted, in the body of your comments and you
Fishers Lane, Rm. 1061, Rockville, MD such as medical information, your or must identify this information as
20852. anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked
Dated: February 9, 2018. confidential business information, such as ‘‘confidential’’ will not be disclosed
Leslie Kux,
as a manufacturing process. Please note except in accordance with 21 CFR 10.20
that if you include your name, contact and other applicable disclosure law. For
Associate Commissioner for Policy.
information, or other information that more information about FDA’s posting
[FR Doc. 2018–03134 Filed 2–14–18; 8:45 am] identifies you in the body of your of comments to public dockets, see 80
BILLING CODE 4164–01–P comments, that information will be FR 56469, September 18, 2015, or access
posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
• If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
DEPARTMENT OF HEALTH AND with confidential information that you 23389.pdf.
HUMAN SERVICES do not wish to be made available to the Docket: For access to the docket to
public, submit the comment as a read background documents or the
Food and Drug Administration
written/paper submission and in the electronic and written/paper comments
[Docket No. FDA–2011–D–0800] manner detailed (see ‘‘Written/Paper received, go to https://
Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the
Regulatory Classification of docket number, found in brackets in the
Pharmaceutical Co-Crystals; Guidance Written/Paper Submissions
heading of this document, into the
for Industry; Availability Submit written/paper submissions as ‘‘Search’’ box and follow the prompts
follows: and/or go to the Dockets Management
AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
HHS. Staff, 5630 Fishers Lane, Rm. 1061,
written/paper submissions): Dockets
ACTION: Notice of availability. Rockville, MD 20852.
Management Staff (HFA–305), Food and
You may submit comments on any
Drug Administration, 5630 Fishers
SUMMARY: The Food and Drug guidance at any time (see 21 CFR
Lane, Rm. 1061, Rockville, MD 20852.
Administration (FDA or Agency) is • For written/paper comments 10.115(g)(5)).
announcing the availability of a submitted to the Dockets Management Submit written requests for single
guidance for industry entitled Staff, FDA will post your comment, as copies of this guidance to the Division
‘‘Regulatory Classification of well as any attachments, except for of Drug Information, Center for Drug
Pharmaceutical Co-Crystals.’’ This information submitted, marked and Evaluation and Research, Food and
guidance provides applicants planning identified, as confidential, if submitted Drug Administration, 10001 New
to submit new drug applications and as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building,
abbreviated new drug applications with Instructions: All submissions received 4th Floor, Silver Spring, MD 20993–
information on the appropriate must include the Docket No. FDA– 0002. Send one self-addressed adhesive
regulatory classification of 2011–D–0800 for ‘‘Regulatory label to assist that office in processing
pharmaceutical co-crystal solid-state Classification of Pharmaceutical Co- your requests. See the SUPPLEMENTARY
forms. It also provides information Crystals.’’ Received comments will be INFORMATION section for electronic
about the data that applicants should placed in the docket and, except for access to the guidance document.
submit to support the appropriate those submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT:
classification of a co-crystal as well as Submissions,’’ publicly viewable at Richard (Rik) Lostritto, Center for Drug
the regulatory implications of the https://www.regulations.gov or at the Evaluation and Research, Food and
classification. This guidance finalizes Dockets Management Staff office Drug Administration, 10903 New
the draft guidance for industry entitled between 9 a.m. and 4 p.m., Monday Hampshire Ave., Bldg. 51, Rm. 4148,
‘‘Regulatory Classification of through Friday. Silver Spring, MD 20993–0002, 301–
Pharmaceutical Co-Crystals’’ published • Confidential Submissions—To 796–1697.
in August 2016. submit a comment with confidential SUPPLEMENTARY INFORMATION:
DATES: The announcement of the information that you do not wish to be
guidance is published in the Federal made publicly available, submit your I. Background
Register on February 15, 2018. comments only as a written/paper FDA is announcing the availability of
ADDRESSES: You may submit either submission. You should submit two a guidance for industry entitled
electronic or written comments on copies total. One copy will include the ‘‘Regulatory Classification of
Agency guidances at any time as information you claim to be confidential Pharmaceutical Co-Crystals.’’ This
follows: with a heading or cover note that states guidance provides applicants planning
‘‘THIS DOCUMENT CONTAINS to submit new drug applications and
Electronic Submissions CONFIDENTIAL INFORMATION.’’ The abbreviated new drug applications with
Submit electronic comments in the Agency will review this copy, including information on the appropriate
following way: the claimed confidential information, in regulatory classification of
• Federal eRulemaking Portal: its consideration of comments. The pharmaceutical co-crystal solid-state
https://www.regulations.gov. Follow the second copy, which will have the forms. This guidance also provides
instructions for submitting comments. claimed confidential information information about the data that
Comments submitted electronically, redacted/blacked out, will be available applicants should submit to support the
sradovich on DSK3GMQ082PROD with NOTICES
including attachments, to https:// for public viewing and posted on appropriate classification of a co-crystal
www.regulations.gov will be posted to https://www.regulations.gov. Submit as well as the regulatory implications of
the docket unchanged. Because your both copies to the Dockets Management the classification.
comment will be made public, you are Staff. If you do not wish your name and The recommendations in this
solely responsible for ensuring that your contact information to be made publicly guidance apply to materials that the
comment does not include any available, you can provide this Agency has not previously evaluated
confidential information that you or a information on the cover sheet and not and determined to be pharmaceutical
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Document Created: 2018-02-15 00:20:48
Document Modified: 2018-02-15 00:20:48
| 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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 16, 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 14, 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 6861 |
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