82 FR 61008 - Determination of Regulatory Review Period for Purposes of Patent Extension; SIVEXTRO
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 246 (December 26, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 246 (December 26, 2017)
| Page Range | 61008-61010 | |
| FR Document | 2017-27684 |
[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)] [Notices] [Pages 61008-61010] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27684] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-E-2597] Determination of Regulatory Review Period for Purposes of Patent Extension; SIVEXTRO 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 SIVEXTRO 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 February 26, 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 February 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of February 26, 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 June 25, 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''). 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-2597 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; SIVEXTRO.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential [[Page 61009]] 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 SIVEXTRO (tedizolid phosphate). SIVEXTRO is indicated in adults for the treatment of acute bacterial skin and skin structure infections caused by designated susceptible bacteria. Subsequent to this approval, the USPTO received a patent term restoration application for SIVEXTRO (U.S. Patent No. 7,816,379) from Trius Therapeutics, Inc., 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 SIVEXTRO 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 SIVEXTRO is 2,366 days. Of this time, 2,123 days occurred during the testing phase of the regulatory review period, while 243 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: December 30, 2007. The applicant claims December 27, 2007, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was December 30, 2007, 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: October 21, 2013. FDA has verified the applicant's claim that the new drug application (NDA) for SIVEXTRO (NDA 205435) was initially submitted on October 21, 2013. 3. The date the application was approved: June 20, 2014. FDA has verified the applicant's claim that NDA 205435 was approved on June 20, 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 118 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. [[Page 61010]] Dated: December 19, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-27684 Filed 12-22-17; 8:45 am] BILLING CODE 4164-01-P
![61008 Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Notices
had undergone a regulatory review investigation, and must certify that a delivery/courier (for written/paper
period and that the approval of true and complete copy of the petition submissions) will be considered timely
STRIVERDI RESPIMAT represented the has been served upon the patent if they are postmarked or the delivery
first permitted commercial marketing or applicant. (See H. Rept. 857, part 1, 98th service acceptance receipt is on or
use of the product. Thereafter, the Cong., 2d sess., pp. 41–42, 1984.) before that date. Furthermore, any
USPTO requested that FDA determine Petitions should be in the format interested person may petition FDA for
the product’s regulatory review period. specified in 21 CFR 10.30. a determination regarding whether the
Submit petitions electronically to applicant for extension acted with due
II. Determination of Regulatory Review https://www.regulations.gov at Docket
Period diligence during the regulatory review
No. FDA–2013–S–0610. Submit written period by June 25, 2018. See ‘‘Petitions’’
FDA has determined that the petitions (two copies are required) to the in the SUPPLEMENTARY INFORMATION
applicable regulatory review period for Dockets Management Staff (HFA–305), section for more information.
STRIVERDI RESPIMAT is 2,712 days. Food and Drug Administration, 5630
Of this time, 1,903 days occurred during Fishers Lane, Rm. 1061, Rockville, MD Electronic Submissions
the testing phase of the regulatory 20852. Submit electronic comments in the
review period, while 809 days occurred Dated: December 19, 2017. following way:
during the approval phase. These • Federal eRulemaking Portal:
Leslie Kux,
periods of time were derived from the https://www.regulations.gov. Follow the
Associate Commissioner for Policy.
following dates: instructions for submitting comments.
1. The date an exemption under [FR Doc. 2017–27710 Filed 12–22–17; 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 (FD&C Act) (21 U.S.C. www.regulations.gov will be posted to
355(i)) became effective: February 28, the docket unchanged. Because your
2007. FDA has verified the Boehringer DEPARTMENT OF HEALTH AND comment will be made public, you are
Ingelheim Pharma GmbH & Co. KG HUMAN SERVICES solely responsible for ensuring that your
claim that February 28, 2007, is the date Food and Drug Administration comment does not include any
the investigational new drug application confidential information that you or a
(IND) became effective. [Docket No. FDA–2015–E–2597] third party may not wish to be posted,
2. The date the application was such as medical information, your or
initially submitted with respect to the Determination of Regulatory Review anyone else’s Social Security number, or
human drug product under section Period for Purposes of Patent confidential business information, such
505(b) of the FD&C Act: May 14, 2012. Extension; SIVEXTRO as a manufacturing process. Please note
FDA has verified the applicant’s claim AGENCY: Food and Drug Administration, that if you include your name, contact
that the new drug application (NDA) for HHS. information, or other information that
STRIVERDI RESPIMAT (NDA 203108) ACTION: Notice. identifies you in the body of your
was initially submitted on May 14, comments, that information will be
2012. SUMMARY: The Food and Drug posted on https://www.regulations.gov.
3. The date the application was Administration (FDA or the Agency) has • If you want to submit a comment
approved: July 31, 2014. FDA has determined the regulatory review period with confidential information that you
verified the applicant’s claim that NDA for SIVEXTRO and is publishing this do not wish to be made available to the
203108 was approved on July 31, 2014. notice of that determination as required public, submit the comment as a
This determination of the regulatory by law. FDA has made the written/paper submission and in the
review period establishes the maximum determination because of the manner detailed (see ‘‘Written/Paper
potential length of a patent extension. submission of an application to the Submissions’’ and ‘‘Instructions’’).
However, the USPTO applies several Director of the U.S. Patent and
statutory limitations in its calculations Trademark Office (USPTO), Department Written/Paper Submissions
of the actual period for patent extension. of Commerce, for the extension of a Submit written/paper submissions as
In its application for patent extension, patent which claims that human drug follows:
this applicant seeks 1,166 days of patent product. • Mail/Hand delivery/Courier (for
term extension. written/paper submissions): Dockets
DATES: Anyone with knowledge that any
Management Staff (HFA–305), Food and
III. Petitions of the dates as published (in the
Drug Administration, 5630 Fishers
Anyone with knowledge that any of SUPPLEMENTARY INFORMATION section) are
Lane, Rm. 1061, Rockville, MD 20852.
the dates as published are incorrect may incorrect may submit either electronic • For written/paper comments
submit either electronic or written or written comments and ask for a submitted to the Dockets Management
comments and, under 21 CFR 60.24, ask redetermination by February 26, 2018. Staff, FDA will post your comment, as
for a redetermination (see DATES). See ‘‘Petitions’’ in the SUPPLEMENTARY well as any attachments, except for
Furthermore, as specified in § 60.30 (21 INFORMATION section for more
information submitted, marked and
CFR 60.30), any interested person may information. identified, as confidential, if submitted
petition FDA for a determination ADDRESSES: You may submit comments as detailed in ‘‘Instructions.’’
regarding whether the applicant for as follows. Please note that late, Instructions: All submissions received
extension acted with due diligence untimely filed comments will not be must include the Docket No. FDA–
ethrower on DSK3G9T082PROD with NOTICES
during the regulatory review period. To considered. Electronic comments must 2015–E–2597 for ‘‘Determination of
meet its burden, the petition must be submitted on or before February 26, Regulatory Review Period for Purposes
comply with all the requirements of 2018. The https://www.regulations.gov of Patent Extension; SIVEXTRO.’’
§ 60.30, including but not limited to: electronic filing system will accept Received comments, those filed in a
Must be timely (see DATES), must be comments until midnight Eastern Time timely manner (see ADDRESSES), will be
filed in accordance with § 10.20, must at the end of February 26, 2018. placed in the docket and, except for
contain sufficient facts to merit an FDA Comments received by mail/hand those submitted as ‘‘Confidential
VerDate Sep<11>2014 20:21 Dec 22, 2017 Jkt 244001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\26DEN1.SGM 26DEN1](https://thefederalregister.org/doc/82_FR_61254/page/1.svg)
![61010 Federal Register / Vol. 82, No. 246 / Tuesday, December 26, 2017 / Notices
Dated: December 19, 2017. Electronic Submissions copies total. One copy will include the
Leslie Kux, Submit electronic comments in the information you claim to be confidential
Associate Commissioner for Policy. following way: with a heading or cover note that states
[FR Doc. 2017–27684 Filed 12–22–17; 8:45 am] • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
BILLING CODE 4164–01–P https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
instructions for submitting comments. Agency will review this copy, including
Comments submitted electronically, the claimed confidential information, in
DEPARTMENT OF HEALTH AND including attachments, to https:// its consideration of comments. The
HUMAN SERVICES www.regulations.gov will be posted to second copy, which will have the
the docket unchanged. Because your claimed confidential information
Food and Drug Administration comment will be made public, you are redacted/blacked out, will be available
solely responsible for ensuring that your for public viewing and posted on
[Docket Nos. FDA–2015–E–2655 and FDA– comment does not include any https://www.regulations.gov. Submit
2015–E–2656] confidential information that you or a both copies to the Dockets Management
third party may not wish to be posted, Staff. If you do not wish your name and
Determination of Regulatory Review contact information to be made publicly
such as medical information, your or
Period for Purposes of Patent available, you can provide this
anyone else’s Social Security number, or
Extension; ZYKADIA information on the cover sheet and not
confidential business information, such
as a manufacturing process. Please note in the body of your comments and you
AGENCY: Food and Drug Administration, must identify this information as
HHS. that if you include your name, contact
information, or other information that ‘‘confidential.’’ Any information marked
ACTION: Notice. identifies you in the body of your as ‘‘confidential’’ will not be disclosed
comments, that information will be except in accordance with § 10.20 (21
SUMMARY: The Food and Drug posted on https://www.regulations.gov. CFR 10.20) and other applicable
Administration (FDA or the Agency) has • If you want to submit a comment disclosure law. For more information
determined the regulatory review period with confidential information that you about FDA’s posting of comments to
for ZYKADIA and is publishing this do not wish to be made available to the public dockets, see 80 FR 56469,
notice of that determination as required public, submit the comment as a September 18, 2015, or access the
by law. FDA has made the written/paper submission and in the information at: https://www.gpo.gov/
determination because of the manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015-
submission of applications to the Submissions’’ and ‘‘Instructions’’). 23389.pdf.
Director of the U.S. Patent and Docket: For access to the docket to
Trademark Office (USPTO), Department Written/Paper Submissions read background documents or the
of Commerce, for the extension of a Submit written/paper submissions as electronic and written/paper comments
patent which claims that human drug follows: received, go to https://
product. • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
DATES: Anyone with knowledge that any written/paper submissions): Dockets docket number, found in brackets in the
of the dates as published (in the Management Staff (HFA–305), Food and heading of this document, into the
SUPPLEMENTARY INFORMATION section) are
Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
incorrect may submit either electronic Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management
or written comments and ask for a • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061,
redetermination by February 26, 2018. submitted to the Dockets Management Rockville, MD 20852.
See ‘‘Petitions’’ in the SUPPLEMENTARY Staff, FDA will post your comment, as FOR FURTHER INFORMATION CONTACT:
INFORMATION section for more
well as any attachments, except for Beverly Friedman, Office of Regulatory
information. information submitted, marked and Policy, Food and Drug Administration,
identified, as confidential, if submitted 10903 New Hampshire Ave., Bldg. 51,
ADDRESSES: You may submit comments as detailed in ‘‘Instructions.’’ Rm. 6250, Silver Spring, MD 20993,
as follows. Please note that late, Instructions: All submissions received
301–796–3600.
untimely filed comments will not be must include the Docket Nos. FDA–
considered. Electronic comments must 2015–E–2655 and FDA–2015–E–2656 SUPPLEMENTARY INFORMATION:
be submitted on or before February 26, for ‘‘Determination of Regulatory I. Background
2018. The https://www.regulations.gov Review Period for Purposes of Patent
electronic filing system will accept Extension; ZYKADIA.’’ Received The Drug Price Competition and
comments until midnight Eastern Time comments, those filed in a timely Patent Term Restoration Act of 1984
at the end of February 26, 2018. manner (see ADDRESSES), will be placed (Pub. L. 98–417) and the Generic
Comments received by mail/hand in the docket and, except for those Animal Drug and Patent Term
delivery/courier (for written/paper submitted as ‘‘Confidential Restoration Act (Pub. L. 100–670)
submissions) will be considered timely Submissions,’’ publicly viewable at generally provide that a patent may be
if they are postmarked or the delivery https://www.regulations.gov or at the extended for a period of up to 5 years
service acceptance receipt is on or Dockets Management Staff between 9 so long as the patented item (human
before that date. Furthermore, any a.m. and 4 p.m., Monday through drug product, animal drug product,
ethrower on DSK3G9T082PROD with NOTICES
interested person may petition FDA for Friday. medical device, food additive, or color
a determination regarding whether the • Confidential Submissions—To additive) was subject to regulatory
applicant for extension acted with due submit a comment with confidential review by FDA before the item was
diligence during the regulatory review information that you do not wish to be marketed. Under these acts, a product’s
period by June 25, 2018. See ‘‘Petitions’’ made publicly available, submit your regulatory review period forms the basis
in the SUPPLEMENTARY INFORMATION comments only as a written/paper for determining the amount of extension
section for more information. submission. You should submit two an applicant may receive.
VerDate Sep<11>2014 20:21 Dec 22, 2017 Jkt 244001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\26DEN1.SGM 26DEN1](https://thefederalregister.org/doc/82_FR_61254/page/3.svg)
Document Created: 2017-12-23 03:07:19
Document Modified: 2017-12-23 03:07:19
| 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 February 26, 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 61008 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR