Determination of Regulatory Review Period for Purposes of Patent Extension; ZERBAXA, 56253-56255 [2017-25682]

Download as PDF Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices 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 SAVAYSA (edoxaban tosylate monohydrate). SAVAYSA is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and is also indicated for the treatment of deep vein thrombosis and pulmonary embolism following 5–10 days of initial therapy with a parenteral anticoagulant. Subsequent to this approval, the USPTO received a patent term restoration application for SAVAYSA (U.S. Patent No. 7,365,205) from Daiichi Sankyo Co., Ltd., and the USPTO requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated July 12, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of SAVAYSA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. ethrower on DSK3G9T082PROD with NOTICES II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for SAVAYSA is 3,845 days. Of this time, 3,479 days occurred during the testing phase of the regulatory review period, while 366 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: July 1, 2004. FDA has verified the applicant’s claim that July 1, 2004, is the date the investigational new drug application (IND) became effective. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: January 8, 2014. FDA has verified the applicant’s claim that the new drug application (NDA) for VerDate Sep<11>2014 19:51 Nov 27, 2017 Jkt 244001 SAVAYSA (NDA 206316) was initially submitted on January 8, 2014. 3. The date the application was approved: January 8, 2015. FDA has verified the applicant’s claim that NDA 206316 was approved on January 8, 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 1,406 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 § 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 § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 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. 2017–25703 Filed 11–27–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–E–0623] Determination of Regulatory Review Period for Purposes of Patent Extension; ZERBAXA AGENCY: Food and Drug Administration, HHS. PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 ACTION: 56253 Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZERBAXA 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 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. SUMMARY: 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. E:\FR\FM\28NON1.SGM 28NON1 56254 Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices ethrower on DSK3G9T082PROD with NOTICES • 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–0623 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; ZERBAXA.’’ 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 § 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA’s posting of comments to VerDate Sep<11>2014 19:51 Nov 27, 2017 Jkt 244001 public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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 ZERBAXA (ceftolozane sulfate and tazobactam PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 sodium). ZERBAXA is indicated for the treatment of the following infections caused by designated susceptible microorganisms: • Complicated intra-abdominal infections, used in combination with metronidazole and • Complicated urinary tract infections, including pyelonephritis. Subsequent to this approval, the USPTO received a patent term restoration application for ZERBAXA (U.S. Patent No. 7,129,232) from Astellas Pharma, Inc. and Wakunaga Pharmaceutical Co. Ltd., and the USPTO requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated May 10, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of ZERBAXA 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 ZERBAXA is 2,360 days. Of this time, 2,117 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 (the FD&C Act) (21 U.S.C. 355(i)) became effective: July 5, 2008. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on July 5, 2008. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: April 21, 2014. FDA has verified the applicant’s claim that the new drug application (NDA) for ZERBAXA (NDA 206829) was initially submitted on April 21, 2014. 3. The date the application was approved: December 19, 2014. FDA has verified the applicant’s claim that NDA 206829 was approved on December 19, 2014. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,302 days of patent term extension. E:\FR\FM\28NON1.SGM 28NON1 Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices 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 § 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 § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 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. 2017–25682 Filed 11–27–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health ethrower on DSK3G9T082PROD with NOTICES National Institute on Alcohol Abuse and Alcoholism Amended; Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute on Alcohol Abuse and Alcoholism Special Emphasis Panel, December 11, 2017, 1:00 p.m. to December 11, 2017, 3:30 p.m., National Institute on Alcohol Abuse and Alcoholism, 5635 Fishers Lane, Bethesda, MD 20892 which was published in the Federal Register on November 17, 2017, 82 FR 54389. This notice is amended to change the meeting date from December 11, 2017 to December 13, 2017. The meeting time and location remains the same. The meeting is closed to the public. VerDate Sep<11>2014 19:51 Nov 27, 2017 Jkt 244001 Dated: November 21, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–25631 Filed 11–27–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA–2017–0002; Internal Agency Docket No. FEMA–B–1755] Proposed Flood Hazard Determinations Federal Emergency Management Agency, DHS. ACTION: Notice. AGENCY: Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. SUMMARY: Comments are to be submitted on or before February 26, 2018. ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location https://www.fema.gov/ preliminaryfloodhazarddata and the respective Community Map Repository address listed in the tables below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA DATES: PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 56255 Map Service Center at https:// msc.fema.gov for comparison. You may submit comments, identified by Docket No. FEMA–B–1755, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW., Washington, DC 20472, (202) 646–7659, or (email) patrick.sacbibit@fema.dhs.gov. FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW., Washington, DC 20472, (202) 646–7659, or (email) patrick.sacbibit@fema.dhs.gov; or visit the FEMA Map Information eXchange (FMIX) online at https:// www.floodmaps.fema.gov/fhm/fmx_ main.html. SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a). These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective. The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective. Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide E:\FR\FM\28NON1.SGM 28NON1

Agencies

[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)]
[Notices]
[Pages 56253-56255]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25682]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-0623]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; ZERBAXA

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 ZERBAXA 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 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.

[[Page 56254]]

     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-0623 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; ZERBAXA.'' 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.gpo.gov/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 ZERBAXA 
(ceftolozane sulfate and tazobactam sodium). ZERBAXA is indicated for 
the treatment of the following infections caused by designated 
susceptible micro-organisms:
     Complicated intra-abdominal infections, used in 
combination with metronidazole and
     Complicated urinary tract infections, including 
pyelonephritis.
    Subsequent to this approval, the USPTO received a patent term 
restoration application for ZERBAXA (U.S. Patent No. 7,129,232) from 
Astellas Pharma, Inc. and Wakunaga Pharmaceutical Co. Ltd., and the 
USPTO requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated May 10, 
2016, FDA advised the USPTO that this human drug product had undergone 
a regulatory review period and that the approval of ZERBAXA 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 
ZERBAXA is 2,360 days. Of this time, 2,117 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 (the FD&C Act) (21 U.S.C. 355(i)) became 
effective: July 5, 2008. FDA has verified the applicant's claim that 
the date the investigational new drug application became effective was 
on July 5, 2008.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: April 21, 
2014. FDA has verified the applicant's claim that the new drug 
application (NDA) for ZERBAXA (NDA 206829) was initially submitted on 
April 21, 2014.
    3. The date the application was approved: December 19, 2014. FDA 
has verified the applicant's claim that NDA 206829 was approved on 
December 19, 2014.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the USPTO 
applies several statutory limitations in its calculations of the actual 
period for patent extension. In its application for patent extension, 
this applicant seeks 1,302 days of patent term extension.

[[Page 56255]]

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. 2017-25682 Filed 11-27-17; 8:45 am]
BILLING CODE 4164-01-P