82_FR_56480 82 FR 56253 - Determination of Regulatory Review Period for Purposes of Patent Extension; ZERBAXA

82 FR 56253 - Determination of Regulatory Review Period for Purposes of Patent Extension; ZERBAXA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 227 (November 28, 2017)

Page Range56253-56255
FR Document2017-25682

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.

Federal Register, Volume 82 Issue 227 (Tuesday, November 28, 2017)
[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)]
[Notices]
[Pages 56253-56255]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25682]


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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.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 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



                                                                          Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices                                          56253

                                               with the initial submission of an                       SAVAYSA (NDA 206316) was initially                    ACTION:   Notice.
                                               application to market the human drug                    submitted on January 8, 2014.
                                               product and continues until FDA grants                    3. The date the application was                     SUMMARY:    The Food and Drug
                                               permission to market the drug product.                  approved: January 8, 2015. FDA has                    Administration (FDA or the Agency) has
                                               Although only a portion of a regulatory                 verified the applicant’s claim that NDA               determined the regulatory review period
                                               review period may count toward the                      206316 was approved on January 8,                     for ZERBAXA and is publishing this
                                               actual amount of extension that the                     2015.                                                 notice of that determination as required
                                               Director of USPTO may award (for                          This determination of the regulatory                by law. FDA has made the
                                               example, half the testing phase must be                 review period establishes the maximum                 determination because of the
                                               subtracted as well as any time that may                 potential length of a patent extension.               submission of an application to the
                                               have occurred before the patent was                     However, the USPTO applies several                    Director of the U.S. Patent and
                                                                                                       statutory limitations in its calculations             Trademark Office (USPTO), Department
                                               issued), FDA’s determination of the
                                                                                                       of the actual period for patent extension.            of Commerce, for the extension of a
                                               length of a regulatory review period for
                                                                                                       In its application for patent extension,              patent which claims that human drug
                                               a human drug product will include all
                                                                                                       this applicant seeks 1,406 days of patent             product.
                                               of the testing phase and approval phase
                                               as specified in 35 U.S.C. 156(g)(1)(B).                 term extension.                                       DATES: Anyone with knowledge that any
                                                  FDA has approved for marketing the                   III. Petitions                                        of the dates as published (in the
                                               human drug product SAVAYSA                                                                                    SUPPLEMENTARY INFORMATION section) are
                                                                                                          Anyone with knowledge that any of                  incorrect may submit either electronic
                                               (edoxaban tosylate monohydrate).                        the dates as published are incorrect may
                                               SAVAYSA is indicated to reduce the                                                                            or written comments and ask for a
                                                                                                       submit either electronic or written                   redetermination by January 29, 2018.
                                               risk of stroke and systemic embolism in                 comments and, under 21 CFR 60.24, ask
                                               patients with nonvalvular atrial                                                                              Furthermore, any interested person may
                                                                                                       for a redetermination (see DATES).                    petition FDA for a determination
                                               fibrillation and is also indicated for the              Furthermore, as specified in § 60.30 (21
                                               treatment of deep vein thrombosis and                                                                         regarding whether the applicant for
                                                                                                       CFR 60.30), any interested person may                 extension acted with due diligence
                                               pulmonary embolism following 5–10                       petition FDA for a determination
                                               days of initial therapy with a parenteral                                                                     during the regulatory review period by
                                                                                                       regarding whether the applicant for                   May 29, 2018. See ‘‘Petitions’’ in the
                                               anticoagulant. Subsequent to this                       extension acted with due diligence
                                               approval, the USPTO received a patent                                                                         SUPPLEMENTARY INFORMATION section for
                                                                                                       during the regulatory review period. To               more information.
                                               term restoration application for                        meet its burden, the petition must
                                               SAVAYSA (U.S. Patent No. 7,365,205)                                                                           ADDRESSES: You may submit comments
                                                                                                       comply with all the requirements of                   as follows. Please note that late,
                                               from Daiichi Sankyo Co., Ltd., and the                  § 60.30, including but not limited to:
                                               USPTO requested FDA’s assistance in                                                                           untimely filed comments will not be
                                                                                                       Must be timely (see DATES), must be                   considered. Electronic comments must
                                               determining this patent’s eligibility for               filed in accordance with § 10.20, must
                                               patent term restoration. In a letter dated                                                                    be submitted on or before January 29,
                                                                                                       contain sufficient facts to merit an FDA              2018. The https://www.regulations.gov
                                               July 12, 2016, FDA advised the USPTO                    investigation, and must certify that a
                                               that this human drug product had                                                                              electronic filing system will accept
                                                                                                       true and complete copy of the petition                comments until midnight Eastern Time
                                               undergone a regulatory review period                    has been served upon the patent
                                               and that the approval of SAVAYSA                                                                              at the end of January 29, 2018.
                                                                                                       applicant. (See H. Rept. 857, part 1, 98th            Comments received by mail/hand
                                               represented the first permitted                         Cong., 2d sess., pp. 41–42, 1984.)
                                               commercial marketing or use of the                                                                            delivery/courier (for written/paper
                                                                                                       Petitions should be in the format                     submissions) will be considered timely
                                               product. Thereafter, the USPTO                          specified in 21 CFR 10.30.
                                               requested that FDA determine the                                                                              if they are postmarked or the delivery
                                                                                                          Submit petitions electronically to                 service acceptance receipt is on or
                                               product’s regulatory review period.                     https://www.regulations.gov at Docket                 before that date.
                                               II. Determination of Regulatory Review                  No. FDA–2013–S–0610. Submit written
                                               Period                                                  petitions (two copies are required) to the            Electronic Submissions
                                                                                                       Dockets Management Staff (HFA–305),                     Submit electronic comments in the
                                                 FDA has determined that the                           Food and Drug Administration, 5630                    following way:
                                               applicable regulatory review period for                 Fishers Lane, Rm. 1061, Rockville, MD                   • Federal eRulemaking Portal: https://
                                               SAVAYSA is 3,845 days. Of this time,                    20852.                                                www.regulations.gov. Follow the
                                               3,479 days occurred during the testing                                                                        instructions for submitting comments.
                                                                                                         Dated: November 22, 2017.
                                               phase of the regulatory review period,                                                                        Comments submitted electronically,
                                                                                                       Leslie Kux,
                                               while 366 days occurred during the                                                                            including attachments, to https://
                                               approval phase. These periods of time                   Associate Commissioner for Policy.
                                                                                                                                                             www.regulations.gov will be posted to
                                               were derived from the following dates:                  [FR Doc. 2017–25703 Filed 11–27–17; 8:45 am]
                                                                                                                                                             the docket unchanged. Because your
                                                 1. The date an exemption under                        BILLING CODE 4164–01–P
                                                                                                                                                             comment will be made public, you are
                                               section 505(i) of the Federal Food, Drug,                                                                     solely responsible for ensuring that your
                                               and Cosmetic Act (the FD&C Act) (21                                                                           comment does not include any
                                               U.S.C. 355(i)) became effective: July 1,                DEPARTMENT OF HEALTH AND
                                                                                                       HUMAN SERVICES                                        confidential information that you or a
                                               2004. FDA has verified the applicant’s                                                                        third party may not wish to be posted,
                                               claim that July 1, 2004, is the date the                Food and Drug Administration                          such as medical information, your or
                                               investigational new drug application                                                                          anyone else’s Social Security number, or
ethrower on DSK3G9T082PROD with NOTICES




                                               (IND) became effective.                                 [Docket No. FDA–2016–E–0623]                          confidential business information, such
                                                 2. The date the application was                                                                             as a manufacturing process. Please note
                                                                                                       Determination of Regulatory Review
                                               initially submitted with respect to the                                                                       that if you include your name, contact
                                                                                                       Period for Purposes of Patent
                                               human drug product under section                                                                              information, or other information that
                                                                                                       Extension; ZERBAXA
                                               505(b) of the FD&C Act: January 8, 2014.                                                                      identifies you in the body of your
                                               FDA has verified the applicant’s claim                  AGENCY:    Food and Drug Administration,              comments, that information will be
                                               that the new drug application (NDA) for                 HHS.                                                  posted on https://www.regulations.gov.


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                                               56254                      Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices

                                                 • If you want to submit a comment                     public dockets, see 80 FR 56469,                      sodium). ZERBAXA is indicated for the
                                               with confidential information that you                  September 18, 2015, or access the                     treatment of the following infections
                                               do not wish to be made available to the                 information at: https://www.gpo.gov/                  caused by designated susceptible micro-
                                               public, submit the comment as a                         fdsys/pkg/FR-2015-09-18/pdf/2015-                     organisms:
                                               written/paper submission and in the                     23389.pdf.                                               • Complicated intra-abdominal
                                               manner detailed (see ‘‘Written/Paper                       Docket: For access to the docket to                infections, used in combination with
                                               Submissions’’ and ‘‘Instructions’’).                    read background documents or the                      metronidazole and
                                               Written/Paper Submissions                               electronic and written/paper comments                    • Complicated urinary tract
                                                                                                       received, go to https://                              infections, including pyelonephritis.
                                                  Submit written/paper submissions as                  www.regulations.gov and insert the                       Subsequent to this approval, the
                                               follows:                                                docket number, found in brackets in the               USPTO received a patent term
                                                  • Mail/Hand delivery/Courier (for                    heading of this document, into the                    restoration application for ZERBAXA
                                               written/paper submissions): Dockets                     ‘‘Search’’ box and follow the prompts                 (U.S. Patent No. 7,129,232) from
                                               Management Staff (HFA–305), Food and                    and/or go to the Dockets Management                   Astellas Pharma, Inc. and Wakunaga
                                               Drug Administration, 5630 Fishers                       Staff, 5630 Fishers Lane, Rm. 1061,                   Pharmaceutical Co. Ltd., and the
                                               Lane, Rm. 1061, Rockville, MD 20852.                    Rockville, MD 20852.
                                                  • For written/paper comments                                                                               USPTO requested FDA’s assistance in
                                               submitted to the Dockets Management                     FOR FURTHER INFORMATION CONTACT:                      determining this patent’s eligibility for
                                               Staff, FDA will post your comment, as                   Beverly Friedman, Office of Regulatory                patent term restoration. In a letter dated
                                               well as any attachments, except for                     Policy, Food and Drug Administration,                 May 10, 2016, FDA advised the USPTO
                                               information submitted, marked and                       10903 New Hampshire Ave., Bldg. 51,                   that this human drug product had
                                               identified, as confidential, if submitted               Rm. 6250, Silver Spring, MD 20993,                    undergone a regulatory review period
                                               as detailed in ‘‘Instructions.’’                        301–796–3600.                                         and that the approval of ZERBAXA
                                                  Instructions: All submissions received               SUPPLEMENTARY INFORMATION:                            represented the first permitted
                                               must include the Docket No. FDA–                                                                              commercial marketing or use of the
                                                                                                       I. Background                                         product. Thereafter, the USPTO
                                               2016–E–0623 for ‘‘Determination of
                                               Regulatory Review Period for Purposes                      The Drug Price Competition and                     requested that FDA determine the
                                               of Patent Extension; ZERBAXA.’’                         Patent Term Restoration Act of 1984                   product’s regulatory review period.
                                               Received comments, those filed in a                     (Pub. L. 98–417) and the Generic                      II. Determination of Regulatory Review
                                               timely manner (see ADDRESSES), will be                  Animal Drug and Patent Term                           Period
                                               placed in the docket and, except for                    Restoration Act (Pub. L. 100–670)
                                               those submitted as ‘‘Confidential                       generally provide that a patent may be                  FDA has determined that the
                                               Submissions,’’ publicly viewable at                     extended for a period of up to 5 years                applicable regulatory review period for
                                               https://www.regulations.gov or at the                   so long as the patented item (human                   ZERBAXA is 2,360 days. Of this time,
                                               Dockets Management Staff between 9                      drug product, animal drug product,                    2,117 days occurred during the testing
                                               a.m. and 4 p.m., Monday through                         medical device, food additive, or color               phase of the regulatory review period,
                                               Friday.                                                 additive) was subject to regulatory                   while 243 days occurred during the
                                                  • Confidential Submissions—To                        review by FDA before the item was                     approval phase. These periods of time
                                               submit a comment with confidential                      marketed. Under these acts, a product’s               were derived from the following dates:
                                               information that you do not wish to be                  regulatory review period forms the basis                1. The date an exemption under
                                               made publicly available, submit your                    for determining the amount of extension               section 505(i) of the Federal Food, Drug,
                                               comments only as a written/paper                        an applicant may receive.                             and Cosmetic Act (the FD&C Act) (21
                                               submission. You should submit two                          A regulatory review period consists of             U.S.C. 355(i)) became effective: July 5,
                                               copies total. One copy will include the                 two periods of time: A testing phase and              2008. FDA has verified the applicant’s
                                               information you claim to be confidential                an approval phase. For human drug                     claim that the date the investigational
                                               with a heading or cover note that states                products, the testing phase begins when               new drug application became effective
                                               ‘‘THIS DOCUMENT CONTAINS                                the exemption to permit the clinical                  was on July 5, 2008.
                                               CONFIDENTIAL INFORMATION.’’ The                         investigations of the drug becomes                      2. The date the application was
                                               Agency will review this copy, including                 effective and runs until the approval                 initially submitted with respect to the
                                               the claimed confidential information, in                phase begins. The approval phase starts               human drug product under section
                                               its consideration of comments. The                      with the initial submission of an                     505(b) of the FD&C Act: April 21, 2014.
                                               second copy, which will have the                        application to market the human drug                  FDA has verified the applicant’s claim
                                               claimed confidential information                        product and continues until FDA grants                that the new drug application (NDA) for
                                               redacted/blacked out, will be available                 permission to market the drug product.                ZERBAXA (NDA 206829) was initially
                                               for public viewing and posted on                        Although only a portion of a regulatory               submitted on April 21, 2014.
                                               https://www.regulations.gov. Submit                     review period may count toward the                      3. The date the application was
                                               both copies to the Dockets Management                   actual amount of extension that the                   approved: December 19, 2014. FDA has
                                               Staff. If you do not wish your name and                 Director of USPTO may award (for                      verified the applicant’s claim that NDA
                                               contact information to be made publicly                 example, half the testing phase must be               206829 was approved on December 19,
                                               available, you can provide this                         subtracted as well as any time that may               2014.
                                               information on the cover sheet and not                  have occurred before the patent was                     This determination of the regulatory
                                               in the body of your comments and you                    issued), FDA’s determination of the                   review period establishes the maximum
ethrower on DSK3G9T082PROD with NOTICES




                                               must identify this information as                       length of a regulatory review period for              potential length of a patent extension.
                                               ‘‘confidential.’’ Any information marked                a human drug product will include all                 However, the USPTO applies several
                                               as ‘‘confidential’’ will not be disclosed               of the testing phase and approval phase               statutory limitations in its calculations
                                               except in accordance with § 10.20 (21                   as specified in 35 U.S.C. 156(g)(1)(B).               of the actual period for patent extension.
                                               CFR 10.20) and other applicable                            FDA has approved for marketing the                 In its application for patent extension,
                                               disclosure law. For more information                    human drug product ZERBAXA                            this applicant seeks 1,302 days of patent
                                               about FDA’s posting of comments to                      (ceftolozane sulfate and tazobactam                   term extension.


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                                                                          Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices                                          56255

                                               III. Petitions                                            Dated: November 21, 2017.                           Map Service Center at https://
                                                                                                       Melanie J. Pantoja,                                   msc.fema.gov for comparison.
                                                  Anyone with knowledge that any of                    Program Analyst, Office of Federal Advisory              You may submit comments, identified
                                               the dates as published are incorrect may                Committee Policy.                                     by Docket No. FEMA–B–1755, to Rick
                                               submit either electronic or written                     [FR Doc. 2017–25631 Filed 11–27–17; 8:45 am]          Sacbibit, Chief, Engineering Services
                                               comments and, under 21 CFR 60.24, ask                   BILLING CODE 4140–01–P                                Branch, Federal Insurance and
                                               for a redetermination (see DATES).                                                                            Mitigation Administration, FEMA, 400
                                               Furthermore, as specified in § 60.30 (21                                                                      C Street SW., Washington, DC 20472,
                                               CFR 60.30), any interested person may                   DEPARTMENT OF HOMELAND                                (202) 646–7659, or (email)
                                               petition FDA for a determination                        SECURITY                                              patrick.sacbibit@fema.dhs.gov.
                                               regarding whether the applicant for                                                                           FOR FURTHER INFORMATION CONTACT: Rick
                                               extension acted with due diligence                      Federal Emergency Management                          Sacbibit, Chief, Engineering Services
                                               during the regulatory review period. To                 Agency                                                Branch, Federal Insurance and
                                               meet its burden, the petition must                                                                            Mitigation Administration, FEMA, 400
                                                                                                       [Docket ID FEMA–2017–0002; Internal
                                               comply with all the requirements of                     Agency Docket No. FEMA–B–1755]                        C Street SW., Washington, DC 20472,
                                               § 60.30, including but not limited to:                                                                        (202) 646–7659, or (email)
                                               Must be timely (see DATES), must be                     Proposed Flood Hazard                                 patrick.sacbibit@fema.dhs.gov; or visit
                                               filed in accordance with § 10.20, must                  Determinations                                        the FEMA Map Information eXchange
                                               contain sufficient facts to merit an FDA                                                                      (FMIX) online at https://
                                                                                                       AGENCY: Federal Emergency                             www.floodmaps.fema.gov/fhm/fmx_
                                               investigation, and must certify that a                  Management Agency, DHS.
                                               true and complete copy of the petition                                                                        main.html.
                                                                                                       ACTION: Notice.
                                               has been served upon the patent                                                                               SUPPLEMENTARY INFORMATION: FEMA
                                               applicant. (See H. Rept. 857, part 1, 98th              SUMMARY:   Comments are requested on                  proposes to make flood hazard
                                               Cong., 2d sess., pp. 41–42, 1984.)                      proposed flood hazard determinations,                 determinations for each community
                                               Petitions should be in the format                       which may include additions or                        listed below, in accordance with section
                                               specified in 21 CFR 10.30.                              modifications of any Base Flood                       110 of the Flood Disaster Protection Act
                                                                                                       Elevation (BFE), base flood depth,                    of 1973, 42 U.S.C. 4104, and 44 CFR
                                                  Submit petitions electronically to                                                                         67.4(a).
                                               https://www.regulations.gov at Docket                   Special Flood Hazard Area (SFHA)
                                                                                                       boundary or zone designation, or                         These proposed flood hazard
                                               No. FDA–2013–S–0610. Submit written                                                                           determinations, together with the
                                               petitions (two copies are required) to the              regulatory floodway on the Flood
                                                                                                       Insurance Rate Maps (FIRMs), and                      floodplain management criteria required
                                               Dockets Management Staff (HFA–305),                                                                           by 44 CFR 60.3, are the minimum that
                                                                                                       where applicable, in the supporting
                                               Food and Drug Administration, 5630                                                                            are required. They should not be
                                                                                                       Flood Insurance Study (FIS) reports for
                                               Fishers Lane, Rm. 1061, Rockville, MD                                                                         construed to mean that the community
                                                                                                       the communities listed in the table
                                               20852.                                                  below. The purpose of this notice is to               must change any existing ordinances
                                                 Dated: November 22, 2017.                             seek general information and comment                  that are more stringent in their
                                                                                                       regarding the preliminary FIRM, and                   floodplain management requirements.
                                               Leslie Kux,
                                                                                                       where applicable, the FIS report that the             The community may at any time enact
                                               Associate Commissioner for Policy.                                                                            stricter requirements of its own or
                                               [FR Doc. 2017–25682 Filed 11–27–17; 8:45 am]
                                                                                                       Federal Emergency Management Agency
                                                                                                       (FEMA) has provided to the affected                   pursuant to policies established by other
                                               BILLING CODE 4164–01–P
                                                                                                       communities. The FIRM and FIS report                  Federal, State, or regional entities.
                                                                                                       are the basis of the floodplain                       These flood hazard determinations are
                                                                                                       management measures that the                          used to meet the floodplain
                                               DEPARTMENT OF HEALTH AND                                                                                      management requirements of the NFIP
                                                                                                       community is required either to adopt
                                               HUMAN SERVICES                                          or to show evidence of having in effect               and also are used to calculate the
                                                                                                       in order to qualify or remain qualified               appropriate flood insurance premium
                                               National Institutes of Health                                                                                 rates for new buildings built after the
                                                                                                       for participation in the National Flood
                                                                                                       Insurance Program (NFIP). In addition,                FIRM and FIS report become effective.
                                               National Institute on Alcohol Abuse                                                                              The communities affected by the
                                               and Alcoholism Amended; Notice of                       the FIRM and FIS report, once effective,
                                                                                                       will be used by insurance agents and                  flood hazard determinations are
                                               Meeting                                                                                                       provided in the tables below. Any
                                                                                                       others to calculate appropriate flood
                                                                                                       insurance premium rates for new                       request for reconsideration of the
                                                 Notice is hereby given of a change in                                                                       revised flood hazard information shown
                                               the meeting of the National Institute on                buildings and the contents of those
                                                                                                       buildings.                                            on the Preliminary FIRM and FIS report
                                               Alcohol Abuse and Alcoholism Special                                                                          that satisfies the data requirements
                                               Emphasis Panel, December 11, 2017,                      DATES:  Comments are to be submitted                  outlined in 44 CFR 67.6(b) is considered
                                               1:00 p.m. to December 11, 2017, 3:30                    on or before February 26, 2018.                       an appeal. Comments unrelated to the
                                               p.m., National Institute on Alcohol                     ADDRESSES: The Preliminary FIRM, and                  flood hazard determinations also will be
                                               Abuse and Alcoholism, 5635 Fishers                      where applicable, the FIS report for                  considered before the FIRM and FIS
                                               Lane, Bethesda, MD 20892 which was                      each community are available for                      report become effective.
                                               published in the Federal Register on                    inspection at both the online location                   Use of a Scientific Resolution Panel
ethrower on DSK3G9T082PROD with NOTICES




                                               November 17, 2017, 82 FR 54389.                         https://www.fema.gov/                                 (SRP) is available to communities in
                                                                                                       preliminaryfloodhazarddata and the                    support of the appeal resolution
                                                 This notice is amended to change the
                                                                                                       respective Community Map Repository                   process. SRPs are independent panels of
                                               meeting date from December 11, 2017 to
                                                                                                       address listed in the tables below.                   experts in hydrology, hydraulics, and
                                               December 13, 2017. The meeting time
                                                                                                       Additionally, the current effective FIRM              other pertinent sciences established to
                                               and location remains the same. The                      and FIS report for each community are                 review conflicting scientific and
                                               meeting is closed to the public.                        accessible online through the FEMA                    technical data and provide


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Document Created: 2017-11-28 01:51:12
Document Modified: 2017-11-28 01:51:12
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAnyone 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.
ContactBeverly 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 Citation82 FR 56253 

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