81_FR_84075 81 FR 83850 - Determination of Regulatory Review Period for Purposes of Patent Extension; RUCONEST

81 FR 83850 - Determination of Regulatory Review Period for Purposes of Patent Extension; RUCONEST

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 225 (November 22, 2016)

Page Range83850-83852
FR Document2016-28046

The Food and Drug Administration (FDA) has determined the regulatory review period for RUCONEST and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

Federal Register, Volume 81 Issue 225 (Tuesday, November 22, 2016)
[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)]
[Notices]
[Pages 83850-83852]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-28046]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-E-2663; FDA-2015-E-2890]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for RUCONEST and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of applications to the Director of the U.S. 
Patent and Trademark Office (USPTO), Department of Commerce, for the 
extension of a patent which claims that human biological product.

DATES: Anyone with knowledge that any of the dates as published (see 
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either 
electronic or written comments and ask for a redetermination by January 
23, 2017. 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 22, 2017. See 
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more 
information.

ADDRESSES: You may submit comments as follows:

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets

[[Page 83851]]

Management, FDA will post your comment, as well as any attachments, 
except for information submitted, marked and identified, as 
confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos. 
FDA-2015-E-2663 and FDA-2015-E-2890 for ``Determination of Regulatory 
Review Period for Purposes of Patent Extension; RUCONEST.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 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 biological products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the biological product becomes effective and runs 
until the approval phase begins. The approval phase starts with the 
initial submission of an application to market the human biological 
product and continues until FDA grants permission to market the 
biological 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 biological 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 biologic product RUCONEST 
(rhC1INH). RUCONEST is indicated for treatment of acute attacks of 
hereditary angioedema in adult and adolescent patients. Subsequent to 
this approval, the USPTO received patent term restoration applications 
for RUCONEST (U.S. Patent Nos. 7,067,713 and RE43,691) from Pharming 
Intellectual Property B.V., and the USPTO requested FDA's assistance in 
determining this patent's eligibility for patent term restoration. In a 
letter dated October 19, 2015, FDA advised the USPTO that this human 
biological product had undergone a regulatory review period and that 
the approval of RUCONEST 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 
RUCONEST is 3,502 days. Of this time, 3,045 days occurred during the 
testing phase of the regulatory review period, while 457 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 (21 U.S.C. 355(i)) became effective: December 
15, 2004. The applicant claims July 29, 2004, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was December 15, 2004, 
which was the first date after receipt of the IND that the 
investigational studies were allowed to proceed.
    2. The date the application was initially submitted with respect to 
the human biological product under section 351 of the Public Health 
Service Act (42 U.S.C. 262): April 16, 2013. FDA has verified the 
applicant's claim that the biologics license application (BLA) for 
RUCONEST (BLA 125495) was initially submitted on April 16, 2013.
    3. The date the application was approved: July 16, 2014. FDA has 
verified the applicant's claim that BLA 125495 was approved on July 16, 
2014.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the USPTO 
applies several statutory limitations in its calculations of the actual 
period for patent extension. In its applications for patent extension, 
this applicant seeks 1,698 days or 557 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 ask for 
a redetermination (see DATES). 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. 
To meet its burden, the petition must be timely (see DATES) and contain 
sufficient facts to merit an FDA investigation. (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.

[[Page 83852]]

    Submit petitions electronically to https://www.regulations.gov at 
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are 
required) to the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28046 Filed 11-21-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                83850                      Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices

                                                CORE VALVE SYSTEM is indicated for                      verified the applicants’ claims that PMA              RUCONEST and is publishing this
                                                relief of aortic stenosis in patients with              P130021 was approved on January 17,                   notice of that determination as required
                                                symptomatic heart disease due to severe                 2014.                                                 by law. FDA has made the
                                                native calcific aortic stenosis (aortic                   This determination of the regulatory                determination because of the
                                                valve area ≤0.8 cm2, a mean aortic valve                review period establishes the maximum                 submission of applications to the
                                                gradient of >40 mmHg, or a peak aortic-                 potential length of a patent extension.               Director of the U.S. Patent and
                                                jet velocity of 4.0 m/s) and with native                However, the USPTO applies several                    Trademark Office (USPTO), Department
                                                aortic annulus diameters between 18                     statutory limitations in its calculations             of Commerce, for the extension of a
                                                and 29 mm who are judged by a heart                     of the actual period for patent extension.            patent which claims that human
                                                team, including a cardiac surgeon, to be                In its applications for patent extension,             biological product.
                                                at extreme risk or inoperable for open                  these applicants seek 685 days, 360                   DATES: Anyone with knowledge that any
                                                surgical therapy (predicted risk of                     days, or 66 days of patent term                       of the dates as published (see the
                                                operative mortality and or serious                      extension.                                            SUPPLEMENTARY INFORMATION section) are
                                                irreversible morbidity ≥50% at 30 days).                                                                      incorrect may submit either electronic
                                                                                                        III. Petitions
                                                Subsequent to this approval, the USPTO                                                                        or written comments and ask for a
                                                received patent term restoration                           Anyone with knowledge that any of                  redetermination by January 23, 2017.
                                                applications for CORE VALVE SYSTEM                      the dates as published are incorrect may              Furthermore, any interested person may
                                                (U.S. Patent Nos. 5,957,949; 7,018,406;                 submit either electronic or written                   petition FDA for a determination
                                                8,226,710; and 8,579,966 from                           comments and ask for a redetermination                regarding whether the applicant for
                                                Medtronic Corevalve LLC and U.S.                        (see DATES). Furthermore, any interested              extension acted with due diligence
                                                Patent No. 5,957,949 from Medtronic                     person may petition FDA for a                         during the regulatory review period by
                                                Vascular Inc.), and the USPTO                           determination regarding whether the                   May 22, 2017. See ‘‘Petitions’’ in the
                                                requested FDA’s assistance in                           applicant for extension acted with due                SUPPLEMENTARY INFORMATION section for
                                                determining the patents’ eligibility for                diligence during the regulatory review                more information.
                                                patent term restoration. In two letters                 period. To meet its burden, the petition              ADDRESSES: You may submit comments
                                                dated October 19, 2015, FDA advised                     must be timely (see DATES) and contain                as follows:
                                                the USPTO that this medical device had                  sufficient facts to merit an FDA
                                                undergone a regulatory review period                    investigation. (See H. Rept. 857, part 1,             Electronic Submissions
                                                and that the approval of CORE VALVE                     98th Cong., 2d sess., pp. 41–42, 1984.)                 Submit electronic comments in the
                                                SYSTEM represented the first permitted                  Petitions should be in the format                     following way:
                                                commercial marketing or use of the                      specified in 21 CFR 10.30.                              • Federal eRulemaking Portal:
                                                product. Thereafter, the USPTO                             Submit petitions electronically to                 https://www.regulations.gov. Follow the
                                                requested that FDA determine the                        https://www.regulations.gov at Docket                 instructions for submitting comments.
                                                product’s regulatory review period.                     No. FDA–2013–S–0610. Submit written                   Comments submitted electronically,
                                                                                                        petitions (two copies are required) to the            including attachments, to https://
                                                II. Determination of Regulatory Review
                                                                                                        Division of Dockets Management (HFA–                  www.regulations.gov will be posted to
                                                Period
                                                                                                        305), Food and Drug Administration,                   the docket unchanged. Because your
                                                   FDA has determined that the                          5630 Fishers Lane, Rm. 1061, Rockville,               comment will be made public, you are
                                                applicable regulatory review period for                 MD 20852. Petitions that have not been                solely responsible for ensuring that your
                                                CORE VALVE SYSTEM is 1,194 days.                        made publicly available on https://                   comment does not include any
                                                Of this time, 1,017 days occurred during                www.regulations.gov may be viewed in                  confidential information that you or a
                                                the testing phase of the regulatory                     the Division of Dockets Management                    third party may not wish to be posted,
                                                review period, while 177 days occurred                  between 9 a.m. and 4 p.m., Monday                     such as medical information, your or
                                                during the approval phase. These                        through Friday.                                       anyone else’s Social Security number, or
                                                periods of time were derived from the                                                                         confidential business information, such
                                                                                                          Dated: November 16, 2016.
                                                following dates:                                                                                              as a manufacturing process. Please note
                                                   1. The date an exemption under                       Leslie Kux,
                                                                                                        Associate Commissioner for Policy.
                                                                                                                                                              that if you include your name, contact
                                                section 520(g) of the Federal Food, Drug,                                                                     information, or other information that
                                                and Cosmetic Act (the FD&C Act) (21                     [FR Doc. 2016–28047 Filed 11–21–16; 8:45 am]
                                                                                                                                                              identifies you in the body of your
                                                U.S.C. 360j(g)) involving this device                   BILLING CODE 4164–01–P
                                                                                                                                                              comments, that information will be
                                                became effective: October 13, 2010. FDA                                                                       posted on https://www.regulations.gov.
                                                has verified the applicants’ claims that                                                                        • If you want to submit a comment
                                                the date the investigational device                     DEPARTMENT OF HEALTH AND
                                                                                                                                                              with confidential information that you
                                                exemption required under section                        HUMAN SERVICES
                                                                                                                                                              do not wish to be made available to the
                                                520(g) of the FD&C act for human tests                                                                        public, submit the comment as a
                                                                                                        Food and Drug Administration
                                                to begin became effective October 13,                                                                         written/paper submission and in the
                                                2010.                                                   [Docket Nos. FDA–2015–E–2663; FDA–                    manner detailed (see ‘‘Written/Paper
                                                   2. The date an application was                       2015–E–2890]
                                                                                                                                                              Submissions’’ and ‘‘Instructions’’).
                                                initially submitted with respect to the
                                                device under section 515 of the Federal                 Determination of Regulatory Review                    Written/Paper Submissions
                                                Food, Drug, and Cosmetic Act (21 U.S.C.                 Period for Purposes of Patent                           Submit written/paper submissions as
                                                                                                        Extension; RUCONEST
sradovich on DSK3GMQ082PROD with NOTICES




                                                360e): July 25, 2013. FDA has verified                                                                        follows:
                                                the applicants’ claims that the                         AGENCY:    Food and Drug Administration,                • Mail/Hand delivery/Courier (for
                                                premarket approval application (PMA)                    HHS.                                                  written/paper submissions): Division of
                                                for CORE VALVE SYSTEM (PMA                              ACTION:   Notice.                                     Dockets Management (HFA–305), Food
                                                P130021) was initially submitted July                                                                         and Drug Administration, 5630 Fishers
                                                25, 2013.                                               SUMMARY:   The Food and Drug                          Lane, Rm. 1061, Rockville, MD 20852.
                                                   3. The date the application was                      Administration (FDA) has determined                     • For written/paper comments
                                                approved: January 17, 2014. FDA has                     the regulatory review period for                      submitted to the Division of Dockets


                                           VerDate Sep<11>2014   16:52 Nov 21, 2016   Jkt 241001   PO 00000   Frm 00054   Fmt 4703   Sfmt 4703   E:\FR\FM\22NON1.SGM   22NON1


                                                                           Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices                                           83851

                                                Management, FDA will post your                          FOR FURTHER INFORMATION CONTACT:                      represented the first permitted
                                                comment, as well as any attachments,                    Beverly Friedman, Office of Regulatory                commercial marketing or use of the
                                                except for information submitted,                       Policy, Food and Drug Administration,                 product. Thereafter, the USPTO
                                                marked and identified, as confidential,                 10903 New Hampshire Ave., Bldg. 51,                   requested that FDA determine the
                                                if submitted as detailed in                             Rm. 6250, Silver Spring, MD 20993,                    product’s regulatory review period.
                                                ‘‘Instructions.’’                                       301–796–3600.
                                                                                                                                                              II. Determination of Regulatory Review
                                                   Instructions: All submissions received               SUPPLEMENTARY INFORMATION:                            Period
                                                must include the Docket Nos. FDA–                       I. Background                                            FDA has determined that the
                                                2015–E–2663 and FDA–2015–E–2890                                                                               applicable regulatory review period for
                                                                                                           The Drug Price Competition and
                                                for ‘‘Determination of Regulatory                                                                             RUCONEST is 3,502 days. Of this time,
                                                                                                        Patent Term Restoration Act of 1984
                                                Review Period for Purposes of Patent                    (Pub. L. 98–417) and the Generic                      3,045 days occurred during the testing
                                                Extension; RUCONEST.’’ Received                         Animal Drug and Patent Term                           phase of the regulatory review period,
                                                comments will be placed in the docket                   Restoration Act (Pub. L. 100–670)                     while 457 days occurred during the
                                                and, except for those submitted as                      generally provide that a patent may be                approval phase. These periods of time
                                                ‘‘Confidential Submissions,’’ publicly                  extended for a period of up to 5 years                were derived from the following dates:
                                                viewable at https://www.regulations.gov                 so long as the patented item (human                      1. The date an exemption under
                                                or at the Division of Dockets                           drug product, animal drug product,                    section 505(i) of the Federal Food, Drug,
                                                Management between 9 a.m. and 4 p.m.,                   medical device, food additive, or color               and Cosmetic Act (21 U.S.C. 355(i))
                                                Monday through Friday.                                  additive) was subject to regulatory                   became effective: December 15, 2004.
                                                   • Confidential Submissions—To                        review by FDA before the item was                     The applicant claims July 29, 2004, as
                                                submit a comment with confidential                      marketed. Under these acts, a product’s               the date the investigational new drug
                                                information that you do not wish to be                  regulatory review period forms the basis              application (IND) became effective.
                                                made publicly available, submit your                    for determining the amount of extension               However, FDA records indicate that the
                                                comments only as a written/paper                        an applicant may receive.                             IND effective date was December 15,
                                                submission. You should submit two                          A regulatory review period consists of             2004, which was the first date after
                                                copies total. One copy will include the                 two periods of time: A testing phase and              receipt of the IND that the
                                                information you claim to be confidential                an approval phase. For human                          investigational studies were allowed to
                                                with a heading or cover note that states                biological products, the testing phase                proceed.
                                                ‘‘THIS DOCUMENT CONTAINS                                begins when the exemption to permit                      2. The date the application was
                                                CONFIDENTIAL INFORMATION.’’ The                         the clinical investigations of the                    initially submitted with respect to the
                                                Agency will review this copy, including                 biological product becomes effective                  human biological product under section
                                                the claimed confidential information, in                and runs until the approval phase                     351 of the Public Health Service Act (42
                                                its consideration of comments. The                      begins. The approval phase starts with                U.S.C. 262): April 16, 2013. FDA has
                                                second copy, which will have the                        the initial submission of an application              verified the applicant’s claim that the
                                                claimed confidential information                        to market the human biological product                biologics license application (BLA) for
                                                redacted/blacked out, will be available                 and continues until FDA grants                        RUCONEST (BLA 125495) was initially
                                                for public viewing and posted on                        permission to market the biological                   submitted on April 16, 2013.
                                                https://www.regulations.gov. Submit                     product. Although only a portion of a                    3. The date the application was
                                                both copies to the Division of Dockets                  regulatory review period may count                    approved: July 16, 2014. FDA has
                                                Management. If you do not wish your                     toward the actual amount of extension                 verified the applicant’s claim that BLA
                                                name and contact information to be                      that the Director of USPTO may award                  125495 was approved on July 16, 2014.
                                                                                                        (for example, half the testing phase must                This determination of the regulatory
                                                made publicly available, you can
                                                                                                        be subtracted as well as any time that                review period establishes the maximum
                                                provide this information on the cover
                                                                                                        may have occurred before the patent                   potential length of a patent extension.
                                                sheet and not in the body of your
                                                                                                        was issued), FDA’s determination of the               However, the USPTO applies several
                                                comments and you must identify this
                                                                                                        length of a regulatory review period for              statutory limitations in its calculations
                                                information as ‘‘confidential.’’ Any
                                                                                                        a human biological product will include               of the actual period for patent extension.
                                                information marked as ‘‘confidential’’
                                                                                                        all of the testing phase and approval                 In its applications for patent extension,
                                                will not be disclosed except in
                                                                                                        phase as specified in 35 U.S.C.                       this applicant seeks 1,698 days or 557
                                                accordance with 21 CFR 10.20 and other
                                                                                                        156(g)(1)(B).                                         days of patent term extension.
                                                applicable disclosure law. For more                        FDA has approved for marketing the
                                                information about FDA’s posting of                      human biologic product RUCONEST                       III. Petitions
                                                comments to public dockets, see 80 FR                   (rhC1INH). RUCONEST is indicated for                     Anyone with knowledge that any of
                                                56469, September 18, 2015, or access                    treatment of acute attacks of hereditary              the dates as published are incorrect may
                                                the information at: http://www.fda.gov/                 angioedema in adult and adolescent                    submit either electronic or written
                                                regulatoryinformation/dockets/                          patients. Subsequent to this approval,                comments and ask for a redetermination
                                                default.htm.                                            the USPTO received patent term                        (see DATES). Furthermore, any interested
                                                   Docket: For access to the docket to                  restoration applications for RUCONEST                 person may petition FDA for a
                                                read background documents or the                        (U.S. Patent Nos. 7,067,713 and                       determination regarding whether the
                                                electronic and written/paper comments                   RE43,691) from Pharming Intellectual                  applicant for extension acted with due
                                                received, go to https://                                Property B.V., and the USPTO requested                diligence during the regulatory review
sradovich on DSK3GMQ082PROD with NOTICES




                                                www.regulations.gov and insert the                      FDA’s assistance in determining this                  period. To meet its burden, the petition
                                                docket number, found in brackets in the                 patent’s eligibility for patent term                  must be timely (see DATES) and contain
                                                heading of this document, into the                      restoration. In a letter dated October 19,            sufficient facts to merit an FDA
                                                ‘‘Search’’ box and follow the prompts                   2015, FDA advised the USPTO that this                 investigation. (See H. Rept. 857, part 1,
                                                and/or go to the Division of Dockets                    human biological product had                          98th Cong., 2d sess., pp. 41–42, 1984.)
                                                Management, 5630 Fishers Lane, Rm.                      undergone a regulatory review period                  Petitions should be in the format
                                                1061, Rockville, MD 20852.                              and that the approval of RUCONEST                     specified in 21 CFR 10.30.


                                           VerDate Sep<11>2014   16:52 Nov 21, 2016   Jkt 241001   PO 00000   Frm 00055   Fmt 4703   Sfmt 4703   E:\FR\FM\22NON1.SGM   22NON1


                                                83852                      Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices

                                                  Submit petitions electronically to                    the docket unchanged. Because your                    for public viewing and posted on
                                                https://www.regulations.gov at Docket                   comment will be made public, you are                  https://www.regulations.gov. Submit
                                                No. FDA–2013–S–0610. Submit written                     solely responsible for ensuring that your             both copies to the Division of Dockets
                                                petitions (two copies are required) to the              comment does not include any                          Management. If you do not wish your
                                                Division of Dockets Management (HFA–                    confidential information that you or a                name and contact information to be
                                                305), Food and Drug Administration,                     third party may not wish to be posted,                made publicly available, you can
                                                5630 Fishers Lane, Rm. 1061, Rockville,                 such as medical information, your or                  provide this information on the cover
                                                MD 20852.                                               anyone else’s Social Security number, or              sheet and not in the body of your
                                                  Dated: November 16, 2016.                             confidential business information, such               comments and you must identify this
                                                                                                        as a manufacturing process. Please note               information as ‘‘confidential.’’ Any
                                                Leslie Kux,
                                                                                                        that if you include your name, contact                information marked as ‘‘confidential’’
                                                Associate Commissioner for Policy.                      information, or other information that                will not be disclosed except in
                                                [FR Doc. 2016–28046 Filed 11–21–16; 8:45 am]            identifies you in the body of your                    accordance with 21 CFR 10.20 and other
                                                BILLING CODE 4164–01–P                                  comments, that information will be                    applicable disclosure law. For more
                                                                                                        posted on https://www.regulations.gov.                information about FDA’s posting of
                                                                                                          • If you want to submit a comment                   comments to public dockets, see 80 FR
                                                DEPARTMENT OF HEALTH AND                                with confidential information that you                56469, September 18, 2015, or access
                                                HUMAN SERVICES                                          do not wish to be made available to the               the information at: http://www.fda.gov/
                                                                                                        public, submit the comment as a                       regulatoryinformation/dockets/
                                                Food and Drug Administration                            written/paper submission and in the                   default.htm.
                                                [Docket No. FDA–2015–E–2724]                            manner detailed (see ‘‘Written/Paper                     Docket: For access to the docket to
                                                                                                        Submissions’’ and ‘‘Instructions’’).                  read background documents or the
                                                Determination of Regulatory Review                                                                            electronic and written/paper comments
                                                Period for Purposes of Patent                           Written/Paper Submissions
                                                                                                                                                              received, go to https://
                                                Extension; CERDELGA                                        Submit written/paper submissions as
                                                                                                                                                              www.regulations.gov and insert the
                                                                                                        follows:
                                                AGENCY:    Food and Drug Administration,                                                                      docket number, found in brackets in the
                                                                                                           • Mail/Hand delivery/Courier (for
                                                HHS.                                                                                                          heading of this document, into the
                                                                                                        written/paper submissions): Division of
                                                ACTION:   Notice.                                                                                             ‘‘Search’’ box and follow the prompts
                                                                                                        Dockets Management (HFA–305), Food
                                                                                                                                                              and/or go to the Division of Dockets
                                                                                                        and Drug Administration, 5630 Fishers
                                                SUMMARY:   The Food and Drug                                                                                  Management, 5630 Fishers Lane, Rm.
                                                                                                        Lane, Rm. 1061, Rockville, MD 20852.
                                                Administration (FDA) has determined                        • For written/paper comments                       1061, Rockville, MD 20852.
                                                the regulatory review period for                        submitted to the Division of Dockets                  FOR FURTHER INFORMATION CONTACT:
                                                CERDELGA and is publishing this                         Management, FDA will post your                        Beverly Friedman, Office of Regulatory
                                                notice of that determination as required                comment, as well as any attachments,                  Policy, Food and Drug Administration,
                                                by law. FDA has made the                                except for information submitted,                     10903 New Hampshire Ave., Bldg. 51,
                                                determination because of the                            marked and identified, as confidential,               Rm. 6250, Silver Spring, MD 20993,
                                                submission of an application to the                     if submitted as detailed in                           301–796–3600.
                                                Director of the U.S. Patent and                         ‘‘Instructions.’’                                     SUPPLEMENTARY INFORMATION:
                                                Trademark Office (USPTO), Department                       Instructions: All submissions received
                                                of Commerce, for the extension of a                     must include the Docket No. FDA–                      I. Background
                                                patent which claims that human drug                     2015–E–2724 for ‘‘Determination of                       The Drug Price Competition and
                                                product.                                                Regulatory Review Period for Purposes                 Patent Term Restoration Act of 1984
                                                DATES: Anyone with knowledge that any                   of Patent Extension; CERDELGA.’’                      (Pub. L. 98–417) and the Generic
                                                of the dates as published (in the                       Received comments will be placed in                   Animal Drug and Patent Term
                                                SUPPLEMENTARY INFORMATION section) are                  the docket and, except for those                      Restoration Act (Pub. L. 100–670)
                                                incorrect may submit either electronic                  submitted as ‘‘Confidential                           generally provide that a patent may be
                                                or written comments and ask for a                       Submissions,’’ publicly viewable at                   extended for a period of up to 5 years
                                                redetermination by January 23, 2017.                    https://www.regulations.gov or at the                 so long as the patented item (human
                                                Furthermore, any interested person may                  Division of Dockets Management                        drug product, animal drug product,
                                                petition FDA for a determination                        between 9 a.m. and 4 p.m., Monday                     medical device, food additive, or color
                                                regarding whether the applicant for                     through Friday.                                       additive) was subject to regulatory
                                                extension acted with due diligence                         • Confidential Submissions—To                      review by FDA before the item was
                                                during the regulatory review period by                  submit a comment with confidential                    marketed. Under these acts, a product’s
                                                May 22, 2017. See ‘‘Petitions’’ in the                  information that you do not wish to be                regulatory review period forms the basis
                                                SUPPLEMENTARY INFORMATION section for                   made publicly available, submit your                  for determining the amount of extension
                                                more information.                                       comments only as a written/paper                      an applicant may receive.
                                                ADDRESSES: You may submit comments                      submission. You should submit two                        A regulatory review period consists of
                                                as follows:                                             copies total. One copy will include the               two periods of time: A testing phase and
                                                                                                        information you claim to be confidential              an approval phase. For human drug
                                                Electronic Submissions                                  with a heading or cover note that states              products, the testing phase begins when
                                                                                                        ‘‘THIS DOCUMENT CONTAINS                              the exemption to permit the clinical
sradovich on DSK3GMQ082PROD with NOTICES




                                                  Submit electronic comments in the
                                                following way:                                          CONFIDENTIAL INFORMATION.’’ The                       investigations of the drug becomes
                                                  • Federal eRulemaking Portal:                         Agency will review this copy, including               effective and runs until the approval
                                                https://www.regulations.gov. Follow the                 the claimed confidential information, in              phase begins. The approval phase starts
                                                instructions for submitting comments.                   its consideration of comments. The                    with the initial submission of an
                                                Comments submitted electronically,                      second copy, which will have the                      application to market the human drug
                                                including attachments, to https://                      claimed confidential information                      product and continues until FDA grants
                                                www.regulations.gov will be posted to                   redacted/blacked out, will be available               permission to market the drug product.


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Document Created: 2018-02-14 08:29:27
Document Modified: 2018-02-14 08:29:27
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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by January 23, 2017. 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 22, 2017. 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 Citation81 FR 83850 

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