81_FR_39769 81 FR 39652 - Determination of Regulatory Review Period for Purposes of Patent Extension; ZILVER PTX DRUG ELUTING PERIPHERAL STENT

81 FR 39652 - Determination of Regulatory Review Period for Purposes of Patent Extension; ZILVER PTX DRUG ELUTING PERIPHERAL STENT

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 117 (June 17, 2016)

Page Range39652-39653
FR Document2016-14356

The Food and Drug Administration (FDA) has determined the regulatory review period for ZILVER PTX DRUG ELUTING PERIPHERAL STENT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application by Cook Medical Technologies, LLC, to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

Federal Register, Volume 81 Issue 117 (Friday, June 17, 2016)
[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)]
[Notices]
[Pages 39652-39653]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-14356]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-0677]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; ZILVER PTX DRUG ELUTING PERIPHERAL STENT

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for ZILVER PTX DRUG ELUTING PERIPHERAL STENT 
and is publishing this notice of that determination as required by law. 
FDA has made the determination because of the submission of an 
application by Cook Medical Technologies, LLC, to the Director of the 
U.S. Patent and Trademark Office (USPTO), Department of Commerce, for 
the extension of a patent which claims that medical device.

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 August 
16, 2016. 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 December 14, 2016. 
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: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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 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 No. 
FDA-2013-E-0677 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; ZILVER PTX DRUG ELUTING PERIPHERAL 
STENT.'' Received comments will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
http://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 http://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

[[Page 39653]]

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 http://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 medical devices, the testing 
phase begins with a clinical investigation of the device and runs until 
the approval phase begins. The approval phase starts with the initial 
submission of an application to market the device and continues until 
permission to market the device is granted. Although only a portion of 
a regulatory review period may count toward the actual amount of 
extension that the Director of USPTO may award (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 medical device will include all of the 
testing phase and approval phase as specified in 35 U.S.C. 
156(g)(3)(B).
    FDA has approved for marketing the medical device ZILVER PTX DRUG 
ELUTING PERIPHERAL STENT. ZILVER PTX DRUG ELUTING PERIPHERAL STENT is 
indicated for improving luminal diameter for the treatment of de novo 
or restenotic symptomatic lesions in native vascular disease of the 
above-the-knee femoropopliteal arteries having reference vessel 
diameters from 4 millimeters (mm) to 9 mm and total lesion lengths up 
to 140 mm per limb and 280 mm per patient. Subsequent to this approval, 
the USPTO received a patent term restoration application for ZILVER PTX 
DRUG ELUTING PERIPHERAL STENT (U.S. Patent No. 6,299,604) from Cook 
Medical Technologies, LLC, and the USPTO requested FDA's assistance in 
determining this patent's eligibility for patent term restoration. In a 
letter dated March 25, 2014, FDA advised the USPTO that this medical 
device had undergone a regulatory review period and that the approval 
of ZILVER PTX DRUG ELUTING PERIPHERAL STENT 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 
ZILVER PTX DRUG ELUTING PERIPHERAL STENT is 3,075 days. Of this time, 
2,180 days occurred during the testing phase of the regulatory review 
period, while 895 days occurred during the approval phase. These 
periods of time were derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving 
this device became effective: June 16, 2004. FDA has verified the 
applicant's claim that the date the investigational device exemption 
(IDE) required under section 520(g) of the FD&C Act for human tests to 
begin became effective was June 16, 2004.
    2. The date an application was initially submitted with respect to 
the device under section 515 of the FD&C Act (21 U.S.C. 360e): June 4, 
2010. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for ZILVER PTX DRUG ELUTING PERIPHERAL STENT 
(PMA P100022) was initially submitted June 4, 2010.
    3. The date the application was approved: November 14, 2012. FDA 
has verified the applicant's claim that PMA P100022 was approved on 
November 14, 2012.
    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 1,826 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.
    Submit petitions electronically to http://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: June 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14356 Filed 6-16-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                39652                           Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices

                                                I. Background                                           DEPARTMENT OF HEALTH AND                               comments, that information will be
                                                                                                        HUMAN SERVICES                                         posted on http://www.regulations.gov.
                                                  In the Federal Register of January 19,                                                                         • If you want to submit a comment
                                                2016 (81 FR 2874), FDA published the                    Food and Drug Administration                           with confidential information that you
                                                notice of availability for a draft guidance                                                                    do not wish to be made available to the
                                                for industry entitled ‘‘Modified Release                [Docket No. FDA–2013–E–0677]                           public, submit the comment as a
                                                Veterinary Parenteral Dosage Forms:                                                                            written/paper submission and in the
                                                                                                        Determination of Regulatory Review
                                                Development, Evaluation, and                                                                                   manner detailed (see ‘‘Written/Paper
                                                                                                        Period for Purposes of Patent
                                                Establishment of Specifications,’’ giving                                                                      Submissions’’ and ‘‘Instructions’’).
                                                                                                        Extension; ZILVER PTX DRUG
                                                interested persons until March 21, 2016,                ELUTING PERIPHERAL STENT                               Written/Paper Submissions
                                                to comment on the draft, and those
                                                comments were considered as the                         AGENCY:    Food and Drug Administration,                  Submit written/paper submissions as
                                                                                                        HHS.                                                   follows:
                                                guidance was finalized. The guidance                                                                              • Mail/Hand delivery/Courier (for
                                                announced in this notice finalizes the                  ACTION:   Notice.                                      written/paper submissions): Division of
                                                draft guidance dated January 2016.                                                                             Dockets Management (HFA–305), Food
                                                                                                        SUMMARY:   The Food and Drug
                                                II. Significance of Guidance                            Administration (FDA) has determined                    and Drug Administration, 5630 Fishers
                                                                                                        the regulatory review period for ZILVER                Lane, Rm. 1061, Rockville, MD 20852.
                                                   This level 1 guidance is being issued                                                                          • For written/paper comments
                                                                                                        PTX DRUG ELUTING PERIPHERAL
                                                consistent with FDA’s good guidance                                                                            submitted to the Division of Dockets
                                                                                                        STENT and is publishing this notice of
                                                practices regulation (21 CFR 10.115).                                                                          Management, FDA will post your
                                                                                                        that determination as required by law.
                                                The guidance represents the current                                                                            comment, as well as any attachments,
                                                                                                        FDA has made the determination
                                                thinking of FDA on ‘‘Modified Release                                                                          except for information submitted,
                                                                                                        because of the submission of an
                                                Veterinary Parenteral Dosage Forms:                                                                            marked and identified, as confidential,
                                                                                                        application by Cook Medical
                                                Development, Evaluation, and                                                                                   if submitted as detailed in
                                                                                                        Technologies, LLC, to the Director of the
                                                Establishment of Specifications.’’ It does                                                                     ‘‘Instructions.’’
                                                                                                        U.S. Patent and Trademark Office                          Instructions: All submissions received
                                                not establish any rights for any person                 (USPTO), Department of Commerce, for                   must include the Docket No. FDA–
                                                and is not binding on FDA or the public.                the extension of a patent which claims                 2013–E–0677 for ‘‘Determination of
                                                You can use an alternative approach if                  that medical device.                                   Regulatory Review Period for Purposes
                                                it satisfies the requirements of the                    DATES: Anyone with knowledge that any                  of Patent Extension; ZILVER PTX DRUG
                                                applicable statutes and regulations.                    of the dates as published (see the                     ELUTING PERIPHERAL STENT.’’
                                                                                                        SUPPLEMENTARY INFORMATION section) are                 Received comments will be placed in
                                                III. Paperwork Reduction Act of 1995
                                                                                                        incorrect may submit either electronic                 the docket and, except for those
                                                  This guidance refers to previously                    or written comments and ask for a                      submitted as ‘‘Confidential
                                                approved collections of information                     redetermination by August 16, 2016.                    Submissions,’’ publicly viewable at
                                                found in FDA regulations. These                         Furthermore, any interested person may                 http://www.regulations.gov or at the
                                                collections of information are subject to               petition FDA for a determination                       Division of Dockets Management
                                                review by the Office of Management and                  regarding whether the applicant for                    between 9 a.m. and 4 p.m., Monday
                                                Budget (OMB) under the Paperwork                        extension acted with due diligence                     through Friday.
                                                Reduction Act of 1995 (44 U.S.C. 3501–                  during the regulatory review period by                    • Confidential Submissions—To
                                                                                                        December 14, 2016. See ‘‘Petitions’’ in                submit a comment with confidential
                                                3520). The collections of information in
                                                                                                        the SUPPLEMENTARY INFORMATION section                  information that you do not wish to be
                                                21 CFR part 514 have been approved
                                                                                                        for more information.                                  made publicly available, submit your
                                                under OMB control number 0910–0032;
                                                                                                        ADDRESSES: You may submit comments                     comments only as a written/paper
                                                the collections of information in section
                                                                                                        as follows:                                            submission. You should submit two
                                                512(n)(1) of the FD&C Act (21 U.S.C.
                                                                                                                                                               copies total. One copy will include the
                                                360k) have been approved under OMB                      Electronic Submissions                                 information you claim to be confidential
                                                control number 0910–0669.                                 Submit electronic comments in the                    with a heading or cover note that states
                                                IV. Electronic Access                                   following way:                                         ‘‘THIS DOCUMENT CONTAINS
                                                                                                          • Federal eRulemaking Portal: http://                CONFIDENTIAL INFORMATION.’’ The
                                                  Persons with access to the Internet                   www.regulations.gov. Follow the                        Agency will review this copy, including
                                                may obtain the guidance at either http://               instructions for submitting comments.                  the claimed confidential information, in
                                                www.fda.gov/AnimalVeterinary/                           Comments submitted electronically,                     its consideration of comments. The
                                                GuidanceComplianceEnforcement/                          including attachments, to http://                      second copy, which will have the
                                                GuidanceforIndustry/default.htm or                      www.regulations.gov will be posted to                  claimed confidential information
                                                http://www.regulations.gov.                             the docket unchanged. Because your                     redacted/blacked out, will be available
                                                                                                        comment will be made public, you are                   for public viewing and posted on http://
                                                  Dated: June 13, 2016.
                                                                                                        solely responsible for ensuring that your              www.regulations.gov. Submit both
                                                Leslie Kux,                                             comment does not include any                           copies to the Division of Dockets
                                                Associate Commissioner for Policy.                      confidential information that you or a                 Management. If you do not wish your
                                                [FR Doc. 2016–14355 Filed 6–16–16; 8:45 am]             third party may not wish to be posted,                 name and contact information to be
sradovich on DSK3TPTVN1PROD with NOTICES




                                                BILLING CODE 4164–01–P                                  such as medical information, your or                   made publicly available, you can
                                                                                                        anyone else’s Social Security number, or               provide this information on the cover
                                                                                                        confidential business information, such                sheet and not in the body of your
                                                                                                        as a manufacturing process. Please note                comments and you must identify this
                                                                                                        that if you include your name, contact                 information as ‘‘confidential.’’ Any
                                                                                                        information, or other information that                 information marked as ‘‘confidential’’
                                                                                                        identifies you in the body of your                     will not be disclosed except in


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                                                                                Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices                                                  39653

                                                accordance with 21 CFR 10.20 and other                  ELUTING PERIPHERAL STENT.                                This determination of the regulatory
                                                applicable disclosure law. For more                     ZILVER PTX DRUG ELUTING                                review period establishes the maximum
                                                information about FDA’s posting of                      PERIPHERAL STENT is indicated for                      potential length of a patent extension.
                                                comments to public dockets, see 80 FR                   improving luminal diameter for the                     However, the USPTO applies several
                                                56469, September 18, 2015, or access                    treatment of de novo or restenotic                     statutory limitations in its calculations
                                                the information at: http://www.fda.gov/                 symptomatic lesions in native vascular                 of the actual period for patent extension.
                                                regulatoryinformation/dockets/                          disease of the above-the-knee                          In its application for patent extension,
                                                default.htm.                                            femoropopliteal arteries having                        this applicant seeks 1,826 days of patent
                                                   Docket: For access to the docket to                  reference vessel diameters from 4                      term extension.
                                                read background documents or the                        millimeters (mm) to 9 mm and total
                                                                                                                                                               III. Petitions
                                                electronic and written/paper comments                   lesion lengths up to 140 mm per limb
                                                received, go to http://                                 and 280 mm per patient. Subsequent to                     Anyone with knowledge that any of
                                                www.regulations.gov and insert the                      this approval, the USPTO received a                    the dates as published are incorrect may
                                                docket number, found in brackets in the                 patent term restoration application for                submit either electronic or written
                                                heading of this document, into the                      ZILVER PTX DRUG ELUTING                                comments and ask for a redetermination
                                                ‘‘Search’’ box and follow the prompts                   PERIPHERAL STENT (U.S. Patent No.                      (see DATES). Furthermore, any interested
                                                and/or go to the Division of Dockets                    6,299,604) from Cook Medical                           person may petition FDA for a
                                                Management, 5630 Fishers Lane, Rm.                      Technologies, LLC, and the USPTO                       determination regarding whether the
                                                1061, Rockville, MD 20852.                              requested FDA’s assistance in                          applicant for extension acted with due
                                                                                                        determining this patent’s eligibility for              diligence during the regulatory review
                                                FOR FURTHER INFORMATION CONTACT:
                                                                                                        patent term restoration. In a letter dated             period. To meet its burden, the petition
                                                Beverly Friedman, Office of Regulatory
                                                                                                        March 25, 2014, FDA advised the                        must be timely (see DATES) and contain
                                                Policy, Food and Drug Administration,
                                                                                                        USPTO that this medical device had                     sufficient facts to merit an FDA
                                                10903 New Hampshire Ave., Bldg. 51,                                                                            investigation. (See H. Rept. 857, part 1,
                                                Rm. 6250, Silver Spring, MD 20993,                      undergone a regulatory review period
                                                                                                        and that the approval of ZILVER PTX                    98th Cong., 2d sess., pp. 41–42, 1984.)
                                                301–796–3600.                                                                                                  Petitions should be in the format
                                                                                                        DRUG ELUTING PERIPHERAL STENT
                                                SUPPLEMENTARY INFORMATION:                                                                                     specified in 21 CFR 10.30.
                                                                                                        represented the first permitted
                                                I. Background                                           commercial marketing or use of the                        Submit petitions electronically to
                                                                                                        product. Thereafter, the USPTO                         http://www.regulations.gov at Docket
                                                   The Drug Price Competition and                                                                              No. FDA–2013–S–0610. Submit written
                                                                                                        requested that FDA determine the
                                                Patent Term Restoration Act of 1984                                                                            petitions (two copies are required) to the
                                                                                                        product’s regulatory review period.
                                                (Pub. L. 98–417) and the Generic                                                                               Division of Dockets Management (HFA–
                                                Animal Drug and Patent Term                             II. Determination of Regulatory Review                 305), Food and Drug Administration,
                                                Restoration Act (Pub. L. 100–670)                       Period                                                 5630 Fishers Lane, Rm. 1061, Rockville,
                                                generally provide that a patent may be                     FDA has determined that the                         MD 20852.
                                                extended for a period of up to 5 years                  applicable regulatory review period for                  Dated: June 13, 2016.
                                                so long as the patented item (human                     ZILVER PTX DRUG ELUTING
                                                drug product, animal drug product,                                                                             Leslie Kux,
                                                                                                        PERIPHERAL STENT is 3,075 days. Of
                                                medical device, food additive, or color                                                                        Associate Commissioner for Policy.
                                                                                                        this time, 2,180 days occurred during
                                                additive) was subject to regulatory                                                                            [FR Doc. 2016–14356 Filed 6–16–16; 8:45 am]
                                                                                                        the testing phase of the regulatory
                                                review by FDA before the item was                       review period, while 895 days occurred                 BILLING CODE 4164–01–P
                                                marketed. Under these acts, a product’s                 during the approval phase. These
                                                regulatory review period forms the basis                periods of time were derived from the
                                                for determining the amount of extension                                                                        DEPARTMENT OF HEALTH AND
                                                                                                        following dates:
                                                an applicant may receive.                                  1. The date an exemption under                      HUMAN SERVICES
                                                   A regulatory review period consists of               section 520(g) of the Federal Food, Drug,              Food and Drug Administration
                                                two periods of time: A testing phase and                and Cosmetic Act (the FD&C Act) (21
                                                an approval phase. For medical devices,                 U.S.C. 360j(g)) involving this device                  [Docket No. FDA–2016–N–1486]
                                                the testing phase begins with a clinical                became effective: June 16, 2004. FDA
                                                investigation of the device and runs                    has verified the applicant’s claim that                Authorizations of Emergency Use of In
                                                until the approval phase begins. The                    the date the investigational device                    Vitro Diagnostic Devices for Detection
                                                approval phase starts with the initial                  exemption (IDE) required under section                 of Zika Virus; Availability
                                                submission of an application to market                  520(g) of the FD&C Act for human tests                 AGENCY:   Food and Drug Administration,
                                                the device and continues until                          to begin became effective was June 16,                 HHS.
                                                permission to market the device is                      2004.                                                  ACTION:   Notice.
                                                granted. Although only a portion of a                      2. The date an application was
                                                regulatory review period may count                      initially submitted with respect to the                SUMMARY:   The Food and Drug
                                                toward the actual amount of extension                   device under section 515 of the FD&C                   Administration (FDA) is announcing the
                                                that the Director of USPTO may award                    Act (21 U.S.C. 360e): June 4, 2010. FDA                issuance of two Emergency Use
                                                (half the testing phase must be                         has verified the applicant’s claim that                Authorizations (EUAs) (the
                                                subtracted as well as any time that may                 the premarket approval application                     Authorizations) for two in vitro
                                                have occurred before the patent was                     (PMA) for ZILVER PTX DRUG ELUTING                      diagnostic devices for detection of Zika
sradovich on DSK3TPTVN1PROD with NOTICES




                                                issued), FDA’s determination of the                     PERIPHERAL STENT (PMA P100022)                         virus in response to the Zika virus
                                                length of a regulatory review period for                was initially submitted June 4, 2010.                  outbreak in the Americas. FDA issued
                                                a medical device will include all of the                   3. The date the application was                     these Authorizations under the Federal
                                                testing phase and approval phase as                     approved: November 14, 2012. FDA has                   Food, Drug, and Cosmetic Act (the
                                                specified in 35 U.S.C. 156(g)(3)(B).                    verified the applicant’s claim that PMA                FD&C Act), as requested by Focus
                                                   FDA has approved for marketing the                   P100022 was approved on November                       Diagnostics, Inc., and altona Diagnostics
                                                medical device ZILVER PTX DRUG                          14, 2012.                                              GmbH. The Authorizations contain,


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Document Created: 2016-06-17 01:04:33
Document Modified: 2016-06-17 01:04:33
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 August 16, 2016. 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 December 14, 2016. 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 39652 

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