80_FR_77883 80 FR 77643 - Determination of Regulatory Review Period for Purposes of Patent Extension; RAXIBACUMAB

80 FR 77643 - Determination of Regulatory Review Period for Purposes of Patent Extension; RAXIBACUMAB

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 240 (December 15, 2015)

Page Range77643-77645
FR Document2015-31400

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

Federal Register, Volume 80 Issue 240 (Tuesday, December 15, 2015)
[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)]
[Notices]
[Pages 77643-77645]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31400]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-1575]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for RAXIBACUMAB and is publishing this notice 
of that determination as required by law. FDA has made the 
determination because of the submission of an application to the 
Director of the U.S. Patent and Trademark Office (USPTO), Department of 
Commerce, for the extension of a patent which claims that human 
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 
February 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 June 13, 
2016. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for 
more information.

[[Page 77644]]


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-1575 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; RAXIBACUMAB''. 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 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 human biological products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the biological 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 
RAXIBACUMAB (raxibacumab). RAXIBACUMAB is indicated for treatment of 
adult and pediatric patients with inhalational anthrax due to Bacillus 
anthracis in combination with appropriate antibacterial drugs, and for 
prophylaxis of inhalational anthrax when alternative therapies are not 
available or are not appropriate. Subsequent to this approval, the 
USPTO received a patent term restoration application for RAXIBACUMAB 
(U.S. Patent No. 7,906,119) from Human Genome Sciences, and the USPTO 
requested FDA's assistance in determining this patent's eligibility for 
patent term restoration. In a letter dated January 31, 2014, FDA 
advised the USPTO that this human biological product had undergone a 
regulatory review period and that the approval of RAXIBACUMAB 
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 
RAXIBACUMAB is 3,465 days. Of this time, 2,154 days occurred during the 
testing phase of the regulatory review period, while 1,311 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))

[[Page 77645]]

became effective: June 22, 2003. The applicant claims July 18, 2003, as 
the date the investigational new drug application (IND) became 
effective. However, FDA records indicate that the IND effective date 
was June 22, 2003, which was 30 days after FDA receipt of the IND.
    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): May 14, 2009. The applicant claims June 
15, 2012, as the date the biologics license application (BLA) for 
RAXIBACUMAB (BLA 125349/0) was initially submitted. However, FDA 
records indicate that BLA 125349/0 was submitted on May 14, 2009.
    3. The date the application was approved: December 14, 2012. FDA 
has verified the applicant's claim that BLA 125349/0 was approved on 
December 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 412 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. 
Petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-31400 Filed 12-14-15; 8:45 am]
 BILLING CODE 4164-01-P



                                                                               Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices                                                77643

                                                    used in a variety of settings including,                accuracy, reliability and safety of POC                  Transcripts: Please be advised that as
                                                    but not limited to, physician’s office                  PT/INR devices.                                       soon as a transcript is available, it will
                                                    laboratory, anti-coagulation clinic,                       • Types of quality control and the test            be accessible at http://
                                                    patient bedside, hospital emergency                     system elements assessed by the                       www.regulations.gov. It may be viewed
                                                    department, and prescription home use.                  controls.                                             at the Division of Dockets Management
                                                    The purpose of POC PT/INR testing is                       • Challenges associated with different             (see ADDRESSES). A transcript will also
                                                    to monitor warfarin and to provide                      sample matrices (venous, fingerstick,                 be available in either hardcopy or on
                                                    immediate information to physicians                     arterial).                                            CD–ROM, after submission of a
                                                    about the patient’s anticoagulation                        Registration: Registration is free and             Freedom of Information request. The
                                                    status so that this information can be                  available on a first-come, first-served               Freedom of Information office address is
                                                    integrated into appropriate treatment                   basis. Persons interested in attending                available on the Agency’s Web site at
                                                    decisions that can improve patient                      this public workshop must register                    http://www.fda.gov. A link to the
                                                    outcomes. POC PT/INR testing is                         online by 4 p.m., January 15, 2016. Early             transcripts will also be available
                                                    increasingly being viewed as a testing                  registration is recommended because                   approximately 45 days after the public
                                                    modality with performance expectations                  facilities are limited and, therefore, FDA            workshop on the Internet at http://
                                                    similar to that of traditional laboratory               may limit the number of participants                  www.fda.gov/MedicalDevices/
                                                    testing. From a regulatory standpoint,                  from each organization. If time and                   NewsEvents/WorkshopsConferences/
                                                    POC PT/INR devices have been                            space permits, onsite registration on the             default.htm. (Select this public
                                                    reviewed and cleared for prescription                   day of the public workshop will be                    workshop from the posted events list).
                                                    use under appropriate professional                      provided beginning at 7 a.m.
                                                                                                               If you need special accommodations                   Dated: December 7, 2015.
                                                    supervision or prescription home use                                                                          Leslie Kux,
                                                                                                            due to a disability, please contact Susan
                                                    (patient self-testing), depending on the
                                                                                                            Monahan, Center for Devices and                       Associate Commissioner for Policy.
                                                    claimed intended use. For this
                                                                                                            Radiological Health, Office of                        [FR Doc. 2015–31404 Filed 12–14–15; 8:45 am]
                                                    workshop, both settings will be open for
                                                                                                            Communication and Education, 301–                     BILLING CODE 4164–01–P
                                                    discussion.
                                                                                                            796–5661, email: Susan.Monahan@
                                                    II. Topics for Discussion at the Public                 fda.hhs.gov no later than January 11,
                                                    Workshop                                                2016.                                                 DEPARTMENT OF HEALTH AND
                                                                                                               To register for the public workshop,               HUMAN SERVICES
                                                      This public workshop will consist of                  please visit FDA’s Medical Devices
                                                    presentations covering the topics listed                News & Events—Workshops &                             Food and Drug Administration
                                                    in this document. Following the                         Conferences calendar at http://
                                                    presentations, there will be a moderated                www.fda.gov/MedicalDevices/
                                                    panel discussion where participants                                                                           [Docket No. FDA–2013–E–1575]
                                                                                                            NewsEvents/WorkshopsConferences/
                                                    will be asked to provide their                          default.htm. (Select this public                      Determination of Regulatory Review
                                                    perspectives. The workshop panel                        workshop from the posted events list.)                Period for Purposes of Patent
                                                    discussion will focus on identifying                    Please provide complete contact                       Extension; RAXIBACUMAB
                                                    potential solutions to address the                      information for each attendee, including
                                                    scientific and regulatory challenges                    name, title, affiliation, address, email,             AGENCY:    Food and Drug Administration,
                                                    associated with POC PT/INR devices. In                  and telephone number. Those without                   HHS.
                                                    advance of the meeting, FDA plans to                    Internet access should contact Susan                  ACTION:   Notice.
                                                    post a discussion paper outlining FDA’s                 Monahan (contact for special
                                                    current thinking on the various topics                  accommodations) to register. Registrants              SUMMARY:   The Food and Drug
                                                    mentioned in the following list, and                    will receive confirmation after they have             Administration (FDA) has determined
                                                    invite comment on this from the                         been accepted. You will be notified if                the regulatory review period for
                                                    community.                                              you are on a waiting list.                            RAXIBACUMAB and is publishing this
                                                      Topics to be discussed at the public                     Streaming Webcast of the Public                    notice of that determination as required
                                                    workshop include, but are not limited                   Workshop: This public workshop will                   by law. FDA has made the
                                                    to, the following:                                      also be Webcast. The Webcast link will                determination because of the
                                                      • Current regulatory process involved                 be available on the workshop Web page                 submission of an application to the
                                                    with the clearance of POC PT/INR                        after January 18, 2016. Please visit                  Director of the U.S. Patent and
                                                    devices.                                                FDA’s Medical Devices News &                          Trademark Office (USPTO), Department
                                                      • Current benefit/risk balance of POC                 Events—Workshops & Conferences                        of Commerce, for the extension of a
                                                    PT/INR devices.                                         calendar at http://www.fda.gov/                       patent which claims that human
                                                      • Technological differences amongst                   MedicalDevices/NewsEvents/                            biological product.
                                                    marketed POC PT/INR devices,                            WorkshopsConferences/default.htm.                     DATES: Anyone with knowledge that any
                                                    advantages and limitations of each                      (Select this public workshop from the                 of the dates as published (see the
                                                    technology, and comparability of test                   posted events list.) If you have never                SUPPLEMENTARY INFORMATION section) are
                                                    results obtained using different                        attended a Connect Pro event before,                  incorrect may submit either electronic
                                                    technologies.                                           test your connection at https://                      or written comments and ask for a
                                                      • Challenges associated with                          collaboration.fda.gov/common/help/en/                 redetermination by February 16, 2016.
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    correlating results from whole blood                    support/meeting_test.htm. To get a                    Furthermore, any interested person may
                                                    POC PT/INR devices to conventional                      quick overview of the Connect Pro                     petition FDA for a determination
                                                    plasma-based laboratory tests.                          program, visit http://www.adobe.com/                  regarding whether the applicant for
                                                      • Appropriate study design for                        go/connectpro_overview. FDA has                       extension acted with due diligence
                                                    validation and usability studies from the               verified the Web site addresses, as of the            during the regulatory review period by
                                                    perspectives of the Agency,                             date this document publishes in the                   June 13, 2016. See ‘‘Petitions’’ in the
                                                    manufacturers and end users to help                     Federal Register, but Web sites are                   SUPPLEMENTARY INFORMATION section for
                                                    improve our understanding of the                        subject to change over time.                          more information.


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                                                    77644                       Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices

                                                    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
                                                    Electronic Submissions
                                                                                                             with a heading or cover note that states              biological products, the testing phase
                                                      Submit electronic comments in the                      ‘‘THIS DOCUMENT CONTAINS                              begins when the exemption to permit
                                                    following way:                                           CONFIDENTIAL INFORMATION’’. The                       the clinical investigations of the
                                                      • Federal eRulemaking Portal: http://                  Agency will review this copy, including               biological becomes effective and runs
                                                    www.regulations.gov. Follow the                          the claimed confidential information, in              until the approval phase begins. The
                                                    instructions for submitting comments.                    its consideration of comments. The                    approval phase starts with the initial
                                                    Comments submitted electronically,                       second copy, which will have the                      submission of an application to market
                                                    including attachments, to http://                        claimed confidential information                      the human biological product and
                                                    www.regulations.gov will be posted to                    redacted/blacked out, will be available               continues until FDA grants permission
                                                    the docket unchanged. Because your                       for public viewing and posted on http://              to market the biological product.
                                                    comment will be made public, you are                     www.regulations.gov. Submit both                      Although only a portion of a regulatory
                                                    solely responsible for ensuring that your                copies to the Division of Dockets                     review period may count toward the
                                                    comment does not include any                             Management. If you do not wish your                   actual amount of extension that the
                                                    confidential information that you or a                   name and contact information to be                    Director of USPTO may award (for
                                                    third party may not wish to be posted,                   made publicly available, you can                      example, half the testing phase must be
                                                    such as medical information, your or                     provide this information on the cover                 subtracted as well as any time that may
                                                    anyone else’s Social Security number, or                 sheet and not in the body of your                     have occurred before the patent was
                                                    confidential business information, such                  comments and you must identify this                   issued), FDA’s determination of the
                                                    as a manufacturing process. Please note                  information as ‘‘confidential’’. Any                  length of a regulatory review period for
                                                    that if you include your name, contact                   information marked as ‘‘confidential’’                a human biological product will include
                                                    information, or other information that                   will not be disclosed except in                       all of the testing phase and approval
                                                    identifies you in the body of your                       accordance with 21 CFR 10.20 and other                phase as specified in 35 U.S.C.
                                                    comments, that information will be                       applicable disclosure law. For more                   156(g)(1)(B).
                                                    posted on http://www.regulations.gov.                    information about FDA’s posting of                       FDA has approved for marketing the
                                                      • If you want to submit a comment                      comments to public dockets, see 80 FR                 human biologic product
                                                    with confidential information that you                   56469, September 18, 2015, or access                  RAXIBACUMAB (raxibacumab).
                                                    do not wish to be made available to the                  the information at: http://www.fda.gov/               RAXIBACUMAB is indicated for
                                                    public, submit the comment as a                          regulatoryinformation/dockets/                        treatment of adult and pediatric patients
                                                    written/paper submission and in the                      default.htm.                                          with inhalational anthrax due to
                                                    manner detailed (see ‘‘Written/Paper                        Docket: For access to the docket to                Bacillus anthracis in combination with
                                                    Submissions’’ and ‘‘Instructions’’).                     read background documents or the                      appropriate antibacterial drugs, and for
                                                                                                             electronic and written/paper comments                 prophylaxis of inhalational anthrax
                                                    Written/Paper Submissions                                                                                      when alternative therapies are not
                                                                                                             received, go to http://
                                                       Submit written/paper submissions as                                                                         available or are not appropriate.
                                                                                                             www.regulations.gov and insert the
                                                    follows:                                                                                                       Subsequent to this approval, the USPTO
                                                       • Mail/Hand delivery/Courier (for                     docket number, found in brackets in the
                                                                                                             heading of this document, into the                    received a patent term restoration
                                                    written/paper submissions): Division of                                                                        application for RAXIBACUMAB (U.S.
                                                    Dockets Management (HFA–305), Food                       ‘‘Search’’ box and follow the prompts
                                                                                                             and/or go to the Division of Dockets                  Patent No. 7,906,119) from Human
                                                    and Drug Administration, 5630 Fishers                                                                          Genome Sciences, and the USPTO
                                                    Lane, Rm. 1061, Rockville, MD 20852.                     Management, 5630 Fishers Lane, Rm.
                                                                                                                                                                   requested FDA’s assistance in
                                                       • For written/paper comments                          1061, Rockville, MD 20852.
                                                                                                                                                                   determining this patent’s eligibility for
                                                    submitted to the Division of Dockets                     FOR FURTHER INFORMATION CONTACT:                      patent term restoration. In a letter dated
                                                    Management, FDA will post your                           Beverly Friedman, Office of Regulatory                January 31, 2014, FDA advised the
                                                    comment, as well as any attachments,                     Policy, Food and Drug Administration,                 USPTO that this human biological
                                                    except for information submitted,                        10903 New Hampshire Ave., Bldg. 51,                   product had undergone a regulatory
                                                    marked and identified, as confidential,                  Rm. 6250, Silver Spring, MD 20993,                    review period and that the approval of
                                                    if submitted as detailed in                              301–796–3600.                                         RAXIBACUMAB represented the first
                                                    ‘‘Instructions.’’                                        SUPPLEMENTARY INFORMATION:                            permitted commercial marketing or use
                                                       Instructions: All submissions received                                                                      of the product. Thereafter, the USPTO
                                                    must include the Docket No. FDA–                         I. Background
                                                                                                                                                                   requested that FDA determine the
                                                    2013–E–1575 for ‘‘Determination of                         The Drug Price Competition and                      product’s regulatory review period.
                                                    Regulatory Review Period for Purposes                    Patent Term Restoration Act of 1984
                                                    of Patent Extension; RAXIBACUMAB’’.                      (Pub. L. 98–417) and the Generic                      II. Determination of Regulatory Review
                                                    Received comments will be placed in                      Animal Drug and Patent Term                           Period
                                                    the docket and, except for those                         Restoration Act (Pub. L. 100–670)                        FDA has determined that the
                                                    submitted as ‘‘Confidential                              generally provide that a patent may be                applicable regulatory review period for
                                                    Submissions,’’ publicly viewable at                      extended for a period of up to 5 years                RAXIBACUMAB is 3,465 days. Of this
                                                    http://www.regulations.gov or at the                     so long as the patented item (human                   time, 2,154 days occurred during the
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    Division of Dockets Management                           drug product, animal drug product,                    testing phase of the regulatory review
                                                    between 9 a.m. and 4 p.m., Monday                        medical device, food additive, or color               period, while 1,311 days occurred
                                                    through Friday.                                          additive) was subject to regulatory                   during the approval phase. These
                                                       • Confidential Submissions—To                         review by FDA before the item was                     periods of time were derived from the
                                                    submit a comment with confidential                       marketed. Under these acts, a product’s               following dates:
                                                    information that you do not wish to be                   regulatory review period forms the basis                 1. The date an exemption under
                                                    made publicly available, submit your                     for determining the amount of extension               section 505(i) of the Federal Food, Drug,
                                                    comments only as a written/paper                         an applicant may receive.                             and Cosmetic Act (21 U.S.C. 355(i))


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                                                                               Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices                                          77645

                                                    became effective: June 22, 2003. The                      Dated: December 7, 2015.                            considers your comment on this draft
                                                    applicant claims July 18, 2003, as the                  Leslie Kux,                                           guidance before it begins work on the
                                                    date the investigational new drug                       Associate Commissioner for Policy.                    final version of the guidance, submit
                                                    application (IND) became effective.                     [FR Doc. 2015–31400 Filed 12–14–15; 8:45 am]          either electronic or written comments
                                                    However, FDA records indicate that the                  BILLING CODE 4164–01–P
                                                                                                                                                                  on the draft guidance by March 14,
                                                    IND effective date was June 22, 2003,                                                                         2016.
                                                    which was 30 days after FDA receipt of                                                                        ADDRESSES:    You may submit comments
                                                    the IND.                                                DEPARTMENT OF HEALTH AND                              as follows:
                                                      2. The date the application was                       HUMAN SERVICES
                                                                                                                                                                  Electronic Submissions
                                                    initially submitted with respect to the                 Food and Drug Administration
                                                    human biological product under section                                                                          Submit electronic comments in the
                                                    351 of the Public Health Service Act (42                [Docket No. FDA–2013–D–1143]                          following way:
                                                    U.S.C. 262): May 14, 2009. The                                                                                  • Federal eRulemaking Portal: http://
                                                    applicant claims June 15, 2012, as the                  Use of Nucleic Acid Tests To Reduce                   www.regulations.gov. Follow the
                                                    date the biologics license application                  the Risk of Transmission of West Nile                 instructions for submitting comments.
                                                                                                            Virus From Living Donors of Human                     Comments submitted electronically,
                                                    (BLA) for RAXIBACUMAB (BLA
                                                                                                            Cells, Tissues, and Cellular and                      including attachments, to http://
                                                    125349/0) was initially submitted.
                                                                                                            Tissue-Based Products; Draft                          www.regulations.gov will be posted to
                                                    However, FDA records indicate that
                                                                                                            Guidance for Industry; Availability                   the docket unchanged. Because your
                                                    BLA 125349/0 was submitted on May
                                                                                                                                                                  comment will be made public, you are
                                                    14, 2009.                                               AGENCY:    Food and Drug Administration,              solely responsible for ensuring that your
                                                      3. The date the application was                       HHS.                                                  comment does not include any
                                                    approved: December 14, 2012. FDA has                    ACTION:   Notice of availability.                     confidential information that you or a
                                                    verified the applicant’s claim that BLA                                                                       third party may not wish to be posted,
                                                                                                            SUMMARY:    The Food and Drug
                                                    125349/0 was approved on December                                                                             such as medical information, your or
                                                                                                            Administration (FDA or Agency) is
                                                    14, 2012.                                                                                                     anyone else’s Social Security number, or
                                                                                                            announcing the availability of a draft
                                                      This determination of the regulatory                                                                        confidential business information, such
                                                                                                            document entitled ‘‘Use of Nucleic Acid
                                                    review period establishes the maximum                                                                         as a manufacturing process. Please note
                                                                                                            Tests to Reduce the Risk of
                                                    potential length of a patent extension.                                                                       that if you include your name, contact
                                                                                                            Transmission of West Nile Virus from
                                                    However, the USPTO applies several                                                                            information, or other information that
                                                                                                            Living Donors of Human Cells, Tissues,
                                                    statutory limitations in its calculations                                                                     identifies you in the body of your
                                                                                                            and Cellular and Tissue-Based Products
                                                                                                                                                                  comments, that information will be
                                                    of the actual period for patent extension.              (HCT/Ps); Draft Guidance for Industry.’’
                                                                                                                                                                  posted on http://www.regulations.gov.
                                                    In its application for patent extension,                The draft guidance document provides
                                                                                                                                                                    • If you want to submit a comment
                                                    this applicant seeks 412 days of patent                 establishments that make donor
                                                                                                                                                                  with confidential information that you
                                                    term extension.                                         eligibility determinations for donors of
                                                                                                                                                                  do not wish to be made available to the
                                                                                                            HCT/Ps with recommendations for
                                                    III. Petitions                                                                                                public, submit the comment as a
                                                                                                            testing living donors for West Nile Virus
                                                                                                                                                                  written/paper submission and in the
                                                      Anyone with knowledge that any of                     (WNV). The draft guidance recommends
                                                                                                                                                                  manner detailed (see ‘‘Written/Paper
                                                    the dates as published are incorrect may                the use of an FDA-licensed nucleic acid
                                                                                                                                                                  Submissions’’ and ‘‘Instructions’’).
                                                    submit either electronic or written                     test (NAT) to test living donors of HCT/
                                                    comments and ask for a redetermination                  Ps for evidence of infection with WNV.                Written/Paper Submissions
                                                                                                            The guidance does not provide                            Submit written/paper submissions as
                                                    (see DATES). Furthermore, any interested
                                                                                                            recommendations regarding testing of                  follows:
                                                    person may petition FDA for a
                                                                                                            cadaveric HCT/P donors for WNV. The                      • Mail/Hand delivery/Courier (for
                                                    determination regarding whether the
                                                                                                            draft guidance replaces the draft                     written/paper submissions): Division of
                                                    applicant for extension acted with due                  guidance entitled ‘‘Draft Guidance for
                                                    diligence during the regulatory review                                                                        Dockets Management (HFA–305), Food
                                                                                                            Industry: Use of Nucleic Acid Tests to                and Drug Administration, 5630 Fishers
                                                    period. To meet its burden, the petition                Reduce the Risk of Transmission of
                                                    must be timely (see DATES) and contain                                                                        Lane, Rm. 1061, Rockville, MD 20852.
                                                                                                            West Nile Virus from Donors of Human                     • For written/paper comments
                                                    sufficient facts to merit an FDA                        Cells, Tissues, and Cellular and Tissue-
                                                    investigation. (See H. Rept. 857, part 1,                                                                     submitted to the Division of Dockets
                                                                                                            Based Products (HCT/Ps)’’ dated                       Management, FDA will post your
                                                    98th Cong., 2d sess., pp. 41–42, 1984.)                 October 2013. The donor testing
                                                    Petitions should be in the format                                                                             comment, as well as any attachments,
                                                                                                            recommendations in the draft guidance,                except for information submitted,
                                                    specified in 21 CFR 10.30.                              when finalized, will supplement the                   marked and identified, as confidential,
                                                      Submit petitions electronically to                    donor screening recommendations for                   if submitted as detailed in
                                                    http://www.regulations.gov at Docket                    WNV (which will remain in place) and                  ‘‘Instructions.’’
                                                    No. FDA–2013–S–0610. Submit written                     supersede the ‘‘West Nile Virus (WNV)’’                  Instructions: All submissions received
                                                    petitions (two copies are required) to the              section in Appendix 6 of the guidance                 must include the Docket No. FDA–
                                                    Division of Dockets Management (HFA–                    entitled ‘‘Guidance for Industry:                     2013–D–1143 for ‘‘Use of Nucleic Acid
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    305), Food and Drug Administration,                     Eligibility Determination for Donors of               Tests to Reduce the Risk of
                                                    5630 Fishers Lane, Rm. 1061, Rockville,                 Human Cells, Tissues, and Cellular and                Transmission of West Nile Virus from
                                                    MD 20852. Petitions that have not been                  Tissue-Based Products (HCT/Ps)’’ dated                Living Donors of Human Cells, Tissues,
                                                    made publicly available on http://                      August 2007 (2007 Donor Eligibility                   and Cellular and Tissue-Based Products
                                                    www.regulations.gov may be viewed in                    Guidance).                                            (HCT/Ps); Draft Guidance for Industry.’’
                                                    the Division of Dockets Management                      DATES: Although you can comment on                    Received comments will be placed in
                                                    between 9 a.m. and 4 p.m., Monday                       any guidance at any time (see 21 CFR                  the docket and, except for those
                                                    through Friday.                                         10.115(g)(5)), to ensure that the Agency              submitted as ‘‘Confidential


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Document Created: 2018-03-02 09:16:21
Document Modified: 2018-03-02 09:16:21
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 February 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 June 13, 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 Citation80 FR 77643 

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