80_FR_29821 80 FR 29722 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Renewal

80 FR 29722 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 99 (May 22, 2015)

Page Range29722-29723
FR Document2015-12401

The Food and Drug Administration (FDA) is announcing the renewal of the Medical Imaging Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Medical Imaging Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the May 18, 2015, expiration date.

Federal Register, Volume 80 Issue 99 (Friday, May 22, 2015)
[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29722-29723]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-12401]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Advisory Committee; Medical Imaging Drugs Advisory Committee; 
Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Renewal of Federal advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
renewal of the Medical Imaging Drugs Advisory Committee by the 
Commissioner of Food and Drugs (the Commissioner). The Commissioner has 
determined that it is in the public interest to renew the Medical 
Imaging Drugs Advisory Committee for an additional 2 years beyond the 
charter expiration date. The new charter will be in effect until the 
May 18, 2015, expiration date.

DATES: Authority for the Medical Imaging Drugs Advisory Committee will 
expire on May 18, 2017, unless the Commissioner formally determines 
that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Lauren D. Tesh, Division of Advisory 
Committee and Consultant Management, Office of Executive Programs, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, 
Silver Spring, MD 20993-0002; 301-796-9001, email: [email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by 
the Department of Health and Human Services pursuant to 45 CFR part 11 
and by the General Services Administration, FDA is announcing the 
renewal of the Medical Imaging Drugs Advisory Committee (the 
Committee). The Committee is a discretionary Federal advisory committee 
established to provide advice to the Commissioner. The Committee 
advises the Commissioner or designee in discharging responsibilities as 
they relate to helping to ensure safe and effective drugs for human use 
and, as required, any other product for which FDA has regulatory 
responsibility.
    The Committee reviews and evaluates data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in diagnostic and therapeutic procedures using radioactive 
pharmaceuticals and contrast media used in diagnostic radiology and 
makes appropriate recommendations to the Commissioner.

[[Page 29723]]

    The Committee shall consist of a core of 12 voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities knowledgeable in the 
fields of nuclear medicine, radiology, epidemiology or statistics, and 
related specialties. Members will be invited to serve for overlapping 
terms of up to 4 years. Almost all non-Federal members of this 
committee serve as Special Government Employees. The core of voting 
members may include one technically qualified member, selected by the 
Commissioner or designee, who is identified with consumer interests and 
is recommended by either a consortium of consumer-oriented 
organizations or other interested persons. In addition to the voting 
members, the Committee may include one non-voting member who is 
identified with industry interests.
    Further information regarding the most recent charter and other 
information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/MedicalImagingDrugsAdvisoryCommittee/default.htm or by contacting the Designated Federal Officer (Please see 
FOR FURTHER INFORMATION CONTACT). In light of the fact that no change 
has been made to the committee name or description of duties, no 
amendment will be made to 21 CFR 14.100.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app.). For general information related to FDA advisory 
committees please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: May 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12401 Filed 5-21-15; 8:45 am]
BILLING CODE 4164-01-P



                                                    29722                            Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices

                                                    recommendations to the Agency on                        orally or in writing, on issues pending               DEPARTMENT OF HEALTH AND
                                                    FDA’s regulatory issues.                                before the committee. Written                         HUMAN SERVICES
                                                       Date and Time: The meeting will be                   submissions may be made to the contact
                                                    held on July 9, 2015, from 8 a.m. to                    person on or before June 24, 2015. Oral               Food and Drug Administration
                                                    12:30 p.m.                                              presentations from the public will be                 [Docket No. FDA–2015–N–0001]
                                                       Location: FDA White Oak Campus,                      scheduled between approximately 10:30
                                                    10903 New Hampshire Ave., Bldg. 31                      a.m. to 11:30 a.m. Those individuals                  Advisory Committee; Medical Imaging
                                                    Conference Center, the Great Room (Rm.                                                                        Drugs Advisory Committee; Renewal
                                                                                                            interested in making formal oral
                                                    1503), Silver Spring, MD 20993–0002.
                                                                                                            presentations should notify the contact               AGENCY:   Food and Drug Administration,
                                                    Answers to commonly asked questions
                                                    including information regarding special                 person and submit a brief statement of                HHS.
                                                    accommodations due to a disability,                     the general nature of the evidence or                 ACTION:Renewal of Federal advisory
                                                    visitor parking, and transportation may                 arguments they wish to present, the                   committee.
                                                    be accessed at: http://www.fda.gov/                     names and addresses of proposed
                                                    AdvisoryCommittees/                                     participants, and an indication of the                SUMMARY:   The Food and Drug
                                                    AboutAdvisoryCommittees/                                approximate time requested to make                    Administration (FDA) is announcing the
                                                    ucm408555.htm.                                          their presentation on or before June 16,              renewal of the Medical Imaging Drugs
                                                       Contact Person: Lauren D. Tesh,                      2015. Time allotted for each                          Advisory Committee by the
                                                    Center for Drug Evaluation and                          presentation may be limited. If the                   Commissioner of Food and Drugs (the
                                                    Research, Food and Drug                                 number of registrants requesting to                   Commissioner). The Commissioner has
                                                    Administration, 10903 New Hampshire                                                                           determined that it is in the public
                                                                                                            speak is greater than can be reasonably
                                                    Ave., Bldg. 31, Rm. 2417, Silver Spring,                                                                      interest to renew the Medical Imaging
                                                                                                            accommodated during the scheduled                     Drugs Advisory Committee for an
                                                    MD 20993–0002, 301–796–9001, FAX:                       open public hearing session, FDA may
                                                    301–847–8533, ODAC@fda.hhs.gov, or                                                                            additional 2 years beyond the charter
                                                                                                            conduct a lottery to determine the                    expiration date. The new charter will be
                                                    FDA Advisory Committee Information                      speakers for the scheduled open public
                                                    Line, 1–800–741–8138 (301–443–0572                                                                            in effect until the May 18, 2015,
                                                                                                            hearing session. The contact person will              expiration date.
                                                    in the Washington, DC area). A notice in
                                                                                                            notify interested persons regarding their             DATES: Authority for the Medical
                                                    the Federal Register about last minute
                                                                                                            request to speak by June 17, 2014.                    Imaging Drugs Advisory Committee will
                                                    modifications that impact a previously
                                                    announced advisory committee meeting                      Persons attending FDA’s advisory                    expire on May 18, 2017, unless the
                                                    cannot always be published quickly                      committee meetings are advised that the               Commissioner formally determines that
                                                    enough to provide timely notice.                        Agency is not responsible for providing               renewal is in the public interest.
                                                    Therefore, you should always check the                  access to electrical outlets.                         FOR FURTHER INFORMATION CONTACT:
                                                    Agency’s Web site at http://                              FDA welcomes the attendance of the                  Lauren D. Tesh, Division of Advisory
                                                    www.fda.gov/AdvisoryCommittees/                                                                               Committee and Consultant
                                                                                                            public at its advisory committee
                                                    default.htm and scroll down to the                                                                            Management, Office of Executive
                                                                                                            meetings and will make every effort to
                                                    appropriate advisory committee meeting                                                                        Programs, Food and Drug
                                                                                                            accommodate persons with physical                     Administration, 10903 New Hampshire
                                                    link, or call the advisory committee
                                                                                                            disabilities or special needs. If you                 Ave., Bldg. 31, Rm. 2417, Silver Spring,
                                                    information line to learn about possible
                                                    modifications before coming to the                      require special accommodations due to                 MD 20993–0002; 301–796–9001, email:
                                                    meeting.                                                a disability, please contact Lauren D.                MIDAC@fda.hhs.gov.
                                                       Agenda: The committee will discuss                   Tesh at least 7 days in advance of the                SUPPLEMENTARY INFORMATION: Pursuant
                                                    biologics license application 125547,                   meeting.                                              to 41 CFR 102–3.65 and approval by the
                                                    necitumumab injection, application                        FDA is committed to the orderly                     Department of Health and Human
                                                    submitted by Eli Lilly and Company.                     conduct of its advisory committee                     Services pursuant to 45 CFR part 11 and
                                                    The proposed indication (use) for this                  meetings. Please visit our Web site at                by the General Services Administration,
                                                    product is in combination with                          http://www.fda.gov/                                   FDA is announcing the renewal of the
                                                    gemcitabine and cisplatin for first-line                AdvisoryCommittees/                                   Medical Imaging Drugs Advisory
                                                    treatment of patients with locally                      AboutAdvisoryCommittees/                              Committee (the Committee). The
                                                    advanced or metastatic squamous non-                    ucm111462.htm for procedures on                       Committee is a discretionary Federal
                                                    small cell lung cancer.                                 public conduct during advisory                        advisory committee established to
                                                       FDA intends to make background                                                                             provide advice to the Commissioner.
                                                                                                            committee meetings.
                                                    material available to the public no later                                                                     The Committee advises the
                                                    than 2 business days before the meeting.                  Notice of this meeting is given under               Commissioner or designee in
                                                    If FDA is unable to post the background                 the Federal Advisory Committee Act (5                 discharging responsibilities as they
                                                    material on its Web site prior to the                   U.S.C. app. 2).                                       relate to helping to ensure safe and
                                                    meeting, the background material will                     Dated: May 15, 2015.                                effective drugs for human use and, as
                                                    be made publicly available at the                       Leslie Kux,
                                                                                                                                                                  required, any other product for which
                                                    location of the advisory committee                                                                            FDA has regulatory responsibility.
                                                    meeting, and the background material                    Associate Commissioner for Policy.                       The Committee reviews and evaluates
                                                    will be posted on FDA’s Web site after                  [FR Doc. 2015–12403 Filed 5–21–15; 8:45 am]           data concerning the safety and
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    the meeting. Background material is                     BILLING CODE 4164–01–P                                effectiveness of marketed and
                                                    available at http://www.fda.gov/                                                                              investigational human drug products for
                                                    AdvisoryCommittees/Calendar/                                                                                  use in diagnostic and therapeutic
                                                    default.htm. Scroll down to the                                                                               procedures using radioactive
                                                    appropriate advisory committee meeting                                                                        pharmaceuticals and contrast media
                                                    link.                                                                                                         used in diagnostic radiology and makes
                                                       Procedure: Interested persons may                                                                          appropriate recommendations to the
                                                    present data, information, or views,                                                                          Commissioner.


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                                                                                     Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices                                            29723

                                                      The Committee shall consist of a core                 law. FDA has made the determination                   colorectal cancer who have been
                                                    of 12 voting members including the                      because of the submission of an                       previously treated with
                                                    Chair. Members and the Chair are                        application to the Director of the U.S.               fluoropyrimidine-, oxaliplatin- and
                                                    selected by the Commissioner or                         Patent and Trademark Office (USPTO),                  irinotecan-based chemotherapy, an anti-
                                                    designee from among authorities                         Department of Commerce, for the                       VEGF therapy, and if KRAS wild type,
                                                    knowledgeable in the fields of nuclear                  extension of a patent which claims that               an anti-EGRF therapy. Subsequent to
                                                    medicine, radiology, epidemiology or                    human drug product.                                   this approval, the USPTO received a
                                                    statistics, and related specialties.                    ADDRESSES: Submit electronic                          patent term restoration application for
                                                    Members will be invited to serve for                    comments to http://                                   STIVARGA (U.S. Patent No. 7,351,834)
                                                    overlapping terms of up to 4 years.                     www.regulations.gov. Submit written                   from Bayer HealthCare LLC, and the
                                                    Almost all non-Federal members of this                  petitions (two copies are required) and               USPTO requested FDA’s assistance in
                                                    committee serve as Special Government                   written comments to the Division of                   determining this patent’s eligibility for
                                                    Employees. The core of voting members                   Dockets Management (HFA–305), Food                    patent term restoration. In a letter dated
                                                    may include one technically qualified                   and Drug Administration, 5630 Fishers                 May 23, 2014, FDA advised the USPTO
                                                    member, selected by the Commissioner                    Lane, Rm. 1061, Rockville, MD 20852.                  that this human drug product had
                                                    or designee, who is identified with                     Submit petitions electronically to                    undergone a regulatory review period
                                                    consumer interests and is recommended                   http://www.regulations.gov at Docket                  and that the approval of STIVARGA
                                                    by either a consortium of consumer-                     No. FDA–2013–S–0610.                                  represented the first permitted
                                                    oriented organizations or other                         FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                                  commercial marketing or use of the
                                                    interested persons. In addition to the                  Beverly Friedman, Office of                           product. Thereafter, the USPTO
                                                    voting members, the Committee may                       Management, Food and Drug                             requested that FDA determine the
                                                    include one non-voting member who is                                                                          product’s regulatory review period.
                                                                                                            Administration, 10001 New Hampshire
                                                    identified with industry interests.                                                                              FDA has determined that the
                                                                                                            Ave., Hillandale Bldg., Rm. 3180, Silver
                                                      Further information regarding the                                                                           applicable regulatory review period for
                                                                                                            Spring, MD 20993, 301–796–7900.                       STIVARGA is 2,234 days. Of this time,
                                                    most recent charter and other                           SUPPLEMENTARY INFORMATION: The Drug
                                                    information can be found at http://www.                                                                       2,080 days occurred during the testing
                                                                                                            Price Competition and Patent Term                     phase of the regulatory review period,
                                                    fda.gov/AdvisoryCommittees/                             Restoration Act of 1984 (Pub. L. 98–417)
                                                    CommitteesMeetingMaterials/Drugs/                                                                             while 154 days occurred during the
                                                                                                            and the Generic Animal Drug and Patent                approval phase. These periods of time
                                                    MedicalImagingDrugsAdvisory                             Term Restoration Act (Pub. L. 100–670)
                                                    Committee/default.htm or by contacting                                                                        were derived from the following dates:
                                                                                                            generally provide that a patent may be                   1. The date an exemption under
                                                    the Designated Federal Officer (Please                  extended for a period of up to 5 years                section 505(i) of the Federal Food, Drug,
                                                    see FOR FURTHER INFORMATION CONTACT).                   so long as the patented item (human                   and Cosmetic Act (the FD&C Act) (21
                                                    In light of the fact that no change has                 drug product, animal drug product,                    U.S.C. 355(i)) became effective: August
                                                    been made to the committee name or                      medical device, food additive, or color               18, 2006. FDA has verified the
                                                    description of duties, no amendment                     additive) was subject to regulatory                   applicant’s claim that the date the
                                                    will be made to 21 CFR 14.100.                          review by FDA before the item was                     investigational new drug application
                                                      This notice is issued under the                       marketed. Under these acts, a product’s               became effective was on August 18,
                                                    Federal Advisory Committee Act (5                       regulatory review period forms the basis              2006.
                                                    U.S.C. app.). For general information                   for determining the amount of extension                  2. The date the application was
                                                    related to FDA advisory committees                      an applicant may receive.                             initially submitted with respect to the
                                                    please visit us at http://www.fda.gov/                     A regulatory review period consists of             human drug product under section
                                                    AdvisoryCommittees/default.htm.                         two periods of time: A testing phase and              505(b) of the FD&C Act: April 27, 2012.
                                                      Dated: May 18, 2015.                                  an approval phase. For human drug                     FDA has verified the applicant’s claim
                                                    Leslie Kux,                                             products, the testing phase begins when               that the new drug application (NDA) for
                                                    Associate Commissioner for Policy.                      the exemption to permit the clinical                  STIVARGA (NDA 203085) was
                                                    [FR Doc. 2015–12401 Filed 5–21–15; 8:45 am]             investigations of the drug becomes                    submitted on April 27, 2012.
                                                    BILLING CODE 4164–01–P
                                                                                                            effective and runs until the approval                    3. The date the application was
                                                                                                            phase begins. The approval phase starts               approved: September 27, 2012. FDA has
                                                                                                            with the initial submission of an                     verified the applicant’s claim that NDA
                                                    DEPARTMENT OF HEALTH AND                                application to market the human drug                  203085 was approved on September 27,
                                                    HUMAN SERVICES                                          product and continues until FDA grants                2012.
                                                                                                            permission to market the drug product.                   This determination of the regulatory
                                                    Food and Drug Administration                            Although only a portion of a regulatory               review period establishes the maximum
                                                                                                            review period may count toward the                    potential length of a patent extension.
                                                    [Docket No. FDA–2014–E–0307]
                                                                                                            actual amount of extension that the                   However, the USPTO applies several
                                                    Determination of Regulatory Review                      Director of USPTO may award (for                      statutory limitations in its calculations
                                                    Period for Purposes of Patent                           example, half the testing phase must be               of the actual period for patent extension.
                                                    Extension; STIVARGA                                     subtracted as well as any time that may               In its application for patent extension,
                                                                                                            have occurred before the patent was                   this applicant seeks 898 days of patent
                                                               Food and Drug Administration,                issued), FDA’s determination of the                   term extension.
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    AGENCY:
                                                    HHS.                                                    length of a regulatory review period for                 Anyone with knowledge that any of
                                                    ACTION:   Notice.                                       a human drug product will include all                 the dates as published are incorrect may
                                                                                                            of the testing phase and approval phase               submit to the Division of Dockets
                                                    SUMMARY:   The Food and Drug                            as specified in 35 U.S.C. 156(g)(1)(B).               Management (see ADDRESSES) either
                                                    Administration (FDA) has determined                        FDA has approved for marketing the                 electronic or written comments and ask
                                                    the regulatory review period for                        human drug product STIVARGA                           for a redetermination by July 21, 2015.
                                                    STIVARGA and is publishing this notice                  (regorafenib). STIVARGA is indicated                  Furthermore, any interested person may
                                                    of that determination as required by                    for treatment of patients with metastatic             petition FDA for a determination


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Document Created: 2015-12-15 15:46:22
Document Modified: 2015-12-15 15:46:22
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
ActionRenewal of Federal advisory committee.
DatesAuthority for the Medical Imaging Drugs Advisory Committee will expire on May 18, 2017, unless the Commissioner formally determines that renewal is in the public interest.
ContactLauren D. Tesh, Division of Advisory Committee and Consultant Management, Office of Executive Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002; 301-796-9001, email: [email protected]
FR Citation80 FR 29722 

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