Advisory Committee; Medical Imaging Drugs Advisory Committee; Renewal, 29722-29723 [2015-12401]

Download as PDF asabaliauskas on DSK5VPTVN1PROD with NOTICES 29722 Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on July 9, 2015, from 8 a.m. to 12:30 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. Contact Person: Lauren D. Tesh, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301–796–9001, FAX: 301–847–8533, ODAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss biologics license application 125547, necitumumab injection, application submitted by Eli Lilly and Company. The proposed indication (use) for this product is in combination with gemcitabine and cisplatin for first-line treatment of patients with locally advanced or metastatic squamous nonsmall cell lung cancer. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, VerDate Sep<11>2014 18:19 May 21, 2015 Jkt 235001 orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before June 24, 2015. Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11:30 a.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before June 16, 2015. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 17, 2014. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Lauren D. Tesh at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: May 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–12403 Filed 5–21–15; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00121 Fmt 4703 Sfmt 4703 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. Renewal of Federal advisory committee. ACTION: 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: MIDAC@fda.hhs.gov. 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. SUMMARY: E:\FR\FM\22MYN1.SGM 22MYN1 Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices 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 consumeroriented 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 https://www. fda.gov/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/ MedicalImagingDrugsAdvisory Committee/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 https://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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–E–0307] asabaliauskas on DSK5VPTVN1PROD with NOTICES Determination of Regulatory Review Period for Purposes of Patent Extension; STIVARGA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for STIVARGA and is publishing this notice of that determination as required by SUMMARY: VerDate Sep<11>2014 18:19 May 21, 2015 Jkt 235001 law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written petitions (two copies are required) and written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Management, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Bldg., Rm. 3180, Silver Spring, MD 20993, 301–796–7900. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved for marketing the human drug product STIVARGA (regorafenib). STIVARGA is indicated for treatment of patients with metastatic PO 00000 Frm 00122 Fmt 4703 Sfmt 4703 29723 colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an antiVEGF therapy, and if KRAS wild type, an anti-EGRF therapy. Subsequent to this approval, the USPTO received a patent term restoration application for STIVARGA (U.S. Patent No. 7,351,834) from Bayer HealthCare LLC, and the USPTO requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated May 23, 2014, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of STIVARGA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for STIVARGA is 2,234 days. Of this time, 2,080 days occurred during the testing phase of the regulatory review period, while 154 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: August 18, 2006. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on August 18, 2006. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: April 27, 2012. FDA has verified the applicant’s claim that the new drug application (NDA) for STIVARGA (NDA 203085) was submitted on April 27, 2012. 3. The date the application was approved: September 27, 2012. FDA has verified the applicant’s claim that NDA 203085 was approved on September 27, 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 898 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments and ask for a redetermination by July 21, 2015. Furthermore, any interested person may petition FDA for a determination E:\FR\FM\22MYN1.SGM 22MYN1

Agencies

[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29722-29723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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

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: MIDAC@fda.hhs.gov.

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 https://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 https://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
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