Oncologic Drugs Advisory Committee; Notice of Meeting, 75680-75681 [2010-30502]

Download as PDF jdjones on DSK8KYBLC1PROD with NOTICES 75680 Federal Register / Vol. 75, No. 233 / Monday, December 6, 2010 / Notices 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 Patents and Trademarks 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 recently approved for marketing the human drug product BESIVANCE (besifloxacin hydrochloride). BESIVANCE is indicated for treatment of bacterial conjunctivitis. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for BESIVANCE (U.S. Patent No. 5,447,926) from Bausch & Lomb Inc., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated May 10, 2010, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of BESIVANCE represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for BESIVANCE is 2,271 days. Of this time, 1,910 days occurred during the testing phase of the regulatory review period, while 361 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: March 12, 2003. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on March 12, 2003. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: June 2, 2008. FDA has verified the applicant’s claim that the new drug application (NDA) for VerDate Mar<15>2010 15:27 Dec 03, 2010 Jkt 223001 Besivance (NDA 22–308) was submitted on June 2, 2008. 3. The date the application was approved: May 28, 2009. FDA has verified the applicant’s claim that NDA 22–308 was approved on May 28, 2009. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,316 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 February 4, 2011. 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 6, 2011. To meet its burden, the petition must 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. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments and written petitions. It is only necessary to send one set of comments. It is no longer necessary to send three copies of mailed comments. However, if you submit a written petition, you must submit three copies of the petition. Identify comments with the docket number found in brackets in the heading of this document. Comments and petitions that have not been made publicly available on regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: October 22, 2010. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. 2010–30510 Filed 12–3–10; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Oncologic Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on February 9, 2011, from 8 a.m. to 12:30 p.m. Location: FDA White Oak Campus, Building 31 Conference Center, the Great Room (rm. 1503), 10903 New Hampshire Ave., Silver Spring, MD 20993–0002. Information regarding special accommodations due to a disability, visitor parking and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘White Oak Conference Center Parking and Transportation Information for FDA Advisory Committee Meetings.’’ Please note that visitors to the White Oak Campus must have a valid driver’s license or other picture ID, and must enter through Building 1. Contact Person: Nicole Vesely, 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, e-mail: Nicole.vesely@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512542. Please call the Information Line for up-to-date information on this meeting. 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 and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. E:\FR\FM\06DEN1.SGM 06DEN1 jdjones on DSK8KYBLC1PROD with NOTICES Federal Register / Vol. 75, No. 233 / Monday, December 6, 2010 / Notices Agenda: On February 9, 2011, the committee will discuss biologics license application (BLA) 125377, with the proposed trade name YERVOY (ipilimumab), submitted by BristolMyers Squibb Co. The proposed indication (use) for this product is for the treatment of advanced melanoma in patients who have received prior therapy. 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 link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before January 25, 2011. 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 January 14, 2011. 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 January 18, 2011. 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 Nicole Vesely at least 7 days in advance of the meeting. VerDate Mar<15>2010 15:27 Dec 03, 2010 Jkt 223001 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: December 1, 2010. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2010–30502 Filed 12–3–10; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on January 20, 2011, from 8 a.m. to 5 p.m. and on January 21, 2011, from 8 a.m. to 12 p.m. Location: FDA White Oak Campus, Building 31 Conference Center, the Great Room (rm. 1503), 10903 New Hampshire Ave., Silver Spring, MD 20993–0002. Information regarding special accommodations due to a disability, visitor parking and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You’’, click on ‘‘White Oak Conference Center Parking and Transportation Information for FDA Advisory Committee Meetings’’. Please note that visitors to the White Oak Campus must have a valid driver’s license or other picture ID, and must enter through Building 1. PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 75681 Contact Person: Diem-Kieu Ngo, 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, e-mail: diem.ngo@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512543. Please call the Information Line for up-to-date information on this meeting. 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 and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On January 20, 2011, the committee will discuss new drug application (NDA) 202–008, florbetapir F 18 injection, sponsored by Avid Radiopharmaceuticals, Inc., proposed for use in positron emission tomography (PET) imaging of b-amyloid (betaamyloid) aggregates in the brain to help rule out Alzheimer’s disease. On January 21, 2011, the committee will discuss NDA 201–277, gadobutrol injection, sponsored by Bayer HealthCare Pharmaceuticals, proposed for use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity (abnormal blood supply and circulation) of the central nervous system. The BBB is an area consisting of specialized cells that restrict passage of certain molecules from the bloodstream into the brain. 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 link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before January 5, 2011. E:\FR\FM\06DEN1.SGM 06DEN1

Agencies

[Federal Register Volume 75, Number 233 (Monday, December 6, 2010)]
[Notices]
[Pages 75680-75681]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30502]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Oncologic Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on February 9, 2011, from 8 
a.m. to 12:30 p.m.
    Location: FDA White Oak Campus, Building 31 Conference Center, the 
Great Room (rm. 1503), 10903 New Hampshire Ave., Silver Spring, MD 
20993-0002. Information regarding special accommodations due to a 
disability, visitor parking and transportation may be accessed at: 
http:[sol][sol]www.fda.gov/AdvisoryCommittees/default.htm; under the 
heading ``Resources for You,'' click on ``White Oak Conference Center 
Parking and Transportation Information for FDA Advisory Committee 
Meetings.'' Please note that visitors to the White Oak Campus must have 
a valid driver's license or other picture ID, and must enter through 
Building 1.
    Contact Person: Nicole Vesely, 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, e-mail: Nicole.vesely@fda.hhs.gov, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512542. Please call the Information Line for up-to-date 
information on this meeting. 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 
and call the appropriate advisory committee hot line/phone line to 
learn about possible modifications before coming to the meeting.

[[Page 75681]]

    Agenda: On February 9, 2011, the committee will discuss biologics 
license application (BLA) 125377, with the proposed trade name YERVOY 
(ipilimumab), submitted by Bristol-Myers Squibb Co. The proposed 
indication (use) for this product is for the treatment of advanced 
melanoma in patients who have received prior therapy.
    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 http:[sol][sol]www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
January 25, 2011. 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 January 14, 2011. 
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 January 18, 2011.
    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 Nicole Vesely 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 http:[sol][sol]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: December 1, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-30502 Filed 12-3-10; 8:45 am]
BILLING CODE 4160-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.