1182 Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices

Advisory Committee Information Line, submitted by GlaxoSmithKline, present, the names and addresses of 1–800–741–8138 (301–443–0572 in the indicated for the treatment of patients proposed participants, and an Washington, DC area), and follow the with types of leukemia or lymphoma indication of the approximate time prompts to the desired center or product known as T-cell acute lymphoblastic requested to make their presentation on area. Please call the Information Line for leukemia and T-cell lymphoblastic or before January 14, 2011. Time up-to-date information on this meeting. lymphoma whose disease has not allotted for each presentation may be A notice in the Federal Register about responded to or has relapsed following limited. If the number of registrants last minute modifications that impact a treatment with at least two requesting to speak is greater than can previously announced advisory chemotherapy regimens; (5) BLA be reasonably accommodated during the committee meeting cannot always be 125147, tradename VECTIBIX scheduled open public hearing session, published quickly enough to provide (panitumumab), application submitted FDA may conduct a lottery to determine timely notice. Therefore, you should by Amgen Inc., indicated for the the speakers for the scheduled open always check the Agency’s Web site and treatment of EGFR-expressing, public hearing session. The contact call the appropriate advisory committee metastatic colorectal carcinoma with person will notify interested persons hot line/phone line to learn about disease progression on or following regarding their request to speak by possible modifications before coming to fluoropyrimidine-, oxaliplatin-, and January 18, 2011. the meeting. irinotecan-containing chemotherapy Persons attending FDA’s advisory Agenda: The committee will hear regimens; and (6) sNDA 21–588/025, committee meetings are advised that the updates on new drug applications tradename GLEEVEC (imatinib Agency is not responsible for providing (NDAs) and biologics license mesylate) tablets, application submitted access to electrical outlets. applications (BLAs) approved under 21 by Novartis Pharmaceuticals Corp., FDA welcomes the attendance of the CFR 314.500 and 601.40 (subpart H and indicated for the adjuvant (additional) public at its advisory committee subpart E, respectively, accelerated treatment of adult patients following meetings and will make every effort to approval regulations) prior to January 1, complete gross resection (removal) of a accommodate persons with physical 2009. These updates will provide form of cancer known as Kit (CD117) disabilities or special needs. If you information related to the status of positive gastrointestinal stromal tumors require special accommodations due to phase IV clinical studies and to (GIST). a disability, please contact Nicole difficulties associated with completion Based on the updates provided, the Vesely at least 7 days in advance of the of phase IV commitments. Phase IV committee will have a general meeting. studies are postmarketing studies to discussion centering on possible ways FDA is committed to the orderly confirm clinical benefit of a drug after to improve the planning and conduct of conduct of its advisory committee it receives accelerated approval. trials to confirm clinical benefit (post meetings. Please visit our Web site at Specifically, the committee will marketing requirements). The overall http://www.fda.gov/ receive updates on the following goal will be the optimization of the AdvisoryCommittees/ products: (1) BLA 125084, trade name accelerated approval process with a AboutAdvisoryCommittees/ ERBITUX (cetuximab), application focus on decreasing the amount of time ucm111462.htm for procedures on submitted by Imclone Systems Inc., to confirm (or fail to confirm) clinical public conduct during advisory used in combination with the anticancer benefit while continuing to provide committee meetings. agent irinotecan and indicated for the early availability of promising oncology Notice of this meeting is given under treatment of epidermal growth factor products. the Federal Advisory Committee Act (5 receptor (EGFR)-expressing colorectal FDA intends to make background U.S.C. app. 2). cancer that has metastasized (spread material available to the public no later Dated: January 3, 2011. beyond the colon or rectum) in patients than 2 business days before the meeting. for whom chemotherapy using If FDA is unable to post the background Jill Hartzler Warner, irinotecan alone is ineffective or less material on its Web site prior to the Acting Associate Commissioner for Special effective; (2) supplemental BLA (sBLA) meeting, the background material will Medical Programs. 125011/24, trade name BEXXAR be made publicly available at the [FR Doc. 2011–32 Filed 1–6–11; 8:45 am] (tositumomab and Iodine I 131 location of the advisory committee BILLING CODE 4160–01–P tositumomab), application submitted by meeting, and the background material SmithKline Beecham Corp. doing will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND business as (d/b/a) GlaxoSmithKline, the meeting. Background material is HUMAN SERVICES indicated for the treatment of patients available at http://www.fda.gov/ with varieties of non-Hodgkin’s AdvisoryCommittees/Calendar/ Food and Drug Administration lymphoma known as CD20 antigen- default.htm. Scroll down to the expressing relapsed or refractory, low appropriate advisory committee link. [Docket No. FDA–2010–N–0633] grade, follicular, or transformed non- Procedure: Interested persons may Hodgkin’s lymphoma, who have not present data, information, or views, Determination of System Attributes for received the drug Rituximab; (3) NDA orally or in writing, on issues pending the Tracking and Tracing of 21–673, tradename CLOLAR before the committee. Written Prescription Drugs; Public Workshop (clofarabine) for intravenous infusion, submissions may be made to the contact AGENCY: Food and Drug Administration, application submitted by Genzyme person on or before January 25, 2011. HHS. Corp., indicated for the treatment of Oral presentations from the public will ACTION: Notice of public workshop; pediatric patients 1 to 21 years old with be scheduled between approximately request for comments. acute lymphoblastic leukemia (ALL) 1:30 p.m. and 2:30 p.m. Those whose disease has not responded to or individuals interested in making formal SUMMARY: The Food and Drug has relapsed following treatment with at oral presentations should notify the Administration (FDA) is announcing a least two prior chemotherapy regimens; contact person and submit a brief public workshop entitled (4) NDA 21–877, tradename ARRANON statement of the general nature of the ‘‘Determination of System Attributes for (nelarabine) Injection, application evidence or arguments they wish to the Tracking and Tracing of Prescription

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Drugs.’’ This public workshop is purpose of securing the drug supply (2) mail your registration information to intended to provide a forum for chain against counterfeit, diverted, the contact person (see FOR FURTHER discussing potential approaches toward subpotent, substandard, adulterated, INFORMATION CONTACT). Registration a track and trace system and obtaining misbranded, or expired drugs. In information should include registrant input from supply chain partners on addition, section 505D of the FD&C Act name, company or organization, attributes and standards for the directs the Secretary to consult with address, phone number, and email identification, authentication, and specific entities to prioritize and address. Registration requests should be tracking and tracing of prescription drug develop standards for identification, received by February 1, 2011. packages, and to further the Agency’s validation, authentication, and tracking Registration is free. Seats are limited. goal of protecting public health by and tracing of prescription drugs. FDA may limit the numbers of securing the drug supply chain against In March 2010, FDA issued a final participants from each organization the introduction of counterfeit and other guidance for industry which describes based on space limitations. Registrants substandard drugs. the Agency’s current recommendation will receive confirmation upon DATES: The public workshop will be for standardized numerical acceptance for participation in the held on February 15 and 16, 2011, from identification (also known as workshop. Onsite registration on the 9 a.m. to 5 p.m. Submit electronic or serialization) for prescription drug day of the meeting will be based on written comments on the posted packages (Standards for Securing the space availability on the day of the information or on the workshop to the Drug Supply Chain—Standardized event starting at 8 a.m. If registration docket by April 16, 2011. Numerical Identification for reaches maximum capacity, FDA will ADDRESSES: The public workshop will Prescription Drug Packages, Guidance post a notice closing meeting be held at FDA’s White Oak Campus, for Industry—Final Guidance 1). This registration for the workshop on FDA’s 10903 New Hampshire Ave., Bldg. 31, guidance is intended to be the first of Web site at: http://www.fda.gov/Drugs/ room 1503, Silver Spring, MD 20993. To several steps that FDA may take to DrugSafety/ucm169828.htm. If you need register for the public meeting, e-mail implement section 505D of the FD&C special accommodations due to a your registration information to Act and further improve the security of disability, please contact Connie Jung [email protected]. See the drug supply chain. As FDA (see FOR FURTHER INFORMATION CONTACT) section III of this document for continues to work on developing at least 7 days in advance. registration details. Submit electronic additional standards for securing the IV. Parking Information comments to http:// drug supply chain, the agency is seeking www.regulations.gov. Submit written public input to ensure that we consider If you are driving to FDA’s White Oak comments to the Division of Dockets information regarding all supply chain Campus, you should proceed to the Management (HFA–305), Food and Drug participants. South East Surface Parking Lot to park Administration, 5630 Fishers Lane, rm. your vehicle. Shuttle service is available II. Purpose of the Workshop 1061, Rockville, MD 20852. All from the bus shelters in the South East comments should be identified with the This public workshop is intended to Lot to Building 1. The FDA campus is docket number found in the brackets in explore approaches for achieving an a Federal facility, therefore all meeting the heading of this document. effective and feasible track and trace attendees must enter through Building 1 FOR FURTHER INFORMATION CONTACT: system for finished prescription drug and follow security procedures. Connie Jung, Office of the products from the supply chain Dated: January 3, 2011. Commissioner, Food and Drug stakeholder’s point of view, including Leslie Kux, industry and the public, and to obtain Administration, 10903 New Hampshire Acting Assistant Commissioner for Policy. Ave., Silver Spring, MD 20993, 301– views on system attributes and standards that would facilitate [FR Doc. 2011–72 Filed 1–6–11; 8:45 am] 796–4830, e-mail: BILLING CODE 4160–01–P [email protected]. identification, authentication, and tracking and tracing of prescription drug SUPPLEMENTARY INFORMATION: packages. We intend to discuss with DEPARTMENT OF HEALTH AND I. Background stakeholders the necessary elements to HUMAN SERVICES Since the formation of the first accomplish effective authentication and Counterfeit Drug Task Force in 2003, identify desirable features of a track and Health Resources and Services FDA has strongly advocated for a multi- trace system. Participants will not be Administration layered approach to securing the supply asked to develop consensus opinions Agency Information Collection chain and protecting consumers from during the discussion, but rather to Activities: Submission for OMB the threats posed by counterfeit drugs. provide their individual perspectives. By February 4, 2011, FDA will post Review; Comment Request The ability to track and trace finished information on our Web site (http:// drug products in the supply chain plays www.fda.gov/Drugs/DrugSafety/ Periodically, the Health Resources a significant role in providing ucm169828.htm) under ‘‘Standards and Services Administration (HRSA) transparency and accountability in the Development for Prescription Drug publishes abstracts of information drug supply chain. On September 27, Supply Chain Security.’’ as follows: collection requests under review by the 2007, the Food and Drug Administration • Workshop agenda, Office of Management and Budget Amendments Act of 2007 (FDAAA) • Workshop discussion topics. (OMB), in compliance with the (Pub. L. 110–85) was signed into law. Paperwork Reduction Act of 1995 (44 Section 913 of this legislation created III. How To Register for the Workshop U.S.C. Chapter 35). To request a copy of section 505D of the Federal Food, Drug, To register for the workshop either: the clearance requests submitted to and Cosmetic Act (the FD&C Act), (1) E-mail your registration information OMB for review, call the HRSA Reports which requires the Secretary of Health to [email protected] or Clearance Office on (301) 443–1129. and Human Services (the Secretary) to The following request has been develop standards and identify and 1 http://www.fda.gov/RegulatoryInformation/ submitted to the OMB for review under validate effective technologies for the Guidances/ucm125505.htm. the Paperwork Reduction Act of 1995:

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