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

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. 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: The committee will hear 

updates on new drug applications 

(NDAs) and biologics license 

applications (BLAs) approved under 21 

CFR 314.500 and 601.40 (subpart H and 

subpart E, respectively, accelerated 

approval regulations) prior to January 1, 

2009. These updates will provide 

information related to the status of 

phase IV clinical studies and to 

difficulties associated with completion 

of phase IV commitments. Phase IV 

studies are postmarketing studies to 

confirm clinical benefit of a drug after 

it receives accelerated approval. 

Specifically, the committee will 

receive updates on the following 

products: (1) BLA 125084, trade name 

ERBITUX (cetuximab), application 

submitted by Imclone Systems Inc., 

used in combination with the anticancer 

agent irinotecan and indicated for the 

treatment of epidermal growth factor 

receptor (EGFR)-expressing colorectal 

cancer that has metastasized (spread 

beyond the colon or rectum) in patients 

for whom chemotherapy using 

irinotecan alone is ineffective or less 

effective; (2) supplemental BLA (sBLA) 

125011/24, trade name BEXXAR 

(tositumomab and Iodine I 131 

tositumomab), application submitted by 

SmithKline Beecham Corp. doing 

business as (d/b/a) GlaxoSmithKline, 

indicated for the treatment of patients 

with varieties of non-Hodgkin’s 

lymphoma known as CD20 antigenexpressing relapsed or refractory, low 

grade, follicular, or transformed nonHodgkin’s lymphoma, who have not 

received the drug Rituximab; (3) NDA 

21–673, tradename CLOLAR 

(clofarabine) for intravenous infusion, 

application submitted by Genzyme 

Corp., indicated for the treatment of 

pediatric patients 1 to 21 years old with 

acute lymphoblastic leukemia (ALL) 

whose disease has not responded to or 

has relapsed following treatment with at 

least two prior chemotherapy regimens; 

(4) NDA 21–877, tradename ARRANON 

(nelarabine) Injection, application 

submitted by GlaxoSmithKline, 

indicated for the treatment of patients 

with types of leukemia or lymphoma 

known as T-cell acute lymphoblastic 

leukemia and T-cell lymphoblastic 

lymphoma whose disease has not 

responded to or has relapsed following 

treatment with at least two 

chemotherapy regimens; (5) BLA 

125147, tradename VECTIBIX 

(panitumumab), application submitted 

by Amgen Inc., indicated for the 

treatment of EGFR-expressing, 

metastatic colorectal carcinoma with 

disease progression on or following 

fluoropyrimidine-, oxaliplatin-, and 

irinotecan-containing chemotherapy 

regimens; and (6) sNDA 21–588/025, 

tradename GLEEVEC (imatinib 

mesylate) tablets, application submitted 

by Novartis Pharmaceuticals Corp., 

indicated for the adjuvant (additional) 

treatment of adult patients following 

complete gross resection (removal) of a 

form of cancer known as Kit (CD117) 

positive gastrointestinal stromal tumors 

(GIST). 

Based on the updates provided, the 

committee will have a general 

discussion centering on possible ways 

to improve the planning and conduct of 

trials to confirm clinical benefit (post 

marketing requirements). The overall 

goal will be the optimization of the 

accelerated approval process with a 

focus on decreasing the amount of time 

to confirm (or fail to confirm) clinical 

benefit while continuing to provide 

early availability of promising oncology 

products. 

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://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 

1:30 p.m. and 2:30 p.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://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: January 3, 2011. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2011–32 Filed 1–6–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0633] 

Determination of System Attributes for 

the Tracking and Tracing of 

Prescription Drugs; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public workshop entitled 

‘‘Determination of System Attributes for 

the Tracking and Tracing of Prescription 


jdjones on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices 1183 

1http://www.fda.gov/RegulatoryInformation/ 

Guidances/ucm125505.htm. 

Drugs.’’ This public workshop is 

intended to provide a forum for 

discussing potential approaches toward 

a track and trace system and obtaining 

input from supply chain partners on 

attributes and standards for the 

identification, authentication, and 

tracking and tracing of prescription drug 

packages, and to further the Agency’s 

goal of protecting public health by 

securing the drug supply chain against 

the introduction of counterfeit and other 

substandard drugs. 

DATES: The public workshop will be 

held on February 15 and 16, 2011, from 

9 a.m. to 5 p.m. Submit electronic or 

written comments on the posted 

information or on the workshop to the 

docket by April 16, 2011. 

ADDRESSES: The public workshop will 

be held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

room 1503, Silver Spring, MD 20993. To 

register for the public meeting, e-mail 

your registration information to 

drug.trackandtrace@fda.hhs.gov. See 

section III of this document for 

registration details. Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in the brackets in 

the heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Connie Jung, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–4830, e-mail: 

connie.jung@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Since the formation of the first 

Counterfeit Drug Task Force in 2003, 

FDA has strongly advocated for a multilayered approach to securing the supply 

chain and protecting consumers from 

the threats posed by counterfeit drugs. 

The ability to track and trace finished 

drug products in the supply chain plays 

a significant role in providing 

transparency and accountability in the 

drug supply chain. On September 27, 

2007, the Food and Drug Administration 

Amendments Act of 2007 (FDAAA) 

(Pub. L. 110–85) was signed into law. 

Section 913 of this legislation created 

section 505D of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act), 

which requires the Secretary of Health 

and Human Services (the Secretary) to 

develop standards and identify and 

validate effective technologies for the 

purpose of securing the drug supply 

chain against counterfeit, diverted, 

subpotent, substandard, adulterated, 

misbranded, or expired drugs. In 

addition, section 505D of the FD&C Act 

directs the Secretary to consult with 

specific entities to prioritize and 

develop standards for identification, 

validation, authentication, and tracking 

and tracing of prescription drugs. 

In March 2010, FDA issued a final 

guidance for industry which describes 

the Agency’s current recommendation 

for standardized numerical 

identification (also known as 

serialization) for prescription drug 

packages (Standards for Securing the 

Drug Supply Chain—Standardized 

Numerical Identification for 

Prescription Drug Packages, Guidance 

for Industry—Final Guidance 1). This 

guidance is intended to be the first of 

several steps that FDA may take to 

implement section 505D of the FD&C 

Act and further improve the security of 

the drug supply chain. As FDA 

continues to work on developing 

additional standards for securing the 

drug supply chain, the agency is seeking 

public input to ensure that we consider 

information regarding all supply chain 

participants. 

II. Purpose of the Workshop 

This public workshop is intended to 

explore approaches for achieving an 

effective and feasible track and trace 

system for finished prescription drug 

products from the supply chain 

stakeholder’s point of view, including 

industry and the public, and to obtain 

views on system attributes and 

standards that would facilitate 

identification, authentication, and 

tracking and tracing of prescription drug 

packages. We intend to discuss with 

stakeholders the necessary elements to 

accomplish effective authentication and 

identify desirable features of a track and 

trace system. Participants will not be 

asked to develop consensus opinions 

during the discussion, but rather to 

provide their individual perspectives. 

By February 4, 2011, FDA will post 

information on our Web site (http:// 

www.fda.gov/Drugs/DrugSafety/ 

ucm169828.htm) under ‘‘Standards 

Development for Prescription Drug 

Supply Chain Security.’’ as follows: 

• Workshop agenda, 

• Workshop discussion topics. 

III. How To Register for the Workshop 

To register for the workshop either: 

(1) E-mail your registration information 

to drug.trackandtrace@fda.hhs.gov or 

(2) mail your registration information to 

the contact person (see FOR FURTHER

INFORMATION CONTACT). Registration 

information should include registrant 

name, company or organization, 

address, phone number, and email 

address. Registration requests should be 

received by February 1, 2011. 

Registration is free. Seats are limited. 

FDA may limit the numbers of 

participants from each organization 

based on space limitations. Registrants 

will receive confirmation upon 

acceptance for participation in the 

workshop. Onsite registration on the 

day of the meeting will be based on 

space availability on the day of the 

event starting at 8 a.m. If registration 

reaches maximum capacity, FDA will 

post a notice closing meeting 

registration for the workshop on FDA’s 

Web site at: http://www.fda.gov/Drugs/ 

DrugSafety/ucm169828.htm. If you need 

special accommodations due to a 

disability, please contact Connie Jung 

(see FOR FURTHER INFORMATION CONTACT) 

at least 7 days in advance. 

IV. Parking Information 

If you are driving to FDA’s White Oak 

Campus, you should proceed to the 

South East Surface Parking Lot to park 

your vehicle. Shuttle service is available 

from the bus shelters in the South East 

Lot to Building 1. The FDA campus is 

a Federal facility, therefore all meeting 

attendees must enter through Building 1 

and follow security procedures. 

Dated: January 3, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–72 Filed 1–6–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, call the HRSA Reports 

Clearance Office on (301) 443–1129. 

The following request has been 

submitted to the OMB for review under 

the Paperwork Reduction Act of 1995: 


jdjones on DSK8KYBLC1PROD with NOTICES