52760 Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Notices 

pheochromocytoma and endolymphatic 

sac tumors). 

Renal clear cell carcinoma (RCC) 

develops in approximately 75% of VHL 

patients by age 60 and is a leading cause 

of death in this population. Inactivation 

(mutation or methylation) of the VHL 

gene is associated with greater than 90% 

of all clear cell RCC (including sporadic 

cases) (Nickerson et al. Clin Cancer Res 

2008;14:4726–34). Thus, subjects with 

compromised VHL function represent a 

significant population that has or is at 

risk for developing cancer, including 

RCC. There is data that HIF–2a may be 

important in all or most cancers 

(Franovic et al. Proc Natl Acad Sci U S 

A 2009;106:21306–11). 

Inventors: W. Marston Linehan (NCI), 

Tracey A. Rouault (NICHD), James B. 

Mitchell (NCI), Murali K. Cherukuri 

(NCI). 

Patent Status: U.S. Provisional 

Application No. 61/265,194 filed 30 

Nov 2009 (HHS Reference No. E–133– 

2009/0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Sabarni Chatterjee, 

Ph.D.; 301–435–5587; chatterjeesa@

mail.nih.gov. 

Collaborative Research Opportunity: 

The Center for Cancer Research, 

Urologic Oncology Branch, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize the use of Tempol to 

target HIF–2a in cancer. Please contact 

John Hewes, Ph.D. at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 

Chimeric Anti-human ROR1 

Monoclonal Antibodies 

Description of Invention: Available for 

licensing are mouse anti-human 

receptor tyrosine kinase-like orphan 

receptor 1 (ROR1) monoclonal 

antibodies (mAbs). ROR1 is a signature 

cell surface antigen for B-cell chronic 

lymphocytic leukemia (B–CLL) and 

mantle cell lymphoma (MCL) cells, two 

incurable B-cell malignancies that are 

newly diagnosed in approximately 

15,000 and 3,500 patients per year, 

respectively, in the United States. 

Currently, there are no therapeutic 

mAbs that specifically target B–CLL or 

MCL cells. Anti-ROR1 mAbs may be 

linked to chemical drugs or biological 

toxins thus providing cytotoxic delivery 

to malignant B-cells and not normal 

cells. Additionally, these antibodies can 

be fused to radioisotopes and can be 

used to diagnose B–CLL and MCL 

malignancies. 

Applications: 

• B–CLL and MCL antibody 

therapeutics. 

• Method to diagnose B–CLL and 

MCL. 

Advantages: Selective targeting to 

malignant B–CLL and MCL cells. 

Development Status: The technology 

is currently in the pre-clinical stage of 

development. 

Market: 

• The monoclonal antibody market is 

one of the fastest growing sectors of the 

pharmaceutical industry with a 48.1% 

growth between 2003 and 2004 and the 

potential to reach $30.3 billion in 2010. 

This growth rate is driven by the 

evolution of chimeric and humanized to 

fully humanized antibody therapeutics. 

• Approximately 18,500 patients with 

ROR1-expressing B-cell malignancies 

are newly diagnosed annually in the 

United States. 

Inventors: Christoph Rader and 

Sivasubramanian Baskar (NCI). 

Related Publications: 

1. S Baskar et al. Unique cell surface 

expression of receptor tyrosine kinase 

ROR1 in human B-cell chronic 

lymphocytic leukemia. Clin Cancer Res. 

2008 Jan 15;14(2):396–404. [PubMed: 

18223214] 

2. M Hudecek et al. The B-cell tumor 

associated antigen ROR1 can be targeted 

with T-cells modified to express a 

ROR1-specific chimeric antigen 

receptor. Blood. 2010 Aug 11; Epub 

ahead of print. [PubMed: 20702778] 

Patent Status: 

• U.S. Provisional Application No. 

61/172,099 filed 23 Apr 2009 (HHS 

Reference No. E–097–2009/0–US–01). 

• PCT Application No. PCT/US10/ 

32208 filed 23 Apr 2010 (HHS Reference 

No. E–097–2009/0–PCT–02). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Jennifer Wong; 

301–435–4633; wongje@mail.nih.gov. 

Collaborative Research Opportunity: 

The Center for Cancer Research, 

Experimental Transplantation and 

Immunology Branch is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize anti-ROR1 mAbs, 

antibody-drug conjugates, 

radioimmunoconjugates, bispecific 

antibodies, and other therapeutic or 

diagnostic modalities. Please contact 

John D. Hewes, Ph.D. at 301–435–3121 

or hewesj@mail.nih.gov for more 

information. 

Dated: August 23, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–21349 Filed 8–26–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–0031–N] 

Medicare Program; Listening Session 

Regarding the Implementation of 

Section 10332 of the Patient Protection 

and Affordable Care Act, Availability of 

Medicare Data for Performance 

Measurement 

DATE: September 20, 2010. 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces a 

listening session to receive comments 

regarding implementation of section 

10332 of the Patient Protection and 

Affordable Care Act (the Affordable Care 

Act), which amended section 1874 of 

the Social Security Act: Availability of 

Medicare Data for Performance 

Measurement. The purpose of the 

listening session is to solicit input from 

potential stakeholders on key 

components of the design of the 

program. We are soliciting input on the 

types of organizations that may be 

interested in receiving data as qualified 

entities under this provision; the criteria 

such organizations will have to meet for 

participation; procedures for CMS to 

approve interested organizations for 

participation; provider communities 

and geographic areas that might be 

served by these entities; data elements 

required, and the sources and types of 

other data that these organizations 

might match to Medicare claims; 

challenges in calculating performance 

measures from the data, and issues 

related to the identification, selection, 

and reporting of the performance 

measures. 

DATES: Meeting Date: The listening 

session will be held on Monday, 

September 20, 2010 from 9 a.m. until 1 

p.m. Eastern Daylight Time (e.d.t.). 

Deadline for Meeting Registration and 

Request for Special Accommodations: 

Registration opens on August 27, 2010. 

Registration must be completed by 5 

p.m. e.d.t. on September 16, 2010. 

Requests for special accommodations 

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Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Notices 52761 

must be received by 5 p.m. e.d.t. on 

September 16, 2010. 

Deadline for Submission of Written 

Comments or Statements: Written 

comments or statements may be sent via 

mail, fax, or electronically to the 

address specified in the ADDRESSES

section of this notice and must be 

received by 5 p.m. e.d.t. on September 

27, 2010. 

ADDRESSES: Meeting Location: The 

listening session will be held in the 

main auditorium of the Central Building 

of the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, MD 21244–1850. 

Registration and Special 

Accommodations: Persons interested in 

attending the meeting or participating 

by teleconference must register by 

completing the on-line registration via 

the CMS Web site at http:// 

www.cms.gov. Individuals who require 

special accommodations should send an 

e-mail request to 

colleen.bruce@cms.hhs.gov or by 

regular mail to Colleen Bruce at the 

address specified in the FOR FURTHER

INFORMATION CONTACT section of this 

notice. 

FOR FURTHER INFORMATION CONTACT: For 

further information regarding the 

September 20, 2010 listening session 

contact Colleen Bruce at (410) 786– 

5529. You may also send inquiries about 

this listening session by e-mail to 

colleen.bruce@cms.hhs.gov or by regular 

mail at Centers for Medicare & Medicaid 

Services, Mail Stop C5–19–16, 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

All persons planning to make a 

statement in person at the listening 

session are encouraged to submit 

statements in writing at the listening 

session and should subsequently submit 

the information electronically by the 

timeframe specified in the DATES section 

of this notice. 

I. Background 

Section 10332 of the Patient 

Protection and Affordable Care Act (the 

Affordable Care Act) adds a new 

subsection to section 1874 of the Social 

Security Act (the Act), which requires 

that the Secretary of the Department of 

Health and Human Services (the 

Secretary) to make data available to 

qualified entities for the evaluation of 

the performance of providers of services 

and suppliers by January 1, 2012. A 

qualified entity is a public or private 

entity that meets qualifications 

established by the Secretary and that 

proposes to use claims data to evaluate 

the performance of providers of services 

and suppliers on measures of quality, 

efficiency, effectiveness, and resource 

use. These data will be standardized 

extracts of Medicare Parts A, B, and D 

claims data for one or more specified 

geographic areas and time periods 

requested by a qualified entity. This 

provision specifies that the Secretary 

shall take such actions as deemed 

necessary to protect the identity of 

individual beneficiaries. The data shall 

be made available to qualified entities at 

a fee equal to the cost of making such 

data available. 

Section 1874 of the Act states that a 

qualified entity requesting data under 

this subsection must: 

• Submit a description of the 

methodologies it will use to evaluate the 

performance of providers and suppliers; 

• Use standard/endorsed measures, or 

alternative measures if the Secretary so 

determines; 

• Include data made available under 

this subsection with claims data from 

other sources in the evaluation of 

performance of providers of services 

and suppliers; 

• Only use data made available, and 

information derived from an evaluation 

of the performance of providers and 

suppliers, for the reports required by 

this provision; 

• Include in the reports an 

understandable description of the 

measures, risk adjustment methods, 

physician attribution methods, other 

applicable methods, and data 

specifications and limitations; 

• Receive prior review by the 

Secretary of the format of proposed 

reports; 

• Make the information available 

confidentially, to any provider or 

supplier prior to the public release of 

such report; and 

• Only include information on a 

provider of services or supplier in 

aggregate form. 

This section must be implemented by 

January 1, 2012. 

II. Listening Session Format 

The listening session will be held on 

September 20, 2010. Employers, health 

plans and their representatives, measure 

developers, health care providers and 

professionals, professional associations, 

consumer organizations, community 

representatives, and other interested 

stakeholders are invited to participate, 

in person or by teleconference. The 

session will begin at 9:00 a.m. e.d.t. 

with an overview of the objectives for 

the session and a brief summary of the 

requirements of section 10332 of the 

Affordable Care Act. Beginning at 

approximately 9:30 a.m. e.d.t., the 

remainder of the meeting will be 

devoted to presenting the questions for 

comment and receiving comments on 

design and policy options in four topic 

areas—(1) Eligibility criteria and the 

application process for qualified 

entities; (2) definition and selection of 

quality and performance measures; (3) 

data extraction and distribution process; 

and (4) data privacy and security 

requirements, including oversight. The 

agenda will provide opportunities for 

brief two-minute comments from on-site 

session attendees regarding the 

questions for comment and design and 

policy options. As time allows, 

telephone participants will also have 

the opportunity to provide brief twominute comments. The meeting will 

conclude by 1 p.m. with brief comments 

on our next steps. The opinions and 

alternatives provided during this 

meeting will assist us as we develop 

requirements for this program. We 

anticipate posting background materials 

and the questions for comment on the 

CMS Web site at http://www.cms.gov/ 

approximately two weeks before the 

session. 

III. Registration Instructions 

For security reasons, any persons 

wishing to attend this meeting must 

register by the date listed in the DATES

section of this notice. Persons interested 

in attending the meeting or participating 

by teleconference must register by 

completing the on-line registration via 

the designated Web site at http:// 

www.cms.gov. The on-line registration 

system will generate a confirmation 

page to indicate the completion of your 

registration. Participants should print 

this page as his or her registration 

receipt. 

Individuals may also participate in 

the listening session by teleconference. 

Registration is required as the number of 

call-in lines will be limited. The call-in 

number will be provided upon 

confirmation of registration. 

An audio download and transcript of 

the listening session will be available 

within two weeks after completion of 

the listening session through the CMS 

Web site at http://www.cms.gov. 

IV. Security, Building, and Parking 

Guidelines 

This meeting will be held in a Federal 

government building; therefore, Federal 

security measures are applicable. In 

planning your arrival time, we 

recommend allowing additional time to 

clear security. The on-site check-in for 

visitors will begin at 8:15 a.m. e.d.t. We 

recommend that participants allow 

sufficient time to complete security 

checkpoints. 

Security measures include the 

following: 

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52762 Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Notices 

• Presentation of government-issued 

photographic identification to the 

Federal Protective Service or Guard 

Service personnel. 

• Interior and exterior inspection of 

vehicles (this includes engine and trunk 

inspection) at the entrance to the 

grounds. Parking permits and 

instructions will be issued after the 

vehicle inspection. 

• Passing through a metal detector 

and inspection of items brought into the 

building. We note that all items brought 

to CMS, whether personal or for the 

purpose of demonstration or to support 

a demonstration, are subject to 

inspection. 

We cannot assume responsibility for 

coordinating the receipt, transfer, 

transport, storage, set-up, safety, or 

timely arrival of any personal 

belongings or items used for 

demonstration or to support a 

demonstration. 

We note that individuals who are not 

registered in advance will not be 

permitted to enter the building and will 

be unable to attend the meeting. The 

public may not enter the building earlier 

than 45 minutes prior to the convening 

of the meeting. All visitors must be 

escorted in areas other than the lower 

and first floor levels in the Central 

Building. Seating capacity is limited to 

the first 250 registrants. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: August 18, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2010–21369 Filed 8–26–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye Institute; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Eye Institute 

Special Emphasis Panel, NEI Institutional 

Training Grant Applications II. 

Date: September 1, 2010. 

Time: 12:30 p.m. to 1:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, NEI, 

5635 Fishers Lane, Rockville, MD 20892. 

(Telephone Conference Call) 

Contact Person: Anne E. Schaffner, PhD, 

Scientific Review Officer, Division of 

Extramural Research, National Eye Institute, 

National Institutes of Health, 5635 Fishers 

Lane, Suite 1300, MSC 9300, 301–451–2020, 

aes@nei.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.867, Vision Research, 

National Institutes of Health, HHS) 

Dated: August 23, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–21346 Filed 8–26–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Cardiovascular and Renal 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: Cardiovascular 

and Renal 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 September 20, 2010, from 8 a.m. 

to 5 p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel phone number is 301–589–5200. 

Contact Person: Anuja Patel, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., White Oak Bldg. 32, 

rm. 2417, Silver Spring, MD 20993– 

0002, 301–796–9001, FAX: 301–847– 

8540, email: anuja.patel@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014512533. 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 discuss 

new drug application (NDA) 22–512, 

dabigatran etexilate mesylate capsules, 

sponsored by Boehringer Ingelheim 

Pharmaceuticals, Inc., for the proposed 

indication of prevention of stroke in 

patients with atrial fibrillation 

(abnormally rapid contractions of the 

atria, the upper chambers of the heart). 

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 September 8, 2010. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. Those desiring to make 

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 August 30, 2010. 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 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES