Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices 58411 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.867, Vision Research, 

National Institutes of Health, HHS) 

Dated: September 20, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–23979 Filed 9–23–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0481] 

Center for Veterinary Medicine 

eSubmitter Workshop; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled: ‘‘Center for Veterinary 

Medicine (CVM) eSubmitter Workshop.’’ 

The purpose of the public workshop is 

to provide the regulated animal health 

industry that submits new animal drug 

applications to CVM’s Office of New 

Animal Drug Evaluation (ONADE) 

access to the beta-release of the 

electronic submission tool (eSubmitter) 

developed by CVM as agreed to in the 

Animal Drug User Fee Amendments 

(ADUFA II) of 2008 (http:// 

www.fda.gov/ForIndustry/UserFees/ 

AnimalDrugUserFeeActADUFA/ 

ucm044941.htm). The ONADE will be 

soliciting feedback on both the 

eSubmitter tool and its compatibility 

with the industry’s current IT systems, 

as well as the questions asked within 

the tool. 

This workshop will fulfill one of the 

10 workshops agreed to in ADUFA II. 

The workshop will provide insight on 

the eSubmitter template development 

and its customization for the animal 

health industry as well as providing 

break-out sessions in which specific 

submissions will be built as part of the 

demonstration. Lastly, the ONADE will 

be seeking up to nine participating 

companies to work with CVM in testing 

the transmission of eSubmitter 

developed files through FDA’s 

electronic submission gateway (ESG) 

and CVM’s electronic submission 

system (ESS). Information about the 

workshop and availability of the 

eSubmitter tool can be found on FDA’s 

eSubmitter Web site at http:// 

www.fda.gov/ForIndustry/ 

FDAeSubmitter/default.htm. 

Dates and Time: The public workshop 

will be held on October 21, 2010, from 

9 a.m. to 4 p.m. (EST/EDST). 

Location: The public workshop will 

be held virtually through both Adobe 

Connect Pro on-line and with 

conference call-in numbers. Both the 

call-in numbers and the Adobe Connect 

Pro web link will be emailed to all 

registrants. 

Contact Person: Charles Andres, 

Center for Veterinary Medicine (HFV– 

100), Food and Drug Administration, 

7520 Standish Pl., Rockville, MD 20855, 

240–276–8229, email: 

charles.andres@fda.hhs.gov. 

Registration: Registration for the 

workshop can be made at: https:// 

collaboration.fda.gov/ 

cvm_esubmitter_workshop_oct21/event/ 

registration.html on or before October 

15, 2010. There is no registration fee for 

the public workshop. If you need 

special accommodations due to a 

disability, please contact Charles 

Andres (see Contact Person) at least 7 

days in advance. 

Comments: FDA is holding this public 

workshop to obtain information about 

the eSubmitter tool. The deadline for 

submitting comments regarding this 

public workshop is December 31, 2010. 

Regardless of whether a person 

attended the public workshop, 

interested persons may submit either 

electronic or written comments 

regarding this document. 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. It is only 

necessary to send one set of comments. 

It is no longer necessary to send two 

copies of mailed comments. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Transcripts: Transcripts of the public 

workshop may be requested in writing 

from the Freedom of Information Office 

(HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857, 

approximately 15 working days after the 

public workshop at a cost of 10 cents 

per page. A recording of the public 

workshop will be available on the 

Internet at http://www.fda.gov/ 

ForIndustry/FDAeSubmitter/ 

default.htm. 

Dated: September 17, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–23972 Filed 9–23–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3233–N] 

Medicare Program; Town Hall Meeting 

on the Physician Compare Web Site, 

October 27, 2010 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: Section 10331 of the Patient 

Protection and Affordable Care Act of 

2010, ‘‘Public Reporting of Performance 

Information’’ requires CMS to establish 

a Physician Compare Web site by 

January 1, 2011. This notice announces 

a Town Hall meeting to discuss the 

Physician Compare Web site. The 

purpose of this Town Hall meeting is to 

solicit input from stakeholders on the 

Physician Compare Web site. The 

opinions and alternatives provided 

during this meeting will assist us in 

future expansion of the Physician 

Compare Web site. The meeting is open 

to the public, but attendance is limited 

to space available. 

DATES: Meeting Date: Wednesday, 

October 27, 2010 from 1 to 5 p.m., 

eastern daylight time (e.d.t.). 

Timeframe for Meeting Registration: 

Monday, September 27, 2010 through 

Wednesday, October 13, 2010 at 5 p.m., 

e.d.t. 

Deadline for Special 

Accommodations Requests: Wednesday, 

October 13, 2010 at 5 p.m., e.d.t. 

ADDRESSES: Meeting Location: The 

Town Hall meeting will be held in the 

main auditorium of the Centers for 

Medicare and Medicaid Services single 

site, 7500 Security Boulevard, 

Baltimore, MD 21244. 

Registration and Special 

Accommodations: Persons interested in 

attending the meeting or participating 

by teleconference must register by 

completing the online registration via 

the Web site at http:// 

www.usqualitymeasures.org/qm/. 

Individuals who require special 

accommodations should send a request 

via e-mail or regular mail to the contact 

specified in the FOR FURTHER

INFORMATION CONTACT section of this 

notice. 


srobinson on DSKHWCL6B1PROD with NOTICES
58412 Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices 

Written Comments or Statements: 

Written comments or statements may be 

sent via e-mail to 

physiciancompare@cms.hhs.gov or sent 

via regular mail to: Centers for Medicare 

& Medicaid Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850, 

Mail Stop S3–02–01, Attn: Physician 

Compare Town Hall Meeting 

Comments. All persons planning to 

make a statement in person at the 

listening session are urged to submit 

statements in writing during the Town 

Hall meeting and should subsequently 

submit the information electronically by 

the timeframe specified in the DATES

section of this notice. 

FOR FURTHER INFORMATION CONTACT: 

Regina Chell, Centers for Medicare & 

Medicaid Services, Office of Clinical 

Standards and Quality, Mailstop S3–02– 

01, Attn: Physician Compare Town Hall 

Meeting, 7500 Security Boulevard, 

Baltimore, MD 21244 or contact Ms. 

Chell by phone at 410–786–6551, or via 

e-mail at Regina.Chell@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 10331 of the Patient 

Protection and Affordable Care Act of 

2010 (the Affordable Care Act) requires 

CMS to establish a Web site, which will 

be known as Physician Compare, 

containing information on physicians 

enrolled in the Medicare program and 

other eligible professionals who 

participate in the Physician Quality 

Reporting Initiative (PQRI) by January 1, 

2011. Section 10331 of the Affordable 

Care Act also requires CMS to 

implement a plan to make information 

on physician performance publicly 

available through the Physician 

Compare Web site no later than January 

1, 2013 (and for reporting periods 

beginning no earlier than January 1, 

2012). 

In implementing section 10331 of the 

Affordable Care Act, the law requires 

establishing processes, to the extent 

practicable, to ensure the following: 

• The data made public are 

statistically valid and reliable, and 

provide an accurate and robust portrayal 

of performance. 

• Appropriate attribution of care. 

• Timely statistical performance 

feedback. 

• The data reflects the care provided 

to all patients including Medicare and 

other payers where such data would 

more accurately portray performance. 

• Physicians and other eligible 

professionals have a reasonable 

opportunity to review their individual 

data prior to publication. 

The Affordable Care Act also requires 

the assurance of patient privacy, input 

from multi-stakeholder groups, and 

taking into consideration the plan to 

transition to value-based purchasing. 

Section 10331 of the Affordable Care 

Act also requires CMS to submit a 

Report to Congress on the Physician 

Compare Web site by January 15, 2015, 

and authorizes CMS to establish a 

demonstration program by January 1, 

2019, to provide financial incentives to 

Medicare beneficiaries who are 

furnished services by high quality 

physicians. The Affordable Care Act 

requires that the measures include, to 

the extent practicable, the following: 

• Measures collected under the PQRI; 

• An assessment of patient health 

outcomes and the functional status of 

patients; 

• An assessment of the continuity 

and coordination of care and care 

transitions, including episodes of care 

and risk-adjusted resource use; 

• An assessment of efficiency; 

• An assessment of patient 

experience and patient, caregiver, and 

family engagement; 

• An assessment of the safety, 

effectiveness, and timeliness of care; 

and 

• Other information as determined 

appropriate by the Secretary. 

II. Town Hall Format 

The Town Hall meeting will begin 

with an overview of the objectives for 

the session. The remainder of the 

meeting will be devoted to presenting 

and receiving input on possible key 

Web site design issues. 

Following each presentation, the 

meeting agenda will provide 

opportunities for brief 2-minute 

comments on each of the key issues 

from on-site session attendees. As time 

allows, telephone participants will also 

have the opportunity to provide brief 2- 

minute comments on each of the key 

issues. Written submissions will also be 

accepted through the timeframe 

specified in the DATES section of this 

notice. 

III. Registration Instructions 

There is no registration fee. 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 online registration via 

the Web site at http:// 

www.usqualitymeasures.org/qm/. The 

online registration system will generate 

a confirmation page to indicate the 

completion of your registration. Please 

print this page as your registration 

receipt. If seating capacity has been 

reached, you will be notified that the 

meeting has reached capacity. 

Individuals may also participate in 

the Town Hall meeting 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. 

We anticipate posting an audio 

download and/or transcript of the Town 

Hall meeting on the CMS Web site after 

completion of the listening session at 

http://www.usqualitymeasures.org/qm/. 

IV. Security, Building, and Parking 

Guidelines 

Because this meeting will be located 

on Federal property, for security 

reasons, any persons wishing to attend 

this meeting must register by the 

deadline specified in the DATES section 

of this notice at the address specified in 

the ADDRESSES section of this notice. 

Individuals who have not registered in 

advance will not be allowed to enter the 

building to attend the meeting. Seating 

capacity is limited to the first 250 

registrants. 

The on-site check-in for visitors will 

begin 45 minutes prior to the start of the 

meeting. Please allow sufficient time to 

go through the security checkpoints. It 

is suggested that you arrive no later than 

30 minutes before the start of the 

meeting so that you will be able to 

arrive at the meeting on time. All items 

brought to the building, whether 

personal or for the purpose of 

demonstration or to support a 

presentation, are subject to inspection. 

Security measures will include 

inspection of vehicles, inside and out, at 

the entrance to the grounds. In addition, 

all persons entering the building must 

pass through a metal detector. All items 

brought to CMS, including personal 

items such as laptops, cell phones, and 

P.D.A’s, are subject to physical 

inspection. 

Authority: Section 10331 of the Affordable 

Care Act. 

(Catalog of Federal Domestic Assistance 

Program No. 93–773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Insurance 

Program) 

Dated: September 16, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare and 

Medicaid Services. 

[FR Doc. 2010–23792 Filed 9–23–10; 8:45 am] 

BILLING CODE 4120–01–P 


srobinson on DSKHWCL6B1PROD with NOTICES