Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 78247 

her term until a successor has been 

sworn in. 

A Federal official, designated by the 

Secretary or the Administrator, must 

serve as the Chair and facilitate the 

Panel meetings. The Chair’s term must 

usually be for a period of 4 years, but 

it may be extended at the discretion of 

the Administrator or his or her duly 

appointed designee. 

In order to conduct the business of the 

Panel, a quorum is required. A quorum 

exists when a majority of currently 

appointed members is present at full 

Panel or subcommittee meetings or is 

participating in conference calls. 

With the approval of the Secretary or 

designee, subcommittees consisting of 

two or more Panel members may be 

established to perform functions within 

the Panel’s jurisdiction. One of the 

members will be designated by his or 

her peers as chair of the subcommittee. 

The Department Committee 

Management Officer will be notified 

upon establishment of each 

subcommittee and will be provided 

information on its name, membership, 

function, and estimated frequency of 

meetings. The advice or 

recommendations of a subcommittee or 

working group must be deliberated by 

the Panel. A subcommittee may not 

report directly to a Federal official, but 

rather it must report to the parent Panel. 

The FACA provides that a Designated 

Federal Officer (DFO) must be 

appointed to a Federal advisory 

committee to attend each Panel meeting 

and to ensure that all procedures adhere 

to applicable statutory, regulatory, and 

DHHS General Administration Manual 

directives. The DFO approves and 

prepares all meeting agendas; calls all 

Panel or subcommittee meetings; 

adjourns any meeting when he or she 

determines adjournment to be in the 

public interest; and chairs meetings 

when directed to do so by the Secretary 

or the Administrator. The DFO or his or 

her designee must be present at all full 

Panel and subcommittee meetings. The 

CMS must also provide management 

and support services to the Panel. 

E. APC Panel Meetings 

Meetings must be held up to three 

times a year at the call of the DFO. The 

agenda, which sets the boundaries for 

discussion, is developed by CMS and 

approved by the DFO. Meetings are 

open to the public, except as 

determined otherwise by the Secretary 

or other official to whom the authority 

has been delegated in accordance with 

the Government in the Sunshine Act (5 

U.S.C. 552b(c)) and FACA. The Panel 

Chair must facilitate all Panel meetings. 

Adequate advance notice of all 

meetings must be published in the 

Federal Register, as required by 

applicable laws and departmental 

regulations, stating reasonably 

accessible and convenient locations and 

times. Meetings must be conducted, and 

records of the proceedings kept, as 

required by applicable laws and 

departmental regulations. The records of 

the Panel and established 

subcommittees must be managed in 

accordance with General Records 

Schedule 26, Item 2, or other approved 

Agency records disposition schedule. 

These records must be available for 

public inspection and copying, subject 

to the Freedom of Information Act (5 

U.S.C. 552). 

F. Compensation 

All members must serve on a 

voluntary basis, without compensation, 

pursuant to advance written agreement. 

Members of the Panel must be entitled 

to receive reimbursement for travel 

expenses and per diem in lieu of 

subsistence, in accordance with 

Standard Government Travel 

Regulations. 

G. Annual Cost Estimate 

Estimated fiscal year (FY) 2011 

annual cost for operating the Panel, 

including travel expenses for members 

but excluding staff support, is $77,000. 

The estimated annual person-years of 

staff support required for the APC Panel 

is 1.0 full-time equivalent (FTE) at an 

estimated annual cost of $105,575. 

Estimated FY 2012 annual cost for 

operating the Panel, including travel 

expenses for members but excluding 

staff support, is $80,000. The estimated 

annual person-years of staff support 

required for the APC Panel is 1.0 FTE 

at an estimated annual cost of $107,650. 

H. Termination Date 

Unless renewed by appropriate action 

prior to its expiration, the APC Panel 

must terminate 2 years from the date the 

charter is filed. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare-Supplementary Medical Insurance 

Program) 

Dated: December 2, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2010–31372 Filed 12–14–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3236–N] 

Medicare Program; Town Hall Meeting 

on Physician Quality Reporting System 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces a 

Town Hall Meeting to discuss the 

Physician Quality Reporting System 

(previously known as the Physician 

Quality Reporting Initiative (PQRI)). The 

purpose of the Town Hall Meeting is to 

solicit input from participating 

stakeholders on the individual quality 

measures and measures groups being 

considered for possible inclusion in the 

proposed set of quality measures for use 

in the 2012 Physician Quality Reporting 

System and key components of the 

design of the Physician Quality 

Reporting System. Measure developers, 

eligible professionals, professionals 

associations, such as medical specialty 

societies, and other interested 

stakeholders are invited to participate, 

in person or by teleconference. The 

meeting is open to the public, but 

attendance is limited to space and 

teleconference lines available. 

DATES: Meeting Date: The Town Hall 

Meeting will be held on February 9, 

2011, from 10 a.m. until 4 p.m. eastern 

standard time (e.s.t). 

Deadline for Registration of Presenters 

of the Town Hall Meeting: All presenters 

for the Town Hall meeting must register 

and submit their discussion item(s) by 

5 p.m. e.s.t. on January 18, 2011. 

Deadline for Registration of All Other 

Participants for the Town Hall Meeting 

and Request for Special 

Accommodations: Registration opens on 

December 20, 2010. All other 

participants must register no later than 

5 p.m. e.s.t. on January 28, 2011. 

Requests for special accommodations 

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

January 28, 2010. 

Deadline for Submission of Comments 

on Key Issues for the Town Hall 

Meeting: Written comments on key 

issues for discussion at the Town Hall 

Meeting must be received by 5 p.m. 

e.s.t. on January 21, 2011. 

Deadline for Submission of Other 

Written Comments or Statements: 

Written comments or statements on 

issues that were discussed at this Town 

Hall Meeting or other comments, may be 

sent via regular mail, fax, or 

electronically to the address specified in 


hsrobinson on DSK69SOYB1PROD with NOTICES
78248 Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 

the ADDRESSES section of this notice and 

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

February 25, 2011. 

ADDRESSES: Meeting Location: The 

Town Hall Meeting 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 Web site at http:// 

www.usqualitymeasures.org. 

Individuals who require special 

accommodations should send a request 

via email or regular mail to the contact 

specified in the FOR FURTHER

INFORMATION section of this notice. 

Submission of Written Comments or 

Statements: Written comments or 

statements may be sent via e-mail to 

Physician_

Reporting_TEMP@cms.hhs.gov. or sent 

via regular mail to: Attn: 2012 Physician 

Quality Reporting System Town Hall 

Meeting Comments, Office of Clinical 

Standards and Quality, Centers for 

Medicare & Medicaid Services, Mail 

Stop S3–02–01, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

FOR FURTHER INFORMATION CONTACT: 

Jacquelyn Kosh-Suber, (410).786–6889 

via e-mail at 

Jacquelyn.Koshsuber@cms.hhs.gov. or 

via regular mail as specified in the 

ADDRESSES section of this notice. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Physician Quality Reporting 

System is a voluntary reporting program 

in which eligible professionals and 

group practices report data on quality 

measures. An eligible professional who 

satisfactorily reports data on quality 

measures may qualify to earn a 

Physician Quality Reporting System 

incentive payment based on a 

percentage of the eligible professional’s 

(or, in the case of a group practice, the 

group’s) total estimated allowed 

Medicare Part B charges for covered 

professional services furnished during a 

specified reporting period. Under 

section 1848(k)(3)(B) of the Social 

Security Act (the Act), the term ‘‘eligible 

professional’’ means any of the 

following: 

• A physician. 

• A practitioner described in section 

1842(b)(18)(C) of the Act. 

• A physical or occupational 

therapist or a qualified speech-language 

pathologist or qualified audiologist. 

Detailed information about the 

Physician Quality Reporting System is 

available on the CMS Web site at 

http://www.cms.hhs.gov/PQRI. 

Our goals for the 2012 Physician 

Quality Reporting System include 

increasing participation in light of a 

payment adjustment that begins in 2015, 

leveraging the benefits of alternative 

reporting mechanisms, such as registrybased reporting, EHR-based reporting, 

and the group practice reporting option, 

and increasing alignment with other 

programs, such as the EHR Incentive 

Program. 

This Town Hall meeting will be 

hosted to solicit input from eligible 

professionals and other interested 

parties on the individual quality 

measure and measures group 

suggestions received in response to the 

‘‘2012 Physician Quality Reporting 

System Call for Measures’’ and on other 

changes being considered for the future 

with regard to the key components of 

the Physician Quality Reporting System 

described in this notice. 

II. Town Hall Meeting 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 each of the major 

components of the Physician Quality 

Reporting System including the 

following: 

• The individual quality measures 

and measures group suggestions 

received in response to the ‘‘2012 

Physician Quality Reporting System 

Call for Measures’’ (for more 

information, see the CMS Measures 

Management System Web site at 

http://www.cms.gov/MMS/13_

Call%20for%20Measures.asp#

TopOfPage). 

• Reporting mechanism. 

• Reporting period. 

• Criteria for satisfactory reporting. 

• The group practice reporting 

option. 

• The Maintenance of Certification 

Program Incentive. 

Following each presentation, the 

meeting agenda will provide 

opportunities for brief comments on 

each of the key issues from on-site 

session attendees. The time for each 

presenter’s comments will be 

approximately 2 minutes and will be 

based on the number of registered 

presenters. As time allows, telephone 

participants will also have the 

opportunity to provide brief comments 

of no more than 2 minutes on each of 

the key issues. Presenters will be 

scheduled to speak in the order in 

which they register. Therefore, 

individuals who would like to present 

must register and submit their 

comment(s) to the address specified in 

the ADDRESSES section of this notice by 

the date specified in the DATES section 

of this notice. All other written 

submissions will be accepted and 

presented at the meeting if they are 

received at the address specified in the 

ADDRESSES section of this notice by the 

date specified in the DATES section of 

this notice. 

We anticipate posting an audio 

download and/or transcript of the Town 

Hall meeting on the CMS PQRI Web site 

after completion of the meeting. See 

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

PQRI. The opinions and alternatives 

provided during this meeting will assist 

us as we develop the Physician Quality 

Reporting System for 2012. We 

anticipate posting a summary of the 

individual quality measures and 

measures groups for possible inclusion 

in the proposed set of quality measures, 

as well as possible program design 

options under consideration for use in 

the 2012 Physician Quality Reporting 

System on the Physician Quality 

Reporting System section of the CMS 

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

PQRI by January 21, 2011. 

III. Registration Instructions 

While 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. 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. Individuals 

may also register via telephone by 

calling the contact listed in the FOR

FURTHER INFORMATION section of this 

notice or via regular mail to the address 

listed in the ADDRESSES section of this 

notice. 

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 you to arrive at the central 


hsrobinson on DSK69SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 78249 

building no later than 9 a.m. e.s.t. to 

allow for enough time to clear security 

and to check in before the meeting 

begins. The on-site check-in for visitors 

will begin at 9:30 a.m. e.s.t. All items 

brought to the building, whether 

personal or for the purpose of 

demonstration or to support a 

presentation, including items such as 

laptops, cell phones, and palm pilots, 

are subject to physical inspection. 

Security measures include the 

following: 

• 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, 

setup, safety, or timely arrival of any 

personal belongings or items used for 

demonstration or to support a 

demonstration. 

Note: 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. 

Authority: Section 503 of Public Law 108– 

173. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program). 

Dated: December 7, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2010–31301 Filed 12–13–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0008] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on Citizen Petitions and 

Petitions for Stay of Action Subject to 

Section 505(q) of the Federal Food, 

Drug, and Cosmetic Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(PRA). 

DATES: Fax written comments on the 

collection of information by January 14, 

2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910—NEW and 

title ‘‘Guidance for Industry on Citizen 

Petitions and Petitions for Stay of 

Action Subject to Section 505(q) of the 

Federal Food, Drug, and Cosmetic Act.’’ 

Also include the FDA docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850. 301– 

796–3792. E-mail: 

elizabeth.berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Industry on Citizen 

Petitions and Petitions for Stay of 

Action Subject to Section 505(q) of the 

Federal Food, Drug, and Cosmetic Act 

In the Federal Register of January 21, 

2009 (74 FR 3611), FDA announced the 

availability of a draft guidance for 

industry entitled ‘‘Draft Guidance for 

Industry on Citizen Petitions and 

Petitions for Stay of Action Subject to 

Section 505(q) of the Federal Food, 

Drug, and Cosmetic Act’’ (FD&C Act). 

FDA is now in the process of finalizing 

this guidance. In that Federal Register 

notice, FDA provided the public with 60 

days to comment on the proposed 

collection of information. FDA received 

no comments pertaining to the 

information collection in the draft 

guidance. 

Description of Respondents: 

Respondents to this collection of 

information as it is related to citizen 

petitions are individuals or households, 

State or local governments, not-forprofit institutions, and businesses or 

other for-profit institutions or groups. 

Respondents to this collection of 

information as it is related to petitions 

for stay of Agency action are persons 

who choose to file a petition for an 

administrative stay of action. 

Burden Estimate: Section 505(q)(1)(H) 

of the FD&C Act requires that citizen 

petitions and petitions for stay of 

Agency action that are subject to section 

505(q) include a certification to be 

considered for review by FDA. Section 

505(q)(1)(I) of the FD&C Act requires 

that supplemental information or 

comments to such citizen petitions and 

petitions for stay of Agency action 

include a verification to be accepted for 

review by FDA. This guidance describes 

our current thinking on the 

interpretation of these requirements. 

The guidance sets forth the criteria the 

Agency will use in determining if the 

provisions of section 505(q) apply to a 

particular citizen petition or petition for 

stay of agency action. One of the criteria 

for a citizen petition or petition for stay 

of Agency action to be subject to section 

505(q) of the FD&C Act is that a related 

ANDA or 505(b)(2) application is 

pending at the time the citizen petition 

or petition for stay is submitted. 

Because petitioners or commenters may 

not be aware of the existence of a 

pending ANDA or 505(b)(2) application, 

the guidance recommends that all 

petitioners challenging the 

approvability of a possible ANDA or 

505(b)(2) application include the 

certification required in section 

505(q)(1)(H) of the FD&C Act and that 

petitioners and commenters submitting 

supplements or comments, respectively, 

to a citizen petition or petition for stay 

of action challenging the approvability 

of a possible ANDA or 505(b)(2) 

application include the verification 

required in section 505(q)(1)(I) of the 

FD&C Act. The guidance also 

recommends that if a petitioner submits 

a citizen petition or petition for stay of 

Agency action that is missing the 


hsrobinson on DSK69SOYB1PROD with NOTICES