Federal Register / Vol. 77, No. 32 / Thursday, February 16, 2012 / Notices 9255 

free: 1–800–CDC–INFO, email: 

dcas@cdc.gov. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

Notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: February 7, 2012. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2012–3587 Filed 2–15–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1594–N] 

Medicare Program: Notice of Six 

Membership Appointments to the 

Advisory Panel on Hospital Outpatient 

Payment 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: This notice announces six 

new membership appointments to the 

Advisory Panel on Hospital Outpatient 

Payment (HOP, the Panel). The six 

appointments to the 19 member Panel 

will each serve a 4-year period. Five of 

the new members will have terms that 

begin on February 1, 2012 and 

continuing through January 31, 2016. 

The sixth member’s term will begin on 

August 1, 2012 and continuing through 

July 31, 2016. The purpose of the Panel 

is to advise the Secretary of the 

Department of Health and Human 

Services and the Administrator of the 

Centers for Medicare & Medicaid 

Services concerning the clinical 

integrity of the Ambulatory Payment 

Classification groups and their weights. 

The Panel also addresses and makes 

recommendations regarding supervision 

of outpatient services. The advice 

provided by the Panel will be 

considered as we prepare the annual 

updates for the hospital outpatient 

prospective payment system. 

FOR FURTHER INFORMATION CONTACT: For 

additional information on the Panel 

meeting dates, agenda topics, copy of 

the charter, as well as updates to the 

Panel’s activities, search our Internet 

Web site: https://www.cms.gov/FACA/

05_AdvisoryPanelonAmbulatory

PaymentClassification

Groups.asp#TopOfPage. (Note: There is 

an UNDERSCORE after FACA/05_; there 

is no space.) 

For other information regarding the 

Panel, contact Paula Smith, the 

Designated Federal Officer at CMS, 

Center for Medicare, Hospital and 

Ambulatory Policy Group, Division of 

Outpatient Care, 7500 Security 

Boulevard, Mail Stop C4–05–13, 

Baltimore, MD 21244–1850, phone (410) 

786–4709. Information can also be 

obtained by contacting the CMS 

Advisory Committees’ Information Line 

at 1–877–449–5659 (toll free) and (410) 

786–9379 (local). 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Secretary of the Department of 

Health and Human Services (the 

Secretary) is required by section 

1833(t)(9)(A) of the Social Security Act 

(the Act) (42 U.S.C. 1395l(t)(9)(A)) and 

section 222 of the Public Health Service 

Act (PHS Act) (42 U.S.C. 217a) to 

consult with an expert outside advisory 

panel on the clinical integrity of the 

Ambulatory Payment Classification 

groups and weights. The Advisory Panel 

on Hospital Outpatient Payment (HOP, 

the Panel) is governed by the provisions 

of the Federal Advisory Committee Act 

(FACA) (Pub. L. 92–463, as amended (5 

U.S.C. Appendix 2), which sets forth 

standards for the formation and use of 

advisory panels. The Panel Charter 

provides that the Panel shall meet up to 

3 times annually. We consider the 

technical advice provided by the Panel 

as we prepare the proposed and final 

rules to update the outpatient 

prospective payment system for the next 

calendar year. 

The Panel shall consist of a chair and 

up to 19 members who are full-time 

employees of hospitals, hospital 

systems, or other Medicare providers. 

The Secretary or a designee selects the 

Panel membership based upon either 

self-nominations or nominations 

submitted by Medicare providers and 

other interested organizations. New 

appointments are made in a manner that 

ensures a balanced membership under 

the FACA guidelines. 

The Panel presently consists of the 

following members and a Chair: (The 

asterisk [*] indicates a Panel member 

whose term expires on July 31, 2012). 

• Edith Hambrick, M.D., J.D., Chair, 

CMS Medical Officer. 

• Ruth L. Bush, M.D., M.P.H. 

• Kari S. Cornicelli, C.P.A., FHFMA. 

• Dawn L. Francis, M.D., M.H.S. 

• Kathleen Graham, R.N., M.S.H.A.* 

• David A. Halsey, M.D. 

• Brian D. Kavanagh, M.D., MPH. 

• Judith T. Kelly, R.H.I.T., R.H.I.A., 

C.C.S. 

• Scott Manaker, M.D., Ph.D. 

• John Marshall, CRA, RCC, CIRCC, 

RT(R), FAHRA. 

• Jacqueline Phillips. 

• Randall A. Oyer, M.D. 

• Daniel J. Pothen, M.S., RHIA, CHPS. 

• Gregory Przybylski, M.D. 

• Marianna V. Spanaki-Varela, MD, 

Ph.D., M.B.A. 

II. Provisions of the Notice 

We published a notice in the Federal 

Register on November 25, 2011, entitled 

‘‘Medicare Program; Renaming and 

Other Changes to the Advisory Panel on 

Hospital Outpatient Payment Charter 

(Formerly the Advisory Panel on 

Ambulatory Payment Classification 

Groups) and Request for Nominations’’ 

(76 FR 72708). The notice requested 

nominations to be added to the Panel by 

replacing one Panel member whose term 

expires on July 31, 2012; replacing one 

Panel member who resigned; and by 

adding four new Panel members (two of 

these designated as Critical Access 

Hospital representatives (see the 

November 30, 2011 final rule, (76 FR 

74363)) to address appropriate 

supervision level for hospital outpatient 

services. As a result of that November 

25, 2012 notice and the November 30, 

2011 final rule, we are announcing six 

new members to the Panel. Their 

appointments are for 4-year terms 

commencing on February 1, 2012 and 

August 1, 2012. 

New Appointments to the Panel—The 

new members of the Panel with terms 

beginning on February 1, 2012 and 

continuing through January 31, 2016 are 

as follows: 

• Lanny Copeland, M.D., 

• Jim Nelson, 

• Leah Osbahr, 

• Traci Rabine; and 

• Gale Walker 

The new member of the Panel with a 

term beginning on August 1, 2012, and 

continuing through July 31, 2016 is: 

• Karen Borman, M.D. 

III. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

(Catalog of Federal Domestic Assistance 

Program; No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 


srobinson on DSK4SPTVN1PROD with NOTICES
9256 Federal Register / Vol. 77, No. 32 / Thursday, February 16, 2012 / Notices 

Medicare—Supplementary Medical 

Insurance Program) 

Section 1833(t)(9)(A) of the Act (42 U.S.C. 

1395l(t)(9)(A)). The Panel is governed by the 

provisions of the Federal Advisory 

Committee Act, as amended (5 U.S.C. 

Appendix 2). 

Dated: February 8, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–3643 Filed 2–15–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0123] 

Design and Methodology for 

Postmarket Surveillance Studies Under 

Section 522 of the Federal Food, Drug, 

and Cosmetic Act; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public workshop entitled ‘‘Design and 

Methodology for Postmarket 

Surveillance Studies under Section 522 

of the Federal Food, Drug and Cosmetic 

Act’’. The purpose of the public 

workshop is to provide a forum for 

discussion among FDA, industry, 

governmental agencies, academia, 

clinicians and various stakeholders with 

experience in epidemiology, statistics, 

and biomedical research to advance the 

design and methodologies for medical 

device surveillance studies in the 

‘‘postmarket’’ setting, i.e., after FDA 

premarket approval or clearance of the 

device and marketing of the device has 

begun. 

DATES: The meeting will be held on 

March 7, 2012, from 8 a.m. to 5:30 p.m. 

ADDRESSES: The meeting will be held at 

the FDA White Oak Campus, 10903 

New Hampshire Ave., Bldg. 31, Rm 

1503 (the Great Room), Silver Spring, 

MD 20993. For parking and security 

information, please visit the following 

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

AboutFDA/WorkingatFDA/ 

BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. The public workshop 

will also be available to be viewed 

online via webcast. 

FOR FURTHER INFORMATION CONTACT: 

Samantha Jacobs, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4201C, Silver 

Spring, MD 20993, 301–796–6897, 

email: samantha.jacobs@fda.hhs.gov; or 

Mary Beth Ritchey, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4118, Silver Spring, 

MD 20993, 301–796–6638, email: 

maryelizabeth.ritchey@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Registration: To register for the public 

workshop, please visit the following 

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

MedicalDevices/NewsEvents/ 

WorkshopsConferences/ucm289465.htm 

(or go to http://www.fda.gov and select 

the FDA Medical Devices News & 

Events—Workshops & Conferences 

calendar and select this public 

workshop from the posted events list). 

Please provide complete contact 

information for each attendee, including 

name, title, affiliation, address, email, 

and telephone number. For persons 

interested in attending this workshop 

and without Internet access, please call 

one of the people listed in the FOR

FURTHER INFORMATION CONTACT section 

in this document in order to register. 

Registrants will receive confirmation 

once they have been accepted. You will 

be notified if you are on a waitlist. 

There is no fee to attend the public 

workshop, but attendees must register in 

advance. Registration will be on a firstcome, first-served basis. Persons 

interesting in attending this workshop 

must register online by February 29, 

2012. Registration is mandatory as space 

is limited and onsite registration will 

not be available. FDA may limit the 

number of participants from each 

organization. 

If you need special accommodations 

due to a disability, please contact Susan 

Monahan at 

susan.monahan@fda.hhs.gov no later 

than March 1, 2012. 

Security: Non-U.S. citizens are subject 

to additional security screening, and 

they should register as soon as possible. 

Entrance for the public meeting 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please visit the Web site 

address in the ADDRESSES section of this 

document. 

Streaming Webcast of the Public 

Workshop: This workshop will also be 

webcast. Persons interested in viewing 

the webcast must register online by 5 

p.m. on February 29, 2012. Early 

registration is recommended because 

webcast connections are limited. 

Organizations are requested to register 

all participants, but view using one 

connection per location. Webcast 

participants will be sent technical 

system requirements after registration, 

and will be sent connection access 

information after March 1, 2012. If you 

have never attended a Connect Pro 

meeting before, test your connection at: 

https://collaboration.fda.gov/common/ 

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit: http://www.adobe.com/ 

go/connectpro_overview. (FDA has 

verified the Web site addresses in this 

document, but FDA is not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register.) 

Background: Under section 522(a) of 

the Federal Food, Drug and Cosmetic 

Act (FD&C Act), enacted by the Food 

and Drug Administration Modernization 

Act of 1997 (FDAMA) (Pub. L. 105–115, 

§ 212, 111 Stat. 2346), codified at 21 

U.S.C. 360l(a), FDA may order a 

manufacturer to conduct postmarket 

surveillance for any Class II or Class III 

device (i) Intended to be implanted in 

the human body for more than 1 year or 

to be used to sustain or support life 

outside a device user facility, or (ii) 

whose failure would be reasonably 

likely to have serious adverse health 

consequences. The Food and Drug 

Administration Amendments of 2007 

(FDAAA) (Pub. L. 110–85, § 307, 121 

Stat. 865) expanded the scope of section 

522 to include devices intended for 

pediatric use. 

Agenda for the Public Workshop 

1. Why are we holding this public 

workshop? 

The purpose of the proposed 

workshop is to facilitate discussion 

among the FDA, industry, governmental 

agencies, academia, clinicians, and key 

stakeholders with experience in 

epidemiology, statistics, and biomedical 

research in the scientific community to 

advance the design and methodologies 

for medical device surveillance studies 

in the postmarket setting. 

2. Who is the target audience for this 

public workshop? Who should attend 

this public workshop? 

This workshop is open to all 

interested parties. The target audience is 

professionals in the scientific 

community interested in advancing the 

infrastructure and methodology for 

postmarket surveillance studies. 

3. What are the topics we intend to 

address at the public workshop? 

We intend to discuss a large number 

of issues at the workshop, including, but 

not limited to the following: 


srobinson on DSK4SPTVN1PROD with NOTICES