Federal Register / Vol. 75, No. 127 / Friday, July 2, 2010 / Notices 38533 

FDA may, for good cause, extend this 

30-day period. Reconsideration of a 

denial or withdrawal of approval of a 

PMA may be sought only by the 

applicant; in these cases, the 30-day 

period will begin when the applicant is 

notified by FDA in writing of its 

decision. 

The regulations provide that FDA 

publish a quarterly list of available 

safety and effectiveness summaries of 

PMA approvals and denials that were 

announced during that quarter. The 

following is a list of approved PMAs for 

which summaries of safety and 

effectiveness were placed on the 

Internet from January 1, 2010, through 

March 31, 2010. There were no denial 

actions during this period. The list 

provides the manufacturer’s name, the 

product’s generic name or the trade 

name, and the approval date. 

TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1, 

2010, THROUGH MARCH 31, 2010 

PMA No. 

Docket No. Applicant Trade Name Approval Date 

P010047 

FDA–2010–M–0068 

Neomend, Inc. PROGEL PLEURAL AIR LEAK SEALANT January 14, 2010 

P060040/S005 

FDA–2010–M–0078 

Thoratec Corp. THORATEC HEARTMATE II LEFT VENTRICULAR 

ASSIST SYSTEM (LVAS) 

January 20, 2010 

H080002 

FDA–2010–M–0063 

Medtronic, Inc. MEDTRONIC MELODY TRANSCATHETER PULMONARY VALVE (MODEL PB10) AND 

MEDTRONIC ENSEMBLE TRANSCATHETER 

VALVE DELIVERY SYSTEM (NU10) 

January 25, 2010 

P090003 

FDA–2010–M–0135 

Boston Scientific Corp. EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM March 5, 2010 

P090006 

FDA–2010–M–0158 

Medtronic Vascular COMPLETE SE VASCULAR STENT SYSTEM March 17, 2010 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

www.fda.gov/cdrh/pmapage.html. 

Dated: June 28, 2010. 

Nancy Stade, 

Acting Associate Director for Regulations and 

Policy, Center for Devices and Radiological 

Health. 

[FR Doc. 2010–16139 Filed 7–1–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; 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 materials, 

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 Institute on 

Alcohol Abuse and Alcoholism Special 

Emphasis Panel ZAA1 HH01—AA3 Member 

Conflicts. 

Date: July 30, 2010. 

Time: 11 a.m. to 12 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5635 

Fishers Lane, Bethesda, MD 20892. 

Contact Person: Lorraine Gunzerath, PhD, 

MBA, Scientific Review Officer, National 

Institute on Alcohol Abuse and Alcoholism, 

Office of Extramural Activities, Extramural 

Project Officer, 5635 Fishers Lane, Room 

2121, Bethesda, MD 20892–9304, 301–443– 

2369. 

(Catalogue of Federal Domestic Assistance 

Program Nos.) 

Dated: June 25, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–16037 Filed 7–1–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1571–N] 

Medicare Program; Second SemiAnnual Meeting of the Advisory Panel 

on Ambulatory Payment Classification 

Groups—August 23 & 24, 2010 

AGENCY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: This notice announces the 

second semi-annual meeting of the 

Advisory Panel on Ambulatory Payment 

Classification (APC) Groups (the Panel) 

for 2010. The purpose of the Panel is to 

review the APC groups and their 

associated weights and to advise the 

Secretary of the Department of Health 

and Human Services (DHHS) (the 

Secretary) and the Administrator of the 

Centers for Medicare & Medicaid 

Services (CMS) (the Administrator) 

concerning the clinical integrity of the 

APC groups and their associated 

weights. We will consider the Panel’s 

advice as we prepare the final rule that 

would update the hospital Outpatient 

Prospective Payment System (OPPS) for 

CY 2011. 

DATES: Meeting Dates: We are 

scheduling the second semi-annual 


emcdonald on DSK2BSOYB1PROD with NOTICES
38534 Federal Register / Vol. 75, No. 127 / Friday, July 2, 2010 / Notices 

1The times listed in this notice are approximate 

times; consequently, the meetings may last longer 

than listed in this notice, but will not begin before 

the posted times. 

meeting in 2010 for the following dates 

and times: 

• Monday, August 23, 2010, 1 p.m. to 

5 p.m. eastern standard time (e.d.t.).1

• Tuesday, August 24, 2010, 8 a.m. to 

5 p.m. (e.d.t.).1

Deadlines 

Deadline for Hardcopy Comments 

(including the comment in electronic 

format)/Suggested Agenda Topics—5 

p.m. (e.d.t.), Monday, August 2, 2010. 

Deadline for Hardcopy Presentations, 

including the required electronic 

documents as discussed below—5 p.m. 

(e.d.t.), Monday, August 2, 2010. 

Deadline for Attendance 

Registration—5 p.m. (e.d.t.), 

Wednesday, August 16, 2010. 

Deadline for Special 

Accommodations—5 p.m. (e.d.t.), 

Wednesday, August 16, 2010. 

Submission of Materials to the 

Designated Federal Officer (DFO) 

Because of staffing and resource 

limitations, we cannot accept written 

comments and presentations by FAX, 

nor can we print written comments and 

presentations received electronically for 

dissemination at the meeting. 

Only hardcopy comments and 

presentations can be reproduced for 

public dissemination. All hardcopy 

presentations must be accompanied by 

Form CMS–20017 (revised 01/07). The 

form is now available through the CMS 

Forms Web site. The Uniform Resource 

Locator (URL) for linking to this form is 

as follows: http://www.cms.hhs.gov/

cmsforms/downloads/cms20017.pdf. 

Presenters must use the most recent 

copy of CMS–20017 (updated 01/07) at 

the above URL. Additionally, presenters 

must clearly explain the action(s) that 

they are requesting CMS to take in the 

appropriate section of the form. They 

must also clarify their relationship to 

the organization that they represent in 

the presentation. 

Note: Issues that are vague, or that are 

outside the scope of the APC Panel’s 

purpose, will not be considered for 

presentations and comments. There will be 

no exceptions to this rule. We appreciate 

your cooperation on this matter. 

We are also requiring electronic 

versions of the written comments and 

presentations, in addition to the 

hardcopies. 

In summary, presenters and/or 

commenters must do the following: 

• Send both electronic and hardcopy 

versions of their presentations and 

written comments by the prescribed 

deadlines. 

• Send electronic transmissions to the 

e-mail address below. 

• Do not send pictures of patients in 

any of the documents unless their faces 

have been blocked out. 

• Do not send documents 

electronically that have been archived. 

• Mail (or send by courier) to the 

Designated Federal Officer (DFO) all 

hardcopies, accompanied by Form 

CMS–20017 (revised 01/07), if they are 

presenting, as specified in the FOR

FURTHER INFORMATION CONTACT section of 

this notice. 

• Commenters are not required to 

send Form CMS–20017 with their 

written comments. 

ADDRESSES: The meeting will be held in 

the Auditorium, CMS Central Office, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

FOR FURTHER INFORMATION CONTACT: For 

further information, contact: Shirl 

Ackerman-Ross, Designated Federal 

Official (DFO), CMS, CMM, HAPG, 

DOC, 7500 Security Boulevard, Mail 

Stop C4–05–17, Baltimore, MD 21244– 

1850. Phone: (410) 786–4474. 

Note: We recommend that you advise 

couriers of the following information: When 

delivering hardcopies of presentations to 

CMS, if no one answers at the above phone 

number, please call (410) 786–4532 or (410) 

786–9316. 

The e-mail address for comments, 

presentations, and registration requests 

is CMS APCPanel@cms.hhs.gov. 

Note: There is NO underscore in this email address; there is a SPACE between CMS 

and APCPanel. 

News media representatives must 

contact our Public Affairs Office at (202) 

690–6145. 

Advisory Committees’ Information 

Lines: The phone numbers for the CMS 

Federal Advisory Committee Hotline are 

1–877–449–5659 (toll free) and (410) 

786–9379 (local). 

Web Sites: Please access the CMS Web 

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

05_AdvisoryPanelonAmbulatory

PaymentClassification

Groups.asp#TopOfPage to obtain the 

following information: 

Note: There is an UNDERSCORE after 

FACA/05(like this_); there is no space. 

• Additional information on the APC 

meeting agenda topics. 

• Updates to the Panel’s activities. 

• Copies of the current Charter. 

• Membership requirements. 

You may also search information 

about the APC Panel and its 

membership in the FACA database at 

the following URL: https:// 

www.fido.gov/facadatabase/public.asp. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Secretary is required by section 

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

(the Act) to consult with an expert, 

outside advisory panel on the clinical 

integrity of the APC groups and weights 

established under the Medicare hospital 

OPPS. 

The APC Panel meets up to three 

times annually. The Charter requires 

that the Panel must be fairly balanced in 

its membership in terms of the points of 

view represented and the functions to 

be performed. The Panel consists of up 

to 15 members who are representatives 

of providers and a Chair. 

Each Panel member must be 

employed full-time by a hospital, 

hospital system, or other Medicare 

provider subject to payment under the 

OPPS. The Secretary or Administrator 

selects the Panel membership based 

upon either self-nominations or 

nominations submitted by Medicare 

providers and other interested 

organizations. 

All members must have technical 

expertise to enable them to participate 

fully in the Panel’s work. Such expertise 

encompasses hospital payment systems; 

hospital medical care delivery systems; 

provider billing systems; APC groups; 

Current Procedural Terminology codes; 

and alpha-numeric Health Care 

Common Procedure Coding System 

codes; and the use of, and payment for, 

drugs, medical devices, and other 

services in the outpatient setting, as 

well as other forms of relevant expertise. 

Details regarding membership 

requirements for the APC Panel are 

found on the FACA and CMS Web sites 

as listed above. 

The Panel presently consists of the 

following members: 

• E.L. Hambrick, M.D., J.D., Chair, 

CMS Medical Officer. 

• Ruth L. Bush, M.D., M.P.H. 

• Dawn L. Francis, M.D., M.H.S. 

• Patrick A. Grusenmeyer, Sc.D., 

F.A.C.H.E. 

• Kathleen Graham, R.N., M.S.H.A., 

C.P.H.Q., A.C.M. 

• David Halsey, M.D. 

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

R.H.I.A., C.C.S. 

• Michael D. Mills, Ph.D. 

• Agatha L. Nolen, D.Ph., M.S., 

F.A.S.H.P. 

• Randall A. Oyer, M.D. 

• Beverly Khnie Philip, M.D. 

• Daniel Pothen, M.S., R.H.I.A., 

C.P.H.I.M.S., C.C.S.-P, C.H.C. 

• Gregory Przybylski, M.D. 

• Russ Ranallo, M.S., B.S. 

• Michael A. Ross, M.D., F.A.C.E.P. 

• Patricia Spencer-Cisek, M.S., 

A.P.R.N.-B.C., A.O.C.N. 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 127 / Friday, July 2, 2010 / Notices 38535 

II. Agenda 

The agenda for the August 2010 

meeting will provide for discussion and 

comment on the following topics as 

designated in the Panel’s Charter: 

• Addressing whether procedures 

within an APC group are similar both 

clinically and in terms of resource use. 

• Evaluating APC group weights. 

• Reviewing the packaging of OPPS 

services and costs, including the 

methodology and the impact on APC 

groups and payment. 

• Removing procedures from the 

inpatient list for payment under the 

OPPS. 

• Using single and multiple 

procedure claims data for CMS’ 

determination of APC group weights. 

• Addressing other technical issues 

concerning APC group structure. 

Note: The subject matter before the Panel 

will be limited to these and related topics. 

Issues related to calculation of the OPPS 

conversion factor, charge compression, passthrough payments, or wage adjustments are 

not within the scope of the Panel’s purpose. 

Therefore, these issues will not be considered 

for presentations and/or comments. There 

will be no exceptions to this rule. We 

appreciate your cooperation on this matter. 

The Panel may use data collected or 

developed by entities and organizations, 

other than the Department of Health and 

Human Services (DHHS) and CMS, in 

conducting its review. We recommend 

organizations to submit data for the 

Panel’s and CMS staff’s review. 

III. Written Comments and Suggested 

Agenda Topics 

Hardcopy and electronic written 

comments and suggested agenda topics 

should be sent to the DFO as specified 

in the ADDRESSES section of this notice. 

The DFO must receive these items by 5 

p.m. (e.d.t.), Monday, August 2, 2010. 

There will be no exceptions. We 

appreciate your cooperation on this 

matter. 

The written comments and suggested 

agenda topics submitted for the August 

2010 APC Panel meeting must fall 

within the subject categories outlined in 

the Panel’s Charter and as listed in the 

Agenda section of this notice. 

IV. Oral Presentations 

Individuals or organizations wishing 

to make 5-minute oral presentations 

must submit hardcopy and electronic 

versions of their presentations to the 

DFO by 5 p.m. (e.d.t.), Monday, August 

2, 2010, for consideration. 

The number of oral presentations may 

be limited by the time available. Oral 

presentations should not exceed 5 

minutes in length for an individual or 

an organization. 

The Chair may further limit time 

allowed for presentations due to the 

number of oral presentations, if 

necessary. Presentation times listed in 

the public agenda are approximate and 

presenters should be prepared to 

present earlier and later than indicated. 

V. Presenter and Presentation 

Information 

All presenters must submit Form 

CMS–20017 (revised 01/07). Hardcopies 

are required for oral presentations; 

however, electronic submissions of 

Form CMS–20017 are optional. The 

DFO must receive the following 

information from those wishing to make 

oral presentations: 

• Form CMS–20017 completed with 

all pertinent information identified on 

the first page of the presentation. 

• One hardcopy of presentation. 

• Electronic copy of presentation. 

• Personal registration information as 

described in the ‘‘Meeting Attendance’’ 

section below. 

• Those persons wishing to submit 

comments only must send hardcopy and 

electronic versions of their comments, 

but they are not required to submit 

Form CMS–20017. 

VI. Collection of Information 

Requirements 

This document does not impose any 

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). 

VII. Oral Comments 

In addition to formal oral 

presentations, there will be opportunity 

during the meeting for public oral 

comments, which will be limited to 1 

minute for each individual and a total 

of 3 minutes per organization. 

VIII. Meeting Attendance 

The meeting is open to the public; 

however, attendance is limited to space 

available. Attendance will be 

determined on a first-come, first-served 

basis. 

Persons wishing to attend this 

meeting, which is located on Federal 

property, must e-mail the DFO to 

register in advance no later than 5 p.m. 

(e.d.t.), Wednesday, August 16, 2010. A 

confirmation will be sent to the 

requester(s) by return e-mail. 

The following personal information 

must be e-mailed to the DFO by the date 

and time above: 

• Name(s) of attendee(s). 

• Title(s). 

• Organization. 

• E-mail address(es). 

• Telephone number(s). 

IX. Security, Building, and Parking 

Guidelines 

The following are the security, 

building, and parking guidelines: 

• Persons attending the meeting 

including presenters must be registered 

and on the attendance list by the 

prescribed date. 

• Individuals who are not registered 

in advance will not be permitted to 

enter the building and will be unable to 

attend the meeting. 

• Attendees must present 

photographic identification to the 

Federal Protective Service or Guard 

Service personnel before entering the 

building. 

• Security measures include 

inspection of vehicles, inside and out, at 

the entrance to the grounds. 

• All persons entering the building 

must pass through a metal detector. 

• All items brought into CMS 

including personal items, such as 

laptops, cell phones, and palm pilots, 

are subject to physical inspection. 

• The public may enter the building 

30 to 45 minutes before the meeting 

convenes each day. 

• All visitors must be escorted in 

areas other than the lower and first-floor 

levels in the Central Building. 

• The main-entrance guards will 

issue parking permits and instructions 

upon arrival at the building. 

X. Special Accommodations 

Individuals requiring sign-language 

interpretation or other special 

accommodations must send a request 

for these services to the DFO by 5 p.m. 

(e.d.t.), Monday, August 16, 2010. 

XI. Panel Recommendations and 

Discussions 

The Panel’s recommendations at any 

APC Panel meeting generally are not 

final until they have been reviewed and 

approved by the Panel on the last day 

prior to final adjournment. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: June 18, 2010. 

Marilyn Tavenner, 

Acting Administrator and Chief Operating 

Officer, Centers for Medicare & Medicaid 

Services. 

[FR Doc. 2010–16163 Filed 6–30–10; 4:15 pm] 

BILLING CODE 4120–01–P 


emcdonald on DSK2BSOYB1PROD with NOTICES