Federal Register / Vol. 72, No. 101 / Friday, May 25, 2007 / Notices 29331 

summary will list other comments 

received on or before 15 days after the 

meeting, or August 1, 2007. The 

summary will also display CMS’

tentative payment determinations, and 

interested individuals may submit 

written comments on the tentative 

payment determinations by September 

21, 2007 to the address specified in the 

summary. 

III. Registration Instructions 

We are coordinating the public 

meeting registration. Beginning June 18, 

2007 registration may be completed online at http://www.cms.hhs.gov/ 

ClinicalLabFeeSched. The following 

information must be submitted when 

registering: Name; company name; 

address; telephone number(s); and Email address(es). 

When registering, individuals who 

want to make a presentation must also 

specify which new clinical laboratory 

test code(s) they will be presenting. A 

confirmation will be sent upon receipt 

of the registration. 

Registration Deadline: Individuals 

must register by July 11, 2007. 

IV. Security, Building, and Parking 

Guidelines 

The 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. In order to gain access to 

the building and grounds, participants 

must bring a government-issued photo 

identification and a copy of your written 

meeting registration confirmation. 

Persons without proper identification 

may be denied access to the building. 

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 30 to 45 

minutes prior to the convening of the 

meeting. 

Security measures also 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, whether personal or for 

the purpose of demonstration or to 

support a presentation, are subject to 

inspection. 

V. Special Accommodations 

Individuals attending a meeting who 

are hearing or visually impaired and 

have special requirements, or a 

condition that requires special 

assistance, should provide the 

information upon registering for the 

meeting. 

Authority: Section 1102, 1833(h), and 1871 

of the Social Security Act (42 U.S.C. 1302, 42 

U.S.C. 13951, and 42 U.S.C. 1395hh) 

(Catalog of Federal Domestic Assistance 

Program No. 93.774, Medicare—

Supplementary Medical Insurance Program) 

Dated: March 22, 2007. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E7–9525 Filed 5–24–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3172–N] 

Medicare Program; Meeting of the 

Medicare Coverage Advisory 

Committee—July 18, 2007 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces a 

public meeting of the Medicare 

Evidence Development Coverage 

Advisory Committee (MedCAC or 

Committee), formerly the Medicare 

Coverage Advisory Committee (MCAC). 

The Committee generally provides 

advice and recommendations about 

whether scientific evidence is adequate 

to determine whether certain medical 

items and services are reasonable and 

necessary under the Medicare statute. 

This meeting concerns percutaneous 

transluminal angioplasty (PTA) and 

stenting of the renal arteries. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. App. 2, section 10(a)). 

DATES: Meeting Date: The public 

meeting will be held on Wednesday, 

July 18, 2007 from 7:30 a.m. until 4:30 

p.m., eastern daylight time (e.d.t.). 

Deadlines for Registration and 

Request for Special Accommodations: 

Registration must be completed no later 

than 5 p.m., e.d.t. on Monday, July 9, 

2007. Request for special 

accommodations must be received by 5 

p.m., e.d.t. Tuesday, July 10, 2007. 

Deadlines for Written Comments and 

Presentations: Written comments and 

presentations must be received by June 

18, 2007, 5 p.m., e.d.t. Presentations, 

once submitted, are final. No further 

changes to the presentation can be 

accepted after submission. 

ADDRESSES: Meeting Location: The 

meeting will be held in the main 

auditorium of the Centers for Medicare 

& Medicaid Services, 7500 Security 

Boulevard, Baltimore, MD 21244. 

Presentation and Comment 

Submission: Interested persons may 

present data, information, or views 

orally or in writing on issues pending 

before the Committee. Presentation and 

written comments must be submitted by 

e-mail to 

Michelle.Atkinson@cms.hhs.gov or by 

regular mail to Michelle Atkinson, 

Executive Secretary for MedCAC, 

Centers for Medicare & Medicaid 

Services, Office of Clinical Standards 

and Quality, Coverage and Analysis 

Group, C1–09–06, 7500 Security 

Boulevard, Baltimore, MD 21244. 

Registration and Special 

Accommodations: Individuals wishing 

to participate or who need special 

accommodations, or both, may register 

by phone or e-mail by contacting Maria 

Ellis at 410–786–0309 or 

Maria.Ellis@cms.hhs.gov no later than 5 

p.m., e.d.t on Monday, July 9, 2007. 

Persons attending the meeting who are 

hearing or visually impaired, or have a 

condition that requires special 

assistance or accommodations, are 

asked to contact Michelle Atkinson, 

Executive Secretary for MedCAC, no 

later than July 9, 2007. 

Web site: You may access up-to-date 

information on this meeting at http:// 

www.cms.hhs.gov/FACA/ 

02_MCAC.asp#TopOfPage. 

FOR FURTHER INFORMATION CONTACT: 

Michelle Atkinson, Executive Secretary 

for MedCAC, 410–786–2881; 

Michelle.Atkinson@cms.hhs.gov; 

Centers for Medicare & Medicaid 

Services, OCSQ—Coverage and Analysis 

Group, C1–09–06, 7500 Security 

Boulevard, Baltimore, MD 21244). 

SUPPLEMENTARY INFORMATION: 

I. Background 

On December 14, 1998, we published 

a notice in the Federal Register (63 FR 

68780) to describe the Medicare 

Coverage Advisory Committee (MCAC), 

which provides advice and 

recommendations to CMS about clinical 

issues. 

This notice announces the July 18, 

2007 public meeting of the Committee. 

During this meeting, the Committee will 

discuss evidence and hear presentations 

from the public concerning the use of 

PTA and stenting of the renal arteries 

for the treatment of atherosclerotic renal 

artery stenosis (ARAS). The clinical 

outcomes in the Medicare population 

will be discussed. MedCAC will review 

the following kinds of evidence: 

• The most informative measures of 

clinical outcomes. 

• Indications. 


jlentini on PROD1PC65 with NOTICES
29332 Federal Register / Vol. 72, No. 101 / Friday, May 25, 2007 / Notices 

• Clinical outcomes for the different 

treatment options. 

• Complications. 

• Harms and adverse events. 

• Persistence of benefits and harms 

over time. 

• Generalizability to the Medicare 

population in routine practice. 

In addition to evaluating the available 

data, the Committee will identify areas 

in which the current data are deficient 

and in which additional research is 

warranted. Background information 

about this topic, including panel 

materials, is available at http:// 

www.cms.hhs.gov/coverage. 

II. Meeting Procedures 

This meeting is open to the public. 

The Committee will hear oral 

presentations from the public for 

approximately 45 minutes. The 

Committee may limit the number and 

duration of oral presentations to the 

time available. If you wish to make 

formal presentations, you must notify 

the Executive Secretary for MCAC (see 

FOR FURTHER INFORMATION CONTACT) and 

submit the following to the address 

listed in the ADDRESSES section of this 

notice by the date listed in the DATES

section of this notice: (1) A brief 

statement of the general nature of the 

evidence or arguments you wish to 

present; (2) the names and addresses of 

proposed participants; and (3) a written 

copy of your presentation. Your 

presentation should consider the 

questions we have posed to the 

Committee and focus on the issues 

specific to the topic. 

The questions will be available on the 

following Web site: http:// 

www.cms.hhs.gov/FACA/ 

02_MCAC.asp#TopOfPage We require 

that you declare at the meeting whether 

you have any financial involvement 

with manufacturers of any items or 

services being discussed (or with their 

competitors). 

After the public and CMS 

presentations, the Committee will 

deliberate openly on the topic. 

Interested persons may observe the 

deliberations, but the Committee will 

not hear further comments during this 

time except at the request of the 

chairperson. The Committee will also 

allow a 15 minute unscheduled open 

public session for any attendee to 

address issues specific to the topic. At 

the conclusion of the day, the members 

will vote and the Committee will make 

its recommendation. 

III. Registration Instructions 

The Coverage and Analysis Group is 

coordinating meeting registration. While 

there is no registration fee, individuals 

must register to attend. Register by 

contacting Maria Ellis by phone or 

e-mail as specified in the ADDRESSES

section. Please provide your full name 

(as it appears on your State-issued 

driver’s license), address, organization, 

telephone, fax number(s), and e-mail 

address. You will receive a registration 

confirmation with instructions for your 

arrival at the CMS complex. 

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 dates 

specified in the DATES section. 

Individuals who have not registered in 

advance will not be allowed to enter the 

building to attend the meeting. 

The on-site check-in for visitors will 

begin at 7 a.m. Please allow sufficient 

time to go through the security 

checkpoints at both the entrance to the 

grounds and the entrance to the 

building. 

Security measures also include a full 

inspection of vehicles, inside and 

exterior areas (rear, trunk, and engine) at 

the entrance to the grounds. In addition, 

all individuals entering the building 

must pass through a metal detector. All 

items brought to CMS, whether personal 

or for the purpose of or support of 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 a 

demonstration or to support a 

demonstration. 

Parking permits and instructions will 

be issued upon arrival. 

Authority: 5 U.S.C. App. 2, section 10(a). 

Dated: May 8, 2007. 

Barry M. Straube, 

Chief Medical Officer and Director, Office 

of Clinical Standards and Quality. 

[FR Doc. E7–9780 Filed 5–24–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0200] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Health and Diet 

Survey 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

FDA’s Health and Diet Survey. 

DATES: Submit written or electronic 

comments on the collection of 

information by July 24, 2007. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 


jlentini on PROD1PC65 with NOTICES