68944 Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Notices 

In addition, if the cost incurred by the 

intermediary, RHHI, carrier, or DMEPOS 

regional carrier to meet its contractual 

requirements exceeds the amount that 

we find to be reasonable and adequate 

to meet the cost that must be incurred 

by an efficiently and economically 

operated intermediary or carrier, these 

high costs may also be grounds for 

adverse action. 

IX. Collection of Information 

Requirements 

This document does not impose 

information collection and record 

keeping requirements. Consequently the 

Office of Management and Budget need 

not review it under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

X. Response to Comments 

Because of the large number of items 

of correspondence we normally receive 

on Federal Register documents 

published for comment, we are unable 

to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the Comment Period

section of this preamble, and, if we 

proceed with a subsequent document, 

we will respond to the comments in the 

preamble of that document. 

XI. Regulatory Impact Statement 

We have examined the impacts of this 

notice as required by Executive Order 

12866 (September 1993, Regulatory 

Planning and Review), the Regulatory 

Flexibility Act (RFA) (September 16, 

1980, Pub. L. 96–354), section 1102(b) of 

the Act, the Unfunded Mandates Reform 

Act of 1995 (Pub. L. 104–4), and 

Executive Order 13132. 

Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

if regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety effects, distributive impacts, 

and equity). A regulatory impact 

analysis (RIA) must be prepared for 

major rules with economically 

significant effects ($100 million in any 

one year). Since this notice only 

describes criteria and standards for 

evaluating FIs (including RHHIs), 

carriers, and DMEPOS regional carriers 

and has no significant economic impact 

on the program, its beneficiaries, 

providers or suppliers, this is not a 

major notice. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

businesses, but intermediaries, RHHIs, 

carriers and DMEPOS regional carriers 

are not small businesses. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule may have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. This notice does not affect 

small rural hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies assess anticipated costs 

and benefits before issuing any rule that 

may result in expenditure in any 1 year 

by State, local, or tribal governments, in 

the aggregate, or by the private sector, of 

$110 million. In accordance with 

section 202, we have determined that 

the notice does not impose any 

unfunded mandates on States, local or 

tribal governments, or on the private 

sector. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a notice 

that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has federalism implications. 

We have determined that the notice 

does not significantly affect the rights, 

roles, and responsibilities of States. 

We have not prepared a Regulatory 

Impact Analysis for this notice, in 

accordance with Executive Order 12866, 

because it will not have a significant 

economic impact, nor does it impose 

any unfunded mandates on State, local, 

or tribal governments or the private 

sector. Furthermore, we certify that the 

notice will not have a significant impact 

on a substantial number of small entities 

or small rural hospitals. 

In accordance with the provisions of 

Executive Order 12866, this notice was 

reviewed by the Office of Management 

and Budget.

Authority: Sections 1816(f), 1834(a)(12), 

and 1842(b) of the Social Security Act (42 

U.S.C. 1395h(f), 1395m(a)(12), and 1395u(b))

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance, and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program)

Dated: May 27, 2004. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services.

Editorial Note: This document was 

recieved at the Office of the Federal Register 

on November 23, 2004.

[FR Doc. 04–26278 Filed 11–24–04; 8:45 am] 

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3149–N] 

Medicare Program; Meeting of the 

Medicare Coverage Advisory 

Committee—January 25, 2005

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS.

ACTION: Notice.

SUMMARY: This notice announces a 

public meeting of the Medicare 

Coverage Advisory Committee (MCAC). 

The Committee 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 the data from 

and the quality of clinical evidence 

pertaining to the effects of lifestyle 

modification such as diet, exercise, 

stress reduction and group counseling 

as it relates to reversal or resolution of 

diseases such as coronary heart disease 

and diabetes. Notice of this meeting is 

given under the Federal Advisory 

Committee Act (5 U.S.C. App. 2, section 

10(a)).

DATES: The public meeting will be held 

on Tuesday, January 25, 2005, from 7:30 

a.m. until 4:30 p.m. e.s.t. 

Deadline for Presentations and 

Comments: Written comments and 

presentations must be received by 

December 27, 2005, 5 p.m., e.s.t.

ADDRESSES: The meeting will be held in 

the auditorium at the Centers for 

Medicare & Medicaid Services, 7500 

Security Blvd, Baltimore, MD 21244. 

Presentations and Comments:

Interested persons may present data, 

information, or views orally or in 

writing on issues pending before the 

Committee. Please submit written 

comments to Michelle Atkinson, by email at Matkinson@cms.hhs.gov or by 

mail to the Executive Secretary for 

MCAC, Coverage and Analysis Group, 

Office of Clinical Standards and 

Quality, Centers for Medicare & 

Medicaid Services, 7500 Security 

Boulevard, Mail Stop C1–09–06, 

Baltimore, MD 21244. 

Web site: You may access up-to-date 

information on this meeting at http://

www.cms.hhs.gov/mcac/

default.asp#meetings.

Hotline: You may access up-to-date 

information on this meeting on the CMS 

Advisory Committee Information 

Hotline, 1–877–449–5659 (toll free) or 

in the Baltimore area (410) 786–9379.

Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Notices 68945

FOR FURTHER INFORMATION CONTACT:

Michelle Atkinson, Executive Secretary, 

by telephone at 410–786–2881 or by email at Matkinson@cms.hhs.gov.

SUPPLEMENTARY INFORMATION: 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 us about clinical 

issues. This notice announces a public 

meeting of the Committee. 

Meeting Topic: The Committee will 

address the data from and the quality of 

clinical evidence pertaining to the 

effects of lifestyle modification such as 

diet, exercise, stress reduction and 

group counseling as it relates to reversal 

or resolution of diseases such as 

coronary heart disease and diabetes. 

Background information about this 

topic, including panel materials, is 

available on the Internet at http://

www.cms.hhs.gov/coverage/.

Procedure: 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 named in the 

FOR FURTHER INFORMATION CONTACT

section and submit the following by the 

Deadline for Presentations and 

Comments date listed in the DATES

section of this notice: a brief statement 

of the general nature of the evidence or 

arguments you wish to present, and the 

names and addresses of proposed 

participants. A written copy of your 

presentation must be provided to each 

Committee member before offering your 

public comments. Your presentation 

must address the questions asked by us 

to the Committee. The questions will be 

available on our Web site at http://

www.cms.hhs.gov/mcac/

default.asp#meetings. If the specific 

questions are not addressed, your 

presentation will not be accepted. We 

request that you declare at the meeting 

whether or not 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. 

Registration Instructions 

The Coverage and Analysis Group is 

coordinating meeting registration. While 

there is no registration fee, individuals 

must register to attend. You may register 

by contacting Maria Ellis at 410–786–

0309, mailing address: Coverage and 

Analysis Group, OCSQ; Centers for 

Medicare & Medicaid Services; 7500 

Security Blvd, Mailstop: C1–09–06; 

Baltimore, MD 21244, or by e-mail at 

Mellis@cms.hhs.gov. Please provide 

your name, address, organization, 

telephone and fax number, and e-mail 

address. 

You will receive a registration 

confirmation with instructions for your 

arrival at the CMS complex. You will be 

notified if the seating capacity has been 

reached. 

Because the meeting is located on 

Federal property, for security reasons, 

any persons wishing to attend this 

meeting must register by close of 

business on January 17, 2005. In order 

to gain access to the building and 

grounds, participants must show to the 

Federal Protective Service or guard 

service personnel, government-issued 

photo identification and a copy of their 

registration confirmation. Individuals 

who have not registered in advance will 

not be allowed to enter the building to 

attend the meeting. 

Special Accommodations: Persons 

attending the meeting who are hearing 

or visually impaired, or have a 

condition that requires special 

assistance or accommodations, are 

asked to notify the Executive Secretary 

by January 3, 2005 (see FOR FURTHER

INFORMATION CONTACT).

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

(Catalog of Federal Domestic Assistance 

Program No. 93.774, Medicare—

Supplementary Medical Insurance Program)

Dated: November 17, 2004. 

Sean R. Tunis, 

Director, Office of Clinical Standards and 

Quality, Centers for Medicare & Medicaid 

Services.

[FR Doc. 04–26173 Filed 11–24–04; 8:45 am] 

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

Industry Exchange Workshop on Food 

and Drug Administration Clinical Trial 

Requirements; Public Workshop

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice of public workshop.

SUMMARY: The Food and Drug 

Administration (FDA) Pacific Region, in 

cooperation with the Society of Clinical 

Research Associates (SoCRA), is 

announcing a workshop on FDA 

Clinical trial statutory and regulatory 

requirements. Topics for discussion 

include: Pre-IND (investigational new 

drug application) meetings and FDA 

meeting process, medical device, drug 

and biological product aspects of 

clinical research, investigator initiated 

research, informed consent 

requirements, adverse event reporting, 

how FDA conducts bioresearch 

inspections, ethics in subject 

enrollment, FDA regulation of 

Institutional Review Boards, FDA and 

confidence in the conduct of clinical 

research, and what happens after the 

FDA inspection. This 2-day workshop 

for the clinical research community 

targets sponsors, monitors, clinical 

investigators, institutional review 

boards, and those who interact with 

them for the purpose of conducting FDA 

regulated clinical research. The 

workshop will include both industry 

and FDA perspectives on proper 

conduct of clinical trials regulated by 

FDA.

Date and Time: The public workshop 

is scheduled for Wednesday, January 12, 

2005, from 8:15 a.m. to 4:15 p.m. and 

Thursday, January 13, 2005, from 8:15 

a.m. to 4 p.m.

Location: The public workshop will 

be held at the Holiday Inn Fisherman’s 

Wharf, 1300 Columbus Ave., San 

Francisco, CA 94133, 415–771–9000, 

FAX: 415–771–7006.

Contact: Marcia Madrigal, Small 

Business Representative, FDA, 1301 

Clay St., suite 1180–N, Oakland, CA 

94612–5217, FAX: 510–637–3977, email: marcia.madrigal@fda.gov.

Registration: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number) and the registration fee of $485 

(member) or $560 (nonmember), $460 

(government employee nonmember) 

(includes a 1 year membership). The 

registration fee for FDA employees is 

waived. Make the registration fee 

payable to SoCRA, P.O. Box 101,