17354 Federal Register / Vol. 73, No. 63 / Tuesday, April 1, 2008 / Notices 

Deadline for Submitting a Request for 

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 contact the Executive Secretary 

as specified in the FOR FURTHER

INFORMATION CONTACT section of this 

notice no later than 5 p.m., d.s.t. Friday, 

May 9, 2008. 

ADDRESSES: Meeting Location: The 

meeting will be held in the main 

auditorium of the Centers for Medicare 

& Medicaid Services, 7500 Security 

Blvd., Baltimore, MD 21244. 

Submission of Presentations and 

Comments: Presentation materials and 

written comments that will be presented 

at the meeting must be submitted via email to 

MedCACpresentations@cms.hhs.gov or 

by regular mail to the contact listed in 

the FOR FURTHER INFORMATION CONTACT

section of this notice by the date 

specified in the DATES section of this 

notice. 

FOR FURTHER INFORMATION CONTACT: 

Maria Ellis, 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 or contact Ms. Ellis by phone 

(410–786–0309) or via e-mail at 

Maria.Ellis@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

MedCAC, formerly known as the 

Medicare Coverage Advisory Committee 

(MCAC), provides advice and 

recommendations to CMS regarding 

clinical issues. (For more information 

on MCAC, see the December 14, 1998 

Federal Register (63 FR 68780).) This 

notice announces the May 21, 2008, 

public meeting of the Committee. 

During this meeting, the Committee will 

discuss the desirable characteristics of 

research trials in neurorehabilitation. 

Due to the broad nature of this topic, the 

Committee will focus on the key 

questions of clinical trial design, 

methodology and analysis in the context 

of stroke rehabilitation. Background 

information about this topic, including 

panel materials, will become available 

at http://www.cms.hhs.gov/coverage. 

II. Meeting Format 

This meeting is open to the public. 

The Committee will hear oral 

presentations from the public for 

approximately 30 minutes. The 

Committee may limit the number and 

duration of oral presentations to the 

time available. Your comments should 

focus on issues specific to the list of 

topics that we have proposed to the 

Committee. The list of research topics to 

be discussed at the meeting will be 

available on the following Web site 

prior to the meeting: http:// 

www.cms.hhs.gov/mcd/ 

index_list.asp?list_type=mcac. 

We require that you declare at the 

meeting whether you have any financial 

involvement with manufacturers (or 

their competitors) of any items or 

services being discussed. 

The Committee will deliberate openly 

on the topics under consideration. 

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 topics 

under consideration. At the conclusion 

of the day, the members will vote and 

the Committee will make its 

recommendation(s) to CMS. 

III. Registration Instructions 

CMS’ Coverage and Analysis Group is 

coordinating the meeting registration. 

While there is no registration fee, 

individuals must register to attend. You 

may register by contacting the person 

listed in the FOR FURTHER INFORMATION

CONTACT section of this notice by the 

deadline listed in the DATES section of 

this notice. 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 or you will 

be notified the seating capacity has been 

reached. 

IV. Security, Building, and Parking 

Guidelines 

This meeting will be held in a Federal 

government building; therefore, Federal 

security measures are applicable. We 

recommend that confirmed registrants 

arrive reasonably early, but no earlier 

than 45 minutes prior to the start of the 

meeting, to allow additional time to 

clear security. Security measures 

include the following: 

• Presentation of government-issued 

photographic identification to the 

Federal Protective Service or Guard 

Service personnel. 

• Inspection of vehicle’s interior and 

exterior (this includes engine and trunk 

inspection) at the entrance to the 

grounds. Parking permits and 

instructions will be issued after the 

vehicle inspection. 

• Inspection, via metal detector or 

other applicable means of all persons 

brought entering the building. We note 

that all items brought into CMS, 

whether personal or for the purpose of 

presentation or to support a 

presentation, 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 

presentation or to support a 

presentation. 

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 30 to 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. 

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

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: March 14, 2008. 

Barry M. Straube, 

Chief Medical Officer and Director, Office 

of Clinical Standards and Quality, Centers 

for Medicare & Medicaid Services. 

[FR Doc. E8–5882 Filed 3–31–08; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

The Essentials of Food and Drug 

Administration Medical Device 

Regulations: A Primer for 

Manufacturers and Suppliers; Public 

Seminar 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public seminar. 

SUMMARY: The Food and Drug 

Administration’s (FDA’s) Center for 

Devices and Radiological Health and 

Office of Regulatory Affairs, in 

cooperation with AdvaMed’s Medical 

Technology Learning Institute, is 

announcing a series of three seminars 

on FDA medical device regulations. 

These 2-day seminars, which are 

designed to address the training needs 

of startup and small device 

manufacturers and their suppliers, will 

include both industry and FDA 

perspectives and a question and answer 

period. 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 73, No. 63 / Tuesday, April 1, 2008 / Notices 17355 

1FDA has verified the Web site addresses, but 

FDA is not responsible for any subsequent changes 

to the Web sites after this document publishes in 

the Federal Register. 

Dates: The seminars are planned for 

the following dates: 

1. April 8 and 9, 2008, in Rosemont, 

IL 60018. Details about dates are posted 

on AdvaMed’s Web site at: 

www.Advamedmtli.org/Chicago.1

2. May 13 and 14, 2008, Bethesda, MD 

20852. Details about dates are posted on 

AdvaMed’s Web site at 

www.Advamedmtli.org/Bethesda. 

3. June 17 and 18, 2008, Queens, NY. 

Details about dates are posted on 

AdvaMed’s Web site at: 

www.Advamedmtli.org/New York. 

Locations: The seminars are planned 

for the following locations: 

1. April 8 and 9, 2008, Westin O’Hare, 

6100 North River Rd., Rosemont, IL 

60018. Details about location sites are 

posted on AdvaMed’s Web site at: 

www.Advamedmtli.org/Chicago. 

2. May 13 and 14, 2008, Marriott 

Bethesda North Conference Center, 

White Flint Auditorium, 5101 Marinelli 

Rd., North Bethesda, MD 20852. Details 

about location sites are posted on 

AdvaMed’s Web site at: 

www.advamedmtli.org/Bethesda. 

3. June 17 and 18, 2008, Crowne Plaza 

New York-LaGuardia, 104–04–Ditmars 

Blvd., East Elmhurst, NY 11369. Details 

about location sites are posted on 

AdvaMed’s Web site at: 

www.advamedmtli.org/NewYork. 

Contact: For FDA: William Sutton, 

Division of Small Manufacturers, 

International and Consumer Assistance, 

Center for Devices and Radiological 

Health (HFZ–220), 1350 Piccard Dr., 

Rockville, MD 20850, 800–638–2041, 

ext. 125, FAX: 240–276–3151, e-mail: 

William.sutton@fda.hhs.gov. 

For AdvaMed: Veronica Allen, 202–

434–7231, FAX: 202–783–8750, e-mail: 

VAllen@AdvaMed.org. 

Registration: The registration fee for a 

limited number of FDA employees is 

waived. Send registration information 

(including name, title, firm name, 

address, telephone, and fax number) 

and the registration fee of $525 per 

person to AdvaMed, contact Veronica 

Allen, 202–434–7231, FAX: 202–783–

8750. Payment forms accepted are major 

credit card (MasterCard, Visa, or 

American Express) or company check. If 

you wish to pay by check, contact 

Veronica Allen at 

VAllen@Advamed.org. 

To register via the Internet, go to 

www.AdvaMed.org. The latest 

information on dates/venue sites will be 

posted on this Web site at: 

www.advamedmtli.org/Chicago, 

www.admedmtli.org/Bethesda, and 

www.advamedmtli.org/NewYork (FDA 

has verified the Web site addresses, but 

is not responsible for changes to the 

Web sites after this document publishes 

in the Federal Register). 

For more information on the meeting, 

or for questions on registration, contact 

Veronica Allen (see Contact). 

Attendees are responsible for their 

own accommodations. For further hotel 

information and driving directions, go 

to the registration Web site. 

The registration fee will be used to 

offset the expenses of hosting the 

conference, including meals (breakfast 

and a lunch), refreshments, meeting 

rooms, and training materials. It also 

includes a networking reception on the 

evening of the first day of each seminar. 

Space is limited; therefore, interested 

parties are encouraged to register early. 

There will be no onsite registration. 

If you need special accommodations 

due to a disability, please contact 

Veronica Allen (see Contact) at 

AdvaMed as soon as possible. 

SUPPLEMENTARY INFORMATION: The 

‘‘Essentials of FDA Medical Device 

Regulations: A Primer for Manufacturers 

and Suppliers’’ seminar helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health by educating 

new entrepreneurs on the essentials of 

FDA device regulations. FDA has made 

education of the medical device 

community a high priority to assure the 

quality of products reaching the 

marketplace and to increase the rate of 

voluntary industry compliance with 

regulations. 

The seminar helps to implement the 

objectives of section 903 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

393) and the FDA Plan for Statutory 

Compliance, which includes working 

more closely with stakeholders and 

ensuring access to needed scientific and 

technical expertise. The seminar also 

furthers the goals of the Small Business 

Regulatory Enforcement Fairness Act 

(Public Law 104–121) by providing 

outreach activities by Government 

agencies directed at small businesses. 

The following topics, as well as 

others, will be discussed at the seminar: 

• Doing business in a regulated 

industry; 

• Organizational structure of FDA; 

• Overview of the quality system 

regulation; 

• Design controls; 

• Documents, records, and change 

control; 

• Purchasing controls and acceptance 

activities; 

• Production and process control; 

• Corrective and preventive actions; 

• Complaints, medical device reports, 

corrections, and recalls; 

• Compliance issues; 

• Management responsibility; 

• Interacting with FDA—Where do 

you go for assistance? 

• General question and answer 

session; 

• Manufacturers and suppliers—the 

chain regulatory responsibility; 

• Reimbursement of medical 

technology; 

• The AdvaMed code of ethics; and 

• Fraud and abuse. 

Dated: March 27, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. 08–1085 Filed 3–28–08; 11:48 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Tribal Management Grant Program 

Announcement Type: New and 

Competing Continuation Discretionary 

Funding Cycle for Fiscal Year 2009. 

Funding Announcement Number: 

HHS–2009–IHS–TMD–0001. 

Catalog of Federal Domestic 

Assistance Numbers(s): 93.228. 

Key Dates: Training: Application 

Requirements Session: April 30–May 1, 

May 14–15, and June 11–12, 2008. 

Grant Writing Session: June 23–27, 

2008. 

Application Deadline Date: August 1, 

2008. 

Receipt Date for Final Tribal 

Resolution: October 3, 2008. 

Review Date: October 6–10, 2008. 

Application Notification Date: 

November 12, 2008. 

Earliest Anticipated Start Date: 

January 1, 2009. 

I. Funding Opportunity Description 

The Indian Health Service (IHS) 

announces competitive grant 

applications for the Tribal Management 

Grant (TMG) Program. This program is 

authorized under Section 103(b)(2) and 

Section 103(e) of the Indian SelfDetermination and Education 

Assistance Act, Public Law 93–638, as 

amended. This program is described at 

93.228 in the Catalog of Federal 

Domestic Assistance (CFDA). 

The TMG Program is a national 

competitive discretionary grant program 

pursuant to 45 CFR part 75 and 45 CFR 

part 92 established to assist Federallyrecognized Tribes and Triballymstockstill on PROD1PC66 with NOTICES