Sei sulla pagina 1di 2

17354 Federal Register / Vol. 73, No.

63 / Tuesday, April 1, 2008 / Notices

Deadline for Submitting a Request for time available. Your comments should • Inspection, via metal detector or
Special Accommodations: Persons focus on issues specific to the list of other applicable means of all persons
attending the meeting who are hearing topics that we have proposed to the brought entering the building. We note
or visually impaired, or have a Committee. The list of research topics to that all items brought into CMS,
condition that requires special be discussed at the meeting will be whether personal or for the purpose of
assistance or accommodations, are available on the following Web site presentation or to support a
asked to contact the Executive Secretary prior to the meeting: http:// presentation, are subject to inspection.
as specified in the FOR FURTHER www.cms.hhs.gov/mcd/ We cannot assume responsibility for
INFORMATION CONTACT section of this index_list.asp?list_type=mcac. coordinating the receipt, transfer,
notice no later than 5 p.m., d.s.t. Friday, We require that you declare at the transport, storage, set-up, safety, or
May 9, 2008. meeting whether you have any financial timely arrival of any personal
ADDRESSES: Meeting Location: The involvement with manufacturers (or belongings or items used for
meeting will be held in the main their competitors) of any items or presentation or to support a
auditorium of the Centers for Medicare services being discussed. presentation.
& Medicaid Services, 7500 Security The Committee will deliberate openly
Note: Individuals who are not registered in
Blvd., Baltimore, MD 21244. on the topics under consideration. advance will not be permitted to enter the
Submission of Presentations and Interested persons may observe the building and will be unable to attend the
Comments: Presentation materials and deliberations, but the Committee will meeting. The public may not enter the
written comments that will be presented not hear further comments during this building earlier than 30 to 45 minutes prior
at the meeting must be submitted via e- time except at the request of the to the convening of the meeting. All visitors
mail to chairperson. The Committee will also must be escorted in areas other than the
MedCACpresentations@cms.hhs.gov or allow a 15-minute unscheduled open lower and first floor levels in the Central
public session for any attendee to Building.
by regular mail to the contact listed in
the FOR FURTHER INFORMATION CONTACT address issues specific to the topics Authority: 5 U.S.C. App. 2, section 10(a).
section of this notice by the date under consideration. At the conclusion
of the day, the members will vote and (Catalog of Federal Domestic Assistance
specified in the DATES section of this Program No. 93.773, Medicare—Hospital
notice. the Committee will make its
Insurance; and Program No. 93.774,
recommendation(s) to CMS. Medicare—Supplementary Medical
FOR FURTHER INFORMATION CONTACT:
Maria Ellis, Executive Secretary for III. Registration Instructions Insurance Program)
MedCAC, Centers for Medicare & CMS’ Coverage and Analysis Group is Dated: March 14, 2008.
Medicaid Services, Office of Clinical coordinating the meeting registration. Barry M. Straube,
Standards and Quality, Coverage and While there is no registration fee, Chief Medical Officer and Director, Office
Analysis Group, C1–09–06, 7500 individuals must register to attend. You of Clinical Standards and Quality, Centers
Security Boulevard, Baltimore, MD may register by contacting the person for Medicare & Medicaid Services.
21244 or contact Ms. Ellis by phone listed in the FOR FURTHER INFORMATION [FR Doc. E8–5882 Filed 3–31–08; 8:45 am]
(410–786–0309) or via e-mail at CONTACT section of this notice by the BILLING CODE 4120–01–P
Maria.Ellis@cms.hhs.gov. deadline listed in the DATES section of
SUPPLEMENTARY INFORMATION: this notice. Please provide your full
name (as it appears on your state-issued DEPARTMENT OF HEALTH AND
I. Background HUMAN SERVICES
driver’s license), address, organization,
MedCAC, formerly known as the telephone, fax number(s), and e-mail
Medicare Coverage Advisory Committee address. You will receive a registration Food and Drug Administration
(MCAC), provides advice and confirmation with instructions for your
recommendations to CMS regarding The Essentials of Food and Drug
arrival at the CMS complex or you will
clinical issues. (For more information Administration Medical Device
be notified the seating capacity has been
on MCAC, see the December 14, 1998 Regulations: A Primer for
reached.
Federal Register (63 FR 68780).) This Manufacturers and Suppliers; Public
notice announces the May 21, 2008, IV. Security, Building, and Parking Seminar
public meeting of the Committee. Guidelines
AGENCY: Food and Drug Administration,
During this meeting, the Committee will This meeting will be held in a Federal
HHS.
discuss the desirable characteristics of government building; therefore, Federal
research trials in neurorehabilitation. security measures are applicable. We ACTION: Notice of public seminar.
Due to the broad nature of this topic, the recommend that confirmed registrants
Committee will focus on the key arrive reasonably early, but no earlier SUMMARY: The Food and Drug
questions of clinical trial design, than 45 minutes prior to the start of the Administration’s (FDA’s) Center for
methodology and analysis in the context meeting, to allow additional time to Devices and Radiological Health and
of stroke rehabilitation. Background clear security. Security measures Office of Regulatory Affairs, in
information about this topic, including include the following: cooperation with AdvaMed’s Medical
panel materials, will become available • Presentation of government-issued Technology Learning Institute, is
at http://www.cms.hhs.gov/coverage. photographic identification to the announcing a series of three seminars
Federal Protective Service or Guard on FDA medical device regulations.
II. Meeting Format Service personnel. These 2-day seminars, which are
mstockstill on PROD1PC66 with NOTICES

This meeting is open to the public. • Inspection of vehicle’s interior and designed to address the training needs
The Committee will hear oral exterior (this includes engine and trunk of startup and small device
presentations from the public for inspection) at the entrance to the manufacturers and their suppliers, will
approximately 30 minutes. The grounds. Parking permits and include both industry and FDA
Committee may limit the number and instructions will be issued after the perspectives and a question and answer
duration of oral presentations to the vehicle inspection. period.

VerDate Aug<31>2005 16:40 Mar 31, 2008 Jkt 214001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\01APN1.SGM 01APN1
Federal Register / Vol. 73, No. 63 / Tuesday, April 1, 2008 / Notices 17355

Dates: The seminars are planned for www.admedmtli.org/Bethesda, and • Corrective and preventive actions;
the following dates: www.advamedmtli.org/NewYork (FDA • Complaints, medical device reports,
1. April 8 and 9, 2008, in Rosemont, has verified the Web site addresses, but corrections, and recalls;
IL 60018. Details about dates are posted is not responsible for changes to the • Compliance issues;
on AdvaMed’s Web site at: Web sites after this document publishes • Management responsibility;
www.Advamedmtli.org/Chicago.1 in the Federal Register). • Interacting with FDA—Where do
2. May 13 and 14, 2008, Bethesda, MD For more information on the meeting, you go for assistance?
20852. Details about dates are posted on or for questions on registration, contact • General question and answer
AdvaMed’s Web site at Veronica Allen (see Contact). session;
www.Advamedmtli.org/Bethesda. Attendees are responsible for their • Manufacturers and suppliers—the
3. June 17 and 18, 2008, Queens, NY. own accommodations. For further hotel chain regulatory responsibility;
Details about dates are posted on information and driving directions, go • Reimbursement of medical
AdvaMed’s Web site at: to the registration Web site. technology;
www.Advamedmtli.org/New York. The registration fee will be used to • The AdvaMed code of ethics; and
Locations: The seminars are planned offset the expenses of hosting the • Fraud and abuse.
for the following locations: conference, including meals (breakfast Dated: March 27, 2008.
1. April 8 and 9, 2008, Westin O’Hare, and a lunch), refreshments, meeting Jeffrey Shuren,
6100 North River Rd., Rosemont, IL rooms, and training materials. It also Associate Commissioner for Policy and
60018. Details about location sites are includes a networking reception on the Planning.
posted on AdvaMed’s Web site at: evening of the first day of each seminar. [FR Doc. 08–1085 Filed 3–28–08; 11:48 am]
www.Advamedmtli.org/Chicago. Space is limited; therefore, interested BILLING CODE 4160–01–S
2. May 13 and 14, 2008, Marriott parties are encouraged to register early.
Bethesda North Conference Center, There will be no onsite registration.
White Flint Auditorium, 5101 Marinelli If you need special accommodations DEPARTMENT OF HEALTH AND
Rd., North Bethesda, MD 20852. Details due to a disability, please contact HUMAN SERVICES
about location sites are posted on Veronica Allen (see Contact) at
AdvaMed’s Web site at: AdvaMed as soon as possible. Indian Health Service
www.advamedmtli.org/Bethesda. SUPPLEMENTARY INFORMATION: The
3. June 17 and 18, 2008, Crowne Plaza ‘‘Essentials of FDA Medical Device Tribal Management Grant Program
New York-LaGuardia, 104–04–Ditmars Regulations: A Primer for Manufacturers Announcement Type: New and
Blvd., East Elmhurst, NY 11369. Details and Suppliers’’ seminar helps fulfill the Competing Continuation Discretionary
about location sites are posted on Department of Health and Human Funding Cycle for Fiscal Year 2009.
AdvaMed’s Web site at: Services’ and FDA’s important mission Funding Announcement Number:
www.advamedmtli.org/NewYork. to protect the public health by educating HHS–2009–IHS–TMD–0001.
Contact: For FDA: William Sutton, new entrepreneurs on the essentials of Catalog of Federal Domestic
Division of Small Manufacturers, FDA device regulations. FDA has made Assistance Numbers(s): 93.228.
International and Consumer Assistance, education of the medical device Key Dates: Training: Application
Center for Devices and Radiological community a high priority to assure the Requirements Session: April 30–May 1,
Health (HFZ–220), 1350 Piccard Dr., quality of products reaching the May 14–15, and June 11–12, 2008.
Rockville, MD 20850, 800–638–2041, marketplace and to increase the rate of Grant Writing Session: June 23–27,
ext. 125, FAX: 240–276–3151, e-mail: voluntary industry compliance with 2008.
William.sutton@fda.hhs.gov. regulations. Application Deadline Date: August 1,
For AdvaMed: Veronica Allen, 202– The seminar helps to implement the 2008.
434–7231, FAX: 202–783–8750, e-mail: objectives of section 903 of the Federal Receipt Date for Final Tribal
VAllen@AdvaMed.org. Food, Drug, and Cosmetic Act (21 U.S.C. Resolution: October 3, 2008.
Registration: The registration fee for a 393) and the FDA Plan for Statutory Review Date: October 6–10, 2008.
limited number of FDA employees is Compliance, which includes working Application Notification Date:
waived. Send registration information more closely with stakeholders and November 12, 2008.
(including name, title, firm name, ensuring access to needed scientific and Earliest Anticipated Start Date:
address, telephone, and fax number) technical expertise. The seminar also January 1, 2009.
and the registration fee of $525 per furthers the goals of the Small Business
person to AdvaMed, contact Veronica Regulatory Enforcement Fairness Act I. Funding Opportunity Description
Allen, 202–434–7231, FAX: 202–783– (Public Law 104–121) by providing The Indian Health Service (IHS)
8750. Payment forms accepted are major outreach activities by Government announces competitive grant
credit card (MasterCard, Visa, or agencies directed at small businesses. applications for the Tribal Management
American Express) or company check. If The following topics, as well as Grant (TMG) Program. This program is
you wish to pay by check, contact others, will be discussed at the seminar: authorized under Section 103(b)(2) and
Veronica Allen at • Doing business in a regulated Section 103(e) of the Indian Self-
VAllen@Advamed.org. industry; Determination and Education
To register via the Internet, go to • Organizational structure of FDA; Assistance Act, Public Law 93–638, as
www.AdvaMed.org. The latest • Overview of the quality system amended. This program is described at
information on dates/venue sites will be regulation; 93.228 in the Catalog of Federal
posted on this Web site at:
mstockstill on PROD1PC66 with NOTICES

• Design controls; Domestic Assistance (CFDA).


www.advamedmtli.org/Chicago, • Documents, records, and change The TMG Program is a national
1 FDA has verified the Web site addresses, but
control; competitive discretionary grant program
FDA is not responsible for any subsequent changes
• Purchasing controls and acceptance pursuant to 45 CFR part 75 and 45 CFR
to the Web sites after this document publishes in activities; part 92 established to assist Federally-
the Federal Register. • Production and process control; recognized Tribes and Tribally-

VerDate Aug<31>2005 16:40 Mar 31, 2008 Jkt 214001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\01APN1.SGM 01APN1