58414 Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 20, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–23952 Filed 9–23–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0268] 

Dental Products Panel of the Medical 

Devices Advisory Committee; 

Amendment of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

The Food and Drug Administration 

(FDA) is announcing an amendment to 

the notice of meeting of the Dental 

Products Panel of the Medical Devices 

Advisory Committee. This meeting was 

announced in the Federal Register of 

June 11, 2010 (75 FR 33315). The 

amendment is being made to reflect a 

change in the Agenda portion of the 

document. There are no other changes. 

FOR FURTHER INFORMATION CONTACT: Olga 

I. Claudio, Food and Drug 

Administration, Center for Devices and 

Radiological Health, 10903 New 

Hampshire Ave., Bldg. 66, rm. 1553, 

Silver Spring, MD 20993–0002, 301– 

796–7608, or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington DC 

area), code 3014512518. Please call the 

Information Line for up-to-date 

information on this meeting. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 11, 2010, FDA 

announced that a meeting of the Dental 

Products Panel of the Medical Devices 

Advisory Committee would be held on 

December 14 and 15, 2010. On page 

33316, in the first column, in the 

Agenda portion of the document, in the 

second full paragraph, in the second 

sentence, the phrase ‘‘(docket numbers 

FDA–2008–N–0163 and FDA–2009–P– 

0357)’’ is changed to read as follows: 

‘‘(docket numbers FDA–2008–N–0163, 

FDA–2009–P–0357, and FDA–2010–P– 

0056–0001)’’ 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to the advisory committees. 

Dated: September 21, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–23914 Filed 9–23–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3240–N] 

Medicare Program; Meeting of the 

Medicare Evidence Development and 

Coverage Advisory Committee— 

November 17, 2010 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces that a 

public meeting of the Medicare 

Evidence Development & Coverage 

Advisory Committee (MEDCAC) 

(‘‘Committee’’) will be held on 

Wednesday, November 17, 2010. The 

Committee generally provides advice 

and recommendations concerning the 

adequacy of scientific evidence needed 

to determine whether certain medical 

items and services can be covered under 

the Medicare statute. This meeting will 

focus on the currently available 

evidence regarding the clinical benefits 

and harms of on-label and off-label use 

of Autologous Cellular Immunotherapy 

Treatment of Metastatic Prostate Cancer. 

This meeting is open to the public in 

accordance with 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, 

November 17, 2010 from 7:30 a.m. until 

4:30 p.m., Eastern Standard Time (EST). 

Deadline for Submission of Written 

Comments: Written comments must be 

received at the address specified in the 

ADDRESSES section of this notice by 5 

p.m. EST, October 18, 2010. Once 

submitted, all comments are final. 

Deadlines for Speaker Registration 

and Presentation Materials: The 

deadline to register to be a speaker and 

to submit powerpoint presentation 

materials and writings that will be used 

in support of an oral presentation, is 5 

p.m., EST on Wednesday, October 18, 

2010. Speakers may register by phone or 

via e-mail by contacting the person 

listed in the FOR FURTHER INFORMATION

CONTACT section of this notice. 

Presentation materials must be received 

at the address specified in the 

ADDRESSES section of this notice. 

Deadline for All Other Attendees 

Registration: Individuals may register 

online at http://www.cms.gov/mcd/ 

index_list.asp?list_type=mcac via e-mail 

at MEDCAC_Registration@cms.hhs.gov, 

or by phone by contacting the person 

listed in the FOR FURTHER INFORMATION

CONTACT section of this notice by 5 p.m. 

EST, Wednesday, November 10, 2010. 

We will be broadcasting the meeting via 

Webinar. You must register for the 

Webinar portion of the meeting at 

https://webinar.cms.hhs.gov/_a7/ 

txmetaprostatemedcac1117/event/ 

registration.html by 5 p.m. EST, 

Wednesday, November 10, 2010. 

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., EST Friday, 

November 5, 2010. 

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. 

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 

The 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 November 17, 

2010, public meeting of the Committee. 

During this meeting, the Committee will 

discuss the currently available evidence 

regarding the clinical benefits and 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices 58415 

harms of on-label and off-label use of 

Autologous Cellular Immunotherapy 

Treatment of Metastatic Prostate Cancer. 

Background information about this 

topic, including panel materials, is 

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

center/coverage.asp. We encourage the 

participation of appropriate 

organizations with expertise in the use 

of Autologous Cellular Immunotherapy 

Treatment of Metastatic Prostate Cancer. 

II. Meeting Format 

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. 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 meeting registration. While 

there is no registration fee, individuals 

must register to attend. You may register 

online at http://www.cms.gov/mcd/ 

index_list.asp?list_type=mcac, via email at 

MEDCAC_Registration@cms.hhs.gov, or 

by phone 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. 

You must register for the Webinar 

portion of the meeting at https:// 

webinar.cms.hhs.gov/_a7/ 

txmetaprostatemedcac1117/event/ 

registration.html by the deadline listed 

in the DATES section of this notice. 

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 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: September 8, 2010. 

Barry M. Straube 

Chief Medical Officer and Director, Office 

of Clinical Standards and Quality, Centers 

for Medicare & Medicaid Services. 

[FR Doc. 2010–23582 Filed 9–23–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Prevention, Prophylaxis, 

Cure, Amelioration, and/or Treatment 

of Infection and/or the Effects Thereof 

of Chikungunya Infections in Humans 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: This is notice, in accordance 

with 35 U.S.C. 209(c)(1) and 37 CFR 

404.7(a)(1)(i), that the National 

Institutes of Health (NIH), Department 

of Health and Human Services, is 

contemplating the grant of an exclusive 

license to practice the invention 

embodied in Patent Applications USSN 

61/118,206, filed on November 26, 2008, 

and 61/201,118, filed on December 5, 

2008; and PCT/US2009/006294, filed 

November 24, 2009; entitled ‘‘Virus Like 

Particle Compositions and Methods of 

Use’’, to Merck Sharp & Dohme Corp. 

having a place of business in 770 

Sumneytown Pike, West Point, PA 

19486. The patent rights in this 

invention have been assigned to the 

United States of America. 

DATES: Only written comments and/or 

application for a license that are 

received by the NIH Office of 

Technology Transfer on or before 

October 25, 2010 will be considered. 

ADDRESSES: Requests for a copy of the 

patent application, inquiries, comments 

and other materials relating to the 

contemplated license should be directed 

to: Cristina Thalhammer-Reyero, PhD , 

M.B.A., Office of Technology Transfer, 

National Institutes of Health, 6011 

Executive Boulevard, Suite 325, 

Rockville, MD 20852–3804; E-mail: 

ThalhamC@mail.nih.gov; Telephone: 

301–435–4507; Facsimile: 301–402– 

0220. 

SUPPLEMENTARY INFORMATION: The 

prospective worldwide exclusive 

license will be royalty bearing and will 

comply with the terms and conditions 

of 35 U.S.C. 209 and 37 CFR 404.7. The 

prospective exclusive license may be 

granted unless, within 30 days from the 

date of this published Notice, NIH 

receives written evidence and argument 

that establishes that the grant of the 

license would not be consistent with the 

requirements of 35 U.S.C. 209 and 37 

CFR 404.7. 

The invention relates to compositions 

and methods of use as vaccines of viruslike particles (VLPs) expressing one or 

more alphavirus capsid or envelope 

proteins, and in particular Chikungunya 


srobinson on DSKHWCL6B1PROD with NOTICES