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
58416 Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices 

virus (CHIKV) envelope proteins. The 

invention also describes DNA, viral or 

other gene-based vector and VLP 

vaccines, methods of making and 

methods of their use in inducing 

immunity to alphavirus infection. 

Alphaviruses are RNA-containing 

viruses that cause a wide variety of 

mosquito-transmitted diseases, 

including equine encephalitis. CHIKV, 

an alphavirus in the family Togaviridae, 

was first isolated in Tanzania in 1952 

and is transmitted to humans by 

mosquitoes. The disease caused by 

CHIKV resembles infection by dengue 

virus, characterized by rash, high fever, 

and severe, sometimes persistent 

arthritis. 

The field of use may be limited to 

‘‘Prevention, prophylaxis, cure, 

amelioration, and/or treatment of 

infection and/or the effects thereof of 

Chikungunya infections in humans’’. 

Properly filed competing applications 

for a license filed in response to this 

notice will be treated as objections to 

the contemplated license. Comments 

and objections submitted in response to 

this notice will not be made available 

for public inspection, and, to the extent 

permitted by law, will not be released 

under the Freedom of Information Act, 

5 U.S.C. 552. 

Dated: September 20, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

& Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–23975 Filed 9–23–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Statement of Organization, Functions 

and Delegations of Authority 

This notice amends Part R of the 

Statement of Organization, Functions 

and Delegations of Authority of the 

Department of Health and Human 

Services (HHS), Health Resources and 

Services Administration (HRSA) (60 FR 

56605, as amended November 6, 1995; 

as last amended at 75 FR 57282–57283 

dated September 20, 2010). 

This notice reflects organizational 

changes in the Health Resources and 

Services Administration. Specifically, 

this notice updates the functional 

statement for the Bureau of Clinician 

Recruitment and Service (RU) to reduce 

fragmentation and overlap and establish 

an increased emphasis on policy and 

program development, external 

communication and outreach, customer 

service and system and analytical 

support. 

Chapter RU—Bureau of Clinician 

Recruitment and Service 

Section RU–10, Organization 

Delete in its entirety and replace with 

the following: 

The Office of the Associate 

Administrator (RU) is headed by the 

Associate Administrator, Bureau of 

Clinician Recruitment and Service 

(BCRS), who reports directly to the 

Administrator, Health Resources and 

Services Administration. BCRS includes 

the following components: 

(1) Office of the Associate Administrator 

(RU); 

(2) Office of Legal and Compliance 

(RU1); 

(3) Division of National Health Service 

Corps (RU5); 

(4) Division of Nursing and Public 

Health (RU6); 

(5) Division of External Affairs (RU7); 

(6) Office of Policy and Program 

Development (RU8); 

(7) Division of Program Operations 

(RU9); 

(8) Division of Regional Operations 

(RU10); and 

(9) Office of Business Operations 

(RU11). 

Section RU–20, Functions 

(1) Delete the functional statement for 

the Bureau of Clinician Recruitment and 

Service (RU) and replace in its entirety. 

Office of the Associate Administrator 

(RU) 

Provides overall leadership, direction, 

coordination, and planning in support 

of Bureau of Clinician Recruitment and 

Service (BCRS) programs that are 

designed to improve the health of the 

Nation’s underserved communities and 

vulnerable populations by coordinating 

the recruitment and retention of caring 

health professionals in the healthcare 

system and supporting communities’ 

efforts to build more integrated and 

sustainable systems of care. Specifically: 

(1) Establishes program goals, objectives 

and priorities, and provides oversight as 

to their execution; (2) plans, directs, 

coordinates and evaluates Bureau-wide 

management activities; (3) maintains 

effective relationships within HRSA and 

with other Department of Health and 

Human Services (HHS) organizations, 

other Federal agencies, State and local 

governments, and other public and 

private organizations concerned with 

improving the health status of the 

Nation’s underserved communities and 

vulnerable populations by recruiting 

and retaining health care clinicians into 

service in areas of greatest need; (4) 

plans, directs and coordinates Bureauwide administrative management 

activities, i.e., budget, personnel, 

procurements, delegations of authority, 

and has responsibilities related to the 

awarding of BCRS funds; and (5) 

oversees the development of BCRS 

program policies. 

Office of Legal and Compliance (RU1) 

Serves as the focal point for service 

obligation issue resolution and quality 

assurance for the Bureau’s programs. 

Specifically: (1) Analyzes, administers 

and manages procedures for the BCRS 

portfolio of scholarship and loan 

repayment participants who have 

breached their service obligation, 

requested a waiver or suspension, and/ 

or are in default and have requested to 

serve under a Forbearance, Judgment or 

Settlement Agreement; (2) reviews 

default recommendations, determines 

the action of default, and initiates and 

monitors procedures for default debt 

collection; (3) provides programmatic 

information to Agency officials, the 

Office of the General Counsel, the Office 

of Inspector General, Program Support 

Center, and the Department of Justice 

for default debt collection, trials, 

bankruptcy hearings, and other 

activities; (4) reviews requests and 

makes determinations regarding 

scholarship and loan repayment 

participants’ eligibility for a suspension 

or waiver of their service or default debt 

obligation; (5) implements policies and 

procedures in conjunction with default 

reduction activities, including return to 

service arrangements and other actions 

to maximize compliance with 

scholarship and loan repayment service 

obligations; and (6) serves as the BCRS 

quality assurance function. 

Division of National Health Service 

Corps (RU5) 

Serves as the point of contact for 

responding to inquiries, disseminating 

program information, providing 

technical assistance, and processing 

applications and awards pertaining to 

National Health Service Corps (NHSC) 

scholarship and loan repayment 

programs and site approvals. 

Specifically: (1) Reviews, ranks and 

selects participants for the scholarship 

and loan repayment programs; (2) 

verifies and processes loan and lender 

related payments in prescribed manner 

and maintains current information on 

scholarship and loan repayment 

applications and awards through 

automated BCRS information systems; 

(3) provides oversight, processing and 

coordination of reviews of NHSC site 


srobinson on DSKHWCL6B1PROD with NOTICES