Federal Register / Vol. 75, No. 227 / Friday, November 26, 2010 / Notices 72831 

efficient and effective manner, and 

perform reviews of quality of care in an 

area of medical practice where actual 

performance is measured against 

objective criteria, which defines 

acceptable and adequate practice. The 

selected organization must have a 

consumer representative on its 

governing board. 

The Omnibus Budget Reconciliation 

Act of 1987 (Pub. L. 100–203) amended 

section 1153 of the Act by adding 

paragraph (i). This provision prohibits 

CMS from renewing the contract of any 

QIO that is not an in-State QIO without 

first publishing in the Federal Register 

a notice announcing when the contract 

will expire. This notice must be 

published no later than 6 months before 

the date the contract expires and must 

specify the period of time during which 

an in-State organization may submit a 

proposal for the QIO contract for that 

State. If one or more qualified in-State 

organizations submit a proposal for the 

QIO contract within the specified period 

of time, we cannot automatically renew 

the current contract on a 

noncompetitive basis, but must instead 

provide for competition for the contract 

in the same manner used for a new 

contract under section 1153(b) of the 

Act. An in-State QIO is defined under 

section 1153(i)(3) of the Act as a QIO 

that has its primary place of business in 

the State in which review will be 

conducted (or, be a subsidiary of a 

parent corporation, whose headquarters 

is located in that State). 

There are currently 4 QIO contracts 

with entities that do not meet the 

statutory definition of an in-State QIO. 

The areas affected for purposes of this 

notice along with the respective contract 

expiration dates are as follows: 

Vermont—July 31, 2011 

Maine—July 31, 2011 

Idaho—July 31, 2011 

South Carolina—July 31, 2011 

II. Provisions of the Notice 

This notice announces the scheduled 

expiration dates of the current contracts 

between CMS and the out-of-State QIOs 

responsible for review in the areas 

mentioned above. 

Interested in-State organizations may 

submit a proposal in competing to 

become the QIO for these States. In 

order to be eligible for contract award, 

the organization must have its primary 

place of business in the States in which 

review will be conducted or be a 

subsidiary of a parent corporation, 

whose headquarters is located in that 

State. In order to be eligible for contract 

award, each interested organization 

must further demonstrate that it meets 

the following requirements: 

A. Be Either a Physician-Sponsored or a 

Physician-Access Organization 

1. Physician-Sponsored Organization 

a. The organization must be composed 

of a substantial number of the licensed 

doctors of medicine and osteopathy 

practicing medicine or surgery in the 

review area, who are representative of 

the physicians practicing in the review 

area. 

b. The organization must not be a 

health care facility, health care facility 

association, health care facility affiliate, 

or payor organization. However, statutes 

and regulations provide that, in the 

event CMS determines no otherwise 

qualified non-payor organization is 

available to undertake a given QIO 

contract, CMS may select a payor 

organization which otherwise meets 

requirements to be eligible to conduct 

Utilization and Quality Control Peer 

Review as specified in Part B of Title XI 

of the Act and its implementing 

regulations. 

c. In order to meet the ‘‘substantial 

number of doctors of medicine and 

osteopathy’’ requirements as specified 

above in paragraph A.1.a, an 

organization must state and have 

documentation in its files showing that 

it is composed of at least 10 percent of 

the licensed doctors of medicine and 

osteopathy practicing medicine or 

surgery in the review area. In order to 

meet the representation requirements as 

specified above in paragraph A.1.a, an 

organization must state and have 

documentation in its files demonstrating 

that it is composed of at least 20 percent 

of the licensed doctors of medicine and 

osteopathy practicing medicine or 

surgery in the review area. 

Alternatively, if the organization does 

not demonstrate that it is composed of 

at least 20 percent of the licensed 

doctors of medicine and osteopathy 

practicing medicine or surgery in the 

review area, the organization must 

demonstrate in its proposal, through 

letters of support from physicians or 

physician organizations, or through 

other means, that it is representative of 

the area physicians. 

2. Physician-Access Organization 

a. The organization must have 

available to it, by arrangement or 

otherwise, the services of a sufficient 

number of licensed doctors of medicine 

or osteopathy practicing medicine or 

surgery in the review area to ensure 

adequate peer review of the services 

furnished by the various medical 

specialties and subspecialties. 

b. The organization must not be a 

health care facility, health care facility 

association, health care facility affiliate, 

or payor organization. 

c. An organization meets the 

requirements specified above in 

paragraph A.2.a., if it demonstrates that 

it has available to it at least one 

physician in every generally recognized 

specialty and has an arrangement or 

arrangements with physicians under 

which the physicians would conduct 

review for the organization. 

B. Have at Least One Individual Who Is 

a Representative of Consumers on Its 

Governing Board 

If one or more organizations meet the 

above requirements in a QIO area and 

submit proposals for the contracts in 

accordance with this notice, we will 

consider those organizations to be 

potential sources for the 4 contracts 

upon their expiration. These 

organizations will be entitled to 

participate in a full and open 

competition for the QIO contract to 

perform the QIO statement of work. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare-Supplementary Medical Insurance 

Program) 

Dated: October 28, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2010–28817 Filed 11–24–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Committee to the Director 

(ACD), Centers for Disease Control and 

Prevention (CDC)—Ethics 

Subcommittee (ES) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the CDC announces 

the following meeting of the 

aforementioned subcommittee: 

Time and Date: 2 p.m.—3:30 p.m. Eastern 

Standard Time, January 4, 2011. 

Place: Teleconference. 

Status: Open to the public, limited only by 

availability of telephone ports. The public is 

welcome to participate during the public 

comment period. A public comment period 

is tentatively scheduled from 3 p.m.—3:15 

p.m. To participate in the teleconference, 

please dial 1–877–928–1204 and enter 

conference code 4305992. 

Purpose: The ES will provide counsel to 

the ACD, CDC, regarding a broad range of 

public health ethics questions and issues 

arising from programs, scientists and 

practitioners. 


srobinson on DSKHWCL6B1PROD with NOTICES
72832 Federal Register / Vol. 75, No. 227 / Friday, November 26, 2010 / Notices 

Matter to be Discussed: The ES will discuss 

a strategy for addressing its charge to provide 

a preliminary overview to the ACD on ethical 

issues related to non-communicable disease 

prevention and control and an ethics 

framework to guide CDC programs and 

activities. 

The agenda is subject to change as 

priorities dictate. 

Contact Person for More Information: Drue 

Barrett, Ph.D., Designated Federal Officer, 

ACD, CDC—ES, CDC, 1600 Clifton Road, NE., 

M/S D–50, Atlanta, Georgia 30333. 

Telephone (404) 639–4690. E-mail: 

dbarrett@cdc.gov. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: November 18, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–29774 Filed 11–24–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0585] 

Neurological Devices Panel of the 

Medical Devices Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Neurological 

Devices Panel of the Medical Devices 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on January 27 and 28, 2011, from 

8 a.m. to 6 p.m. 

FDA is opening a docket for public 

comment on this meeting. The docket 

number is FDA–2010–N–0585. The 

docket will open for public comment on 

November 26, 2010. The docket will 

close on January 25, 2011. Interested 

persons may submit electronic or 

written comments regarding this 

meeting. Submit electronic comments to 

http://www.regulations.gov. Submit 

written comments to the Division of 

Dockets Management, Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit a 

single copy of electronic comments or a 

paper copy of any mailed comments, 

except that individuals may submit one 

paper copy. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

meeting notice. Received comments 

may be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Location: Hilton Washington DC 

North/Gaithersburg, Ballroom, 620 Perry 

Pkwy., Gaithersburg, MD. 

Contact Person: James Engles, Food 

and Drug Administration, Center for 

Devices and Radiological Health, 10903 

New Hampshire Ave., Silver Spring, MD 

20993, or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area), code 3014512513. Please call the 

Information Line for up-to-date 

information on this meeting. A notice in 

the Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site and call the 

appropriate advisory committee hot 

line/phone line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: On January 27 and 28, 2011, 

the committee will discuss and make 

recommendations regarding the possible 

reclassification of devices indicated for 

use in electroconvulsive therapy. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before January 14, 2011. 

Oral presentations from the public will 

be scheduled at approximately 10 a.m., 

immediately following the FDA’s 

presentation, on January 27, 2011. 

Those individuals interested in making 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before January 6, 2011. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by January 7, 2011. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. FDA 

welcomes the attendance of the public 

at its advisory committee meetings and 

will make every effort to accommodate 

persons with physical disabilities or 

special needs. If you require special 

accommodations due to a disability, 

please contact AnnMarie Williams, 

Conference Management Staff, at 301– 

796–5966 at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: November 18, 2010. 

Thinh Nguyen, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–29824 Filed 11–24–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 


srobinson on DSKHWCL6B1PROD with NOTICES