65362 Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Notices 

Medicare conditions for participation 

for psychiatric hospitals. 

III. Evaluation of Deeming Authority 

Request 

The Joint Commission submitted all 

the necessary materials to enable us to 

make a determination concerning its 

request for approval as a deeming 

organization for psychiatric hospitals. 

This application was determined to be 

complete on September 3, 2010. Under 

section 1865(a)(2) of the Act and § 488.8 

(Federal review of accrediting 

organizations), our review and 

evaluation of the Joint Commission will 

be conducted in accordance with, but 

not necessarily limited to, the following 

factors: 

• The equivalency of the Joint 

Commission’s standards for a 

psychiatric hospital as compared with 

CMS’ psychiatric hospital conditions of 

participation. 

• The Joint Commission’s survey 

process to determine the following: 

+ The composition of the survey 

team, surveyor qualifications, and the 

ability of the organization to provide 

continuing surveyor training. 

+ The comparability of the Joint 

Commission’s processes to those of 

State agencies, including survey 

frequency, and the ability to investigate 

and respond appropriately to 

complaints against accredited facilities. 

+ The Joint Commission’s processes 

and procedures for monitoring 

psychiatric hospitals found out of 

compliance with the Joint Commission’s 

program requirements. These 

monitoring procedures are used only 

when the Joint Commission identifies 

noncompliance. If noncompliance is 

identified through validation reviews, 

the State survey agency monitors 

corrections as specified at § 488.7(d). 

+ The Joint Commission’s capacity to 

report deficiencies to the surveyed 

facilities and respond to the facility’s 

plan of correction in a timely manner. 

+ The Joint Commission’s capacity to 

provide us with electronic data and 

reports necessary for effective validation 

and assessment of the organization’s 

survey process. 

+ The adequacy of the Joint 

Commission’s staff and other resources, 

and its financial viability. 

+ The Joint Commission’s capacity to 

adequately fund required surveys. 

+ The Joint Commission’s policies 

with respect to whether surveys are 

announced or unannounced, to assure 

that surveys are unannounced. 

+ The Joint Commission’s agreement 

to provide us with a copy of the most 

current accreditation survey together 

with any other information related to 

the survey as we may require (including 

corrective action plans). 

IV. Response to Public Comments and 

Notice Upon Completion of Evaluation 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

Upon completion of our evaluation, 

including evaluation of comments 

received as a result of this notice, we 

will publish a final notice in the Federal 

Register announcing the result of our 

evaluation. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

VI. Regulatory Impact Statement 

In accordance with the provisions of 

Executive Order 12866, the Office of 

Management and Budget did not review 

this proposed notice. 

In accordance with Executive Order 

13132, we have determined that this 

proposed notice would not have a 

significant effect on the rights of States, 

local or Tribal governments. 

Authority: Section 1865 of the Social 

Security Act (42 U.S.C. 1395bb). 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program; No. 93.773, Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: October 14, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2010–26716 Filed 10–21–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Oncologic Drugs 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: Oncologic Drugs 

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 December 1, 2010, from 8 a.m. 

to 5 p.m. 

Location: FDA White Oak Campus, 

Bldg 31, the Great Room, White Oak 

Conference Center (rm. 1503), 10903 

New Hampshire Ave., Silver Spring, MD 

20993–0002. Information regarding 

special accommodations due to a 

disability, visitor parking, and 

transportation may be accessed at: 

http://www.fda.gov/ 

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You’’, click 

on ‘‘White Oak Conference Center 

Parking and Transportation Information 

for FDA Advisory Committee Meetings’’. 

Contact Person: Nicole Vesely, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, FAX: 301–847–8533, e-mail: 

Nicole.vesely@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 301–451– 

2542. 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 December 1, 2010, the 

committee will discuss supplemental 

new drug applications (sNDAs) 021– 

319/S–024, trade name AVODART 

(dutasteride) Soft Gelatin Capsules, 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Notices 65363 

manufactured by SmithKline Beecham 

Corp. d/b/a (doing business as) 

GlaxoSmithKline and 020–180/S–034, 

trade name PROSCAR (finasteride) 

Tablets, manufactured by Merck & Co., 

Inc. The proposed indication (use) for 

AVODART (dutasteride) is for reduction 

in the risk of prostate cancer in men at 

increased risk of developing the disease. 

The population at increased risk of 

prostate cancer includes men with an 

elevated serum prostate-specific antigen 

(PSA) or men otherwise determined to 

be at increased risk based on other 

associated risk factors such as age, race, 

and family history. There is no 

proposed expansion of the indication 

for PROSCAR (finasteride); however, in 

light of the Prostate Cancer Prevention 

Trial (PCPT) which demonstrated a 

statistically significant reduction in the 

7-year period prevalence of prostate 

cancer with finasteride (PROSCAR) 

treatment, and which reported an 

imbalance in high Gleason grade 

prostate cancers (indicating more 

aggressive cancers) in the finasteride 

treatment arm vs. placebo, the efficacy 

and safety of both products for use in 

prostate cancer risk reduction will be 

examined. 

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 November 16, 2010. 

Oral presentations from the public will 

be scheduled between approximately 

2:30 p.m. to 3:30 p.m. Those desiring to 

make 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 November 8, 2010. 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 

November 9, 2010. 

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 Nicole 

Vesely 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: October 13, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–26651 Filed 10–21–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Basic Behavioral and Social Science 

Opportunity Network (OppNet) 

ACTION: Notice. 

SUMMARY: A two-day meeting 

highlighting OppNet’s activities and 

future goals is scheduled for Thursday, 

October 28, and Friday, October 29, 

2010, at the Hyatt Regency Washington 

on Capitol Hill, 400 New Jersey Avenue, 

NW., Washington DC 20001. This is the 

first public meeting to promote and 

publicize the Basic Behavioral and 

Social Science Opportunity Network 

(OppNet) initiative. Attendance is 

limited to prior registration via http:// 

www.regonline.com/oppnet. 

Background: The Basic Behavioral 

and Social Science Opportunity 

Network (OppNet) is a trans-NIH 

initiative to expand the agency’s 

funding of basic behavioral and social 

sciences research (b-BSSR). OppNet 

prioritizes activities and initiatives that 

focus on basic mechanisms of behavior 

and social processes that are relevant to 

the missions and public health 

challenges of multiple NIH Institutes, 

Centers, and Offices (ICOs) and that 

build upon existing NIH investments 

without replicating them. http:// 

www.oppnet.nih.gov. 

Participating: The meeting will take 

place on October 28, from 9 a.m. to 4:30 

p.m., and October 29, from 8:30 a.m. to 

2:30 p.m., at the Hyatt Regency 

Washington on Capitol Hill, 400 New 

Jersey Avenue, NW., Washington DC 

20001. 

FOR FURTHER INFORMATION CONTACT: To 

register, visit the registration Web site at 

http://regonline.com/oppnet, call 

William Elwood at 301–402–0116, or email elwoodwi@od.nih.gov. 

Dated: October 15, 2010. 

Lawrence A. Tabak, 

Principal Deputy Director, National Institutes 

of Health. 

[FR Doc. 2010–26709 Filed 10–21–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meeting 

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 meeting. 

The meeting 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., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel; Review of Minority Biomedical 

Research Neuro Grant Applications. 

Date: December 6, 2010. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency-Bethesda, 7400 

Wisconsin Avenue, One Bethesda Metro 

Center, Bethesda, MD 20814. 

Contact Person: John J. Laffan, PhD, 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 

Natcher Building, Room 3AN18J, Bethesda, 

MD 20892, 301–594–2773, 

laffanjo@mail.nih.gov. 


emcdonald on DSK2BSOYB1PROD with NOTICES