65360 Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Notices 

Æ Unsafe conditions—circumstances 

that increase the probability of a patient 

safety event. 

Common Formats Version 1.1 is 

currently limited to patient safety 

reporting for acute care hospitals and is 

designed to support the first stage in the 

improvement cycle. Version 1.1 

includes two general types of formats, 

generic and event specific. The generic 

Common Formats pertain to all patient 

safety concerns. The three generic 

formats are: Healthcare Event Reporting 

Form, Patient Information Form, and 

Summary of Initial Report. The eventspecific Common Formats pertain to 

frequently occurring and/or serious 

patient safety events. The eight eventspecific formats are: Blood or Blood 

Product, Device or Medical/Surgical 

Supply, Fall, Healthcare-Associated 

Infection, Medication or Other 

Substance, Perinatal, Pressure Ulcer, 

and Surgery or Anesthesia. 

As part of the Agency’s efforts to 

continually refine and update the 

formats, AHRQ has issued a significant 

revision of the previously released 

Common Format—Device or Medical/ 

Surgical Supply. In conjunction with 

the Food and Drug Administration 

(FDA) and the Office of the National 

Coordinator for Health Information 

Technology (ONC), AHRQ developed 

the beta version of this event-specific 

format to capture information about 

patient safety events that are related to 

HIT. Subsequently, the format was 

reviewed and revised by an interagency 

Federal Patient Safety Work Group 

(PSWG). The enhanced format, Device 

or Medical/Surgical Supply including 

HIT Device, will be incorporated into 

the next version of the Common 

Formats (Version 1.2). 

This revised format includes a 

description of patient safety events and 

unsafe conditions to be reported (event 

description) and a sample patient safety 

aggregate report and individual event 

summary. The Device or Medical/ 

Surgical Supply including HIT Device 

Common Format is available at the 

Patient Safety Organization (PSO) 

Privacy Protection Center (PPC) Web 

site: https://www.psoppc.org/web/ 

patientsafety. 

Commenting on Device or Medical/ 

Surgical Supply Including HIT Device 

Common Format, Version 1.1 

To allow for greater participation by 

the private sector in the subsequent 

development of the Common Formats, 

AHRQ engaged the National Quality 

Forum (NQF), a non-profit organization 

focused on health care quality, to solicit 

comments and advice to guide the 

further refinement of the Common 

Formats. The NQF began this process 

with feedback on AHRQ’s 0.1 Beta 

release of the Common Formats. Based 

upon the expert panel’s feedback, 

AHRQ, in conjunction with the PSWG, 

further revised and refined the Common 

Formats and released Version 1.0. 

The review process above was 

repeated again from September 2009 

through February 2010 to further refine 

Common Formats Version 1.0 and 

incorporate public comments prior to 

finalization of the technical 

specifications for electronic 

implementation. These revised formats 

are now available as Version 1.1. 

As evidenced by the release of this 

Device or Medical/Surgical Supply 

including HIT Device format, AHRQ is 

committed to continuing refinement of 

the Common Formats. The Agency is 

specifically interested in obtaining 

feedback from both the private and 

public sectors, particularly from those 

who use the Common Formats, to guide 

their improvement. Information on how 

to comment and provide feedback on 

the Common Formats, Version 1.1 and 

the Device or Medical/Surgical Supply 

including HIT Device beta version, is 

available at the National Quality Forum 

(NQF) Web site for Common Formats: 

http://www.Quality.forum.org/projects/ 

commonformats.aspx. 

Common Formats Development 

In anticipation of the need for 

Common Formats, AHRQ began their 

development in 2005 by creating an 

inventory of functioning private and 

public sector patient safety reporting 

systems. This inventory provides an 

evidence base that informs construction 

of the Common Formats. The inventory 

now numbers 69 and includes many 

systems from the private sector, 

including prominent academic settings, 

hospital systems, and international 

reporting systems (e.g., from the United 

Kingdom and the Commonwealth of 

Australia). In addition, virtually all 

major Federal patient safety reporting 

systems are included, such as those 

from the Centers for Disease Control and 

Prevention (CDC), FDA, the Department 

of Defense (DOD), and the Department 

of Veterans Affairs (VA). 

Since February 2005, AHRQ has 

coordinated the PSWG to assist AHRQ 

with developing and maintaining the 

Common Formats. The PSWG includes 

major health agencies within the HHS– 

CDC, Centers for Medicare & Medicaid 

Services, FDA, Health Resources and 

Services Administration, the Indian 

Health Service, the National Institutes of 

Health, the National Library of 

Medicine, ONC, the Office of Public 

Health and Science, the Substance 

Abuse and Mental Health Services 

Administration—as well as the DoD and 

the VA. 

The PSWG assists AHRQ with 

assuring the consistency of definitions/ 

formats with those of relevant 

government agencies as refinement of 

the Common Formats continues. To the 

extent practicable, the Common Formats 

are also aligned with World Health 

Organization (WHO) concepts, 

framework, and definitions contained in 

their draft International Classification 

for Patient Safety (ICPS). 

The process for updating and refining 

the formats will continue to be an 

iterative one. More information on the 

Common Formats Version 1.1 can be 

obtained through AHRQ’s PSO Web site: 

http://www.PSO.AHRQ.qov/index.html. 

Dated: October 12, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–26667 Filed 10–21–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2326–PN] 

Medicare and Medicaid Programs; 

Application by the Joint Commission 

for Deeming Authority for Psychiatric 

Hospitals 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed notice. 

SUMMARY This proposed notice with 

comment period acknowledges the 

receipt of an application from the Joint 

Commission for recognition as a 

national accrediting organization for 

psychiatric hospitals that wish to 

participate in the Medicare or Medicaid 

programs. Section 1865(a)(3)(A) of the 

Social Security Act requires that within 

60 days of receipt of an organization’s 

complete application, we publish a 

notice that identifies the national 

accrediting body making the request, 

describes the nature of the request, and 

provides at least a 30-day public 

comment period. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on November 22, 2010. 

ADDRESSES: In commenting, please refer 

to file code CMS–2326–PN. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Notices 65361 

You may submit comments in one of 

four ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http:// 

www.cms.hhs.gov/eRulemaking. Click 

on the link ‘‘Submit electronic 

comments on CMS regulations with an 

open comment period.’’ (Attachments 

should be in Microsoft Word, 

WordPerfect, or Excel; however, we 

prefer Microsoft Word.) 

2. By regular mail. You may mail 

written comments (one original and two 

copies) to the following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–2326– 

PN, P.O. Box 8010, Baltimore, MD 

21244–8010. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments (one 

original and two copies) to the following 

address only: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–2326–PN, Mail Stop C4–26–05, 

7500 Security Boulevard, Baltimore, MD 

21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments (one original 

and two copies) before the close of the 

comment period to one of the following 

addresses. If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786– 

9994 in advance to schedule your 

arrival with one of our staff members. 

Room 445–G, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201; or 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

(Because access to the interior of the 

HHH Building is not readily available to 

persons without Federal government 

identification, commenters are 

encouraged to leave their comments in 

the CMS drop slots located in the main 

lobby of the building. A stamp-in clock 

is available for persons wishing to retain 

a proof of filing by stamping in and 

retaining an extra copy of the comments 

being filed.) 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: L. 

Tyler Whitaker, (410) 786–5236. Patricia 

Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this proposed notice to assist 

us in fully considering issues and 

developing policies. You can assist us 

by referencing the file code CMS–2326– 

PN and the specific ‘‘issue identifier’’ 

that precedes the section on which you 

choose to comment. 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http://www.cms.hhs.gov/ 

eRulemaking. Click on the link 

‘‘Electronic Comments on CMS 

Regulations’’ on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services from a psychiatric hospital 

provided certain requirements are met. 

Section 1861(f) of the Social Security 

Act (the Act) establishes distinct criteria 

for facilities seeking designation as a 

psychiatric hospital. Regulations 

concerning provider agreements are at 

42 CFR part 489 and those pertaining to 

activities relating to the survey and 

certification of facilities are at 42 CFR 

part 488. The regulations at 42 CFR part 

482, subpart E specify, among other 

things, the conditions that a psychiatric 

hospital must meet in order to 

participate in the Medicare program. 

Generally, in order to enter into a 

provider agreement with the Medicare 

program, a psychiatric hospital must 

first be certified by a State survey 

agency as complying with the 

applicable conditions or requirements 

set forth in 42 CFR part 482. Thereafter, 

the psychiatric hospital is subject to 

regular surveys by a State survey agency 

to determine whether it continues to 

meet these requirements. However, 

there is an alternative to surveys by 

State agencies. 

Section 1865(a)(1) of the Act provides 

that, if a provider entity demonstrates 

through accreditation by an approved 

national accrediting organization that all 

applicable Medicare conditions are met 

or exceeded, we will deem those 

provider entities as having met the 

requirements. Accreditation by an 

accrediting organization is voluntary 

and is not required for Medicare 

participation. 

If an accrediting organization is 

recognized by the Secretary as having 

standards for accreditation that meet or 

exceed Medicare requirements, any 

provider entity accredited by the 

national accrediting body’s approved 

program would be deemed to meet the 

Medicare conditions. A national 

accrediting organization applying for 

deeming authority under 42 CFR part 

488, subpart A must provide us with 

reasonable assurance that the 

accrediting organization requires the 

accredited provider entities to meet 

requirements that are at least as 

stringent as the Medicare conditions of 

participation. The regulations at 

§ 488.8(d)(3) require accrediting 

organizations to reapply for continued 

deeming authority every 6 years or 

sooner as determined by us. 

II. Approval of Deeming Organizations 

Section 1865(a)(2) of the Act and our 

regulations at § 488.8(a) require that our 

findings concerning review and 

approval of a national accrediting 

organization’s requirements consider, 

among other factors, the applying 

accrediting organization’s requirements 

for accreditation; survey procedures; 

resources for conducting required 

surveys; capacity to furnish information 

for use in enforcement activities; 

monitoring procedures for provider 

entities found not in compliance with 

the conditions or requirements; and the 

ability to provide us with the necessary 

data for validation. 

Section 1865(a)(3)(A) of the Act 

further requires that we publish, within 

60 days of receipt of an organization’s 

complete application, a notice 

identifying the national accrediting 

body making the request, describing the 

nature of the request, and providing at 

least a 30-day public comment period. 

We have 210 days from the receipt of a 

complete application to publish notice 

of approval or denial of the application. 

The purpose of this proposed notice 

is to inform the public of the Joint 

Commission’s request for deeming 

authority for psychiatric hospitals. This 

notice also solicits public comment on 

whether the Joint Commission’s 

requirements meet or exceed the 


emcdonald on DSK2BSOYB1PROD with NOTICES
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