65358 Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Notices 

(OMB) a request to review and approve 

the information collection listed below. 

This proposed information collection 

project was previously published in the 

Federal Register (74 FR 59544) on 

November 18, 2009 and allowed 60 days 

for public comment. No public 

comment was received in response to 

the notice. The purpose of this notice is 

to allow 30 days for public comment to 

be submitted directly to OMB. 

Proposed Collection: Title: Office of 

Urban Indian Health Programs (OUIHP) 

Uniform Data System (UDS). Type of 

Information Collection Request: Initial 

request and four-year extension, for data 

collection to ensure compliance with 

legislative mandates and report to 

Congress and policymakers on program 

accomplishments. Form Number(s): 

There are currently no form numbers. 

Reporting formats are contained in the 

UDS Instruction Manual. Need and Use 

of Information Collection: The UDS 

contains the annual reporting 

requirements for the cluster of primary 

health care and case management/ 

outreach and referral grantees funded by 

the IHS. The UDS includes reporting 

requirements for grantees of the OUIHP. 

The authorizing statute is Title V of 

Public Law 94–437, of the Indian Health 

Care Improvement Act, as amended. IHS 

will collect data in the UDS which will 

be used to ensure compliance with the 

legislative mandates and report to 

Congress and policymakers on program 

accomplishments. To meet these 

objectives, the OUIHP requires a core set 

of data collected annually that is 

appropriate for monitoring and 

evaluating performance and reporting 

on annual trends. Affected Public: Title 

V funded urban Indian health programs. 

Type of Respondents: Title V urban 

Indian health programs. 

The table below provides: Types of 

data collection instruments, Number of 

respondents, Responses per respondent, 

Total annual responses, Average burden 

hours per response, and Total annual 

burden hours. 

Data collection instrument(s) Number of 

respondents 

Responses 

per 

respondent 

Total annual 

responses 

Average 

burden hours 

per response* 

Total annual 

burden hours 

Universal Report .................................................................. 34 1 34 8.00 

(480 min) 

272 

American Indian/Alaska Native Report ................................ 34 1 34 8.00 

(480 min) 

272 

Total .............................................................................. 68 544 

* For ease of understanding, burden hours are also provided in actual minutes. 

There are no Capital Costs, Operating 

Costs, and/or Maintenance Costs to 

report. 

Request for Comments: Your written 

comments and/or suggestions are 

invited on one or more of the following 

points: (a) Whether the information 

collection activity is necessary to carry 

out an agency function; (b) whether the 

agency processes the information 

collected in a useful and timely fashion; 

(c) the accuracy of public burden 

estimate (the estimated amount of time 

needed for individual respondents to 

provide the requested information); (d) 

whether the methodology and 

assumptions used to determine the 

estimate are logical; (e) ways to enhance 

the quality, utility, and clarity of the 

information being collected; and (f) 

ways to minimize the public burden 

through the use of automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

Direct Comments to OMB: Send your 

written comments and suggestions 

regarding the proposed information 

collection contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time to: Office of Management and 

Budget, Office of Regulatory Affairs, 

Attention: Desk Officer for IHS, New 

Executive Office Building, Room 10235, 

Washington, DC 20503. 

Send Comments and Requests for 

Further Information: Send your written 

comments and requests for more 

information on the proposed collection 

or requests to obtain a copy of the data 

collection instrument(s) and 

instructions to: Mr. Hershel Gorham, 

Reports Clearance Officer, 801 

Thompson Avenue, TMP, Suite 450, 

Rockville, MD 20852; call non-toll free 

(301) 443–4792; send via facsimile to 

(301) 443–9879; or send your e-mail 

requests, comments, and return address 

to: hershel.gorham@ihs.gov. 

Comment Due Date: Your comments 

regarding this information collection are 

best assured of having full effect if 

received within 30 days of the date of 

this publication. 

Dated: October 7, 2010. 

Yvette Roubideaux, 

Director, Indian Health Service. 

[FR Doc. 2010–26429 Filed 10–21–10; 8:45 am] 

BILLING CODE 4165–16–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Interstate Administrative 

Subpoena. 

OMB No.: 0970–0152. 

Description: Section 452(a)(11) of the 

Social Security Act requires the 

Secretary of the Department of Health 

and Human Services to promulgate a 

form for administrative subpoenas to be 

used in State child support enforcement 

programs to collect information for use 

in the establishment, modification and 

enforcement of child support orders in 

interstate cases. Section 454(9)(E) of the 

Social Security Act requires each State 

to cooperate with any other State in 

using the Federal form for issuance of 

administrative subpoenas in interstate 

child support cases. Tribal IV–D 

agencies are not required to use this 

form but may choose to do so. OMB 

approval of this form is expiring in 

February 2011 and the Administration 

for Children and Families is requesting 

an extension of this form. 

Respondents: State, local or Tribal 

agencies administering a child support 

enforcement program under title IV–D 

of the Social Security Act. 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Notices 65359 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total burden 

hours 

Administrative Subpoena ................................................................. 35,286 1 0.50 17,643 

Estimated Total Annual Burden 

Hours: 17,643 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–7285, 

E-mail: 

OIRA_SUBMISSION@OMB.EOP.GOV, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: October 19, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–26693 Filed 10–21–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Common Formats for Patient Safety 

Data Collection and Event Reporting 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice of availability—revised 

and enhanced event-specific common 

format. 

SUMMARY: The Patient Safety and 

Quality Improvement Act of 2005, 42 

U.S.C. 299b–21 to b–26, (Patient Safety 

Act) provides for the formation of 

Patient Safety Organizations (PSOs), 

which collect, aggregate, and analyze 

confidential information regarding the 

quality and safety of healthcare 

delivery. The Patient Safety Act (at 42 

U.S.C. 299b–23) authorizes the 

collection of this information in a 

standardized manner, as explained in 

the related Patient Safety and Quality 

Improvement Final Rule, 42 CFR part 3 

(Patient Safety Rule), published in the 

Federal Register on November 21, 2008: 

73 FR 70731–70814. As authorized by 

the Secretary of HHS, AHRQ 

coordinates the development of a set of 

common definitions and reporting 

formats (Common Formats) that allow 

healthcare providers to voluntarily 

collect and submit standardized 

information regarding patient safety 

events. The purpose of this notice is to 

announce the availability of a 

significant revision of a previously 

released Common Format for public 

review and comment. 

DATES: Ongoing public input. 

ADDRESSES: The revised Device or 

Medical/Surgical Supply including 

Health Information Technology (HIT) 

Device format and the remaining 

Common Formats Version 1.1 can be 

accessed electronically at the following 

HHS Web site: http:// 

www.PSO.AHRQ.gov/index.html. 

FOR FURTHER INFORMATION CONTACT: 

Deborah Perfetto, Center for Quality 

Improvement and Patient Safety, AHRQ, 

540 Gaither Road, Rockville, MD 20850; 

Telephone (toll free): (866) 403–3697; 

Telephone (local): (301) 427–1111; TTY 

(toll free): (866) 438–7231; TTY (local): 

(301) 427–1130; E-mail: 

PSO@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The Patient Safety Act and Patient 

Safety Rule establish a framework by 

which doctors, hospitals, and other 

healthcare providers may voluntarily 

report information regarding patient 

safety events and quality of care. 

Information that is assembled and 

developed by providers for reporting to 

PSOs and the information received and 

analyzed by PSOs—called ‘‘patient 

safety work product’’—is privileged and 

confidential. Patient safety work 

product is used to identify events, 

patterns of care, and unsafe conditions 

that increase risks and hazards to 

patients. Definitions and other details 

about PSOs and patient safety work 

product are included in the Patient 

Safety Rule. 

The Patient Safety Act and Patient 

Safety Rule require PSOs, to the extent 

practical and appropriate, to collect 

patient safety work product from 

providers in a standardized manner in 

order to permit valid comparisons of 

similar cases among similar providers. 

The collection of patient safety work 

product allows the aggregation of 

sufficient data to identify and address 

underlying causal factors of patient 

safety problems. Both the Patient Safety 

Act and Patient Safety Rule can be 

accessed electronically at: http:// 

www.PSO.AHRQ.gov/requlations/ 

regulations.htm. 

In order to facilitate standardized data 

collection, the Secretary of HHS 

authorized AHRQ to develop and 

maintain the Common Formats to 

improve the safety and quality of 

healthcare delivery. In August 2008, 

AHRQ issued the initial release of the 

formats, Version 0.1 Beta. The second 

release of the Common Formats, Version 

1.0, was announced in the Federal 

Register on September 2, 2009: 74 FR 

45457–45458. This release was later 

replaced by Version 1.1, as announced 

in the Federal Register on March 31, 

2010: 75 FR 16140–16142. 

Version 1.1 includes updated event 

descriptions, forms, and technical 

specifications for software developers. 

Definition of Common Formats 

The term ‘‘Common Formats’’ is used 

to describe clinical definitions and 

technical requirements developed for 

the uniform collection and reporting of 

patient safety data, including all 

supporting material. The Common 

Formats are not intended to replace any 

current mandatory reporting system, 

collaborative/voluntary reporting 

system, research-related reporting 

system, or other reporting/recording 

system. 

The scope of Common Formats 

applies to all patient safety concerns 

including: 

Æ Incidents—patient safety events 

that reached the patient, whether or not 

there was harm, 

Æ Near misses or close calls—patient 

safety events that did not reach the 

patient, and 


emcdonald on DSK2BSOYB1PROD with NOTICES