Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices 16785 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

facilities 

Total burden 

hours 

Average 

hourly wage 

rate * 

Total cost 

burden 

Medical Records Extraction ............................................................................. 2 4 $31.99 $128 

NH Provider Pre-Implementation Questionnaire ............................................. 2 3 83.59 251 

NH Provider Post-Implementation Questionnaire ............................................ 3 6 83.59 502 

ED Physician Post-implementation Questionnaire .......................................... 1 8 83.59 669 

Nurse Pre/Post Implementation Questionnaire ............................................... 5 10 31.99 320 

NH Leadership Post-Implementation Questionnaire ....................................... 3 1 51.45 511 

Total .......................................................................................................... 14 32 n/a 1,921 

* Based upon the mean of the average wages, National Occupational Employment and Wage Estimates, U.S. Department of Labor, Bureau of 

Labor Statistics. May 2009. Hourly mean wage for registered nurse ($31.99), physician ($83.59), and NH administrator ($51.45). 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the total and 

annualized cost for conducting this 

research. The total budget for this two 

year study is $458,812. 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

Cost component Total Annualized 

cost 

Project Administration .............................................................................................................................................. $60, 511 $30,256 

Initial Antibiogram Development and Implementation ............................................................................................. 47,618 23,809 

Expansion of Antibiogram Development and Implementation ................................................................................ 36,948 18,474 

Toolkit—Development and Refinement ................................................................................................................... 92,688 46,344 

Evaluation ................................................................................................................................................................ 153,978 76,989 

Final Report and Dissemination .............................................................................................................................. 67,071 33,536 

Total .................................................................................................................................................................. 458,812 229,406 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, comments on AHRQ’s 

information collection are requested 

with regard to any of the following: (a) 

Whether the proposed collection of 

information is necessary for the proper 

performance of AHRQ healthcare 

research and healthcare information 

dissemination functions, including 

whether the information will have 

practical utility; (b) the accuracy of 

AHRQ’s estimate of burden (including 

hours and costs) of the proposed 

collection(s) of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(d) ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: March 15, 2011. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2011–6848 Filed 3–24–11; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Meeting for Software Developers on 

the Technical Specifications for 

Common Formats for Patient Safety 

Data Collection and Event Reporting 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice of public meeting. 

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. 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. In order to support the Common 

Formats, AHRQ has provided technical 

specifications to promote 

standardization by ensuring that data 

collected by PSOs and other entities are 

clinically and electronically 

comparable. More information on the 

Common Formats, including the 

technical specifications, can be obtained 

through AHRQ’s PSO Web site: http:// 

www.PSO.AHRQ.GOV/index.html. 

The purpose of this notice is to 

announce a meeting to discuss the 

technical specifications, including the 

Hospital Common Formats technical 

specifications and the Skilled Nursing 

Facility Common Formats. This meeting 

is designed as an interactive forum 

where PSOs and software developers 

can provide input on these technical 


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16786 Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices 

specifications for the Common Formats. 

AHRQ especially requests input from 

those entities which have used AHRQ’s 

technical specifications and 

implemented, or plan to implement, the 

formats electronically. 

DATES: The meeting will be held from 10 

a.m. to 3:30 p.m. on May 11, 2011. 

ADDRESSES: The meeting will be held at 

the Hilton Washington DC/Rockville 

Meeting Center, 1750 Rockville Pike, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Susan Grinder, 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. 

If sign language interpretation or other 

reasonable accommodation for a 

disability is needed, please contact the 

Food and Drug Administration (FDA) 

Office of Equal Employment 

Opportunity and Disability Management 

at (301) 827–4840, no later than April 

28, 2011. 

SUPPLEMENTARY INFORMATION: 

Background 

The Patient Safety Act and Patient 

Safety Rule establish a framework by 

which doctors, hospitals, skilled 

nursing facilities, 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, including 

any relevant guidance, can be accessed 

electronically at: http:// 

www.PSO.AHRQ.GOV/REGULATIONS/ 

REGULATIONS.htm. 

In order to facilitate standardized data 

collection, AHRQ develops and 

maintains 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, developed for 

acute care hospitals. 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. As an update to this release, 

AHRQ developed the beta version of an 

event-specific format—Device or 

Supply, including Health Information 

Technology—to capture information 

about patient safety events that are 

related to health information 

technology. This update was announced 

in the Federal Register on October 22, 

2010: 75 FR 65359–65360. Most 

recently, AHRQ released the beta 

version of the Skilled Nursing Facilities 

format for reporting of patient safety 

events in skilled nursing facilities as 

announced in the Federal Register on 

March 7, 2011: 76 FR 12358–12359. 

This meeting will focus on discussion 

of the technical specifications, which 

provide direction to software developers 

that plan to implement the Common 

Formats electronically. The technical 

specifications are a critical component 

that allow for the aggregation of patient 

safety event data by standardizing the 

patient safety event information 

collected and specifying standard rules 

for data collection, as well as providing 

guidance for how and when to create 

data elements, their valid values, and 

conditional and go-to logic for the data 

elements. In addition to standardizing 

the information collected, they specify 

the data submission file format. 

The technical specifications consist of 

the following: 

Æ Data dictionary—defines data 

elements and their attributes (data 

element name, answer values, field 

length, guide for use, etc.) included in 

Common Formats; 

Æ Clinical document architecture 

(CDA) implementation guide—provides 

instructions for developing a Health 

Level Seven (HL7) CDA Extensible 

Markup Language (XML) file to transmit 

the Common Formats Patient Safety 

data from the PSO to the PPC using the 

Common Formats; 

Æ Validation rules and errors 

document-specifies and defines the 

validation rules that will be applied to 

the Common Formats data elements 

submitted to the PPC; 

Æ Common Formats flow charts— 

diagrams the valid paths to complete 

generic and event specific formats (a 

complete event report); 

Æ Local specifications—provides 

specifications for processing, linking 

and reporting on events and details 

specifications for reports; and 

Æ Metadata registry—includes 

descriptive facts about information 

contained in the data dictionary to 

illustrate how such data corresponds 

with similar data elements used by 

other Federal agencies and standards 

development organizations [e.g., HL–7, 

International Standards Organization 

(ISO)]. 

Agenda, Registration and Other 

Information About the Meeting 

On Wednesday, May 11, 2011, the 

meeting will convene at 10 a.m. with an 

overview of the Common Formats, 

including the Hospital Common 

Formats Version 1.1 technical 

specifications, the next steps for the 

Skilled Nursing Facility Common 

Formats, and Common Formats version 

issues. Next, AHRQ staff and contractors 

who developed the formats will provide 

an update on the report specifications 

scheduled to be released in March 2011. 

Finally, the meeting will focus on data 

submission both by PSOs and by 

vendors on behalf of a PSO. Throughout 

the meeting there will be interactive 

discussion to allow meeting participants 

not only to provide input, but also to 

respond to the input provided by others. 

A more specific proposed agenda will 

be posted before the meeting at http:// 

guest.cvent.com/d/wdqbt8/6X. 

AHRQ requests that interested 

persons register with the PSO Privacy 

Protection Center (PSO PPC) on the 

Internet at http://GUEST.cvent.com/d/ 

wdgbt8/4W to participate in the 

meeting. The contact at the PSO PPC is 

Rhonda Davis who can be reached by 

telephone at (866) 571–7712 and by email at support@psoppc.ORG. 

Additional logistical information for the 

meeting is also available from the PSO 

PPC. The meeting space will 

accommodate approximately 144 

participants. Interested persons are 

encouraged to register as soon as 

possible for the meeting. Non-registered 

individuals will be able to attend the 

meeting in person if space is available. 

We invite review of the technical 

specifications for Common Formats 

prior to the meeting. The formats can be 

accessed through AHRQ’s PSO Web site 

at http://www.pso.AHRQ.GOV/formats/ 

commonfmt.htm. AHRQ is committed to 


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Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices 16787 

continuing refinement of the Common 

Formats. AHRQ welcomes questions 

from prospective meeting participants 

and interested individuals on the 

technical specifications for Common 

Formats. These questions should be emailed to support@psoppc.ORG no later 

than April 27, 2011. AHRQ will use the 

input received at this meeting as we 

continue to update and refine the 

Common Formats. 

A summary of the meeting will be 

provided upon request. If you are 

unable to participate in the meeting and 

would like a copy of the summary, 

please send an e-mail to 

support@psoppc.ORG and it will be sent 

as soon as it is available after the 

meeting. 

Dated: March 15, 2011. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2011–6852 Filed 3–24–11; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Board on Radiation and 

Worker Health (ABRWH or Advisory 

Board), National Institute for 

Occupational Safety and Health 

(NIOSH) 

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

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC), 

announces the following meeting for the 

aforementioned committee: 

Time and Date: 11 a.m.–2 p.m., April 20, 

2011. 

Place: Audio Conference Call via FTS 

Conferencing. The USA toll-free, dial-in 

number is 1–866–659–0537 and the pass 

code is 9933701. 

Status: Open to the public, but without a 

public comment period. 

Background: The Advisory Board was 

established under the Energy Employees 

Occupational Illness Compensation Program 

Act of 2000 to advise the President on a 

variety of policy and technical functions 

required to implement and effectively 

manage the new compensation program. Key 

functions of the Advisory Board include 

providing advice on the development of 

probability of causation guidelines, which 

have been promulgated by the Department of 

Health and Human Services (HHS) as a final 

rule; advice on methods of dose 

reconstruction, which have also been 

promulgated by HHS as a final rule; advice 

on the scientific validity and quality of dose 

estimation and reconstruction efforts being 

performed for purposes of the compensation 

program; and advice on petitions to add 

classes of workers to the Special Exposure 

Cohort (SEC). 

In December 2000, the President delegated 

responsibility for funding, staffing, and 

operating the Advisory Board to HHS, which 

subsequently delegated this authority to the 

CDC. NIOSH implements this responsibility 

for CDC. The charter was issued on August 

3, 2001, renewed at appropriate intervals, 

most recently, August 3, 2009, and will 

expire on August 3, 2011. 

Purpose: This Advisory Board is charged 

with (a) Providing advice to the Secretary, 

HHS, on the development of guidelines 

under Executive Order 13179; (b) providing 

advice to the Secretary, HHS, on the 

scientific validity and quality of dose 

reconstruction efforts performed for this 

program; and (c) upon request by the 

Secretary, HHS, advising the Secretary on 

whether there is a class of employees at any 

Department of Energy facility who were 

exposed to radiation but for whom it is not 

feasible to estimate their radiation dose, and 

on whether there is reasonable likelihood 

that such radiation doses may have 

endangered the health of members of this 

class. 

Matters to be Discussed: The agenda for the 

conference call includes: NIOSH 10-Year 

Review of its Division of Compensation 

Analysis and Support (DCAS) Program; 

Subcommittee and Work Group Updates; 

DCAS SEC Petition Evaluations Update for 

the May 2011 Advisory Board Meeting; and 

Board Correspondence. 

The agenda is subject to change as 

priorities dictate. 

Because there is not a public comment 

period, written comments may be submitted. 

Any written comments received will be 

included in the official record of the meeting 

and should be submitted to the contact 

person below in advance of the meeting. 

Contact Person for More Information: 

Theodore M. Katz, M.P.A., Executive 

Secretary, NIOSH, CDC, 1600 Clifton Rd., 

NE., Mailstop: E–20, Atlanta, GA 30333, 

Telephone (513) 533–6800, Toll Free 1–800– 

CDC–INFO, E-mail ocas@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: March 18, 2011. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2011–7076 Filed 3–24–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Subcommittee for Dose 

Reconstruction Reviews (SDRR), 

Advisory Board on Radiation and 

Worker Health (ABRWH or the 

Advisory Board), National Institute for 

Occupational Safety and Health 

(NIOSH) 

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

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC), 

announces the following meeting for the 

aforementioned subcommittee: 

Time and Date: 9 a.m.–5 p.m., April 18, 

2011. 

Place: Cincinnati Airport Marriott, 2395 

Progress Drive, Hebron, Kentucky 41018. 

Telephone (859) 334–4611, Fax (859) 334– 

4619. 

Status: Open to the public, but without a 

public comment period. To access by 

conference call dial the following 

information 1 (866) 659–0537, Participant 

Pass Code 9933701. 

Background: The Advisory Board was 

established under the Energy Employees 

Occupational Illness Compensation Program 

Act of 2000 to advise the President on a 

variety of policy and technical functions 

required to implement and effectively 

manage the new compensation program. Key 

functions of the Advisory Board include 

providing advice on the development of 

probability of causation guidelines that have 

been promulgated by the Department of 

Health and Human Services (HHS) as a final 

rule; advice on methods of dose 

reconstruction which have also been 

promulgated by HHS as a final rule; advice 

on the scientific validity and quality of dose 

estimation and reconstruction efforts being 

performed for purposes of the compensation 

program; and advice on petitions to add 

classes of workers to the Special Exposure 

Cohort (SEC). 

In December 2000, the President delegated 

responsibility for funding, staffing, and 

operating the Advisory Board to HHS, which 

subsequently delegated this authority to CDC. 

NIOSH implements this responsibility for 

CDC. The charter was issued on August 3, 

2001, renewed at appropriate intervals, and 

will expire on August 3, 2011. 

Purpose: The Advisory Board is charged 

with (a) Providing advice to the Secretary, 

HHS, on the development of guidelines 

under Executive Order 13179; (b) providing 

advice to the Secretary, HHS, on the 

scientific validity and quality of dose 

reconstruction efforts performed for this 

program; and (c) upon request by the 

Secretary, HHS, advise the Secretary on 

whether there is a class of employees at any 

Department of Energy facility who were 

exposed to radiation but for whom it is not 

feasible to estimate their radiation dose, and 

on whether there is reasonable likelihood 


erowe on DSK5CLS3C1PROD with NOTICES