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

EXHIBIT 

### 2—E STIMATED 

### A NNUALIZED 

### COST 

### B URDEN

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—E STIMATED 

### TOTAL AND 

### A NNUALIZED 

### 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


### 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 bytelephone 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


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

continuing refinement of the Common Formats. AHRQ welcomes questions from prospective meeting participants and interested individuals on the technical specifications for CommonFormats. 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