### 12063 Federal Register / Vol. 78, No. 35 / Thursday, February 21, 2013 / Notices

balanced in terms of points of view represented and the functions to be performed by the advisory committee. Every effort is made to ensure that the views of women, all ethnic and racial groups, and people with disabilities are represented on HHS federal advisory committees. Therefore, the Department encourages nominations of qualified candidates from these groups. The Department also takes into consideration geographic diversity in the composition of the committee. Appointment to this committee shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic

status.

Individuals who are appointed as public members of federal advisory committees are classified as special government employees (SGEs). SGEs who are appointed to serve as members of federal advisory committees are subject to the ethical standards of conduct for federal employees. Upon entering the position and annually throughout the term of appointment, the public members appointed to the ACBTSA will be required to complete and submit a report of their financial holdings, including information about consultancies and research grants or contracts, so that an ethics analysis can be conducted to ensure that members are not involved in activities in the private sector that may pose potential conflicts of interest for performance of their official duties for the Committee.

Dated: February 15, 2013. James J. Berger, Senior Advisor for Blood Policy.

[FR Doc. 2013–04036 Filed 2–20–13; 8:45 am]

**BILLING CODE 4150–41–P**

**DEPARTMENT OF HEALTH AND HUMAN SERVICES** 

**Announcement of Requirements and Registration for healthfinder.gov**  **Mobile App Challenge; Correction**

**AGENCY :**  Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and
Human Services.

**ACTION :**  Notice; correction.

**SUMMARY :**  The Office of Disease Prevention and Health Promotion published a document in the Federal Register of December 6, 2012, announcing the requirements and criteria for the healthfinder.gov Mobile App Challenge. The document contained inaccurate wording in one subsection of the terms and conditions.

**FOR FURTHER INFORMATION CONTACT :**  Silje Lier, MPH, Communication Advisor, Office of Disease Prevention and Health Promotion, U.S. Department of Health and Human Services. Email Silje.Lier@hhs.gov; phone 240–453–

6113.

Correction

In the Federal Register of December 6, 2012, in FR Doc. 2012–29520, on pages 72864–72865, in the second column, correct section 9 under the ‘‘Eligibility Rules’’ caption to read:

(9) Each applicant retains title and full ownership in and to their submission. Applicant expressly reserves all intellectual property rights not expressly granted under this agreement. Applicants must agree to irrevocably grant to federal government a non-exclusive, royalty free, perpetual, irrevocable, worldwide license and right, with the right to sublicense, under entrant’s intellectual property rights, in the event that an entrant wins, to use, reproduce, publicly perform, publicly display, and freely distribute the submission provided by such entrant (with or without any modifications or derivative works thereto), or any portion or feature thereof, for a period of one (1) year following the date that the challenge winner is selected.

Dated: February 6, 2013. Don Wright, Deputy Assistant Secretary for Disease Prevention and Health Promotion, Office of Disease Prevention and Health Promotion.

[FR Doc. 2013–03882 Filed 2–20–13; 8:45 am]

**BILLING CODE 4150–32–P**

**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 health care 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 health care 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 Common Formats technical specifications. This meeting is designed as an interactive forum where PSOs and software developers can provide input on these technical specifications. 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 8:30 a.m. to 4:00 p.m. on Friday, April
26, 2013.

**ADDRESSES :**  The meeting will be held at the John M. Eisenberg Conference Center, Agency for Healthcare Research and Quality, 540 Gaither Road Rockville, MD 20850.

**FOR FURTHER INFORMATION CONTACT :**  Eileen Hogan, 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; Email: 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
10, 2013.

**SUPPLEMENTARY INFORMATION :**  Background

The Patient Safety Act and Patient Safety Rule establish a framework by which doctors, hospitals, skilled nursing facilities, and other health care


### 12064 Federal Register / Vol. 78, No. 35 / Thursday, February 21, 2013 / Notices

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 collaboration with the interagency Federal Patient Safety Workgroup (PSWG), the National Quality Forum (NQF) and the public, AHRQ has developed Common Formats for two settings of care—acute care hospitals and skilled nursing facilities—in order to facilitate standardized data collection. The term ‘‘Common Formats’’ refers to the common definitions and reporting formats that allow health care providers to collect and submit standardized information regarding patient safety events. AHRQ’s Common Formats include:

• Event descriptions (descriptions of patient safety events and unsafe conditions to be reported),

• Specifications for patient safety aggregate reports and individual event summaries,

• Delineation of data elements to be collected for different types of events to populate the reports,

• A user’s guide and quick guide, and

• Technical specifications for electronic data collection and reporting.

AHRQ convenes the PSWG to assist AHRQ with developing and maintaining the Common Formats. The PSWG includes major health agencies within the Department of Health and Human Services (HHS)—the Centers for Disease Control and Prevention, Centers for Medicare & Medicaid Services, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, National Library of Medicine, Office of the National Coordinator for Health Information Technology, Office of Public Health and Science, and Substance Abuse and Mental Health Services Administration—as well as the Department of Defense and Department of Veterans Affairs.

When developing Common Formats, AHRQ first reviews existing patient safety event reporting systems from a variety of health care organizations. In collaboration with the PSWG and Federal subject matter experts, AHRQ drafts and releases beta versions of the Common Formats for public review and

comment.

Through a contract with AHRQ, NQF solicits feedback on the beta (and subsequent) versions of the Common Formats from private sector organizations and individuals. The NQF, a nonprofit organization that focuses on health care quality, then convenes an expert panel to review the comments received and provide feedback to AHRQ. Based upon the expert panel’s feedback, AHRQ, in conjunction with the PSWG, further revises the Common Formats.

The technical specifications promote standardization of collected patient safety event information by specifying rules for data collection and submission, as well as by providing guidance for how and when to create data elements, their valid values, conditional and go-to logic, and reports. These specifications will ensure that data collected by PSOs and other entities have comparable clinical meaning.

The technical specifications also provide direction to software developers, so that the Common Formats can be implemented electronically, and to PS0s, so that the Common Formats can be submitted electronically to the PSO PrivacyProtection Center (PSOPPC) for data deidentification and transmission to the Network of Patient Safety Databases (NPSD).

Most recently, AHRQ and the PSWG announced the release of Common Formats—Hospital Version 1.2 in the Federal Register on April 13, 2012: 77 FR 22322–22324. The Common Format—Readmissions Version 0.1 Beta for analysis of the circumstances surrounding readmissions into acute care hospitals was announced in the Federal Register on July 20, 2012: 77 FR

42736–42737.

The Software Developer’s meeting will focus on discussion of the implementation and use of Hospital Common Formats 1.1 and 1.2; the technical specifications, which provide direction to software developers that plan to implement the Common Formats electronically; and future development plans for the Common Formats. The technical specifications are a critical component that allow for the aggregation of patient safety event data.

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 file to transmit the Common Formats Patient Safety data from the PSO to the PSO 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 PSO 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 Friday, April 26, 2013, a premeeting seminar will convene at 8:30 a.m. with focus on data submission, including discussion of technical specifications and aggregate reports. Then, the general meeting will start at 10:00 a.m. with an overview of Federal efforts related to the Common Formats. The agenda will continue with presentations and discussion of implementations of Hospital Common Formats Version 1.1 and 1.2 and next steps for upcoming Common Formats releases. AHRQ staff and contractors will also review database functionality, which is available through the PSO PPC, for PSOs to generate aggregate reports with technical specifications. Finally, the meeting will review data submission both by PSOs and by vendors on behalf of a PSO. Throughout the meeting there will be interactive discussion to allow


### 12065 Federal Register / Vol. 78, No. 35 / Thursday, February 21, 2013 / Notices

meeting participants not only to provide input, but also to respond to the input provided by others. A more specific agenda will be provided to meeting registrants before the meeting.

AHRQ requests that interested persons register with the PSO PPC to participate in the meeting. The contact at the PSO PPC is Mark Baliff 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 150 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.

Prior to the meeting, AHRQ invites review of the technical specifications for Common Formats. The formats can be accessed through AHRQ’s PSO Web site

at http://www.pso.AHRQ.GOV/formats/ commonfmt.htm. AHRQ is committed to continuing refinement of the Common Formats, and welcomes questions from prospective meeting participants and interested individuals on the technical specifications. These questions should be emailed to SUPPORT@PSOPPC.ORG no later than April 10th, 2013. AHRQ will use the input received at this meeting to further update and refine the
Common Formats.

Dated: February 7, 2013. Carolyn M. Clancy,

Director.

[FR Doc. 2013–03911 Filed 2–20–13; 8:45 am]

**BILLING CODE 4160–90–M**

**DEPARTMENT OF HEALTH AND HUMAN SERVICES** 

**Agency for Healthcare Research and Quality** 

**Patient Safety Organizations: Delisting for Cause for Independent Data Safety**  **Monitoring, Inc.**

**AGENCY :**  Agency for Healthcare Research and Quality (AHRQ), HHS.

**ACTION :**  Notice of Delisting.

**SUMMARY :**  AHRQ has delisted Independent Data Safety Monitoring, Inc. due to its failure to correct a deficiency. The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) authorizes the listing of PSOs, which are entities or component organizations whose mission and primary activity is to conduct activities to improve patient safety and the quality of health care delivery. HHS issued the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) to implement the Patient Safety Act. AHRQ administers the provisions of the Patient Safety Act and Patient Safety Rule relating to the listing and operation of PSOs.

**DATES :**  The directories for both listed and delisted PSOs are ongoing and reviewed weekly by AHRQ. The delisting was effective at 12:00 Midnight ET (2400) on January 15, 2013.

**ADDRESSES :**  Both directories can be accessed electronically at the following HHS Web site: http:// www.pso.AHRQ.gov/index.html

. **FOR FURTHER INFORMATION CONTACT :**  Eileen Hogan, 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; Email: psoAHRQ.hhs.gov.

**SUPPLEMENTARY INFORMATION :**  Background

The Patient Safety Act, Public Law 109–41,42 U.S.C. 299b–21 b–26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety Rule, 42 CFR part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ‘‘delisted’’ by the Secretary if it is found no longer to meet the requirements of the Patient Safety Act and Patient Safety Rule. Section 3.108(d) of the Patient Safety Rule requires AHRQ to provide public notice when it removes an organization from the list of federally approved
PSOs.

Independent Data Safety Monitoring, Inc. failed to respond to a Notice of Preliminary Finding of Deficiency sent by AHRQ pursuant to 42 CFR 3.108(a)(2) and a Notice of Proposed Revocation and Delisting sent by AHRQ pursuant to 42 CFR 3.108(a)(3)(iii)(C) which found that Independent Data Safety Monitoring, Inc. had not complied with its attestation to notify the Secretary if there has been a change in the accuracy of the information it submitted for initial listing, which includes contact information for the PSO (42 CFR 3.102(a)(1)(vi)). Independent Data Safety Monitoring, Inc. did not exercise its opportunity to be heard in writing to respond to the deficiency specified in the notices, and has not provided any evidence of a good faith effort to correct the deficiency. As such, pursuant to 42 CFR 3.108(a)(4)(iii), the notice of proposed revocation became final as a matter of law and the basis for revocation.

Accordingly, AHRQ has revoked the listing of Independent Data Safety Monitoring, Inc., PSO number P0114, effective at 12:00 Midnight ET (2400) on January 15, 2013.

More information on PSOs can be obtained through AHRQ’s PSO Web site

at http://www.pso.AHRQ.gov/ index.html.

Dated: February 11, 2013. Carolyn M. Clancy,

Director.

[FR Doc. 2013–03909 Filed 2–20–13; 8:45 am]

**BILLING CODE 4160–90–M**

**DEPARTMENT OF HEALTH AND HUMAN SERVICES** 

**Centers for Disease Control and Prevention** 

**National Institute for Occupational Safety and Health Personal Protective**  **Technology for Pesticide Handlers: Stakeholder Meeting** 

**AGENCY :**  The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

**ACTION :**  Notice of public meeting.

**SUMMARY :**  The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ‘‘Pesticide Handler Personal Protective Technology Stakeholder Meeting’’.

Stakeholder Meeting Time and Date: 4 p.m.–6 p.m. EDT, March 25, 2013

[Optional] 8 a.m.–6 p.m. EDT, March 26, 2013.

Place: NIOSH, Patriots Plaza 1, 395 E. Street, SW., Room 9000, Washington, DC 20201. This meeting will also be accessible remotely through Live Meeting with advanced registration.

Purpose of the Meeting: This meeting is being held to motivate and educate pesticide handlers and pesticide workers to use best pesticide personal protective equipment practices. This stakeholder meeting allows NIOSH to facilitate focused communication and exchange ideas and solutions between key stakeholder groups. Stakeholder feedback is sought to provide input to future updates of the NIOSH Personal