Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 7605 

technology to minimize the information 

collection burden. 

Darius Taylor, 

Information Collection Clearance Officer. 

[FR Doc. 2015–02760 Filed 2–10–15; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Decision To Evaluate a Petition To 

Designate a Class of Employees From 

the Carborundum Company in Niagara 

Falls, New York, To Be Included in the 

Special Exposure Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention, Department of Health 

and Human Services. 

ACTION: Notice. 

SUMMARY: NIOSH gives notice as 

required by 42 CFR 83.12(e) of a 

decision to evaluate a petition to 

designate a class of employees from the 

Carborundum Company in Niagara 

Falls, New York, to be included in the 

Special Exposure Cohort under the 

Energy Employees Occupational Illness 

Compensation Program Act of 2000. The 

initial proposed definition for the class 

being evaluated, subject to revision as 

warranted by the evaluation, is as 

follows: 

Facility: Carborundum Company. 

Location: Niagara Falls, New York. 

Job Titles and/or Job Duties: All 

employees who worked in any area. 

Period of Employment: January 1, 

1943 through December 31, 1976. 

FOR FURTHER INFORMATION CONTACT: 

Stuart L. Hinnefeld, Director, Division 

of Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health, 1090 Tusculum 

Avenue, MS C–46, Cincinnati, OH 

45226–1938, Telephone 877–222–7570. 

Information requests can also be 

submitted by email to DCAS@CDC.GOV. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health. 

[FR Doc. 2015–02803 Filed 2–10–15; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Meeting for Software Developers on 

the Common Formats for Patient 

Safety Data Collection and Event 

Reporting 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), Department of 

Health and Human Services (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(b)) 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 

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. 

The purpose of this notice is to 

announce a meeting to discuss the 

Common Formats. This meeting is 

designed as an interactive forum where 

software developers and PSOs can 

provide input on the formats. AHRQ 

especially requests participation by and 

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 

10:00 a.m. to 3:30 p.m. on Friday, April 

24, 2015. 

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. 

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 

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 

practicable 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/LEGISLATION. 

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. 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. 


tkelley on DSK3SPTVN1PROD with NOTICES
7606 Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 

AHRQ convenes the PSWG to assist 

AHRQ with developing and maintaining 

the Common Formats. The PSWG 

includes major health agencies within 

HHS—the Centers for Disease Control 

and Prevention, Centers for Medicare 

and 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, the 

NQF solicits feedback on the initial 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 PSOs, so that the 

Common Formats can be submitted 

electronically to the PSO Privacy 

Protection Center (PSOPPC) for data deidentification and transmission to the 

Network of Patient Safety Databases 

(NPSD). 

Common Formats 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 PSOPPC 

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 PSOPPC; 

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 

The 2015 meeting will be an 

interactive forum designed to allow 

meeting participants not only to provide 

input but also to respond to the input 

provided by others. The meeting agenda 

will include: An overview of Federal 

efforts related to the Common Formats; 

presentations and discussion of 

implementation of Common Formats 

Event Reporting—Hospital Versions 1.1 

and 1.2; and, a review of data 

submission both by PSOs and by 

vendors on behalf of PSOs. 

AHRQ requests that interested 

persons send an email to the PSOPPC at 

support@psoppc.ORG for registration 

information. The meeting space will 

accommodate approximately 150 

participants. Before the meeting, a 

detailed agenda and logistical 

information will be provided to 

registrants. Prior to the meeting, AHRQ 

invites review of the technical 

specifications for Common Formats 

which can be accessed through AHRQ’s 

PSO Web site at http://

www.pso.AHRQ.GOV/formats/

commonfmt.htm. 

Dated: February 3, 2015. 

Richard Kronick, 

Director. 

[FR Doc. 2015–02590 Filed 2–10–15; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Opportunity To Collaborate in the 

Evaluation of Simplified Nucleic Acid 

Tests for Detecting and Quantifying 

HIV 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (DHHS). 

ACTION: General notice. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), 

Department of Health and Human 

Services (HHS) announces an 

opportunity for industry and the public 

to collaborate on a project to evaluate 

simplified nucleic acid tests. HHS/CDC 

is interested in evaluating simplified 

nucleic acid tests that (1) can be used 

near a patient with rapid turn-around of 

results (2) can be used to aid in the 

diagnosis of HIV–1 infection, and (3) 

have the potential to be used in 

moderately complex and/or waived 

laboratories as defined under the 

Clinical Laboratory Improvement 

Amendment (CLIA) regulations. Tests of 

interest include those that use whole 

blood, serum, plasma, or dried blood 

spots. Performance will be evaluated 

relative to HHS/Food and Drug 

Administration (FDA)-approved 

qualitative and quantitative nucleic acid 

tests as well as antibody immunoassays. 

More than one collaborator may be 

selected. 

DATES: Formal proposals must be 

received on or before April 13, 2015. 

ADDRESSES: Formal proposals should be 

submitted to Division of HIV/AIDS 

Prevention, National Center for HIV/

AIDS, Viral Hepatitis, STD, and TB 

Prevention, Centers for Disease Control 

and Prevention, 1600 Clifton Road NE., 

Mailstop E–46, Atlanta, Georgia 30329, 

Attn: Simplified Nucleic Acid Tests 

Evaluation Project. If you are interested 

in submitting a proposal, please send a 

letter of interest to Dr. Michele Owen at 

smo2@cdc.gov by March 13, 2015. The 

letter of interest is not considered a 

formal proposal and is not required; 

however, it is highly recommended, as 

it will assist CDC in planning for the 

review process. The formal proposal 

will still need to be submitted according 

to the instructions in this notice. 

FOR FURTHER INFORMATION CONTACT: 

Questions on the project should be 

addressed to: Laura Wesolowski, 

National Center for HIV/AIDS, Viral 

Hepatitis, STD, and TB Prevention, 

Centers for Disease Control and 


tkelley on DSK3SPTVN1PROD with NOTICES