22322 Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices 

1http://nctt.nih.gov/27543703. 

2http://ntp.niehs.nih.gov/go/28213. 

3http://www.epa.gov/ncct/Tox21/. 

4http://www.fda.gov/. 

FOR FURTHER INFORMATION CONTACT: 

Nominations of assays should be 

submitted online at http:// 

iccvam.niehs.nih.gov/contact/Tox21- 

nomination.htm (preferred means) or to 

Dr. Warren Casey, Deputy Director, 

NICEATM, NIEHS, P.O. Box 12233, 

Mail Stop: K2–16, Research Triangle 

Park, NC 27709, (telephone) 919–541– 

2384, (fax) 919–541–0947, (email) 

niceatm@niehs.nih.gov. Courier address: 

NICEATM, NIEHS, Room 2034, 530 

Davis Drive, Morrisville, NC 27560. 

SUPPLEMENTARY INFORMATION: 

Background 

The Tox21 Consortium is a 

collaboration of the NIH Center for 

Translational Therapeutics (NCTT),1

NIEHS/NTP,2 U.S. Environmental 

Protection Agency (EPA),3 and U.S. 

Food and Drug Administration (FDA).4

The goal of Tox21 is to develop, 

validate, and translate innovative HTS 

methods to characterize the impact of 

chemicals on key steps in toxicity 

pathways and ultimately to provide 

tools to risk assessors to protect human 

health and the environment. 

The Tox21 HTS Initiative aims to 

prioritize substances for in-depth 

toxicological evaluation, identify 

mechanisms of action for further 

investigation, and develop predictive 

models for in vivo biological responses 

using efficient, high throughput in vitro 

assays. Tox21 also aims to expand the 

ability to screen environmental 

compounds for organ-specific toxicity, 

focusing in particular on the liver, 

kidney, and nervous system. 

The current Tox21 inventory of 

10,000 chemicals covers a variety of 

classifications, including consumer 

products, food additives, human and 

veterinary drugs, manufacturing 

intermediates, and pesticides. These 

10,000 chemicals are being profiled 

using HTS assays designed to estimate 

toxicity potential and identify the 

specific perturbations they induce in 

biological pathways. 

Request for Nominations of HTS Assays 

NICEATM requests nominations of in 

vitro HTS toxicity assays that might be 

used in the Tox21 testing program. 

Tox21 intends to develop a systematic 

view of how chemicals interact with 

and affect biological systems using its 

collection of 10,000 chemicals. To 

achieve this goal, assays, which target 

all pathways relevant to toxicity, are 

needed to assess chemicals’ effects. 

Nominated assays will be assessed for 

their overall applicability to the Tox21 

HTS program in terms of biological 

relevance, cost, and potential for 

adaption to a HTS format. Suitable 

assays will then be prioritized for use by 

the NCTT. Protocol information and test 

data submitted in response to this notice 

may be incorporated into future NCTT 

and NICEATM reports and publications 

as appropriate. 

Nominations should consider the 

following general criteria: (1) Relevance 

to the goals of the Tox21 Initiative 

(http://nctt.nih.gov/27543703), (2) high 

throughput capability of the assay (96- 

well format or higher, with no obvious 

impediments to miniaturization to a 

1536-well format), (3) evaluation of 

preliminary assay performance using 

appropriate reference compounds, (4) 

validation status of the assay, (5) 

availability of complete detailed 

protocols, and (6) efficiency and cost of 

the assay. A list of compatibility criteria 

for 1536-well biochemical and cellbased assays is available at http:// 

nctt.nih.gov/27545107. 

Assay nominations should be 

submitted electronically using the 

online form (http:// 

iccvam.niehs.nih.gov/contact/Tox21- 

nomination.htm). When submitting HTS 

assay nominations and protocol 

information, please reference this 

Federal Register notice and provide 

appropriate contact information (name, 

affiliation, mailing address, phone, fax, 

email, and sponsoring organization as 

applicable). NICEATM prefers 

submission of the nominations via the 

Web site identified above; however, 

submissions by mail, fax, or email are 

acceptable. Questions about the 

submission process should be directed 

to Dr. Warren Casey (see FOR FURTHER

INFORMATION CONTACT). 

Background Information on NICEATM 

NICEATM was established in 1998 to 

administer and provide scientific 

support for the Interagency 

Coordinating Committee on the 

Validation of Alternative Methods 

(ICCVAM), which is composed of 15 

member Federal agencies and includes 

the EPA, FDA, NIEHS, and NIH. The 

ICCVAM Authorization Act of 2000 (42 

U.S.C. 285l–2, 285l-5, available at http:// 

iccvam.niehs.nih.gov/about/ 

PL106545.htm) established ICCVAM as 

a permanent interagency committee of 

the NIEHS under NICEATM. NICEATM 

and ICCVAM conduct technical 

evaluations of new, revised, and 

alternative safety testing methods with 

regulatory applicability and promote the 

scientific validation and regulatory 

acceptance of safety-testing methods 

that more accurately assess the safety 

and hazards of chemicals and products 

and that will reduce, refine (enhance 

animal well-being and decrease or 

eliminate pain and distress), or replace 

animal use. NICEATM also conducts 

independent validation studies to assess 

the usefulness and limitations of new, 

revised, and alternative test methods 

and strategies applicable to the safetytesting needs of Federal agencies. In 

2012, NICEATM began providing 

support to Tox21 regarding HTS assay 

nomination and review. 

NICEATM and ICCVAM welcome the 

public nomination of new, revised, and 

alternative test methods and strategies 

applicable to the needs of Federal 

agencies. Additional information about 

NICEATM can be found on the 

NICEATM–ICCVAM Web site (http:// 

iccvam.niehs.nih.gov). 

Dated: April 5, 2012. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2012–8942 Filed 4–12–12; 8:45 am] 

BILLING CODE 4140–01–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—New 

Common Format. 

SUMMARY: As authorized by the 

Secretary of HHS, AHRQ coordinates 

the development of a set of common 

definitions and reporting formats 

(Common Formats) for reporting patient 

safety events to Patient Safety 

Organizations (PS0s). The purpose of 

this notice is to announce the 

availability of new Common Formats— 

Hospital Version 1.2 for public review 

and comment. 

DATES: Ongoing public input. 

ADDRESSES: The new Common 

Formats—Hospital Version 1.2, version 

dated April 2012, and the remaining 

Common Formats can be accessed 

electronically at the following HHS Web 

site: http://www.PSO.AHRQ.gov/ 

index.html. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn Niane, Center for Quality 

Improvement and Patient Safety, AHRQ, 

540 Gaither Road, Rockville, MD 20850; 

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


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Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices 22323 

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 and Quality 

Improvement Act of 2005, 42 U.S.C. 

299b–21 to b–26, (Patient Safety Act) 

provides for the formation of PS0s, 

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 healthcare 

providers to voluntarily collect and 

submit 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. The collection of patient safety 

work product allows the aggregation of 

sufficient data to identify and address 

underlying causal factors of patient 

safety problems. 

The Patient Safety Act and Patient 

Safety Rule establish a framework by 

which doctors, hospitals, skilled 

nursing facilities, and other healthcare 

providers may assemble 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 Act and Patient Safety Rule 

which can be accessed electronically at: 

http://www.PSO.AHRQ.gov/ 

REGULATIONS/REGULATIONS.htm. 

Definition of Common Formats 

The term ‘‘Common Formats’’ refers 

to the common definitions and reporting 

formats, specified by AHRQ, that allow 

health care providers to collect and 

submit standardized information 

regarding patient safety events. 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; rather the formats are 

intended to enhance the ability of health 

care providers to report information that 

is standardized both clinically and 

electronically. 

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 scope of Common 

Formats applies to all patient safety 

concerns including: Incidents—patient 

safety events that reached the patient, 

whether or not there was harm; near 

misses or close calls—patient safety 

events that did not reach the patient; 

and unsafe conditions—circumstances 

that increase the probability of a patient 

safety event. 

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. 

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. They 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 

Privacy Protection Center (PPC) for data 

de-identification and transmission to 

the Network of Patient Safety Databases 

(NPSD). 

The Common Formats include two 

general types of formats, generic and 

event-specific. The generic Common 

Formats pertain to all patient safety 

concerns. The three generic formats are: 

Healthcare Event Reporting Form, 

Patient Information Form, and Summary 

of Initial Report. The event-specific 

Common Formats pertain to frequentlyoccurring and/or serious patient safety 

events. 

Since the initial release of the 

Common Formats in August 2008, 

AHRQ regularly revises the formats 

based upon public comment. The 

Common Formats—Hospital Version 1.2 

features new content to incorporate the 

event specific formats entitled Venous 

Thromboembolism (VTE) and Device or 

Medical/Surgical Supply including 

Health Information Technology (HIT) 

Device. Common Formats—Hospital 

Version 1.2, which also includes minor 

changes to existing modules and 

technical specifications, is available at 

the PSO PPC Web site: https:// 

www.PSOPPC.ORG/web/patientsafety. 

Common Formats Development 

In anticipation of the need for 

Common Formats, AHRQ began their 

development by creating an inventory of 

functioning private and public sector 

patient safety reporting systems. This 

inventory provides an evidence base 

that informs construction of the 

Common Formats. The inventory 

includes many systems from the private 

sector, including prominent academic 

settings, hospital systems, and 

international reporting systems (e.g., 

from the United Kingdom and the 

Commonwealth of Australia). In 

addition, virtually all major Federal 

patient safety reporting systems are 

included, such as those from the Centers 

for Disease Control and Prevention 

(CDC), the Food and Drug 

Administration (FDA), the Department 

of Defense (DoD), and the Department of 

Veterans Affairs (VA). 

Since February 2005, AHRQ has 

convened the PSWG to assist AHRQ 

with developing and maintaining the 

Common Formats. The PSWG includes 

major health agencies within HHS— 

CDC, Centers for Medicare & Medicaid 

Services, FDA, 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 

DoD and VA. 

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. The PSWG assists AHRQ 

with assuring the consistency of 

definitions/formats with those of 

relevant government agencies as 

refinement of the Common Formats 

continues. To the extent practicable, the 

Common Formats are also aligned with 

World Health Organization (WHO) 

concepts, framework, and definitions 


pmangrum on DSK3VPTVN1PROD with NOTICES
22324 Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices 

contained in their draft International 

Classification for Patient Safety (ICPS). 

Commenting on Common Formats 

Hospital 1.2 

To allow for greater participation by 

the private sector in the subsequent 

development of the Common Formats, 

AHRQ engaged the NQF, a non-profit 

organization focused on health care 

quality, to solicit comments and advice 

to guide the further refinement of the 

Common Formats. The NQF then 

convenes an expert panel to review the 

comments received and provide 

feedback. The NQF began this process 

with feedback on AHRQ’s 0.1 Beta 

release of the Common Formats in 2008. 

Based upon the expert panel’s feedback, 

AHRQ, in conjunction with the PSWG, 

revises and refines the Common 

Formats. 

The Agency is specifically interested 

in obtaining feedback from both the 

private and public sectors on the new 

Common Formats—Hospital Version 1.2 

to guide the improvement of the 

formats. Information on how to 

comment and provide feedback on the 

Common Formats—Hospital Version 

1.2, is available at the NQF Web site for 

Common Formats: http:// 

www.Quality.forum.ORG/projects/ 

commonformats.aspx. 

The process for updating and refining 

the formats will continue to be an 

iterative one. Future versions of the 

Common Formats will be developed for 

ambulatory settings, such as ambulatory 

surgery centers and physician and 

practitioner offices. More information 

on the Common Formats can be 

obtained through AHRQ’s PSO Web site: 

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

Dated: April 5, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–8743 Filed 4–12–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Correction—Solicitation for 

Nominations for Members of the U.S. 

Preventive Services Task Force 

(USPSTF) 

The original date of publication for 

this Federal Register notice was March 

28, 2012, Volume 77, Number 60, pages 

18823–18825. On this publication, 

Gloria Washington’s email address is 

incorrect in two places of page 18824 

under subheadings ADDRESSES: and FOR

FURTHER INFORMATION CONTACT:. The 

correct email address for Gloria 

Washington is: USPSTFmember

nominations@AHRQ.HHS.GOV 

Dated: April 4, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–8737 Filed 4–12–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Treatment of Tinnitus 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for scientific 

information submissions. 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) is seeking 

scientific information submissions from 

manufacturers of cochlear implants, 

sound masking devices, hearing aids, 

and transcranial magnetic stimulation 

medical devices. Scientific information 

is being solicited to inform our 

Comparative Effectiveness Review of 

Evaluation and Treatment of Tinnitus, 

which is currently being conducted by 

the Evidence-based Practice Centers for 

the AHRQ Effective Health Care 

Program. Access to published and 

unpublished pertinent scientific 

information on this device will improve 

the quality of this comparative 

effectiveness review. AHRQ is 

requesting this scientific information 

and conducting this comparative 

effectiveness review pursuant to Section 

1013 of the Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003, Public Law 108–173. 

DATES: Submission Deadline on or 

before May 14, 2012. 

ADDRESSES: Online submissions: 

http://effectivehealthcare.AHRQ.gov/ 

index.cfm/submitscientific-informationpackets/. Please select the study for 

which you are submitting information 

from the list of current studies and 

complete the form to upload your 

documents. 

Email submissions: 

ehcsrc@ohsu.edu (please do not send 

zipped files—they are automatically 

deleted for security reasons). 

Print submissions: Robin Paynter, 

Oregon Health and Science University, 

Oregon Evidence-based Practice Center, 

3181 SW Sam Jackson Park Road, Mail 

Code: BICC, Portland, OR 97239–3098. 

FOR FURTHER INFORMATION CONTACT: 

Robin Paynter, Research Librarian, 

Telephone: 503–494–0147 or Email: 

ehcsrc@ohsu.edu. 

SUPPLEMENTARY INFORMATION: In 

accordance with Section 1013 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003, Public Law 108–173, the Agency 

for Healthcare Research and Quality has 

commissioned the Effective Health Care 

(EHC) Program Evidence-based Practice 

Centers to complete a comparative 

effectiveness review of the evidence for 

evaluation and treatment of tinnitus. 

The EHC Program is dedicated to 

identifying as many studies as possible 

that are relevant to the questions for 

each of its reviews. In order to do so, we 

are supplementing the usual manual 

and electronic database searches of the 

literature by systematically requesting 

information (e.g., details of studies 

conducted) from medical device 

industry stakeholders through public 

information requests, including via the 

Federal Register and direct postal and/ 

or online solicitations. We are looking 

for studies that report on treatment of 

tinnitus, including those that describe 

adverse events, as specified in the key 

questions detailed below. The entire 

research protocol, including the key 

questions, is also available online at: 

http://www.effectivehealthcare.AHRQ.

gov/index.cfm/search-for-guidesreviews-and-reports/?pageaction=

displayproduct&productid=811#4755. 

This notice is a request for industry 

stakeholders to submit the following: 

• A current product label, if 

applicable (preferably an electronic PDF 

file). 

• Information identifying published 

randomized controlled trials and 

observational studies relevant to the 

clinical outcomes. Please provide both a 

list of citations and reprints if possible. 

• Information identifying 

unpublished randomized controlled 

trials and observational studies relevant 

to the clinical outcomes. If possible, 

please provide a summary that includes 

the following elements: study number, 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, primary and secondary 

outcomes, baseline characteristics, 

number of patients screened/eligible/ 

enrolled/lost to withdrawn/follow-up/ 

analyzed, and effectiveness/efficacy and 

safety results. 

• Registered ClinicalTrials.gov 

studies. Please provide a list including 

the ClinicalTrials.gov identifier, 

condition, and intervention. 

Your contribution is very beneficial to 

this program. AHRQ is not requesting 


pmangrum on DSK3VPTVN1PROD with NOTICES