11120 Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices 

In order to assist AHRQ and CMS to 

assess the importance, validity, and 

feasibility of submitted measures, a 

Subcommittee on Children’s Healthcare 

Quality Measures of the AHRQ National 

Advisory Council on Healthcare 

Research and Quality (SNAC) has been 

established (http://www.ahrq.gov/ 

chipra/panellist11.htm). The 

Subcommittee will consider measures 

submitted through this public call, and 

measures submitted by the 7 AHRQ– 

CMS Centers of Excellence. 

CHIPRA asks that measures in the 

improved core sets be: evidence-based; 

able to identify disparities by race, 

ethnicity, socioeconomic status, and 

special health care need; risk-adjusted 

as appropriate; and designed to ensure 

that data are collected and reported in 

a standard format that permits 

comparison of quality and data at a 

State, plan, and provider level. 

Dated: February 15, 2012. 

Carolyn M. Clancy, 

AHRQ Director. 

[FR Doc. 2012–4267 Filed 2–23–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Patient Safety Organizations: 

Voluntary Relinquishment From UAB 

Health System Patient Safety 

Organization 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice of Delisting. 

SUMMARY: AHRQ has accepted a 

notification of voluntary relinquishment 

from the UAB Health System Patient 

Safety Organization of its status as a 

Patient Safety Organization (PSO). The 

Patient Safety and Quality Improvement 

Act of 2005 (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 and Quality 

Improvement Final Rule (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 

to no longer meet the requirements of 

the Patient Safety Act and Patient Safety 

Rule, including when a PSO chooses to 

voluntarily relinquish its status as a 

PSO for any reason. 

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 13, 2012. 

ADDRESSES: Both directories can be 

accessed electronically at the following 

HHS Web site: http:// 

www.pso.AHRQ.gov/index.html. 

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; Email: 

pso@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The 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 Rule to 

implement the Patient Safety Act. 

AHRQ administers the provisions of the 

Patient Safety Act and Patient Safety 

Rule (PDF file, 450 KB. PDF Help) 

relating to the listing and operation of 

PSOs. 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. AHRQ has accepted a 

notification from the UAB Health 

System Patient Safety Organization, 

PSO number P0042, which is a 

component entity of the UAB Health 

System to voluntarily relinquish its 

status as a PSO. Accordingly, the UAB 

Health System Patient Safety 

Organization was delisted effective at 

12:00 Midnight ET (2400) on January 13, 

2012. 

More information on PSOs can be 

obtained through AHRQ’s PSO Web site 

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

index.html. 

Dated: February 15, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–4265 Filed 2–23–12; 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 Strategies for Patients With 

Peripheral Artery Disease (PAD) 

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 peripheral artery 

disease treatment medical devices. 

Scientific information is being solicited 

to inform our Comparative Effectiveness 

Review of Treatment Strategies for 

Patients with Peripheral Artery Disease 

(PAD), 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 March 26, 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 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices 11121 

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 

treatment strategies for patients with 

peripheral artery disease (PAD). 

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 

strategies for patients with peripheral 

artery disease, 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-forGUIDESreviews-and-reports/

?PAGEaction=displayproduct&

productid=948#4546. 

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 

and will not consider marketing 

material, health economics information, 

or information on other indications. 

This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. In addition to your scientific 

information please submit an index 

document outlining the relevant 

information in each file along with a 

statement regarding whether or not the 

submission comprises all of the 

complete information available. 

Please Note: The contents of all 

submissions, regardless of format, will be 

available to the public upon request unless 

prohibited by law. 

The draft of this review will be posted 

on AHRQ’s EHC program Web site and 

available for public comment for a 

period of 4 weeks. If you would like to 

be notified when the draft is posted, 

please sign up for the email list at: 

http://effectivehealthcare.AHRQ.gov/ 

index.cfm/join-the-email-list1/. 

The Key Questions 

KQ 1: In adults with peripheral artery 

disease (PAD), including asymptomatic 

patients and symptomatic patients with 

atypical leg symptoms, intermittent 

claudication (IC), or critical limb 

ischemia (CLI): 

a. What is the comparative 

effectiveness of aspirin and other 

antiplatelet agents in reducing the risk 

of adverse cardiovascular events (e.g., 

all-cause mortality, myocardial 

infarction, stroke, cardiovascular death), 

functional capacity, and quality of life? 

b. Does the effectiveness of treatments 

vary according to the patient’s PAD 

classification or by subgroup (age, sex, 

race, risk factors, or comorbidities)? 

c. What are the significant safety 

concerns associated with each treatment 

strategy (e.g., adverse drug reactions, 

bleeding)? Do the safety concerns vary 

by subgroup (age, sex, race, risk factors, 

comorbidities, or PAD classification)? 

KQ2: In adults with symptomatic PAD 

(atypical leg symptoms or IC): a. What 

is the comparative effectiveness of 

exercise training, medications 

(cilostazol, pentoxifylline), 

endovascular intervention 

(percutaneous transluminal angioplasty, 

atherectomy, or stents), and/or surgical 

revascularization (endarterectomy, 

bypass surgery) on outcomes including 

vessel patency, repeat revascularization, 

wound healing, analog pain scale score, 

cardiovascular events (e.g., all-cause 

mortality, myocardial infarction, stroke, 

cardiovascular death), amputation, 

functional capacity, and quality of life? 

b. Does the effectiveness of treatments 

vary by use of exercise and medical 

therapy prior to invasive management or 

by subgroup (age, sex, race, risk factors, 

comorbidities, or anatomic location of 

disease)? 

c. What are the significant safety 

concerns associated with each treatment 

strategy (e.g., adverse drug reactions, 

bleeding, contrast nephropathy, 

radiation, infection, exercise-related 

harms, and periprocedural 

complications causing acute limb 

ischemia)? Do the safety concerns vary 

by subgroup (age, sex, race, risk factors, 

comorbidities, anatomic location of 

disease)? 

KQ3: In adults with CLI due to PAD: 

a. What is the comparative 

effectiveness of endovascular 

intervention (percutaneous transluminal 

angioplasty, atherectomy, or stents) and 

surgical revascularization 

(endarterectomy, bypass surgery) for 

outcomes including vessel patency, 

repeat revascularization, wound 

healing, analog pain scale score, 

cardiovascular events (e.g., all-cause 

mortality, myocardial infarction, stroke, 

cardiovascular death), amputation, 

functional capacity, and quality of life? 

b. Does the effectiveness of treatments 

vary by subgroup (age, sex, race, risk 

factors, comorbidities, or anatomic 

location of disease)? 

c. What are the significant safety 

concerns associated with each treatment 

strategy (e.g., adverse drug reactions, 

bleeding, contrast nephropathy, 

radiation, infection, and periprocedural 

complications causing acute limb 

ischemia)? Do the safety concerns vary 

by subgroup (age, sex, race, risk factors, 

comorbidities, or anatomic location of 

disease)? 

Dated: February 15, 2012. 

Carolyn M. Clancy, 

AHRQ, Director. 

[FR Doc. 2012–4261 Filed 2–23–12; 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 Atrial Fibrillation 

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 atrial fibrillation 

medical devices. Scientific information 

is being solicited to inform our 

Comparative Effectiveness Review of the 

Treatment of Atrial Fibrillation, which 

is currently being conducted by the 

Evidence-based Practice Centers for the 

AHRQ Effective Health Care Program. 


srobinson on DSK4SPTVN1PROD with NOTICES