74788 Federal Register / Vol. 76, No. 231 / Thursday, December 1, 2011 / Notices 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued 

Form name/Deliberative method Number of 

respondents 

Total burden 

hours 

Average hourly 

wage rate Total cost burden 

Educational Materials ...................................................................... 1685 1685 21.35 35,975 

Knowledge and Attitudes Pretest Survey ........................................ 1685 843 $21.35 $17,998 

Knowledge and Attitudes Post-test Survey ..................................... 1685 562 21.35 11,999 

Deliberative Experience Survey ...................................................... 1056 264 21.35 5,636 

Total .......................................................................................... 8852 N/A N/A 248,662 

* Based upon the mean of the wages for 00–000 All Occupations ($21.35), May 2010 National Occupational Employment and Wage Estimates. 

United States, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ http://www.bls.gov/oes/current/oes_nat.htm#00–0000. 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 below breaks down the costs 

related to this study. These are the costs 

associated with the portion of the 

contract awarded to AIR to conduct the 

experiment. Since the implementation 

and evaluation periods will span 24 

months, the costs have been annualized 

by taking the total cost and dividing by 

2. 

EXHIBIT 3—ESTIMATED ANNUALIZED COST TO THE FEDERAL GOVERNMENT

Cost component Total cost Annualized cost 

Project Management ........................................................................................................................................ $60,106 $30,053 

Technical Expert Panel .................................................................................................................................... 117,793 58,896 

Technology Tools ............................................................................................................................................ 177,580 88,790 

Develop Educational Materials ........................................................................................................................ 368,624 184,312 

Evaluation Plan ................................................................................................................................................ 214,566 107,283 

Implement Methods ......................................................................................................................................... 1,624,169 812,085 

Conceptual Framework .................................................................................................................................... 50,195 25,098 

Data Processing and Analysis ......................................................................................................................... 566,846 283,423 

Reporting ......................................................................................................................................................... 135,693 67,847 

Overhead ......................................................................................................................................................... 1,281,340 640,670 

Total .......................................................................................................................................................... 4,596,914 2,298,457 

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: November 16, 2011. 

Carolyn Clancy, 

Director. 

[FR Doc. 2011–30795 Filed 11–30–11; 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 

HealthWatch, Inc. 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice of delisting. 

SUMMARY: AHRQ has accepted a 

notification of voluntary relinquishment 

from HealthWatch, Inc. 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 Midnight 

ET (2400) on November 1, 2011. 

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: 


emcdonald on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 231 / Thursday, December 1, 2011 / Notices 74789 

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 

HealthWatch, Inc., PSO number P0010, 

which is a component entity of Quality 

Health Strategies, Inc., to voluntarily 

relinquish its status as a PSO. 

Accordingly, HealthWatch, Inc. was 

delisted effective at 12 Midnight ET 

(2400) on November 1, 2011. 

More information on PSOs can be 

obtained through AHRQ’s PSO Web site 

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

index.html. 

Dated: November 16, 2011. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2011–30798 Filed 11–30–11; 8:45 a.m.] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Pressure Ulcer Treatment Medical 

Devices 

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 pressure ulcer 

treatment medical devices, such as (but 

not limited to): Ultrasonic wound care 

systems, negative pressure therapy 

units, turning & positioning systems, 

special mattresses, mattress covers, 

pillows, cushions, etc. Scientific 

information is being solicited to inform 

our Pressure Ulcer Treatment Strategies: 

A Comparative Effectiveness Review, 

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 these devices 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 January 3, 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 

pressure ulcer treatment strategies. 

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 pressure ulcer 

treatment strategies, 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://effective

healthcare.AHRQ.gov/index.cfm/search

-for-guides-reviews-and-reports/

?pageaction=displayproduct&productid

=838#3870. 

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 

A preliminary set of KQs was posted 

on the Effective Health Care Program 

Web site of the Agency for Healthcare 

Research and Quality (AHRQ), and 

public comments were collected and 

evaluated. 

A Summary of the Public Comments 

Most of the public comments 

addressed specific patient or treatment 

characteristics and settings. 

Commenters suggested that the review 


emcdonald on DSK5VPTVN1PROD with NOTICES