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unpublished pertinent scientific 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
74790 Federal Register / Vol. 76, No. 231 / Thursday, December 1, 2011 / Notices 

should address combinations of 

treatments, co-morbid conditions, and 

ulcer characteristics that require an 

individualized approach to treatment. 

These comments led us to expand the 

potential range of treatments evaluated 

in the review. Because treatment goals 

for patients in hospice care differ widely 

from patients with pressure ulcers in 

other settings (wound healing may not 

be a goal of hospice care), we excluded 

hospice from the list of care settings to 

be reviewed. The final set of KQs is as 

follows: 

Final Key Questions 

Question 1 

In adults with pressure ulcers, what is 

the comparative effectiveness of 

treatment strategies for improved health 

outcomes including but not limited to: 

Complete wound healing, healing time, 

reduced wound surface area, pain, and 

prevention of serious complications of 

infection? 

Question 1a 

Does the comparative effectiveness of 

treatment strategies differ according to 

features of the pressure ulcers, such as 

anatomic site or severity at baseline? 

Question 1b 

Does the comparative effectiveness of 

treatment strategies differ according to 

patient characteristics, including but not 

limited to: Age; race/ethnicity; body 

weight; specific medical co-morbidities; 

and known risk factors for pressure 

ulcers, such as functional ability, 

nutritional status, or incontinence? 

Question 1c 

Does the comparative effectiveness of 

treatment strategies differ according to 

patient care settings such as home, 

nursing facility, or hospital, or 

according to features of patient care 

settings, including but not limited to 

nurse/patient staffing ratio, staff 

education and training in wound care, 

the use of wound care teams, and home 

caregiver support and training? 

Question 2 

What are the harms of treatments for 

pressure ulcers? 

Question 2a 

Do the harms of treatment strategies 

differ according to features of the 

pressure ulcers, such as anatomic site or 

severity at baseline? 

Question 2b 

Do the harms of treatment strategies 

differ according to patient 

characteristics, including: Age, race/ 

ethnicity; body weight; specific medical 

co-morbidities; and knows risk factors 

for pressure ulcers, such as functional 

ability, nutritional status, or 

incontinence? 

Question 2c 

Do the harms of treatment strategies 

differ according to patient care settings 

such as home, nursing facility, or 

hospital, or according to features of 

patient care settings, including but not 

limited to nurse/patient staffing ratio, 

staff education and training in wound 

care, the use of wound care teams, and 

home caregiver support and training? 

The following PICOTS were identified 

for each KQ and include: 

Population 

• Adults ages 18 and older with 

pressure ulcers. 

Interventions 

• Various treatment strategies for 

pressure ulcers including but not 

limited to therapies that address the 

underlying contributing factors 

(e.g., support surfaces and nutritional 

supplements); therapies that address 

local wound care (e.g., absorbent wound 

dressings and biological agents); 

surgical repair; and adjunctive therapies 

(e.g., physical therapy). 

• Combined treatment modalities 

(co-interventions) will also be evaluated 

(such as comparing two treatments in 

combination with a single treatment). 

Comparators 

• Placebo or active control, usual 

care, or other interventions. 

Outcomes 

• For effectiveness: Complete wound 

healing, healing time, reduced wound 

surface area, pain, and prevention of 

serious complications of infection. 

• For harms of treatment: Pain, 

dermatologic complications, bleeding, 

and infection. 

Timing 

• Any duration of follow-up. 

Settings 

• Patient care settings, such as home, 

nursing facility, or hospital. 

Dated: November 16, 2011. 

Carolyn M. Clancy, 

AHRQ, Director. 

[FR Doc. 2011–30796 Filed 11–30–11; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0327] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Generic Clearance for the Collection of 

Qualitative Feedback on FDA Service 

Delivery 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Generic Clearance for the Collection of 

Qualitative Feedback on FDA Service 

Delivery’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, (301) 796– 

3794, Jonnalynn.Capezzuto@fda.hhs.

gov. 

SUPPLEMENTARY INFORMATION: On May 

26, 2011, the Agency submitted a 

proposed collection of information 

entitled ‘‘Generic Clearance for the 

Collection of Qualitative Feedback on 

FDA Service Delivery’’ to OMB for 

review and clearance under 44 U.S.C. 

3507. An Agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. OMB has now 

approved the information collection and 

has assigned OMB control number 

0910–0697. The approval expires on 

November 30, 2014. A copy of the 

supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/

public/do/PRAMain. 

Dated: November 25, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–30877 Filed 11–30–11; 8:45 am] 

BILLING CODE 4160–01–P 


emcdonald on DSK5VPTVN1PROD with NOTICES