Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Agency for Healthcare Research and Quality

# 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 chronic venous ulcer treatment medical devices. Scientific information is being solicited to inform our Chronic Venous Ulcers: A Comparative Effectiveness Review of Treatment Modalities report, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished                               ( print page 24719)                            pertinent scientific information on this device will improve the quality of this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 25, 2012.

# ADDRESSES:

*Online submissions:**http://effectivehealthcare.AHRQ.gov/​index.cfm/​submit-scientific-information-packets/​*. 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 chronic venous ulcer treatment modalities.

                    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 chronic venous ulcer treatments, 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-guides-reviews-and-reports/​?productid=​995&​pageaction=​displayproduct#4886*

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

### Question 1

For patients with chronic venous leg ulcers, what are the benefits and harms of using dressings that regulate wound moisture with or without active chemical, enzymatic, biologic, or antimicrobial components in conjunction with compression systems when compared with using solely compression systems?

### Question 2

a. For patients with chronic venous leg ulcers that do not have clinical signs of cellulitis that are being treated with compression systems, what are the benefits and harms of using systemic antibiotics when compared with using solely compression systems?

b. For patients with chronic venous leg ulcers that do not have clinical signs of cellulitis that are being treated with dressings that regulate wound moisture with or without active chemical, enzymatic, biologic, or antimicrobial components, what are the benefits and harms of using systemic antibiotics when compared with using dressings alone?

#### Question 3

a. For patients with chronic venous leg ulcers, what are the benefits and harms of surgical procedures aimed at the underlying venous abnormalities when compared with using solely compression systems?

b. For patients with chronic venous leg ulcers, what are the comparative benefits and harms of different surgical procedures for a given type of venous reflux and obstruction?

Dated: April 12, 2012.

Carolyn M. Clancy,

AHRQ, Director.

[FR Doc. 2012-9820 Filed 4-24-12; 8:45 am]

BILLING CODE 4160-90-M