Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices 11123 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Local Therapies for Unresectable 

Colorectal Cancer Metastases to the 

Liver 

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 unresectable colorectal 

cancer medical devices. Scientific 

information is being solicited to inform 

our Comparative Effectiveness Review 

of Local Therapies for Unresectable 

Colorectal Cancer Metastases to the 

Liver, 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published and unpublished pertinent 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://effective

healthcare.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 

local therapies for unresectable 

colorectal cancer metastases to the liver. 

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 local therapies 

for unresectable colorectal cancer 

metastases to the liver, 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-reportsflPAGE

action=displayproduct&productid=949. 

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 

What is the comparative effectiveness 

of the various liver-directed therapies in 

patients whose disease is refractory to 

systemic therapy for unresectable 

colorectal cancer (CRC) metastases to 

the liver and who have minimal 

evidence of extrahepatic disease? 

Question 2 

What are the comparative harms of 

the various liver-directed therapies in 

patients whose disease is refractory to 

systemic therapy for unresectable CRC 

metastases to the liver and who have 

minimal evidence of extrahepatic 

disease? 

Question 3 

What is the comparative effectiveness 

of the various liver-directed therapies in 

patients who are candidates for liverdirected therapy as an adjunct to 

systemic therapy for unresectable CRC 

metastases to the liver and have no 

evidence of extrahepatic disease? 

Question 4 

What are the comparative harms of 

the various liver-directed therapies in 

patients who are candidates for liverdirected therapy as an adjunct to 

systemic therapy for unresectable CRC 

metastases to the liver and have no 

evidence of extrahepatic disease? 

Dated: February 15, 2012. 

Carolyn M. Clancy, 

AHRQ, Director. 

[FR Doc. 2012–4256 Filed 2–23–12; 8:45 am] 

BILLING CODE 4160–90–M 


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