[Federal Register Volume 77, Number 37 (Friday, February 24, 2012)]
[Notices]
[Page 11123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4256]



[[Page 11123]]

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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.

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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published and unpublished pertinent scientific information on this 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://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: [email protected] (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: [email protected].

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-for-GUIDESreviews-and-reportsflPAGEaction=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 liver-directed 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 liver-directed 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