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[Federal Register Volume 77, Number 81 (Thursday, April 26, 2012)]
[Notices]
[Pages 24959-24960]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10011]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

Scientific Information Request on Local Therapies for 
Unresectable Primary Hepatocellular Carcinoma

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 local, 
minimally invasive, medical devices for unresectable primary 
hepatocellular carcinoma (e.g., ablation, radiotherapy, or embolization 
devices). Scientific information is being solicited to inform our 
Comparative Effectiveness Review of Local Therapies for Unresectable 
Primary Hepatocellular Carcinoma, 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 Access to published and unpublished pertinent scientific 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 May 29, 2012.

ADDRESSES: 
    Online submissions: http://effectivehealthcare.AHRQ.gov/index.cfm/submitscientific-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 primary hepatocellular carcinoma.
    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 primary hepatocellular carcinoma, 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-quides-reviews-and-reports/?productid=1012&pageaction=displayproduct#5056.
    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.

[[Page 24960]]

    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 with hepatocellular carcinoma (HCC) who are not 
otherwise candidates for surgical resection or transplantation with no 
evidence of extrahepatic disease regarding survival and quality of 
life?

Question 2

    What are the comparative harms of the various liver-directed 
therapies in patients with HCC who are not otherwise candidates for 
surgical resection or transplantation with no evidence of extrahepatic 
disease regarding adverse events?

Question 3

    Are there differences in comparative effectiveness of various 
liver-directed therapies in patients with HCC who are not otherwise 
candidates for surgical resection or transplantation for specific 
patient and tumor characteristics, such as age, gender, disease 
etiology, and Child-Pugh score?

    Dated: April 19, 2012.
Carolyn M. Clancy,
AHRQ, Director.
[FR Doc. 2012-10011 Filed 4-25-12; 8:45 am]
BILLING CODE 4160-90-M
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