[Federal Register Volume 77, Number 80 (Wednesday, April 25, 2012)]
[Notices]
[Pages 24717-24718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-9817]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Local Therapies for the 
Treatment of Stage I Non-Small Cell Lung Cancer and Endobronchial 
Obstruction Due to Advanced Lung Tumors

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 
Conventional Two-Dimensional External Beam Radiotherapy (2D-EBRT), 3-
dimensional conformal radiation therapy (3D-CRT), Intensity-modulated 
radiation therapy (IMRT), Stereotactic body radiation therapy (SBRT), 
Proton beam radiotherapy (PBR), Brachytherapy, Radiofrequency ablation, 
Endobronchial debridement and stents, and Nd-YAG Laser Therapy medical 
devices. Scientific information is being solicited to inform our 
Comparative Effectiveness Review of Local Therapies for the Treatment 
of Stage I Non-Small Cell Lung Cancer and Endobronchial Obstruction Due 
to Advanced Lung Tumors, 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 Access to published and unpublished pertinent scientific 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

[[Page 24718]]

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: [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 the treatment of stage I non-small 
cell lung cancer and endobronchial obstruction due to advanced lung 
tumors.
    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 the 
treatment of stage I non-small cell lung cancer and endobronchial 
obstruction due to advanced lung tumors, 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-reports/?pageaction=displayproduct&productid=965.
    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 are the comparative benefits and harms of local nonsurgical 
therapies for documented (clinical or biopsy) stage I (T1NOMO, T2NOMO) 
Non-Small Cell Lung Cancer (NSCLC) in adult patients (age 18 years or 
older) who are not surgical candidates because of the presence of 
contraindications to major surgery, for example, cardiac insufficiency, 
poor pulmonary function, presence of severe intercurrent illness, or 
poor performance status?

Question 2

    What are the comparative benefits and harms of local nonsurgical 
therapies for documented (clinical or biopsy) stage I (T1NOMO, T2NOMO) 
NSCLC in adult patients (age 18 years or older) whose tumor is deemed 
operable but decline surgery?

Question 3

    1. What are the comparative short- and long-term benefits and harms 
of local therapies given with palliative or curative intent to patients 
With stage IIIa NSCLC with endoluminal obstruction of the trachea, main 
stem, or lobar bronchi and recurrent or persistent thoracic symptoms 
such as hemoptysis, cough, dyspnea, and post-obstructive pneumonitis?
    2. What are the comparative short- and long-term benefits and harms 
of local palliative therapies in patients with advanced stage (IIIb or 
IV) NSCLC with endoluminal obstruction of the trachea, main stem, or 
lobar bronchi and recurrent or persistent thoracic symptoms such as 
hemoptysis, cough, dyspnea, and post-obstructive pneumonitis?

    Dated: April 12, 2012.
Carolyn M. Clancy,
AHRQ, Director.
[FR Doc. 2012-9817 Filed 4-24-12; 8:45 am]
BILLING CODE 4160-90-M