Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Notices 24717 

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 

otitis media with effusion treatments. 

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 treatments for 

otitis media with effusion, 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.effective

healthcare.AHRQ.gov/index.cfm/search

-for-guides-reviews-and-reports/ 

?pageaction=displayproduct&

productid=1013#5070. 

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unpublished randomized controlled 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enrolled/lost to withdrawn/follow-up/ 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 (KQs) 

KQ 1: What is the comparative 

effectiveness of the following treatment 

options (active treatments and watchful 

waiting) in affecting clinical outcomes 

or health care utilization in patients 

with OME? Clinical outcomes include 

changes in: OME signs (middle ear 

fluid) and symptoms (fullness in ear, 

difficulty in hearing), objective hearing 

thresholds, episodes of Acute Otitis 

Media (AOM), and vestibular function 

such as balance and coordination. 

Treatment options include: 

a. Tympanostomy tubes 

b. Adenoidectomy with or without 

myringotomy 

c. Myringotomy 

d. Oral or topical nasal steroids 

e. Autoinflation 

f. Complementary and alternative 

medical procedures 

g. Watchful waiting 

h. Variations in surgical technique or 

procedure 

KQ 2: What is the comparative 

effectiveness of the different treatment 

options listed in KQ 1 (active treatments 

and watchful waiting) in improving 

functional and health-related quality-oflife outcomes in patients with OME? 

Outcomes include: Hearing, speech and 

language development, auditory 

processing, academic achievement, 

attention and behavioral outcomes, 

health-related quality of life, and patient 

and parent satisfaction with care. 

KQ 3: What are the differences in 

harms or tolerability among the different 

treatment options? 

KQ 4: What are the comparative 

benefits and harms of treatment options 

in subgroups of patients with OME? 

Subgroups include: 

a. Patients of different age groups 

b. Patients of different racial/ethnic 

backgrounds 

c. Patients in different socioeconomic 

status groups 

d. Patients with comorbidities such as 

craniofacial abnormalities (e.g., cleft 

palate), Down syndrome, and existing 

speech, language, and hearing 

problems 

e. Patients with a medical history of 

AOM or OME (with and without 

clinical hearing loss) 

KQ 5: Is the comparative effectiveness 

of treatment options affected by the 

following: Health insurance coverage, 

physician specialty, type of facility of 

the treatment provider, geographic 

location, continuity of care, or prior 

inoculation with the pneumococcal 

vaccine? 

Dated: April 12, 2012. 

Carolyn M. Clancy, 

AHRQ, Director. 

[FR Doc. 2012–9818 Filed 4–24–12; 8:45 am] 

BILLING CODE 4160–90–M 

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 TwoDimensional 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 


pmangrum on DSK3VPTVN1PROD with NOTICES
24718 Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Notices 

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://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 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.effectivehealth

care.AHRQ.gov/index.cfm/search-forguidesreviews-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 shortand 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 shortand 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Chronic Venous Ulcers Treatments 

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 


pmangrum on DSK3VPTVN1PROD with NOTICES