77834 Federal Register / Vol. 76, No. 240 / Wednesday, December 14, 2011 / Notices 

genetic testing for CYP2C19 variants 

predict intermediate and clinical 

outcomes following treatment 

initiation? 

a. What is the analytic validity 

(technical test performance) of the 

various assays used for CYP2C19 

genetic testing? 

b. What is the clinical validity 

(predictive accuracy) of genetic testing 

for predicting intermediate and clinical 

outcomes in patients who are receiving 

clopidogrel therapy? 

c. Do the following factors modify the 

association between genetic test results 

and clinical outcomes? 

i. Co-medications. 

ii. Patient-level factors (e.g., race or 

ethnicity, age, sex, disease severity, or 

comorbidities). 

iii. Test-related factors (e.g., betweenassay differences). 

iv. System-level factors (e.g., settings 

where testing is performed). 

Key Question 2 

In patient populations receiving 

clopidogrel therapy, does phenotypic 

testing of platelet reactivity predict 

intermediate and clinical outcomes? 

a. What is the analytic validity 

(technical test performance) of the 

various assays used in phenotypic 

testing of platelet reactivity? 

b. What is the clinical validity 

(predictive accuracy) of phenotypic 

testing for predicting intermediate and 

clinical outcomes in patients who are 

receiving clopidogrel therapy? 

c. Do the following factors modify the 

association between phenotypic test 

results and clinical outcomes? 

i. Co-medications. 

ii. Patient-level factors (e.g., race or 

ethnicity, age, sex, disease severity, or 

comorbidities). 

iii. Test-related factors (e.g., betweenassay differences). 

iv. System-level factors (e.g., settings 

where testing is performed). 

Key Question 3 

What is the comparative effectiveness 

of alternative test-and-treat strategies 

(including a no-testing strategy) for 

therapeutic decision making regarding 

antiplatelet therapy among patients who 

are candidates for clopidogrel-based 

treatment? 

a. What is the comparative 

effectiveness of the following testing 

strategies on therapeutic decision 

making, platelet reactivity during 

followup, and clinical outcomes in 

patients who are candidates for 

antiplatelet treatment? 

i. Genetic testing for CYP2C19. 

ii. Genetic testing for CYP2C19 

followed by phenotypic testing for 

platelet reactivity. 

iii. Phenotypic testing for platelet 

reactivity. 

iv. No testing. 

b. How do modifying factors (e.g., race 

or ethnicity, age, sex, comorbidities, 

diet, or the time between conducting the 

test and obtaining results) affect the 

association of alternative phenotypic or 

genetic test-and-treat strategies and 

patient outcomes? Alternative testguided treatments can include nonclopidogrel antiplatelet agents or highdose clopidogrel regimens. 

Key Question 4 

What are the potential adverse effects 

or harms from genetic or phenotypic 

testing per se or from test-directed 

treatments? 

Dated: December 2, 2011. 

Carolyn M. Clancy, 

AHRQ, Director. 

[FR Doc. 2011–32047 Filed 12–13–11; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Intravascular Diagnostic and Imaging 

Medical Devices 

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 intravascular 

diagnostic and imaging medical devices, 

including: Fractional Flow Reserve 

(FFR), Coronary Flow Reserve (CFR), 

Intravascular Ultrasound (IVUS), 

Intravascular Ultrasound (VH–IVUS) 

with Virtual Histology, Optical Coherent 

Tomography (OCT), Near-Infrared 

Spectroscopy (NIR), Angioscopy, 

Intravascular Magnetic Resonance 

Imaging (MRI), Elastrography, and 

Thermography. Scientific information is 

being solicited to inform our 

Comparative Effectiveness Review of 

Intravascular Diagnostic Procedures and 

Imaging Techniques versus 

Angiography Alone, 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 January 13, 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 

intravascular diagnostic procedures and 

imaging techniques versus angiography 

alone. 

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 intravascular 

diagnostic and imaging medical devices, 

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-guides-reviewsand-reports/?pageaction=display

product&productid=766#3456. 

This notice is a request for industry 

stakeholders to submit the following: 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 76, No. 240 / Wednesday, December 14, 2011 / Notices 77835 

• 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/. 

Key Questions 

• Key Question 1: For patients 

undergoing diagnostic coronary 

angiography to evaluate the presence/ 

extent of Coronary Artery Disease (CAD) 

in order to decide on the necessity for 

coronary intervention, what is the 

impact of using an IVDx technique— 

when compared to angiography alone— 

on the diagnostic thinking and 

therapeutic decision making, short-term 

outcomes, and long-term outcomes? 

• Key Question 2: For patients 

undergoing Percutaneous Coronary 

Intervention (PCI), what is the impact of 

using an Intravascular Diagnostic Device 

(IVDx) technique to guide the PCI 

procedure (either immediately prior to 

or during the procedure)—when 

compared to angiography-guided PCI— 

on the diagnostic thinking and 

therapeutic decision making, short-term 

outcomes, and long-term outcomes? 

• Key Question 3: For patients having 

just undergone a PCI, what is the impact 

of using an IVDx technique to evaluate 

the success of PCI immediately after the 

procedure—when compared to 

angiography alone—on the diagnostic 

thinking and therapeutic decision 

making, short-term outcomes, and longterm outcomes? 

• Key Question 4: How do different 

IVDx techniques compare to each other 

in their effects on the diagnostic 

thinking and therapeutic decision 

making, short-term outcomes, and longterm outcomes? 

• During diagnostic coronary 

angiography for the evaluation of the 

presence/extent of CAD and the 

potential necessity of coronary 

intervention? 

• During PCI to guide the procedure? 

• Immediately after PCI to evaluate 

the success of PCI? 

• Key Question 5: What factors (e.g., 

patient/physician characteristics, 

availability of prior noninvasive testing, 

type of PCI performed) influence the 

effect of IVDx techniques—when 

compared to angiography (or among 

different IVDx techniques)—on the 

diagnostic thinking and therapeutic 

decision making, short-term outcomes, 

and long-term outcomes? 

• During diagnostic coronary 

angiography for the evaluation of the 

presence/extent of CAD and the 

potential need for coronary 

intervention? 

• During PCI to guide the procedure? 

• Immediately after PCI to evaluate 

the success of PCI? 

Dated: November 23, 2011. 

Carolyn M. Clancy, 

AHRQ, Director. 

[FR Doc. 2011–32048 Filed 12–13–11; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day-12–12BW] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an 

email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC 20503 or by fax to (202) 395–5806. 

Written comments should be received 

within 30 days of this notice. 

Proposed Project 

Generic Clearance for the Collection 

of Qualitative Feedback on Agency 

Service Delivery—new—Centers for 

Disease Control and Prevention (CDC), 

National Center on Birth Defects and 

Developmental Disabilities (NCBDDD). 

As part of a Federal Government-wide 

effort to streamline the process to seek 

feedback from the public on service 

delivery, the CDC has submitted a 

Generic Information Collection Request 

(Generic ICR): ‘‘Generic Clearance for 

the Collection of Qualitative Feedback 

on Agency Service Delivery ’’ to OMB 

for approval under the Paperwork 

Reduction Act (PRA) (44 U.S.C. 3501 et. 

seq.). 

To request additional information, 

please contact Daniel L. Holcomb, 

Reports Clearance Officer, Centers for 

Disease Control and Prevention, 1600 

Clifton Road, MS–D74, Atlanta, GA 

30333 or send an email to omb@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Title: Generic Clearance for the 

Collection of Qualitative Feedback on 

Agency Service Delivery. 

Abstract: The information collection 

activity will garner qualitative customer 

and stakeholder feedback in an efficient, 

timely manner, in accordance with the 

Administration’s commitment to 

improving service delivery. By 

qualitative feedback we mean 

information that provides useful 

insights on perceptions and opinions, 

but are not statistical surveys that yield 

quantitative results that can be 

generalized to the population of study. 

This feedback will provide insights into 

customer or stakeholder perceptions, 

experiences and expectations, provide 

an early warning of issues with service, 

or focus attention on areas where 

communication, training or changes in 

operations might improve delivery of 

products or services. These collections 

will allow for ongoing, collaborative and 

actionable communications between the 

Agency and its customers and 

stakeholders. It will also allow feedback 

to contribute directly to the 

improvement of program management. 

mstockstill on DSK4VPTVN1PROD with NOTICES