3594 Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices 

OPA will utilize these data in three 

main ways: 

First, OPA needs to prepare grantees 

and Title X centers to respond to 

changes in the health system. As more 

individuals obtain health insurance, 

OPA needs to understand how 

individual Title X centers may be 

affected. Second, OPA invests in 

national training centers that are 

charged with providing national 

training, resources and technical 

assistance to grantees. Data collected 

from this effort will be used to inform 

the work of the training centers so they 

can better support the Title X grantees. 

Third, this data will help OPA better 

understand challenges affecting Title X 

centers in order to better work with 

HHS entities and national stakeholders 

to provide resources to Title X centers. 

Data will be collected through an online 

data collection tool directly from 

grantees and from Title X centers. 

Likely Respondents: This annual 

reporting requirement is centers that 

receive funding (either directly from 

OPA or through a subrecipient or 

grantee agency) for family planning 

services authorized and funded by the 

Title X Family Planning Program 

[‘‘Population Research and Voluntary 

Family Planning Programs’’ (Pub. L. 91– 

572)], which was enacted in 1970 as 

Title X of the Public Health Service Act 

(Section 1001 of Title X of the Public 

Health Service Act, 42 United States 

Code [U.S.C.] 300). 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions, to 

develop, acquire, install and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information, to train 

personnel and to be able to respond to 

a collection of information, to search 

data sources, to complete and review 

the collection of information, and to 

transmit or otherwise disclose the 

information. 

Based on some pilot work, the total 

annual burden hours estimated for this 

ICR are summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

annualized 

burden per 

response 

(hours) 

Annualized 

total burden 

(hours) 

Grantees ........................................... Sustainability Assessment—Grantees.92 1 0.66 60.72 

Service Sites ..................................... Sustainability Assessment—Sites .... 4,168 1 0.66 2,750.88 

Totals ......................................... ........................................................... 4,260 ........................ ........................ 2811.60 

OS specifically requests comments on 

(1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Darius Taylor, 

Information Collection Clearance Officer. 

[FR Doc. 2015–01099 Filed 1–22–15; 8:45 am] 

BILLING CODE 4150–48–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Noninvasive Testing for Coronary 

Artery Disease 

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 

the public. Scientific information is 

being solicited to inform our review of 

‘‘Noninvasive Testing for Coronary 

Artery Disease’’, which is currently 

being conducted by the AHRQ’s 

Evidence-based Practice Centers (EPC) 

Programs. Access to published and 

unpublished pertinent scientific 

information will improve the quality of 

this review. AHRQ is conducting this 

systematic review pursuant to Section 

902(a) of the Public Health Service Act, 

42 U.S.C. 299a(a). 

DATES: Submission Deadline on or 

before February 23, 2015. 

ADDRESSES: Online submissions: http:// 

effectivehealthcare.AHRQ.gov/

index.cfm/submit-scientificinformation-packets/. Please select the 

study for which you are submitting 

information from the list to upload your 

documents. 

Email submissions: SIPS@epc-src.org. 

Print submissions: 

Mailing Address: Portland VA 

Research Foundation,Scientific 

Resource Center, ATTN: Scientific 

Information Packet Coordinator, PO Box 

69539, Portland, OR 97239. Shipping 

Address (FedEx, UPS, etc.): Portland VA 

Research Foundation, Scientific 

Resource Center, ATTN: Scientific 

Information Packet Coordinator, 3710 

SW U.S. Veterans Hospital Road, Mail 

Code: R&D 71, Portland, OR 97239. 

FOR FURTHER INFORMATION CONTACT: 

Ryan McKenna, Telephone: 503–220– 

8262 ext. 58653 or Email: SIPS@epcsrc.org. 

SUPPLEMENTARY INFORMATION: The 

Agency for Healthcare Research and 

Quality has commissioned the 

Evidence-based Practice Centers (EPC) 

Programs to complete a review of the 

evidence for ‘‘Noninvasive Testing for 

Coronary Artery Disease’’. 

The EPC 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 requesting information 

from the public (e.g., details of studies 

conducted). We are looking for studies 

that report on ‘‘Noninvasive Testing for 

Coronary Artery Disease’’, including 

those that describe adverse events. The 

entire research protocol, including the 

key questions, is also available online 

at: http://effectivehealthcare.ahrq.gov/

search-for-guides-reviews-and-reports/

?pageaction=displayproduct&

productID=2017. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices 3595 

This notice is to notify the public that 

the EPC Program would find the 

following information on ‘‘Noninvasive 

Testing for Coronary Artery Disease’’ 

helpful: 

• A list of completed studies that 

your organization has sponsored for this 

indication. In the list, please indicate 

whether results are available on 

ClinicalTrials.gov along with the 

ClinicalTrials.gov trial number. 

• For completed studies that do not 

have results on ClinicalTrials.gov, 

please provide a summary, including 

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 follow-up/withdrawn/

analyzed, effectiveness/efficacy, and 

safety results. 

• A list of ongoing studies that your 

organization has sponsored for this 

indication. In the list, please provide the 

ClinicalTrials.gov trial number or, if the 

trial is not registered, the protocol for 

the study including a study number, the 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, and primary and secondary 

outcomes. 

• Description of whether the above 

studies constitute all Phase II and above 

clinical trials sponsored by your 

organization for this indication and an 

index outlining the relevant information 

in each submitted file. 

Your contribution will be very 

beneficial to the EPC Program. The 

contents of all submissions will be made 

available to the public upon request. 

Materials submitted must be publicly 

available or can be made public. 

Materials that are considered 

confidential; marketing materials; study 

types not included in the review; or 

information on indications not included 

in the review cannot be used by the EPC 

Program. This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. 

The draft of this review will be posted 

on AHRQ’s EPC 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 systematic review will answer the 

following questions. This information is 

provided as background. AHRQ is not 

requesting that the public provide 

answers to these questions. The entire 

research protocol, is available online at: 

http://effectivehealthcare.ahrq.gov/

search-for-guides-reviews-and-reports/

?pageaction=isplayproduct&

productID=2017. 

The Key Questions 

In stable, symptomatic patients with 

suspected coronary artery disease (CAD) 

who do not have previously diagnosed 

CAD and who have had a resting 

electrocardiogram (ECG): 

1. For patients considered to be at 

very low or low risk for CAD, what is the 

comparative effectiveness of anatomic 

tests (compared with each other, 

standard of care, or no testing): 

(a) For improving primary clinical 

health outcomes (e.g., quality of life, 

avoiding myocardial infarction)? In the 

absence of comparative studies linking 

testing with outcomes, do the tests 

predict future clinical events (predictive 

accuracy)? 

(b) What are the adverse effects, 

consequences, or harms of testing? 

(c) How do noninvasive tests differ in 

terms of clinical management based on 

test results, including referral for 

coronary angiography or additional 

noninvasive testing? 

(d) What harms are associated with 

additional testing following anatomic 

tests? 

(e) Is there differential effectiveness or 

harm based on patient characteristics 

(e.g., sex, age, comorbidities)? 

2. For patients considered to be at 

very low or low risk for CAD, what is the 

comparative effectiveness of functional 

tests (compared with each other, 

standard of care, or no testing): 

(f) For improving primary clinical 

health outcomes (e.g., quality of life, 

avoiding myocardial infarction)? In the 

absence of comparative studies linking 

testing with outcomes, do the tests 

predict future clinical events (predictive 

accuracy)? 

(g) What are the adverse effects, 

consequences or harms of testing? 

(h) How do noninvasive tests differ in 

terms of clinical management based on 

test results, including referral for 

coronary angiography or additional 

noninvasive testing? 

(i) What harms are associated with 

additional testing following anatomic 

tests? 

(j) Is there differential effectiveness or 

harm based on patient characteristics 

(e.g., sex, age, comorbidities) or the 

patient’s ability to exercise? 

3. For patients considered to be at 

intermediate to high risk for CAD, what 

is the comparative effectiveness of 

anatomic tests (compared with each 

other standard of care, or no testing): 

(k) For improving primary clinical 

health outcomes (e.g., quality of life, 

avoiding myocardial infarction)? In the 

absence of comparative studies linking 

testing with outcomes, do the tests 

predict future clinical events (predictive 

accuracy)? 

(l) What are the adverse effects, 

consequences, or harms of testing? 

(m) How do noninvasive tests differ in 

terms of clinical management based on 

test results, including referral for 

coronary angiography or additional 

noninvasive testing? 

(n) What harms are associated with 

additional testing following anatomic 

tests? 

(o) Is there differential effectiveness or 

harm based on patient characteristics 

(e.g., sex, age, comorbidities)? 

4. For patients considered to be at 

intermediate to high risk for CAD, what 

is the comparative effectiveness of 

functional tests (compared with each 

other, standard of care, or no testing): 

(p) For improving primary clinical 

health outcomes (e.g., quality of life, 

avoiding myocardial infarction)? In the 

absence of comparative studies linking 

testing with outcomes, do the tests 

predict future clinical events (predictive 

accuracy)? 

(q) What are the adverse effects, 

consequences, or harms of testing? 

(r) How do noninvasive tests differ in 

terms of clinical management based on 

test results, including referral for 

coronary angiography or additional 

noninvasive testing? 

(s) What harms are associated with 

additional testing following anatomic 

tests? 

(t) Is there differential effectiveness or 

harm based on patient characteristics 

(e.g., sex, age, comorbidities) or the 

patient’s ability to exercise? 

5. What is the comparative 

effectiveness of anatomic tests versus 

functional tests in those who are at very 

low or low risk for CAD? 

(u) For improving primary clinical 

health outcomes (e.g., quality of life, 

avoiding myocardial infarction)? 

(v) What are the adverse effects, 

consequences or harms of testing? 

(w) How do noninvasive tests differ in 

terms of clinical management based on 

test results, including referral for 

coronary angiography or additional 

noninvasive testing? 

(x) What harms are associated with 

additional testing following anatomic 

tests? 

(y) Is there differential effectiveness or 

harm based on patient characteristics 

(e.g., sex, age, comorbidities) or the 

patient’s ability to exercise? 

6. What is the comparative 

effectiveness of anatomic tests versus 

functional tests in those who are at 

intermediate to high risk for CAD? 


tkelley on DSK3SPTVN1PROD with NOTICES
3596 Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices 

(z) For improving primary clinical 

health outcomes (e.g., quality of life, 

avoiding myocardial infarction)? 

(aa) What are the adverse effects, 

consequences or harms of testing? 

(bb) How do noninvasive tests differ 

in terms of clinical management based 

on test results, including referral for 

coronary angiography or additional 

noninvasive testing? 

(cc) What harms are associated with 

additional testing following anatomic 

tests? 

(dd) Is there differential effectiveness 

or harm based on patient characteristics 

(e.g., sex, age, comorbidities) or the 

patient’s ability to exercise? 

PICOTS (Population, Intervention, 

Comparator, Outcome, Timing, Setting) 

Patient Population of Interest and PreTest Risk of CAD: 

The patient population is stable, 

symptomatic patients with suspected 

CAD who do not have previously 

diagnosed CAD and who have had a 

resting ECG. The definitions of risk 

categories are based on those described 

in the ACCF/AHA 2012 Guideline.8 In 

general, patient presentation and 

symptoms are primarily used to inform 

pre-test probability in the population of 

interest. The review will attempt to 

stratify studies based on these 

characteristics if definitions are not 

provided. 

• Include patients whose risk for CAD 

may be considered as follows: 

Æ Those considered to be at very low 

or low risk of CAD based on having 

none or only one of the following: 

• Patient age and gender (female <65 

years old, male <55 years old) 

• Negative family history for CAD 

• <2 CAD risk factors (including 

hypertension, diabetes, smoking, 

dyslipidemia, metabolic syndrome) 

• New onset angina/chest pain 

(including noncardiac or atypical chest 

pain, angina equivalents, unstable 

angina without non-ST-segment 

elevation myocardial infarction 

[NSTEMI], ST-segment elevation 

myocardial infarction [STEMI]) 

• Normal or non-diagnostic resting 

ECG 

Æ Those considered to be at 

intermediate to high risk of CAD based 

on having two or more of the following: 

• Patient age and gender (female ≥65 

years old, male ≥55 years old) 

• Positive family history for CAD 

• ≥2 CAD risk factors (including 

hypertension, diabetes, smoking, 

dyslipidemia, metabolic syndrome) 

• New onset or progressive angina/

chest pain or those with prolonged 

angina at rest (or relieved with rest or 

nitroglycerin) or nocturnal angina 

(angina including typical, atypical, 

definite, probable) 

• Possible ECG changes (e.g., T-wave, 

NSTEMI) or nondiagnostic ECG 

• Presence of other vascular disease 

(carotid disease, peripheral artery 

disease [PAD]) 

• Exclude patients with any of the 

following characteristics: 

Æ Unstable angina with elevated 

serum cardiac biomarkers, ECG changes, 

etc. 

Æ Definite acute coronary syndrome 

(ACS), Non-ST-Elevation Acute 

Coronary Syndromes (NSTE–ACS), 

NSTEMI, STEMI 

Æ Asymptomatic patients, including 

those being screened prior to surgery 

Interventions 

This systematic review will focus on 

widely available noninvasive tests used 

for diagnosis of CAD or dysfunction that 

results in symptoms attributable to 

myocardial ischemia. Coronary artery 

calcium scoring has been included since 

it has been proposed primarily for its 

ability to exclude the presence of 

obstructive disease but not necessarily 

to confirm the presence of flow-limiting 

stenosis. 

Interventions for inclusion are: 

• Functional tests (including exercise, 

vasodilator and/or dobutamine as 

stressor where appropriate) 

Æ Exercise electrocardiogram without 

imaging 

Æ Exercise/pharmacologic 

echocardiography (with or without 

myocardial echo contrast) 

Æ Exercise/pharmacologic cardiac 

nuclear imaging 

Æ SPECT 

Æ PET 

Æ Pharmacologic stress MRI 

Æ CT perfusion 

• Anatomic imaging 

Æ Coronary calcium scoring via 

electron beam CT (EBCT) or 

multidetector CT (MDCT) 

Æ CCTA 

Comparators 

Comparisons between noninvasive 

tests included in the interventions; 

comparisons with no testing or standard 

of care. (Contextual information will be 

provided in the background only for 

comparisons of noninvasive tests with 

invasive coronary angiography with or 

without FFR and for comparison 

between noninvasive tests on traditional 

diagnostic test measures such as 

sensitivity and specificity.) 

Outcomes 

• Clinical outcomes 

Æ Quality of life (QOL) 

Æ Change in angina (e.g., worsening) 

Æ MI 

Æ Heart failure 

Æ Stroke 

Æ Death 

Æ Hospitalization for cardiovascular 

events (acute coronary syndrome, heart 

failure, arrhythmias) 

Æ Dysrhythmia 

• Intermediate outcomes 

Æ Need for additional testing 

(including referral for invasive testing) 

Æ Management based on revised posttest risk stratification, including: 

• Guideline-directed medical therapy 

(GDMT), including management of 

lipids, blood pressure, and diabetes; 

counseling related to diet, physical 

activity, smoking cessation, alcohol use, 

and management of psychological 

factors; use of additional therapies to 

reduce risk of MI and death (e.g., 

antiplatelet therapy). 

• Any need for subsequent 

revascularization (percutaneous 

coronary intervention [PCI] or coronary 

artery bypass grafting [CABG]) 

• Harms, risks and consequences of 

testing 

Æ Procedural harms, adverse events of 

testing (e.g., renal failure, allergy, 

nephrogenic systemic fibrosis, contrastrelated harms, adverse reactions to 

drugs for stress tests), vascular 

complications 

Æ Consequences of testing (e.g., 

radiation exposure, psychological 

consequences, consequences of 

additional testing or incidental findings) 

Setting 

Nonemergent inpatient settings or 

ambulatory/outpatient settings, 

including emergency department. 

Timing 

At time of first test for evaluation 

using a noninvasive test other than 

resting ECG. 

Dated: December 29, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2015–00763 Filed 1–22–15; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Strategies to Treat and Manage 

Infantile Hemangioma 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for Scientific 

Information Submissions. 


tkelley on DSK3SPTVN1PROD with NOTICES