Federal Register / Vol. 77, No. 17 / Thursday, January 26, 2012 / Notices 4043 

Estimated Annual Costs to the Federal 

Government 

The maximum cost to the Federal 

Government is estimated to be $217,451 

annually for two years. 

Exhibit 3 shows the total and 

annualized cost by the major cost 

components. 

EXHIBIT 3—ESTIMATED TOTAL AND

ANNUALIZED COST

Cost component Total cost Annualized 

cost 

Project Development .................. $153,750 $76,875 

Data Collection Activities ................ 162,465 81,233 

Data Processing 

and Analysis ...... 33,563 16,781 

Project Management .................. 22,625 11,313 

Overhead .............. 62,500 31,250 

Total ............... 434,903 217,451 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, comments on AHRQ’s 

information collection are requested 

with regard to any of the following: (a) 

Whether the proposed collection of 

information is necessary for the proper 

performance of AHRQ healthcare 

research and healthcare information 

dissemination functions, including 

whether the information will have 

practical utility; (b) the accuracy of 

AHRQ’s estimate of burden (including 

hours and costs) of the proposed 

collection(s) of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(d) ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: January 17, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–1398 Filed 1–25–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on the 

Use of Natriuretic Peptide 

Measurement in the Management of 

Heart Failure 

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 

medical device manufacturers of 

natriuretic peptide measurement assays. 

Scientific information is being solicited 

to inform our Comparative Effectiveness 

Review of Use of Natriuretic Peptide 

Measurement in the Management of 

Heart Failure, 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 February 27, 2012. 

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 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 

use of natriuretic peptide measurement 

in the management of heart failure. 

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 natriuretic 

peptide measurement assays, 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:// 

effectivehealthcare.ahrq.gov/index.cfm/ 

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

?pageaction=displayproduct&

productid=899#4210. 

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 

mstockstill on DSK4VPTVN1PROD with NOTICES

4044 Federal Register / Vol. 77, No. 17 / Thursday, January 26, 2012 / Notices 

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 

Key Question 1: In patients presenting 

to the emergency department or urgent 

care facilities with signs or symptoms 

suggestive of heart failure (HF): 

1. What is the test performance of 

BNP and NT-proBNP for HF? 

2. What are the optimal decision cut 

points for BNP and NT-proBNP to 

diagnose and exclude HF? 

3. What determinants affect the test 

performance of BNP and NTproBNP 

(e.g., age, gender, comorbidity)? 

Key Question 2: In patients presenting 

to a primary care physician with risk 

factors, signs, or symptoms suggestive of 

HF: 

1. What is the test performance of 

BNP and NT-proBNP for HF? 

2. What are the optimal decision cut 

points for BNP and NT-proBNP to 

diagnose and exclude HF? 

3. What determinants affect the test 

performance of BNP and NTproBNP 

(e.g., age, gender, comorbidity)? 

Key Question 3: In HF populations, is 

BNP or NT-pro BNP measured at 

admission, discharge or change between 

admission and discharge an 

independent predictor of morbidity and 

mortality outcomes? 

Key Question 4: In HF populations, 

does BNP measured at admission, 

discharge or change between admission 

and discharge add predictive 

information to other prognostic 

methods? 

Key Question 5: Is BNP or NT-pro 

BNP measured in the community setting 

an independent predictor of morbidity 

and mortality outcomes in general 

populations? 

Key Question 6: In patients with HF, 

does BNP assisted therapy or intensified 

therapy compared to usual care, 

improve outcomes? 

Key Question 7: What is the biological 

variation of BNP and NT-proBNP in 

patients with HF and without HF? 

Dated: January 17, 2012. 

Carolyn M. Clancy, 

Director, AHRQ. 

[FR Doc. 2012–1403 Filed 1–25–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration on Aging 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Annual Reporting 

Requirements for the Older American 

Act Title VI Grant Program 

AGENCY: Administration on Aging, HHS. 

ACTION: Notice. 

SUMMARY: The Administration on Aging 

(AoA) is announcing an opportunity for 

public comment on the proposed 

extension of an existing collection of 

information by the agency. 

Under the Paperwork Reduction Act 

of 1995 (the PRA), Federal agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection requirements relating to 

Performance Reports for Title VI grants. 

DATES: Submit written or electronic 

comments on the collection of 

information by March 26, 2012. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: Margaret.Graves@aoa.

hhs.gov. Submit written comments on 

the collection of information to Margaret 

Graves, Administration on Aging, 

Washington, DC 20201 or by fax at (202) 

357–3560). 

FOR FURTHER INFORMATION CONTACT: 

Margaret Graves at (202) 357–3502 or 

Margaret.Graves@aoa.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency request 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, AoA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following collection 

of information, AoA invites comments 

on: (1) Whether the proposed collection 

of information is necessary for the 

proper performance of AoA’s functions, 

including whether the information will 

have practical utility; (2) the accuracy of 

AoA’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

when appropriate, and other forms of 

information technology. 

AoA estimates the burden of this 

collection of information as follows: 

Annual submission of the Program 

Performance Reports are due 90 days 

after the end of the budget period and 

final project period. 

Respondents: Federally Recognized 

Tribes, Tribal and Native Hawaiian 

Organizations receiving grants under 

Title VI, Part A, Grants for Native 

Americans; Title VI, Part B, Native 

Hawaiian Program and Title VI, Part C, 

Native American Caregiver Support 

Program. 

Estimated Number of Responses: 256. 

Total Estimated Burden Hours: 640. 

Dated: January 23, 2012. 

Kathy Greenlee, 

Assistant Secretary for Aging. 

[FR Doc. 2012–1605 Filed 1–25–12; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30-Day-12–0805] 

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) 639–7570 or send an 

mstockstill on DSK4VPTVN1PROD with NOTICES