43274 Federal Register / Vol. 72, No. 149 / Friday, August 3, 2007 / Notices 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from AHRQ’s Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ, Reports 

Clearance Officer, (301) 427–1477. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

‘‘Voluntary Customer Surveys Generic 

Clearance for the Agency for Healthcare 

Research and Quality’’

In response to Executive Order 12962, 

the Agency for Healthcare Research and 

Quality (AHRQ) plans to conduct 

voluntary customer surveys to assess 

strengths and weaknesses in agency 

program services. Customer surveys to 

be conducted by AHRQ may include 

readership surveys from individuals 

using AHRQ automated and electronic 

technology databases to determine 

satisfaction with the information 

provided or surveys to assess effect of 

the grants streamlining efforts. Results 

of these surveys will be used in future 

program planning initiatives and to 

redirect resources and efforts, as 

needed, to improve AHRQ program 

services. The current clearance will 

expire January 31, 2008. This is a 

request for a generic approval from 

OMB to conduct customer surveys over 

the next three years. 

Methods of Collection 

The data will be collected using a 

combination of methodologies 

appropriate to each survey. These 

methodologies include: 

• Evaluation forms; 

• Mail surveys; 

• Focus groups; 

• Automated and electronic 

technology (e.g., e-mail, Web-based 

surveys, instant fax, AHRQ Publication 

Clearinghouse customer feedback) and, 

• Telephone surveys. 

ESTIMATED ANNUAL RESPONDENT BURDEN

Type of Survey No. of 

respondents 

Average 

hour burden/response Total hours 

of burden 

Mail/Telephone Surveys .......................................................................................................................... 51,200 0.15 7,680 

Automated/Web-based ............................................................................................................................ 52,000 0.163 8,476 

Focus Groups .......................................................................................................................................... 200 1.0 200 

Totals ................................................................................................................................................ 103,400 NA 16,356 

This information collection will not 

impose a cost burden on the 

respondents beyond that associated 

with their time to provide the required 

data. There will be no additional costs 

for capital equipment, software, 

computer services, etc. 

Estimated Annual Costs to the Federal 

Government 

The mail and telephone surveys and 

focus groups will in some cases be 

carried out under contract. Assuming 

the contract cost per survey is $50,000–

$100,000, and for each focus group is 

$20,000, total contract costs could be 

$720,000 per year. 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

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 health care research and health 

care 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: July 30, 2007. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 07–3813 Filed 8–2–07; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, Department of health and 

Human Services. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) allow the proposed 

information collection project: 

‘‘Chartering Value Exchanges for Valuedriven Health Care.’’ The information 

collection will take the form of narrative 

responses to semiannual Requests for 

Proposals to participate in a learning 

network of mature multi-stakeholder 

community health care collaboratives 

established to measure, report, and 

improve the quality and cost of 

available healthcare. In accordance with 

the Paperwork Reduction Act of 1995, 

Public Law 104–13 (44 U.S.C. 

3506(c)(2)(A)), AHRQ invites the public 

to comment on this proposed 

information collection. 

DATES: Comments on this notice must be 

received by September 4, 2007. 

ADDRESSES: Written comments should 

be submitted to: Karen Matsuoka by fax 

at (202) 395–6974 (attention: AHRQ’s 

desk officer) or by e-mail at 

OIRA_submission@omb.eop.gov 

(attention: AHRQ’s desk officer). 

Copies of the proposed collection 

plans, application form, and specific 

details on the estimated burden can be 

obtained from AHRQ’s Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ, Reports 

Clearance Officer, (301) 427–1477, or by 

e-mail at doris.lefkowitz@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 72, No. 149 / Friday, August 3, 2007 / Notices 43275 

Proposed Project 

‘‘Charting Value Exchanges for Valuedriven Healthcare’’

This project proposes to twice 

annually post a public call for parties 

interested in becoming chartered as 

Value Exchanges for Value-driven 

Healthcare, described in the Background 

Section below. Anticipated benefits of 

being a chartered Value Exchange 

include (1) Participation in an AHRQmanaged Learning Network and (2) 

access to Medicare patient de-identified 

provider performance measurement 

results. 

Background 

The Secretary of Health and Human 

Services has created and is 

implementing a Value-driven 

Healthcare Initiative to enhance person 

and population-centered care by 

improving the quality of healthcare 

services and reducing healthcare costs. 

Related HHS goals and objectives reflect 

the President’s Executive Order 13410: 

Promoting quality and Efficient Health 

Care in Federal Government 

Administered or Sponsored Health Care 

Programs (August 2006) and encompass 

(1) Promotion of the establishment of 

health information technology 

interoperability standards for 

exchanging price and quality healthcare 

data; (2) promotion of the availability 

and use of transparent, nationwide 

consensus based and endorsed quality 

measures; (3) promotion of the 

availability and use of transparent, 

nationwide consensus based and 

endorsed measures of price/cost; and (4) 

promotion of the use of provider and 

consumer incentives for high quality 

and cost efficient healthcare. 

This Initiative’s designed on three 

fundamental principles. The first is that 

at its care, healthcare is ‘‘local’’—

provided in uniquely constituted 

cultural and market-based 

environments. As such, improving the 

value of healthcare requires a critical 

mass of community stakeholders: Public 

and private purchasers, health plans, 

providers, and consumers, as well as 

other relevant community entities (e.g., 

local health information exchange 

organizations, Quality Improvement 

Organizations, state data organizations) 

investing their time and resources 

toward shared cost and quality 

improvement goals. We refer to such 

representative community entities as 

local multi-stakeholder collaboratives. 

Scattered across the country there are 

community collaboratives in various 

stages of development ranging from 

mature multi-stakeholder collaboratives 

(defined as ongoing collaboration among 

representatives from purchasers, health 

plans, providers, and consumers) to 

communities where collaboration does 

not include representatives from all four 

groups. 

The second principle is that broad 

access to accurate, meaningful 

information will improve the value of 

healthcare services by (1) stimulating 

provider improvement, (2) engaging 

consumers in provider selection and 

treatment choices, and (3) enabling 

purchasers to align consumer and 

provider incentives. Generating the 

information needed to accomplish this 

is maximized when performance 

measures can be calculated based on all 

payer data. 

The third principle is that 

establishing a nation-wide learning 

network will accelerate market-based 

health care improvement. Learning 

networks are an evidence-based 

organizational mechanism to achieve 

rapid identification, dissemination and 

adoption of best practices. They are 

comprised of individuals or groups 

focused on achieving common broad 

goals. 

Based on the above, AHRQ plans to 

(1) identify and designate qualified 

mature community-based multistakeholder groups as Chartered Value 

Exchanges and establish a nation-wide 

learning network for them. 

Chartered Value Exchanges (CVEs) 

AHRQ envisions Chartered Value 

Exchanges as having four core and three 

important non-core functions as 

described below. 

Four (4) Core Functions 

Engagement of Stakeholders in 

Collaboration: 

Effectively engaging representatives 

from all four critical stakeholders: 

purchaser, health plan, provider, and 

consumer representatives as well as 

from Health Information Exchanges, 

Quality Improvement Organizations, 

state data organizations and other 

community stakeholders in ongoing 

collaboration is a core CVE function. 

Use of Measures: 

Getting nationwide consensus based 

and endorsed performance measures 

locally adopted and used is a core CVE 

function. Developing new measures is 

not. Measures could be generated 

nationally or generated locally based on 

clear protocols. Optimally, measures 

would be constructed by pooling 

information from all relevant sources 

and would ultimately address all six 

Institute of Medicine performance 

domains of safety, timeliness, 

effectiveness, efficiency, equitableness, 

and patient-centeredness. 

Provider Engagement in Improvement: 

Directly engaging providers to use 

performance information is a core CVE 

function and is not limited to informing 

providers of results. Engagement 

requires active ongoing dialogue that 

includes but is not limited to improving 

data accuracy and data interpretability. 

While provider engagement is anchored 

locally, CVEs will operate in a national 

environment and should encourage 

involvement, support and ongoing 

dialogue between national, regional, and 

local entities. 

Consumer Engagement: 

Engaging consumers to use 

performance information is a core CVE 

function and is not limited to reporting 

of information. This function may be 

met, however, by assuring usable 

information is made available to other 

entities that would use and distribute 

that information to consumers. 

Three (3) Important (Non-core) 

Functions 

Promoting HIT and HIE 

The role of the CVE is to: (1) Facilitate 

the use of interoperable health 

information technologies and health 

information exchange either directly or 

through alignment with regional health 

information networks and (2) promote 

the ongoing migration of measure 

calculation based solely on aggregated 

claims data to measure calculation that 

includes aggregated electronic clinical 

data and fosters real time patient care 

improvement. 

Facilitating Rewards for Better 

Performance 

The role of the CVE is to facilitate or 

enable the use of performance measures 

to reward and foster better provider 

performance and consumer behavior. 

The function may be met by serving as 

a catalyst attempting to influence 

regional or national health plans and 

purchasers. 

Supporting Knowledge Transfer and 

Conducting Ongoing Improvement of 

Efforts 

Sharing discoveries and lessons 

learned within the CVE community, the 

CVE learning network, and interested 

public at large is an expectation of how 

a CVE conducts itself. Likewise, it is an 

expectation that a CVE will practice 

continues quality improvement in all 

that it does. 

The Chartered Value Exchange 

designation will be applied to the 

collective work occurring within a 

mstockstill on PROD1PC66 with NOTICES

43276 Federal Register / Vol. 72, No. 149 / Friday, August 3, 2007 / Notices 

community regardless of how many 

organizations divide up the work. 

AHRQ does not plan, however, to 

impose a particular definition of 

community based on geography or 

population density. AHRQ recognizes 

the need to respect local culture, 

relationships, and priorities, and will 

maintain a flexible and inclusive 

approach to selection and designation. 

AHRQ does not require a Value 

Exchange to be an incorporated nonprofit entity. AHRQ expects CVEs to 

adopt nationwide consensus based and 

endorsed principles and standards 

where they exist and as they are made 

available. To be eligible, interested 

parties must first be recognized by HHS 

Secretary Michael O. Leavitt as a 

Community Leader for Value-driven 

Healthcare. For additional information 

on Community Leader recognition, see 

http://www.hhs.gov/transparency/ 

communities/communityleaders/ 

communities.html. 

Learning Network 

Goals of the Learning Network will be 

to facilitate sharing of CVE experiences 

and lessons learned; identify and share 

promising practices that improve 

healthcare value; identify gaps where 

innovation is needed; raise issues to be 

addressed by national consensusbuilding organizations; and provide onthe-ground perspective to inform and 

participate in setting national priorities 

for healthcare quality and cost 

improvement. The Learning Network 

will provide technical assistance in 

such areas as collaborative production 

of public reports, effective pay for 

performance, and use of consumer 

incentives, and will ultimately work 

with CVEs to implement a core measure 

set derived from nationwide consensus 

based and endorsed measures. 

Method of Collection 

Each RFP will be posted on the AHRQ 

public Web site (http://www.ahrq.gov) 

with a link to the AHRQ site on the HHS 

transparency Web site as well. The RFP 

instructions will direct interested 

parties to electronically submit narrative 

information (maximum 3000 words) to 

AHRQ that describes their current 

activities and/or plans to perform the 

four core functions and three important 

non-core functions. In addition, 

applicants will be asked to describe 

their staff/consultant/in-kind resource 

arrangements to provide needed 

expertise; their ability to raise funds or 

in-kind support from multiple 

stakeholders; and their ability to manage 

projects and finances as indications of 

their organizational capacity to 

accomplish the four core functions. 

Review teams comprised of purchaser, 

health plan, provider, consumer, and 

federal representatives will be 

assembled. Review teams will include 

experts from Health Information 

Exchanges and the Quality 

Improvement Organization community. 

Each enrollment period will be open for 

two months. Applications will be 

assigned and scored as they are received 

at AHRQ. AHRQ staff will screen the 

application for Community Leader 

status, then distribute it to each member 

of the 5 member review team. The 

application will be individually scored 

by each of the review team members 

within two weeks. The completed 

scoring forms will be returned to AHRQ 

who will then generate the team’s 

average scores per function for that 

applicant. The Scoring Form uses the 

following rating scale and definitions to 

guide the evaluations: 

Evaluation Guide: To standardize the 

interpretation of the rating sale, please 

use the following definitions to guide 

your choices: 

• Excellent (5 points): Clear 

demonstration of activity already in 

progress. 

• Very Good (4 points): Activity 

partially in progress and effective plan 

to further mature articulated. 

• Average (3 points): Effective plan 

articulated. 

• Fair (2 points): Attempts to address 

but hasn’t effectively articulated plan or 

success. 

• Poor (1 point): Ignores issue. 

Minimum average scores have been 

set for each function, and are weighted 

to reflect the importance of the 

particular function. Engagement of 

critical stakeholders has a minimum 

average score of 4.5 while engagement 

of others, use of performance measures, 

provider engagement and consumer 

engagement each have minimum 

average scores set at 3.0. Non-core 

functions including promotion of HIT 

and HIE, facilitation of rewards for 

better performance, participation in 

knowledge transfer, and ongoing 

improvement of efforts each have 

minimum average scores set at 2.0. 

Organizational capacity requires a 

minimum average score of 2.0 also. 

Individual application scores can range 

from a possible high of 27 to a low of 

10, but the acceptance of any applicant 

will be based on meeting the minimum 

average score required for each function 

as well as organizational capacity. A 

grid of all applicants’ average scores by 

function will be presented to the AHRQ 

Executive Leadership Team to make 

final decisions on how many and which 

applicants will be chartered at the end 

of the first month and at the close of the 

enrollment period. Attempts will be 

made to maximize geographical and 

population diversity. Successful 

applicants will be notified within one 

month of review. 

Estimated Annual Respondent Burden 

EXHIBIT 1.—ESTIMATE OF COST BURDEN TO RESPONDENTS

Data collection effort 

Number of 

estimated 

respondents 

Estimated 

time per 

respondent 

in hours 

Estimated 

total burden 

hours 

Average 

hourly wage 

rate 

Estimated 

annual cost 

burden to 

respondents 

Draft narrative response to RFP by Collaborative Manager ................... 50 8 400 $34.67 $13,868 

Narrative reviews by 1–2 members of Collaborative executive committee .................................................................................................... 75 1 75 57.90 4,342.50 

Narrative revisions by Collaborative Manager ......................................... 50 8 400 34.67 13,868 

Assembly of narrative with any supporting documents by Collaborative 

Assistant ............................................................................................... 50 2 100 12.58 1,258 

Total .................................................................................................. 225 .................... 950 .................... 33,336.50 

This information collection will not 

impose a cost burden on the respondent 

beyond that associated with the above 

estimates of the time needed to provide 

the application-requested information. 

There will be no additional substantial 

costs to respondents anticipated, e.g. for 

capital equipment, software, computer 

services. 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 72, No. 149 / Friday, August 3, 2007 / Notices 43277 

Estimated Costs to the Federal 

Government 

The total cost to the government for 

its proposal review activity is estimated 

to be $500,000 annually. 

Request for Comments 

In accordance with the above-cited 

legislation, comments on the 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 health care 

improvement and information 

dissemination functions of AHRQ, 

including whether the information 

requested 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 

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 request for OMB 

approval of the proposed information 

collection. All comments will become a 

matter of public record. 

Dated: July 30, 2007. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 07–3814 Filed 8–2–07; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Food Safety and Security Monitoring 

Project—Radiological Health; 

Availability of Cooperative Agreements 

Under a Limited Competition; Request 

for Applications: FD07–005; Catalog of 

Federal Domestic Assistance Number: 

93.448 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

I. Funding Opportunity Description 

The Food and Drug Administration 

(FDA), Office of Regulatory Affairs 

(ORA), Division of Federal-State 

Relations, is announcing the availability 

of cooperative agreements for 

equipment, supplies, personnel, 

training, and facility upgrades to Food 

Emergency Response Laboratory 

Network (FERN) radiological 

laboratories of State, local, and tribal 

governments. The cooperative 

agreements are to enable the analyses of 

foods and food products in the event 

that redundancy and/or additional 

laboratory surge capacity is needed by 

FERN for analyses related to 

radiological terrorism or other 

emergency situations. These cooperative 

agreements are also intended to expand 

participation in networks to enhance 

Federal, State, local, and tribal 

governmental food safety and security 

efforts. This notice supersedes the 

request for applications that published 

in the Federal Register of August 24, 

2006 (71 FR 50068). 

A. Background 

ORA is the primary inspection and 

analysis component of FDA and has 

approximately 1,600 investigators, 

inspectors, and analysts who cover the 

country’s approximately 95,000 FDAregulated businesses. These 

investigators inspect more than 15,000 

facilities per year and ORA laboratories 

analyze several thousand samples per 

year. ORA conducts special 

investigations, conducts food inspection 

recall audits, performs consumer 

complaint inspections, and collects 

samples of regulated products. 

Increasingly, ORA has been called upon 

to expand the testing program that 

addresses the increasing threat to food 

safety and security through intentional 

radiological terrorism events. Toward 

this end, ORA has developed 

radiological screening and analysis 

methodologies that are used to evaluate 

foods and food products in such 

situations. However, in the event of a 

large-scale emergent incident, analytical 

sample capacity in ORA field 

laboratories has a finite limit. 

Information from ongoing relationships 

with State partners indicates limited 

redundancy in State food testing 

laboratories; both in terms of analytical 

capabilities and analytical sample 

capacity. Several State food testing 

laboratories lack the specialized 

equipment to perform the analyses, and/ 

or the specific methodological expertise 

in the types of analyses performed for 

screening foods and food products 

involving radiological terrorism events. 

The events of September 11, 2001, 

reinforced the need to enhance the 

security of the U.S. food supply. 

Congress responded by passing the 

Bioterrorism Act, which President 

George W. Bush signed into law on June 

12, 2002. The Bioterrorism Act is 

divided into the following five titles: 

Title I—National Preparedness for 

Bioterrorism and Other Public 

Health Emergencies, 

Title II—Enhancing Controls on 

Dangerous Biological Agents and 

Toxins, 

Title III—Protecting Safety and 

Security of Food and Drug Supply, 

Title IV—Drinking Water Security and 

Safety, and 

Title V—Additional Provisions. 

Subtitle A of the Bioterrorism Act, 

‘‘Protection of Food Supply,’’ section 

312, ‘‘Surveillance and Information 

Grants and Authorities,’’ amends part B 

of Title III of the Public Health Service 

Act to authorize the Secretary of Health 

and Human Services to award grants to 

States and Indian tribes to expand 

participation in networks to enhance 

Federal, State, and local food safety 

efforts. This may include meeting the 

costs of establishing and maintaining 

the food safety surveillance, technical, 

and laboratory capacity needed for such 

participation. 

FDA will support the projects covered 

by this document under the authority of 

section 312 of the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002 (the 

Bioterrorism Act) (Public Law 107–188). 

This program is described in the Catalog 

of Federal Domestic Assistance under 

number 93.448. 

B. Program Research Goals 

The goal of ORA’s cooperative 

agreement program is to complement, 

develop, and improve State, local, and 

Indian tribal food safety and security 

testing programs. This will be 

accomplished through the provision of 

equipment, supplies, personnel, facility 

upgrades, training in current food 

testing methodologies, participation in 

proficiency testing to establish 

additional reliable laboratory sample 

analysis capacity, analysis of 

surveillance samples, and, in 

cooperation with FDA, participation in 

method enhancement activities 

designed to extend analytical 

capabilities. In the event of a large-scale 

radiological terrorism event affecting 

foods or food products, the recipient 

may be required to perform selected 

radiological analyses of domestic and 

imported food samples collected and 

supplied to the laboratory by FDA or 

other Federal agencies through FDA. 

These samples may consist of, but are 

not limited to, the following: Vegetables 

and fruits (fresh and packaged), juices 

(concentrate and diluted), grains and 

grain products, seafood and other fish 

products, milk and other dairy products, 

infant formula, baby foods, bottled 

water, condiments, and alcoholic 

products (beer, wine, scotch). 

mstockstill on PROD1PC66 with NOTICES