62410 Federal Register / Vol. 76, No. 195 / Friday, October 7, 2011 / Notices 

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, HHS. 

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) approve the proposed 

information collection project: 

‘‘Evaluation of the Children’s Health 

Insurance Program Reauthorization Act 

of 2009 (CHIPRA) Quality 

Demonstration Grant Program.’’ In 

accordance with the Paperwork 

Reduction Act, 44 U.S.C. 3501–3521, 

AHRQ invites the public to comment on 

this proposed information collection. 

This proposed information collection 

was previously published in the Federal 

Register on August 3rd, 2011 and 

allowed 60 days for public comment. 

One comment was received. The 

purpose of this notice is to allow an 

additional 30 days for public comment. 

DATES: Comments on this notice must be 

received by November 7, 2011. 

ADDRESSES: Written comments should 

be submitted to: AHRQ’s OMB Desk 

Officer by fax at (202) 395–6974 

(attention: AHRQ’s desk officer) or by email at OIRA_submission@omb.eop.gov 

(attention: AHRQ’s desk officer). 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from the AHRQ 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: 

Proposed Project 

Evaluation of the Children’s Health 

Insurance Program Reauthorization Act 

of 2009 (CHIPRA) Quality 

Demonstration Grant Program 

AHRQ is requesting approval from the 

Office of Management and Budget 

(OMB) for data collection to support a 

national evaluation of the quality 

demonstration grants authorized and 

appropriated funding under subsection 

(d) of Sec. 401(a) of the Children’s 

Health Insurance Program 

Reauthorization Act of 2009 (CHIPRA) 

(Attachment A). Evaluating whether the 

CHIPRA demonstration grants improve 

the quality of care received by children 

in Medicaid and CHIP aligns with 

AHRQ’s mission of improving the 

quality and effectiveness of health care 

in the United States. 

CHIPRA included funding for fiveyear grants so that states can 

demonstrate effective, replicable 

strategies for improving the quality of 

children’s health care in Medicaid and 

CHIP. In February 2010, the U.S. 

Department of Health and Human 

Services announced the award of 10 

demonstration grants. Six of the grantee 

states are partnering with other states, 

for a total of 18 demonstration states. 

The demonstration states are: Colorado 

(partnering with New Mexico); Florida 

(with Illinois); Maine (with Vermont); 

Maryland (with Wyoming and Georgia); 

Massachusetts; North Carolina; Oregon 

(with Alaska and West Virginia); 

Pennsylvania; South Carolina; and Utah 

(with Idaho). 

These demonstration states are 

implementing 48 distinct projects in at 

least one of five possible grant 

categories, A to E. Category A grantees 

are experimenting with and/or 

evaluating the use of new pediatric 

quality measures. Category B grantees 

are promoting health information 

technology (HIT) for improved care 

delivery and patient outcomes. Category 

C grantees are expanding personcentered medical homes or other 

provider-based levels of service 

delivery. Category D grantees will 

evaluate the impact of a model pediatric 

electronic health record. Category E 

grantees are testing other state-designed 

approaches to quality improvement in 

Medicaid and CHIP. 

This research has the following goals: 

(1) To identify CHIPRA state activities 

that measurably improve the nation’s 

health care, especially as it pertains to 

children. 

(2) To develop a deep, systematic 

understanding of how CHIPRA 

demonstration states carried out their 

grant-funded projects. 

(3) To understand why the CHIPRA 

demonstration states pursued certain 

strategies. 

(4) To understand whether and how 

the CHIPRA demonstration states’ 

efforts affected outcomes related to 

knowledge and behavior change in 

targeted providers and/or consumers of 

health care. 

This study is being conducted by 

AHRQ through its contractor, 

Mathematica Policy Research, and two 

subcontractors, pursuant to AHRQ’s 

statutory authority to conduct and 

support research on healthcare and on 

systems for the delivery of such care, 

including activities with respect to the 

quality, effectiveness, efficiency, 

appropriateness and value of healthcare 

services and with respect to quality 

measurement and improvement, 42 

U.S.C. 299a(a)(1) and (2). 

Method of Collection 

To achieve the goals of this project the 

following data collections will be 

implemented: 

(1) Key Staff Interviews—two rounds 

of semi-structured interviews with key 

staff directly involved in the design and 

oversight of grant-funded activities in 

each of the 18 demonstration states. Key 

staff includes the project director, 

project manager, and principal 

investigator and/or medical director. 

The purpose of these interviews is to 

gain insight into the implementation of 

demonstration projects, to understand 

contextual factors, and to identify 

lessons and implications for the broad 

application and sustainability of 

projects. Because key staff have the most 

knowledge of project design and 

implementation, they will be 

interviewed annually. This request for 

OMB approval covers the first two 

annual interviews with key staff. 

(2) Implementation Staff Interviews— 

semi-structured interviews with staff 

involved in the day-to-day 

implementation of grant-funded projects 

in each of the 18 demonstration states. 

These staff members include state 

agency employees, provider trainers or 

coaches, health IT vendors, and/or 

project consultants. The purpose of 

these interviews is to gain insight into 

the opportunities and challenges related 

to key technical aspects of project 

implementation. 

(3) Stakeholder Interviews—semistructured interviews with external 

stakeholders that have a direct interest 

in children’s care quality in Medicaid 

and CHIP in each of the 18 

demonstration states. Stakeholders 

include representatives of managed care 

organizations, state chapters of the 

American Academy of Pediatrics, 

advocacy organizations for children and 

families, and social service agencies. 

These stakeholders will be familiar with 

the CHIPRA projects and may serve on 

advisory panels or workgroups related 

to one or more projects. The interviews 

will gather insight into the 

opportunities and challenges related to 

project implementation, stakeholder 

satisfaction with their project 

involvement, and contextual factors. 

(4) Health Care Provider Interviews— 

semi-structured interviews with health 

care providers who are, or are not, 


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Federal Register / Vol. 76, No. 195 / Friday, October 7, 2011 / Notices 62411 

participating in demonstration grant 

activities (participating and comparison 

providers, respectively) in each of the 

18 demonstration states. Providers can 

include clinicians from private 

practices, public clinics, Federally 

qualified health centers, care 

management entities, or school based 

health centers. The interviews with 

participating providers will capture 

information about project-related 

activities, providers’ perceptions of the 

likelihood of achieving intended 

outcomes, and providers’ involvement 

in other quality-improvement 

initiatives. The interviews with 

comparison providers will ask about the 

providers’ experiences providing care to 

children in Medicaid and CHIP, 

coordinating with other providers, use 

of HIT, and provision of patientcentered care. 

(5) Non-demonstration States 

Interviews—semi-structured interviews 

with knowledgeable Medicaid or CHIP 

personnel including the Medicaid/CHIP 

director, the Medicaid health-IT 

coordinator, and/or project directors for 

state medical home initiatives in 9 nondemonstration states. The purpose of 

these interviews is to enrich AHRQ’s 

understanding of how the CHIPRA 

quality grants contribute to improved 

care quality above and beyond other 

quality-related initiatives happening at 

the same time. Examples of other 

quality-related initiatives include those 

funded by the HITECH Act, the 

Pediatric Quality Measures Program, 

and various medical home initiatives. 

The information collected through the 

semi-structured interviews will be a key 

source of evidence for the national 

evaluation of the demonstration. 

Collecting high-quality, timely 

interview data from a wide range of 

knowledgeable respondents directly 

serves AHRQ’s goal of understanding 

project implementation and the 

selection and execution of strategies, 

and of identifying the particular 

activities and resources that contributed 

most to any observed improvement in 

children’s care quality. The products 

that will result from this project include 

practice profiles, replication guides, 

case studies, and peer-reviewed journal 

articles. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the 

respondent’s time to participate in this 

evaluation. Key Staff Interviews will be 

conducted twice with 4 persons from 

each of the 18 CHIPRA demonstration 

States and will last for about 11⁄2 hours. 

Implementation Staff Interviews will 

include 16 persons from each of the 18 

CHIPRA demonstration States and take 

an hour to complete. Stakeholder 

Interviews will include 8 persons from 

each of the 18 CHIPRA demonstration 

States and also take an hour to 

complete. Health Care Provider 

Interviews will be conducted with 12 

persons from each of the 18 CHIPRA 

demonstration States and will last 45 

minutes. Non-demonstration States 

Interviews will be conducted with 5 

persons from 9 non-demonstration 

States and will take about 1 hour to 

complete. The total burden for this 

evaluation is estimated to be 855 hours. 

Exhibit 2 shows the estimated 

annualized cost burden associated with 

the respondent’s time to participate in 

this evaluation. The total cost burden is 

estimated to be $32,914. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Data collection Number of respondents 

Number of 

States 

Number of responses per 

respondent 

Hours per response Total burden 

hours 

Key Staff Interviews ............................................................. 4 18 2 1.5 216 

Implementation Staff Interviews ........................................... 16 18 1 1 288 

Stakeholder Interviews ......................................................... 8 18 1 1 144 

Health Care Provider Interviews .......................................... 12 18 1 45/60 162 

Non-demonstration States Interviews .................................. 5 9 1 1 45 

Total .............................................................................. 45 na na na 855 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Data collection Number of respondents 

Number of 

States 

Total burden 

hours 

Average hourly wage * Total cost burden 

Key Staff Interviews ............................................................. 4 18 216 $36.35 $7,852 

Implementation Staff Interviews ........................................... 16 18 288 34.67 9,985 

Stakeholder Interviews ......................................................... 8 18 144 18.68 2,690 

Health Care Provider Interviews .......................................... 12 18 162 62.50 10,125 

Non-demonstration States Interviews .................................. 5 9 45 50.26 2,262 

Total .............................................................................. 45 na 855 na 32,914 

* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United States May 2009, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ Key project staff are state government workers who are general managers. Other implementation 

personnel are state workers who are managers of social and community services. External stakeholders are civilian workers who are in community and social services occupations. Participant providers are civilian pediatric physicians. Medicaid/CHIP personnel are Federal employees in a 

medical and health service management role. 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the total and 

annualized cost for this evaluation. The 

total cost to the government of the entire 

evaluation contract is $8,258,311 

(including a base period and four option 

periods); the annualized cost is 

$1,651,662 per year (Exhibit 3). These 

costs will be incurred from 2010 to 

2012. 

EXHIBIT 3—ESTIMATED TOTAL AND

ANNUAL COST

Cost component Total cost Annual 

cost 

Administration ....... $571,422 $114,284 


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62412 Federal Register / Vol. 76, No. 195 / Friday, October 7, 2011 / Notices 

EXHIBIT 3—ESTIMATED TOTAL AND

ANNUAL COST—Continued 

Cost component Total cost Annual 

cost 

Coordination ......... 38,003 7,601 

Stakeholder Feedback ................... 201,637 40,327 

Technical Expert 

Panel ................. 359,276 71,855 

Evaluation Design 

& Implementation .................... 3,981,390 796,278 

Technical Assistance Plan .......... 934,440 186,888 

Data Collection Instruments .......... 138,997 27,799 

OMB Clearance .... 35,617 17,808 

Section 508 Compliance ............... 13,883 2,777 

Data and Analysis 

Reports .............. 735,426 147,085 

Interim Evaluation 

Reports .............. 408,803 81,761 

Dissemination ....... 736,149 184,037 

Final Report .......... 103,269 103,269 

Total ............... 8,258,311 1,651,662 

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: September 26, 2011. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2011–25691 Filed 10–6–11; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–11–0576] 

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 

Possession, Use, and Transfer of 

Select Agents and Toxins (OMB) 

Control No. (0920–0576) Exp. 12/31/ 

2011—Revision—Office of Public 

Health Preparedness and Response 

(OPHPR), Division of Select Agents and 

Toxins (DSAT), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

The Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002, Subtitle A of 

Public Law 107–188 (42 U.S.C. 262a), 

requires the United States Department 

of Health and Human Services (HHS) to 

regulate the possession, use, and 

transfer of biological agents or toxins 

(i.e., select agents and toxins) that could 

pose a severe threat to public health and 

safety. The Agricultural Bioterrorism 

Protection Act of 2002, Subtitle B of 

Public Law 107–188 (7 U.S.C. 8401), 

requires the United States Department 

of Agriculture (USDA) to regulate the 

possession, use, and transfer of 

biological agents or toxins (i.e., select 

agents and toxins) that could pose a 

severe threat to animal or plant health, 

or animal or plant products. In 

accordance with these Acts, HHS and 

USDA promulgated regulations 

requiring entities to register with the 

CDC or the Animal and Plant Health 

Inspection Service (APHIS) if they 

possess, use, or transfer a select agent or 

toxin (42 CFR part 73, 7 CFR part 331, 

and 9 CFR part 121). 

CDC is requesting continued OMB 

approval to collect this information 

through the use of five forms: (1) 

Application for Registration, (2) Request 

to Transfer Select Agent or Toxin, (3) 

Report of Theft, Loss, or Release of 

Select Agent and Toxin, (4) Report of 

Identification of Select Agent or Toxin, 

and (5) Request for Exemption. Revision 

will be made to (2) Request to Transfer 

Select Agent or Toxin, (3) Report of 

Theft, Loss, or Release of Select Agent 

and Toxin, (4) Report of Identification of 

Select Agent or Toxin. There will be no 

revisions made to the Application for 

Registration and Request for Exemption 

The total estimated annualized burden 

for all data collection is 8,878 hours. 

Information will be collected via fax, email and mail from respondents of the 

320 entities registered with the Select 

Agent Program. Annualized burden 

hours were calculated by multiplying 

the average number of hours used to 

complete the: (1) Application for 

Registration; (2) Request to Transfer 

Select Agent or Toxin; (3) Report of 

Theft, Loss, or Release of Select Agent 

or Toxin; (4) Report of Identification of 

Select Agent or Toxin; and (5) Request 

for Exemption. The estimated 

annualized burden for the 2008 

Possession, Use, and Transfer of Select 

Agents and Toxins submission was 

9,656.5 hours. The 2011 estimated 

annualized burden hours are 8,878. 

Burden has been reduced by 778.5 

hours due to the removal of similar 

questions on the Request to Transfer 

Select Agent or Toxin (Form 2), Report 

of Theft, Loss, or Release of Select Agent 

or Toxin (Form 3) and the Report of 

Identification of Select Agent or Toxin 

(Form 4). Therefore respondents are not 

required to answer as many questions as 

requested in the previous data 

collection tool. 

The Request to Transfer Select Agent 

or Toxin form (42 CFR 73.16) will be 

used by entities requesting transfer of a 

select agent or toxin to their facility. 

CDC in conjunction with APHIS has 

revised the Request to Transfer Select 

Agent or Toxin form by requiring the 

recipient to submit the initial request, 

be notified by the sender of the expected 

shipment date, and verify if the 

shipment did not occur. Estimated 

average time to complete this form is 1 

hour, 30 minutes. Based on data 

regarding the transfer requests received 

since the last submission, CDC estimates 

1 transfer requests submitted per 

registered entity on an annual basis. 

The Report of Theft, Loss, or Release 

of Select Agent and Toxin form (42 CFR 

73.19(a)(b)) must be completed by 

entities whenever there is theft, loss, or 

release of a select agent or toxin. 

Estimated average time to complete this 

form is 1 hour. Based on data regarding 

the reports received since the last 

submission, CDC estimates that 1 report 


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