Attachment H -- Federal Register Notice

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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 for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

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 [email protected]
(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
[email protected].
SUMMARY:

SUPPLEMENTARY INFORMATION:

Proposed Project

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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

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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

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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
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
Number of respondents

Data collection

Number of
States

Number of responses per
respondent

Hours per response

Total burden
hours

Key Staff Interviews .............................................................
Implementation Staff Interviews ...........................................
Stakeholder Interviews .........................................................
Health Care Provider Interviews ..........................................
Non-demonstration States Interviews ..................................

4
16
8
12
5

18
18
18
18
9

2
1
1
1
1

1.5
1
1
45/60
1

216
288
144
162
45

Total ..............................................................................

45

na

na

na

855

Average hourly wage *

Total cost burden

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of respondents

Data collection

Number of
States

Total burden
hours

Key Staff Interviews .............................................................
Implementation Staff Interviews ...........................................
Stakeholder Interviews .........................................................
Health Care Provider Interviews ..........................................
Non-demonstration States Interviews ..................................

4
16
8
12
5

18
18
18
18
9

216
288
144
162
45

$36.35
34.67
18.68
62.50
50.26

$7,852
9,985
2,690
10,125
2,262

Total ..............................................................................

45

na

855

na

32,914

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* 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

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(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.

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EXHIBIT 3—ESTIMATED TOTAL AND
ANNUAL COST
Cost component
Administration .......

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Total cost
$571,422

Annual
cost
$114,284

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

EXHIBIT 3—ESTIMATED TOTAL AND
ANNUAL COST—Continued

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Annual
cost

Centers for Disease Control and
Prevention

Cost component
Coordination .........
Stakeholder Feedback ...................
Technical Expert
Panel .................
Evaluation Design
& Implementation ....................
Technical Assistance Plan ..........
Data Collection Instruments ..........
OMB Clearance ....
Section 508 Compliance ...............
Data and Analysis
Reports ..............
Interim Evaluation
Reports ..............
Dissemination .......
Final Report ..........
Total ...............

Total cost
38,003

7,601

201,637

40,327

359,276

71,855

3,981,390
934,440
138,997
35,617
13,883
735,426
408,803
736,149
103,269
8,258,311

103,269
1,651,662

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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

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Agency Forms Undergoing Paperwork
Reduction Act Review

The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
796,278 review by the Office of Management and
Budget (OMB) in compliance with the
186,888
Paperwork Reduction Act (44 U.S.C.
27,799 chapter 35). To request a copy of these
17,808 requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an e2,777 mail to [email protected]. Send written
comments to CDC Desk Officer, Office of
147,085 Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
81,761 Written comments should be received
184,037 within 30 days of this notice.

Request for Comments

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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

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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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