Attachment B -- 30 Day Federal Register Notice

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EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued
Total cost
(millions)

Cost component
Data Collection Activities .............................................................................................................................
Data Processing ..........................................................................................................................................
Production of Public Use Data Files ...........................................................................................................
Project Management ....................................................................................................................................

86.7
21.39
19.53
3.93

28.9
7.13
6.51
1.31

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

142.8

47.6

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 1, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9–16567 Filed 7–13–09; 8:45 am]

information collection under the
project: ‘‘Evaluation of AHRQ’s Effective
Health Care Program.’’ 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.
This proposed information collection
was previously published in the Federal
Register on April 24th, 2009 and
allowed 60 days for public comment. No
comments were 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 August 13, 2009.
ADDRESSES: Written comments should
be submitted to: AHRQs 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

BILLING CODE 4160–90–M

’’Evaluation of AHRQ’s Effective Health
Care Program’’

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

AHRQ proposes to perform an
evaluation of the Effective Health Care
(EHC) programs’ governance structure,
methods for engaging stakeholders and
approaches to setting national research
priorities. Pursuant to Section 1013 of
the Medicare Prescription Drug,
Improvement, and Modernization Act of
2003, Public Law 108–173, the EHC
program was established by AHRQ to
conduct research, demonstrations, and
evaluations designed to improve the
quality, effectiveness, and efficiency of
Medicare, Medicaid, and the State
Children’s Health Insurance Program.
The EHC program was designed to
provide effectiveness and comparative
effectiveness evidence of medical

Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
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Annualized cost
(millions)

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

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treatments, therapeutics, devices and
drugs to assist policymakers, health care
providers, clinicians, consumers, and
other stakeholders in making informed
decisions. The EHC program has offered
a platform for combining explicit
reviews of scientific evidence on the
clinical effectiveness of pharmaceuticals
and other health care interventions, as
well as the translation and
dissemination of scientific findings into
meaningfui messages for a wide variety
of audiences. It serves as an interface
between the clinical research entities
and health policy making entities. This
program also provides a critical step in
AHRQ’s mission to support informed
decision making. In addition to its
program staff, the EHC program relies
on four centers to generate and
disseminate evidence: The Evidencebased Practice Centers (EPCs), the
Developing Evidence to Inform
Decisions about Effectiveness (DEcIDE)
Network Centers, the John M. Eisenberg
Clinical Decisions and Communications
Science Center, and the Centers for
Education & Research on Therapeutics
(CERTs). Since the process of
developing and disseminating this
evidence is a complex undertaking,
AHRQ has contracted with IMPAQ
International, LLC and Abt Associates,
Inc. (henceforth referred to as the
‘‘IMPAQ team’’) to perform this
evaluation.
Information will be collected to
identify strengths and weaknesses in the
current EHC program’s governance
structure, methods for engaging
stakeholders, and approaches to setting
priorities for the research conducted by
the EHC program. The second phase of
the evaluation will be to contrast the
EHC program with international
programs of similar purpose. To
implement this evaluation, the IMPAQ
team will conduct the following
information collections:
(1) Key informant interviews about
the governance structure of the EHC
program;
(2) An online survey of EHC center
staff and EHC program users and
stakeholders;

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Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 / Notices

(3) An Appreciative Inquiry workshop
with EHC program staff and
stakeholders;
(4) A document review (will not
impose a burden on research
participants) and
(5) Interviews with staff at
international organizations of similar
purpose (will not impose a burden on
U.S. citizens).
The latter two activities do not require
OMB approval and are not discussed
further in this notice. The information
collected will ultimately be used to
develop a roadmap, including at least
three alternative models of governance
and operation, to be submitted to AHRQ
that could be used to help guide future
programmatic development.
Method of Data Collection
Key Informant Interviews
Semi-structured key informant
interviews will be used to understand
the EHC program’s governance
components and structure, from the
vantage point of individuals governing
the program, governed by the program,
contributing to the program in various
capacities, or impacted by the program’s
activities. Thirteen EHC Research
Centers Staff, two EHC Stakeholder
Group Members, and nineteen EHC
Program Users and Stakeholders will be
interviewed about the governance
structure of the EHC program.
Additional key informant interviews
with twenty five EHC Program Users
and Stakeholders will be used to collect
more detailed information on the
success or impact of the EHC program
product that results from its governance
element or approach, or about a specific,
important governance element.

All key informant interviews will be
tape recorded to improve data capture,
with prior permission from the
participants.
Online Survey
A structured, web-based online
survey of EHC program Research
Centers Staff and EHC program Users
and Stakeholders will be used to gather
information about the EHC program.
The survey will provide a robust view
of the EHC governance system by
providing feedback from a broad group
of individuals whose work is related to
the program. Specifically, the survey
will collect data about these
individuals’ engagement and
involvement with the EHC program;
perceptions of the program’s
governance; experiences with the
development, production,
dissemination, and use of EHC
products; and their beliefs regarding the
quality and nature of the collaborative
work, including public-private
partnerships, being done within centers,
across centers, and between centers and
stakeholders.
Appreciative Inquiry Workshop
Small- and large-group discussions as
part of an Appreciative Inquiry
workshop will be designed to encourage
EHC decision-makers (AHRQ staff, EHC
program staff, AHRQ project officers for
each of the Research Center networks,
principal investigators or other
representatives from each of the
Research Center network) and key
program stakeholders or uers to
consider anddecide which are the
preferred alternative governance models
or elements for which roadmaps should

be developed. Appreciative Inquiry (AI)
approach is an organizational
development process that engages
individuals within an organization in
renewal, change, and focused
performance. The AI approach focuses
on successes and opportunities to
improve things by looking forward,
rather than looking back on the
problems or issues. The AI workshop is
expected to facilitate consensus among
decision-makers to contribute to the
endorsement of the roadmap(s), and to
encourage utilization of the evaluation
findings. The workshop will involve a
creative thinking process that will build
on existing successes, identify and rank
preferred alternatives, and ultimately
develop a plan to strengthen the EHC
program’s governance system.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents to participate in this
evaluation. Key informant interviews
will be conducted about the governance
structure of the EHC program and will
last about one hour. The online survey
will be completed by 95 EHC program
Research Centers Staff and 170 EHC
Program Users and Stakeholders and
will require about 15 minutes to
complete. The Appreciative Inquiry
workshop will be conducted with 20
participants and will last about 6 hours.
The total burden hours are estimated to
be 246 hours. Exhibit 2 shows the
estimated annualized cost burden based
on the respondents’ time to participate
in the evaluation. The total cost burden
is estimated to be $12,297.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

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Activity name

Number of
responses
per
respondent

Hours per
response

Total burden
hours

Key Informant Interviews with EHC Research Centers Staff ..........................
Online Survey with EHC Research Centers Staff ...........................................
Key Informant Interviews with EHC Stakeholder Group Members .................
Key Informant Interviews with EHC Program Users and Stakeholders ..........
Online Survey with EHC Program Users and Stakeholders ...........................
Key Informant Interviews with EHC Program Users and Stakeholders to Develop Cases .................................................................................................
Appreciative Inquiry Workshop ........................................................................

13
95
2
19
170

1
1
1
1
1

1
15/60
1
1
15/60

13
24
2
19
43

25
20

1
1

1
6

25
120

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

344

na

na

246

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Activity name
Key Informant Interviews with EHC Research Centers Staff ..........................
Online Survey with EHC Research Centers Staff ...........................................

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Total burden
hours

13
95

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13
24

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Average
hourly
wage rate*
$54.27
54.27

Total cost
burden
$706
1,302

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Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of
respondents

Activity name

Total burden
hours

Average
hourly
wage rate*

Total cost
burden

Key Informant Interviews with EHC Stakeholder Group Members .................
Key Informant Interviews with EHC Program Users and Stakeholders ..........
Online Survey with EHC Program Users and Stakeholders ...........................
Key Informant Interviews with EHC Program Users and Stakeholders to Develop Cases .................................................................................................
Appreciative Inquiry Workshop ........................................................................

2
19
170

2
19
43

43.52
46.73
46.73

87
888
2,009

25
20

25
120

46.73
51.14

1,168
6,137

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

344

246

na

12,297

* Wage rates were calculated using the following data: (1) For the Governance Interviews and the Online Survey with EHC Research Centers
Staff the hourly rate is a weighted average for physicians ($58.76 per hour) and medical and health services managers ($37.82); (2) for the Governance Interviews with EHC Stakeholder Group Members the hourly rate is the rate for average for medical and health services managers
($37.82); (3) for the Governance Interviews and the Online Survey with EHC Program Users and Stakeholders the hourly rate is a weighted average for physicians ($58.76 per hour), general and operations managers ($43.52 per hour), medical and health services managers ($37.82 per
hour), and social and community service managers ($24.73 per hour); (4) for the Workshop the hourly rate is a weighted average for physicians
($58.76 per hour) and general and operations managers ($43.52 per hour) from the mean of the average wages, National Compensation Survey:
Occupational Wages in the United States 2006, U.S. Department of Labor, Bureau of Labor Statistics.

Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the estimated cost of
this one year data collection for the
evaluation of the EHC program,
including the cost of developing the
methodology and data collection
instruments, collecting and analyzing
the data, publishing the results, etc. The
work will be carried out by IMPAQ
International and Abt Associates under
contract to the Agency for Healthcare
Research and Quality.

EXHIBIT 3—ESTIMATED ANNUAL COST
TO THE FEDERAL GOVERNMENT

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 2, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9–16568 Filed 7–13–09; 8:45 am]
BILLING CODE 4160–90–M

Cost component

Total cost

Project Development ................
Data Collection Activities ..........
Data Processing and Analysis
Publication of Results ...............
Project Management ................

$137,901
179,172
170,577
63,686
97,236

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

648,572

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0212]

* Please note the costs include fully loaded
costs (overhead, G&A).

mstockstill on DSKH9S0YB1PROD with NOTICES

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)

VerDate Nov<24>2008

17:50 Jul 13, 2009

Jkt 217001

Draft Guidance for Industry on
‘‘Incorporation of Physical-Chemical
Identifiers into Solid Oral Dosage Form
Drug Products for Anticounterfeiting,’’
Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Incorporation of
Physical-Chemical Identifiers into Solid
Oral Dosage Form Drug Products for
Anticounterfeiting.’’ This draft guidance
provides recommendations to
pharmaceutical manufacturers on
design considerations for incorporating
physical-chemical identifiers (PCIDs)
into solid oral dosage forms (SODFs),

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supporting documentation to be
submitted in new drug applications
(NDAs) and abbreviated new drug
applications (ANDAs) to address the
proposed incorporation of PCIDs in
SODFs, supporting documentation to be
submitted in postapproval submissions
to report or request approval to
incorporate PCIDs into SODFs, and
procedures for reporting or requesting
approval to incorporate PCIDs into
SODFs as a postapproval change. This
draft guidance also provides our
recommendations regarding evaluation
of toxicological and other concerns for
PCIDs that are incorporated into
packaging and labeling and procedures
for reporting or requesting approval to
add PCIDs to packaging and containers
as a postapproval change.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by October 13, 2009.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments on
the draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.

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