Attachment H -- Federal Register Notice

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Federal Register / Vol. 76, No. 16 / Tuesday, January 25, 2011 / Notices

Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ1s 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 3, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–1172 Filed 1–24–11; 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 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:
‘‘Synthesis Reports for Grants and
Cooperative Agreements for
Transforming Healthcare Quality
through Information Technology
(THQIT).’’ In accordance with the
Paperwork Reduction Act, 44 U.S.C.
3501–3520, AHRQ invites the public to
comment on this proposed information
collection.
This proposed information collection
was previously published in the Federal
Register on November 2, 2010 and

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SUMMARY:

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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 February 24, 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].
SUPPLEMENTARY INFORMATION:

Proposed Project
Synthesis Reports for Grants and
Cooperative Agreements for
Transforming Healthcare Quality
Through Information Technology
(THQIT)
AHRQ’s health information
technology initiative is part of the
Nation’s strategy to put information
technology to work in health care. By
developing secure and private electronic
health records and making health
information available electronically
when and where it is needed, health IT
can improve the quality of care, even as
it makes health care more cost-effective.
This proposed information collection
will help AHRQ enhance the evidence
base to support effective information
technology (IT) implementation and add
to knowledge about health IT by
synthesizing and drawing lessons from
its Transforming Healthcare Quality
through Information Technology
(THQIT) program.
From 2004–2010, the THQIT program
has supported the adoption of health IT
through 118 grants and cooperative
agreements. These grants fall into three
main categories: planning grants,
implementation grants and value
demonstration grants. Planning grants
are intended to develop health IT
infrastructure and data-sharing capacity
among clinical provider organizations in
their communities by (1) Creating
multidisciplinary collaboratives and
coalitions of health care providers, (2)
conducting needs assessments and
feasibility studies, and (3) developing
plans to implement electronic health
records. Implementation grants support
community-wide and regional health IT

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systems by (1) Developing shared
registries, electronic health record
systems, and telemedicine networks, (2)
integrating clinical data from a variety
of health IT systems, including
pharmacy, laboratory, and public health
organizations, (3) redesigning clinical
workflow to improve patient care and
provider access to information and (4)
creating novel methods for delivering
information to providers. Value
demonstration grants evaluate how the
adoption of health IT will (1) Impact
quality, safety, and resource use in
large, integrated delivery systems, (2)
advance the effectiveness of Web-based,
patient education tools and (3) improve
patient transitions between health care
facilities and their homes. The program
places an emphasis on grants to rural
health organizations.
AHRQ does not currently have a
system in place for assessing the overall
outcomes and lessons learned from
these health IT grants. This project seeks
to create such a system and has the
following goals:
(1) Further the state of knowledge of
health IT planning, implementation,
and effects by synthesizing the
experiences of THQIT grantees and the
reported effects of the grants;
(2) Translate this knowledge into a
practical tool to assist rural hospitals
with electronic health record
implementations; and
(3) Translate this knowledge into
recommendations for AHRQ activities.
This study is being conducted by
AHRQ through its contractor,
Mathematica Policy Research, Inc.
(Mathematica), pursuant to AHRQ’s
statutory authority to conduct and
support research (1) on healthcare and
on systems for the delivery of such care,
42 U.S.C. 299a, and (2) on information
systems for health care improvement. 42
U.S.C. 299b–3.
Method of Collection
To achieve the goals of this project the
following data collections will be
implemented:
(1) Planning Grant Survey for all
grantees that received a planning grant;
(2) Implementation Grant Survey for
all grantees that received an
implementation grant;
(3) Value Grant Survey for all grantees
that received a value grant; and
(4) In-Depth Interviews will be
conducted via telephone with a sample
of grantees from each of the three types
of grants. Given the complex nature of
many of the projects conducted under
these grants, from each selected grantee
organization 1 to 3 persons with
different areas of expertise will
participate in the interview with the

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Federal Register / Vol. 76, No. 16 / Tuesday, January 25, 2011 / Notices
most knowledgeable person responding
to a given question. Questions vary by
grant type.
These proposed data collections will
gather information from grantee
principal investigators on topics
including: (1) Partnerships, which were
required of all the grantees—what types
are most effective and long-lasting and
how partnerships can be made more
effective; (2) planning for health IT—
information that can help identify
successful pathways; (3)
implementation of health IT—including
common and unique barriers and
facilitators to implementation across
types of health IT and care settings; (4)
the outcomes, benefits, and drawbacks
of the grant projects; and (5) the
sustainability and expansion of
implemented health IT.
Collecting this information will assist
AHRQ in its mission of supporting the
synthesis and dissemination of available
evidence for the planning,
implementation, and use of health IT by
patients, practitioners, providers,
purchasers, policymakers, and
educators.

The proposed data collection is also
designed to assist AHRQ in improving
the effectiveness with which it supports
future research, synthesis, and
initiatives on health IT topics. The
grantees’ experiences with the THQIT
grant process and features is an
important topic covered including
feedback on whether the funding and
time period were sufficient, how
effective the grant was in furthering
health IT in grantee organizations, and
whether planning grants are a useful
mechanism to prepare health care
organizations and researchers to
participate in future large-scale
research.
This research also supports AHRQ’s
mission, 42 U.S.C. 299(c), to specifically
focus on rural populations and priority
populations by collecting information
on special factors affecting rural health
care grantees, and the outcomes of the
grant projects for AHRQ priority
populations.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours associated

with the respondents’ time to
participate in this research. The Value
Grant Survey will be completed by the
24 grantees that received a value grant
and takes 30 minutes to complete. The
Planning Grant Survey will be
completed by all 38 recipients of a
planning grant and requires 30 minutes
to complete. The Implementation Grant
Survey will be completed by the 56
grantees that received an
implementation grant and takes 45
minutes to complete. In-depth
interviews will be conducted with 1 to
3 persons (2 on average) from each of 30
different grantee organizations and is
estimated to average 1.8 hours; actual
burden will vary since some sections
apply to specific grant types. The total
annualized burden is estimated to be
181 hours.
Exhibit 2 shows the estimated
annualized cost burden associated with
the respondents’ time to participate in
this research. The total annualized cost
burden is estimated to be $7,917.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name

Number of
response per
respondent

Hours per
response

Total burden
hours

Value Grant Survey .........................................................................................
Planning Grant Survey ....................................................................................
Implementation Grant Survey ..........................................................................
In-Depth Interviews ..........................................................................................

24
38
56
30

1
1
1
2

30/60
30/60
45/60
1.8

12
19
42
108

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

148

n/a

n/a

181

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Form name

Total burden
hours

Average hourly wage rate*

Total Cost
burden

Value Grant Survey .........................................................................................
Planning Grant Survey ....................................................................................
Implementation Grant Survey ..........................................................................
In-Depth Interviews ..........................................................................................

24
38
56
30

12
19
42
108

43.74
43.74
43.74
43.74

$525
831
1,837
4,724

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

148

181

na

7,917

*Based upon the mean of the average wages for medical and health services managers, Department of Labor, Bureau of Labor Statistics, Occupational and Employment Wages. May 2009. Accessed at: http://www.bls.gov/news.release/pdf/ocwage.pdf.

Estimated Annual Costs to the Federal
Government

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Exhibit 3 shows the estimated total
and annualized cost for this project.

Although data collection activities will
last for one year, the entire project will
span 2.25 years; therefore, the
annualized costs cover two and a

quarter years. The total project cost is
estimated to be $600,055.

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST
Cost component

Total cost

Project Development .......................................................................................................................................................
Data Collection Activities .................................................................................................................................................
Data Processing and Analysis .........................................................................................................................................

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$80,584
72,198
52,389

Annualized
cost
$35,815
32,088
23,284

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Federal Register / Vol. 76, No. 16 / Tuesday, January 25, 2011 / Notices
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued
Cost component

Annualized
cost

Publication of Results ......................................................................................................................................................
Project Management ........................................................................................................................................................
Overhead .........................................................................................................................................................................

149,476
70,313
175,095

66,434
31,250
77,820

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

600,055

266,691

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 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 3, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–1169 Filed 1–24–11; 8:45 am]
BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0370]

mstockstill on DSKH9S0YB1PROD with NOTICES

Total cost

Draft Guidance for Industry: Questions
and Answers Regarding
Implementation of the Menu Labeling
Provisions of Section 4205 of the
Patient Protection and Affordable Care
Act of 2010; Withdrawal of Draft
Guidance
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice; withdrawal.

The Food and Drug
Administration (FDA) is announcing the

SUMMARY:

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withdrawal of a draft guidance entitled
‘‘Draft Guidance for Industry: Questions
and Answers Regarding Implementation
of the Menu Labeling Provisions of
Section 4205 of the Patient Protection
and Affordable Care Act of 2010’’ dated
August 2010, that was announced in the
Federal Register of August 25, 2010.
FDA now intends to complete the notice
and comment rulemaking process for
the Patient Protection and Affordable
Care Act of 2010 (hereinafter ‘‘section
4205’’) before initiating enforcement
activities based, in part, on extensive
comments on the draft guidance
submitted to the Agency. FDA believes
that this approach to implementing
section 4205 will minimize uncertainty
and confusion among all interested
persons.
The withdrawal is effective
January 25, 2011.

DATES:

FOR FURTHER INFORMATION CONTACT:

Geraldine A. June, Center for Foods
Safety and Applied Nutrition (HFS–
820), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, 301–436–2371.
In a notice
published in the Federal Register of
August 25, 2010 (75 FR 52426), FDA
announced the availability of a draft
guidance entitled ‘‘Draft Guidance for
Industry: Questions and Answers
Regarding Implementation of the Menu
Labeling Provisions of Section 4205 of
the Patient Protection and Affordable
Care Act of 2010.’’ As stated in the draft
guidance, certain provisions of section
4205 became requirements immediately
upon enactment of the law. FDA
recognized that industry may need
additional guidance from the Agency
and time to comply with these
provisions. As a result, FDA stated that
it expected to refrain from initiating
enforcement action against
establishments that are subject to, but
not in compliance with, the provisions
of section 4205 that became
requirements immediately upon
enactment of the law until a time period
established in the draft guidance. FDA
also stated that it anticipated issuing the
guidance in December 2010.

SUPPLEMENTARY INFORMATION:

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Based, in part, on extensive comments
on the draft guidance submitted to the
Agency, FDA now intends to complete
the notice-and-comment rulemaking
process for section 4205 before initiating
enforcement activities. As noted in the
draft guidance, FDA is required to issue
proposed regulations to carry out
provisions of section 4205 no later than
March 23, 2011. FDA intends to meet
this statutory deadline. In the course of
developing the proposed rule, the
Agency has considered the comments
received on the draft guidance. FDA
will then review the comments it
receives on the proposed rule and issue
a final rule expeditiously.
FDA believes that this approach to
implementing section 4205 will
minimize uncertainty and confusion
among all interested persons. The
Agency also believes that expeditious
completion of the rulemaking process
will most rapidly lead to full and
consistent availability of the newly
required nutrition information for
consumers.
For these reasons, FDA is at this time
withdrawing the draft guidance entitled
‘‘Draft Guidance for Industry: Questions
and Answers Regarding Implementation
of the Menu Labeling Provisions of
Section 4205 of the Patient Protection
and Affordable Care Act of 2010.’’
Dated: January 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–1530 Filed 1–21–11; 12:00 pm]
BILLING CODE 4160–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0559]

Guidance for Industry on Process
Validation: General Principles and
Practices; Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) is announcing the

SUMMARY:

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