Attachment E -- Federal Register Notice

Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Notices
domestic emergency involving anthrax,
no current heightened risk of an anthrax
attack, and no credible information
indicating an imminent threat of an
attack involving Bacillus anthracis.
Pursuant to section 564(b) of the Federal
Food, Drug, and Cosmetic Act, 21 U.S.C.
360bbb–3(b), and on the basis of such
determination, on October 1, 2008,
former Secretary of Health and Human
Services, Michael O. Leavitt, declared
an emergency justifying the
authorization of the emergency use of
doxycycline hyclate tablets
accompanied by emergency use
information subject to the terms of any
authorization issued under 21 U.S.C.
360bbb–3(a).1
Pursuant to section 564(b)(2)(B) of the
Federal Food, Drug, and Cosmetic Act,
21 U.S.C. 360bbb–3(b), and on the basis
of Secretary Chertoff’s September 23,
2008 determination, I hereby renew
former Secretary Leavitt’s October 1,
2008 declaration of an emergency
justifying the authorization of the
emergency use of doxycycline hyclate
tablets accompanied by emergency use
information subject to the terms of any
authorization issued under 21 U.S.C.
360bbb–3(a) and amend the declaration
to justify the authorization of all oral
formulations of doxycycline
accompanied by emergency use
information subject to the terms of any
authorization issued under 21 U.S.C.
360bbb–3(a). I previously renewed the
declaration on October 1, 2009 and
October 1, 2010.2 I am issuing this
notice in accordance with section
564(b)(4) of the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. 360bbb–3(b)(4).
Dated: July 20, 2011.
Kathleen Sebelius,
Secretary.
[FR Doc. 2011–18937 Filed 7–26–11; 8:45 am]
BILLING CODE P

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: ‘‘Pre-test
of an Assisted Living Consensus
Instrument.’’ 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 May 11, 2011 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 26, 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.
SUMMARY:

SUPPLEMENTARY INFORMATION:

Proposed Project

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Pre-Test of an Assisted Living
Consensus Instrument

1 Pursuant to section 564(b)(4) of the Federal
Food, Drug, and Cosmetic Act, notice of the
determination by the Secretary of Homeland
Security and the declaration by the Secretary of
Health and Human Services was provided at 73 FR
58242 (October 6, 2008).
2 Pursuant to section 564(b)(4) of the Federal
Food, Drug, and Cosmetic Act, notices of the
renewal of the declaration of the Secretary of Health
and Human Services were provided at 74 FR 51,279
(Oct. 6, 2009) and 75 FR 61,489 (Oct. 5, 2010).

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Using a consensus-based process and
in partnership with the Center for
Excellence in Assisted Living (CEAL),
AHRQ has developed a data collection
tool that will collect uniform
information about individual assisted
living facilities (ALFs) in the United
States to increase the value of healthcare
for consumers by helping them make
informed choices when selecting an
ALF. Included in the development
process were a voluntary committee of

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national representatives of Assisted
Living Facilities, consumers, and
researchers.
Assisted living (AL) is a relatively
new long-term care option that currently
serves approximately one million older
and dependent Americans. Unlike
skilled nursing facilities which are
federally regulated and relatively
uniform from state to state, ALFs vary
from state to state, as well as within
each state, reflecting various core values
that embrace consumer choice and
provider diversity.
Most states mandate a set of basic
services that an ALF must offer, such as
meals and housekeeping. The upper
limits of allowable services are also
often prescribed. However, within the
range of services required and allowed,
ALFs in most states are given some
latitude as to who they choose to serve
and what services they choose to
provide. Further, the choice of services
is not always confined by geography;
that is, given the widespread dispersion
of families, potential AL residents may
be looking to choose among assisted
living properties in different states,
thereby widening the choices available.
While some ALFs are equipped to
serve a wide range of resident needs, it
is more common that an assisted living
property will address a particular
‘‘market niche.’’ There are many ways in
which ALFs offer diversity — in the
religious or cultural affiliations of its
target market; in the house rules that
influence expectations about dress and
behavior in the dining room; in the
admission and discharge criteria in
place; as well as in the range of services
provided. Major variation is found in
the extent to which a particular ALF is
able and willing to serve those with
dementia. While most ALFs admit and
retain residents with mild cognitive
impairment, those without a specialized
dementia program may have difficulty
serving residents with common
symptoms such as a lack of safety
awareness, wandering, sleep
disturbances and agitation.
To some extent, admission and
discharge criteria are dictated by the
laws and regulations of the state in
which a particular ALP operates.
Beyond this, ALFs have considerable
latitude in assessing individuals whom
they will admit and retain in their
facilities.
In addition to the assessment of
needed services in relation to the
services that are available, the ability to
pay for AL services is a critical factor for
both the consumer and ALF decisionmaking about whether and when an
individual moves into and out of a
particular ALF. Approximately ten

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Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Notices

percent of AL residents receive
subsidies through State Medicaid
Waiver or State Plan programs, and
fewer than three percent are covered by
long-term care insurance. Thus, a
substantial percentage of AL consumers
use savings and other assets, including
proceeds from the sale of their homes,
to pay for their stay in an ALF. In
choosing an ALF, consumers need to
consider whether a particular facility is
able to accept Medicaid or other third
party payments, both now and in the
future, should their assets become
depleted.
This research has the following goals:
(1) Refine the data collection tool
through pre-testing with a sample of
ALFs; and
(2) Make the data collection tool
publically available through the AHRQ
website.
This study is being conducted by
AHRQ through its contractor, Abt
Associates Inc., 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. 42 U.S.C. 299a(a)(1).
Method of Collection
To achieve the goals of this project the
following data collection will be
undertaken:
(1) Telephone verification. The
purpose of the telephone verification is
to ensure that the most current mailing
address of each ALF is utilized for the
survey pre-test, and to obtain the name
of the Administrator or Executive
Director of the ALF so the mailed pretest survey can be addressed directly to
that person; and
(2) Pre-test of the Assisted Living
Provider Information Tool for Consumer
Education. The data collection will
include information on several topics of
interest to consumers including services
available in ALFs and costs of those
services, criteria for moving into and out
of an ALF, resident’s rights, house rules,
life safety features, staffing within the
ALF, and the availability of dementia
care services within the ALF. The
purpose of the pre-test is to assess the

utility of the data collection tool as well
as the feasibility for its implementation.
The data that will be collected
through this effort will be used to make
final refinements to the Assisted Living
Provider Information Tool for Consumer
Education and to make adjustments to
the recommended processes for
implementing a similar data collection
effort on a broader basis.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden for the respondents’
time to participate in this project. The
telephone verification will be completed
by 285 AL providers and will take
approximately one minute to complete.
The pre-test of the Assisted Living
Provider Information Tool for Consumer
Education will be completed by 191
ALFs and will require approximately 25
minutes to complete. The total annual
burden is estimated to be 85 hours.
Exhibit 2 shows the estimated
annualized cost burden associated with
the respondents’ time to participate in
this project. The total annualized cost
burden is estimated to be $3,576.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name

Number of
responses per
respondent

Hours per
response

Total burden
hours

Telephone verification ......................................................................................
Pre-test ............................................................................................................

285
191

1
1

1/60
25/60

5
80

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

476

na

na

85

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Form name

Total burden
hours

Average
hourly wage
rate *

Total cost
burden

Telephone verification ......................................................................................
Pre-test ............................................................................................................

285
191

5
80

$15.37
43.74

$77
3,499

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

476

85

na

3,576

* Based upon the mean of the average wages reflected in the National Compensation Survey (May 2009), US. Department of Labor, Bureau of
Labor Statistics. Wage categories used: Phone verification—office and administrative support workers; pre-test—medical and health services
managers in the United States.

Estimated Annual Costs to the Federal
Government

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The total cost of this contract to the
government is $424,000. The project

extends over four years, but this request
is for a one-year OMB clearance. Exhibit
3 shows a breakdown of the total cost
as well as the annualized cost.

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST
Cost component

Total cost

Project Development ...............................................................................................................................................
Data Collection Activities .........................................................................................................................................
Data Processing and Analysis .................................................................................................................................
Reporting of results .................................................................................................................................................

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$125,000
90,000
30,000
30,000

Annualized
cost
$31,250
22,500
7,500
7,500

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Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Notices
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued
Cost component

Annualized
cost

Project Management ................................................................................................................................................

164,552

41,138

Total Costs .......................................................................................................................................................

439,552

109,888

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: July 13, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–18789 Filed 7–26–11; 8:45 am]
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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 ARRA Comparative
Effectiveness Research Dissemination
Contractor Efforts.’’ In accordance with

SUMMARY:
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Total cost

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the Paperwork Reduction Act, 44 U.S.C.
3501–3521, AHRQ invites the public to
comment on this proposed information
collection.
DATES: Comments on this notice must be
received by September 26, 2011.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@AHRQ.hhs.gov.
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 ARRA Comparative
Effectiveness Research Dissemination
Contractor Efforts
Today, both patients and their health
care providers have many options when
deciding on a treatment plan.
Information available to patients and
their health care providers offers great
opportunities for informed decision
making. However, the volume of
information that needs to be reviewed
and synthesized can be daunting. To
complicate matters, studies may offer
conflicting information or have a
conflict of interest (e.g., research
sponsored by pharmaceutical
companies that make drugs). Sorting
through conflicting information requires
a background in research that most
patients do not have, and physicians
have limited time to conduct these
reviews. Having a neutral third party
review research, draw conclusions, and
disseminate findings is necessary to
ensure effective health care delivery and
consumption of quality care.
AHRQ recognizes the need to fill this
gap and has taken a lead role in
developing mechanisms for reviewing
and disseminating Comparative
Effectiveness Research (CER) and
findings to clinicians, health care
decision makers, purchasers/business
decision makers, and consumers
through its Effective Healthcare Program

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(EHCP). CER directly compares the
benefits, potential risks, and costs of
two or more health care interventions.
These direct comparisons allow
assessments of how well a health care
treatment or intervention works under
real-world conditions. AHRQ has paid
careful attention not only to how studies
are conducted but also to how results
are communicated to its audiences.
To augment AHRQ’s existing CER
dissemination efforts performed by the
Eisenberg Center and other initiatives,
AHRQ is conducting four one-time
projects to test other ways to
disseminate CER results. These four
related projects will test new
approaches to CER dissemination and
promote awareness of the EHCP.
Collectively, dissemination efforts will
reach AHRQ’s priority audiences of:
clinical decision makers, health care
system decision makers, purchasers/
business decision makers, public policy
decision makers, and consumers/
patients.
Through these four projects AHRQ
aims to: (1) Educate professional and
consumer audiences about CER; (2)
inform professional and consumer
audiences about AHRQ’s EHCP; (3) and
inform a wide range of audiences about
new EHCP research findings.
This project will evaluate the
effectiveness of these four new
dissemination efforts. The evaluation
has four main goals:
1. Assess the effectiveness of the four
dissemination strategies in creating
awareness of CER, specific CER topics,
and the EHCP.
2. Assess the effectiveness of the four
dissemination strategies in fostering
knowledge and understanding of CER
finding, specific CER topics, and the
EHCP.
3. Assess the effectiveness of the four
dissemination strategies in promoting
utilization, including use of the EHCP
materials by consumers and by
clinicians in patient care and if usage by
clinicians is increasing across time.
4. Assess the effectiveness of the four
dissemination strategies in supporting
the benefits of using CER, and specific
CER topics, for both patients and health
care providers.
This study is being conducted by
AHRQ through its contractor, IMPAQ

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