Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Notices 44927 

1Pursuant 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). 

2Pursuant 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). 

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: 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: ‘‘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. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Pre-Test of an Assisted Living 

Consensus Instrument 

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 

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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44928 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

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Telephone verification ...................................................................................... 285 1 1/60 5 

Pre-test ............................................................................................................ 191 1 25/60 80 

Total .......................................................................................................... 476 na na 85 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

respondents 

Total burden 

hours 

Average 

hourly wage 

rate * 

Total cost 

burden 

Telephone verification ...................................................................................... 285 5 $15.37 $77 

Pre-test ............................................................................................................ 191 80 43.74 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 

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 Annualized 

cost 

Project Development ............................................................................................................................................... $125,000 $31,250 

Data Collection Activities ......................................................................................................................................... 90,000 22,500 

Data Processing and Analysis ................................................................................................................................. 30,000 7,500 

Reporting of results ................................................................................................................................................. 30,000 7,500 


sroberts on DSK5SPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Notices 44929 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued 

Cost component Total cost 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] 

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: 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 ARRA Comparative 

Effectiveness Research Dissemination 

Contractor Efforts.’’ In accordance with 

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 

(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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