Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Notices 60461 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondents 

Number of 

respondents 

Number of 

responses per 

respondent 

Average burden response 

(in hours) 

Total 

burden 

(in 

hours) 

Fellowship applicants .................................................................................................... 1122 1 40/60 748 

Fellowship alumni .......................................................................................................... 454 1 15/60 114 

Total ............................................................................................................................... 1576 ........................ ........................ 862 

Dated: September 23, 2010. 

Maryam I. Daneshvar, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2010–24479 Filed 9–29–10; 8:45 am] 

BILLING CODE 4163–18–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: 

‘‘Reduction of Clostridium difficile 

Infections in a Regional Collaborative of 

Inpatient Healthcare Settings through 

Implementation of Antimicrobial 

Stewardship.’’ 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 July 23, 2010 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 November 1, 2010. 

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 

Reduction of Clostridium Difficile 

Infections in a Regional Collaborative of 

Inpatient Healthcare Settings Through 

Implementation of Antimicrobial 

Stewardship 

Healthcare Acquired Infections (HAIs) 

caused almost 100,000 deaths among 

the 2.1 million people who acquired 

infections while hospitalized in 2000, 

and HAI rates have risen relentlessly 

since then. Alarmingly, 70% of HAIs are 

due to bacteria that are resistant to 

commonly used antibiotics (Huang 

2007). This project is designed to 

evaluate the implementation of a 

program to reduce Clostridium difficile 

Infection (CDI) in acute care facilities 

via Antimicrobial Stewardship 

Programs (ASPs). Working with an 

already existing collaborative network 

of acute care facilities in New York that 

currently collect and report mandatory 

data on CDI rates and practice strict 

environmental controls, this project will 

go beyond environmental strategies in 

order to attempt to reduce rates of CDI. 

ASPs seek to promote the appropriate 

use of antimicrobials via several 

methods including selecting the 

appropriate dose, duration and route of 

administration of antibiotics. Using 

antibiotics appropriately can potentially 

improve efficacy, reduce costs, and keep 

drug-related adverse events to a 

minimum. The project is a partnership 

with Boston University School of Public 

Health (BUSPH), Montefiore Medical 

Center (MMC), and Greater New York 

Hospital Association (GNYHA). 

The overall aims of the research are to 

evaluate the implementation of ASPs 

specific to CDI at 11 participating 

hospitals (6 intervention sites and 5 

control sites) and to create a draft ASP 

Toolkit. More specifically, the pilot 

study has been designed to provide 

information to meet the following 

objectives: 

1. Identify the antimicrobial 

stewardship activities, both currently in 

place and those yet to be identified, 

specific to each site’s individual needs, 

to optimize antimicrobial prescribing 

practices to reduce CDI. 

2. Assess prescriber perceptions 

related to ASP. 

3. Assess barriers and facilitators to 

ASP implementation. 

4. Develop a draft ASP Toolkit to help 

hospitals optimize their antimicrobial 

prescribing practices to reduce CDI. 

New York (NY) State currently 

requires ongoing reporting of C-difficile 

data for both clinical and surveillance 

purposes. As part of an arrangement 

with NY State, the Greater New York 

Hospital Association (GNYHA) also 

collects and analyzes these data through 

their CDI collaborative. These data 

include tracking baseline rates of CDI, 

including pharmacy data, data related to 

rates of CDI, patient outcomes, and data 

about infection control practices (such 

as hand-washing and other 

environmental controls to prevent 

spread of infection). The data are 

collected on standardized forms that are 

required by both the state and the 

Centers for Disease Control and 

Prevention (CDC). The data collected at 

these participating hospitals are also 

collected at multiple hospitals 

nationwide as part of routine patient 

care and quality. In addition to new data 

collections initiated specifically for this 

project, this routine and ongoing 

mandatory data collection will serve as 

the project’s knowledge base to allow 

the assessment of ASP programs. 

From the GNYHA data, a three-month 

sample from the participating hospitals 

will be analyzed by Montefiore Medical 

Center (MMC) and GNYHA to obtain 

baseline information. This data will 

enable a comparison of the rates of CDI 

before and after the implementation of 

an ASP. The ASP will be implemented 

at 6 hospitals (intervention sites), while 

5 other hospitals will serve as control 

sites and continue with their current 

practices, including conducting general 

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60462 Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Notices 

infection and environmental controls. 

The specific elements of the ASPs will 

vary by hospital based on priorities and 

what is possible at each facility as well 

as by the antibiotic(s) targeted and will 

likely include some of the following: 

• Formulary review/changes, 

restrictions and preauthorization of 

implicated antimicrobials. 

• Feedback to providers of implicated 

antimicrobials. 

• Processes and algorithms for 

empiric and streamlined regimens for 

Specific diagnoses/pathogens. 

• Antibiotic order form with 

automatic stop orders. 

• Novel combinations of approaches 

to the use of stewardship staff or 

technology for stewardship (e.g., 

software, text paging, pyxis pharmacy 

machines for tracking and promoting 

proper antibiotic prescribing), and 

• Educational efforts for clinicians 

and patients upon diagnosis. 

While the ongoing mandatory 

reporting will allow the measurement of 

change over time in CDI rates, it does 

not provide the necessary information 

that hospitals need about the challenges 

of implementing an ASP. 

Method of Collection 

The following data collection 

activities will be implemented to 

achieve the objectives of this project: 

1. Focus Groups with no more than 6 

staff members at the intervention and 

control hospitals. The focus groups will 

be conducted one time only, by 

telephone and approximately 12 months 

after the implementation begins. The 

focus group guides will differ for the 

intervention and control sites, although 

there will be a common core of 

questions. The common core of the 

focus group protocol will address the 

following: Issues related to experience 

with the GNYI–L& environmental and 

infection control practices they have 

already been utilizing, strategies they 

have already used to reduce CDI and 

perceptions of those strategies, barriers 

to the environmental practices, 

particular areas of challenge, facilitators, 

and factors they think have contributed 

most to their institution’s CDI rates. For 

the intervention sites, the goal of the 

focus group will be to understand in a 

more in-depth and qualitative manner, 

the experience of actually implementing 

the ASP. For the control sites, the goal 

will be to understand what they have 

learned in being a control site and their 

plans moving forward. In addition to the 

core questions, questions will be asked 

about their interest in starting an ASP 

program, goals and priorities, 

expectations of facilitators and barriers 

and if and when they plan to implement 

an ASP. 

2. ASP Questionnaire will be 

administered twice, pre and post 

implementation, to a sample of about 70 

hospital staff at both the intervention 

and control hospitals. Intervention and 

control facilities will receive the same 

questionnaire. The purpose of this 

survey is to measure the staff’s 

perception of the scope of CDI at their 

facility, current antibiotic prescribing 

practices, the perceived need for ASPs 

and how these change over time. The 

questionnaire also collects some 

background information such as the 

staff members’ primary work area, time 

worked in their profession and time 

worked in this hospital. 

While the reporting/surveillance data 

required by the State of NY and the CDC 

can measure rates of CDI and compare 

how hospitals are doing, these data do 

not capture many important issues. A 

major reason that most hospitals do not 

have active, robust ASPs is because they 

can be incredibly challenging to 

develop, administer and manage. They 

require changes in prescribing practices 

and the active agreement and 

participation of physicians, pharmacists 

and administrators. Physicians and 

pharmacists may challenge restrictions 

in formularies and determine that a 

patient may not be given a specific 

antibiotic. But the severity of CDI makes 

it very important for hospitals to 

determine optimal methods for 

implementing successful ASPs. This 

pilot study will collect data to allow the 

comparison of perceptions and 

experiences between hospitals that do 

and do not attempt to implement an 

ASP. Reflections and feedback directly 

from prescribers and the ASP team 

using qualitative data collection 

procedures are needed to fully 

understand what it means or would 

mean to implement an ASP. The lessons 

learned from this project will be useful 

to health care facilities considering 

implementing an ASP, and will inform 

the development of a draft ASP Toolkit; 

this Toolkit will be evaluated in a 

separate project before being 

disseminated. 

This study is being conducted by 

AHRQ through its contractor, BUSPH 

and their partners Montefiore Medical 

Center (MMC), and Greater New York 

Hospital Association (GNYHA), 

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 and with respect to quality 

measurement and improvement. 42 

U.S.C. 299a(a)(1) and (2). 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the 

respondents’ time to participate in this 

pilot study. Focus Groups will be 

conducted post-intervention with 

approximately 6 staff members at each 

of the 11 study sites (5 control sites and 

6 intervention sites) for a total of 66 

individuals, approximately 36 at the 

intervention sites and approximately 30 

at the control sites. The control site 

focus groups will last approximately 45 

minutes. The intervention site focus 

groups will last approximately 60 

minutes. 

The ASP questionnaire will be 

administered twice, pre and postintervention, to about 70 staff members 

at each of the 11 participating sites and 

takes about 7 minutes to complete. The 

total annualized burden is estimated to 

be 239 hours. 

Exhibit 2 shows the estimated 

annualized cost burden associated with 

the respondents’ time to participate in 

this study. The total cost burden is 

estimated to be $15,037. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

hospitals 

Number of responses per 

hospital 

Hours per response Total burden 

hours 

Focus groups at intervention sites .................................................................. 6 6 1 36 

Focus groups at control sites .......................................................................... 5 6 45/60 23 

ASP Questionnaire .......................................................................................... 11 140 7/60 180 

Total .......................................................................................................... 22 n/a n/a 239 

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Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Notices 60463 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

hospitals 

Total burden 

hours 

Average hourly wage rate* Total cost burden 

Focus groups at intervention sites .................................................................. 6 36 $57.38 $2,066 

Focus groups at control sites .......................................................................... 5 23 57.38 1,320 

ASP Questionnaire .......................................................................................... 11 180 64.73 11,651 

Total .......................................................................................................... 22 239 n/a 15,037 

* The hourly wage for the focus 

groups is based upon the mean of the 

average wages for physicians ($79.33), 

pharmacists ($50.13), and medical and 

health services managers ($42.67). The 

hourly wage for the surveys is based 

upon the average wages for physicians 

($79.33) and pharmacists ($50.13). 

These data come from the May 2008 

National Occupational Employment and 

Wage Estimates, United States,—U.S. 

Bureau of Labor Statistics Division of 

Occupational Employment Statistics, 

May 2008, National Occupational 

Employment and Wage Estimates, 

http://www.bls.gov/oes/2008/may/ 

oes_nat.htmb#11-0000. 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the annualized and 

total cost to the federal government for 

this two year research project. Project 

Management includes activities related 

to coordination between BUSPH staff, 

contracted staff at MMC and GNYIIA, 

and monthly phone calls with the task 

order officer. Project development 

covers steps taken to revise the research 

plan and begin implementation. The 

total cost is estimated to be $999,995. 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST TO THE GOVERNMENT

Cost component Annualized 

cost Total cost 

Project Management ................................................................................................................................................ $28,315 $56,629 

Project Development ............................................................................................................................................... 84,944 169,400 

Data Collection and Analysis ................................................................................................................................... 169,888 339,776 

Technical Assistance and Consultation ................................................................................................................... 60,750 121,500 

Confirmatory lab testing ........................................................................................................................................... 20,000 40,000 

Travel ....................................................................................................................................................................... 7,500 15,000 

Project Supplies and materials ................................................................................................................................ 2,450 4,900 

Overhead ................................................................................................................................................................. 126,395 252,790 

Total .................................................................................................................................................................. 499,998 999,995 

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: September 17, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–24423 Filed 9–29–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0374] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Petition to Request 

an Exemption From 100 Percent 

Identity Testing of Dietary Ingredients: 

Current Good Manufacturing Practice 

in Manufacturing, Packaging, Labeling, 

or Holding Operations for Dietary 

Supplements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by November 

1, 2010. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0608. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

mstockstill on DSKH9S0YB1PROD with NOTICES6