Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Notices 43169 

Department of Health and Human 

Services, is publishing the following 

summary of proposed collections for 

public comment. Interested persons are 

invited to send comments regarding this 

burden estimate or any other aspect of 

this collection of information, including 

any of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Medicare 

Prescription Drug Benefit Plan; Use: 

Section 101 of Title I of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 added 

sections 1860D–1 through D–42 to 

establish this new program. Part D plans 

use the information discussed to comply 

with the eligibility and associated Part 

D participating requirements. CMS will 

use this information to approve contract 

applications, monitor compliance with 

contract requirements, make proper 

payment to plans, and to ensure that 

correct information is disclosed to 

enrollees, both potential enrollees and 

enrollees. Form Number: CMS–10141 

(OMB#: 0938–0964); Frequency: Yearly; 

Affected Public: Individuals and 

households, and business or other forprofit and not-for-profit institutions; 

Number of Respondents: 19,937,660; 

Total Annual Responses: 43,153,271; 

Total Annual Hours: 36,520,101. (For 

policy questions regarding this 

collection contact Christine Hinds at 

410–786–4578. For all other issues call 

410–786–1326.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Consumer 

Assessment of Health Care Providers 

and Systems (CAHPS); Use: CMS is 

required to collect and report 

information on the quality of health care 

services and prescription drug coverage 

available to persons enrolled in a 

Medicare health or prescription drug 

plan under provisions in the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA). 

Specifically, the MMA under Sec. 

1860D–4 (Information to Facilitate 

Enrollment) requires CMS to conduct 

consumer satisfaction surveys regarding 

Medicare prescription drug plans and 

Medicare Advantage plans and report 

this information to Medicare 

beneficiaries prior to the Medicare 

annual enrollment period. The Medicare 

CAHPS survey meets the requirement of 

collecting and publicly reporting 

consumer satisfaction information. Refer 

to the supporting documents to review 

the current collection changes. Form 

Number: CMS–R–246 (OMB#: 0938– 

0732); Frequency: Yearly; Affected 

Public: Individuals and households, and 

business or other for-profit and not-forprofit institutions; Number of 

Respondents: 567,324; Total Annual 

Responses: 567,324; Total Annual 

Hours: 242,376. (For policy questions 

regarding this collection contact 

Elizabeth Goldstein at 410–786–6665. 

For all other issues call 410–786–1326.) 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Notice of Denial 

of Medicare Prescription Drug Coverage: 

Use: Section 1860D–4(g)(1) of the Social 

Security Act requires Part D plan 

sponsors that deny prescription drug 

coverage to provide a written notice of 

the denial to the enrollee. The purpose 

of this notice is to provide information 

to enrollees when prescription drug 

coverage has been denied, in whole or 

in part, by their Part D plans. The notice 

must be readable, understandable, and 

state the specific reasons for the denial. 

The notice must also remind enrollees 

about their rights and protections 

related to requests for prescription drug 

coverage and include an explanation of 

both the standard and expedited 

redetermination processes and the rest 

of the appeal process. For a list of 

changes, refer to the summary of 

changes document. Form Number: 

CMS–10146 (OMB#: 0938–0976); 

Frequency: Daily; Affected Public: 

Business or other for-profits; Number of 

Respondents: 456; Total Annual 

Responses: 290,344; Total Annual 

Hours: 145,172. (For policy questions 

regarding this collection contact 

Kathryn M. Smith at 410–786–7623. For 

all other issues call 410–786–1326.) 

4. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Detailed 

Explanation of Non-Coverage (42 CFR 

422.626(e)(1)), and Notice of Medicare 

Non-Coverage (42 CFR 422.624(b)(1)); 

Use: Under section 42 CFR 422.624 

(b)(1), skilled nursing facilities (SNFs), 

home health agencies (HHAs), and 

comprehensive outpatient rehabilitation 

facilities (CORFs) must deliver to 

Medicare health plan enrollees a 2-day 

advance notice of termination of 

services. Per requirements at 42 CFR 

422.626(e)(1), plans must deliver 

detailed notices to the Quality 

Improvement Organization (QIO) and 

enrollees whenever an enrollee appeals 

a termination of services. The Notice of 

Medicare Non-Coverage (NOMNC) and 

the Detailed Explanation of NonCoverage (DENC) fulfill these regulatory 

requirements. Additionally, 42 CFR 

417.600(b) provides that cost plans must 

follow these same fast track appeal 

notification procedures for their 

enrollees in SNFs, HHAs and CORFs. 

Refer to the crosswalk document for a 

list of changes. Form Number: CMS– 

10095 (OMB#: 0938–0910); Frequency: 

Yearly; Affected Public: Business or 

other for-profits and not-for-profit 

institutions; Number of Respondents: 

25,655; Total Annual Responses: 

100,785; Total Annual Hours: 45,353.25 

(For policy questions regarding this 

collection contact Stephanie Simons at 

206–615–2420. For all other issues call 

410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web Site 

address at http://www.cms.hhs.gov/

PaperworkReductionActof1995, or 

E-mail your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on August 23, 2010. OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer; Fax 

Number: (202) 395–6974; E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: July 19, 2010. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2010–17898 Filed 7–22–10; 8:45 am] 

BILLING CODE 4120–01–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. 

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43170 Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Notices 

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. 

DATES: Comments on this notice must be 

received by September 21, 2010. 

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 

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 

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-[A] 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 

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Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Notices 43171 

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 

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 .......................................................................................................... 22 237 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.htm#b11–0000. 

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 GNYHA, 

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. 

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43172 Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Notices 

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: July 9, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–17796 Filed 7–22–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Toxic Substances and 

Disease 

Board of Scientific Counselors, 

National Center for Environmental 

Health/Agency for Toxic Substances 

and Disease Registry (BSC, NCEH/ 

ATSDR): Notice of Charter Renewal 

This gives notice under the Federal 

Advisory Committee Act (Pub. L. 92– 

463) of October 6, 1972, that the Board 

of Scientific Counselors, Agency for 

Toxic Substances and Disease Registry, 

of the Department of Health and Human 

Services, has been renewed for a 2-year 

period extending through May 21, 2012. 

For further information, contact Paula 

Burgess, M.D., Ph.D., Designated 

Federal Officer, BSC, NCEH/ATSDR, 

1600 Clifton Road, NE, Mailstop E–28, 

Atlanta, Georgia 30333, telephone 404/ 

488–0574, e-mail. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both CDC 

and the Agency for Toxic Substances 

and Disease Registry. 

Dated: July 15, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–18063 Filed 7–22–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0347] 

International Conference on 

Harmonisation; Draft Guidance on Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

International Conference on 

Harmonisation Regions; Annex 13 on 

Bulk Density and Tapped Density of 

Powders General Chapter; Availability; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register of July 14, 2010 (75 FR 40843). 

The document announced the 

availability of a draft guidance entitled 

‘‘Q4B Evaluation and Recommendation 

of Pharmacopoeial Texts for Use in the 

ICH Regions; Annex 13: Bulk Density 

and Tapped Density of Powders General 

Chapter.’’ The document was published 

with an incorrect docket number. This 

document corrects that error. 

FOR FURTHER INFORMATION CONTACT: 

Joyce Strong, Office of Policy, Planning 

and Budget, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 3208, Silver Spring, 

MD 20993–0002, 301–796–9148. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2010–17055, appearing on page 40843 

in the Federal Register of Wednesday, 

July 14, 2010, the following correction 

is made: 

On page 40843, in the first column, in 

the headings section of the document, 

‘‘[Docket No. FDA–2010–N–0344]’’ is 

corrected to read ‘‘[Docket No. FDA– 

2010–D–0347]’’. 

Dated: July 20, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–18119 Filed 7–22–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Administration for Children and 

Families 

Maternal, Infant, and Early Childhood 

Home Visiting Program 

AGENCY: Health Resources and Services 

Administration and Administration for 

Children and Families, HHS. 

ACTION: Request for public comment on 

criteria for evidence of effectiveness of 

home visiting program models for 

pregnant women, expectant fathers, and 

caregivers of children birth through 

kindergarten entry. 

SUMMARY: The Health Resources and 

Services Administration and 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES