Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices 45859 

to augment the agency’s current 

surveillance capabilities. The proposed 

system will enable queries of distributed 

data sources quickly and securely for 

relevant product safety information. 

Data will continue to be managed by its 

owners, and only data of organizations 

who agree to participate in this system 

will be included. Operations will adhere 

to strict privacy and security safeguards. 

The success of this Initiative will 

depend largely on the content, quality, 

searchability, and responsiveness of 

participating data sources and/or data 

environments. It is essential that FDA 

understand the strengths and limitations 

of potential data sources that might be 

included in the Sentinel Initiative. This 

survey will be used to collect 

information from potentially 

participating data sources and/or 

environments. The data we are seeking 

will describe the characteristics of the 

data available, not personally 

identifiable information. The findings 

will help FDA plan for this proposed 

system and for future work related to 

the Sentinel Initiative. 

This survey will collect information 

on the scope, content, structure, quality, 

and timeliness of data; patient 

population(s), duration of followup, and 

capture of care across all settings; 

availability, experience, and interest of 

investigators with knowledge of the data 

in using it for post-market product 

safety surveillance as well as plans for 

further data source enhancements; 

availability, experience, and interest of 

investigators with knowledge of the data 

in participating in a distributed data 

system; and barriers that exist to 

including each data source in the 

Sentinel Initiative. 

In the Federal Register of March 9, 

2009 (74 FR 10053), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions to which one comment was 

received but was outside the scope of 

the PRA. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Data Source and/or Environment 

Survey 250 1 250 24.5 6,125 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA estimates that approximately 250 

respondents will participate in this 

voluntary survey. These respondents 

will consist mostly of other Federal 

agencies, health plan data sources, 

health information exchanges, large 

multi-specialty medical groups and 

academic medical centers, large hospital 

systems, pharmacies, medical societies, 

consumer-oriented Web sites, 

commercial data sets, research 

networks, lab data, and registries. 

Each respondent will extend 

approximately 24.5 hours to complete 

one survey for a total of 6,125 hours 

(250 x 1 x 24.5 = 6,125). 

Dated: August 27, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–21364 Filed 9–3–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–09–09BW] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an 

e-mail to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Postural Analysis in Low-Seam 

Mines—Existing collection without an 

OMB control number—National 

Institute for Occupational Safety and 

Health (NIOSH), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

NIOSH, under Public Law 91–596, 

sections 20 and 22 (section 20–22, 

Occupational Safety and Health Act of 

1970) has the responsibility to conduct 

research relating to innovative methods, 

techniques, and approaches dealing 

with occupational safety and health 

problems. 

According to the Mining Safety and 

Health Administration (MSHA) injury 

database, 227 knee injuries were 

reported in underground coal mining in 

2007. With data from the National 

Institute for Occupational Safety and 

Health (NIOSH), it can be estimated that 

the financial burden of knee injuries 

was nearly three million dollars in 2007. 

Typically, mine workers utilize 

kneepads to better distribute the 

pressures at the knee. The effectiveness 

of these kneepads is to be investigated 

in a study by NIOSH. Thus, NIOSH will 

be determining the forces, stresses, and 

moments at the knee while in postures 

associated with low-seam mining. At 

this time, the postures utilized by lowseam mine workers and their frequency 

of use are unknown. Therefore, before 

conducting this larger, experimental 

study, the existing collection without an 

OMB control number was required. 

The aim of the field study described 

in this document was to determine the 

postures predominantly used by lowseam mine workers such that they may 

complete the various tasks associated 

with their job duties. A questionnaire 

was developed for each of the major job 

types seen in low-seam mines with 

continuous miners (continuous miner 

operator, roof bolter operator, shuttle car 

operator, mobile bridge operator, 

mechanic, beltman, maintenance shift 

worker, foreman). The questionnaire 

asked basic demographic information 

(e.g., time in job type, years in mining, 

age). Additionally, a series of questions 

were asked such that it could be 

determined if a mine worker is likely to 

have a knee injury, even if it is 

undiagnosed. These questions were 

developed with the help of a physical 

therapist. A schematic of possible 

postures was then presented to the mine 

workers and they were asked to identify 

the primary two postures they utilize to 

complete their job duties. The 

questionnaire then asked mine workers 

to identify the primary postures they 

utilize to complete specific tasks (e.g., 

hanging curtain, building stoppings) 

that are part of their job duties. Finally, 


srobinson on DSKHWCL6B1PROD with NOTICES
45860 Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices 

mine workers were asked to identify 

those postures that are least and most 

comfortable/stressful. There is no cost to 

respondents other than their time. The 

total estimated annual burden hours are 

12. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

per response 

(in hours) 

Continuous miner operator ............................. Continuous Miner Operator Form .................. 5 1 10/60 

Foreman .......................................................... Foreman Form ............................................... 5 1 10/60 

Maintenance Shift Worker .............................. Maintenance Shift Worker Form .................... 10 1 10/60 

Mobile Bridge Operator ................................... Mobile Bridge Operator Form ........................ 10 1 10/60 

Roof Bolter Operator ....................................... Roof Bolter Operator Form ............................ 14 1 10/60 

Scoop Operator ............................................... Scoop Operator Form .................................... 6 1 10/60 

Shuttle Car Operator ....................................... Shuttle Car Operator Form ............................ 6 1 10/60 

Mechanic ......................................................... Mechanic Form .............................................. 6 1 10/60 

Beltman ........................................................... Beltman Form ................................................. 2 1 10/60 

Dated: August 27, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–21376 Filed 9–3–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10079 and CMS– 

10293] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) 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 functions; 

(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: Hospital Wage 

Index Occupational Mix Survey and 

Supporting Regulations in 42 CFR, 

Section 412.64; Use: Section 304(c) of 

Public Law 106–554 amended section 

1886(d)(3)(E) of the Social Security Act 

to require CMS to collect data every 3 

years on the occupational mix of 

employees for each short-term, acute 

care hospital participating in the 

Medicare program, in order to construct 

an occupational mix adjustment to the 

wage index, for application beginning 

October 1, 2004 (the FY 2005 wage 

index). The purpose of the occupational 

mix adjustment is to control for the 

effect of hospitals’ employment choices 

on the wage index. Refer to the 

summary of changes document for a list 

of current changes. Form Number: 

CMS–10079 (OMB#: 0938–0907); 

Frequency: Reporting—Yearly, 

Biennially and Occasionally; Affected 

Public: Private Sector—Business or 

other for-profits and Not-for-profit 

institutions; Number of Respondents: 

3,522; Total Annual Responses: 3,522; 

Total Annual Hours: 1,690,560. (For 

policy questions regarding this 

collection contact Taimyra Jones at 410– 

786–1562. For all other issues call 410– 

786–1326.) 

2. Type of Information Collection 

Request: New Collection; Title of 

Information Collection: Tribal 

Consultation State Plan Amendment 

Template; Use: Effective July 1, 2009, 

section 5006 of the American Recovery 

and Reinvestment Act of 2009 (Recovery 

Act) amended section 1902(a)(73) of the 

Act to require that certain States utilize 

a process for the State to seek advice on 

a regular, ongoing basis from designees 

of the Indian Health Service (IHS) and 

Urban Indian Organizations concerning 

Medicaid and Children’s Health 

Insurance Program (CHIP) matters 

having a direct effect on them. The 

consultation process is required for the 

37 States in which 1 or more Indian 

Health Programs or Urban Indian 

Organizations furnish health care 

services. The State Medicaid agency for 

each of these States will complete the 

template page and submit it for approval 

as part of a State plan amendment, to 

document how it meets the 

requirements for tribal consultation. 

Form Number: CMS–10293 (OMB#: 

0938–NEW); Frequency: Reporting— 

Once and occasionally; Affected Public: 

State, Local, or Tribal Governments; 

Number of Respondents: 37; Total 

Annual Responses: 37; Total Annual 

Hours: 37. (For policy questions 

regarding this collection contact Mary 

Corddry at 410–786–6618. 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 

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

PaperworkReductionActof1995, or Email 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. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by November 3, 2009: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 


srobinson on DSKHWCL6B1PROD with NOTICES