30096 Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Notices 

45 CFR section/IHS form Number of 

respondents 

Responses 

per 

respondent 

Burden per 

response* 

(mins) 

Total annual 

burden 

Total Annual Burden ................................................................................. 5 174,375 

*For ease of understanding, burden hours are provided in actual minutes. 

The total estimated burden for this 

collection of information is 174,375 

hours. 

There are no capital costs, operating 

costs and/or maintenance costs to 

respondents. 

Request for Comments: Your written 

comments and/or suggestions are 

invited on one or more of the following 

points: (a) Whether the information 

collection activity is necessary to carry 

out an agency function; (b) whether the 

agency processes the information 

collected in a useful and timely fashion; 

(c) the accuracy of public burden 

estimate (the estimated amount of time 

needed for individual respondents to 

provide the requested information); (d) 

whether the methodology and 

assumptions used to determine the 

estimate are logical; (e) ways to enhance 

the quality, utility, and clarity of the 

information being collected; and (f) 

ways to minimize the public burden 

through the use of automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

Send Comments and Requests for 

Further Information: Send your written 

comments and requests for more 

information on the proposed collection 

or requests to obtain a copy of the data 

collection instrument(s) and 

instructions to: Ms. Betty Gould, Acting 

IHS Reports Clearance Officer, 801 

Thompson Avenue, TMP, Suite 450, 

Rockville, MD 20852, call non-toll free 

(301) 443–7899, send via facsimile to 

(301) 443–9879, or send your e-mail 

requests, comments, and return address 

to: betty.gould@ihs.gov. 

Comment Due Date: Your comments 

regarding this information collection are 

best assured of having full effect if 

received within 60 days of the date of 

this publication. 

Dated: June 17, 2009. 

Robert G. McSwain, 

Deputy Director for Management Operations, 

Indian Health Service. 

[FR Doc. E9–14841 Filed 6–23–09; 8:45 am] 

BILLING CODE 4165–16–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–09–09BW] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 and 

send comments to Maryam I. Daneshvar, 

CDC Acting Reports Clearance Officer, 

1600 Clifton Road, MS–D74, Atlanta, 

GA 30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection 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 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Postural Analysis in Low-Seam 

Mines—New—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 proposed field study must be 

conducted. 

The aim of the proposed field study 

is to determine the postures 

predominantly used by low-seam 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 

asks basic demographic information 

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

age). Additionally, a series of questions 

are asked such that it may 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 will then be presented to the 

mine workers and they will be asked to 

identify the primary two postures they 

utilize to complete their job duties. The 

questionnaire then asks 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, 

mine workers are asked to identify those 

postures that are least and most 

comfortable/stressful. There is no cost to 

respondents other than their time. 

Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Notices 30097 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

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

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

Maintenance Shift Worker ................ Maintenance Shift Worker Form ...... 10 1 10/60 2 

Mobile Bridge Operator .................... Mobile Bridge Operator Form .......... 10 1 10/60 2 

Roof Bolter Operator ........................ Roof Bolter Operator Form .............. 14 1 10/60 2 

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

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

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

Beltman ............................................. Beltman Form ................................... 2 1 10/60 0.5 

Total ........................................... ........................................................... ........................ ........................ ........................ 12 

Dated: June 11, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–14834 Filed 6–23–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0275] 

Convener of Active Medical Product 

Surveillance Discussion (U13) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of grant funds for the 

support of a neutral, independent 

institution and/or organization that 

proposes appropriate methods and 

processes for convening a broad range of 

stakeholders with relevant expertise to 

manage and support conferences and 

meetings. The focus of the conferences 

and meetings is to explore and address 

methodological, data development, 

technical, and communication issues 

related to active medical product 

surveillance. The awardee would be 

expected to synthesize, summarize, and 

communicate findings from these 

conferences and meetings to a broad 

range of organizations and individuals 

who have the capability to use the 

information to further develop and 

create active medical product 

surveillance methods and systems. 

DATES: The application due date is July 

15, 2009. The earliest start date is in 

September 2009. 

FOR FURTHER INFORMATION AND

ADDITIONAL REQUIREMENTS CONTACT: 

Programmatic/Peer Review Contact: 

Melissa Robb, Office of Critical Path 

Programs, Office of the 

Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

rm. 14B–45, Rockville, MD 20857, 

301–827–1516, e-mail: 

melissa.robb@fda.hhs.gov. 

Financial or Grants Management 

Contact: Gladys M. Bohler, Office of 

Acquisitions and Grant Services, 

Food and Drug Administration, 

5630 Fishers Lane, rm. 2105, 

Rockville, MD 20857, 301–827– 

7168, FAX: 301–827–7101, e-mail: 

gladys.bohler@fda.hhs.gov. 

For more information on this funding 

opportunity announcement (FOA) and 

to obtain detailed requirements, please 

refer to the full FOA located at http:// 

www.fda.gov/Safety/FDAsSentinel

Initiative/ucm149345.htm. 

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description 

Request for Applications (RFA) Number: 

RFA–FD09–012 

Catalog of Federal Domestic Assistance 

Number: 93.103 

A. Background 

In 2007, Congress enacted the Food 

and Drug Administration Amendments 

Act of 2007 (FDAAA). Section 905 of 

this statute calls for the Secretary of 

Health and Human Services (the 

Secretary) to develop methods to obtain 

access to disparate data sources and to 

establish an active postmarket risk 

identification and analysis system that 

links and analyzes safety data from 

multiple sources. The law sets a goal of 

access to data from 25 million patients 

by July 1, 2010, and 100 million patients 

by July 1, 2012. The law also requires 

FDA to work closely with partners from 

public, academic, and private entities. 

In May 2008, the Secretary and the 

Commissioner of Food and Drugs 

announced the launch of the Sentinel 

Initiative, a long-term effort to create a 

national electronic system for 

monitoring regulated product safety. 

Once implemented, the Sentinel System 

is intended to augment FDA’s existing 

postmarket (primarily passive) safety 

surveillance systems and to enable FDA 

to actively gather information about the 

postmarket safety and performance of its 

regulated products. FDA views its 

Sentinel Initiative as a mechanism 

through which some of the requirements 

mandated in FDAAA can be carried out. 

As currently envisioned, the Sentinel 

System will enable FDA to capitalize on 

the capabilities of multiple, existing 

automated healthcare data systems (e.g. 

electronic health record systems, 

administrative claims databases, 

registries). The Sentinel System will 

enable queries of disparate data sources 

quickly and securely for relevant 

regulated 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 involved. FDA questions would 

be sent to appropriate, participating data 

holders, who would, in accordance with 

existing privacy and security safeguards, 

evaluate their data and send results 

summaries to FDA for review. 

Following announcement of the 

Sentinel Initiative in May 2008, FDA’s 

first step has been to create a broad 

public forum for discussion of issues 

related to developing and implementing 

the Sentinel System. During 2008, FDA 

sponsored a series of exploratory 

meetings with a broad variety of 

stakeholders to identify key issues that 

will need to be addressed before, 

during, and after implementation of the 

Sentinel System. Key questions include, 

for example, what level of collaboration 

between public and private entities 

would best ensure the success of the 

initiative; how a possible governance 

model could be identified and 

developed; what kind of methods and 

tools will be needed to facilitate the