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 

30098 Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Notices 

development and sharing of highly 

technical summary results derived from 

automated healthcare data in disparate 

systems; and what privacy and security 

safeguards will be needed and how will 

they be maintained. 

B. Research Objectives 

These initial discussions have focused 

on many of the policy and procedural 

needs of developing the Sentinel 

System. However, to proceed, additional 

meetings and working groups need to be 

formed to explore in greater depth the 

science of safety needed to support this 

initiative, as well as methods for 

communicating about the information 

learned from the system. Topics to be 

addressed include specific topics, 

issues, and questions related to the 

development of active medical product 

surveillance methodologies and tools. 

Subsequently, the information from 

these meetings and working groups 

must be described, managed, and made 

available to the public using a 

transparent and open approach. 

C. Eligibility Information 

The following organizations/ 

institutions are eligible to apply: Nonprofit organizations. 

Foreign institutions are not eligible to 

apply for conference grant support. An 

international conference can be 

supported through the U.S. 

representative organization of an 

established international scientific or 

professional society. 

II. Award Information/Funds Available 

A. Award Amount 

FDA anticipates providing up to 

$600,000 (direct cost only) during fiscal 

year (FY) 2009 to support efforts 

outlined in this FOA. One award will be 

made. 

This Cooperative Agreement ensures 

substantial FDA involvement in this 

program and will include, but not be 

limited to, co-development of the 

meeting(s) priorities and agendas and 

providing feedback on reports and 

publications related to meeting 

proceedings on identified topics. 

B. Length of Support 

Subject to the availability of Federal 

funds and successful performance, and 

if the FOA stated objectives are met, an 

additional 4 years of support up to 

$600,000 (direct and indirect costs 

combined) per year may be available. 

III. Electronic Application, 

Registration, and Submission 

Only electronic applications will be 

accepted. To submit an electronic 

application in response to this FOA, 

applicants should first review the full 

announcement located at http:// 

www.fda.gov/Safety/FDAsSentinel

Initiative/ucm149345.htm. 

For all electronically submitted 

applications, the following steps are 

required. 

• Step 1: Obtain a Dun and Bradstreet 

(DUNS) Number 

• Step 2: Register With Central 

Contractor Registration 

• Step 3: Obtain Username & 

Password 

• Step 4: Authorized Organization 

Representative (AOR) Authorization 

• Step 5: Track AOR Status 

• Step 6: Register With Electronic 

Research Administration (eRA) 

Commons 

Steps 1 through 5, in detail, can be 

found at http://www07.grants.gov/ 

applicants/organization_registration.jsp. 

Step 6, in detail, can be found at https:// 

commons.era.nih.gov/commons/ 

registration/registrationInstructions.jsp. 

After you have followed these steps, 

submit electronic applications to http:// 

www.grants.gov. 

Dated: June 19, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–14904 Filed 6–23–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Center for Injury Prevention 

and Control Initial Review Group 

(NCIPC IRG) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC), 

announces the following meeting of the 

aforementioned committee: 

Times and Date: 9 a.m.–9:30 a.m., July 14, 

2009(Open) 9:30 a.m.–5 p.m., July 14, 

2009(Closed) 9 a.m.–5 p.m., July 15, 

2009(Closed) 

Place: Doubletree Hotel Atlanta-Buckhead, 

3342 Peachtree Road, Atlanta, GA 30326, 

Telephone: (404) 231–1234. 

Status: Portions of the meetings will be 

closed to the public in accordance with 

provisions set forth in Section 552b(c)(4) and 

(6), Title 5, U.S.C., and the Determination of 

the Director, Management Analysis and 

Services Office, CDC, pursuant to Section 

10(d) of Public Law 92–463. 

Purpose: This group is charged with 

providing advice and guidance to the 

Secretary, Department of Health and Human 

Services, and the Director, CDC, concerning 

the scientific and technical merit of grant and 

cooperative agreement applications received 

from academic institutions and other public 

and private profit and nonprofit 

organizations, including State and local 

government agencies, to conduct specific 

injury research that focuses on prevention 

and control. 

Matters To Be Discussed: The meeting will 

include the review, discussion, and 

evaluation of individual research cooperative 

agreement applications submitted in 

response to Fiscal Year 2009 Requests for 

Applications related to the following 

individual research announcement: RFA– 

CD–09–001 ‘‘Translating Research to Protect 

Health through Health Promotion, 

Prevention, and Preparedness (R18)’’ for the 

National Center for Injury Prevention and 

Control (NCIPC) applications. 

Agenda items are subject to change as 

priorities dictate. 

Contact Person for More Information: Jane 

Suen, Dr.P.H., M.S., NCIPC, CDC, 4770 

Buford Highway, NE., Mailstop F–62, 

Atlanta, Georgia 30341. Telephone: (770) 

488–4281. 

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: June 12, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E9–14740 Filed 6–23–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Public Health Service Act, Section 

330(e) 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notification of Exception to 

Competition—Replacement Grant. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) is 

issuing a non-competitive award to the 

Community Health Clinics of Northeast 

Texas (CHCNET) to avoid disruption 

and continue providing primary health 

care services to the population of Smith 

County, Texas, as an independent 

organization from the Northeast Texas 

Public Health District (NETPHD). 

SUPPLEMENTARY INFORMATION: 

Intended Recipient of the Award: 

Community Health Clinics of Northeast 

Texas. 

Amount of the Award: $326,308.00 

(initial seven-month supplement,