Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices 48089 

Malignancies also have been transmitted 

by solid organs. The Health Resources 

and Services Administration (HRSA) 

oversees the transplantation of solid 

organs through the Organ Procurement 

and Transplantation Network (OPTN) 

administered by the United Network for 

Organ Sharing (UNOS). OPTN policy 

requires reporting of all potential donorderived infections to UNOS and 

notification of institutions that 

recovered organs and tissues from that 

donor. 

For tissues, disease transmission 

reports are less frequent but include 

transmission of HCV, Group A 

streptococcus, Clostridium spp, and 

Chryseobacterium meningosepticum. 

Unlike solid organs, risk of disease 

transmission depends on multiple 

factors related to the graft, including the 

feasibility and effectiveness of 

processing, which may vary according 

to tissue type and specific processing or 

manipulation procedures. The Food and 

Drug Administration (FDA), Center for 

Biologics Evaluation and Research, 

regulates articles containing or 

consisting of human cells or tissues 

intended for implantation, 

transplantation, infusion, or transfer 

into a human recipient as human cells, 

tissues, or cellular or tissue-based 

products (HCT/Ps). HCT/P 

establishments are required to report to 

FDA all serious infections following 

graft transplantation. However, 

healthcare providers are not required to 

report adverse events, and healthcare 

facilities that do not perform any steps 

in tissue manufacture (recovery, 

processing, storage, labeling, packaging, 

distribution, or donor screening or 

testing) are not subject to any FDA 

regulation for HCT/Ps. 

Because organs and tissues can come 

from the same donor, a TSN should 

provide the mechanism for 

standardizing allograft identifiers, 

tracking of organ and tissue receipt, 

rapid notification of and response to 

potential disease transmissions, 

benchmarking of sentinel events and 

integration into a national biovigilance 

network. Specifically utilizing these 

system characteristics, all relevant 

recovery, processing, distributing and 

implanting institutions could rapidly 

communicate when a possible disease 

transmission is identified. This may 

prevent any further use of allografts 

with transmissible diseases in 

additional recipients after a problem is 

recognized and allow for earlier 

initiation of treatment or prophylaxis of 

recipients, potentially resulting in 

reduction of transmission events or 

resulting morbidity and mortality. 

A national TSN needs to avoid 

duplication of the OPTN or of FDA 

reporting mechanisms; however, 

interfacing with these existing systems 

is critical. A national TSN could be 

coordinated by CDC in collaboration 

with other agencies of the Department of 

Health and Human Services (HHS) and 

external partners. In addition, HHS has 

recognized health information 

technology (IT) data and exchange 

standards to promote the exchange of 

health information across the healthcare 

landscape. The National Health IT 

activities initiated by the HHS Office of 

the National Coordinator for Health IT 

(ONC) has examined incorporating 

reporting criteria into Electronic Health 

Records (EHRs) which could assist in 

the possible identification and reporting 

of public health cases and adverse 

events. Reporting criteria which are 

incorporated and utilized by EHRs may 

include: general and specific reporting 

considerations, as well as the 

identification of data and events that 

may trigger a report, additional 

questions that may need to be asked of 

reporters, and the identification of 

specific data that may need to be 

reported. Integrating these requirements 

into a national TSN system is vital to 

the long term viability of the program. 

Dated: September 14, 2009. 

Tanja Popovic, 

Chief Science Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–22658 Filed 9–18–09; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Statement of Organization, Functions 

and Delegations of Authority 

This notice amends Part R of the 

Statement of Organization, Functions 

and Delegations of Authority of the 

Department of Health and Human 

Services (HHS), Health Resources and 

Services Administration (HRSA) (60 FR 

56605, as amended November 6, 1995; 

as last amended at 74 FR 37718–37723 

dated July 29, 2009). 

This notice reflects organizational 

changes in the Health Resources and 

Services Administration. This notice 

renames the Office of Performance 

Review (RE) to the Office of Regional 

Operations (ORO) (RE), and changes the 

mission and functions of the office. 

Chapter RE—Office of Regional 

Operations (RE) 

Section RE–00, Mission 

Delete in its entirety and replace with 

the following: 

The mission of ORO is to improve 

health care systems and America’s 

health care safety net, increase access to 

quality care, reduce disparities, and 

advance public health by providing 

leadership in support of the HHS and 

HRSA missions, goals and strategic 

priorities in each region. 

Section RE–10, Organization 

Delete in its entirety and replace with 

the following: 

The Office of Regional Operations 

(RE) is headed by the Associate 

Administrator who reports directly to 

the Administrator, Health Resources 

and Services Administration. The Office 

of Regional Operations includes the 

following components: 

1. Office of the Associate 

Administrator (RE); 

2. Boston Regional Division (RF12) 

serves Connecticut, Maine, 

Massachusetts, New Hampshire, Rhode 

Island and Vermont; 

3. New York Regional Division (RF13) 

serves New Jersey, New York, Puerto 

Rico and the United States Virgin 

Islands; 

4. Philadelphia Regional Division 

(RF11) serves Delaware, Maryland, 

Pennsylvania, Virginia, West Virginia 

and the District of Columbia; 

5. Atlanta Regional Division (RF21) 

serves Alabama, Florida, Georgia, 

Kentucky, Mississippi, North Carolina, 

South Carolina and Tennessee; 

6. Chicago Regional Division (RF31) 

serves Illinois, Indiana, Michigan, 

Minnesota, Ohio and Wisconsin; 

7. Dallas Regional Division (RF41) 

serves Arkansas, Louisiana, New 

Mexico, Oklahoma and Texas; 

8. Kansas City Regional Division 

(RF32) serves Iowa, Kansas, Missouri 

and Nebraska; 

9. Denver Regional Division (RF42) 

serves Colorado, Montana, North 

Dakota, South Dakota, Utah and 

Wyoming; 

10. San Francisco Regional Division 

(RF51) serves Arizona, California, 

Hawaii, Nevada, American Samoa, 

Commonwealth of the Northern Mariana 

Islands, Federated States of Micronesia, 

Guam, Republic of the Marshall Islands 

and the Republic of Palau; and 

11. Seattle Regional Division (RF52) 

serves Alaska, Idaho, Oregon and 

Washington. 

Section RE–20, Functions 

Delete in its entirety and replace with 

the following: 

mstockstill on DSKH9S0YB1PROD with NOTICES

48090 Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices 

ORO serves as the regional 

component of HRSA by: (1) Providing 

leadership on HRSA’s mission, goals, 

priorities and initiatives in regions, 

States and territories; (2) providing 

ongoing surveillance and analysis of 

health care environmental trends and 

making recommendations to HRSA 

Senior Management and other 

government officials on ways to 

improve the effectiveness of policies 

and programs; (3) generating and 

sustaining collaborative efforts between 

State health care leaders, HRSA 

managers and HRSA program resources 

in each State to improve public health 

and health care systems; (4) fostering 

greater alignment and collaboration 

between HRSA’s assets, private and 

other public assets in communities, in 

pursuit of commonly held goals and 

improved/integrated systems of care; (5) 

providing assistance to grant recipients 

in partnership with HRSA program 

leaders, including: (a) the conduct of 

performance reviews, (b) the conduct of 

site visits for grantees with problems 

meeting program requirements or 

demonstrating poor operational 

performance, (c) the conduct of other 

types of site visits in support of HRSA 

programs, and (d) the collection and 

dissemination of leading/innovative 

practices; (6) providing support for 

recruitment and retention of primary 

health care providers in Health 

Professions Shortage Areas; (7) 

conducting other activities designed to 

improve access to quality care, reduce 

disparities and improve public health in 

accordance with HRSA authorities and 

in partnership with related public and 

private sector organizations; and (8) 

exercising line management authority 

related to general administrative and 

management functions of ORO. 

Section RB–30, Delegations of Authority 

All delegations of authority and redelegations of authority made to HRSA 

officials that were in effect immediately 

prior to this reorganization, and that are 

consistent with this reorganization, 

shall continue in effect pending further 

re-delegation. 

This reorganization is effective upon 

the date of signature. 

Dated: September 14, 2009. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. E9–22602 Filed 9–18–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Docket ID: FEMA–2009–0001] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice; 60-day notice and 

request for comments; new information 

collection; OMB No. 1660–NEW2; 

FEMA Form 089–6, FRSGP Investment 

Justification. 

SUMMARY: The Federal Emergency 

Management Agency, as part of its 

continuing effort to reduce paperwork 

and respondent burden, invites the 

general public and other Federal 

agencies to take this opportunity to 

comment on a proposed new 

information collection. In accordance 

with the Paperwork Reduction Act of 

1995, this Notice seeks comments 

concerning the Freight Rail Security 

Grant Program (FRSGP). 

DATES: Comments must be submitted on 

or before November 20, 2009. 

ADDRESSES: To avoid duplicate 

submissions to the docket, please use 

only one of the following means to 

submit comments: 

(1) Online. Submit comments at 

http://www.regulations.gov under 

docket ID FEMA–2009–0001. Follow the 

instructions for submitting comments. 

(2) Mail. Submit written comments to 

Office of Chief Counsel, Regulation and 

Policy Team, DHS/FEMA, 500 C Street, 

SW., Room 835, Wash., DC 20472–3100. 

(3) Facsimile. Submit comments to 

(703) 483–2999. 

(4) E-mail. Submit comments to 

FEMA–POLICY@dhs.gov. Include docket 

ID FEMA–2009–0001 in the subject line. 

All submissions received must 

include the agency name and docket ID. 

Regardless of the method used for 

submitting comments or material, all 

submissions will be posted, without 

change, to the Federal eRulemaking 

Portal at http://www.regulations.gov, 

and will include any personal 

information you provide. Therefore, 

submitting this information makes it 

public. You may wish to read the 

Privacy Act notice that is available on 

the Privacy and Use Notice link on the 

Administration Navigation Bar of 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Contact Alexander Mrazik, Program 

Analyst, Grant Programs Directorate, 

202–786–9732 for additional 

information. You may contact the 

Records Management Branch for copies 

of the proposed collection of 

information at facsimile number (202) 

646–3347 or e-mail address: FEMA– 

Information-Collections@dhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Freight Rail Security Grant Program 

(FRSGP) is a component of the Transit 

Security Grant Program (TSGP) and 

funds security training for railroad 

frontline employees, the completion of 

vulnerability assessments, the 

development of security plans and the 

acquisition of GPS tracking on railroad 

cars within the freight rail industry. The 

FRSGP is one tool among a 

comprehensive set of measures 

authorized by Congress and 

implemented by the Administration to 

help strengthen the Nation’s critical 

infrastructure against risks associated 

with potential terrorist attacks. 

The collection of information for 

FRSGP is mandated by section 1513, 

Title XV of the Implementing 

Recommendations of the 9/11 

Commission Act of 2007 (6 U.S.C. 1163) 

which states that the Secretary, in 

consultation with the Administrator of 

the Transportation Security 

Administration and other appropriate 

agencies or officials, is authorized to 

make grants to railroad carriers, the 

Alaska Railroad, security-sensitive 

materials (SSM) offerors who ship by 

railroad, owners of railroad cars used in 

the transportation of security-sensitive 

materials, State and local governments 

(for railroad passenger facilities and 

infrastructure not owned by Amtrak), 

and Amtrak for intercity passenger 

railroad and freight railroad security 

improvements. Additionally, the 

Secretary shall determine the 

requirements for recipients of grants and 

may award grants based upon railroad 

carrier vulnerability assessments and 

security plans. 

Collection of Information 

Title: FEMA FY 2009 Preparedness 

Grants: Freight Rail Security Grant 

Program (FRSGP). 

Type of Information Collection: New 

information collection. 

OMB Number: OMB No. 1660–NEW2. 

Form Titles and Numbers: FEMA 

Form 089–6, FRSGP Investment 

Justification. 

Abstract: The FRSGP Investment 

Justification is submitted with the 

application which provides narrative 

details on proposed investments. These 

Investment Justifications must 

demonstrate how proposed projects 

address gaps and deficiencies in current 

programs and capabilities and the 

mstockstill on DSKH9S0YB1PROD with NOTICES