48088 Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices 

• How is adverse event information 

from these sources being received, 

reviewed, and processed? 

• What challenges are presented in 

handling adverse event information 

from these sources? 

• What uncertainties are there 

regarding what should be reported from 

these sources to meet FDA adverse 

event reporting obligations? 

IV. Notice of Hearing Under 21 CFR 

Part 15 

The Commissioner is announcing that 

the public hearing will be held in 

accordance with part 15 (21 CFR part 

15). The hearing will be conducted by 

a presiding officer, accompanied by 

FDA senior management from the Office 

of the Commissioner and the Center for 

Drug Evaluation and Research. 

Under § 15.30, the hearing is informal, 

and the rules of evidence do not apply. 

No participant may interrupt the 

presentation of another participant. 

Only the presiding officer and panel 

members may question any person 

during or at the conclusion of each 

presentation. Public hearings under part 

15 are subject to FDA’s policy and 

procedures for electronic media 

coverage of FDA’s public administrative 

proceedings (part 10 (21 CFR part 10), 

subpart C). Under § 10.205, 

representatives of the electronic media 

may be permitted, subject to certain 

limitations, to videotape, film, or 

otherwise record FDA’s public 

administrative proceedings, including 

presentations by participants. The 

hearing will be transcribed as stipulated 

in § 15.30(b). To the extent that the 

conditions for the hearing, as described 

in this document, conflict with any 

provisions set out in part 15, this 

document acts as a waiver of those 

provisions as specified in § 15.30(h). 

V. Comments 

Regardless of attendance at the public 

hearing, interested persons may submit 

written or electronic comments to the 

Division of Dockets Management (see 

ADDRESSES). Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments should be identified 

with the docket number found in 

brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

VI. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(see ADDRESSES). A transcript will also 

be available in either hardcopy or on 

CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. 

Dated: September 16, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–22618 Filed 9–18–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Request for Information Regarding 

Development and Operation of a 

Transplantation Sentinel Network 

AGENCY: Office of Blood, Organ and 

Other Tissue Safety, Division of 

Healthcare Quality Promotion, Center 

for Preparedness, Detection, and Control 

of Infectious Diseases, Centers for 

Disease Control and Prevention, 

Department of Health and Human 

Services. 

ACTION: Request for information notice. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC) is seeking 

information on development and 

operation of a national transplantation 

sentinel network (TSN) for the United 

States, including resources needed for 

management of such a system. The 

purpose of the network is to detect and 

prevent disease transmission from organ 

and tissue allografts recovered for 

transplantation. 

In June 2005, the CDC announced a 

Request for Application (RFA) through 

a cooperative agreement for 

development of a TSN for organizations 

that recover, process, distribute, and 

implant organs and tissues. The overall 

goal of the system was to improve 

patient safety for organ and tissue 

recipients. The RFA objectives were to: 

(1) Identify and track organs and tissues 

to facilitate intervention following 

recognition of infections among 

recipients or donors; (2) improve 

communication among those in the 

transplant community, healthcare 

facilities and public health agencies 

concerning potential risks for 

transmission of infections; and (3) 

improve pathologic and microbiologic 

capabilities on cadaveric donor 

specimen samples through shared 

resources. Development and field 

testing of the prototype was completed 

in 2008. 

For this RFI, respondents are asked to 

describe experiences, plans or opinions 

regarding aspects of completing and 

operating a TSN system; system 

governance, security, and marketing; 

user training; and operational and 

infrastructure management. Responses 

need not address every aspect of this 

RFI; responses may be limited to 

address specific components or portions 

of a section. The specific sections 

requested for comments are: (1) 

Transition of Transplantation 

Transmission Sentinel Network (TTSN) 

Prototype to Full Production; (2) 

Standardization and Compatibility 

Issues; (3) Reporting Criteria; (4) 

Interoperability and Interfacing with 

Existing Data Sources; (5) System 

Operation and Infrastructure 

Management; (6) Analysis Plan 

including Feedback to Users; (7) Patient 

Health Information Privacy and 

Security; and (8) System Governance. 

DATES: Comments must be submitted on 

or before December 11, 2009. 

ADDRESSES: The entire TSN RFI can be 

accessed at http://wwwdev.cdc.gov/ 

ncidod/dhqp/pdf/ttsn/RFI_TSN_

FedRegDoc_9909.pdf. Electronic 

responses are preferred and should be 

sent to TransplantRFI@cdc.gov. 

Responses sent in hard copy format 

must be securely bound and sent to 

Debbie Seem, Office of Blood, Organ 

and other Tissue Safety, Division of 

Healthcare Quality Promotion, Centers 

for Disease Control and Prevention, 

Building 16, MS–A07, 1600 Clifton 

Road, NE., Atlanta, GA, 30329–4018, 

Telephone number: 404–639–3234, Email Address: gqi4@cdc.gov. 

SUPPLEMENTARY INFORMATION: Each year 

in the United States, more than 28,000 

solid organs and 2 million tissues are 

transplanted, including heart, lung, 

liver, kidneys, pancreas, intestine, bone, 

skin, heart valves, tendons, fascia and 

corneas. Donor-derived infections have 

been identified as a source of morbidity 

and mortality among both solid organ 

and tissue transplant recipients. 

Infectious transmission identified in 

the past few years among solid organs 

have reflected a broad array of viruses, 

bacteria, and parasites, resulting in a 

high proportion of mortality amongst 

infected recipients; examples include 

HIV, hepatitis C virus (HCV), 

lymphocytic choriomeningitis virus, 

Mycobacterium tuberculosis, 

Pseudomonas aeruginosa, Strongyloides 

spp, and Trypanosoma cruzi, the 

etiologic agent of Chagas Disease. 

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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: 

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