Federal Register / Vol. 74, No. 187 / Tuesday, September 29, 2009 / Notices 49881 

material will be made publicly available at 

the location of the advisory committee 

meeting, and the background material will be 

posted on FDA’s Web site after the meeting. 

Background material is available at http://

www.fda.gov/AdvisoryCommittees/Calendar/

default.htm. Scroll down to the appropriate 

advisory committee link. 

Procedure: On November 16, 2009, from 8 

a.m. to 5:30 p.m. and on November 17, 2009, 

from 8 a.m. to 3:15 p.m., the meeting is open 

to the public. Interested persons may present 

data, information, or views, orally or in 

writing, on issues pending before the 

committee. Written submissions may be 

made to the contact person on or before 

November 9, 2009. Oral presentations from 

the public will be scheduled between 

approximately 11 a.m. and 11:30 a.m. and 

between 4 p.m. and 4:30 p.m. on November 

16, 2009, and between approximately 10:30 

a.m. and 11 a.m., and 2:15 and 2:45 p.m. on 

November 17, 2009. Those desiring to make 

formal oral presentations should notify the 

contact person and submit a brief statement 

of the general nature of the evidence or 

arguments they wish to present, the names 

and addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on or 

before October 30, 2009. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to speak is 

greater than can be reasonably 

accommodated during the scheduled open 

public hearing session, FDA may conduct a 

lottery to determine the speakers for the 

scheduled open public hearing session. The 

contact person will notify interested persons 

regarding their request to speak by November 

2, 2009. 

Closed Committee Deliberations : On 

November 17, 2009, from approximately 3 

p.m. until 5 p.m., the meeting will be closed 

to permit discussion and review of trade 

secret and/or confidential commercial 

information (5 U.S.C. 552b(c)(4)). The 

committee will hear presentations and 

discuss sponsor, trade secret and confidential 

information. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee meetings 

and will make every effort to accommodate 

persons with physical disabilities or special 

needs. If you require special accommodations 

due to a disability, please contact William 

Freas or Pearline K. Muckelvene at least 7 

days in advance of the meeting. 

FDA is committed to the orderly conduct 

of its advisory committee meetings. Please 

visit our Web site at http://www.fda.gov/

AdvisoryCommittees/AboutAdvisory

Committees/ucm111462.htm for procedures 

on public conduct during advisory 

committee meetings. 

Notice of this meeting is given under the 

Federal Advisory Committee Act (5 U.S.C. 

app. 2). 

Dated: September 23, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–23434 Filed 9–28–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

‘‘CORRECTED Version of 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://www.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, E-mail 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. 

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 


jlentini on DSKJ8SOYB1PROD with NOTICES
49882 Federal Register / Vol. 74, No. 187 / Tuesday, September 29, 2009 / Notices 

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. 

Tanja Popovic, 

Chief Science Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–23427 Filed 9–28–09; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

[Docket No. DHS–2009–0038] 

Privacy Act of 1974; Department of 

Homeland Security/ALL–004 General 

Information Technology Access 

Account Records System of Records 

AGENCY: Privacy Office; DHS. 

ACTION: Notice of Privacy Act system of 

records update. 

SUMMARY: In accordance with the 

Privacy Act of 1974 the Department of 

Homeland Security proposes to update 

and reissue a Department of Homeland 

Security system of records notice titled, 

Department of Homeland Security/ALL– 

004 General Information Technology 

Access Account Records System of 

Records. As a result of the biennial 

review of this system, the Department 

proposes to include the addition of 

social security numbers in the categories 

of records covered by the system for the 

purpose of identifying an individual for 

system access. Additionally, a new 

routine use has been added for the 

purpose of sharing with the media 

where appropriate. This updated system 

will be included in the Department of 

Homeland Security’s inventory of 

record systems. 

DATES: Written comments must be 

submitted on or before October 29, 

2009. 

ADDRESSES: You may submit comments, 

identified by Docket Number DHS– 

2009–0038 by one of the following 

methods: 

• Federal e-Rulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 703–483–2999. 

• Mail: Mary Ellen Callahan, Chief 

Privacy Officer, Privacy Office, 

Department of Homeland Security, 

Washington, DC 20528. 

• Instructions: All submissions 

received must include the agency name 

and docket number for this rulemaking. 

All comments received will be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. 

• Docket: For access to the docket to 

read background documents or 

comments received go to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: For 

general questions and for privacy issues 

please contact: Mary Ellen Callahan 

(703–235–0780), Chief Privacy Officer, 

Privacy Office, U.S. Department of 

Homeland Security, Washington, DC 

20528. 

SUPPLEMENTARY INFORMATION: 

I. Background 

As part of its efforts to maintain its 

Privacy Act record systems, the 

Department of Homeland Security 

(DHS) is updating and reissuing a 

Department-wide system of records 

under the Privacy Act (5 U.S.C. 552a) 

for DHS/ALL–004 General Information 

Technology Access Account Records 

System of Records (73 FR 28139, May 

15, 2008). This will ensure that all 

components of DHS follow the same 

privacy rules for collecting and 

handling information technology access 

account records. The collection and 

maintenance of this information will 

assist DHS in managing the 

Department’s information technology 

access account records. 

This system of records is part of DHS’ 

ongoing record integration and 

management efforts. This system 

consists of information collected in 

order to provide authorized individuals 

with access to DHS information 

technology resources. This information 

includes user name, business affiliation, 

account information and passwords. 

In accordance with the Privacy Act of 

1974, DHS is giving notice that it 

proposes to update and reissue a DHS 

system of records notice titled, DHS/ 

ALL–004 General Information 

Technology Access Account Records 

System of Records. As a result of the 

biennial review of this system, the 


jlentini on DSKJ8SOYB1PROD with NOTICES