49880 Federal Register / Vol. 74, No. 187 / Tuesday, September 29, 2009 / Notices 

MSC 7890, Bethesda, MD 20892, 301–435– 

2514, stassid@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 21, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–23240 Filed 9–28–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0443] 

Anti-Infective Drugs Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Anti-Infective Drugs 

Advisory Committee. 

General Function of the Committee: To 

provide advice and recommendations to the 

agency on FDA’s regulatory issues. 

Date and Time: The meeting will be held 

on October 26, 2009, from 8:30 a.m. to 4 p.m. 

Addresses: Electronic comments should be 

submitted to http://www.regulations.gov. 

Enter ‘‘FDA–2009–N–0443’’ and follow the 

prompts to submit your statement. Written 

comments should be submitted to the 

Division of Dockets Management (HFA-305), 

Food and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. All 

comments received will be posted without 

change, including any personal information 

provided. Comments received on or before 

October 5, 2009, will be provided to the 

committee before the meeting. 

Location: Hilton Washington DC/Silver 

Spring, The Ballrooms, 8727 Colesville Rd., 

Silver Spring, MD. The hotel phone number 

is 301–589–5200. 

Contact Person: Minh Doan, Center for 

Drug Evaluation and Research (HFD–21), 

Food and Drug Administration, 5600 Fishers 

Lane (for express delivery, 5630 Fishers 

Lane, rm. 1093), Rockville, MD 20857, 301– 

827–7001, FAX: 301–827–6776, e-mail: 

Minh.Doan@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800–741– 

8138 (301–443–0572 in the Washington DC 

area), code 3014512530. Please call the 

Information Line for up-to-date information 

on this meeting. A notice in the Federal 

Register about last minute modifications that 

impact a previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide timely 

notice. Therefore, you should always check 

the agency’s Web site and call the 

appropriate advisory committee hot line/ 

phone line to learn about possible 

modifications before coming to the meeting. 

Agenda: The committee will discuss 

updating susceptibility test information in 

systemic antibacterial drug product labeling. 

FDA intends to make background material 

available to the public no later than 2 

business days before the meeting. If FDA is 

unable to post the background material on its 

Web site prior to the meeting, the background 

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: 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 

October 16, 2009. Oral presentations from the 

public will be scheduled between 

approximately 12:45 p.m. and 1:45 p.m. 

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 9, 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 October 12, 2009. 

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 Minh Doan 

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: 9/23/09. 

David Horowitz, 

Assistant Commissioner for Policy 

[FR Doc. E9–23437 Filed 9–28–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Blood Products Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Blood Products 

Advisory Committee. 

General Function of the Committee: To 

provide advice and recommendations to the 

agency on FDA’s regulatory issues. 

Date and Time: The meeting will be held 

on November 16, 2009, from 8 a.m. to 5:30 

p.m. and on November 17, 2009, from 8 a.m. 

to 5 p.m. 

Location: Bethesda Marriott Hotel, 5151 

Pooks Hill Rd., Bethesda, MD 20814. 

Contact Person: William Freas or Pearline 

K. Muckelvene, Center for Biologics 

Evaluation and Research (CBER), Food and 

Drug Administration, 1401 Rockville Pike 

(HFM–71), Rockville, MD 20852, 301–827– 

0314, or FDA Advisory Committee 

Information Line, 1–800–741–8138 (301– 

443–0572 in the Washington, DC area), code 

3014519516. Please call the Information Line 

for up-to-date information on this meeting. A 

notice in the Federal Register about last 

minute modifications that impact a 

previously announced advisory committee 

meeting cannot always be published quickly 

enough to provide timely notice. Therefore, 

you should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn about 

possible modifications before coming to the 

meeting. 

Agenda: On November 16, 2009, in the 

morning the Committee will hear updates on 

the following topics: the HHS Advisory 

Committee on Blood Safety and Availability, 

Dengue virus outbreak, and 2009 A/H1N1 

Pandemic and the impact on blood safety and 

availability. The Committee will then discuss 

blood donor deferral for malaria risk 

associated with travel to Mexico. In the 

afternoon the Committee will discuss the 

design of a new phase III study of pathogen 

inactivation of human platelets using the 

Cerus, INTERCEPT Blood System. On 

November 17, 2009, in the morning the 

Committee will discuss blood pressure and 

pulse as blood donor eligibility criteria, and 

in the afternoon the committee will discuss 

the public health need and performance 

characteristics of over-the-counter home-use 

HIV test kits. 

FDA intends to make background material 

available to the public no later than 2 

business days before the meeting. If FDA is 

unable to post the background material on its 

Web site prior to the meeting, the background 


jlentini on DSKJ8SOYB1PROD with NOTICES
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