Federal Register / Vol. 75, No. 83 / Friday, April 30, 2010 / Notices 22817 

Time and Date: 3:30 p.m.–4:30 p.m., May 

17, 2010. 

Place: Teleconference. 

Status: Open to the public. The toll free 

dial in number is (800) 369–2094 and the 

passcode is 3518331. Teleconference access 

is limited only by availability of telephone 

ports. Registration and teleconference logon 

information is also available at http:// 

www.cdc.gov/hicpac/. 

Purpose: The Committee is charged with 

providing advice and guidance to the 

Secretary, Department of Health and Human 

Services; the Director, CDC; and the Director, 

National Center for Emerging and Zoonotic 

Infectious Diseases (NCEZID), regarding the 

practice of hospital infection control and 

strategies for surveillance, prevention, and 

control of healthcare-associated infections 

(e.g., nosocomial infections), antimicrobial 

resistance, and related events in settings 

where healthcare is provided, including 

hospitals, ambulatory and long-term care 

facilities, and home health agencies. The 

committee shall also advise CDC on periodic 

updating of existing guidelines, development 

of new guidelines, guideline evaluation, and 

other policy statements regarding prevention 

of healthcare-associated infections and 

healthcare-related conditions. 

Matters To Be Discussed: The agenda will 

include a follow up discussion on the draft 

Guidelines for the Prevention of Intravascular 

Catheter-Related Infections. 

Agenda items are subject to change as 

priorities dictate. 

For More Information Contact: Michelle W. 

King, HICPAC, Division of Healthcare 

Quality Promotion, NCEZID, CDC, l600 

Clifton Road, NE., Mailstop A–07, Atlanta, 

Georgia 30333, Telephone: (404) 639–2936, 

E-mail: HICPAC@cdc.gov. 

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 

Substance and Disease Registry. 

Dated: April 26, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–10090 Filed 4–29–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Emerging Infectious Diseases: 

Evaluation to Implementation for 

Transfusion and Transplantation 

Safety and Quantitative Risk 

Assessment: Blood Safety and 

Availability; Public Workshops 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshops. 

The Food and Drug Administration 

(FDA) is announcing two public 

workshops entitled ‘‘Emerging Infectious 

Diseases: Evaluation to Implementation 

for Transfusion and Transplantation 

Safety’’ (EID public workshop) and 

‘‘Quantitative Risk Assessment: Blood 

Safety and Availability’’ (QRA public 

workshop), respectively. The workshops 

have been scheduled on consecutive 

days to allow interested parties to attend 

both. The EID public workshop is a 2- 

day workshop; the purpose is to review 

the strategies used for identification, 

prioritization, and response to EID that 

are relevant to blood, cells, tissues and 

organs. The workshop has been planned 

in partnership with the HHS Office of 

Science and Public Health, Centers for 

Disease Control and Prevention, 

National Institutes of Health and Health 

Resources Services Administration. The 

QRA public workshop is a 1-day 

workshop; the purpose is to review the 

scientific principles of risk assessment 

and to discuss the role of risk 

assessment in the regulatory process, 

specifically as it relates to blood safety 

and availability. The public workshops 

will feature presentations, case studies 

and round table discussions led by 

national and international experts from 

government, academia and industry. 

Date and Time: The EID public 

workshop will be held on May 11 and 

12, 2010, from 8:00 a.m. to 5:30 p.m., 

each day. The QRA public workshop 

will be held on May 13, 2010, from 8:30 

a.m. to 5:00 p.m. 

Location: Both public workshops will 

be held at the Hilton Washington DC 

North/Gaithersburg, 620 Perry Pkwy., 

Gaithersburg, MD 20877. 

Contact Person: Persons interested in 

the EID public workshop should contact 

Rhonda Dawson, Center for Biologics 

Evaluation and Research (HFM–302), 

Food and Drug Administration, 1401 

Rockville Pike, Suite 550N, Rockville, 

MD 20852–1448, 301–827–6129, FAX: 

301–827–2843, e-mail: 

rhonda.dawson@fda.hhs.gov. 

Persons interested in the QRA public 

workshop should contact Mark O. 

Walderhaug, Center for Biologics 

Evaluation and Research (HFM–210), 

Food and Drug Administration, 1401 

Rockville Pike, Suite 400S, Rockville, 

MD 20852–1448, 301–827–6028, FAX: 

301–827–0648, e-mail: 

mark.walderhaug@fda.hhs.gov. 

Registration: Mail or fax your 

registration information (including 

name, title, firm name, address, 

telephone and fax numbers) to the 

appropriate contact person (see Contact 

Person) by May 5, 2010. There is no 

registration fee for either public 

workshop. Early registration is 

recommended because seating is 

limited. Registration on the days of the 

public workshops will be provided on a 

space available basis beginning at 7:30 

a.m. 

If you need special accommodations 

due to a disability, please contact the 

appropriate contact person (see Contact 

Person) at least 7 days in advance. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the following two public 

workshops: 

1. EID Public Workshop 

The characterization of risk from, and 

prioritization of response to, emerging 

infectious diseases relevant to blood, 

cells, tissue and organ safety has always 

been a complicated process. In terms of 

preparedness, when multiple EID agents 

threaten blood, cells, tissue and organ 

safety, it can be a challenge to prioritize 

efforts to address the resulting risk 

related issues since there is no single 

approach or formula that guarantees an 

ideal prioritization process. The EID 

public workshop will address processes 

for early threat detection and risk 

reduction of EID agents that are relevant 

to blood, cells, tissues and organs, 

including methods of ‘‘horizon 

scanning,’’ risk assessment, risk 

communication and application of 

emerging pathogen detection and 

pathogen reduction technologies. In 

addition, the workshop will discuss 

research needed to help address issues 

regarding appropriate screening and 

testing for donors of human organs, 

cells, and tissues for transplantation. 

The first day of the workshop will 

focus on transfusion safety and include 

discussions on the following topics: (1) 

The identification, surveillance and 

prioritization of EID agents in the 

United States (U.S.) and internationally; 

(2) risk assessment methodologies; and 

(3) tools to address EIDs, including 

pathogen reduction technologies, 

microarray sequencing and prion 

detection capabilities. The second day 

of the workshop will address organ, cell 

and tissue transplantation safety. Topics 

for discussion include the following: (1) 

The regulatory frameworks for cells, 

tissue and organ transplantation; (2) 

approaches to the identification and 

evaluation of EIDs in the U.S. and 

internationally; (3) risk assessment 

methodologies; and (4) current research 

priorities, limitations and opportunities. 

2. QRA Public Workshop 

FDA’s mission to protect public 

health is a complex challenge that 

frequently requires regulators to use 

sophisticated analyses of risk and 

benefit to reach informed decisions 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
22818 Federal Register / Vol. 75, No. 83 / Friday, April 30, 2010 / Notices 

concerning the safety and effectiveness 

of therapeutics. To reach optimal 

decisions, regulators will often use a 

risk analysis that involves a deliberative 

process of risk management, risk 

communication and risk assessment. 

The workshop aims to increase the 

transparency of the decision-making 

process at FDA by increasing public 

understanding of risk assessment in the 

regulatory process for blood products. 

Risk assessment is a process that 

reflects a structured approach of hazard 

identification, hazard characterization, 

exposure assessment and risk 

characterization. The QRA public 

workshop is designed to enhance 

understanding of the agency’s 

operations and decision-making process 

in this regard. The workshop will 

discuss the principles of risk 

assessment, and a detailed case study 

using a recent risk assessment related to 

blood safety and availability will be 

presented. 

Transcripts: Transcripts of the public 

workshop may be requested in writing 

from the Freedom of Information Office 

(HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857, 

approximately 15 working days after the 

public workshop at a cost of 10 cents 

per page. A transcript of the public 

workshop will be available on the 

Internet at http://www.fda.gov/ 

BiologicsBloodVaccines/NewsEvents/ 

WorkshopsMeetingsConferences/ 

TranscriptsMinutes/default.htm. 

Dated: April 26, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10040 Filed 4–29–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Environmental Health Sciences Special 

Emphasis Panel; Virtual Consortium for 

Transdisciplinary/Translational 

Environmental Research (VICTER). 

Date: May 26, 2010. 

Time: 8:30 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Nat. Inst. of Environmental Health 

Sciences, Building 101, Rodbell Auditorium, 

111 T.W. Alexander Drive, Research Triangle 

Park, NC 27709. 

Contact Person: Janice B. Allen, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, Division of Extramural 

Research and Training, Nat. Institute of 

Environmental Health Science, P.O. Box 

12233, MD EC–30/Room 3170 B, Research 

Triangle Park, NC 27709, 919/541–7556. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.115, Biometry and Risk 

Estimation—Health Risks from 

Environmental Exposures; 93.142, NIEHS 

Hazardous Waste Worker Health and Safety 

Training; 93.143, NIEHS Superfund 

Hazardous Substances—Basic Research and 

Education; 93.894, Resources and Manpower 

Development in the Environmental Health 

Sciences; 93.113, Biological Response to 

Environmental Health Hazards; 93.114, 

Applied Toxicological Research and Testing, 

National Institutes of Health, HHS) 

Dated: April 26, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–10146 Filed 4–29–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Center for Scientific 

Review Special Emphasis Panel, May 

26, 2010, 11 a.m. to May 26, 2010, 2 

p.m., National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

which was published in the Federal 

Register on April 21, 2010, 75 FR 

20852–20853. 

The meeting title has been changed to 

‘‘Meeting Conflict: Cancer Biomarker.’’ 

The meeting is closed to the public. 

Dated: April 28, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–10145 Filed 4–29–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable materials, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Initial 

Review Group, Neurological Sciences and 

Disorders C. 

Date: June 3–4, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Mayflower Park Hotel, 405 Olive 

Way, Seattle, WA 98101. 

Contact Person: William C. Benzing, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, NIH/NINDS/Neuroscience 

Center, 6001 Executive Blvd., Suite 3208, 

MSC 9529, Bethesda, MD 20892–9529, 301– 

496–0660, Benzingw@mail.nih.gov. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Initial 

Review Group, NST–1 Subcommittee. 

Date: June 3–4, 2010. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Argonaut Hotel, 495 Jefferson Street, 

San Francisco, CA 94109. 

Contact Person: Raul A. Saavedra, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, NIH/NINDS/Neuroscience 

Center, 6001 Executive Blvd., Suite 3208, 

MSC 9529, Bethesda, MD 20892–9529, 301– 

496–9223, Saavedrr@ninds.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: April 28, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–10144 Filed 4–29–10; 8:45 am] 

BILLING CODE 4140–01–P 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1