6404 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Notices 

Dated: February 1, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–2769 Filed 2–8–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0045] (formerly 

Docket No. 2004N–0408) 

Regulatory Site Visit Training Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA’s) Center for 

Biologics Evaluation and Research 

(CBER) is announcing an invitation for 

participation in its Regulatory Site Visit 

Training Program (RSVP). This training 

program is intended to give CBER 

regulatory review, compliance, and 

other relevant staff an opportunity to 

visit biologics facilities. These visits are 

intended to allow CBER staff to directly 

observe routine manufacturing practices 

and to give CBER staff a better 

understanding of the biologics industry, 

including its challenges and operations. 

The purpose of this notice is to invite 

biologics facilities to contact CBER for 

more information if they are interested 

in participating in this program. 

DATES: Submit a written or electronic 

request for participation in this program 

by March 11, 2010. The request should 

include a description of your facility 

relative to products regulated by CBER. 

Please specify the physical address(es) 

of the site(s) you are offering. 

ADDRESSES: If your biologics facility is 

interested in offering a site visit, you 

should submit a request to participate in 

the program to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic requests to http:// 

www.regulations.gov. If you previously 

responded to earlier requests to 

participate in this program and you 

continue to be interested in 

participating, please renew your request 

through a submission to the Division of 

Dockets Management. 

FOR FURTHER INFORMATION CONTACT: 

Lonnie W. Henderson, Division of 

Manufacturers Assistance and Training, 

Center for Biologics Evaluation and 

Research (HFM–49), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448, 

301–827–2000, FAX: 301–827–3079, email: matt@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CBER regulates certain biological 

products including blood and blood 

products, vaccines, and cellular, tissue, 

and gene therapies. CBER is committed 

to advancing the public health through 

innovative activities that help ensure 

the safety, effectiveness and availability 

of biological products to patients. To 

support this primary goal, CBER has 

initiated various training and 

development programs, including 

programs to further enhance 

performance of its compliance staff, 

regulatory review staff, and other 

relevant staff. CBER seeks to 

continuously enhance and update 

review efficiency and quality, and the 

quality of its regulatory efforts and 

interactions, by providing CBER staff 

with a better understanding of the 

biologics industry and its operations. 

Further, CBER seeks to enhance: (1) Its 

understanding of current industry 

practices, and regulatory impacts and 

needs; and (2) communication between 

CBER staff and industry. CBER initiated 

its RSVP in 2005, and through these 

annual notices, is requesting those firms 

that have previously applied and are 

still interested in participating, to 

reaffirm their interest, as well as 

requesting new interested parties to 

apply. 

II. RSVP 

A. Regulatory Site Visits 

In this program, over a period of time 

to be agreed upon with the facility, 

small groups of CBER staff may observe 

operations of biologics establishments, 

including for example, blood and tissue 

establishments. The visits may include 

packaging facilities, quality control and 

pathology/toxicology laboratories, and 

regulatory affairs operations. These 

visits, or any part of the program, are 

not intended as a mechanism to inspect, 

assess, judge, or perform a regulatory 

function, but are meant to improve 

mutual understanding and to provide an 

avenue for open dialogue between the 

biologics industry and CBER. 

B. Site Selection 

All travel expenses associated with 

the site visits will be the responsibility 

of CBER. Therefore, selection of 

potential facilities will be based on the 

coordination of CBER’s priorities for 

staff training as well as the limited 

available resources for this program. In 

addition to logistical and other resource 

factors to consider, a key element of site 

selection is a successful compliance 

record with FDA or another agency with 

which we have a memorandum of 

understanding. If a site visit also 

involves a visit to a separate physical 

location of another firm under contract 

to the applicant, the other firm also 

needs to agree to participate in the 

program, as well as have a satisfactory 

compliance history. 

III. Requests for Participation 

Requests are to be identified with the 

docket number found in the brackets in 

the heading of this document. Received 

requests are available for public 

examination in the Division of Dockets 

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

Monday through Friday. 

Dated: February 4, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–2758 Filed 2–8–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Internal Agency Docket No. FEMA–3308– 

EM; Docket ID FEMA–2010–0002] 

Oklahoma; Emergency and Related 

Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: This is a notice of the 

Presidential declaration of an 

emergency for the State of Oklahoma 

(FEMA–3308–EM), dated January 30, 

2010, and related determinations. 

DATES: Effective Date: January 30, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Miller, Disaster Assistance 

Directorate, Federal Emergency 

Management Agency, 500 C Street, SW., 

Washington, DC 20472, (202) 646–3886. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that, in a letter dated 

January 30, 2010, the President issued 

an emergency declaration under the 

authority of the Robert T. Stafford 

Disaster Relief and Emergency 

Assistance Act, 42 U.S.C. 5121–5207 

(the Stafford Act), as follows: 

I have determined that the emergency 

conditions in certain areas of the State of 

Oklahoma resulting from a severe winter 

storm beginning on January 28, 2010, and 

continuing, are of sufficient severity and 

magnitude to warrant an emergency 

declaration under the Robert T. Stafford 


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