Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Notices 6403 

Date: February 9, 2010. 

Closed: 8:30 a.m. to 12 p.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: National Institutes of Health, 

Lawton Chiles International House, Bethesda, 

MD 20892. 

Open: 12 p.m. to 3:30 p.m. 

Agenda: A report of the FIC Director on 

updates and overviews of new FIC initiatives. 

Topics to be discussed: New Developments 

in Chronic Disease Research and Training. 

Place: National Institutes of Health, 

Lawton Chiles International House, Bethesda, 

MD 20892. 

Contact Person: Robert Eiss, Public Health 

Advisor, Fogarty International Center, 

National Institutes of Health, 31 Center Drive, 

Room B2C02, Bethesda, MD 20892.(301) 

496–1415. eissr@mail.nih.gov. 

This meeting is being published less than 

15 days prior to the meeting due to timing 

limitations imposed by administrative 

matters. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, drivers license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institutes/Center’s home page: http:// 

www.nih.gov/fic/about/advisory.html, where 

an agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.106, Minority International 

Research Training Grant in the Biomedical 

and Behavioral Sciences; 93.154, Special 

International Postdoctoral Research Program 

in Acquired Immunodeficiency Syndrome; 

93.168, International Cooperative 

Biodiversity Groups Program; 93.934, Fogarty 

International Research Collaboration Award; 

93.989, Senior International Fellowship 

Awards Program, National Institutes of 

Health, HHS) 

Dated: February 1, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–2559 Filed 2–8–10; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Center for Health Statistics 

(NCHS), Classifications and Public 

Health Data Standards Staff, 

announces the following meeting: 

Name: ICD–9–CM Coordination and 

Maintenance Committee meeting. 

Time and Date: 9 a.m.–4:30 p.m., 

March 9–10, 2010. 

Place: Centers for Medicare and 

Medicaid Services (CMS) Auditorium, 

7500 Security Boulevard, Baltimore, 

Maryland. 

Status: Open to the public. 

Purpose: The ICD–9–CM Coordination 

and Maintenance (C&M) Committee will 

hold its first meeting of the 2010 

calendar year cycle on Tuesday and 

Wednesday March 9–10, 2010. The 

C&M meeting is a public forum for the 

presentation of proposed modifications 

to the International Classification of 

Diseases, Ninth-Revision, Clinical 

Modification. 

Matters to be Discussed: Tentative 

agenda items include: 

March 9, 2010: 

ICD–10 updates: GEMs; Freeze 

update; ICD–10–CM/ICD–10–PCS 

updates 

Application of Collagen Based Tissue 

Sealant Patches 

Biopsy of Soft Tissue Mass 

Central Venous Catheter Placement 

Using Intra-Atrial 

Electrocardiographic Guidance 

Circulating Tumor Cell Enumeration, 

Magnetic 

Closed Chest Intra-cardiac Mitral 

Valve Repair 

Continuous Glucose Monitoring 

Fat Graft to Breast 

Insertion of Intracranial 

Neurostimulator Lead(s) 

Internal Fixation of Sternum 

Intralaminar Lumbar Decompression 

and Laminotomy with 

Epidurography 

Intra-operative Fluorescence Vascular 

Angiography (IFVA) 

Laparoscopic Hernia Repair without 

Mesh 

Thoracoscopic Cardiac Ablation 

Addenda (procedures) 

March 10, 2010: 

Acquired absence of joint 

Brain death 

Eaton-Lambert Syndrome 

E. coli infection 

Fluency disorders (stuttering) 

Glaucoma staging 

H1N1 (Swine flu) 

Transfusion transmitted infections 

Uranium exposure 

Addenda (diagnoses) 

Contact Person for Additional 

Information: Amy Blum, Medical 

Systems Specialist, Classifications and 

Public Health Data Standards Staff, 

NCHS, 3311 Toledo Road, Room 2402, 

Hyattsville, Maryland 20782, e-mail 

alb8@cdc.gov, telephone 301–458–4106 

(diagnosis), Mady Hue, Health 

Insurance Specialist, Division of Acute 

Care, CMS, 7500 Security Blvd., 

Baltimore, Maryland 21244, e-mail 

marilu.hue@cms.hhs.gov, telephone 

410–786–4510 (procedures). Note: CMS 

and NCHS will no longer be providing 

paper copies of handouts for the 

meeting. Electronic copies of all meeting 

materials will be posted on the CMS and 

NCHS Web sites prior to the meeting at 

http://www.cms.hhs.gov/ 

ICD9ProviderDiagnosticCodes/ 

03_meetings.asp#TopOfPage and http:// 

www.cdc.gov/nchs/icd/ 

icd9cm_maintenance.htm. 

Notice: Because of increased security 

requirements CMS has instituted 

stringent procedures for entrance into 

the building by non-government 

employees. Persons without a 

government I.D. will need to show an 

official form of picture I.D., (such as a 

drivers license), and sign-in at the 

security desk upon entering the 

building. 

Those who wish to attend a specific 

ICD–9–CM C&M meeting in the CMS 

auditorium must submit their name and 

organization for addition to the meeting 

visitor list. Those wishing to attend the 

March 9–10, 2010 meeting must submit 

their name and organization by March 5, 

2010 for inclusion on the visitor list. 

This visitor list will be maintained at 

the front desk of the CMS building and 

used by the guards to admit visitors to 

the meeting. Those who attended 

previous ICD–9–CM C&M meetings will 

no longer be automatically added to the 

visitor list. You must request inclusion 

of your name prior to each meeting you 

attend. Register to attend the meeting 

on-line at: http://www.cms.hhs.gov/ 

apps/events/. 

Notice: This is a public meeting. 

However, because of fire code 

requirements, should the number of 

attendants meet the capacity of the 

room, the meeting will be closed. 

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 Substances 

and Disease Registry. 


Cprice-sewell on DSK2BSOYB1PROD with NOTICES
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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