Federal Register / Vol. 74, No. 132 / Monday, July 13, 2009 / Notices 33451 

Dated: July 7, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E9–16461 Filed 7–10–09; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0284] 

Food and Drug Administration 

Regulation and Licensure of Whole 

Blood and Blood Components, 

Including Source Plasma; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled ‘‘FDA Regulation and Licensure 

of Whole Blood and Blood Components, 

Including Source Plasma.’’ The purpose 

of the workshop is to educate industry 

on the licensure requirements and 

license application procedures for 

Whole Blood and blood components, 

including Source Plasma, and request 

comments on this topic. 

Dates and Time: The public workshop 

will be held on September 15, 2009, 

from 8 a.m. to 5:30 p.m. and September 

16, 2009, from 8 a.m. to 4 p.m. 

Location: The public workshop will 

be held at The Universities at Shady 

Grove Conference Center, 9630 

Gudelsky Dr., Bldg. 1, Rockville, MD 

20850. 

Contact Person: Rhonda Dawson, 

Center for Biologics Evaluation and 

Research (HFM–302), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 400N, Rockville, MD 20852–1448, 

301–827–6129, FAX: 301–827–2843, email: rhonda.dawson@fda.hhs.gov. 

Registration: Mail, fax, or e-mail your 

registration information (including 

name, title, firm name, address, 

telephone, and fax numbers) to the 

contact person (see Contact Person) by 

August 17, 2009. There is no registration 

fee for the public workshop. Early 

registration is recommended because 

seating is limited. Registration on the 

day of the public workshop 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 

Rhonda Dawson (see Contact Person) at 

least 7 days in advance of the workshop. 

Comments: All individuals wishing to 

submit questions to be addressed at the 

public workshop should submit written 

or electronic comments by August 17, 

2009, to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. Submit a single 

copy of electronic comments or two 

paper copies of any mailed comments, 

except that individuals may submit one 

paper copy. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

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

Monday through Friday. 

SUPPLEMENTARY INFORMATION: FDA held 

a licensing workshop for blood 

establishments in 1995 to advise the 

blood and plasma industry on how to 

apply for a U.S. license to distribute 

Whole Blood and blood components, 

including Source Plasma, in interstate 

commerce. This workshop will build 

upon the 1995 workshop and provide 

regulatory updates since the last 

workshop. The workshop will include 

presentations by FDA on the following 

topics: (1) Requirements for licensure 

and applicable regulations and guidance 

documents for Whole Blood and blood 

components, including Source Plasma; 

(2) managed review process; (3) review 

criteria for various submissions; (4) 

blood establishment registration and 

product listing requirements; (5) 

inspections of blood establishments 

pending licensure and approval; and (6) 

requests for exceptions or use of 

alternative procedures to the 

regulations. The workshop will include 

a question and answer session with 

workshop participants. 

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/cber/ 

minutes/workshop-min.htm. 

Dated: July 7, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–16657 Filed 7–10–09; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Committee on Immunization 

Practices (ACIP) 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC), 

announces the following meeting of the 

aforementioned committee: 

Time and Date: 8 a.m.–4 p.m., July 29, 

2009. 

Place: CDC, Tom Harkin Global 

Communications Center, 1600 Clifton Road, 

NE., Building 19, Kent ‘‘Oz’’ Nelson 

Auditorium, Atlanta, Georgia 30333. 

Status: Open to the public, limited only by 

the space available. 

Purpose: The committee is charged with 

advising the Director, CDC, on the 

appropriate uses of immunizing agents. In 

addition, under 42 U.S.C. Section 1396s, the 

committee is mandated to establish and 

periodically review and, as appropriate, 

revise the list of vaccines for administration 

to vaccine-eligible children through the 

Vaccines for Children program, along with 

schedules regarding the appropriate 

periodicity, dosage, and contraindications 

applicable to the vaccines. 

Matters To Be Discussed: The agenda will 

include discussions related to 

recommendations for use of influenza 

vaccines in the prevention and control of 

novel (pandemic) influenza A (H1N1); novel 

H1N1 epidemiology in the United States; 

novel H1N epidemiology, international 

settings; modeling novel H1N1 influenza 

impact and impact of vaccination; 

implementation planning; vaccine 

development and formulation; and the Food 

and Drug Administration/Vaccines and 

Related Biological Products Advisory 

Committee update. Agenda items are subject 

to change as priorities dictate. 

Contact Person for More Information: 

Antonette Hill, Immunization Services 

Division, National Center for Immunization 

and Respiratory Diseases, CDC, 1600 Clifton 

Road, NE., Mailstop E–05, Atlanta, Georgia 

30333, Telephone: (404) 639–8836, Fax: (404) 

639–8905. 

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 the CDC and Agency for Toxic 

Substances and Disease Registry. 

Dated: July 6, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E9–16475 Filed 7–10–09; 8:45 am] 

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