Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Notices 68385

I. Background

In the Federal Register of April 19, 

2000 (65 FR 20992), FDA’s Center for 

Veterinary Medicine (CVM) announced 

plans to develop a prototypic risk 

assessment (RA) model that accounts for 

the transfer of resistance determinants 

from bacteria in food-producing animals 

to bacteria in humans. CVM also 

requested comments on their approach 

to the RA model, requested that 

scientific data and information relevant 

to the conduct of the RA be submitted, 

and indicated its intention to work with 

stakeholders to assess potential risks.

The outcome of our work is a 

document entitled ‘‘Draft Risk 

Assessment of Streptogramin Resistance 

in Enterococcus faecium Attributable to 

the Use of Streptogramins in Animals.’’

This draft risk assessment specifically 

addresses the link between the use of 

the streptogramin antimicrobial, 

virginiamycin, in food-producing 

animals and the development of 

resistance to the related streptogramins, 

quinupristin-dalfopristin, used to treat 

human enterococcal infections. 

Enterococcus bacteria include 

commensal strains normally present in 

the intestines of animals and man. This 

risk assessment focuses on the 

opportunistic pathogen Enterococcus 

faecium.

In an effort to better ensure broad 

awareness of this Federal Register

notice, FDA will make copies available 

through the FDA Dockets Listserv (http:/

/www.fda.gov/ohrms/dockets/

FDAMAIL/DMBemaillist.htm). To be 

added to any of FDA’s free e-mail 

subscription services go to: http://

www.fda.gov. Click on ‘‘Subscribe to 

FDA’s E-mail Lists’’, then follow the 

instructions provided.

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance. Two 

copies of mailed comments are to be 

submitted, except that individuals may 

submit one copy. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. The draft guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

Dated: November 13, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–25979 Filed 11–23–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Center for Substance Abuse 

Prevention; Notice of Meeting 

Pursuant to Pub. L. 92–463, notice is 

hereby given of the meeting of the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

Drug Testing Advisory Board to be held 

in December 2004. 

On December 7, the Board will meet 

in an open session from 8:30 a.m. to 

9:30 a.m. The open session will include 

a Department of Health and Human 

Services drug testing program update, a 

Department of Transportation drug 

testing program update, and a Nuclear 

Regulatory Commission drug testing 

program update. Attendance by the 

public will be limited to space available. 

Public comments are welcome. Please 

communicate with the individual listed 

as contact below to make arrangements 

to comment or to request special 

accommodations for persons with 

disabilities. 

The Board will also meet in closed 

sessions on December 7 from 9:30 a.m. 

to 4:30 p.m. and on December 8 from 

8:30 a.m. until noon to develop the 

analytical and administrative policies 

for the final Revisions to the Mandatory 

Guidelines for Federal Workplace Drug 

Testing Program that were published as 

proposed revisions in the Federal 

Register on April 13, 2004 (69 FR 

19673). The submissions from 285 

commenters have been made available 

to the public on the Web site http://

workplace.samhsa.gov. This portion of 

the meeting must be conducted in 

closed sessions since discussing such 

public comments in an open session 

and then developing the policies will 

significantly frustrate the Department’s 

ability to develop the Final Notice of 

Revisions to the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs. The HHS Office of General 

Counsel made the determination that 

such matters are protected by exemption 

9(B) of section 552b(c) of title 5 U.S.C. 

and therefore may be closed to the 

public. 

A roster of the board members may be 

obtained from: Mrs. Giselle Hersh, 

Division of Workplace Programs, 1 

Choke Cherry Road, Room 2–1035, 

Rockville, MD 20857, 240–276–2600 

(telephone). The transcript of the open 

session will be available on the 

following Web site: http://

workplace.samhsa.gov. Additional 

information for this meeting may be 

obtained by contacting the individual 

listed below. 

Committee Name: Substance Abuse 

and Mental Health Services, 

Administration Drug Testing Advisory 

Board. 

Meeting Date: December 7, 2004; 8:30 

a.m.–4:30 p.m., December 8, 2004; 8:30 

a.m.–Noon. 

Place: Residence Inn by Marriott, 

7335 Wisconsin Avenue, Bethesda, 

Maryland 20814. 

Type: Open: December 7, 2004; 8:30 

a.m.–9:30 a.m., Closed: December 7, 

2004; 9:30 a.m.–4:30 p.m., Closed:

December 8, 2004; 8:30 a.m.–Noon. 

Contact: Donna M. Bush, Ph.D., 

Executive Secretary, 1 Choke Cherry 

Road, Room 2–1035, Rockville, 

Maryland 20857, Email: 

Donna.Bush@samhsa.hhs.gov, 240–

276–2600 (telephone) or 240–276–2610 

(fax).

Dated: November 15, 2004. 

Toian Vaughn, 

Committee Management Officer, Substance 

Abuse and Mental Health Services 

Administration.

[FR Doc. 04–26025 Filed 11–23–04; 8:45 am] 

BILLING CODE 4162–20–P

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

[Docket No. DHS–2004–0023] 

Homeland Security Advisory Council

AGENCY: Office of the Secretary, DHS.

ACTION: Notice of Federal Advisory 

Committee Meeting. 

SUMMARY: The Homeland Security 

Advisory Council (HSAC) will hold a 

meeting for purposes of (1) receiving 

reports from Senior Advisory 

Committees; (2) receiving briefings from 

DHS staff on Departmental initiatives; 

and (3) holding roundtable deliberations 

and discussions among HSAC members.

DATES: The Homeland Security 

Advisory Council (HSAC) will hold its 

next meeting in San Diego, CA on 

Tuesday, December 14, 2004.

ADDRESSES: This meeting will be 

partially closed; the open portions of the 

meeting for purposes of (1) above will 

be held at the Westin Horton Plaza 

Hotel Library, 910 Broadway Circle, San 

Diego, CA 92101 from 9:30 a.m. to 11:30 

a.m. The closed portions of the meeting, 

for purposes of (2) and (3) above will be 

held at the Westin Horton Plaza Hotel 

Harbor Room, 910 Broadway Circle, San 

Diego, CA 92101 from 8:30 a.m. to 9:20 

a.m. and from 11:30 a.m. to 3:30 p.m.