68384 Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Notices 

of the act. FDA shall, within 60 days of 

receiving such a request, classify the 

device by written order. This 

classification shall be the initial 

classification of the device.

Within 30 days after the issuance of 

an order classifying the device, FDA 

must publish a notice in the Federal 

Register announcing such classification. 

Because of the timeframes established 

by section 513(f)(2) of the act, FDA has 

determined, under § 10.115(g)(2) (21 

CFR 10.115(g)(2)), that it is not feasible 

to allow for public participation before 

issuing this guidance as a final guidance 

document. Therefore, FDA is issuing 

this guidance document as a level 1 

guidance document that is immediately 

in effect. FDA will consider any 

comments that are received in response 

to this notice to determine whether to 

amend the guidance document.

II. Significance of Guidance

This guidance is being issued 

consistent with FDA’s GGPs regulation 

(§ 10.115). The guidance represents the 

agency’s current thinking on newborn 

screening test systems for amino acids, 

free carnitine, and acylcarnitines that 

utilize tandem mass spectrometry. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations.

III. Electronic Access

To receive ‘‘Class II Special Controls 

Guidance Document: Newborn 

Screening Test Systems for Amino 

Acids, Free Carnitine, and 

Acylcarnitines Using Tandem Mass 

Spectrometry’’ by fax machine, call the 

Center for Devices and Radiological 

Health (CDRH) Facts-On-Demand 

system at 800–899–0381 or 301–827–

0111 from a touch-tone telephone. Press 

1 to enter the system. At the second 

voice prompt, press 1 to order a 

document. Enter the document number 

(1301) followed by the pound sign (#). 

Follow the remaining voice prompts to 

complete your request.

Persons interested in obtaining a copy 

of the guidance may also do so by using 

the Internet. CDRH maintains an entry 

on the Internet for easy access to 

information, including text, graphics, 

and files that may be downloaded to a 

personal computer with Internet access. 

Updated on a regular basis, the CDRH 

home page includes device safety alerts, 

Federal Register reprints, information 

on premarket submissions (including 

lists of cleared submissions, approved 

applications, and manufacturers’

addresses), small manufacturer’s 

assistance, information on video 

conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http://

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

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

ohrms/dockets.

IV. Paperwork Reduction Act of 1995

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (the PRA) (44 

U.S.C. 3501–3520). The collections of 

information addressed in the guidance 

document have been approved by OMB 

in accordance with the PRA under the 

regulations governing premarket 

notification submissions (21 CFR part 

807, subpart E, OMB control number 

0910–0120). The labeling provisions 

addressed in the guidance have been 

approved by OMB under OMB control 

number 0910–0485.

V. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

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.

Dated: November 15, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–25976 Filed 11–23–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0479]

Draft Risk Assessment of 

Streptogramin Resistance in 

Enterococcus faecium Attributable to 

the Use of Streptogramins in Animals; 

Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of, and is requesting 

comment on, a draft risk assessment of 

the potential impact that food-animal 

use of streptogramin antimicrobials has 

on the resistance to chemically similar 

streptogramins used to treat human 

enterococcal infections. The veterinary 

drug of interest in this risk assessment 

is the streptogramin, virginiamycin, a 

drug approved for use in chicken, 

turkey, swine, and cattle feed. FDA will 

consider information received during 

the comment period in its preparation of 

a final risk assessment.

DATES: Submit written or electronic 

comments on the draft risk assessment 

document by January 24, 2005. FDA 

will accept comments, data, and 

information after the deadline, but to 

assure consideration by the agency, we 

must receive comments by this date.

ADDRESSES: Single copies of this draft 

risk assessment are available from the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Please enclose a 

self-addressed, adhesive label to assist 

that office in processing your request. 

This draft risk assessment is also 

available on the Internet at: http://

www.fda.gov/cvm/antimicrobial/

antimicrobial.htm.

Send written comments on this draft 

risk assessment 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.accessdata.fda.gov/scripts/oc/

dockets/commentdocket.cfm.

FOR FURTHER INFORMATION CONTACT:

Barry Hooberman, Center for Veterinary 

Medicine (HFV–102), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–8557, email: bhooberm@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

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.