Federal Register / Vol. 69, No. 247 / Monday, December 27, 2004 / Notices 77259

ADDRESSES: Submit written comments 

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.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:

Kelly Williams-Randolph, Center for 

Food Safety and Applied Nutrition 

(HFS–810), Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301–

436–2506, FAX: 301–436–2639, or email: Kelly.Williams@cfsan.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of October 20, 

2004, FDA published a notice 

announcing a public meeting on 

November 15, 2004, and soliciting 

comments on FDA’s premarket 

notification program for NDIs with an 

opportunity for public comment for 45 

days. FDA requested comments from 

industry, consumers, and other 

interested members of the public 

concerning the content and format 

requirements for NDI notifications made 

under section 413(a)(2) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

350b(a)(2)). FDA held this meeting to 

give the public an opportunity to 

provide information and views on 

topics outlined in the notice. The 

agency intends to consider all 

comments received in the meeting and 

sent to the docket in determining 

whether any future action is necessary 

or appropriate.

The agency has received a request 

from a number of trade associations for 

an extension of the comment period to 

and including February 1, 2005. The 

request set forth several reasons in 

support of allowing additional time to 

submit comments. First, according to 

the request, the 45-day comment period 

did not allow sufficient time for 

interested parties to adequately address 

the large number of detailed and 

specific questions put forth by FDA and 

the significant impact on industry, 

especially small businesses, of the 

issues raised in the notice. The request 

noted that the questions (many of which 

contained subparts) will require 

extended industry discussion to ensure 

broad input from member firms and to 

organize the information obtained from 

their member companies. Second, the 

request noted that the original December 

3, 2004, deadline for submitting 

comments did not provide interested 

parties enough time to consider the 

transcript of the November 15, 2004, 

meeting in developing their comments. 

The request explained that an extension 

until February 1, 2005, would allow 

industry to submit more focused and 

detailed comments without significantly 

delaying the agency’s consideration of 

the issues set forth in the meeting 

notice.

FDA has considered the request and 

is reopening the comment period for the 

October 20, 2004, notice until February 

1, 2005. The agency agrees that 

reopening the comment period will 

allow adequate time for interested 

persons to submit comments without 

significantly delaying the agency’s 

consideration of the issues set forth in 

the October 20, 2004, notice.

II. Request for Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the issues raised in 

the October 20, 2004, notice. 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: December 17, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–28135 Filed 12–23–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND 

SECURITY 

Directorate of Information Analysis 

and Infrastructure Protection (IAIP) 

[DHS–2004–0032] 

Open Meeting of National 

Infrastructure Advisory Council (NIAC)

AGENCY: Directorate of Information 

Analysis and Infrastructure Protection, 

DHS.

ACTION: Notice of meeting.

SUMMARY: The National Infrastructure 

Advisory Council (NIAC) will meet on 

Tuesday, January 11, 2005, from 1 p.m. 

to 4 p.m. at the Hamilton Crowne Plaza 

in Washington, DC. The meeting will be 

open to the public. Limited seating will 

be available. Reservations are not 

accepted. 

The NIAC advises the President of the 

United States on the security of critical 

infrastructures which include banking 

and finance, transportation, energy, 

manufacturing, and emergency 

government services. At this meeting, 

the NIAC will be briefed on the status 

of several Working Group activities that 

the Council undertook at its last 

meeting.

DATES: The NIAC will meet Tuesday, 

January 11, 2005, from 1 p.m. to 4 p.m.

ADDRESSES: The NIAC will meet at the 

Hamilton Crowne Plaza, 14th and K 

Street, NW., Washington, DC. You may 

submit comments, identified by DHS 

Docket DHS–2004–0032 by one of the 

following methods: 

• EPA Federal Partner EDOCKET 

Web Site: http://www.epa.gov/

feddocket. Follow the instructions for 

submitting comments on the Web site. 

• Federal eRulemaking Portal: http://

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail/Hand Delivery/Courier: 

Department of Homeland Security, Attn: 

Ms. Nancy J. Wong, Infrastructure 

Coordination Division, Directorate of 

Information Analysis and Infrastructure 

Protection/703–235–5352, Anacostia 

Navel Annex, 245 Murray Lane, SW., 

Building 410, Washington, DC 20528, 

7:30 a.m. to 4 p.m. 

Instructions: All submissions received 

must include the DHS–2004–0032. All 

comments received will be posted 

without change to http://www.epa.gov/

feddocket, including any personal 

information provided.

FOR FURTHER INFORMATION CONTACT:

Nancy J. Wong, NIAC Designated 

Federal Official, telephone 703–235–

5352.

SUPPLEMENTARY INFORMATION: Notice of 

these meetings is given under the 

Federal Advisory Committee Act, 5 

U.S.C. App. 2.

AGENDA OF COMMITTEE MEETING ON JANUARY 11, 2005 

I. Opening of Meeting ..................... Nancy J. Wong, U.S. Department of Homeland Security (DHS)/Designated Federal Officer, NIAC. 

II. Roll Call of Members .................. Nancy J. Wong. 

III. Opening Remarks and Introductions.NIAC Chairman, Erle A. Nye, Chairman of the Board, TXU Corporation. 

NIAC Vice Chairman, John T. Chambers, Chairman and CEO, Cisco Systems, Inc. 

77260 Federal Register / Vol. 69, No. 247 / Monday, December 27, 2004 / Notices 

AGENDA OF COMMITTEE MEETING ON JANUARY 11, 2005—Continued

The Honorable Tom Ridge, Secretary, Department of Homeland Security (Invited). 

Lt. Gen. Frank Libutti, Under Secretary for Information Analysis and Infrastructure Protection (IAIP), DHS 

(Invited). 

Robert P. Liscouski, Assistant Secretary for Infrastructure Protection, DHS (Invited). 

Frances Fragos Townsend, Special Assistant to the President for Critical Infrastructure. 

IV. Introduction and Welcome of 

New NIAC Members.

NIAC Chairman Erle A. Nye. 

V. Ethics Briefing ............................ Robert Coyle, DHS Office of Government Ethics. 

VI. Approval of October Minutes .... NIAC Chairman Erle A. Nye. 

VII. Briefing of the New DHS Sector 

Partnership Model.

Mr. R. James Caverly, Director, Infrastructure Coordination Division, DHS. 

VIII. Status Reports on Current Initiatives.NIAC Chairman Erle A. Nye Presiding. 

A. Intelligence Process and 

Work Products Regarding 

Critical Infrastructures.

NIAC Vice Chairman John T. Chambers, Chairman & CEO, Cisco Systems, Inc. and Chief Gilbert 

Gallegos, Police Chief, City of Albuquerque, New Mexico, NIAC Member. 

B. Risk Management Approaches Protection.Thomas E. Noonan, Chairman, President to & CEO, Internet Security Systems, Inc., NIAC Member; Martha Marsh, President & CEO, Stanford Hospital and Clinics, NIAC Member. 

C. Assuring Adequate National 

Intellectual Capital to Secure 

Cyber-Based Critical Infrastructures.

Alfred R. Berkeley III, e-Xchange Advantage Corp., NIAC Member and Dr. Linwood Rose, President, 

James Madison University, NIAC Member. 

IX. Reports Related to Past NIAC 

Recommendations.

NIAC Chairman Erle A. Nye Presiding. 

A. Summary of NIAC Recommendations by Subject 

Area.

Nancy J. Wong, U.S. Department of Homeland Security (DHS)/Designated Federal Official, NIAC. 

X. Presentation/Discussion of DHS/

DOJ Cyber Security Survey.

Presentation by Patrick J. Morrissey, Deputy Director, Law Enforcement and Intelligence, National Cyber 

Security Division (NCSD), Department of Homeland Security. 

XI. New Business ............................ NIAC Chairman Erle A. Nye, NIAC Members. 

XII. Adjournment ............................. NIAC Chairman Erle A. Nye. 

Procedural 

These meetings are open to the 

public. Please note that the meetings 

may close early if all business is 

finished. 

Information on Services for Individuals 

With Disabilities 

For information on facilities or 

services for individuals with 

disabilities, or to request special 

assistance at the meeting, telephone the 

Designated Federal Official as soon as 

possible.

Dated: December 13, 2004. 

Nancy J. Wong, 

Designated Federal Official for NIAC.

[FR Doc. 04–28206 Filed 12–23–04; 8:45 am] 

BILLING CODE 4410–10–P

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2004–19946] 

Random Drug Testing Rate for 

Covered Crewmembers

AGENCY: Coast Guard, DHS.

ACTION: Notice of minimum random 

drug testing rate. 

SUMMARY: The Coast Guard has set the 

calendar year 2005 minimum random 

drug testing rate at 50 percent of 

covered crewmembers. An evaluation of 

the 2003 Management Information 

System (MIS) data collection forms 

submitted by marine employers 

determined that random drug testing on 

covered crewmembers for the calendar 

year 2003 resulted in positive test 

results 2.07 percent of the time. Based 

on this percentage, we will maintain the 

minimum random drug testing rate at 50 

percent of covered crewmembers for the 

calendar year 2005.

DATES: The minimum random drug 

testing rate is effective January 1, 2005 

through December 31, 2005. You must 

submit your 2004 MIS reports no later 

than March 15, 2005.

ADDRESSES: The annual MIS report may 

by submitted in writing to Commandant 

(G–MOA), U.S. Coast Guard 

Headquarters, 2100 Second Street SW., 

Room 2404, Washington, DC 20593–

0001 or by electronic submission to the 

following Internet address: http://

www.uscg.mil/hq/g-m/moa/dapip.htm.

FOR FURTHER INFORMATION CONTACT: For 

questions about this notice, please 

contact Mr. Robert C. Schoening, Drug 

and Alcohol Program Manager, Office of 

Investigations and Analysis (G–MOA), 

U.S. Coast Guard Headquarters, 

telephone (202) 267–0684. If you have 

questions on viewing the docket, call 

Andrea M. Jenkins, Program Manager, 

Dockets Operations, Department of 

Transportation, telephone (202) 366–

0271.

SUPPLEMENTARY INFORMATION: Under 46 

CFR 16.230, the Coast Guard requires 

marine employers to establish random 

drug testing programs for covered 

crewmembers on inspected and 

uninspected vessels. All marine 

employers are required to collect and 

maintain a record of drug testing 

program data for each calendar year, 

January 1 through December 31. You 

must submit this data by 15 March of 

the following year to the Coast Guard in 

an annual MIS report. 

You may either submit your own MIS 

report or have a consortium or other 

employer representative submit the data 

in a consolidated MIS report. The 

chemical drug testing data is essential to 

analyze our current approach for 

deterring and detecting illegal drug 

abuse in the maritime industry. 

Since 2003 MIS data indicates that the 

positive random testing rate is greater 

than one percent industry-wide (2.07 

percent), the Coast Guard announces 

that the minimum random drug testing 

rate is set at 50 percent of covered 

employees for the period of January 1, 

2005, through December 31, 2005, in 

accordance with 46 CFR 16.230(e). 

Each year we will publish a notice 

reporting the results of the previous 

calendar year’s MIS data, and the 

minimum annual percentage rate for