Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Notices 57611 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

The ICH guidance entitled ‘‘E2B Data 

Elements for Transmission of Individual 

Case Safety Reports’’ was signed off by 

ICH in July 1997 and issued by FDA in 

January 1998 (63 FR 2396, January 15, 

1998). ICH subsequently issued a 

revised guidance entitled ‘‘E2B(M) 

Clinical Safety Data Management: Data 

Elements for Transmission of Individual 

Case Safety Reports’’ (E2B(M)), to 

provide additional information and 

clarification. ICH signed off on E2B(M) 

in November 2001, and FDA issued the 

revised guidance in April 2002. 

In May 2005, the ICH Steering 

Committee agreed that the E2B(M) draft 

guidance should be made available for 

public comment. The draft guidance is 

the product of the E2B(R) Expert 

Working Group of the ICH. Comments 

about the draft guidance will be 

considered by FDA and the E2B(R) 

Expert Working Group. 

FDA is announcing the availability of 

the draft guidance entitled ‘‘E2B(R) 

Clinical Safety Data Management: Data 

Elements for Transmission of Individual 

Case Safety Reports,’’ which revises the 

previous E2B guidances to include 

additional information and clarification 

for the electronic transmission of 

individual case safety reports. The draft 

guidance incorporates adjustments 

based on experience gained after 

implementation of the guidance in the 

three ICH regions and expands the use 

of the standard data elements to support 

vaccine reporting. For electronic 

transmissions, the draft guidance is 

intended to be used with the ICH M2 

individual case safety report (ICSR) 

message specification. The draft 

guidance recommends that electronic 

transmission of individual case safety 

reports be implemented using the 

Medical Dictionary for Regulatory 

Activities (MedDRA) and ICH M5 data 

elements and standards where 

applicable. 

FDA has identified in public Docket 

No. 1992S–0251 (formerly Docket No. 

92S–0251) postmarketing individual 

case safety reports as submission types 

that the agency can accept in electronic 

format. FDA believes the ICH 

recommendations for the electronic 

transmission of these reports will result 

in more effective and efficient safety 

reporting to regulatory authorities 

worldwide. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on this topic. 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 statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance. 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. The draft guidance and 

received comments may be seen in the 

Division of Dockets Management 

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

through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/ohrms/dockets/ 

default.htm, http://www.fda.gov/cder/ 

guidance/index.htm, or http:// 

www.fda.gov/cber/publications.htm. 

Dated: September 26, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–19655 Filed 9–30–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

Waiver of Compliance With Navigation 

and Inspection Laws; Gulf Coast 

States 

AGENCY: Office of the Secretary, DHS. 

ACTION: Notice. 

The combined effect of Hurricanes 

Rita and Katrina is one of the largest 

natural disasters to ever strike the 

United States. The hurricanes have 

significantly disrupted production of oil 

and gas in the Gulf of Mexico, have 

caused many Gulf Coast oil refineries to 

go out of service because of flooding, 

lack of electric power or other reasons, 

and have significantly disrupted the 

pipeline transportation of oil and 

refined products from the Gulf Coast 

States. These production losses, outages, 

and disruptions have caused increases 

in the price of oil, gasoline and other 

refined products. The Department of 

Homeland Security has received reports 

of threatened or actual shortages of 

gasoline, jet fuel, and/or other refined 

products as a result of the hurricanes. 

Companies that produce and/or ship 

petroleum and/or refined petroleum 

products have submitted to the 

Department requests for waivers of the 

Merchant Marine Act of 1920 (the 

‘‘Jones Act’’). See, 46 U.S.C. App. 

section 1; 46 U.S.C. App. section 883. 

This and related laws are generally 

referred to as the ‘‘coastwise laws.’’

These laws provide, among other things, 

that only vessels built and owned by 

citizens of the United States and flagged 

in the United States can carry 

merchandise between U.S. ports. 

The Secretary of Homeland Security 

is vested with the authority and 

discretion to waive the coastwise laws 

‘‘to such extent and in such manner and 

upon such terms as he may prescribe, 

either upon his own initiative or upon 

the written recommendation of the head 

of any other Government agency, 

whenever he deems that such action is 

necessary in the interest of national 

defense.’’ In consultation with and upon 

the recommendation of the Secretary of 

Energy, I have determined that such a 

waiver, in accordance with the terms set 

forth below, is in the interest of the 

national defense. 

57612 Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Notices 

The catastrophic destruction brought 

about by Hurricanes Rita and Katrina 

has dramatically impeded, and in some 

places in the affected region stopped 

altogether, production and 

transportation or transmission of oil, 

refined petroleum products, natural gas, 

and electricity. Much of the lost oil 

production is from producing areas in 

the Gulf of Mexico which have been 

leased pursuant to programs of the 

Department of the Interior. This lost 

production, refining, and transportation 

capacity has resulted in the actual or 

threatened unavailability of gasoline, jet 

fuel and other refined products, and 

threatens the Nation’s economic and 

national security. I believe that waiver 

of the coastwise laws would facilitate 

the transportation of oil and refined 

petroleum products in and from 

portions of the United States affected by 

the hurricanes, and to other regions 

affected by the disruptions that have 

occurred in the Gulf Coast area. 

Therefore, I am exercising my 

discretion and authority to waive the 

coastwise laws generally for the 

transportation of petroleum and refined 

petroleum products for the period until 

12:01 a.m., October 24, 2005. On 

September 1, 2005, I exercised my 

discretion and authority to waive the 

coastwise laws generally for the 

transportation of petroleum released 

from the Strategic Petroleum Reserve, 

whether pursuant to an exchange, sale 

or otherwise, undertaken in response to 

the circumstances arising from 

Hurricane Katrina. I am today exercising 

my discretion and authority to extend 

that waiver of the coastwise laws 

generally for the transportation of 

petroleum released from the Strategic 

Petroleum Reserve, whether pursuant to 

an exchange, sale, or otherwise, 

undertaken in response to the 

circumstances arising from Hurricane 

Rita. I find, for the reasons set forth 

above, that such waivers are necessary 

in the interest of national defense. 

Executed this 26th day of September, 2005. 

Michael Chertoff, 

Secretary. 

[FR Doc. 05–19820 Filed 9–29–05; 1:23 pm] 

BILLING CODE 4410–10–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2005–22499] 

Integrated Anti-Swimmer System; Draft 

Programmatic Environmental 

Assessment 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of availability and 

request for comments. 

SUMMARY: The Coast Guard announces 

the availability of the Draft 

Programmatic Environmental 

Assessment (PEA) of the Integrated 

Anti-Swimmer System (IAS). The Coast 

Guard is proposing to deploy and 

operate the IAS for temporary periods at 

various U.S. ports throughout the U.S. 

Maritime Domain, when necessary. The 

purpose of the Proposed Action is to 

increase the Coast Guard’s ability to 

detect, track, classify, and interdict, if 

necessary, potential underwater threats 

and as a result, protect personnel, ships, 

and property from sabotage and/or other 

subversive acts. Potential threats 

targeted by the IAS include combat 

divers and unmanned vehicles. The IAS 

will be co-located with, and used by, the 

Coast Guard’s newly established 

Maritime Safety and Security Teams 

(MSSTs). The IAS is proposed to be 

used at a range necessary to maintain 

situational awareness and allow the 

MSSTs sufficient time to react and 

counter a detected threat. Extensive 

research and analysis of alternatives has 

led to the conclusion that an active 

sonar system is the only currently 

available technology that affords this 

capability. 

DATES: Comments and related material 

must reach the Docket Management 

Facility on or before November 17, 

2005. 

ADDRESSES: To make sure that your 

comments and related material are not 

entered more than once in the docket, 

please submit them by only one of the 

following means: 

(1) Electronically through the Web 

Site for the Docket Management System 

at http://dms.dot.gov. 

(2) By mail to the Docket Management 

Facility, (USCG–2005–22499), U.S. 

Department of Transportation, room PL–

401, 400 Seventh Street SW., 

Washington, DC 20590–0001. 

(3) By fax to the Docket Management 

Facility at 202–493–2251. 

(4) By delivery to room PL–401 on the 

Plaza level of the Nassif Building, 400 

Seventh Street SW., Washington, DC, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

The telephone number is 202–366–

9329. 

The Docket Management Facility 

maintains the public docket for this 

notice. Comments and material received 

from the public, as well as the draft 

Programmatic Environmental 

Assessment (PEA), will become part of 

this docket and will be available for 

inspection or copying at room PL–401 

on the Plaza level of the Nassif Building, 

400 Seventh Street SW., Washington, 

DC, between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

You may also find this docket, 

including the PEA, on the Internet at 

http://dms.dot.gov. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this notice, the 

proposed project, or the associated PEA, 

call Mr. Kenneth McDaniel at (202) 267–

1505 or by e-mail at 

kmcdaniel@comdt.uscg.mil. If you have 

questions on viewing or submitting 

material to the docket, call Andrea M. 

Jenkins, Program Manager, Docket 

Operations, telephone 202–366–0271. 

SUPPLEMENTARY INFORMATION: 

Request for Comments 

We encourage you to submit 

comments and related material on the 

draft Programmatic Environmental 

Assessment (PEA). If you do so, please 

include your name and address, identify 

the docket number for this notice 

(USCG–2005–22499) and give the 

reasons for each comment. You may 

submit your comments and material by 

mail, hand delivery, fax, or electronic 

means to the Docket Management 

Facility at the address under ADDRESSES; 

but please submit your comments and 

material by only one means. If you 

submit them by mail or hand delivery, 

submit them in an unbound format, no 

larger than 81⁄2 by 11 inches, suitable for 

copying and electronic filing. If you 

submit them by mail and would like to 

know they reached the Facility, please 

enclose a stamped, self-addressed 

postcard or envelope. We will consider 

all comments and material received 

during the comment period. 

Proposed Action 

Domestic port safety and security has 

long been a core Coast Guard mission. 

However, in the wake of the terrorist 

attacks committed on September 11, 

2001, emerging threats to the U.S. 

homeland have prompted an increased 

Coast Guard focus on protecting 

domestic ports and the U.S. Maritime 

Transportation System from terrorist 

threats. 

As part of the U.S. response to these 

threats, the Coast Guard has undertaken