Waiver of Compliance With Navigation and Inspection Laws; Gulf Coast States, 57611-57612 [05-19820]
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Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Notices
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Committee agreed that the E2B(M) draft
guidance should be made available for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 The draft guidance is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about the draft guidance will be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the draft guidance entitled ‘‘E2B(R)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
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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 https://
www.fda.gov/ohrms/dockets/
default.htm, https://www.fda.gov/cder/
guidance/index.htm, or https://
www.fda.gov/cber/publications.htm.
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57611
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
Office of the Secretary, DHS.
Notice.
AGENCY:
ACTION:
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.
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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
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG–2005–22499]
Integrated Anti-Swimmer System; Draft
Programmatic Environmental
Assessment
Coast Guard, DHS.
Notice of availability and
request for comments.
AGENCY:
ACTION:
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.
Comments and related material
must reach the Docket Management
Facility on or before November 17,
2005.
DATES:
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 https://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
ADDRESSES:
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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
https://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
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]]>Agencies
[Federal Register Volume 70, Number 190 (Monday, October 3, 2005)]
[Notices]
[Pages 57611-57612]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-19820]
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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.
[[Page 57612]]
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
