Prince William Sound Regional Citizens' Advisory Committee Charter Renewal, 24607-24608 [05-9301]
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Federal Register / Vol. 70, No. 89 / Tuesday, May 10, 2005 / Notices
continue to evaluate that information.
We intend to work as quickly as
possible to assess and address the safety
issues identified on the Drug Watch,
and we will continue to communicate
important information about drug risks
that are known with greater certainty
using traditional means, such as public
health advisories. Our goal with the
Drug Watch is to share emerging safety
information before we have fully
determined its significance or taken
final regulatory action so that patients
and healthcare professionals will have
the most current information concerning
the potential risks and benefits of
marketed drug products.
This draft guidance is being issued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The draft guidance, when finalized, will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 FDA’s Drug Watch for emerging drug
safety information. 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.
III. 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comments on the draft guidance.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 The draft guidance and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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either http:/
/www.fda.gov/cder/guidance/index.htm
or https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: May 4, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–9297 Filed 5–5–05; 3:42 pm]
BILLING CODE 4160–01–S
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16:17 May 09, 2005
Jkt 205001
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[CGD 17–05–005]
Prince William Sound Regional
Citizens’ Advisory Committee Charter
Renewal
Coast Guard, DHS.
Notice of recertification.
AGENCY:
ACTION:
SUMMARY: The purpose of this notice is
to inform the public that the Coast
Guard has recertified the Prince William
Sound Regional Citizens’ Advisory
Council (PWSRCAC) as an alternative
voluntary advisory group for Prince
William Sound, Alaska. This
certification allows the PWSRCAC to
monitor the activities of terminal
facilities and crude oil tankers under the
Prince William Sound Program
established by statute.
DATES: This recertification is effective
for the period from March 1, 2005,
through February 28, 2006.
FOR FURTHER INFORMATION CONTACT:
Commander, Seventeenth Coast Guard
District, Marine Safety Division,
Response Branch by phone at (907) 463–
2804, or by mail at P.O. Box 25517;
Juneau, Alaska 99802.
SUPPLEMENTARY INFORMATION:
Background and Purpose
As part of the Oil Pollution Act of
1990, Congress passed the Oil Terminal
and Oil Tanker Environmental
Oversight and Monitoring Act of 1990
(the Act), 33 U.S.C. 2732, to foster a
long-term partnership among industry,
government, and local communities in
overseeing compliance with
environmental concerns in the
operation of crude oil terminals and oil
tankers.
On October 18, 1991, the President
delegated his authority under 33 U.S.C
2732 (o) to the Secretary of
Transportation in Executive Order
12777, section 8(g) (see 56 FR 54757;
October 22, 1991) for purposes of
certifying advisory councils, or groups,
subject to the Act. On March 3, 1992,
the Secretary redelegated that authority
to the Commandant of the USCG (see 57
FR 8582; March 11, 1992). The
Commandant redelegated that authority
to the Chief, Office of Marine Safety,
Security and Environmental Protection
(G–M) on March 19, 1992 (letter #5402).
On July 7, 1993, the USCG published
a policy statement, 58 FR 36504, to
clarify the factors that shall be
considered in making the determination
as to whether advisory councils, or
PO 00000
Frm 00110
Fmt 4703
Sfmt 4703
24607
groups, should be certified in
accordance with the Act.
The Assistant Commandant for
Marine Safety and Environmental
Protection (G–M), redelegated
recertification authority for advisory
councils, or groups, to the Commander,
Seventeenth Coast Guard District on
February 26, 1999 (letter #16450).
On September 16, 2002, the USCG
published a policy statement, 67 FR
58440, that changed the recertification
procedures such that applicants are
required to provide the USCG with
comprehensive information every three
years (triennially). For each of the two
years between the triennial application
procedure, applicants submit a letter
requesting recertification that includes a
description of any substantive changes
to the information provided at the
previous triennial recertification.
Discussion of Comments
The January 12, 2005, the USCG
published a Notice of Application
Submission Deadline; Request for
Comments for Recertification of Prince
William Sound Regional Citizens’
Advisory Council in the Federal
Register (70 FR 2181). We received 17
letters commenting on the proposed
action. No public meeting was
requested, and none was held. Of the 17
comments received, 16 were positive.
These letters in support of the
recertification consistently cited
PWSRCAC’s broad representation of the
respective community’s interests,
appropriate actions to keep the public
informed, improvements to both spill
response preparation and spill
prevention, and oil spill industry
monitoring efforts that combat
complacency—as intended by the Act.
The USCG received one comment in
opposition to PWSRCAC’s
recertification. The Native Village of
Eyak (NVE) recommended the Coast
Guard de-certify the PWSRCAC because
it neither represents the NVE, nor can it
afford representation to the NVE
through membership on the PWSRCAC
Board of Directors. The NVE stated that
a separate Tribal oversight group should
be created. They further stated that
advisory group funding should be
directed to this Tribal oversight group,
and that this group would exist in
addition to, not in place of, the
PWSRCAC. NVE has twice before
voiced this opposition in letters of
comment on PWSRCAC’s 2001 and
2002 recertification. Commandant,
Seventeenth Coast District answered
NVE’s opposition, with direct responses
dated September 7, 2001, and July 11,
2002. For the purpose of public record,
those responses are provided here:
E:\FR\FM\10MYN1.SGM
10MYN1
24608
Federal Register / Vol. 70, No. 89 / Tuesday, May 10, 2005 / Notices
The September 7, 2001, U.S. Coast
Guard response to the Native Village of
Eyak letter dated July 24, 2001, states
‘‘[I] have received and reviewed your
letter that does not support the
recertification of the PWSRCAC. Thank
you for you input. Although I
understand your position and concerns
that the Native Village of Eyak has never
been represented by the PWSRCAC and
therefore the Native Village of Eyak does
not feel the PWSRCAC is broadly
representative of the interests and
communities in the area, after careful
consideration, I do not feel this single
issue would justify the U.S. Coast Guard
not recertifying the PWSRCAC. In light
of your concerns, I have requested, in
writing, that the PWSRCAC board
contact your Tribal Council and open a
dialogue with you to ensure your
concerns are reflected in the
PWSRCAC’s Activities. Additionally, I
recommend that you open a dialog, if
you desire, with the PWSRCAC Board of
Directors concerning membership on
the Board, as membership native
villages is consistent with Section
2732(d)(A)(iii) of OPA 90. To respond to
your question regarding an investigation
into the finances of the RCAC, the Coast
Guard is currently conducting a ‘‘best
practices’’ audit to assist the PWSRCAC
in decreasing their administrative
overhead. This audit is still ongoing,
and it would be premature for me to
further comment on the potential
outcome prior to its completion. My
staff and I look forward to working with
you on our common goal of improving
the safe and environmentally sound
transport of oil in PWS and surrounding
communities.’’
The July 11, 2002, U.S. Coast Guard
response to the Native Village of Eyak
letter dated July 29, 2002, states ‘‘I have
received and reviewed your letter
concerning the recertification of the
Regional Citizens’ Advisory Council
(RCAC) for Prince William Sound
(PWS). The Coast Guard greatly values
the important role the Native Village of
Eyak Traditional Council (NVETC) plays
in the PWS community. Thank you for
your input and for this opportunity to
consult with you about the PWS RCAC
and The Oil Pollution Act of 1990 (OPA
90).’’
The history, background, and legal
character of the PWS RCAC, along with
its funding and responsibilities are
unique and worthy of more discussion.
The PWS RCAC is an independent, nonprofit organization founded in 1989.
Though it received Federal oversight
like many independent, non-profit
organizations, it is not a Federal agency.
The PWS RCAC is a local organization
that predates the passage of OPA 90.
VerDate jul<14>2003
16:17 May 09, 2005
Jkt 205001
The existence of the PWS RCAC was
specifically recognized in OPA 90
where it is defined as an ‘‘alternate
voluntary advisory group.’’
The Alyeska Pipeline Service
Company pays the PWS RCAC $2
million annually in the form of a longterm contract. In return for this funding,
the PWS RCAC must annually show that
it ‘‘fosters the goals and purposes’’ of
OPA 90 and is ‘‘broadly representative
of the communities and interests in the
vicinity of the terminal facilities and
Prince William Sound.’’ In March 1991,
then-President Bush initially certified
the PWS RCRC as meeting these broad
goals. That certification responsibility
was delegated to the Coast Guard in
1991, and for the last ten years the Coast
Guard has unconditionally recertified
the PWS RCAC annually.
Alyeska funds the PWS RCAC, and
the Coast Guard makes sure the PWS
RCRC operates in a fashion that is
broadly consistent with OPA 90. For
example, the PWS RCAC’s
responsibilities under OPA 90 are
limited to monitoring crude oil terminal
and tanker operation in PWS. As such,
the PWS RCAC had no role in the
response to the F/V WINDY BAY oil
spill, which was a diesel fuel oil spill.
In such cases, however, the PWS RCAC
can and does offer advice based on it
local knowledge and in fact facilitated
our close cooperation in response to that
spill.
In your letter, you made three specific
requests. The first was the ‘‘the PWS
RCAC be decertified on the basis of not
broadly representing interests and
communities in the area.’’ I have the
authority to grant that request, but
cannot grant it. I find that the PWS
RCAC does broadly represent the PWS
community. The PWS RCAC board
includes a broad spectrum of the native
and non-native community, the fishing
and oil industry, and environmental and
recreational organizations as prescribed
by OPA 90. Last year after you made
similar critical recertification comment,
the PWS RCAC invited the NVETC to
seek a seat on the board of the RCAC.
You decided not to act on that offer. I
cannot find your decision not to join the
PWS RCAC to be basis for
decertification.
Your second request was the ‘‘a new
group following strict letter of the law
in OPA 90 be formed.’’ Unfortunately, I
have neither the authority to grant this
request nor the expertise to help you
achieve it on your own. The Coast
Guard did not create the PWS RCAC
and cannot act to create a competing
alternative.
Your third request was that ‘‘a Tribal
oversight group with equal status to the
PO 00000
Frm 00111
Fmt 4703
Sfmt 4703
U.S. government and State of Alaska be
created.’’ Again I have neither the
authority nor the expertise to create
such an organization. I do encourage
you to reconsider your decision not to
seek a seat on the PWS RCAC. Though
the PWS RCAC is an independent, nonfederal, non-profit organization over
which I have limited influence, I would
ask the PWS RCAC seriously consider a
renewed request by you for a seat on the
board.
In your letter, you suggested the
formation of a Tribal Council of the
Native Tribes and Villages in PWS that
would exist in addition to PWS RCAC.
I appreciate that such a network would
facilitate the discussion of mutual issues
and concerns. Though the Coast Guard
is not empowered to sponsor such an
enterprise, I would welcome the
information and advice such a group
could offer. You may wish to approach
the PWS RCAC about such a tribal
group.
I would also like to assure you that
the Coast Guard recognizes its
government-to-government consultative
relationship with the Native Village of
Eyak. I am grateful for this opportunity
to consult with you. I hope to continue
to work you on emergent cases like the
F/V WINDY BAY case and on any other
matters of mutual concern.’’
NVE has voiced no new opposition
for 2005. The USCG, standing by its
direct responses above, likewise offers
no new response to NVE’s running
opposition.
Recertification: By letter dated March
2, 2005, the Commander, Seventeenth
Coast Guard certified that the
PWSRCAC qualifies as an alternative
voluntary advisory group under 33
U.S.C. 2732(o). This recertification
terminates on February 28, 2006.
Dated: March 4, 2005.
James C. Olson,
Rear Admiral, U.S. Coast Guard, Commander,
Seventeenth Coast Guard District.
[FR Doc. 05–9301 Filed 5–9–05; 8:45 am]
BILLING CODE 4910–15–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[CGD08–05–020]
Houston/Galveston Navigation Safety
Advisory Committee
Coast Guard, DHS.
Notice of meetings; change of
meeting date and location.
AGENCY:
ACTION:
SUMMARY: The Houston/Galveston
Navigation Safety Advisory Committee
E:\FR\FM\10MYN1.SGM
10MYN1
Agencies
[Federal Register Volume 70, Number 89 (Tuesday, May 10, 2005)]
[Notices]
[Pages 24607-24608]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9301]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
Coast Guard
[CGD 17-05-005]
Prince William Sound Regional Citizens' Advisory Committee
Charter Renewal
AGENCY: Coast Guard, DHS.
ACTION: Notice of recertification.
-----------------------------------------------------------------------
SUMMARY: The purpose of this notice is to inform the public that the
Coast Guard has recertified the Prince William Sound Regional Citizens'
Advisory Council (PWSRCAC) as an alternative voluntary advisory group
for Prince William Sound, Alaska. This certification allows the PWSRCAC
to monitor the activities of terminal facilities and crude oil tankers
under the Prince William Sound Program established by statute.
DATES: This recertification is effective for the period from March 1,
2005, through February 28, 2006.
FOR FURTHER INFORMATION CONTACT: Commander, Seventeenth Coast Guard
District, Marine Safety Division, Response Branch by phone at (907)
463-2804, or by mail at P.O. Box 25517; Juneau, Alaska 99802.
SUPPLEMENTARY INFORMATION:
Background and Purpose
As part of the Oil Pollution Act of 1990, Congress passed the Oil
Terminal and Oil Tanker Environmental Oversight and Monitoring Act of
1990 (the Act), 33 U.S.C. 2732, to foster a long-term partnership among
industry, government, and local communities in overseeing compliance
with environmental concerns in the operation of crude oil terminals and
oil tankers.
On October 18, 1991, the President delegated his authority under 33
U.S.C 2732 (o) to the Secretary of Transportation in Executive Order
12777, section 8(g) (see 56 FR 54757; October 22, 1991) for purposes of
certifying advisory councils, or groups, subject to the Act. On March
3, 1992, the Secretary redelegated that authority to the Commandant of
the USCG (see 57 FR 8582; March 11, 1992). The Commandant redelegated
that authority to the Chief, Office of Marine Safety, Security and
Environmental Protection (G-M) on March 19, 1992 (letter
5402).
On July 7, 1993, the USCG published a policy statement, 58 FR
36504, to clarify the factors that shall be considered in making the
determination as to whether advisory councils, or groups, should be
certified in accordance with the Act.
The Assistant Commandant for Marine Safety and Environmental
Protection (G-M), redelegated recertification authority for advisory
councils, or groups, to the Commander, Seventeenth Coast Guard District
on February 26, 1999 (letter 16450).
On September 16, 2002, the USCG published a policy statement, 67 FR
58440, that changed the recertification procedures such that applicants
are required to provide the USCG with comprehensive information every
three years (triennially). For each of the two years between the
triennial application procedure, applicants submit a letter requesting
recertification that includes a description of any substantive changes
to the information provided at the previous triennial recertification.
Discussion of Comments
The January 12, 2005, the USCG published a Notice of Application
Submission Deadline; Request for Comments for Recertification of Prince
William Sound Regional Citizens' Advisory Council in the Federal
Register (70 FR 2181). We received 17 letters commenting on the
proposed action. No public meeting was requested, and none was held. Of
the 17 comments received, 16 were positive. These letters in support of
the recertification consistently cited PWSRCAC's broad representation
of the respective community's interests, appropriate actions to keep
the public informed, improvements to both spill response preparation
and spill prevention, and oil spill industry monitoring efforts that
combat complacency--as intended by the Act.
The USCG received one comment in opposition to PWSRCAC's
recertification. The Native Village of Eyak (NVE) recommended the Coast
Guard de-certify the PWSRCAC because it neither represents the NVE, nor
can it afford representation to the NVE through membership on the
PWSRCAC Board of Directors. The NVE stated that a separate Tribal
oversight group should be created. They further stated that advisory
group funding should be directed to this Tribal oversight group, and
that this group would exist in addition to, not in place of, the
PWSRCAC. NVE has twice before voiced this opposition in letters of
comment on PWSRCAC's 2001 and 2002 recertification. Commandant,
Seventeenth Coast District answered NVE's opposition, with direct
responses dated September 7, 2001, and July 11, 2002. For the purpose
of public record, those responses are provided here:
[[Page 24608]]
The September 7, 2001, U.S. Coast Guard response to the Native
Village of Eyak letter dated July 24, 2001, states ``[I] have received
and reviewed your letter that does not support the recertification of
the PWSRCAC. Thank you for you input. Although I understand your
position and concerns that the Native Village of Eyak has never been
represented by the PWSRCAC and therefore the Native Village of Eyak
does not feel the PWSRCAC is broadly representative of the interests
and communities in the area, after careful consideration, I do not feel
this single issue would justify the U.S. Coast Guard not recertifying
the PWSRCAC. In light of your concerns, I have requested, in writing,
that the PWSRCAC board contact your Tribal Council and open a dialogue
with you to ensure your concerns are reflected in the PWSRCAC's
Activities. Additionally, I recommend that you open a dialog, if you
desire, with the PWSRCAC Board of Directors concerning membership on
the Board, as membership native villages is consistent with Section
2732(d)(A)(iii) of OPA 90. To respond to your question regarding an
investigation into the finances of the RCAC, the Coast Guard is
currently conducting a ``best practices'' audit to assist the PWSRCAC
in decreasing their administrative overhead. This audit is still
ongoing, and it would be premature for me to further comment on the
potential outcome prior to its completion. My staff and I look forward
to working with you on our common goal of improving the safe and
environmentally sound transport of oil in PWS and surrounding
communities.''
The July 11, 2002, U.S. Coast Guard response to the Native Village
of Eyak letter dated July 29, 2002, states ``I have received and
reviewed your letter concerning the recertification of the Regional
Citizens' Advisory Council (RCAC) for Prince William Sound (PWS). The
Coast Guard greatly values the important role the Native Village of
Eyak Traditional Council (NVETC) plays in the PWS community. Thank you
for your input and for this opportunity to consult with you about the
PWS RCAC and The Oil Pollution Act of 1990 (OPA 90).''
The history, background, and legal character of the PWS RCAC, along
with its funding and responsibilities are unique and worthy of more
discussion. The PWS RCAC is an independent, non-profit organization
founded in 1989. Though it received Federal oversight like many
independent, non-profit organizations, it is not a Federal agency. The
PWS RCAC is a local organization that predates the passage of OPA 90.
The existence of the PWS RCAC was specifically recognized in OPA 90
where it is defined as an ``alternate voluntary advisory group.''
The Alyeska Pipeline Service Company pays the PWS RCAC $2 million
annually in the form of a long-term contract. In return for this
funding, the PWS RCAC must annually show that it ``fosters the goals
and purposes'' of OPA 90 and is ``broadly representative of the
communities and interests in the vicinity of the terminal facilities
and Prince William Sound.'' In March 1991, then-President Bush
initially certified the PWS RCRC as meeting these broad goals. That
certification responsibility was delegated to the Coast Guard in 1991,
and for the last ten years the Coast Guard has unconditionally
recertified the PWS RCAC annually.
Alyeska funds the PWS RCAC, and the Coast Guard makes sure the PWS
RCRC operates in a fashion that is broadly consistent with OPA 90. For
example, the PWS RCAC's responsibilities under OPA 90 are limited to
monitoring crude oil terminal and tanker operation in PWS. As such, the
PWS RCAC had no role in the response to the F/V WINDY BAY oil spill,
which was a diesel fuel oil spill. In such cases, however, the PWS RCAC
can and does offer advice based on it local knowledge and in fact
facilitated our close cooperation in response to that spill.
In your letter, you made three specific requests. The first was the
``the PWS RCAC be decertified on the basis of not broadly representing
interests and communities in the area.'' I have the authority to grant
that request, but cannot grant it. I find that the PWS RCAC does
broadly represent the PWS community. The PWS RCAC board includes a
broad spectrum of the native and non-native community, the fishing and
oil industry, and environmental and recreational organizations as
prescribed by OPA 90. Last year after you made similar critical
recertification comment, the PWS RCAC invited the NVETC to seek a seat
on the board of the RCAC. You decided not to act on that offer. I
cannot find your decision not to join the PWS RCAC to be basis for
decertification.
Your second request was the ``a new group following strict letter
of the law in OPA 90 be formed.'' Unfortunately, I have neither the
authority to grant this request nor the expertise to help you achieve
it on your own. The Coast Guard did not create the PWS RCAC and cannot
act to create a competing alternative.
Your third request was that ``a Tribal oversight group with equal
status to the U.S. government and State of Alaska be created.'' Again I
have neither the authority nor the expertise to create such an
organization. I do encourage you to reconsider your decision not to
seek a seat on the PWS RCAC. Though the PWS RCAC is an independent,
non-federal, non-profit organization over which I have limited
influence, I would ask the PWS RCAC seriously consider a renewed
request by you for a seat on the board.
In your letter, you suggested the formation of a Tribal Council of
the Native Tribes and Villages in PWS that would exist in addition to
PWS RCAC. I appreciate that such a network would facilitate the
discussion of mutual issues and concerns. Though the Coast Guard is not
empowered to sponsor such an enterprise, I would welcome the
information and advice such a group could offer. You may wish to
approach the PWS RCAC about such a tribal group.
I would also like to assure you that the Coast Guard recognizes its
government-to-government consultative relationship with the Native
Village of Eyak. I am grateful for this opportunity to consult with
you. I hope to continue to work you on emergent cases like the F/V
WINDY BAY case and on any other matters of mutual concern.''
NVE has voiced no new opposition for 2005. The USCG, standing by
its direct responses above, likewise offers no new response to NVE's
running opposition.
Recertification: By letter dated March 2, 2005, the Commander,
Seventeenth Coast Guard certified that the PWSRCAC qualifies as an
alternative voluntary advisory group under 33 U.S.C. 2732(o). This
recertification terminates on February 28, 2006.
Dated: March 4, 2005.
James C. Olson,
Rear Admiral, U.S. Coast Guard, Commander, Seventeenth Coast Guard
District.
[FR Doc. 05-9301 Filed 5-9-05; 8:45 am]
BILLING CODE 4910-15-P