Notice of Meeting; Advisory Council on Historic Preservation, 71135-71136 [2010-29355]
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Federal Register / Vol. 75, No. 224 / Monday, November 22, 2010 / Notices
Contact Person: Suzan Nadi, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217B,
MSC 7846, Bethesda, MD 20892, 301–435–
1259, nadis@csr.nih.gov.
Name of Committee: Bioengineering
Sciences & Technologies Integrated Review
Group; Biomaterials and Biointerfaces Study
Section.
Date: January 5–6, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Steven J Zullo, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5146,
MSC 7849, Bethesda, MD 20892, 301–435–
2810, zullost@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 16, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–29361 Filed 11–19–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0586]
Hoffmann-La Roche Inc.; Withdrawal of
Approval of a New Drug Application
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of a new drug application
(NDA) for ACCUTANE (isotretinoin)
Capsules held by Hoffmann-La Roche
Inc., 340 Kingsland St., Nutley, NJ
07110–1199. Hoffmann-La Roche Inc.
notified the Agency in writing that the
drug product was no longer marketed
and requested that the approval of the
application be withdrawn.
DATES: Effective Date: November 22,
2010.
jlentini on DSKJ8SOYB1PROD with NOTICES
SUMMARY:
HoffmannLa Roche Inc. has requested that FDA
withdraw approval of NDA 18–662,
ACCUTANE (isotretinoin) Capsules,
under the process in § 314.150(c) (21
CFR 314.150(c)), stating that the drug
product is no longer marketed.
Hoffmann-La Roche Inc. has also, by its
request, waived its opportunity for a
hearing. Withdrawal of approval of an
application under § 314.150(c) is
without prejudice to refiling.
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 355(e)) and
under authority delegated to the
Director, Center for Drug Evaluation and
Research, by the Commissioner of Food
and Drugs, approval of NDA 18–662,
ACCUTANE (isotretinoin) Capsules, and
all amendments and supplements
thereto, is hereby withdrawn, effective
November 22, 2010. Introduction or
delivery for introduction into interstate
commerce of a product without an
approved application violates sections
301(a) and (d) of the FD&C Act (21
U.S.C. 331(a) and (d)). ACCUTANE
(isotretinoin) Capsules that are in
inventory on the date that this notice
becomes effective (see the DATES
section) may continue to be dispensed
until the inventories have been depleted
or the drug product has reached its
expiration date or otherwise become
violative, whichever occurs first.
In the Federal Register of July 7, 2010
(75 FR 39024), FDA issued a notice
announcing its determination that
ACCUTANE (isotretinoin) Capsules
were not withdrawn from sale for
reasons of safety or effectiveness, and
isotretinoin continues to be marketed
under approved abbreviated new drug
applications (ANDAs). The holders of
ANDAs for isotretinoin are subject to an
approved risk evaluation and mitigation
strategy (REMS) under section 505–1 of
the FD&C Act (21 U.S.C. 355–1), and the
REMS, known as the iPLEDGE program,
remains in effect.
SUPPLEMENTARY INFORMATION:
Dated: November 2, 2010.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 2010–29348 Filed 11–19–10; 8:45 am]
BILLING CODE 4160–01–P
ADVISORY COUNCIL ON HISTORIC
PRESERVATION
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366,
Silver Spring, MD 20993–0002, 301–
796–3601.
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Notice of Meeting; Advisory Council on
Historic Preservation
Advisory Council on Historic
Preservation.
ACTION: Notice of meeting.
AGENCY:
PO 00000
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71135
Notice is hereby given that
the Advisory Council on Historic
Preservation (ACHP) will meet
Thursday, December 2, 2010. The
meeting will be held in Room MO9 of
the Old Post Office Building, 1100
Pennsylvania Ave, NW., Washington,
DC at 9 a.m.
The ACHP was established by the
National Historic Preservation Act of
1966 (16 U.S.C. 470 et seq.) to advise the
President and Congress on national
historic preservation policy and to
comment upon Federal, federally
assisted, and federally licensed
undertakings having an effect upon
properties listed in or eligible for
inclusion in the National Register of
Historic Places. The ACHP’s members
are the Architect of the Capitol; the
Secretaries of the Interior, Agriculture,
Defense, Housing and Urban
Development, Commerce, Education,
Veterans Affairs, and Transportation;
the Administrator of the General
Services Administration; the Chairman
of the National Trust for Historic
Preservation; the President of the
National Conference of State Historic
Preservation Officers; a Governor; a
Mayor; a Native American; and eight
non-Federal members appointed by the
President.
SUMMARY:
Call to Order—9 a.m.
I. Chairman’s Welcome
II. Chairman’s Report
III. Executive Director’s Report
IV. Native American Activities
A. Native American Program Report
1. HUD Delegation of Tribal
Consultation Responsibilities
2. DOI–DoD–ACHP Memorandum of
Understanding on Consultation
with Native Hawaiians
B. Native American Advisory Group
V. Strategic Planning: Next Steps
VI. Sustainability and Historic
Preservation Task Force
VII. Preservation Initiatives Committee
A. America’s Great Outdoors Initiative
and Historic Preservation
B. Economic Benefits Study
C. Legislation
VIII. Federal Agency Programs
Committee
A. Historic Preservation and Energy
Development Working Group
B. National Trust Section 106 Report
C. Section 106 Update
IX. Communications, Education, and
Outreach Committee
A. Engaging Youth in Historic
Preservation
B. New Directions for ACHP Awards
Programs
X. New Business
XI. Adjourn
Note: The meetings of the ACHP are open
to the public.
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71136
Federal Register / Vol. 75, No. 224 / Monday, November 22, 2010 / Notices
If you need special accommodations
due to a disability, please contact the
Advisory Council on Historic
Preservation, 1100 Pennsylvania
Avenue, NW., Room 803, Washington,
DC, 202–606–8503, at least seven (7)
days prior to the meeting. For further
information: Additional information
concerning the meeting is available from
the Executive Director, Advisory
Council on Historic Preservation, 1100
Pennsylvania Avenue, NW., #803,
Washington, DC 20004.
Dated: November 16, 2010.
John M. Fowler,
Executive Director.
[FR Doc. 2010–29355 Filed 11–19–10; 8:45 am]
BILLING CODE 4310–K6–M
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID: FEMA–2010–0065]
Public Meetings of National Flood
Insurance Program (NFIP) Reform
Effort; Correction
Federal Emergency
Management Agency, DHS.
ACTION: Announcement of Public
Meetings; correction.
AGENCY:
The Federal Emergency
Management Agency (FEMA) published
a document in the Federal Register on
November 10, 2010 (75 FR 69096),
announcing two public meetings. The
document contained an incorrect e-mail
address. Due to the incorrect e-mail
address, FEMA is lengthening the
amount of time that the public has to
contact FEMA to request special
accommodations. FEMA has chosen to
republish the corrected notice in its
entirety. This notice announces two
public meetings of the National Flood
Insurance Program (NFIP) Reform Effort.
In performing its mission, FEMA
believes it is important to continually
update stakeholders on its programs and
answer any questions and listen to
comments from them on how its
programs can be more efficient and
effective at meeting the needs of the
public. To this end, FEMA has engaged
in a comprehensive reform effort to
address the concerns of the wide array
of stakeholders involved in the ongoing
debate about the NFIP. FEMA chose a
participatory policy analysis framework
to guide the NFIP Reform effort. Policy
analysis employs systematic inquiry and
evaluation to assess policy alternatives.
The participatory policy analysis
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SUMMARY:
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process allows public decisions to be
made in a structured, defensible, and
collaborative manner.
The effort is comprised of three
phases designed to engage the greatest
number of stakeholders and consider
the largest breadth of public policy
options. Phase I focused on the capture
and analysis of stakeholder concerns
and recommendations. During Phase II,
FEMA performed additional analysis of
existing data and identified a set of
evaluation criteria. In Phase III, a
portfolio of public policy alternatives is
being developed and will be analyzed
using the evaluation criteria. The
resulting recommendations will be
reported to FEMA leadership. The
purpose of the public meetings is to
describe, update, and explain straw man
policy alternatives and to answer
questions and listen to comments from
interested stakeholders. Additional
information on the straw man policy
alternatives has been made available
prior to the meeting via the NFIP
Reform website and has been posted to
Docket ID: FEMA–2010–0065.
In addition, through these public
meetings, FEMA will accept stakeholder
input of the policy evaluation process
through the use of a pair-wise
comparison method. The pair-wise tool
is also available via the NFIP Reform
Web site at https://www.fema.gov/
business/nfip/nfip_reform.shtm.
DATES: Meeting Date: The first public
meeting will be held on December 2,
2010, from 10 a.m. to 5 p.m. EST. This
meeting will be held in Washington, DC.
The second public meeting will be held
on December 9, 2010, from 10 a.m. to 5
p.m. MST. This meeting will be held in
Denver, CO.
Comment Date: Written comments
must be received by December 31, 2010.
ADDRESSES: All written comments must
be received by Friday, December 31,
2010. All submissions received must
include the Docket ID: FEMA–2010–
0065 and may be submitted by any one
of the following methods:
Federal Rulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments
on the Web site.
E-mail: FEMA–RULES@dhs.gov.
Include Docket ID: FEMA–2010–0065 in
the subject line of the message.
Facsimile: (703) 483–2999.
Mail: FEMA, Office of Chief Counsel,
500 C Street, SW., Room 840,
Washington, DC 20472–3100.
Hand Delivery/Courier: FEMA, Office
of Chief Counsel, 500 C Street, SW.,
Room 840, Washington, DC 20472–
3100.
Instructions: All submissions received
must include the Docket ID: FEMA–
PO 00000
Frm 00070
Fmt 4703
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2010–0065. Comments received will
also be posted without alteration at
https://www.regulations.gov, including
any personal information provided. You
may want to read the Privacy Act Notice
located on the Privacy and Use Notice
link on the Administration Navigation
Bar of the Web site https://
www.regulations.gov.
Docket: For access to the docket to
read documents or comments received
by FEMA, go to https://
www.regulations.gov. The straw man
policy alternatives have been posted to
Docket ID: FEMA–2010–0065.
Special Accomodations: For anyone
attending the meeting who is hearing or
visually impaired, or who requires
special assistance or accommodations,
please contact Jason ‘‘Tommy’’ Kennedy
by November 29, 2010. For further
information, please contact Mr.
Kennedy by telephone at 202–646–3779.
Meeting Locations: The first public
meeting will be held in Washington, DC,
at the Washington Marriott at Metro
Center, 775 12th Street NW.,
Washington, DC. The second public
meeting will be held in Denver,
Colorado at the Denver Federal Center,
Building 810—Entrance W–5, Denver,
CO.
Meeting Accessibility: Due to space
constraints of the facilities, seating will
be limited to 200 participants. To
reserve a seat in advance, please provide
a request via email or mail with the
contact information of the participant
(including name, mailing address, and
e-mail address), the meeting(s) to be
attended, and include the subject/
attention line (or on the envelope if by
mail): Reservation Request for NFIP
Reform Meeting. Advance reservations
must be received 3 business days prior
to the meeting to ensure processing.
Unregistered participants will be
accepted after all participants with
reservations have been accommodated
and will be admitted on a first-come,
first-serve basis, provided the 200
person capacity is not exceeded. To
submit reservations, please email:
FEMA–NFIP–REFORM@dhs.gov or send
by mail to the address listed in the FOR
FURTHER INFORMATION CONTACT caption.
Web site: https://www.fema.gov/
business/nfip/nfip_reform.shtm.
FOR FURTHER INFORMATION CONTACT:
Michael Grimm, by telephone at 202–
646–2878 or by e-mail at FEMA-NFIPREFORM@dhs.gov. Mailing Address:
NFIP Reform, 1800 South Bell Street,
Room 970, Arlington, VA 20598–3030.
Meeting Topics: Background
information about these topics is
available on the NFIP Reform website.
The straw man policy alternatives have
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Agencies
[Federal Register Volume 75, Number 224 (Monday, November 22, 2010)]
[Notices]
[Pages 71135-71136]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29355]
=======================================================================
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ADVISORY COUNCIL ON HISTORIC PRESERVATION
Notice of Meeting; Advisory Council on Historic Preservation
AGENCY: Advisory Council on Historic Preservation.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: Notice is hereby given that the Advisory Council on Historic
Preservation (ACHP) will meet Thursday, December 2, 2010. The meeting
will be held in Room MO9 of the Old Post Office Building, 1100
Pennsylvania Ave, NW., Washington, DC at 9 a.m.
The ACHP was established by the National Historic Preservation Act
of 1966 (16 U.S.C. 470 et seq.) to advise the President and Congress on
national historic preservation policy and to comment upon Federal,
federally assisted, and federally licensed undertakings having an
effect upon properties listed in or eligible for inclusion in the
National Register of Historic Places. The ACHP's members are the
Architect of the Capitol; the Secretaries of the Interior, Agriculture,
Defense, Housing and Urban Development, Commerce, Education, Veterans
Affairs, and Transportation; the Administrator of the General Services
Administration; the Chairman of the National Trust for Historic
Preservation; the President of the National Conference of State
Historic Preservation Officers; a Governor; a Mayor; a Native American;
and eight non-Federal members appointed by the President.
Call to Order--9 a.m.
I. Chairman's Welcome
II. Chairman's Report
III. Executive Director's Report
IV. Native American Activities
A. Native American Program Report
1. HUD Delegation of Tribal Consultation Responsibilities
2. DOI-DoD-ACHP Memorandum of Understanding on Consultation with
Native Hawaiians
B. Native American Advisory Group
V. Strategic Planning: Next Steps
VI. Sustainability and Historic Preservation Task Force
VII. Preservation Initiatives Committee
A. America's Great Outdoors Initiative and Historic Preservation
B. Economic Benefits Study
C. Legislation
VIII. Federal Agency Programs Committee
A. Historic Preservation and Energy Development Working Group
B. National Trust Section 106 Report
C. Section 106 Update
IX. Communications, Education, and Outreach Committee
A. Engaging Youth in Historic Preservation
B. New Directions for ACHP Awards Programs
X. New Business
XI. Adjourn
Note: The meetings of the ACHP are open to the public.
[[Page 71136]]
If you need special accommodations due to a disability, please
contact the Advisory Council on Historic Preservation, 1100
Pennsylvania Avenue, NW., Room 803, Washington, DC, 202-606-8503, at
least seven (7) days prior to the meeting. For further information:
Additional information concerning the meeting is available from the
Executive Director, Advisory Council on Historic Preservation, 1100
Pennsylvania Avenue, NW., 803, Washington, DC 20004.
Dated: November 16, 2010.
John M. Fowler,
Executive Director.
[FR Doc. 2010-29355 Filed 11-19-10; 8:45 am]
BILLING CODE 4310-K6-M