Notice of Intent To Prepare an Environmental Impact Statement and Notice of Scoping Meeting, 56088-56089 [2018-24557]
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Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices
khammond on DSK30JT082PROD with NOTICES
2018 (Docket No. FDA–2018–P–2506),
under 21 CFR 10.25 and 21 CFR 10.30,
requesting that the Agency determine
whether AXIRON (testosterone)
transdermal metered solution, 30 mg/1.5
mL actuation, was withdrawn from sale
for reasons of safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that AXIRON (testosterone)
transdermal metered solution, 30 mg/1.5
mL actuation, was not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that AXIRON
(testosterone) transdermal metered
solution, 30 mg/1.5 mL actuation, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of AXIRON
(testosterone) transdermal metered
solution, 30 mg/1.5 mL actuation, from
sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have found no information
that would indicate that this drug
product was withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list AXIRON (testosterone)
transdermal metered solution, 30 mg/1.5
mL actuation, in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness. FDA
will not begin procedures to withdraw
approval of approved ANDAs that refer
to this drug product. Additional ANDAs
that refer to this drug product may also
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they meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for this drug product should be revised
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: November 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24604 Filed 11–8–18; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice of Intent To Prepare an
Environmental Impact Statement and
Notice of Scoping Meeting
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In accordance with the
National Environmental Policy Act, the
National Institutes of Health (NIH) is
issuing this notice to advise the public
that an environmental impact statement
will be prepared for the Surgery,
Radiology and Lab Medicine Building
with associated Utility Vault and Patient
Parking Garage project located on the
National Institutes of Health, Bethesda
Campus, Bethesda, Maryland.
DATES: The Scoping Meeting is planned
for November 28, 2018, from 6 p.m.-9
p.m., with the formal presentation to
begin at 7 p.m. Scoping comments must
be postmarked no later than December
29, 2018, to ensure they are considered.
ADDRESSES: The Scoping Meeting will
be held at 6001 Executive Boulevard,
Rockville, MD 20852. All comments and
questions on the Scoping Meeting and
the Environmental Impact Statement
should be directed to Valerie
Nottingham, Deputy Director, Division
of Environmental Protection, Office of
Research Facilities, NIH, B13/2S11,
9000 Rockville Pike, Bethesda,
Maryland 20892, telephone 301–496–
7775; fax 301–480–0204; or email:
nihnepa@mail.nih.gov.
FOR FURTHER INFORMATION CONTACT:
Valerie Nottingham, Deputy Director,
Division of Environmental Protection,
Office of Research Facilities, NIH, B13/
2S11, 9000 Rockville Pike, Bethesda,
Maryland 20892, telephone 301–496–
7775; fax 301–480–0204; or email:
nihnepa@mail.nih.gov. For the purpose
of National Institutes of Health (NIH)
and its National Environmental Policy
Act (NEPA) procedures, the delegation
of authority to administer, interpret and
oversee the applicable environmental
laws, Executive Orders and regulations
for the NIH including the authority to
oversee and manage the NIH NEPA
program for assessing environmental
impacts and publish final decisions has
been given to the Director, Office of
Research Facilities Development and
Operation, Mr. Daniel G. Wheeland.
SUPPLEMENTARY INFORMATION: The NIH’s
mission is to seek fundamental
knowledge about the nature and
behavior of living systems and the
application of that knowledge to
SUMMARY:
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enhance health, lengthen life, and
reduce illness and disability. In order to
fulfill and uphold this mission the
infrastructure of the NIH Bethesda
Campus must be able to support the
NIH’s biomedical research programs.
The proposed Surgery, Radiology and
Lab Medicine Building with associated
Utility Vault and Patient Parking Garage
project is to house General Radiology
and Imaging Services (RADIS), the
Department of Perioperative Medicine
(DPM), the Department of Laboratory
Medicine (DLM) and the relocated
functions for the National Cancer
Institute (NCI) in a state-of-the-art, safe,
functionally efficient, flexible and costeffective facility. During the study
period, NIH expanded the building
program to also include space for the
National Heart, Lung & Blood Institute’s
(NHLBI) Cardiovascular Intervention
Program (Cath Lab) and for the
Interventional Radiology (IR) Program.
The proposed project consists of nine
(9) levels above grade (including
interstitial floors and a roof penthouse)
and two (2) levels below grade. The
proposed 505,200 building gross square
feet (BGSF) of new construction will be
linked to the west lab wing of the
existing CRC (Building 10), which will
include an additional 82,960 BGSF of
interior renovation. The proposed new
building addition foot print of 53,270
BGSF will be positioned between the
CRC and Convent Drive.
The proposed project scope also
includes the relocation of a portion of
the existing campus utility tunnel,
reconstruction of the displaced
children’s playground and connection
to the new Pedestrian Tunnel that will
be constructed with the proposed
Patient Parking Garage across Convent
Drive. Additionally, the project will
include the installation of supporting
infrastructure, such as emergency
generators and medical gas storage, in
the new Utility Vault and Utility Yard
that will be constructed across Convent
Drive as part of a separate, enabling
project.
In accordance with 40 CFR 1500–1508
and Health and Human Services (HHS)
environmental procedures, NIH will
prepare an Environmental Impact
Statement (EIS) for the proposed project.
The EIS will evaluate the impacts of the
alternatives should development occur
as proposed. Among the items the EIS
will examine are the implications of the
project on community infrastructure,
including, but not limited to, utilities,
storm water management, traffic and
transportation, and other public
services.
To ensure that the public is afforded
the greatest opportunity to participate in
E:\FR\FM\09NON1.SGM
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Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices
the planning and environmental review
process, NIH is inviting oral and written
comments on the proposed project and
related environmental issues.
The NIH will be sponsoring a public
Scoping Meeting to provide individuals
an opportunity to share their ideas,
including recommended alternatives
and environmental issues the EIS
should consider. All interested parties
are encouraged to attend. NIH has
established a 30-day public comment
period for the scoping process.
Dated: October 29, 2018.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2018–24557 Filed 11–8–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[1651–0096]
Agency Information Collection
Activities: Transfer of Cargo to a
Container Station
U.S. Customs and Border
Protection (CBP), Department of
Homeland Security.
ACTION: 30-Day notice and request for
comments; Extension of an existing
collection of information.
AGENCY:
The Department of Homeland
Security, U.S. Customs and Border
Protection will be submitting the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995 (PRA). The
information collection is published in
the Federal Register to obtain comments
from the public and affected agencies.
Comments are encouraged and will be
accepted (no later than December 10,
2018) to be assured of consideration.
ADDRESSES: Interested persons are
invited to submit written comments on
this proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to the OMB Desk Officer for Customs
and Border Protection, Department of
Homeland Security, and sent via
electronic mail to dhsdeskofficer@
omb.eop.gov.
khammond on DSK30JT082PROD with NOTICES
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Requests for additional PRA information
should be directed to Seth Renkema,
Chief, Economic Impact Analysis
Branch, U.S. Customs and Border
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Jkt 247001
Protection, Office of Trade, Regulations
and Rulings, 90 K Street NE, 10th Floor,
Washington, DC 20229–1177,
Telephone number (202) 325–0056 or
via email CBP_PRA@cbp.dhs.gov. Please
note that the contact information
provided here is solely for questions
regarding this notice. Individuals
seeking information about other CBP
programs should contact the CBP
National Customer Service Center at
877–227–5511, (TTY) 1–800–877–8339,
or CBP website at https://
www.cbp.gov/.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and other
Federal agencies to comment on the
proposed and/or continuing information
collections pursuant to the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.). This proposed information
collection was previously published in
the Federal Register (Volume 83 FR
Page 33233) on July 17, 2018, allowing
for a 60-day comment period. This
notice allows for an additional 30 days
for public comments. This process is
conducted in accordance with 5 CFR
1320.8. Written comments and
suggestions from the public and affected
agencies should address one or more of
the following four points: (1) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information will have
practical utility; (2) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
suggestions to enhance the quality,
utility, and clarity of the information to
be collected; and (4) suggestions to
minimize the burden of the collection of
information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology, e.g., permitting
electronic submission of responses. The
comments that are submitted will be
summarized and included in the request
for approval. All comments will become
a matter of public record.
Overview of This Information
Collection
Title: Transfer of Cargo to a Container
Station.
OMB Number: 1651–0096.
Current Actions: CBP proposes to
extend the expiration date of this
information collection with no change
to the burden hours or to the
information collected.
Type of Review: Extension (without
change).
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56089
Affected Public: Businesses.
Abstract: Before the filing of an entry
of merchandise for the purpose of
breaking bulk and redelivering cargo,
containerized cargo may be moved from
the place of unlading to a designated
container station or may be received
directly at the container station from a
bonded carrier after transportation inbond in accordance with 19 CFR 19.41.
This also applies to loose cargo as part
of containerized cargo. In accordance
with 19 CFR 19.42, the container station
operator may make a request for the
transfer of a container to the station by
submitting to CBP an abstract of the
manifest for the transferred containers
including the bill of lading number,
marks, numbers, description of the
contents and consignee.
Estimated Number of Respondents:
14,327.
Estimated Number of Annual
Responses per Respondent: 25.
Estimated Total Annual Responses:
358,175.
Estimated Time per Response: 7
minutes.
Estimated Total Annual Burden
Hours: 41,548.
Dated: November 6, 2018.
Seth D. Renkema,
Branch Chief, Economic Impact Analysis
Branch, U.S. Customs and Border Protection.
[FR Doc. 2018–24595 Filed 11–8–18; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Office of the Secretary
[Docket No. DHS–2018–0066]
DHS Data Privacy and Integrity
Advisory Committee
Privacy Office, Department of
Homeland Security (DHS).
ACTION: Committee Management; notice
of Federal Advisory Committee meeting.
AGENCY:
The DHS Data Privacy and
Integrity Advisory Committee will meet
on Monday, December 10, 2018, in
Washington, DC The meeting will be
open to the public.
DATES: The DHS Data Privacy and
Integrity Advisory Committee will meet
on Monday, December 10, 2018, from
1:00 p.m. to 4:00 p.m. Please note that
the meeting may end early if the
Committee has completed its business.
ADDRESSES: The meeting will be held
both in person in Washington, DC at 90
K Street NE, 12th Floor, Room 1204,
Washington, DC 20002, and via online
forum (URL will be posted on the
SUMMARY:
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]]>Agencies
[Federal Register Volume 83, Number 218 (Friday, November 9, 2018)]
[Notices]
[Pages 56088-56089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24557]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Notice of Intent To Prepare an Environmental Impact Statement and
Notice of Scoping Meeting
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with the National Environmental Policy Act, the
National Institutes of Health (NIH) is issuing this notice to advise
the public that an environmental impact statement will be prepared for
the Surgery, Radiology and Lab Medicine Building with associated
Utility Vault and Patient Parking Garage project located on the
National Institutes of Health, Bethesda Campus, Bethesda, Maryland.
DATES: The Scoping Meeting is planned for November 28, 2018, from 6
p.m.-9 p.m., with the formal presentation to begin at 7 p.m. Scoping
comments must be postmarked no later than December 29, 2018, to ensure
they are considered.
ADDRESSES: The Scoping Meeting will be held at 6001 Executive
Boulevard, Rockville, MD 20852. All comments and questions on the
Scoping Meeting and the Environmental Impact Statement should be
directed to Valerie Nottingham, Deputy Director, Division of
Environmental Protection, Office of Research Facilities, NIH, B13/2S11,
9000 Rockville Pike, Bethesda, Maryland 20892, telephone 301-496-7775;
fax 301-480-0204; or email: [email protected].
FOR FURTHER INFORMATION CONTACT: Valerie Nottingham, Deputy Director,
Division of Environmental Protection, Office of Research Facilities,
NIH, B13/2S11, 9000 Rockville Pike, Bethesda, Maryland 20892, telephone
301-496-7775; fax 301-480-0204; or email: [email protected]. For the
purpose of National Institutes of Health (NIH) and its National
Environmental Policy Act (NEPA) procedures, the delegation of authority
to administer, interpret and oversee the applicable environmental laws,
Executive Orders and regulations for the NIH including the authority to
oversee and manage the NIH NEPA program for assessing environmental
impacts and publish final decisions has been given to the Director,
Office of Research Facilities Development and Operation, Mr. Daniel G.
Wheeland.
SUPPLEMENTARY INFORMATION: The NIH's mission is to seek fundamental
knowledge about the nature and behavior of living systems and the
application of that knowledge to enhance health, lengthen life, and
reduce illness and disability. In order to fulfill and uphold this
mission the infrastructure of the NIH Bethesda Campus must be able to
support the NIH's biomedical research programs.
The proposed Surgery, Radiology and Lab Medicine Building with
associated Utility Vault and Patient Parking Garage project is to house
General Radiology and Imaging Services (RADIS), the Department of
Perioperative Medicine (DPM), the Department of Laboratory Medicine
(DLM) and the relocated functions for the National Cancer Institute
(NCI) in a state-of-the-art, safe, functionally efficient, flexible and
cost-effective facility. During the study period, NIH expanded the
building program to also include space for the National Heart, Lung &
Blood Institute's (NHLBI) Cardiovascular Intervention Program (Cath
Lab) and for the Interventional Radiology (IR) Program.
The proposed project consists of nine (9) levels above grade
(including interstitial floors and a roof penthouse) and two (2) levels
below grade. The proposed 505,200 building gross square feet (BGSF) of
new construction will be linked to the west lab wing of the existing
CRC (Building 10), which will include an additional 82,960 BGSF of
interior renovation. The proposed new building addition foot print of
53,270 BGSF will be positioned between the CRC and Convent Drive.
The proposed project scope also includes the relocation of a
portion of the existing campus utility tunnel, reconstruction of the
displaced children's playground and connection to the new Pedestrian
Tunnel that will be constructed with the proposed Patient Parking
Garage across Convent Drive. Additionally, the project will include the
installation of supporting infrastructure, such as emergency generators
and medical gas storage, in the new Utility Vault and Utility Yard that
will be constructed across Convent Drive as part of a separate,
enabling project.
In accordance with 40 CFR 1500-1508 and Health and Human Services
(HHS) environmental procedures, NIH will prepare an Environmental
Impact Statement (EIS) for the proposed project. The EIS will evaluate
the impacts of the alternatives should development occur as proposed.
Among the items the EIS will examine are the implications of the
project on community infrastructure, including, but not limited to,
utilities, storm water management, traffic and transportation, and
other public services.
To ensure that the public is afforded the greatest opportunity to
participate in
[[Page 56089]]
the planning and environmental review process, NIH is inviting oral and
written comments on the proposed project and related environmental
issues.
The NIH will be sponsoring a public Scoping Meeting to provide
individuals an opportunity to share their ideas, including recommended
alternatives and environmental issues the EIS should consider. All
interested parties are encouraged to attend. NIH has established a 30-
day public comment period for the scoping process.
Dated: October 29, 2018.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2018-24557 Filed 11-8-18; 8:45 am]
BILLING CODE 4140-01-P
