Approval of Expansion of Subzone 61T; Plaza Warehousing & Realty Corporation; Caguas, Puerto Rico, 64443-64444 [2020-22541]
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Federal Register / Vol. 85, No. 198 / Tuesday, October 13, 2020 / Notices
various government agencies, as well as
to serve as a benchmark for the
estimates compiled from the Monthly
Retail Trade Report. Results will be
made available, at the United States
summary level, for selected retail trade
industries approximately fourteen
months after the end of the reference
year. ARTS estimates are publicly
released based on the North American
Industry Classification System (NAICS),
which has been widely adopted
throughout both the public and private
sectors.
As requested by the Bureau of
Economic Analysis (BEA), every five
years, in survey years ending in ‘‘2’’ and
‘‘7’’, ARTS requests data on detailed
operating expenses from firms. The last
time ARTS collected detailed operating
expenses was in 2018 for the 2017
survey year. The plan is to reinstate
some of these questions in 2023 as part
of the 2022 survey year ARTS data
collection. For survey year 2020
(collected in 2021), the ARTS will also
include improved language and
ordering of the questions on the value
of inventories and inventory valuation
method to ensure a better understanding
and response to the questions from
respondents. Effective with survey year
2020 and consistent with the agency’s
goal of harmonizing content across all
annual surveys as recommended by the
National Academy of Sciences, ARTS
will no longer collect accounts
receivable data. Survey year 2019
estimates (to be released in February
2021) will be the final year that
accounts receivable data are available to
the public.
The Census Bureau published a presubmission notice in the Federal
Register on Monday, July 6, 2020 (Vol.
85, No. 129). The notice, which was
located on pages 40199 and 40200,
proposed additional questions on the
ARTS related to the impact of the
coronavirus pandemic on firms for
survey year 2020. After internal
discussions, the Census Bureau decided
it will not include additional questions
on this survey related to the impact that
the coronavirus pandemic had on firms.
This request is for the clearance of
two electronic worksheets, the SA–44D
and SA–44T. From survey year 2016
through survey year 2019, there were
eight electronic form types (SA–44, SA–
44A, SA–44C, SA–44D, SA–44E, SA–
44N SA–44S and SA–44T). Starting
with survey year 2020 (which will be
collected in 2021), there will only be the
two electronic form types named above.
Forms SA–44, SA–44A, SA–44C, SA–
44E, SA–44N and SA–44S, are being
combined with the remaining forms to
reduce respondent burden by
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streamlining data collection operations
on the number of forms received by a
company. The two remaining
worksheets will collect data from
companies with and without
merchandise lines, enable us to collect
information on a NAICS basis, and to
request similar data items. Variations in
the electronic worksheets are needed to
address the size of the firm, kind-ofbusiness, or data items requested.
The Bureau of Economic Analysis
(BEA) uses the data to estimate the
change in the private inventories
component of gross domestic product
(GDP) and output in both the
benchmark and annual input-output (I–
O) accounts and GDP by industry. Data
on sales taxes are also used to prepare
estimates of GDP by industry and to
derive industry output for the I–O
accounts. Data on detailed operating
expenses are collected on this survey
quinquennially and used to produce
national estimates of value added, gross
output, and intermediate inputs, and
serve as a benchmark for the annual
industry accounts, which provide the
control totals for the GDP-by-state
accounts.
The Bureau of Labor Statistics uses
the data as input to its Producer Price
Indexes and in developing productivity
measurements. Private businesses use
the estimates in computing business
activity indexes.
Other government agencies and
businesses use the data to satisfy a
variety of public and business needs
such as economic market analysis,
company performance, and forecasting
future demands.
Affected Public: Business or other forprofit organizations.
Frequency: Annually.
Respondent’s Obligation: Mandatory.
Legal Authority: Title 13, United
States Code, Sections 131 and 182.
This information collection request
may be viewed at www.reginfo.gov.
Follow the instructions to view the
Department of Commerce collections
currently under review by OMB.
Written comments and
recommendations for the proposed
information collection should be
submitted within 30 days of the
publication of this notice on the
following website www.reginfo.gov/
public/do/PRAMain. Find this
particular information collection by
selecting ‘‘Currently under 30-day
Review—Open for Public Comments’’ or
by using the search function and
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64443
entering either the title of the collection
or the OMB Control Number 0607–0013.
Sheleen Dumas,
Department PRA Clearance Officer, Office of
the Chief Information Officer, Commerce
Department.
[FR Doc. 2020–22641 Filed 10–9–20; 8:45 am]
BILLING CODE 3510–07–P
DEPARTMENT OF COMMERCE
Foreign-Trade Zones Board
[Order No. 2106]
Approval of Expansion of Subzone
61T; Plaza Warehousing & Realty
Corporation; Caguas, Puerto Rico
Pursuant to its authority under the ForeignTrade Zones Act of June 18, 1934, as
amended (19 U.S.C. 81a–81u), the ForeignTrade Zones Board (the Board) adopts the
following Order:
Whereas, the Foreign-Trade Zones
(FTZ) Act provides for ‘‘. . . the
establishment . . . of foreign-trade
zones in ports of entry of the United
States, to expedite and encourage
foreign commerce, and for other
purposes,’’ and authorizes the ForeignTrade Zones Board to grant to qualified
corporations the privilege of
establishing foreign-trade zones in or
adjacent to U.S. Customs and Border
Protection ports of entry;
Whereas, the Board’s regulations (15
CFR part 400) provide for the
establishment of subzones for specific
uses;
Whereas, the Department of Economic
Development and Commerce, grantee of
Foreign-Trade Zone 61, has made
application to the Board to expand
Subzone 61T on behalf of Plaza
Warehousing & Realty Corporation to
include additional acreage in Caguas,
Puerto Rico (FTZ Docket B–46–2020,
docketed July 20, 2020);
Whereas, notice inviting public
comment has been given in the Federal
Register (85 FR 45373, July 28, 2020)
and the application has been processed
pursuant to the FTZ Act and the Board’s
regulations; and,
Whereas, the Board adopts the
findings and recommendations of the
examiner’s memorandum, and finds that
the requirements of the FTZ Act and the
Board’s regulations are satisfied;
Now, therefore, the Board hereby
approves the expansion of Subzone 61T
at the facility of Plaza Warehousing &
Realty Corporation, located in Caguas,
Puerto Rico, as described in the
application and Federal Register notice,
subject to the FTZ Act and the Board’s
regulations, including Section 400.13.
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Federal Register / Vol. 85, No. 198 / Tuesday, October 13, 2020 / Notices
Dated: October 6, 2020.
Jeffrey I. Kessler,
Assistant Secretary for Enforcement and
Compliance, Alternate Chairman, ForeignTrade Zones Board.
[FR Doc. 2020–22541 Filed 10–9–20; 8:45 am]
BILLING CODE 3510–DS–P
DEPARTMENT OF COMMERCE
National Institute of Standards and
Technology
Flow Cytometry Standards Consortium
National Institute of Standards
and Technology, Department of
Commerce.
ACTION: Notice of research consortium.
AGENCY:
The National Institute of
Standards and Technology (NIST), an
agency of the United States Department
of Commerce, in support of efforts to
develop standards for regenerative
medicine and advanced therapies, is
establishing the Flow Cytometry
Standards Consortium (‘‘Consortium’’).
The Consortium will bring together
stakeholders to identify and address
measurement and standards needs
related to flow cytometry used in the
characterization and testing of cell and
gene therapies. The Consortium efforts
are intended to develop measurement
solutions and standards to improve
measurement confidence, establish
measurement traceability, and enable
comparability in flow cytometry
measurements. Participation fees will be
at least $25,000 annually or in-kind
contributions of equivalent value.
Participants will be required to sign a
Cooperative Research and Development
Agreement (CRADA).
DATES: The Consortium’s activities will
commence on December 1, 2020
(‘‘Commencement Date’’). NIST will
accept letters of interest to participate in
this Consortium on an ongoing basis.
ADDRESSES: Completed letters of interest
or requests for additional information
about the Consortium can be directed
via mail to the Consortium Manager, Dr.
Lili Wang, Biosystems and Biomaterials
Division of NIST’s Material
Measurement Laboratory, 100 Bureau
Drive, Mail Stop 8312, Gaithersburg,
Maryland 20899, or via electronic mail
to flowcytometry@nist.gov, or by
telephone at (301) 975–2447.
FOR FURTHER INFORMATION CONTACT:
J’aime Maynard, CRADA Administrator,
National Institute of Standards and
Technology’s Technology Partnerships
Office, by mail to 100 Bureau Drive,
Mail Stop 2200, Gaithersburg, Maryland
20899, by electronic mail to
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SUMMARY:
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Jaime.maynard@nist.gov, or by
telephone at (301) 975–8408.
SUPPLEMENTARY INFORMATION: Advances
in cell and gene-based therapeutics as
well as other regenerative medicine
products have increased the need for
high quality, robust, and validated
measurements for cell characterization.
Flow cytometry, including imaging
cytometry, has emerged as an important
platform due to its ability to rapidly and
simultaneously characterize
heterogeneous cell populations and
subcellular analytes. For example, flow
cytometry has been critical for
establishing identity, purity, and
potency for Chimeric Antigen Receptor
(CAR)-T cell manufacturing; and
associated data to support the approval
of Biological License Applications
(BLA) by the U.S. Food and Drug
Administration (FDA) and the approval
by the European Medicines Agency
(EMA). In addition, multiparameter flow
cytometric measurements are routinely
carried out in vaccine, drug and cancer
research, clinical diagnosis, and
immunotherapies. However, challenges
remain with respect to measurement
confidence and comparability of
measurement results from different
instrument platforms, locations, and
over time, hindering critical decisionmaking based on flow cytometry data in
research and clinical settings.
NIST has extensively engaged with
stakeholders to identify measurement
needs. These include hosting joint
workshops with the U.S. FDA and with
the International Society for
Advancement of Cytometry (ISAC) that
brought together experts and
stakeholders from industry, academia
and government to discuss unique
challenges for cell and gene therapy.
The workshops identified three
common, pre-competitive measurement
needs: (1) High-quality reference
materials, (2) confidence in the
procedures from standardization/interlaboratory studies, and (3) uncertainty
associated with specimen quality and/or
pre-analytical processes.
This Consortium aims to develop
measurement solutions and standards
for flow cytometry, including improving
measurement confidence by establishing
traceability and assisting measurement
comparability. Measurement
applications to be addressed may
include the use of flow cytometry for
the characterization and testing for cell
identity, purity, count, activity, potency,
and biomarker expression. The working
cell types will be determined based on
the collective input of the Consortium
members and can start with common
immunotherapy cell types, e.g., T cells,
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iPSCs, and NK cells. To fulfill the
objectives of the Consortium, associated
critical reagents, such as antibodies,
plasmids, and viral vectors pertaining to
the development of the high-quality
measurements and reference materials,
will be characterized using orthogonal
measurement capabilities, e.g., ddPCR,
qPCR, NGS, Flow-FISH, nanoflow
cytometry, and mass spectrometry, most
of which are available at NIST as a part
of the NIST Advanced Therapy
Program. NIST may also leverage
current capabilities such as the state-ofthe-art flow cytometry and automation
capabilities and expertise, ERF
measurement service, blood cell
characterization, cell counting expertise,
as well as existing collaborations with
calibration bead and cytometer
manufacturers, international
metrological institutions, and Standards
Development Organizations (SDOs)
such as CLSI to advance the goals of this
Consortium.
The Consortium is expected to form
several Working Groups to continuously
identify and address needs and gaps in
quantitative cytometry through
workshops, public meetings, and other
collaborative efforts. The scope of
Working Groups can include:
(1) Equivalent Number of Reference
Fluorophores (ERF) Measurement
Service:
a. Develop reference standards
including reference materials, reference
data, reference methods, and
measurement service for assigning the
ERF to calibration microspheres and
assessing the associated uncertainties
and utilities. This is the first step
towards reliable quantitative
measurements in flow cytometry.
(2) Reference Material Selection and
Design:
a. Develop candidate reference
standards including biological reference
materials, reference data, reference
methods;
b. Evaluate common reagents and
control materials including various
types of compensation controls;
c. Design and carry out interlaboratory
testing to characterize and evaluate the
reference materials using multiple
methods, including orthogonal methods.
(3) Assay and Protocol Selection and
Design:
a. Establish an inventory of existing
protocols, shared data, existing
standards;
b. Generate standard operating
procedures/methods for cross platform
assay standardization and data analysis;
c. Test the robustness of assays and
associated uncertainties.
No proprietary information will be
shared as part of the Consortium.
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Agencies
[Federal Register Volume 85, Number 198 (Tuesday, October 13, 2020)]
[Notices]
[Pages 64443-64444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22541]
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DEPARTMENT OF COMMERCE
Foreign-Trade Zones Board
[Order No. 2106]
Approval of Expansion of Subzone 61T; Plaza Warehousing & Realty
Corporation; Caguas, Puerto Rico
Pursuant to its authority under the Foreign-Trade Zones Act of
June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade
Zones Board (the Board) adopts the following Order:
Whereas, the Foreign-Trade Zones (FTZ) Act provides for ``. . . the
establishment . . . of foreign-trade zones in ports of entry of the
United States, to expedite and encourage foreign commerce, and for
other purposes,'' and authorizes the Foreign-Trade Zones Board to grant
to qualified corporations the privilege of establishing foreign-trade
zones in or adjacent to U.S. Customs and Border Protection ports of
entry;
Whereas, the Board's regulations (15 CFR part 400) provide for the
establishment of subzones for specific uses;
Whereas, the Department of Economic Development and Commerce,
grantee of Foreign-Trade Zone 61, has made application to the Board to
expand Subzone 61T on behalf of Plaza Warehousing & Realty Corporation
to include additional acreage in Caguas, Puerto Rico (FTZ Docket B-46-
2020, docketed July 20, 2020);
Whereas, notice inviting public comment has been given in the
Federal Register (85 FR 45373, July 28, 2020) and the application has
been processed pursuant to the FTZ Act and the Board's regulations;
and,
Whereas, the Board adopts the findings and recommendations of the
examiner's memorandum, and finds that the requirements of the FTZ Act
and the Board's regulations are satisfied;
Now, therefore, the Board hereby approves the expansion of Subzone
61T at the facility of Plaza Warehousing & Realty Corporation, located
in Caguas, Puerto Rico, as described in the application and Federal
Register notice, subject to the FTZ Act and the Board's regulations,
including Section 400.13.
[[Page 64444]]
Dated: October 6, 2020.
Jeffrey I. Kessler,
Assistant Secretary for Enforcement and Compliance, Alternate Chairman,
Foreign-Trade Zones Board.
[FR Doc. 2020-22541 Filed 10-9-20; 8:45 am]
BILLING CODE 3510-DS-P