Notice of Buy America Waiver, 35118-35120 [2016-12834]
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35118
Federal Register / Vol. 81, No. 105 / Wednesday, June 1, 2016 / Notices
change that are filed with the
Commission, and all written
communications relating to the
proposed rule change between the
Commission and any person, other than
those that may be withheld from the
public in accordance with the
provisions of 5 U.S.C. 552, will be
available for Web site viewing and
printing in the Commission’s Public
Reference Room, 100 F Street NE.,
Washington, DC 20549, on official
business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the
filing also will be available for
inspection and copying at the principal
office of the Exchange. All comments
received will be posted without change;
the Commission does not edit personal
identifying information from
submissions. You should submit only
information that you wish to make
available publicly. All submissions
should refer to File No. SR–BatsBYX–
2016–09, and should be submitted on or
before June 22, 2016.
For the Commission, by the Division of
Trading and Markets, pursuant to delegated
authority.18
Brent J. Fields,
Secretary.
Regulatory Affairs, Office of
Management and Budget, New
Executive Office Building, Washington,
DC 20503.
FOR FURTHER INFORMATION CONTACT:
Curtis Rich, Agency Clearance Officer,
(202) 205–7030 curtis.rich@sba.gov.
Copies: A copy of the Form OMB 83–
1, supporting statement, and other
documents submitted to OMB for
review may be obtained from the
Agency Clearance Officer.
SUPPLEMENTARY INFORMATION: The Small
Business Regulatory Enforcement
Fairness Act of 1996, 15 U.S.C. Sec.
657(b)(2)(B), requires the SBA National
Ombudsman to establish a means for
SBA to receive comments on regulatory
and compliance actions from small
entities regarding their disagreements
with a Federal Agency action. The
Ombudsman uses it to obtain the
agency’s response, encourage a fresh
look by the agency at a high level, and
build a more small business-friendly
regulatory environment.
Solicitation of Public Comments:
Title: Federal Agency Comment Form.
Description of Respondents: Small
Entities.
Form Number: 1993.
Estimated Annual Responses: 340.
Estimated Annual Hour Burden: 263.
on a first-come basis. Members of the
public wishing to attend the meeting
will need to show photo identification
in order to gain access to the meeting
location.
FOR FURTHER INFORMATION CONTACT: The
BOV’s Designated Federal Officer or
Point of Contact Brian Blower; 202 366–
2765; Brian.Blower@dot.gov.
SUPPLEMENTARY INFORMATION: Any
member of the public is permitted to file
a written statement with the Academy
BOV. Written statements should be sent
to the Designated Federal Officer at:
Brian Blower; 1200 New Jersey Ave. SE.,
W28–313, Washington, DC 20590 or via
email at Brian.Blower@Dot.gov. (Please
contact the Designated Federal Officer
for information on submitting comments
via fax.) Written statements must be
received no later than three working
days prior to the next meeting in order
to provide time for member
consideration. By rule, no member of
the public attending open meetings will
be allowed to present questions from the
floor or speak to any issue under
consideration by the BOV.
Authority: 46 U.S.C. 51312; 5 U.S.C. app.
552b; 41 CFR 102–3.140 through 102–3.165.
Curtis B. Rich,
Management Analyst.
By Order of the Maritime Administrator.
Dated: May 26, 2016.
T. Mitchell Hudson, Jr.,
Secretary, Maritime Administration.
[FR Doc. 2016–12741 Filed 5–31–16; 8:45 am]
[FR Doc. 2016–12833 Filed 5–31–16; 8:45 am]
Reporting and Recordkeeping
Requirements Under OMB Review
BILLING CODE 8025–01–P
BILLING CODE 4910–81–P
Small Business Administration.
ACTION: 30-Day notice.
DEPARTMENT OF TRANSPORTATION
[FR Doc. 2016–12781 Filed 5–31–16; 8:45 am]
BILLING CODE 8011–01–P
SMALL BUSINESS ADMINISTRATION
AGENCY:
The Small Business
Administration (SBA) is publishing this
notice to comply with requirements of
the Paperwork Reduction Act (PRA) (44
U.S.C. Chapter 35), which requires
agencies to submit proposed reporting
and recordkeeping requirements to
OMB for review and approval, and to
publish a notice in the Federal Register
notifying the public that the agency has
made such a submission. This notice
also allows an additional 30 days for
public comments.
DATES: Submit comments on or before
July 1, 2016.
ADDRESSES: Comments should refer to
the information collection by name and/
or OMB Control Number and should be
sent to: Agency Clearance Officer, Curtis
Rich, Small Business Administration,
409 3rd Street SW., 5th Floor,
Washington, DC 20416; and SBA Desk
Officer, Office of Information and
Maritime Administration
National Highway Traffic Safety
Administration
U.S. Merchant Marine Academy Board
of Visitors Meeting
[Docket No. NHTSA–2016–0063]
sradovich on DSK3TPTVN1PROD with NOTICES
SUMMARY:
18 17
CFR 200.30–3(a)(12).
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DEPARTMENT OF TRANSPORTATION
Maritime Administration.
ACTION: Meeting notice.
AGENCY:
The U.S. Department of
Transportation, Maritime
Administration (MARAD) announces
that the following U.S. Merchant Marine
Academy (‘‘Academy’’) Board of
Visitors (BOV) meeting will take place:
1. Date: June 14, 2016.
2. Time: 2:00 p.m.
3. Location: Capital Visitors Center,
Washington, DC Room to be
determined.
4. Purpose of the Meeting: The
purpose of this meeting is to brief BOV
members on the Academy Advisory
Board’s annual report to the Secretary of
Transportation and the status of
reaccreditation.
5. Public Access to the Meeting: This
meeting is open to the public. Seating is
SUMMARY:
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Notice of Buy America Waiver
National Highway Traffic
Safety Administration (NHTSA),
Department of Transportation (DOT).
ACTION: Notice of Buy America Waiver.
AGENCY:
This notice provides
NHTSA’s finding with respect to a
request to waive the requirements of
Buy America from the New York
Governor’s Traffic Safety Committee
(GTSC). NHTSA finds that a nonavailability waiver of the Buy America
requirement is appropriate for New
York’s purchase of a liquid
chromatography-tandem mass
spectrometry instrument using Federal
highway traffic safety grant funds
because that product is not produced in
the United States.
DATES: The effective date of this waiver
is June 16, 2016. Written comments
SUMMARY:
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sradovich on DSK3TPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 105 / Wednesday, June 1, 2016 / Notices
regarding this notice may be submitted
to NHTSA and must be received on or
before: June 16, 2016.
ADDRESSES: Written comments may be
submitted using any one of the
following methods:
• Mail: Docket Management Facility,
M–30, U.S. Department of
Transportation, West Building, Ground
Floor, Rm. W12–140, 1200 New Jersey
Avenue SE., Washington, DC 20590.
• Fax: Written comments may be
faxed to (202) 493–2251.
• Internet: To submit comments
electronically, go to the Federal
regulations Web site at https://
www.regulations.gov. Follow the online
instructions for submitting comments.
• Hand Delivery: West Building
Ground Floor, Room W12–140, 1200
New Jersey Avenue, SE., between 9 a.m.
and 5 p.m. Eastern Time, Monday
through Friday, except Federal holidays.
Instructions: All comments submitted
in relation to this waiver must include
the agency name and docket number.
Please note that all comments received
will be posted without change to https://
www.regulations.gov, including any
personal information provided. You
may also call the Docket at 202–366–
9324.
FOR FURTHER INFORMATION CONTACT: For
program issues, contact Barbara Sauers,
Office of Regional Operations and
Program Delivery, NHTSA (phone: 202–
366–0144). For legal issues, contact
Andrew DiMarsico, Office of Chief
Counsel, NHTSA (phone: 202–366–
5263). You may send mail to these
officials at the National Highway Traffic
Safety Administration, 1200 New Jersey
Avenue SE., Washington, DC 20590.
SUPPLEMENTARY INFORMATION: This
notice provides NHTSA’s finding that a
waiver of the Buy America requirement,
23 U.S.C. 313, is appropriate for the
GTSC to purchase a liquid
chromatography-tandem mass
spectrometry device and its accessories
for approximately $400,000 using grant
funds authorized under 23 U.S.C.
405(d). Section 405(d) funds are
available for use by State highway safety
programs to support effective programs
to reduce driving under the influence of
alcohol, drugs, or the combination of
alcohol and drugs, including
enforcement efforts. 23 U.S.C. 405(d).
States may use Section 405(d) grant
funds to improve blood-alcohol
concentration testing and reporting and
developing impaired driving
information systems. Id.
Buy America provides that NHTSA
‘‘shall not obligate any funds authorized
to be appropriated to carry out the
Surface Transportation Assistance Act
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21:59 May 31, 2016
Jkt 238001
of 1982 (96 Stat. 2097) or [Title 23] and
administered by the Department of
Transportation, unless steel, iron, and
manufactured products used in such
project are produced in the United
States.’’ 23 U.S.C. 313. However,
NHTSA may waive those requirements
if NHTSA finds ‘‘(1) that their
application would be inconsistent with
the public interest; (2) that such
materials and products are not produced
in the United States in sufficient and
reasonably available quantities and of a
satisfactory quality; or (3) that the
inclusion of domestic material will
increase the cost of the overall project
contract by more than 25 percent.’’ 23
U.S.C. 313(b).
The New York GTSC seeks a waiver
to purchase a liquid chromatographytandem mass spectrometry device (LC/
MS/MS system) using Federal grant
funds to be used by the New York State
Police Forensic Investigation Center’s
Toxicology Section (FIC) to analyze
drugs in impaired driving case samples.
The cost of a LC/MS/MS system is
approximately $400,000.
Liquid chromatography-tandem mass
spectrometry is an analytical chemistry
technique that combines the physical
separation capabilities of liquid
chromatography with the mass analysis
capabilities of mass spectrometry. It is a
technique that has very high sensitivity
and selectivity that is oriented towards
the separation, general detection and
potential identification of chemicals of
particular masses in the presence of
other chemicals. This complex
analytical technique involves two
separate but connected instruments.
These two instruments are each
comprised of advanced scientific
equipment, and this equipment is
essential for the function of the entire
LC/MS/MS system. The liquid
chromatograph (LC) portion performs
the chromatography part of the analysis
that separates the drugs of interest from
any interferences in the sample and
passes them to a detector at known time
intervals. Some essential pieces of
equipment within the LC system are the
autosampler, which is used to inject all
the samples, the pump used to control
the mobile phase flow rate, the mixer
used to precisely blend the mobile
phases, and the degasser used to remove
air from the mobile phase. The detector,
a tandem mass spectrometer (MS/MS),
uniquely identifies the drug by
comparing its fragmentation pattern to a
known library match. Some of the
essential equipment within the MS/MS
system are the rotary pump used to
create a vacuum environment, the
source used to fragment the drug into
ions, the quadrupole mass analyzers
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Frm 00151
Fmt 4703
Sfmt 4703
35119
used to filter the desired fragmented
ions, the collision cell used to further
fragment the filtered drug parent ions,
and the ion detector (electron
multiplier) used to detect every ion of
selected mass that passes through the
quadrupoles. In addition, a computer
system with advanced software is used
to control the entire LC/MS/MS
instrument to provide more accurate
reporting of the findings.
In support of its waiver request, GTSC
states it seeks to purchase the LC/MS/
MS instrument to replace a gas
chromatography-mass spectrometry
(GC/MS). GTSC adds that while GC/MS
has long been an effective technique for
the analysis of blood and urine for trace
levels of drugs, LC/MS/MS has emerged
in recent years as the preferred
instrumentation. It adds that the
benefits of LC/MS/MS are numerous,
including increased sensitivity (which
reduces sample consumption and
lowers detection limits), fewer
interferences from other drugs or
metabolites (which can potentially
reduce the number of inconclusive
results), quicker and easier sample
preparation, and faster run times.
According to GTSC, these advantages
can help to reduce overall turnaround
time and give the analysts more time for
additional casework. GTSC adds that
the FIC is one of the only toxicology
labs in the state that does not currently
have an LC/MS/MS instrument and is
unable to meet current driving under
the influence detection guidelines for
detection limits for many of the drug
assays using a GC/MS instrument.
The GTSC claims that there are no
LC/MS/MS instruments manufactured
or assembled in the United States. It
states that Agilent Technologies, Waters
Corporation, AB Sciex (a subsidiary of
Danaher Corporation), Thermo Fisher
Scientific and Shimadzu are the only
manufacturers that offer a full LC/MS/
MS instrument that are proven within
the forensic toxicology community. The
GTSC adds that it compared the
available LC/MS/MS instruments’
relative cost, size, service and training
packages, pre-existing methods, method
transfer (within the forensic toxicology
community), technical capability,
software, LC and MS/MS compatibility,
and country of origin. Although the
features of the instruments vary, GTSC
states that the critical needs for the FIC
are size, pre-existing methods, and
method transfer ability. First, the LC/
MS/MS instrument must meet the
available space in the FIC laboratory.
According to the GTSC, the FIC plans to
purchase a second instrument within a
few years to support additional
casework. The GTSC identified three
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sradovich on DSK3TPTVN1PROD with NOTICES
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Federal Register / Vol. 81, No. 105 / Wednesday, June 1, 2016 / Notices
manufacturers (Waters, AB Sciex and
Thermo Fisher Scientific) that produce
an instrument that is small enough for
two instruments to fit within the FIC
laboratory. Second, the GTSC identified
four manufacturers that have forensic
toxicology packages that are included
with the software, that contain preloaded methods that are already
developed and are widely used in the
toxicology community. According to
GTSC, this last feature is critical since
it will permit the FIC to communicate
with other labs for assistance with
methods and troubleshooting, which
would save considerable time and
resources. GTSC states that Waters,
Agilent, AB Sciex and Thermo Fisher
Scientific meet its pre-existing methods
and transfer methods requirements.
NHTSA conducted similar
assessments 1 and was unable to locate
domestic manufacturers of LC/MS/MS
instruments with the specifications
required by GTSC. Based upon New
York GTSC’s and NHTSA’s analysis,
NHTSA is unaware of an LC/MS/MS
instrument that is manufactured
domestically. Since an LC/MS/MS
instrument is unavailable from a
domestic manufacturer and the
equipment would improve bloodalcohol testing and reporting by
increasing detection, reducing drug
interference, and increasing processing
speed to advance the purpose of 23
U.S.C. 405(d), a Buy America waiver is
appropriate. NHTSA invites public
comment on this conclusion.
We note that NHTSA highway safety
grant funds are intended to support
traffic safety programs in the States. The
goal of the impaired driving
countermeasures grant is to have States
adopt and implement effective programs
to reduce driving under the influence of
alcohol, drugs, or the combination of
alcohol and drugs. Activities and
equipment fully funded and purchased
using NHTSA 405(d) grant funds must
be used solely to support this goal. For
all funded activities and equipment that
have both related and unrelated
highway safety grant components, the
Federal share is based proportionately
on the projected use for the highway
safety grant purpose. Therefore, if a
State plans to use an item of equipment
50 percent of the time to support its
federally funded traffic safety program
and 50 percent of the time to support
1 NHTSA conducted internet searches, reviewed
manufacturer Web sites, public information, and
reviewed several Web sites that catalog domesticmade products (www.usaonly.us;
www.americansworking.com;
www.madeinamericaforever.com; and
www.madeinusa.org) to locate domestically made
LC/MS/MS instruments.
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21:59 May 31, 2016
Jkt 238001
unrelated state programs, the NHTSA
participation cannot exceed 50 percent
of the total cost of the equipment.
In light of the above discussion, and
pursuant to 23 U.S.C. 313(b)(2), NHTSA
finds that it is appropriate to grant a
waiver from the Buy America
requirements to GTSC in order to
purchase a LC/MS/MS instrument. This
waiver is effective through fiscal year
2016 and expires at the conclusion of
fiscal year 2016 (September 30, 2016). In
accordance with the provisions of
Section 117 of the Safe, Accountable,
Flexible, Efficient Transportation Equity
Act: A Legacy of Users Technical
Corrections Act of 2008 (Pub. L. 110–
244, 122 Stat. 1572), NHTSA is
providing this notice as its finding that
a waiver of the Buy America
requirements is appropriate for the
purchase of a LC/MS/MS instrument.
Written comments on this finding
may be submitted through any of the
methods discussed above. NHTSA may
reconsider this finding if, through
comment, it learns of additional
relevant information regarding its
decision to grant the GTSC waiver
request.
This finding should not be construed
as an endorsement or approval of any
products by NHTSA or the U.S.
Department of Transportation. The
United States Government does not
endorse products or manufacturers.
Authority: 23 U.S.C. 313; Pub. L. 110–161;
Pub. L. 110–244.
Issued in Washington, DC, on May 25,
2016, under authority delegated in 49 CFR
1.95.
Paul A. Hemmersbaugh,
Chief Counsel.
[FR Doc. 2016–12834 Filed 5–31–16; 8:45 am]
BILLING CODE 4910–59–P
DEPARTMENT OF THE TREASURY
Office of the Comptroller of the
Currency
[OCC Charter Number 703395]
Illinois-Service Federal Savings and
Loan Association, Chicago, Illinois;
Approval of Conversion Application
Notice is hereby given that on April
25, 2016, the Office of the Comptroller
of the Currency (OCC) approved the
application of Illinois-Service Federal
Savings and Loan Association, Chicago,
Illinois, to convert to the stock form of
organization. Copies of the application
are available for inspection on the OCC
Web site at the FOIA Electronic Reading
Room https://foia-pal.occ.gov/
palMain.aspx. If you have any
PO 00000
Frm 00152
Fmt 4703
Sfmt 4703
questions, please call OCC Licensing
Activities at (202) 649–6260.
Dated: May 24, 2016.
By the Office of the Comptroller of the
Currency.
Stephen A. Lybarger,
Deputy Comptroller for Licensing.
[FR Doc. 2016–12839 Filed 5–31–16; 8:45 am]
BILLING CODE 4810–33–P
DEPARTMENT OF THE TREASURY
Submission for OMB Review;
Comment Request
May 25, 2016.
The Department of the Treasury will
submit the following information
collection requests to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995, Public Law 104–13, on or after the
date of publication of this notice.
DATES: Comments should be received on
or before July 1, 2016 to be assured of
consideration.
ADDRESSES: Send comments regarding
the burden estimates, or any other
aspect of the information collections,
including suggestions for reducing the
burden, to (1) Office of Information and
Regulatory Affairs, Office of
Management and Budget, Attention:
Desk Officer for Treasury, New
Executive Office Building, Room 10235,
Washington, DC 20503, or email at
OIRA_Submission@OMB.EOP.gov and
(2) Treasury PRA Clearance Officer,
1750 Pennsylvania Ave. NW., Suite
8117, Washington, DC 20220, or email
at PRA@treasury.gov.
FOR FURTHER INFORMATION CONTACT:
Copies of the submissions may be
obtained by emailing PRA@treasury.gov,
calling (202) 622–1295, or viewing the
entire information collection request at
www.reginfo.gov.
Internal Revenue Service (IRS)
OMB Control Number: 1545–1546.
Type of Review: Extension of a
previously approved collection.
Title: Revenue Procedure 97–33,
EFTPS (Electronic Federal Tax Payment
System).
Abstract: Some taxpayers are required
by regulations issued under Sec. 6302
(h) of the Internal Revenue Code to
make Federal Tax Deposits (FTDs) using
the Electronic Federal Tax Payment
System (EFTPS). Other taxpayers may
choose to voluntarily participate in
EFTPS. EFTPS requires that a taxpayer
complete an enrollment form to provide
the information the IRS needs to
properly credit the taxpayer’s account.
E:\FR\FM\01JNN1.SGM
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Agencies
[Federal Register Volume 81, Number 105 (Wednesday, June 1, 2016)]
[Notices]
[Pages 35118-35120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12834]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration
[Docket No. NHTSA-2016-0063]
Notice of Buy America Waiver
AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).
ACTION: Notice of Buy America Waiver.
-----------------------------------------------------------------------
SUMMARY: This notice provides NHTSA's finding with respect to a request
to waive the requirements of Buy America from the New York Governor's
Traffic Safety Committee (GTSC). NHTSA finds that a non-availability
waiver of the Buy America requirement is appropriate for New York's
purchase of a liquid chromatography-tandem mass spectrometry instrument
using Federal highway traffic safety grant funds because that product
is not produced in the United States.
DATES: The effective date of this waiver is June 16, 2016. Written
comments
[[Page 35119]]
regarding this notice may be submitted to NHTSA and must be received on
or before: June 16, 2016.
ADDRESSES: Written comments may be submitted using any one of the
following methods:
Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, West Building, Ground Floor, Rm. W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
Fax: Written comments may be faxed to (202) 493-2251.
Internet: To submit comments electronically, go to the
Federal regulations Web site at https://www.regulations.gov. Follow the
online instructions for submitting comments.
Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m. Eastern Time,
Monday through Friday, except Federal holidays.
Instructions: All comments submitted in relation to this waiver
must include the agency name and docket number. Please note that all
comments received will be posted without change to https://www.regulations.gov, including any personal information provided. You
may also call the Docket at 202-366-9324.
FOR FURTHER INFORMATION CONTACT: For program issues, contact Barbara
Sauers, Office of Regional Operations and Program Delivery, NHTSA
(phone: 202-366-0144). For legal issues, contact Andrew DiMarsico,
Office of Chief Counsel, NHTSA (phone: 202-366-5263). You may send mail
to these officials at the National Highway Traffic Safety
Administration, 1200 New Jersey Avenue SE., Washington, DC 20590.
SUPPLEMENTARY INFORMATION: This notice provides NHTSA's finding that a
waiver of the Buy America requirement, 23 U.S.C. 313, is appropriate
for the GTSC to purchase a liquid chromatography-tandem mass
spectrometry device and its accessories for approximately $400,000
using grant funds authorized under 23 U.S.C. 405(d). Section 405(d)
funds are available for use by State highway safety programs to support
effective programs to reduce driving under the influence of alcohol,
drugs, or the combination of alcohol and drugs, including enforcement
efforts. 23 U.S.C. 405(d). States may use Section 405(d) grant funds to
improve blood-alcohol concentration testing and reporting and
developing impaired driving information systems. Id.
Buy America provides that NHTSA ``shall not obligate any funds
authorized to be appropriated to carry out the Surface Transportation
Assistance Act of 1982 (96 Stat. 2097) or [Title 23] and administered
by the Department of Transportation, unless steel, iron, and
manufactured products used in such project are produced in the United
States.'' 23 U.S.C. 313. However, NHTSA may waive those requirements if
NHTSA finds ``(1) that their application would be inconsistent with the
public interest; (2) that such materials and products are not produced
in the United States in sufficient and reasonably available quantities
and of a satisfactory quality; or (3) that the inclusion of domestic
material will increase the cost of the overall project contract by more
than 25 percent.'' 23 U.S.C. 313(b).
The New York GTSC seeks a waiver to purchase a liquid
chromatography-tandem mass spectrometry device (LC/MS/MS system) using
Federal grant funds to be used by the New York State Police Forensic
Investigation Center's Toxicology Section (FIC) to analyze drugs in
impaired driving case samples. The cost of a LC/MS/MS system is
approximately $400,000.
Liquid chromatography-tandem mass spectrometry is an analytical
chemistry technique that combines the physical separation capabilities
of liquid chromatography with the mass analysis capabilities of mass
spectrometry. It is a technique that has very high sensitivity and
selectivity that is oriented towards the separation, general detection
and potential identification of chemicals of particular masses in the
presence of other chemicals. This complex analytical technique involves
two separate but connected instruments. These two instruments are each
comprised of advanced scientific equipment, and this equipment is
essential for the function of the entire LC/MS/MS system. The liquid
chromatograph (LC) portion performs the chromatography part of the
analysis that separates the drugs of interest from any interferences in
the sample and passes them to a detector at known time intervals. Some
essential pieces of equipment within the LC system are the autosampler,
which is used to inject all the samples, the pump used to control the
mobile phase flow rate, the mixer used to precisely blend the mobile
phases, and the degasser used to remove air from the mobile phase. The
detector, a tandem mass spectrometer (MS/MS), uniquely identifies the
drug by comparing its fragmentation pattern to a known library match.
Some of the essential equipment within the MS/MS system are the rotary
pump used to create a vacuum environment, the source used to fragment
the drug into ions, the quadrupole mass analyzers used to filter the
desired fragmented ions, the collision cell used to further fragment
the filtered drug parent ions, and the ion detector (electron
multiplier) used to detect every ion of selected mass that passes
through the quadrupoles. In addition, a computer system with advanced
software is used to control the entire LC/MS/MS instrument to provide
more accurate reporting of the findings.
In support of its waiver request, GTSC states it seeks to purchase
the LC/MS/MS instrument to replace a gas chromatography-mass
spectrometry (GC/MS). GTSC adds that while GC/MS has long been an
effective technique for the analysis of blood and urine for trace
levels of drugs, LC/MS/MS has emerged in recent years as the preferred
instrumentation. It adds that the benefits of LC/MS/MS are numerous,
including increased sensitivity (which reduces sample consumption and
lowers detection limits), fewer interferences from other drugs or
metabolites (which can potentially reduce the number of inconclusive
results), quicker and easier sample preparation, and faster run times.
According to GTSC, these advantages can help to reduce overall
turnaround time and give the analysts more time for additional
casework. GTSC adds that the FIC is one of the only toxicology labs in
the state that does not currently have an LC/MS/MS instrument and is
unable to meet current driving under the influence detection guidelines
for detection limits for many of the drug assays using a GC/MS
instrument.
The GTSC claims that there are no LC/MS/MS instruments manufactured
or assembled in the United States. It states that Agilent Technologies,
Waters Corporation, AB Sciex (a subsidiary of Danaher Corporation),
Thermo Fisher Scientific and Shimadzu are the only manufacturers that
offer a full LC/MS/MS instrument that are proven within the forensic
toxicology community. The GTSC adds that it compared the available LC/
MS/MS instruments' relative cost, size, service and training packages,
pre-existing methods, method transfer (within the forensic toxicology
community), technical capability, software, LC and MS/MS compatibility,
and country of origin. Although the features of the instruments vary,
GTSC states that the critical needs for the FIC are size, pre-existing
methods, and method transfer ability. First, the LC/MS/MS instrument
must meet the available space in the FIC laboratory. According to the
GTSC, the FIC plans to purchase a second instrument within a few years
to support additional casework. The GTSC identified three
[[Page 35120]]
manufacturers (Waters, AB Sciex and Thermo Fisher Scientific) that
produce an instrument that is small enough for two instruments to fit
within the FIC laboratory. Second, the GTSC identified four
manufacturers that have forensic toxicology packages that are included
with the software, that contain pre-loaded methods that are already
developed and are widely used in the toxicology community. According to
GTSC, this last feature is critical since it will permit the FIC to
communicate with other labs for assistance with methods and
troubleshooting, which would save considerable time and resources. GTSC
states that Waters, Agilent, AB Sciex and Thermo Fisher Scientific meet
its pre-existing methods and transfer methods requirements.
NHTSA conducted similar assessments \1\ and was unable to locate
domestic manufacturers of LC/MS/MS instruments with the specifications
required by GTSC. Based upon New York GTSC's and NHTSA's analysis,
NHTSA is unaware of an LC/MS/MS instrument that is manufactured
domestically. Since an LC/MS/MS instrument is unavailable from a
domestic manufacturer and the equipment would improve blood-alcohol
testing and reporting by increasing detection, reducing drug
interference, and increasing processing speed to advance the purpose of
23 U.S.C. 405(d), a Buy America waiver is appropriate. NHTSA invites
public comment on this conclusion.
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\1\ NHTSA conducted internet searches, reviewed manufacturer Web
sites, public information, and reviewed several Web sites that
catalog domestic-made products (www.usaonly.us;
www.americansworking.com; www.madeinamericaforever.com; and
www.madeinusa.org) to locate domestically made LC/MS/MS instruments.
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We note that NHTSA highway safety grant funds are intended to
support traffic safety programs in the States. The goal of the impaired
driving countermeasures grant is to have States adopt and implement
effective programs to reduce driving under the influence of alcohol,
drugs, or the combination of alcohol and drugs. Activities and
equipment fully funded and purchased using NHTSA 405(d) grant funds
must be used solely to support this goal. For all funded activities and
equipment that have both related and unrelated highway safety grant
components, the Federal share is based proportionately on the projected
use for the highway safety grant purpose. Therefore, if a State plans
to use an item of equipment 50 percent of the time to support its
federally funded traffic safety program and 50 percent of the time to
support unrelated state programs, the NHTSA participation cannot exceed
50 percent of the total cost of the equipment.
In light of the above discussion, and pursuant to 23 U.S.C.
313(b)(2), NHTSA finds that it is appropriate to grant a waiver from
the Buy America requirements to GTSC in order to purchase a LC/MS/MS
instrument. This waiver is effective through fiscal year 2016 and
expires at the conclusion of fiscal year 2016 (September 30, 2016). In
accordance with the provisions of Section 117 of the Safe, Accountable,
Flexible, Efficient Transportation Equity Act: A Legacy of Users
Technical Corrections Act of 2008 (Pub. L. 110-244, 122 Stat. 1572),
NHTSA is providing this notice as its finding that a waiver of the Buy
America requirements is appropriate for the purchase of a LC/MS/MS
instrument.
Written comments on this finding may be submitted through any of
the methods discussed above. NHTSA may reconsider this finding if,
through comment, it learns of additional relevant information regarding
its decision to grant the GTSC waiver request.
This finding should not be construed as an endorsement or approval
of any products by NHTSA or the U.S. Department of Transportation. The
United States Government does not endorse products or manufacturers.
Authority: 23 U.S.C. 313; Pub. L. 110-161; Pub. L. 110-244.
Issued in Washington, DC, on May 25, 2016, under authority
delegated in 49 CFR 1.95.
Paul A. Hemmersbaugh,
Chief Counsel.
[FR Doc. 2016-12834 Filed 5-31-16; 8:45 am]
BILLING CODE 4910-59-P