
[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]


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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.

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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

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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 http://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 http://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

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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


