Highway Safety Programs; Conforming Products List of Screening Devices to Measure Alcohol in Bodily Fluids, 54972-54974 [05-18501]
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Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices
has previously approved a similar
proposal by another self-regulatory
organization.7
IV. Conclusion
It is therefore ordered, pursuant to
Section 19(b)(2) of the Act,8 that the
proposed rule change (SR–Amex–2005–
024) be, and it hereby is, approved.
For the Commission, by the Division of
Market Regulation, pursuant to delegated
authority.9
Jonathan G. Katz,
Secretary.
[FR Doc. 05–18550 Filed 9–16–05; 8:45 am]
BILLING CODE 8010–01–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
BILLING CODE 4910–13–M
[Docket No. NHTSA–05–21436]
Highway Safety Programs; Conforming
Products List of Screening Devices to
Measure Alcohol in Bodily Fluids
Federal Aviation
Administration, DOT.
ACTION: Notice of issuance of policy
statement.
AGENCY:
National Highway Traffic
Safety Administration, DOT.
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces the
issuance of a Federal Aviation
Administration (FAA) policy for
certification of bonded structures. This
notice is necessary to advise the public,
especially manufacturers of normal, and
acrobatic category airplanes, and
commuter category airplanes and their
suppliers, that the FAA has adopted a
policy on bonded joints and structures.
DATES: Policy statement PS–ACE100–
2005–10038 was issued by the Manager
of the Small Airplane Directorate on
September 2, 2005.
How to Obtain Copies: A paper copy
of policy statement may be obtained by
writing to the following: Small Airplane
Directorate, Standards Office (ACE–
110), Aircraft Certification Service,
Federal Aviation Administration, 901
Locust Street, Room 301, Kansas City,
MO 64106. The policy statement will
also be available on the Internet at the
following address https://www.faa.gov/
regulations_policies/.
FOR FURTHER INFORMATION CONTACT:
Lester Cheng, Federal Aviation
Administration, Small Airplane
Directorate, Regulations & Policy, ACE–
111, 901 Locust Street, Room 301,
7 See Securities Exchange Act Release No. 28731
(January 2, 1991), 56 FR 906 (January 9, 1991) (SR–
NASD–90–61).
8 15 U.S.C. 78s(b)(2).
9 17 CFR 200.30–3(a)(12).
Jkt 205001
Issued in Kansas City, Missouri on
September 12, 2005.
James E. Jackson,
Acting Manager, Small Airplane Directorate,
Aircraft Certification Service.
[FR Doc. 05–18504 Filed 9–16–05; 8:45am]
National Highway Traffic Safety
Administration
Policy on Bonded Joints and
Structures—Technical Issues and
Certification Considerations
15:48 Sep 16, 2005
Background
We announced the availability of the
policy statement on May 27, 2005 (70
FR 30829). We revised the policy in
response to the comments, and the
policy has been adopted.
DEPARTMENT OF TRANSPORTATION
[Policy Statement Number PS–ACE100–
2005–10038]
VerDate Aug<31>2005
Kansas City, Missouri 64106; telephone:
(316) 946–4111; fax: 816–4090; e-mail:
lester.cheng@faa.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY: This Notice amends and
updates the list of devices that conform
to the Model Specifications for
Screening Devices to Measure Alcohol
in Bodily Fluids.
EFFECTIVE DATE: September 19, 2005.
FOR FURTHER INFORMATION CONTACT: Dr.
James F. Frank, Office of Research and
Technology, Behavioral Research
Division (NTI–131), National Highway
Traffic Safety Administration, 400
Seventh Street, SW., Washington, DC
20590; Telephone: (202) 366–5593.
SUPPLEMENTARY INFORMATION: On August
2, 1994, NHTSA published Model
Specifications for Screening Devices to
Measure Alcohol in Bodily Fluids (59
FR 39382). These specifications
established performance criteria and
methods for testing alcohol screening
devices to measure alcohol content. The
specifications support State laws that
target youthful offenders (e.g., ‘‘zero
tolerance’’ laws) and the Department of
Transportation’s workplace alcohol
testing program. NHTSA published its
first Conforming Products List (CPL) for
screening devices on December 2, 1994
(59 FR 61923, with corrections on
December 16, 1994 in 59 FR 65128),
identifying the devices that meet
NHTSA’s Model Specifications for
Screening Devices to Measure Alcohol
in Bodily Fluids. Five (5) devices
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Sfmt 4703
appeared on that first list. Thereafter,
NHTSA amended the CPL on August 15,
1995 (60 FR 42214) and on May 4, 2001
(66 FR 22639), adding seven (7) devices
to the CPL in those two (2) actions.
Since the publication of the last CPL,
NHTSA has evaluated additional
devices at the Volpe National
Transportation Systems Center (VNTSC)
in Cambridge, Massachusetts, resulting
in the following changes to the CPL.
(1) AK Solutions, Inc. of Palisades
Park, New Jersey submitted seven (7)
different electronic screening devices
for testing, all of which use a semiconductor sensor. Their trade names
are: (a) ‘‘Alcoscan AL–2500’’; (b)
‘‘AlcoChecker’’; (c) ‘‘AlcoKey’’; (d)
‘‘AlcoMate’’; (e) ‘‘AlcoMate Pro’’; (f)
‘‘Alcoscan AL–5000’’; and (g) Alcoscan
AL–6000. All of these devices meet the
NHTSA Model Specifications for
Screening Devices to Measure Alcohol
in Bodily Fluids.
(2) Guth Laboratories, Inc. of
Harrisburg, Pennsylvania submitted for
testing the ‘‘Alcotector WAT89EC–1’’
screening device, an electronic device
that uses a fuel cell sensor and has a
digital display. This device meets the
NHTSA Model Specifications for
Screening Devices to Measure Alcohol
in Bodily Fluids.
(3) Q–3 Innovations, Inc. of
Independence, Iowa submitted for
testing the ‘‘Alcohawk Precision,’’ an
electronic screening device that uses a
semiconductor sensor and has a digital
display. This device meets the NHTSA
Model Specifications for Screening
Devices to Measure Alcohol in Bodily
Fluids.
(4) Q–3 Innovations, Inc. certified that
it also sells the ‘‘Alcohawk Elite,’’
which is the same technical device as
the ‘‘Alcohawk Precision,’’ and has
only cosmetic differences not related to
the alcohol-measuring capability of the
device. Hence, the ‘‘Alcohawk Elite’’
will also be listed on the CPL. Q–3
Innovations, Inc. also sells the
‘‘Alcohawk ABI’’, which is the same
device as the ‘‘ABI’’ manufactured by
Han International Co., Ltd. of Seoul,
Korea. As the Han ‘‘ABI’’ already
appears on the CPL, and Han
International has certified that the
‘‘Alcohawk ABI’’ is the same device,
the ‘‘Alcohawk ABI’’ will also be listed
on the CPL. Finally, Q–3 Innovations
sells the ‘‘Alcohawk PRO’’, also
manufactured by Han International.
This device was previously submitted
by AK Solutions, Inc. and approved for
inclusion on the CPL. While Han
International continues to manufacture
the device, it is now sold as the
‘‘Alcohawk PRO’’ by Q–3 Innovations,
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Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices
Inc. Hence, the ‘‘Alcohawk PRO’’ will
also be added to the CPL.
(5) Seju Co., of Korea submitted the
‘‘Safe-Slim’’ handheld, electronic
screening device that uses a semiconductor sensor. It meets the NHTSA
Model Specifications for Screening
Devices to Measure Alcohol in Bodily
Fluids.
All of the above devices are being
added to the CPL with this publication.
(6) When NHTSA published the CPL
on May 4, 2001, it added the ‘‘Alcohol
√’’ manufactured by Akers Laboratories,
Inc. After that date, Akers Laboratories,
Inc. changed its name to Akers
Biosciences, Inc. and continued
distributing a device that NHTSA
understood to be the same device tested
and approved for listing on the CPL in
May, 2001. The Akers device listed on
the CPL is no longer manufactured.
Accordingly, the ‘‘Alcohol √’’ is being
removed from the CPL with this
publication. No other Akers device
currently is approved for inclusion on
the CPL.
In addition to the above changes,
NHTSA is making the following
housekeeping changes to the CPL:
(7) OraSure Technologies, Inc. of
Bethlehem, Pennsylvania continues to
manufacture the Q.E.D. A150 Saliva
Alcohol Test. On the previous CPL,
NHTSA listed STC Technologies, Inc. as
a manufacturer of the same device. STC
Technologies, Inc. changed its name to
OraSure Technologies, Inc. OraSure
Technologies, Inc. has certified that no
unexpired devices called the Q.E.D.
A150 Saliva Alcohol Test and sold
under the STC Technologies, Inc label
exist in the marketplace. Hence, NHTSA
is removing the name STC
Technologies, Inc. from the CPL.
(8) Alco Check International, Inc. of
Hudsonville, Michigan has certified that
the ‘‘Alco Screen 3000’’ is no longer in
service, was sold under a private label
for only a very brief period of time, and
none has been serviced for at least five
years. Accordingly, the manufacturer
concurs with the removal of the device
from the CPL.
(9) Sound Off, Inc. of Hudsonville,
Michigan has certified that the ‘‘Alco
Screen 1000’’ is no longer in service,
was sold under a private label for only
a very brief period of time, and none has
been serviced for at least five years.
Accordingly, the manufacturer concurs
with the removal of the device from the
CPL.
(10) PAS Systems International, Inc.
of Fredericksburg, Virginia has certified
54973
that the ‘‘PAS IIIa’’ device has not been
manufactured for more than five years,
and no instruments have been returned
for service or calibration during the past
five years. Accordingly, the
manufacturer concurs with the removal
of the device from the CPL.
(11) Varian Inc. of Lake Forest,
California acquired the ‘‘On-Site
Alcohol’’ saliva-alcohol screening
device previously owned by Roche
Diagnostics Systems. Varian, Inc. has
certified that the ‘‘On-Site Alcohol’’
device they are selling is identical to the
device previously sold by Roche.
Accordingly, this CPL will list the
Varian, Inc. ‘‘On-Site Alcohol’’ salivaalcohol screening device. The Roche
Diagnostics device will be removed
from the CPL. The Roche device had a
shelf-life of one year, and Varian began
selling the device more than one year
ago. Therefore, any of these devices that
might exist in the marketplace has
expired, warranting removal of the
Roche Diagnostics device from the CPL.
Consistent with paragraphs (1)
through (11) above, NHTSA amends the
Conforming Products List of Screening
Devices to Measure Alcohol in Bodily
Fluids to read as follows:
CONFORMING PRODUCTS LIST OF ALCOHOL SCREENING DEVICES
Manufacturer
Device(s)
AK Solutions, Inc., Palisades Park, NJ 1 ..................................................................................................
Alcoscan AL–2500.
AlcoChecker.
AlcoKey.
EAlcoMate.
AlcoMate Pro.
Alcoscan AL–5000.
Alcoscan AL–6000.
Alco Check International, Hudsonville, MI ............................................................................................... Alco Check 3000 D.O.T.
Alco Check 9000.
Chematics, Inc., North Webster, IN ......................................................................................................... ALCO-SCREEN 02TM. 2
Guth Laboratories, Inc., Harrisburg, PA .................................................................................................. Alco Tector Mark X.
Mark X Alcohol Checker.
Alcotector WAT89EC–1.
Han International Co., Ltd., Seoul, Korea 3 .............................................................................................. A.B.I. (Alcohol Breath Indicator).
OraSure Technologies, Inc., Bethlehem, PA ........................................................................................... Q.E.D. A150 Saliva Alcohol Test.
PAS Systems International, Inc., Fredericksburg, VA ............................................................................. PAS Vr.
Q3 Innovations, Inc., Independence, IA 4 ................................................................................................ Alcohawk Precision.
Alcohawk Elite.
Alcohawk ABI.
Alcohawk PRO.
Repco Marketing, Inc., Raleigh, NC ........................................................................................................ Alco Tec III.
Seju Co. of Taejeon, Korea ..................................................................................................................... Safe-Slim.
Sound Off, Inc., Hudsonville, MI .............................................................................................................. Digitox D.O.T.
Varian, Inc., Lake Forest, CA .................................................................................................................. Q.E.D. A150 Saliva Alcohol Test. 5
The devices manufactured by Chematics, Inc., OraSure Technologies, Inc., and Varian, Inc. are all single-use, disposable saliva alcohol test devices. All of the other devices listed on the CPL are electronic breath testers. The device called the ‘‘Alcotector WAT89EC–1’’ manufactured
by Guth Laboratories, Inc. and the PAS Vr device manufactured by PAS Systems International, Inc. use fuel-cell sensors, whereas all other
electronic devices listed on the CPL use semi-conductor sensors.
1 The
AlcoMate was manufactured by Han International of Seoul, Korea, but marketed and sold in the U.S. by AK Solutions.
VerDate Aug<31>2005
15:48 Sep 16, 2005
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Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices
2 While the ALCO-SCREEN 02TM saliva-alcohol screening device manufactured by Chematics, Inc. passed the requirements of the Model
Specifications when tested at 40 °C (104 °F), the manufacturer has indicated that the device cannot exceed storage temperatures of 27 ° (80 °F).
Instructions to this effect are stated on all packaging accompanying the device. Accordingly, the device should not be stored at temperatures
above 27 °C (80 °F). If the device is stored at or below 27 °C (80 °F) and used at higher temperatures (i.e., within a minute), the device meets the
Model Specifications and the results persist for 10–15 minutes. If the device is stored at or below 27 °C (80 °F) and equilibrated at 40 °C (104 °F)
for an hour prior to sample application, the device fails to meet the Model Specifications. Storage at temperatures above 27 °C (80 °F), for even
brief periods of time, may result in false negative readings.
3 Han International does not market or sell devices directly in the U. S. market. Other devices manufactured by Han International are listed
under AK Solutions, Inc. and Q–3 Innovations, Inc.
4 The AlcoHawk ABI is the same device as that listed under Han International as the ‘‘ABI’’ and is manufactured for Q–3 Innovations by Han
International. The Alcohawk PRO is the same device as the AlcoMate marketed and sold by AK Solutions, and also manufactured by Han International.
5 While this device passed all of the requirements of the Model Specifications, readings should be taken only after the time specified by the
manufacturer. For valid readings, the user should follow the manufacturer’s instructions. Readings should be taken one (1) minute after a sample
is introduced at or above 30 °C (86 °F); readings should be taken after two (2) minutes at 18 °C–29 °C (64.4 °–84.2 °F); and readings should be
taken after five (5) minutes when testing at temperatures at or below 17 °C (62.6 °F). If the reading is taken before five (5) minutes has elapsed
under the cold conditions, the user is likely to obtain a reading that underestimates the actual saliva-alcohol level.
Issued on: September 13, 2005.
Marilena Amoni,
Associate Administrator for Program
Development and Delivery.
[FR Doc. 05–18501 Filed 9–16–05; 8:45 am]
BILLING CODE 4910–59–P
DEPARTMENT OF TRANSPORTATION
Surface Transportation Board
Release of Waybill Data
The Surface Transportation Board has
received a request from Baker & Miller
PLLC on behalf of the Kansas City
Southern Railway Company (WB595–
3—9/6/2005) for permission to use
certain data from the Board’s 2002–2004
Carload Waybill Samples. A copy of the
requests may be obtained from the
Office of Economics, Environmental
Analysis, and Administration.
The waybill sample contains
confidential railroad and shipper data;
therefore, if any parties object to these
requests, they should file their
objections with the Director of the
Board’s Office of Economics,
Environmental Analysis, and
Administration within 14 calendar days
of the date of this notice. The rules for
release of waybill data are codified at 49
CFR 1244.9.
Contact: Mac Frampton, (202) 565–
1541.
Vernon A. Williams,
Secretary.
[FR Doc. 05–18568 Filed 9–16–05; 8:45 am]
BILLING CODE 4915–01–P
DEPARTMENT OF TRANSPORTATION
Surface Transportation Board
rights agreement entered into between
BNSF and Union Pacific Railroad
Company (UP), submits this verified
notice for an exemption of the modified
written trackage rights agreement
governing UP’s existing overhead
trackage rights over BNSF’s line of
railroad between MP 365.85 at UP Jct.,
WA, and MP 365.14 at Fish Lake, WA,
approximately 0.70 miles, on BNSF’s
Spokane Subdivision (the Joint
Trackage).1 The modification of trackage
rights relates to UP’s assumption of
maintenance functions for a particular
segment of the Joint Trackage, except for
signal maintenance which will continue
to be the responsibility of BNSF. UP
will continue to have rights to use the
Joint Trackage as provided in the
Agreement.
The transaction was scheduled to be
consummated on September 6, 2005,
and operations under this exemption
were planned to begin on that date.
The purpose of this transaction is to
modify the Agreement to change the
maintenance obligations in order to
promote operating and maintenance
efficiencies and better align the parties’
maintenance obligations relative to
usage.
As a condition to this exemption, any
employees affected by the trackage
rights will be protected by the
conditions imposed in Norfolk and
Western Ry. Co.—Trackage Rights—BN,
354 I.C.C. 605 (1978), as modified in
Mendocino Coast Ry., Inc.—Lease and
Operate, 360 I.C.C. 653 (1980).
This notice is filed under 49 CFR
1180.2(d)(7). If it contains false or
misleading information, the exemption
is void ab initio. Petitions to revoke the
exemption under 49 U.S.C. 10502(d)
may be filed at any time. The filing of
[STB Finance Docket No. 34732]
Union Pacific Railroad Company—
Trackage Rights Exemption—BNSF
Railway Company
BNSF Railway Company (BNSF),
pursuant to a modified written trackage
VerDate Aug<31>2005
15:48 Sep 16, 2005
Jkt 205001
1 UP acquired the nonexclusive right to use the
Joint Trackage under an agreement dated January
27, 1972, by and between the Oregon-Washington
Railroad & Navigation Company, and its lessees, UP
and Burlington Northern Inc. (BNSF’s predecessor
in interest), as amended by a supplemental
agreement dated May 6, 1982 (collectively, the
Agreement).
PO 00000
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Fmt 4703
Sfmt 4703
a petition to revoke will not
automatically stay the transaction.
An original and 10 copies of all
pleadings, referring to STB Finance
Docket No. 34732, must be filed with
the Surface Transportation Board, 1925
K Street, NW., Washington, DC 20423–
0001. In addition, one copy of each
pleading must be served on Sarah W.
Bailiff, BNSF RAILWAY COMPANY,
2500 Lou Menk Drive, P.O. Box 961039,
Fort Worth, TX 76161–0039.
Board decisions and notices are
available on our Web site at https://
www.stb.dot.gov.
Decided: By the Board, David M.
Konschnik, Director, Office of Proceedings.
Vernon A. Williams,
Secretary.
[FR Doc. 05–18413 Filed 9–16–05; 8:45 am]
BILLING CODE 4915–01–P
DEPARTMENT OF THE TREASURY
Submission to OMB for Approval and
Request for Comment for Form 1040
and Schedules A, B, C, C–EZ, D, D–1,
E, EIC, F, H, J, R, and SE, Form 1040A
and Schedules 1, 2, and 3, Form
1040EZ, Form 1040X, and All
Attachments to These Forms
SUMMARY: The Department of the
Treasury has submitted the public
information collections described in this
notice to the Office of Management and
Budget (OMB) for review and approval
under the Paperwork Reduction Act of
1995, Public Law 104–13.
DATES: Written comments should be
received on or before October 19, 2005,
to be assured of consideration.
ADDRESSES: Copies of the submission
may be obtained by contacting the
Internal Revenue Service by e-mail
(Glenn.P.Kirkland@irs.gov) or by calling
(202) 622–3428 (not a toll-free call).
Comments regarding this information
collection should be addressed to OMB
by e-mail
(Alexander_T._Hunt@omb.eop.gov) or
by paper mail to Desk Officer for the
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]]>Agencies
[Federal Register Volume 70, Number 180 (Monday, September 19, 2005)]
[Notices]
[Pages 54972-54974]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18501]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration
[Docket No. NHTSA-05-21436]
Highway Safety Programs; Conforming Products List of Screening
Devices to Measure Alcohol in Bodily Fluids
AGENCY: National Highway Traffic Safety Administration, DOT.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This Notice amends and updates the list of devices that
conform to the Model Specifications for Screening Devices to Measure
Alcohol in Bodily Fluids.
EFFECTIVE DATE: September 19, 2005.
FOR FURTHER INFORMATION CONTACT: Dr. James F. Frank, Office of Research
and Technology, Behavioral Research Division (NTI-131), National
Highway Traffic Safety Administration, 400 Seventh Street, SW.,
Washington, DC 20590; Telephone: (202) 366-5593.
SUPPLEMENTARY INFORMATION: On August 2, 1994, NHTSA published Model
Specifications for Screening Devices to Measure Alcohol in Bodily
Fluids (59 FR 39382). These specifications established performance
criteria and methods for testing alcohol screening devices to measure
alcohol content. The specifications support State laws that target
youthful offenders (e.g., ``zero tolerance'' laws) and the Department
of Transportation's workplace alcohol testing program. NHTSA published
its first Conforming Products List (CPL) for screening devices on
December 2, 1994 (59 FR 61923, with corrections on December 16, 1994 in
59 FR 65128), identifying the devices that meet NHTSA's Model
Specifications for Screening Devices to Measure Alcohol in Bodily
Fluids. Five (5) devices appeared on that first list. Thereafter, NHTSA
amended the CPL on August 15, 1995 (60 FR 42214) and on May 4, 2001 (66
FR 22639), adding seven (7) devices to the CPL in those two (2)
actions.
Since the publication of the last CPL, NHTSA has evaluated
additional devices at the Volpe National Transportation Systems Center
(VNTSC) in Cambridge, Massachusetts, resulting in the following changes
to the CPL.
(1) AK Solutions, Inc. of Palisades Park, New Jersey submitted
seven (7) different electronic screening devices for testing, all of
which use a semi-conductor sensor. Their trade names are: (a)
``Alcoscan AL-2500''; (b) ``AlcoChecker''; (c) ``AlcoKey''; (d)
``AlcoMate''; (e) ``AlcoMate Pro''; (f) ``Alcoscan AL-5000''; and (g)
Alcoscan AL-6000. All of these devices meet the NHTSA Model
Specifications for Screening Devices to Measure Alcohol in Bodily
Fluids.
(2) Guth Laboratories, Inc. of Harrisburg, Pennsylvania submitted
for testing the ``Alcotector WAT89EC-1'' screening device, an
electronic device that uses a fuel cell sensor and has a digital
display. This device meets the NHTSA Model Specifications for Screening
Devices to Measure Alcohol in Bodily Fluids.
(3) Q-3 Innovations, Inc. of Independence, Iowa submitted for
testing the ``Alcohawk[supreg] Precision,'' an electronic screening
device that uses a semiconductor sensor and has a digital display. This
device meets the NHTSA Model Specifications for Screening Devices to
Measure Alcohol in Bodily Fluids.
(4) Q-3 Innovations, Inc. certified that it also sells the
``Alcohawk[supreg] Elite,'' which is the same technical device as the
``Alcohawk[supreg] Precision,'' and has only cosmetic differences not
related to the alcohol-measuring capability of the device. Hence, the
``Alcohawk[supreg] Elite'' will also be listed on the CPL. Q-3
Innovations, Inc. also sells the ``Alcohawk[supreg] ABI'', which is the
same device as the ``ABI'' manufactured by Han International Co., Ltd.
of Seoul, Korea. As the Han ``ABI'' already appears on the CPL, and Han
International has certified that the ``Alcohawk[supreg] ABI'' is the
same device, the ``Alcohawk[supreg] ABI'' will also be listed on the
CPL. Finally, Q-3 Innovations sells the ``Alcohawk[supreg] PRO'', also
manufactured by Han International. This device was previously submitted
by AK Solutions, Inc. and approved for inclusion on the CPL. While Han
International continues to manufacture the device, it is now sold as
the ``Alcohawk[supreg] PRO'' by Q-3 Innovations,
[[Page 54973]]
Inc. Hence, the ``Alcohawk[supreg] PRO'' will also be added to the CPL.
(5) Seju Co., of Korea submitted the ``Safe-Slim'' handheld,
electronic screening device that uses a semi-conductor sensor. It meets
the NHTSA Model Specifications for Screening Devices to Measure Alcohol
in Bodily Fluids.
All of the above devices are being added to the CPL with this
publication.
(6) When NHTSA published the CPL on May 4, 2001, it added the
``Alcohol [radic]'' manufactured by Akers Laboratories, Inc. After that
date, Akers Laboratories, Inc. changed its name to Akers Biosciences,
Inc. and continued distributing a device that NHTSA understood to be
the same device tested and approved for listing on the CPL in May,
2001. The Akers device listed on the CPL is no longer manufactured.
Accordingly, the ``Alcohol [radic]'' is being removed from the CPL with
this publication. No other Akers device currently is approved for
inclusion on the CPL.
In addition to the above changes, NHTSA is making the following
housekeeping changes to the CPL:
(7) OraSure Technologies, Inc. of Bethlehem, Pennsylvania continues
to manufacture the Q.E.D. A150 Saliva Alcohol Test. On the previous
CPL, NHTSA listed STC Technologies, Inc. as a manufacturer of the same
device. STC Technologies, Inc. changed its name to OraSure
Technologies, Inc. OraSure Technologies, Inc. has certified that no
unexpired devices called the Q.E.D. A150 Saliva Alcohol Test and sold
under the STC Technologies, Inc label exist in the marketplace. Hence,
NHTSA is removing the name STC Technologies, Inc. from the CPL.
(8) Alco Check International, Inc. of Hudsonville, Michigan has
certified that the ``Alco Screen 3000'' is no longer in service, was
sold under a private label for only a very brief period of time, and
none has been serviced for at least five years. Accordingly, the
manufacturer concurs with the removal of the device from the CPL.
(9) Sound Off, Inc. of Hudsonville, Michigan has certified that the
``Alco Screen 1000'' is no longer in service, was sold under a private
label for only a very brief period of time, and none has been serviced
for at least five years. Accordingly, the manufacturer concurs with the
removal of the device from the CPL.
(10) PAS Systems International, Inc. of Fredericksburg, Virginia
has certified that the ``PAS IIIa'' device has not been manufactured
for more than five years, and no instruments have been returned for
service or calibration during the past five years. Accordingly, the
manufacturer concurs with the removal of the device from the CPL.
(11) Varian Inc. of Lake Forest, California acquired the ``On-Site
Alcohol'' saliva-alcohol screening device previously owned by Roche
Diagnostics Systems. Varian, Inc. has certified that the ``On-Site
Alcohol'' device they are selling is identical to the device previously
sold by Roche. Accordingly, this CPL will list the Varian, Inc. ``On-
Site Alcohol'' saliva-alcohol screening device. The Roche Diagnostics
device will be removed from the CPL. The Roche device had a shelf-life
of one year, and Varian began selling the device more than one year
ago. Therefore, any of these devices that might exist in the
marketplace has expired, warranting removal of the Roche Diagnostics
device from the CPL.
Consistent with paragraphs (1) through (11) above, NHTSA amends the
Conforming Products List of Screening Devices to Measure Alcohol in
Bodily Fluids to read as follows:
Conforming Products List of ALcohol Screening Devices
----------------------------------------------------------------------------------------------------------------
Manufacturer Device(s)
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AK Solutions, Inc., Palisades Park, NJ \1\... Alcoscan AL-2500.
AlcoChecker.
AlcoKey.
EAlcoMate.
AlcoMate Pro.
Alcoscan AL-5000.
Alcoscan AL-6000.
Alco Check International, Hudsonville, MI.... Alco Check 3000 D.O.T.
Alco Check 9000.
Chematics, Inc., North Webster, IN........... ALCO-SCREEN 02TM. \2\
Guth Laboratories, Inc., Harrisburg, PA...... Alco Tector Mark X.
Mark X Alcohol Checker.
Alcotector WAT89EC-1.
Han International Co., Ltd., Seoul, Korea \3\ A.B.I. (Alcohol Breath Indicator).
OraSure Technologies, Inc., Bethlehem, PA.... Q.E.D. A150 Saliva Alcohol Test.
PAS Systems International, Inc., PAS Vr.
Fredericksburg, VA.
Q3 Innovations, Inc., Independence, IA \4\... Alcohawk[supreg] Precision.
Alcohawk[supreg] Elite.
Alcohawk[supreg] ABI.
Alcohawk[supreg] PRO.
Repco Marketing, Inc., Raleigh, NC........... Alco Tec III.
Seju Co. of Taejeon, Korea................... Safe-Slim.
Sound Off, Inc., Hudsonville, MI............. Digitox D.O.T.
Varian, Inc., Lake Forest, CA................ Q.E.D. A150 Saliva Alcohol Test. \5\
The devices manufactured by Chematics, Inc., OraSure Technologies, Inc., and Varian, Inc. are all single-use,
disposable saliva alcohol test devices. All of the other devices listed on the CPL are electronic breath
testers. The device called the ``Alcotector WAT89EC-1'' manufactured by Guth Laboratories, Inc. and the PAS Vr
device manufactured by PAS Systems International, Inc. use fuel-cell sensors, whereas all other electronic
devices listed on the CPL use semi-conductor sensors.
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\1\ The AlcoMate was manufactured by Han International of Seoul, Korea, but marketed and sold in the U.S. by AK
Solutions.
[[Page 54974]]
\2\ While the ALCO-SCREEN 02TM saliva-alcohol screening device manufactured by Chematics, Inc. passed the
requirements of the Model Specifications when tested at 40 [deg]C (104 [deg]F), the manufacturer has indicated
that the device cannot exceed storage temperatures of 27 [deg] (80 [deg]F). Instructions to this effect are
stated on all packaging accompanying the device. Accordingly, the device should not be stored at temperatures
above 27 [deg]C (80 [deg]F). If the device is stored at or below 27 [deg]C (80 [deg]F) and used at higher
temperatures (i.e., within a minute), the device meets the Model Specifications and the results persist for 10-
15 minutes. If the device is stored at or below 27 [deg]C (80 [deg]F) and equilibrated at 40 [deg]C (104
[deg]F) for an hour prior to sample application, the device fails to meet the Model Specifications. Storage at
temperatures above 27 [deg]C (80 [deg]F), for even brief periods of time, may result in false negative
readings.
\3\ Han International does not market or sell devices directly in the U. S. market. Other devices manufactured
by Han International are listed under AK Solutions, Inc. and Q-3 Innovations, Inc.
\4\ The AlcoHawk ABI is the same device as that listed under Han International as the ``ABI'' and is
manufactured for Q-3 Innovations by Han International. The Alcohawk PRO is the same device as the AlcoMate
marketed and sold by AK Solutions, and also manufactured by Han International.
\5\ While this device passed all of the requirements of the Model Specifications, readings should be taken only
after the time specified by the manufacturer. For valid readings, the user should follow the manufacturer's
instructions. Readings should be taken one (1) minute after a sample is introduced at or above 30 [deg]C (86
[deg]F); readings should be taken after two (2) minutes at 18 [deg]C-29 [deg]C (64.4 [deg]-84.2 [deg]F); and
readings should be taken after five (5) minutes when testing at temperatures at or below 17 [deg]C (62.6
[deg]F). If the reading is taken before five (5) minutes has elapsed under the cold conditions, the user is
likely to obtain a reading that underestimates the actual saliva-alcohol level.
Issued on: September 13, 2005.
Marilena Amoni,
Associate Administrator for Program Development and Delivery.
[FR Doc. 05-18501 Filed 9-16-05; 8:45 am]
BILLING CODE 4910-59-P
