Highway Safety Programs; Model Specifications for Screening; Devices to Measure Alcohol in Bodily Fluids, 16956-16960 [E8-6520]

Download as PDF 16956 Federal Register / Vol. 73, No. 62 / Monday, March 31, 2008 / Notices National Highway Traffic Safety Administration require interpretation by a test administrator or technician. Because the agency has determined the BASS device is not necessary for inclusion in the Model Specifications, this notice removes all references to the BASS device. Additionally, in order to ensure product integrity, this notice provides guidelines for retesting devices when manufacturers contemplate changes, revisions, or upgrades to alcohol screening devices on the Conforming Products List (CPL). These revisions to the Model Specifications will not affect devices currently listed on the CPL. DATES: Effective Date: Revisions to these Model Specifications become effective on March 31, 2008. FOR FURTHER INFORMATION CONTACT: For technical issues: Ms. De Carlo Ciccel, Behavioral Research Division, NTI–131, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590; Telephone: (202) 366–1694. For legal issues: Mr. David Bonelli, Office of Chief Counsel, NCC–113, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590; Telephone: (202) 366–5834. SUPPLEMENTARY INFORMATION: [NHTSA Docket No. 2008–0030] I. Background Highway Safety Programs; Model Specifications for Screening; Devices to Measure Alcohol in Bodily Fluids As indicated in the Model Specifications published in 1994, the agency will modify and improve the Model Specifications as new data and test procedures become available and will alter the test procedures, as necessary, to meet unique design features of specific devices. Since publication of the Model Specifications, the agency encountered difficulties ensuring the accuracy of testing ISDs and also determined the use of the BASS is not necessary for inclusion in the Model Specifications. These events made it necessary to revise the Model Specifications. On December 14, 2007, (72 FR 71188), NHTSA proposed and sought comments on amendments and revisions to the Model Specifications published in 1994. In the notice, NHTSA explained that the 1994 Model Specifications allowed for evaluation of screening devices that require subjective interpretation of test results by a test administrator or technician. These ISDs differ from devices that provide objective test results, including the use of digital technology or the appearance of lights or marks based on the presence or absence of alcohol. For instance, use of pass/fail lights or enzymes that react IGNATYUK #8127804 and JIM KILABUK #7420754) would operate in the Beaufort Sea or Chukchi Sea adjacent to Alaska, under certain conditions, and for a limited period of time. Section 705 of Pub.L. 109–347 allows the use of foreign-flag vessels in this regard if the Maritime Administration determines that U.S.flag vessels are not suitable or reasonably available. The Maritime Administration is posting this notice in the Federal Register providing the public 30 days notice of our intention to provide a determination allowing for the use of foreign-flag vessels in this regard, if suitable and available U.S.-flag vessels are not otherwise identified. The Maritime Administration’s determination will be for the period through December 31, 2009. By order of the Maritime Administrator. Dated: March 25, 2008. Christine Gurland, Acting Secretary, Maritime Administration. [FR Doc. E8–6567 Filed 3–28–08; 8:45 am] BILLING CODE 4910–81–P DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration (NHTSA), DOT. ACTION: Notice. mmaher on PROD1PC76 with NOTICES AGENCY: SUMMARY: This notice revises Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids (Model Specifications) published in the Federal Register on August 2, 1994 (59 FR 39382). These devices test for the presence of alcohol using breath or bodily fluids such as saliva. The Model Specifications support State laws that target youthful offenders (i.e., ‘‘zero tolerance’’ laws) and the Department of Transportation’s regulations on Alcohol Misuse Prevention, and encourage industry efforts to develop new technologies (e.g., non-breath devices) that measure alcohol content from bodily fluids. This notice removed testing of Interpretive Screening Devices (ISDs) and use of the Breath Alcohol Sample Simulator (BASS) device from the Model Specifications. The ISDs did not provide an unambiguous test result, as test results for ISDs are subjective and VerDate Aug<31>2005 18:00 Mar 28, 2008 Jkt 214001 PO 00000 Frm 00121 Fmt 4703 Sfmt 4703 with alcohol to produce an unambiguous mark provide objective test results. Also, the 1994 Model Specifications required that interpretive devices be evaluated subjectively under five lighting conditions (fluorescent, incandescent, mercury, sodium and daylight) by a panel of ten novice evaluators who are not color blind. Since publication of the 1994 Model Specifications, NHTSA evaluated eight separate ISDs. Of those eight ISD evaluations, none resulted in a successful outcome in the panel test described above. In one evaluation, the device passed the test under all lighting conditions except sodium. This device is no longer manufactured. Although many novice evaluators were able to judge the correct test outcome in the eight ISD evaluations, some could not, even though the manufacturers’ instructions were conveyed to the evaluators and all evaluators passed tests to determine their color perception ability. This subjective interpretation of test results does not ensure accuracy and precision required to protect public safety. Due to repeated problems in evaluating ISDs, NHTSA proposed to remove altogether testing of ISDs and all references to interpretive or color indicator tests from the Model Specifications. The 1994 Model Specifications provided for the use of the Breath Alcohol Sample Simulator (BASS) device for delivering alcohol-in-air test samples. The use of the BASS device is not necessary for inclusion in the Model Specifications because the BASS device is intended for use in testing the sampling efficiency of evidential breath testers. There is no sampling efficiency test in the Model Specifications for alcohol screening devices. The alcoholin-air test sample for breath alcohol screening devices is supplied by a calibrating unit. Therefore, the agency proposed to remove all references to the BASS device from the Model Specifications. The 1994 Model Specifications also provide procedures to conduct special investigations and re-test a device if information gathered indicates that a device listed on the CPL is not performing in accordance with the Model Specifications. The agency proposed the addition of Appendix B to provide guidance regarding notification and re-testing when manufacturers contemplate revisions to devices listed on the CPL. The proposed Appendix follows the language used in the Model Specifications for evidential breath testing devices (58 FR 48705). Upon notification by a manufacturer of a contemplated change to a device listed E:\FR\FM\31MRN1.SGM 31MRN1 Federal Register / Vol. 73, No. 62 / Monday, March 31, 2008 / Notices mmaher on PROD1PC76 with NOTICES on the CPL, NHTSA proposed that it would determine whether re-testing is required. Such determination would look at several factors, including the nature and reason for the change, the scope of the change, the effects of the change on the performance of the device, and how the change will be documented for the benefit of the user. NHTSA would list device revisions and whether re-testing was required in the next update to the CPL. Appendix B also would state that NHTSA may retest any device listed on the CPL at any time to determine continued compliance and performance with the Model Specifications. A device found not to perform in accordance with the Model Specifications would be subject to the special investigation procedures discussed below. Having received no comments on any aspect of the agency’s proposal, this notice adopts the proposed revisions, including the ‘‘Procedures’’ and ‘‘Model Specifications for Alcohol Screening Devices,’’ without change. II. Procedures This section describes the current procedures. The DOT Volpe National Transportation Systems Center (VNTSC), RTV–4F, Kendall Square, Cambridge, MA 02142 tests products manufacturers submit to determine whether the products meet the model specifications. Tests are conducted semiannually, or as necessary. Manufacturers are required to apply to NHTSA for a test date by writing to the Office of Behavioral Safety Research, NTI–130, NHTSA, 1200 New Jersey Avenue, SE., Washington, DC 20590. At least 30 days are typically required from the date of notification until the test can be scheduled. One week prior to the scheduled initiation of the test program, manufacturers must deliver their devices to VNTSC. If the devices are disposable, the manufacturer must deliver at least 300 such devices; if the devices are reusable, the manufacturer need submit only a single device. If a manufacturer of a reusable device wishes to submit a duplicate, backup instrument, it may so do. The manufacturer is responsible for ensuring that the devices operate properly and are packaged correctly. The manufacturer must also deliver the operator’s manual (or instructions) and the maintenance manual (if any) that is to be supplied with the purchase of the device, as well as specifications and drawings fully describing the device and its use. Information determined to be proprietary will be respected. (See 49 CFR Part 512, regarding the procedure VerDate Aug<31>2005 18:00 Mar 28, 2008 Jkt 214001 by which NHTSA will consider claims of confidentiality.) In addition, the manufacturer must submit a self-certification, certifying that the manufacturer meets the requirements according to the U.S. Food and Drug Administration (FDA) Good Manufacturing Practices regulations for devices used for medical purposes (21 CFR Part 820), and that the device’s label meets the requirements in FDA’s Labeling regulations for devices used for medical purposes (21 CFR Part 809.10), even if the devices are not to be used for medical purposes. See Appendix A to this notice. The manufacturer has the right to check its device(s) between the time of arrival at VNTSC and the start of the tests, but will have no access to the device(s) during the tests. Any malfunction of a device resulting in failure to complete any of the tests satisfactorily will result in a determination that the device does not conform to the Model Specifications. If a device is found not to conform to the Model Specifications, it may be resubmitted for the next testing cycle after appropriate corrections have been made. However, the agency reserves the discretion to determine whether to conduct any retest. The agency intends to update and republish the CPL in the Federal Register annually. Republications of the CPL add conforming alcohol screening devices tested since the last CPL republication. NHTSA will continue to provide notification in the Federal Register when the agency amends the Model Specifications as new data and test procedures become available and will retest devices when necessary. The NHTSA Office of Behavioral Safety Research is the point of contact for information about acceptance testing and field performance of devices that are in the marketplace. NHTSA requests that users of alcohol screening devices provide both acceptance and field performance data to the Office of Behavioral Safety Research when such data indicate potential performance problems. Information from users will help NHTSA monitor whether alcohol screening devices are performing according to the NHTSA Model Specifications. If information gathered indicates that a device on the CPL is not performing in accordance with the Model Specifications, NHTSA may direct VNTSC to conduct a special investigation. An investigation may include visits to users and additional tests of devices obtained on the open market. If the investigation indicates PO 00000 Frm 00122 Fmt 4703 Sfmt 4703 16957 that a device actually sold on the market does not meet the Model Specifications, the manufacturer will be notified that the device may be removed from the CPL. In this event, the manufacturer will have 30 days from the date of notification to reply. Based on the VNTSC investigation and any data provided by the manufacturer, NHTSA will decide whether the device should remain on the CPL. If the device is removed from the CPL, the manufacturer will be permitted to resubmit an improved device to VNTSC for testing when it believes the problems causing its failure have been resolved. Upon resubmission, the manufacturer must submit a statement describing what has been done to overcome the problems that led to failure of the device. The agency reserves the discretion to determine whether to conduct any retest. If information gathered indicates that the manufacturer of a device on the CPL does not comply with the requirements in FDA’s Good Manufacturing Practices regulations for devices used for medical purposes or that the device’s label does not comply with the requirements in FDA’s labeling regulations for devices used for medical purposes, NHTSA may investigate the matter in consultation with FDA and will notify the manufacturer that the device may be removed from the CPL. The manufacturer will have 30 days from the date of notification to reply. Based on any data provided by the manufacturer and investigative findings, NHTSA will decide whether the device should remain on the CPL. If the device is removed from the CPL, the manufacturer will be permitted to resubmit a self-certification, certifying that the manufacturer or its device complies with these FDA requirements when it believes the problems causing its non-compliance have been resolved. Upon resubmission, the manufacturer must submit a statement describing what has been done to overcome the problems that led to non-compliance. In accordance with the foregoing, the amendments of the Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids, are set forth below. Model Specifications for Alcohol Screening Devices 1. Purpose and Scope These specifications establish performance criteria and methods for testing of alcohol screening devices. Alcohol screening devices use bodily fluids to detect the presence of 0.020 or more BAC (see below) with sufficient E:\FR\FM\31MRN1.SGM 31MRN1 16958 Federal Register / Vol. 73, No. 62 / Monday, March 31, 2008 / Notices accuracy for screening purposes. These specifications are intended primarily for use in the conformance testing of alcohol screening devices. 2. Classification 2.1 Disposable Alcohol Screening Devices. Alcohol screening devices designed for a single use. 2.2 Reusable Alcohol Screening Devices. Alcohol screening devices designed to be reused. mmaher on PROD1PC76 with NOTICES 3. Definitions 3.1 Alcohol. The intoxicating agent in beverage alcohol, ethyl alcohol or other low molecular weight alcohols including methyl or isopropyl alcohol. 3.2 Alcohol Screening Device. A device that is used to detect the presence of 0.020 or more BAC. The device may measure any bodily fluid for this purpose, but shall provide output in BAC units. Test results must be indicated unambiguously by numerical read-out or by other means, such as by the use of lights or by the appearance of a distinctive mark but not by color change. 3.3 Blood alcohol concentration (BAC). Grams alcohol per 100 milliliters of blood or grams alcohol per 210 liters of breath in accordance with the Uniform Vehicle Code, Section 11–903(a)(5) 1 (BrAC is often used to indicate that the measurement is a breath measurement); or grams alcohol per 100 milliliters of saliva. 3.4 Calibrating Unit. A device that produces an alcohol-inair test sample of known concentration and that meets the NHTSA Model Specifications for Calibrating Units (72 FR 34742). 3.5 Bodily Fluid. Any bodily fluid capable of being used to estimate alcohol concentration, provided the relationship between such bodily fluid and BAC has been established according to scientifically acceptable standards. Such fluids include but are not limited to blood, exhaled deep lung breath and saliva. 3.6 Scientifically Acceptable Substitutes. Fluids that have been scientifically accepted as equivalent to bodily fluids for testing purposes, such as aqueous alcohol test solutions on a one-to-one basis for blood or saliva. 1 Available from the National Committee on Uniform Traffic Laws and Ordinances, 107 S. West Street, # 10, Alexandria, VA 22314. Web site address: http://www.ncutle.org VerDate Aug<31>2005 18:00 Mar 28, 2008 Jkt 214001 4. Test Methods and Requirements Testing will be performed according to the instructions that normally accompany the submitted device and under the conditions specified in the tests below. 4.1 Test 1. Precision and Accuracy. Perform 40 trials under normal laboratory conditions including 20 trials at 0.008 BAC and 20 trials at 0.032 BAC. Use a calibrating unit for this test for breath devices and preparations of bodily fluids or scientifically acceptable substitutes for non-breath devices. Perform tests using a VNTSC investigator. To conform at 0.008 BAC, not more than one positive result. To conform at 0.032 BAC, not more than one nonpositive result. 4.2 Test 2. Blank Reading. Perform 20 trials under normal laboratory conditions at 0.000 BAC. Use non-alcoholic human breath for breath devices and non-alcoholic bodily fluids or scientifically acceptable substitutes for non-breath devices. Perform tests using a VNTSC investigator. To conform: no positive results. If the device is capable of providing a reading of greater than 0.000 BAC and less than 0.020 BAC, not more than one such result. 4.3 Test 3. Cigarette smoke interference (only breath and saliva test devices). Perform five trials at 0.000 BAC. Select an alcohol-free person who smokes cigarettes for this test. Ask the person selected to smoke approximately one half of a cigarette. Within one minute after smoking, or after a waiting period specified in the manufacturer’s instructions, administer the alcohol screening device test according to the manufacturer’s instructions. Then ask the person to take another smoke and repeat the test to produce a total of five trials. To conform: no positive results. 4.4 Temperature. Test at low and high ambient temperature. 4.4.1 Test 4.1. Low Ambient Temperature. Perform 40 trials at 10 degrees Centigrade (C), including 20 trials at 0.008 BAC and 20 trials at 0.032 BAC. Use a calibrating unit for this test for breath devices and preparations of bodily fluids or scientifically acceptable substitutes for non-breath devices. To conform at 0.008 BAC, not more than one positive result. To conform at 0.032 BAC, not more than one nonpositive result. 4.4.2 Test 4.2 High Ambient Temperature. PO 00000 Frm 00123 Fmt 4703 Sfmt 4703 Perform trials of 40 devices at 40 degrees C, including 20 trials at 0.008 BAC and 20 trials at 0.032 BAC. Use a calibrating unit for this test for breath devices and preparations of bodily fluids or scientifically acceptable substitutes for non-breath devices. To conform at 0.008 BAC, not more than one positive result. To conform at 0.032 BAC, not more than one nonpositive result. 4.5. Test 5. Vibration. Perform 40 trials, including 20 trials at 0.008 BAC and 20 trials at 0.032 BAC. Use a calibrating unit for this test for breath devices and preparations of bodily fluids or scientifically acceptable substitutes for non-breath devices. Mount the screening device on a shake table and vibrate the table in simple harmonic motion through each of its three major axes, as specified below. Sweep through each frequency range in 2.5 minutes, then reverse the sweep to the starting frequency in 2.5 minutes. Disposable testers may be placed in a suitable box mounted on the shake table. Test after vibration. Frequency (hertz) Amplitude (inches, peak to peak) 10 to 30 .................................... 30 to 60 .................................... 0.30 0.15 To conform at 0.008 BAC, not more than one positive result. To conform at 0.032 BAC not more than one nonpositive result. Appendix A—Labeling Instructions for Alcohol Screening Devices’ Intended Use Provide the intended use including the specimen matrix (e.g. saliva, breath), the assay type (quantitative, semiquantitative), the purpose of performing the assay, and the individual designated to perform the assay. e.g.: This product is intended for the (quantitative, semi-quantitative) determination of alcohol in —define matrix (for e.g., saliva, breath, sweat) to perform screening alcohol assays. This product is recommended for use by individuals who have been trained in the administration of screening devices. Description of Testing System Provide the principles of the procedure for performing the alcohol screening assay. e.g.: This product uses (alcohol dehydrogenase, infrared technology, etc.) to perform the test. Chemical Reaction Sequence Describe the chemical reaction sequence, if applicable. E:\FR\FM\31MRN1.SGM 31MRN1 Federal Register / Vol. 73, No. 62 / Monday, March 31, 2008 / Notices Reagents: List the concentration, strength, and composition of the reactive ingredients. List the non-reactive ingredients. Reagent Preparation and Storage Provide instructions for preparing the reagents, if applicable. Provide instructions for storing the reagents, if applicable. Provide any signs of deterioration of the reagents, if applicable. Provide the reagents’ shelf life and opened expiration dating, if applicable. e.g.: Tests in unopened packaging are stable until the date printed on the product container when stored at 22–28 degrees C. If packaging is opened, tests must be conducted at once. Provide a caution not to use the reagents beyond the expiration date. Provide the description of the required frequency of equipment maintenance and function checks. Provide the instructions for any remedial action to be taken when the equipment performs outside of its operating range. Provide any operational precautions and limitations. Provide instructions for the protection of equipment and instrumentation from fluctuations or interruptions in electrical current that could adversely affect test results and reports, if applicable. Disposable Tests If applicable, the function and stability of the test can be determined by the examination of the procedural ‘‘built in’’ controls contained in the product. If these controls are not working, the test is invalid and must be repeated. Disposable/Instrumented Devices Calibration Results Disposable tests are pre-calibrated. No additional calibration is required. Reusable (Instrumented) tests require calibration. Provide information regarding how calibrations are to be conducted, if applicable, including the number and concentration of calibrators, and the frequency of calibration. Provide instructions for calibration and recalibration. Provide the criteria for acceptability of calibration. Describe how the user obtains the test results, e.g., from an instrument readout, printout, etc. Describe the results in terms of blood alcohol concentration. Describe what concentration indicates a positive result and what concentration indicates a negative result. Test Procedure (Disposable) Dynamic Range Provide adequate step-by-step instructions for performing the test and determining the results. Provide the operating range of the product. mmaher on PROD1PC76 with NOTICES Jkt 214001 Technical Assistance List an 800 number the user may contact for further information or technical assistance. Appendix B—Guidelines for Re-testing of Modified Screening Devices Authority: 23 U.S.C. 403; 49 CFR 1.50; 49 CFR Part 501. Quality Control (QC) Provide instructions for collecting and handling the sample. Provide criteria for specimen rejection, if applicable. Specimen Collection 18:00 Mar 28, 2008 Provide pertinent bibliography. Manufacturers contemplating revisions to an alcohol screening device listed on the Conforming Products List (CPL) are advised that the revision may affect the status of the device on the CPL. The manufacturer should inform NHTSA of the contemplated change so that a judgment can be made whether or not re-testing the revised alcohol screening device is necessary. The following lists the type of information NHTSA uses in determining the necessity to re-test an alcohol screening device, and is provided as guidance to manufacturers: • Manufacturer and Model Name. • Nature and reason for change(s). • Scope of change(s) (e.g., Will existing devices be retrofitted? Will the change apply to some users but not others?) • Will the change(s) affect performance of the device with regard to the Model Specifications? (Precision and accuracy, blank reading, temperature operations, or vibrations.) • How will the change(s) be documented for the benefit of the user? (e.g., Will the change(s) be documented in service bulletins and/or service manuals? If not, why not?) If necessary for clarity, drawings of the listed and changed device may also be helpful in NHTSA’s deliberations. If, upon review of information provided by a manufacturer, it is determined that re-testing is not warranted, a statement to that effect will be included in the next scheduled CPL update. NHTSA reserves the right to test any CPL-listed device on the open market to determine continued compliance and performance in accordance with these Model Specifications. Devices found not to comply with or perform in accordance with the Model Specifications are subject to the investigation provisions stated above in section II, Procedures. If external quality control materials are used, provide the number, type, matrix and concentration of the QC materials. Provide directions for performing quality control procedures. Provide an adequate description of the remedial action to be taken when the QC results fail to meet the criteria for acceptability. Provide directions for interpretation of the results of quality control samples. VerDate Aug<31>2005 References List the substances that have been evaluated with your product that do or 1. List any reagents that may be hazardous such as caustic compounds, sodium azide or other hazardous reagents and instructions for disposal, if applicable. 2. Provide warning to user to treat all samples as potentially infective. Include instructions for handling and disposal of the sample. Provide adequate step-by-step instruction for performing the test. Provide the installation procedures and, if applicable, any special requirements. Provide the space and ventilation requirements. do not interfere at the concentration indicated. Specificity Precautions Test Procedure (Re-usable/ Instrumented) 16959 Limitations List the substances or factors that may interfere with the test and cause false results including technical or procedural errors. Precision and Accuracy Only devices that meet the precision and accuracy of these Model Specifications will be included on NHTSA’s Conforming Products List for alcohol screening devices. PO 00000 Frm 00124 Fmt 4703 Sfmt 4703 E:\FR\FM\31MRN1.SGM 31MRN1 16960 Federal Register / Vol. 73, No. 62 / Monday, March 31, 2008 / Notices Issued on: March 25, 2008. Marilena Amoni, Associate Administrator for the Office of Research and Program Development. [FR Doc. E8–6520 Filed 3–28–08; 8:45 am] BILLING CODE 4910–59–P DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration [Docket No. NHTSA–2008–0051] Notice of Receipt of Petition for Decision That Nonconforming 2000 Chevrolet Tahoe Multipurpose Passenger Vehicles Are Eligible for Importation National Highway Traffic Safety Administration, DOT. ACTION: Notice of receipt of petition for decision that nonconforming 2000 Chevrolet Tahoe multipurpose passenger vehicles are eligible for importation. mmaher on PROD1PC76 with NOTICES AGENCY: SUMMARY: This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that 2000 Chevrolet Tahoe multipurpose passenger vehicles that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS) are eligible for importation into the United States because (1) they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards, and (2) they are capable of being readily altered to conform to the standards. DATES: The closing date for comments on the petition is April 30, 2008. ADDRESSES: Comments should refer to the docket and notice numbers above and be submitted by any of the following methods: • Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting comments. • Mail: Docket Management Facility: U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West Building Ground Floor, Room W12–140, Washington, DC 20590–0001. • Hand Delivery or Courier: West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m. ET, Monday through Friday, except Federal holidays. • Fax: 202–493–2251. Instructions: Comments must be written in the English language, and be VerDate Aug<31>2005 18:00 Mar 28, 2008 Jkt 214001 no greater than 15 pages in length, although there is no limit to the length of necessary attachments to the comments. If comments are submitted in hard copy form, please ensure that two copies are provided. If you wish to receive confirmation that your comments were received, please enclose a stamped, self-addressed postcard with the comments. Note that all comments received will be posted without change to http://www.regulations.gov, including any personal information provided. Please see the Privacy Act heading below. Privacy Act: Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT’s complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477–78). How to Read Comments Submitted to the Docket: You may read the comments received by Docket Management at the address and times given above. You may also view the documents from the Internet at http://www.regulations.gov. Follow the online instructions for accessing the dockets. The docket ID number and title of this notice are shown at the heading of this document notice. Please note that even after the comment closing date, we will continue to file relevant information in the Docket as it becomes available. Further, some people may submit late comments. Accordingly, we recommend that you periodically search the Docket for new material. FOR FURTHER INFORMATION CONTACT: Coleman Sachs, Office of Vehicle Safety Compliance, NHTSA (202–366–3151). SUPPLEMENTARY INFORMATION: Background Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not originally manufactured to conform to all applicable FMVSS shall be refused admission into the United States unless NHTSA has decided that the motor vehicle is substantially similar to a motor vehicle originally manufactured for sale in the United States, certified under 49 U.S.C. 30115, and of the same model year as the model of the motor vehicle to be compared, and is capable of being readily altered to conform to all applicable FMVSS. Petitions for eligibility decisions may be submitted by either manufacturers or importers who have registered with NHTSA pursuant to 49 CFR Part 592. As PO 00000 Frm 00125 Fmt 4703 Sfmt 4703 specified in 49 CFR 593.7, NHTSA publishes notice in the Federal Register of each petition that it receives, and affords interested persons an opportunity to comment on the petition. At the close of the comment period, NHTSA decides, on the basis of the petition and any comments that it has received, whether the vehicle is eligible for importation. The agency then publishes this decision in the Federal Register. Barry Taylor Enterprises of Richmond, California (BTE)(Registered Importer 01–280) has petitioned NHTSA to decide whether nonconforming 2000 Chevrolet Tahoe multipurpose passenger vehicles are eligible for importation into the United States. The vehicles which BTE believes are substantially similar are 2000 Chevrolet Tahoe multipurpose passenger vehicles that were manufactured for sale in the United States and certified by their manufacturer as conforming to all applicable FMVSS. The petitioner claims that it carefully compared non-U.S. certified 2000 Chevrolet Tahoe multipurpose passenger vehicles to their U.S.-certified counterparts, and found the vehicles to be substantially similar with respect to compliance with most FMVSS. BTE submitted information with its petition intended to demonstrate that non-U.S. certified 2000 Chevrolet Tahoe multipurpose passenger vehicles, as originally manufactured, conform to many FMVSS in the same manner as their U.S. certified counterparts, or are capable of being readily altered to conform to those standards. Specifically, the petitioner claims that non-U.S. certified 2000 Chevrolet Tahoe multipurpose passenger vehicles are identical to their U.S.-certified counterparts with respect to compliance with Standard Nos. 102 Transmission Shift Lever Sequence, Starter Interlock, and Transmission Braking Effect, 103 Windshield Defrosting and Defogging Systems, 104 Windshield Wiping and Washing Systems, 106 Brake Hoses, 111 Rearview Mirrors, 113 Hood Latch System, 114 Theft Protection, 116 Motor Vehicle Brake Fluids, 118 PowerOperated Window, Partition, and Roof Panel Systems, 119 New Pneumatic Tires for Vehicles Other than Passenger Cars, 120 Tire Selection and Rims for Motor Vehicles Other than Passenger Cars, 124 Accelerator Control Systems, 135 Passenger Car Brake Systems, 201 Occupant Protection in Interior Impact, 202 Head Restraints, 204 Steering Control Rearward Displacement, 205 Glazing Materials, 206 Door Locks and Door Retention Components, 207 Seating Systems, 208 Occupant Crash E:\FR\FM\31MRN1.SGM 31MRN1

Agencies

[Federal Register Volume 73, Number 62 (Monday, March 31, 2008)]
[Notices]
[Pages 16956-16960]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6520]


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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[NHTSA Docket No. 2008-0030]


Highway Safety Programs; Model Specifications for Screening; 
Devices to Measure Alcohol in Bodily Fluids

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Notice.

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SUMMARY: This notice revises Model Specifications for Screening Devices 
to Measure Alcohol in Bodily Fluids (Model Specifications) published in 
the Federal Register on August 2, 1994 (59 FR 39382). These devices 
test for the presence of alcohol using breath or bodily fluids such as 
saliva. The Model Specifications support State laws that target 
youthful offenders (i.e., ``zero tolerance'' laws) and the Department 
of Transportation's regulations on Alcohol Misuse Prevention, and 
encourage industry efforts to develop new technologies (e.g., non-
breath devices) that measure alcohol content from bodily fluids.
    This notice removed testing of Interpretive Screening Devices 
(ISDs) and use of the Breath Alcohol Sample Simulator (BASS) device 
from the Model Specifications. The ISDs did not provide an unambiguous 
test result, as test results for ISDs are subjective and require 
interpretation by a test administrator or technician. Because the 
agency has determined the BASS device is not necessary for inclusion in 
the Model Specifications, this notice removes all references to the 
BASS device.
    Additionally, in order to ensure product integrity, this notice 
provides guidelines for retesting devices when manufacturers 
contemplate changes, revisions, or upgrades to alcohol screening 
devices on the Conforming Products List (CPL).
    These revisions to the Model Specifications will not affect devices 
currently listed on the CPL.

DATES: Effective Date: Revisions to these Model Specifications become 
effective on March 31, 2008.

FOR FURTHER INFORMATION CONTACT: For technical issues: Ms. De Carlo 
Ciccel, Behavioral Research Division, NTI-131, National Highway Traffic 
Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 
20590; Telephone: (202) 366-1694. For legal issues: Mr. David Bonelli, 
Office of Chief Counsel, NCC-113, National Highway Traffic Safety 
Administration, 1200 New Jersey Avenue SE., Washington, DC 20590; 
Telephone: (202) 366-5834.

SUPPLEMENTARY INFORMATION: 

I. Background

    As indicated in the Model Specifications published in 1994, the 
agency will modify and improve the Model Specifications as new data and 
test procedures become available and will alter the test procedures, as 
necessary, to meet unique design features of specific devices. Since 
publication of the Model Specifications, the agency encountered 
difficulties ensuring the accuracy of testing ISDs and also determined 
the use of the BASS is not necessary for inclusion in the Model 
Specifications. These events made it necessary to revise the Model 
Specifications.
    On December 14, 2007, (72 FR 71188), NHTSA proposed and sought 
comments on amendments and revisions to the Model Specifications 
published in 1994. In the notice, NHTSA explained that the 1994 Model 
Specifications allowed for evaluation of screening devices that require 
subjective interpretation of test results by a test administrator or 
technician. These ISDs differ from devices that provide objective test 
results, including the use of digital technology or the appearance of 
lights or marks based on the presence or absence of alcohol. For 
instance, use of pass/fail lights or enzymes that react with alcohol to 
produce an unambiguous mark provide objective test results. Also, the 
1994 Model Specifications required that interpretive devices be 
evaluated subjectively under five lighting conditions (fluorescent, 
incandescent, mercury, sodium and daylight) by a panel of ten novice 
evaluators who are not color blind. Since publication of the 1994 Model 
Specifications, NHTSA evaluated eight separate ISDs. Of those eight ISD 
evaluations, none resulted in a successful outcome in the panel test 
described above. In one evaluation, the device passed the test under 
all lighting conditions except sodium. This device is no longer 
manufactured. Although many novice evaluators were able to judge the 
correct test outcome in the eight ISD evaluations, some could not, even 
though the manufacturers' instructions were conveyed to the evaluators 
and all evaluators passed tests to determine their color perception 
ability. This subjective interpretation of test results does not ensure 
accuracy and precision required to protect public safety. Due to 
repeated problems in evaluating ISDs, NHTSA proposed to remove 
altogether testing of ISDs and all references to interpretive or color 
indicator tests from the Model Specifications.
    The 1994 Model Specifications provided for the use of the Breath 
Alcohol Sample Simulator (BASS) device for delivering alcohol-in-air 
test samples. The use of the BASS device is not necessary for inclusion 
in the Model Specifications because the BASS device is intended for use 
in testing the sampling efficiency of evidential breath testers. There 
is no sampling efficiency test in the Model Specifications for alcohol 
screening devices. The alcohol-in-air test sample for breath alcohol 
screening devices is supplied by a calibrating unit. Therefore, the 
agency proposed to remove all references to the BASS device from the 
Model Specifications.
    The 1994 Model Specifications also provide procedures to conduct 
special investigations and re-test a device if information gathered 
indicates that a device listed on the CPL is not performing in 
accordance with the Model Specifications. The agency proposed the 
addition of Appendix B to provide guidance regarding notification and 
re-testing when manufacturers contemplate revisions to devices listed 
on the CPL. The proposed Appendix follows the language used in the 
Model Specifications for evidential breath testing devices (58 FR 
48705). Upon notification by a manufacturer of a contemplated change to 
a device listed

[[Page 16957]]

on the CPL, NHTSA proposed that it would determine whether re-testing 
is required. Such determination would look at several factors, 
including the nature and reason for the change, the scope of the 
change, the effects of the change on the performance of the device, and 
how the change will be documented for the benefit of the user. NHTSA 
would list device revisions and whether re-testing was required in the 
next update to the CPL. Appendix B also would state that NHTSA may re-
test any device listed on the CPL at any time to determine continued 
compliance and performance with the Model Specifications. A device 
found not to perform in accordance with the Model Specifications would 
be subject to the special investigation procedures discussed below.
    Having received no comments on any aspect of the agency's proposal, 
this notice adopts the proposed revisions, including the ``Procedures'' 
and ``Model Specifications for Alcohol Screening Devices,'' without 
change.

II. Procedures

    This section describes the current procedures. The DOT Volpe 
National Transportation Systems Center (VNTSC), RTV-4F, Kendall Square, 
Cambridge, MA 02142 tests products manufacturers submit to determine 
whether the products meet the model specifications. Tests are conducted 
semiannually, or as necessary. Manufacturers are required to apply to 
NHTSA for a test date by writing to the Office of Behavioral Safety 
Research, NTI-130, NHTSA, 1200 New Jersey Avenue, SE., Washington, DC 
20590. At least 30 days are typically required from the date of 
notification until the test can be scheduled.
    One week prior to the scheduled initiation of the test program, 
manufacturers must deliver their devices to VNTSC. If the devices are 
disposable, the manufacturer must deliver at least 300 such devices; if 
the devices are reusable, the manufacturer need submit only a single 
device. If a manufacturer of a reusable device wishes to submit a 
duplicate, backup instrument, it may so do. The manufacturer is 
responsible for ensuring that the devices operate properly and are 
packaged correctly. The manufacturer must also deliver the operator's 
manual (or instructions) and the maintenance manual (if any) that is to 
be supplied with the purchase of the device, as well as specifications 
and drawings fully describing the device and its use. Information 
determined to be proprietary will be respected. (See 49 CFR Part 512, 
regarding the procedure by which NHTSA will consider claims of 
confidentiality.)
    In addition, the manufacturer must submit a self-certification, 
certifying that the manufacturer meets the requirements according to 
the U.S. Food and Drug Administration (FDA) Good Manufacturing 
Practices regulations for devices used for medical purposes (21 CFR 
Part 820), and that the device's label meets the requirements in FDA's 
Labeling regulations for devices used for medical purposes (21 CFR Part 
809.10), even if the devices are not to be used for medical purposes. 
See Appendix A to this notice.
    The manufacturer has the right to check its device(s) between the 
time of arrival at VNTSC and the start of the tests, but will have no 
access to the device(s) during the tests. Any malfunction of a device 
resulting in failure to complete any of the tests satisfactorily will 
result in a determination that the device does not conform to the Model 
Specifications. If a device is found not to conform to the Model 
Specifications, it may be resubmitted for the next testing cycle after 
appropriate corrections have been made. However, the agency reserves 
the discretion to determine whether to conduct any retest.
    The agency intends to update and republish the CPL in the Federal 
Register annually. Republications of the CPL add conforming alcohol 
screening devices tested since the last CPL republication.
    NHTSA will continue to provide notification in the Federal Register 
when the agency amends the Model Specifications as new data and test 
procedures become available and will retest devices when necessary.
    The NHTSA Office of Behavioral Safety Research is the point of 
contact for information about acceptance testing and field performance 
of devices that are in the marketplace. NHTSA requests that users of 
alcohol screening devices provide both acceptance and field performance 
data to the Office of Behavioral Safety Research when such data 
indicate potential performance problems. Information from users will 
help NHTSA monitor whether alcohol screening devices are performing 
according to the NHTSA Model Specifications.
    If information gathered indicates that a device on the CPL is not 
performing in accordance with the Model Specifications, NHTSA may 
direct VNTSC to conduct a special investigation. An investigation may 
include visits to users and additional tests of devices obtained on the 
open market. If the investigation indicates that a device actually sold 
on the market does not meet the Model Specifications, the manufacturer 
will be notified that the device may be removed from the CPL. In this 
event, the manufacturer will have 30 days from the date of notification 
to reply. Based on the VNTSC investigation and any data provided by the 
manufacturer, NHTSA will decide whether the device should remain on the 
CPL. If the device is removed from the CPL, the manufacturer will be 
permitted to resubmit an improved device to VNTSC for testing when it 
believes the problems causing its failure have been resolved. Upon 
resubmission, the manufacturer must submit a statement describing what 
has been done to overcome the problems that led to failure of the 
device. The agency reserves the discretion to determine whether to 
conduct any retest.
    If information gathered indicates that the manufacturer of a device 
on the CPL does not comply with the requirements in FDA's Good 
Manufacturing Practices regulations for devices used for medical 
purposes or that the device's label does not comply with the 
requirements in FDA's labeling regulations for devices used for medical 
purposes, NHTSA may investigate the matter in consultation with FDA and 
will notify the manufacturer that the device may be removed from the 
CPL. The manufacturer will have 30 days from the date of notification 
to reply. Based on any data provided by the manufacturer and 
investigative findings, NHTSA will decide whether the device should 
remain on the CPL. If the device is removed from the CPL, the 
manufacturer will be permitted to resubmit a self-certification, 
certifying that the manufacturer or its device complies with these FDA 
requirements when it believes the problems causing its non-compliance 
have been resolved. Upon resubmission, the manufacturer must submit a 
statement describing what has been done to overcome the problems that 
led to non-compliance.
    In accordance with the foregoing, the amendments of the Model 
Specifications for Screening Devices to Measure Alcohol in Bodily 
Fluids, are set forth below.

Model Specifications for Alcohol Screening Devices

1. Purpose and Scope
    These specifications establish performance criteria and methods for 
testing of alcohol screening devices. Alcohol screening devices use 
bodily fluids to detect the presence of 0.020 or more BAC (see below) 
with sufficient

[[Page 16958]]

accuracy for screening purposes. These specifications are intended 
primarily for use in the conformance testing of alcohol screening 
devices.
2. Classification
    2.1 Disposable Alcohol Screening Devices.
    Alcohol screening devices designed for a single use.
    2.2 Reusable Alcohol Screening Devices.
    Alcohol screening devices designed to be reused.
3. Definitions
    3.1 Alcohol.
    The intoxicating agent in beverage alcohol, ethyl alcohol or other 
low molecular weight alcohols including methyl or isopropyl alcohol.
    3.2 Alcohol Screening Device.
    A device that is used to detect the presence of 0.020 or more BAC. 
The device may measure any bodily fluid for this purpose, but shall 
provide output in BAC units. Test results must be indicated 
unambiguously by numerical read-out or by other means, such as by the 
use of lights or by the appearance of a distinctive mark but not by 
color change.
    3.3 Blood alcohol concentration (BAC).
    Grams alcohol per 100 milliliters of blood or grams alcohol per 210 
liters of breath in accordance with the Uniform Vehicle Code, Section 
11-903(a)(5) \1\ (BrAC is often used to indicate that the measurement 
is a breath measurement); or grams alcohol per 100 milliliters of 
saliva.
---------------------------------------------------------------------------

    \1\ Available from the National Committee on Uniform Traffic 
Laws and Ordinances, 107 S. West Street,  10, Alexandria, 
VA 22314. Web site address: http://www.ncutle.org
---------------------------------------------------------------------------

    3.4 Calibrating Unit.
    A device that produces an alcohol-in-air test sample of known 
concentration and that meets the NHTSA Model Specifications for 
Calibrating Units (72 FR 34742).
    3.5 Bodily Fluid.
    Any bodily fluid capable of being used to estimate alcohol 
concentration, provided the relationship between such bodily fluid and 
BAC has been established according to scientifically acceptable 
standards. Such fluids include but are not limited to blood, exhaled 
deep lung breath and saliva.
    3.6 Scientifically Acceptable Substitutes.
    Fluids that have been scientifically accepted as equivalent to 
bodily fluids for testing purposes, such as aqueous alcohol test 
solutions on a one-to-one basis for blood or saliva.
4. Test Methods and Requirements
    Testing will be performed according to the instructions that 
normally accompany the submitted device and under the conditions 
specified in the tests below.
    4.1 Test 1. Precision and Accuracy.
    Perform 40 trials under normal laboratory conditions including 20 
trials at 0.008 BAC and 20 trials at 0.032 BAC. Use a calibrating unit 
for this test for breath devices and preparations of bodily fluids or 
scientifically acceptable substitutes for non-breath devices. Perform 
tests using a VNTSC investigator.
    To conform at 0.008 BAC, not more than one positive result. To 
conform at 0.032 BAC, not more than one non-positive result.
    4.2 Test 2. Blank Reading.
    Perform 20 trials under normal laboratory conditions at 0.000 BAC. 
Use non-alcoholic human breath for breath devices and non-alcoholic 
bodily fluids or scientifically acceptable substitutes for non-breath 
devices. Perform tests using a VNTSC investigator.
    To conform: no positive results. If the device is capable of 
providing a reading of greater than 0.000 BAC and less than 0.020 BAC, 
not more than one such result.
    4.3 Test 3. Cigarette smoke interference (only breath and saliva 
test devices).
    Perform five trials at 0.000 BAC. Select an alcohol-free person who 
smokes cigarettes for this test. Ask the person selected to smoke 
approximately one half of a cigarette. Within one minute after smoking, 
or after a waiting period specified in the manufacturer's instructions, 
administer the alcohol screening device test according to the 
manufacturer's instructions. Then ask the person to take another smoke 
and repeat the test to produce a total of five trials.
    To conform: no positive results.
    4.4 Temperature.
    Test at low and high ambient temperature.
    4.4.1 Test 4.1. Low Ambient Temperature.
    Perform 40 trials at 10 degrees Centigrade (C), including 20 trials 
at 0.008 BAC and 20 trials at 0.032 BAC. Use a calibrating unit for 
this test for breath devices and preparations of bodily fluids or 
scientifically acceptable substitutes for non-breath devices.
    To conform at 0.008 BAC, not more than one positive result. To 
conform at 0.032 BAC, not more than one non-positive result.
    4.4.2 Test 4.2 High Ambient Temperature.
    Perform trials of 40 devices at 40 degrees C, including 20 trials 
at 0.008 BAC and 20 trials at 0.032 BAC. Use a calibrating unit for 
this test for breath devices and preparations of bodily fluids or 
scientifically acceptable substitutes for non-breath devices.
    To conform at 0.008 BAC, not more than one positive result. To 
conform at 0.032 BAC, not more than one non-positive result.
    4.5. Test 5. Vibration.
    Perform 40 trials, including 20 trials at 0.008 BAC and 20 trials 
at 0.032 BAC. Use a calibrating unit for this test for breath devices 
and preparations of bodily fluids or scientifically acceptable 
substitutes for non-breath devices.
    Mount the screening device on a shake table and vibrate the table 
in simple harmonic motion through each of its three major axes, as 
specified below. Sweep through each frequency range in 2.5 minutes, 
then reverse the sweep to the starting frequency in 2.5 minutes. 
Disposable testers may be placed in a suitable box mounted on the shake 
table. Test after vibration.

------------------------------------------------------------------------
                                                              Amplitude
                                                               (inches,
                     Frequency (hertz)                         peak to
                                                                peak)
------------------------------------------------------------------------
10 to 30...................................................         0.30
30 to 60...................................................         0.15
------------------------------------------------------------------------

    To conform at 0.008 BAC, not more than one positive result. To 
conform at 0.032 BAC not more than one non-positive result.
    Appendix A--Labeling Instructions for Alcohol Screening Devices' 
Intended Use Provide the intended use including the specimen matrix 
(e.g. saliva, breath), the assay type (quantitative, semi-
quantitative), the purpose of performing the assay, and the individual 
designated to perform the assay.
    e.g.: This product is intended for the (quantitative, semi-
quantitative) determination of alcohol in --define matrix (for e.g., 
saliva, breath, sweat) to perform screening alcohol assays.
     This product is recommended for use by individuals who have been 
trained in the administration of screening devices.
Description of Testing System
    Provide the principles of the procedure for performing the alcohol 
screening assay.
    e.g.: This product uses (alcohol dehydrogenase, infrared 
technology, etc.) to perform the test.
Chemical Reaction Sequence
    Describe the chemical reaction sequence, if applicable.

[[Page 16959]]

    Reagents: List the concentration, strength, and composition of the 
reactive ingredients.
    List the non-reactive ingredients.
Reagent Preparation and Storage
    Provide instructions for preparing the reagents, if applicable.
    Provide instructions for storing the reagents, if applicable.
    Provide any signs of deterioration of the reagents, if applicable.
    Provide the reagents' shelf life and opened expiration dating, if 
applicable.
    e.g.: Tests in unopened packaging are stable until the date printed 
on the product container when stored at 22-28 degrees C. If packaging 
is opened, tests must be conducted at once.
    Provide a caution not to use the reagents beyond the expiration 
date.
Precautions
    1. List any reagents that may be hazardous such as caustic 
compounds, sodium azide or other hazardous reagents and instructions 
for disposal, if applicable.
    2. Provide warning to user to treat all samples as potentially 
infective. Include instructions for handling and disposal of the 
sample.
Specimen Collection
    Provide instructions for collecting and handling the sample.
    Provide criteria for specimen rejection, if applicable.
Calibration
    Disposable tests are pre-calibrated. No additional calibration is 
required.
    Reusable (Instrumented) tests require calibration.
    Provide information regarding how calibrations are to be conducted, 
if applicable, including the number and concentration of calibrators, 
and the frequency of calibration.
    Provide instructions for calibration and recalibration.
    Provide the criteria for acceptability of calibration.
Test Procedure (Disposable)
    Provide adequate step-by-step instructions for performing the test 
and determining the results.
Test Procedure (Re-usable/Instrumented)
    Provide adequate step-by-step instruction for performing the test.
    Provide the installation procedures and, if applicable, any special 
requirements.
    Provide the space and ventilation requirements.
    Provide the description of the required frequency of equipment 
maintenance and function checks.
    Provide the instructions for any remedial action to be taken when 
the equipment performs outside of its operating range.
    Provide any operational precautions and limitations.
    Provide instructions for the protection of equipment and 
instrumentation from fluctuations or interruptions in electrical 
current that could adversely affect test results and reports, if 
applicable.

Quality Control (QC)

Disposable Tests
    If applicable, the function and stability of the test can be 
determined by the examination of the procedural ``built in'' controls 
contained in the product. If these controls are not working, the test 
is invalid and must be repeated.
Disposable/Instrumented Devices
    If external quality control materials are used, provide the number, 
type, matrix and concentration of the QC materials.
    Provide directions for performing quality control procedures.
    Provide an adequate description of the remedial action to be taken 
when the QC results fail to meet the criteria for acceptability.
    Provide directions for interpretation of the results of quality 
control samples.
Results
    Describe how the user obtains the test results, e.g., from an 
instrument read-out, printout, etc.
    Describe the results in terms of blood alcohol concentration.
    Describe what concentration indicates a positive result and what 
concentration indicates a negative result.
Limitations
    List the substances or factors that may interfere with the test and 
cause false results including technical or procedural errors.
Dynamic Range
    Provide the operating range of the product.
Precision and Accuracy
    Only devices that meet the precision and accuracy of these Model 
Specifications will be included on NHTSA's Conforming Products List for 
alcohol screening devices.
Specificity
    List the substances that have been evaluated with your product that 
do or do not interfere at the concentration indicated.
References
    Provide pertinent bibliography.
Technical Assistance
    List an 800 number the user may contact for further information or 
technical assistance.
Appendix B--Guidelines for Re-testing of Modified Screening Devices
    Manufacturers contemplating revisions to an alcohol screening 
device listed on the Conforming Products List (CPL) are advised that 
the revision may affect the status of the device on the CPL. The 
manufacturer should inform NHTSA of the contemplated change so that a 
judgment can be made whether or not re-testing the revised alcohol 
screening device is necessary. The following lists the type of 
information NHTSA uses in determining the necessity to re-test an 
alcohol screening device, and is provided as guidance to manufacturers:
     Manufacturer and Model Name.
     Nature and reason for change(s).
     Scope of change(s) (e.g., Will existing devices be 
retrofitted? Will the change apply to some users but not others?)
     Will the change(s) affect performance of the device with 
regard to the Model Specifications? (Precision and accuracy, blank 
reading, temperature operations, or vibrations.)
     How will the change(s) be documented for the benefit of 
the user? (e.g., Will the change(s) be documented in service bulletins 
and/or service manuals? If not, why not?)
    If necessary for clarity, drawings of the listed and changed device 
may also be helpful in NHTSA's deliberations.
    If, upon review of information provided by a manufacturer, it is 
determined that re-testing is not warranted, a statement to that effect 
will be included in the next scheduled CPL update.
    NHTSA reserves the right to test any CPL-listed device on the open 
market to determine continued compliance and performance in accordance 
with these Model Specifications. Devices found not to comply with or 
perform in accordance with the Model Specifications are subject to the 
investigation provisions stated above in section II, Procedures.

    Authority: 23 U.S.C. 403; 49 CFR 1.50; 49 CFR Part 501.


[[Page 16960]]


    Issued on: March 25, 2008.
Marilena Amoni,
Associate Administrator for the Office of Research and Program 
Development.
[FR Doc. E8-6520 Filed 3-28-08; 8:45 am]
BILLING CODE 4910-59-P