RFP_DTNH2216R00036.pdf

DTNH2216R00036

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

1 69

C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

CAUTION: LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

(Date)(Hour) local timeuntildepository located in copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

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K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

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G

F

E

D

C

B

A

SEC. DESCRIPTION PAGE(S) (X) DESCRIPTION SEC. (X)

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

CALENDAR DAYS (%)30 CALENDAR DAYS (%)20 CALENDAR DAYS (%)10 CALENDAR DAYS (%)

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the

12. In compliance with the above, the undersigned agrees, if this offer is accepted within ______________ calendar days (60 calendar days unless a different period is inserted

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

CODE 24. ADMINISTERED BY (If other than Item 7)

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

41 U.S.C. 253 (c) ( 10 U.S.C. 2304 (c) (

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

DTNH2216RQ-0015805/04/2016

X

NHTSA NPO-320

Office of Acquisition Management 1200 New Jersey Ave SE Washington DC 20590

1230 ES 08/15/2016

VANESSA WALLACE 202

vanessa.wallace.ctr@dot.gov

366-9773

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PAGE(S)

Sherese Gray

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (Rev. 9-97)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

1-2

4-20 21-22 24-28 29-33 34-39

40-45

47-53

54-69

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 69

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

DTNH2216R00036

(A) (B) (C) (D) (E) (F)

Feasibility of Field Sobriety Test for THC--Phase II Laboratory Study

FOB: Unknown

00001 Feasibility of Field Sobriety Test

OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

NSN 7540-01-152-8067

REQUEST FOR PROPOSAL

Examine the Feasibility of a Standardized Field Test for

Marijuana Impairment: Laboratory Evaluations

SOLICITATION # DTNH2216R00036

SECTION B SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 SERVICES

a. The Contractor shall furnish all the necessary facilities, materials, personnel and services to perform the effort entitled: “Examine the Feasibility of a

Standardized Field Test for Marijuana Impairment: Laboratory

Evaluations” in support for the National Highway Traffic Safety

Administration’s (NHTSA), Office of Behavioral Safety Research in accordance with Section C, “Statement of Work” and as itemized in Section F, “Deliveries or Performance.” All support services provided to the Government shall be performed by the Contractor’s employees or personnel otherwise retained by the Contractor to fulfill specific work requirements of the resultant

Contract.

b. The Government anticipates award of a Cost Plus Fixed Fee (CPFF) contract as described in FAR 16.306.

B.2 TOTAL ESTIMATED AMOUNT

The total estimated amount for this contract is $__________ which comprises a total estimated cost of $__________ and a fixed fee of $_________.

Note: The Contracting Officer (CO) is the only individual who can legally commit or obligate the Government to the expenditure of public funds. No cost chargeable to the proposed contract can be incurred before receipt of a fully executed contract or specific written authorization from the Contracting Officer.

(End of Section B)

SECTION C DESCRIPTION/SPECS./WORK STATEMENT

C.1 BACKGROUND

The National Highway Traffic Safety Administration (NHTSA) is an agency of the

U.S. Department of Transportation (DOT). NHTSA’s mission is to save lives, prevent injuries and reduce traffic-related health care and other economic costs.

Pursuant to its authority under 23 U.S.C. 401, et. seq., the agency develops, researches, promotes and implements effective educational, engineering and enforcement programs with the goal of ending preventable tragedies and reducing economic costs associated with vehicle use and highway travel.

The Office of Behavioral Safety Research focuses on improving the safety of drivers, occupants, pedestrians, and other road users through laboratory research, field studies, national surveys, and analyses of observational and archival data.

Police officers often use roadside tests to determine alcohol impairment as part of

Driving While Intoxicated/Impaired (DWI) arrests. During a typical investigation, a police officer, who has reason to believe that a driver is impaired by alcohol, will administer a series of roadside tests to the driver. The roadside tests serve to confirm the initial suspicion and may provide probable cause to arrest the driver for DWI. The driver's performance on these tests is also a critical part of the evidence presented in court to support the DWI charge. The Standardized Field Sobriety Test (SFST ) which is used widely today, was calibrated to assist officers in determining whether the Blood Alcohol

Concentration (BAC ) of a person stopped for suspicion of DWI is above or below .10 grams per deciliter (g/dL). Currently the test battery is calibrated to and validated at .08 grams per deciliter (g/dL) BAC

Currently, there is no similar test for use at roadside to determine whether a driver is impaired by a drug, other than alcohol. NHTSA’s 2013-2014 National Roadside

Survey found that 20.0 % of weekend nighttime drivers were positive for a drug . The most prevalent drug found was marijuana , at 12.6%

Given the prevalence of marijuana-positive drivers, and current of legal use of marijuana (e.g., Alaska, The SFST consists of the Walk and Turn Test, One Leg Stand, and a measure of Horizontal Gaze Nystagmus.

Anderson, T, Schweitz, R., & Snyder, M. (1983). Field evaluation of a behavioral test battery for DWI (DOT HS

806 475). Washington, DC: National Highway Traffic Safety Administration.

The BAC is measured as the weight of alcohol in a volume of blood, measured in grams per deciliter or g/dL).

Stuster, J., & Burns, M. (1998). Validation of the standardized field sobriety test battery at BACs below 0.10 percent (DOT HS 808 839). Washington, DC: National Highway Traffic Safety Administration.

4 Over-the-counter, prescription, or illegal drug 5The terms marijuana, cannabis, and THC will be used interchangeably to represent the active ingredient

(THC) in the plant (marijuana, Latin name cannabis).

6 Berning, A., Compton, R., & Wochinger, K. (2015). Results of the 2013–2014 National Roadside Survey of

Alcohol and Drug Use by Drivers (DOT HS 812 118). Washington, DC: National Highway Traffic Safety

Administration.

Colorado, Oregon, Washington, and the District of Columbia, which have legalized recreational use), NHTSA seeks to explore the feasibility of a standardized test battery for roadside use to detect marijuana impairment in drivers.

NHTSA is examining the feasibility of a standardized field test for marijuana impairment in phases. In Phase I of this project, NHTSA awarded a contract to gather, evaluate, and interpret recent literature on tests of impairment from marijuana or other drug use. A number of different tests were reviewed, including tests of cognitive ability, behavioral tests, tests of physical capability, physiological tests, and driving skills tests. Based on the results of the review, NHTSA has selected a list of tests to be validated in a laboratory studies for Phase II. These tests can be categorized into 5 general domains:

1. General Cognition/Memory (e.g., free recall tests, divided attention tasks, time production tasks, tonal preference tasks);

2. Inhibitory Processes (e.g., reaction time tasks, stop-signal tasks, go/no-go tasks, identical pairs paradigm);

3. Hand-Eye Coordination (e.g., critical tracking tasks, rotor pursuit tasks, and stylus-and-groove task);

4. General Motor Coordination (e.g., one-leg stand test, body sway evaluations, finger-to-nose test); and

5. Emotional Processing (e.g., facial emotion recognition tasks, identical pairs paradigm).

The results of the laboratory tests will determine whether NHTSA will move forward to Phase III—field studies. The goal of the field studies will be to develop a test battery that will be examined in diverse settings, given by diverse users, and administered with inexpensive or low-tech equipment/means.

This project, Phase II, covers only the laboratory evaluation of tests within the above domains that NHTSA will select.

C.2 OBJECTIVES

The objectives of this contract are to:

1. Operationally define the constructs, impairment, drug detection, and performance, so that variations in performance based on dosing can be identified;

2. Establish procedures for determining which tests shall be used and methods for evaluating the tests (e.g., validity, specificity, sensitivity, and reliability);

3. Arrange for collecting blood or oral fluid samples from subjects prior to or after testing to determine whether blood or oral fluid levels correlate with observed changes in performance;

4. Provide an analysis of the test results and a scoring system for evaluating results;

5. Based on the results of the evaluations, make recommendations for

a. Promising test and/or combinations of tests that could be further validated in additional laboratory and/or field studies (that can be demonstrated to be useful in diverse settings and by diverse users, and with inexpensive or low-tech equipment/means);

b. Determining testing procedures (e.g., number of trials for criterion score, test item order); and

c. Estimating the time and cost of developing the test or test battery.

C. 3 GENERAL REQUIREMENTS

The Contractor shall carry out laboratory-controlled evaluations to assess the accuracy, feasibility, and utility of individual tests, and potential combinations of tests, to work towards the development of a standardized battery to determine whether a person has recently used marijuana. A complex issue that needs to be thoroughly discussed is defining “impairment” and how that will be quantified and/or scored with individual tests and/or combinations of tests to determine either the presence of a drug or determine impairment. Can a test or tests be developed that would accurately and reliably determine whether a subject has recently used or is impaired by marijuana? Such a test, or combination of tests, should have a low false positive rate and a low false negative rate

(less critical).

It is expected that testing would include dosing subjects with marijuana, and performing the selected tests. As such, the contractor shall discuss all issues involved with testing subjects with cannabis, including human subjects and legal issues.

C.4 DEFINITIONS AND ACRONYMS

The following is a list of key definitions and acronyms used throughout the Statement of Work (SOW). This list may not be exhaustive.

C.4.1 Acronyms

APA American Psychological Association

BAC Blood Alcohol Content

CD Compact Disc

CO Contracting Officer

COR Contracting Officer’s Representative

CS Contracting Specialist

DEA Drug Enforcement Agency

DOT U.S. Department of Transportation

DWI Driving While Intoxicated

FAR Federal Acquisition Regulation

FDA Food and Drug Administration

HTML Hyper Text Markup Language

IDE Investigational Device Exemption

IND Investigational New Drug

IRB Internal Review Board

NHTSA National Highway Traffic Safety Administration

OMB Office of Management and Budget

PDF Portable Document Format

PII Personally Identifiable Information

POC Point of Contact

QAR Quality Assurance Reviewer

SFST Standardized Field Sobriety Test

SOW Statement of Work

TAR Transportation Acquisition Regulation

THC Tetrahydrocannabinol

.jpg Joint Photographic Expert Group

.tiff Tagged Image Format

C.5 SPECIFIC REQUIRMENTS

Below is more detailed description of each of the tasks necessary to complete the project objectives.

C.5.1 Conduct Kick-Off Meeting

The objective of this task is for the Contractor to meet with the NHTSA, COR, CO and/or CS, and any other interested NHTSA personnel to discuss the administration of the Contract, the project’s objectives, planned course of action, milestones and deliverables, and other issues the Contractor or

Government identifies.

The Contractor shall work with the NHTSA COR to prepare a “Kick-Off” briefing on the project for NHTSA personnel. The meeting shall cover the project’s objectives, overall project methodology, plan for accomplishing each task, and discussion of potential issues. The briefing will be approximately one (1) hour, with the NHTSA COR leading the discussion, especially regarding the objectives and overall strategy, with the Contractor providing information on specific approaches for accomplishing individual tasks. The

Contractor shall submit draft briefing materials (e.g., PowerPoint slides) to the

NHTSA COR at least one week before the briefing. The NHTSA COR will provide comments on the materials within 3 days of receipt.

Immediately following the formal Kick-Off briefing, the Contractor shall meet with the NHTSA COR, and other NHTSA staff with particular interest in the area, in a working meeting to discuss any unresolved issues.

The kick-off briefing and follow-up meeting may be held at NHTSA

Headquarters in Washington, DC, or, at the NHTSA COR’s request, may occur as a conference call. Overall, the Contractor shall allow for a minimum of three (3) hours of meeting time with NHTSA to complete this task.

The result of this task will be to gain a better understanding between NHTSA and the Contractor as to project goals and how they will be accomplished.

This task shall be completed within six (6) weeks after award.

C.5.2 Refine the Study Protocol

The Contractor shall make adjustments to the Draft Study Protocol submitted with their proposals based on discussions with NHTSA and other interested parties during the Kick-Off and other discussions.

The Draft Study Protocol shall address at least the following:

a) The number of participants to be used;

b) Demographic profile of potential participants (i.e., age, sex, ethnicity, drug use experience);

c) How subjects will be recruited and screened, and compensated;

d) Address optimal experience and current use of marijuana;

e) Dosing procedures, including dose amount and how the participants shall ingest the drug;

f) single drug dosing vs. drug+ alcohol dosing;

g) Safety / emergency medical procedures;

h) Identity of the individuals(s) who will administer the measures;

i) Order of testing, and how dosed level of marijuana shall be maintained;

j) Scoring of measures/determination of decrement and “impairment” of performance;

k) Reliability of the measures (e.g., test-retest reliability); and

l) Validity assessments (e.g., construct, criterion, and external)

The Revised Study Protocol shall be submitted to the NHTSA COR within eight (8) weeks after award. Within two (2) weeks from the time NHTSA receives the Contractor’s Revised Study Protocol, the NHTSA COR will either approve the protocol, or will contact the Contractor for revisions.

NHTSA may elect to add optional tasks (see C.5.13-C.5.18) that will allow the Contractor to pilot test additional individual, contextual, and study design characteristics (e.g., demographic characteristics, dosing levels, dosing procedures, potency levels, tests and test combinations, alcohol level(s)) that may impact impairment and/or performance on the tests. The optional tasks will allow for additional participants to be recruited to address additional individual, contextual, and study design characteristics. The Contractor shall prioritize the order in which additional individual and contextual characteristics should be addressed and evaluated for the initial study and for the optional tasks.

C.5.3 Submit Study Protocol for IRB, FDA, and DEA Review

Because this solicitation involves clinical research, it requires at least one physician with a DEA license(s) to serve as the Principal Investigator (PI).

The Contractor’s PI (i.e., the Physician) shall be responsible for overseeing all aspects of the initiation and execution of the study. Study Investigators (e.g., Co-PI, Project Manager) will contribute substantially to the preparation of these materials, but the PI will need to modify them as appropriate for their site and obtain the necessary regulatory approvals. The project Manager and other contractor staff shall be responsible of all other aspects required to carry out the project protocol (e.g., recruiting participants, conducting the tests, and collecting biological specimens).

The Contractor shall submit the study protocol (including informed consent document), to an IRB for approval. The PI shall interact with the IRB as appropriate to ensure approval, including timely response to any questions, requests for additional information, or stipulation. Depending on the method that the cannabis will be administered, (e.g., smoked, inhaled, eaten) the

Contractor shall also have to submit an Investigational New Drug (IND) and/or an Investigational Device Exemption (IDE) application to the FDA for approval to administer the cannabis as described in the research protocol. The

Contractor shall have to acquire a DEA license to receive and store cannabis for the study, if the Contractor does not have a preexisting license.

The Study Protocol shall be submitted to the IRB within two (2) weeks of receiving feedback from the NHTSA COR. Following IRB approval, the contractor shall submit their respective applications to FDA and DEA for approval.

C.5.4 Submit Data Analysis Plan

Within two (2) weeks of IRB approval of the Study Protocol, the Contractor shall submit a detailed Data Analysis Plan that addresses how decrements in performance shall be operationally defined, how the tests shall be evaluated, and as necessary, how test battery development shall be determined.

The contractor, considering the percentage of false positives and false negatives, shall rank the tests, according to the sensitivity, specificity, and accuracy of the tests in determining whether a subject is impaired. The analysis shall include the probability that each test is capable of identifying a participant as being impaired following cannabis ingestion.

Other factors may influence the probability that a test is capable of identifying a participant that is impaired following cannabis ingestion. Some of those factors include drug experience, demographic characteristics, or other individual or contextual aspects that contribute to the participants performing differently on the tests. If the Contractor includes these factors as part of the study design, the contractor shall also separately rank the tests by the particular covariate.

The Contractor shall specify the analyses developed to address each of the research questions (developed in collaboration with NHTSA Staff). The

Contractor shall discuss and perform, but shall not be limited to, descriptive, nonparametric, regression, and discriminant function analyses of the data, and any other analyses suggested by the contractor and/or NHTSA COR, and approved by NHTSA.

The Contractor shall provide a data analysis plan to the NHTSA COR within two

(2) weeks of IRB approval. The NHTSA COR will provide the Contractor with any needed comments within two (2) weeks of receipt. Data analysis (see C.5.7) shall not proceed until the Contractor has received consent from the NHTSA

COR.

C.5.5 Commence Participant Recruitment, Enrollment, Screening, & Training

To fulfill the objectives of this task, the contractor shall

1. Recruit sufficient study applicants;

2. Enroll participants through an initial screening procedure;

a) Perform the formal Study Screening Procedure;

b) Retain sufficient (n=12) participants to study completion;

3. Train enrolled participants in study procedures; and

4. Schedule the study sessions to maximize resources.

The Contractor shall employ all IRB-approved recruiting methods, including print, radio, television, and internet advertising. Effort, such as follow-up phone calls, shall be made to retain enrolled participants for the duration of the study.

The Contractor shall use an initial phone interview to determine eligibility based upon criteria as defined by the protocol. Study staff shall explain the study, time commitment, and compensation at this time, and answer any questions raised by potential participants. The Contractor shall invite eligible applicants to the clinical unit for an in-person comprehensive psychological and medical evaluation to confirm compliance with all study criteria.

The Contractor shall provide consent documents to eligible applicants in person using the consent form and consent procedures approved by the IRB.

A participant will be considered enrolled in the study once s/he has signed the consent document. No research study procedures (apart from recruitment and the basic initial screening) will occur prior to enrollment.

Within two (2) weeks of IRB approval of the Study Protocol, the Contractor shall commence participant recruitment, enrollment, screening, and training.

C.5.6 Carry Out the Study Protocol

The contractor shall carry out tasks C.5.6a-C.5.6d to execute the study methodology and procedures as detailed in the IRB-approved study protocol

(see Task C.5.3).

C.5.6a—Conduct the Participants through the Study Protocol. The contractor shall guide enrolled participants through the dosing regimen and all study tests as described by the IRB-approved protocol through the following actions:

Admission to a research unit the night before dosing;

Transportation to the research facility the morning of dosing;

Administration of study drugs, depending on the experimental condition;

Evaluation using cognitive and psychomotor tests;

Administration and evaluation of participants’ examinations to determine eligibility for discharge;

Provision of a second-night stay at the research unit, if judged by the clinical staff to be medically necessary (NHTSA expects this to occur no more than a maximum of 3 times during the administration of the study protocol);

Confirmation that the participant remains study eligible at the start of the study;

Treatment and follow-up until resolution of any adverse events as necessary.

The Contractor shall follow all procedures as detailed by the IRB-approved research protocol. Participants will spend the night prior to dosing in the research unit to ensure no intoxication immediately prior to dosing. The

Contractor shall provide all meals, beverages, and appropriate lodging to participants for the duration of the study session, including the inpatient stay(s). The urine of female participants with reproductive potential shall be screened for pregnancy prior to each session.

The Contractor shall arrange for transportation from the research unit to the study facility on the morning of dosing. The Contractor shall be responsible for preparing the cannabis doses as described by the protocol, and maintain the double-blind nature of the experiment (those administering drugs and in contact with participants must be kept blind to the nature of the administered drugs). Study staff shall administer drugs to participants per the IRB-approved protocol procedure in a controlled and supervised manner. Study staff shall monitor participants for the entire session duration after dosing. The

Contractor shall handle any adverse events in accordance with IRB and FDA guidelines and good clinical practice and standards of medical care.

The Contractor shall provide participants with the option for a second night inpatient stay at the research unit, and transportation, if they accept. At the conclusion of the session, qualified study staff will administer an exam to determine participant’s eligibility for discharge. The Contractor shall provide transportation home after the study session (at no expense to participants), and advise participants not to drive for the remainder of the day.

C.5.6b—Carry Out Biological Specimen Collection. The contractor shall carry out Biological Specimen Collection and appropriately store the following specimens for each participant/session at the specific time points as described by the IRB- approved protocol:

Oral fluid collection by collection devices (TBD); and

Whole blood or plasma collection

The Contractor shall possess and maintain the breath analysis equipment. The breath analysis shall be conducted and recorded each time biological specimens are collected per the IRB-approved protocol.

Oral fluid shall be collected at each time point indicated by the IRB-approved protocol, using a collection device (which shall be determined by NHTSA and the Contractor prior to submitting the protocol to the IRB; the Contractor shall make suggestions for devices they deem appropriate, along with justification for the suggestion(s)). All relevant study staff shall be trained on oral fluid collection as appropriate.

The Contractor shall ensure that peripheral venous blood collection occurs at appropriate times as indicated by the protocol, using IRB-approved procedures and good clinical practice. An indwelling peripheral venous catheter may be placed by qualified clinicians to facilitate this process and minimize participant discomfort. Each time point will require two blood samples; blood samples will be stored refrigerated or on ice; study staff must centrifuge and separate plasma from the correct collection tube within 2 hours of collection. Blood and plasma samples will then be frozen at -20°C until shipment, on dry ice, to a drug testing laboratory (whether the contractor or

NHTSA shall procure the drug testing laboratory shall be determined at a later date by NHTSA, see Section C.5.14, Optional Task B). The contractor shall train study staff in blood sample storage and shipment procedures as appropriate.

The Contractor shall collect all biological specimens into appropriate containers as specified by the IRB-approved protocol, and store specimens in appropriate containers as specified by the protocol, in a secure freezer with proper identification labels. These labels must include the encoded participant information and collection time, and shall exclude personally identifiable information (PII). The samples shall be overnight-shipped frozen on dry ice using a certified courier service to be determined drug-testing laboratory. In the interim, the specimens shall be batched for shipment, and maintained in adequate frozen storage of at least 20C.

C.5.6c—Administer Tests. The Contractor shall administer tests to assess the impact of cannabis ingestion as described in the IRB-approved study protocol.

NHTSA staff shall make suggestions for the types of tests to be performed in the IRB-approved study protocol. Examples of these evaluations may include psychological evaluations of impulsivity and risk perception.

Study staff shall administer the test described by the protocol at the times indicated. All data collected should be stored on a secure server.

C.5.6d—Document Data Collection & Study Procedures. The contractor shall document all procedural aspects using IRB-approved forms. The

Contractor shall keep thorough records of all measurements made per the

IRB-approved protocol that includes:

vital signs, periodically monitored (i.e., heart rate, systolic and diastolic blood pressure, respiratory rate) in accordance with the IRB-approved study protocol;

the date/time of all procedures during study sessions;

any adverse events in accordance with IRB and FDA guidelines, including date, time of onset and resolution, seriousness, severity, study relatedness, steps taken to treat (if any), and condition of participant at resolution of adverse event or last contact; all adverse events, including, but not limited, to adverse drug reactions, shall be documented in accordance with IRB guidelines and good clinical practice;

verification of continued eligibility shall be recorded along with associated time and date.

These records shall be stored and secured by the contractor, organized by participant and experimental condition, and made available to the NHTSA

COR upon request.

Initiation of Data collection shall begin within 1 month of IND/IDE & IRB approval. Completion data collection shall occur within 28 months of

IND/IDE & IRB approval.

Monthly progress reports, within 1 month of IRB approval, should begin to include the number of enrolled participants, the number of completed sessions per participant, and any other pertinent information—through the data collection period. All recorded experimental data, including reports of adverse events, shall be recorded and reported within 2 working days of the session for all adverse events, except serious adverse events that must be reported within

1 day to the NHTSA COR, and as required by the FDA for all other parties.

(See also sections F.4.1 and F.4.1a)

C.5.7 Implement Data Analysis Plan

The goal is to determine, which among the tests, singularly and in combination, are best to use in determining drug impairment or detect drug impairment. Within 24 months after award, the Contractor shall begin to analyze the data collected in task C.5.6d as outlined in the approved Data

Analysis Plan (see task C.5.4). The Contractor shall complete data analysis within 36 months contract award.

C.5.8 Submit Outline of Final Report

Within 18 months after award, the Contractor shall submit a detailed outline of the draft of the final report. The outline should include: 1) Bullet points of major highlights of each section, along with subheadings: Background, Method, Results, Discussion, and Conclusions; 2) Proposed page count; 3)

Proposed appendices.

The NHTSA COR will review the Final Report Outline and provide comments to the Contractor within one (1) week of receipt.

C.5.9 Submit Draft Final Report

Two draft reports shall be submitted one for COR review and the second for

NHTSA agency-wide review.

The Contractor shall be responsible for preparing reports during the course of this project. The Contractor shall ensure that the Quality Assurance Reviewer, a senior technical person who did not participate in the project, reviews both the draft and the final versions of all reports to ensure that they are clearly written, complete, and address all of the objectives of this project as included in the Statement of Work. The QAR shall thoroughly inspect the full report to ensure that it is internally consistent from start to finish, and that the conclusions flow from the methodology and results noted in the report. For

Final versions of each report, the QAR shall ensure that NHTSA’s comments from the draft versions were appropriately addressed, or document for the

COR why revisions were not made. All print materials shall be provided to the

NHTSA COR in the proper format, outlined in Section D—Packaging and

Marking.

This quality assurance review shall be completed prior to each draft, and then also for each final report, being submitted to the COR. The reviewer shall submit a memo to the COR, along with each draft and final report, attesting to the quality of the report.

The Contractor shall submit the draft final report (DFR) within 30 months after contract award. The Contractor shall prepare a detailed final report including: 1) an executive summary; 2) background section that will discuss measuring impairment and performance of drug-dosed participants (especially those dosed with cannabis), and will detail the project’s objectives, methodology, results, conclusions, and related appendices. This report will describe how the data were collected and analyzed. It will include a 2-3 page executive summary, along with the following sections—background, method, results, discussion, conclusions, and appendices (if needed). The report will adhere to the standards detailed in the 6 th

Edition, Publication Manual of the

American Psychological Association (APA).

The Contractor shall pay special attention to and address the following project objectives throughout the report:

a) Operationally define the constructs, impairment, drug detection, and performance, so that variations in performance based on dosing can be identified;

b) Establish procedures for evaluating the tests (e.g., validity, specificity, sensitivity, and reliability);

c) Provide an analysis of the test results and a scoring system for evaluating results;

d) Based on the results of the evaluations, make recommendations for

1) Promising test and/or combinations of tests that could be further validated in additional laboratory and/or field studies (that can be demonstrated to be useful in diverse settings and by diverse users, and with inexpensive or low-tech equipment/means);

2) Determining testing procedures (e.g., number of trials for criterion score, test item order); and

3) Estimating the time and cost of developing the test or test battery.

The NHTSA COR will review the Draft Final Report and provide comments to the Contractor within four (4) weeks of NHTSA’s receipt of the Draft Final

Report.

Within two (2) weeks of having received the COR’s comments, the Contractor shall prepare a second draft final report incorporating the comments and feedback from the COR. When the COR has deemed the draft final report acceptable, it will be circulated for Agency Review.

The NHTSA COR and other NHTSA staff will review the second Draft Final

Report and provide comments Contractor within ten (10) weeks of NHTSA’s receipt of the second Draft Final Report.

C.5.10 Submit a Final Data Set with Documentation

The Contractor shall provide three (3) copies of the final database formatted for direct PC use by NHTSA staff and with associated documentation, to the

NHTSA COR, in the following formats:

One (1) copy shall be formatted for SPSS;

One (1) copy shall be formatted for SAS;

One (1) copy shall be formatted in Comma Separated Values format.

The Contractor shall format the databases for ease of use for analysis and constructing new variables with this factor a consideration when determining whether to format questionnaire items as string or numeric variables, and the capability of turning on or off weighted values.

The documentation attached to the databases shall include:

Detailed specification of all variables in the database. The documentation shall include the variable name, the questionnaire item to which it relates, field location, and range.

Frequencies for all variables.

Within thirty-six (36) months of contract award, the Contractor shall deliver the database set with documentation to the COR.

Within four (4) weeks of receipt of the Memorandum, the COR will provide comments and either approve the database deliverable or request changes.

C.5.11 Submit Final Report

Within 40 months after award, the Contractor shall provide a Final Report that presents the background, objectives, methodology, and results of the analyses, and summarizes the findings and conclusions of the project. The

Final Report shall incorporate any revisions based on comments received from

NHTSA Agency Review.

The final print materials shall be provided to NHTSA in both camera ready and appropriate media formats (disk, CD-ROM) with graphics and printing specifications to guide NHTSA’s printing office and any outside organization.

In accordance with the section on Performance Deliverable/Milestones

Schedule, Item #19, the Contractor shall submit to the NHTSA COR two (2) hard copies and one (1) electronic copy of the Final Report.

The Contractor shall provide the Final Report to the COTR in the following manner:

1) A camera-ready version of the document as printed.

2) An electronic version of the complete document in the original program that was used for the printing process (e.g. MS word, word perfect, etc.).

If the document requires several different programs (e.g. MS Word, WordPerfect, PageMaker etc.), each component must be available as a separate file on appropriate media, properly labeled with the program format and what files are contained (e.g. MS Word [version XX, etc.]---

FST Laboratory Studies).

3) A file containing the complete assembled document with all colors, charts, sidebars, photographs and graphics (in order of appearance) prepared in

Portable Document Format (PDF), html or other format requested by

NHTSA for use on the NHTSA home page. The file can also be delivered on a CD Rom or flash drive.

Additional printing specifications are located in Section D.

C.5.12 Conduct Final Briefing

Within 36 months after contract award, the Contractor shall conduct a final briefing to NHTSA personnel and other funding representatives in

Washington, DC. The meeting shall cover the project’s objectives, overall project methodology, plan for accomplishing each task, and discussion of potential issues. The briefing will be approximately one (1) hour, with the

NHTSA COR leading the discussion, especially regarding the objectives and overall strategy, with the Contractor providing information on specific approaches for accomplishing individual tasks. The Contractor shall submit draft briefing materials (e.g., PowerPoint slides) to the NHTSA COR within one (1) week before the briefing. The NHTSA COR will provide comments on the materials within 3 days of receipt.

C.5.13 Optional Task A—Procure the Drug

NHTSA is uncertain whether it will be necessary for the Contractor to procure the drug, cannabis, for the study and for the potential optional tasks. NHTSA is researching options for partnering with another Federal agency to procure the drug and to perform laboratory analyses on the biological specimens that are collected.

The NHTSA CO will notify the contractor within two (2) months after contract award of NHTSA’s intent to exercise this optional task. The optional task will be executed through a unilateral modification.

For this optional task, the Contractor shall purchase cannabis through the

NIDA Drug Supply Program for the purpose of performing research on human participants. Within 4 weeks of NHTSA exercising Optional Task

7 Details on the ordering guidelines for Marijuana and Marijuana Cigarettes can be found at:

https://www.drugabuse.gov/drugs-abuse/marijuana/nidas-role-in-providing-marijuana-research https://www.drugabuse.gov/drugs-abuse/marijuana/nidas-role-in-providing-marijuana-research

A, the Contractor shall work with the NHTSA COR to develop and submit a request package which includes the study protocol, contact information, credentials, drug details (e.g., the quantity of the drug, drug concentration, mode of administration), and other information needed to justify the request, to the NIDA Drug Supply Program.

C.5.14 Optional Task B—Procure Drug-Testing Laboratory Services

NHTSA is uncertain whether it will be necessary for the Contractor to procure drug-testing laboratory to perform screening and confirmatory tests on the oral fluid and blood samples collected from the study participants. Task C.5.6b details how the Contractor shall carry out the biological specimen collection and a how the samples shall be prepared for shipment to the drug-testing laboratory.

Should NHTSA deem it necessary to exercise this optional task, the

Contractor shall, in conjunction with a toxicological laboratory, develop a drug testing plan for the toxicology laboratory, noting types of testing equipment, procedures, and cut-off levels. The Contractor shall assume that

100 oral fluid and blood samples will be laboratory-tested.

The NHTSA CO will notify the contractor within two (2) months after

Contract award of NHTSA’s intent to exercise this optional task. The optional task will be executed through a unilateral modification. The

Contractor shall procure Drug-Testing Laboratory Services within 2 weeks of execution of this optional task.

The Contractor shall submit the drug testing plan to the COR within 1 month of NHTSA exercising the Optional Task. The COR will review the document and provide the Contractor with comments within 2 weeks of receipt. Once the Contractor has made changes to the drug testing plan requested by the COR, the drug testing plan will become part of the overall

Research Protocol.

C.5.15 Optional Task C—Add Additional Participants

NHTSA may elect to add twelve (12) additional participants to allow the

Contractor to pilot test additional individual, contextual, and study design characteristics (e.g., demographic characteristics, dosing levels, dosing procedures, potency levels, tests and test combinations, alcohol level(s)) that may impact impairment and/or performance on the tests. The optional tasks will allow for additional participants to be recruited to address additional individuals, contextual, and study design characteristics. Contractor shall prioritize the order in which additional individuals and contextual the optional tasks. (See C.5.5 and C.5.6 for the specific requirements.)

The NHTSA CO will notify the contractor within fifteen (15) months after optional task will be executed through a unilateral modification.

Data collection and analyses associated with this optional task shall be incorporated into the Final Report and work associated with this task shall be completed within the period of performance.

C.5.16 Optional Task D—Add Additional Participants characteristics (e.g., demographic characteristics, dosing levels, dosing procedures, potency levels, tests and test combinations, alcohol level(s)) that may impact impairment and/or performance on the tests. This optional task will allow additional participants to be recruited to address additional individuals, contextual, and study design characteristics. Contractor shall prioritize the order in which additional individuals and contextual

The NHTSA CO will notify the contractor within eighteen (18) months after

C.5.17 Optional Task E—Add Additional Participants characteristics (e.g., demographic characteristics, dosing levels, dosing procedures, potency levels, tests and test combinations, alcohol level(s)) that may impact impairment and/or performance on the tests. This optional task will allow the contractor to recruit additional participants to address additional individuals, contextual, and study design characteristics. Contractor shall prioritize the order in which additional individuals and contextual

The NHTSA CO will notify the contractor within twenty-one (21) months after Contract award of NHTSA’s intent to exercise this optional task. The

C.5.18 Optional Task F—Add Additional Participants characteristics (e.g., demographic characteristics, dosing levels, dosing procedures, potency levels, tests and test combinations, alcohol level(s)) that may impact impairment and/or performance on the tests. This optional task will allow additional participants to be recruited to address additional individuals, contextual, and study design characteristics. Contractor shall prioritize the order in which additional individuals and contextual

The NHTSA CO will notify the contractor within twenty-four (24) months after Contract award of NHTSA’s intent to exercise this optional task. The

(End of Section C)

SECTION D PACKAGING AND MARKING

D.1 PACKAGING AND MARKING

Preservation and packaging of all shipments or mailing of all work delivered under this contract shall be done in accordance with good commercial practices and to insure acceptance by common carrier (if applicable) and safe transportation at the most economical rate(s).

Any deliverables required by this contract shall be submitted to the applicable personnel identified in Section F of this contract. Due to security concerns, deliverables transmitted via regular U.S. Mail experience significant delay in reaching an intended destination and, as part of the screening process, may be damaged. For these reasons, the U.S. Mail should not be used to transmit deliverables. Rather, the

Contractor is encouraged to use electronic mail to the maximum extent possible.

D.2 FORMATTING TEXT AND IMAGE DELIVERABLES

For those deliverables submitted electronically as text or image files, the following specifications apply.

D.2.1 TEXT

Text files shall be delivered in Microsoft WORD 2010 format. Font type of Times

New Roman with a font size of 12 shall be used throughout the document. The

Contractor shall minimize additional formatting as much as possible e.g., avoid use of columns) Avoid using any design/layout elements (however, see D.2.2, D.2.3, and

D.2.4 below.)

D.2.2 CHARTS AND GRAPHS

The Contractor shall develop charts or graphs using Microsoft EXCEL 2010 or similar format and shall insert these in the appropriate places within the text document. The Contractor shall also provide the Microsoft EXCEL source file from which charts or graphs were developed.

D.2.3 ILLUSTRATIONS

NHTSA’s Office of Communication Services is responsible for developing or acquiring most illustrations found in NHTSA publications. These illustrations can take two forms:

a. Graphics – In the majority of cases, the Office of Communication Services will develop any needed graphics in collaboration with the COR. The Contractor shall provide text, graphs, and charts following the guidelines stipulated in D.2.1 and

D.2.2 above. In some cases, the Contractor may be required to develop graphics.

b. In these cases, the Contractor shall use only software approved by the U.S.

Government Printing Office (e.g. Adobe Illustrator.)

c. Photographs – When photos are used in Agency publications, the Office of

Communication Services typically uses existing photos or photos purchased through royalty-free sources. In the event the Contractor must supply photos for use in a publication, the photos must be high resolution images at least 300 dpi at the size used in the publication. Photos shall be supplied on a CD or DVD in either .tiff format (for scanned images) or .jpg (for images downloaded to the CD or DVD directly from the digital camera.).

NOTE: If a photograph is supplied by an outside source (Contractor, grantee, national organization, etc.), a release form must accompany the photo indicating that the human subjects in the photo authorize NHTSA to use the photo in its publications and on its Internet site. The Contractor is responsible for ensuring that the necessary arrangements have been made with the photographer and the subjects in the photo to ensure that NHTSA has unlimited rights to use the images in print and on the web.

The Contractor shall obtain, and provide to NHTSA, a written statement indicating that NHTSA has unlimited, unrestricted rights to the use of the photos.

D.2.4 WEB-BASED IMAGES

Occasionally, web-based images may be used in NHTSA publications. The

Contractor is cautioned that copyright laws restrict use of many of these images even if this is not expressly indicated at the website. Additionally, the resolution of most web-based images is not high enough to provide a clear image when published. For these reasons, web-based images should not be used.

(End of Section D)

SECTION E INSPECTION AND ACCEPTANCE

All work hereunder shall be subject to review by the Government.

E.1 FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/?q=browsefar

Federal Acquisition Regulation (FAR) Clauses:

52.246-5 INSPECTION OF SERVICES - COST-REIMBURSEMENT (APR

1984)

E.2 INSPECTION AND/OR ACCEPTANCE

The NHTSA Contracting Officer’s Representative (COR), as designated in the resultant contract shall be responsible for performing the inspection of all services rendered under this contract and for recommending acceptance of replacement/correction of services or materials that fail to meet the contract requirements to the NHTSA Contracting Officer (CO).

(End of Section E) https://www.acquisition.gov/?q=browsefar

SECTION F DELIVERIES OR PERFORMANCE

F.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text.