Round_2_Questions_and_Responses.pdf

Questions & Responses for NHTSA Request for Proposal (RFP) Solicitation

DTNH2216R00036

Amendment 000001

Examine the Feasibility of a Standardize Field Test for

Marijuana Impairment: Laboratory Evaluation

1. Question: Page 3, Section B.1 entitled “Services” Can non-US based consultants be included?

Response:

Yes, non-US-Based consultants can be included as part of this effort.

2. Question: Page 8, Section C5.2 entitled “Refine the Study Protocol”

a. What is the estimated contract amount?

b. How much can the contract amount change based on the post-award negotiations?

It is not the Government’s practice to reveal this information. There can be adverse impact to the Government‘s negotiation strategy and position by disclosing this information.

3. Question: Page 34, Section H1 entitled “Special Data Rights Provisions.” Can we use any data collected as part of this study for subsequent (e.g. NIH) grants and if allowed, would NHSTA need to be notified and can the agency veto such uses?

Can data collected in this study be used for outside academic purposes, e.g. to author peer-reviewed papers outside the scope of the contract, as long as these publications acknowledge that data were gathered as part of an NHTSA study?

It is NHTSA policy to make all data (with privacy-related information, such as

Personally-Identifiable Information, excluded) available to the public after the release/publication of NHTSA’s deliverable (i.e., the final report).

4. The following questions below are in reference to Page 59; L.10 entitled “Technical

Approach/Understanding.”

Are there specific types of individuals (e.g. medical marijuana users; infrequent marijuana users) that the agency is expecting to have in the test population?

NHTSA’s is focused on the quantity and frequency of marijuana use as part of the

Amendment 000001 inclusion criteria, rather than how the participants are able to acquire the drug. NHTSA welcomes Offerors to make suggestions for inclusion and exclusion criteria that they believe would be appropriate for determining the study sample. Offerors should justify the rationale for these criteria.

With regard to the cognitive testing, are there any recommendations for specific tests within these domains, or for a specific, preferred test platform? In other words, does

NHTSA already have a fixed battery and a preferred test platform, or will proposals be judged on how the cognitive test protocol is defined by the contract institution?

NHTSA has identified several potential tests which fall within the domains listed in the

RFP. However, that report has not yet been published. Thus NHTSA welcomes Offerors to suggest potential tests within those domains the Offerors believe would be appropriate as a part of the protocol (and to justify, in brief, those suggestions). NHTSA will determine which tests will be a part of the final protocol after the contract has been awarded.

NHTSA does not have a fixed test battery or preferred test platform. As for how the

Offerors proposals (i.e., cognitive test protocols) will be evaluated, NHTSA will follow

Section M.3.1 Technical Approach/Understanding of the RFP, “…All aspects of the study—e.g., laboratory experimental design, dosing of subjects with a drug, researcher training, selection and recruitment of subjects, data collection protocol, and data analysis strategies—will be evaluated for technical merit. The Offeror will also be evaluated its discussion of potential problems/ issues that may arise during the conduct of the project and strategies for mitigating or eliminating problems.”

Is it expected that alternative versions of each test be available for each test domain?

Though some tests may have only one version available, Offerors are welcome to discuss the necessity of using alternative versions of each test.

Is the Phase 1 report available? If not, which investigators produced this report?

The report for Phase I of this study will not be published before the end date of this solicitation. Thus NHTSA acknowledges that offerors cannot include any information from that study. It is not necessary for Offerors on this project to have additional knowledge of the results of the feasibility phase or the pilot tests beyond what is included

Amendment 000001 in this Statement of Work. All Offerors’ proposals will be evaluated using the criteria in

Section M the RFP.

The call for proposals mentions other drugs besides marijuana, but it was not clear whether or not the most competitive proposal would necessarily test commonly abused drugs.

NHTSA has determined, based on the complexity of requirement, that drugs other than alcohol will not be included in the study design. As for alcohol, NHTSA would prefer to begin the study without alcohol as a potential variable and potentially introduce alcohol as a variable once there have been study results with those dosed only on THC.

As for “competitive proposals” NHTSA is looking for creative and innovative study designs, suggestions (for procedures, participants, etc.,), and approaches to this project and prefers proposals that go beyond repeating information found in the RFP.

Should the study design include drugs other than alcohol and marijuana as part of the study design? In particular, should proposals test the synergistic effects of using more than one drug?

NHTSA has determined, based on the complexity of requirement, that drugs other than alcohol will not be included in the study design. If alcohol is later included as a study variable, then evaluating the synergistic effects of using more than one drug will be an appropriate outcome.

Would it be expected that different levels of marijuana and/or alcohol intoxication would be explored?

If alcohol is included as a study variable, then different dosing levels of alcohol may be considered. Different levels of marijuana potency is a variable that Offerors can consider as a part of the study protocol (see C.5.2 Refine the Study Protocol and the Optional

Tasks C-F).

Since relatively small numbers of participants are listed in the solicitation, is it assumed that each participant will be involved in multiple assessments?

Amendment 000001

Offerors are welcome propose the methods believed necessary to accomplish the project objectives. Twelve participants is a starting point (note: there are increments of 12 participants that NHTSA may exercise as optional tasks). NHTSA would suggest that

Offerors first describe what can be accomplished with 12 participants (e.g., the participants are run through multiple conditions or tests). Offerors should also feel free to suggest what can be accomplished by having a larger n for the base study and justify their suggestions (by for example, offering example power analyses to determine the appropriate n for the study sample). Offerors also need to account for how the additional participants in the Optional Tasks (C-F) would be used in the study.

5. Question: Page 5, Section C.2 entitled “Objectives.” The 12 subjects mentioned for the primary study seems entirely insufficient given the aims of establishing validity, specificity, sensitivity and reliability. We would’ve expected the scope of the Phase II work to be over a hundred participants, perhaps even far more depending on statistically-determined needs for certainty, confidence intervals, etc. How was this small number determined?

The sample size was determined based on cost considerations from previous, similar projects.

Offerors are welcome propose the methods believed necessary to accomplish the main objectives. Twelve participants is a starting point (note: there are increments of 12 participants that NHTSA may exercise as optional tasks). NHTSA would suggest that

Offerors first describe what can be accomplished with 12 participants (e.g., the participants are run through multiple conditions or tests). Offerors should also feel free to suggest what can be accomplished by having a larger n for the base study and justify their suggestions (by for example, offering example power analyses to determine the appropriate n for the study sample). Offerors need to also account for how the additional participants in the Optional Tasks (C-F) would be used in the study.