Request for Applications (RFA)

Disease Control and Environmental Epidemiology Division

Medical Marijuana Research Grant Program
RFA #1353


Application documents are available at:
www.colorado.gov/pacific/cdphe/medical-marijuana-research-grant-program


Submission Instructions
Mail application package to:
Medical Marijuana Research Grant Program
Attn: Elyse Contreras
DCEED-3510
Colorado Department of Public Health and Environment
4300 Cherry Creek Drive South
Denver, CO 80246-1530

OR

Deliver application package in person to:
Colorado Department of Public Health and Environment
4300 Cherry Creek Drive South, Building A
Denver, CO 80246
Please check in at the security desk on the first floor of Building A.
Staff will be available to receive your application.


Applications must be received by 5:00 p.m., Tuesday October 14, 2014

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CDPHE RFA #1353

Table of Contents

Background and Overview 3
Purpose and Intent 4
Eligibility 4
Project Budget, Timeline, Life of Project 4
Funding Areas and Priorities 5
How to Apply . 6
Submission Instructions 9
Application Technical Assistance 11
Application Timeline 12
Review and Selection 12
Post-Selection Process .. 14
Administrative Information . 15


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CDPHE RFA #1353
BACKGROUND AND OVERVIEW
Background
Over 100,000 Coloradans currently use medical marijuana for relief from constitutionally authorized debilitating
medical conditions that do not respond adequately to conventional treatments. More information is needed to further
understand potential therapeutic uses of marijuana and its component parts. Research on the therapeutic effects of
marijuana and its component parts could benefit thousands of Coloradans who suffer from additional debilitating
medical conditions that do not respond to conventional treatments and are not currently permissible medical
conditions for medical marijuana use.

The Colorado Department of Public Health and Environment (CDPHE) considers proposals to add additional
debilitating medical conditions to the list of conditions for which a person may use medical marijuana through the
medical marijuana program. CDPHE needs additional medical research on the potential therapeutic benefits of
marijuana and its component parts to add new debilitating medical conditions to Colorados medical marijuana
program, and help physicians better understand the effects of medical marijuana.

Medical marijuana research programs funded by other states (e.g., California) have advanced the scientific
knowledge about how marijuana works and methods to ensure appropriate dosing. Colorado can now advance that
knowledge further. Colorado is a national leader in the development of new strains of marijuana and its component
parts that appear to have promising therapeutic effects. Therefore, the Colorado General Assembly passed Senate
Bill 14-155 in May 2014, which created the Colorado Medical Marijuana Research Grant Program within CDPHE.

Definition of Terms
Cannabidiol: one of the major cannabinoids found in marijuana, which has no psychoactive properties

Cannabinoid: a class of diverse chemical compounds found in marijuana, including THC and cannabidiol, that
act on receptors in the human body; although more than 70 such compounds are contained in the plant, only a few
are considered principal or major ones

CDPHE: The Colorado Department of Public Health and Environment (i.e., the state health department)

Clinical trials: intervention study design in which investigators administer an intervention (e.g., new drug) to
study participants; includes the specialized case of a randomized controlled trial in which investigators randomly
allocate eligible people to receive the intervention or placebo (i.e., control group)

Component parts: the principal cannabinoids of marijuana for which there is current medicinal use or interest,
including
9
-tetrahydrocannabinol (THC) and cannabidiol (CBD); these may either be extracted from the plant and
purified, or synthesized

DEA: federal Drug Enforcement Agency

FDA: federal Food and Drug Administration

IRB: Institutional Review Board - also known as an independent ethics committee or ethical review board, is
a committee that has been formally designated to approve, monitor, and review biomedical and behavioral
research involving humans

Marijuana: seeds, leaves, buds, and flowers of the plant (genus) cannabis

NIH: National Institutes of Health

Observational trials (studies): a type of study in which individuals are observed or certain outcomes are
measured; no attempt is made to affect the outcome (for example, no treatment is given)

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CDPHE RFA #1353
Pre-clinical studies: refer to the testing of a drug or other medical treatment in animals before trials may be
carried out in humans; during preclinical drug development, the drugs toxic and pharmacologic effects need to be
evaluated

Scientific Advisory Council: the advisory committee authorized and specified by Senate Bill 14-155 to evaluate
research grant applications to the Medical Marijuana Research Grant Program, and submit recommendations to the
State Board of Health for funding

THC:
9
-tetrahydrocannabinol, the most notable cannabinoid found in marijuana and the primary psychoactive
compound of marijuana


PURPOSE AND INTENT

The purpose and intent of this grant program is to fund objective scientific research intended to determine
the general medical efficacy and appropriate administration of marijuana and its component parts as part of
medical treatment. Such research should have clear benefit for current or future Colorado medical
marijuana patients.

ELIGIBILITY

Eligible organizations that may apply for funding (i.e., agencies submitting an application) include Colorado and
non-Colorado (within the United States) not-for profit organizations, health care organizations, governmental
entities and higher education institutions. Colorado applicants may partner with non-Colorado entities. For-profit
entities may partner with eligible organizations listed above, but may not be the primary applicant (i.e., the
submitting agency).

Principal investigators must have a demonstrated record of successful grant-funded research, including peer-
review publications. Preference will be given to applications with Colorado investigators or co-investigators,
and to studies involving Colorado patients.


PROJECT BUDGET, TIMELINE AND LIFE OF PROJECT

Project Budget
Senate Bill 14-155 authorized CDPHE to spend up to $10 million from the Medical Marijuana Program cash fund to
support medical marijuana health research during the 5 year period July 1, 2014 through June 30, 2019. Up to $1
million of the $10 million is for grant program administration. Thus, up to $9 million will be awarded through this
RFA to fund medical marijuana health research projects beginning no earlier than January 1, 2015 for a project
period of up to 3 years duration. The actual number and amount of grant awards will depend on the number and
quality of applications and amount of funding requested, as well as recommendations made during the review
process.

Award Period (Life of Project)
This RFA may result in a single or multiple year (up to 3 years) contract, depending upon the proposed project
duration. The initial contract will be effective upon approval by the State Controller. The contract may not be
renewed.

Award Size
It is anticipated that there will be from 6 to 10 awards with an average award size of approximately $500,000 per
budget year for up to 3 years of funding. The maximum full project award that will be considered is $2 million.

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CDPHE RFA #1353
FUNDING AREAS AND PRIORITIES

Types of Studies to be Funded
Research proposals may include randomized controlled clinical trials and observational (i.e., non-randomized, non-
controlled) studies that will help determine medical efficacy and/or appropriate administration of medical marijuana
or its component parts. Research proposals may also include pre-clinical studies using animal models. Basic science
(i.e., in vitro) studies (e.g., biochemical markers or inflammation markers) may only be proposed as adjuncts to
clinical trials, observational studies, or animal model studies.

Priority wil be given to clinical trials and observational studies in humans, especially studies that will clearly
contribute to determining the general medical efficacy or appropriate adminstration of medical marijuana
and its component parts.

Diseases or conditions that will be considered should be based on clear justification which includes promising
published scientific evidence as well as potential benefit to Colorado patients. No more than $4.5 million will be
awarded for studies regarding any one disease or condition unless there are insuffcient numbers of proposed quality
studies for other conditions.

Authorizations to conduct marijuana-related research
Under the Drug Free Schools and Communities Act, Institutions of higher education have an obligation to comply
with federal drug laws as a condition of receiving grant funding or other financial assistance under any federal
program. As a Schedule I substance, it remains illegal under federal law to import, manufacture, distribute,
possess, or use marijuana. However, federal law provides the Food and Drug Administration (FDA) with the ability
to approve research using Schedule I controlled substances.

The following guidance may apply to applicants depending upon the nature of the proposed study and the type and
funding status of the applicant organization. Principal investigators should review this guidance with their
organizations legal council to determine its applicability.

Human Clinical Trials/Clinical Studies - Under federal law, a researcher who wishes to administer
marijuana (or its component parts) to human subjects must:
Submit an investigational New Drug application to the FDA.
Obtain a registration from the Drug Enforcement Administration (DEA)
Obtain approval from the appropriate Institutional Review Board (IRB)
Receive a determination from the U.S. Department of Health and Human Services that the investigator is
qualified and the proposed research has merit.
Acquire the marijuana from the National Institute on Drug Abuses approved source
Follow DEA regulations and guidelines for storage and prescription.

Human Observational Studies These are studies in which subjects use marijuana (or its component parts),
but the researcher does NOT procure it for the subjects, the marijuana/component parts is not consumed on
the institutions campus. For these types of studies, the researcher must:
Obtain approval from the appropriate IRB

Animal Studies - Under federal law, a researcher who wishes to use marijuana (or its component parts) for
research involving animals must:
Obtain a registration from the DEA
Obtain approval from the appropriate institutional animal care and use committee
Acquire the marijuana from the NIDA approved source.
Follow DEA regulations and guidelines for storage and prescription

BasicResearch - Under federal law, a researcher who wishes to use marijuana (or its component parts) for
research that does not involve human subjects or animals, yet is directed toward greater knowledge or
understanding of the fundamental aspects of marijuana must:
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CDPHE RFA #1353
Obtain a registration from the DEA
Acquire the marijuana from the NIDA approved source.
Follow DEA regulations and guidelines for storage and prescription

Cannabinoid Testing
Testing of marijuana or its component parts for chemical composition and potency by a state certified Colorado
laboratory or another laboratory meeting similar quality standards and qualifications is strongly recommended as
part of clinical trials, observational studies (in which the study subjects procure their own marijuana or component
parts), or animal studies involving the administration of marijuana or its component parts.

Testing of blood, serum, or plasma levels of cannabinoids are recommended as part of clinical studies and
should be performed by a College of American Pathologists (CAP) accredited laboratory with an appropriately
sensitive, specific and validated assay using methodology such as high performance liquid chromatography-tandem
mass spectrometry (LC-MS/MS).


HOW TO APPLY

NOTE: Applications that fail to follow ALL of the requirements will NOT be reviewed.

Letter of Intent
A letter of intent is REQUIRED and is due by 5:00 pm mountain daylight time on Thursday September 18,
2014 at the following email address:
marijuana.research@state.co.us

Applications will NOT be reviewed if a letter of intent is NOT submitted by the specified deadline.
Letters of intent are not binding; there is no penalty for applications that deviate from information in the letter.
Receipt of these letters is necessary to adequately implement the application review process.

The letter of intent should be concise (i.e., 1 page) and list the following information:
Lead organization or entity name
Name, address, telephone number of Principal Investigator
Collaborating organization(s) or entity name(s) with names of co-investigators
Proposed duration of project (no more than 3 years)
Approximate amount of funding being requested for the entire project
Proposed topic or descriptive title
Type of study and/or study design


Application Page Formatting and Length
Applications must follow all the formatting requirements:
Application Font: Times New Roman
Application Font Size: 12 point
Application Spacing: Single or double spaced, 1 margins on all sides
Application Printing: Double sided printing preferred, but not required
Page Numbering: Number all pages at the bottom right corner of the page
Page Limits applications that exceed these page limits will NOT be reviewed:
o Executive Summary: no more than 1 page
o Description of Key personnel: no more than 2 pages
o Narrative/Research Plan: (parts A-D below) no more than 12 pages
Binding: Binder clips ONLY. Applications may NOT be stapled, in three ring binders, or otherwise bound
Headings: The original headings for each and all sections of the response should be included.

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CDPHE RFA #1353

Attachments
Other than biosketches/resumes of key personnel (see below) and the required forms (Attachments A-C) that
are part of the application packet, NO other attachments are allowed (and if submitted, will NOT be
reviewed).


Application Executive Summary
Describe the purpose/intent of the proposed project.
Clearly state how the project meets the purpose and intent of the grant program, including how the proposed
project has clear benefit for Colorado patients.
State the purpose, key aims and expected outcomes.
Summarize the study design and methods, including analysis plan


Description of Experience/Qualifications of Key Personnel
Describe the principal investigators demonstrated record of successful grant-funded research, including peer-
review publications.
Describe the training and past experience of key personnel relevant to the proposed project, including scientists,
clinicians, epidemiologists, statisticians, and other staff involved with study coordination or conduct.
Attach biosketches or resumes, limited to 3 pages each, of all key study personnel.


Application Narrative/Research Plan
The application narrative must address each section clearly and concisely, and include all of the required
information for the section.

A. Background & Significance
Clearly describe the issue/problem that your project proposes to address.
o State primary specific aim
o State secondary aim(s)
Summarize relevant peer-reviewed scientific journal articles and other publications.
Provide complete list of references cited (within this section and NOT as an attachment).
Provide plans to prepare and submit a manuscript of research findings from the proposed project, whether
positive or negative, to a suitable peer-review journal (applicants should budget time and estimated costs for draft
manuscript preparation during the final project year, which will meet the final reporting requirement).

B. Capacity/Program Infrastructure
Describe applicants (i.e., organizational entitys) infrastructure and capacity to support the proposed project,
including experience successfully conducting similar studies.

C. Research Design and Methods
Describe the overall project design and methods, including:
Overview
Plans to obtain applicable federal authorizations
Subjects and procedures
Recruitment
Protection of human subjects
Ethical use of vertebrate animals (as appropriate)
Randomization (clinical trials only)
Intervention
Control group or comparison group (as appropriate)
Measurements (clinical/laboratory, surveys, questionnaires)
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CDPHE RFA #1353
Statistical analysis
o Staffing
o Sample size and power calculations
o Primary analysis
o Secondary analyses
Data Safety and monitoring (clinical trials only)
Documentation of adverse effects (all human studies)

D. Laboratory Testing
Describe plans for cannabinoid and related testing by certified/accredited laboratories, and describe qualifications of
laboratories being proposed to conduct testing along with methods to be used for:
marijuana or its component parts for chemical composition and potency
blood, serum, or plasma cannabinoid levels

E. Budget
A budget template is provided and can be found as Attachment B.
Please provide a detailed budget for the first budget year (i.e., 12 months) using the spreadsheet provided.
Do not modify the format of the spreadsheet. The budget must explain all expenses included.
Applicants are responsible for ensuring the calculations in the budget are accurate.
Detailed subcontractor budgets must be provided using separate copies of the same budget template.
There will be no reimbursement of pre-award costs.
CDPHE reserves the right to deny requests for any item listed in the budget that is deemed to be unnecessary
for the implementation of the project.

Funding Period:
Proposed initial (i.e., Project Year 1) budget must be for no more than 12 months. Instructions on providing
budget estimates for future project years follow below.

Unallowable Expenses:
Funds from this grant may not be used for:
o capital construction
o building renovations
o lobbying
o conference attendance other than for scientific presentation regarding the proposed project
o cell phones

Indirect Rate:
Indirect costs are limited to a maximum of 15 percent of direct costs (i.e., personal services, supplies
and operating, travel, other). For the contractual budget category, the primary applicant agency is
limited to a maximum indirect cost (flow through on subcontracts) rate of 2 percent.

Agencies that have indirect costs less than the15 percent cap should reflect their indirect costs at the actual
rate. The method of allocating indirect costs (overhead to be allocated and the basis of allocation) shall
comply with generally accepted accounting principles that are consistently applied. Agencies that do not
have indirect costs should not collect indirect costs and should budget for all costs in the appropriate direct
cost category.

This same indirect cost rate guidance is applicable to any subcontractor(s) as well.


Budget Categories:
Personal Services
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CDPHE RFA #1353
List all personnel to perform work for the project. Include proposed salaries, time and effort percentage
(full time equivalent or FTE), and fringe benefits. In the justification, include the role and expected
contribution of budgeted personnel.

Supplies and Operating
Include a list of all allowable supplies and operating expenses, and show calculations. The justification
should describe the rationale, necessity and reasonableness of the operation costs budgeted.

Travel
Include all travel and indicate whether in-state or out-of-state. Approval of requests to travel to an out-of-
state conference will be at the discretion of CDPHE and must involve formal scientific presentation of the
funded project. Funding for international conference attendance is not allowed.

Other
Include items not included in the previous budget categories.
- Requests for equipment are at the discretion of CDPHE. Equipment with a unit cost of less than $5,000
is considered a supply (e.g., desktop or laptop computers).
- If equipment costs are granted, the equipment remains the property of CDPHE.
- If equipment is not used exclusively to conduct project activities funded in your application, clearly
describe how you will allocate the equipment costs to other funding sources so that funds awarded
from this announcement pay only for the portion used to conduct stated activities.
- Large equipment purchases may require additional insurance requirements. The contractors estimates
for those costs should be included.
- Grantees may not generally use the funding for the purchase of furniture or certain types of large
equipment. Any such proposed spending must be indentified in the budget and may be disallowed.

Contractual
Include all subcontracts planned to complete the proposed work. Detailed subcontractor budgets must be
provided using separate copies of the same budget template (Attachment B) used for the overall
project budget. Restrictions outlined in the budget guidelines, including cost reimbursement terms, shall
also apply to subcontracts. No subcontractor may be pre-paid for services.

Future Years Funding Estimates
o Provide estimates of Year 2 and Year 3 funding, if applicable, in spaces provided BOTH at
the bottom of the main budget (Attachment B), AND in the Applicant Information Form
(Attachment A).
o Applicants should budget time and estimated costs for draft manuscript preparation during
the final project year (which will meet the final reporting requirement).
o Detailed budgets will be required prior to awarding of funds for conducting future year activities
for approved projects.


SUBMISSION INSTRUCTIONS

This Request for Applications (RFA) is issued by the Medical Marijuana Research Grant Program, Disease Control
and Environmental Epidemiology Division at the Colorado Department of Public Health and Environment
(CDPHE), also referred to as the "State".

During the solicitation process for this RFA, all official communication with Applicants will be via notices on the
CDPHE grant program web site. Notices may include any modifications to administrative or performance
requirements, answers to inquiries received, clarifications to requirements, and the announcement of selected
grantees. Applicants are responsible for monitoring for publication of modifications to this solicitation. It is
incumbent upon Applicants to carefully and regularly monitor for any such notices. Applicants are not to
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CDPHE RFA #1353
contact any other state office or individual regarding this RFA. Applicants are not to rely on any other statements
that alter any specification or other term or condition of the solicitation.

Applications must be received on or before the due date and time as indicated below.

LATE APPLICATIONS WILL NOT BE ACCEPTED.

It is the responsibility of the Applicant to ensure that its application is received by the CDPHE Medical Marijuana
Research Grant Program at the location listed in these instructions on or before the due date and time. Applicants
mailing their applications must allow sufficient mail delivery time to ensure receipt of their applications by the time
specified.

All materials submitted shall become the property of the CDPHE, and will not be returned unless the RFA
solicitation is cancelled prior to the submittal due date, in which case applications will be returned unopened or
opened only for identification purposes.

All materials submitted will become public record and open to inspection after the award notice is issued. Any
materials requested to be treated as confidential and/or proprietary information are to be packaged separately and
clearly identified. Such request must include justification for the request. The request will be reviewed and either
approved or denied in writing by the CDPHE Purchasing Director. If denied, the proposer will have the opportunity
to withdraw its entire application, or to remove the restrictions. (Ref 24-72-201 et.seq, C.R.S., as amended, Public
[open] Records) Neither cost nor pricing information or a total application will be considered confidential and/or
proprietary.

Application Submission Checklist
An application that is missing any of the items listed below will be considered INCOMPLETE and NOT
reviewed. The forms and templates provided are REQUIRED. Applications will not be accepted in any other
format.
Cover letter signed by executive director or authorized official of applicant agency
Attachment A: Applicant Information Form
Copy of letter of intent that was previously submitted
Attachment B: Budget Template
Detailed sub-contractor budget(s) using budget template (Attachment B)
Application Executive Summary
Description of key personnel
Application narrative/research plan
Attachment C: W-9 Form
Biosketches/resumes of key personnel (limited to maximum of 3 pages each)

Application Deadline
All applications must be received by the Colorado Department of Public Health and Environment by
5:00 p.m. on Tuesday October 14, 2014.
Late applications or those submitted by facsimile or email will not be accepted.
Applications that do not include all required components will not be reviewed.

Application submission package must include:
One (1) original hard copy application with original signature on cover letter.
Five (5) photocopies of the full application and all required forms/attachments
One (1) flash drive with the full application and all required forms/attachments


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CDPHE RFA #1353
Mail application package to:
Medical Marijuana Research Grant Program
Attn: Elyse Contreras
DCEED-3510, Colorado Department of Public Health and Environment
4300 Cherry Creek Drive South
Denver, CO 80246-1530

OR

Deliver application package in person to:
Colorado Department of Public Health and Environment
4300 Cherry Creek Drive South, Building A
Denver, CO 80246
Please check in at the security desk on the first floor of Building A.
Staff will be available to receive applications.

Submission agreement:
By submission of an application, the Applicant agrees as follows:
Awarded applicants are required to provide a valid insurance certificate prior to commencement of any work or
services. It is a provision of the contract that all applicable insurance coverages remain in effect during the
contract and that a new certificate is provided to the CDPHE each time coverage is renewed.
Applicant testifies that submitted prices were arrived at independently and there was no collusion involved.
The Applicant guarantees to the State that it understands and agrees to the terms and conditions of this
solicitation and that they will not default from performance by virtue of a mistake or misunderstanding.
Applicants shall seek clarification from the CDPHE Program Contact of any specifications, terms and/or
conditions that they determine to be unclear. The failure of an applicant to seek clarification may be deemed a
waiver of any such clarification.
Pursuant to C.R.S. 24-30-202.4 (as amended), the State Controller may withhold debts owed to State agencies
under the vendor offset intercept system for: (a) unpaid child support debt or child support arrearages; (b)
unpaid balance of tax, accrued interest, or other charges specified in Article 22, Title 39, C.R.S.; (c) unpaid
loans due to the student loan division of the department of higher education; (d) owed amounts required to be
paid to the unemployment compensation fund; and (e) other unpaid debts owing to the State or any agency
thereof, the amount of which is found to be owing as a result of final agency determination or reduced to
judgment as certified by the Controller.
The CDPHE reserves the right to reject any and all applications or parts thereof, and to waive informalities or
irregularities.


APPLICATION TECHNICAL ASSISTANCE

Inquiries
Applicants may submit questions via email to obtain clarification of requirements concerning this RFA by
Wednesday, September 10, 2014. No inquiries will be accepted after this date and time.
Send all questions to:
marijuana.research@state.co.us

Clearly identify your inquiries with:
RFA #1353 in the subject line of the email
Colorado Medical Marijuana Research Grant Program
The page and section to which the inquiry applies.

Responses to applicant questions will be posted here by close of business on the date indicated in the Application
Timeline listed below. Applicants are not to rely on any other statements that alter any specification or other term or
condition of the RFA.
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CDPHE RFA #1353

Pre-application Conference
No Pre-application conference will be held. Please submit all inquiries as instructed above.


APPLICATION TIMELINE

RFA release 9/3/2014

Deadline for applicants to submit written questions related to the RFA. Submit
all inquiries by email to: marijuana.research@state.co.us

9/10/2014
Responses to submitted questions will be posted by this date to program web site 9/16/2014
REQUIRED Letter of Intent (via email) deadline 9/18/2014
APPLICATION SUBMISSION (mailed or in person) DEADLINE

10/14/2014
Application review process [10/15 11/19]
Funding recommendations determined by Scientific Advisory Council 11/21/2014
Presentation of funding recommendations to the Colorado Board of Health 12/17/2014
Anticipated grant award start date [early 2015]


REVIEW AND SELECTION

Applications will initially be screened by CDPHE for completeness and adherence to the purpose/intent, eligibility
criteria, and instructions of this RFA (see pages 4-5). Incomplete applications, as well as those not clearly
consistent with the purpose/intent, eligibility criteria, and page limits will NOT be further reviewed.

The program developed a modified National Institutes of Health (NIH) Scientific Review Group - Peer Review
Process to ensure use of a well-accepted and appropriate method for scoring and selection of the best qualified
applications for this unique research grant program. Applications will be evaluated by the grant programs Scientific
Advisory Council for scientific and technical merit and likelihood of significant impact.

Three primary reviewers will be assigned to review and score each application. Depending upon the number of
applications received, ad hoc reviewers (who are not Scientific Advisory Council members) may be recruited to help
staff the primary review process. Primary reviewer scores will be averaged for each application, and the top scoring
applications will be discussed and scored by the full Scientific Advisory Council (SAC) on November 21, 2014 to
arrive at funding recommendations.

Review Criteria
The 6 criteria described below will be used during the primary review process.

Significance
- Does the project address an important problem or critical barrier to progress in the field?
- If the aims of the project are achieved, how will scientific knowledge and/or clinical practice be improved?
- How will successful completion of the aims change the concepts, research methods, or treatments for this
condition?
- Does the applicant provide plans to prepare and submit a manuscript of research findings, whether positive
or negative to a suitable peer-review journal?

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CDPHE RFA #1353
Investigators
- Are the Principal Investigator(s), collaborator(s), or other researchers well suited to the project?
- If early stage investigators, do they have appropriate experience and training?
- If established investigators, have they demonstrated an ongoing record of accomplishments, including peer-
review publications?
- If the project is collaborative or multi-PI, do the investigators have complementary and integrated
expertise; is the organizational structure appropriate for the project?

Approach
- Are the overall strategy, methods, and analyses well-reasoned, appropriate, and feasible to accomplish the
specific aims of the project?
- Are appropriate and meaningful outcomes measured, including those based on laboratory testing?
- Is required laboratory testing described (for applicable study designs)?
- Are potential problems and benchmarks for success presented? How will risky aspects be managed?
- Are the procedures for collecting and analyzing data and proposed statistical methods appropriate?

Environment
- Will the scientific environment in which the work will be done contribute to the probability of success?
- Are the agency/organization support, equipment and other physical resources available to the investigators
adequate for the project proposed?
- Will the project benefit from unique features of the scientific environment, subject populations, or
collaborative arrangements?

Protection of human subjects or vertebrate animals
- If the project involves human subjects, are there adequate plans to address the protection of human subjects
from research risks, including plans for the project to be reviewed, approved and monitored by a suitable
Institutional Review Board?
- If the project involves vertebrate animals, are the following five points adequately addressed: 1) proposed
use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of
animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care;
4) procedures for limiting discomfort, distress, pain, and injury to that which is unavoidable in the conduct
of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or
comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent
with the AVMA Guidelines on Euthanasia?
- If the project involves vertebrate animals, are there plans for the project to be reviewed and approved by a
suitable institutional animal care and use-committee?

Budget
- Is the overall budget, as well as individual line items, reasonable considering the scope of research
activities?
- Does the budget provide adequate detail to justify the rationale and amount requested for each line item?

Overall Impact Score
This score is not necessarily the average of the 6 individual criterion scores. Rather, it reflects an overall
assessment of the likelihood for the project to exert a significant contribution to the goal of determining the
medical efficacy and appropriate administration of marijuana and its component parts, especially for current
and future Colorado medical marijuana patients.


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CDPHE RFA #1353
Application Review Process/Scoring
A 10-point rating scale (10 = exceptional; 1 = poor) will be used for the 6 review criteria and for the overall impact
score.

Primary reviewers will assign a working score (i.e., not to be submitted) for each of the 6 review criteria above.
These scores will inform their assignment of a Primary Review Overall Impact Score which will then be averaged
with those of the other primary reviewers for each application to determine which applications are discussed and
scored by the full Scientific Advisory Committee.

During the Scientific Advisory Council scoring meeting, after each top scoring application from primary review is
presented and discussed, eligible committee members (without conflicts of interest) will provide SAC Review
Overall Impact Scores. The average of these scores will then be calculated and multiplied by ten. Thus, the
resulting score will range from 100 (exceptional impact) to 10 (poor impact). Finally, any preference points for
Colorado investigators, Colorado-based studies, and priority study designs (clinical trials and observational studies)
will be added to determine the Final SAC Funding Score.

Applications will be recommended to the State Board of Health for final funding approval based on descending
order of Final SAC Funding Scores, up to the maximum amount of funding authorized for this grant program.

Notification and Decision
Provisional awardees (based on Scientific Advisory Council funding recommendations) will be notified by phone
and email. Once approved for funding by the State Board of Health, awardees will be re-notified by phone and
email. Those who are not awarded will be notified by email.

No appeal is allowed. Concerns or complaints about the RFA process and its outcomes should be submitted to
the attention of the Manager, Medical Marijuana Research Grant Program via email at:
marijuana.research@state.co.us
Include the phrase RFA Concerns in the email subject line.


POST SELECTION PROCESS

Funding Restrictions
For projects that involve human subjects, contracts will not be executed and funding will not be awarded
until approval by a federally recognized Institutional Review Board (IRB) has been submitted to CDPHE.

For projects that involve vertebrate animals, contracts will not be executed and funding will not be awarded
until approval by an institutional animal care and use-committee has been submitted to CDPHE.

Contract Negotiation Process
The State reserves the right to request revisions to the budget or research plan of any applicant.

Reporting
Grantees must submit ongoing progress reports, due two weeks following the end of each calendar quarter, that at a
minimum include numbers of patients (or animals) enrolled and any scientifically valid preliminary results:
- Quarterly progress reports
- Annual updates which may replace the fourth fiscal quarter report
- Final report at the end of project funding which takes the form of a draft manuscript for publication and
includes the following sections: Introduction, Methods, Results, Discussion, Conclusions.

Insurance Requirements
Successful applicants must comply with the States insurance requirements to protect the grantee and the state from
any damages or loss. The grantee will need to submit certificates of insurance demonstrating coverage for
Professional Liability and other coverage required by the State as outlined below. The certificate must include the
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State of Colorado as an additional insured on the Commercial General Liability and Automobile Liability Insurance
policies* and Commercial General Liability Insurance written on ISO occurrence form CG 00 01 10/93 or
equivalent, covering premises operations, fire damage, independent contractors, products and completed operations,
blanket contractual liability, personal injury, and advertising liability with minimum limits as follows:

- $1,000,000 each occurrence
- $1,000,000 general aggregate
- $1,000,000 products and completed operations aggregate
- $50,000 any one fire

* Automobile Liability Insurance covering any auto (including owned, hired and non-owned autos) with a
minimum limit as follows: $1,000,000 each accident combined single limit.


ADMINISTRATIVE INFORMATION
A. Modification or Withdrawal of Applications
Applications may be modified or withdrawn by the Applicant prior to the established submission due
date and time.
B. Addendum or Supplement to Request For Application
This RFA will be modified if necessary to concur with pending (September 2014) revisions to
Colorado Board of Health Regulations 5 CCR 1006-2 which pertain to this grant program. In the
event that it becomes necessary to revise any part of this RFA, a modification will be posted here. It
shall be the responsibility of the Applicants to regularly monitor this site for any such postings.
Failure to retrieve such modifications, and include their provisions in your application, may result in
your application being disqualified.

Should the Applicant find any part of the solicitation to be discrepant, incomplete, or otherwise
questionable in any respect, the Applicant shall be responsible to call such matters to the attention of
the purchasing agent immediately. Failure to do so shall be at the Applicants risk. Amendments to
this solicitation will be official only if published here. Applicants should not rely on verbal statements
that alter this solicitation.
C. Acceptance of RFA Terms
An application submitted in response to this RFA shall constitute a binding offer. The autographic
signature of the Applicant or of a designee legally authorized to execute contractual obligations shall
indicate acknowledgment of this condition. A submission in response to this RFA acknowledges
acceptance by the Applicant of all terms and conditions, including compensation, as set forth herein.
An Applicant shall identify clearly and thoroughly any variations between the Applicants application
and the State's RFA. Failure to do so shall be deemed a waiver of any rights to subsequently modify
the terms of performance, except as outlined or specified in the RFA.
D. Confidential/Proprietary Information
Any restrictions of the use or inspection of material contained within the application shall be clearly
stated in the application itself. Written requests for confidentiality shall be submitted by the Applicant
with the application. The Applicant must state specifically what elements of the application are to be
considered confidential/proprietary and must state the statutory basis for the request under the Public
(open) Records Act. (24-72-201 et seq., C.R.S.) Confidential or proprietary information must be
readily identified, marked and separated from the rest of the application. Co-mingling of confidential
and/or proprietary and other information is NOT acceptable. Neither an application in its entirety, nor
application price information will be considered confidential and proprietary. Any information that
will be included in any contract resulting from the RFA cannot be considered confidential.

The CDPHE will make a written determination as to the apparent validity of any written request for
confidentiality. In the event the CDPHE does not concur with the Applicants request for
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confidentiality, the written determination will be sent to the Applicant. Ref 24-72-201 et seq.,
C.R.S., as amended, Public (open) Records Act.

Applicant(s) acknowledge that they may come into contact with confidential information contained in
the records or files of the State in connection with any resulting contract or in connection with the
performance of its obligations under any resulting contract. The awarded Applicant(s) shall keep such
records and information confidential and shall comply with all laws and regulations concerning the
confidentiality of such records to the same extent as such laws and regulations apply to the State.

The awarded Applicant(s) shall notify its employees that they are subject to the confidentiality
requirements as set forth above, and shall provide each employee with a written explanation of the
confidentiality requirement before the employee is permitted access to confidential data. Awarded
Applicant(s) shall provide and maintain a secure environment that ensures confidentiality. The
confidentiality of all information will be respected and no confidential information shall be distributed
or sold to any third party nor used by awarded Applicant(s) or its assignees and/or subcontractors in
any way except as authorized by this contract. Confidential information shall not be retained in any
files or otherwise by awarded Applicant(s). Disclosure of such information may be cause for legal
action against the awarded Applicant(s). Defense of any such action shall be the sole responsibility of
the awarded Applicant(s). Unless directed otherwise, awarded Applicant(s) is required to keep all
State information in a secure, confidential manner.
E. Response Material Ownership
The State of Colorado has the right to retain the original application and other RFA response materials
for our files. As such, the State of Colorado may retain or dispose of all copies as is lawfully deemed
appropriate. The State of Colorado has the right to use any or all information/material presented in
reply to the RFA, subject to limitations outlined in the Proprietary/Confidential Information clause.
Applicant expressly agrees that the State may use the materials for all lawful State purposes, including
the right to reproduce copies of the material submitted for purposes of evaluation, and to make the
information available to the public in accordance with the provisions of the Public Records Act.
F. RFA Cancellation
The State reserves the right to cancel this Request for Application in its entirety or individual phases
at any time, without penalty.
G. Selection of Successful Application and Notice of Intent to Award
The State reserves the right to make an award on receipt of initial applications, so Applicants are
encouraged to submit their most favorable application at the time established for receipt of
applications. Applicants not meeting the requirements identified in the RFA shall be ineligible for
further consideration. The State may conduct discussions with Applicants in the competitive range
(those most responsive to the requirements and reasonably susceptible of being selected for award) for
the purpose of promoting understanding of the States requirements and the Applicants application,
to clarify requirements, make adjustments in services to be performed, and in prices. Changes to
applications, if permitted, will be requested in writing from Applicants. If application revisions are
permitted after oral presentations and discussions, a date will be established in writing by the State for
submission of best and final offers (BAFO). Applicants will not be provided an opportunity for
comprehensive application revisions.

Upon review and approval of the evaluation committees recommendation for award, the CDPHE will
issue Notice of Intent to Make an Award letter(s) to all Applicants. (recommended)
H. Award of Contract/Standard (Model) Contract/Legislative Changes
The award will be made to that Applicant(s) whose application, conforming to the RFA, has been
determined to be responsive and responsible and most advantageous to the State of Colorado,
considering the evaluation factors set forth in this announcement. A contract must be completed and
signed by all parties. In the event the parties are unable to enter into a contract in a reasonable
timeframe, the State may elect to rescind the "Notice of Intent to Make an Award" communication
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and make the award to the next most responsive and responsible Applicant. The successful
Applicant(s) is required to enter into a formal Contract with CDPHE. The State of Colorado reserves
the right to amend the contract in response to future legislative changes that affect this project.
I. Term of the Contract
This RFA may result in one or more multiple year contracts not to exceed 3 years. The initial contract
will be effective upon approval by the State Controller's designee for up to 3 years.
J. Acceptance of Application Content
The contents of the application (including persons specified to implement the project) of the
successful Applicant will become contractual obligations if acquisition action ensues. Failure of the
successful Applicant to accept these obligations in a contract, purchase document, delivery order or
similar acquisition instrument may result in cancellation of the award and such Applicant may be
removed from future solicitations.
K. Order of Precedence
In the event of any conflict or inconsistency between terms of this request for application and the
offer, such conflict or inconsistency shall be resolved first, by giving effect to the terms and
conditions of the contract, second to the request for application, and third, to the application.
L. Venue
The parties agree that venue for any action related to performance of this contract shall be in the City
and County of Denver, Colorado.
M. State Ownership of Contract Products / Services
Any software, research, reports, studies, data, photographs, negatives or other documents, drawings,
models, materials, or work product of any type, including drafts, prepared in response to the contract
resulting from this RFA shall be available to the State for the States non-exclusive use, which use
shall include but not be limited to the right to copy, publish, display, transfer, and prepare derivative
works.

N. Incurring Costs
The State of Colorado is not liable for any cost incurred by Applicants prior to issuance of a legally
executed contract or procurement document. No property interest of any nature shall occur until a
contract is awarded and signed by all concerned parties.
O. Non-Discrimination
The Applicant shall comply with all applicable state and federal laws, rules and regulations involving
non-discrimination on the basis of race, color, religion, national origin, age or sex.
P. Rejection of Applications
The State of Colorado reserves the right to reject any or all applications received in response to this
RFA, to waive informalities and minor irregularities in applications received, and to accept any
portion of an application or all items proposed if deemed in the best interest of the State of Colorado
to do so.
Q. Parent Company
If an Applicant is owned or controlled by a parent company, the name, main office address, and
parent companys tax identification number must be provided in the solicitation response. The tax
identification number provided must be that of the Applicant responding to the RFA. The Applicant
must be a legal entity with the legal right to contract and must be registered in the State of Colorado to
conduct business.
R. News Releases
No news releases pertaining to this RFA shall be made prior to execution of the contract without prior
written approval of CDPHE.
S. Contract Cancellation
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CDPHE reserves the right to cancel, for cause, convenience, or lack of fiscal funding, any contract
resulting from this RFA by providing timely notice to the contractor.
T. Certification of Independent Price Determination
1. By submission of this application, each Applicant certifies, and in the case of a joint
application, each party thereto certifies as to its own organization, that in connection with this
procurement:
a. The prices in this application have been arrived at independently, without consultation,
communication, or agreement for the purpose of restricting competition, as to any matter
relating to such prices with any other Applicant or with any competitor;
b. Unless otherwise required by law, the prices which have been submitted in this application
have not been knowingly disclosed by the Applicant and will not knowingly be disclosed by
the Applicant prior to opening, directly or indirectly to any other Applicant or to any
competitor; and
c. No attempt has been made or will be made by the Applicant to induce any other person or
firm to submit or not submit a application for the purpose of restricting competition.
2. Each person signing the Request for Application Cover Sheet & Signature Page of this application
certifies that:
a. He is the person in the Applicant's organization responsible within that organization for the
decision as to the prices being offered herein and that he has not participated, and will not
participate, in any action contrary to (1)(a) through (1)(c) above; or
b. He is not the person in the Applicant's organization responsible within that organization for
the decision as to the prices being offered herein but that he has been authorized in writing to
act as agent for the persons responsible for such decision, in certifying that such persons have
not participated, and will not participate, in any action contrary to (1)(a) through (1)(c) above,
and as their agent does hereby so certify; and he has not participated, and will not participate,
in any action contrary to (1)(a) through (1)(c) above.
3. An application will not be considered for award where (1)(a), (1)(c), or (2) above have been
deleted or modified. Where (1)(b) above has been deleted or modified, the application will not be
considered for award unless the Applicant furnishes with the application a signed statement which
sets forth in detail the circumstances of the disclosure and the head of the agency (CDPHE)
determines that such disclosure was not made for the purpose of restricting competition.
U. Taxes
CDPHE, as purchaser, is exempt from all federal excise taxes under Chapter 32 of the Internal
Revenue Code (Registration No. 84-730123K). CDPHEs Colorado State and Local Sales Tax
Exemption Number is 98-02565. Applicant is hereby notified that when materials are purchased in
certain political sub-divisions (for example in the City of Denver) the Applicant may be required to
pay sales tax even though the ultimate product or service is provided to the State of Colorado. This
sales tax will not be reimbursed by the State.
V. Assignment and Delegation
Except for assignment of antitrust claims, neither party to any resulting contract may assign or
delegate any portion of the contract without the prior written consent of the other party.

Awarded vendor(s) will be allowed to subcontract portions of this RFA. Awarded vendor(s) shall be
fully accountable to the CDPHE and shall ensure that all subcontractors agree to and comply with the
terms and conditions of the contract. During contract performance, the CDPHE may request and
awarded vendor(s) shall provide proof of subcontractor compliance with CDPHE terms and
conditions.
W. Availability of Funds
Financial obligations of the State payable after the current fiscal year are contingent upon funds for
that purpose being appropriated, budgeted, and otherwise made available. In the event funds are not
appropriated, any resulting contract will become null and void, without penalty to the State of
Colorado.
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X. Performance Outside the State of Colorado
The following language regarding performance outside the state of Colorado shall be included in all
contracts resulting from this announcement.

Following the Effective Date, Contractor shall provide written notice to the State, in accordance with
the Notices and Representatives provision, within 20 days of the earlier to occur of Contractors
decision to perform, or its execution of an agreement with a Subcontractor to perform, Services
outside the State of Colorado and/or the United States. Such notice shall specify the type of Services
to be performed outside the State of Colorado and/or the United States and the reason why it is
necessary or advantageous to perform such Services at such location or locations. All notices received
by the State pursuant to this provision shall be posted on the Colorado Department of Personnel &
Administrations website. Knowing failure by Contractor to provide notice to the State under this
provision shall constitute a material breach of this Contract.