75N950-19R-00004.pdf

National Institute on Drug Abuse Request for Proposal (RFP) No. 75N950-19R-00004 “Medication Discovery Using Rat Models of Relapse”

Issued by:

Andrew Hotaling, Contracting Officer NIDA Section, Contracts Management Branch Blue Office of Acquisition, NIDA National Institute on Drug Abuse, NIH 6001 Executive Boulevard Room 4211, MSC 9559 Bethesda, MD 20892-9559

Point of Contact: Tracy Cain, Contracting Officer E-Mail: tracy.cain@nih.gov Phone: 301.443.6677

DATE ISSUED: Thursday, March 21, 2019

PROPOSAL DUE DATE: Monday, April 22, 2019, 2:00 P.M. Eastern Time

The National Institute on Drug Abuse invites you to submit a proposal responding to the requirements of this RFP No. 75N950-19R-00004 titled “Medication Discovery Using Rat Models of Relapse”.

This RFP is prepared in accordance with the Uniform Contract Format (UCF) prescribed for Government wide application by the Federal Acquisition Regulation (FAR). The UCF is both an RFP and contract award document. The resulting contract will consist of Parts I, II, III of the Uniform Contract Format.

We expect to award a cost reimbursement level of effort-type contract for a base period of 1 year with potential for four 1-year option years and additional option quantities. We will fund options dependent on the previous year's performance and the availability of funds. Please anticipate that the base performance period of the contract will be from July 10, 2019 to July 9, 2020. You must respond with technical and pricing proposals for the entire project and total period of performance, including separately priced option years and option quantities.

General

Part IV of the RFP contains instructions, provisions, and evaluation factors for the submission and review of proposals. Attachment 2 is a "Proposal Intent Response Sheet." Please complete this form and return it to tracy.cain@nih.gov by April 5, 2019. The balance of Parts I, II, and III contain provisions, clauses, and special requirements which will be made a part of any resultant award. Please review these sections and consider their impact on performance, capability, technical, and cost factors as you develop your proposal. Do not fill in blanks or otherwise mailto:tracy.cain@nih.gov mailto:tracy.cain@nih.gov complete portions of Parts I, II, and III which appear to require additional information. The Government will complete these items prior to contract award and, if negotiations are conducted, will tailor those items through final negotiations.

Furnish in writing (e-mail is acceptable) to the Contracting Officer any areas of uncertainty, which, in your opinion, require clarification or correction. You must submit your questions in sufficient time for receipt by the Contracting Officer on or before April 5, 2019. Mark the e-mail, "Offeror's Questions, RFP No. 75N950-19R-00004."

The Business Proposal

The Business Proposal must contain a detailed breakdown of costs by task, for each cost category/element, an explanation of the basis for all costs, and provide documentation to support these costs. Please utilize the Breakdown of Proposed Estimated Costs and Excel spreadsheet contained in Attachment 10.

A completed Form NIH-2043, “Proposal Summary and Data Record” must be included with the Business Proposal. Include the e-mail addresses of both the Principal Investigator and the responsible business representative on the form.

The Offeror must submit its Travel Policy, Total Compensation Plan and Annual Report with the initial Business Proposal.

See Section L.2.c. for additional detail.

The Technical Proposal

Offerors shall complete and attach the “Technical Proposal Cover Sheet” to their technical proposal. Be sure to list all professional personnel and organizations named in the proposal who have any role in the proposed work including staff, subcontractors, collaborating organizations, and consultants. Organizational affiliation(s) must be shown for each person named. If needed, additional sheets may be included using the same format. This information is vital to ensure that no conflicts of interest exist with the review committee members.

Format and content requirements for the Technical Proposal are detailed in Section L.2.b.

Submitting a Proposal

Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov) no later than Monday, April 22, 2019, 2:00 P.M. Eastern Time. Proposals submitted by facsimile, e-mail, or hard copy will not be accepted. An official authorized to bind your organization must sign the proposal.

Offerors are solely responsible for submitting proposals in a timely manner. Please note that creating an account to submit may take up to three (3) business days. Please plan accordingly. Additional instructions on how to submit a proposal via eCPS can be found at https://ecps.nih.gov/home/howto and in Attachment 01.

http://rcb.cancer.gov/rcb-internet/forms/2043.pdf http://ocm.od.nih.gov/contracts/rfps/TechCov.htm https://ecps.nih.gov/ https://ecps.nih.gov/home/howto

All notices related to this solicitation will be posted on FedBizOpps (https://www.fbo.gov) as well as the NIDA Contracts Home Page (https://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps). If you would like to receive e-mail notifications of updates to this solicitation, please register with FedBizOpps.

In accordance with FAR 15.306(a)(3) and FAR 52.215-1, the Government intends to evaluate proposals and award a contract without discussions. Therefore, your initial proposal should contain the best terms from cost or price and technical standpoints. The Government does, however, reserve the right to conduct discussions if the Contracting Officer determines them to be necessary.

Disclaimers

This RFP does not commit the Government to pay the costs for the preparation and submission of a proposal. The Contracting Officer is the only individual who legally can commit the Government to the expenditure of public funds in connection with this acquisition.

Any contract award for this requirement is contingent on the availability of funds (see FAR 52.232-18, Availability of Funds – April 1984).

The National Institute on Drug Abuse appreciates your interest in this RFP and looks forward to receipt of your proposal. Requests for any information concerning this RFP should be directed to Tracy Cain, at the NIDA Section, Contracts Management Branch Blue, who may be reached at (301) 443-6677; collect calls will not be accepted. Discussions with any other individual outside the NIDA Section, Contracts Management Branch Blue should not occur.

Sincerely, Andrew Hotaling, Contracting Officer NIDA Section, Contracts Management Branch Blue Office of Acquisition, NIDA/NIH

Enclosure https://www.fbo.gov/ https://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps https://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: P.L. 102-321

2. Request for Proposal (RFP) Number:

75N950-19R-00004

3. Issue Date:

03/21/2019

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Medication Discovery Using Rat Models of Relapse

6. ISSUED BY:

NIDA Section Contracts Management Branch Blue, Office of Acquisition National Institute on Drug Abuse, National Institutes of Health 6001 Executive Blvd, Ste 4211 MSC 9559 Bethesda, Maryland 20892-9559*

*If delivering by other than USPS, change the city and zip code to Rockville, MD 20852

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 2:00 PM local time on April 22, 2019. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043."

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "Packaging and Delivery of the Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website."

If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the eCPS Website.IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE

OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH

subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition," LOCATED IN

SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at http://www.sam.gov

11. FOR INFORMATION CALL: Tracy Cain, Contracting Officer

PHONE: 301-443-6677

e-MAIL: tracy.cain@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Andrew Hotaling Contracting Officer, NIDA Section Office of Acquisitions, NIDA Contracts Management Branch Blue http://www.sam.gov

RFP Number : 75N950-19R-00004

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. LEVEL OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Standards for Privacy of Individually Identifiable Health Information

10. Privacy Act - Treatment of Proposal Information

11. Selection of Offerors

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12. Institutional Responsibility Regarding Investigator Conflicts of Interest

13. ROTC Access and Federal Military Recruiting on Campus

14. Certification of Filing and Payment of Taxes

15. Past Performance Information

16. Electronic Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015)

17. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Care of Live Vertebrate Animals

5. Research Involving Live Vertebrate Animals

6. Obtaining and Disseminating Biomedical Research Resources

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Total Compensation Plan

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer's Annual Financial Report

14. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. LIVE VERTEBRATE ANIMALS EVALUATION

4. MANDATORY QUALIFICATION CRITERIA

5. EVALUATION OF OPTIONS

6. EVALUATION OF DATA SHARING PLAN

7. TECHNICAL EVALUATION FACTORS

8. PAST PERFORMANCE FACTOR

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PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS IF NECESSARY AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION

TO UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The objective of this contract is to determine the in vivo efficacy of novel compounds in animal models of relapse using cocaine, nicotine, methamphetamine, or opioids. This includes the following tests in animals trained to self-administer cocaine (for example): (1) the ability of a test compound to block footshock or other stressor-induced reinstatement of responding after a period of experimental extinction; (2) the ability of a test compound to block or reduce priming-induced reinstatement of responding after a period of extinction; and (3) the ability of a test compound to block the effects of a conditioned cue (previously paired with the training drug) to reinstate responding for the training drug after a period of extinction.

ARTICLE B.2. ESTIMATED COST - OPTION

a. The estimated cost of the Base Period of this contract is $ .

b. The fixed fee for the Base Period of this contract is $ . The fixed fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended.

Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

c. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the Base Period is $ .

d. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Estimated Cost ($) Fixed Fee ($) Estimated Cost Plus Fixed Fee ($)

Base Period Option Period 1 Option Period 2 Option Period 3 Option Period 4 Total

[Base Period and Option(s)]

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e. If the Government exercises any of its option quantites pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Estimated Cost ($) Fixed Fee ($) Estimated Cost Plus Fixed Fee ($)

Option Quantity 1 Option Quantity 2 Option Quantity 3 Option Quantity 4 Option Quantity 5 Option Quantity 6 Total Option Quantities:

f.

Ultimate Contract Value (Base Period, Option Periods, and Option Quantities):

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.NIDA reserves the right to have the contracted services in this contract benefit NIDA and other components of NIH.

[Remainder of Page Intentionally Left Blank]

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, below:

I. BACKGROUND INFORMATION

This contract supports the NIDA Addiction Treatment Discovery Program, providing for the in vivo evaluation, in rodents, of potential pharmacotherapies that would specifically prevent relapse to cocaine and other drugs of abuse. It also provides support for the development of methods and protocols to be used for compound evaluation including drug self-administration.

The Addiction Treatment Discovery Program was originally focused on the discovery and development of treatments that will produce two specific types of clinical effects. The first, agonist-type therapy, is based on the successful use of this type of treatment approach in the treatment of smokers (nicotine replacement) and heroin users (methadone and buprenorphine). The second, antagonist or blocking-type therapy, is based on successful use of this strategy for opiates (naltrexone). An existing set of other NIDA contracts support screening measures (locomotor activity, drug discrimination, and self-administration) that have been successful in identifying lead compounds for these two types of medications, some of which will be further evaluated for clinical efficacy.

However, there exists another identified clinical need in addition to agonist and antagonist therapy, and that is the need for medications to prevent relapse. Whereas it is possible that agonist/antagonist type medications may prevent craving and subsequent relapse to cocaine use, there now exist more advanced behavioral screens, using reinstatement of extinguished drug self-administration in models of relapse, which may prove useful in identifying additional medications. Such a screen incorporates several clinically relevant aspects of relapse, including exposure to stressors, exposure to cues associated with the drug, and exposure to low doses of the drug itself. Use of these relapse models may permit the discovery of medications that differ from agonist/ antagonist types of medications, and may include anxiolytics, antidepressants, and potential treatments with other non-dopaminergic mechanisms of action. As such, this project represents an important addition to the capabilities of the Addiction Treatment Discovery Program. In addition, NIDA wishes to continue its expansion of contract capabilities to enable use of models of relapse to other drugs of abuse (such as but not limited to methamphetamine, nicotine, opioids, and marijuana). This testing represents an essential component of the Division's medication development efforts; the resulting data guide decisions regarding advancement of compounds to preclinical safety evaluations and eventual clinical trials.

The NIDA Division of Therapeutics and Medical Consequences (DTMC) established a policy to encourage chemists and pharmaceutical companies to take part in NIDA's preclinical medication discovery programs, including the Addiction Treatment Discovery Program. The policy provides that those who submit compounds to NIDA for evaluation in the programs have all rights to publish data generated on their compounds. NIDA sends the compounds, hereafter referred to as "test compounds," to NIDA testing sites in a blinded fashion. NIDA does not provide the identity of test compounds to the testing sites, but instead, provides only essential compound information, such as storage, solubility, and doses. Because the selected Contractor will serve as a testing site for the NIDA Addiction Treatment Discovery Program, it is unlikely that NIDA will allow the Contractor to publish any test compound data created under this contract. However, the Contractor may publish data created during the course of evaluating "standard compounds." Standard compounds are those compounds obtained directly by the Contractor for evaluation under the contract, with the resulting data available for immediate release to NIDA and the scientific community.

II. OBJECTIVES

In brief, the objectives of this contract are to determine the in vivo efficacy of novel compounds in animal models of relapse. This includes the following tests in animals trained to self-administer cocaine or other drugs of abuse;

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(1) the ability of a test compound to block or reduce footshock- or other stressor-induced reinstatement of responding after a period of experimental extinction;

(2) the ability of a test compound to block or reduce drug-priming-induced reinstatement of responding after a period of extinction; and

(3) the ability of a test compound to block or reduce the effects of a conditioned cue (previously paired with drug) to reinstate responding for the training drug after a period of extinction.

An integral part of this work is to develop methods and to design and implement protocols for the evaluation of test compounds. A number of laboratories have used some of the methodologies described in the literature.

While recognizing the need for methods development, NIDA anticipates that by Option Period 1, if Options are exercised, the majority of the Contractor's efforts will be devoted to test compound evaluations. The Contractor shall identify and acquire standard compounds that merit the aforementioned types of evaluation. In addition, if NIDA exercises specific contract options, this contract shall support follow-up rodent pharmacology studies of compounds identified as promising potential drug-dependence treatment agents including through the use of drug self-administration studies. The details of these latter studies cannot be specified before contract award;

they will depend upon specific successes in NIDA's medication discovery efforts and scientific advances in the general field of drug abuse research. Written reports documenting the study findings are the anticipated end products of this contract.

III.Services to be Performed

A.GENERAL REQUIREMENTS

1. Independently, and not as an agent of the Government, the Contractor shall furnish all necessary labor, materials, supplies, equipment, and services (except as otherwise specified herein) and perform the work set forth below.

2. The Contracting Officers Representative (COR) will monitor all work under this contract.

B. SPECIFIC REQUIREMENTS

During the effective period of this contract Years 1 through 5 (if Options are exercised), the Contractor shall perform the work described in Tasks 1 through 5.

TASK 1. As directed by the NIDA COR, the Contractor shall devote up to 12,784-person hours per year to evaluating the efficacy of compounds in one or more models of relapse to drug self-administration. In these models, the Contractor shall train rats to self-administer cocaine (or another drug of abuse specified by the NIDA COR, for example, methamphetamine, nicotine, opioids, or THC) at stable levels. Following training, the contractor will extinguish, and then reinstate the behavior using a stimulus that reliably reinstates the self-administration behavior. The Contractor shall develop standard protocols and characterize them with standard compounds. The Contractor will then utilize the standard protocols for evaluating the effects of test compounds on the ability of three types of stimuli to produce reinstatement.

These stimuli are 1) a priming dose of the training drug, 2) exposure to a laboratory stressor, and 3) exposure to a drug-associated cue. The Contractor shall devote at least 24 chambers to this work if rats have additional "home" cages, or at least 36 chambers if rats will dwell in the test chambers. For those compounds specified by the NIDA COR, the Contractor shall also evaluate effects of test compounds on rats trained to respond for an alternative reinforcer (for example, food) under a procedure similar to that utilized for drug self-administration. NIDA anticipates that this latter testing will be required only for a limited number of compounds because this work is currently being conducted under another contract. The Contractor shall compare each dose of a compound to its vehicle with regard to its ability to prevent or reduce reinstatement of responding for drug or its ability to impair responding on the non-active lever. Unless otherwise directed by the NIDA COR, the Contractor shall use a minimum of 12 rats to evaluate the effects of each dose of compound under study. The specific details of

- 8 -each protocol, the specific compounds to be evaluated (standard compounds as well as test compounds), and the doses of each compound that the Contractor utilizes are subject to the approval of the NIDA COR. The NIDA COR shall specify the route of administration that the Contractor shall use for each test compound. Occasionally, the Contractor shall administer a test compound by oral gavage, if so directed by the NIDA COR. Although it is probable that the contract will require reinstatement studies involving cocaine, it is also possible that the Contract will require the development and utilization of similar reinstatement protocols for self-administration of another drug of abuse, such as but not limited to methamphetamine, nicotine, opioids, or THC. The Contractor shall utilize protocols using drugs of abuse other than cocaine if directed by the NIDA COR. The Contractor shall blind the identity of all standard compounds under evaluation to those who are conducting the assays. NIDA recognizes the specific details of the reinstatement protocols adopted for this contract will influence the maximum number of compounds that the Contractor can evaluate using the operant chambers specified in this Task. Depending on the type(s) of reinstatement models in which the Contractor evaluates each compound and the final details of each protocol, NIDA anticipates that the contractor will evaluate 15 to 30 compounds per year. For each standard compound or test compound evaluated, the contractor shall prepare a Compound Evaluation Report.

TASK 2. Approximately every twelve months, the Contractor shall attend a meeting (up to two days) with NIDA staff and possibly as many as six consultants to review past, current, and future work under this contract. Prior to each meeting, the Contractor shall prepare and organize "pre-meeting packets" in 4 sections. Section 1 shall have a summary of all data presented and a description of relevant methods. Section 2 shall provide a summary of all problems encountered when implementing the tasks required by the contract, as well as suggested solutions for those problems. Section 3 shall include proposals for improving or expanding protocols utilized for Task 1 evaluations. Section 4 shall suggest compounds for potential evaluation under the contract and suggested doses to be evaluated for each compound. If so requested by the NIDA COR, methods included in Section 1 shall be in a research protocol format, with a description of each testing type. The Contractor shall provide this information (the pre-meeting packets) to the consultants and the NIDA COR at least two weeks in advance of the meeting. The Contractor shall present this information at the meeting and subsequently prepare a "meeting report" to summarize and synthesize the results of the meeting, including specific consultant recommendations. During the meeting, the Contractor shall obtain consultant suggestions regarding additional compounds that may merit evaluation under the contract and, by a method approved by the NIDA COR, use the consultants to prioritize the compounds suggested for each task. The Contractor shall include the resulting prioritized compound lists in the meeting report. In most cases, the meeting site is in the Washington, D.C. area. However, in some special circumstances the NIDA COR may designate another meeting site, such as at a professional meeting (e.g., a College on Problems of Drug Dependence meeting, a Society for Neuroscience meeting, etc.). NIDA will reimburse the Contractor's travel expenses (up to four people) to all consultant meetings in accordance with federal travel regulations.

Following each meeting, the NIDA COR shall approve a specific list of compounds for the Contractor to acquire. The Contractor shall attempt to obtain and evaluate those compounds. The Contractor shall not attempt to obtain any compounds for evaluation under this contract without approval of the NIDA COR. Throughout the life of the contract, the NIDA COR shall arrange for blinded test compounds to be sent to the Contractor for evaluation. Test compounds and standard compounds were differentiated above (see Background Information). Information generated on standard compounds must be immediately available for distribution to the scientific community (e.g., through presentation at a consultant meeting or through publication). Therefore, the Contractor, in the course of acquiring standard compounds, shall not enter into any agreement that would limit the availability of data generated on the compounds. In many cases, the Contractor will purchase standard compounds from a commercial source or obtain them free of charge from the NIDA Drug Supply Program. In all other cases, the Contractor shall request standard compounds through letters that include the following statement: "The contractor will evaluate the compound as

- 9 -a standard, and will make available to the scientific community the data that the contractor generates on the compound. Data on standard compounds will not be confidential."

In the event that the contract cannot obtain a standard compound, the NIDA COR may provide the compound to the contractor as a test compound. In some cases, NIDA may be able to arrange for (under a separate contract) the synthesis of an interesting compound for evaluation as either a standard compound or a test compound, depending upon the specific compound.

TASK 3. Throughout the life of the contract, the Contractor shall maintain a chronological log of compound receipt. When the Contractor receives compounds (standards compound or test compounds) sent by the COR for evaluation, then the Contractor shall make several log entries: (1) the test compound name or Addiction Treatment Discovery Program identification number and (2) tests authorized (3) the doses authorized (4) the vehicle (5) the pretreatment time, (6) the date of receipt.

TASK 4. Throughout the life of the contract, the Contractor shall maintain a log of compound evaluation. This log shall contain five columns. In Column 1, date of study initiation (date laboratory testing begins). In Column 2 identify the compound under study (compound name or Addiction Treatment Discovery Program code number). In Column 3 describe the study description. In Column 4 enter the study completion date (date that Contractor completes laboratory testing). In Column 5 enter the date that resulting Compound Evaluation Report is sent to the NIDA Project Officer. The Contractor shall maintain this table chronologically, by date of study initiation. The Contractor shall update this table at least once each month.

TASK 5. If appropriate contract options are exercised, the Contractor shall, as directed by the NIDA COR, utilize a specified number of person hours for several purposes. These person hours shall be used (1) for supplemental protocol development for Task 1; (2) for designated "follow-up studies for compounds identified as promising potential treatment agents which could include drug self-administration; (3) for additional testing of compounds in Task 1; and,

(4) for the preparation of corresponding data reports. The details of these Task 5 studies cannot be specified in advance of contract award; rather, the NIDA COR shall specify the details as the decision is made to exercise contract options. The Contractor and the NIDA COR will jointly determine study designs, which possibly could involve chronic test compound administration, cocaine reinstatement tests using female rats, or reinstatement protocols for methamphetamine self-administration or self-administration of other drugs of abuse. Data reports shall adhere to a format determined by the NIDA COR.

During each period of the effective performance of this contract (Years 1 through 5), the Government may exercise any or all of the following options up to 4 times each.

Option 1: The Contractor shall devote up to 1,000-person hours to the work described under Task 5.

Option 2: The Contractor shall devote up to 2,000-person hours to the work described under Task 5.

Option 3: The Contractor shall devote up to 4,000-person hours to the work described under Task 5.

Option 4: The Contractor may incur up to $20,000 in direct cost for laboratory supplies, equipment, animals, and/or animal per diem charges as required for the work described under Task 5.

Option 5: The Contractor may incur up to $40,000 in direct cost for laboratory supplies, equipment, animals, and/or animal per diem charges as required for the work described under Task 5.

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Option 6: The Contractor may incur up to $60,000 in direct cost for laboratory supplies, equipment, animals, and/or animal per diem charges as required for the work described under Task 5.

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format, as specified in Section F of the RFP.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

a. Technical Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [Note: the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

1.) Study Reports: For each compound evaluated in Task 1, the Contractor shall submit one electronic copy of a Study Report to the NIDA COR within 30 days of the completion of each compound studied. The purpose of these reports is to inform DTMC, as well as the submitter whose compound is being tested, of the results obtained. These reports shall accurately and completely outline the results of each individual test on each test compound.

A prototype of this report will be provided to the Contractor by the NIDA COR. The format of the Study Report shall include: Date of report, title (to include test compound identification number/batch number), experimental protocol utilized (e.g., Stress-induced reinstatement to cocaine self-administration), NIDA DTMC Contract number (N01DA-19-8949), Contractor name(s), abstract of methods and experimental findings, detailed methods, methods of data analysis, description of compound(s) and vehicle(s) utilized, detailed description of experimental results including calculation of compound potency and presentation of data in graphical and/or tabular form for the group of experimental subjects.

The Contractor shall ensure that all Study Reports are free from spelling, typographical, or grammatical errors. Study Reports containing such errors shall be deemed unacceptable and returned to the Contractor for correction. A revised report will be submitted with the date of the revision. Study reports will be transmitted electronically as specified by the NIDA COR.

2.) Monthly Progress Reports: Within the first five business days of each calendar month, the Contractor shall submit one electronic copy of a report on activities during the preceding month. In the Monthly Progress Report, the Contractor shall briefly summarize (1-2 paragraphs) results in the different behavioral tests and include a discussion of any problems encountered and recommendations to rectify the problem(s). This report shall include a listing of any formal correspondence with NIDA. The Monthly Progress Report shall also contain an updated chronological listing of compound authorization, receipt, usage and evaluation relevant to the month under report.

3.) Annual Progress Reports: Not later than fifteen business days after the end of each year of contract work, the Contractor shall submit a report on activities during the year.

This report shall contain a summary of notable achievements, methods followed for each http://www.hhs.gov/web/508/index.html

- 11 -protocol, results obtained, problems encountered and their solutions, and an updated chronological listing of compound authorization, receipt, usage and evaluation during the year under report. A summary of any consultant meeting(s) held during the year should be included. An electronic copy is to be sent to the NIDA COR and one copy to the Contract Officer.

4.) Final Report: On or before the expiration date of the contract, the Contractor shall provide a comprehensive summary of work conducted during the entire contract period.

This report shall incorporate the final annual report and shall contain a summary of notable achievements, methods followed for each protocol, results obtained, problems encountered and their solutions, and an updated chronological listing of compound authorization, receipt, usage and evaluation during the period under report. A summary of any consultant meeting(s) held during the year should be included. Electronic copies are to be sent to the NIDA COR and to the Contract Officer.

5.) Laboratory records and proprietary test compounds: On or before the expiration date of this contract, if so instructed by the NIDA COR, the contractor shall ship these items to the NIDA COR in Rockville, Maryland.

6.) Pre-meeting Packets: Pre-meeting packets will be prepared by the Contractor as described in Task 2. One copy shall be provided to each consultant and the remainder to NIDA COR as described in Task 2.

7.) Meeting Reports: These reports shall be prepared by the contractor as described in Task 2. Two copies shall be sent to the NIDA COR no later than 2 weeks after completion of each meeting.

2. Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

b. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.

45 CFR Part 94 is available at: http://www.ecfr.gov/cgi-bin/text-idx?

c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45.

See Part 94.5, Management and reporting of financial conflicts of interest for complete information on reporting requirements.

(Reference subparagraph g. of the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS

http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45

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INFORMATION AND/OR PHYSICAL SECURITY

A. The Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/NIH IRT teams within 24 hours, whether the response is positive or negative.

FISMA defines an incident as "an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system;

or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cyber security and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by Federal Information Security Modernization Act (FISMA) as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as "a suspected or confirmed incident involving PII" .

In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) shall:

a. Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract so as to avoid a secondary sensitive information incident with FIPS 140-2 validated encryption.

b. NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor shall send NIH approved notifications to affected individuals in accordance with https://ocio.nih.gov/ InfoSecurity/IncidentResponse/Pages/ir_guidelines.aspx

c. Report all suspected and confirmed information security and privacy incidents and breaches to the NIH Incident Response Team (IRT) via email at IRT@mail.nih.gov, COR, CO, the NIH Office of the SOP (or his or her designee), and other stakeholders, including incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour, and consistent with the applicable NIH and HHS policy and procedures, NIST standards and guidelines, as well as US-CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall:

a. cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

b. not include any sensitive information in the subject or body of any reporting e-mail; and

c. encrypt sensitive information in attachments to email, media, etc.

d. Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information HHS and NIH incident response policies when handling PII breaches.

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e. Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls.

This may also involve physical access to contractor facilities during a breach/incident investigation within an hour of discovery.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer.

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Contracting Officer NIDA Section, Contracts Management Branch Blue Office of Acquisition, NIDA National Institutes of Health 6001 Executive Blvd Ste 4211, MSC 9559 *Bethesda, Maryland 20892- 9559

*For delivery service or hand delivery, use Rockville, Marlyand 20852.

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is required as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

http://www.iedison.gov

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SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

[Remainder of this Page Intentionally Left Blank]

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SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, the Contracting Officer's Representative (COR), whose position is described in Section G, is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institute on Drug Abuse National Institues of Health 6001 Executive Blvd Bethesda, Maryland 20892

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR Clause 52.246-9, Inspection of Research and Development (Short Form) (April 1984).

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from 07/10/2019 through 07/09/2020.

b. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:

Option Option Period Option Period 1 (Contract Year 2) 07/10/2020 - 07/09/2021 Option Period 2 (Contract Year 3) 07/10/2021 - 07/09/2022 Option Period 3 (Contract Year 4) 07/10/2022 - 07/09/2023 Option Period 4 (Contract Year 5) 07/10/2023 - 07/09/2024

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

a. The items specified below as described in the…