RFP_Number_N01DA-17-8932.PDF

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Law 92-218 as amended

2. Request for Proposal (RFP) Number:

N01DA-17-8932

3. Issue Date:

September 23, 2016

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Preclinical Medications Discovery and Abuse Liability Testing for NIDA

6. ISSUED BY:

National Institute on Drug Abuse/NIH NIDA R&D Contracts Management Branch 6001 Executive Boulevard, Room 4211 - MSC 9559 Bethesda, MD 20892-9559*

*For delivery service (e.g. FedEx, UPS, etc.) change 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 3:00pm local time on November 7, 2016. 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 PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

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: Mark McNally, Contract Specialist

PHONE: 301-443-6677

e-MAIL: mcnallyme@mail.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Kenneth E. Goodling Contracting Officer NIDA R&D Contracts Management Branch Office of Acquisition/NIDA http://www.sam.gov

RFP Number : N01DA-17-8932

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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. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

11. Institutional Responsibility Regarding Investigator Conflicts of Interest

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12. ROTC Access and Federal Military Recruiting on Campus

13. Certification of Filing and Payment of Taxes

14. Past Performance Information

15. Information and Physical Access Security

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. TECHNICAL EVALUATION FACTORS

7. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

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

This contract provides support for evaluation of potential pharmacotherapies for drug dependence disorders in both rodents and primates. It also provides support for abuse liability-related testing of new street drugs, medications, or potential medications in rodents and primates. The primary emphasis is on testing conducted for NIDA’s Addiction Treatment Discovery Program (ATDP). To a lesser extent, the contract will generate abuse liability data for use in decisions pertaining to scheduling of drugs under domestic laws (Controlled Substances Act) and international treaties (Single Convention and Psychotropic Convention). NIDA’s testing needs for this contract will be dynamic, due to the influences of such factors as opportunities for NIDA/pharmaceutical company collaboration, advances in the field of drug addiction research, and advice from consultants to the ATDP. As a result, the details of all tests to be conducted under this contract cannot be specified in advance of contract award. Testing shall include but shall not be limited to: assessment of the in vivo receptor activity of novel opioid compounds, evaluation of compounds for their ability to produce, block or prevent physical dependence in rodents and/or primates, evaluation of compounds in operant models of behavior, including responding for food reinforcement and intracranial self-stimulation, and evaluation of compounds in other animal models relevant to drug abuse and addiction. The anticipated end results of each evaluation conducted under this contract are written reports detailing study findings.

ARTICLE B.2. ESTIMATED COST PLUS FIXED FEE - 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:

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Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Base Period (Contract Year 1)

Option Periods:

Option Year 1 (Contract Year 2)

Option Year 2 (Contract Year 3)

Option Year 3 (Contract Year 4)

Option Year 4 (Contract Year 5)

Option Quantities:

Option 1 (Base Period - Contract Year 1)

Option 2 (Base Period - Contract Year 1)

Option 3 (Base Period - Contract Year 1)

Option 4 (Base Period - Contract Year 1)

Option 5 (Base Period - Contract Year 1)

Option 6 (Base Period - Contract Year 1)

Option 7 (Base Period - Contract Year 1)

Option 8 (Base Period - Contract Year 1)

Option 9 (Base Period - Contract Year 1)

Option 1 (Option Year 1 - Contract Year 2)

Option 2 (Option Year 1 - Contract Year 2)

Option 3 (Option Year 1 - Contract Year 2)

Option 4 (Option Year 1 - Contract Year 2)

Option 5 (Option Year 1 - Contract Year 2)

Option 6 (Option Year 1 - Contract Year 2)

Option 7 (Option Year 1 - Contract Year 2)

Option 8 (Option Year 1 - Contract Year 2)

Option 9 (Option Year 1 - Contract Year 2)

Option 1 (Option Year 2 - Contract Year 3)

Option 2 (Option Year 2 - Contract Year 3)

Option 3 (Option Year 2 - Contract Year 3)

Option 4 (Option Year 2 - Contract Year 3)

Option 5 (Option Year 2 - Contract Year 3)

Option 6 (Option Year 2 - Contract Year 3)

Option 7 (Option Year 2 - Contract Year 3)

Option 8 (Option Year 2 - Contract Year 3)

Option 9 (Option Year 2 - Contract Year 3)

Option 1 (Option Year 3 - Contract Year 4)

Option 2 (Option Year 3 - Contract Year 4)

Option 3 (Option Year 3 - Contract Year 4)

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Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Option 4 (Option Year 3 - Contract Year 4)

Option 5 (Option Year 3 - Contract Year 4)

Option 6 (Option Year 3 - Contract Year 4)

Option 7 (Option Year 3 - Contract Year 4)

Option 8 (Option Year 3 - Contract Year 4)

Option 9 (Option Year 3 - Contract Year 4)

Option 1 (Option Year 4 - Contract Year 5)

Option 2 (Option Year 4 - Contract Year 5)

Option 3 (Option Year 4 - Contract Year 5)

Option 4 (Option Year 4 - Contract Year 5)

Option 5 (Option Year 4 - Contract Year 5)

Option 6 (Option Year 4 - Contract Year 5)

Option 7 (Option Year 4 - Contract Year 5)

Option 8 (Option Year 4 - Contract Year 5)

Option 9 (Option Year 4 - Contract Year 5)

Total

[Base Period and Option(s)]

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.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

I. Background Information and Objectives

A. Background Information

The present contract represents the competitive renewal of an existing National Institute on Drug Abuse (NIDA) contract (N01DA-12-8904) with the Virginia Commonwealth University. It provides support for the evaluation of potential pharmacotherapies for drug use disorders using rodents and/or primates. It also provides support for abuse liability testing of new street drugs, medications, or potential medications in rodents and/or primates. The primary emphasis is on testing conducted for NIDA's Addiction Treatment Discovery Program (ATDP). To a lesser extent, the contract will generate abuse liability data for use in decisions pertaining to scheduling of drugs under domestic laws (Controlled Substances Act) and international treaties (Single Convention and Psychotropic Convention).

The NIDA ATDP was created in 2005 through the combination of NIDA's existing Cocaine Treatment Discovery Program, Opiate Treatment Discovery Program and Methamphetamine Treatment Discovery Program, as well as smaller existing medications discovery initiatives related to smoking cessation and marijuana dependence treatment. In part, this consolidation was in response to the decreased availability of contract funds within NIDA; efficiencies and increased flexibility have been achieved by consolidating contract resources that were previously cocaine-, opiate-, or methamphetamine-specific. The current contract will continue to provide the efficiency and flexibility established in previous iterations of the contract (contract numbers N01DA-07-8859 and N01DA-12-8904) effort focused on medications discovery for the treatment of substance use disorders and abuse liability of street drugs testing for the purposes of drug scheduling.

The present contract represents an integral piece of a much larger ATDP infrastructure; separate contracts support in vitro receptor activity testing, in silico predictive toxicology testing (e.g., computational toxicology based on compound structure) and in vitro predictive safety testing (e.g., hERG channel assay to predict QT prolongation and the Ames assay to predict mutagenicity), as well as the evaluation of compounds in behavioral pharmacology studies (e.g., locomotor activity, drug discrimination, drug self-administration, and models of relapse to drug-seeking assays) in mice, rats, and monkeys. Within the larger NIDA Medications Development Program, the ATDP feeds into contract-supported preclinical and clinical development efforts.

Thus, compounds from the ATDP that show promise as potential drug addiction treatments may advance through appropriate safety and efficacy testing. With regard to abuse liability testing, the present contract also represents a piece of a larger NIDA contract infrastructure. For example, in vitro receptor binding and functional activity data, as well as drug discrimination and self-administration data are obtained by NIDA from other existing contracts to gain insight into the abuse potential of medication development candidates or new street drugs.

To encourage chemists and pharmaceutical companies to submit compounds to the ATDP, NIDA has established a policy which states that compound submitters retain all rights to publish data generated on their compounds. The potential medications submitted to NIDA, hereafter referred to as "test compounds", are sent to NIDA testing sites in a blinded fashion. The identity of each test compound is not revealed to the testing sites; only essential compound information, such as solubility, appropriate storage conditions, dose, and pretreatment time, are provided to the testing sites by NIDA. As the present Contractor will serve as a testing site for the ATDP, it is unlikely that the Contractor will be allowed by NIDA to publish any test compound data generated under this contract. On the other hand, the Contractor will not be prohibited from publishing data which is generated during the course of evaluating "standard compounds", defined as those compounds obtained directly by the Contractor for evaluation under the contract, as directed by NIDA, with the resulting data available for immediate release to NIDA and the scientific community. In general, new street drugs characterized for abuse liability will be standard compounds.

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B. Objectives

In brief, the objectives of this contract are to conduct specific pharmacological evaluations of potential substance use disorder treatment medications and to conduct preclinical abuse liability studies of new street drugs, medications, or potential medications in rodents and/or primates.

NIDA's testing needs for this contract will be dynamic, due to the influences of such factors as opportunities for NIDA/pharmaceutical company collaboration, advances in the field of drug addiction research, and advice from consultants to the ATDP. As a result, the details of all tests to be conducted under this contract cannot be specified in advance of contract award. Testing shall include but shall not be limited to: evaluation of compounds in operant models of behavior in rodents, including responding for food reinforcement and intracranial self-stimulation, and evaluation of compounds against withdrawal from abused substances such as nicotine in rodents. Testing will also possibly include the evaluation of compounds in other animal models relevant to drug abuse and addiction, the assessment of the in vivo receptor activity of novel compounds, and the evaluation of compounds for their ability to produce, block or prevent physical dependence in rodents and/or primates. The anticipated end results of each evaluation conducted under this contract are written reports detailing study findings.

II. 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 NIDA Contracting Officer's Representative (COR), whose position is defined in Section G of this contract, will monitor all work under this contract.

B. Specific Requirements

1. Task Requirements

Specifically, the contractor shall perform the following tasks:

Task 1: As specified by the COR, the Contractor shall evaluate compounds for their effects on non-reinforced operant responding (compound effects shall be evaluated under extinction conditions) in rats previously trained to self-administer food. The purpose of these studies will be to serve as behavioral "selectivity controls" for compound evaluations in relapse models (i.e., models of stress-, cue-, and drug prime-induced reinstatement of drug-seeking behavior). The relapse model studies are currently supported under a different NIDA contract.

For this Task, rats will be allowed unlimited access to food until they reach a final weight of 320-340 g. The rats will then be maintained within this weight range by food-restriction. For each rat, the Contractor shall conduct training or test sessions on at least five consecutive days per week. The Contractor shall test at least 8 subjects/dose of test compound or standard compound so as to provide sufficient statistical power. Studies conducted under this Task shall use a between-subjects design. The Contractor shall blind the identity of all test compounds under evaluation to those who are testing the animals. All other protocol details (e.g., route of administration, doses to be tested, vehicle, pretreatment time, etc.) shall be provided by the COR. Each study shall be regarded as one "compound evaluation." On average, it is anticipated that vehicle and three doses of compound shall be evaluated in each compound evaluation under this Task.

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Task 2: As specified by the COR, the Contractor shall evaluate compounds in a protocol designed to provide dosing guidance for the studies described under Task 1. The studies will be conducted as described under Task 1 except that the Contractor shall test at least 4 subjects/dose and, if authorized by the COR, rats previously used for a Task 1 study may be utilized. On average, it is anticipated that vehicle and four doses of a compound shall be evaluated in each compound evaluation under this Task.

Task 3: As specified by the COR, the Contractor shall use the intracranial self-stimulation (ICSS) procedure to evaluate compounds for their ability to produce reinforcement ("reward") or aversive effects, for their ability to alter the reinforcing ("rewarding") properties of drugs of abuse, or for their ability to alter the aversive state that exists during withdrawal from the chronic administration of a drug of abuse.

For this Task, the Contractor shall conduct training, maintenance, or test sessions on at least five consecutive days per week for each rat. The Contractor shall test no fewer than 6 subjects/dose of test compound. This study will use a between-subjects design. The Contractor shall blind the identity of all test compounds under evaluation to those who are testing the animals. All other protocol details (e.g., evaluation of the test compound alone versus in combination with another drug, route of administration, doses to be tested, vehicle, pretreatment time etc.) shall be provided by the COR. Each study (meaning drug alone, blockade of reward effects or blockade of withdrawal effects) shall be regarded as one "compound evaluation." On average, it is anticipated that vehicle and three doses of test compound shall be evaluated in each compound evaluation under this Task.

Task 4: As specified by the COR, the Contractor shall evaluate a compound in assays to determine its ability to alter the aversive state of withdrawal from nicotine in rodents.

For this Task, the Contractor shall produce nicotine dependence (e.g., using minipumps or repeated injections) and then assess compound effects against spontaneous or precipitated withdrawal by measuring somatic signs, hyperalgesia and affective withdrawal signs (e.g., alterations in anxiety-like behavior). The Contractor shall test no fewer than 6 subjects/dose of test compound. This study will use a between-subjects design. All other protocol details (e.g., route of administration, doses of test compound to be tested, vehicle, pretreatment time, etc.) shall be provided by the COR. Each study shall be regarded as one "compound evaluation" The Contractor shall blind the identity of all test compounds under evaluation to those who are testing the animals. On average, it is anticipated that vehicle and three doses of test compound shall be evaluated in each compound evaluation under this Task.

Task 5: As specified by the COR, the Contractor shall determine whether or not a compound has intrinsic physical dependence capacity by conducting a primary physical dependence test using non-dependent, drug-naïve rats or monkeys. In this test, the subjects shall receive the compound on a rising dose schedule until significant side effects are noted. The dosage of compound shall then be reduced and maintained for a period of 30 to 40 days. During this time, the subjects shall be challenged periodically with an antagonist, as specified by the COR, and the subjects shall be observed to determine whether or not withdrawal is precipitated. On the final day of treatment following the last dose of compound, subjects shall be observed several times over the course of 24 hours and signs and symptoms shall be recorded to assess spontaneous withdrawal. The Contractor shall compare and contrast the profile of the withdrawal symptoms observed following test compound administration with the profile observed when a known addicting substance is similarly evaluated. The precise details of all experimental protocols shall be subject to the approval of the COR. The Contractor shall blind the identity of all test compounds under evaluation to those who are observing the animals. Each study shall be regarded as one "compound evaluation." If it is necessary to conduct these studies using non-human primates, the Contractor will be expected to have the facilities and expertise necessary in order to obtain, house, and test monkeys in operant or non-

- 10 -operant assays, and it is expected that contract options for additional funds or manpower will be exercised. The design of these studies will be specified if the need arises.

Task 6: As specified by the COR, the Contractor shall evaluate a compound in assays to determine its in vivo receptor activity in rats or mice. The purpose of these studies will be to follow up on novel compounds found to exhibit desirable in vitro receptor activity profiles (with the in vitro work having been conducted elsewhere, e.g., under NIDA grants).

The precise nature of these types of assays cannot be predicted in advance but may include such tests as the Tetrad test or its individual components, antinociception, body temperature, or elevated plus maze. NIDA recognizes that the Contractor initially may need to evaluate several standard compounds to validate these assays and, throughout the life of the contract, the Contractor will be encouraged to suggest possible ways of improving or expanding these assays. As an example of one possible approach to the design of these assays, compounds might be evaluated for kappa-opiate antagonist properties by measuring their ability to antagonize the antinociceptive effects of a selective kappa-opiate receptor agonist, or if needed, a compound might be evaluated in the Tetrad test. The specific details of each assay shall be proposed by the Contractor when needed by NIDA, and shall be subject to the approval of the COR. The route of administration to be used for each test compound shall be specified by the COR. In some cases, the Contractor may be required to administer a test compound by oral gavage.

In each assay, the Contractor shall utilize 6 to 10 subjects per dose of compound, and each compound shall be evaluated at doses ranging from a dose which is inactive to either a dose which produces maximal effects or a maximum dose (e.g., 100 mg/kg) specified by the COR. The Contractor shall blind the identity of all test compounds under evaluation to those who are testing the animals. The evaluation of one compound, as just described, in one assay (e.g., in an assay for mu agonist activity) shall be regarded as one "compound evaluation."

Task 7: When the appropriate contract options are exercised, the Contractor shall conduct additional pharmacology studies in rodents or primates as specified by the COR. Because NIDA's testing needs are dynamic, the details of these studies cannot be specified in advance of contract award. Similar Tasks under previous NIDA contracts have supported studies that range from the establishment of new animal models of addiction, such as heroin and cocaine self-administration "relapse models." They have also supported test compound-specific studies of potential medications that have advanced from discovery to preclinical development. Although some experimental procedures may already be established in the Contractor's laboratory, it is anticipated by NIDA that substantial methods development efforts will sometimes be required under this Task. Among the techniques currently under consideration by NIDA for possible application under this Task are conditioned place preference and drug self-administration in rats. Details of all methods development efforts, as well as details of all protocols for compound evaluations, shall be subject to the approval of the COR. If it is necessary to conduct these studies using non-human primates, the Contractor will be expected to have the facilities and expertise necessary in order to obtain, house, and test monkeys in operant or non-operant assays, and it is expected that contract options for additional funds or manpower will be exercised. The design of these studies will be specified if the need arises.

Task 8: Up to once every 12 months, as specified by the COR and approved by the Contracting Officer, the Contractor shall attend a meeting (up to two days in length) with NIDA staff for the purpose of reviewing past, current, and future work under this contract. Consultants (as many as six) may also be in attendance. Specific items for discussion will be subject to the approval of the COR. Prior to each meeting, the Contractor shall prepare "pre-meeting" packets organized as follows: section 1 - summary of all data to be presented and description of relevant methods; section 2 - summary of all problems encountered in the implementation of Tasks required by the contract, as well as suggested solutions for those problems; section 3 - proposals for improving or

- 11 -expanding protocols; section 4 - suggested compounds for potential evaluation under the contract and suggested doses to be evaluated for each compound. If so requested by the COR, methods included in section 1 shall be in a research protocol format, with each type of testing described on separate pages. The Contractor shall provide this information (the pre-meeting packets) to attendees and the COR at least 3 weeks in advance of the meeting. The Contractor shall present this information at the meeting and subsequently prepare a "post-meeting report" to summarize and synthesize the results of the meeting, including specific consultant recommendations. In most cases, the site of the meetings shall be in the Washington, D.C. area. However, in some special circumstances the 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.).

This contract (N01DA-17-8932) shall be responsible for payment of the Contractor's travel expenses (up to three persons) to all consultant meetings. All expenses for the consultants will be paid by another NIDA contract. The COR shall specify which individuals will serve as consultants.

Following each meeting, the COR may approve a specific list of "standard compounds" for the Contractor to acquire. The Contractor shall attempt to obtain and evaluate these compounds. The Contractor shall not attempt to obtain any compounds for evaluation under this contract without approval of the COR. Throughout the life of the contract, the 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). Unless otherwise approved by the COR, 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) and the Contractor, in the course of acquiring standard compounds, shall not enter into any agreement which would limit the availability of data generated on the compounds.

Task 9: Throughout the life of the contract, the Contractor shall maintain a chronological log of compound receipt in electronic spreadsheet format. When each compound (standard compound or test compound) to be evaluated under the contract is received, three log entries shall be made: (1) the test compound's name or Addiction Treatment Discovery Program identification number; (2) the source of the compound; and (3) the date of receipt.

Task 10: Throughout the life of the contract, the Contractor shall maintain a log of compound evaluation in electronic spreadsheet format. This log shall contain five columns, as follows: column 1 - date of study initiation (date laboratory testing begins); column 2 -compound under study (compound name or code number); column 3 - study description;

column 4 - study completion date (date that Contractor deems laboratory testing to be finished); column 5 - date that resulting Compound Evaluation Report is sent to the COR.

The Contractor shall maintain this table chronologically, by date of study initiation. The Contractor shall update this table at least once each month.

Task 11: The Contractor shall retain, for the duration of this contract, all laboratory notebooks (which shall include hard copies of raw data) and any electronic data files generated under this contract, as well as all coded ATDP test compounds received for evaluation under this contract. All ATDP test compounds shall be properly stored according to storage requirements provided to the Contractor by NIDA. Electronic data files shall be labeled and recorded in a manner that allows their association with corresponding laboratory notebook entries and hard copies of raw data. Electronic files of all study reports shall be labeled according to ATDP compound number and date of evaluation. All electronic files shall be generated in a format compatible with current NIDA hardware and software, as determined by the COR. If requested by the COR, the Contractor shall ship the laboratory notebooks and electronic files to the COR on or before the expiration date of this contract. The Contractor shall ship the compounds, following authorization by the COR, to the NIDA-contracted compound distribution site on or before the expiration date of the contract.

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2. Schedule of work

Because NIDA's needs for specific abuse liability and medications discovery testing vary from year to year and cannot be predicted in advance, NIDA wishes to maintain flexibility with regard to the amount of work to be conducted under each of the above Tasks during any given year. Each year, the amount of work to be conducted under the above Tasks shall be at the discretion of the COR.

I. Standard (Non-Option) Work:

Year 1: The Contractor shall conduct all the work described under Tasks 1-11.

The distribution of efforts shall be at the discretion of the COR. NIDA's testing needs vary from year to year and requirements must remain flexible. However, it is anticipated that the Contractor shall conduct approximately 12 compound evaluations as described under Tasks 1and 2, 4 compound evaluations as described under Task 3, 6 compound evaluations as described under Task 4, 1 compound evaluation in rodents as described in Task 5, and 2 compound evaluations as described in Task 6. For bidding purposes, assume that Task 6 would involve the Tetrad test.

Years 2 through 5 (Option Years): The Contractor shall conduct all the work described under Tasks 1-11. The distribution of efforts shall be at the discretion of the COR. NIDA's testing needs vary from year to year and requirements must remain flexible. However, it is anticipated that the Contractor shall conduct approximately 12 compound evaluations as described under Tasks 1and 2, 4 compound evaluations as described under Task 3, 6 compound evaluations as described under Task 4, 1 compound evaluation in rodents as described in Task 5, and 2 compound evaluations as described in Task 6. For bidding purposes, assume that Task 6 would involve the Tetrad test.

II. Options (each available one time each contract year):

Option 1: The Contractor shall devote up to an additional 1,880 person hours of senior laboratory technician effort to work conducted under the contract.

Option 2: The Contractor shall devote up to an additional 3,760 person hours of senior laboratory technician effort to work conducted under the contract.

Option 3: The Contractor shall devote up to an additional 470 person hours of Senior Scientist (Ph.D. level or equivalent) effort to work conducted under the contract.

Option 4: The Contractor shall devote up to an additional 940 person hours of Senior Scientist (Ph.D. level or equivalent) effort to work conducted under the contract.

Option 5: The Contractor shall devote up to an additional 470 person hours of Scientist (Ph.D. level or equivalent) effort to work conducted under the contract.

Option 6: The Contractor shall devote up to an additional 940 person hours of Scientist (Ph.D. level or equivalent) effort to work conducted under the contract.

Option 7: As required for the work described under Tasks 1through 7, the Contractor shall pay up to $20,000 (direct cost) for additional laboratory supplies, animal purchases, animal per diem charges, and/or equipment.

Option 8: As required for the work described under Tasks 1through 7, the Contractor shall pay up to $30,000 (direct cost) for additional laboratory supplies, animal purchases, animal per diem charges, and/or equipment.

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Option 9: As required for the work described under Tasks 1through 7, the Contractor shall pay up to $50,000 (direct cost) for additional laboratory supplies, animal purchases, animal per diem charges, and/or equipment.

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition hardcopies of reports shall be submitted to the Contracting Officer in accordance with Section F.

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."

All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

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) Monthly: On or before the 5th working day following each month, the Contractor shall submit one copy in Microsoft Word or PDF format of a report on activities during the 1 month period. This report will be transmitted electronically and provided by the contractor to the NIDA COR. In the report, the Contractor shall include: section 1 - a brief (one or two paragraph) summary of any problems encountered while conducting established tests, as well as progress in any ongoing assay development work; section 2 - the log of compound receipt (Task 9) and evaluation (Task 10); section J - an inventory list of monkeys being utilized for this contract (if used); and section 4 - a description of the circumstances surrounding the death of any monkey during the reporting period (if used). With regard to the log of compound evaluation, relevant pages shall be those that list current (uncompleted) studies and/or completed studies which yielded Compound Evaluation Reports within the reporting period.

2) Compound Evaluation Reports: For each compound evaluation that is completed, the Contractor shall submit one electronic copy in Microsoft Word or PDF format of a Compound Evaluation Report to the NIDA COR. Each Compound Evaluation Report shall be due not later than 30 calendar days after the study completion date specified in the Contractor's log of compound evaluation. The format shall be as follows:

Front cover to contain: Date, title (to include test compound identification number or standard compound name and type of study) agency (NIDA), and NIDA COR name/address/phone number, contract number (N01DA-17-8932), contractor name, and investigator names.

Main body to contain: (1) A brief (one or two paragraph) summary of the findings (2) detailed methods, including vehicle, route of administration, pretreatment time, and statistical methods, and (3) study results. Specific values or graphs to be included in the results section will be subject to the approval of the NIDA COR. Depending upon the type of study, graphical representations of data may be required.

http://www.hhs.gov/web/508/index.html

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3) Annual Progress Reports: On or before the 5th working day following the end of each contract year, the contractor shall submit a report on activities during the year. Two copies in Microsoft Word or PDF format shall be sent, one to the NIDA COR and one copy sent to the NIDA Contracting Officer. In the report, the Contractor shall include: section 1 -a summary of what the contractor regards as the most significant results generated on standard compounds during the past 6 months; section 2 - a brief (maximum of 2 paragraph) summary of any problems encountered while conducting established tests and, if applicable, a description of how those problems were resolved, as well as a brief (maximum of 2 paragraphs) summary of progress in any assay development work; section 3 - the log of compound receipt (Task 8); and section 4 - the log of compound evaluation (Task 9); section 5 - an inventory list of monkeys being utilized for this contract (if used); and section 6 - a description of the circumstances surrounding the death of any monkey during the last 6 months of the year under report (if used). The summary of significant findings (section 1) should not be an all-inclusive summary of data generated on standard compounds but, rather, a summary of highlights. The Contractor shall not summarize any data generated on test compounds. With regard to the log of compound evaluation (section 4), relevant pages shall be those which list current studies and/or completed studies which yielded Compound Evaluation Reports of the year under report. The Annual Progress Report, as just described, will incorporate the last monthly Progress Report for the year; a separate report will not be required.

4) Pre-Meeting Packets: The Contractor shall prepare Pre-Meeting Packets as described under Task 8. One copy of each shall be prepared. One copy shall be delivered to each consultant and the remainder to the NIDA COR at least 3 weeks in advance of the meeting.

5) Meeting Reports: Following each contract/consultant meeting, the Contractor shall prepare a Meeting Report as described under Task 8. One copy in Microsoft Word or PDF format Meeting Report shall be delivered to the NIDA COR not later than 2 weeks after the relevant meeting.

6) Final Report: The Final Report shall include: section 1 - a summary of what the contractor regards as the most significant results generated on standard compounds during the entire contract period; section 2 - a summary of any problems encountered while conducting established tests and, if applicable, a description of how those problems were resolved, as well as a summary of progress in assay development work during the entire period of the contract; section 3 - the log of compound receipt (Task 9) for the last year of the contract period; section 4 - the log of compound evaluation (Task 10) for the last year of the contract period; section 5 - an inventory list of monkeys being utilized for this contract during the last 6 months (if used); and section 6 - a description of the circumstances surrounding the death of any monkey during the last year (if used). The summary of significant findings (section

1) should not be an all-inclusive summary of data generated on standard compounds but, rather, a summary of highlights. The Contractor shall not summarize any data generated on test compounds. The Final Report, as just described, will incorporate the last Monthly Progress Report and the last Annual Progress Report; separate reports will not be required.

The Final Report shall be submitted in accordance with ARTICLE F.1 DELIVERIES of this contract; one electronic copy Microsoft Word or PDF format shall be sent to the NIDA COR and one electronic copy shall be sent to the NIDA Contracting Officer.

7) Laboratory Records and Test Compounds: These include all items listed in Task 11. 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.

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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.)

2. Information Security and Physical Access Reporting Requirements

The Contractor shall submit the following reports as required by the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract. Note: Each report listed below includes a reference to the appropriate subparagraph of this article.

a. Roster of Employees Requiring Suitability Investigations

The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the contract who will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Contracting Officer's Representative (COR), with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. (Reference subparagraph A.d. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

b. IT Security Plan (IT-SP)

The contractor shall submit the IT-SP within thirty (30) days after contract award. The IT-SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The IT-SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT-SP only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT-SP applies.

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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The Contractor shall review and update the IT-SP in accordance with NIST SP 800-53A, Guide for Assessing the Security Controls in Federal Information Systems and Organizations, on an annual basis.

(Reference subparagraph D.c.1. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

c. IT Risk Assessment (IT-RA)

The contractor shall submit the IT-RA within thirty (30) days after contract award. The IT-RA shall be consistent, in form and content, with NIST SP 800-30, Risk Management Guide for Information Technology Systems, and any additions or augmentations described in the HHS-OCIO Information Systems Security and Privacy Policy.

The Contractor shall update the IT-RA on an annual basis.

(Reference subparagraph D.c.2. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

d. FIPS 199 Assessment

The Contractor shall submit a FIPS 199 Assessment within thirty (30) days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard.

(Reference subparagraph D.c.3. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECITON H of this contract.

e. IT Security Certification and Accreditation (IT-SC&A)

The Contractor shall submit written proof to the Contracting Officer that an IT-SC&A was performed within three (3) months after contract award.

The Contractor shall perform an annual security control assessment and provide to the Contracting Officer verification that the IT-SC&A remains valid.

(Reference subparagraph D.c.4. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

f. Reporting of New and Departing Employees

The Contractor shall notify the Contracting Officer's Representative (COR) and Contracting Officer within five working days of staffing changes for positions that require suitability determinations as follows:

a. New Employees who have or will have access to HHS Information systems or data: Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability level held by the former incumbent.