RFP No. 75N95020R00002.pdf

National Institute on Drug Abuse Request for Proposal (RFP) No. 75N95020R00002

“Clinical Research Coordinating Center for NIDA’s Clinical Trials Network”

Issued by:

Andrew Hotaling, Contracting Officer NIDA Section, Contracts Management Branch Blue Office of Acquisitions, NIDA National Institute on Drug Abuse, NIH c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892 Point of Contact: Tracy Cain, Contracting Officer E-Mail: tracy.cain@nih.gov Phone: 301.443.6677

DATE ISSUED: Thursday, March 5, 2020

PROPOSAL DUE DATE: Thursday, April 16, 2020, 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. 75N95020R00002 titled “Clinical Research Coordinating Center for NIDA’s Clinical Trials Network”.

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 an Indefinite Delivery Indefinite Quantity (Task Order) cost reimbursement level of effort-type contract for a period of 5 years. Please anticipate that the base performance period of the contract will be from August 14, 2020 to August 13, 2025. You must respond with technical and pricing proposals for the entire project and total period of performance.

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 March 20, 2020. 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 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.

mailto:tracy.cain@nih.gov mailto:tracy.cain@nih.gov

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 March 20, 2020. Mark the e-mail, "Offeror's Questions, RFP No. 75N95020R00002."

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 Thursday, April 16, 2020, 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.

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

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 Acquisitions, NIDA/NIH

Enclosure 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 as amended

2. Request for Proposal (RFP) Number:

75N95020R00002

3. Issue Date:

March 5, 2020

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Clinical Research Coordinating Center for NIDA’s Clinical Trials Network

6. ISSUED BY:

NIDA Section, Contracts Management Branch Blue Office of Acquisitions, National Institute on Drug Abuse, NIH c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892

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 3:00 PM local time on April 16, 2020. 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 R. Hotaling Contracting Officer Office of Acquisitions http://www.sam.gov

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1. Requisition or other Purchase Authority: P.L. 102-321 as amended NIDA Section, Contracts Management Branch, Blue

RFP Number : 75N95020R00002

- 3 -

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. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. 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

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11. Selection of Offerors

12. Institutional Responsibility Regarding Investigator Conflicts of Interest

13. Certification of Filing and Payment of Taxes

14. 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. 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. MANDATORY QUALIFICATION CRITERIA

4. EVALUATION OF OPTIONS

5. TECHNICAL EVALUATION FACTORS

6. 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 for the Contractor to provide bio-medical and behavioral research resources and clinical research coordinating services to support the NIDA Clinical Trials Network (CTN) in its goal of conducting multi-site clinical trials to test the effectiveness of new science-based drug abuse treatments in community settings.

ARTICLE B.2. PRICES/COSTS

1. This is an Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $500,000 (minimum) and not more than a total of

$37,500,000 (maximum) for successful performance of this contract. The minimum amount is inclusive of all task orders issued under this contract. Total compensation will be based on the combined negotiated task orders.

2. For cost reimbursement Task Orders, the fixed fee for individual task orders will be negotiated by task order. The fixed fee shall be paid in installments as negotiated (based on percentage of completion of work or the percent of total effort expended), as determined by the Contracting Officer, and shall be subject to the withholding provision 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. Payment of fixed fee shall not be made in less than monthly increments.

3. The costs set forth in this ARTICLE will cover the contract period August 14, 2020 through August 13, 2025.

4. The Government will issue Task Orders based on the work described in SECTION C of this contract.

5. Ordering procedures are described in the TASK ORDER PROCEDURE Article in SECTION G of this contract.

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ARTICLE B.3. ESTIMATED COST - OPTION

1. Unless the Government exercises its option pursuant to the option clause referenced in ARTICLE I.3.

ADDITIONAL CONTRACT CLAUSES, this contract consists only of the Base Period specified in the Statement of Work as defined in SECTIONS C and F, for the price set forth in ARTICLE B.2. of this contract.

2. Pursuant to FAR Clause 52.217-7, Option for Increased Quantity- Separately Priced Line Item, FAR Clause 52.217-8, Option to Extend Services and FAR Clause 52.217-9 Option to Extend the Term of the Contract set forth in ARTICLE I.3. and ARTICLE I.4. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform the Option Period( s) and Option Quantities specified in the Statement of Work as defined in SECTIONS C and F of this contract. If the Government exercises this/ these option( s), notice must be given 15 days before the expiration date of the contract. Specific information regarding the time frame for this notice is set forth in the OPTION PROVISION Article in SECTION H of this contract. The estimated cost plus fixed fee of the task order will be increased as set forth in paragraph 3., below.

3. 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:

Description of Option Item( s) - or- Option Service( s)

Estimated Cost Fixed Fee Estimated Cost plus Fixed Fee

Option Quantity Task A: Administrative and Concept Support Services (This option may be exercised 5 times during each contract year.)

Option Quantity Task B: Research Protocol Development and Support (This option may be exercised 5 times during each contract year.)

ARTICLE B.4. 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.5. 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.

To ensure that the Contractor is aware of the criticality of beginning contract close out process immediately following contract expiration, the Contractor shall include an Advance Understandings provision identifying the requirement to

- 7 -submit certain close out documents at the time of delivery of the final report under the contract, and is advised that quick close out procedures in accordance with FAR 42.7 shall be used by the Government to the maximum extent possible to expedite the administrative close of the contract or task order.

[Remainder of Page Intentionally Left Blank]

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. I. Background and Objectives

A. Background Information

The National Institute on Drug Abuse (NIDA) was established in 1974, and in 1992 it became part of the National Institutes of Health, Department of Health and Human Services. NIDA's mission is to "…lead the Nation in bringing the power of science to bear on drug abuse and addiction." NIDA supports over 85 percent of the world's research on the health aspects of drug abuse and addiction. NIDA-supported science addresses the most fundamental and essential questions about drug abuse, ranging from the molecule to managed care, and from DNA to community outreach research.

NIDA's Clinical Trial Network (CTN) was established in 1999 to bridge the gap between research and practice to improve treatment of substance use disorders (SUD) nationwide.

The CTN seeks to address critical research questions with direct relevance to clinical practice and the needs of patients. Over the last two decades, the CTN's research infrastructure and agenda have evolved to reflect the changing landscape of the SUD treatment community, transformation of health care systems, and emerging scientific advancements. The CTN has been engaging providers in general medical settings and healthcare systems, and in 2015 the Network built upon and expanded its research portfolio encouraging adoption of innovative bioinformatics approaches, new technology, and "learning healthcare system" principles to enhance the efficiency of SUD clinical research and clinical care.

The CTN conducts clinical trials in sites located across the nation and in other countries.

These are usually studies of behavioral, pharmacological, and integrated behavioral and pharmacological treatment interventions in rigorous, clinical trials to determine efficacy, effectiveness, practicality, and feasibility across a broad range of treatment settings and diversified patient populations and to transfer research results to physicians, clinicians, providers, and patients. These studies are typically Phase III clinical trials, but can also include Phase I, Phase II, Phase IV, and/or registry trials or surveys. More information on the CTN and the CTN's research portfolio is available at https://www.drugabuse.gov/about-nida/ organization/cctn/ctn.

B. Objectives

NIDA requires a clinical research organization to support and provide resources to the CTN in managing and carrying out multiple trials in drug abuse research. This contractor will provide support for research protocol development, regulatory oversight; monitoring protocol implementation; research staff training; supplying pharmaceutical services and clinical support;

drug testing and analytical laboratory services; committee and subcommittee participation;

and, expert consultation and support services .

The current solicitation is a re-competition for the current National Drug Abuse Treatment Clinical Trials Network Clinical Coordinating Center (CCC) contract in advance of its expiration in August 2020. The awardee of this contract will be required to work closely with both the CTN's Research Nodes and the CTN's Data & Statistics Center to support the CTN's portfolio.

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C. References:

Publicly Accessible Websites - NIDA maintains a publicly accessible websites to provide information on the CTN. This website can be accessed at http://www.nida.nih.gov/ctn

Publications - Since its inception, numerous journal articles have been published highlighting the work of the CTN. A listing of these articles and other CTN-related publications can be viewed at http://ctndisseminationlibrarv.org .

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

3. The contractor shall work closely with other NIDA contractors to coordinate efforts and cooperate in all areas to maximize efficiency and effectiveness. This contract does not obligate NIDA to acquire all services described herein from this contract exclusively. Once NIDA has ordered the minimum amount as set forth in SECTION B, NIDA is not obligated to make additional purchases for services under this contract.

B. Specific Requirements

The purpose of the contract is to provide a wide range of support services to aid NIDA in its goal of establishing and operating NIDA's Clinical Trials Network. The range of support services required under this contract includes:

1. Providing support for regulatory functions and requirements;

2. Reviewing and monitoring protocol implementation;

3. Providing training to research staff;

4. Supplying pharmaceutical services and clinical support;

5. Providing drug testing and analytical laboratory services;

6. Providing support for protocol development in the areas related to the tasks specified in this Statement of Work;

7. Participating in relevant committee and subcommittee meetings and conference calls; and

8. Providing other expert consultation and support services as needed

For proposal purposes, the CTN anticipates requiring support for 15-20 multi-site research studies during the first year of this contract and as many as four to six research studies annually thereafter (engaging several large health care systems and as many as 20-30 sites per study). The minimum amount of services that may be ordered under this contract is valued at $500,000. The maximum amount of services that may be ordered under this contract is valued at $37,500,000.

The following is a more detailed description of the types of tasks that may be assigned to the Contractor under this contract, although all these tasks may not be carried out necessarily in every year. The Contractor shall not perform any work for the Government unless authorized by http://www.nida.nih.gov/ctn http://ctndisseminationlibrarv.org/

- 10 -an appropriately awarded task order, which shall specify which task areas are to be performed.

Specifically, the Contractor is required to provide the following services through awarded task orders:

Task 1. Provide support for regulatory functions and requirements

This includes the following subtasks:

a. Verify that participating study sites have met all regulatory and training requirements (e.g. GCP training, Human subjects training, protocol training, etc.) and that all regulatory and mandatory training documentation is on file prior to beginning human subjects research activities.

b. Review informed consent forms for compliance with federal requirements, and endorse study sites for accrual startup only after verifying local Institutional Review Board (IRB) approval of the protocol and informed consent form(s).

c. Monitor regulatory compliance for all study participants at each participating study site and verify that sites remain in regulatory compliance throughout the trial.

d. Maintain files of all important regulatory documents related to each trial that provide evidence of compliance with regulations. This includes but is not limited to copies of all IRB approvals protocols and approved consent forms for each study site, by protocol. Establish and keep up-to-date a readily accessible log of such information.

e. Provide advice and assistance to CTN Investigators with the following: 1) obtaining and maintaining local IRB approval; 2) establishing and maintaining human subject protection assurances with the Office of Human Research Protections (OHRP); and

3) complying with all applicable federal regulations, such as the HIPAA privacy rule.

f. Monitor timeliness of study site submissions to IRBs; initial protocol and all revisions, as well as renewals.

g. When applicable, prepare, review, revise and submit FDA applications and required documents for an Investigational New Drug (IND) and New Drug Application (NDA).

h. Provide consultation on regulatory issues raised by the Data and Safety Monitoring Board, Nodes, or study sites regarding safety and AE/SAE reporting.

i. Monitor protocol violations, including enrollment violations (e.g. Participants failing to meet protocol inclusion criteria), and report serious violations in a timely manner as directed by the GPO.

j. Submit regular status reports on regulatory compliance as directed by the GPO.

k. Periodically review and provide recommendations regarding the CTN's policy and guidance documents on Regulatory Affairs.

l. Keep CCTN, Node and study site staff up-to-date on clinical trials and human subject protection regulations.

m. Periodically review and recommend updates regarding CTN's policy and guidance documents on regulatory compliance.

Task 2. Review and monitor protocol implementation

This includes the following subtasks:

a. Coordinate and conduct initiation, periodic interim and closeout visits to study sites to monitor their study-related functions and implementation of trials.

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Quality Assurance (QA) initiation visits:

• Determining whether sites are ready to conduct the study (i.e. that relevant staff have received necessary training, that sites have met all regulatory requirements, and have received all protocol materials, supplies, drugs, CRFs, etc.).

For proposal purposes, initiation site visits are typically conducted once per site per protocol, and take 1.5 days to complete.

QA Initiation visits:

• Assessing fidelity to medical and behavioral therapies as specified in protocols;

• Checking for adherence to and compliance with all procedures specified by the protocol, such as adhering to subject eligibility criteria, properly consenting each participant, maintaining constant vigilance to protect the safety of all subjects, providing all interventions in the specified manner, collecting all needed assessments and specimens, fully documenting all procedures and assessments, and utilizing staff with appropriate training and qualifications to complete study procedures;

• Checking for adherence to procedures for reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)

• Assessing the quality of research data by establishing a mechanism for on-site monitoring of participant records in order to validate the data collected and transmitted. This will be conducted in cooperation with the Data and Statistics Center contractor;

• Checking for appropriate collection, storage and transport of patient samples, videotapes, audiotapes, etc.;

• Checking f or study records maintenance;

• Checking for study product accountability;

• Checking f or adherence to and compliance with all relevant CTN Standard Operating Procedures (SOP's); and

• the various components of site operation and management that are directly related to conducting CTN trials, such as organization and utilization of site staff, appropriate staff backup, communication among clinical, technical and administrative staff, and the adequacy of site facilities and study equipment.

For proposal purposes, interim site visits are typically conducted 2 to 3 times annually per site per protocol, and take 2 days to complete.

QA closeout visits:

• Determining whether sites have completed all necessary tasks per protocol, have resolved all data queries, are ready to store all records, have accounted for drugs and supplies, etc.

For proposal purposes, close out visits are typically conducted once for each study site and last 1.5 days.

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b. Promptly report to the GPO and designee(s) problems or deviations from accepted practice or standards, and include recommendations for resolution and improvement of site performance.

c. Submit site visit reports as directed to the GPO or designee. These reports should be marked "For Internal Use Only".

d. Review reports of local site visits conducted and prepared by QA personnel at each Node, and report in writing the results of these reviews to the GPO and designee(s), alerting them of any important issues immediately.

e. Keep track of all QA issues reported, per site, per protocol, and follow up to resolution.

f. Monitor recruitment, inform the GPO and designee(s) when enrollment is considerably slower than expected, based on planned enrollment targets for each site provided by the GPO, and provide suggestions for improving the recruitment rate.

g. Inform, in a timely manner, the GPO and designee(s) of protocol implementation issues related to the tasks specified in this Statement of Work that are causing important delays or unexpected expenses, and provide suggestions about how to resolve them.

h. Prepare, in collaboration with the Data and Statistics Center contractor, the QA sections of reports to the Data and Safety Monitoring Board.

i. Provide, as directed by the GPO, information related to the tasks specified in this Statement of Work that is needed to populate a database for management tracking of approved protocols and implemented studies, including project timelines and resources. This database will be developed by the Data and Statistics Contractor, and will track the life cycle of studies from concept generation through protocol development, review, approval and accrual, to final closeout and publication of the main results.

j. Periodically review and provide recommendations regarding the CTN's policy and guidance documents on Quality Assurance.

k. Provide a space to store hard copies of study files, including but not limited to participants' records. It is anticipated that a file room which is 10 feet by 10 feet in size, with file cabinet storage, will be sufficient to store these files.

For proposal purposes, the Offeror may assume $1500 in direct travel costs for each QA monitoring visit.

Task 3. Provide training to research staff

a. Participate in the development and conduct of study orientation and study closeout meetings for research staff and site investigators.

b. Provide central and on-site, face-to-face and web-based training, certification and re-training of research staff on topics such as:

• General clinical research conduct (e.g. Good Clinical Practice);

• Proceedures for Adverse Event/ Serious Adverse Event reporting;

• Study assessments;

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• CTN's Standard Operating Procedures; and

• NIH required certifications for the protection of human subjects.

c. Maintain a database to track all CTN-related training completed by CTN study staff.

d. Enter information on all CTN-related training completed by CTN Node staff in the training tracking database.

e. Periodically review and recommend updates regarding CTN's policy and guidance documents on training.

Task 4. Provide pharmaceutical services and clinical support

This includes the following subtasks:

a. Manage the receipt, packaging, storage and distribution of medications and other study products to study sites as specified in protocols.

b. Purchase required medications/placebos or other study products and prepare them in individual patient kits with proper labeling for product names and administering instructions.

c. Maintain an inventory tracking system for study products.

d. Acquire and maintain a proper inventory level of study products for timely shipment to sites while minimizing waste due to expiration.

e. Prepare protocol-specific documents providing information regarding study product packaging, dosage strength and labeling.

f. Obtain adequate regulatory (e.g. FDA and DEA) permits for handling both controlled and non-controlled substances.

g. Provide adequate climate-controlled storage space for study products and operate in accordance with good manufacturing practice.

h. Perform quantitative and qualitative confirmatory analyses of study material.

i. Coordinate the distribution of study materials with site personnel for both non-controlled and controlled substance and maintain records of valid and necessary registration of site, e.g. DEA registration.

j. Provide central disposal for unused study drugs in stock or from sites, in compliance with all local and federal rules and regulations.

k. Establish and maintain a computerized tracking system to keep inventories and distribution records.

l. Develop Clinical Trials Agreements (CTAs) or Memoranda of Understanding with manufacturers providing study products or kits to the CTN. CTAs will also include language on the company's access (if any) to data from the study.

m. Provide other clinical support, e.g. EKG or ECG machine lease/rental, cardiologist consultation, etc.

n. Periodically review and recommend updates regarding CTN's policy and guidance documents on pharmaceutical services and clinical support.

Task 5. Provide drug testing and analytical laboratory services

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a. Acquire, distribute and track on-site testing devices to sites participating in CTN trials. Onsite testing devices include illicit drug screening devices, sample collection containers, pregnancy tests, adulterant check sticks, saliva alcohol test, HIV/HCV screening kits, and other devices commonly used in drug addiction research.

b. Implement and manage quality assurance programs to monitor drug testing, including product evaluation, comparison and validity testing.

c. Supply shipping instructions, containers and labels to sites.

d. Maintain an inventory tracking system for study products to include supplies on hand as well as shipping records containing information on quantities, items, and shipping destination.

e. Make arrangements for incremental deliveries of the required supply to the site in quantities commensurable to the usage or enrollment rate of the site.

f. Monitor product performance and resolve with site personnel if products fail to perform properly.

g. Have in place necessary registrations and licenses with regulatory agencies for all operations.

h. Conduct Medical/laboratory procedures and tests as necessary. All tests must be conducted by a certified or accredited facility with established quality control procedures and validation of testing instruments as warranted.

i. Establish analytical methodologies for illicit drugs and their metabolites, and perform timely analyses of biological samples, including immunoassay, using automated analyzer and other analytical instrumentation for confirmatory analyses.

j. Evaluate new drug detection products, perform literature searches and provide information on state-of-the-art drug testing/screening methodology for illicit drugs and markers for infectious diseases (e.g. HIV, HCV and STD).

k. Periodically review and recommend updates regarding CTN's policy and guidance documents on laboratory testing and support.

Task 6. Provide support for protocol development in the areas related to the tasks in this SOW

This includes the following subtasks:

a. Provide clinical trials specialists to assist in preparing protocol-related documents such as training plan, quality assurance plan, regulatory plan, data and safety monitoring plan, and study product distribution and management plan, following a standard protocol template; and to assist in preparing the sections of Final Study Reports related to the tasks specified in this Statement of Work.

b. For Protocol Review Board (PRB) and Data and Safety Monitoring Board (DSMB) meetings, prepare materials related to the tasks specified in this Statement of Work.

Typically, one PRB meeting is held per protocol prior to protocol approval and DSMB meetings are held annually per protocol. These meetings are held in the Washington, DC area.

c. For all CTN study operation manuals, develop and update the sections that are related to the tasks specified in this Statement of Work, including corresponding amendments.

d. Support and participate in annual protocol meetings (in the Washington, DC area) and weekly conference calls with study staff to discuss and resolve issues related to the tasks specified in this Statement of Work, and serve as liaison between the LI

- 15 -team and CTN staff. These meetings and conference calls occur during the entire lifespan of each protocol, including protocol development, implementation, closeout and analysis/reporting stages.

e. Reproduce and distribute study protocols and operation manuals to participating study sites. The documents may be distributed electronically or in hard copy, and may be used in protocol training or refresher training for the studies.

f. Per federal and local regulations, maintain confidentiality and security of all data files and documents (hard copy as well as electronic) produced in fulfilling all tasks specified in this Statement of Work.

g. Use a web-based electronic document management system to post and update routine documents related to the tasks specified in this document.

h. Periodically review and recommend updates regarding CTN's policy and guidance documents on protocol development.

Task 7. Participate in relevant committee and subcommittee meetings and conference calls

This includes the following subtasks:

a. Commit one senior staff member with extensive experience in managing clinical trials, preferably in the drug abuse field, to represent the Clinical Coordinating Center on the CTN Steering Committee, and to participate in all Steering Committee meetings (annual face-to-face meeting and monthly conference calls).

b. Commit staff members to participate in activities of relevant CTN committees, subcommittees and Special Interest Groups.

c. Under direction of the COR, work with NIDA and the CTN on exploration of the development and use of common CRF pages and study assessments.

Task 8. Provide other expert consultation and support services

It is anticipated that subcontractors (e.g. study ECG equipment rental, cardiology reading, etc.) and/or consultants (e.g. Clinical Expert for 400 hours per year not to exceed $150 per hour) will be required to provide expertise in certain fields, and that the contractor will need to make agreements with them at the direction of the GPO. These consultants, as requested by the GPO, may be needed to perform services related to clinical trials operations. For proposal purposes, the offeror may assume that four

(4) consultants/subcontracts at $60,000 each may be required.

Schedule of Work

NOTE: The appropriate distribution of efforts between the various Tasks cannot be specified prior to contract award and this distribution will change throughout the life of the contract.

C. Task Orders for Proposal Evaluation

1. For purposes of proposal preparation, offerors are to provide a technical proposal and cost estimates for each of the three types of task orders described below.

The types summarized below are general descriptions of task orders that NIDA anticipates ordering under the contract. However, throughout the ordering period of this contract, task orders may involve one or more of the tasks (1-7) described above and are not limited by the types described below.

a. Sample Task Order A - Administrative and Concept Support Services

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This sample task order requires services as described in Tasks 1 - 8 above to support preliminary research and discussions on new concepts up to approval for protocol development. It will also include support for administrative tasks such as report writing, invoicing, maintaining certifications, and other tasks necessary to support NIDA's mission.

For proposal purposes, offerors may assume that a task order of this nature will require an estimated 4,000 hours of effort over a period of one year, with an additional four 1-year option periods.

b. Sample Task Order B - Research Protocol Development and Support

The contractor shall provide support for protocol development after a research concept has been approved for protocol development. This task order shall require the contractor to perform services described in Tasks 1 - 7 above such as assisting with study development, implementation, and conduct. The offeror will demonstrate their understanding of this task by describing the work needed to be performed from the Tasks 1 - 8 above.

For proposal purposes, offerors may assume that a task order of this nature will require an estimated 9,000 hours of effort in the base period of one year, with an additional four 1-year option periods to support a trial with the following characteristics:

Study Design : Participants will be randomized to either medication for opioid use disorder or treatment as usual. Participants in both conditions will receive weekly therapy/medical management visits.

Population : A total of 200 participants will be randomized from among 8 study sites.

Medication (non-IND): Sublingual buprenorphine/naloxone @ 16mg daily during treatment phase.

Testing : Weekly (treatment phase) and Monthly (follow-up phase) urine drug screening for opioids, oxycodone, barbiturates, benzodiazepines, cocaine, amphetamine, methamphetamine, 3.4-methylendeioxy-methamphetamine, tetrahydrocannabinol, methadone, phencyclidine, fentanyl, and buprenorphine

Study Timeline : 36 months (study start-up = 8 months, recruitment phase = 12 months, treatment phase = 3 months per participant, follow-up phase = 6 months per participant, and 4 months study closeout)

NIDA intends to award a Task Order of Type A at the time of contract award and one or more Task Orders of Type B.

2. Option Quantity Tasks

a. Option Quantity 1: Administrative and Concept Support Services

If exercised, the Contractor shall devote up to an additional 1,040 labor hours (Tasks 1-7) to support preliminary research and discussions on new concepts up to approval for protocol development. This option may be exercised up to five (5) times during each contract year.

b. Option Quantity 2: Research Protocol Development and Support

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If exercised, the Contractor shall devote up to an additional 2,080 labor hours of support (tasks 1-8) for protocol development and implementation. This option may be exercised up to five (5) times during each contract year.

For purposes of proposal preparation, offerors are to provide a technical proposal and cost estimates for each of the two types of Option Quantities as described above. The types summarized are general descriptions of the Option Quantities that NIDA anticipates ordering under the contract. However, if option quantities are utilized for any individual task order they will be clearly defined in the individual Task Order RFP and be determined and evaluated at the time of task order solicitation and award.

The Government may order one or more of the tasks described above. The amount of work will depend upon programmatic needs and availability of funding, and may vary from year to year. Due to changes in priorities within NIDA, the projected workload cannot be precisely described for each year.

The Contractor shall initiate work only when directed by issuance of an approved Task Order. (See Section G for Task Order ordering procedures.)

b. The applicable Privacy Act System of Records Number will be specified and shall be used in any design, development, or operation work to be performed under the resultant contract. Disposition of records shall be in accordance with SECTION C of the contract, and by direction of the Contracting Officer's Representative (COR).

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.

The Contractor will meet (by conference call or face-to-face) with NIDA's Contracting Officer's Representative (COR) and designee(s) once per week during the first year of the contract, and at least once every two weeks thereafter.

The Contractor shall deliver a project plan to identify the tasks, schedules, and milestones. In addition to the reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with F.1. Deliveries of this contract:

1. Technical Progress Reports

Quarterly Progress Report:

Quarterly progress reports shall be brief reports:

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

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• work accomplished during the period;

• progress on all trials/ projects

• planned activities for the upcoming period; and

• a description of any problems experienced or anticipated in the upcoming period.

One (1) copy of this report will go to the COR and one copy to the Alternate COR within ten (10) business days following the end of each contract quarter. The first reporting period consists of the first full three months of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each three month quarter.

Annual Progress Report.

This report shall include a summation of the work accomplished under the contract for the period covered. An annual report will not be required for the period when the Final Report is due. A quarterly report shall not be submitted when an annual report is due.

Task Order Report

This report shall include a summation of the work accomplished under issued task orders.

This will cover the entire period of performance for that task. It should include highlights, issues and their resolution, recommendations or lessons learned, etc.

Final Report

This report is to include a summation of the work performed for the entire contract period of performance. The Final Report shall be submitted in accordance with the Deliveries article of Section F of this contract . An annual report will not be required for the period when the Final Report is due.

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.

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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