RFP HHS-NIH-DA-12-242_RFP_published 02-03-12.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Law 92-218; OMB 0990-0115

2. Request for Proposal (RFP) Number:

HHS-NIH-DA-2012-242

3. Issue Date:

02/03/2012

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : FAST-PS

6. ISSUED BY:

National Institute of Mental Health (NIMH) Section NIMH/NIA Research and Development (R&D) Contracts Management Branch (CMB) National Institute of Drug Abuse (NIDA) Neuroscience Consolidated Operations Acquisition Center (COAC) National Institutes of Health 6001 Executive Boulevard, Room 8154, MSC 9661 Bethesda, MD 20892-9661

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 04:30PM local time on 03/22/2012. 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 requred 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 HHSAR Clause 352.215-70, "Late Proposals and Revisions"

LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the Central Contractor Registry (CCR) prior to award of a contract. http:// www.ccr.gov

11. FOR INFORMATION CALL: Marla J. Jacobson

PHONE: 301-443-3775

e-MAIL: jacobsonmj@mail.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

1) All questions should be made in writing by email to:

jacobsonmj@mail.nih.gov by 03/08/2012.

2) See important Additional Proposal Instructions in Section J, Attachment 6.

Bruce E. Anderson Contracting Officer NIMH, Contracts Section, R&D CMB Office of Acquisitions, NIDA Neuroscience

COAC

http://www.ccr.gov http://www.ccr.gov

RFP Number : HHS-NIH-DA-2012-242

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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. ESTIMATE OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

j. LATE PROPOSALS AND REVISIONS

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. ROTC Access and Federal Military Recruiting on Campus

14. Past Performance Information

15. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Human Subjects

Notice to Offerors of Requirements of 45 CFR Part 46, Protection of Human Subjects, HHSAR 270-4(a)

Instructions to Offerors Regarding Protection of Human Subjects

Required Education in the Protection of Human Research Participants

Inclusion of Women and Minorities in Research Involving Human Subjects

Inclusion of Children in Research Involving Human Subjects

Research Involving Prisoners as Subjects

Data and Safety Monitoring in Clinical Trials

Registration and Results Reporting for Applicable Clinical Trials in ClinicalTrials.gov

5. Obtaining and Disseminating Biomedical Research Resources

6. Information and Physical Access Security

7. Electronic and Information Technology Accessibility, HHSAR 352.239-73(a)

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. Cost and Pricing Data

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

6. Salary Rate Limitation

7. Small Business Subcontracting Plan

8. Mentor Protege Program, HHSAR 352.219-70

9. HUBZone Small Business Concerns

10. Extent of Small Disadvantaged Business Participation

11. Other Administrative Data

12. Qualifications of the Offeror

13. Subcontractors

14. Proposer's Annual Financial Report

15. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. HUMAN SUBJECT EVALUATION

4. EVALUATION OF DATA SHARING PLAN

5. TECHNICAL EVALUATION CRITERIA

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6. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

7. PAST PERFORMANCE FACTOR

8. EXTENT OF SMALL DISADVANTAGED BUSINESS PARTICIPATION

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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 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 will require establishing a small group of clinical trial sites that will focus on identifying and testing promising pharmacological interventions for the treatment of psychotic spectrum disorders. "Fast-Fail" trials, spanning a range that may include First in Human, Proof of Clinical Mechanism, or Proof of Concept trials in adults.

An Indefinite Delivery Indefinite Quantity Contract is anticipated. The total quantity of trials to be performed under this contract and the schedule for performing these trials cannot be determined at this time.

ARTICLE B.2. PRICES/COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.

The minimum value of this contract is $50,000 and the maximum value is $9,000,000.

ARTICLE B.3. PRICES/COSTS

a. 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 $50,000 (minimum) nor more than a total of $9,000,000 (maximum) for successful performance of this contract.

b. The maximum costs set forth in this ARTICLE will cover the contract period 09/15/2012 through 09/14/2015.

c. Funding during the contract above the minimum guarantee will be subject to approval of proposals in response to Task Order Request for Proposals (TORFPs) solicited when the need arises for research services. All funding is subject to the contract ceiling amount.

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

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) Acquisition, by purchase or

- 6 -lease, of any interest in real property; 2) Special rearrangement or alteration of facilities; 3) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 4) Travel Costs; 5) Consultant Costs; 6) Subcontract Costs; 7) Patient Care Costs; 8) Accountable Government Property; and 9) 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.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated 01/09/2012, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

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 Technical Representative (COTR).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, one hardcopy of each report shall be submitted to the Contracting Officer (with the exception of the weekly and monthly reports as noted below).

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 specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Helpful Resources."

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: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

For proposal preparation purposes only, with the exception of the monthly reports, it is estimated that in addition to the required electronic version(s) 1 hard copies of these reports will be required as follows:

[X] Monthly (In-Depth Study/Trial Task Progress Reports) [X] Annually (Both Contract Progress Reports and Study Progress Reports with requirements for Draft Annual Progress Reports)

[X] Final - Upon final completion of each study (with a requirement for a Draft Final Study Progress Report)

[X] Final - Upon final completion of the contract (with a requirement for a Draft Final Progress Report) http://www.hhs.gov/web/508/index.html

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2. Summary of Salient Results

The Contractor will be required to prepare and submit, with each final study report and with the final contract report, a summary (not to exceed 250 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.

3. Monthly (in-depth) Study Progress Reports

These reports will be submitted throughout the contract. When specific trials are approved to begin, they will focus on the data outlined below.

The first report shall cover the period consisting of the first full calendar month following the effective date of the task order and any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month. Reports shall be due on or before the 15th of each month following the reporting period. The Monthly Study Reports shall not be due the month that the Annual Study Reports and Final Study Report are due. At a minimum this report shall include:

(1) Status of IRB and DSMB approvals.

(2) Summary of any changes made to study/trial design and any determination/recommendations made by NIMH DSMB, IRB, or other relevant parties.

(3) Recruitment status for each active clinical trial including the number of subjects enrolled in the study and their demographic characteristics, subjects screened but not enrolled and reasons why not enrolled, subjects that have completed the study, and anticipated subject enrollment and completion schedules for the remainder of the study.

(4) List of adverse reactions, complications, and problems encountered and their resolution.

(5) A summary of any changes in Site-PI, essential other personnel, or Performance Sites.

(6) Status of data management and analysis.

(7) Summary of any site visits.

4. Annual Study Progress Reports

The Contractor shall submit an Annual Study Report, which provides an overview of study/trial, study progress made in the preceding twelve (12) months, and future plans. The report shall be due within thirty (30) calendar days after the anniversary date of the contract each year. An Annual Study Report shall not be due when the Final Study Report is due.

5. Annual Contract Progress Reports

The Contractor shall submit Annual Contract Reports, which provides an overview of the Contract accomplishments, and a summary of all major functions completed the preceding twelve (12) months.

The reports shall be due within thirty (30) calendar days after the anniversary date of the contract each year. An Annual Contract Report shall not be due when the Contract Final Report is due.

6. Final Study Progress Reports

The Contractor shall submit Final Study Reports to the COTR. The Final Study Report shall summarize the activities and accomplishments for the entire period of performance. Summary charts of the most important activities shall also be included. This report shall be in sufficient detail to explain comprehensively the results achieved, and shall summarize data and statistical analyses performed in text, tabular and graphical form. In addition, the Final Study Report shall include a summary (not to exceed 250 words) of salient results achieved during the period of performance. The Study Final Reports are due within six (6) months from the date data is locked on each clinical trial funded under this contract.

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7. Final Contract Progress Report

The Final Report shall summarize the activities and accomplishments of the Contracct for the entire Contract period. Summary charts of the most important activities shall also be included. This report shall be in sufficient detail to explain comprehensively the tasks accomplished and the results achieved, and shall summarize data and statistical analyses performed in text, tabular and graphical form. In addition, the Final Contract Report shall include a summary (not to exceed 500 words) of salient results achieved during the period of performance. The Contract Final Report is due on or before the completion date of the contract.

b. Other Reports/Deliverables

1. 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 Technical Representative (COTR), with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. (Reference subparagraph A.e. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

b. IT Security Plan (IT-SP)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, 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.

The Contractor shall review and update the IT-SP in accordance with NIST SP 800-26, Security Self-Assessment Guide for Information Technology Systems and FIPS 200, 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)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, 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

- 10 -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

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, 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)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, 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 Technical Representative (COTR) 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. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate security level.

b. Departing Employees: 1) Provide the name, position title, and security clearance level held by or pending for the individual; and 2) Perform and document the actions identified in the "Employee Separation Checklist", attached in Section J, ATTACHMENTS of this contract, when a Contractor/Subcontractor employee terminates work under this contract. All documentation shall be made available to the COTR and/or Contracting Officer upon request.

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

g. Contractor - Employee Non-Disclosure Agreement(s)

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The contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information - Contractor Agreement" form for each contractor and subcontractor employee who may have access to non-public Department information under this contract. This form is located at: http://ocio.nih.gov/docs/public/ Nondisclosure.pdf.

(Reference subparagraph E.3.d. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

h. Vulnerability Scanning Reports

The Contractor shall report the results of the required monthly special vulnerability scans no later than 10 days following the end of each reporting period. If required monthly, this report may be included as part of the Technical Progress Report. Otherwise, this report shall be submitted under separate cover on a monthly basis.

(Reference subparagraph E.5. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

2. Section 508 Annual Report

The contractor shall submit an annual Section 508 report in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY Article in SECTION H of this contract. The Section 508 Report Template and Instructions for completing the report are available at: http://www.hhs.gov/od under "Vendor Information and Documents."

3. Final Data Set(s) and Other Material(s)

The Contractor shall provide the GPO with the final, cleaned, edited, and documented database containing all study data, and all associated programs, source code, codebooks, indices, data tables, documentation, etc., in a format that is readily usable by NIMH or a third party. The Final Data Set(s) and Other Material(s) are due within six (6) months from the date data is locked on each clinical trial funded under this contract.

4. Registration and reporting of results to ClinicalTrials.gov

The Contractor shall register and post results in accordance with ARTICLE H.5 REGISTRATION AND

RESULTS REPORTING FOR APPLICABLE CLINICALTRIALS IN CLINICALTRIALS.GOV.

5. Minutes of Project Meetings

The Contractor shall prepare minutes of Contract meetings (e.g., weekly calls (Administrative Task), Steering Committee meetings, intervention selection meetings), as determined by the GPO, and distribute a draft of them to the GPO and other relevant parties within seven (7) working days after each meeting for review and a final version within two (2) weeks.

6. Monthly Administrative Task Reports

These reports will be submitted throughout the contract. During any periods when no trials are approved/active, this report will focus on a discussion of efforts to identify new promising compounds.

The Contractor shall submit Monthly Administrative Task Reports. The first report shall cover the period consisting of the first full calendar month following the effective date of the contract and any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar http://ocio.nih.gov/docs/public/Nondisclosure.pdf http://ocio.nih.gov/docs/public/Nondisclosure.pdf http://www.hhs.gov/od

- 12 -month. Reports shall be due on or before the 15th of each month following the reporting period. The Monthly Administrative Task Reports shall not be due the month that the Annual Administrative Task Reports and Final Contract Report are due. At a minimum this report shall include:

(1) An overview that highlights the most significant activities of the Contract.

(2) A description of opportunities, problems (e.g., study delays, delays in identifying suitable interventions), or difficulties that arose during the reporting period, as well as proposed solutions or steps taken to solve problems.

(3) A description of the Contract progress including a brief summary of each ongoing study/trial. An in-depth report shall be submitted separately for each study.

(4) Status of potential upcoming clinical trials, including identification of additional promising interventions for testing through the Contract organization.

(5) Summary of meetings, including any determination/recommendations made by the Steering Committee.

(6) A summary of any changes in Site-PIs, essential other personnel, or Performance Sites.

(7) A brief description of any other impediments to achieving the goals of the contract, any factors having cost implications, and recommendations for resolution should be included.

(8) Any other information pertinent to the contract.

7. Recruitment Reports

The Contractor shall submit Recruitment Reports twice a month to the GPO and the CO, with the following information: report date, title of protocol, targeted/planned number of enrolled subjects, number of subjects enrolled and their demographic characteristics (i.e., gender, race, ethnicity), subjects screened but not enrolled and reasons why not enrolled, subjects that have completed the study, and anticipated subject enrollment and completion schedules for the remainder of the study/ trial. In the case of slow recruitment, the Contractor should include a brief narrative discussing what measures have been taken and what the plans are to increase the recruitment pace.

8. DSMB Reports

The Contractor shall submit DSMB Reports thrice-yearly to the GPO, the CO, and other designated NIMH extramural staff collaborator, detailing study progress, subjects screened, subjects enrolled, adverse reactions, complications, and any other problems encountered and their resolution. The reports shall present overall study information as well as data for each site.

9. Annual Reports for Gender/Minority Tracking

The Contractor shall submit Annual Reports for Gender/Minority Tracking to the GPO, with the following information: report date, title of protocol, date enrollment/recruitment was initiated, date enrollment/recruitment was completed, targeted/planned number of enrolled subjects, and a count of enrolled subjects by gender, race, and ethnicity.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

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

Contracting Officer NiDA Neuroscience COAC, NIH, DHHS R&D Contracts Mgmnt Branch Office of Acquisitions Supporting National Institute of Mental Health 6001 Executive Blvd., Room 8154 Bethesda, Maryland 20892- 9661

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

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

http://www.iedison.gov

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SECTION D - PACKAGING, MARKING AND SHIPPING

ARTICLE D.1. PACKAGING

Refer to Attachment 3, Statement of Work, Section III., E., for biomaterials packing instructions

ARTICLE D.2. MARKING

Refer to Attachment 3, Statement of Work, Section III., E., for biomaterials marking instructions

ARTICLE D.3. SHIPPING

Refer to Attachment 3, Statement of Work, Section III., E., for biomaterials shipping instructions

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SECTION E - INSPECTION AND ACCEPTANCE

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

b. For the purpose of this SECTION, is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institute for Mental Health Research Division of Adult Translational Research, Experimental Therapeutics Branch, Psychotic and Mood and Anxiety Disorders Treatment Dev. Programs 6001 Executive Boulevard Room : 7125 MSC 9632 Bethesda, MD 20892-9632

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

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

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

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The period of performance of this contract shall be from 09/15/2012 through 09/14/2015.

ARTICLE F.2. DELIVERIES

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

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered in accordance with and by the date(s) specified below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract:

Item Description Method of Delivery/Quantity

Delivery Schedule

(1) In-Depth Study/Trial Task Progress Report

Electronic Monthly, 15 Calendar days after the completion of each full month in accordance with Article C.2 and as specified in the approved Task Order

(2) Draft Annual Study/Trial Progress Report

Electronic Annually, Provide a draft to the Contracting Officer and COTR/GPO ten (10) calendar days prior to the annual study/trial report delivery date. Provide detail in accordance with Article C.2

(3) Annual Study/Trial Progress Report

Electronic & one (1) Hardcopy

Annually, No later than the

15 th calendar day of the month following the end of each contract year. Provide detail in accordance with Article C.2

(4) Draft Annual Progress Report

Electronic Annually, Ten (10) calendar days prior to the delivery date. Provide detail in accordance with Article C.2

(5) Annual Progress Report Electronic & one (1) Hardcopy

Annually, No later than the

15 th calendar day of the month following the end of each contract year. Provide detail in accordance with Article C.2

(6) Draft Final Study/Trial Progress Report

Electronic Ten (10) calendar days prior to the final study/trial progress report delivery

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Item Description Method of Delivery/Quantity

Delivery Schedule date. Provide detail in accordance with Article C.2

(7) Final Study/Trial Progress Report

Electronic & one (1) Hardcopy

By completion date of the task order. Provide detail in accordance with Article C.2

(8)

Draft Final Progress Report Electronic Ten (10) calendar days prior to the final progress report delivery date. Provide detail in accordance with Article C.2.

(9) Final Progress Report Electronic & one (1) Hardcopy

By completion date of the contract. Provide detail in accordance with Article C.2

(10) Summary of Salient Results Electronic & one (1) Hardcopy

With each final study progress report and with the final contract progress report, in accordance with Article C.2

(11) Roster of Employees Requiring Suitability Investigations (including status updates on background investigations)

Electronic Within 30 calendar days of the effective date of the Contract and within 30 days of new contractor or subcontractor employees added to contract. In accordance with Article C.2 and Article H.19

(12) IT Security Plan (IT-SP) Electronic & one (1) Hardcopy

Within 30 days after award of the contract, in accordance with Article C.2 and Article H.19

(13) IT Risk Assessment (IT-RA) Electronic & one (1) Hardcopy

Within 30 days after contract award and annually thereafter, as per Article H.19.D.c.2. In accordance with Article C.2 and Article H.19

(14) FIPS 199 Assessment Electronic & one (1) Hardcopy

Within 30 days, in accordance with H.18

(15) IT Security Certification and Accreditation (IT-SC&A)

Electronic & one (1) Hardcopy

Within 3 months after contract award, in accordance with Article H.19 and Article C.2

(16) Employee Separation Checklist/Reporting of New and Departing Employees

Electronic In accordance with Article H.19

(17) Contractor - Employee Non- Disclosure Agreements

Electronic As applicable, within 60 days of contract award and within 60 days from new Contractor and/or subcontractor employees' dates of hire. In accordance with Article C.2 and Article H.19

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Item Description Method of Delivery/Quantity

Delivery Schedule

(18) Vulnerability Scanning Reports

Electronic Monthly, in accordance with Article C.2 and Article H.19

(19) Information Security Training and Report

Electronic Report to be submitted within 30 calendar days of contract award; and within 30 days of new contractor/ subcontractor employee hire dates, and annually in with the Annual Progress Report.

In accordance with Article H.19

(20) Section 508 Annual Report Electronic Annually, with the corresponding Annual Progress Report and with the Final Report, in accordance with Article C.2 and Article H.18

(21) Final Data Set(s) and Other Material(s)

Electronic & one (1) Hardcopy

At completion of each study and at completion of the contract performance, in accordance with Article C.2

(22) Registration and reporting results to ClinicalTrials.gov

Submission at www.ClinicalTrials.gov

In accordance with Article H.5

(23) Minutes of Project Meetings Electronic Weekly, and/or as meetings are held, in accordance with Article C.2

(24) Administrative Task Reports Electronic Monthly, 15 Calendar days after the completion of each full month. In accordance with Article C.2

(25) Recruitment Reports Electronic Twice monthly, in accordance with Article C.2

(26) DSMB Reports Electronic Thrice yearly (April, August, and December) or as determined by the Govt.

Project Officer (COTR). In accordance with Article C.2 and Article H.4

(27) Annual Reports for Gender/ Minority Tracking

Electronic & one (1) Hardcopy

Annually with the Annual Technical Progress Report. Provide a total contract summary of these reports with the final study and contract reports. In accordance with Article C.2

(28) Required Education - Protection of Human Research Participants

Electronic Prior to substitution of the Principal Investigator of other individuals, in accordance with Article H.3

(29) Small Business Subcontracting Reports

Submission at: http:// www.esrs.gov

Semi-annually, in accordance with Article H.18

(30) Invention Reporting Requirement

Electronic & one (1) Hardcopy

Annually with the Annual Progress Report and with http://www.clinicaltrials.gov/ http://www.esrs.gov/

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Item Description Method of Delivery/Quantity

Delivery Schedule the Final Contract Progress Report. In accordance with Article C.3

(31) Government Property Report Electronic If Government Property is authorized by Task Order, report will be due annually, with the Annual Study/ Trial Progress Report. In accordance with Article G.7

The above items shall be addressed and delivered to:

Addressee Deliverable Item No Quantity Contracting Officer (CO) Items (1) - (32) 1 each by method indicatedabove;*note some items must besubmittedboth electronically and bymail/delivery.

Contracting Officer'sTechnical Representative (COTR)

Items (1) - (10), (21) - (27), and (31)

1 each by method indicated above

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY

1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.acquisition.gov/comp/far/index.html

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989) with Alternate I (April 1984).

http://www.acquisition.gov/comp/far/index.html

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SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER'S TECHNICAL REPRESENTATIVE (COTR)

The following Contracting Officer's Technical Representative (COTR) will represent the Government for the purpose of this contract:

To be specified prior to award.

The COTR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the Statement of Work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The Government may unilaterally change its COTR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.242-70 (January 2006)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

(End of Clause)

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title

ARTICLE G.3. METHOD OF ORDERING

a. Orders issued under this contract may be placed as follows:

[X] in writing

[ ] via telephone

[ ] via facsimile (fax)

[ ] via electronic mail (e-mail)

[ ] Oral [Oral Orders will be confirmed in writing within days of issuance.

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[ ] Other Specify:

b. A Task Order Number shall be given to you at the time the order is approved/placed. The Contractor is cautioned not to accept an order unless one of these numbers is issued.

c. Only the Contracting Officer can approve/award Task Orders under this contract, which will be done under the procedures outlined in Article G.4 TASK ORDER PROCEDURE.

ARTICLE G.4. TASK ORDER PROCEDURE

This contract provides for the issuance of Task Orders on a negotiated basis as follows:

a. General

Only the Contracting Officer may issue Task Orders to the Contractor, providing specific authorization or direction to perform work within the scope of the contract and as specified in the Statement of Work. Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work until a fully executed Task Order has been awarded. The Contractor may incur costs under this contract in performance of task orders and task order modifications issued in accordance with this ARTICLE.

No other costs are authorized unless otherwise specified in the contract or expressly authorized by the Contracting Officer.

b. Requesting Task Order Proposals.

The Contracting Officer or a designated individual may solicit responses to requirements from the Contractor within a technical area covered by a task order requirement in writing. A Task Order Request for Proposals (TORFP) will be prepared and issued for each task order requirement.

Generally, the Task Order Request for Proposal (TORFP) will include but is not limited to the following:

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions

8. Evaluation Factors for Award

The Task Order Proposal must include the following information:

1. A description of the subject selection criteria

2. The proposed dates of enrollment (beginning and end)

3. A description of the proposed outreach programs for recruiting women and minorities as subjects;

4. A compelling rationale for proposed exclusion of any sex/gender or racial/ethnic group;

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All contract clauses contained this contract shall be incorporated in the TORFP and the resultant task order.

If conflicts exist between the contract clauses and the information outlined in the task order, the contract language takes precedence over the information in the task order.

c. Evaluation and Award of Task Order Proposals

The Government will evaluate each Task Order proposal against the requirements of each TORFP. An evaluation of the technical approach, the cost/price, and any other factor specifically identified in the TORFP will be performed.

Discussions will be initiated by the Government if determined necessary. The prices, terms and conditions of the Task Order proposal must be determined fair and reasonable to award the Task.

If a Task Order Proposal is considered to be fair and reasonable, the Contracting Officer will unilaterally issue a Task Order to the Contractor. The Task Order will include the Statement of Work (SOW) and final budget submitted by the Contractor.

Note: After the COTR approves the intervention to pursue, draft protocol, timeline, and recruitment schedule, and, all necessary Task area 1 deliverables are received and accepted (as outlined in the task order), a proposal will be requested for Task 2; acceptance of the Task Area 2 or Task Area 3 proposal for the selected intervention will begin the Task Area 2 or 3 work, as outlined within Attachment 3, Statement of Work.

ARTICLE G.5. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST

a. Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type Contracts NIH(RC)-1 are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. Payment requests shall be submitted to the offices identified below. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer.

a. The original invoice shall be submitted to the following designated billing office:

National Institutes of Health Office of Financial Management Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

b. One copy of the invoice shall be submitted to the following approving official:

Contracting Officer NIDA Neuroscience COAC, NIH, DHHS Room 8154 R&D CMB, Office of Acquisitions NIMH Contracts Section Room 8154

6001 EXECUTIVE BLVD MSC 9661

BETHESDA, MD 20892- 9661

E-Mail: jacobsonmj@mail.nih.gov

In addition to one hardcopy to be mailed to the Contracting Officer, the Contractor shall submit an electronic copy of the payment request to the contract specialist at the email address above. The electronic payment request shall be transmitted as an attachment via e-mail to the address listed

- 23 -above in one of the following formats: Microsoft Word, Microsoft Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number. [Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a "proper invoice."]

2. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is NIDA Neuroscience COAC .

b. Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is NIDA/NIMH R&D Contracts Management .

c. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

d. DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

e. Invoice Matching Option. This contract requires a two-way match.

f. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

g. Task Order Number. [as specified on Task Order document]* Note: Claim costs for only oneTask Order (T.O.) per invoice.

3. Invoicing/Accounting of Costs By Task Order

Costs for each awarded Task Order shall be tracked and invoiced separately, by T.O. number and title (e.g. if two (2) T.O.s are active and ongoing, two (2) separate monthly invoices shall be submitted).

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6452.

c. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to the SALARY RATE LIMITATION LEGISLATION PROVISIONS Article in SECTION

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H of this contract. For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

"I hereby certify that the salaries charged in this invoice are in compliance with the SALARY RATE LIMITATION LEGISLATION PROVISIONS Article in SECTION H of the above referenced contract."

E-Mail:

The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy.