NIMH-08-DN-00019-RFP.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

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

2. Request for Proposal (RFP) Number:

NIMH-08-DN-00019

3. Issue Date:

APRIL 4, 2008

4. Just in Time:

[ ]No

[X]Yes See Part IV Section L

5. Set Aside:

[X]No

[ ]Yes See Part IV Section L

6. Title : Creating a Developmental Gene Expression Atlas for Rhesus Macaque Brain

7. ISSUED BY:

Office of Acquisitions, Neuroscience NIMH R&D Contracts Management Branch National Institute on Drug Abuse, NIH 6001 Executive Blvd., Rm. 8154 Bethesda, MD 20892-9661

8. SUBMIT OFFERS TO:

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

9. 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 4:30 PM local time on JUNE 4, 2008. 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.

10. THIS SOLICITATION REQUIRES DELIVERY OF PROPOSALS TO TWO DIFFERENT LOCATIONS.

THE OFFICIAL POINT OF RECEIPT FOR THE PURPOSE OF DETERMINING TIMELY DELIVERY IS

THE ADDRESS PROVIDED FOR THE OFFICE OF ACQUISITIONS AS STATED IN ATTACHMENT 1,

"PACKAGING AND DELIVERY OF THE PROPOSAL." 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, ENTITLED, "LATE PROPOSALS, AND REVISIONS" LOCATED IN SECTION L.1. OF

THIS SOLICITATION.

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

12. FOR INFORMATION CALL: Bruce E. Anderson

PHONE: (301) 443-2234

e-MAIL: ba9i@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Bruce E. Anderson Contracting Officer, NIH http://www.ccr.gov http://www.ccr.gov

RFP Number : NIMH-08-DN-00019

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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. "JUST IN TIME"

c. NAICS CODE AND SIZE STANDARD

d. TYPE OF CONTRACT AND NUMBER OF AWARDS

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. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

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11. Institutional Responsibility Regarding Conflicting Interests of Investigators

12. Electronic and Information Technology Accessibility

13. 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

5. Information Security

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Cost and Pricing Data

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

4. Salary Rate Limitation in Fiscal Year 2007

5. Small Business Subcontracting Plan

6. HUBZone Small Business Concerns

7. Extent of Small Disadvantaged Business Participation

8. Other Administrative Data

9. Qualifications of the Offeror

10. Subcontractors

11. Proposer's Annual Financial Report

12. Representations and Certifications - SECTION K

13. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. EVALUATION OF OPTIONS

3. EVALUATION OF DATA SHARING PLAN

4. TECHNICAL EVALUATION CRITERIA

5. 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

The primary goal of this contract is to generate a searchable, digital, web-based brain atlas of the Rhesus macaque to be provided as a publicly available research tool to investigators. The macaque brain atlas will detail gene expression patterns for a minimum of 44 genes, through various stages of development (neonatal through young adult) and in each of five (5) distinct brain regions including the medial prefrontal cortex, hippocampus, amygdala, ventral striatum and the primary visual cortex.

ARTICLE B.2. ESTIMATED COST

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

b. The total estimated amount of the contract, represented by the estimated cost for the Base Period is $ .

c. If the Government exercises its option(s) pursuant to the OPTION PROVISION Articles in SECTION H of this contract, the Government's total estimated contract amount represented by the estimated cost will be increased as follows:

d.

Estimated Cost

Base Period

Option Period(s):

Total

[Base Period and Option(s)]

e. Total funds currently available for payment and allotted to this contract are $ . For further provisions on funding, see the LIMITATION OF FUNDS clause referenced in Part II, ARTICLE I.2. Authorized Substitutions of Clauses.

f. It is estimated that the amount currently allotted will cover performance of the contract through .

g. The Contracting Officer may allot additional funds to the contract without the concurrence of the Contractor.

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ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Acquisition, by purchase or 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.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

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 April 4, 2008, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, one (1) hardcopy of the reports specifed below shall be submitted to the Contracting Officer.

a. Technical Progress Reports

1. In addition to any 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. It is estimated that quarterly, annual and final technical reports will be required in electronic format during the contract, but the frequency and specific content of these reports will be determined prior to contract award. Quarterly reports will not be required when annual reports are due and annual reports will not be required when the final report is due.

For proposal preparation purposes only, it is estimated that in addition to the required electronic version(s) two signed hard copies of the reports specified below will be required as follows:

[ ]Monthly [ ]Quarterly [ ]Semi-Annual [X]Annual [ ]Annual (with a requirement for a Draft Annual Report) [X]Final - Upon final completion of the contract [ ]Final - Upon final completion of the contract (with a requirement for a Draft Final Report)

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. Source Code and Object Code

Unless otherwise specified herein, the Contractor shall deliver to the Government, upon the expiration date of the contract, all source code and object code developed, modified, and/or enhanced under this contract.

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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 Extramural Inventions and Technology Resources Branch, OPERA, NIH, 6705 Rockledge Drive, Room 1040-A, 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.

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 National Institutes of Health NIDA Office of Acquisitions, Neuroscience NIMH R&D Contracts Management Branch 6001 Executive Blvd.

NSC, 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

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

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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, NIH 6001 Executive Blvd.

Bethesda, MD 20892

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

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

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

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of the base period of this contract shall be from September 2008 through September 2010.

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

Options Option Period(s)

(1) Four (4) one-year options for additional quantities of tissue analyses;

(2) One (1) four-year option to maintain database only with no new analyses

September 2010 - September 2018 (total possible period of performance if all options are exercised)

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 F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below [and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract]:

b.

Item Description Quantity Delivery Schedule

(1) Publicly Accessible Gene Expression Atlas, with Informatics

See Statement of Work On or before completion of the base period work; see Statement of Work

(2) Quarterly Technical Reports

Electronic transmittal Within 15 days after the end of each contract quarter, including option periods

(3) Annual Technical Report(s)

Electronic transmittal & 2 signed hard copies

Within 30 days after the end of each contract year, including option periods

(4) Final Technical Report Electronic transmittal & 2 signed hard copies

By the end of the contract, including options if exercised

(5) The annual utilization report

1 hardcopy With each annual report;

see Article C.3

(6) Final invention statement 1 hardcopy With the final report; see Article C.3

(7) Provide copy of the database to the GPO, Electronic media

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Item Description Quantity Delivery Schedule upon request, including all source code and object code developed, modified, and/or enhanced under this contract.

By the end of the contract, including options if exercised

(8) Assist in migration of the database to a third party site, if requested to do so by the Project Officer

By the end of the contract, including options if exercised

(9) a) Submit roster 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).

An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for Contractor use at:

http://ais.nci.nih.gov/forms/ Suitability-roster.xls

b) Revisions to the Roster

Electronic transmittal a) Within 14 calendar days after award of the contract, and prior to beginning any work under the contract

b) Submitted within 15 calendar days of the change, and prior to beginning any work under the contract

(10) Complete and submit the required forms for background checks upon notification from the Government. Additional submission instructions can be found at the "NCI Information Technology Security Policies, Background Investigation Process" website: http:// ais.nci.nih.gov .

Electronic transmittal Within 30 days after Government notification of the appropriate level of suitability investigation for each employee

(11) Contractor-Employee Non- Disclosure Agreements (see Section J for agreement)

Electronic transmittal Prior to performing any work under this contract.

(12) Submit and maintain a current listing of individuals who have completed the initial NIH Computer Security Awareness Training course at: http:// irtsectraining.nih.gov/, and the NIH-specified fiscal year refresher course, during the period of

Electronic transmittal Initial training completed prior to performing any contract work; submit this list with 1st quarterly report;

update listing periodically in quarterly reports for any new employees, and for those who have taken annual refresher training http://ais.nci.nih.gov/forms/ http://irtsectraining.nih.gov/

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Item Description Quantity Delivery Schedule performance of the contract.

when completed each contract year.

(13) a) Finalized ISSP (Information System Security Plan) - finalize the draft submitted with the initial proposal

b) Update and resubmit its ISSP to NIH

Electronic transmittal a) No later than 90 calendar days after contract award; in coordination with the Project Officer.

b) Every three years following award or when a major modification has been made to its internal system.

(14) a) Notify the Project Officer, appropriate NIH security officials, and the assigned IT Systems Manager upon termination of an employee.

b) Complete the Employee Separation Checklist form and return to GPO (see Section J for checklist).

Electronic transmittal a) Notify GPO within 24 hours of the time of termination of an employee.

b) Submit Employee Separation Checklist within 30 days after termination.

(15) a) NIST SP 800-53 Self- Assessment

b) The contractor shall annually update and re-submit its Self- Assessment required by NIST SP 800-53, Recommended Security Controls for Federal Information Systems .

( http://csrc.nist.gov/ publications - under Special Publications).

Electronic transmittal a) with the Technical proposal

b) With each annual technical report

c. The above items shall be addressed and delivered to:

Addressee Deliverable Item No Quantity

Government Project Officer 1-15 Electronic transmittals/media, except 1 signed hardcopy of each annual report and the final report

Government Contracting Officer 1-15 Electronic transmittals/media, except 1 signed hardcopy of each annual report and the final report

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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. PROJECT OFFICER

The following Project Officer(s) will represent the Government for the purpose of this contract:

[To be specified prior to award]

The Project Officer 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 Project Officer designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.270-5 (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. 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 as follows:

a. One original to the following designated billing office:

National Institutes of Health Office of Financial Management Commercial Accounts

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2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

b. One copy to the following approving official:

Contracting Officer Office of Acquisitions, Neuroscience National Institute on Drug Abuse, NIH NSC, Room 8154

6001 EXECUTIVE BLVD MSC 9661

BETHESDA, MD 20892-

2. In addition to the requirements specified in FAR Subpart 32.9 for a proper invoice, the Contractor shall include the following information on all payment requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is:

Neurosciences Office of Acquisitions, NIDA/NIMH R&D Contracts Management Branch .

b. Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is:

NIDA Invoices NIMH CMB (NIH/NIDA) .

c. Vendor Identification Number. This is the 7 digit number that appears after the Contractor's name in Block 7 of Standard Form 26. [Note: This only applies to new contracts awarded on/ after June 4, 2007, and any existing contract modified to include the number.]

d. DUNS number or DUNS+4 that identifies the Contractor's name and address exactly as stated on the face page of the contract.

e. Identification of whether payment is to be made using a two-way or three-way match. This contract requires a Two-Way match.

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) - 496-6088.

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 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 P.L.

and the SALARY RATE LIMITATION LEGISLATION PROVISIONS Article in SECTION H of the above referenced contract." .

ARTICLE G.4. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Cost Allocation Department of Health and Human Services 330 Independence Avenue, SW Washington, DC 20201

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These rates are hereby incorporated without further action of the Contracting Officer.

ARTICLE G.5. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, "Contractor's Guide for Control of Government Property," which can be found at:

http://knownet.hhs.gov/log/AgencyPolicy/HHSLogPolicy/contractorsguide.htm.

ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR

42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) shall be submitted [Insert Dates].

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

Contractors that have Internet capability may access evaluations through a secure Web site for review and comment by completing the registration form that can be obtained at the following address:

http://oamp.od.nih.gov/OD/CPS/cps.asp

The registration process requires the Contractor to identify an individual that will serve as a primary contact and who will be authorized access to the evaluation for review and comment. In addition, the Contractor will be required to identify an alternate contact who will be responsible for notifying the cognizant contracting official in the event the primary contact is unavailable to process the evaluation within the required 30-day time frame.

http://knownet.hhs.gov/log/AgencyPolicy/HHSLogPolicy/contractorsguide.htm http://oamp.od.nih.gov/OD/CPS/cps.asp

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SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer.

ARTICLE H.2. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

a. Pursuant to Public Law(s) cited in paragraph b., below, NIH is prohibited from using appropriated funds to support human embryo research. Contract funds may not be used for (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

Additionally, in accordance with a March 4, 1997 Presidential Memorandum, Federal funds may not be used for cloning of human beings b.

Public Law and Section No. Fiscal Year Period Covered

[applicable information to be included at award]

ARTICLE H.3. NEEDLE EXCHANGE

a. Pursuant to Public Law(s) cited in paragraph b., below, contract funds shall not be used to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

ARTICLE H.4. PRESS RELEASES

a. Pursuant to Public Law(s) cited in paragraph b., below, the contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

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ARTICLE H.5. ANTI -LOBBYING

a. Pursuant to Public Law(s) cited in paragraph c., below, contract funds shall only be used for normal and recognized executive-legislative relationships. Contract funds shall not be used, for publicity or propaganda purposes; or for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State legislature, except in presentation to the Congress or any State legislature itself.

b. Contract funds shall not be used to pay salary or expenses of the contractor or any agent acting for the contractor, related to any activity designed to influence legislation or appropriations pending before the Congress or any State legislature.

c.

ARTICLE H.6. OPTION PROVISION

Unless the Government exercises its option(s) pursuant to the Option Clauses set forth in ARTICLE I.3., the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract.

Pursuant to FAR Clause 52.217-9, Option to Extend the Term of the Contract and FAR Clause 52.217-6, Option for Increased Quantity, each set forth in ARTICLE I.3. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract.

If the Government exercises these options, notice must be given at least 60 days prior to the expiration date of this contract or 60 days prior to when additional quantities are required, and the estimated cost of the contract will be increased as set forth in the ESTIMATED COST Article in SECTION B of this contract.

ARTICLE H.7. SUBCONTRACTING PROVISIONS

a. Small Business Subcontracting Plan

1. The Small Business Subcontracting Plan, dated is attached hereto and made a part of this contract.

2. The failure of any Contractor or subcontractor to comply in good faith with FAR Clause 52.219-8, entitled "Utilization of Small Business Concerns" incorporated in this contract and the attached Subcontracting Plan, will be a material breach of such contract or subcontract and subject to the remedies reserved to the Government under FAR Clause 52.219-16 entitled, "Liquidated Damages-Subcontracting Plan."

b. Subcontracting Reports

The Contractor shall submit the following Subcontracting reports electronically via the "electronic Subcontracting Reporting System (eSRS) at http://www.esrs.gov.

1. Individual Subcontract Reports (ISR) http://www.esrs.gov/

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Regardless of the effective date of this contract, the Report shall be submitted on the following dates for the entire life of this contract:

April 30th October 30th

2. Summary Subcontract Report (SSR)

Regardless of the effective date of this contract, the Summary Subcontract Report shall be submitted annually on the following date for the entire life of this contract:

October 30th

For both the Individual and Summary Subcontract Reports, the Contracting Officer shall be included as a contact for notification purposes at the following e-mail address:

Contracting Officer

ARTICLE H.8. SALARY RATE LIMITATION LEGISLATION PROVISIONS

a. Pursuant to the P.L.(s) cited in paragraph b., below, no NIH Fiscal Year funds may be used to pay the direct salary of an individual through this contract at a rate in excess of the applicable amount shown or the applicable Executive Level for the fiscal year covered. Direct salary is exclusive of fringe benefits, overhead and general and administrative expenses (also referred to as "indirect costs" or "facilities and administrative (F & A) costs").

Direct salary has the same meaning as the term "institutional base salary." An individual's direct salary (or institutional base salary) is the annual compensation that the Contractor pays for an individual's appointment whether that individual's time is spent on research, teaching, patient care or other activities. Direct salary (or institutional base salary) excludes any income that an individual may be permitted to earn outside of duties to the Contractor. The annual salary rate limitation also applies to individuals proposed under subcontracts. It does not apply to fees paid to consultants. If this is a multiple year contract, it may be subject to unilateral modifications by the Government if an individual's salary rate used to establish contract funding exceeds any salary rate limitation subsequently established in future HHS appropriation acts.

b.

Public Law and Section No.* Fiscal Year* Dollar Amount of Salary

Limitation*

c. Payment of direct salaries is limited to the Executive Level rate which was in effect on the date(s) the expense was incurred.

[*Applicable information to be included at award]

ARTICLE H.9. INFORMATION SECURITY

The Statement of Work (SOW) requires the Contractor to (1) develop, (2) have the ability to access, or (3) host and/ or maintain a Federal information system(s). Pursuant to Federal and HHS Information Security Program Policies, the Contractor and any subcontractor performing under this contract shall comply with the following requirements:

Federal Information Security Management Act of 2002 (FISMA), Title III, E-Government Act of 2002, Pub. L. No.

107-347 (Dec. 17, 2002); http://csrc.nist.gov/drivers/documents/FISMA-final.pdf

a. Information Type

[ ] Administrative, Management and Support Information http://csrc.nist.gov/drivers/documents/FISMA-final.pdf

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[ ] Mission Based Information

b. Security Categories and Levels

Confidentiality Level: [ ] Low [ ] Moderate [ ] High Integrity Level: [ ] Low [ ] Moderate [ ] High Availability Level: [ ] Low [ ] Moderate [ ] High

Overall Level: [ ] Low [ ] Moderate [ ] High

c. Position Sensitivity Designations

1. The following position sensitivity designations and associated clearance and investigation requirements apply under this contract.

[ ] Level 6: Public Trust - High Risk (Requires Suitability Determination with a BI). Contractor employees assigned to a Level 6 position are subject to a Background Investigation (BI)

[ ] Level 5: Public Trust - Moderate Risk (Requires Suitability Determination with NACIC, MBI or LBI). Contractor employees assigned to a Level 5 position with no previous investigation and approval shall undergo a National Agency Check and Inquiry Investigation plus a Credit Check (NACIC), a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).

[ ] Level 1: Non Sensitive (Requires Suitability Determination with an NACI). Contractor employees assigned to a Level 1 position are subject to a National Agency Check and Inquiry Investigation (NACI).

2. 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 Project Officer, with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change. The Contracting Officer shall notify the Contractor of the appropriate level of suitability investigations to be performed. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for Contractor use at: http://ais.nci.nih.gov/forms/Suitability-roster.xls.

Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification. Additional submission instructions can be found at the "NCI Information Technology Security Policies, Background Investigation Process" website: http://ais.nci.nih.gov.

Contractor/subcontractor employees who have met investigative requirements within the past five years may only require an updated or upgraded investigation.

3. Contractor/Subcontractor employees shall comply with the HHS criteria for the assigned position sensitivity designations prior to performing any work under this contract. The following exceptions apply:

Levels 5 and 1: Contractor/Subcontractor employees may begin work under the contract after the Contractor has submitted the name, position and responsibility of the employee to the Project Officer, as described in paragraph c. (2) above.

http://ais.nci.nih.gov/forms/Suitability-roster.xls http://ais.nci.nih.gov

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Level 6: In special circumstances the Project Officer may request a waiver of the pre-appointment investigation. If the waiver is granted, the Project Officer will provide written authorization for the Contractor/Subcontractor employee to work under the contract.

d. Information Security Training

The Contractor shall ensure that each Contractor/Subcontractor employee has completed the NIH Computer Security Awareness Training course at: http://irtsectraining.nih.gov/ prior to performing any contract work, and thereafter completing the NIH-specified fiscal year refresher course during the period of performance of the contract.

The Contractor shall maintain a listing by name and title of each Contractor/Subcontractor employee working under this contract that has completed the NIH required training. Any additional security training completed by Contractor/Subcontractor staff shall be included on this listing. [The listing of completed training shall be included in the first technical progress report. (See Article C.2. Reporting Requirements.) Any revisions to this listing as a result of staffing changes shall be submitted with next required technical progress report.]

Contractor/Subcontractor staff shall complete the following additional training prior to performing any work under this contract:

e. Rules of Behavior

The Contractor/Subcontractor employees shall comply with the NIH Information Technology General Rules of Behavior at: http://irm.cit.nih.gov/security/nihitrob.html.

f. Personnel Security Responsibilities

Contractor Notification of New and Departing Employees Requiring Background Investigations

1. The Contractor shall notify the Contracting Officer, the Project Officer, and the Security Investigation Reviewer within five working days before a new employee assumes a position that requires a suitability determination or when an employee with a security clearance stops working under the contract. The Government will initiate a background investigation on new employees requiring security clearances and will stop pending background investigations for employees that no longer work under the contract.

2. New employees: 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.

3. Departing employees:

• Provide the name, position title, and security clearance level held by or pending for the individual.

• 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 Project Officer and/or Contracting Officer upon request.

g. Commitment to Protect Non-Public Departmental Information Systems and Data

1. Contractor Agreement

The Contractor and its subcontractors performing under this SOW shall not release, publish, or disclose non-public Departmental information to unauthorized personnel, and shall protect such information in http://irm.cit.nih.gov/security/nihitrob.html

- 22 -accordance with provisions of the following laws and any other pertinent laws and regulations governing the confidentiality of such information:

-18 U.S.C. 641 (Criminal Code: Public Money, Property or Records) -18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information) -Public Law 96-511 (Paperwork Reduction Act)

2. Contractor-Employee Non-Disclosure Agreements

Each Contractor/Subcontractor employee who may have access to non-public Department information under this contract shall complete the Commitment to Protect Non-Public Information - Contractor Agreement. A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the Project Officer prior to performing any work under the contract.

h. NIST SP 800-53 Self-Assessment

The contractor shall annually update and re-submit its Self-Assessment required by NIST SP 800-53, Recommended Security Controls for Federal Information Systems. ( http://csrc.nist.gov/publications - under Special Publications).

Subcontracts: The Contractor's annual update to its Self-Assessment Questionnaire shall include similar information for any subcontractor that performs under the SOW to (1) develop a Federal information system(s) at the Contractor's/Subcontractor's facility, or (2) host and/or maintain a Federal information system(s) at the Contractor's/Subcontractor's facility.

The annual update shall be submitted to the Project Officer, with a copy to the Contracting Officer by: [date/ schedule to be determined by the Project Officer/Contracting Officer].

i. Information System Security Plan

The Contractor's draft ISSP submitted with its proposal shall be finalized in coordination with the Project Officer no later than 90 calendar days after contract award.

Following approval of its draft ISSP, the Contractor shall update and resubmit its ISSP to the Project Officer every three years or when a major modification has been made to its internal system. The Contractor shall use the current ISSP template in Appendix A of NIST SP 800-18, Guide to Developing Security Plans for Federal Information Systems. ( http://csrc.nist.gov/publications/nistpubs/800-18-Rev1/sp800-18-Rev1-final.pdf ).

The details contained in the Contractor's ISSP shall be commensurate with the size and complexity of the requirements of the SOW based on the System Categorization determined above in subparagraph (b) Security Categories and Levels of this Article.

Subcontracts: The Contractor shall include similar information for any subcontractor performing under the SOW with the Contractor whenever the submission of an ISSP is required.

ARTICLE H.10. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY, HHSAR

352.270-19(b) (January 2006)

Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) as amended by Public Law 105-220 under Title IV (Rehabilitation Act Amendments of 1998), all Electronic and Information Technology (EIT) developed, procured, maintained, and/or used under this contract shall be in compliance with the ''Electronic and Information Technology Accessibility Standards'' set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the ''Access Board'') in 36 CFR part 1194. The complete text of Section 508 Final Standards can be accessed at http://www.access-board.gov/sec508/standards.htm.

The standards applicable to this requirement are identified above and in the Statement of Work.

http://csrc.nist.gov/publications http://csrc.nist.gov/publications/nistpubs/800-18-Rev1/sp800-18-Rev1-final.pdf

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Vendors may document conformance using [attached documentation/industry-standard Voluntary Product Accessibility Template at http://www.itic.org/archives/articles/20040506/ faq_voluntary_product_accessibility_template_vpat.php]. Vendors should provide detailed information necessary for determining compliance, including defined contractor-incidental exceptions.

ARTICLE H.11. PUBLICATION AND PUBLICITY

In addition to the requirements set forth in HHSAR Clause 352.270-6, Publications and Publicity incorporated by reference in SECTION I of this contract, the Contractor shall acknowledge the support of the National Institutes of Health whenever publicizing the work under this contract in any media by including an acknowledgment substantially as follows:

"This project has been funded in whole or in part with Federal funds from the National Institute of Mental Health, National Institutes of Health, Department of Health and Human Services, under Contract No.

ARTICLE H.12. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in NIH funded programs is encouraged to report such matters to the HHS Inspector General's Office in writing or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing address is:

Office of Inspector General Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489 Washington, D.C. 20026

ARTICLE H.13. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES

Unique research resources arising from NIH-funded research are to be shared with the scientific research community.

NIH provides guidance, entitled, "Sharing Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts," (Federal Register Notice, December 23, 1999 [64 FR 72090]), concerning the appropriate terms for disseminating and acquiring these research resources. This guidance, found at : http:// ott.od.nih.gov/NewPages/64FR72090.pdf is intended to help contractors ensure that the conditions they impose and accept on the transfer of research tools will facilitate further biomedical research, consistent with the requirements of the Bayh-Dole Act and NIH funding policy.

Note: For the purposes of this Article, the terms, "research tools", "research materials", and "research resources" are used interchangeably and have the same meaning.

ARTICLE H.14. SHARING RESEARCH DATA

[The data sharing plan submitted by the Contractor is acceptable/The Contractor's data sharing plan, dated is hereby incorporated by reference.] The Contractor agrees to adhere to its plan and shall request prior approval of the Contracting Officer for any changes in its plan.

The NIH endorses the sharing of final research data to serve health. this contract is expected to generate research data that must be shared with the public and other researchers. NIH's data sharing policy may be found at the following Web site:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html http://www.itic.org/archives/articles/20040506/faq_voluntary_product_accessibility_template_vpat.php http://www.itic.org/archives/articles/20040506/faq_voluntary_product_accessibility_template_vpat.php…