NIHAO200816amd2.pdf

NOTES TO OFFERORS:

1. Questions must be submitted in writing to Alexander Kramer at kramera@niaid.nih.gov no later than August 20, 2008 at 11:00am local time.

2. Proposals must be received by the Government by the date and time specified in the solicitation. The delivery address is in a secure facility.

PLEASE ALLOW ADEQUATE TIME TO GET YOUR PACKAGE THROUGH

SECURITY AND TO THE CONTRACTING OFFICER OR DESIGNEE BEFORE

THE TIME SPECIFIED.

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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:

NIHAO200816

3. Issue Date:

7/25/08

4. Set Aside:

[X] No

[ ] Yes Part IV Section L

5. Title : Technical Support and Administrative/Management Support Services

6. ISSUED BY:

Office of Acquisitions National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health 10401 Fernwood Road, Room 2NE-28, MSC 4813 Bethesda, MD 20817-4813

7. SUBMIT OFFERS TO:

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

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 2:00 p.m. local time on 8/28/08. 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 TO THE OFFICIAL POINT OF RECEIPT FOR

THE PURPOSE OF DETERMINING TIMELY DELIVERY 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, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH SUBPARAGRAPH (c)(3) OF FAR CLAUSE 52.215-1, ENTITLED, "INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION" 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: Alexander Kramer

PHONE: 301-402-6835

e-MAIL: kramera@niaid.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Contracting Officer Office of Acquisitions National Institute of Allergy and Infectious Diseases http://www.ccr.gov http://www.ccr.gov

RFP Number : NIHAO200816

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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. PRE-PROPOSAL CONFERENCE

e. COMMITMENT OF PUBLIC FUNDS

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

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

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Sample Task Information

8. Potential Award Without Discussions

9. Use of the Metric System of Measurement

10. Standards for Privacy of Individually Identifiable Health Information

11. Privacy Act - Treatment of Proposal Information

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12. Selection of Offerors

13. ROTC Access and Federal Military Recruiting on Campus

14. Past Performance Information

15. Electronic and Information Technology Accessibility

16. Prohibition on Contractor Involvement with Terrorist Activities

17. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Obtaining and Disseminating Biomedical Research Resources

5. Information Security

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

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

5. Total Compensation Plan

6. Other Administrative Data

7. Qualifications of the Offeror

8. Subcontractors

9. Proposer's Annual Financial Report

10. Representations and Certifications - SECTION K

11. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. TECHNICAL EVALUATION CRITERIA

3. PAST PERFORMANCE FACTOR

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PART I - THE SCHEDULE

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

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

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS 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 requirement for this acquisition is to provide the NIAID Division of Clinical Research (DCR) with the ability to rapidly establish collaborations with international government agencies, academia, and health research entities in developing countries in response to urgent research demands of global importance. The contractors' role will be one of technical support and administrative/management oversight to investigators who develop and implement protocols.

ARTICLE B.2. ESTIMATED COST AND FIXED FEE

1. The contract will be an IDIQ utilizing cost plus fixed fee type task orders. The Contractor shall be reimbursed by the Government in an amount not less than a total of $100,000 (minimum) nor more than a total of $ TBD (maximum) for successful performance of this contract. Funds will be obligated on a task order basis.

2. The fixed fee for this contract will be paid on individual task orders. The fixed fee shall be paid in installments based on the percentage of completion of work on each task order, as determined by the Contracting Officer, and subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract. Payment of fixed fee shall not be made in less than monthly increments.

3. Available allotments of funds will be specified on individual task orders. Each task order will also specify the funding allotments with regards to estimated costs and fixed fee. For further provisions on funding, see the LIMITATION OF FUNDS clause referenced in Part II, ARTICLE I.2. Authorized Substitutions of Clauses.

4. The period covered by available funding will be specified on the individual task order.

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

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.

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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 6/17/2008, 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 each report shall be submitted to the Project Officer, unless otherwise specified.

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, 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 [ ] Quarterly [ ] Semi-Annually [ ] Annually [ ] Annually (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)

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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.

ARTICLE D.1. PACKAGING

Samples may be required. If they are, the will be delivered in accordance with Appendix A of the SOW. International shipping rules will be applicable.

ARTICLE D.2. MARKING

All deliveries made under the contract shall be marked for the correct point of contact based on instructions from the Project Officer.

ARTICLE D.3. SHIPPING

All shipments made under the contract shall conform to the instructions provided by the Project Officer. Instructions will be provided for each separate shipment made under the contract.

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SECTION E - INSPECTION AND ACCEPTANCE

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

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

c. Inspection and acceptance will be performed at:

TBD

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 60 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 52.246-5, Inspection of Services - Cost-Reimbursement (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 November 2008 (exact date TBD) through November 2013( exact date TBD).

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]:

Item Description Quantity Delivery Schedule

(1) Monthly Progress Report 1 elec. copy to PO and

CO

The first report is due after the first month of contract performance.

Thereafter, each report is due on/before the 10th of each month following each reporting period.

(2) Monthly Expenditure and Budget Report

1 elec. copy to PO and

CO

The first report is due after the first month of contract performance.

Thereafter, each report is due on/before the 10th of each month following each reporting period.

(3) Government Property Report

1 elec. copy to PO and

CO

The first report is due on/before 15 days after contract initiation.

Thereafter, each report is due on/before the 15th of the month following each 1-year period.

(4) Final Report 1 hard copy to PO 1 original to CO

1 elec. copy to PO and CO

Final Report is due on/ before the completion date of the contract.

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

Addressee Deliverable Item No

Project Officer 1, 2, 3, and 4

Contracting Officer 1, 2, 3, and 4

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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 determined at the time of 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

To be determined at the time of award.

ARTICLE G.3. METHOD OF ORDERING

The Federal Acquisition Streamlining Act requires that each awardee under a multiple award contract, such as the resultant base IDIQ contracts for Technical Support and Administrative/Management Support Services be given a fair opportunity to be considered for each order in excess of $2,500, unless a statutory exception applies. Government Contracting Officers have broad discretion to determine how work will be issued to awardees under multiple award IDIQ contracts, provided the procedures and selection criteria to be used are included in the Request for Proposal(s) and resultant base IDIQ contracts and the procedures allow for consideration of all awardees. Please also be advised that allocation or equitable distribution of orders, or placing order ceilings (under which the total value of orders must stay for each contractor), is contrary to the intent of FASA.

NIAID intends to use various methods to provide Contractors that received a base IDIQ contract a fair opportunity to be considered for subsequent Task Orders. The proposed technical approach, past performance and cost may be considered by NIAID for each task order. The Contracting Officer may request that Contractors submit streamlined proposals for a given Task Order requirement or, alternatively, may use information on-hand. In the latter scenario

- 12 -the selected Contractor will subsequently be asked to provide certain technical information on items such as resource availability and subject recruitment as well as a proposed budget in response to the Task Order requirements.

The NIAID Contracting Officer and the NIAID Project Officer will determine which of the following methods will be used based on the complexity of Task Order.

1. For simple, well defined tasks, such as follow-on tasks or basic administrative and management tasks, the Contracting Officer may select a source based upon past performance on similar tasks, or technical capability as demonstrated in the proposal for the basic contract.

2. For additional work on ongoing projects, the Contracting Officer may select source(s) from those Contractors that were awarded the original Task Order given that all awardees were provided a fair opportunity to be considered for the original Task Order. Selection will be based upon the Government's assessment of the Contractor's Past Performance on the original Task Order.

3. Either scenario described in 1 or 2 above where the Government does not have adequate Past Performance information under the contract or the Government believes it to be in its best interest, may be fully competed under the contract. In such instances the Contracting Officer will issue a written requests for streamlined Technical Proposals and Cost Proposals to all eligible Contractors .

4. For complex new Task Orders, technical approach, management approach, cost or pricing, and past performance are significant evaluation factors, the Contracting Officer will issue a written request for streamlined Technical Proposals and Cost Proposals to all eligible Contractors. These written requests may be issued by e-mail and the request may suggest a page limitation for the Technical Proposal based on the Government's perceived complexity of the Task Order.

Each Request for Task Order Proposals (RFTOP) issued by NIAID under the contract will include the Statement of Work, the Evaluation Factors for award of the Task Order, the required components of the offer to be submitted, the format for submission, and any other issues pertinent to the Task Order, including information on whether it is anticipated that the Task Order will be awarded with or without discussions. Task Orders will be comprised of all of the services described in the Statement of Work for the basic contract or any subset thereof. Contractors will not be required to propose on all RFTOPs. However, those eligible Contractors that decide not to submit a proposal must notify the NIAID Contracting Officer in writing of their intention not to submit a proposal on or before the closing date and time established in the RFTOP for receipt of offers.

An election not to propose on a given RFTOP will not negatively affect or prohibit a Contractor from competing on future RFTOPs. However, it may affect the Contractor's eligibility for continuations or extensions of the given Task Order and the Contractor's eligibility for similar requirement based on the Fair Opportunity to be considered scenarios stated above.

Exceptions to the Fair Opportunity to be Considered Clause

In accordance with FAR 16.505, the requirement for the Fair Opportunity consideration does not apply to orders under $2,500, or to orders above $2,500 where the NIAID Contracting Officer determines that one of the following statutory exceptions applies:

1. The need for the Task Order is so urgent that providing such opportunity would result in unacceptable delays.

2. Only one awardee is capable of providing the services required at the level of quality required because the services are highly specialized.

3. The Task Order should be issued on a sole-source basis in the interest of economy and efficiency as a logical follow-on to a Task Order already issued given that all awardees were given a fair opportunity to be considered on the original order

4. It is necessary to place an order to satisfy a minimum order guarantee under a base IDIQ contract.

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ARTICLE G.4. INDEFINITE DELIVERY CONTRACT PAYMENT METHOD

To initiate and receive prompt payment, the Contractor shall comply with the following procedure:

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

b. Invoices shall be submitted monthly to the address indicated in ARTICLE G. . INVOICE INSTRUCTIONS of this contract. Invoices shall cite the Contract Number and the Task Order Number for each order for which payment is being requested. See ARTICLE G. . INVOICE INSTRUCTIONS for more information about submission of a proper invoice.

ARTICLE G.5. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT

FINANCIAL REPORT

a. Invoice/Financing Request Instructions and Contract Financial Reporting for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 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 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 National Institute of Allergy and Infectious Diseases, NIH 10401 Fernwood Road, Room 2NE-28

BETHESDA, MD 20817

E-Mail:kramera@niaid.nih.gov

The Contractor shall submit an electronic copy of the payment request to the approving official in lieu of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in a format compatible with the computer systems at NIH [e.g., MS Word, MS Excel, or Adobe Portable Document Format (PDF). [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 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 National Institute of Allergy and Infectious Diseases .

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

TBD .

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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) - 496-6452.

ARTICLE G.6. 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 Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health 6100 Building, Room 6B05

6100 EXECUTIVE BLVD MSC-7540

BETHESDA MD 20892-7540

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

ARTICLE G.7. 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.8. 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 every six months.

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

- 15 -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://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. HUMAN MATERIALS

The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

ARTICLE H.3. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

The Contractor shall provide written documentation that all human materials obtained as a result of research involving human subjects conducted under this contract, by collaborating sites, or by subcontractors identified under this contract, were obtained with prior approval by the Office for Human Research Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46 to protect human research subjects. This restriction applies to all collaborating sites without OHRP-approved Assurances, whether domestic or foreign, and compliance must be ensured by the Contractor.

Provision by the Contractor to the Contracting Officer of a properly completed "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption", Form OMB No. 0990-0263(formerly Optional Form 310), certifying IRB review and approval of the protocol from which the human materials were obtained constitutes the written documentation required. The human subject certification can be met by submission of a self designated form, provided that it contains the information required by the "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption", Form OMB No. 0990-0263(formerly Optional Form 310).

ARTICLE H.4. NEEDLE EXCHANGE

Pursuant to the current HHS annual appropriations act, the Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

ARTICLE H.5. PRESS RELEASES

Pursuant to the current HHS annual appropriations act, 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.6. LIMITATION ON USE OF FUNDS FOR PROMOTION OF LEGALIZATION OF

CONTROLLED SUBSTANCES

Pursuant to the current HHS annual appropriations act, the Contractor shall not use contract funds to support activities that promote the legalization of any drug or other substance included in schedule I of the schedules of controlled substances established under section 202 of the Controlled Substances Act (21 U.S.C. 812), except for normal and recognized executive-congressional communications. This limitation shall not apply when the Government determines that there is significant medical evidence of a therapeutic advantage to the use of such drug or other substance or that federally sponsored clinical trials are being conducted to determine therapeutic advantage.

ARTICLE H.7. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING SCIENTIFIC

INFORMATION

Pursuant to the current HHS annual appropriations act, the Contractor shall not use contract funds to disseminate scientific information that is deliberately false or misleading.

ARTICLE H.8. RESTRICTION ON EMPLOYMENT OF UNAUTHORIZED ALIEN WORKERS

Pursuant to the current HHS annual appropriations act, the Contractor shall not use contract funds to employ workers described in section 274A(h)(3) of the Immigration and Nationality Act, which reads as follows:

"(3) Definition of unauthorized alien. - As used in this section, the term 'unauthorized alien' means, with respect to the employment of an alien at a particular time, that the alien is not at that time either (A) an alien lawfully admitted for permanent residence, or (B) authorized to be so employed by this Act or by the Attorney General."

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

[X] Administrative, Management and Support Information

[ ] Mission Based Information

b. Security Categories and Levels

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

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

c. Position Sensitivity Designations http://csrc.nist.gov/drivers/documents/FISMA-final.pdf

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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).

[X] 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.

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. Any revisions to this listing as a result of staffing changes shall be submitted with next required technical progress report.

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

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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 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.

ARTICLE H.10. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY (January 2008)

Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) products and services developed, acquired, maintained, and/or used under this contract/order must comply with the "Electronic and Information Technology Accessibility Provisions" set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the "Access Board") in 36 CFR part 1194. Information about Section 508 provisions is available at http:// http://irm.cit.nih.gov/security/nihitrob.html http://www.section508.gov/

- 20 -www.section508.gov/. The complete text of Section 508 Final provisions can be accessed at http://www.access-board.gov/sec508/provisions.htm.

The Section 508 standards applicable to this contract/order are identified in the Statement of Work. The contractor must provide a written Section 508 conformance certification due at the end of each order/contract exceeding $100,000 when the order/contract duration is one year or less. If it is determined by the Government that EIT products and services provided by the Contractor do not conform to the described accessibility in the Product Assessment Template, remediation of the products and/or services to the level of conformance specified in the vendor's Product Assessment Template will be the responsibility of the Contractor at its own expense.

In the event of a modification(s) to the contract/order, which adds new EIT products and services or revised the type of, or specifications for, products and services the Contractor is to provide, including EIT deliverables such as electronic documents and reports, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template to assist the Government in determining that the EIT products and services support Section 508 accessibility requirements. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://508.hhs.gov.

[(End of HHSAR 352.270-19(b)]

Prior to the Contracting Officer exercising an option for a subsequent performance period/additional quantity or adding increment funding for a subsequent performance period under this contract, as applicable, the Contractor must provide a Section 508 Annual Report to the Contracting Officer and Contracting Officer's Technical Representative (also known as Project Officer or Contracting Officer's Representative). Unless otherwise directed by the Contracting Officer in writing, the Contractor shall provide the cited report in accordance with the following schedule. Instructions for completing the report are available at: http://508.hhs.gov/ under the heading Vendor Information and Documents.

The Contractor's failure to submit a timely and properly completed report may jeopardize the Contracting Officer's exercising an option or adding incremental funding, as applicable.

Schedule for Contractor Submission of Section 508 Annual Report:

[End of HHSAR 352.270-19(c)]

ARTICLE H.11. ACCESS TO NATIONAL INSTITUTES OF HEALTH (NIH) ELECTRONIC MAIL

All Contractor staff that have access to and use of NIH electronic mail (e-mail) must identify themselves as contractors on all outgoing e-mail messages, including those that are sent in reply or are forwarded to another user. To best comply with this requirement, the Contractor staff shall set up an e-mail signature ("AutoSignature") or an electronic business card ("V-card") on each Contractor employee's computer system and/or Personal Digital Assistant (PDA) that will automatically display "Contractor" in the signature area of all e-mails sent.

ARTICLE H.12. CONFIDENTIALITY OF INFORMATION

The following information is covered by HHSAR 352.224-70, Confidentiality of Information (January 2006):

1) proprietary data; 2) sensitive and/or proprietary information contained in the protocol files such as drug formulation, patient toxicity or patient response information; 3) confidential patient information that may be traced back to a patient through clinical data submission; 4) any confidential patient/protocol/clinical data information that may be reviewed, audited or written up in summary tables, audit findings or data submissions that may potentially identify a patient; and 5) confidential information, particularly patient information, that is reviewed during the audit of hospital medical records, original medical source documentation or abstracted information (including patient computer printouts). To ensure confidentiality of patient information and company proprietary information, all unpublished information and materials used with this project are considered proprietary and/or confidential unless otherwise marked, including protocols which shall be totally confidential in the pre-approval stage.

http://www.section508.gov/ http://www.access-board.gov/sec508/provisions.htm http://www.access-board.gov/sec508/provisions.htm http://508.hhs.gov/ http://508.hhs.gov/

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ARTICLE H.13. TASK ORDER/DELIVERY ORDER CONTRACT OMBUDSMAN

In accordance with FAR 16.505(b)(5), the following individual has been designated as the NIH Ombudsman for task order and delivery order contracts.

[The appropriate individual will be included in the resultant contract as follows:]

For R&D Contracts: For Non R&D Contracts:

Dr. Walter Schaffer Dr. Richard G. Wyatt

NIH Competition Advocate NIH Competition Advocate

6705 Rockledge Drive, Room 3537 1 Center Drive, Room 160, MSC 0151

Bethesda, MD 20817 Bethesda, MD 20892-0151

Phone: (301) 435-2687 Phone: (301) 496-4920

FAX: (301) 480-0146 FAX: (301) 402-4273

e-mail: schaffew@od.nih.gov e-mail: e-mail: WyattRG@mail.nih.gov

ARTICLE H.14. 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.15. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)

Pursuant to Public Law 101-391, no Federal funds may be used to sponsor or fund in whole or in part a meeting, convention, conference or training seminar that is conducted in, or that otherwise uses the rooms, facilities, or services of a place of public accommodation that do not meet the requirements of the fire prevention and control guidelines as described in the Public Law. This restriction applies to public accommodations both foreign and domestic.

Public accommodations that meet the requirements can be accessed at: http://www.usfa.fema.gov/hotel/index.htm.

ARTICLE H.16. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST

ACTIVITIES

The Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to E.O. 13224 and P.L. 107-56, prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the Contractor to ensure compliance with these Executive Orders and Laws. This clause must be included in all subcontracts issued under this contract.

mailto:schaffew@od.nih.gov mailto:WyattRG@mail.nih.gov mailto:Htips@os.dhhs.gov http://www.usfa.fema.gov/hotel/index.htm

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ARTICLE H.17. CONSTITUTION DAY

Each educational institution that receives Federal funds for a fiscal year shall hold an educational program on the United States Constitution on September 17 of such year for the students serviced by the educational institution in accordance with Public Law 108-447.

ARTICLE H.18. REGISTRATION FEES FOR…