NHLBI-CSB-(DE)-2013-22-DEL.pdf

Solicitation No. NHLBI-CSB-(DE)-2013-022-DEL

Title: SJÖGREN’S SYNDROME INTERNATIONAL COLLABORATIVE CLINICAL

ALLIANCE (SICCA) BIOREPOSITORY

Note to Offerors

Proposals will be accepted by the National Heart, Lung, and Blood Institute (NHLBI) in accordance with the requirements of Solicitation No. NHLBI-CSB-(DE)-2013-022-DEL, SJÖGREN’S SYNDROME INTERNATIONAL COLLABORATIVE CLINICAL

ALLIANCE (SICCA) BIOREPOSITORY.

A proposal submitted in response to this solicitation shall present a detailed technical plan designed to meet the tasks described in the Statement of Work.

Proposals received in response to this solicitation will be evaluated in accordance with Section M of the solicitation. An award will be made to the responsible offeror whose offer conforms to the solicitation requirements and provides the best value to the Government.

The Government reserves the right to make an award without discussions based solely upon initial proposals. Should the Government hold discussions, you will be notified if your proposal has been selected for discussions. During discussions, offerors will have an opportunity to revise their proposals in response to questions and comments provided by the Government. Please note that if your proposal is selected for negotiations, it does not guarantee that it will be selected for contract award. After receipt of the Final Proposal Revisions (FPR), offerors will be notified if their proposal is selected for award. The Government intends to award one (1) cost-reimbursement, option-type contract with a one-year base period and four (4) one-year options.

The award is expected to be made on or about September 20, 2013.

QUESTIONS AND ANSWERS: Offerors must submit all questions concerning this solicitation in writing to the Contracting Officer, Evanthia Bouzis, at bouzise@mail.nih.gov, and

Contact Specialist, Deirdre Lyons, lyonsde@mail.nih.gov. All questions must be received electronically by 3:00 p.m. EST, February 12, 2013. All Questions and Answers will be posted on FedBizOpps by February 15, 2013.

PROPOSAL DUE DATE: The Proposal Intent Response Form is due February 19, 2013.

Proposals must be received by 2:00 p.m. (EST) on February 25, 2013 at the address specified, and the number of copies specified, in Attachment 1, Packaging and Delivery of Proposal.

mailto:bouzise@mail.nih.gov mailto:lyonsde@mail.nih.gov

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

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

2. Request for Proposal (RFP) Number:

NHLBI-CSB-(DE)-2013-22-DEL

3. Issue Date:

January 24,2013

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Sjogren's International Collaborative Clinical Alliance (SICCA) Biorepository

6. ISSUED BY:

Office of Acquisitions National Heart, Lung, and Blood Institute National Institutes of Health

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 2:30 PM local time on February 25, 2013. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition," LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the Central Contractor Registry (CCR) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at http://www.sam.gov

11. FOR INFORMATION CALL: Evanthia Bouzis

PHONE: 301-435-0367

e-MAIL: bouzise@mail.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Evanthia Bouzis Contracting Officer Office of Acquisitions http://www.sam.gov

RFP Number : NHLBI-CSB-(DE)-2013-22-DEL

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. ESTIMATE OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

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

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Standards for Privacy of Individually Identifiable Health Information

10. Privacy Act - Treatment of Proposal Information

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11. Selection of Offerors

12. ROTC Access and Federal Military Recruiting on Campus

13. Past Performance Information

14. 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 and Physical Access Security

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

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

5. Mentor Protege Program, HHSAR 352.219-70

6. HUBZone Small Business Concerns

7. Extent of Small Disadvantaged Business Participation

8. Total Compensation Plan

9. Other Administrative Data

10. Qualifications of the Offeror

11. Subcontractors

12. Proposer's Annual Financial Report

13. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. EVALUATION OF OPTIONS

4. TECHNICAL EVALUATION CRITERIA

5. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

6. PAST PERFORMANCE FACTOR

7. 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 purpose of this acquisition is to support infrastructure and capacity to store and maintain biospecimens and data collected from subjects enrolled in the Sjögren's International Collaborative Clinical Alliance (SICCA) study and to provide scientific advice regarding study design that optimizes use of the specimens and data prior to distributing these specimens and the accompanying clinical data to qualified investigators.

ARTICLE B.2. ESTIMATED COST - OPTION

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

b. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount will be increased as follows:

Estimated Cost

Base Period TBD

Option Period One (12 months): TBD

Option Period Two (12 months): TBD

Option Period Three (12 months): TBD

Option Period Four (12 months): TBD

Total

[Base Period and Option(s)]

TBD

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general

- 5 -purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

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

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 December 26, 2012, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

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

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, one hardcopy of each report shall be submitted to the Contracting Officer.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Helpful Resources."

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

a. Technical Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

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

A. Semi-Annual Progress Report http://www.hhs.gov/web/508/index.html

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This report shall summarize the activities and progress made during the preceding 6 months. The initial report should cover the first full six months of performance including any fractional part of the initial month.

Thereafter, the reporting period shall consist of six full calendar months. A semi-annual progress report is not required for the periods in which the annual or final technical reports are due. This report must document and summarize work results and activities performed during the reporting period. At minimum, this report should include the following:

• Inventory Report o Summary of biorepository inventory by material type o Usage rates during the reporting period o Outstanding shipping discrepancies during the reporting period

• List of all repository requests and dispositions

• List of reportable QA deviation events and corrective actions

• Report of Communications and Meetings o Summary of communications o Summary of review meetings and disposition recommendations o Report on conference attendance and participation

• Summary Report of Facility and Equipment, including any recommendations for replacement or repair of government-furnished/contractor-acquired equipment

• Planned activities for the next reporting period

B. Annual Technical Progress Report

This report shall summarize the activities and progress made during the preceding 12 months. The first annual report shall be due at the expiration of the contract period or annually if options are exercised. The initial report should cover the first full twelve months of performance including any fractional part of the initial month. Annual reports thereafter are to be submitted at 12 month intervals.

An annual report is not required for the period when the final technical report is due. At minimum, annual reports should include the following information:

• Face page to include contract number, title, period of performance being reported, Contractor's name and address, telephone and facsimile numbers, and date of submission;

• Table of Contents;

• Summary of work performed during the reporting period, including the relationship between the accomplishments made relative to the goals, objectives, and milestones of the Statement of Work;

• Description of any issues or problems encountered and corrective actions planned or taken;

• Planned activities for the next reporting period;

• Copies of manuscripts (published or unpublished) derived from research materials provided under the contract and copies of all abstracts, manuscripts, preprints and publications that resulted from work conducted or any protocol or method developed specifically under this contract during the performance period. Manuscripts and publications resulting from this work must cite the support received from this contract;

• Any additional information pertinent to contract performance;

• Disaster Recovery Plan (DRP).

C. Final Technical Report

The final report should comprehensively summarize the work performed and results obtained for the entire contract period of performance and provide a cumulative representation of the information required in the semi-annual progress reports. A draft of the final report must be submitted to the COR and Contracting Officer for review at least 30 days prior to the expiration date of the contract. The final report is due on the expiration date of the contract.

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2. Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

b. Other Reports/Deliverables

1. Security, back-up and disaster recovery measures - as described in SOW, Task 1. The Contractor shall provide, within 30 days of contract award, detailed plans describing the security, back-up and disaster recovery measures. Revisions specified by the COR will be completed within 2 weeks. The final version will then be submitted for approval by the COR within 1 day following the completion of revisions.

2. Quality Assurance/Quality Control (QA/QC) Plan - as described in SOW, Task 3. The Contractor shall submit, within 30 days of contract award, a detailed plan for QA/QC, including all applicable SOPs. Revisions specified by the COR will be completed within 2 weeks.The final version will then be submitted for approval by the COR within 1 day following the completion of revisions.

3. Dissemination Plan and Access Policies - as described in SOW, Task 4. The draft plan shall be submitted to the COR within 30 days of contract award. The final plan is due within 90 days of contract award.

4. Minutes from Scientific Review Meetings of Biospecimen Requests - as described in SOW, Task

4. The contractor shall submit complete and accurate minutes of biospecimen/data review committee meetings to the COR within 7 business days following the completion of each meeting.

5. Fee Schedule - as described in SOW, Task 5. Due to the COR within 60 days of contract award.

Updates due annually, at minimum.

6. Manual of Operations (MOP) - as described in SOW, Task 11. The Contractor shall be responsible for establishing and maintaining a comprehensive manual of operations containing all standard operating procedures (SOPs) and policies governing the SICCA Biorepository. This includes maintaining a current roster of all committees and assuring sufficient representation on various committees. Draft MOP is due within 60 days of contract award. The final version is due within 90 days of contract award. Revisions to the MOP should be provided to the COR as appropriate.

7. Website Plan - as described in SOW, Task 8. - A Draft Plan for the design and implementation of the SICCA Repository website and web-based systems for ordering materials is due to the COR for review and approval within 30 days of the contract award. The Final Plan and its implementation are due within 45 calendar days after contract award.

8. Database Management Plan (DMP) - as described in SOW, Task 9. Due within 30 days of award.

9. Final Contract Close-out and Transition Report

Plan and execute an orderly, safe and efficient transition of all contract-generated specimens, data, databases, documents and other materials to the Government or a Government designated location on or before the expiration date of the contract. This shall include the following:

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Draft Transition Plan - The Draft Transition Plan shall include:

a. a plan and timeline for the completion of all ongoing contract activities;

b. a plan and timeline for the transfer of all contract-generated specimens, data, databases, documents and other materials;

c. a list of Contractor personnel to be assigned to carry out final transition activities; and

d. an estimate of the cost to complete the transition.

The Draft Transition Plan shall be submitted to the COR for review and approval no later than six months prior to the completion date of the contract.

Final Transition Plan - The Contractor shall revise the Draft Transition Plan in accordance with comments provided by the COR. The Final Transition Plan shall be submitted to the COR within 30 calendar days of the receipt of the COR's comments. After receipt of written approval of the Final Transition Plan by the COR, the Contractor shall implement the approved Final Transition Plan to achieve a complete, timely, and orderly transition of all contract activities, resources and final deliverables by the contract expiration date.

10. Information Security and Physical Access Reporting Requirements

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

a. Roster of Employees Requiring Suitability Investigations

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

b. IT Security Plan (IT-SP)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the contractor shall submit the IT-SP within thirty

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

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

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

c. FIPS 199 Assessment

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit a FIPS 199 Assessment within thirty (30) days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard.

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

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

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit written proof to the Contracting Officer that an IT-SC&A was performed within three (3) months after contract award.

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

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

e. Reporting of New and Departing Employees

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

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

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

(Reference subparagraph E.2.a-c. of the INFORMATION AND PHYSICAL ACCESS

f. Contractor - Employee Non-Disclosure Agreement(s) The contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information - Contractor Agreement" form for each contractor and subcontractor employee who may

- 10 -have access to non-public Department information under this contract. This form is located at: http://ocio.nih.gov/docs/public/Nondisclosure.pdf.

(Reference subparagraph E.3.d. of the INFORMATION AND PHYSICAL ACCESS

g. Vulnerability Scanning Reports

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

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

11. Section 508 Annual Report

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

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.

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, TBD 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 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.

http://ocio.nih.gov/docs/public/Nondisclosure.pdf http://www.hhs.gov/od

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FAR Clause 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984).

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be one year from the date of award.

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:

Option Option Period Option Period One 12 months Option Period Two 12 months Option Period Three 12 months Option Period Four 12 months

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:

Item Description Quantity Delivery Schedule

(1) Semi-Annual Progress

Reports One electronic copy and one hard copy.

The first report shall be due 6 full months after award of contract.

Thereafter, reports shall be due every 6 months.

(2) Annual Progress Report One electronic copy and one hard copy.

The first report shall be due 12 full months after award of contract.

Thereafter, reports shall be due every 12 months if options are exercised.

(3) Final Technical Report One electronic copy and one hard copy.

Expiration date of the contract.

(4) Summary of Salient Results

One electronic copy and one hard copy.

Expiration date of the contract.

(5) Security, back-up and disaster recovery measures

One electronic copy and one hard copy.

The draft plan is due within 30 days of award.

Revisions specified by the COR will be completed within 2 weeks. The final version is due within 1 day following the completion of the revisions.

(6) Quality Assurance/Quality Control (QA/QC) Plan

One electronic copy and one hard copy.

The draft plan is due within 30 days of award.

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Item Description Quantity Delivery Schedule Revisions specified by the COR will be completed within 2 weeks. The final version is due within 1 day following the completion of the revisions.

(7) Dissemination Plan and Access Policies

One electronic copy and one hard copy.

The draft plan is due within 30 days of award. The final version is due within 90 days of award.

(8) Minutes from Scientific Review Meetings of Biospecimen Requests

One electronic copy and one hard copy.

Within 7 working days following the completion of each meeting.

(9) Fee Schedule One electronic copy and one hard copy.

Within 60 days of award.

Updates due annually.

(10) Manual of Operations

(MOP)

One electronic copy and one hard copy.

The draft MOP is due within 60 days of award.

The final version is due within 90 days of award.

(11) Website Plan One electronic copy and one hard copy.

The draft plan is due within 30 days of award.

The final plan and its implementation are due within 45 days of award.

(12) Database Management Plan (DMP)

One electronic copy and one hard copy.

Within 30 days of award.

(13) Final Contract Close-out and Transition Report

One electronic copy and one hard copy.

The Draft Transition Plan shall be submitted to the COR for review and approval no later than six months prior to the completion date of the contract. The Final Transition Plan shall be submitted to the COR within 30 calendar days of the receipt of the COR's comments.

(14) Section 508 Annual Report One electronic copy and one hard copy.

TBD

(15) Information Security and Physical Access Reporting Requirements

One electronic copy and one hard copy.

See Article C.2.b.10.

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

Addressee Deliverable Item No Quantity Contracting Officer's Representative

(COR) - TBD

Items 1 through 15 One electronic copy and one hard copy.

Contracting Officer - TBD Items 1 through 15 One electronic copy and one hard copy.

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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).

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR)

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

TBD

The COR 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 alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.

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 COR designation.

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

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

(End of Clause)

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

Name Title

TBD at time of award http://www.acquisition.gov/comp/far/index.html

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ARTICLE G.3. RECIPIENTS REIMBURSEMENT PROCEDURES

a. During the course of this contract, the Contracting Officer or his duly designated representative will notify the Contractor to make certain shipments of biospecimens and clinical data directly to specified U.S. Government Recipients, Contractors, Government Agencies, or other private organizations and the Contractor shall make such shipments as directed.

b. The Contractor shall bill recipients directly for the cost of packaging, shipping, and special handling of biospecimens and clinical data. The charges for the cost of packaging, shipping, and special handling of biospecimens and clinical data shall be determined by the NIDCR Contracting Officer's Representative in consultation with the Contractor. Under no circumstances shall the Contractor bill prices other than those referenced above and in the Statement of Work.

c. The Contractor shall keep an accurate account of all payments received from recipients of biospecimens and clinical data separate from other fiscal aspects of the contract. The Contractor shall record as credits on monthly invoices to the Government, all payments received from the Government Grantees, Contractors, Government Agencies, or other private organizations. The income from recipients must be credited to the Government in the billing period actually received. Thus, the Contractor shall bill the Government directly for payment of contract costs and shall subtract as a credit all payments received from recipients. The actual collections from sales shall be offset against the gross billing, leaving a net amount due on the invoice.

The NIDCR Contracting Officer's Representative (COR) may direct from time to time that shipments be made entirely at Government expense. The NIDCR Contracting Officer's Representative will have the authority to reduce or waive the fees in special cases.

d. The Contractor shall account for the contract related income separately in accordance with its own double entry accounting system. The Contractor shall submit to the Government a Monthly Summary Sheet of Sales, which is listed as an Attachment in SECTION J of this contract. The Contractor shall submit a copy of this Attachment each month with the Monthly Progress Report.

The administration of the contract related income shall be subject to the terms of this contract, including specifically and without limitation, FAR Clause 52.215-2, Audit and Records--Negotiation, of the General Clauses (including applicable Alternates), and the applicable cost principles of the Federal Acquisition Regulation.

e. The Contractor shall use the following procedures for collection of delinquent accounts:

Step 1 - Accounts 30 days past due. A copy of the invoice shall be sent to the recipient with a notation that the account is overdue and request payment.

Step 2 - Accounts 60 days past due. The Contractor shall turn the account over to a collection agency.

f. When the completion (final) invoice is submitted on this contract, a listing of all outstanding recipient invoices shall be provided along with details as to what disposition is expected on each.

ARTICLE G.4. 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.

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

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

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

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

Contracting Officer Office of Acquisitions

Room TBD

MSC

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

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is the National Heart, Lung, and Blood Institute (NHLBI) .

b. Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is nhlbi_branchbinvoice@mail.nih.gov .

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

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

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

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

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g. The Contract Title is: Sjögren's International Collaborative Clinical Alliance (SICCA) Biorepository

h. Contract Line Items as follows:

Line Item # Line Item Description

1 TBD

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 HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I 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 HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract."

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, "HHS Contracting Guide for Contract of Government Property," which can be found at:

http://www.hhs.gov/hhsmanuals/logisticsmanual/Appendix Q_HHS Contracting Guide.pdf.

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 Subpart 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) will be prepared on TBD .

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 may access evaluations through a secure Web site for review and comment at the following address:

http://www.cpars.gov http://www.hhs.gov/hhsmanuals/logisticsmanual/Appendix%20Q_HHS%20Contracting%20Guide.pdf http://www.cpars.gov

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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 (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.3. NEEDLE DISTRIBUTION

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.4. ACKNOWLEDGEMENT OF FEDERAL FUNDING

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.

ARTICLE H.5. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

ARTICLE H.6. PRIVACY ACT, HHSAR 352.224-70 (January 2006)

This contract requires the Contractor to perform one or more of the following: (a) Design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations. The term "system of records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some

- 18 -identifying number, symbol, or other identifying particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties (5 U.S.C. 552a(i)). The Contractor shall ensure that each of its employees knows the prescribed rules of conduct and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as Department of Health and Human Services employees. These provisions also apply to all subcontracts the Contractor awards under this contract which require the design, development or operation of the designated system(s) of records [5 U.S.C. 552a(m)(1)]. The contract work statement: (a) identifies the system(s) of records and the design, development, or operation work the Contractor is to perform; and (b) specifies the disposition to be made of such records upon completion of contract performance.

(End of clause)

45 CFR Part 5b contains additional information which includes the rules of conduct and other Privacy Act requirements and can be found at: http://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr5b_06.html.

The Privacy Act System of Records applicable to this project is Number 09-25-0200. This document is incorporated into this contract as an Attachment in SECTION J of this contract. This document is also available at: http:// oma.od.nih.gov/ms/privacy/pa-files/read02systems.htm.

ARTICLE H.7. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause set forth in ARTICLE I.3., the contract will consist 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 set forth in ARTICLE I.3. of this contract, the Government may, by unilateral contract modification, require the Contractor to continue performance of the Statement of Work as defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 60 days prior to the expiration date of this contract, and the estimated cost [plus fixed fee] of the contract will be increased as set forth in the ESTIMATED COST Article in SECTION B of this contract.

ARTICLE H.8. INFORMATION AND PHYSICAL ACCESS SECURITY

A. HHS-Controlled Facilities and Information Systems Security

a. To perform the work specified herein, Contractor personnel are expected to have routine (1) physical access to an HHS-controlled facility; (2) physical access to an HHS-controlled information system; (3) access to sensitive HHS data or information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

b. To gain routine physical access to an…