Metabolomics Standards Synthesis Facility- RFP.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority:

2. Request for Proposal (RFP) Number:

NHLBI-CSB-HV-2013-13-RSF

3. Issue Date:

May 8, 2012

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Metabolite Standards Synthesis Center

6. ISSUED BY:

National Institutes of Health National Heart, Lung, & Blood Institute Office of Acquisitions COAC Services Branch 6701 Rockledge Drive Suite 6030 Bethesda, Maryland 20892 MSC7902

7. SUBMIT OFFERS TO:

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

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 3:00pm local time on 7/10/2012. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

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

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH 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. http:// www.ccr.gov

11. FOR INFORMATION CALL: Rashida Ferebee, Contract Specialist

PHONE: 301-435-0360

e-MAIL: ferebeers@nhlbi.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Please submit ALL inquiries regarding this Request for Proposals in writing to the email address provided above. Requests for clarification shall be submitted electronically to the Contract Specialist, no later than June 1, 2012 12:00 p.m. EST. Responses will be provided electronically no later than June 18, 2012.

Nora I. Rivera Contracting Officer Office of Acquisitions http://www.ccr.gov http://www.ccr.gov

RFP Number : NHLBI-CSB-HV-2013-13-RSF

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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

k. LATE PROPOSALS AND REVISIONS

2. INSTRUCTIONS TO OFFERORS

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. Uniform Resource Locators (URLs) in Contract Proposals

6. Page and Formatting Limitations

7. Evaluation of Proposals

8. Potential Award Without Discussions

9. Use of the Metric System of Measurement

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10. Standards for Privacy of Individually Identifiable Health Information

11. Specific Copyright Provisions Applicable to Software Development and/or Enhancement(s)

12. Privacy Act - Treatment of Proposal Information

13. Selection of Offerors

14. Institutional Responsibility Regarding Investigator Conflicts of Interest

15. ROTC Access and Federal Military Recruiting on Campus

16. Past Performance Information

17. Solicitation Provisions Incorporated by Reference

TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Possession, Use and Transfer of Select Biological Agents or Toxins

5. Obtaining and Disseminating Biomedical Research Resources

6. Information and Physical Access Security

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

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. Small Business Subcontracting Plan

6. Mentor Protege Program, HHSAR 352.219-70

7. HUBZone Small Business Concerns

8. Extent of Small Disadvantaged Business Participation

9. Total Compensation Plan

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer's Annual Financial Report

14. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. EVALUATION OF OPTIONS

4. EVALUATION OF DATA SHARING PLAN

5. EVALUATION OF PLAN FOR SHARING MODEL ORGANISMS FOR BIOMEDICAL RESEARCH

6. TECHNICAL EVALUATION CRITERIA

7. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

8. PAST PERFORMANCE FACTOR

9. 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 contractor shall support the NIH Common Fund Metabolomics Program for the production of candidate metabolomic standards, isotopically-labeled and unlabeled, from key mammalian metabolic pathways including but not limited to such pathways as the glycolytic pathway, tricarboxylic acid cycle pathway, sterol, lipid and aminoacid metabolism pathways.

ARTICLE B.2. ESTIMATED COST - OPTION

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

b. The fixed fee for the Base Period of this contract is $ . For completion contracts: The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting OfficerThe total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the Base Period is $ .

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

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Base Period

Option Period(s):

Total

[Base Period and Option(s)]

d. Payments will be made from the following PRISM/NBS Line Items as follows:

PRISM/NBS Line Item No.

Option/Increment Description

PRISM/NBS Line Item Period of Performance Funded Amount

1 07/15/2013 - 07/14/2014

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PRISM/NBS Line Item No.

Option/Increment Description

PRISM/NBS Line Item Period of Performance Funded Amount

2 07/15/2014 - 07/14/2015 3 07/15/2015 - 07/14/2016 4 07/15/2016 - 07/14/2017 5 07/15/2017 - 07/14/2018

f. Payment of fee shall be 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.

The fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended.

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 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 May 04, 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.

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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) 2 hard copies of these reports will be required as follows:

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

2. Summary of Salient Results

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

3. Report on Select Agents or Toxins and/or Highly Pathogenic Agents

For work involving the possession, use, or transfer of a Select Agent or Toxin and/or a Highly Pathogenic Agent, the following information shall also be included in each AnnualProgress Report:

1. Any changes in the use of the Select Agent or Toxin including initiation of "restricted experiments," and/or a Highly Pathogenic Agent, that have resulted in a change in the required biocontainment level, and any resultant change in location, if applicable, as determined by the IBC or equivalent body or institutional biosafety official.

2. If work with a new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent will be conducted in the upcoming reporting period, provide:

a. A list of each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent that will be studied;

b. A brief description of the work that will be done with each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent and whether or not the work is a Select Agent or Toxin restricted experiment as defined in the Select Agents Regulation 42 CFR Part 73, Section 13.b ( http://www.selectagents.gov/Regulations.html) or listed on the U.S. National http://www.hhs.gov/web/508/index.html http://www.selectagents.gov/Regulations.html

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Select Agents Registry restricted experiments website ( http://www.selectagents.gov/ Select%20Agents%20and%20Toxins%20Restricted%20Experiments.html);

c. The name and location for each biocontainment resource/facility, including the name of the organization that operates the facility, and the biocontainment level at which the work will be conducted, with documentation of approval by your IBC or equivalent body or institutional biosafety official. It must be noted if the work is being done in a new location or different location.

d. For work with Select Agents performed in the U.S. provide documentation of registration status of all domestic organizations where Select Agent(s) will be used. For work with Select Agents performed in a non-U.S. country prior NIAID approval is required.

If the IBC or equivalent body or institutional biosafety official has determined, for example, by conducting a risk assessment, that the work that has been performed or is planned to be performed under this contract may be conducted at a biocontainment safety level that is lower than BSL3, a statement to that affect shall be included in each Annual Progress Report.

If no work involving a Select Agent or Toxin and/or a Highly Pathogenic Agent has been performed or is planned to be performed under this contract, a statement to that affect shall be included in each Annual Progress Report.

b. Technical Progress Reports Containing Interim Study Data

1. Legend for Technical Progress Reports Containing Interim Study Data

It is recommended that the Contractor incorporate the following legend on the cover of technical progress reports and reports containing study data that are prepared for use by all working committees in their monitoring of the trial. Working committees include but are not limited to the Data and Safety Monitoring Board (DSMB), Steering Committee and Executive Committee.

"The data, if any, contained in this report/deliverable are preliminary and may contain unvalidated findings.

These data are not intended for public use. Public use of these data could create erroneous conclusions which, if acted upon, could threaten public health or safety."

2. Use of Interim Study Data

Interim data used in technical progress reports and other reports developed for the purpose of study monitoring are not intended for public use. Premature release of such data could result in interpretations that prove to be unreliable or invalid once the study is completed and the full context for the data is known.

Unreliable or invalid interpretations can threaten public health and safety by leading the public and medical practitioners to pursue inappropriate measures. In addition, an interpretation of the interim data that is contrary to study protocol could cause participants to drop out of treatment groups. This could prevent completion of the study. A secondary consequence, not in terms of public health and safety, but one that is important in its own right, is that premature release of the data can lead to financial loss to the Government, since any funds spent on a trial that does not answer the questions posed by the study would be devalued.

In consideration of the above, interim data shall be used only for internal study monitoring purposes with the exception of publications and presentations approved in accordance with the programmatic protocol and study procedures.

c. Other Reports/Deliverables

In addition to those reports required in the Statement of Work (SOW), under Section F, and by other terms of the contract, the contractor shall prepare and submit the following reports in the manner stated below and in accordance with the Statement of Work.

a. Comprehensive Program Summary and Timetable;

http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20Restricted%20Experiments.html http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20Restricted%20Experiments.html

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Within the first 45 calendar days, the Contractor shall develop and submit a master spreadsheet and Gantt chart summarizing the key proposed activities and deliverables (including but not limited to those enumerated below) with timelines for the entire program using a separate chart for each contract year .

b. Manual of Procedures (MOP) The Contractor shall be augment and maintain a manual of procedures containing all SOPs and policies governing Metabolomics Standards Synthesis services. This includes providing a description of all operations of the synthesis facility as well as any additions or revisions of procedures as necessary.

c. Synthesis Reports Reports shall be submitted to the COR within two weeks of completion of synthesis. Each report shall include, but not limited to the following:

(1) compound name, formula, identification number and batch number;

(2) molecular weight;

(3) chemical structure;

(4) date of synthesis;

(5) date and method of analysis;

(6) purity of compound;

(7) amount of the compound;

(8) physical appearance and physical constants;

(9) solubility;

(10) optimal storage conditions;

(11) disposal information; and

(12) synthesis protocol yield.

d. Monthly Technical Progress Report This report shall document and summarize all work results for the period covered by the monthly invoice. This report shall be attached to the copy of the monthly invoice sent to the Contracting Officer. Specifically, the report shall include the contract number, title, period of performance being reported, Contractor's name and address, telephone and facsimile numbers, and date of submission. In addition, it shall include

• A description of the work performed during the reporting period and the standards submitted to the database maintained by the Metabolomics Program.

• A brief overview of any problems that occurred during the current reporting period and their resolution or status.

• A summary of activities planned for the next reporting period including meetings specified in the statement of work and personnel scheduled to attend the meetings.

e. Semi-Annual Technical Progress Report The report shall be concise and informational. They shall include but not be limited to: a cover page which includes the contractor=s name and address; the contract number; the name of the Principal Investigator; a description of overall progress; current problems which may impede performance; and proposed corrective actions; and activities planned for the next reporting period. Specific candidate metabolomic standards production service information shall be in tabular format and include the following: the date of the request, the procedures adopted, information on quality control and quality assurance methods, lot numbers, and date of completed testing. The report shall also address administrative matters and staffing changes. A semi-annual technical report will not be due when the final report is due.

f. Final Report This report shall include a summation of the work performed and results achieved for the entire contract period of performance. The report shall be prepared in the format described for "Monthly Technical Progress Reports" and be in sufficient detail to describe comprehensively the results achieved. The report shall also include a plan for future long-term support of the metabolomic production facility through additional funding sources other than the Government. A draft Final Report is due within thirty (30) calendar days of the contract's expiration date for Contracting Officer and Contracting Officer's Technical Representative's review and approval to proceed with the

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Final Report. The Final Report shall be submitted on or before the last day of the contract performance period and shall be in sufficient detail to serve as a reference document.

g. 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.

h. Invention Reporting Requirement and Annual Invention Report The Contractor shall submit an Annual Invention Report as required by FAR CLAUSE 52.227-11 including, but not limited to, the invention disclosure report, the confirmatory license, and the government support certification.

The annual utilization report shall be submitted in accordance with Articles in SECTION F and H of the contract.

i. Candidate Metabolomic Standards Synthesis and Services Database:

The contractor shall provide all relevant data and results generated for candidate metabolomic standards to a database maintained by the Metabolomics Program.

j. Technical and Business Transition Plan Within the first six months after contract award, the Contractor shall develop and submit a draft of a detailed plan and time table for transitioning the Metabolite Synthesis Facility activities under the contract to another contractor or funding source. The final report is due 15 calendar days after COR review.

k. Information System Security and Physical Access Reporting Requirements:

The contractor shall submit security information reports required by other terms of the contract. See Section H.

l. 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."

m. Monthly Invoices Contractor shall submit monthly invoices as detailed in SECTION G of the contract.

n. Subcontracting Reports The Contract shall submit Individual Subcontract Reports (ISR) and a Summary Subcontract Report (SSR) in accordance with Articles in SECTION F and H.

Other deliverables - Refer to the Statement of Work and other terms of the contract.

1. Source Code and Object Code

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

2. 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

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b. IT Risk Assessment (IT-RA)

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

(30) days after contract award. The IT-RA shall be consistent, in form and content, with NIST SP 800-30, Risk Management Guide for Information Technology Systems, and any additions or augmentations described in the HHS-OCIO Information Systems Security and Privacy Policy.

The Contractor shall update the IT-RA on an annual basis.

(Reference subparagraph D.c.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.2. 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.3. 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.

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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.3.a-c. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

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

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

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. Submit with the semi-annual technical report under separate cover.

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

3. 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."

4. Multiple Principal Investigators Leadership Plan The Contractor shall submit a revised/updated Leadership Plan in the event of a change in any of the Principal Investigators named in the Key Personnel Article in SECTION G of this contract. The revised plan is subject to review and approval by the Contracting Officer.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

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

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

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The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. Thereafter, reports shall be due on or before the 7th calendar day following the reporting period. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Contracting Officer National Institutes of Health

NHLBI

Office of Acquisition 6701 Rockledge Drive, Suite 6030

RK II, MSC 7902

Bethesda, Maryland 20892

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

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

SECTION D - PACKAGING, MARKING AND SHIPPING

TBD

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

ARTICLE D.2. MARKING

ARTICLE D.3. SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

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

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

c. Inspection and acceptance will be performed at:

TBD

http://www.iedison.gov

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

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

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

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The base period of performance of this contract shall be from 07/15/2013 through 07/14/2014.

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 1 07/15/2014-07/14/2015 Option 2 07/15/2015-07/14/2016 Option 3 07/15/2016-07/14/2017 Option 4 07/15/2017-07/14/2018

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:

Item Description

QTY Delivery Schedule

a. Comprehensive Program Summary & Timetable

2 Draft due 45 calendar days after contract award. Final due 15 calendar days after COR review.

b. Manual of Procedures

(MOP)

2 Draft due six months after contract award. Final due 15 calendar days after COR review. Updates within two weeks of any requested revisions.

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Item Description

QTY Delivery Schedule

c. Synthesis Reports 1 Within 2 weeks of completion

d. Monthly Technical Progress Report

2 Include with monthly invoice to the CO

e. Semi-Annual Technical Progress Report

2 30 calendar days after the sixth month

f. Final Report 2 Draft due within 30 calendar days prior to the contract expiration date. Final due on the contract expiration date.

g. Summary of Salient Results 2 Contract Expiration Date

h. Invention Reporting

Requirement and Annual Invention Report

2 7 calendar days after the end of the performance period and every contract year.

i. Updates to the Coordinating Centers Candidate Metabolomic Standards Production & Services Database

2 Within two weeks of completion of each synthesis

j. Technical and Business Transition Plan

Draft due six months after contract award. Final due 15 calendar days after COR review.

k. Information System Security & Physical Access Reporting

2 See Sections C. and H. of the contract.

l. Section 508 Annual Report 2 See Sections C. and H. of the contract.

m. Monthly Invoices 1 Follow instruction in Section G.

n. Subcontracting Reports 1 Follow instructions in Section H.

Copies of deliverables shall be sent to the following addresses:

Addressee: Item Quantity Contracting Officer's Representative National Heart, Lung, and Blood Institute A-L 1 Division of Cardiovascular Sciences Rockledge 2 Building 6701 Rockledge Drive, MSC 7956 Bethesda, MD 20892-7950

Contracting Officer National Heart, Lung, and Blood Institute A-B 1 Office of Acquisitions D-N 1 Rockledge 2 Building, Suite 6030 6701 Rockledge Drive, MSC 7902 Bethesda, MD 20892-7902

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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 Contracting Officer hereby delegates the COR as the Contracting Officer's authorized representative responsible for signing software license agreements issued as a result 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.

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

Name Title

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST 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.

- 16 -

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 National Heart, Lung, & Blood Institute Office of Acquisitions COAC Services Branch 6701 Rockledge Drive, Suite 6030 Bethesda, MD 20892 MSC 7902

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, COAC Services Branch.

b. Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is nhlbi_branchbinvoice@nhlbi.nih.gov. NOTE: This is an internal NHLBI e-mail address. DO NOT submit invoices to the Central Point of Distribution's e-mail address shown.

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.

mailto:nhlbi_branchbinvoice@nhlbi.nih.gov

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g. PRISM/NBS Line Item Number and associated PRISM/NBS Line Item Period of Performance.

ARTICLE G.4. INDIRECT COST RATES

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

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

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

ARTICLE G.5. 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 evaluations will be prepared on an annual basis.

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.csd.disa.mil

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. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED

PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH

NIH-funded investigators shall submit to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) an electronic version of the author's final manuscript, upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. NIH defines the author's final manuscript as the final version accepted http://www.cpars.csd.disa.mil

- 18 -for journal publication, and includes all modifications from the publishing peer review process. The PMC archive will preserve permanently these manuscripts for use by the public, health care providers, educators, scientists, and NIH.

The Policy directs electronic submissions to the NIH/NLM/PMC: http://www.pubmedcentral.nih.gov.

Additional information is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html.

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. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

The Contractor shall not use contract funds for (1) the creation of a human embryo or embryos for research purposes;

or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

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

ARTICLE H.6. 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.7. MULTIPLE PRINCIPAL INVESTIGATORS

The NIH awarded this contract as a multiple Principal Investigators project. The Key Personnel Article in SECTION G of this contract designates the Contact Principal Investigator and all other Principal Investigators.

Contracts designating multiple Principal Investigators require a current Leadership Plan with updates as needed.

The Contractor's Leadership Plan, dated __________, (and as modified thereafter, in accordance with the Reporting Requirements Article in SECTION C of this contract), is hereby incorporated by reference.

ARTICLE H.8. 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 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 http://www.pubmedcentral.nih.gov http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html

- 19 -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.

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…