RFP -NHLBI-PB-(EB)-2009-206-TK .pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

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

2. Request for Proposal (RFP) Number:

NHLBI-PB-(EB)-2009-206-TK

3. Issue Date:

September 3, 2009

4. Set Aside:

[X] No

[ ] Yes Part IV Section L

5. Title : RECOVERY - Development and Launch of an Interoperable and Curated Nanomaterial Registry

6. ISSUED BY:

Office of Acquisitions National Heart, Lung, and Blood National Institutes of Health Two Rockledge Center, MSC 7902 6701 Rockledge Drive, Room 6136A Bethesda, Maryland 20892-7902

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 4:00 P.M. local time on OCTOBER 5, 2009. 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.

If you intend to submit a proposal or have questions regarding this Solicitation, please submitted to the Contracting Officer via email at knoxt@nhlbi.nih.gov . The due date for the proposal intent response sheet, Attachment 2 and questions is SEPTEMBER 10, 2009 until 3:30 P.M. local time.

9. THIS SOLICITATION REQUIRES DELIVERY OF PROPOSALS TO THE OFFICIAL POINT OF RECEIPT FOR

THE PURPOSE OF DETERMINING TIMELY DELIVERY AS STATED IN ATTACHMENT 1, "PACKAGING

AND DELIVERY OF THE PROPOSAL." IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH SUBPARAGRAPH (c)(3) OF FAR CLAUSE 52.215-1, ENTITLED, "INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION" LOCATED IN SECTION L.1.

OF THIS SOLICITATION.

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

11. FOR INFORMATION CALL: Tara Knox

PHONE: 301-402-0834

e-MAIL: knoxt@mail.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Tara Knox Contracting Officer Office of Acquisitions National Heart, Lung, and Blood Institute mailto:knoxt@nhlbi.nih.gov http://www.ccr.gov http://www.ccr.gov

RFP Number : NHLBI-PB-(EB)-2009-206-TK

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. ESTIMATE OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

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. Page and Formatting Limitations

6. Alternate Proposals

7. Evaluation of Proposals

8. Potential Award Without Discussions

9. Use of the Metric System of Measurement

10. Standards for Privacy of Individually Identifiable Health Information

11. Privacy Act - Treatment of Proposal Information

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12. Selection of Offerors

13. ROTC Access and Federal Military Recruiting on Campus

14. Electronic and Information Technology Accessibility

15. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Obtaining and Disseminating Biomedical Research Resources

5. Information Security

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Cost and Pricing Data

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

4. Small Business Subcontracting Plan

5. HUBZone Small Business Concerns

6. Extent of Small Disadvantaged Business Participation

7. Total Compensation Plan

8. Other Administrative Data

9. Qualifications of the Offeror

10. Subcontractors

11. Proposer's Annual Financial Report

12. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. EVALUATION OF OPTIONS

3. EVALUATION OF DATA SHARING PLAN

4. TECHNICAL EVALUATION CRITERIA

5. EXTENT OF SMALL DISADVANTAGED BUSINESS PARTICIPATION

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PART I - THE SCHEDULE

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

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

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS

INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The goal of this project is to establish an authoritative nanomaterial registry, whose primary function is to provide consistent and authoritative information on the biological and environmental interactions of well-characterized nanomaterials, as well as links to associated publications, modeling tools, computational results and manufacturing guidances. It will provide curated data source and assessment information on the health and environmental effects of well-characterized nanomaterials. A set of minimal information about nanomaterials (MIAN), ontology, and standards will be developed through a community effort with broad representation to establish the authoritativeness of the registry. Data evaluation criteria, the curation process, and the level of compliance will be established based on the MIAN, ontology, and standards to guide the curation and evaluate the data collected in the registry. This contract will design, develop, maintain, operate, and upgrade a web-based nanomaterial registry and application. Once the registry is established, minimal information about nanomaterials for biological applications from existing databases will be curated and captured in the registry.

ARTICLE B.2. ESTIMATED COST

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

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 represented by the sum of the estimated cost will be increased as follows:

Estimated Cost

Base Period: 11/30/2009 - 11/29/2012

Option Periods:

Year 1 11/30/2012 - 11/29/2013

Year 2 11/30/2013 - 11/29/2014

Year 3 11/30/2014 - 11/29/2015

Total (Base Period and Options)

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

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

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

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Acquisition, by purchase or lease, of any interest in real property; 2) Special rearrangement or alteration of facilities; 3) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 4) Travel Costs; 5) Consultant Costs; 6) Subcontract Costs; 7) Patient Care Costs; 8) Accountable Government Property; and 9) Research Funding.

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 07/30/2009, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

a. Technical Progress Reports

The contractor shall provide the following reports and documents to the Project Officer following the schedules provided. All reports shall be delivered in both electronic and hard copy unless otherwise specified.

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

[ ] Monthly [X] Quarterly

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[ ] Semi-Annually [X] 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)

1. Program Plan Report

The Program Plan Report shall provide a detailed description of the activities for the entire contractual period. The activities shall be presented in a time-oriented sequence. One-page charts shall be utilized whenever possible. Included in the Program Plan Report shall be the Technical requirements and specifications and plans for upgrading web system software, hardware, and web content. The first report is due 30 days after contract award and annually thereafter.

2. Project Performance Measurements and Evaluation Criteria Report

The contractor shall propose and develop a detailed project performance measurement matrix in relation to the outlined contract objectives. Project performance measurements and evaluation criteria shall be developed to assess the performance of the project. The matrix shall specify objective outcomes, and milestones for assessing progress that are acceptable to the Contracting Officer's Technical Representative (COTR). The Project Performance Measurements and Evaluation Criteria Report (the approved matrix) shall document the efforts performed in the completion of each task described in the technical requirements section in the SOW in detail and shall be submitted with the Quarterly and Annual Operational and Management Project Progress Reports described below.

3. Technical Requirements and Specifications Document

This is a technical document that details the technical requirements that listed in the Technical Requirements section of SOW. It serves as the foundation and specification for building the registry.

It also serves as the original traceability document for use cases, system design and test plan. The report is due the 15th calendar day after the end of the third month.

4. Web System Software, Hardware, and Web Content Upgrade Report

This report should describe what has been updated or upgraded in terms of Web System Software, Hardware, and Web Content for the reporting period. The report is due one time at the end of the third month after contract award.

5. Quarterly Operational and Management Project Progress Reports

This quarterly progress report shall include report of registry usage (hits, download, search, etc), website content upgrading status, web system hardware changes/upgrade status, website operations status, database and resource management operations, Project Performance Measurements and Evaluation Criteria Report (matrix) and ontology development activities. This report is due quarterly.

A Quarterly Report shall not be submitted when the Annual Operational and Management Project Progress Report is due.

6. Annual Operational and Management Project Progress Report

This report shall address progress for the annual period, including but not limited to:

Detailed progress report of findings, activities and accomplishments during the reporting period, and summary of work accomplished during the reporting period and percent complete.

Activities planned for the next reporting period: planned activities, as well as the status of any/all deliverables, including planned delivery date(s) and actual and/or anticipated delivery date(s).

Problems encountered: identification of any problems, issues or delays and recommendations as to their resolution, and any corrective action that was taken to correct identified problems.

Strategy revisions: recommended changes to include any lessons learned.

7. Quarterly Report of database content curated in the registry and content quality control reports

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This report shall document the MIAN and other content of nanomaterials have been curated in the registry. It shall also document the quality of the content that has been curated in the registry.

8. Annual Web System Usage Tracking Report

This report shall provide monthly web system usage statistics, includes but not limited to:

Number of hits Number of registered users Number of unique visitors Number of downloads Number of discussion, comments, review in the forum

9. Annual project management and staffing report

This report shall provide the project status and detailed progress report of findings, activities and accomplishments during the reporting period, and summary of work accomplished during the reporting period and percent complete. It should address the activities planned for the next reporting period. It should identify any problems, issues or delays encountered and provide recommendations as to their resolution, and any corrective action that was taken to correct identified problems. It should recommend any changes for future activities and include any lessons learned.

This report shall provide the project staffing status, including staff knowledge, skills and assigned function and hours.

10. Final Project Report

The Final Report shall document and summarize the results of the entire contract work, highlighting major accomplishments by the entire program. It shall provide an overall summary of the public health impact of the program, including recommendations and conclusions based on the experience and results obtained. The Final Report shall include all information enumerated under the description of the Annual Progress Report, providing detailed reports of metrics as enumerated. It shall provide tables, graphs, diagrams, and drawings in sufficient detail to provide a comprehensive statement of the results achieved by the registry under the program. Included in the Final Report shall be all abstracts and publications (chronological listing, as well as the actual PDF documents) published since the inception of the program. The final report shall provide a final study dataset with documentation.

11. Other Reports

From time to time, the NIH may request additional reports or data summaries which may include analysis, and which must also be provided by the contractor. The due date will be specified if or when the report is requested.

b. Document Deliverables

The Contractor shall provide the following document deliverables to Contracting Officer's Technical Representative (COTR). The following documents shall be posted on the nanomaterials registry web site and delivered to the COTR as documents. The documents should be updated as needed to reflect the community feedback.

• The curation plan and process, including explicit definition of terms used in the registry;

• The minimal information about nanomaterials (MIAN) applied to the registry and the evaluation criteria for gold, silver, and bronze level compliance;

• The Nanomaterial Ontology applied to the registry and the evaluation criteria for gold, silver, and bronze level compliance.

• The nanomaterial identification, matching system, and criteria, and

• The minimal required information about nanomaterials on which regulatory decisions are based and the evaluation criteria for gold, silver, and bronze level compliance.

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c. Web-based Registry Software Deliverables

The contractor shall provide the following web-based registry software and related document deliverables. The registry website, database and software shall be hosted and operated at the contractor's facility during the period of performance.

In the initial development and implementation phase, the contractor shall release a prototype within one year after the contract award. A first version of a full functional registry shall be publicly-released 18 months after the contract award . After the first full functional release, two releases should be planned each year for enhancements and upgrades.

The contractor shall provide the following web-based registry software deliverables to the Contracting Officer's Technical Representative (COTR) during the initial development and implementation phase and in each subsequent release:

• Web-based registry software Software source code and executable (hosted and operated at the contractor's facility during the period of the contract) Installation guide User guide

• Curated content (stored in the registry database)

• Website and user interface design specifications (intended for initial phase. It may need to modify in each subsequent release)

• Database and system architecture of the registry (intended for initial phase. It may need to modify in each subsequent release)

• Use cases document

• Design document

• Software performance evaluation matrix. The contractor shall develop a registry software performance evaluation matrix for major functions of the registry as defined in the technical requirements and specifications in section 1.3.1. The software performance evaluation shall be submitted to the NIH as part of the combined technical and software performance report.

• Registry release and functionality testing report

• Technical requirements and specifications compliance report

• Web content specifications and development report

d. Other Reports/Deliverables

1. American Recovery and Reinvestment Act-Reporting Requirements

This contract requires the Contractor to provide products and/or services that are funded by the American Recovery and Reinvestment Act of 2009 (Recovery Act). Section 1512(c) of the Recovery Act requires the contractor to report on its use of Recovery Act funds under this contract.

The Contractor shall report the information required by FAR 52.204-11(d), which is incorporated into Article I.4. of this contract, using the online reporting tool available at http:// www.FederalReporting.gov.

All work funded, in whole or in part, by the Recovery Act, and for which an invoice is submitted prior to June 30, 2009, shall be reported no later than July 10, 2009. After June 30, 2009, reports are due no later than the 10th day after the end of each calendar quarter.

These reports will be made available to the public.

http://www.FederalReporting.gov

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2. Information Security Reporting Requirements

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

a. Roster of Employees Requiring Suitability Investigations

The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the contract who will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Contracting Officer's Technical Representative, with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change. (Reference subparagraph c.(2) of the INFORMATION SECURITY Article in SECTION H of this contract.)

b. Information Security Training Report

The Contractor shall maintain a listing by name and title of each employee (including subcontractors) working under this contract that has completed the NIH required information security training. Any additional security training completed by Contractor/ Subcontractor staff shall be included on this listing. The listing of completed training shall be included in the first technical progress report. (See Article C.2.a. Technical Progress Reports.) Any revisions to this listing as a result of staffing changes shall be submitted with next required technical progress report. (Reference subparagraph d. of the INFORMATION SECURITY Article in SECTION H of this contract.)

c. Reporting of New and Departing Employees

The Contractor shall notify the Contracting Officer's Technical Representative (COTR) and Contracting Officer within five business days of staffing changes for positions that require suitability determinations as follows (Reference subparagraph f. of the INFORMATION SECURITY Article in SECTION H of this contract.):

(1) New Employees: Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate security level.

(2) Departing Employees: 1) Provide the name, position title, and security clearance level held by or pending for the individual; and 2) Perform and document the actions identified in the "Employee Separation Checklist", attached in Section J, ATTACHMENTS of this contract, when a Contractor/Subcontractor employee terminates work under this contract.

All documentation shall be made available to the COTR and/or Contracting Officer upon request

d. 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/security/Nondisclosure.pdf.

(Reference subparagraph g.of the INFORMATION SECURITY Article in SECTION H of this contract.)

http://ocio.nih.gov/security/Nondisclosure.pdf

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e. Self Assessment & Information Security Plan Reporting

(1) NIST SP 800-53 Self-Assessment (Reference subparagraph h. of the INFORMATION SECURITY Article in SECTION H of this contract.)

The contractor shall annually update and resubmit its Self-Assessment required by NIST SP 800-53, Recommended Security Controls for Federal Information Systems to the Contracting Officer's Technical Representative (COTR), with a copy to the Contracting Officer no later than the completion date of the period of performance. ( http://csrc.nist.gov/ publications - under Special Publications).

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

(2) Information System Security Plan (Reference subparagraph i. of the INFORMATION SECURITY Article in SECTION H of this contract.)

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

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

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

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. Instructions for completing the report are available at: http://508.hhs.gov/.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Extramural Inventions and Technology Resources Branch, OPERA, NIH, 6705 Rockledge Drive, Room 2207, MSC 7987, Bethesda, Maryland 20892-7987 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

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

Contracting Officer National Institutes of Health National Heart, Lung, and Blood Institute Office of Acquisitions Two Rockledge Center, Room 6136A 6701 Rockledge Drive, MSC 7902 http://csrc.nist.gov/publications http://csrc.nist.gov/publications http://csrc.nist.gov/publications/nistpubs/800-18-Rev1/sp800-18-Rev1-final.pdf http://csrc.nist.gov/publications/nistpubs/800-18-Rev1/sp800-18-Rev1-final.pdf http://508.hhs.gov/

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Bethesda, Maryland 20892- 7902

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

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, Contracting Officer's Technical Representative (COTR) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

Contracting Officer's Technical Representative, Biomedical Informatics Programs National Institute of Biomedical Imaging and Bioengineering, NIH 6707 Democracy Blvd, Suite 200, Bethesda, MD 20892

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

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

FAR Clause 52.246-5, 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 from November 30, 2009 through November 29, 2012.

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 Year 1 11/30/2012 - 11/29/2013 Option Year 2 11/30/2013 - 11/29/2014 http://www.iedison.gov

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Option Option Period Option Year 3 11/30/2014 - 11/29/2015

ARTICLE F.2. DELIVERIES

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

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below [and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract]:

Technical Progress Reports Delivery Schedule:

Description Quantity *Delivery Schedule

1. Program Plan Report 2 First report due the 30 th calendar day after contract award and annually thereafter on or before the 30 th calendar day following each reporting period

2. Project Performance Measurements and

Evaluation Criteria Report

2 Due the 15 th calendar day after the end of the 3 rd month

3. Technical Requirements and Specifications

Report

2 Due the 15 th calendar day after the end of the 3 rd month

4. Web System Software, Hardware, and Web

Content Upgrade Report

2 Due the 15 th calendar day after the end of the 3 rd month

5. Quarterly Operational and

ManagementProject Progress Report

2 Due quarterly on or before the 30 th calendar day following each reporting period

6. Annual Operational and Management Project

Progress Report

2 Due annually on or before the 30 th calendar day following each reporting period

7. Quarterly report of database content that is curated in the registry and content quality control report

2 First report due 30 th calendar day after end of the 12 th month and quarterly thereafter on or before the 15 th calendar day following each reporting period.

8. Annual Web System Usage Tracking Report 2 Due annually on or before the 30 th calendar day following each reporting period

9. Draft Final Project Report

2 Due the 15 th calendar day after end of the 9 th month of the final contract year

10. Annual Project Management and Staffing Report

2 Due annually on or before the 30 th calendar day following each reporting period

11. Final project report

2 Due the 30 th calendar day after end of the 11 th month of the final contract year

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Description Quantity *Delivery Schedule

12. Other NIH required reports 2 TBD

* Delivery times are relative to the start date of the contract.

Document Deliverables and Delivery Schedule:

1. The curation plan and process 2 Due the 15 th calendar day after the end of the 6 th month

2. The minimal information about nanomaterials (MIAN) applied to the registry and the evaluation criteria ( e.g., gold, silver and, bronze level compliance)

2 Due the 15 th calendar day after the completion of the 11 th month

3. The Nanomaterial Ontology applied to the registry and the evaluation criteria ( e.g., gold, silver, and, bronze level compliance)

2 Due the 15 th calendar day after the end of the 11 th month

4. The nanomaterial identification and matching system and criteria.

2 Due the 15 th calendar day after the end of the 11 th month

5. The minimal required information about nanomaterials on which regulatory decisions are based and the evaluation criteria ( e.g.,, gold, silver and bronze level compliance)

2 Due the 15 th calendar day after the end of the 11 th month

Web-based Registry Software Deliverables and Delivery Schedule:

1. Web-based registry software - Prototype 1 Due the 15 th calendar day after the end of the 12 th month

2. Web-based registry software - First full functional version

1 Due the 15 th calendar day after the end of the 18 th month

3. Web-based registry software - New releases 1 Due semi-annually after the first release on the 30 th calendar day following each reporting period

4. Combined Website and Software Report, including

(1) website and user interface design specifications; (2) database and system architecture of the registry; and (3) Software design document

2 Due the 15 th calendar day after the end of the 9 th month and update for each release thereafter

5. Combined Technical and Software Performance Report, including: (1) technical requirements and specifications compliance report; (2) software performance evaluation matrix report; and (3) registry release and functionality testing report

2 Due the 15 th calendar day after the end of the 12 th month and update due the

15 th calendar day after for each release thereafter

6. Software use cases document 2 Due the 15 th calendar day after the end of the 9 th month and the update is due the 15 th calendar day after each release thereafter

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Description Quantity *Delivery Schedule

7. Software installation guide 2 First report due the 15 th calendar day after the end of the 12 th month and the update is due the 15 th calendar day after each release thereafter

8. Software user guide 2 Due the 15 th calendar day after he end of the 12 th month and the update is due the 15 th calendar day after each release thereafter

9. Web content specifications and development report and curated content

2 Due the 15 th calendar day after the end of the 12 th month and the update is due the 15 th calendar day after each release thereafter

Other Reports/Deliverables Delivery Schedule:

1. American Recovery and Reinvestment Act-Reporting Requirements

2 As specified in Article C.2.

2. Source Code and Object Code 2 As specified in Article C.2.

3. Roster of Employees Requiring Suitability Investigations 2 As specified in Article C.2.

4. Information Security Training Report 2 As specified in Article C.2.

5. Contractor - Employee Non-Disclosure Agreement(s) 2 As specified in Article C.2.

6. Information System Security Plan 2 As specified in Article C.2.

7. Section 508 Annual Report 2 As specified in Article C.2.

8. Invention Reporting Requirement 2 As specified in Article C.3.

* Delivery times are relative to the start date of the contract.

b. The above items shall be addressed and delivered to: [to be completed at contract award]

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

1998)

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

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

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

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

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SECTION G - CONTRACT ADMINISTRATION DATA

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

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

[to be completed prior to contract award]

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

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

The Contracting Officer hereby delegates the COTR 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 COTR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.270-5 (January 2006)

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

(End of Clause)

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

[to be completed prior to contract award]

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST

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

1. Payment requests shall be submitted 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:

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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, and Blood Institute, NIH Office of Acquisitions Two Rockledge Room 6136A 6701 Rockledge Drive MSC 7902 Bethesda, MD 20892- 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 National Heart, Lung, and Blood Institute .

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

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

ARTICLE G.4. CONTRACT FINANCIAL REPORT

a. Financial reports on the attached Form NIH 2706, Financial Report of Individual Project/Contract, shall be submitted by the Contractor in accordance with the Instructions for Completing Form NIH 2706, which accompany the form, in an original and two copies, not later than the 30th working day after the close of the reporting period. The line entries for subdivisions of work and elements of cost (expenditure categories) which shall be reported within the total contract are listed in paragraph e., below. Subsequent changes and/or additions in the line entries shall be made in writing.

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b. Unless otherwise stated in that part of the Instructions for Completing Form NIH 2706, entitled " PREPARATION INSTRUCTIONS," all columns A through J, shall be completed for each report submitted.

c. The first financial report shall cover the period consisting of the first full Three Calendar Months following the date of the contract, in addition to any fractional part of the initial month. Thereafter, reports will be on a Quarterly basis.

d. The Contracting Officer may require the Contractor to submit detailed support for costs contained in one or more interim financial reports. This clause does not supersede the record retention requirements in FAR Part 4.7.

e. The following is a listing of expenditure categories to be reported:

Expenditure Category A Percentage of Effort/Hours

(1) Direct Labor

(a) Principal Investigator

(b) Co-Principal Investigator

(c) Key Personnel (i) (ii) (iii)

(2) Other Professional Personnel

(3) Personnel - Other

(4) Fringe Benefits

(5) Accountable Personal Property

(6) Materials/Supplies

(7) Patient Care Costs

(8) Travel

(9) Consultant Costs

(10) Premium Pay

(11) Computer Costs

(12) Subcontract Costs

(13) Other Direct Costs

(14) Indirect Costs

(15) G&A Expense

(16) Total Cost

(17) Fee

(18) Total Cost Plus Fixed Fee

f. The Government may unilaterally revise the NIH 2706 to reflect the allotment of additional funds.

ARTICLE G.5. INDIRECT COST RATES

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

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health 6100 Building, Room 6B05

6100 EXECUTIVE BLVD MSC-7540

BETHESDA MD 20892-7540

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

ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

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

42.15. The final performance evaluation will be prepared at the time of completion of work.

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.

a. Electronic Access to Contractor Performance Evaluations

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

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

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

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. SALARY RATE LIMITATION LEGISLATION PROVISIONS

a. The Contractor shall not use NIH Fiscal Year funds to pay the direct salary of an individual through this contract at a rate in excess of Executive Level I. Direct salary is exclusive of fringe benefits, overhead and general and administrative expenses (also referred to as "indirect costs" or "facilities and administrative (F&A) costs"). Direct salary has the same meaning as the term "institutional base salary." An individual's direct salary (or institutional base salary) is the annual compensation that the Contractor pays for an individual's appointment whether that individual's time is spent on research, teaching, patient care or other activities. Direct salary (or institutional base salary) excludes any income that an individual may be permitted to earn outside of duties to the Contractor.

The annual salary rate limitation also applies to individuals proposed under subcontracts. It does not apply to fees paid to consultants. If this is a multiple year contract, it may be subject to unilateral modifications by the Government if an individual's salary rate used to establish contract funding exceeds any salary rate limitation subsequently established in future HHS appropriation acts.

b. Payment of direct salaries is limited to the Executive Level I rate which was in effect on the date(s) the expense was incurred. See the following Web site for Executive Schedule rates of pay: http://www.opm.gov/oca/. (For current year rates, click on Salaries and Wages / Executive Schedule / Rates of Pay for the Executive Schedule.

For prior year rates, click on Salaries and Wages / cursor to bottom of page and select year / Executive http://oamp.od.nih.gov/OD/CPS/cps.asp http://www.opm.gov/oca/

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Schedule / Rates of Pay for the Executive Schedule. Rates are effective January 1 of each calendar year unless otherwise noted.)

ARTICLE H.3. NEEDLE EXCHANGE

The Contractor shall not use…