HDTRA1-11-R-0012-0002.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

See follow ing pages for full details. In summary, revise RFP as follow s:

1) Add Clause H-2 for Test and Evaluation

2) Add Clause 252.203-7004

3) Revise Sections L.1.3.5.3, L.2.2, and L.3.3.3

4) Revise Section M.2.1.2

5) Attached a Revised SOO

1. CONTRACT ID CODE PAGE OF PAGES

S 1 23

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 12-Mar-2013

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X HDTRA1-13-R-0012

X 9B. DATED (SEE ITEM 11)

04-Mar-2013

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

12-Mar-2013

CODE

DEFENSE THREAT REDUCTION AGENCY/J4C

8725 JOHN J. KINGMAN ROAD, MSC 6201

FORT BELVOIR VA 22060-6201

HDTRA1 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

HDTRA1-13-R-0012

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION H - SPECIAL CONTRACT REQUIREMENTS

The following have been added by full text:

H-2

TEST AND EVALUATION

The FDA process is mandatory for approval of diagnostic devices. If the solutions to the posed challenge could potentially be diagnostic device(s), the device(s) must be tested in compliance with FDA regulations and guidelines established by 21 Code of Federal Regulations (CFR). The FDA mandates test and evaluation processes that follow a series of phases that establish the effectiveness of new devices.

(End of Clause)

SECTION I - CONTRACT CLAUSES

The following have been added by reference:

252.203-7004 Display of Fraud Hotline Poster(s) DEC 2012

Section J - List of Documents, Exhibits and Other Attachments

The following have been modified:

Exhibit/Attachment Table of Contents

DOCUMENT TYPE DESCRIPTION PAGES DATE

Exhibit A Contract Data

Requirements List

(CDRL) Base Period

9 22-FEB-2013

Exhibit B CDRL's Option I 9 22-FEB-2013

Exhibit C CDRLs Option II 13 22-FEB-2013

Attachment 1 Statement of Objectives 4 12-MAR-2013

Attachment L-1 Past Performance

Information Form

Attachment L-2 Past Performance

Questionnaire

5 20-FEB-2013

Attachment S-1 Small Business

Commitment Template

1 20-FEB-2013

SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO BIDDERS

L.1.3.5.3 Pages Counted

Each page shall be counted except the following:

past performance questionnaires past performance questionnaire point of contact list cover pages

RFP cross-reference matrix teaming arrangements letters of commitment past performance consent letters client authorization letters tables of contents revision matrix

Small Business Subcontracting Plan glossaries lists of figures, tables, or drawings tabs dividers blank pages

Resumes

L.2.2 SOLICITATION/CONTRACT FORM

Completion of Blocks 12 through 16 and signature and date for Blocks 17 and 18 of the Standard Form

(SF) 33 is required. Each offeror shall complete Section B for the contract line item number (CLIN) proposed with the total estimated costs, as substantiated in the Cost Proposal. Each offeror shall complete

Section F to identify number of months required to perform under the proposed SOW, as substantiated in the Technical Proposal. Signature by the Offeror on the SF 33 constitutes an offer, which the

Government may accept.

The offeror shall include, at the end of the contract documentation, a copy of the proposed SOW which will be incorporated as Attachment 1 and replace the SOO upon contract award. Do not put proprieteary data or restictive markings in/on the SOW.

L.3.3.3 SECTION 2: MANAGEMENT APPROACH

The Offeror shall submit its comprehensive Program Management Plan (PMP) for managing the contract to be awarded. The PMP should demonstrate the Offeror’s ability to innovatively and cost-effectively manage the programs scheduled performance, risks, subcontracts, and data to support the SOO objectives.

At a minimum, the Program Management Plan should address the following elements:

Management of subcontractors

Provision of a Staffing Plan that identifies:

o Qualified key personnel w/Resumes o Organizational Structure o Workforce recruitment and retention o Facilities

Provisions of a Risk Mitigation Plan that identifies:

o Risk Identification, and;

o Resolution Process

Testing and Evaluation management

Intellectual Property management/transfer

Solver Engagement management

Public awareness and education campaign management

Socio-economic commitment*

* Note: This information is submitted as part of Volume I, Proposal Documentation, but shall be evaluated as part of the overall management approach.

SECTION M - EVALUATION FACTORS FOR AWARD

M.2.1.2 Sub-factor B – Management Approach

Evaluation of this sub-factor will be based on the Offeror’s ability to effectively and successfully manage and lead the “Open Innovation Sources for Prize and Challenge effort as demonstrated in Volume II of the proposal.

This sub-factor is met when the Offeror provides a comprehensive management approach that includes an effective organizational structure and management processes with experienced management personnel and demonstrates a thorough, complete, and effective approach to accomplish the overall program and contract objectives as stated in the SOO with an acceptable level of risk.

The following elements will be considered in arriving at a rating but will not be separately rated:

Management of subcontractors and Socio-economic commitment.

Staffing Plan that identifies:

o Qualified key personnel w/Resumes and duties to be performed under the SOW o Organizational Structure o Workforce recruitment and retention o Facilities

Risk Mitigation Plan that identifies:

o Risk Identification, and;

o Resolution Process

Testing and Evaluation management

Intellectual Property management/transfer

Solver Engagement management

Public Relations campaign management

(End of Summary of Changes)

ATTACHMENT 1

STATEMENT OF OBJECTIVES (SOO), 12 March 2013

Open Innovation Sources for Prize and Challenge Services

1.0 OVERALL OBJECTIVES

The Department of Defense (DoD) seeks to enhance its capability to mitigate (i.e., detect and treat) threats to the Armed Forces brought on by a known, emerging, or engineered pathogen.

Infectious diseases can have a range of negative effects on both military operations and global health. Because of the complexity of the problem and immediacy of the need for a solution, DoD seeks to utilize an open innovation strategy to develop a solution. However, the DoD needs to develop a solution at a cost-effective price-point. Grand challenges or prizes offered for solving a problem or addressing a challenge offer substantial cost-savings, solvers will typically invest internal development funds several times greater than the prize. In light of the problem posed, an open innovation development strategy is most likely to quickly yield a set of disruptive solutions to the threats posed by a known, emerging, or engineered pathogen. Specifically, a strategy in which a large market stimulatory grand challenge is defined, developed, advertised, and administered.

1.1 Grand Challenge Solution

To support DoD goals, the Defense Threat Reduction Agency (DTRA) has a requirement to perform, define, develop, advertise, and administer a large market stimulatory grand challenge.

The requirement includes Testing and Evaluation (T&E) of solutions and recommendation of the award of a prize to the Government based on T&E data showing a respondent successfully solved the challenged. DTRA will ultimately validate the recommendation by evaluating the results of the T&E data and verifying the recommended competition winner. Lastly, the government will verify the legal sufficiency of the transfer of IP rights from the competition winner to the

Government and, if verified, award the prize to the competition winner.

1.2 Acquisition Structure

This acquisition consists of a Base effort and two Option efforts. Option Task III is for prize award funds and will not be executed unless the government has selected a prize recipient from the Grand Prize Challenge. The associated activities are described in detail in Section 5 of this document.

1.2.1 Base Period: Market Analysis

Tasks 1-4 of the Contractors Statement of Work

1.2.2 Option I (Roman Numeral One) Period of Performance: Plan Development

Tasks 5-8 of the Contractors Statement of Work

1.2.3 Option II (Roman Numeral Two) Period of Performance: Grand Challenge Execution

Tasks 9-13 of the Contractors Statement of Work.

1.2.4 Option Task III (Roman Numeral Three): Prize Award Task*

Tasks 13 of the Contractors Statement of Work

*Note: All costs, schedule and performance to execute Task 13 of the SOW shall be proposed under Option period II Contract Line Item Number (CLIN) 2001. Optional Task III

CLIN 3001 is only established to hold the Prize Funds.

Assumption(s):

The prize awarded will not exceed $5M.

The maximum period-of-performance is 5 years from the time of Contract award.

This contract is intended to be a single contractor award.

2.0 PERFORMANCE OBJECTIVES

DTRA seeks a contract to perform the effort, entitled “Open Innovation Sources for Prize and

Challenge Services”. The contractor will be responsible for the conduct of all activities to assist agency staff in defining, developing, advertising, and administering a large market stimulatory grand challenge on the topic of point-of-need or point-of-care diagnostics.

3.0 GENERAL OBJECTIVES

The Contractor Shall:

3.1 Prepare a Statement of Work (SOW) that conforms with the instructions of Section L and associated attachments in the Request for Proposal (RFP).

3.2 Provide the necessary qualified personnel, facilities, equipment, supplies, services, subcontractors and related administrative and information technology support to accomplish the objectives.

3.3 Allow access to records, files, and other data derived from this work.

3.4 Provide Government access to all written and electronic communication to and/or from potential solvers/industry.

3.5 Provide Government with advanced notification of all meetings, symposiums, and other types of discussions with solvers/industry.

3.6 Provide and facilitate Government access to the observation of all test and evaluation activities.

4.0 PROGRAM MANAGEMENT OBJECTIVES

4.1 The SOW shall be consistent with the Program Management Plan (PMP) that encompasses the entire scope of work.

4.2 The contractor shall provide Contractor Progress Reports, Contractor Funds Status Reports, and teleconferences and meeting minutes as required by the Contract Data Requirement Lists

(CDRLs).

4.3 The DoD requires all contractors to track manpower in support of United States Code 10

USC 2330a. This is accomplished by data entry into the Enterprise-Wide Contractor Manpower

Reporting Application (eCMRA) system. Therefore the SOW shall include the following statement:

“The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the Defense Threat

Reduction Agency via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil/.

Reporting inputs will be for the labor executed during the period of performance during each

Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013. Contractors may direct questions to the help desk at http://www.ecmra.mil/ .”

5.0 STATEMENT OF WORK DEVELOPMENT OBJECTIVES

5.1 The overall objective:

The overall objective for this requirement is to obtain services to assist the DoD in holding a grand challenge competition to obtain a solution to Point-of-Need or Point-of-Care diagnostics.

The contractor will be responsible for the conduct of all activities to assist agency staff in defining, developing, advertising, and administering a large market stimulatory grand challenge to meet the DoD objective on the topic of point-of-need or point-of-care diagnostics.

5.2 Base Period SOO Tasks:

Task 1: Work with DTRA (“Agency”) and DoD representatives to clearly define the problem to be solved.

Task 2: Identify technological, commercial/market, and/or engineering barriers to solving the problem.

http://www.ecmra.mil/ http://www.ecmra.mil/

Task 3: Identify potential solver communities.

Task 4: Generate a challenge/prize competition concept based off of data from Tasks 1 and

2. The concept must include a recommended prize purse commensurate with market stimulation required to overcome the barriers identified in Task 2.

5.3 Option I Period SOO Tasks:

Task 5: Commensurate with the concept generated in Task 4 of the Base Period, develop competition rules including rules which:

o stimulates the market to overcome specific challenges in the Point-of-Need or

Point-of-Care diagnostics fields including Clinical Laboratory Improvement

Amendments (CLIA) waiver and Current Procedural Terminology (CPT) code award o promotes long-term commercial viability and availability of the solution o establishes testing and evaluation o includes the contractor’s recommended plan for the management (including transfer) of solver intellectual property (IP) rights.

Task 6: Facilitate collaboration or teaming among potential solvers.

Task 7: Develop testing and evaluation protocols and infrastructure.

Task 8: Develop a public awareness and education campaign.

5.4 Option II Period SOO Tasks:

Task 9: Execute the Grand Challenge competition developed in Tasks 1-8.

Task 10: Accomplish Testing and Evaluation of all solutions submitted to the competition.

Task 11: Submit results and make recommendations to the Government which solution should be awarded the prize based off of successful demonstration of meeting all metrics during T&E. If the contract period of performance ends before a single solution meets all metrics, rank all solutions and recommend to the Government top solutions.

Task 12: Accomplish the transfer of the winning solver’s IP to the USG, commensurate with the plan established in Option 1, Task 5.

5.5 Option III Task:

Task 13: Facilitate the award of the prize between the Government and the winning solver.