HDTRA1-07-R-0004Amendment0005withAttachments.pdf

CTB070006240

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

The purpose of this amendment is to close discussions and request Final Proposal Revisions. Final Proposal Revisions are due NLT 1200

(EST), 14 FEB 2008.

In addition, the follow ing revisions are incorporated into the solicitation:

Section J:

1) Incorporate revised Attachement 2, Statement of Objectives (SOO) entitled "Biological Threat Reduction Integrating Contract-Specific Requirement for Ukraine dated 22 January, 2008 (Revised).

2) Incorporate Attachment 10 "Instructions for Submittal of Final Proposal Revision (FPR)".

SEE SF30 BLOCK 14 CONTINUATION PAGE

1. CONTRACT ID CODE PAGE OF PAGES

FAR (48 CFR) 53.243

1 2

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

16C. DATE SIGNED

BY 30-Jan-2008

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 HDTRA1-07-R-0004

X 9B. DATED (SEE ITEM 11)

10-Aug-2007

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

30-Jan-2008

CODE

DEFENSE THREAT REDUCTION AGENCY/BE-BC

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:

HDTRA1-07-R-0004

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

The purpose of this amendment is to close discussions and request Final Proposal Revisions.

Final Proposal Revisions are due NLT 12 (EST), 14 FEB 2008.

In addition, the following revisions are incorporated into the solicitation:

SECTION J - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

The following have been modified:

Attachment 2, Statement of Objectives (SOO) entitled “Biological Threat Reduction Integrating Contract – Specific Requirement for Ukraine” is hereby replaced with Attachment 2 entitled “Biological Threat Reduction Integrating Contract – Specific Requirement for Ukraine”dated 22 January, 2008, 4 pages. The replacement Attachment 2 revise Paragraph 2.0 Overall Program Objectives to more correctly define the effort associated with the CRL; more specifically number

(1) and (2).

The following have been added by full text:

Attachment 10, Instruction for Submittal of Final Proposal Revision (FPR). This attachment provides additional instructions for submittal of FPRs regarding page limitations, number of paper copies, and tracking of changes. Unless otherwise amplified, directed, and/or modified by the following instructions, the instructions provided in the original RFP, Section L, remain in effect. FPRs must be submitted using the same instructions as the original RFP, as modified herein, and are due NLT 1200 (EST), 14 FEB 2008.

(End of Summary of Changes)

ATTACHMENT 2

AMENDMENT 0005

BIOLOGICAL THREAT REDUCTION INTEGRATING CONTRACT (BTRIC)

SPECIFIC REQUIREMENTS FOR UKRAINE

STATEMENT OF OBJECTIVES

22 January 2008 (Revised)

1.0 BACKGROUND. The U.S. Department of Defense (DoD) and the Ukraine Ministry of

Health (MOH) signed the Biological Threat Reduction Implementing Agreement (BTRIA) on August 29, 2005. The BTRIA establishes the Biological Threat Reduction Program (BTRP)—part of the Cooperative Threat Reduction Program under the Defense Threat Reduction Agency—in Ukraine. Ukraine’s Ministry of the Economy approved and registered Phase 1 technical assistance work of the BTRP in March 2007, with a period of performance of December 1, 2006, to March 1, 2009. The U.S. DoD assumes that follow-on registration will take place for Phase 2 work.

The overarching purpose of BTRP in Ukraine is to (1) enhance Ukraine’s existing nationwide network of diagnostic laboratories that deal with especially dangerous pathogens (EDPs), (2) establish a nationwide surveillance and reporting system based on an integrated disease surveillance and reporting hardware and software system (provided as Government Furnished Equipment in the form of the Electronic Integrated Disease Surveillance System (EIDSS)), (3) construct a secure permanent repository for EDPs, and (4) establish Cooperative Biological Research (CBR) projects. CBR project goals include: (a) promoting the use of EIDSS and secure diagnostic laboratories; (b) promoting consolidation of EDPs;

and (c) developing enhanced diagnostics. The BTRP’s epidemiological surveillance system—collectively known as the Threat Agent Detection and Response (TADR) system— is to be fully operational in Ukraine by 2014.

The TADR system will require enhancements at up to 35 designated biological facilities throughout Ukraine, phased primarily on a regional basis. The TADR system also requires the provision for and training on BTRP-standard laboratory practices and methods at these engaged biological facilities, the implementation of CBR projects, training of personnel at all engaged biological facilities on biological safety to U.S. standards, and provision and training at select facilities on biological security to DoD standards. Aside from training on installed equipment, all training will be provided by U.S. Government specialists from such entities as the Centers for Disease Control and Prevention (CDC) in Atlanta and the U.S.

Army.

Once the Ukrainian Executive Agent(s) accepts and commissions each engaged facility for operations, the DoD plans to sustain the operation of the facility, minus utilities, over the course of three years, diminishing support each year after the first by one-third. After the third year, sustainment of that facility becomes the sole responsibility of the appropriate Ukrainian Executive Agent(s).

AMENDMENT 0005

2.0 OVERALL PROGRAM OBJECTIVES. The overarching purpose of this task order is to integrate or synchronize all BTRP projects in Ukraine, including projects already under way and those to be established and completed via separate contracting actions. Efforts include:

(1) upgrades to designated laboratories to Epidemiological Monitoring Stations (EMSs)/Biological Safety Level 2 (BSL-2) diagnostic laboratories; (2) construction of one permanent Central Reference Laboratory (CRL) (at BSL-2 and -3) for human EDP work; (3) BTRP training; (4) and administration of CBR projects. The training and sustainment support will be a parallel effort to support the physical and equipment upgrades and will commence with technical direction from the DoD. Specific objectives are to:

2.1 Assist in enhancing Ukraine’s existing disease surveillance, reporting, and response systems to meet international diagnostic and reporting standards for reliable, integrated tracking and epidemiological evaluation capability.

2.2 Integrate and/or synchronize BTRP efforts in the area of CBR projects, as many as five per year.

2.3 Accommodate the efforts of designated (and separately contracted) training entities of U.S. Government partners.

2.4 Meet Euro–Atlantic standards of biological safety and DoD standards of biological security, counter both external and internal threats, reduce the risk of accidental release of pathogens, and consolidate pathogen collections at a secure interim human CRL prior to transfer to a permanent CRL.

2.5 Deploy modern molecular diagnostics to reduce the need for multiple reference pathogen collections and provide dedicated transport for samples and pathogen consolidation.

2.6 Enhance existing mobile disease response units/national response teams that will be based at locations determined by Ukraine’s Executive Agent(s).

2.7 Encourage higher standards of openness, ethics, and conduct, to integrate biological scientists and institutes into the international scientific community via CBR projects, the transfer of pathogen strains, and reports to the DoD Executive Agent.

3.0 CONTRACT OBJECTIVES. The objectives of the BTRIC in Ukraine are to integrate or synchronize, plan, organize, manage, report, and provide maintenance, training, construction services, technical expertise, and sustainment resources necessary to accomplish the goals of the program. Specific objectives are to:

3.1 Use a systems engineering process to develop an overall TADR system that enhances Ukraine’s ability to identify and respond to an EDP outbreak or bioterrorism emergency at the national, oblast, or rayon levels. In addition, in support of this broader objective, conduct site analyses and provide

AMENDMENT 0005

recommendations at potential locations of EMSs to evaluate their suitability to support the TADR system to include: required upgrades (structural integrity, utilities, laboratory equipment, security systems, etc.); the capability of their staff to meet Euro–Atlantic standards of biological safety and DoD standards of biological security; molecular diagnostics; disease surveillance; and outbreak response.

3.2 Assist designated laboratory staff with the development of CBR proposals and assist with their introduction to the international scientific community in direct support of the BTRP objectives. Conduct administrative management of CBR projects from conception through closeout, establish and distribute grant payments, procure equipment necessary to complete projects at each site, maximizing the use of BTRP-renovated facilities to the extent possible.

3.3 In collaboration with the Ukrainian Executive Agent(s), develop a feasible and cost-efficient integrated sustainment system that allows operational, albeit diminishing, resources for fielded systems through the stand-up period and for three years after commissioning and acceptance of each engaged facility. All sustainment requirements associated with BTRP projects in Ukraine must transition fully and seamlessly to the appropriate Ukrainian Executive Agent after that three-year period.

4.0 MANAGEMENT OBJECTIVES: Specific management objectives are to:

4.1 Maintain flexibility by adjusting program schedule, performance, warranties, subcontracts, and data to support the program objectives of the BTRP as well as the risks and mitigation strategies that the BTRIC sees in Ukraine.

4.2 Taking into account Ukraine’s technical assistance regulations and organizational structures, foster cooperation with Ukrainian Executive Agent(s) and designated laboratories and ensure compliance with the laws and regulations of Ukraine.

4.3 Maintain transparency of BTRP implementation efforts to both the DoD

Executive Agents and the Ukrainian Executive Agent(s).

5.0 CONSTRAINTS: The following constraints apply:

5.1 Because of the quality of human resources available within Ukraine, the use of expatriate personnel assigned to Ukraine shall be minimal through reliance on local national personnel.

5.2 Because of the existence of commercial supply chains in Ukraine, materials and supplies shall be procured from the local economy to the maximum extent practical.

5.3 All Biological Safety and Security/TADR projects (i.e., EMS) shall be planned to be complete within five years of contract award with the exception of the permanent CRL.

5.4 Individual CBR projects shall be planned for a duration of three years or fewer, not including the project development phase. As many as five projects can be ongoing at any one time, but this number reflects projects that are undergoing startup as well as closeout.

5.5 Sustainment resources shall commence only after a facility’s commissioning and acceptance by the Ukrainian Executive Agent(s) for operations of each engaged facility and remain in place for a period of three years, with year one at 100 percent of (“full”) sustainment, year two at 66 percent of sustainment, and year three at 33 percent of sustainment.

5.6 Office space shall be located far from high-rent center city districts and in places that public transportation is reasonably available.

5.7 Vehicles shall not be imported specifically for company use. In addition, the use of leased vehicles shall be kept to an absolute minimum.

ATTACHMENT 10

INSTRUCTIONS FOR SUBMITTAL OF FINAL PROPOSAL REVISION (FPR)

The following provides additional instructions for submittal of FPRs regarding page limitations, number of paper copies, and tracking of changes.

Unless otherwise amplified, directed, and/or modified by the following instructions, the instructions provided in the original RFP, Section L, remain in effect.

FPRs, to include all L-2 information, must be submitted using the same instructions as the original RFP, as modified herein, and are due NLT 1200 (EST), 14 FEB 2008.

Instructions:

1. Tracking of changes:

a. The Offeror shall prepare and submit a separate matrix for each volume that documents any FPR changes. For those changes relating to an EN, the EN number shall be identified. This matrix will not count against the page count and should be considered an additional exemption to those listed in paragraph L.1.3.5.3 of the RFP.

b. If NO changes are made to a volume, the FPR shall state that the specific volume remains unchanged and is the original proposal is considered part of the FPR. Any volume that was affected during the RFP process shall be re-submitted in its entirety. As a specific exemption to this requirement, if only the SF33 is changed within Volume I, then you may submit only the SF33 but state that the remaining Volume I is unchanged and is considered part of the FPR.

c. With the exception to paragraph 1.d. below, all changes shall be annotated with a line bar in the margin and the associated page number shall be updated to reflect that it was affected by the FPR (i.e. Volume II, Page-1-

FPR).

d. All changes to Volume V Cost volume shall be annotated as follows: (1) Changes to the narrative portion shall be annotated with a line bar in the margin and the associated page number shall be updated to reflect that it was affected by the FPR (e.g. Volume V, Page -1-FPR); (2) Changes to the spreadsheet portion shall be annotated with red font within the spreadsheet.

2. Page limitations and number of paper copies: The Offeror shall prepare the proposal as set forth in the Final Proposal Revision Organization Table 1 below.

The titles and contents of the volumes, as well as the page limitations and number of required paper copies shall be as specified.

ATTACHMENT 10

AMENDMENT 0005

Table 1 – Final Proposal Revision Organization

VOLUME VOLUME TITLE PAGE LIMIT

Contract Documentation I

2 copies Formal Offer and Other Contract Documents Unlimited

Mission Capability

Executive Summary 3

Proposal Risk Matrix

Management Plan

Technical Capability

Foreign Operation Plan

II

10 copies

Cost Management

Relevant Present and Past Performance

Description of Team and History 5

Past Performance Narrative 2 per reference

III

3 copies

Attachment(s) L-1 4 per Attachment

IV

10 copies Sample Task

V 2 copies Cost Unlimited

Cost