Revised_2018-N-67801R_PDF_Format.pdf

PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

(Type or Print)

1SOLICITATION, OFFER AND

AWARD

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 98

2. CONTRACT NO.

3. SOLICITATION NO.

2018-N-67801R

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

06/13/2018

6. REQUISITION/PURCHASE

NO.

00HCVGD1-2018-15639

7. ISSUED BY CODE 2543 8. ADDRESS OFFER TO (If other than Item 7)

Centers for Disease Control and Prevention

Office of Acquisition Services (OAS)

2920 Brandywine Rd, RM 3000

Atlanta, GA 30341-5539

Approved as to Form and Legality: _____________________________

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and 5 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in 2920 Brandywine Road, Cologate Bldg. Atlanta, GA 30341 until 2:00pm local time 07/30/2018

CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Liubov Kriel

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-2856

C. E-MAIL ADDRESS

vyh1@cdc.gov

11. TABLE OF CONTENTS

(x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 64

X B SUPPLIES OR SERVICES AND PRICES/COSTS 2 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 16 X J LIST OF ATTACHMENTS 73

X D PACKAGING AND MARKING 47 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 48 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 49 X K OTHER STATEMENTS OF OFFERORS 74

X G CONTRACT ADMINISTRATION DATA 50 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 80

X H SPECIAL CONTRACT REQUIREMENTS 56 X M EVALUATION FACTORS FOR AWARD 87

OFFER (Must be fully completed by offeror) NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO. DATE AMENDMENT NO. DATE

CODE FACILITY 16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( )

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 2543 25. PAYMENT WILL BE MADE BY CODE 434

Centers for Disease Control and Prevention

Office of Acquisition Services (OAS)

2920 Brandywine Rd, RM 3000

Atlanta, GA 30341-5539

Centers for Disease Control and Prevention (FMO)

PO Box 15580 404-718-8100

Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.214©

K

Section A – Solicitation/Contract Form (Continued)

EXECUTIVE SUMMARY

1. Description of the Item(s)/Service(s) being procured:

The Statement of Work (SOW) establishes the requirements for Contractor provided services to include the necessary management and personnel required to provide influenza reagent resource (IRR) services in accordance with the terms, conditions, clauses, provisions, attachments, and specifications included in this solicitation and subsequent contract.

2. Type of Contract:

This is a cost-plus-fixed-fee term solicitation. The contract will be performance-based.

3. Contract Severability:

This contact is severable.

Severability Definition: Severable services are services that are continuing and recurring in nature where an agency realizes a benefit at the time that services are provided even if the contract has not been performed to completion.

Services are considered severable if they can be separated into components that independently provide value to meet an agency’s needs.

4. Format of the Contract:

A transition period of six (6) months, base one year contract with eight (8) one year option periods and one (1) six month option period.

5. The North American Industry Classification System (NAICS):

The NAICS code for this acquisition is 541990. The small business size standard is $15M.

6. Unusual/Specific Aspects of the Acquisition:

Intellectual Property Rights

a. Intellectual property rights to all processes, procedures, protocols, patents, copyrights, etc., developed under this contract shall become and remain the property of the US Government (USG).

Government Ownership of Materials

b. All materials acquired and/or developed under this contract shall become and remain the property of the Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases, Immunization Division (CDC/NCIRD/ID) unless specifically authorized by the USG Contracting Officer and Project Officer.

Review of Data

c. The CDC Contracting Officer must review any materials or data generated under this contract prior to dissemination, release or publication by the Contractor. Review and approval shall be performed in accordance with the current CDC policies and procedures.

Dissemination of Information

d. No information related to data obtained or collected under this contract shall be released or published (including all publications) without the prior written consent of the CDC Contracting Officer and also reviewed and approved by the CDC Office of Communication prior to publication.

7. Contract Administration:

Please submit any and all questions in writing to vyh1@cdc.gov. See Section L.5.

8. Additional information

a) See Sections L and M for important information as to what is required to be submitted in response to this request for proposal and also that all questions must be submitted no later than June 27, 2018.

b) As part of technical evaluation the Government would perform an on-site review of contractor facilities

See Section L.

c) Biosafety and Security Requirements: Prior to commencement of work, the Contractor will submit in writing its plan for complying with the safety and health provisions of this contract and shall meet with the Contracting Officer or his/her designee to discuss and provide the safety plan. If live viruses, bacteria, or inactivated materials will be used the Contractor must comply with all applicable HHS and USDA safety and security requirements and must show evidence of appropriate biosafety containment and Federal Select Agent Program compliance.

d) To be considered for award of this contract, the technical proposal submission must demonstrate at a minimum that the offeror maintains laboratories that are currently registered for work with highly pathogenic avian influenza virus under the United States Federal Select Agent Program for purposes of this acquisition. In addition, proof of Federal Select Agent registration is required as part of the contractor’s technical proposal submission. https://www.selectagents.gov/#

e) Prospective contractors can be provided with login access to the IRR website at www.internationalreagentresource.org upon request, in order to view the current reagent catalog and associated reagent documentation. Some examples of reagent product descriptions, product specifications, and certificates of analyses are also included in Appendices D, E, and F respectively.

Prospective offerors will be provided with a “view only” account with ability to view all currently available catalog items, but they will not be able to place any orders for IRR reagents through this account. To establish a view only account, prospective contractors should contact the Contracting Officer via email at vyh1@cdc.gov.

f) Government-Furnished and/or Contractor Acquired Property

Currently, IRR customers order reagents and kits via a website at https://www.internationalreagentresource.org/. The government will provide the contractor with IRR website code based on a DotNetNuke framework, copies of SQL server derived databases (product catalog, SOLR indexes for searching and DotNetNuke for portal settings and user information) and copies of integration scripts that process or update systems connected to the IRR website (one-way, from IRR to an outside system). If updates to the IRR website are deployed during the transition period, CDC will provide the new contractor with additional source code escrow. Final source code and any open/pending orders will be delivered to the contractor once the contractor has demonstrated system operations. (See Section F of the Statement of Work for additional information.)

Currently, the IRR catalog consists of over 200,000 vials of viruses, bacteria, antigens, antisera, cell lines, monoclonal antibodies, plasmids, and other materials, including over 6,000 conventional and RT- PCR typing kits and panels (See Appendix H – Reagent Catalog). The government will transfer half of the IRR reagent inventory from the incumbent contractor to the new contractor upon Contracting Officer approval of Standard Operating Procedures for reagent receipt, handling, storage, tracking, reporting, and shipping. The second half of the inventory will remain with the incumbent contractor until the new contractor has reestablished full functionality of the IRR website and is capable of assuming responsibility for fulfillment of all new and pending reagent orders. The second half of the reagent inventory will be transferred along with any government furnished property from the list of equipment purchased under the predecessor contract (provided in Section VII of the Statement of Work) that is requested by the contractor.

The government will provide seed stocks and/or primer/probe sequences for the production of reagents listed in Appendix A – Deliverables within 30 days of satisfying all of the following requirements:

(1) Contracting Officer approval of completion of all transition activities, including reestablishment of website functionality, implementation of a new user agreement, and reestablishment of registration processes for new laboratories and/or individuals.

(2) Contracting Officer approval of contractor’s Standard Operating Procedures for production of reagent deliverables, including quality assurance and quality control assays associated with compliance to quality specifications defined in Appendix B - Quality Specifications.

(3) Contracting Officer approval of contractor’s production plan encompassing the schedule and resource allocation for all deliverables and quality control testing, including those produced by subcontractors, for the base year period of performance.

g) Sponsoring program activities will independently fund contract line item (CLIN) basic award quantities for materials listed in SOW Appendix A, of the contract. In addition to annual performance requirements for each sponsoring program activity, each contract line item (CLIN) will also contain "surge" options for additional quantities of 25%, 50% and 75% of the basic award. Surge quantities are in excess of basic award quantities and may or may not be exercised during contract performance.

See Section M for more information on Special Business Proposal Instructions.

Section B - Supplies Or Services And Prices/Costs

Transition Period Items (Period of Performance: 09/29/18 – 03/28/19):

ITEM SUPPLIES / SERVICES QTY/UNIT EST. COST FIXED FEE TOTAL

EST. CPFF

0101 *Optional Line Item* Transition of services from the incumbent contractor to a new Contractor. In accordance with section IV - A in SOW.

6 Months $_________ $__________ $_________

Total Optional Line Item 0101 Value: $_________

Base Period Items (Period of Performance: 03/29/19 – 03/28/20):

ITEM SUPPLIES / SERVICES QTY/

UNIT

EST. COST FIXED FEE TOTAL

0001 Project Management (PM) Core. Contract-wide project management, shared laboratory and storage equipment including repairs and maintenance, reagent order processing and shipping, website development and maintenance, purchase and storage of NCIRD-wide reagents (Appendix A, Part I), and other shared activities in accordance with the SOW requirements.

Mnths

0001-01 *Optional Line Item* PM Surge Option I

Mnths

0001-02 *Optional Line Item* PM Surge Option II

Mnths

0001-03 *Optional Line Item* PM Surge Option III

Mnths

0002 Influenza Core. In accordance with the SOW requirements.

Mnths

0002-01 *Optional Line Item* ID Surge Option I

Mnths

0002-02 *Optional Line Item* ID Surge Option II

Mnths

0002-03 *Optional Line Item* ID Surge Option III

Mnths

0003 DBD Core. In accordance with the SOW requirements.

Mnths

0003-01 *Optional Line Item* DBD Surge Option I

Mnths

0003-02 *Optional Line Item* DBD Surge Option II

Mnths

0003-03 *Optional Line Item* DBD Surge Option III

Mnths

0004 DVD Core. In accordance with the SOW requirements.

Mnths

0004-01 *Optional Line Item* DVD Surge Option I

Mnths

0004-02 *Optional Line Item* DVD Surge Option II

Mnths

0004-03 *Optional Line Item* DVD Surge Option III

Mnths

0005 ODC / Travel 1 Lot $_________ $__________ $__________

Total Base Year Value: EST. COST

FIXED FEE

TOTAL

Option Year 1 Items (Period of Performance: 03/29/20 – 03/28/21):

UNIT

1001 OY1 PM Core. Contract-wide project management, shared laboratory and storage equipment including repairs and maintenance, reagent order processing and shipping, website development and maintenance, purchase and storage of NCIRD-wide reagents (Appendix A, Part I), and other shared activities in accordance with the SOW requirements.

Mnths

1001-01 *Optional Line Item* OY1 PM Surge Option I

Mnths

1001-02 *Optional Line Item* OY1 PM Surge Option II

Mnths

1001-03 *Optional Line Item* OY1 PM Surge Option III

Mnths

1002 OY1 Influenza Core. In accordance with the SOW requirements.

Mnths

1002-01 *Optional Line Item* OY1 Influenza Surge Option I

Mnths

1002-02 *Optional Line Item* OY1 Influenza Surge Option II

Mnths

1002-03 *Optional Line Item* OY1 Influenza Surge Option III

Mnths

1003 OY1 DBD Core. In accordance with the SOW requirements.

Mnths

1003-01 *Optional Line Item* OY1 DBD Surge Option I

Mnths

1003-02 *Optional Line Item* OY1 DBD Surge Option II

Mnths

1003-03 *Optional Line Item* OY1 DBD Surge Option III

Mnths

1004 OY1 DVD Core. In accordance with the SOW requirements.

Mnths

1004-01 *Optional Line Item* OY1 DVD Surge Option I

Mnths

1004-02 *Optional Line Item* OY1 DVD Surge Option II

Mnths

1004-03 *Optional Line Item* OY1 DVD Surge Option III

Mnths

1005 ODC / Travel 1 Lot $_________ $__________ $__________

Total Option Year 1 Value: EST. COST

FIXED FEE

TOTAL

EST. COST

Option Year 2 Items (Period of Performance: 03/29/21 – 03/28/22):

UNIT

2001 OY2 PM Core. Contract-wide project equipment including repairs and maintenance, reagent order processing and shipping, website development and maintenance, purchase and storage of NCIRD-wide reagents (Appendix A, Part I), and other shared activities in accordance with the SOW requirements.

Mnths

2001-01 *Optional Line Item* OY2 PM Surge Option I

Mnths

2001-02 *Optional Line Item* OY2 PM Surge Option II

Mnths

2001-03 *Optional Line Item* OY2 PM Surge Option III

Mnths

2002 OY2 Influenza Core. In accordance with the SOW requirements.

Mnths

2002-01 *Optional Line Item* OY2 Influenza Surge Option I

Mnths

2002-02 *Optional Line Item* OY2 Influenza Surge Option II

Mnths

2002-03 *Optional Line Item* OY2 Influenza Surge Option III

Mnths

2003 OY2 DBD Core. In accordance with the SOW requirements.

Mnths

2003-01 *Optional Line Item* OY2 DBD Surge Option I

Mnths

2003-02 *Optional Line Item* OY2 DBD Surge Option II

Mnths

2003-03 *Optional Line Item* OY2 DBD Surge Option III

Mnths

2004 OY2 DVD Core. In accordance with the SOW requirements.

Mnths

2004-01 *Optional Line Item* OY2 DVD Surge Option I

Mnths

2004-02 *Optional Line Item* OY2 DVD Surge Option II

Mnths

2004-03 *Optional Line Item* OY2 DVD Surge Option III

Mnths

2005 ODC / Travel 1 Lot $_________ $__________ $__________

Total Option Year 2 Value: EST. COST

TOTAL

Option Year 3 Items (Period of Performance: 03/29/22 – 03/28/23):

3001 OY3 PM Core. Contract-wide project equipment including repairs and maintenance, reagent order processing and shipping, website development and maintenance, purchase and storage of NCIRD-wide reagents (Appendix A, Part I), and other shared activities in accordance with the SOW requirements.

Mnths

3001-01 *Optional Line Item* OY3 PM Surge Option I

Mnths

3001-02 *Optional Line Item* OY3 PM Surge Option II

Mnths

3001-03 *Optional Line Item* OY3 PM Surge Option III

Mnths

3002 OY3 Influenza Core. In accordance with the SOW requirements.

Mnths

3002-01 *Optional Line Item* OY3 Influenza Surge Option I

Mnths

3002-02 *Optional Line Item* OY3 Influenza Surge Option II

Mnths

3002-03 *Optional Line Item* OY3 Influenza Surge Option III

Mnths

3003 OY3 DBD Core. In accordance with the SOW requirements.

Mnths

3003-01 *Optional Line Item* OY3 DBD Surge Option I

Mnths

3003-02 *Optional Line Item* OY3 DBD Surge Option II

Mnths

3003-03 *Optional Line Item* OY3 DBD Surge Option III

Mnths

3004 OY3 DVD Core. In accordance with the SOW requirements.

Mnths

3004-01 *Optional Line Item* OY3 DVD Surge Option I

Mnths

3004-02 *Optional Line Item* OY3 DVD Surge Option II

Mnths

3004-03 *Optional Line Item* OY3 DVD Surge Option III

Mnths

3005 ODC / Travel

1 Lot $_________ $__________ $__________

Total Option Year 3 Value: EST. COST

TOTAL

Option Year 4 Items: (Period of Performance: 03/29/23 – 03/28/24):

ITEM SUPPLIES / SERVICES QTY/

UNIT

4001 OY4 PM Core. Contract-wide project equipment including repairs and maintenance, reagent order processing and shipping, website development and maintenance, purchase and storage of NCIRD-wide reagents (Appendix A, Part I), and other shared activities in accordance with the SOW requirements.

Mnths

4001-01 *Optional Line Item* OY4 PM Surge Option I

Mnths

4001-02 *Optional Line Item* OY4 PM Surge Option II

Mnths

4001-03 *Optional Line Item* OY4 PM Surge Option III

Mnths

4002 OY4 Influenza Core. In accordance with the SOW requirements.

Mnths

4002-01 *Optional Line Item* OY4 Influenza Surge Option I

Mnths

4002-02 *Optional Line Item* OY4 Influenza Surge Option II

Mnths

4002-03 *Optional Line Item* OY4 Influenza Surge Option III

Mnths

4003 OY4 DBD Core. In accordance with the SOW requirements.

Mnths

4003-01 *Optional Line Item* OY4 DBD Surge Option I

Mnths

4003-02 *Optional Line Item* OY4 DBD Surge Option II

Mnths

4003-03 *Optional Line Item* OY4 DBD Surge Option III

Mnths

4004 OY4 DVD Core. In accordance with the SOW requirements.

Mnths

4004-01 *Optional Line Item* OY4 DVD Surge Option I

Mnths

4004-02 *Optional Line Item* OY4 DVD Surge Option II

Mnths

4004-03 *Optional Line Item* OY4 DVD Surge Option III

Mnths

4005 ODC / Travel

Total Option Year 4 Value: EST. COST

TOTAL

Option Year 5 Items: (Period of Performance: 03/29/24 – 03/28/25):

5001 OY5 PM Core. Contract-wide project equipment including repairs and maintenance, reagent order processing and shipping, website development and maintenance, purchase and storage of NCIRD-wide reagents (Appendix A, Part I), and other shared activities in accordance with the SOW requirements.

Mnths

5001-01 *Optional Line Item* OY5 PM Surge Option I

Mnths

5001-02 *Optional Line Item* OY5 PM Surge Option II

Mnths

5001-03 *Optional Line Item* OY5 PM Surge Option III

Mnths

5002 OY5 Influenza Core. In accordance with the SOW requirements.

Mnths

5002-01 *Optional Line Item* OY5 Influenza Surge Option I

Mnths

5002-02 *Optional Line Item* OY5 Influenza Surge Option II

Mnths

5002-03 *Optional Line Item* OY5 Influenza Surge Option III

Mnths

5003 OY5 DBD Core. In accordance with the SOW requirements.

Mnths

5003-01 *Optional Line Item* OY5 DBD Surge Option I

Mnths

5003-02 *Optional Line Item* OY5 DBD Surge Option II

Mnths

5003-03 *Optional Line Item* OY5 DBD Surge Option III

Mnths

5004 OY5 DVD Core. In accordance with the SOW requirements.

Mnths

5004-01 *Optional Line Item* OY5 DVD Surge Option I

Mnths

5004-02 *Optional Line Item* OY5 DVD Surge Option II

Mnths

5004-03 *Optional Line Item* OY5 DVD Surge Option III

Mnths

5005 ODC / Travel

Total Option Year 5 Value: EST. COST

TOTAL

Option Year 6 Items (Period of Performance: 03/29/25 – 03/28/26):

UNIT

6001 OY6 PM Core. Contract-wide project equipment including repairs and maintenance, reagent order processing and shipping, website development and maintenance, purchase and storage of NCIRD-wide reagents (Appendix A, Part I), and other shared activities in accordance with the SOW requirements.

Mnths

6001-01 *Optional Line Item* OY6 PM Surge Option I

Mnths

6001-02 *Optional Line Item* OY6 PM Surge Option II

Mnths

6001-03 *Optional Line Item* OY6 PM Surge Option III

Mnths

6002 OY6 Influenza Core. In accordance with the SOW requirements.

Mnths

6002-01 *Optional Line Item* OY6 Influenza Surge Option I

Mnths

6002-02 *Optional Line Item* OY6 Influenza Surge Option II

Mnths

6002-03 *Optional Line Item* OY6 Influenza Surge Option III

Mnths

6003 OY6 DBD Core. In accordance with the SOW requirements.

Mnths

6003-01 *Optional Line Item* OY6 DBD Surge Option I

Mnths

6003-02 *Optional Line Item* OY6 DBD Surge Option II

Mnths

6003-03 *Optional Line Item* OY6 DBD Surge Option III

Mnths

6004 OY6 DVD Core. In accordance with the SOW requirements.

Mnths

6004-01 *Optional Line Item* OY6 DVD Surge Option I

Mnths

6004-02 *Optional Line Item* OY6 DVD Surge Option II

Mnths

6004-03 *Optional Line Item* OY6 DVD Surge Option III

Mnths

6005 ODC / Travel

Total Option Year 6 Value: EST. COST

TOTAL

Option Year 7 Items (Period of Performance: 03/29/26 – 03/28/27):

UNIT

7001 OY7 PM Core. Contract-wide project equipment including repairs and maintenance, reagent order processing and shipping, website development and maintenance, purchase and storage of NCIRD-wide reagents (Appendix A, Part I), and other shared activities in accordance with the SOW requirements.

Mnths

7001-01 *Optional Line Item* OY7 PM Surge Option I

Mnths

7001-02 *Optional Line Item* OY7 PM Surge Option II

Mnths

7001-03 *Optional Line Item* OY7 PM Surge Option III

Mnths

7002 OY7 Influenza Core. In accordance with the SOW requirements.

Mnths

7002-01 *Optional Line Item* OY7 Influenza Surge Option I

Mnths

7002-02 *Optional Line Item* OY7 Influenza Surge Option II

Mnths

7002-03 *Optional Line Item* OY7 Influenza Surge Option III

Mnths

7003 OY7 DBD Core. In accordance with the SOW requirements.

Mnths

7003-01 *Optional Line Item* OY7 DBD Surge Option I

Mnths

7003-02 *Optional Line Item* OY7 DBD Surge Option II

Mnths

7003-03 *Optional Line Item* OY7 DBD Surge Option III

Mnths

7004 OY7 DVD Core. In accordance with the SOW requirements.

Mnths

7004-01 *Optional Line Item* OY7 DVD Surge Option I

Mnths

7004-02 *Optional Line Item* OY7 DVD Surge Option II

Mnths

7004-03 *Optional Line Item* OY7 DVD Surge Option III

Mnths

7005 ODC / Travel

Total Option Year 7 Value: EST. COST

FIXED FEE

TOTAL

Option Year 8 Items (Period of Performance: 03/29/27 – 03/28/28):

8001 OY8 PM Core. Contract-wide project equipment including repairs and maintenance, reagent order processing and shipping, website development and maintenance, purchase and storage of NCIRD-wide reagents (Appendix A, Part I), and other shared activities in accordance with the SOW requirements.

Mnths

8001-01 *Optional Line Item* OY8 PM Surge Option I

Mnths

8001-02 *Optional Line Item* OY8 PM Surge Option II

Mnths

8001-03 *Optional Line Item* OY8 PM Surge Option III

Mnths

8002 OY8 Influenza Core. In accordance with the SOW requirements.

Mnths

8002-01 *Optional Line Item* OY8 Influenza Surge Option I

Mnths

8002-02 *Optional Line Item* OY8 Influenza Surge Option II

Mnths

8002-03 *Optional Line Item* OY8 Influenza Surge Option III

Mnths

8003 OY8 DBD Core. In accordance with the SOW requirements.

Mnths

8003-01 *Optional Line Item* OY8 DBD Surge Option I

Mnths

8003-02 *Optional Line Item* OY8 DBD Surge Option II

Mnths

8003-03 *Optional Line Item* OY8 DBD Surge Option III

Mnths

8004 OY8 DVD Core. In accordance with the SOW requirements.

Mnths

8004-01 *Optional Line Item* OY8 DVD Surge Option I

Mnths

8004-02 *Optional Line Item* OY8 DVD Surge Option II

Mnths

8004-03 *Optional Line Item* OY8 DVD Surge Option III

Mnths

8005 ODC / Travel

Total Option Year 8 Value: EST. COST

FIXED FEE

TOTAL

Option Year 9 Items (Period of Performance: 03/29/28 – 09/28/28):

ITEM SUPPLIES / SERVICES QTY/

UNIT

9001 OY9 PM Core. Contract-wide project equipment including repairs and maintenance, reagent order processing and shipping, website development and maintenance, purchase and storage of NCIRD-wide reagents (Appendix A, Part I), and other shared activities in accordance with the SOW requirements.

Mnths

9001-01 *Optional Line Item* OY9 PM Surge Option I

Mnths

9001-02 *Optional Line Item* OY9 PM Surge Option II

Mnths

9001-03 *Optional Line Item* OY9 PM Surge Option III

Mnths

9002 OY9 Influenza Core. In accordance with the SOW requirements.

Mnths

9002-01 *Optional Line Item* OY9 Influenza Surge Option I

Mnths

9002-02 *Optional Line Item* OY9 Influenza Surge Option II

Mnths

9002-03 *Optional Line Item* OY9 Influenza Surge Option III

Mnths

9003 OY9 DBD Core. In accordance with the SOW requirements.

Mnths

9003-01 *Optional Line Item* OY9 DBD Surge Option I

Mnths

9003-02 *Optional Line Item* OY9 DBD Surge Option II

Mnths

9003-03 *Optional Line Item* OY9 DBD Surge Option III

Mnths

9004 OY9 DVD Core. In accordance with the SOW requirements.

Mnths

9004-01 *Optional Line Item* OY9 DVD Surge Option I

Mnths

9004-02 *Optional Line Item* OY9 DVD Surge Option II

Mnths

9004-03 *Optional Line Item* OY9 DVD Surge Option III

Mnths

9005 ODC / Travel

Total Option Year 9 Value: EST. COST

FIXED FEE

TOTAL

Transition Period Items (Period of Performance: 03/29/28 – 09/28/28):

ITEM SUPPLIES / SERVICES QTY/

UNIT

0001-99 *Optional Line Item* Transition of services, reagents, etc. to a new Contractor. In accordance with section IV - K in the SOW.

Mnths

Total Optional Line Item 0001-99 Value: $_________

TOTAL AGGREGATE COST (BASE

AND ALL OPTION YEARS)

EST. COST

TOTAL EST. CPFF

Section C - Description/Specification/Work Statement

STATEMENT OF WORK

CDC International Reagent Resource (IRR)

I. BACKGROUND AND NEED

The National Center for Immunization and Respiratory Diseases (NCIRD) prevents disease, disability, and death through immunization and by control of respiratory and related diseases. In carrying out its mission, NCIRD: (1) provides leadership, expertise, and service in laboratory and epidemiological sciences, and in immunization program delivery; (2) conducts applied research on disease prevention and control; (3) translates research findings into public health policies and practices; (4) provides diagnostic and reference laboratory services to relevant partners; (5) conducts surveillance and research to determine disease distribution, determinants, and burden nationally and internationally; (6) responds to disease outbreaks domestically and abroad; (7) ensures that public health decisions are made objectively and based upon the highest quality of scientific data; (8) provides technical expertise, education, and training to domestic and international partners; (9) provides leadership to internal and external partners for establishing and maintaining immunization, and other prevention and control programs; (10) develops, implements, and evaluates domestic and international public health policies; (11) communicates information to increase awareness, knowledge, and understanding of public health issues domestically and internationally, and to promote effective immunization programs; (12) aligns the national center focus with the overall strategic goals of CDC; (13) synchronizes all aspects of CDC’s pandemic influenza preparedness and response from strategy through implementation and evaluation; and (14) implements, coordinates, and evaluates programs across NCIRD, Office of Infectious Diseases (OID), and CDC to optimize public health impact.

The National Strategy for Pandemic Influenza, issued by President Bush on November 1, 2005, has guided our nation's preparedness and response to an influenza pandemic with the intent of (1) stopping, slowing or otherwise limiting the spread of a pandemic to the United States; (2) limiting the domestic spread of a pandemic, and mitigating disease, suffering and death; and (3) sustaining infrastructure and mitigating impact to the economy and the functioning of society. Further guidance was provided in “The

Implementation Plan for the National Strategy,” which identified more than 300 actions for Federal departments and agencies and set clear expectations for state and local governments and other non-federal entities. It also provided guidance for all federal departments and agencies on the development of their own plans.

The U.S. Department of Health and Human Services (DHHS) was charged with leading the federal pandemic preparedness, with the Centers for Disease Control and Prevention (CDC) charged with responsibility for detecting the onset of outbreaks with influenza pandemic potential, assisting with the containment of such outbreaks, delaying the introduction and transmission of pandemic viruses in the

United States, and assisting State, Local and Territorial (SLTT) health authorities in the management of an influenza pandemic event.

Based on these guidelines, CDC’s Influenza Division sponsored the “CDC Influenza Reagent Contract

(CDC-IRR)”, which was a ten year contract designed to provide laboratory support to public health professionals as necessary to minimize the impact of an influenza pandemic on the health of Americans.

More specifically, the CDC-IRR Contract served (a) to ensure that adequate stocks of influenza viruses, positive controls, kits, proficiency panels and other research materials were available on a routine basis to

CDC and other partner researchers in order to adequately characterize circulating seasonal and novel viruses and (b) ensure the ability to quickly ramp up production and distribution activities to surge levels in the event of a pandemic or public health emergency.

Based on the success of the CDC Influenza Reagent Resource Contract, currently in the ninth year of its ten year term, its collaboration with Global Health Security Agenda (GHSA), and recent success of CDC’s response to the zika virus outbreak, during which CDC and CDC-partner GHSA and zika researchers benefitted from availability of reagents and research materials common and/or similar to those being made available to influenza researchers under the CDC-IRR Contract, NCIRD has determined that it would be beneficial to the public health, and appropriate under this new contract, to expand the scope of the IRR

Contract beyond influenza to include additional bacterial and viral pathogens that are within the scope of its mission, including non-influenza respiratory viruses and bacteria.

This contract is a critical component of CDC’s efforts to ensure the availability of quality reference pathogens and other reagents to CDC and partner researchers for public health responses and also serves to enhance the CDC’s ability to provide on-site technical assistance to state and local public health laboratories and commercial developers of vaccines, antiviral drugs, and diagnostic tests; in support of our common goal to minimize the impact of bacterial, viral, and respiratory diseases on the health of

Americans.

II. PROJECT OBJECTIVES

The primary objectives of this contract are:

1. to produce quality stocks of NCIRD reference viruses, bacteria, positive controls, detection kits, proficiency panels and other similar type surveillance and research reagents;

2. to ensure that these reagents, and any others critical to the performance of surveillance and other public health-related laboratory activities, are available to the CDC, its public health laboratory partners, and researchers and developers for characterization of circulating and novel viruses and bacteria;

3. to ensure the ability to ramp up acquisition, production, and distribution activities to surge levels as may be needed to meet the needs of a public health emergency.

Special Notes:

a. Similar work was previously provided by American Type Culture Collection under CDC Contract 200-2008-28045.

b. This is a cost reimbursement requirements type contract with options which will be funded annually to meet anticipated routine needs of the government. Appendix A – Deliverables provides a list of all reagents that shall be produced or acquired for inclusion with the IRR catalog during each year of the contract’s performance. Additional funding could be made available to meet anticipated surge requirements (Surge Options I, II, and III) of the contract.

c. Appendix A - Deliverables: Contractor inventories shall be fully stocked by the end of Year 1, and maintained thereafter in accordance with current government priorities. The contractor shall establish the contractor’s reagent catalog composition and inventory levels shall be reviewed on at least an annual basis as part of their acquisition, production, and inventory management plans, and may be adjusted as required to meet the current anticipated needs of the program.

d. Surge Options I, II, and III: Surge options provide for 25%, 50% and 75% increases above the basic award. In the event that surge options are exercised in response to a public health emergency, the government may require expedited delivery of surge quantities as may be needed to meet an imminent threat to public health.

III. SCOPE OF WORK

The contractor will produce or otherwise acquire, characterize, store and distribute CDC-furnished NCIRD pathogens and other reagents, including ancillary reagents critical to the performance of CDC-developed assays, and associated with influenza, non-influenza respiratory viruses and bacteria, and other vaccine preventable bacterial diseases as described in Appendix A - Deliverables. This includes live and inactivated viruses, bacteria, nucleic acids, antisera, proteins, cell lines, hybridomas, monoclonal antibodies.

The purpose of IRR reagents is to assist in characterization of viral and bacterial pathogens as part of CDC surveillance activities; to aid in the development, evaluation, validation and testing of diagnostic products;

to support vaccine development; and to support other research activities that increase awareness, knowledge, and understanding of the public health issues related to these pathogens. The IRR inventory of viruses, bacteria and other reagents will be regularly updated during contract performance to ensure that the catalog reflects current circulating or novel pathogen strains relevant to the ongoing surveillance and research activities of CDC and its partner laboratories.

All reagents produced by the contractor or its subcontractors shall be in accordance with the format and quality specifications as described in Appendix B - Quality Specifications. These reagents will be added to the IRR’s existing inventory of over 200,000 vials of viruses, bacteria, antigens, antisera, cell lines, monoclonal antibodies, plasmids, and other materials, including over 64,000 conventional and RT-PCR typing kits and panels (See Appendix H - Reagent Catalog). All IRR reagents will be manufactured according to a recognized national or international quality standard such as ISO 9001, US current good manufacturing practices, or comparable standards. Manufacturing batch records documenting all production processes and quality control testing for every lot shall be maintained by the contractor and available for CDC review upon request. Contract deliverables include Influenza Real-time RT-PCR kits that are regulated by the Food and Drug Administration (FDA) as in vitro diagnostic reagents. The government will perform an annual review of contractor facilities to ensure that they conform to the requirements of Food and Drug Administration’s Quality System Regulations/Medical Device Good Manufacturing Practices; see 21 CFR Part 820, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySyst emsRegulations/default.htm

Upon approval from CDC, IRR reagents that have met all required quality specifications will be made available to registered persons and institutions through an electronic “storefront” website, www.internationalreagentresource.org to be provided by the government and maintained by the contractor (see Section IV). The contractor will receive and process reagent order requests from the IRR website via their internal ERP system and manage all shipping logistics to recipient laboratories. In fiscal year 2016, the IRR shipped around 13,000 reagents in 1,675 shipments, 88 percent of which were to domestic states and territories.

IV. DETAILED TECHNICAL REQUIREMENTS

Independently and not as an agent of the government, the contractor shall provide all management, labor, facilities, materials, supplies and equipment necessary to operate and maintain the “International Reagent Resource (IRR)” as set forth below.

More specifically, the contractor shall:

A. Facilitate Transition from Incumbent to New Contractor (Optional CLIN 0101)

1. The contractor shall provide an incoming transition plan for receipt, inventory, and storage of existing IRR reagents as part of their technical proposal. At minimum, the transition plan must include a timeline, description of project phases, and necessary facility, equipment and staff resources. (For requirements related to the contractor’s outgoing transition plan, see Section K.)

2. At minimum, priority transition activities shall include receipt of the IRR’s existing reagent inventory, reestablishment of website functionality with Authority to Operate, implementation of a new User Agreement with new and existing registered laboratories (see Section G and Appendix C), reestablishment of registration processes for new laboratories, and receipt of any government furnished equipment associated with storage.

3. Contractor draft SOPs to support priority transition activities from the incumbent contractor shall be provided to the COR for review and comment within 30 days of contract award. The COR will review draft SOPs and furnish written comments to the contractor within 15 days of receipt. The contractor shall address COR comments in writing and submit revised Standard Operating Procedures to the COR for final review and approval within 60 days of contract award. The COR will approve revised SOPs or furnish additional comments to the contractor within 15 days of receipt.

4. The incumbent contractor will continue to operate and maintain the CDC IRR website and fulfill order requests until the new contractor has successfully demonstrated reestablishment of full website functionality, including transmittal of new orders to CDC’s Reagent Order Processing System, receipt of approved orders from CDC’s Reagent Order Processing System, and return of completed shipment data to CDC’s Reagent Order Processing System (see Sections F and H for more details). Within 45 days of contract award, the new contractor will receive the IRR website code based on a DotNetNuke framework, copies of SQL server derived databases (product catalog, SOLR indexes for searching and DotNetNuke for portal settings and user information) and copies of integration scripts that process or update systems connected to the IRR website (one way, from IRR to an outside system), to be used for establishing connectivity to their enterprise resource programs (ERP) and perform initial system testing. If any updates to the IRR website are deployed by the incumbent contractor during the transition period, CDC will provide the new contractor with additional source code escrow. Final source code and any open/pending orders will be delivered to the new contractor once the new contractor had demonstrated system operations.

5. Contractor shall maintain an IT Security Plan, IT Risk Plan and FIPS 199 Assessment and contribute to an IT Security Certification and Accreditation (C&A) before CDC grants Authority to Operate. C&A’s shall be required on at least a triannual basis thereafter, or earlier if system changes require recertification.

6. CDC will provide the new contractor with a complete inventory report of stored IRR organisms, reagents, and other biological or chemical materials, including temperature condition requirements, associated hazards, and/or any permits or license requirements within 15 days of contract award. The new contractor will be responsible for ensuring that their facilities and equipment are compliant with all requirements and regulations prior to transfer of the current IRR reagent inventory.

7. CDC will initiate physical transfer of half of the inventory of every IRR reagent in storage from the incumbent contractor to the new contractor no later than 120 days after contract award under the appropriate temperature conditions, with prior COR approval of SOPs for reagent receipt, storage, tracking and reporting. The second half of the inventory will remain with the incumbent contractor in order to ensure continued IRR operations until the new contractor has completed reestablishment of full functionality of the IRR website in conjunction with their ERP systems and is capable of assuming responsibility for fulfillment of all new and/or pending reagent orders. The second half of the reagent inventory will be physically transferred along with any government furnished storage equipment (e.g. liquid nitrogen tanks, refrigerators, freezers).

8. CDC will provide the new contractor with current IRR registrant data within 30 days of contract award, with monthly updates as needed throughout the transition phase. The new contractor shall be required to establish a User Agreement with all currently authorized users and any new organization that may wish to request IRR contract reagents in the future (See Section G and Appendix C for more details). The User Agreement must be reviewed and approved by HHS and CDC legal authorities before implementation.

9. Within 150 days of contract award, the contractor shall establish an acquisition plan, a production plan, and an inventory management plan. The contractor’s acquisition, production, and inventory management plans shall be reviewed by the COR and CO, approved in writing by the CO prior to implementation, and updated on at least an annual basis. (See Section D for more details).

10. Within 180 days of contract award, the contractor shall establish an Emergency Response

Plan to include the contractor’s acquisition, production and inventory management strategies to meet the surge requirements of a public health emergency. The contractor’s Emergency Response Plan shall be reviewed and approved in writing by the COR and updated on at least an annual basis.

11. Within 180 days of contract award, the contractor shall establish a plan for stability testing of the reagents manufactured by the contractor and its subcontractors in order to ensure that IRR reagents retain, within specified limits and throughout its period of storage and use (i.e., its shelf life), the same physical and functional properties and characteristics that they possessed at the time of manufacture. The contractor’s Stability Testing Plan shall be reviewed and approved in writing by the COR and updated on at least an annual basis.

B. Develop Standard Operating Procedures (SOPs)

1. Prior to performance of any task requirement of this contract, the contractor shall develop draft

SOPs consistent with the methodology and approach reflected in the contractor’s technical proposal to confirm proper contractor receipt, handling, storage and shipment of viruses, bacteria, and other reagents; and contractor performance of all contract tasks.

2. Draft SOPs shall be prepared for each SOW task, including quality assurance and quality control assays associated with compliance to quality specifications, and submitted to the to the NCIRD/ID Contracting Officer’s Representative (COR) for approval prior to implementation. Separate SOPs will be submitted for each requirement. Individual SOPs shall be submitted in phases rather than all at the same time in order to facilitate the review and approval process.

3. The contractor shall submit technical SOPs to confirm how the contractor and their subcontractors plan to manufacture the various viruses, bacteria, and other reagents listed in Appendix A - Deliverables in accordance with the format and quality specifications described in Appendix B – Quality Specifications of the contract. Individual production and quality control protocols shall be required for each item and submitted to the government for approval prior to implementation in order to ensure manufacture of materials that meet or exceed the government’s inspection/acceptance criteria for that item.

4. All other contractor draft SOP’s shall be provided to the COR for review and comment within 60 days of contract award. The COR shall review draft SOPs and furnish written comments to the contractor within 30 days of receipt. The contractor shall address COR comments in writing and submit revised Standard Operating Procedures to the COR for final review and approval within 120 days of contract award. The COR shall approve revised SOPs or furnish additional comments to the contractor within 15 days of receipt.

5. Final COR approval of the SOP for each individual task shall be obtained before the contractor shall be authorized to initiate any work under that task. Contractor SOPs shall be in full compliance with all international, federal, state and local laws and regulations and World Health Organization guidelines, especially with respect to biosafety and security. The contractor’s institutional Quality Assurance (QA) management will be required to approve SOPs prior to release of such materials.

C. Facility Requirements

1. The contractor shall provide dedicated facilities and equipment to receive, handle, propagate, aliquot, fully characterize, vial, weigh, store and ship BSL 1 reagents as well as potentially hazardous viruses and bacteria while maintaining their activity and/or viability under BSL2, BSL2 enhanced, BSL3, and BSL3 enhanced containment conditions, as appropriate. Storage and handling of infectious highly pathogenic avian influenza viruses shall be conducted only in laboratories that are registered for work with highly pathogenic avian influenza virus under the United States Federal Select Agent Program. BSL-4 facilities are not required under this contract. Information regarding requirements for these facilities can be found at https://www.cdc.gov/biosafety/publications/bmbl5/

2. The contractor shall have accredited Animal BSL2, Animal BSL2 enhanced and Animal BSL3 enhanced facilities as governed by the Institutional Animal Care and Use Committee (IACUC) and Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC), or ABSL3 teamed with an ABSL 3 Enhanced Laboratory for purposes of this acquisition. These laboratories shall be registered for work with highly pathogenic avian influenza virus under the United States Federal Select Agent Program.

3. Facility design and SOPs for storage conditions shall include validation procedures and all necessary evidence that the integrity of IRR reagents and associated stocks will be maintained and the risk of accidents or contamination is minimized.

4. Contract deliverables include Influenza Real-time RT-PCR kits that are regulated by the Food and Drug Administration (FDA) as in vitro diagnostic reagents. The government will perform an annual review of contractor facilities to ensure that they conform to the requirements of the Food and Drug Administration’s Quality System Regulations/Medical Device Good Manufacturing Practices and laboratory, storage and shipping facilities shall be available for government inspection as part of the competitive proposal evaluation process; see 21 CFR Part 820, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirement s/QualitySystemsRegulations/default.htm

5. Proof of registration with the Federal Select Agent Program, e.g. certificate, to demonstrate approved laboratory facilities, personnel and SOPs for work with highly pathogenic and exotic avian influenza viruses and/or other respiratory pathogens of human and animal origin shall be provided as part of the contractor’s technical proposal submission.

6. The contractor shall provide suitable air-conditioned floor space sufficient for the installation, storage and maintenance of equipment and all items necessary for the virus and bacteria storage and distribution operation. Refrigeration and cryogenic equipment units will be housed in an air-conditioned facility with the capacity to maintain a room temperature of 66 to 72 °F, when all equipment is operational.

7. The contractor shall provide, maintain and operate facilities for the storage of viral and bacterial collections and derived reagents at 2 to 8°C, at -10 to -20 °C, at -70 to -90 °C, and liquid nitrogen conditions.

8. The contractor shall provide uninterruptible power supply to accommodate the refrigerators/freezers and other critical security and surveillance equipment.

9. The contractor shall ensure that refrigerators, freezers, and incubators are connected to a central alarm system that is monitored 24 hours…