A19_75D30125R73235_Serology Solicitation_Amendment 3.pdf

75D30125R73235, Amendment 2

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE PAGE OF PAGES

1 76

2. AMENDMENT/MODIFICATION NO.

00003

3. EFFECTIVE DATE

03/26/2025

4. REQUISITION/PURCHASE REQ. NO.

000HCJC1-2025-90234

5. PROJECT NO. (If applicable)

6. ISSUED BY CODE 8219 7. ADMINISTERED BY (If other than Item 6) CODE 8219 OFR - Office of Acquisition Services Chamblee Campus Building 102 4770 Buford Highway Atlanta, GA 30341-

OFR - Office of Acquisition Services Chamblee Campus Building 102 4770 Buford Highway Atlanta, GA 30341-

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

All Offerors

X

9A. AMENDMENT OF SOLICITATION NO.

75D30125R73235

9B. DATED (See Item 11)

01/16/2025

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (See Item 13)

CODE FACILITY CODE

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 Offers X is extended, is not extended.

Offers 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 ACKNOWLEGMENT 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

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.)

Amendment 1 to this solicitation is being issued to:

1. Make changes to FAR clauses and provisions as required by new Executive Orders.

2. Update dates for Phase I of the solicitation process.

3. This amendment includes the SF33 for signature, the SF30 for signature, and amended solicitation using track changes.

4. Copy of the amendment with all changes accepted.

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) 16A. NAME OF CONTRACTING OFFICER

Jennifer Gartzke

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA

BY ___________________________________________

(Signature of Contracting Officer)

16C. DATE SIGNED

ITEM 10A.

15A. NAME

AND

ADDRESS

OF

OFFEROR

PAGES

(Type or Print)

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:

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

2 77

2. CONTRACT NO.

3. SOLICITATION NO.

75D30125R73235

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

01/16/2025

6. REQUISITION/PURCHASE NO.

000HCJC1-2025-90234

7. ISSUED BY CODE 8219 8. ADDRESS OFFER TO (If other than Item 7) Centers for Disease Control and Prevention

Chamblee Campus Building 102, MS S102-4 4770 Buford Hwy Atlanta, GA 30341-3717

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 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 Chamblee Campus 4770 Buford Hwy Atlanta, GA 30341 until 2:00pm local time 05/22/2025

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

Jennifer Gartzke

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(404) 498-0020

C. E-MAIL ADDRESS

jgartzke@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 39

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

X C DESCRIPTION/SPECS./WORK STATEMENT 11 J LIST OF ATTACHMENTS 0

D PACKAGING AND MARKING PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 20 REPRESENTATIONS, CERTIFICATIONS, AND 41

X F DELIVERIES OR PERFORMANCE 21 X K OTHER STATEMENTS OF OFFERORS

X G CONTRACT ADMINISTRATION DATA 22 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 58

X H SPECIAL CONTRACT REQUIREMENTS 27 X M EVALUATION FACTORS FOR AWARD 71

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 15948 25. PAYMENT WILL BE MADE BY CODE 15948 OFR - Office of Acquisition Services Chamblee Campus Building 102 4770 Buford Highway Atlanta, GA 30341

OFR - Office of Acquisition Services Chamblee Campus Building 102 4770 Buford Highway Atlanta, GA 30341

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.

K

Section B - Supplies or Services and Prices/Costs

Base Period August 8, 2025 – August 7, 2026

ITEM SUPPLIES / SERVICES QTY /

UNIT

UNIT PRICE Total FFP Price

0001 Provide Sample Testing Services for CDC as outlined in the Performance Work Statement set forth in Section C.

• This is a FFP Line item

• This is a Severable Line Item

Period of Performance (POP): 08/08/2025 – 08/07/2026 Base Period

6,000 tests $______________ $______________

ITEM SUPPLIES / SERVICES QTY /

UNIT PRICE Total NTE Price

0002 Travel

This is a reimbursable CLIN for travel as outlined in Section C.

There is no conference travel allowed.

Period of Performance (POP): 08/08/2025 –

1 Each $______________ $______________

OPTIONAL CLINs

ITEM SUPPLIES / SERVICES EST.

COST

FIXED FEE TOTAL EST. CPFF

0003 Optional Task 1 – Gap Analysis Design, validate and deliver an improved serology assay to CDC as outlined in the Performance Work Statement set forth in Section C.

• This is a CPFF completion Line item

• This is a Non-Severable Line Item

Period of Performance (POP): 08/08/2025 – 08/07/2026 Base Period

0004 Optional Task 2 – Assay Development Design, validate and deliver an improved serology assay to CDC as outlined in the Performance Work Statement set forth in Section C.

• This is a CPFF completion Line item

• This is a Non-Severable Line Item

Period of Performance (POP): 08/08/2025 –

0005 OPTIONAL CLIN: Surge Support

Provide Sample Testing Services for CDC as outlined in the Performance Work Statement set forth in Section C. This is a surge CLIN for 50% above base levels.

• This is a FFP Line item

• This is a Severable Line Item

Period of Performance (POP): 08/08/2025 – 08/07/2026 Base Period

9,000 tests $______________ $______________

0006 OPTIONAL CLIN: Surge Support Provide Sample Testing Services for CDC as outlined in the Performance Work Statement set forth in Section C. This is a surge CLIN for 75% above base levels.

• This is a FFP Line item

• This is a Severable Line Item

Period of Performance (POP): 08/08/2025 – 08/07/2026 Base Period

10,500 tests

BASE PERIOD TOTAL: __________________

Option Period 1 August 8, 2026 – August 7, 2027

ITEM SUPPLIES / SERVICES QTY /

1001 Provide Sample Testing Services for CDC as forth in Section C.

• This is a FFP Line item

• This is a Severable Line Item

Period of Performance (POP): 08/08/2026 –

08/07/2027 OP1

1002 Travel in Section C.

There is no conference travel allowed.

Period of Performance (POP): 08/08/2026 –

COST

FIXED FEE TOTAL EST. CPFF

1003 Optional Task 1 – Gap Analysis Design, validate and deliver an improved serology assay to CDC as outlined in the Performance Work Statement set forth in Section C.

• This is a CPFF completion Line item

• This is a Non-Severable Line Item

Period of Performance (POP): 08/08/2026 –

08/07/2027 OP1

1004 Optional Task 2 – Assay Development Design, validate and deliver an improved serology assay to CDC as outlined in the Performance Work Statement set forth in Section C.

• This is a CPFF completion Line item

• This is a Non-Severable Line Item

Period of Performance (POP): 08/08/2026 –

1005 OPTIONAL CLIN: Surge Support outlined in the Performance Work Statement set forth in Section C. This is a surge CLIN for 50% above base levels.

• This is a FFP Line item

• This is a Severable Line Item

Period of Performance (POP): 08/08/2026 –

08/07/2027 OP1

9,000 tests $______________ $______________

1006 OPTIONAL CLIN: Surge Support Provide Sample Testing Services for CDC as outlined in the Performance Work Statement set forth in Section C. This is a surge CLIN for 75% above base levels.

• This is a FFP Line item

• This is a Severable Line Item

Period of Performance (POP): 08/08/2026 –

08/07/2027 OP1

10,500 tests

OPTION PERIOD 1 TOTAL: _______________________

Option Period 2 August 8, 2027 – August 7, 2028

2001 Provide Sample Testing Services for CDC as forth in Section C.

• This is a FFP Line item

• This is a Severable Line Item

Period of Performance (POP): 08/08/2027 –

08/07/2028 OP2

2002 Travel in Section C.

There is no conference travel allowed.

Period of Performance (POP): 08/08/2027 –

COST

FIXED FEE TOTAL EST. CPFF

2003 Optional Task 1 – Gap Analysis Design, validate and deliver an improved serology assay to CDC as outlined in the Performance Work Statement set forth in Section C.

• This is a CPFF completion Line item

• This is a Non-Severable Line Item

Period of Performance (POP): 08/08/2027 –

08/07/2028 OP2

2004 Optional Task 2 – Assay Development Design, validate and deliver an improved serology assay to CDC as outlined in the Performance Work Statement set forth in Section C.

• This is a CPFF completion Line item

• This is a Non-Severable Line Item

Period of Performance (POP): 08/08/2027 –

2005 OPTIONAL CLIN: Surge Support outlined in the Performance Work Statement set forth in Section C. This is a surge CLIN for 50% above base levels.

• This is a FFP Line item

• This is a Severable Line Item

Period of Performance (POP): 08/08/2027 –

08/07/2028 OP2

9,000 tests $______________ $______________

2006 OPTIONAL CLIN: Surge Support Provide Sample Testing Services for CDC as outlined in the Performance Work Statement set forth in Section C. This is a surge CLIN for 75% above base levels.

• This is a FFP Line item

• This is a Severable Line Item

Period of Performance (POP): 08/08/2027 –

08/07/2028 OP2

10,500 tests

OPTION PERIOD 2 TOTAL: ___________________

Option Period 3 August 8, 2028 – August 7, 2029

ITEM SUPPLIES / SERVICES QTY /

3001 Provide Sample Testing Services for CDC as forth in Section C.

• This is a FFP Line item

• This is a Severable Line Item

Period of Performance (POP): 08/08/2028 –

08/07/2029 OP3

3002 Travel in Section C.

There is no conference travel allowed.

Period of Performance (POP): 08/08/2028 –

COST

FIXED FEE TOTAL EST. CPFF

3003 Optional Task 1 – Gap Analysis Design, validate and deliver an improved serology assay to CDC as outlined in the Performance Work Statement set forth in Section C.

• This is a CPFF completion Line item

• This is a Non-Severable Line Item

Period of Performance (POP): 08/08/2028 –

08/07/2029 OP3

3004 Optional Task 2 – Assay Development Design, validate and deliver an improved serology assay to CDC as outlined in the Performance Work Statement set forth in Section C.

• This is a CPFF completion Line item

• This is a Non-Severable Line Item

Period of Performance (POP): 08/08/2028 –

3005 OPTIONAL CLIN: Surge Support outlined in the Performance Work Statement set forth in Section C. This is a surge CLIN for 50% above base levels.

• This is a FFP Line item

• This is a Severable Line Item

Period of Performance (POP): 08/08/2028 –

08/07/2029 OP3

9,000 tests $______________ $______________

3006 OPTIONAL CLIN: Surge Support Provide Sample Testing Services for CDC as outlined in the Performance Work Statement set forth in Section C. This is a surge CLIN for 75% above base levels.

• This is a FFP Line item

• This is a Severable Line Item

Period of Performance (POP): 08/08/2028 –

08/07/2029 OP3

10,500 tests

OPTION PERIOD 3 TOTAL: __________________

Option Period 4 August 8, 2029 – August 7, 2030

4001 Provide Sample Testing Services for CDC as forth in Section C.

• This is a FFP Line item

• This is a Severable Line Item

Period of Performance (POP): 08/08/2029 –

08/07/2030 OP4

4002 Travel in Section C.

There is no conference travel allowed.

Period of Performance (POP): 08/08/2029 –

08/07/2030 OP4

COST

FIXED FEE TOTAL EST. CPFF

4003 Optional Task 1 – Gap Analysis Design, validate and deliver an improved serology assay to CDC as outlined in the Performance Work Statement set forth in Section C.

• This is a CPFF completion Line item

• This is a Non-Severable Line Item

Period of Performance (POP): 08/08/2029 –

08/07/2030 OP4

4004 Optional Task 2 – Assay Development Design, validate and deliver an improved serology assay to CDC as outlined in the Performance Work Statement set forth in Section C.

• This is a CPFF completion Line item

• This is a Non-Severable Line Item

Period of Performance (POP): 08/08/2029 –

08/07/2030 OP4

OPTION PERIOD 4 TOTAL: ___________________

CONTRACT TOTAL: _________________________

4005 OPTIONAL CLIN: Surge Support outlined in the Performance Work Statement set forth in Section C. This is a surge CLIN for 50% above base levels.

• This is a FFP Line item

• This is a Severable Line Item

Period of Performance (POP): 08/08/2029 –

08/07/2030 OP4

9,000 tests $______________ $______________

4006 OPTIONAL CLIN: Surge Support Provide Sample Testing Services for CDC as outlined in the Performance Work Statement set forth in Section C. This is a surge CLIN for 75% above base levels.

• This is a FFP Line item

• This is a Severable Line Item

Period of Performance (POP): 08/08/2029 –

08/07/2030 OP4

10,500 tests

ESTIMATED TOTAL VALUE

WITH ALL OPTIONS AND

CLIN Firm Fixed Price (if applicable)

Estimated Cost (CPFF)

Fixed Fee

(CPFF)

Total Estimated

CPFF

Base Period Total (Travel, Surge CLINs, base work)

0001, 0002, 0005, N/A N/A N/A

Base Period CPFF: Total 0003, N/A $___________

Option Period 1 Total (Travel, Surge CLINs, base work)

1001, 1002, 1005, N/A N/A N/A

Option Period 1 CPFF: Total 1003, N/A $___________

Option Period 2 Total (Travel, Surge CLINs, base work)

2001, 2002, 2005, N/A N/A N/A

Option Period 2 CPFF: Total 2003, N/A

Option Period 3 Total (Travel, Surge CLINs, base work)

3001, 3002, 3005, N/A N/A N/A

Option Period 3 CPFF: Total 3003, N/A $___________

Option Period 4 Total (Travel, Surge CLINs, base work)

4001, 4002, 4005, N/A N/A N/A

Option Period 4 CPFF: Total 4003, N/A $___________

TOTAL VALUE $_____________

Base Period $__________ Option Period 1 $__________ Option Period 2 $__________ Option Period 3 $__________ Option Period 4 $__________

Total Estimated Value for the Base Period and Option Periods 1 through 4 $__________

B.1 Purpose The purpose of this contract is to provide services that fall within the scope of the work specified in Section C for the project entitled, “Serological Assays for the detection and characterization of influenza viruses.”

B.2 Contract Type and Services This is a competitive full and open procurement.

This acquisition is being competed in accordance with FAR Part 15 - Contracting by Negotiation. The NAICS Code is 325413 "In- Vitro Diagnostic Substance Manufacturing," with a small business size standard of 1,250.

This is a stand-alone, definitized contract to provide virus detection and characterization services. The Government will issue the contract as firm-fixed-price (FFP) with a cost-plus fixed fee (CPFF) completion optional tasks.

B.3 Performance-Based Preference Pursuant to FAR 37.102(a)(1), the Contracting Officer will use performance-based acquisition methods to the maximum extent practicable.

B.4 Travel Pricing Travel will be reimbursed at actual cost in accordance with the limitations set forth in FAR 31.205-46. Fee/profit shall not be applied to travel costs. Contractors may apply G&A to travel in accordance with the Contractor’s usual accounting practices consistent with FAR 31.2. Travel expenses may be identified under a separate CLIN which will be a direct reimbursable in accordance with Federal Travel Regulations on the specific contract.

B.5 Place of Work and Government-Furnished Material The majority of this work under this contract will be performed off-site at the Contractor’s location. Some work will take place on the CDC campus in Atlanta, GA. The government will provide the following:

• The protocol for serological testing

• Positive and negative antiserum, viruses and/or antigens for testing

• Two proficiency panels for testing per each period of performance

• Human samples for testing per each period of performance

B.6 Non-Personal Services Contract Statement This is a non-personal services contract as defined in Federal Acquisition Regulation (FAR) 37.101. The Government will evaluate the quality of support services provided but the Contractor retains control over its employees or agents. The contractor is solely responsible and liable for and expressly agrees to indemnify the Government with respect to any liability producing acts or omissions by it or by its employees.

B.7 Service Contract Act The Service Contract Act applies to this procurement and the wage determination will be incorporated into the final contract once the final place of performance has been determined.

B.8 OPTIONAL CLINs: Surge Support There may be instances where additional testing services are needed above the base 6,000 test level. Two optional surge lines have been added to each option period as well as the base period. One surge line is for 50% above the base level of 6,000 for a total of 9,000 tests. The second surge line is for 75% above the base level of 6,000 for a total of 10,500 tests. It is not possible to know if or when these optional lines would need to be exercised but they will not be exercised later than 180 days prior to the end of each period of performance.

CDCH.17 Option for Increased Quantity – Separately Priced Line Item – Services (July 2024) The Government may require the delivery of the numbered line item(s) under CLIN(s) 0003, 0004, 0005, 0006, 1003, 1004, 1005, 1006, 2003, 2004, 2005, 2006, 3003, 3004, 3005, 3006, 4003, 4004, 4005, and 4006, identified in the Schedule as option item(s), in the quantity and at the price stated in the Schedule, up to the maximum amount identified in the numbered line item. The Contracting Officer may exercise the option by written notice to the Contractor within ___six months prior to the end of the period of performance__; provided that the Government gives the Contractor a preliminary written notice of its intent at least _10_ days before the option period of performance begins.

Section C - Description/Specification/Work Statement

PERFORMANCE WORK STATEMENT (PWS)

Serological Assays for the Detection and Characterization of Influenza Viruses

SECTION 1: BACKGROUND AND NEED

The Influenza Division (ID) at the Centers for Disease Control and Prevention (CDC) is responsible for the detection and characterization of influenza viruses for the purposes of disease surveillance and vaccine strain selection. The Influenza Division is also responsible for influenza outbreak investigations, seasonal vaccine strain selections, and vaccine effectiveness studies. There are often situations where the influenza laboratories are not capable of completing research projects due to a significant outbreak or emergence of a new virus subtype thus requiring a shift of testing priorities. In these cases, serology assays such as Hemagglutinin Inhibition (HAI) assay, need to be outsourced to public study results that can inform and address vaccine strain selection and vaccine effectiveness questions.

HAI assay has been in existence for over 70 years because it is easy to perform. However, this assay is difficult to make mobile and standardize because it relies on the use of red blood cells, antisera dilutions, and humans to read the test results. Development of new and improved serology assays that are comparable to the traditional HAI, is also necessary to help support the detection of emerging influenza viruses in a timely manner. These new assays should have the capability of using high throughput technology to keep with the pace of testing demands associated with global influenza surveillance. Development of these new assays requires thorough validation (i.e., testing against different influenza subtypes, testing against live or either β-Propiolactone (BPL) or ether treated viruses, etc.) to ensure equal or better sensitivity and specificity than the HAI assay.

SECTION 2: PURPOSE

The objective of this contract is to support the Influenza Division through the testing of human sera via hemagglutination inhibition assay as well as develop a new serology platform that is comparable to hemagglutination inhibition assay.

SECTION 3: SCOPE OF WORK

This contract is for one 12-month base period, and four, 12-month option periods for the testing of immunological responses of human samples collected from vaccine effectiveness studies of seasonal and pandemic influenza vaccine, randomized controlled trials of influenza vaccines, and/or outbreak investigations using HAI assay. The testing of human samples will be done in batches and is dependent upon completion of studies or outbreak investigations. The government will provide the schedules for the delivery of the study samples at contract award, if samples are already collected, or two months prior to the study completion. The government will provide standard operating procedures (SOPs) for assay creation to the contractor. The government will also provide two proficiency panels per each period of performance, within the contract performance period as well as positive and negative controls to the contractor, to confirm proper assay performance by contractor technicians. Samples shall be evaluated using government furnished seasonal influenza viruses and/or antigens.

In addition to the core requirement above, the contract also consists of an optional task for the development and validation of a new serology assay comparable to HAI. The government will provide positive and negative controls to the contractor as well as seasonal influenza viruses and/or antigens to validate assay and compare its sensitivity and specificity against HAI.

Independently, and not as an agent of the government, the contractor shall furnish all necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the government, as needed to perform the tasks below.

SECTION 4: TASKS TO BE PERFORMED - TECHNICAL REQUIREMENTS

CORE Requirements

A. SAMPLE TESTING:

Following HAI assay SOP transfer and proficiency panel testing, the contractor shall perform HAI serological assays on human samples. The approximate base level number of samples to be tested per year is 6,000. However, because of the need to quickly attend to outbreak responses and other time sensitive vaccine research questions, additional Surge Options will be created per period of performance (POP) at 50% and 75% above base level of samples. There may be instances where the base level of samples (6,000 samples per POP) and additional levels of serum samples (9,000 and 10,500 samples per POP) may need to run concurrently due to overlapping priorities/studies. These optional surge lines will be exercised no later than 180 days prior to the end of each period of performance. For technical and business proposals, a sample run is defined as the duplicate testing of a sample against a virus or antigen. All laboratory tasks in this contract are expected to take place in a Biosafety Level (BSL) 2 laboratory..

The contractor shall perform an analysis of serum samples by HAI assay using up to seven viruses and/or antigens and document the results to the CDC. Prior to initiation of task, up to four contractor staff will receive a one-week HAI assay training by CDC staff either at CDC or at the contractor’s facility.

The contractor shall complete all requirements specified under Tasks 1 through 3 for the base period and all option periods.

1. Task 1: SOP development and Proficiency Panels

a. Contractor shall provide HAI assay protocols for CDC to review. CDC will review and either return for revision or approve within seven calendar days of receipt. Contractor shall return revised/finalized deliverable within seven calendar days of receipt.

b. Contractor shall provide proficiency panel reports for all serological analysts performing sample testing, to demonstrate successful technology transfer of the SOP from the government to the contractor. This report must be in a digital format and submitted within 14 calendar days of proficiency panel submission by the government. CDC will review and either return for revision or approve within seven calendar days of receipt. Contractor shall return revised deliverable within seven calendar days of receipt.

c. The contractor shall supplement their quality program with comparable proficiency panels if the two panels provided by the government are not sufficient for training staff. The government has the right to inspect the contractor developed comparable panels to ensure they meet the quality and rigor of the government provided proficiency panels.

2. Task 2: Sample testing

a. Contractor shall coordinate the receipt and storage of samples for testing, for retest, and return of residual samples to the government before the final study report is submitted to the government. The study specimens will be applied in batches by the government.

b. Prior to testing human samples, contractor shall communicate with COR and/or government subject matter expert (SME) for technical requirements, including but not limited to testing of acute/convalescent or pre-vaccination/post-vaccination samples on the same HAI plate, duplicate testing, number of positive and negative controls to include on the assay, number of virus back-titrations to include on the assay, and others. These communications are to be completed via teleconference with the government prior to any study initiation. Further, the contractor shall document and share requirements in meeting minutes.

c. The contractor shall seek sources for red blood cells, including but not limited to chicken, turkey, horse, and guinea pig. The contractor shall also seek sources for Receptor Destroying Enzyme (RDE).

d. Samples may need to be repeated if the assays yield unexpected results. Unexpected results could include but are not limited to positive/negative controls and virus back titrations are out of expected ranges, more than two-fold differences between duplicate titers, specific assay did not provide an end point titer for the samples (i.e., ≥ 2560 or ≥ 5120 pending on initial sample dilution assuming samples are being diluted vertically and not horizontally), post-vaccination titers are lower than pre-vaccination titers, etc.

e. Contractor shall conduct all assays in accordance with the SOP, ensure that controls are included in the assay and yield the correct result. The contractor shall perform quality control on all assay results prior to submitting to government for review.

f. Contractor shall perform control assays and trend analysis to monitor assay performance and submit these as an Appendix on the final report to the government.

g. Contractor shall submit results from assays performed electronically to the COR and/or SME within 14 calendar days of completion of the studies as an interim report (see Task 3). Studies are considered complete when all the results from the samples in a specific study or group of samples as defined by the COR and SME have been reviewed and confirmed that any unexpected results have been resolved and controls fall within the expected range per the SOP. Contractor shall submit a final report as described in Task 3.

h. The contractor shall ship all unused samples, viruses, and antigens to the government at study completion.

If the government chooses to have the contractor dispose of the material, specific disposal instructions will be provided. In that event, confirmation from the contractor must be submitted in writing to the government that the disposal of materials was completed. This is optional and may not be needed and shall not be priced in the proposal.

3. Task 3: Result reporting

a. Contractor shall prepare an interim technical report for each study supported under Task 2. This interim report shall be provided in a digital format to the COR and SME for review.

b. Contractor shall prepare a final technical summary report for each period of performance summarizing sample testing including salient accomplishments or issues and their resolution, overall assessment of planned versus actual costs, overall and summary assessment of contractor and subcontractor performance, high-level recommendations for improving the process, and other information as required by the COR or the COR designee. A draft technical summary report shall be provided for review to the COR and shall be finalized upon COR approval, assuming one round of revision. CDC will review and either return for revision or approve within 14 calendar days of receipt. Contractor shall return revised/finalized deliverable within seven calendar days of receipt.

B. PROJECT MANAGEMENT: (Task 4)

1. Contractor shall coordinate a virtual kickoff meeting, develop agenda, and document notes from the meeting. The kickoff meeting shall include project stakeholders including but not limited to government’s SME, the COR, the CO, contractor’s Project Manager, and contractor’s Principal Investigator. Topics to be included in the kickoff meeting include cadence for meetings, logistics for shipping of samples and/or government furnished materials, agenda topics for the study initiation calls, personnel participating in the study initiation calls, etc. The contractor shall provide the COR/SME a copy of the kickoff meeting notes.

2. Contractor shall coordinate meetings prior to testing initiation for each study and shall document notes from the meeting, provide the COR/SME a copy of the notes, and include the notes in the report for the study.

3. The Principal Investigator (or equivalent) shall be responsible for overall compliance with quality requirements, project management and communication, tracking costs and performance, monitoring, and reporting on project status and progress, and recommending modifications to project requirements and timelines, including projects undertaken by subcontractors.

4. Key personnel or other senior staff coordinator(s) shall be available for meetings/teleconferences with the COR and/or Project Investigator or Co-Project Investigator within one business day of a meeting request.

5. Contractor shall provide oral presentations/teleconferences with updates on the status of assigned activities at least biweekly (twice per month) or as needed. Contractor shall document these updates in agendas and meeting notes and share with COR and SME.

6. Contractor shall participate in the preparation of information for peer-reviewed journals and scientific conferences and meetings.

7. By no later than 30 calendar days prior to the completion of each period of performance of the contract, the contractor shall submit a draft annual report to the COR to document work performed during each period of performance. Within 14 calendar days of receipt, the COR will provide review comments to the contractor, to be addressed and/or incorporated into the contractor’s final annual report. Contractor shall return revised deliverable within 14 business days. The annual report must include the following:

a. A cover page containing the following:

1. Contract number and title

2. Period covered by the report

3. Contractor’s name and address

4. Author(s)

5. Date of submission

6. If report is a revision from a previous submitted report, this should also be noted in the cover page

b. Technical progress or accomplishments made during the reporting period.

c. Task schedule status.

d. Travel conducted and meetings attended during the reporting period.

e. Problems experienced during the reporting period and contractor actions to remedy these problems.

f. Problems anticipated in future reporting periods and recommendations to remedy anticipated problems.

g. Performance against the PWS requirements.

h. Deliverables funded and date they were funded.

i. Deliverables scheduled to be completed in the upcoming month.

j. Report on current operational status of any government furnished equipment at the contractor facility, to include status of any requests for repair or replacement.

k. Discussion of any technical or administrative problems encountered during the reporting period, contractor actions taken to resolve, status, projected date of resolution and government assistance that may be required to resolve.

8. Subcontract Award and Management:

a. If it is determined that HAI testing must be subcontracted, the contractor shall identify outside sources for services required for the contract activities.

b. Contractor shall conduct reviews and selection of subcontractors in compliance with FAR Clause

52.244-2.

OPTIONAL TASKS:

The goal of these optional tasks is to design, validate and deliver an improved serology assay that is comparable to the traditional HAI. The assay should have the capability of using high throughput technology to detect influenza subtype-specific antibody for antigenic characterization. This assay shall also characterize viruses within a subtype as either normal reactors (0 to 4-fold lower than reference virus or vaccine strain) or low-reactors (8-fold or more-lower than reference virus or vaccine strain). The contractor shall conduct experiments with the primary goal of creating a platform that meets the technical requirements outlined below.

The contractor shall complete all requirements specified under Optional Tasks 1 and 2. This optional task is cost plus fixed fee. The CDC will exercise this optional task no later than 30 days prior to the end of the current period of performance if it wishes to do so.

1. Task 1: Gap analysis

a. The contractor shall perform a gap analysis in the form of literature searches as well as contact technology companies and experts in the field to determine scientific knowledge gaps and evaluate existing technology that can be applied to this task.

b. Contractor shall provide oral presentations/teleconferences with updates on the status of assigned activities at least biweekly (twice per month) or as needed.

c. To document roadmap for the development of new serological assay, contractor shall develop a report following biweekly calls with the government, outlining the various designs discussed during the biweekly calls and the final design approved by the government. This draft technical proposal shall be reviewed by the COR and SME. This report will be finalized upon COR approval and prior to initiating assay development. CDC will review and either return for revision or approve within 14 calendar days of receipt. Contractor shall return revised deliverable within seven calendar days of receipt.

2. Task 2: Assay development

a. The contractor shall seek sources needed to develop and perform assay including but not limited to red blood cells and RDE.

b. The government will provide positive and negative controls to the contractor as well as seasonal influenza viruses and/or antigens to validate assay and compare its sensitivity and specificity against HAI.

c. Contractor shall perform control assays and trend analysis to monitor assay performance against HAI and submit these as an Appendix on the final report to the government.

d. Contractor shall develop and share SOP with government for the newly designed assay. Contractor shall also provide one-week assay training of up to four CDC staff at CDC’s facility, including a hands-on assay performance by CDC staff to demonstrate successful technology transfer of the SOP from the contractor to the government. CDC will review and either return for revision or approve within 14 calendar days of receipt. Contractor shall return revised deliverable within seven calendar days of receipt.

e. Contractor shall submit all assay comparisons to HAI as an Appendix on the final report to the government.

SECTION 5: GOVERNMENT FURNISHED MATERIALS

• The government will provide protocol for serological testing.

• The government will provide positive and negative antiserum, viruses and/or antigens for testing.

• The government will provide two proficiency panels for proficiency testing per period of performance.

• The government will provide human samples for testing.

SECTION 6: PERIOD OF PERFORMANCE

Base Period: August 8, 2025 – August 7, 2026 Option Period 1: August 8, 2026 – August 7, 2027 Option Period 2: August 8, 2027 – August 7, 2028 Option Period 3: August 8, 2028 – August 7, 2029 Option Period 4: August 8, 2029 – August 7, 2030

SECTION 7: DELIVERABLES/REPORTING SCHEDULE

Deliverables shall be delivered to the government electronically via email with attachments in Word or Excel format.

CORRESPONDING

TASK

DELIVERABLE

DESCRIPTION

QTY/FORMAT DUE DATE DELIVER TO

4 Kickoff Meeting Minutes

Kickoff Meeting agenda

Word 10 calendar days after award

CO, COR

4 Biweekly Status Updates Minutes

Starting 30 calendar days after award

COR, SME

1 HAI SOP Word 21 calendar days after contract award

COR, SME

1 Serological Proficiency Test

Results

Excel Within 14 calendar days of proficiency panel submission

COR, SME

3 Sample Serological Test Results

Excel Submitted periodically, agreed upon the government and the contractor

COR, SME

Optional Task, Task 1 Gap Analysis Technical Proposal

Word / Excel As agreed upon the government

COR, SME

and the contractor

Optional Task, Task 2 Newly Designed Serology Assay SOP

Word Upon completion and validation of assay development

COR, SME

4 Annual Report Word / Excel 30 calendar days after the end of the POP

COR

2 Return of Human Samples, Viruses and/or Antigens or Confirmation of

Material Disposal

Overnight shipment

Upon completion of study or sample testing

COR

SECTION 8: SPECIAL CONSIDERATIONS:

Place of Performance: It is estimated that the work will be performed off-site at the contractor’s facility except for the Optional Project training (one-week assay training at CDC). The contractor shall be responsible for adherence to all applicable safety and Animal Plant Health Inspection Service (APHIS) / CDC select agent regulations.

Travel:

The contractor shall maintain a summary of all approved travel, to include at a minimum, the name of the traveler, location of travel, duration of trip, purpose/objective, and total cost of the trip.

The contractor shall make all necessary arrangements and reimburse employees and associated participants for domestic travel hereunder. Local travel is anticipated, no more than two trips for the duration of the contract, within United States. The purpose of the travel will be to perform work under this contract, including attendance to conferences and meetings. The expected duration of each trip (length of stay) is expected to be a minimum of one day and maximum of five days inclusive of travel days.

Up to four contract staff shall be prepared to travel and attend an in-person meeting and participate in training for HAI assay.

Up to three contract staff shall be prepared to travel and attend an in-person meeting and participate in the training of CDC staff on new serological assay.

Travel Table:

CLIN DESTINATION DURATION

(DAYS)

# TRIPS #STAFF

PER TRIP

PURPOSE

1 Atlanta, Georgia 5 days 1 Up to 4 Training for HAI Assay

2 Atlanta, Georgia 5 days 1 Up to 3 CDC staff training on new assay

Electronic and Information Technology Accessibility

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-aboard.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.

205 WCAG 2.0 Level A & AA Success Criteria 302 Functional Performance Criteria 502 Inoperability with Assistive Technology 504 Authoring Tools 602 Support Documentation 603 Support Services

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues.

Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section- 508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

SECTION 9: PERFORMANCE MATRIX:

The Performance Matrix is the portion of the PWS that explains to the contractor what the government’s expectations are, and how (and how often) deliverables or services will be monitored and evaluated. It also spells out any incentives that would encourage the contractor to exceed the performance standards. It also imposes negative incentives when the outputs/outcomes are below the performance standards.

http://www.hhs.gov/web/508 http://www.access-aboard.gov/sec508/standards.htm http://hhs.gov/web/508 http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html

REQUIRED

SERVICES

SLA

PERFORMANCE

STANDARD

(Completeness, Cost, Reliability, Accuracy, Timeliness, and Quality)

ACCEPTABLE

QUALITY

LEVEL (AQL)

MONITORING

METHOD

(QUALITY

ASSURANCE

SURVEILLANCE

PLAN OR QASP)

INCENTIVES /

DISINCENTIVES

Complete Documentation

Quality and Timeliness

97% Accuracy Date of delivery and COR/program/SME review for quality, weekly progress reviews and reports

Favorable or Unfavorable Performance Evaluation

Full payment according to payment schedule

Kickoff Meeting

Quality and Timeliness

99% on schedule Date of delivery and COR/program/SME review for quality

Favorable or Unfavorable

Return of Human Samples

Timeliness, Quality and Cost

99% on schedule Date of delivery and COR/program/SME review for quality

Favorable or Unfavorable

Training of CDC Staff

Timeliness, Completeness, Quality

99% on schedule Date of delivery and COR/program/SME review for quality

Favorable or Unfavorable

Section D - Packaging and Marking

There are no clauses/provisions included in this section.

Section E - Inspection and Acceptance

E.1 52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at the address below:

www.acquisition.gov

(End of Clause)

FAR SOURCE TITLE AND DATE

52.246-4 Inspection of Services - Fixed-Price (Aug 1996) 52.246-5 Inspection of Services-Cost-Reimbursement (Apr 1984)

Section F - Deliveries or Performance

FAR SOURCE TITLE AND DATE

52.242-15 Stop-Work Order (Aug 1989)

52.242-15, ALT. I Stop-Work Order (Apr 1984)

52.242-17 Government Delay of Work (Apr 1984)

Section G - Contract Administration Data

G.1 HHSAR 352.232-71: Electronic Submission of Payment Requests (Feb 2022)

(a) Definitions. As used in this clause—

(1) “Payment request” means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer’s written authorization with each payment request.

(End of clause)

G.2 Contract Representatives:

• Contracting Officer (CO) and Contract Specialist (CS) responsible for this contract:

Jennifer Gartzke Office of Acquisition Services (OAS) Office of Financial Resources (OFR) Office of the Chief Operating Officer (OCOO) Centers for Disease Control and Prevention (CDC) Atlanta, GA 30341-4146 JGartzke@cdc.gov | 404-498-0020

• Contracting Officer’s Representative responsible for this contract:

TBD

Centers for Disease Control and Prevention (CDC)

G.3 CDCG.02 Contracting Officer’s Representative (Jul 2017)

Performance of the work hereunder shall be subject to the technical directions of the designated COR for this contract.

As used herein, technical directions are…