RFP_2015-N-17131.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)

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

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 95

2. CONTRACT NO.

3. SOLICITATION NO.

2015-N-17131

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

6. REQUISITION/PURCHASE

NO.

00HCVGD1-2016-80791

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

Centers for Disease Control and Prevention

Procurement and Grants Office

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 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 until 12:00p EST local time 09/08/2015

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

Thaddeus Rollins

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-1971

C. E-MAIL ADDRESS

tnr6@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 72

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

X C DESCRIPTION/SPECS./WORK STATEMENT 14 X J LIST OF ATTACHMENTS 81

X D PACKAGING AND MARKING 54 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 55 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 56 X K OTHER STATEMENTS OF OFFERORS 82

X G CONTRACT ADMINISTRATION DATA 57 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 86

X H SPECIAL CONTRACT REQUIREMENTS 65 X M EVALUATION FACTORS FOR AWARD 94

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 8219 25. PAYMENT WILL BE MADE BY CODE 434

Centers for Disease Control and Prevention (CDC)

Procurement and Grants Office (PGO)

2920 Brandywine Road 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 B - Supplies Or Services And Prices/Costs

“Subject to the Availability of Funds”

Base Year: 09/30/15 – 09/29/16

SUPPLIES / SERVICES

POP=Period of Performance

QTY/UNIT

EST.

COST

FIXED FEE

TOTAL

EST.

CPFF

0001 Project Management 1/Job $_________ $__________ $_______

0002-1 Field Immunity Test (FIIT) Development

Studies 1/Job $_________ $__________ $_______

0002-1A FIIT Cartridge Optional 2500/Each $_________ $__________ $_______

0002-2 New Platform Replace FIIT Optional 1/Job $_________ $__________ $_______

0002-2A FIIT Cartridge New Platform Option 2500/Each $_________ $__________ $_______

0003-1 High Throughput Influenza Lab

Immunity Test (HTILIT) 1/Job $_________ $__________ $_______

0003-1A HTILIT Cartridges Optional 2500/Each $_________ $__________ $_______

0003-2 New Platform Replace (HTILIT)

Optional 1/Job $_________ $__________ $_______

0003-2A HTILIT Cartridges, New Platform

Optional 2500/Each $_________ $__________ $_______

Develop Quantitative ELISAs Vaccine

Potency Optional 1/Job $_________ $__________ $_______

Synthetic Hemagglutination Inhibition

(HI) Assay Optional 1/Job $_________ $__________ $_______

0006 Automation of HI Assay Optional 1/Job $_________ $__________ $_______

Biennial Acq. Sera Seroprevalence Est.

Optional (POP=120 days) 1/Job $_________ $__________ $_______

0008-1

Sanger Sequencing Testing of Patient

Specimens Optional Surge (1200 Virus

Isolates) Projects (POP=365 days)

1/Job $_________ $__________ $_______

0008-2

Sanger Sequencing (+7200 Virus

Isolates/month) Optional Surge

(POP=365 days)

1/Job $_________ $__________ $_______

0009-1 Serological Testing Patient HI (9600

Samples) Optional Surge (POP=365 days) 1/Job $_________ $__________ $_______

0009-2

Serological Testing HI (+62,400

Samples/month) Optional Surge

(POP=365 days)

1/Job $_________ $__________ $_______

0009-3

Serological Testing Patient HI (9600

Samples) Optional Surge in BSL3+ facility (POP=365 days)

1/Job $_________ $__________ $_______

0009-4

Serological Testing HI (+62,400

Samples/month) Optional Surge in

BSL3+ facility (POP=365 days)

1/Job $_________ $__________ $_______

POP=Period of Performance

QTY/UNIT

EST.

COST

FIXED FEE

TOTAL

EST.

CPFF

0010-1

Serological Testing Patient Specimen MN

(1600 Samples) Optional Surge in BSL2 facility (POP=120 days)

1/Job $_________ $__________ $_______

0010-2

Serolgical Testing MN (+10400 Samples)

Optional Surge in BSL2 facility

(POP=120 days)

1/Job $_________ $__________ $_______

0010-3

Serological Testing Patient Specimen MN

(1600 Samples) Optional Surge in BSL3+ facility (POP=120 days)

1/Job $_________ $__________ $_______

0010-4

Serolgical Testing MN (+10400 Samples)

Optional Surge in BSL3+ facility

(POP=120 days)

1/Job $_________ $__________ $_______

0011-1

Diagnostic/Serological Testing Infectious

Pathogen (800 Samples) Optional Surge in BSL3+ facility (POP=120 days)

1/Job $_________ $__________ $_______

0011-2

Diagnostic Testing Infectious Pathogen

(+2800 Samples) Optional Surge in

BSL3+ facility (POP=120 days)

1/Job $_________ $__________ $_______

0011-3

Diagnostic/Serological Testing Infectious

Pathogen (800 Samples) Optional Surge in BSL4 facility (POP=120 days)

1/Job $_________ $__________ $_______

0011-4

Diagnostic Testing Infectious Pathogen

(+2800 Samples) Optional Surge in BSL4 facility (POP=120 days)

1/Job $_________ $__________ $_______

0012-1 RT-PCR Testing Patients Specimen (3000

Samples) Optional Surge (POP=180 days) 1/Job $_________ $__________ $_______

0012-2 RT-PCR Testing (+6000 Samples)

Optional Surge (POP=180 days) 1/Job $_________ $__________ $_______

Sequencing IG (20 samples/10 month + up to 1000 Samples/2 months) Optional

Surge (POP=365 days)

1/Job $_________ $__________ $_______

Cell Mediated Immune Assess (640 total samples) Optional Surge (POP=210 days) 1/Job $_________ $__________ $_______

Antibody Binding Avidity Studies (640 total samples) (Optional Surge (POP=120 days)

1/Job $_________ $__________ $_______

NA Antibody Response and Antibody

Dependent (1800 total Samples) Optional

Surge (POP=180 days)

1/Job $_________ $__________ $_______

Total Price – Base Year

EST.

COST

FIXED FEE

TOTAL

EST.

CPFF

Option Year 1: 9/30/16 – 9/29/17

POP=Period of Performance

QTY/UNIT

EST.

COST

FIXED FEE

TOTAL EST.

CPFF

1001 Project Management 1/Job $_________ $__________ $__________

1002-1 Field Immunity Test (FIIT)

Development Studies 1/Job $_________ $__________ $__________

1002-1A FIIT Cartridge Optional 2500/Each $_________ $__________ $__________

1002-2 New Platform Replace FIIT Optional 1/Job $_________ $__________ $__________

1002-2A FIIT Cartridge New Platform Option 2500/Each $_________ $__________ $__________

1003-1 High Throughput Influenza Lab

Immunity Test (HTILIT) 1/Job $_________ $__________ $__________

1003-1A HTILIT Cartridges Optional 2500/Each $_________ $__________ $__________

1003-2 New Platform Replace (HTILIT)

Optional 1/Job $_________ $__________ $__________

1003-2A HTILIT Cartridges, New Platform

Optional 2500/Each $_________ $__________ $__________

Develop Quantitative ELISAs

Vaccine Potency Optional 1/Job $_________ $__________ $__________

Synthetic Hemagglutination

Inhibition (HI) Assay Optional 1/Job $_________ $__________ $__________

1006 Automation of HI Assay Optional 1/Job $_________ $__________ $__________

Biennial Acq. Sera Seroprevalence

Est. Optional (POP=120 days) 1/Job $_N/A__ $_N/A_ $_N/A__

1008-1

Sanger Sequencing Testing of Patient

Specimens Optional Surge (1200

Virus Isolates) Projects (POP=365 days)

1/Job $_________ $__________ $__________

1008-2

Sanger Sequencing (+7200 Virus

Isolates/month) Optional Surge

(POP=365 days)

1/Job $_________ $__________ $__________

1009-1

Serological Testing Patient HI (9600

Samples) Optional Surge (POP=365 days)

1/Job $_________ $__________ $__________

1009-2

Serological Testing HI (+62,400

Samples/month) Optional Surge

(POP=365 days)

1/Job $_________ $__________ $__________

1009-3

Serological Testing Patient HI (9600

Samples) Optional Surge in BSL3+ facility (POP=365 days)

1/Job $_________ $__________ $__________

1009-4

Serological Testing HI (+62,400

Samples/month) Optional Surge in

1/Job $_________ $__________ $__________

POP=Period of Performance

QTY/UNIT

EST.

COST

FIXED FEE

TOTAL

EST.

CPFF

1010-1

Serological Testing Patient Specimen

MN (1600 Samples) Optional Surge in BSL2 facility (POP=120 days)

1/Job $_________ $__________ $__________

1010-2

Serolgical Testing MN (+10400

Samples) Optional Surge in BSL2 facility (POP=120 days)

1/Job $_________ $__________ $__________

1010-3

Serological Testing Patient Specimen

MN (1600 Samples) Optional Surge in BSL3+ facility (POP=120 days)

1/Job $_________ $__________ $__________

1010-4

Serolgical Testing MN (+10400

Samples) Optional Surge in BSL3+ facility (POP=120 days)

1/Job $_________ $__________ $__________

1011-1

Diagnostic/Serological Testing

Infectious Pathogen (800 Samples)

Optional Surge in BSL3+ facility

(POP=120 days)

1/Job $_________ $__________ $__________

1011-2

Diagnostic Testing Infectious

Pathogen (+2800 Samples) Optional

Surge in BSL3+ facility (POP=120 days)

1/Job $_________ $__________ $__________

1011-3

Diagnostic/Serological Testing

Infectious Pathogen (800 Samples)

Optional Surge in BSL4 facility

(POP=120 days)

1/Job $_________ $__________ $__________

1011-4

Diagnostic Testing Infectious

Pathogen (+2800 Samples) Optional

Surge in BSL4 facility (POP=120 days)

1/Job $_________ $__________ $__________

1012-1

RT-PCR Testing Patients Specimen

(3000 Samples) Optional Surge

(POP=180 days)

1/Job $_________ $__________ $__________

1012-2 RT-PCR Testing (+6000 Samples)

Optional Surge (POP=180 days) 1/Job $_________ $__________ $__________

Sequencing IG (20 samples/10 month

+ up to 1000 Samples/2 months)

Optional Surge (POP=365 days)

1/Job $_________ $__________ $__________

Cell Mediated Immune Assess (640 total samples) Optional Surge

(POP=210 days)

1/Job $_________ $__________ $__________

Antibody Binding Avidity Studies

(640 total samples) (Optional Surge

(POP=120 days)

1/Job $_________ $__________ $__________

NA Antibody Response and

Antibody Dependent (1800 total

Samples) Optional Surge (POP=180 days)

1/Job $_________ $__________ $__________

POP=Period of Performance

QTY/UNIT

EST.

COST

FIXED FEE

TOTAL

EST.

CPFF

Total Price – Option Year 1

EST. COST FIXED FEE

TOTAL EST.

Option Year 2: 9/30/17 – 9/29/18

POP=Period of Performance

QTY/UNIT

EST.

COST

FIXED FEE

TOTAL

EST.

CPFF

2001 Project Management 1/Job $_________ $__________ $________

2002-1 Field Immunity Test (FIIT)

Development Studies 1/Job $_________ $__________ $________

2002-1A FIIT Cartridge Optional 2500/Each $_________ $__________ $________

2002-2 New Platform Replace FIIT Optional 1/Job $_________ $__________ $________

2002-2A FIIT Cartridge New Platform Option 2500/Each $_________ $__________ $________

2003-1 High Throughput Influenza Lab

Immunity Test (HTILIT) 1/Job $_________ $__________ $________

2003-1A HTILIT Cartridges Optional 2500/Each $_________ $__________ $________

2003-2 New Platform Replace (HTILIT)

Optional 1/Job $_________ $__________ $________

2003-2A HTILIT Cartridges, New Platform

Optional 2500/Each $_________ $__________ $________

Develop Quantitative ELISAs Vaccine

Potency Optional 1/Job $_________ $__________ $________

Synthetic Hemagglutination Inhibition

(HI) Assay Optional 1/Job $_________ $__________ $________

2006 Automation of HI Assay Optional 1/Job $_________ $__________ $________

Biennial Acq. Sera Seroprevalence Est.

Optional (POP=120 days) 1/Job $_________ $__________ $________

2008-1

Sanger Sequencing Testing of Patient

Specimens Optional Surge (1200 Virus

Isolates) Projects (POP=365 days)

1/Job $_________ $__________ $________

2008-2

Sanger Sequencing (+7200 Virus

Isolates/month) Optional Surge

(POP=365 days)

1/Job $_________ $__________ $________

2009-1

Serological Testing Patient HI (9600

Samples) Optional Surge (POP=365 days)

1/Job $_________ $__________ $________

2009-2

Serological Testing HI (+62,400

Samples/month) Optional Surge

(POP=365 days)

1/Job $_________ $__________ $________

2009-3

Serological Testing Patient HI (9600

Samples) Optional Surge in BSL3+ facility (POP=365 days)

1/Job $_________ $__________ $________

2009-4

Serological Testing HI (+62,400

Samples/month) Optional Surge in

1/Job $_________ $__________ $________

2010-1

Serological Testing Patient Specimen

MN (1600 Samples) Optional Surge in

BSL2 facility (POP=120 days)

1/Job $_________ $__________ $________

2010-2

Serolgical Testing MN (+10400 Samples)

Optional Surge in BSL2 facility

(POP=120 days)

1/Job $_________ $__________ $________

2010-3

Serological Testing Patient Specimen

MN (1600 Samples) Optional Surge in

BSL3+ facility (POP=120 days)

1/Job $_________ $__________ $________

2010-4

Serolgical Testing MN (+10400 Samples)

Optional Surge in BSL3+ facility

(POP=120 days)

1/Job $_________ $__________ $________

2011-1

Diagnostic/Serological Testing Infectious

Pathogen (800 Samples) Optional Surge in BSL3+ facility (POP=120 days)

1/Job $_________ $__________ $________

2011-2

Diagnostic Testing Infectious Pathogen

(+2800 Samples) Optional Surge in

BSL3+ facility (POP=120 days)

1/Job $_________ $__________ $________

2011-3

Diagnostic/Serological Testing Infectious

Pathogen (800 Samples) Optional Surge in BSL4 facility (POP=120 days)

1/Job $_________ $__________ $________

2011-4

Diagnostic Testing Infectious Pathogen

(+2800 Samples) Optional Surge in

BSL4 facility (POP=120 days)

1/Job $_________ $__________ $________

2012-1

RT-PCR Testing Patients Specimen

(3000 Samples) Optional Surge

(POP=180 days)

1/Job $_________ $__________ $________

2012-2 RT-PCR Testing (+6000 Samples)

Optional Surge (POP=180 days) 1/Job $_________ $__________ $________

Sequencing IG (20 samples/10 month + up to 1000 Samples/2 months) Optional

Surge (POP=365 days)

1/Job $_________ $__________ $________

Cell Mediated Immune Assess (640 total samples) Optional Surge (POP=210 days)

1/Job $_________ $__________ $________

Antibody Binding Avidity Studies (640 total samples) (Optional Surge

(POP=120 days)

1/Job $_________ $__________ $________

NA Antibody Response and Antibody

Dependent (1800 total Samples)

Optional Surge (POP=180 days)

1/Job $_________ $__________ $________

Total Price – Option Year 2

COST

FIXED FEE

TOTAL

EST.

Option Year 3: 9/30/18 – 9/29/19

POP=Period of Performance

QTY/UNIT EST. COST FIXED FEE

TOTAL EST.

CPFF

3001 Project Management 1/Job $_________ $__________ $___________

3002-1 Field Immunity Test (FIIT)

Development Studies 1/Job $_________ $__________ $___________

3002-1A FIIT Cartridge Optional 2500/Each $_________ $__________ $___________

3002-2 New Platform Replace FIIT Optional 1/Job $_________ $__________ $___________

3002-2A FIIT Cartridge New Platform Option 2500/Each $_________ $__________ $___________

3003-1 High Throughput Influenza Lab

Immunity Test (HTILIT) 1/Job $_________ $__________ $___________

3003-1A HTILIT Cartridges Optional 2500/Each $_________ $__________ $___________

3003-2 New Platform Replace (HTILIT)

Optional 1/Job $_________ $__________ $___________

3003-2A HTILIT Cartridges, New Platform

Optional 2500/Each $_________ $__________ $___________

Develop Quantitative ELISAs Vaccine

Potency Optional 1/Job $_________ $__________ $___________

Synthetic Hemagglutination Inhibition

(HI) Assay Optional 1/Job $_________ $__________ $___________

3006 Automation of HI Assay Optional 1/Job $_________ $__________ $___________

Biennial Acq. Sera Seroprevalence

Est. Optional (POP=120 days) 1/Job $_N/A__ $_N/A_ $_N/A__

3008-1

Sanger Sequencing Testing of Patient

Specimens Optional Surge (1200 Virus

Isolates) Projects (POP=365 days)

1/Job $_________ $__________ $___________

3008-2

Sanger Sequencing (+7200 Virus

Isolates/month) Optional Surge

(POP=365 days)

1/Job $_________ $__________ $___________

3009-1

Serological Testing Patient HI (9600

Samples) Optional Surge (POP=365 days)

1/Job $_________ $__________ $___________

3009-2

Serological Testing HI (+62,400

Samples/month) Optional Surge

(POP=365 days)

1/Job $_________ $__________ $___________

3009-3

Serological Testing Patient HI (9600

Samples) Optional Surge in BSL3+ facility (POP=365 days)

1/Job $_________ $__________ $___________

POP=Period of Performance

QTY/UNIT EST. COST FIXED FEE

TOTAL EST.

CPFF

3009-4

Serological Testing HI (+62,400

Samples/month) Optional Surge in

BSL3+ facility (POP=365 days)

1/Job $_________ $__________ $___________

3010-1

Serological Testing Patient Specimen

MN (1600 Samples) Optional Surge in

BSL2 facility (POP=120 days)

1/Job $_________ $__________ $___________

3010-2

Serolgical Testing MN (+10400

Samples) Optional Surge in BSL2 facility (POP=120 days)

1/Job $_________ $__________ $___________

3010-3

Serological Testing Patient Specimen

MN (1600 Samples) Optional Surge in

BSL3+ facility (POP=120 days)

1/Job $_________ $__________ $___________

3010-4

Serolgical Testing MN (+10400

Samples) Optional Surge in BSL3+ facility (POP=120 days)

1/Job $_________ $__________ $___________

3011-1

Diagnostic/Serological Testing

Infectious Pathogen (800 Samples)

Optional Surge in BSL3+ facility

(POP=120 days)

1/Job $_________ $__________ $___________

3011-2

Diagnostic Testing Infectious

Pathogen (+2800 Samples) Optional

Surge in BSL3+ facility (POP=120 days)

1/Job $_________ $__________ $___________

3011-3

Diagnostic/Serological Testing

Infectious Pathogen (800 Samples)

Optional Surge in BSL4 facility

(POP=120 days)

1/Job $_________ $__________ $___________

3011-4

Diagnostic Testing Infectious

Pathogen (+2800 Samples) Optional

Surge in BSL4 facility (POP=120 days)

1/Job $_________ $__________ $___________

3012-1

RT-PCR Testing Patients Specimen

(3000 Samples) Optional Surge

(POP=180 days)

1/Job $_________ $__________ $___________

3012-2 RT-PCR Testing (+6000 Samples)

Optional Surge (POP=180 days) 1/Job $_________ $__________ $___________

Sequencing IG (20 samples/10 month

+ up to 1000 Samples/2 months)

Optional Surge (POP=365 days)

1/Job $_________ $__________ $___________

Cell Mediated Immune Assess (640 total samples) Optional Surge

(POP=210 days)

1/Job $_________ $__________ $___________

Antibody Binding Avidity Studies (640 total samples) (Optional Surge

POP=Period of Performance

QTY/UNIT EST. COST FIXED FEE

TOTAL EST.

CPFF

(POP=120 days)

NA Antibody Response and Antibody

Dependent (1800 total Samples)

Optional Surge (POP=180 days)

Total Price – Option Year 3

EST. COST FIXED FEE

TOTAL EST.

Option Year 4: 9/30/19 – 9/29/20

SUPPLIES / SERVICES

POP=Period of Performance

QTY/UNIT

EST.

COST

FIXED

FEE

TOTAL

EST. CPFF

4001 Project Management 1/Job $_______ $_______ $________

4002-1 Field Immunity Test (FIIT) Development

Studies 1/Job $_______ $_______ $________

4002-1A FIIT Cartridge Optional 2500/Each $_______ $_______ $________

4002-2 New Platform Replace FIIT Optional 1/Job $_______ $_______ $________

4002-2A FIIT Cartridge New Platform Option 2500/Each $_______ $_______ $________

4003-1 High Throughput Influenza Lab Immunity

Test (HTILIT) 1/Job $_______ $_______ $________

4003-1A HTILIT Cartridges Optional 2500/Each $_______ $_______ $________

4003-2 New Platform Replace (HTILIT) Optional 1/Job $_______ $_______ $________

4003-2A HTILIT Cartridges, New Platform

Optional 2500/Each $_______ $_______ $________

Develop Quantitative ELISAs Vaccine

Potency Optional 1/Job $_______ $_______ $________

Synthetic Hemagglutination Inhibition

(HI) Assay Optional 1/Job $_______ $_______ $________

4006 Automation of HI Assay Optional 1/Job $_______ $_______ $________

Biennial Acq. Sera Seroprevalence Est.

Optional (POP=120 days) 1/Job $_______ $_______ $________

4008-1

Sanger Sequencing Testing of Patient

Specimens Optional Surge (1200 Virus

Isolates) Projects (POP=365 days)

1/Job $_______ $_______ $________

POP=Period of Performance

QTY/UNIT

EST.

COST

FIXED

FEE

TOTAL

EST. CPFF

4008-2

Sanger Sequencing (+7200 Virus

Isolates/month) Optional Surge (POP=365 days)

1/Job $_______ $_______ $________

4009-1 Serological Testing Patient HI (9600

Samples) Optional Surge (POP=365 days) 1/Job $_______ $_______ $________

4009-2

Serological Testing HI (+62,400

Samples/month) Optional Surge (POP=365 days)

1/Job $_______ $_______ $________

4009-3

Serological Testing Patient HI (9600

Samples) Optional Surge in BSL3+ facility

(POP=365 days)

1/Job $_______ $_______ $________

4009-4

Serological Testing HI (+62,400

Samples/month) Optional Surge in BSL3+ facility (POP=365 days)

1/Job $_______ $_______ $________

4010-1

Serological Testing Patient Specimen MN

(1600 Samples) Optional Surge in BSL2 facility (POP=120 days)

1/Job $_______ $_______ $________

4010-2

Serolgical Testing MN (+10400 Samples)

Optional Surge in BSL2 facility (POP=120 days)

1/Job $_______ $_______ $________

4010-3

Serological Testing Patient Specimen MN

(1600 Samples) Optional Surge in BSL3+ facility (POP=120 days)

1/Job $_______ $_______ $________

4010-4

Serolgical Testing MN (+10400 Samples)

Optional Surge in BSL3+ facility

(POP=120 days)

1/Job $_______ $_______ $________

4011-1

Diagnostic/Serological Testing Infectious

Pathogen (800 Samples) Optional Surge in

BSL3+ facility (POP=120 days)

1/Job $_______ $_______ $________

4011-2

Diagnostic Testing Infectious Pathogen

(+2800 Samples) Optional Surge in BSL3+ facility (POP=120 days)

1/Job $_______ $_______ $________

4011-3

Diagnostic/Serological Testing Infectious

Pathogen (800 Samples) Optional Surge in

BSL4 facility (POP=120 days)

1/Job $_______ $_______ $________

4011-4

Diagnostic Testing Infectious Pathogen

(+2800 Samples) Optional Surge in BSL4 facility (POP=120 days)

1/Job $_______ $_______ $________

4012-1 RT-PCR Testing Patients Specimen (3000

Samples) Optional Surge (POP=180 days) 1/Job $_______ $_______ $________

4012-2 RT-PCR Testing (+6000 Samples) Optional

Surge (POP=180 days) 1/Job $_______ $_______ $________

Sequencing IG (20 samples/10 month + up to 1000 Samples/2 months) Optional Surge

(POP=365 days)

1/Job $_______ $_______ $________

Cell Mediated Immune Assess (640 total samples) Optional Surge (POP=210 days)

POP=Period of Performance

QTY/UNIT

EST.

COST

FIXED

FEE

TOTAL

EST. CPFF

Antibody Binding Avidity Studies (640 total samples) (Optional Surge (POP=120 days)

1/Job $_______ $_______ $________

NA Antibody Response and Antibody

Dependent (1800 total Samples) Optional

Surge (POP=180 days)

Total Price – Option Year 4

COST

FIXED

FEE

TOTAL

EST. CPFF

TOTAL AGGREGATE COST (BASE AND ALL OPTIONS)

*Note: For Optional Surge Projects, the contractors business proposals shall reflect cost estimates at various sample increments; however, the cost estimate above shall reflect the ceiling price for base and additional levels.

EST.

COST

FIXED FEE

TOTAL EST.

Section C - Description/Specification/Work Statement

Statement of Work:

Development of Assays for Characterizing Influenza Viruses and

Detecting Influenza Virus-Specific Antibodies

C.1 Background and Need

The Influenza Division 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. Tests that measure immunity to influenza and characterize the antigenicity of the virus are critical for detecting influenza infection, understanding the mode of transmission, and selecting viruses to be included in the annual vaccine. New, High throughput and automated assays are necessary to keep up the pace with the testing demands of global influenza surveillance. Development of new assays to support surveillance was initiated several years ago, but updates are required to ensure that the assays can detect newly emerging influenza viruses and to keep up with new technologies.

The test most often used to evaluate immunity and antigenicity related to influenza is the hemagglutination inhibition (HI) assay. This assay has been used for over 60 years because it is easy to perform. Data obtained from the assay is essential for World Health Organization (WHO) and Food and Drug Administration (FDA) to make influenza vaccine recommendations. However, this assay is difficult to make mobile, standardize, and automate because it relies on the use of red blood cells, antisera dilutions and humans to read the test results. The purpose of this activity in the contract is to develop new technologies to improve upon the traditional HI assay to make the assay mobile, high-throughput, standardized, and automated.

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, HI assays, microneutralization (MN) assays, Sanger gene sequencing, Reverse

Transcription Polymerase Chain Reaction (RT-PCR) testing for vaccine strain selection and effectiveness studies need to be outsourced to publish study results in a timely manner. Activities supporting vaccine effectiveness and vaccine development, such as avidity antibody assays, Antibody-dependent cell-mediated cytotoxicity (ADCC) and related assays, and B-cell sequencing activities are necessary to support the vaccine development and efficacy determination activities of the entire influenza surveillance process. These activities in the contract will also serve as a vehicle for influenza surge testing when CDC laboratories are overwhelmed with other testing demands.

Influenza pandemics occur when a new strain of influenza virus is easily transmitted to humans. Since 1918 there have been four influenza pandemics, each with different characteristics. The death tolls associated with these pandemics have ranged from ~18,000 to over 50 million. Given the continuous emergence of novel strains, it remains important for pandemic risk assessment purposes to characterize more precisely the frequency of serum cross-reactive antibody to these novel viruses in all age groups in the United States, and to identify past exposure to human influenza viruses that may contribute to differences in the levels of antibodies detected. This information could further be used to assess and better understand the potential for these novel viruses to spread among humans in the United States. It will also serve as a benchmark for incidences of infection in the United States population in the event these novel viruses become more widespread among humans. The purpose of this activity in the contract is to acquire left over sera from various diagnostic laboratories across the United States to establish seroprevalences against emerging novel influenza viruses.

Lastly, as part of the USG pandemic preparedness and response, it is important to evaluate/assess influenza vaccine potency and efficacy with the goals of supporting the development, approval, and production of influenza vaccines.

The purpose of this activity in this activity is the development of an enzyme-linked immunoassay (or equivalent assay) to assess influenza vaccine potency and efficacy.

C.2 Project Objective

The primary purpose of this contract is to study, analyze, advice, research, and develop deliverables to advance

CDC’s related scientific and technical information (STI) through the application of knowledge and resources in achieving the CDC’s mission requirements defined herein. The focus of this contract includes the development of serological and diagnostic assays (for influenza and other infectious disease agents) including a Field Influenza

Immunity Test and a High-Throughput Influenza Laboratory Immunity Test. The contract is also focused on the improvement of current serological assays used at CDC (i.e. HI) including the development of a Synthetic HI assay as well as the development of HI automation system. Lastly, this contract will also focus on the development of an enzyme-linked immunoassay (or equivalent assay) to assess influenza vaccine potency and efficacy. To accomplish these tasks, the contractor shall procure left over sera from various diagnostic laboratories across the United States.

These sera will also allow for the establishment of seroprevalences against emerging novel pathogens including influenza viruses. As part of the Government pandemic preparedness and response, to the contractor shall test patient specimens via HI, MN, and Sanger sequencing. The contractor will also evaluate/assess influenza vaccine potency and efficacy with the goals of supporting the development, approval, and production of influenza vaccines.

Activities supporting vaccine effectiveness and vaccine development, such as avidity antibody assays, Antibody-dependent cell-mediated cytotoxicity (ADCC) and related assays, and B-cell sequencing activities are necessary to support the vaccine development and efficacy determination activities of the entire influenza surveillance process.

These activities in the contract will also serve as a vehicle for influenza surge testing when CDC laboratories are overwhelmed with other testing demands.

C.3 Scope of Work

This is a five year contract (including options) for the provision of Project Management as well as Development of

Assays for the Characterization of Influenza Viruses including a Field Influenza Immunity Test and a High-

Throughput Influenza Laboratory Immunity Test. In addition to these Core Requirements, the contract also consists of Optional Projects to include the Development of Quantitative ELISAs for Vaccine Potency Testing, Development of a Synthetic Hemagglutination Inhibition Assay, Development of an Automated Hemagglutination Inhibition

Assay, and the Biennial Acquisition of Left Over Sera for Influenza Seroprevelance Estimations. Lastly, the contract also consists of Optional Surge Projects which are to be exercised during periods of high testing volume when laboratories at CDC are running at maximum capacity and are unable to complete research projects due to large number of samples related to outbreak investigations and/or emergence of new virus subtypes. The testing of patient samples will be done in batches and is dependent upon completion of studies or outbreak investigations, thus potentially resulting in periods of no performance for these tasks. These Optional Surge Projects include: Sanger

Sequencing Testing of Patient Specimens, Serological Testing of Patient Specimens by Hemagglutination Inhibition or Microneutralization Assays, and Diagnostic/Serological Testing of Patient Specimens by Assays as Defined by

Infections Pathogens.

C.4 Technical Requirements

A. Core Requirements

1. Project Management. The contractor will be responsible for planning, organizing, coordinating, and managing all tasks funded during each base or option year. The contractor will work with each program area that a set of tasks fall under to develop general task, project and activity plans, progress monitoring plans, issue resolution and risk mitigation plans, and user acceptability of completed products, services or deliverables. Contractor shall be responsible for ensuring the technical proficiency and productivity of staff and the quality of the task deliverables. Contractor shall provide status reports and deliverables as directed with allowances for special out of cycle reporting as needed to effectively communicate critical issues or special achievements. Some travel, both domestic and international, may be required to support certain subtasks.

The purpose of this sub-task include: 1) discussion of any unique characteristics of the requirement(s);

2) identification of stakeholders' roles and responsibilities; and 3) establishment of a common understanding of cost, schedule, and performance expectations. Activities under this task will include:

a. Arrange kick-off meeting to discuss project/activity/task plans with COR, CO, program leadership and other subject matter experts (SMEs).

b. Provide on-going evaluation of task work quality and timeliness. This evaluation shall be shared on a monthly basis. The Government reserves the right to modify the timing for the evaluation meetings from a monthly basis to a bi-monthly basis. The format shall be mutually agreed upon by the contractor and COR.

c. Provide a monthly status report. Refer to Section C.5.2 (Monthly Report)

d. Provide an annual report. Refer to Section C.5.3 (Annual Report)

e. Provide a weekly meeting to share development data and contracting issues. Participants will include COR, Program Management, and CDC SMEs.

f. Conduct annual Gap Analysis with CDC SMEs and CORs to determine potential scientific knowledge gaps and develop ideas to reduce these gaps with innovative approaches in the form of a formal on-site meeting including presentation as well as written report.

Specifically, the contractor will perform literature searches as well as contact technology companies and experts in the field to evaluate existing technology that can be applied to the tasks in this contract. This activity will not apply to Optional Surge Tasks. Further, this activity will apply to exercised tasks and only to those identified by the Government as needing a Gap Analysis.

g. Participate in the preparation of information for peer-reviewed journals and scientific conferences and meetings.

*Note to contractor: This task will not be funded alone but in conjunction with any one of the following tasks below. Further, it will only be exercised once for any combination of tasks funded.

Task 1a (kick-off meeting) will be executed at the time of the award. Tasks 1b-g shall be incorporated within each of the tasks below (Tasks 2-16). Further, for bidding purposes, number of labor hours associated with task 1f should be reduced in option years. For bidding purposes, the technical and business proposals should account for a proportional amount of Project Management for each of the tasks.

Travel is associated with this task as represented on section C.6.3.

2.1 Field Influenza Immunity Test (FIIT) Development Studies – CURRENT PLATFORM

VALIDATION ONLY. Serological detection of influenza H2, H5, H7, and H9 infection in the field is important for conducting influenza surveillance for novel or emerging influenza viruses. The current version of the CDC FIIT test was developed under a previous Government contract employing the Dual Path Platform technology from ChemBio Diagnostics Systems Incorporated (Medford, NY).

The first assay prototype utilized full-length recombinant influenza H1, H3, and H5 proteins to detect influenza subtype-specific responses in the blood (Li, et al., in preparation). The most recent assay prototype utilizes recombinant hemagglutinin (HA)1 subunit antigens and full length HA bound to latex beads. The H1, H2, H3, H5, H7, and H9 recombinant HA1 subunit proteins are used in place of full-length antigens to remove cross-reactive stalk epitopes from the assay. To remove cross-reactive antibody against seasonal influenza prior to addition to the test cassette, patient antisera is treated with full length H1 and H3 recombinant HA protein bound to latex beads (unpublished).

Despite efforts to reduce cross-reactive epitopes and antibody from the FIIT, a subset of patients unexposed to novel influenza subtypes exhibit positive responses to novel test antigens. The next generation of FIIT tests shall incorporate new strategies to improve influenza subtype specificity, while maintaining assay sensitivity. These new strategies may include incorporating additional influenza protein antigens (Khuana, et al., 2011), removing cross-reactive antibody from patient specimens, reducing the number of cross-reactive epitopes within the test antigens, or using linear peptide epitopes

(Khuana, et al., 2011).

Although the Government encourages exploration of new strategies over current platform (as described in the option subtask below), the Government prefers to continue using the ChemBio Dual Path

Platform until the Government determines an updated platform is necessary (i.e. If it is determined that new strategies cannot improve the current platform’s specificity and sensitivity). The contractor shall:

a. Utilize the ChemBio Dual Path Platform (http://chembio.com/innovation/platforms/dual-path-platform/) cassette and reader to test existing and new targets. Initiation of this task requires CO approval.

http://chembio.com/innovation/platforms/dual-path-platform/ http://chembio.com/innovation/platforms/dual-path-platform/

b. Evaluate new strategies to help improve the current platform’s sensitivity and specificity, while meeting the technical requirements outlined below in sections C.4.A.2.1.c –

C.4.A.2.1.s.

c. Develop a test that includes antigens for B, H1, H2, H3, H5, H7, H9, and H13 or other novel subtype. The primary purpose of the field assay is to detect novel and emerging influenza viruses (H2, H5, H7, and H9) or other novel subtype. CDC shall entertain strategies that combine seasonal influenza test antigens (B, H1, and H3) in a single test strip or use alternative negative controls (H13). H5 proteins may be used as a mixture of multiple clades. H1 and H3 proteins may also be used as a mixture of proteins to optimize space on the assay device.

d. Recommend strategies requiring multiple test cassettes, if the contractor can demonstrate a significant benefit over using a single cassette. The CDC shall provide recombinant

HA proteins and corresponding ferret sera specific for B, H1, H2, H3, H5, H7, H9, and

H13 influenza viruses (or other novel subtype). Display purified, recombinant HA antigen in its native, trimeric state within the test. The contractor shall seek sources for human antisera against novel and seasonal influenza viruses.

e. Incorporate positive and negative test controls in the rapid assay platform that indicate the test components and the test as a whole are functioning appropriately.

f. Provide results that are semi-quantitative and provide up to four instruments for reading the assay.

g. The new field assay shall have the following features: 1) it is a single use assay in a cassette style format that contains all of the reagents necessary to perform the assay except for the unknown sample of interest; 2) it is suitable for use with serum and/or whole blood samples; 3) all incubation steps are at room temperature; 4) the final result can be read within 30 minutes of applying the unknown sample and are interpretable by individuals with minimal training; 5) it is portable and stable at ambient temperature; 6) contains a storage desiccant to protect the test against humidity; 7) and utilizes recombinant full length HA to remove cross-reactive antibody from patient specimens.

h. The assay shall require no more than 25µL of serum or 50µL of whole blood.

i. Initial assay development may use convalescent and normal ferret serum supplied by

CDC. The contractor, to ensure test specificity, shall also perform tests on normal human antisera. The CDC shall perform validation testing using human antisera specific for novel and emerging virus. In addition to CDC resources, the contractor shall seek sources of antisera against novel and emerging viruses for development testing.

j. The assay shall be specific for HA subtype and be able to detect all HA clades within a subtype. Ideally, the specificity of the assay shall be greater than or equal to 95% using the hemagglutination inhibition assay as a comparator.

k. The assay shall be sensitive enough to detect HA-specific antibody that corresponds to a

CDC hemagglutination inhibition titer of 40. The sensitivity of the assay shall be greater than or equal to 90%.

l. Assess the sensitivity and specificity of the assay using a panel of human samples as made available by the CDC.

m. Define the assay’s temperature stability and shelf-life; an assay that is stable at 22oC

(room temperature) for at least one year is required. The assay shall be stable for use at temperatures between 15 oC and 30 oC and humidity of 85%.

n. The positive predictive value (PPV) of the test for each HA subtype should be 0.90. The negative predictive value (NPV) of the test for each HA subtype should also be 0.90.

PPV = True Positives / (True Positives + False Positives)

NPV = True Negatives / (True Negatives + False Negatives)

o. The intra-and inter-assay Coefficient of Variation (CV) should be less than or equal to

30%.

p. Work Plan, Monthly Reports, and Annual Reports: Refer to Section C.5.1 – C.5.3 (Work

Plan, Monthly Report, Annual Report)

q. Prototype Assay* and Instructions: If a successful assay prototype is developed (either with the ChemBio Dual Path Platform or a new platform altogether), the contractor shall deliver 500 prototype laboratory cassettes for validation testing to the CDC. The prototypes shall include all reagents, sample buffers, and/or diluents required to perform the assays. If required for the assay, installation of one instrument and training on the protocol (up to 5 CDC personnel) shall be completed by the contractor.

Written assay protocols shall be provided by the contractor. If additional development is required after CDC prototype validation to meet product specifications, additional development shall be performed to better meet assay specifications and an additional 500 prototype cassettes shall be provided.

Once a final CDC approved prototype is developed, the contractor must deliver 250 cassettes/cartridges.

r. Stability Study: For the final prototype assay format, the contractor shall deliver an evaluation of temperature stability and shelf-life of the test. Temperature stability studies shall include accelerated studies conducted at 37oC or higher, in addition to a twelve month real time stability study.

s. Data Summary: Refer to Section C.5.7 (Data Summary).

*Note to contractor: The CDC, upon review and approval, shall have the option to purchase additional lots of cassettes or other testing cartridge/device described under Core Requirements

C.4.A.2.1.q (e.g., 250, 500, 750, or 1000). For CDC to assess the quantities that the Government will purchase, the contractor will pre-price these cassettes at the varying quantities.

3.1 High-Throughput Influenza Laboratory Immunity Test (HTILIT) Development Studies –

CURRENT PLATFORM VALIDATION ONLY. The goal of this task is to design, produce, and deliver a High-Throughput Influenza Laboratory Immunity Test (HTILIT) that detects influenza subtype-specific antibody in patient specimens. High-throughput serology testing of patient specimens is important for conducting influenza surveillance for novel or emerging influenza viruses. The current version of the CDC HTILIT test employs the xMAP technology (Luminex Corporation, Austin, TX). The first assay prototype utilized full-length recombinant influenza H1, H3, and H5 proteins to detect influenza subtype-specific responses in the blood (Li, et al., in preparation). The most recent prototype utilizes recombinant HA1 subunit antigens and full length HA bound to latex beads. The H1, H2, H3, H5, H7, and H9 recombinant HA1 subunit proteins are used in place of full-length antigens to remove cross-reactive stalk epitopes from the assay. To deplete cross-reactive antibody against seasonal influenza, patient antisera is first treated with full length H1 and H3 recombinant HA proteins bound to latex beads (unpublished).

Despite efforts to reduce cross-reactive epitopes and antibody from the HTILIT test, a subset of patients unexposed to novel influenza subtypes exhibit positive responses to novel test antigens. The next generation of HTILIT tests shall incorporate new strategies to improve influenza subtype specificity, while maintaining assay sensitivity. These new strategies could include incorporating additional influenza protein antigens (Khuana, et al., 2011), removing cross-reactive antibody from patient specimens, reducing the number of cross-reactive epitopes within the test antigens, or using linear peptide epitopes (Khuana, et al., 2011).

Although the Government encourages exploration of new strategies over current platform (as described in the option subtask below), the Government prefers to continue using the Luminex xMap Platform until the Government determines an updated platform is necessary (i.e. If it is determined that new strategies cannot improve the current platform’s specificity and sensitivity). The contractor shall:

a. The test shall utilize the Luminex xMap technology and reader

(http://www.luminexcorp.com/TechnologiesScience/xMAPTechnology/) to test existing and new targets. Initiation of this task requires CO approval.

http://www.luminexcorp.com/TechnologiesScience/xMAPTechnology/

b. Evaluate new strategies to help improve the current platform’s sensitivity and specificity, while meeting the technical requirements outlined below in sections C.4.A.3.1.c –

C.4.A.3.1.r.

c. The test shall include antigens for B, H1, H2, H3, H5, H7, H9, and H13 or other novel subtype. The primary purpose of the field assay is to detect novel and emerging influenza viruses (H2, H5, H7, and H9) or other novel subtype. The Government will entertain strategies that use alternative negative controls (H13).

d. The high-throughput assay platform shall incorporate positive and negative test controls that indicate the test components and the test as a whole are functioning appropriately.

e. The results shall be quantitative and the contractor shall provide an instrument for reading the assay.

f. The new laboratory assay shall have the following features: 1) the assay shall be compatible with automated sample handling equipment so that large numbers of samples can be processed with minimal hands-on manipulation; 2) suitable for use with serum and/or plasma; 3) ideally, be cell-free and antibody based; 4) capable of testing specimens from multiple species; 5) utilize recombinant full length HA to deplete cross-reactive antibody from patients specimens’ 6) and be truly multiplexed. The assay shall be simple enough for laboratories to run and for minimally trained people to interpret the data.

g. The assay shall require no more than 10 µl or serum or 20 µl of plasma.

h. Initial assay development shall use convalescent and normal ferret serum supplied by

CDC. The contractor, to ensure test specificity, shall also perform tests on normal human antisera. The CDC shall perform validation testing using human antisera specific for novel and emerging virus. The Government encourages the contractor to seek sources of antisera against novel and emerging viruses for development testing.

i. The assay shall be specific for HA subtype and be able to detect all HA clades within a subtype. Ideally, the specificity of the assay should be greater than or equal to 95% using the hemagglutination inhibition assay as a comparator.

j. The assay shall be sensitive enough to detect HA-specific antibody that corresponds to a

CDC hemagglutination inhibition titer of 40. The sensitivity of the assay shall be greater than or equal to 90%.

k. The contractor shall assess the sensitivity and specificity of the assay using a panel of human samples as made available by the CDC.

l. The assay’s temperature stability and shelf life shall be defined. An assay that is stable at

-20oC for at least one year is required. The assay shall be stable for use at temperatures between 15oC and 30oC and humidity of 85%.

m. The positive predictive value (PPV) of the test for each HA subtype shall be 0.90. The negative predictive value (NPV) of the test for each HA subtype shall also be 0.90.

PPV = True Positives / (True Positives + False Positives)

NPV = True Negatives / (True Negatives + False Negatives)

n. The intra- and inter- assay CV shall be less than or equal to 25%.

o. Work Plan, Monthly Reports, and Annual Reports: Refer to Section C.5.1 – C.5.3 (Work

Plan, Monthly Report, Annual Report)

p. Prototype Assay* and Instructions: If a successful assay prototype is developed, the contractor shall deliver kits for 500 tests for validation testing to the CDC. The prototypes shall include all reagents, sample buffers, and/or diluents required to perform the assays. If required for the assay, installation of instrumentation and training on the

Written assay protocols shall be provided by the contractor. If additional development is required after CDC prototype validation to meet product specifications, additional development shall be performed to better meet assay specifications and additional kits for 500 tests shall be provided

Once a final CDC approved prototype is developed, the contractor must deliver 250 tests.

q. Stability Study: For the final prototype assay format, the…