Attachment 5 - Sample Task Order A-02.pdf

ATTACHMENT 5: SAMPLE TASK ORDER ASSOCIATED WITH TASK AREA A: BACTERIA,

FUNGI, AND TOXINS

IN VITRO ASSESSMENTS OF ANTIMICROBIAL ACTIVITY

SAMPLE TASK ORDER A02

“Determination of In Vitro Efficacy of Antitoxin Candidates”

NOTE: Offerors proposing for Task Area A must include in their proposal a response to either Sample Task Order A01 or A02. There is no added value in submitting multiple proposals in a single Task Area. The Offeror should be encouraged to submit its best proposal – i.e., the one for which it has the highest qualifications and capabilities.

Offerors proposing for Task Area A must submit a proposal that includes information pertaining to Task Area A only.

The following Sample Task Order is provided to assess the Offeror’s capabilities to conduct and fulfill the requirements of the Statement of Work for projects of similar scope and size to be issued under contracts awarded in response to this solicitation. Although the Sample Task Order will NOT be executed nor will awards be made for the Same Task Order, Offerors are to include in their proposals a response that specifies the methods by which each Sample Task Order would be accomplished and include an associated budget.

Offerors should refer to the Additional Technical Proposal Instructions and Additional Business Proposal Instructions for guidance regarding preparation of their proposals.

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

1. PRICES

This is a firm-fixed price type task order.

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

Statement of Work

I. SCOPE

Determination of in vitro 50% maximal inhibitory concentration (IC50) of candidate anti-toxin test articles using a validated toxin neutralization assay.

II. TECHNICAL REQUIREMENTS

Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below.

The requirements for Task Area A defined in the base Statement of Work apply to all work performed under this Task Order.

In addition to the requirements laid out in the base Statement of Work, the Contractor shall perform the following:

1. Toxin Neutralization Testing:

a. The Contractor shall store and maintain of all candidate test articles provided to the Contractor by the Government or through a third-party under conditions specified by the COR.

b. The Contractor shall Perform dose response curves, IC50 determinations, and statistical analyses for 40 anti-toxin candidates in one (1) validated toxin neutralization assay from Table 1.

Table 1 - Toxins

c. The Contractor shall complete testing within 30 days of receipt of test articles.

d. The Contractor shall provide the results of all assays performed for each candidate test article in accordance with the Reporting Requirements described herein.

2. Communications and Reporting

a. The Contractor shall conduct monthly teleconference calls with the COR to report on progress and provide minutes of each teleconference in accordance with the Reporting Requirements and Delivery Schedule.

b. The Contractor shall provide a Final Report in accordance with the Reporting

Requirements and Delivery Schedule.

Botulinum neurotoxins Clostridium perfringens Epsilon Toxin Bacillus anthracis lethal factor, edema factor, or protective antigen Staphylococcal enterotoxin B (SEB) Ricin

SECTION D – PACKAGING, MARKING, AND SHIPPING

There are no additional D. clauses applicable to this Task Order beyond those in the base contract.

SECTION E – INSPECTION AND ACCEPTANCE

There are no additional E. clauses applicable to this Task Order beyond those in the base contract.

SECTION F – DELIVERIES OR PERFORMANCE

1. PERIOD OF PERFORMANCE

The period of performance for this Sample Task Order is ten (10) months.

2. TASK ORDER REPORTING REQUIREMENTS AND DELIVERABLES

Technical Reports

All reports required herein shall be submitted in electronic format. All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973.

Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at:

http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

1. Final Report

This report is to include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved and shall include:

• Assay format

• Test article preparation and use

• Toxin source or preparation method

• Controls used

• Neutralization results

The Final Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this task order.

Other Reports and Deliverables

All reports required herein shall be submitted in electronic format.

http://www.hhs.gov/web/508/index.html

1. Compound Test Result Reports The Compound Test Result Report shall include:

a. A title page containing:

i. Contract number, task order number and title

ii. Test article identifier(s)

iii. Control article identifier(s)

b. Documentation of preparation, lot number, and use of test article(s); toxin source or reagents used in its preparation along with toxin certificate of analysis; origin of eukaryotic cell lines, description of cull culture and assay conditions; and control article(s);

c. Description of any technical or performance problems encountered, along with proposed corrective action taken;

d. Reference neutralization curves for each control compound against each toxin in the panel;

e. Results of all determinations performed including a dose response curve, IC50, appropriate statistical analysis, and supporting data for each test article;

f. Description of attempts to remedy any measured control neutralization value more than 2-fold different from reference values.

2. Monthly Teleconference Minutes The Contractor shall provide and deliver, in accordance with the Delivery Schedule, minutes of the monthly teleconferences which include the following:

a. List of action items (including who is responsible for the action item).

b. Summary of any high-level decisions made during the teleconference.

c. Number of assays performed and committed to date as well as remaining number of assays.

d. Summary of concerns raised during the teleconference and the plan to address these concerns.

e. Appendix including all Compound Test Result Reports finalized during that month.

TASK ORDER DELIVERY SCHEDULE

Item Report Recipient Delivery Schedule

1. Final Report 1 electronic copy to COR and CO.

Due on/before the completion date of the task order.

2. Compound Test Result Report

1 electronic copy to COR and CO.

Due on/before 30 calendar days following completion of testing on a compound.

Compounds completed during the final 30 days of this task order shall be submitted on the expiration date of the task order

3. Monthly Teleconference Minutes

1 electronic copy to COR and CO.

On or before 7 calendar days following the teleconference

SECTION G – TASK ORDER ADMINISTRATION DATA

There are no additional G. clauses applicable to this Task Order beyond those in the base contract.

SECTION H – TASK ORDER ADMINISTRATION DATA

There are no additional H. clauses applicable to this Task Order beyond those in the base contract.