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This document provides additional business proposal instructions for a solicitation seeking genetic toxicology support services. The contract will have a one year base period and nine option years, with an additional six month extension possible. Services include in vivo and in vitro mutagenicity and genotoxicity assays on approximately 20 chemicals annually, including bacterial reverse mutation assays, micronucleus assays, Pig-a gene mutation assays, and comet assays. Offerors should assume testing requirements detailed in the statement of work and provide cost estimates for the base and option years using labor, material, travel, and other assumptions specified in the document. The business proposal format outlined must be followed in submitting cost and pricing data.

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ATTACHMENT 20

Additional Business Proposal Instructions

These additional Business Proposal instructions reflect the requirements of the Request for Proposal (RFP). While Section L. of the RFP provides general Business Proposal instructions, these instructions are tailored to the specific requirements of the RFP and provide uniform costing assumptions and business clarifications.

The business proposal shall be submitted as a separate volume from the technical proposal. The following information should be used to assist offerors in preparing the business proposal.

A. Base and Options Structure

The contract shall be proposed as a cost plus fixed fee, level of effort type contract and shall consist of one (1) base year + nine (9) option years to extend for a total possible performance period of ten (10) years. An option for an additional 6-months is also provided in accordance with FAR 52.217-8 for a possible total of 10.5 years.

In addition, Option A may be exercised to add additional level of effort to the contract period of performance. This option may be exercise multiple times as needed during each period of performance, up to 30% of the base level of effort for that particular period.

B. Cost Assumptions

In order to estimate the cost for the Base year and each optional year of the contract, offerors are to assume a start date of June 6, 2020 and shall assume that each year of the contract, the following will be required:

1) Labor – The Government's estimate for the work set forth in the SOW is 2.35 full time equivalents (FTEs) annually for the base and option years. The number of FTEs is for informational purposes and is not meant to be restrictive. Offerors may propose a different level of effort than those provided here. The direct labor effort includes subcontractor and consultant effort.

2) Materials/Supplies

The purchase of materials and supplies (e.g., MicroFlow® Micronucleus kits, bacterial tester strains, MultiFlow® reagents, comet assay slides, hazardous waste disposal) shall be directed by the COR and reimbursed as appropriate. For costing estimates only, the following mix of assays can be assumed to be required on an annual basis. (see Attachment 1 – Statement of Work – for details)

• 15 bacterial mutagenicity assays (15 test articles) in 3 strains of bacteria, +/- rat liver S9. Test articles will be supplied by the NTP.

• 5 in vivo peripheral blood erythrocyte micronucleus assays on samples supplied by a remote NTP animal facility; each test will have 25 male and 25 female mice, and 25 male and 25 female rats. Data will be collected using flow cytometric techniques (In Vivo MicroFlow assay, Litron Laboratories).

• 3 in vivo Pig-a gene mutation assays on blood samples supplied by a remote NTP animal facility; each test will have 25 male and 25 female mice, and 25 male and 25 female rats. Data will be collected using flow cytometric techniques.

The same blood samples supplied for micronucleus assessments will be split to allow for measurement of Pig-a mutation frequencies in these 3 studies.

• 2 short-term (4 day) in vivo comet assays, one in male mice (supplied by the NTP) and one in male rats (purchased through a designated vendor by the Contract Laboratory); each test will examine 30 animals in total, 3 tissues per animal (glandular stomach, liver, brain hippocampus). For the comet assay, both a primary and a back-up sample for each tissue will be stored frozen in a minus 80 °C freezer. At a future date, frozen samples will be thawed and processed for DNA damage assessment using the comet assay. In addition, peripheral blood will be collected from each animal, fixed for possible future assessment of micronucleated erythrocytes using flow cytometric techniques, and stored frozen in a minus 80 °C freezer.

• 15 in vitro micronucleus assays in TK6 cells, +/- induced rat liver S9, with test articles supplied by the NTP. All tests will be run in triplicate, and all tests will be repeated. Data will be collected using flow cytometric techniques (MicroFlow assay).

• 5 MultiFlow™ DNA Damage Assays on 5 NTP-supplied test articles.

3) Travel, Meetings, and Conferences – Assume all airfare to be economy class, and hotel and per diem at US Government rates for the applicable city/location. WebEx meetings may be substituted for in-person meetings at the discretion of the COR. For purposes of proposing, assume the following:

• Travel to one professional scientific meeting annually for one key personnel (for example, the Principle Investigator), as described in the SOW.

• Other travel and meeting costs may be proposed based on management of subcontracts and other task activities.

4) Special Shipping and Packaging – The Offeror shall include, in anticipated packaging and shipping costs, sending out 100 samples twice annually to 2 external laboratories for analysis.

5) Include the costs of providing short-term (≤_3 y) specimen storage, as described in the

SOW.

6) Government Furnished Equipment and Property – Refer to the attached Government

Property and Equipment list for a list of the equipment and property to be transferred to the contract.

C. Business Proposal Format

Refer to Business Proposal Instructions, Section L of this solicitation. The Instructions contain the requirements for proper submission of cost/price data which must be adhered to. This format should be used as a guideline. It may require amending to meet the specific requirements of this solicitation. This format must be used to submit the breakdown of all proposed estimated cost elements. List each cost element and sub-element for direct costs, indirect costs and fee, if applicable. In addition, provide detailed calculations for all items. For example:

1) For all personnel, list the name, title, rate per hour and number of hours proposed. If a pool of personnel is proposed, list the composition of the pool and how the proposed cost was calculated. List the factor used for the escalation rate applied between years.

2) For all materials, supplies, and other direct costs, list all unit prices, etc., to detail how the calculations were made.

3) For each assay type described in Section 2.1 of the SOW (e.g., bacterial mutation assay, in vitro micronucleus assay), provide an approximate cost along with the assumptions upon which this calculation is based.

4) For all indirect costs, list the rate applied and the base the rate it is applied to.

5) For all travel, list the specifics for each trip.

6) For any subcontract proposed, submit a separate breakdown format.

7) Justification for the need of some cost elements may be listed as an attachment, i.e., special equipment, above average consultant fees, etc.

8) If the Government has provided "uniform pricing assumptions" for this solicitation, the offeror must should identify each item. If a deviation from the uniform cost assumption is made, identify the deviation and provide an explanation.

Costs should be presented as follows:

• Base Years Cost Estimate (base year and each of the 9 option years) – provide a cost estimate for the base year and each successive year.

• Overall Cost Estimate (base + 9 option years + Option A at 30% each year) – provide a cost estimate for the base year and each successive year which also includes Option A.

• Summary Cost Estimate (base + 9 option years + Option A at 30% each year) - Provide an overall summary cost estimate for all years and options.

• Option for 6-month extension estimate (see description below).

Optional 6-month extension under FAR 52.217-8 - If necessary, a separate option may be exercised in accordance with FAR 52.217-8 at the end of the contract to extend the period of performance for six months beyond year ten (10) of the contract. Please provide a separate cost spreadsheet for this 6-month extension at the same rates in existence for Year 10.

An electronic spreadsheet is available to assist you in the preparation of your business proposal. It is in EXCEL format and has instructions for use and submission. Use of this spreadsheet is optional but recommended. The electronic spreadsheet form is located here:

http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_Dec2012.xlsx

IMPORTANT NOTE: Save this file on your computer before opening, otherwise, you will be prompted for a user name and a password and you will lose all the data you may have inserted.

http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_Dec2012.xlsx

File details come from the government source that posted it. Updated .