FDA-SOL-1162579.05.10.16_(2).doc

Solicitation No.: FDA-RFP-1162579 Page 1 of 19 Title: Custom “Ready to Use” Toxin/Poison Standard Mixtures Packages/Kits/Sets for 14 FERN cCAP Laboratories and the FDA Forensic Chemistry Center

SECTION 1 – SUPPLIES AND SERVICES AND PRICES

1.1 SOLICITATION DESCRIPTION

This solicitation is a Request for Proposals (RFP). The solicitation document and incorporated provision and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-87-2 dated April 06, 2016. The associated North American Industry Classification System (NAICS) Code is 541712 RESEARCH AND DEVELOPMENT IN THE PHYSICAL, ENGINEERING, AND LIFE SCIENCES (EXCEPT BIOTECHNOLOGY). Its associated Small Business Size Standard is 500 employees. This RFP is issued as a set-aside for small business. Any firm that believes it is capable of providing the required service as stated herein may submit a capability statement to document its ability to provide the required services.

1.2 CONTRACT TYPE

The anticipated contract type is Indefinite Delivery Indefinite Quantity (IDIQ) with the issuance Firm Fixed Price Task Orders.

1.3 CONTRACT CEILING

The IDIQ guaranteed minimum amount of $2,500.00 over five years (5). The contract maximum ceiling amount will be $500,000.00 over five (5) years.

1.4 CONTRACT PERIOD OF PERFORMANCE

The period of performance for this IDIQ will be for a base year with four (4) one year options beginning date of award.

Base Year: July 06, 2016 through July 05, 2017 The following option is anticipate:

Option Year 1: July 06, 2017 through July 05, 2018 Option Year 2: July 06, 2018 through July 05, 2019 Option Year 3: July 06, 2019 through July 05, 2020 Option Year 4: July 06, 2020 through July 05, 2021

1.5 PRICING/COST

Total Amount Including All Options

SECTION 2 – DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

2.1 BACKGROUND

The FDA/FERN laboratories are tasked with the mission to protect the integrity of the United States food supply from dangerous chemical and biological contamination. Threats to the Nation’s food supply must be rapidly identified and reported so as to mitigate any potential public hazard. The FDA/FERN laboratories sit on the frontlines in protecting the Nation’s food supply by performing accurate scientific testing on human food and animal feed. Chemical standards are critical for accurate scientific testing because they are used as a central piece in scientific methods/protocols used to ensure the integrity of the analytical process. Potentially hazardous food and feed samples, submitted to the FDA/FERN cCap laboratories for poison/toxin analysis, require specific analytical reference materials be used as part of the methods/protocols to assure reproducible and accurate results. Therefore, these standards (product) are critical for the Government to protect the public health. The selected contractor must accurately and timely meet the requisite product specifications for the FDA/FERN cCAP to accomplish its mission. Therefore, based on the needs of the Agency to successfully perform its mission, the contractor will promptly provide standard product to each of the fifteen (15) laboratories expeditiously and then on an as needed basis. This will allow the government to respond to and detect food and feed contamination and to prevent illness or considerable loss of life resulting from accidental or natural contamination of food and feed.

2.2 SCOPE OF WORK

Food Emergency Response Network (FERN) Chemistry Cooperative Agreement Program (cCAP) laboratories and the FDA Forensics Chemistry laboratory in total shall require a contractor to provide a minimum of fifteen (15) individual chemical standard packages/kits/set units within a period of one (1) year. These chemical standards are to be prepared by the successful contractor as “ready to use” packages/kits/sets which will include stock standard mixes, spiking standard mixes and working standard mixes. Each chemical standard package/kit/set unit (hereafter referred to as the “product”) will be delivered to each of the laboratory listed in deliverable. Depending on frequency of product usage within each laboratory, additional product may be immediately required and therefore the contractor must always be ready and capable to immediately prepare, provide and ship additional product on an as needed basis expeditiously according to the mutually agreed upon timeframe established upon award of this contract between the government and contractor.

2.3 APPLICABLE DOCUMENTS

2.3.1 Recipe/list of chemicals necessary to prepare the standards - A list of all necessary chemicals and their required concentrations will be provided for the potential contractor to help the contractor determine capability and capacity to meet the Government’s requirements for this item (Section 3).

2.3.2 Non-Disclosure Agreement (NDA) - The contractor shall be required to sign a Confidentiality Agreement before specifications of the individual components in the standard mixtures can be disclosed.

2.4 STATEMENT OF WORK

The contractor shall prepare and provide a minimum of fifteen (15) product kit units as described within section 3.4.

2.4.1 Management Requirements/Objectives. Chemical standards shall be prepared by the vendor and delivered as a unit kit/package considered as “the product” so that the government can execute analyses to determine Toxins/Poisons in Food and Feed to support food defense and regulatory analysis of the Food Emergency Response Network (FERN) samples.

2.4.2 Product Preparation Instructions and Specifications Requirements.

2.4.2.1 - 1.0 ml, 100 ug/ml Acetonitrile sealed Stock Standard ampule--ampule will contain a custom mix of 45 toxins/poisons and with or without at least one internal standard (to be determined after award of contract) at a nominal concentration of 100 ug/ml for each component in the mixture. The accuracy of concentration for each component shall be plus/minus 5% of the nominal concentration.

2.4.2.2 - 5 – 1.0 ml, 20 ug/ml Acetonitrile sealed Spiking Standard ampule--ampule will contain a custom mix of 45 toxins/poisons with or without at least one internal standard (to be determined after award of contract) at a nominal concentration of 20 ug/ml for each component in the mixture. The accuracy of concentration for each component shall be plus/minus 5% of the nominal.

2.4.2.3 - 5 – 1.0 ml, 1.0 ug/ml Acetonitrile Working Standard ampule-- ampule will contain a custom mix of 45 toxins/poisons with or without at least one internal standard (to be determined after award of contract) at a nominal concentration of 1.0 ug/ml for each component in the mixture. The accuracy of concentration for each component shall be plus/minus 5% of the nominal.

2.5 Technical Requirements

2.5.1 Certificate of Analysis. Contractor shall first provide a detailed proposal of the analytics which will be used to ensure the accuracy of the Certificate of Analysis. The Contractor shall provide a Certificate of Analysis that must be supported by analytical data to verify accuracy.

2.5.2 Lot Number. The contractor shall provide a Lot Number on every item containing a chemical which shall include a one year expiration date from the date of manufacture/preparation of each standard within a package/kit/set.

2.5.3 Contractor laboratory accreditation. Contractors should detail ISO accreditation. Contractors with ISO 17025 or similar accreditation are preferred.

2.5.4 Non-Disclosure Agreement to affirm confidentiality. The contractor, once selected, shall be required to sign a Confidentiality Agreement before specific specifications of the individual components in the standard mixtures can be disclosed.

DELIVERABLES

The deliverables apply to each task order awarded

Received Upon Delivery - Each potential vendor shall provide the government with a delivery schedule that they can perform. The kits are custom made and the vendor will have to identify the lead time necessary to make the kits. The Contractor is responsible for ensuring prompt timely delivery. The Government expects that each of the individual fifteen (15) final product units (package/kit) shall consist of all of the described standards prepared exactly as described within PART 3 and each containing the appropriate documentation of Quality Assurance for each item within the package/kit as described within Section 2.

Address to provide deliverable:

US FDA

Forensic Chemistry Center

Douglas Heitkemper, Ph.D.

6751 Steger Dr., Cincinnati, OH 45237

(513) 679-2700 ext. 187 douglas.heitkemper@fda.hhs.gov Reliability Program - Upon delivery the contractor should allow a laboratory two (2) weeks for the prepared standards to be initially tested for accuracy and viability within experimental protocol. Upon completion of delivery the contractor shall assign a representative/agent that shall address any issues the technical lead/analyst/user may incur moving forward in the future. This contractor representative shall be available to troubleshoot any problems with the product. If the contractor’s initial delivery of product standards have been demonstrated as inaccurate, this will be communicated to the contractor by a government representative no later than ten (10) business days upon receipt of the standards as the standards will then be deemed unacceptable for use and the Contractor shall replace the standards, at Contractor’s expense, with new standards.

SECTION 3 - PACKING AND MARKING

All deliverables required under this contract shall be packed, and marked in accordance with the best commercial practices to ensure safe and timely delivery.

SHIPMENT AND MARKING

Shipment of deliverable items shall be as follows:

Ship to:

US FDA

Forensic Chemistry Center

6751 Steger Dr., Cincinnati, OH 45237

Mark for: TBD

The Contractor shall mark each shipment with their company name, contract number, task order number, identification of the item, quantity of items, and notice of partial or final delivery. For electronic deliverables, the Contractor shall identify the title of the document and contract number in the subject line of the email

SECTION 4 - INSPECTION AND ACCEPTANCE

The FDA COR will inspect and make acceptance decisions for all materials, documents, and services provided under this contract.

For the purpose of this Section, the FDA COR is the authorized representative of the Contracting Officer.

SECTION 5 - DELIVERIES OR PERFORMANCE

Deliverables shall be established with the issuance of each task order. All deliverables shall be delivered F.O.B. Destination to the COR for acceptance.

Electronic Submission:

The Contractor shall submit all required reports electronically in Microsoft Word 2007 compatible format with 12 point font to the COR. The Contractor shall submit all data to the COR in SAS transport (.xpt) and/or Microsoft Excel (.xlsx) format. The Contractor shall confirm all electronic documents submitted to the FDA are virus free before transmittal to the FDA.

SECTION 6 - CONTRACT ADMINISTRATION

6.1 CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The following COR will represent the Government for the purpose of this contract

(To be determined upon contract award)

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under these contracts. Only the Contracting Officer has authority to direct or negotiate any changes in a contract or task order, including modifying or extending the period of performance, changing the delivery schedule, and authorizing reimbursement to the Contractor for any costs incurred during the performance of their contracts.

The contact information for the FDA Contracting Officer is the following:

Linda Troutman Contract Officer U. S. Food and Drug Administration

Office of Acquisition and Grants Services

60 8th Street, NE Linda.Troutman@fda.hhs.gov 404-253-1258

The contact information for the contractor is as follows:

Name:

Shall be provided at time of award

Email:

Telephone:

6.2 INVOICING SUBMISSION

A. The Contractor shall submit all invoices to the addresses and in the manners specified below:

(I) One original to the Contract Specialist:

U.S. Food and Drug Administration

Office of Acquisitions and Grants Services

ATTN: Linda Troutman, Contracting Officer 60 8th Street NE Room 116 Atlanta, GA 30309 Email: Linda.Troutman@fda.hhs.gov

(II) One copy to the COR clearly marked as a “Courtesy Copy Only:”

U.S. Food and Drug Administration

ATTN: (To be determined upon contract award); COR

Address:

Email: XXXXX@fda.hhs.gov e methods of delivery include mail, hand delivery, and email. Please submit all invoices by email in adobe portable document format (pdf) whenever possible.

B. Invoices submitted under these contracts must comply with the requirements set forth in FAR 52.232-33 (Payment by Electronic Funds Transfer— System for Award Management (SAM) (Jul 2013)) and the other applicable FAR clauses specified herein. The Contractor shall maintain current, accurate, and complete information in the SAM database, as displayed on the SAM website, until receipt of final payment under their contract.

To constitute a proper invoice, the invoice must be submitted on company letterhead and include the following:

(I) Name and address of the Contractor;

(II) Invoice date and number;

(III) Contract and task order numbers;

(IV) Description, quantity, unit of measure, unit price, and extended price for supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; and (c) any other supporting information necessary to clarify questionable expenditures;

(V) Shipping number and date of shipping, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(VI) Terms of any discount for prompt payment offered;

(VII) Name and address of official to whom payment is to be sent (must be the same as that in the contract, task order, or in a proper notice of assignment)

(VIII) Name, title, and phone number of person to notify in event of a defective invoice;

(IX) Taxpayer Identification Number (TIN);

(X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;

(XI) Name and telephone number of the FDA COR; and (XII) Any other information or documentation required by the contract or task order.

The Contractor shall attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) List of all invoices submitted to date under the subject order, including the following: (1) invoice number, amount, and date submitted to the Contract Specialist; and (2) corresponding payment amount and date received payment.

(b) Total estimated amounts yet to be invoiced under the task order.

D. Questions regarding invoice payments shall be directed to the FDA Payment Office at the following mail and email addresses and phone numbers:

Office of Financial Services U.S. Food and Drug Administration

10903 New Hampshire Avenue

W032, Second Floor

Mail Hub 2145

Building 32, Room 2162

Silver Spring MD 20993-0002

Attn: Vendor Payments

Phone Numbers: (301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov Payment is only authorized upon successful completion of tasks and/or deliverables in accordance with the payment and pricing terms of each task and upon receipt and acceptance of a proper invoice.

Proper invoice submission includes following the invoice instructions herein and the terms of the task order. Payment will be made on a task order basis. Final payment of a task order will occur upon verification by the FDA COR there is successful completion of the task order.

6.3 KEY CONTRACTOR PERSONNEL

The above named individuals are designated as key personnel for this contract and are considered essential for its successful performance. In the event any of the key personnel are unable to perform as proposed for any reason during the performance of the contract, the Contractor shall immediately notify the COR and Contacting Officer in writing. Such notice shall include an explanation for lack of performance, a proposed replacement by someone of equal or better qualifications and experience, and shall explain the impact on performance. The Contractor shall provide the Contracting Officer and the COR the same personnel information (e.g. resumes) for replacement personnel as the Contractor provided for the initial personnel. Replacement personnel shall have at least the same or equivalent knowledge, skills, and abilities that are necessary to complete the work on this contract as the original assigned personnel. All replacements are subject to the prior approval of the Contracting Officer.

The following labor category is considered key: Project Manager

SECTION 7 - SPECIAL CONTRACT REQUIREMENTS

Section 508 STANDARD Requirements The Contractor shall ensure all deliverables are in compliance with Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended (508 standards), which requires electronic and information technology (EIT) to be accessible to people with disabilities. Information about Section 508 compliance is available at http://www.section508.gov/.

SECTION 8 –CONTRACT CLAUSES

8.1 FAR 52.252-2, Clauses Incorporated by Reference (February 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: www.acquisition.gov/far/index.html.

OCT 1996

FAR CLAUSE 52.217-8 OPTION TO EXTEND SERVICES (November 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within the period specified in the Schedule.

FAR CLAUSE 52.217-9 OPTION TO EXTEND THE TERMS OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 60 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years.

FAR CLAUSE 52.216-18 ORDERING (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from through the life of the contract.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered “issued” when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

FAR CLAUSE 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $2,500.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of $500,000.00;

(2) Any order for a combination of items in excess of $500,000.00; or

(3) A series of orders from the same ordering office within 30 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 5 days after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

FAR CLAUSE 52.216-22 INDEFINITE QUANTITY (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the “maximum.” The Government shall order at least the quantity of supplies or services designated in the Schedule as the “minimum.”

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after contract expiration.

8.2 Department of Health and Human Services Acquisition Regulation (HHSAR) Clauses Incorporated by Reference This contract incorporates the following HHSAR 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 following website: http://www.hhs.gov/policies/hhsar/.

8.3 Conflicts of Interest

Each offeror shall warrant that, to the best of its knowledge and belief, and except as otherwise disclosed in its proposal, it does not have any actual, potential, or apparent conflict of interests pertaining to the subject procurement, as described in FAR Subpart 9.5 and HHS and FDA policies, for its organization, employees, or subcontractors proposed to be working under procurement.

Each offeror shall agree that, if it is awarded a contract for this procurement and discovers an actual, potential, or apparent conflict of interest with respect to this procurement after executing its contract, it shall make an immediate and full disclosure in writing to the FDA Contracting Officer and COR for its contract, including a description of any actions the Contractor has taken or proposes to take to avoid, neutralize, or mitigate any conflict of interest. The Contractor shall act impartially and objectively and must avoid actions that would cause a reasonable person to question their impartiality or engage in activities that may result in an unfair competitive advantage, such as:

1. Giving preferential treatment to any individual or organization which has submitted applications, information, or data;

2. Soliciting any gift or other item or accept any gift or other item of monetary value exceeding $20.00 from any person or entity seeking official action from, doing business with, or conducting activities related to the evaluations and work performed under its contract. The Contractor shall not accept individual gifts with an aggregate market value of greater than $50.00 in a calendar year.

3. Disclosing non-public information unless otherwise authorized (see Subsection 5.1, PUBLICATIONS AND PRESENTATIONS).

4. Participating in matters involving parties who are likely to or can directly affect the financial interest of people in the Contractor’s personnel households or relatives of Contractor personnel with whom they have a close personal relationship.

5. Not disqualifying themselves from participating in matters involving former Contractor employees who were Contractor employees within the past three years or the former Contractor employee representatives who might represent a conflict of interest.

The Government reserves the right to exercise any remedy available at law or equity, including termination of a contract for cause or convenience, should the Government determine remedial action is necessary to address any actual, potential, or apparent conflict of interest.

The Contractor shall include a clause substantially similar to this conflicts of interest clause in any subcontract.

SECTION 9 - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

9.1 RESPONSE DATE AND TIME

All proposals and proposal revisions shall be submitted electronically via email to Linda Troutman@fda.hhs.gov on or before 12:30pm Eastern Time on June 03, 2016.

Note: Late proposals will not be evaluated.

9.2 PROPOSAL INSTRUCTIONS

HHSAR PROVISION Incorporated by Reference This solicitation incorporates the following HHSAR provision by reference with the same force and effect as if it was given in full text. Upon request, the Contracting Officer will make the full text available. Also, the full text of a clause may be accessed electronically at the following website: http://www.hhs.gov/policies/hhsar/.

FAR PROVISION IN FULL TEXT

52.233-2, Service of Protest (SEP 2006)

(a) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from the Contracting Officer and the Head of Contracting Activity (HCA):

U.S. Food and Drug Administration

Office of Acquisitions and Grants Services

60 8th Street, NE Atlanta, GA 30309

(b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

(End of Provision)

Format

Cover Letter

Offerors shall include a cover page which shall include the following:

· Point of contact (name, telephone number, and email address),

· Business size and type (e.g. small, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, etc.),

· Dun and Bradstreet (DUNS) and Taxpayer Identification (TIN) numbers, and

· As an addendum to the cover letter:

· Completed representations, certifications, and other statements (see Section 10), including certification that all company information listed in the SAM website is complete, accurate, and current (see FAR 52.212-3, Offeror Representations and Certifications -- Commercial Items (May 2014) and

· Affirmation of the lack of conflicts of interest or information related to any actual, potential, or apparent conflicts of interest which may affect the offeror’s ability to perform this requirement in an impartial and objective manner or that may result in an unfair competitive advantage in accordance with the Conflicts of Interest terms in Section 8.

In addition to a cover letter, offerors shall submit proposals with two separate attachments preferably in adobe portable document format (pdf) or if not, in another commonly used format, such as Microsoft Word. One attachment (Volume 1) shall consistent of exclusively all technical, management and relevant past performance documentation and the other attachment (Volume 2) shall consistent of only all price and supportive documentation.

VOLUME 1: TECHNICAL PROPOSAL, MANAGEMENT/STAFFING PLAN AND RELEVANT PAST PERFORMANCE

Technical Proposal:

Offerors shall submit a technical proposal that comprehensively demonstrates the offeror has the technical capability to perform all tasks and deliverables described in this solicitation.

Offerors technical proposal shall not exceed 25 8.5 inch by 11 inch pages with margins no less than one inch on each boarder with a font size no smaller than 12 point, except for tables and graphics which shall have a font size no smaller than 9 point. The FDA will evaluate only the pages within the page limitations, starting at the first page and continuing up to the 25 page limit. The 25 page limit excludes the following:

· A cover page and table of contents

· Resumes, although resumes shall not exceed two pages per resume.

· Relevant past performance information.

Factor 1: Technical Capabilities:

Sub-Factor 1: The Offeror shall describe how their company develops custom ready to use toxin/poison standard mixture packages/kit/sets.

Sub-Factor 2: The Offeror shall describe their company’s knowledge level of toxin/poison standard mixture packages/kit/sets

Sub-Factor 3: The Offeror shall describe their company’s knowledge level regarding specific technical capabilities and logistical processes in preparing toxin/poison standard mixture packages/kit/sets.

Sub-Factor 4: The Offeror shall describe how their company has measured successes/failures/limitations for developing custom ready to use toxin/poison standard mixture packages/kit/sets, if applicable.

Factor 2: Management/Skill Plan:

Sub-Factor 1: Management Plan

The Offeror shall provide examples to demonstrate that your company has the following capabilities to devote to the development of a pilot project program:

a) strong program management skills

b) flexibility

c) creative and innovative thought processes

Sub-Factor 2: Staffing Plan

The Offeror shall describe the amount of staff and their experience that will be available or responsible for this project.

Factor 3: Relevant Past Performance:

Sub- Factor 1: Proposals shall include a minimum of three recent, relevant references for similar requirements in terms of size, scope, duration, complexity, and price to the work described in this solicitation that have been performed within the last three years. Offerors shall also provide information on past performance problems and any resulting corrective actions.

VOLUME 2: BUSINESS/PRICE PROPOSAL

Price:

Sub-Factor 1 – The Offeror shall complete the pricing table as described in Section 1 and provide supportive pricing information to assist the Government in its determination that the prices quoted are fair and reasonable. In addition, the offer shall provide two pricing options/considerations for this contract: one with stability data supporting the 1- year expiry and one without stability data supporting the one (1) year expiry.

SECTION 10 – EVALUATION FACTORS FOR AWARDS

EVALUATION CRITERIA

The FDA’s source selection decisions will be based on a lowest price technically acceptable (LPTA) process which incorporates the following four factors and sub factors listed in descending order of importance:

The Technical, Management/Staffing Plan, Relevant Past Performance, and Price evaluation criteria as described below. The FDA anticipates making a single award to a responsible offeror that offers the best value to the Government.

TECHNICAL EVALUATION

The FDA will technically evaluate each proposal based on the following scheme:

Factor 1: Technical Capabilities

The Offeror’s technical capabilities will be evaluated based on their knowledge and experience with the process to develop custom ready made to use toxin/poison standard mixtures packages/kit/sets.

Factor 2: Management/Staffing Plan The Offeror’s ability to provide a strong management and staffing plan will be evaluated. This includes program management skills, flexibility and creative and innovative thought processes. The plan could consist of examples of effective communication, staff flexibility/optimization and success at meeting project deadlines, and workload management and innovative thought process capabilities

Factor 3: Relevant Past Performance The Government will evaluate three recent, relevant past performances which shall include three references for similar requirements in terms of size, scope, duration, complexity, and price to the work described in this solicitation that have been performed within the last three years. Offerors shall also provide information on past performance problems and any resulting corrective actions.

Factor 4: Price

The Offeror’s pricing table, as described in Section 1, and supportive pricing information will assist the Government in its evaluation that the prices quoted are fair, reasonable and support the relevant needs and objectives of this solicitation. In addition, the offer shall provide two pricing options/considerations for this contract: one with stability data supporting the 1- year expiry and one without stability data supporting the one (1) year expiry.