Solicitation_No._FDA-15-SOL-1146775_(7-24).pdf

Solicitation No. FDA-15-SOL-1146775

PART 1: COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This solicitation is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures, as applicable.

The solicitation number is FDA-15-SOL-1146775, which is issued as a Request for Proposals

(RFP).

The solicitation document and incorporated provisions and clauses are in effect through the Federal Acquisition Circular (FAC) 2005-83, dated July 2, 2015.

The associated North American Industry Classification System (NAICS) Code is 561990: All Other Support Services. The Small Business size standard is $11 million. This procurement is unrestricted and solicited as a full and open competition

PART 2: SUPPLIES/SERVICES AND PRICES/COSTS

2.1 Supplies/Services

The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm-Fixed Unit Price contract for the procurement of Third Party Recall Audit Checks.

2.2 Pricing:

CLIN Item Description Qty U/I Unit Price

Extended Price

Base Year: Third Party Recall Audit Checks, in accordance with the requirements stated in Part 3:

Description/Statement of Work. 1,000 EA $ $

Optional Recall Audit Checks (to be performed during the Base Year) 200 EA $ $

Option Year 1: Third Party Recall Audit Checks, in accordance with the requirements stated in Part 3:

Description/Statement of Work. 1,000 EA $ $

Optional Recall Audit Checks (to be performed during Option Year

1) 200 EA $ $

CLIN Item Description Qty U/I Unit Price

Extended Price

Option Year 2: Third Party Recall Audit Checks, in accordance with the requirements stated in Part 3:

Description/Statement of Work. 1,000 EA $ $

Optional Recall Audit Checks (to be performed during Option Year

2) 200 EA $ $

Option Year 3: Third Party Recall Audit Checks, in accordance with the requirements stated in Part 3:

Description/Statement of Work. 1,000 EA $ $

Optional Recall Audit Checks (to be performed during Option Year

3) 200 EA $ $

Option Year 4: Third Party Recall Audit Checks, in accordance with the requirements stated in Part 3:

Description/Statement of Work. 1,000 EA $ $

Optional Recall Audit Checks (to be performed during Option Year

4) 200 EA $ $

TOTAL $

PART 3: DESCRIPTION/STATEMENT OF WORK

A. PROJECT TITLE: Third Party Recall Audit Checks

B. STATEMENT OF WORK

1. Background

The Food and Drug Administration (FDA) protects public health by coordinating, initiating, and/or monitoring regulatory and recall actions, reviewing and managing compliance policies and processes, and evaluating data to assess and enhance agency compliance activities.

The Office of Regulatory Affairs (ORA) within FDA has substantially evolved its product safety and quality model in order to keep ahead of the possible risks in an ever changing world of manufacturers and producers. While import growth rates have accelerated, so too has the need for highly standardized operations within the Government and the marketplace.

The new global implications have forced FDA to recognize major implications, such as pressures to reduce cost, increase productivity and capitalize on quality improvement activities, while maintaining strong global safety standards.

A recall is a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers. A correction is further defined as the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location. Any firm may initiate a recall when its product is deemed to be in violation of FDA regulations and laws. Throughout the execution of a recall, it is the FDA’s responsibility to provide guidance to recalling firms, determine the hazard posed by the recalled product, inform the public of potential health risks, and monitor firms’ recall effectiveness, in part, by conducting recall audit checks (RACs) at recalling firm’s consignees to determine whether the consignee received the recall notification and followed instructions in the notification.

Recall classification means the numerical designation (i.e., I, II, or III), assigned by the FDA to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled. The respective definitions are as follows:

• Class I recall: A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

• Class II recall: A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

• Class III recall: A situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

2. Objectives

The purpose of this contract is to conduct approximately 1,000 annual recall audit checks (RACs) of FDA regulated products. Each RAC will be requested by the Government on an incident basis, focused on Class I recalls and Class II recalls. Additional audit recall checks may be required through the exercise of options, up to a maximum of 6,000 recall audit checks over the life of the contract.

Product Types: The Government requires that recall audit checks be performed of any FDA-regulated product, as designated in each recall audit assignment.

The work under this contract shall include performing this activity throughout the distribution channels of the recalled product. This could result in simultaneous and rapid deployment of resources to multiple locations that could expand across the United States, including Hawaii and Alaska. The number of RACs to be conducted per assignment also cannot be predicted, but could range between 10-1,000 RACs. The timeframe for a RAC assignment will range between 1-10 work days, with the majority of assignments expected to last between 2-3 work days. However, the Contractor must be capable of conducting 1,000 RACs in a 5-work day assignment, if required.

The results of each recall audit conducted shall be provided by the Contractor to the FDA via a secure, secured web-based reporting system.

3. Scope of Work

The Contractor shall conduct recall audit checks based on the information contained in the RAC Assignment Memo issued by the FDA (see Attachment 1 - Sample Assignment). RACs shall be conducted in-person at each location identified in the RAC assignment. The Contractor shall dress neatly and professionally and shall conduct RACs during the consignee’s normal business hours, Monday through Friday, unless the assignment indicates otherwise (i.e., weekend, holiday or after-hour RACs may be authorized).

When conducting the RAC, the Contractor shall determine whether the consignee received the recall notification and is following, or has followed, the instructions in the notification. The Contractor shall recognize and adjust to the differences in a firm’s recall strategy (e.g., a recall strategy may not remove the recalled product from the market, but may correct the recalled product in some manner). Upon arrival at the consignee’s place of business, the Contractor shall ask to speak with the most responsible individual for recalls. The Contractor shall ask a series of previously established questions (See Attachment 2 – Form FDA 3177), shall check consignee records, if available, and shall visually check retail shelves and, if appropriate, storage areas for the product subject to the recall.

The Contractor shall provide written reports to the Contracting Officer Representative (COR) at 24, 48, and 72 hour intervals after the initiation of an individual RAC assignment. The reports must detail the current RAC status of each consignee. The Contractor shall notify FDA immediately when a consignee refuses to, or failed to follow, the recalling firm’s instructions or refused to allow the Contractor to conduct the RAC.

The Contractor shall have thirty (30) calendar days after the contract effective date to establish processes and ensure adequate infrastructure is available to meet FDA’s simultaneous rapid deployment requirements. The Contractor shall have an adequate number of trained employees nationwide that can rapidly deploy within 24 hours to respond to a RAC assignment, in order to conduct RACs within the specified time frames. The Contractor shall have a computerized data system (see below) in place to collect, process, and submit RAC data to FDA.

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Tasks

1. Recall Audit Check (RAC)

The Contractor shall conduct each RAC primarily to confirm the consignee received and followed the instructions in the recall notification. The Contractor shall not handle the recalled product. The Contractor’s role additionally is to provide information if the consignee is unaware of the recall and to note the consignee’s intended actions to comply with the recall strategy contained in the firms recall notification.

The Contractor will receive the recall audit check work via assignments by the FDA COR, or authorized Office of Enforcement and Import Operations, Division of Enforcement recall staff, as identified by the COR in writing (see Attachment 1 for a sample assignment).

Upon receipt of a work assignment, the Contractor shall review the assignment, resolve any questions, ensure sufficient staff is assigned based on the details of individual assignments, and initiate the RAC.

When conducting the audit, the Contractor shall confirm the consignee received and followed the instructions in the recall notification. This may include verifying that there is no recalled product at the specific consignee(s) identified in the RAC assignment or that the consignee removed the affected product from use. Contractor shall attempt to identify if any recalled product was previously received and sold/used by the consignee. These actions shall be accomplished by asking a series of previously established questions and by visually checking, if appropriate, records, shelves, and storage areas for the product subject to recall. Not all recalls will necessarily require that the product must be returned to the recalling firm.

At a minimum, the Contractor shall:

a. Determine if the consignee was aware of the recall and received the notification from the recalling firm. If the consignee was not previously notified, the Contractor shall provide the consignee with a copy of the recall notice.

b. Determine if the consignee is following the recall instructions.

c. Determine the quantity of the product available for sale or use at the time of the audit, or obtain quantities of the product that has been returned or corrected.

d. Determine the Global Positioning System (GPS) coordinates of the consignee.

e. Provide proof the audit was conducted at the designated address (e.g., by photo).

In the event a RAC discloses that:

a. The facility was not notified of the recall by the same method of notification included in the assignment,

b. The recalled product remains available for sale or use, or

c. The facility has not complied with the recall notice:

The Contractor shall red flag the Daily Detailed Report (DDR) as potentially ineffective and inform the assigned District Office and Office of Enforcement and Import Operations through the daily DDR and Daily Summary Report (DSR) reports; and report the status of the RAC assignment to the FDA within the identified reporting period in the assignment document (see Task 3).

2. Computerized System

The Contractor shall have a computerized data system to be used for the management of recall audit checks that includes, but is not limited to, data collection, storage, reporting, and tracking. The FDA shall have permission to access the computerized data system. The system must be capable of storing the data collected during the recall audit checks and allow access through a secure web-based system that is capable of scaling for up to 200 FDA employees working with the recall audit check information.

Reported on items shall, at a minimum, be real-time; 24-7 accessible; and captured on a secured web-based system that displays results in, at a minimum, a downloadable spreadsheet format and color coded map-based format (state, region, national) to allow for quick visualization of results. Information for all assignments shall be retrievable by the FDA in the same format as it was captured for a period of up to six (6) months after the contract expiration date.

The Contractor shall familiarize FDA personnel on its data collection system so the FDA can verify the audits will collect the information required during an audit. FDA personnel need to know how to use the Contractor’s system if we are allowed access to retrieve data. E-mail can be used to transmit instructions for using their system or copies of training documents.

3. Reporting

The Contractor shall provide written reports to the COR or designee on each RAC assignment. Reports should be based on an individual RAC assignment containing grouped results from each individual audit. The frequency of reports should be determined by the assignment (e.g., 24, 48, 72hrs after initiation of the audit assignments). This allows FDA to determine the status of the whole assignment and of individual consignee audit assignments.

This also allows the Contractor to notify the FDA immediately of any potential issues with the entire assignment or an individual consignee audit. For example: Assignments are delayed due to weather conditions at the location of the assignment, consignee refused entry of third party auditor (this would require FDA to intervene or conduct the audit), consignee is refusing to provide adequate access to the facility (this would require FDA to intervene or contact the consignee and ask them to cooperate as if the individual were an FDA Investigator).

Each assignment requires that three (3) types of reports shall be provided to: the COR, Office of Enforcement and Import Operations, and assigned District Office:

3.1 Daily Detailed Report (DDR): The minimum data elements required are the critical data elements noted in the list below, the additional data elements listed as “Not Critical,” which are preferred to be included, and any Contractor-recommended data elements based on best industry practice:

a. Recall Enterprise System (RES) event number (this information will be provided on the assignment) – Critical

b. Recalling Firm Name and address (this information will be provided on the assignment) – Critical

c. Name of the recalled product (this information will be provided on the assignment) – Critical

d. Name of person conducting the recall audit check (or unique ID number) – Critical

e. Date and time audit check was conducted – Critical

f. Name of facility being audited – Critical

g. Location of facility in separate fields (Street Address, City, State, Zip) – Critical

h. GPS coordinates – Critical

i. Photos of facility – Critical

j. Name of person interviewed – Critical

k. Interviewed person’s position title – Critical

l. Consignee business phone – Not Critical

m. Did the consignee handle or sell the specific recalled product – Not Critical

n. Was recalled product available for sale or use? (If yes, specify which product(s)) –

Critical

o. Approximate quantity of recalled product available for sale or use – Not Critical

i. Was recalled product quarantined for future return/correction/disposal, Yes or No? -

Critical If yes:

ii. Approximate quantity quarantined – Not Critical

iii. Intended method of return/correction/disposal, if known – Not Critical

p. Was recalled product already returned/corrected/disposed, Yes or No? – Critical If yes:

i. Approximate quantity – Not Critical

ii. Method of return/correction/disposal, if known – Not Critical

r. Did the facility receive a recall notice, Yes or No? - Critical If yes:

i. Date notified – Not Critical

ii. Method of notification – Was the notification the same notification included in the recall audit check assignment? – Critical

q. Who was the notification received from? – Critical

r. If the facility received the same notification in the recall assignment, did the facility follow the instructions in the recall notification, Yes or No? If no, explain. – Critical

s. Was the product distributed to another account – Critical If yes:

i. Did the consignee conduct a sub-recall – Critical

3.2 Daily Summary Report (DSR): The minimum data elements required are the critical data the assignment) - Critical

b. Recalling Firm (this information will be provided on the assignment) - Critical

c. Name of the recalled product (this information will be provided on the assignment) –

Critical

d. Did the consignee conduct a sub-recall - Critical

e. Number of facilities audited (ongoing and completed) - Critical

f. Number of facilities to be audited - Critical

g. Problems encountered – specific - Critical

h. Anticipated completion date – Not Critical

3.3 Final Summary Report (FSR): The minimum data elements required are the critical data the assignment) - Critical

b. Recalling Firm (this information will be provided on the assignment) - Critical

c. Name of the recalled product (this information will be provided on the assignment) -

Critical

d. Number of facilities audited - Critical

e. Findings

1. % of consignees that received the recall notice prior to recall audit - Critical

2. % of consignees that were complying or had complied with recall notice - Critical

f. Problems encountered and resolution - Critical

3.4 Monthly Contract Status Report (MCSR): The minimum data elements required are the critical data elements noted in the list below, the additional data elements listed as “Not Critical,” which are preferred to be included, and any Contractor-recommended data elements based on best industry practice:.

a. Total number of audit checks received to date - Critical

b. Status of audit checks received to date - Critical

1. New - not yet initiated/assigned - Critical

2. In process - initiated but not completed - Critical

3. Completed - Critical

c. Number of audit checks remaining on the contract - Critical

d. Issues/concerns - Critical

Quality Control

The Contractor shall complete assigned RACs in accordance with the timeframe contained in the assignment. The Contractor is required to prepare and submit error-free RAC reports on time.

C. Reporting Requirements/Deliverables

Deliverables

Document Frequency Format Deliver y Method

Comment

Daily Detailed Report

(DDR)

Daily, 1-day (24 hours) after each event day for duration of the assignment

Excel Secured- Web

Minimum data elements listed below under “Format and Content”

A 3-day assignment should deliver 3 DDRs

Daily Summary Report (DSR)

Daily, 1-day (24hrs) after each event day for duration of the assignment

PDF /

Excel

Secured- Web

A 3-day assignment should deliver 3 DSRs

Final Summary Report

(FSR)

1 business day after assignment completion

PDF /

Excel

Secured- Web

Monthly Contract Status Report (MCSR)

15th day after end of month

PDF/Wor d

E-mail

D. Security and Privacy

The Contractor and Contractor personnel performing work under this contract must satisfy all requirements for appropriate security eligibility in dealing with access to sensitive information. The Contractor shall be required to undergo a security clearance, acceptable to the FDA. Performance of work may require the Contractor personnel to have access to and use of data and information which may be considered proprietary to a Government agency or Government contractor, or which may otherwise be of such nature that its dissemination or use, other than in performance of a subsequent work statement, would be adverse to the interest of the FDA or others. The FDA, thereof, owns all proprietary information and all copies. The Contractor agrees that Contractor personnel will not divulge or release data and information developed or obtained in connection with the performance of the resulting contract, unless made public by the FDA, except to authorize FDA personnel or upon the written approval of the COR.

Except as may otherwise be permitted by a data owner, the Contractor agrees not to use, disclose or reproduce proprietary data, other than as required in performance of the contract;

provided, however, that nothing herein shall be construed as precluding the use of any data independently acquired by the Contractor without such limitation. The FDA owns all proprietary information and the Contractor is required to return to the FDA all copies of data obtained or developed upon completion of the work.

Due to the sensitive nature of the information involved, all Contractor personnel shall be required to sign a non-disclosure agreement (via Form FDA 3398, to be provided upon award) before data and information otherwise exempt from public disclosure (e.g., Privacy Act or Data Collected Under and Assurance of Confidentiality) may be disclosed to them.

PART 4: PERFORMANCE

4.1 Period of Performance:

Period of Performance: The period of performance for this contract shall be for 12-month period, with four (4) 12-month option periods. Increased quantity options have been included for each year to add additional RAC assignments, should they become necessary.

4.2 Place of Performance:

The place of performance will be across the United States, including Alaska and Hawaii.

PART 5: CONTRACT ADMINISTRATION

5.1 Contracting Officer Representative (COR)

The name of the COR will be provided at the time of award.

The services provided hereunder will be inspected and accepted by the COR specified at the time of award. If the services are not acceptable, the COR will document the nonconforming items and immediately notify the Contracting Officer (CO).

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

5.2 Contracting Officer

The Contracting Officer (CO) for this procurement is: (to be determined at time of award)

The CO is the only person with authority to act as an agent of the Government under this contract. Only the CO has the authority to:

(1) Direct or negotiate any changes in the RFP;

(2) Modify or extend the period of performance;

(3) Change the delivery schedule;

(4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or

(5) Otherwise change any terms and conditions of this contract

5.3 Contract Specialist

The Contract Specialist for this procurement is: (to be determined at time of award)

5.4 FDA Invoice Requirements

Invoices shall be emailed to the following:

Title Email Address Contracting Officer’s Representative (to be completed upon award) Contract Specialist (to be completed upon award) Contracting Officer (to be completed upon award) Office of Financial Services fdavendorpaymentteam@fda.gov

The Contractor shall submit one copy of each invoice to the address specified below:

OFM Vendor Payments Services

DHHS/FDA/OFM/DPS

10903 New Hampshire Ave Bldg. 32 – Rm 2162

Silver Spring, MD 20993-0002

301.827.3742 or 866.807.3742 fdavendorpaymentsteam@fda.gov

Invoices submitted under this contract must comply with the requirements set forth in FAR clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer – System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

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

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) BPA number, Call Order number, contract line item number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

mailto:fdavendorpaymentsteam@fda.gov

(v) Shipping number and date of shipment, 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;

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

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this BPA.

(x) Electronic funds transfer (EFT) banking information.

An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (i) through (x) of this clause must be included in the electronic invoice.

Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

Questions relating to when payment will be received should be directed to FDA payment office at (301) 827-3742 or 866-807-3742; fdavendorpaymentsteam@fda.gov

5.5 Receipt and Acceptance of Supplies/Services:

The supplies and/or services delivered hereunder will be inspected and accepted at destination by the Contracting Officer Representative (COR) specified below. If the supplies or services are acceptable, the COR will promptly forward a report of inspection and acceptance to the payment office. If the supplies and/or services are not acceptable, the COR will document the nonconforming items/services and immediately notify the Contracting Officer.

PART 6: PROVISIONS, INSTRUCTION AND EVALUATION

The provision at FAR 52.212-1 Instructions to Offerors—Commercial Items (APR 2014) applies to this solicitation.

The provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (MAR 2015), applies to this solicitation. An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via https://www.sam.gov/portal/SAM/#1 .

Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from award consideration.

Proposal Preparation Instructions:

All responsible sources may submit a proposal, which will be considered if received by the due date. Proposals must be submitted no later than Friday, August 14, 2015, 2:00 PM, Eastern Time. Proposals shall be submitted electronically via e-mail. The subject line shall read: FDA-15-SOL-1146675: Third Party Recall Audit Checks. Faxed proposals will not be accepted.

mailto:fdavendorpaymentsteam@fda.gov https://www.sam.gov/portal/SAM/#1

Late submissions will be treated in accordance with the solicitation provision at FAR 52.212- 1(f).

Offerors may submit all questions regarding this RFP to Zetherine Gore, via email at zetherine.gore@fda.hhs.gov. The FDA must receive the questions no later than 2:00 P.M., Eastern Time, Wednesday, July 29, 2015. The subject line must read: RFP No. FDA-15- SOL-1146775: Third Party Recall Audit Checks. The FDA will not answer questions received after this date and time, and will not answer questions submitted to individuals other than the named contact point (no phone calls, please). RFP questions and FDA responses will be posted to the Federal Business Opportunities (FedBizOpps) web site. It is the vendor's responsibility to check the FedBizOpps web site for the questions and answers and any other amendments issued for this RFP.

A complete proposal must consist of a cover letter; Volume 1-Technical Proposal; and Volume 2–Business/Price Proposal; and Volume 3-Past Performance, as detailed below.

Incomplete proposals will be considered non-responsive and will not be further evaluated.

Each volume shall be sent as a separate document. The Technical Proposal (Volume 1) and Business/Price Proposal (Volume 2) must be kept separate from each other. Kept separate is defined as not including any cost/price information in the Technical Proposal (Volume 1).

The Technical Proposal must not make reference to pricing data in order that the technical evaluation may be made strictly on the basis of technical merit. Proposals must be submitted in either pdf (Adobe Acrobat 7.0 or older) format or in the original native format (e.g., Word or Excel).

All proposals will be handled by the Government in accordance with FAR Subpart 3.104.

Information requested by the Government herein must be furnished in writing and be fully and completely in compliance with RFP instructions. The information requested and the manner of submission is essential to permit prompt evaluation of all proposals on a fair and uniform basis. Simple statements of compliance with the RFP requirements without a detailed description of how compliance will be accomplished may not be considered sufficient evidence that the Contractor can meet the technical requirements.

Contractor employees responsible for preparing material that may be source selection information must mark each page that the Contractor believes contains source selection information with the legend “Source Selection Information”.

This is an open-market combined synopsis/solicitation for services as defined herein. The Government intends to award a contract as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all proposals must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

mailto:zetherine.gore@fda.hhs.gov

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

The offeror shall list the exception(s) and rationale for the exception(s).

The Government reserves the right to make an award without conducting communications with offerors.

For planning purposes, if your organization intends to submit a proposal in response to this solicitation, please inform the Contract Specialist of your intent by sending an email to Zetherine Gore, Contract Specialist, at zetherine.gore@fda.hhs.gov, by no later than 2:00 PM, Eastern Time, Friday, August 10, 2015.

Period for Acceptance of Offers: The offeror agrees to hold the offered prices firm through September 30, 2015.

The signature of an official authorized to bind the offeror shall be placed on each volume.

Each volume shall be submitted as follows:

I. Technical Volume 1:

A. Approach and Understanding

The offeror shall describe how it proposes to accomplish the requirements of the Statement of Work. The technical proposal shall include detailed information which demonstrates the offeror’s technical understanding and approach and understanding of the SOW. The offeror shall describe its quality control program, and how the proposed personnel and resources shall be used to accomplish the specific requirements of the SOW tasks.

B. Organizational Experience and Capacity

The offeor shall describe its organizational relationships, structure and staffing, teaming and subcontractor arrangements (if applicable). The offeror shall submit any resumes and supporting documents necessary to determine the offeror’ s level of experience, qualifications, and certifications for performing and managing the contract requirements.

mailto:zetherine.gore@fda.hhs.gov

II. Business/Price Volume 2

The price proposed shall be detailed and represent the offeror’s response to the schedule of services as listed in Part 2 and described in Part 3 above.

An electronic copy in both PDF and Excel format of the Business/Price Volume shall be submitted. The business proposal must provide sufficient detail to determine whether the proposed solution represents the best value to FDA. Where pricing data is derived via formula, the offeror must show formulas that are clearly visible in the individual cells and verifiable. Include any notes or assumptions not described elsewhere in your proposal.

Offerors are encouraged to include a commercial price list with their proposal, as applicable.

Every page of the pricing volume must be numbered. There is no page limit to the pricing volume.

All total dollar amounts provided shall be rounded to the nearest cent.

The Government is not responsible for locating or securing any information which is not identified in the proposal; however, the Government reserves the right to obtain information for use in the evaluation from any and all sources, including sources outside of the Government. Offerors should include their DUNS number with the proposal.

Any assumptions forming the basis of the submittal must be clearly identified in the cover letter submitted with the RFP.

III. Past Performance Volume 3

The Past Performance Volume shall describe the offeror’s success in performing contracts/orders that are similar in size, scope and complexity to the work described in the SOW. Offerors shall submit a listing of three (3) such contracts/orders completed during the last three (3) years and all contracts/orders currently in process. Contracts/Orders listed may include those with the Federal government, state and local governments, and commercial customers. Offerors with no previous past performance will be evaluated neutrally. Offerors shall submit the following past performance information: 1. Name of contracting organization; 2. Contract number; 3. Contract type; 4. Total contract value; 5. Description of requirement; 6. Contracting Officer’s name, address, telephone number, and email address;

and 7. Government Program Manager’s name, address, telephone number, and email address.

Evaluation Criteria and Basis for Award:

FAR 52.212-2 Evaluation-Commercial Items (Oct 2014)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Technical

A. Approach and Understanding B. Organizational Experience and Capacity

Past Performance Price

Technical and past performance, when combined, are significantly more important than cost or price.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced.

Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of provision)

EVALUATION FACTORS

Technical Evaluation

A. Approach and Understanding

This technical sub-factor will be evaluated based upon: (1) the extent to which the offeror demonstrates an understanding of the background, history, purpose, and goals of this contract and the overall contract requirements; (2) the technical soundness and specificity of the offeror’s proposed approach for completion of the tasks described in the Statement of Work (SOW); (3) the effectiveness of the offeror’s identification and discussion of outstanding issues and logistical concerns; (4) the planned approach for the use and management of personnel and resources required in the performance of this contract; (5) the effectiveness of the offeror’s proposed approach to addressing any perceived issues or other constraints to meeting requirements or project goals; and (6) an assessment of the offeror’s explanation for how it intends to provide the required services within the given time frame(s) and in the most efficient and cost-productive manner; (7) the methodology for identifying deficiencies and minimizing risks in the quality of services performed before the level of performance becomes unacceptable.

B. Organizational Experience/Capacity:

This technical sub-factor will be evaluated based upon the successful demonstration of the offeror’s organizational relationships, structure and staffing, teaming and subcontractor arrangements (if applicable), resumes, and supporting documents submitted of proposed key personnel to determine the offeror’s level of experience, qualifications, and certifications for performing and managing the contract requirements.

Past Performance Evaluation

Past Performance is a risk assessment and is part of the Contractor responsibility determination. The Government will assess the relative performance risks associated with each offer. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance. The assessment of performance risk is not intended to be a product of a mechanical or mathematical analysis of an offeror's performance on a list of contracts, but rather the product of subjective judgment by the Government after it considers relevant information. When assessing performance risks, the Government will focus on the past performance of the offeror as it relates to all acquisition requirements, such as the offeror's record of performing according to specifications, including standards of good workmanship;

the offeror's record of controlling and forecasting costs; the offeror's adherence to contract schedules, including the administrative aspects of performance; the offeror's reputation for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the offeror's business-like concern for the interest of the customer. The Government will consider the currency and relevance of the information, source of the information, context of the data, and general trends in the offeror's performance. The lack of a past performance record may result in an unknown performance risk assessment, which will neither be used to the advantage nor disadvantage of the offeror. References other than those identified by the offeror may be contacted by the Government to obtain additional information (e.g., Contractor Performance Assessment Reporting System (CPARS), Department of Defense’s Past Performance Information Retrieval System (PPIRs).

Price Evaluation

The Government will separately evaluate proposed pricing to determine that prices are fair, reasonable and realistic.

PART 7: CONTRACT CLAUSES

CLAUSES INCORPORATED BY REFERENCE

FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address/es:

www.acquisition.gov/far/index.html

The following clauses are incorporated by reference:

FAR 52.204-7 System for Award Management (JUL 2013) FAR 52-204-16 Commercial and Government Entity Code Reporting (NOV 2014) FAR 52.204-18 Commercial and Government Entity Code Maintenance (NOV 2014) FAR 52.212-4 Contract Terms and Conditions-Commercial Items (MAY 2015) FAR 52.216-24 Limitation of Government Liability (APR 1984) FAR 52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran – Representation and Certification

(DEC 2012)

FAR 52.232-40 Providing Accelerated Payment to Small Business Subcontractors

(DEC 2013)

FAR 52.233-2 Service of Protest (SEP 2006) FAR 52.246-4 Inspection of Services-Fixed Price (AUG 1996)

FAR CLAUSES INCORPORATED BY FULL TEXT

The following clauses are incorporated by full text:

FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (May 2015)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Dec 2014)

(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004)(Public Laws

108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the

Contracting Officer has indicated as being incorporated in this contract by reference to http://www.acquisition.gov/far/index.html https://www.acquisition.gov/sites/default/files/current/far/html/52_207_211.html#wp1146366 https://www.acquisition.gov/sites/default/files/current/far/html/52_233_240.html#wp1113329 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t29t32+1665+30++%2831%29%20%20AND%20%28%2831%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_233_240.html#wp1113344 http://uscode.house.gov/ implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

_X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery

Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

_X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with

Contractors Debarred, Suspended, or Proposed for Debarment. (Aug 2013) (31 U.S.C. 6101 note).

_X_ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

__ (10) [Reserved].

__ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011)

(15 U.S.C. 657a).

__ (ii) Alternate I (Nov 2011) of 52.219-3.

__ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (ii) Alternate I (JAN 2011) of 52.219-4.

__ (13) [Reserved] __ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C.

644).

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

__ (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C.

644).

https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1137622 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1141983 http://uscode.house.gov/ http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1144881 https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1141649 http://uscode.house.gov/ https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1151163 https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1151299 https://www.acquisition.gov/sites/default/files/current/far/html/52_207_211.html#wp1140926 https://www.acquisition.gov/sites/default/files/current/far/html/52_207_211.html#wp1145644 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1135955 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1135955 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1135970 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1135970 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136004 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136017 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+492+90++%2815%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20

__ (ii) Alternate I (Oct 1995) of 52.219-7.

__ (iii) Alternate II (Mar 2004) of 52.219-7.

_X_ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C.

637(d)(2) and (3)).

_X_ (17)(i) 52.219-9, Small Business Subcontracting Plan (Oct 2014) (15 U.S.C.

637(d)(4)).

__ (ii) Alternate I (Oct 2001) of 52.219-9.

_X (iii) Alternate II (Oct 2001) of 52.219-9.

__ (iv) Alternate III (Oct 2014) of 52.219-9.

__ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011)(15 U.S.C. 644(r)).

__ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

_X (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C.

637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside

(Nov 2011) (15 U.S.C. 657 f).

__ (22) 52.219-28, Post Award Small Business Program Representation (Jul 2013) (15

U.S.C. 632(a)(2)).

__ (23) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned

Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB)

Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)).

_X (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

__ (26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2014)

(E.O. 13126).

_X (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

_X (29) 52.222-35, Equal Opportunity for Veterans (Jul 2014)(38 U.S.C. 4212).

_X (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29

U.S.C. 793).

_X (31) 52.222-37, Employment Reports on Veterans (JUL 2014) (38 U.S.C. 4212).

_X (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations

Act (Dec 2010) (E.O. 13496).

_X (33)(i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter

78 and E.O. 13627).

__ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

__ (34) 52.222-54, Employment Eligibility Verification (AUG 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

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