FDA-RFP-1154326_Final_(Updated_8-10-2015).pdf

Solicitation No.: FDA-RFP-1154326 Title: Pilot Projects for Drug Supply Chain Security Act

SECTION 1 – SUPPLIES AND SERVICES AND PRICES

1.1 SOLICITATION DESCRIPTION

This solicitation is a Request for Proposals (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-82. The applicable North American Industry Classification System (NAICS) codes assigned to this synopsis is 541990. Its associated Small Business size standard is $14 Million.

1.2 CONTRACT TYPE

The FDA anticipates award of a Non-Commercial Firm-Fixed Price Contract.

1.4 PRICING

TASKING DESCRIPTION TOTAL

AMT.

Task 1 Kick-Off Meeting with FDA Project Officer

(PO)/Contract Officer Representative (COR) and other FDA staff

Task 2 Development of Pilot Project Program $ Task 3 Proposed Pilot Project Program and Public Workshop

Public Announcement and Comment Period

Task 4 Public Workshop $ Task 5 Final Pilot Project Program Public Announcement $ Task 6 Selection of Pilot Project Program Participants $ Task 7 Design Strategy Meeting $ Task 8 Pre-Launch Meeting(s) $ Task 9 Implementation of Pilot Project(s)

Task 10 Monitoring Pilot Project(s) Development, Execution, Progress, and Completion by Participants

Task 11 Progress Reports of Completed Pilot Projects $ Task 12 Final Comprehensive Evaluation Report of Completed

Pilot Projects

Task 13 Final Report of the Pilot Project Program $ Travel

TOTAL AMOUNT

SECTION 2 - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

2.1 BACKGROUND

The Drug Supply Chain Security Act (DSCSA), Title II of the Drug Quality and Security Act which was enacted November 27, 2013, requires FDA to establish pilot project(s) to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. These pilot project(s) will require coordination with manufacturers, re-packagers, wholesale distributors, and dispensers and build upon efforts to enhance the safety and security of the pharmaceutical distribution supply chain, consider any pilot project previously conducted, and inform FDA guidance for industry developed to implement the law. Development and implementation of a program for these pilot project(s) will require intense support and oversight for a finite period of time.

The needs of these pilot project(s) exceed ODSIR’s current capability, and can be more efficiently and cost effectively met by a contract instead of requesting additional FTEs.

2.2 OBJECTIVE

The objective of this contract is to 1) Develop a program for the DSCSA pilot projects that explores and evaluates methods to enhance the safety and security of the pharmaceutical distribution supply chain, and 2) Implement a program for the DSCSA pilot projects.

2.3 SCOPE OF WORK

Development and implementation of a program for the pilot projects will include, but is not limited to: development of the program structure, determination of the scope of the pilot projects and what issues should be covered, ensuring the pilot project design fulfills the requirement of the DSCSA, development of an enrollment process for potential participants, development of timing and schedule, development of monitoring and reporting schedule, development of pilot project metrics and evaluation plan; and development of a communication plan. The pilot project(s) developed under the DSCSA need to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain, through a) utilization of the product identifier for tracing of a product throughout the supply chain and may include verification of product identifier, including the use of aggregation and inference; b) improvement of the technical capabilities of each sector and subsector to comply with systems and processes needed to utilize the product identifiers to enhance tracing of a product; and c) identification of system attributes that are necessary to implement the requirements established under the DSCSA.

2.4 STATEMENT OF WORK

The Contractor shall perform the following tasks and submit deliverables related to this requirement as follows:

TASK TO BE ACCOMPLISHED

Task 1 – Kick-Off Meeting with FDA Project Officer (PO)/Contract Officer Representative (COR) and other FDA staff Fulfillment of this task will ensure FDA and contractor agree on key components of the design of the program for pilot project(s). Contractor will, at a minimum, need to be prepared to discuss:

1) Scope of program

2) Charge of program and work group

3) Workplan (including key tasks, milestones and deadlines)

4) Key deliverables and evaluation plan for program performance

Task 2 – Development of Pilot Project Program The contractor will work with FDA subject-matter-experts assigned to these activities to develop the structure of the pilot project program. This should include, but not limited to: determination of the scope of the pilot projects and what issues should be covered, ensuring the pilot project design fulfills the requirement of the DSCSA, development of an enrollment process for potential participants, development of timing and schedule;

development of monitoring and reporting schedule; development of pilot project metrics and evaluation plan; and development of a communication plan. The contractor will assist in background research and writing internal documents or communication that will aid in the development of the program.

Task 3 – Proposed Pilot Project Program and Public Workshop Public Announcement and Comment Period The contractor shall work with FDA to draft and publish a Federal Register Notice announcing the proposed program for public comment and planned public workshop. A public docket will be established to receive comments from interested stakeholders. The contractor shall work with FDA to review and consider the public comments received and assist in modifying the pilot project program if needed.

Task 4 – Public Workshop

The contractor shall work with FDA to conduct a public workshop as a forum for discussion and input by interested stakeholders. The contractor shall assist FDA in the development of workshop materials, conduct the workshop, summarize comments, and develop a summary of the public workshop. Input received at the workshop may be considered for revision of the proposed pilot project program in Task 3.

Task 5 - Final Pilot Project Program Public Announcement

The contractor shall work with FDA to draft and publish a Federal Register Notice announcing the final pilot project program. The notice will include the request for participation by members of the pharmaceutical distribution supply chain, and the request for information regarding pilot projects conducted prior to the date of enactment of the DSCSA. In addition, the notice should elaborate on pilot project design, including descriptions of whom and what prescription drug products may be eligible for the project, participant responsibilities, and evaluation methods.

Task 6 – Selection of Pilot Project Program Participants The contractor shall assist FDA in managing the enrollment process for pilot project program. The contract shall provide participant enrollment information to FDA staff assigned to review and make participant selections, and compile FDA recommendations for program participants. The contractor shall contact applicants that were selected for the program.

Task 7 – Design Strategy Meeting The contractor shall convene, if applicable, design strategy meeting(s) with selected pilot project participants, FDA subject-matter-experts, and other stakeholders as appropriate, on the DSCSA and traceability. Other stakeholders may include representatives from an international standards development organization fluent in traceability standards or solution providers. Specific design and evaluation criteria should be discussed that meet the overarching goals of the program.

Task 8 – Pre-Launch Meeting(s) Following design and evaluation acceptance with all participating stakeholders, the contractor shall hold pre-launch meeting(s) with pertinent FDA staff to provide details of the accepted design and to coordinate with FDA. Following the meeting with FDA, the contractor shall hold a meeting with all program participants and provide the design and evaluation criteria that have been accepted, including time periods for performance by participants.

Task 9 – Implementation of Pilot Project(s) The contractor shall work with FDA and program participants to ensure that program procedures are followed. The time frame for initiation and time period for execution of each pilot project will be determined on a case-by-case basis through consultation with FDA and based on the design strategy meeting(s).

Task 10 – Monitoring Pilot Project(s) Development, Execution, Progress, and Completion by Participants For each pilot project, the contractor shall develop and follow a schedule for monitoring pilot project development, execution (includes application of product identifiers, exchange of product tracing, management of data, use of aggregation and inference), progress (includes periodic reporting from participants), and completion. The contractor shall meet with FDA staff each month (or other schedule determined by FDA) and provide status updates of each pilot project. Additional meetings may be needed on an ad-hoc basis.

Task 11 – Progress Reports of Completed Pilot Projects For each completed pilot project, the contractor shall work with the participants of each pilot project to compile a report based on progress reports provided by the pilot project participants during execution of the pilot project. Draft and interim reports shall be provided to FDA for review and comment. For those pilot projects that are completed during the contract period, final reports shall be provided to FDA within 15 days of the completion of the pilot project.

Task 12 – Final Comprehensive Evaluation Report of Completed Pilot Projects Using the pilot project metrics and evaluation plan developed under Task 2 and 7, the contractor shall work with FDA to evaluate components of and/or full pilot project execution, for those pilots that are conducted and completed during the contract period.

The contractor shall assist the FDA in compiling results of the each evaluation and generate an evaluation report. The contractor shall assist FDA with drafting a comprehensive report of all evaluations of completed pilot projects during the contract period. The final comprehensive report of evaluations shall be provided to FDA within 1 month of the completion of the last pilot project that was completed during the contract period.

Task 13 – Final Report of the Pilot Project Program

Within 1 month after the final comprehensive report of evaluation of the pilot projects is completed and provided to FDA, the contractor shall provide a final report of the pilot project program based on the activities conducted during the contract period. This report should include, but not limited to, description of the program and procedures, summary of results, and evaluation of the program.

DELIVERABLES

Task/Deliverable Schedule

Deliverable Task/Description Quantity/Media Date Completed

1 Kick-Off Meeting Materials (Task 1)

Various (electronic MS Word or Power Point)

At least 1 day prior to Kick-Off Meeting

2 Conduct Kick-Off Meeting (Task 1)

Various (electronic MS Word or Power Point)Various

At least 1 week following the initiation/awarding of the contract

3 Summary of Kick-Off Meeting (Task 1)

Various (electronic MS Word or Power Point)

1 week following Kick-Off Meeting

4 Conduct working group meetings to develop the Pilot Project Program (Task 2)

Various (electronic MS Word or Power Point)

Within 50 days after Kick-off Meeting

5 Draft Proposed Pilot Project Program (Task 2)

Various (electronic MS Word or Power Point)

Within 60 days after Kick-Off Meeting

6 Develop Federal Register Notice Announcing Proposed Pilot Project Program and Public Workshop (Task 3)

Electronic MS Word file

Within 60days after Kick-Off Meeting

7 Develop Public Workshop Material (Task 3 and 4)

Various (electronic MS Word or Power Point)

Within 90 days after Kick-Off Meeting

8 Conduct Public Workshop (Task 4)

Within 120 days after Kick-Off Meeting or within 20 days following publication of the Federal Register Notice

9 Review docket comments for Proposed Pilot Project Program and Public Workshop (Task 3, 4, 5)

Within 130 days after Kick-Off Meeting or within 10 days of completion of the Public Workshop

10 Develop Federal Register Notice Announcing Final Pilot Project Program (Task 5)

Within 135 days after Kick-off Meeting or within 15 days of completion of the Public Workshop

11 Manage, selection and enrollment of Pilot Project Participants (Task 6)

Electronic MS Word file and/or pdf

Within 175 after Kick-off Meeting or 30 days following publication of Federal Register Notice

12 Conduct Design Strategy Meeting(s) (Task 7)

N/A Within 185 days after Kick-off Meeting or within 15 days that participants are selected and notified by FDA

13 Summary of Design Strategy Meeting(s) (Task 7)

Electronic MS Word file

Within 7 days following each Design Strategy Meeting(s)

14 Pre-Launch Meeting(s) Materials (Task 8)

Various (electronic MS Word or Power Point)

At least 1 day prior to the pre-launch meeting

15 Pre-Launch Meeting with Stakeholders (Task 8)

N/A Within 14 days following Design Strategy Meeting(s) Deliverable 13

16 Summary of Pre-Launch Meeting with Stakeholders (Task 8)

Electronic MS Word file

Within 3 days following Pre- Launch Meeting (Deliverable 15)

17 Implement Pilot Project(s) (Task 9)

Within 5 days of the Pre-Launch Meeting (Deliverable 15)

18 Monthly or Interim Status Updates of each pilot project(s) (Task 10)

Electronic MS Word file or other

Periodic; TBD on pilot project

19 Written Progress Reports of Each Completed Pilot Projects (Task 11)

Electronic MS Word file

Anytime between 1 -15 days after completion of pilot project

20 Written Final Comprehensive Evaluation Report of Completed Pilot Projects (Task 12)

Electronic MS Word file and/or pdf

Within 1 month of completion of pilot projects

21 Final Written Final Report of the Pilot Project Program (Task 13)

Electronic MS Word file and/or pdf

Within 1 month after the final comprehensive evaluation report of the pilot projects (Deliverable 20)

TRAVEL

Travel to and from Silver Spring, MD (Washington DC metropolitan area) may be required for contractor’s experts. Such travel will include reasonable transportation (coach class), lodging and meals, for up to eight (8) face-to-face meetings with FDA, industry, or other stakeholders over the period of performance. Travel will be reimbursed in accordance with Federal Travel Regulations (FTR).

PERIOD OF PERFORMANCE

The Period of Performance for this requirement is eight months from date of award.

PLACE OF PERFORMANCE

Performance of this requirement will be at the Contractor’s facility. Face-to-face meetings will be held at FDA’s White Oak Campus in Silver Spring, Maryland.

SECTION 3 - PACKAGING AND MARKING

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

SHIPMENT AND MARKING

Shipment of deliverable items shall be as follows:

Ship to: White Oak Campus, Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Silver Spring, Maryland 20993.

Mark for: TBD

The Contractor shall mark each shipment with their company name, contract 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.

5.1. PUBLICATIONS AND PRESENTATIONS:

The Contractor shall not present, publish, or otherwise release any information arising out of their contract without the express prior written permission of the COR. The COR will determine what, if any, information may be releasable for publication, presentation, or through another means and will determine the content of the released information, including any authorship decisions.

SECTION 6 - CONTRACT ADMINISTRATION

6.1 CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The following COR will represent the FDA for the purpose of this contract: (To Be Determined Upon Contract Award)

The COR is responsible for the following: (1) monitoring the Contractor’s technical progress, including surveillance and assessment of performance and recommending to the FDA Contracting Officer changes in requirements; (2) interpreting Statement of Works and any other technical performance requirements; (3) performing technical evaluations;

(4) performing technical inspections and acceptances; 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:

TBD

U.S. Food and Drug Administration Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 @fda.hhs.gov Telephone:

The contact information for the FDA Contract Specialist is the following:

William Lee

Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 William.Lee@fda.hhs.gov Telephone: (240) 402-7597

The contact information for the contractor is as follows:

Name:

Email:

Phone:

6.2 INVOICE 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: William Lee, Contract Specialist 5630 Fishers Lane Room 2129, HFA-500 Rockville, MD 20857

Email: William.Lee@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

Acceptable 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;

mailto:XXXXX@fda.hhs.gov

(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

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.

mailto:fdavendorpaymentsteam@fda.gov

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

7.1. 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/.

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.

Reg. No. Clause Title Date

52.202-1 DEFINITIONS NOV 2013

52.203-3 Gratuities APR 1984

52.203-5 COVENANT AGAINST CONTINGENT FEES APR 1984

52.203-7 ANTI-KICKBACK PROCEDURES OCT 2010

52.203-8 CANCELLATION, RESCISSION, AND

RECOVERY OF FUNDS FOR ILLEGAL OR

IMPROPER ACTIVITY

MAY 2014

52.203-10 PRICE OR FEE ADJUSTMENT FOR ILLEGAL

OR IMPROPER ACTIVITY

MAY 2014

52.203-12 LIMITATION ON PAYMENTS TO INFLUENCE

CERTAIN FEDERAL TRANSACTIONS

OCT 2010

52.203-13 CONTRACTOR CODE OF BUSINESS ETHICS

AND CONDUCT

APR 2010

52.203-14 DISPLAY OF HOTLINE POSTER(S) DEC 2007

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER

RIGHTS AND REQUIREMENT TO INFORM

EMPLOYEES OF WHISTLEBLOWER RIGHTS

APR 2014

52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON

RECYCLED PAPER

MAY 2011

52.204-10 REPORTING EXECUTIVE COMPENSATION

AND FIRST-TIER SUBCONTRACT AWARDS

JUL 2013

52.209-6 Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment

Aug 2013

52.209-9 UPDATES OF PUBLICLY AVAILABLE

INFORMATION REGARDING RESPONSIBILITY

MATTERS

JUL 2013

52.215-2

AUDIT AND RECORDS--NEGOTIATION OCT 2010

52.215-8 ORDER OF PRECEDENCE--UNIFORM

CONTRACT FORMAT

OCT 1997

52.215-23 LIMITATIONS ON PASS-THROUGH CHARGES OCT 2009

http://www.acquisition.gov/far/index.html

52.216-18 ORDERING OCT 1996

52.219-8 UTILIZATION OF SMALL BUSINESS

CONCERNS

MAY 2014

52.219-9 SMALL BUSINESS SUBCONTRACTING PLAN OCT 2014

52.219-9 SMALL BUSINESS SUBCONTRACTING PLAN--

ALTERNATE II

OCT 2001

52.219-16 LIQUIDATED DAMAGES--SUBCONTRACTING

PLAN

JAN 1999

52.222-26 EQUAL OPPORTUNITY MAR 2007

52.222-54 EMPLOYMENT ELIGIBILITY VERIFICATION JAN 2009

52.227-

14, ALT.

IV

RIGHTS IN DATA—GENERAL DEC 2007

52.233-3 PROTEST AFTER AWARD AUG 1996

52.233-4 APPLICABLE LAW FOR BREACH OF

CONTRACTCLAIM

OCT 2004

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.

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/.

Reg. No. Clause Title Date

352.201-70 Paperwork Reduction Act JAN 2006

352.202-1 Definitions JAN 2006

352.203-70 Anti-Lobbying JAN 2006 http://www.hhs.gov/policies/hhsar/

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations

JAN 2010

352.224-70 Privacy JAN 2006

352.231-71 Pricing of Adjustments JAN 2001

352.270-4 Protection of Human Subjects JAN 2006

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 William.Lee@fda.hhs.gov on or before 12:30pm Eastern Time on August 17, 2015.

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):

http://www.hhs.gov/policies/hhsar/

Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857

(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:

o 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 o 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 developed metrics regarding successes/failures/limitations for a pilot project(s).

Sub-Factor 2: The Offeror shall describe their company’s knowledge level of the pharmaceutical supply chain and distribution of finished prescription drugs in the U.S.

Sub-Factor 3: The Offeror shall describe their company’s knowledge level regarding specific technical capabilities and logistical processes (barcoding/item level and case level serialization/databases/lot # tracking) of both large and small pharmaceutical supply chain members (including manufacturers, repackagers, wholesale distributors and pharmacies).

Sub-Factor 4: The Offeror shall describe how their company has measured successes/failures/limitations for a pilot project involving finished prescription drugs, if applicable.

Factor 2: Management/Staffing 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: Offerors shall provide a matrix of recent, relevant past performance, which shall include the following: a short description of the work, the dates of work performance, the name of the clients and their phone numbers and email addresses, so the FDA may be able to conduct a reference check. 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.

SECTION 10 - EVALUATION FACTORS FOR AWARDS

EVALUATION CRITERIA

The FDA’s source selection decisions will be based on a best value tradeoff 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 are 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 entire pharmaceutical supply chain. This includes, but is not limited to, the following: technical capabilities and logistical processes such as barcoding, serialization, data, and aggregation/inference. Also, knowledge and participation with technologies and standard setting organizations with be considered. In addition, the Offeror’s knowledge and experience with developing metrics will be evaluated. This includes metrics related to system performance, accuracy of data, and product tracing success.

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.