RFP_for_Studies_to_Enhance_FDA_Communications_Medical_Countermeasures.doc

Subject: Studies to Enhance FDA Communications Addressing Medical Countermeasures Prescription Drug Products Solicitation Number: FDA-16-RFP-1160119 Part 1 – Description

1.1 This is a Request for Proposal (RFP) for Studies to Enhance FDA Communications Addressing Medical Countermeasures Prescription Drug Products.

1.2 The associated North American Industrial Classification System (NAICS) code for this procurement is 541990. This requirement is a total small business set-aside.

Part 2 – Supplies or services and Prices/Costs

2.1 Description of Equipment/Services

Description

Tasks: Initial Planning Meeting, Progress Reports, Meetings, Draft Research Strategy Work Plan and Final Research Strategy Work Plan (Deliverable 1-5)

Tasks: Focus Group Materials Development, Data Collection and Analysis and Submission of Final Material (Deliverable 6-9)

Tasks: Preparation for and Completion of Web Survey and associated reports (Deliverable 10-12 and Partial of 14)

Tasks: Messaging and Information Revision Plan and implementation (Deliverable 13, 14 (partial) and 16)

Tasks: Final Presentation and Delivery of All Raw Data (Deliverable 17 and 18:

Contract Total:

Part 3 – Description/Specifications/Work Statement

3.1 Introduction

The Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) has an ongoing responsibility to communicate about the medical products it approves. The Center believes that timely communication of information about regulated medical products shall provide health care professionals, patients, consumers, and other interested persons access to the most current and reliable information concerning the potential risks and benefits of these products, helping them to make more informed treatment choices.

In order to ensure the messages, materials and information CDER is providing shall be easily understood and acted upon, provides a basis for informed decision-making, and promotes trust in the Agency, its communications must be evidence-based, i.e. consistent with the best science, and they must be evaluated to determine how well they are accomplishing their objectives and how they shall be improved.

Effective communication when the nation is facing a health threat shall be critical for the FDA. History has shown that these health threats surface quickly, affect large numbers of geographically disparate people, and last for some time.

For many health threats, medical countermeasures, medicines in particular, represent a lifeline to the affected public. However, some of these medicines are not widely used or available. Furthermore, these medicines may carry unique or undocumented risks. For this reason, it is imperative that the FDA communicate rapidly and effectively with the public so they understand the risks associated with these medicines and will be able to maximize their benefits and minimize their risks.

3.2 Objectives:

In an effort to most efficiently and effectively communicate about various medical countermeasures that could be used to treat a variety of health threats associated with biological, chemical and radiological terrorism exposures, FDA’s Center for Drug Evaluation and Research’s Office of Communications (CDER/OCOMM) wishes to engage a contractor to plan and conduct qualitative and quantitative testing of a series of medical countermeasures-related risk communication messages and information that can be used in each of these public health emergencies with the general public, including vulnerable and special needs groups; and to use the information gathered from this testing to revise and update these messages and materials. This testing will be used to determine the public’s information priorities regarding various medical countermeasures in a public health emergency; explore the attitudes, beliefs, understanding, and behavioral intentions of members of the public with respect to draft messages relating to various medical countermeasures used during a public health emergency; and prioritize the anticipated concerns of members of the public and their information needs related to medical countermeasures during a public health emergency.

In order to accomplish this testing, CDER/OCOMM proposes conducting 24 focus groups in five cities nationwide followed by a survey to gain input for enhancing our ability to communicate during these emergencies. This testing should explore the effectiveness of the messages/information with respect to comprehension, exposure, recall, reception, reaction, retention, interpretation, motivation to act, and/or performing desired outcomes, or other activities deemed appropriate. The focus groups should be audio and video recorded, and transcribed. The online survey should build on the focus group findings and provide generalizable and practical findings. The messages and information to be tested were developed based on prior qualitative formative research.

This work is critical to strengthening the Agency’s ability to fulfill its public health mission by raising awareness of and educating various audiences/stakeholders about medical countermeasures medications that may be used during a public health emergency.

3.3 Scope of Work

The contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things, except as provided in the schedule, necessary for or incident to the performance of the work as described above and below. The FDA expects this work will require expert knowledge in both qualitative and quantitative data collection and analysis related to testing of concepts, messages, and materials, especially related to health data; and a thorough understanding of CDER’s regulatory authorities related to medical products and medical countermeasures. The contractor shall furnish such expertise. The scope of this contract shall cover all aspects of data collection, data analysis, evaluation and reporting, and other tasks determined to be necessary to plan and implement the research strategy. All work products, deliverables, materials and media developed under this Statement of Work become the property of FDA, and cannot be used or distributed in any form without the express written permission of the CDER/OCOMM Project Manager and COR (See section 7.9).

3.4 Tasks

In conjunction with CDER/OCOMM, the contractor shall plan and implement the research described in this statement of objectives, including developing the overall strategy(ies), methodology(ies), protocol(s), and analyses for the work necessary. The contractor shall design and develop the key deliverables described in Part 5.3 (below) to address the key objectives outlined in Part 3.2 (above). Key tasks shall include the following:

3.4.1 The contractor shall participate in an initial kick-off meeting with CDER/OCOMM and other subject matter experts. The purpose of this meeting is to discuss key objectives of the study and other aspects that may need clarification, and a proposed work plan and progress schedule. The aim of these discussions is to provide the contractor the information needed to develop a detailed formative research strategy work plan for the topic and objectives.

3.4.2 The contractor shall develop a detailed formative research strategy work plan.

Within 2 week after the kick-off meeting, the contractor shall submit a draft research strategy work plan to the CDER/OCOMM Project Manager for FDA review and comment. FDA will review and comment on the work plan, and re-submit it to the contractor 1 week after receipt of the draft plan. Based on the comments received, the contractor shall submit a revised work plan incorporating FDA’s feedback to the OCOMM Project Manager 1 week after receiving FDA comments. The work plan shall include:

a) A complete formative research strategy laying out the data collection and analysis methodologies and justifications; screening and recruitment strategies, including those related to engaging participants from vulnerable and special groups; research questions, etc.

b) A timeline for performing the work to produce the deliverables specified in Section E, including any necessary internal and external clearances.

c) Regular updates with the CDER/OCOMM Project Manager, and/or other subject matter experts.

d) Key milestones

e) Staffing plans

f) Delivery timeline of the work products described in Part 5.3

3.4.3 Following CDER/OCOMM approval of the work plan, the contractor shall execute all facets of the work plan, including:

a) Participation in regular team teleconferences with FDA

b) Monthly written progress reports

c) Develop research protocols; moderators guide, screening and recruitment strategies; OMB, internal IRB and CDER Research in Human Subjects Committee (RIHSC) packages; and other study materials.

3.4.4 After each phase of data collection and analysis has been completed (for focus groups and for survey), the contractor shall:

a) Within 2 weeks, provide top-line summary findings and all raw data.

b) Within 4 weeks after submission of topline summary, contractor will provide a draft report of the research activities that includes an executive summary; project background; detailed description of the methodologies, participants and recruitment techniques; statistical or other analysis, including a step-by-step description of the analyses; findings; and discussion, including implications and recommendations; and other information deemed necessary to clearly communicate about this project to internal and external audiences. The format of each report will be determined jointly by the CDER/OCOMM Project Manager and the contractor project manager.

c) FDA will submit feedback on each draft report within 2 weeks of receipt. The contractor will have two weeks from time it receives feedback from FDA to re-submit the revised final report with FDA’s comments and questions addressed. The format of the reports will be determined jointly by the OCOMM Project Manager and the contractor Project Manager, with FDA having final approval of format and content.

d) Within 1 week after the draft survey report is submitted to FDA for review, Contractor will also submit a draft plan for updating the messages/information based on the focus group and survey findings. FDA will submit feedback on the draft plan within 2 weeks of receipt. The contractor will have two weeks from time it receives feedback from FDA to re-submit the revised final plan for updating the messages/information with FDA’s comments and questions addressed.

3.4.5 Within 4 weeks after FDA approves the final plan for updating the messages/information, contractor will revise the complete series of messages and information based on the FDA-approved plan and submit for FDA review. FDA will submit feedback on the revised messages/information revision plan within 2 weeks of receipt, and the contractor will have two weeks from time it receives feedback from FDA to re-submit the revised messages/information for final FDA approval.

3.4.6 Within 4 weeks after contractor re-submits the revised messages/information, contractor will make an in-person PowerPoint presentation to discuss the complete combined findings of the activities to the OCOMM Project Manager and other FDA subject matter experts/staff.

3.4.7 Within 1 week after the FDA presentation, contractor will deliver all project raw data and analyses, including any related descriptions or explanations; and other research materials delivered on disk (or other storage format).

3.5 Kick Off Meeting

A kick off meeting will be held with the contractor within 2 weeks after contract award.

Part 4 – Inspection and Acceptance 4.1 The Contracting Officer’s Representative (COR) (see Part 6) will perform inspection and acceptance of materials and services in writing, giving specific reasons, in the event of a rejection of any deliverables.

Part 5 – Deliverables and Performance 5.1 Place of Performance The Contractor may perform all work for this contract at its own premises or at an offsite appropriate facility. If face-to-face meetings are requested either by the Government or by the Contractor, these meetings will occur at the Government’s Hillandale or White Oak facilities. Otherwise, all business conducted between the Government and the Contractor will be conducted by phone or email.

5.2 Period of Performance This work will begin from the date of contract signing, and will be performed during a period of one year to about August 30, 2017. However, the term of the contract will be through August 30, 2018, to allow for any delays in obtaining the necessary OMB and/or RIHSC clearances.

5.3 Deliverables

(No specific dates)

5.4 Reporting Requirements

The Contractor shall prepare monthly reports of work performed and the report will be used as basis for monthly invoices. The monthly reports shall be due by the first Monday of each month.

Part 6 – Contract Administration Data

6.1 Contracting Officers Representative (COR) The following COR will represent the Government for the purpose of this contract:

(To Be Determined at the Time of 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 Government may unilaterally change its COR designation.

6.2 Contract Specialist

The contact information for the Contracting Specialist is:

Tara Hobson

5630 Fishers Lane, Room 2115

Rockville, MD 20857

Tara.Hobson@fda.hhs.gov

(240) 402-7586 Fax: (301) 827-7101

6.3 Contracting Officer

The contact information for the Contracting Officer is:

Department of Health and Human Services

Food & Drug Administration, OAGS

Attn: Tara Hobson, Room 2042 5630 Fishers Lane

Rockville, MD 20857

Phone: (240) 402-7586 Tara.Hobson@fda.hhs.gov

6.4 Contractor Point of Contact

The contact information for the Contractor Point of Contact is: (To Be Determined at the Award of the Contract)

Name:

Address:

Phone Number:

Email:

6.5 Key Personnel

The Contractor shall provide the names and qualifications of the key personnel assigned to this contract. The individuals cited below are key personnel.

Name

Title Project Manager

The Contractor shall provide a Project Manager who shall be responsible for all Contractor work performed under this project. The Project Manager will be the single point of contact for the OCOMM Project Manager. It is anticipated that the Project Manager shall be one of the senior-level employees provided by the Contractor for this work effort. The name of the project manager, and the name(s) of any alternate(s) who shall act for the Contractor in the absence of the project manager, shall be provided to the Government as part of the contractor’s proposal. During any absence of the project manager, only one alternate shall have full authority to act for the Contractor on all matters relating to work performed under this task order. The Contractor shall not replace the designated Project Manager without prior notification (15 business days) and approval from the Contracting Officer.

The Contractor’s Project Manager shall be available to the OCOMM COR/OCOMM Project Manager via telephone between the hours of 8:30AM and 4:30 PM EST Monday through Friday and shall respond to request(s) for discussion or resolution of technical problems within 48 hours of notification.

The Contractor shall provide qualified personnel to perform all requirements specified in this SOO/SOW.

Before replacing any Key personnel, the Contractor shall notify the Contracting Officer at least 15 business days in advance, submit written justification for replacement, and provide the resumes of any proposed substitute(s). All proposed substitutes shall possess qualifications equal to or superior to those of the Key personnel being replaced. The Contractor shall not replace Key personnel without Contracting Officer's approval. The Government may designate any additional positions as Key personnel at the time of award

6.6 INVOICE SUBMISSION

A.

The Contractor shall submit all invoices to all addresses in the manner specified below:

(I) One original and one copy to the approving official:

U.S. Food and Drug Administration Office of Acquisitions and Grants Services

ATTN: Tara Hobson, CO/CS

5630 Fishers Lane Room 2042, HFA-500

Rockville, Maryland 20857

E-mail: Tara.Hobson@FDA.HHS.GOV *** Acceptable methods of delivery include: mail, hand delivery and email (II) One copy to the contracting officer technical representative (COR) or other program center/office designee, clearly marked “courtesy copy only”:

U.S. Food and Drug Administration ATTN: (To Be Determined at the Award of the Contract) 10001 New Hampshire Avenue Silver Spring, MD 20993 E-mail: @FDA.HHS.GOV

*** Acceptable methods of delivery include: mail, hand delivery and email B.

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 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:

(I) Name and address of the contractor;

(II) Invoice date and Invoice Number;

(III) Purchase Order/Award Number;

(IV) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(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 (must be the the same as that in the purchase order/award, or in a proper notice of assignment);

(VIII) Name, title and phone number of person to notify in event of 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 Contracting Officer Representative (COR) or other program center/office point of contract, as referenced on the purchase order;

(XII) Any other information or documentation required by the purchase order/award.

(XIII) Contractor is □ is not □ required to 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 award, including the following:

(1) Invoice number, amount, and date submitted

(2) Corresponding payment amount and date received

(b) Total amount of all payments received to date under the subject contract or order

(c) And, for definitized contracts or orders only, total estimated amounts yet to be invoices for the current, active period of performance C.

An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) Format. All items listed in (I) through (XII) 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.

D.

Questions regarding invoice payments should be directed to the FDA Payment Office at:

Office of Financial Services Food and Drug Administration 10903 New Hampshire Ave

WO32-Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

Attn: Vendor Payments fdavendorpaymentsteam@fda.gov

6.7 INVOICE PAYMENTS

Payments will be made based on the deliverables cited in the pricing table in section 2.1.

PART 7-SPECIAL CONTRACT REQUIREMENTS

7.1 Non-Disclosure Statement

Each selected Contractor personnel assigned to work on this project shall be required to sign a non-disclosure statement regarding key aspects of the project and project content.

7.2 Roles and Responsibilities

The Contractor shall work directly with the OCOMM COR and OCOMM Project Manager to transmit and receive work under this contract. The Contractor shall communicate by email or phone to accomplish this work. Face-to-face meetings will occur at the discretion of the OCOMM Project Manager. Sufficient time must be allotted in the schedule for OCOMM to obtain all necessary approvals from any other offices in CDER/FDA.

7.3 Employee Identification

Contractor employees visiting Government facilities shall comply with all Government escort rules and requirements. All Contractor employees shall identify themselves as Contractors when their status is not readily apparent and display identification and visitor badges in plain view above the waist at all times.

7.4 Employee Conduct

Contractor employees shall present a professional appearance at all times and their conduct shall not discredit the Government.

7.5 Removing Employees for Misconduct or Security Reasons

The Government may, at its sole discretion, direct the Contractor to remove any Contractor employee from the Government facilities for misconduct or security reasons. Removal does not relieve the Contractor of the responsibility to continue providing the services required under any task order awarded. The Contracting Officer will provide the Contractor with a written explanation to support any request to remove an employee.

7.6 Conflict of Interest

The Contractor shall not employ any person who is an employee of the United States Government if that employment would or would appear to cause a conflict of interest.

7.7 Contractor Conformance with Applicable Laws, Regulations, Policies, and Standards

The Contractor shall be responsible for knowledge of and compliance with all applicable federal laws, regulations, policies, and standards at the government-wide, HHS, and FDA levels. At the government-wide level, these include the Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST), and General Accounting Office (GAO).

7.8 Security/Privacy

It is not anticipated that the Contractor will be exposed to sensitive Agency information or data. However, the Contractor agrees that all contract personnel will not divulge or release any information or data developed or obtained in connection with performance of this contract unless this information is made public by FDA or upon written approval by the OCOMM Project Manager. The Contractor shall develop a plan to protect the privacy of users who participate in any facet of this procurement. The Contractor will work closely with the OCOMM Project Manager to make sure there is a privacy plan in place for this procurement.

7.9 Government Property

All materials and media developed in the course of this contract become the property of the U.S. Government and cannot be used or distributed in any form without the express written permission of the CDER/OCOMM Project Manager and COR. If for some reason, work under this contract is incomplete, all materials and media under development will be transferred to the OCOMM Project Manager and OCOMM COR. Similarly, at the conclusion of this contract, all materials and media developed in the course of this contract shall be transferred to the OCOMM COR and OCOMM Project Manager.

7.10 Section 508 Compliance

The Contractor shall conform to all requisite HHS and FDA requirements for 508 compliance. All final delivered applications must be compliant with requirements specified in Section 508 of the Federal Rehabilitation Act as amended in 1998.

All materials developed under this procurement must conform to HHS guidelines for 508 compliance as stated on the HHS Web site.

PART 8-CONTRACT CLAUSES

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

52.212-4 Contract Terms and Conditions-Commercial Items (May 2015)

8.2 FAR Clauses by Full Text 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Jun 2016)

(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 (Nov 2015)

(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, 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 implement provisions of law or Executive orders applicable to acquisitions of commercial items:

_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 (Oct 2015) (41 U.S.C. 3509).

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

___ (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Oct 2015) (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 (Oct 2015) (31 U.S.C. 6101 note).

___ (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]

_x__ (14) (i) 52.219-6, Notice of Total Small Business 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).

___ (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)).

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2015) (15 U.S.C. 637 (d)(4)).

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

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

___ (iv) Alternate III (Oct 2015) of 52.219-9.

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

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

___ (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. 657f).

_x__ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

___ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

___ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).

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

_x__ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Feb 2016) (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 (Oct 2015) (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 (Feb 2016) (38 U.S.C. 4212).

___ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

___ (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 (Oct 2015). (E. O. 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.)

___ (35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O.13693).

___ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

___ (38) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514

___ (ii) Alternate I (Oct 2015) of 52.223-13.

___ (39) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-14.

___ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

___ (41) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-16.

___ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513).

___ (43) 25.223-20, Aerosols (Jun 2016) (E.O. 13693).

___ (44) 52.223-21, Foams (Jun 2016) (E.O. 13696).

___ (45) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

___ (46) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43).

___ (ii) Alternate I (May 2014) of 52.225-3.

___ (iii) Alternate II (May 2014) of 52.225-3.

___ (iv) Alternate III (May 2014) of 52.225-3.

___ (47) 52.225-5, Trade Agreements (Feb 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_x__ (48) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

___ (49) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

___ (50) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

___ (51) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

___ (52) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)).

___ (53) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__x_ (54) 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (55) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (56) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

___ (57) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (58) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631).

___ (ii) Alternate I (Apr 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or executive orders applicable to acquisitions of commercial items:

___ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495)

___ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.).

___ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

___ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67).

___ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

___ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67).

___ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67).

___ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (E.O. 13658).

___ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792).

___ (10) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)).

(d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

(ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.

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

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

(vi) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

(vii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(viii) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

(ix) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(x) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67).

(xi) ____ (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

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

(xii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.)

(xiii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67)

(xiv) 52.222-54, Employment Eligibility Verification (Oct 2015) (E. O. 12989).

(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(xvi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xvii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xviii) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

8.3 HHSAR Clauses

Part 9– Instructions to the Offerors

9.1 FAR provisions Incorporated by Reference

This contract incorporates one or more provisions 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:

FAR Clause

Description

Date

52.212-1

Instructions to Offerors – (Oct 2015)

Commercial Items

An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at (System Award Management) http://sam.gov. If an offeror has not completed the annual representations and certifications electronically at the SAM website, the offeror shall complete and submit only paragraphs (c) through (m) of this provision.

FAR Clause

Description

Date

52.212-3

Offeror Representations (Apr 2016)

And Certifications-

Commercial Items

9.2 Proposal Instructions

RFP Due Date: Proposal shall be received via email to tara.hobson@fda.hhs.gov before 12:00 PM (1200) EASTERN TIME on July 20, 2016. Offerors shall ensure the RFP number is visible in the header of the email.

Fax quotes shall not be accepted.

All Offerors shall be registered in the System Award Management (SAM) prior to the award of the contract. You may register by going to www.sam.gov.

9.3 Technical Proposal

1) The Offeror shall demonstrate that they can meet all the objectives in Part 3.2.

2) The Offeror shall demonstrate that they can develop a research strategy and data analysis work plan for the requirement.

3) The Offeror shall demonstrate that they can provide qualitative and quantitative health data collection and data analysis.

4) The Offeror shall demonstrate they can provide the methodologies required.

9.4 Relevant Past Performance The Offeror shall identify three projects that it has performed within the last three years for the same or similar requirements.

9.5 Price Proposal

The price proposal shall represent the Offeror’s response to the requirements of the solicitation.

The Offerors ability to complete pricing table in Part 2.1.

PART 10 – Evaluation Factors for Award

10.1 Evaluation Factors The Government will evaluate the quote to ensure that it is technically acceptable in accordance with the requirements in Part 3 and that the price is fair and reasonable from the Offeror. Award will be made to the party whose proposal offers the best value to the Government; Technical, Past Performance, and Price will be considered. The Government may award this contract other than lowest price technically acceptable offer. The Government will evaluate information based of the following evaluation criteria: 1) Technical Capability, 2) Past Performance and 3) Price. Technical Capability when combined with Past Performance is significantly more important than price. When all factors are equal, price becomes the determining factor.

10. 2 Technical Capability

1) The Offeror meets and exceeds the capability for all the objectives in Part 3.2.

2) The Offeror meets and exceeds the capability that they can develop a research strategy and data analysis work plan for the requirement.

3) The Offeror meets and exceeds the capability that they can provide qualitative and quantitative health data collection and data analysis.

4) The Offeror meets and exceeds the capability they can provide the methodologies required.

10.3 Relevant Past Performance

The offeror has demonstrated that they are capable of performing related work within the last three years for the same or similar requirements.

10. 4 Price The price proposal shall represent the Offeror’s response to the requirements of the solicitation.

The Offerors ability to complete pricing table in Part 2.1.

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