Combined Synopsis_Solicitation 1226556 04212020.pdf

75F40120Q00045 Material Performance Study Services

This is a combined synopsis/solicitation for commercial services prepared in accordance with the

Federal Acquisition Regulation (FAR) format Subpart 12.6, as supplemented with additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-05.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE

SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is

75F4012Q00045 and is being issued as a Request for Quote (RFQ). The solicitation is being issued in conjunction with FAR PART 13.106. The associated North American Industry

Classification System (NAICS) Code for this solicitation is 541611. This requirement is Full and Open Competition. Prospective Offerors are responsible for downloading the solicitation and any amendments. The Government reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing best value and discussions are not necessary.

Contract Type-Commercial Services – Firm Fixed Price

The U. S. Food and Drug Administration (FDA), Center for Devices and Radiological Health

(CDRH) has a need to procure a Materials Performance Study services.

A. STATEMENT OF WORK

1 OBJECTIVE

The objective is a service contract to establish a safety profile for up to 50 commonly used materials by medical application.

2 MISSION

The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.

We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

3 BACKGROUND

Overall, Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Providing patients with access to safe medical devices that meet their health care needs remains a top FDA priority. The Medical Device Safety Action Plan: Protecting Patients, Promoting

Public Health outlines how the agency will encourage innovation to improve safety, detect safety risks earlier, and keep doctors and patients better informed.

In the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, the

FDA describes a key action it will take is to establish a robust medical device patient safety net in the United States.

Information is publicly available to link specific materials (as opposed to the device) with safety and performance, but CDRH does not have access to a considered summary: in essence, the real world data exists, but there is an ongoing need to collate the data and turn it into real world evidence as it relates to the use of these materials in medical devices that seek FDA approval, and inform the Agency on development and modification of these types of devices.

4 SCOPE

The Contractor shall be a Federally-Listed Patient Safety Organization (PSO) with the Agency for Healthcare Research and Quality (ASQR). The Contractor shall be required to possess a strong track record in understanding implications of material properties regarding to the performance of medical devices. Independently and not as an agent of the Government. The

Contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incident to the performance of the work as described below.

The Contractor shall provide a systematic review of available scientific literature and PSO and accident file databases which includes: bench/pre-clinical, animal, and clinical data to assess and describe what is currently known regarding the local and systemic responses, including any associations with specific clinical outcomes such as cancer or auto-immune processes, which may occur with exposure to the material relevant to medical devices. These responses may be due to direct material toxicity, persistent or undesired immunologic/inflammatory reactions, as well as areas where specific effects have been not observed or proven to be absent. Scientific literature shall be limited to high quality, peer reviewed, publicly available scientific publications.

For each material in each material group, the Vendor shall:

1. Review the last 10 years of English-speaking literature for the specific material as it relates to medical devices;

2. Review Patient Safety Organization (PSO) and accident file databases for the last

10 years for the specific material as it relates to medical devices;

3. Provide statements on what “the world” knows;

4. Define gaps in scientific knowledge related to the material;

5. Provide suggestions on relevant next steps FDA may take to protect patient safety.

CDRH will provide the Contractor a list of specific materials commonly used in medical devices which cover categories including polymers/plastics, ceramics, metals/ alloys and other materials.

The list will indicate if each material are easy or complex.

The Contractor shall consider how various forms or properties of the specific material

(such as shape, density, degree of porosity/perforation, etc.) as well as different patient characteristics (e.g., gender, the presence of conditions such as diabetes, auto-immune disease, etc.), and location of the implant (e.g., type of tissue contacted) may impact any host response or other aspects related to a material’s safety.

The initial list of materials shall be initially selected as those which are most commonly used in devices, and those which may appear more frequently than others in analyses of product recalls.

CDRH will reserve the right to add or remove materials of interest as the project progresses.

5 TASKS

5. 1 TASK 1- REVIEW SCIENTIFIC MATERIALS

The Contractor shall provide a systematic review of available scientific literature and PSO and accident file databases in the last ten years which includes bench/pre-clinical, animal, and clinical data to assess and describe what is currently known regarding the local and systemic responses, including any associations with specific clinical outcomes such as cancer or auto-immune processes, which may occur with exposure to the material relevant to medical devices.

These responses may be due to direct material toxicity, persistent or undesired immunologic/inflammatory reactions, as well as areas where specific effects have been not observed or proven to be absent. Scientific literature shall be limited to high quality, peer reviewed, publicly available scientific publications.

Materials shall be evaluated with regard to all characteristics including, but not limited to surface characteristics manufacturing methods (where known) and material manufacturer. Additionally, materials shall be considered with regard to the device type (e.g. permanent implant or transient contact) as well as patient contact (e.g. physiology or immune status).

Undertake a systematic and structured review of relevant, available scientific literature.:

Relevant can be defined as peer reviewed scientific publications that have been made publicly available, as well as other credible information that may be available to Contractor such as surveillance information. Articles shall be restricted to those published in English and which have been published in the last 10 years. However, significant milestone articles of greater age shall be included.

5.2 TASK 2 -SUBMIT MATERIALS REPORTS

The Material report shall be the Contractor’s Evaluation of a safety profile of the specific material with regards to all characteristics including, but not limited to surface characteristics manufacturing methods (where know) and material manufacturing. Additionally, Material shall be considered with regard to the device type (e.g. per permanent implant transient contract) as well as patient contact (e.g. Physiology or immune status.)

In the materials report, the Contractor shall provide statements on what “the world” knows, define gaps in scientific knowledge related to the material; and, provide suggestions on relevant next steps FDA may take to protect patient safety with included references. The reports should be submitted electronically.

5.3 Kick Off Meeting:

Kick off meeting to be held with Contractor and facility lead to review the list of requirements including list of up to 50 materials, prioritized.

6 DELIVERABLES

The Contractor shall submit the following deliverables electronically per the schedule below, as a result of specific tasks in performance of the activities in this SOW. The Contracting Officer

(CO) or Contracting Officer Representative (COR) has the authority to accept or reject deliverables. The acceptance of deliverables and satisfactory work performance required under this contract shall be based upon the timeliness, accuracy and suitability of the deliverable.

Table 1 Deliverables

Deliverables Task Deliverables Frequency/Due Date

5.3 Kick off meeting as

described in Task 5.3 Within 5 days of award

2 5.1 Review 6 Scientific

Materials as described in

5.1 (Base Period) 15 days before Period of Performance ends

3 5.2 Submit 6 Materials

Reports as described in 5.2 (Base Period) 15 days before Period of Performance ends

4 5.1 Review 20 Scientific

Materials as described in

5.1 (Option Period 1) 15 days before Period of Performance ends

75F40120Q00045 Material Performance Study

5 5.2 Submit 20 Materials

Reports as described in 5.2 (Option Period1) 15 days before Period of Performance ends

6 5.1 Review 14 Scientific

Materials as described in

5.1 (Option Period 2) 15 days before Period of Performance ends

7 5.2 Submit 14 Materials

Reports as described in 5.2 (Option Period2) 15 days before Period of Performance ends

7.0 SECURITY AND PRIVACY

The Contractor shall not require access to sensitive Agency information or data. But the

Contractor agrees that contract personnel will not divulge, or release information or data developed or obtained in connection with performance of this contract, unless made public by

FDA or upon written approval by the COR.

8.0 CONTRACTOR CONFORMANCE WITH APPLICABLE LAWS, REGULATIONS, POLICIES AND

STANDARDS

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

Government Accountability Office (GAO). These can be primarily found at or through the

Federal CIO Council website at: http://www.cio.gov.

9.0 PLACE OF PERFORMANCE

The performance shall be conducted at the Contractor’s location.

10.0 GOVERNMENT PROPERTY

None provided.

11.0 GOVERNMENT CONTACTS

The recommended COR in CDRH is listed below:

COR:

TBD

http://www.cio.gov/

B. PERIOD OF PERFORMANCE:

The period of performance for this award shall be for a Base Period, with two options of

(12 month) periods:

Base Period: 6 months

Option Period 1: 12 months

Option Period 2: 12 months

C. LINE ITEM AND PRICES:

Table 2 Line Items and Prices

Description Quantity Price

Line Item 1 Base Period (6 months)

Material Performance

Study Services

1 lot $

Line Item 2 Option Period 1, Material Performance

Study Services

1 lot $

Line Item 3 Option Period 2, Material Performance

Study Services

1 lot $

Total:

Provide a fixed price quote in accordance with the Statement of Work identified.

D. GOVERNMENT HOLIDAYS

a. The Government hereby provides notification that Government personnel observe the listed days as holidays:

(1) New Year's Day (6) Labor Day

(2) Martin Luther King's Birthday (7) Columbus Day

(3) President’s Day (8) Veterans' Day

(4) Memorial Day (9) Thanksgiving Day

(5) Independence Day (10) Christmas Day

b. In addition to the days designated as holidays, the Government observes the following days:

(1) Any other day designated by Federal Statute

(2) Any other day designated by Executive Order

(3) Any other day designated by the President’s Proclamation

c. When any such day falls on a Saturday, the following Monday is observed. Except for designated around-the-clock or emergency operations, Contractor personnel will not be able to perform on-site under this contract with FDA on holidays set forth above. The Contractor will not charge any holiday as direct charge to the award.

d. It is understood and agreed between the Government and the Contractor that observance of such days by Government personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation except as set forth within the award.

e. Nothing in this clause abrogates the rights and responsibilities of the parties relating to stop work provisions as cited in other sections of this contract.

E. EVALUATION AND AWARD:

Lowest Priced, Technically Acceptable (LPTA)

F. INSTRUCTIONS TO OFFEROR FOR PROPOSAL SUBMISSION

FAR 52.212-1 Instructions to Offerors—Commercial Items (MAR 2020)

PROPOSAL SUBMISSION FORMAT:

***Proposal shall be in 2 volumes: 1 Technical and 2 Price. The volumes shall be separate and complete. The volumes shall be separate and complete, so that evaluation of one may be accomplished independently of, and concurrently with, the evaluation of the other. No pricing information shall be provided in volume 1.***

The total number of pages for the technical quote shall not exceed ten (10) pages, using 1” margins, single spaced, font type Time New Roman, and a font size of 12.

***The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote or proposal. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.***

QUESTIONS DEADLINE: Interested offerors shall submit questions electronically to

Patricia.Natividad@fda.hhs.gov no later than May 6, 2020, 10:00 a.m. Eastern Standard Time.

mailto:Patricia.Natividad@fda.hhs.gov

Please include the company name, FDA solicitation number, and “Question(s)” in the subject line.

PROPOSAL DUE: All Volumes for the quotes are due, electronically through email to patricia.natividad@fda.hhs.gov, no later than May 13, 2020, 10:00 a.m. Eastern Standard Time.

Ensure the email subject line annotates the solicitation number and description:

75F40120Q00045 Material Performance Study Services.

G. FAR CLAUSES AND PROVISIONS AND HHSAR CLAUSES AND PROVISIONS

FAR clauses referenced in this RFQ can be found on the following website:

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

HHSAR clauses referenced in this RFQ can be found on the following website:

https://www.acquisition.gov/hhsar.

The following provisions and clauses apply: FAR 52.212-1, Instructions to Offerors Commercial

Items; FAR 52.212-2, Evaluation-Commercial Items; FAR 52.212-4, Contract Terms and

Conditions Commercial Item; FAR 52.212-5, Contract Terms and Conditions Required to

Implement Statutes Or Executive Orders--Commercial Items; FAR 52.204-10, Reporting

Executive Compensation and First-Tier Subcontract Awards; FAR 52.204-14, Service Contract

Reporting Requirements, FAR 52.209-6, Protecting the Government’s Interest When

Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment; FAR

52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters; FAR

52.222-3, Convict Labor ; FAR 52.222-19, Child Labor-Cooperation with Authorities and

Remedies; FAR 52.222-35, Equal Opportunity for Veteran; FAR 52.222-36, Equal Opportunity for Workers with Disabilities; FAR 52.222-36; FAR 52.222-37, Employment Reports on

Veterans; FAR 52.222-40, Notification of Employee Rights Under the National Labor Relations

Act FAR 52.222-50, Combating Trafficking in Persons; FAR 52.223-18, Encouraging

Contractor Policies to Ban Text Messaging While Driving; FAR 52.232-33, Payment by

Electronic Funds Transfer-System for Award Management; FAR 52.222-41, Service Contract

Labor Standards; FAR 52.222-42, Statement of Equivalent Rates for Federal Hires; FAR 52.222-

43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple

Year and Option Contracts); FAR 52.222-55, Minimum Wages Under Executive Order 13658;

FAR 52.222-62, Paid Sick Leave Under Executive Order 13706; FAR 52.217-5, Evaluation of

Options; FAR 52.217-8, Option to Extend Services; 52.217-9, FAR 52.222-3, Convict Labor;

FAR 52.222-19, Child Labor--Cooperation with Authorities and Remedies; FAR 52.222-21, Prohibition of Segregated Facilities; FAR 52.222-26, Equal Opportunity; FAR 52.222-36, Affirmative Action for Workers with Disabilities; FAR 52.225-13 Restrictions on Certain

Foreign Purchases.

Parties responding to this solicitation may submit their offer in accordance with their standard commercial practices (e.g. on company letterhead, formal quote form, etc) but shall include the mailto:patricia.natividad@fda.hhs.gov http://www.acquisition.gov/far/index.html following information: 1) company’s complete mailing and remittance addresses 2) discounts for prompt payment if applicable; 3) Dun & Bradstreet number; 4) Taxpayer ID number; 5) Catalog or Published Price Listing applicable to the service; 6) Offerors shall meet specifications as noted in the synopsis. Offerors shall include a completed copy of the provision at 52.212-3, Offeror

Representations and Certifications/Commercial Items with their offer. Note: Contractor shall be registered and active in the System for Award Management (SAM) prior to the award of a contract. You may register by going to www.sam.gov.

HHSAR Clauses and Provisions by Reference:

HHSAR 353.203-70 Anti-lobbying (Dec 2015)

HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity

Investigation (Dec 2015)

HHSAR 352.239-73 Electronic and Information Technology Accessibility Notice (December

18, 2015)

HHSAR 353.239.74 Electronic and Information Technology Accessibility (DEC 2015)

H. INVOICE SUBMISSION REQUIREMENTS

A. FDA Three-Way Match Invoicing Procedures (Three-Way Match)

The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments

Division of Payment Services

10903 New Hampshire Ave

WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

301-827-3742

FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the COR. The COR is (TBD)

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 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:

http://www.sam.gov/

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite-

Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(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;

(d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(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 (Prompt Payment terms other than NET

30);

(vii) Name and address of official to whom payment is to be sent (must be 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) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT);

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other

Program Center/Office point of contact, as referenced on the award;

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, Contractor is 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, & date submitted

(2) corresponding payment amount & 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 invoiced for the current, active period of performance;

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xiii) 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 the e-mail address provided above in Section A.

Parties responding to this solicitation may submit their offer in accordance with their standard commercial practices (e.g. on company letterhead, formal quote form, etc) but shall include the following information: 1) company’s complete mailing and remittance addresses 2) discounts for prompt payment if applicable; 3) Dun & Bradstreet number; 4) Taxpayer ID number; 5) Catalog or Published Price Listing applicable to the service; 6) Offerors shall meet specifications as noted in the synopsis. Offerors shall include a completed copy of the provision at 52.212-3, Offeror

Representations and Certifications/Commercial Items with their offer. Note: Contractor shall be registered and active in the System for Award Management (SAM) prior to the award of a contract. You may register by going to www.beta.sam.gov

I. ATTACHMENTS:

Attachment Number Title Date

1 Wage Determination WD 2015-4281 rev. 15 12/23/2019 http://www.beta.sam.gov/