RFQ1247113 Biomarker Database Search Solutions.docx

FDA-21-RFQ-1247113 Page 2 of 6 Biomarker Database Search Solutions

Offeror Name DUNS

PART 1 – GENERAL INFORMATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 and 13.501(a), as supplemented with additional information in this notice. Quotes are being requested and this announcement constitutes the only solicitation. The Government contemplates issuing a firm fixed-price purchase order resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2021-07 dated August 11, 2021.

The associated North American Industrial Classification System (NAICS) code for this procurement is 519130: Internet Publishing And Broadcasting And Web Search Portals, with an associated size standard in number of employees of 1,000. This requirement is being solicited as a Full & Open/Unrestricted.

PART 2 – SUPPLIES OR SERVICES AND PRICES/COSTS

Contract Type: The Government intends to issue a firm fixed-price purchase order resulting from this solicitation.

Pricing Table:

PART 3 – DESCRIPTION OF REQUIREMENT

Background/Objectives

In 2004, FDA’s Critical Path Initiative (CPI) recognized that the process of drug development and the availability of new therapies were not fully benefitting from the many advances in biomedical science. In addition, drug development had become increasingly challenging and resource intensive. An important area identified by the CPI as potentially enabling significant progress in drug development was applying those scientific advances as new tools to aid the development process. Such tools could speed the availability of new products that may be more safe and effective.

In response, CDER has undertaken multiple initiatives to support the development of new Drug Development Tools (DDTs). Among these efforts has been the creation of a formal qualification process, described in this guidance, that CDER can use when working with submitters of DDTs to guide development as submitters refine the tools and rigorously evaluates them for use in the regulatory process. DDTs are methods, materials, or measures that aid drug development. DDTs include, but are not limited to, biomarkers, clinical outcome assessments (COAs), and animal models for drug development under the Animal Rule. Drug developers can use a DDT that has been qualified within a specific context of use (COU) for the qualified purpose during drug development as long as:

• The study is conducted properly (e.g., all procedures and protocols specified in the COU are followed).

• The DDT is used for the qualified purpose.

• At the time of qualification, there is no new information that conflicts with the basis for qualification.

Once a DDT has been qualified, CDER reviewers can feel confident of the application of the DDT within the qualified COU and not have to re-confirm the Drug development tool’s utility.

FDA has seen significant interest in the qualification of biomarkers, COAs, and animal models for drug development under the Animal Rule. Previously, if multiple sponsors were interested in using a particular DDT, or one sponsor was interested in using a DDT in multiple different clinical settings, FDA staff would have to perform multiple evaluations of the data to justify the DDT use on a case-by-case basis. If instead, a formal qualification is achieved under the principles described in this guidance, the relevant data will need to be reviewed only once. Subsequently, the DDT could be relied on within the qualified COU, largely without further detailed review.

To that end, CDER would like to the use of Biomarker Database Access and Search to assist in the evaluation and recommendations for biomarker DDT Qualification.

2.2 Objectives:

CDER is seeking access to well-curated (manually and automatically tagged, sorted and organized based on biomarker types and use) knowledge (scientific publications and reports, clinical trials, regulatory submissions to the global health authorities) database and search/analytics capabilities to assist FDA in reviewing and making an informed data-driven decision about the adequacy of the submitted data to support Drug Development Tool qualification. Licensing access to a suite of biomarker-related contents and analytical tools will be used to support and speed up the evaluation and recommendations for biomarker DDT submissions.

2.3 Scope of Work

The contractor will be responsible for delivering web-based licenses to access the database and a suite of its search/analytics tools (e.g. data source and validity, pathway, incidence and prevalence analyses) for biomarker, digital health and medical product (drug, biologics, and medical devises) development related topics in publications, clinical trials and other written materials. The database should be well curated for biomarker contexts and up-to-date reflecting the current advancement of knowledge and consensus in the scientific communities. The search/analytics tools are expected to be currently commercially available, Off-The Shelf products (COTS) and ready to be used by the staff in the biomarker qualification staff at CDER-FDA.

2.4 Biomarker Database/Tools Pilot Access (CLIN 1);

The Contractor shall provide the FDA with continuous access to the services for five (5) Concurrent End Users (floating licenses to allow flexible users) and/or ten (10) Named End Users.

3.4.1 Salient Characteristics of the Search and Retrieval of Clinical Trial Data for Drugs, Biologics, Medical Devices, and Biomarkers

The services described above, at a minimum shall meet or exceed the following minimum salient characteristics:

1. Shall have the ability to search by indication, clinical trial types, or events.

2. Shall allow access to Data dictionaries, by keyword

3. Shall allow access to controlled vocabularies

4. Shall allow access to indices for:

a. Disease therapy areas

b. Actions and drug classes

c. Patient segment and eligibility criteria

d. Inclusion criteria:

i. gene variants,

ii. endpoints,

iii. biomarkers,

iv. combination therapies,

v. trial designs,

vi. adverse events.

5. Shall allow access to data lakes of:

a. Abstracted literature articles on clinical outcomes

b. Clinical development,

c. Meeting abstracts

6. Shall have the ability to generate analytical visualization, inclusive of:

a. Sources of data and validity (concurrence or approvals) of findings

b. Aggregated and summarized views of related findings

c. View distribution of indication, intervention, sponsor, phase, recruitment status, country design, and active control.

d. Generate trial timelines including a longitudinal view of trial start dates, insights on trial duration trends, and expected, actual, or projected end dates for a given indication, company, or individual drug.

e. Export visualizations in Excel or PowerPoint so findings can be easily updated and shared with users.

7. Shall have the ability to use biomarkers for drug target identification

8. Shall have the ability to use network analysis to:

a. make gene-disease association with biomarkers

b. identify putative pathways,

c. identify transcription factors involved,

d. make functional predictions,

e. identify conservation scores,

f. identify population frequencies,

g. identify biological and clinical evidence.

h. generate visualizations in maps or networks.

9. Shall have the ability to perform functional analysis of:

a. Next Generation Sequencing,

b. gene expression,

c. Copy Number Variation,

d. microarray,

e. metabolic,

f. proteomics,

g. microRNA,

h. siRNA,

i. screening data.

10. Shall have the ability to simulate molecular interactions

11. Shall have the ability to perform knowledge mining by searching and retrieving:

a. chemical metabolism

b. toxicity information

c. transcription factors,

d. receptors,

e. ligands,

f. kinases,

g. drugs,

h. endogenous metabolites,

i. other molecular classes;

j. species-specific directional interactions between protein-protein, protein-DNA and protein-RNA interactions,

k. drug targeting,

l. bioactive molecules and their effects; using:

i. ontologies of diseases

ii. vocabularies

iii. dictionaries

iv. pathway maps including disease-maps

2.4.2 Salient Characteristics of Cross-Sectional Evaluation of Measurement Properties

1. Shall have the ability to search and retrieve drug data for:

a. Drugs & Biologics: essential chemical and pharmacological information, and the development status of bioactive compounds in the drug pipeline.

b. Experimental Pharmacology: data from experimental studies that delineate drug/

c. receptor and enzyme/target cell interactions.

d. Experimental Models: identify the best animal models to use and evaluate models

e. used in competitor drug development.

f. Pharmacokinetics/Metabolism: data from experimental and clinical studies that delineate the absorption, distribution, metabolism and excretion (ADME) profile of a drug.

g. Organic Synthesis: routes of synthesis (schemes, intermediates, reagents, end products) for drugs currently on the market or in development.

h. Disease Briefings: dynamic executive summaries on the current status of and future trends in drug therapy.

i. Genomics: use relationships between genes and diseases to gain insight into underlying biological mechanisms and identify potential new drug targets.

j. Targets & Pathways: find out about precedented targets and explore their role in pathological pathways.

2. Shall have the ability to perform discovery of clinical trials by searching:

a. biological, chemical and pharmacological data on compounds with demonstrated biological activity by:

i. access to product summaries

b. patent family records, including:

i. chemical structures emerging from the patent and

c. biomedical literature

3. Shall allow access to key information from in vitro and in vivo pharmacological assays and pharmacokinetics studies.

4. Shall have the ability to contextualize and assess the relative importance of each biomarker by exploring the related drugs, pharmacological and PK data endpoints, clinical studies, targets, and genes using:

i. standardized terminology

1. Biomarker name and synonyms

2. Biological entities/processes involved

3. All roles or utilities (e.g. pre-clinical setting as possible candidates for translation into the clinic, or newly emerging uses)

4. Measurement techniques

5. Associated drugs and mechanisms of action

a. Associated gene variants

5. Shall allow classification of biomarkers into lifecycle phases and disciplines

6. Shall have the ability to use biomarkers for drug target identification

7. Shall have the ability to use network analysis to:

a. make gene-disease association with biomarkers

b. identify putative pathways,

c. identify transcription factors involved,

d. make functional predictions,

e. identify conservation scores,

f. identify population frequencies,

g. identify biological and clinical evidence.

h. generate visualizations in maps or networks.

8. Shall have the ability to perform functional analysis of:

a. Next Generation Sequencing,

b. gene expression,

c. Copy Number Variation,

d. microarray,

e. metabolic,

f. proteomics,

g. microRNA,

h. siRNA,

i. screening data.

9. Shall have the ability to simulate molecular interactions

10. Shall have the ability to perform knowledge mining by searching and retrieving:

a. chemical metabolism

b. toxicity information

c. transcription factors,

d. receptors,

e. ligands,

f. kinases,

g. drugs,

h. endogenous metabolites,

i. other molecular classes;

j. species-specific directional interactions between protein-protein, protein-DNA and protein-RNA interactions,

k. drug targeting,

l. bioactive molecules and their effects;

11. Shall have the ability to access:

a. ontologies of diseases

b. vocabularies

c. dictionaries

d. pathway maps including disease-maps

2.4.3 Longitudinal Evaluations Requirements

1. Context of Use by Disease Ara/Organ Toxicity:

a. Shall have the ability to discover biomarkers by searching and linking drugs, targets and genes to biomarkers information from a diverse range of sources, for patient stratification by:

i. Target identification and target activity

ii. Proof of mechanism

iii. Proof of concept

iv. Safety/toxicology studies

2. Context Of Use By Targeted Population

a. Shall have the ability to access Incidence and prevalence summaries and reports by disease, age, sex, race/ethnicity, by searching and retrieving by:

i. patient data trends based on different settings:

ii. Hospital inpatients and their profiles

iii. Emergency room visits / databases

iv. Hospital outpatients and their profiles

v. Physician office visits and their profiles

vi. By procedures performed, concomitant diagnoses, patient age/ sex/race, principal source of payment, disposition.

3. Shall have the ability to access Incidence and prevalence summaries and reports by disease, age, sex, race/ethnicity, by searching and retrieving by ICD-9 codes

4. Shall have the ability to search and retrieve:

a. Clinical Studies: information on clinical trials of drugs currently under study or in use in humans.

b. Companies and Research Institutes: essential information on public and private companies, academic centers and research institutions active in the field of pharmaceuticals and biotechnology.

c. Literature: references to current biomedical literature, abstracts and proceedings from congresses and symposia and company communications.

5. Shall have references to the most recent patent literature reflecting drug research activity throughout the world.

2.5 Other Requirements and Capabilities (CLIN 1-5);

All items received under this contract and any subsequent task orders shall include the following services:

2.5.1 User Training

The Contractor shall provide training for users The training shall be initiated within 30 days of award and continue throughout the duration of contract/task orders. The Contractor shall provide a support package comprised of written documentation that includes technical, analytical, and clinical support throughout the length of the contract.

2.5.2 Technical Support

Ongoing technical, analytical, and clinical support by phone or by e-mail shall be required for all certified users of the data during business hours (8:30am-6:00pm EST) excluding federal holidays throughout the length of the contract in accordance with the service levels established in the Performance Requirements Summary Table (PRST) in the contract.

2.5.3 Status Reports

Each quarter of the base period the contractor shall provide progress reports on the accomplishments performed that period. Each quarterly report should be delivered electronically to the COR and should include:

1. Work accomplished during the previous quarter.

2. Planned activities for the upcoming period.

3. Descriptions of any problems experienced during the previous quarter or anticipated in the upcoming quarter, solutions, or recommended plan for addressing issues (if applicable).

2.5.4 Option Periods 1-4

Throughout the active period of performance, the Government may issue contracts or purchase orders inclusive of any of the items identified at the rates provided in section 2. The Government will provide the number of users and specific products at the issuance of each Order Proposal.

PART 3 Contracts Management Requirements

Performance Evaluation Plan:

Throughout performance the contractor shall be evaluated to determine whether it meets the threshold of the performance requirements summary table (PRST), below. When the performance threshold is not met, the FDA Contracting Officers Representative (COR) will notify the Contract Specialist/Officer. The Contractor shall reply to all performance inquiries listed below with a resolution within 15 business days of receipt. Failure to meet the Acceptable Quality Level shall be captured as non-performance and provided to the Contracting Officer for action. The Government reserves the right to alter or change the surveillance methods at its own discretion.

Performance Requirements Summary Table (PRST): The purpose of this section is to define performance evaluation procedures.

The successful Contractor shall provide Data Resource and Services

The Contractor shall notify the FDA 48 hours in advance of any circumstances resulting in loss of access to the data source due to planned downtime The Contractor shall notify the FDA within 30 minutes (Monday-Friday, 9:00 AM – 5:00 PM Eastern Time) from the onset of unplanned downtime with an estimate of time for restoration of access

PART 4- DELIVERABLES AND PERFORMANCE

Deliverables Table

6. Period of Performance

One Base Year Plus Four Option Years

PART 4 - PACKAGING, MARKING and SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. The contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. All delivered equipment shall be newly manufactured, not used or refurbished or previously used for demonstration.

PART 5 – INSPECTION AND ACCEPTANCE

Inspection and acceptance will be performed at the delivery location. The Technical Point of Contact will perform inspection and acceptance of the materials delivered. Acceptance is communicated in writing unless otherwise indicated by the Contracting Officer of Technical POC within 30 days of receipt of the deliverable(s). If a rejection is issued, the Contractor shall correct any deficiencies within fifteen (15) days from the time the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the contractor shall immediately notify the Technical POC of the reason for the delay and provide a proposed corrective action plan within three (3) business days.

PART 6 – DELIVERIES OR PERFORMANCE

The POC for the CCH Subscription will be identified at the time of award. The Contractor shall contact the Government POC at least 48 hours prior to delivery or service. Unless otherwise specified, deliveries, installation and trainings shall occur at the Place of performance specified above, Monday through Friday (excluding Federal Holidays between the hours of 8:00 a.m. and 4:00 p.m. in accordance of the delivery location time zone (Eastern Time, Central Time, or Pacific Time)). Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day.

PART 7 – CONTRACT ADMINISTRATION DATA

The following personnel shall represent the Government for the purpose of this contract:

Technical Representative:

To be determined upon contract award

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

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to (1) Direct or negotiate any changes in the RFQ; (2) Modify or extend the period of performance; (3) Change the delivery schedule; (4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) Otherwise change any terms and conditions of this contract.

Payment Schedule:

Unless otherwise agreed to by the Technical POC, the Contractor shall submit invoices subsequent to the delivery of the required services.

FDA Three-Way Match Invoicing Procedures:

A. 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.

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:

(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:

(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:

(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 Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

PART 8 – CONTRACT PROVISIONS AND CLAUSES

FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): https://acquisition.gov/far/

52.204-13 – System for Award Management Maintenance (Oct 2018) 52.204-18 – Commercial and Government Entity Code Maintenance (Aug 2020) 52.212-4 – Contract Terms and Conditions – Commercial Items (Oct 2018) 52.232-39 – Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 – Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

(End of clause)

CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS. (JUL 2021)

(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) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (JUL 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78 ( 19 U.S.C. 3805 note)).

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

__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUNE 2020), with Alternate I (OCT 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

_X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509)).

_X_ (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.)

_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101 note).

__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) (41 U.S.C. 2313).

__ (10) [Reserved].

__ (11)

(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (MAR 2020) (15 U.S.C. 657a).

__ (ii) Alternate I (MAR 2020) of 52.219-3.

__ (12)

(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (MAR 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (ii) Alternate I (MAR 2020) of 52.219-4.

__ (13) [Reserved] __ (14)

(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

__ (ii) Alternate I (MAR 2020) of 52.219-6.

__ (15)

(i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

__ (ii) Alternate I (MAR 2020) of 52.219-7.

__ (16) 52.219-8, Utilization of Small Business Concerns (OCT 2018) (15 U.S.C. 637(d)(2) and (3)).

__ (17)

(i) 52.219-9, Small Business Subcontracting Plan (JUN 2020) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (NOV 2016) of 52.219-9.

__ (iii) Alternate II (NOV 2016) of 52.219-9.

__ (iv) Alternate III (JUN 2020) of 52.219-9.

__ (v) Alternate IV (JUN 2020) of 52.219-9 __ (18)

(i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) (15 U.S.C. 644(r)).

__ (ii) Alternate I (MAR 2020) of 52.219-13.

__ (19) 52.219-14, Limitations on Subcontracting (MAR 2020) (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 (MAR 2020) (15 U.S.C. 657f).

__ (22)

(i) 52.219-28, Post Award Small Business Program Rerepresentation (NOV 2020) (15 U.S.C. 632(a)(2)).

__ (ii) Alternate I (MAR 2020) of 52.219-28.

__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (MAR 2020) (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 (Mar2020) (15 U.S.C. 637(m)).

__ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15 U.S.C. 644(r)).

__ (26) 52.219-33, Nonmanufacturer Rule (MAR 2020) (15U.S.C. 637(a)(17)).

_X_ (27) 52.222-3, Convict Labor (JUN 2003) (E.O.11755).

_X_ (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (JAN2020) (E.O.13126).

_X_ (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

_X_ (30)

(i) 52.222-26, Equal Opportunity (SEP 2016) (E.O.11246).

__ (ii) Alternate I (FEB 1999) of 52.222-26.

_X_ (31)

(i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

__ (ii) Alternate I (JUL 2014) of 52.222-35.

_X_ (32)

(i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

__ (ii) Alternate I (JUL 2014) of 52.222-36.

__ (33) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

_X_ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

_X_ (35)

(i) 52.222-50, Combating Trafficking in Persons (OCT 2020) (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).

_X_ (36) 52.222-54, Employment Eligibility Verification (OCT 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

__ (37)

(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.)

__ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

__ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

__ (40)

(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.

__ (41)

(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun2014) of 52.223-14.

__ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (MAY 2020) (42 U.S.C. 8259b).

__ (43)

(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.

_X_ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513).

__ (45) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

__ (46) 52.223-21, Foams (Jun2016) (E.O. 13693).

_X_ (47)

(i) 52.224-3 Privacy Training (JAN 2017) (5 U.S.C. 552 a).

__ (ii) Alternate I (JAN 2017) of 52.224-3.

__ (48) 52.225-1, Buy American-Supplies (JAN2021) (41 U.S.C. chapter 83).

__ (49)

(i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (JAN 2021)(41 U.S.C.chapter83, 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 (JAN 2021) of 52.225-3.

__ (iii) Alternate II (JAN 2021) of 52.225-3.

__ (iv) Alternate III (JAN 2021) of 52.225-3.

__ (50) 52.225-5, Trade Agreements (OCT 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__ (51) 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302Note).

__ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov2007) (42 U.S.C. 5150).

__ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) (42 U.S.C. 5150).

__ (55) 52.229-12, Tax on Certain Foreign Procurements (FEB 2021) .

__ (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (FEB 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (57) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (58) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (OCT2018) (31 U.S.C. 3332).

__ (59) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (60) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).

__ (61) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a).

__ (62) 52.242-5, Payments to Small Business Subcontractors (JAN 2017) (15 U.S.C. 637(d)(13)).

__ (63)

(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB 2006) ( 46 U.S.C. 55305 and 10 U.S.C. 2631).

__ (ii) Alternate I (APR 2003) of 52.247-64.

__ (iii) Alternate II (FEB 2006) 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) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter67).

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (AUG 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67).

__ (5) 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).

__ (6) 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).

__ (7) 52.222-55, Minimum Wages Under Executive Order 13658 (NOV 2020).

__ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

__ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792).

(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, as defined in FAR 2.101, on the date of award of this contract, 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 (JUN 2020) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (JUL 2018) (Section 1634 of Pub. L. 115-91).

(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

(v) 52.219-8, Utilization of Small Business Concerns (OCT 2018) (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 the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(vi) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

(vii) 52.222-26, Equal Opportunity (SEP 2015) (E.O.11246).

(viii) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

(x) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

(xi) 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.

(xii) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

(xiii)

(A) 52.222-50, Combating Trafficking in Persons (OCT 2020) (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 and E.O. 13627).

(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May2014) (41 U.S.C. chapter 67).

(xv) 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).

(xvi) 52.222-54, Employment Eligibility Verification (OCT 2015) (E.O. 12989).

(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (NOV 2020).

(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

(xix)

(A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

(B) Alternate I (JAN 2017) of 52.224-3.

(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB 2006) ( 46 U.S.C. 55305 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.

(End of clause)

BRAND NAME OR EQUAL (AUG 1999)

(a) If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation.

(b) To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must-

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by-

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications.

(c) The Contracting Officer will evaluate "equal" products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation.

(End of provision) 52.217-9 Option To Extend the Term of the Contract (MAR 2000)

The Government may extend the term of this contract by written notice to the Contractor any time before the contract expires; provided that the Government gives the Contractor a preliminary written notice of its intent to extend any time before the contract expires. The preliminary notice does not commit the Government to an extension.

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

The total duration of this contract, including the exercise of any options under this clause, shall not exceed five years.

(End of clause)

HHSAR Clauses:

HHSAR Clauses and Provisions can be viewed in full text at: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html

352.203-70 Anti-Lobbying (Dec 2015)

352.222-70 -- Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)

352.231-70 Salary Rate Limitation (Dec 2015)

FAR 52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998) This solicitation incorporates one or more solicitation 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): www.acquisition.gov/far

52.212-1 - Instructions to Offerors – Commercial Items (Jul 2021)

· See Part 9 below 52.212-2 - Evaluation – Commercial Items (Oct 2014)

· See Part 10 below 52.204-7 - System for Award Management (Oct 2018)

· All offerors shall be registered in the SAM database with completed representations and certifications.

52.204-16 - Commercial and Government Entity Code Reporting (Jul 2016) 52.204-18 - Commercial and Government Entity Code Maintenance (Jul 2016) 52.212-3 - Offeror Representations and Certifications -- Commercial Items (Oct 2018)

· If an offeror has not completed annual representations and certifications in the SAM database, offerors shall include a completed copy of the provision at 52.212-3 with this offer 52.219-1 - Small Business Program Representations (Oct 2014)

· If an offeror has not completed annual representations and certifications in the SAM database, offerors shall include a completed copy of the provision at 52.219-1 with this offer

(End of provision)

PART 9 – INSTRUCTIONS TO THE OFFEROR

The provision at FAR 52.212-1 incorporated above is tailored as follows. Quotes shall be submitted no later than 4:00 p.m. (Eastern Time) on Thursday September 2, 2021. Quotes shall be submitted via email in native MS Word or Excel or PDF format to the Contract Specialist, Todd Johnston at Todd.Johnston@fda.hhs.gov.

The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. If the offeror or applicant submits documents that contain macros the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

The offeror’s quote must outline all characteristics of the requirement listed in Part 3 – Description of Requirements. The contractor quote shall provide sufficient information to allow the Government to evaluate that the Contractor is capable of meeting the requirement. The Government is not responsible for locating or securing any information which is not identified in the quote. In accordance with FAR 52.211-6 – Brand Name or Equal, offerors shall provide the brand name product referenced in this solicitation, unless the offeror clearly indicates that the product being offered is an “equal” product. Offerors may propose equivalent equipment; however, it shall demonstrate that the proposed equipment meets or exceeds the minimum salient characteristics. Offerors shall furnish as part of their quote all descriptive material necessary for the Government to determine whether the proposed products meet all technical requirements specified in Part 3.

The Offeror shall submit a completed pricing table in Part 2 for a firm fixed-price order. The Contractor shall provide the price and all detailed documentation to support the total cost of the quote. The firm fixed-price proposed shall be inclusive of all shipping and any other costs associated with meeting all the requirements listed in Part 3 – Description of Requirements. If an offeror has not completed annual representations and certifications in the SAM database, offerors shall also include a completed copy of the provisions at 52.212-3 and 52.219-1.

PART 10 – GENERAL EVALUATION INFORMATION

The Government intends to award a firm-fixed price purchase order resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most…