Sol Doc.pdf

Solicitation Number: 75F40123R00104

U.S. Food and Drug Administration Request for Quotes

Legislative Tracking Publication Web-Based Subscription Solicitation No.:75F40123R00104

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This procurement is being conducted under simplified acquisitions procedures in accordance with FAR Parts 12 and 13.

The NAICS code is 519290, Internet Search Portals.

The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2023-04, Effective 06/02/2023

The Government is in no way obligated to make an award, nor to pay any costs incurred by the Contractor in preparing and submitting its quote.

1. Background:

On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (FSPTCA) was signed into law, giving the FDA Center for Tobacco Products (CTP)authority to regulate tobacco-product manufacturing, distribution and marketing - this includes labeling, health warnings, tobacco product standards, good manufacturing practices as well as tobacco product constituents, ingredients, and additives.

There are several strategic goals of CTP:

• Facilitate Center-wide efforts to identify, prioritize, and develop new policies and initiatives to reduce tobacco use and its harms

• Evaluate the effectiveness of CTP policies and initiatives in reducing tobacco use and its harms and guide the development of improvements and more effective alternatives

• Establish and maintain meaningful and appropriate relationships with the government and nongovernment agencies and organizations, the tobacco industry, and others to strengthen support for CTP and improve the development and implementation of CTP policies and initiatives

• Serve as a resource to CTP for information about the tobacco industry, tobacco use and its harms, and costs, and tobacco control and its benefits, and for related legal, economic and policy analysis

One of the most challenging goals is to: “Establish and maintain meaningful and appropriate relationships with the government and non-government agencies and organizations, the tobacco industry, and others to strengthen support for CTP and improve the development and implementation of CTP policies and initiatives”. In order to meet this goal to meet the dynamic needs of the center, CTP-OM & OCD require efficient access to an online legislative tracking tool as it relates to tobacco developments and legislation.

This type of activity requires careful attention to detail, reliable sources of information (high accuracy and frequency), and a format that is easily manipulated for use by various audiences. Additionally, use of this service has allowed CTP to support the regulatory science behind the Center’s regulatory authorities. CTP would like to maintain access to timely and efficient information in order to continue to successfully meet its strategic goal

2. Objectives:

The purpose of this document is to purchase an online legislative tracking publication subscription service.

Responsibilities of the CTP Budget Formulation and Planning Team (BFPT) include formulating the Center’s budget for upcoming fiscal years as well as responding to Congressional Appropriations inquiries.

CTP requires up-to-date information regarding appropriations actions, notices of hearings, and other relevant information. In addition, CTP-OCD requires the online subscription system access to track federal and state legislative and regulatory developments as it relates to tobacco. This online subscription system access shall be able to provide daily email notifications summarizing congressional actions, events, news reports, and analysis; access to congressional databases for searching both current and historical congressional action reports, hearing transcripts, bill, report, and law text, bill analysis, floor votes for bills and amendments, member profiles and biographies; and various other archived information.

3. Requirements:

The contractor shall provide FDA CTP users with 25 licenses:

a. Access Requirements:

• Real-time, up to the minute legislative and regulatory updates.

• Allow for users to search all 50 states and federal government legislation, executive orders, and regulations.

• Allow for access to reports and legislative and/or regulatory analysis on special topics.

• Customized and instant congressional news and news relevant to the Department of Health and Human Services.

• Ability to access and provide archived information instantly without the use of second and third party platforms.

• Customized alerts and query results for specific queries.

• Ability to provide customized reports on legislative and regulatory activities without sacrificing data integrity.

• Platform for sharing information amongst end user team members, others within the end users organization, end user partners, stakeholders, and the general public.

• Media updates and alerts about legislative and regulatory activities of all 50 states and the federal government.

• Ability to provide both public and private access with specialized permissions.

• Linking of information to seminal resources.

• Web-based subscription system that does not require integration into the FDA IT architecture.

• Option to allow users to create specialized legislative tracking documents, tables, and reports that may be made available to the public.

• The vendor will send daily emails and notifications to all CTP licensed users. The emails will be sent in the afternoon and will provide a summary of Congressional hearings and news reports. Notifications would be Congressional actions such as the passage of a bill or press release.

• The subscription will also allow CTP users to search legislative tracking databases for Congressional transcripts, bill and report language and amendment text, bill analysis, Congressional action reports, floor votes, and various other archived information.

b. Technical Support Requirements:

Technical support to troubleshoot connectivity issues, user accounts and access. Support is required during normal business hours (8:30a - 5:00p Eastern Time, Monday - Friday, excluding Government holidays).

c. Training Requirements:

Provision of remote and in-person training, as needed and requested by the COR, on the subscription and the services provided under the access requirements.

4. Inspection/Acceptance:

The Contracting Officer (CO) or duly authorized representative shall perform inspection and acceptance of products. The performance criteria for these products shall be timely delivery and closure of all activities and deliverables listed within Section 5 of this SOW and within the established Period of Performance.

5. Deliverables Deliverables Qty Period of

Performance Unit Price Extended

Price Legislative Tracking Web-Based Subscription 25 Base: 8/6/2023-

8/5/2024

Legislative Tracking Web-Based Subscription 25 Option Year 1:

8/6/2024-8/5/2024

Legislative Tracking Web-Based Subscription 25 Option Year 2:

8/6/2025-8/5/2026

Legislative Tracking Web-Based Subscription 25 Option Year 3:

8/6/2026-8/5/2027

Delivery:

The Vendor shall deliver the list of licensed CTP users on or before August 6th, 2023 via e-mail to the COR.

The COR will then assess the delivery and provide acceptance.

All emails will be delivered to the point of contact identified between the COR and vendor. Access to the Congressional Quarterly Online Publication given to CTP licensed users identified by the COR.

6. Place of Performance The contractors’ performance shall take place at the contractor’s facility. However, the contractor’s technical staff/ help desk staff shall be contacted via telephone and email for help desk support as outlined in the “Technical Support Requirements” section above.

7. Period of Performance:

The anticipated Base Period of Performance: 8/6/2023 – 8/5/2024 Option Year 1 POP: 8/6/2024 – 8/5/2025 Option Year 2 POP: 8/6/2025 – 8/5/2026 Option Year 3 POP: 8/6/2026 – 8/5/2027

8. Point of Contact:

Contracting Officer (CO):

Sephora Calderon 4041 Powder Mill Rd., 4th Floor Beltsville, MD 20705 301.795.0965 Sephora.calderon@fda.hhs.gov

Contracting Officer’s Representative (COR):

Entered at Award

9. Order Type:

The order type is Firm Fixed Price

10. Contracting Officer’s Authority The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this order and notwithstanding any provisions contained elsewhere in the order, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the order terms and conditions, including price. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the order and modify any term or condition of the order. The CO is the only individual who can legally obligate Government funds.

The Contracting Officer’s Representative (COR) or Project Officer is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the order price, terms or mailto:Sephora.calderon@fda.hhs.gov conditions. The COR/Project Officer is responsible for the technical aspects of the project and serves as technical liaison with the Contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the order.

11. Authorized Reseller/Servicing Agent:

The Contractor shall be the software Original Equipment Manufacturer (OEM) or an authorized reseller/servicing agent of the software OEM.

The Contractor shall notify the Contract Specialist / Contracting Officer immediately if this requirement is registered by a reseller with the OEM.

12. Order of Precedence:

The Contractor shall follow the terms and conditions of this contract. Should the Contractor include any additional terms and conditions resulting in conflicts between this document and the Contractor’s document, the Order of Precedence shall be as specified in FAR Clause 52.212-4. The Contractor shall not auto-renew any subscriptions, licenses, maintenances and services not authorized under this contract. Any auto-renewals are at the risk of the Contractor, and the Government will not reimburse the Contractor.

In the event of any inconsistencies between any licensing agreement incorporated into this order as an attachment and the FAR and HHSAR Clauses incorporated into this order, the FAR or HHSAR Clauses shall take precedence.

13. Security:

It is not anticipated that the contractor will be exposed to sensitive Agency information or data. But, the contractor agrees that the 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 Project Officer.

14. Invoice Instructions:

The clause at 52.212-4, Contract Terms and Conditions—Commercial Items (NOV 2021), applies to this acquisition with the following addenda:

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (JAN 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to

(1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

- Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

- Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

- Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

- Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

- Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

- Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

- Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. 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.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the

CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA 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.

15. Clauses:

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 address: https://www.acquisition.gov/browse/index/far

(End of Clause)

FAR CLAUSE NO. DESCRIPTION DATE

52.204-19 Incorporation by Reference of Representations and Certifications (DEC 2014) https://www.acquisition.gov/browse/index/far

52.232-39 Unenforceability of Unauthorized Obligations (JUN 2013)

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Products and Commercial Services. (JUN 2023)

(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 products and commercial services:

(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 (NOV 2021) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

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

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) ( 31 U.S.C.

3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (AUG 1996) ( 31 U.S.C. 3553).

(7) 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 products and commercial services:

__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I (Nov 2021) ( 41 U.S.C. 4704 and 10 U.S.C. 4655).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) ( 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.)

_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).

_X_ (8) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).

__ (9) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Nov 2021) ( 31 U.S.C. 6101 note).

__ (10) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) ( 41 U.S.C. 2313).

__ (11) [Reserved].

__ (12) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022) ( 15 U.S.C. 657a).

__ (13) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) ( 15 U.S.C. 657a).

__ (14) [Reserved] _X_ (15)

(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.

__ (16)

(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.

__ (17) 52.219-8, Utilization of Small Business Concerns (Oct 2022) ( 15 U.S.C. 637(d)(2) and (3)).

__ (18)

(i) 52.219-9, Small Business Subcontracting Plan (Oct 2022) ( 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 (Sep 2021) of 52.219-9.

__ (19)

(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.

__ (20) 52.219-14, Limitations on Subcontracting (Oct 2022) ( 15 U.S.C. 637s).

__ (21) 52.219-16, Liquidated Damages-Subcontracting Plan (Sep 2021) ( 15 U.S.C. 637(d)(4)(F)(i)).

__ (22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Oct 2022) ( 15 U.S.C. 657f).

_X_ (23)

(i) 52.219-28, Post Award Small Business Program Rerepresentation (Mar 2023)( 15 U.S.C. 632(a)(2)).

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

__ (24) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Oct 2022) ( 15 U.S.C. 637(m)).

__ (25) 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 (Oct 2022) ( 15 U.S.C. 637(m)).

__ (26) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) ( 15 U.S.C. 644(r)).

__ (27) 52.219-33, Nonmanufacturer Rule (Sep 2021) ( 15U.S.C. 637(a)(17)).

_X_ (28) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

_X_ (29) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Dec 2022) (E.O.13126).

_X_ (30) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (31)

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

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

_X_ (32)

(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_ (33)

(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.

_X_ (34) 52.222-37, Employment Reports on Veterans (Jun 2020) ( 38 U.S.C. 4212).

__ (35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X_ (36)

(i) 52.222-50, Combating Trafficking in Persons (Nov 2021) ( 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).

__ (37) 52.222-54, Employment Eligibility Verification (May 2022) (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

__ (38)

(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.)

__ (39) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

__ (40) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

__ (41)

(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.

__ (42)

(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.

__ (43) 52.223-15, Energy Efficiency in Energy-Consuming Products (May 2020) ( 42 U.S.C. 8259b).

__ (44)

(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_ (45) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) (E.O. 13513).

__ (46) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

__ (47) 52.223-21, Foams (Jun2016) (E.O. 13693).

__ (48)

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

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

__ (49)

(i) 52.225-1, Buy American-Supplies (Oct 2022) ( 41 U.S.C. chapter 83).

__ (ii) Alternate I (Oct 2022) of 52.225-1.

__ (50)

(i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (Dec 2022) ( 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.C. chapter 29 (sections 4501-4732), Public Law 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 [Reserved].

__ (iii) Alternate II (Dec 2022) of 52.225-3.

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

__ (v) Alternate IV (Oct 2022) of 52.225-3.

__ (51) 52.225-5, Trade Agreements (Dec 2022) ( 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (52) 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).

__ (53) 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.

Subtitle A, Part V, Subpart G Note).

__ (54) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) ( 42 U.S.C. 5150).

__ (55) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) ( 42 U.S.C. 5150).

__ (56) 52.229-12, Tax on Certain Foreign Procurements (Feb 2021).

__ (57) 52.232-29, Terms for Financing of Purchases of Commercial Products and Commercial Services (Nov 2021) ( 41 U.S.C. 4505, 10 U.S.C. 3805).

__ (58) 52.232-30, Installment Payments for Commercial Products and Commercial Services (Nov 2021) ( 41 U.S.C. 4505, 10 U.S.C. 3805).

__ (59) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) ( 31 U.S.C. 3332).

__ (60) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) ( 31 U.S.C. 3332).

__ (61) 52.232-36, Payment by Third Party (May 2014) ( 31 U.S.C. 3332).

__ (62) 52.239-1, Privacy or Security Safeguards (Aug 1996) ( 5 U.S.C. 552a).

__ (63) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) ( 15 U.S.C. 637(d)(13)).

__ (64)

(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) ( 46 U.S.C. 55305 and 10 U.S.C. 2631).

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

__ (iii) Alternate II (Nov 2021) 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 products and commercial services:

__ (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 for Contractor Workers Under Executive Order 14026 (Jan 2022).

__ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (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 products or commercial services. 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 (Nov 2021) ( 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 (Nov 2021) (Section 1634 of Pub. L. 115-91).

(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(v) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).

(vi) 52.219-8, Utilization of Small Business Concerns (Oct 2022) ( 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.

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

(viii) 52.222-26, Equal Opportunity (Sep 2015) (E.O.11246).

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

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

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

(xii) 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.

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

(xiv)

(A) 52.222-50, Combating Trafficking in Persons (Nov 2021) ( 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).

(xv) 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).

(xvi) 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).

(xvii) 52.222-54, Employment Eligibility Verification (May 2022) (E.O. 12989).

(xviii) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan 2022).

(xix) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

(xx)

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

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

(xxi) 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.

Subtitle A, Part V, Subpart G Note).

(xxii) 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.

(xxiii) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) ( 31 U.S.C. 3903 and 10 U.S.C. 3801). Flow down required in accordance with paragraph (c) of 52.232-40.

(xxiv) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) ( 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 products and commercial services a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause) 52.217-9 Option to Extend the Term of the Contract (MAR 2000)

(a) 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.

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

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed four (4) years.

(End of Clause)

HHSAR CLAUSE NO. DESCRIPTION DATE

352.203-70 Anti-Lobbying (DEC 2015) 352.208-70 Printing and Duplication (DEC 2015) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations

(DEC 2015)

352.227-70 Publications and Publicity (DEC 2015) 352.231-70 Salary Rate Limitation (DEC 2015) 352.232-71 Electronic Submission of Payment Requests (FEB 2022)

(a) Definitions. As used in this clause- Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system.

Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(End of Clause)

352.239-74 Electronic and Information Technology Accessibility (DEC 2015)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the Access Board) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(c) The Section 508 accessibility standards applicable to this contract are:

- Must meet WCAG 2.0 A and AA

- E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

- E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

- E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

- E205 Electronic Content (Appendix A, Application and Scoping Requirements)

- E207 Software (Appendix A, Application and Scoping Requirements)

- E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

- Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements)

- Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

- 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

- Electronic content must be accessible to HHS acceptance criteria.

- Accessibility checklists for various formats are available at the HHS site. Materials that are final items must be compliant with Section 508 at time of delivery, except upon approval of the Contracting Officer or Representative.

(d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website:

(http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards.

Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(End of clause)

16. Provisions:

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 address:

https://www.acquisition.gov/far/part-52#FAR_52_252_1

(End of Provision)

52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements—Representation (JAN 2017) 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021) 52.204-26 Covered Telecommunications Equipment or Services-Representation (OCT 2020)

The provision at 52-212-1 Instructions to Offerors -Commercial Products and Commercial Services (Mar 2023) is applicable to this requirement.

The provision at 52.212-2, Evaluation—Commercial Items (Nov 2021), is applicable to this requirement. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a contract resulting from this solicitation to the responsible quoter whose quote meets the specifications listed under this solicitation and is the lowest priced quote received in response to this solicitation. Therefore, award will be made to quoter whose quote is determined to be Lowest Price Technically Acceptable. A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful quoter within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Dec 2022), applies to this acquisition. The quoter shall complete only paragraph (b) of this provision if the quoter has completed the annual representations and certification electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal.

The below Health and Human Services Acquisition Regulation (HHSAR) provision apply. HHSAR Clauses can be viewed in full text at: Part 352—Solicitation Provisions and Contract Clauses | HHS.gov

352.239-73 – Electronic and Information Technology Accessibility Notice (Dec 2015)

(End of Provision) https://www.acquisition.gov/far/part-52#FAR_52_252_1

17. Instructions to Quoters:

Please read these instructions carefully. All items required to be included in the quotation as delineated in these instructions must be provided in Quoter’s quotations.

A. Instructions to Quoters:

1. All responsible sources may submit a quote, which if timely received, shall be considered. The quote and any questions shall reference solicitation number 75F40123R00104.

2.Quoters shall submit a complete pricing for all products listed in this RFQ. Partial quotes will not be considered. Incomplete pricing or pricing with omissions may not be considered for award.

3. Quoters should ensure that their initial submission represents their best pricing and that all information is provided to determine technical acceptability. The Government will not research items to determine compatibility; all information regarding compatibility must be contained within the quotation.

4. Quotations shall meet all the requirements of this solicitation in order to be considered technically acceptable.

5. Quoters shall submit all assumptions in their quotation.

6. Quote shall be valid for 30 days.

7. Quoter shall be an Original Equipment Manufacturer, authorized reseller and/or servicing agent of the software manufacturer.

8. Quotes shall meet all the salient characteristics of this solicitation. Quotes should contain all requirements outlined in this solicitation.

9. Quoters shall submit all applicable terms and conditions in full text as attachments, appendix, or exhibits.

10. Quoters shall submit Section 508 Product Accessibility Templates (PAT) in full text with their quotations.

For more information regarding PATs see: http://www.hhs.gov/web/section-508/contracting/technology-products/product-accessiblity-template/

11. Questions and quotes shall be submitted electronically via email to Sephora Calderon at sephora.calderon@fda.hhs.gov. Questions must be submitted by July 25, 2023 by 12:00 PM ET. All quotes must be submitted to the point of contact listed above on or before July 28, 2023 by 12:00 PM ET.

12. It is the quoter’s responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any).

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

B. Evaluation:

1. Technical Features Meeting/Exceeding Salient Requirements.

2. Total Price

18. Award Determination:

The Government shall award a contract resulting from this solicitation to the responsible Quoter as a fixed-price contract on the lowest price technically acceptable (LPTA) evaluation method. Award will be made on the basis of the lowest evaluated price meeting or exceeding the non-cost factor (technical conformance to http://www.hhs.gov/web/section-508/contracting/technology-products/product-accessiblity-template/ http://www.hhs.gov/web/section-508/contracting/technology-products/product-accessiblity-template/ mailto:sephora.calderon@fda.hhs.gov the requirements of the solicitation). The Government intends to evaluate offers and award a contract without discussions. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the best interest of the Government; accept other than the lowest offer; and waive informalities and minor irregularities in offers received.

End of Solicitation