FDA-23-RFQ-CBER-114719.docx

FDA-23-RFQ-CBER-114719 Page 2 of 6 CBER Audio, Visual, Voting, and Web Conference Services

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 13.106, as supplemented with additional information included 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 2023-01 dated December 1, 2022.

The associated North American Industrial Classification System (NAICS) code for this procurement is 541513- Computer Facilities Management Services, with an associated size standard of $32.5M.

PART 2 – SUPPLIES OR SERVICES AND PRICES/COSTS

Contract Type: Firm Fixed-Price Purchase Order

Pricing Table:

1 – Base Year

Meeting 6 AV

Meeting 7 AV

Meeting 8 AV

2 – Option Year 1

Meeting 6 AV

Meeting 7 AV

Meeting 8 AV

PART 3 – DESCRIPTION OF REQUIREMENT

1. Background

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

The mission of the Center for Biologics Evaluation and Research (CBER) is to ensure the safety, purity, potency, and effectiveness of biological products including vaccines, allergenics, blood and blood products, and cells, tissues, and gene therapies for the prevention, diagnosis, and treatment of human diseases, conditions, or injury. Through our mission, we also seek to protect the public against the threats of emerging infectious diseases and bioterrorism.

CBER provides consumers, patients, their caregivers, and practitioners with understandable and accessible science-based information about the products that it regulates. Information of this type is also the subject of forums held between CBER and its stakeholder community in advisory committee meetings.

The CBER Division of Scientific Advisors and Consultants is responsible for the administrative management of CBER’s advisory committees and external peer review of CBER intramural laboratory research programs called the site visits. These Advisory Committees meet frequently to review, discuss, evaluate, and make recommendations on available data concerning the safety, effectiveness, and appropriate use of biological products that are intended for use in the prevention, treatment, or diagnosis of human disease.

CBER has four Advisory Committees:

· Allergenic Products Advisory Committee

· Blood Products Advisory Committee

· Cellular, Tissue, and Gene Therapies Advisory Committee

· Vaccines and Related Biological Products Advisory Committee

2. Purpose/Objective

The purpose of this acquisition is to procure audio, visual, web conference, and voting services support for CBER’s advisory committee meetings.

Number of Advisory Committee Meetings: CBER has one and two-day meetings throughout the year. The majority of the meetings are one day.

3. Scope of Work

The Contractor will provide audio, visual, web conference, and voting support. The services and equipment shall be provided by the company for the related deliverables for the meeting. The contractor shall perform in a manner that meets the highest level of professional standards and adheres to leading industry practices. All Contractor personnel are expected to routinely respond promptly, professionally, and courteously to requests for service assistance.

At all locations (on-site, off-site, virtually by web conference, or hybrid meeting) the Contractor shall provide one or more systems to enable voting at CBER Advisory Committee Meetings. For on-site and off-site the Contractor should include the rental and use of a designated voting machine for use at the CBER Advisory Committee Meetings.

At all locations (on-site, off-site, virtually by web conference, or hybrid) the Contractor shall provide technical support and coordination of audio, visual, web conference, and voting services, of Advisory Committee Meetings. For on-site this includes coordinating with the FDA Great Room at 10903 New Hampshire Ave, Silver Spring, MD 20993 and non-FDA locations (site to be determined).

Services at off-site locations include but are not limited to provision of contractor support for the rental and use of a designated voting machine and up to 25 microphones (the Government cannot provide microphones at this location). Additional equipment including power strips, extension cords, batteries, back-up equipment for power-outage, etc. should be kept ready on hand at the site along with dedicated on-site qualified technical support personnel.

The Contractor shall provide technical support expertise in setting up the audiovisual equipment to function effectively and troubleshooting necessary to resolve all audiovisual malfunctions throughout the duration of the Advisory Committee and site visit meetings.

The official meeting date and location will be provided no later than sixty (60) days before the event. In some cases, a meeting may be scheduled on shorter notice. The duration of these meetings is from 8:30 am – 6:00 pm. In rare cases, if the meeting duration needs to be extended beyond the usual timings indicated above due to unforeseen circumstances, it is expected that the AV contractor, equipment and service technician remain at the site till successful completion of the meeting. The contractor shall provide the name of the service technician who brings and operates the AV equipment including the voting machine to the assigned Designated Federal Officer (DFO) of CBER at least seven (7) business days prior to the meeting date. The technician shall arrive at the meeting site one day prior to the start of the meeting to set-up the equipment. The technician is required to stay until the meeting ends even if the meeting goes beyond the scheduled end time. Should the meeting end after 6:00 pm, no additional charges for voting machine rental services shall be incurred by the FDA.

For virtual web conference meetings, depending on the web conference platform, the Contractor will work with FDA staff prior to the meeting day to provide guidance and training in the web conference platform to meeting participants, create the web conference layout meeting room, provide meeting room link, and upload presentations.

Voting System Requirements:

The contractor shall provide a dedicated voting system with knowledgeable technicians to operate the system. Contractor should have the flexibility to offer two different choices of voting systems, one for in person meetings and another for virtual web conference meetings. The voting system should be adaptable for a hybrid type of meeting.

Voting in person meetings:

In accordance with FDA policy to allow for transparency of all FDA Advisory Committee activities, the equipment (e.g. voting microphone) shall allow for simultaneous voting, utilize push-to-talk capabilities, display individual votes on the screens with voting participant names, and final tallies immediately after the voting is completed. All voting system software and laptops for presentations shall be provided by the Contractor. The voting machine shall include voting keys assigned to each delegated microphone by participant name. All votes shall be displayed simultaneously on the video screen via a projector. At the end of the meeting, the Contractor shall provide CBER with a file of the voting results. The Contractor shall provide Push-to-Talk Table Microphones for the participants as advised by the meeting point of contact. The push-to-talk voting microphones shall have yes, no, and abstention voting keys, an LED light that allows users to know when their microphone is on, headphone jacks for the hearing impaired, a built-in loudspeaker, and a priority key for switching off all live microphones.

Voting for virtual web conference meetings:

Contractor should be able to create a system that will be compatible with the web conference platform. For example, in Adobe Connect a poll pod could be customized for voting. A report of the voting should be provided after the advisory committee meeting.

4. Tasks/Deliverables

The Contractor shall provide all required deliverables in accordance with the following schedule:

On-site or off-site

8 weeks prior to meeting date

Audio visual equipment will be set up around the meeting table and around the room as directed by the Designated Federal Officer or Designated Committee Management Specialist. The government will provide microphones and the projection system at the White Oak Conference Center (but the contractor needs bring the voting machine, related software to capture, calculate and project the voting results onto the screen).

No later than 12 hours before meeting date

Voting, Visual, Audio

Voting Service

· Run and operate the voting system software.

· Provide all labor, equipment, power and sound necessary for the use of the delegate voting system for the duration of the conference.

· Must be able to display on screen individual panel members vote (during voting questions)

Equipment, Labor and Training

· Proper testing of audio and video equipment and setup to ensure that all components work optimally and will be fully operational at the meeting start time.

· Repair failed equipment or have replacement equipment on site.

· Provide a qualified technician on site to perform troubleshooting and services/repairs including instructing government personnel and guest speakers in the use of this equipment.

Visual

· Contractor must provide a designated laptop to upload and run all requested slide presentations for both FDA and non-FDA presenters.

· Technician must be available throughout the meeting to upload and seamlessly run slide presentations without interruption

· Must be able to follow oral presentations to quickly and seamlessly transition to slides during the presentation

· Must promptly transition to specific slide number upon request from the presenter(s)

· Provide immediate troubleshooting and repair if video and/or visual feed is lost

Audio

· Minimize all speaker background noise and interference

· Ensure that all speakers and microphones are working optimally throughout the meeting

· Provide background music during breaks, if requested

· Provide immediate troubleshooting and repair if audio is lost.

Day of meeting

An email sent to DFO with voting results 1-2 business days after meeting.

Virtual Web Conference

8 weeks prior to meeting date

Start to coordinate set-up of captioning and web streaming (e.g Youtube)

8 weeks prior to meeting date

5 weeks prior to meeting date

1 week prior to meeting date

1-7 days prior to meeting date

1-7 days prior to meeting date

Day of meeting

Day of meeting

Day of meeting

Day of meeting

An email sent to DFO with voting results 1-2 business days after meeting.

Post meeting

As needed

Ongoing

Note about Shorter Timeline: FDA will try to provide the contractor enough notice of a potential meeting date for the above deliverable timeline. However, there may likely be cases in which a meeting is scheduled under a compressed time schedule. In that case the contractor will need to be flexible enough to accommodate the shorter schedule.

5. Government Furnished Equipment

The government will provide microphones and the projection system for meetings located at the FDA Great Room. The FDA Great Room can provide HDMI cables to connect laptops to the projectors in the Great Room if needed. Services at off-site locations include but are not limited to provision of contractor support for the rental and use of a delegated voting machine and 25 microphones (the Government cannot provide microphones at this location). Additional equipment including power strips, extension cords, batteries, back-up equipment for power-outage, etc. should be on hand at site along with dedicated on-site qualified support personnel.

6. Security

The Contractor will enter as a visitor at FDA White Oak Campus, Building 31. The Contractor shall provide services to support the hours of the conference. The Contractor shall be familiar with building security enforcement at the FDA White Oak Campus. Security at the meeting location is strictly enforced, and the technicians must know how and when to enter the building to ensure they arrive on time for proper setup prior to the meeting.

7. Personnel

The Contractor shall provide start to finish project management, planning, and coordination of contract staff, with staff across the FDA, phone service, FDA CDRH studio, and other IT. Contractor shall participate in project meetings and identify a lead point of contact for each advisory committee meeting.

The contractor or assigned technician should provide pre-meeting training to meeting participants on how to access the virtual meeting and use camera and unmute/mute the microphone functions etc.

The Contractor should describe and provide examples of past in person meetings they have provided audiovisual support.

The Contractor should both describe and demonstrate knowledge and experience in setting up and leading/hosting technical aspects of meetings held by web conference platforms such as Adobe Connect, Zoom, or other platforms. Especially experience with advisory committee meetings. Contractor may provide an example recording of past virtual web conferences held. For reference see recording of past CBER advisory committee meetings, click on announcement and meeting materials at any of the dates on this webpage: https://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/2021-meeting-materials-vaccines-and-related-biological-products-advisory-committee

The Contractor should describe their ability to train others for virtual web conferences. The Contractor should be able to have staff that can train participates prior to advisory committee meeting on various technical aspects (for example, connecting, how to mute/unmute, raise hand, how to move slides, vote in poll etc.) of participating in a web conference meeting. Depending on the type of web conference platforms ease of use for new users, a few one-hour training sessions for different participant groups may be needed 1-2 weeks prior to each advisory committee meeting.

The Contractor should be able to troubleshoot any technical issues for virtual web conferences the day of advisory committee meetings.

8. Travel

It will be the Contractors responsibility to cover travel costs of their staff to the meeting site.

10. Government Holidays

Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) due to inclement weather.

PART 4 – INSPECTION AND ACCEPTANCE

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Contracting Officer Representative (COR) specified below. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the Contracting Officer.

PART 5 – DELIVERIES OR PERFORMANCE

Place of Performance On-site or off-site or remotely virtually by web conference or hybrid. On-site to be held in the FDA Great Room at 10903 New Hampshire Ave, Silver Spring, MD 20993-0002 and off site would be non-FDA locations (site to be determined). Remotely, by virtual web conference to be through Adobe Connect, Zoom, and/or other web conference platforms. There should be an option for a hybrid type of meeting both on-site or off-site, plus virtual by web conference.

The Contractor shall contact the Contracting Officer Representative (COR) at least 48 hours prior to delivery or service. Unless otherwise specified, deliveries shall be made to 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 with 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.

Period of Performance Base Year: 1/31/2023-1/30/2024 Option Year 1: 1/31/2024-1/30/2025

PART 6 – CONTRACT ADMINISTRATION DATA

The following personnel shall represent the Government to this contract:

Contracting Officer’s Representative:

To be determined upon contract award

The Contracting Officer’s 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.

PART 7 – 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/

FAR 52.204-13 – System for Award Management Maintenance (Oct 2018) FAR 52.204-18 – Commercial and Government Entity Code Maintenance (Jul 2016) FAR 52.212-4 – Contract Terms and Conditions – Commercial Items (Oct 2018) FAR 52.232-39 – Unenforceability of Unauthorized Obligations (Jun 2013) FAR 52.232-40 – Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

FAR Clauses in Full Text:

FAR 52.212-5 – Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Oct 2022)

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

(4) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(5) 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 (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509)).

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

___ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (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. (Oct 2015) (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 (Nov 2011) (15 U.S.C.657a).

___ (ii) Alternate I (Nov 2011) of 52.219-3.

___ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

___ (ii) Alternate I (Jan 2011) of 52.219-4.

___ (13) [Reserved] __ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C.644).

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

___ (ii) Alternate I (Oct 1995) of 52.219-7.

___ (iii) Alternate II (Mar 2004) of 52.219-7.

___ (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 (Aug 2018) (15 U.S.C. 637(d)(4)) ___ (ii) Alternate I (Jan 2017) of 52.219-9.

___ (iii) Alternate II (Nov 2016) of 52.219-9.

___ (iv) Alternate III (Nov 2016) of 52.219-9.

___ (v) Alternate IV (Aug 2018) of 52.219-9 ___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

___ (19) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C.637(a)(14)).

___ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f).

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

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

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

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

_X_ (26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2018) (E.O.13126).

_X_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (28) (i) 52.222-26, Equal Opportunity (Sept 2016) (E.O.11246).

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

___ (29) (i) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

___ (ii) Alternate I (July 2014) of 52.222-35.

___ (30) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.793).

___ (ii) Alternate I (July 2014) of 52.222-36.

___ (31) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

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

_X_ (33) (i) 52.222-50, Combating Trafficking in Persons (Jan 2019) (22 U.S.C. chapter 78 and E.O. 13627).

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

___ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (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.)

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

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

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

___ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun2016) (E.O. 13693).

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

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

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

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

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

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

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

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

___ (43) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

___ (44) 52.223-21, Foams (Jun 2016) (E.O. 13693).

___ (45) (i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).

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

___ (46) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C. chapter 83).

___ (47) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

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

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

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

___ (48) 52.225-5, Trade Agreements (Aug 2018) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (49) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

___ (50) 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).

___ (51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

___ (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

___ (53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C.4505, 10 U.S.C.2307(f)).

___ (54) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C.4505, 10 U.S.C.2307(f)).

_X_ (55) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) (31 U.S.C. 3332).

___ (56) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C.3332).

___ (57) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C.3332).

___ (58) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (59) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).

___ (60) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

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

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

___ (2) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).

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

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

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

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

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

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

___ (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).

___ (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (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, and does not contain the clause at 52.215-2, Audit and Records-Negotiation.

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

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

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

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

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

(ii) 52.203-19, 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) 52.219-8, 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 $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

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

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

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

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

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

(x) 52.222-37, Employment Reports on Veterans (Feb 2016) (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 (Jan 2019) (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 (May 2014) (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 (Dec 2015).

(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 (May 2014) (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. Appx.1241(b) and 10 U.S.C.2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

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

(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

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 352.239-73 Electronic Information and Technology Accessibility Notice (Dec 2015) 352.239-74 Electronic and Information Technology Accessibility (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)

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.

Contract Provisions 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 (Oct 2016)

• See Part 8 below 52.212-2 – Evaluation – Commercial Items (Oct 2014)

• See Part 9 below 52.204-7 - System for Award Management (Oct 2018)

• All offerors shall be registered in the SAM database with completed representations and certifications, including FAR 52.212-3 and 52.219-1.

FAR 52.204-16 - Commercial and Government Entity Code Reporting (Jul 2016) FAR 52.204-18 - Commercial and Government Entity Code Maintenance (Jul 2016)

PART 8 – INSTRUCTIONS TO THE OFFEROR

The provision at FAR 52.212-1 incorporated above is tailored as follows. Quotes shall be submitted no later than 12:00 p.m. (Eastern Time) on Friday, January 6, 2023. Quotes shall be submitted via email in native MS Word or Excel or PDF format to the Contract Specialist, Maeve Xavier at Maeve.Xavier@fda.hhs.gov. The subject line shall read: FDA-23-RFQ-CBER-114719. Quoters must submit all questions regarding the RFQ to Maeve Xavier, via email, Maeve.Xavier@fda.hhs.gov, no later than 12:00 pm (Eastern Time) on Tuesday, December 20, 2022. The subject line shall read: FDA-23-RFQ-CBER-114719 Questions.

The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e., email blocks, quarantine). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, 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 –…