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This request for quote from the Department of Health and Human Services Food and Drug Administration solicits an Executive Certificate in Organization Development Consulting and Change Leadership. The FDA seeks to procure a hybrid online and in-person certificate program covering topics such as organizational theory, cultivating self as an instrument of change, collecting data and designing feedback, change theory and practices, and working with group dynamics and conflict. Quotes are due no later than February 7, 2024, with a period of performance from April 10, 2024 to December 15, 2024. The certificate program must be provided for one FDA team attendee and include monthly multi-day sessions with half-day faculty meetings following each course.

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75F401-24-Q-121752

Solicitation

EXECUTIVE CERTIFICATE IN ORGANIZATION DEVELOPMENT CONSULTING

& CHANGE LEADERSHIP

Solicitation Number: 75F401-24-Q-121752

Product Service Code: B550

NAICS Code: 561110

Response Due Date: 07 February 2024

Description:

I. This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

II. This acquisition is issued as a Request for Quote (RFQ).

III. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-02.

IV. For purposes of this acquisition, the associated NAICS code is 561110. The small business size standard is 12.5 million.

V. Line-Item Structure: The following is a list of line-item number(s) and items, quantities, and units of measure, (including option(s), if applicable) and should be reflected in the Offeror’s quote/proposal:

Line Item Description Quantity Price

1 Executive Certificate in Organization Development Consulting & Change Leadership

STATEMENT OF WORK

Executive Certificate in Organization Development Consulting & Change Leadership

1. BACKGROUND

As part of the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) regulates over the counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered "drugs.”

The Office of Executive Programs (OEP) oversees a variety of Center-wide programs, including executive project management, the Center’s executive secretariat function, scientific advisory committees, training, and development, CDER’s ombudsman, and program and administrative management. Within OEP, the Division of Learning and Organizational Development (DLOD) provides employee training, development, and continuing education opportunities for CDER.

FDA has a unique responsibility to provide education to a variety of constituents, to include FDA staff, clinical investigators, the public, medical professionals, healthcare professionals, industry, consumers, and academia. Education and training are of the highest priority to FDA, and FDA continues to be responsive to the needs of these stakeholders by offering training opportunities leveraging various forums and formats.

For CDER to carry out its mission, the organization is going through large scale change efforts including restructuring existing offices and divisions, standing up new offices and hiring more staff. Due to these change efforts, CDER is experiencing organizational challenges. The agency requires expertise to support the effective growth and change necessary to carry-out its mission.

OEP/DLOD has a need for professional skills, including organizational development, change management, action planning and strategic communications support. The U.S. Food and Drug Administration requires training to ensure staff are well prepared for meeting critical mission objectives. The FDA is seeking to procure an Executive Certificate in Organization Development Consulting & Change Leadership with a curriculum designed to meet organizations where they currently are – where the concepts of work and workplace are being reimagined, where DEIA and OD are becoming intertwined, and where learning and practice are being redefined in hybrid environments.

2. OBJECTIVES

The objective of this requirement is to acquire an Executive Certificate in Organization Development Consulting & Change Leadership designed for change leaders, internal practitioners in Human Resources (HR), Organization Development (OD), and Diversity, Equity, & Inclusion (DEI) to develop essential skills in organizational development consulting and change management to better understand organizational systems and help facilitate sustainable change processes at all levels of the OD system.

3. SCOPE

The FDA seeks to obtain an online certificate program for one FDA Team attendee. Classes shall meet monthly for 3-4 full days followed by a half-day faculty-led learning team meeting on Friday after each course.

The courses shall cover the following topics and delivery methods:

Organizational Theory, online/remote Cultivating Self as an Instrument of Change, in-person Collecting Data and Designing Feedback, online/remote Change Theory and Practices, online/remote Working with Group Dynamics and Conflict, in-person Designing Interventions that Move Systems to Action, online/remote Facilitating Inclusive Dialogue and Clear Decision Making in Organizations, in-person Integrating and Applying Lessons Learned, online/remote Organization Development Consulting Application, online/remote

4. DELIVERABLES / TASKS

Task/Deliverable Name Distribution/Allocation Due Task 1- Organization Development Consulting & Change Leadership Training

FDA Team Registered Attendee

During period of performance April 10, 2024-December 15, Task 2- Provide Training Certificate upon successful completion of course requirements

FDA Team Registered Attendee

Within 1 month of successful course completion

5. OTHER REQUIREMENTS

N/A

6. PERIOD OF PERFORMANCE

April 10, 2024 – December 15, 2024

7. PLACE OF PERFORMANCE

Hybrid delivery of live online/remote and in-person sessions within the FDA headquarters White Oak commuting area.

8. GOVERNMENT FURNISHED PROPERTY (GFP)/GOVERNMENT FURNISHED

INFORMATION

N/A

9. SECURITY AND PRIVACY REQUIREMENTS

N/A

10. HOLIDAYS AND GOVERNMENT CLOSURES

The following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, DC area:

New Year’s Day Martin Luther King Day President’s Day Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

In the event of inclement weather when the Federal government is closed, the Contractor is not required to provide on-site service. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Contract).

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

11. ADDITIONAL TERMS AND CONDITIONS

CLAUSES INCORPORATED BY REFERENCE

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 shall make their full text available. Also, the full text of a clause may be accessed electronically at: www.acquisition.gov/far/index.html.

The provision at 52.212-1, Instructions to Offerors applies to this acquisition. The following addenda have been attached to this provision:

In addition to the requirements set for the in FAR 52.212-1, all offers responding to this solicitation must provide their business size in relation to the NAICS code contained in this solicitation and shall identify any socioeconomic categories to which they belong.

Evaluation Criteria - The specific evaluation criteria to be used are as follows:

Lowest Price Technically Acceptable (LPTA)

Offerors shall include a completed copy of the provision at FAR 52.212-3 (with its Alternate I), Offeror Representations with its offer.

The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. The following addenda have been attached to this clause: NONE.

The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items applies to this acquisition.

The following additional FAR clauses cited are applicable:

52.204-7 System for Award Management (Oct 2018) 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) 52.204-13 System for Award Management Maintenance (Oct 2018) 52.204-16 Commercial and Government Entity Code Reporting (Aug 2020) 52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020) 52.204-19 Incorporation by Reference of Representations and Certifications (Dec 2014) 52.204-21 Basic Safeguarding of Covered Contractor Information Systems (Nov 2021) 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) 52.204-27 Prohibition on a ByteDance Covered Application (Jun 2023) 52.209-6 Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Nov 2021) 52.219-28 Post-Award Small Business Program Rerepresentation (Sep 2023) 52.222-3 Convict Labor (June 2003) 52.222-21 Prohibition of Segregated Facilities (Apr 2015) 52.222-26 Equal Opportunity (Sept 2016) 52.222-50 Combating Trafficking in Persons (Nov 2021) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020)

52.225-13 Restrictions on certain foreign purchases (Feb 2021) 52.232-33 Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) 52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004)

HHSAR clauses and provisions:

The full text of a clause may be accessed electronically at:

http://www.hhs.gov/policies/hhsar/:

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations. (Dec 2015) 352.239-73 Electronic and Information Technology Accessibility Notice 352.239-74 Electronic and Information Technology Accessibility Notice 352.232-71 Electronic Submission of Payment Requests (Feb 2022)

12. INVOICE INSTRUCTIONS

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 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 http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/ 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).

(a) Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts.

(1) 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.

(b) 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:

(1) list of all invoices submitted to date under the subject award, including the following:

- invoice number, amount, & date submitted

- corresponding payment amount & date received

- total amount of all payments received to date under the subject contract or order

- and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

(c) 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.

(d) 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.

(e) 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.

(f) 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.

(g) 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.

(END OF CLAUSE)

13. SECTION 508 COMPLIANCE

HHS Section 508 and Accessibility Standards Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998 (P.L. 105-220) requires that when Federal agencies develop, procure, maintain, or use information and communication technology (ICT), it shall be accessible to people with disabilities. Federal employees and members of the public who have disabilities must have access to, and use of, information and data that is comparable to people without disabilities.

All products, platforms and services delivered as part of this work statement that are ICT, or contain ICT, must conform to the Revised 508 Standards, which are located at 36 C.F.R. §

1194.1 & Apps. A, B, C & D, and available at https://www.access-board.gov/ict/.

All requirements are applicable to support services and documentation deliverables. All functional performance criteria apply when using an alternative design or technology that achieves substantially equivalent or greater accessibility and usability by individuals with disabilities, than would be provided by conformance to one or more of the requirements in Chapters 4-6 of the Revised 508 Standards, or when Chapters 4-6 do not address one or more functions of ICT.

For each proposed product, platform, or service, a fully completed Accessibility Conformance Report (ACR) using the Voluntary Product Accessibility Template (VPAT) (https://www.itic.org/policy/accessibility/vpat) must be submitted. Evaluation will be on an Acceptable/Unacceptable basis.

Prior to acceptance of deliverables, the offeror must demonstrate conformance to the HHS Section 508 requirements via HHS Section 508 checklist(s) (https://www.hhs.gov/web/section- 508/accessibility-checklists/index.html). The government reserves the right to perform testing on required ICT items to validate the offeror’s Section 508 conformance claims. If the government determines that Section 508 conformance does not meet the HHS Section 508 requirements, the government shall, at its option, require the offeror to remediate the item, at no additional cost to the government, to align with the HHS Section 508 conformance requirements prior to acceptance.

References:

•Section 508 Standards: https://www.access-board.gov/ict/ •HHS Policy on Section 508 Compliance and Accessibility of Information and Communications Technology (ICT): https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/department-of-health-and-human-services-hhs-policy-on-section-508-and-accessibility-of-technology.html •HHS Accessibility and Section 508 Compliance Checklists: https://www.hhs.gov/web/section- 508/accessibility-checklists/index.html

14. Quotes are due electronically via email to Natalie.Brown@fda.hhs.gov for this acquisition no later than 07 FEB 2024, 11:59 am. Eastern Time. Late submissions may not be evaluated.

The subject line shall read: 75F401-24-Q-121752 Executive Certificate in Organization Development Consulting & Change Leadership

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

The following language will be included in the resultant contract award:

Be advised that the FDA does not accept documents which contain the use of macros. Document submissions required throughout the period of performance of this contract shall not have macro enabled functionality, and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

1. BACKGROUND
2. OBJECTIVES
3. scope
4. deliverables / TASKS
5. Other Requirements
6. period of performance
7. place of performance
8. Government Furnished property (GFp)/Government Furnished Information
9. SeCURITY and PRivacy REQUIREMENTS

File details come from the government source that posted it. Updated .