CSS_75N95024Q00252 (amended).pdf

COMBINED SYNOPSIS / SOLICITATION COMPETITIVE

Solicitation Number: 75N95024Q00252

TITLE: Biological Therapeutics Product Development Subject Matter Expert Consulting Services

Introductory Statement

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) 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.

The Government reserves the right to make one award, multiple awards, or no awards as a result of this solicitation.

Solicitation Number and Authority

The solicitation number is 75N95024Q00252 and the solicitation is issued as a Request for Quotations (RFQ).

This acquisition is for a commercial item or service and is conducted under the authority of the FAR Part 13—Simplif ied Acquisition Procedures; FAR Subpart 13.5—Simplified Procedures for Certain Commercial Items; and FAR Part 12—Acquisition of Commercial Items and is expected to exceed the simplif ied acquisition threshold.

Applicable Federal Acquisition Circular

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-03, dated February 23, 2024.

NAICS Code and Small Business Standard

The associated NAICS code is 541690 (All Scientif ic and Technical Consulting Services) and the small business size standard is $19 million.

This acquisition is not set aside for small businesses.

Anticipated Contract Type

The Government intends to award 1-2 labor hour type contracts. It is anticipated that any contracts that are awarded will include option periods and optional line items in accordance with FAR clauses 52.217-9, Option to Extend the Term of the Contract and 52.217-7, Option for Increased Quantity-Separately Priced Line Item.

Description of Requirement

The purpose of this requirement is to acquire high-level subject matter expert (SME) support for translational product development at the National Institute of Neurological Disorders and Stroke

(NINDS). This requirement provides support that is critical to the broad range of NINDS translational product development activities that are in-process, planned, and evolving.

Please refer to Attachment #1 - Statement of Work (SOW) for complete details and specifications.

Period and Place of Performance

Period of Performance: The anticipated period of performance is a one-year base period from the effective date of award and two (2) subsequent one-year option periods as follows:

Base Period: April 18, 2024 – April 17, 2025 Option Period One: April 18, 2025 – April 17, 2026 Option Period Two: April 18, 2026 – April 17, 2027

Place of Performance: The primary place of performance shall be the Contractor site. Video conference and email shall be the primary mode of communication; however, the Contractor may be required to work at Government facilities or facilities of selected principal investigators on an as needed basis for short duration such as site visit or in-person meeting.

Applicability of FAR clause 52.212-1

The provision at FAR 52.212-1, Instructions to Offerors – Commercial Items (SEP 2023), applies to this acquisition. The following instructions are included as an addendum.

SUBCONTRACTING PROVISIONS

a. Small Business Subcontracting Plan

1. In accordance with FAR 19.704 and FAR Clause 52.219-9, the submission of a subcontracting plan by other than small business offeror(s) is a requirement as a part of the quotation submission process and is to be submitted at the time of the offeror’s Phase One submission. An offeror’s subcontracting plan must be determined to be acceptable by the Contracting Officer, prior to the contract award.

2. The failure of any Contractor or subcontractor to comply in good faith with FAR Clause 52.219-8, entitled " Utilization of Small Business Concerns" incorporated in this contract and the attached Subcontracting Plan, will be a material breach of such contract or subcontract and subject to the remedies reserved to the Government under FAR Clause 52.219-16 entitled, "Liquidated Damages- Subcontracting Plan."

b. Subcontract Reports

1. An offeror is to submit their respective subcontracting plan electronically using the U.S. Department of Health and Human Services (HHS) Small Business Customer Experience (SBCX) system at https://osdbu.hhs.gov/subcontracting/6f6b1eba-a3cc-4840-9962-3b4db77a9f5e.

The Offeror shall follow the instructions outlined in the SBCX Industry Guide at:

https://osdbu.hhs.gov/subcontracting/6f6b1eba-a3cc-4840-9962-3b4db77a9f5e https://oamp.od.nih.gov/sites/default/files/DGS/SBCX%20Industry%20Subcontra cting%20Guide.pdf to successfully submit their subcontracting plan by the quotation submission deadline.

2. The official point of receipt for determining timely submission of an offeror’s subcontracting plan is the SBCX system and/or email notif ication. Once the subcontracting plan is successfully submitted in the SBCX system the offeror should receive an email notif ication and confirmation message of completion upon submission.

3. If an offeror’s subcontracting plan is not confirmed as received within the SBCX system by the quotation submission date specified in the solicitation, it will be considered late in accordance with paragraph (f) of FAR Clause 52.212-1, Instructions to Offeror- Commercial Products and Commercial Services.

Disposition of late submittals of a subcontracting plan by an offeror via the SBCX system is at the discretion of the Contracting Officer.

4. Any technical questions regarding the use of the SBCX system may be submitted via email message to the SBCX help desk at client.support@apexlogic.com. The client support hours of operation are Monday

- Friday, 6:00 a.m. - 8:00 p.m. Eastern Standard Time (EST). Note: help desk tickets can be submitted 24 hours a day / 7 days a week and a representative will respond within the presented client support hours of operation for assistance.

5. Individual Subcontract Reports (ISR)

The Contractor must submit the following Subcontracting reports electronically via the Subcontracting Reporting System (eSRS) at https://www.esrs.gov/.

Regardless of the effective date of this contract, the Report shall be due on the following dates for the entire life of this contract:

April 30th October 30th Expiration Date of Contract

6. Summary Subcontract Report (SSR)

Regardless of the effective date of this contract, the Summary Subcontract Report must be submitted annually on the following date for the entire life of this contract:

October 30th

For both the Individual and Summary Subcontract Reports, the Contract Specialist must be included as a contact for notif ication purposes at the following e- mail address:

Evan Feely - evan.feely@nih.gov

As described in Attachment #5 – Evaluation Criteria, technical evaluation of quotes submitted in response to this solicitation shall take place in two phases.

https://oamp.od.nih.gov/sites/default/files/DGS/SBCX%20Industry%20Subcontracting%20Guide.pdf https://oamp.od.nih.gov/sites/default/files/DGS/SBCX%20Industry%20Subcontracting%20Guide.pdf mailto:client.support@apexlogic.com https://www.esrs.gov/ mailto:evan.feely@nih.gov

During Phase One, quotes shall be evaluated against the criteria for Technical Factor 1:

Personnel Qualifications and for conformance to the solicitation instructions. Therefore, Offeror shall initially submit only the required information outlined under Phase One Response Requirements.

Phase One Response Requirements:

Responses to this solicitation must include clear and convincing evidence of the Offeror’s capability of fulf illing the requirement as it relates to the following evaluation factors:

• Technical Factor 1: Personnel Qualif ications;

o Sub-factor 1: Professional Experience and Expertise in Drug Discovery and

Development o Sub-factor 2: Educational Degrees and Certif ications o Sub-factor 3: Collaborative Team Experience

• Price Evaluation

• Past Performance

• Subcontracting

If applicable, the offeror is also required to submit a completed small business subcontracting plan through SBCX.gov at the time of its’ Phase One submission,.

Responses will be evaluated in accordance with the evaluation criteria identif ied in this solicitation as well as the SOW requirements.

Technical Requirements:

Phase One responses must include clear and convincing evidence of the Offeror’s capability of fulf illing the requirement as it relates to Technical Factor 1: Personnel Qualifications.

These responses shall include resumes of proposed key personnel, consultants, and any subcontractors, as well as a letter of commitment from proposed key personnel. These responses should also clearly identify whether proposed personnel will be or are an employee of the Offeror. Please note that all proposed key personnel must be employed by the Offeror no later than the start of the contract’s period of performance.

Please note, however, that while resumes of all proposed key personnel are required, they are NOT, by themselves, sufficient. Offerors MUST also submit a separate narrative demonstrating how proposed Key Personnel satisfy the Personnel Qualifications evaluation criteria. Please carefully examine the evaluation criteria prior to writing this narrative.

Business Requirements:

Offerors are required to complete Attachment #4 – Price Template. Offerors are only to fill in the highlighted cells (including the proposed labor rate and the number of consultants being proposed); all other cells will then auto-populate. Offerors must submit the completed pricing template in Excel (do not convert to PDF) as a separate attachment and shall not combine or embed the pricing template with other materials.

Phase One Instructions

The Government anticipates annual funding for an estimated 100 labor hours and has included an annual not to exceed amount of 3,800 optional hours (for a total annual ceiling of 3,900 hours). The Government will also reimburse the successful Offeror(s) for travel-related expenses that are necessary for performance of this requirement up to the designated not-to-exceed amounts. These funds shall be provided only after it is determined there is a need for travel. All travel requests require advance approval by the Government.

In recognition of these facts, Offeror must include the following statement in its’ response:

“It is anticipated that the Government will fund an estimated amount of 100 hours and that a maximum of up to 3,800 additional hours may be funded and exercised in any increment during each contract period. It is also understood that a not‐to‐exceed travel amount may be funded and exercised during each contract period and may only be used with advance approval. Any billable travel expenses that are submitted for reimbursement shall comply with the Federal Travel Regulation (FTR).”

If the Offeror proposes the involvement of any additional staff beyond those described in the SOW, it must clearly articulate their role and why it believes additional personnel are necessary to fulf ill the requirement. The Offeror must also specify how this time will be charged (e.g., direct hourly rate or included within overhead). Finally, the Offeror is required to document its’ rationale for any proposed Other Direct Costs (ODCs) besides travel as well as the total amount. If any of these conditions are applicable, the Offeror shall add rows for the additional costs to the Price Template and include a Price Narrative in its response.

Salary Rate Limitation:

Offerors are advised that no NIH funds may be used to pay the direct annual salary of an individual through any contract awarded as a result of this solicitation at a rate in excess of the Executive Schedule, Level II* (direct salary is exclusive of Overhead, Fringe Benefits and General and Administrative expenses, also referred to as "indirect cost" or "facilities and administrative (F&A) costs"). Direct salary has the same meaning as the term "institutional base salary." An individual's direct salary (or institutional base salary) is the annual compensation that the Offeror pays for an individual's appointment whether that individual's time is spent on research, teaching, patient care, or other activities. Direct salary (or institutional base salary) excludes any income that an individual may be permitted to earn outside of duties to the Offeror.

This does not preclude Offerors from absorbing that portion of an employee's annual salary (plus the dollar amount for fringe benefits and associated indirect costs) that exceeds a rate of the Executive Schedule, Level II*. The Executive Schedule, Level II* annual salary rate limitation also applies to individuals proposed under subcontracts as well as consultants.

LINK TO EXECUTIVE SCHEDULE RATES OF PAY:

https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/ (For current year rates, click on Salaries and Wages/Executive Schedule/Rates of Pay for the Executive Schedule. For prior year rates, click on Salaries and Wages/select Another Year at the top of the page/Executive Schedule/Rates of Pay for the Executive Schedule. Rates are effective January 1 of each calendar year unless otherwise noted.)

*Note to Offerors: Offerors must adhere to the current Fiscal Year Executive Level II Salary Rate when preparing its response. All costs associated with any resultant contract award shall fully comply with the current Fiscal Year Executive Level II Salary rates.

https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/

Offerors are instructed to certify that their quoted labor rates comply with the Department of Health and Human Services Acquisition Regulation (HHSAR) Clause 352.231-70 Salary Rate Limitation through completing Attachment #3 – Representations and Certifications.

Past Performance:

Offeror shall identify 1-2 awards with the Federal Government and/or commercial customers that demonstrate recent and relevant past performance. Relevant is defined as work similar in complexity and magnitude to the work described in the SOW.

Offeror shall include the following information in their past performance examples:

• Project title

• Description of the project

• Contract number

• Contract amount

• Government Agency/Organization

• Point of contact name, address, and phone number

• Contract and, if applicable, task order number

• Current status, e.g., completed and/or if in progress, start and estimated completion dates

• SOW paragraphs that the reference applies to

• Key personnel (please highlight those individuals who worked on the relevant project(s) and are also being proposed for this effort.)

• A brief narrative of why you deem the reference to be relevant to this effort

Response:

Offeror responses shall be no more than ten (10) single-sided pages in length. This page limit includes the following:

(i) Cover Page, if applicable

(ii) Executive Summary, if applicable

(iii) Table of Contents, if applicable

(iv) Key Personnel Narrative (no more than two pages)

(v) Price Narrative, if applicable

(vi) Past Performance Examples

This page limit does NOT include:

(i) Key Personnel Resume(s)

(ii) Letter(s) of Commitment

(iii) Representations and Certif ications

(iv) Completed Price Template

Additional Required Information:

In addition to the previously discussed requirements, Offerors must include the following in their response:

1) Company’s Full Name and Address

2) Unique Entity ID (UEI), Commercial And Government Entity (CAGE) Code, and

Taxpayer Identif ication Number (TIN)

3) Name, Telephone Number, and Email Address of Person Authorized to Provide Quote

Please note that, to be considered for award, Offerors must also be actively registered in the System for Award Management (SAM), accessible at www.sam.gov, at the time of quote submission.

QUOTES DUE: To be considered for Phase One evaluation, Offeror must submit all required materials by 5:00 PM Eastern Time on May 17, 2024, and reference solicitation number 75N95024Q00252. Responses must be submitted electronically to Evan Feely, Contract Specialist, at evan.feel@nih.gov Fax responses will NOT be accepted.

All timely and responsive quotes that fully comply with the solicitation instructions and are submitted by responsible Offerors will be evaluated by the Technical Evaluation Panel (TEP).

Only the highest-rated Offerors will be given the opportunity to submit materials pertaining to Phase Two. Depending on the quality of the quotes received, these Offerors may also be required to give an oral presentation to members of the contracting and program office.

The Government reserves the right to determine whether oral presentations are necessary. If it determines they are, presenting Offerors must follow the format described in the following section.

During Phase Two, respondents whose quotes received the highest ratings for Phase One will be given an opportunity to conduct oral presentations. These presentations will be conducted virtually in accordance with the Government’s instructions outlined in the “Instructions to Offerors” section of this solicitation.

The TEP will primarily use these presentations to evaluate Offeror’s proposed technical approach as well as the quality of its oral communication/presentation skills in accordance with Technical Factor 2: Understanding the Project and Technical Approach and Technical Factor 3:

Communication and Oral Presentation Skills. Additionally, they will be evaluated by using the criteria for the following factors:

• Technical Factor 1: Personnel Qualif ications

• Technical Factor 2: Understanding the Project and Technical Approach, and

• Technical Factor 3: Communication and Oral Presentation Skills.

Please note that during Phase Two of the evaluation process, the Government may revise any Offeror’s score for Technical Factor 1 and/or its evaluation of the Offeror’s price and past performance if merited by that Offeror’s oral presentation and Phase Two response.

Please also note that, if required, all presentations will take place via virtual conferences.

The Contracting Officer will provide eligible Offerors with the information necessary to attend the conferences, including, if applicable, the virtual meeting link, password, and/or call-in number.

Oral Presentation Requirements:

It is strongly recommended that the Key Personnel who would perform the work described in the SOW conduct or participate in the Offeror’s presentation. Offerors shall discuss their Phase One responses and present their proposed technical approach and understanding of the requirement during the oral presentation, which will include, at a minimum:

Phase Two Instructions http://www.sam.gov/ mailto:evan.feel@nih.gov

• Background discussion of the work contemplated under this project

• Personnel qualif ications and specific areas of expertise relevant to the SOW

• Proposed technical approach for fulf illing the requirements described in the SOW, including how the key personnel would characterize their role and responsibilities

• Anticipated problems and constraints likely to be encountered in performing the work and potential plans and solutions for resolving them

• If applicable, examples of how the Offeror has effectively trained other project staff or clients in their discipline.

Phase Two Written Response Requirements:

Responses to this solicitation must include clear and convincing evidence of an Offeror’s capability of fulf illing the requirement as it relates to all evaluation factors:

• Technical Factor 1: Personnel Qualif ications;

• Technical Factor 2: Understanding the Project and Technical Approach;

• Technical Factor 3: Communication and Oral Presentation Skills;

• Price; and

• Past Performance.

Responses will be evaluated in accordance with the evaluation criteria identif ied in this solicitation as well as the SOW requirements.

The offer’s response shall be no more than fifteen (15) single-sided pages in length. This page limit includes the following:

(i) Cover Page, if applicable

(ii) Executive Summary, if applicable

(iii) Table of Contents, if applicable

(iv) Key Personnel Narrative (no more than two pages)

(v) Technical Approach Narrative (no more than two pages)

(vi) Price Narrative, if applicable

(vii) Past Performance Examples

This page limit does NOT include:

(i) Key Personnel Resume(s)

(ii) Letter(s) of Commitment

(iii) Representations and Certif ications

(iv) Completed Price Template

(v) Electronic Copy of Oral Presentation materials, if applicable

Applicability of FAR provision 52.212-2

The provision at FAR 52.212-2, Evaluation – Commercial Items (Nov 2021), applies to this acquisition. Attachment #5 – Evaluation Criteria is provided as an addendum.

Applicability of FAR provision 52.212-3

The provision at FAR 52.212-3, Offeror Representations and Certif ications – Commercial Items (Feb 2024), applies to this acquisition.

The provision is included in full text at Attachment #3 – Representations and Certifications.

The offeror must submit a completed and signed version of this form with its response.

Applicability of FAR clause 52.212-4

The clause at FAR 52.212-4, Contract Terms and Conditions – Commercial Items (Nov 2023), Alternate I (Nov 2021) applies to this acquisition and is incorporated by reference.

Applicability of FAR clause 52.212-5

The clause at 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Feb 2024) applies to this acquisition.

FAR 52.212-5 is included in full text at Attachment #2 - Additional Terms and Conditions.

Applicability of Defense Priorities and Allocations System (DPAS)

The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

Any questions regarding this solicitation must be submitted electronically to the Contract Specialist, Evan Feely, at evan.feely@nih.gov by 5:00 PM Eastern Time on April 30, 2024.

Fax responses will NOT be accepted.

Attachment #1 – Statement of Work (SOW) Attachment #2 – Additional Terms and Conditions Attachment #3 – Representations and Certif ications Attachment #4 – Price Template Attachment #5 – Evaluation Criteria Attachment #6 – Invoicing Instructions Attachment #7 – Information/Physical Access Security Requirements

Questions Regarding Solicitation

RFQ Attachments mailto:evan.feely@nih.gov