Amended_Combined_Synopsis_Solicitation_Pharmaceutics_Formulation_CMC.pdf

AMENDED COMBINED SYNOPSIS / SOLICITATION - COMPETITIVE

Solicitation No. 75N95022Q00393

TITLE: Pharmaceutics Formulation / Chemistry Manufacturing and Controls Consulting Services for Small Molecules and/or Biologics

This is a combined synopsis/solicitation (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 anticipates awarding one to four purchase orders at a fair and reasonable price as a result of this Solicitation. The Government reserves the right to make one award, multiple awards, or no awards at all.

The Solicitation number is 75N94022Q00393 and the Solicitation is issued as a Request for Quotation (RFQ).

This acquisition is for a commercial product or service and is conducted under the authority of FAR Part 13—Simplified Acquisition Procedures, FAR Subpart 13.5—Simplified Procedures for Certain Commercial Products and Commercial Services, and FAR Part 12— Acquisition of Commercial Products and Commercial Services. The acquisitions is expected to exceed the simplified acquisition threshold.

This Solicitation document and the incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2022-06 effective May 26, 2022.

The associated NAICS code is 541990 – All Other Professional, Scientific, and Technical Services, and the small business size standard is $17.0 million.

This acquisition is a total small business set-aside.

The Government intends to award one to four Labor-Hour Purchase Orders with Options to Extend the Term of the Contract and Options for Increased Quantity-Separately Price Line Item.

Introductory Statement

Solicitation Number and Authority

Applicable Federal Acquisition Circular

NAICS Code and Small Business Standard

Anticipated Contract Type

Statement of Need and Purpose:

The National Institute of Neurological Disorders and Stroke (NINDS) requires consulting services from senior scientific level, industry-experienced drug discovery and development consultants with expertise in Pharmaceutics Formulation/Chemistry Manufacturing and Controls (CMC) Consulting Services for Small Molecules and/or Biologics, to provide technical guidance to the National Institutes of Health’s (NIH) Blueprint Neurotherapeutics Network (BPN) program and to other NIH, neuroscience-focused drug discovery and development programs.

These consulting services are needed on a part-time basis; the number of hours will vary depending on the needs, quality and complexity of the of assigned project. The NIH estimates that up to four (4), part-time consultants will be required during the base period of performance and the required level-of-effort will be 20 to 800 hours per consultant per year.

Please refer to Attachment 1. Statement of Work (SOW) for complete details.

Period of Performance:

The base period of performance is anticipated to be August 1, 2022 to July 31, 2023 followed by two option period of one year each.

Place of Performance:

The primary place of performance shall be the Quoter’s site. Video conferencing and email shall be the primary mode of communication. The consultant will be expected to attend a kick-off meeting at the start of a project. Kick-off meetings are anticipated to be 6 to 8 hours in duration, and may be held at a principal investigator’s (PI) facility or conducted remotely. If held at a PI’s facility, the Government will pay for the consultant’s travel expenses to attend the kick-off meeting, in accordance with FAR 31.205-46 - Travel costs.

Applicability of FAR 52.212-1 The provision at FAR 52.212-1, Instructions to Offerors – Commercial Products and Commercial Services (Nov 2021), applies to this acquisition. The instructions below are provided as an addendum.

As described in Attachment 7. Evaluation Criteria, technical evaluation of quotes submitted in response to this RFQ shall occur in two phases as described below.

In Phase One, quotes shall be evaluated and scored against the criteria for Technical Factor 1: Personnel Qualifications. Therefore, responses to this RFQ should include the information requested under Phase One Response Requirements.

Phase One Response Requirements:

Responses to this RFQ must include clear and convincing evidence of the Quoter’s capability of fulfilling the requirement as it relates to the following evaluation factors:

Description of Requirement

Period and Place of Performance

Phase One Instructions

• Technical Factor 1: Personnel Qualifications

• Price

• Past Performance

Responses will be evaluated in accordance with the evaluation criteria for Technical Factor 1 as set forth in Attachment 7. Evaluation Criteria.

Technical Requirements:

Phase One responses must include clear and convincing evidence of the Quoter’s capability of performing the work described in the attached Statement of Work, based upon the evaluation criteria for Technical Factor 1: Personnel Qualifications.

Responses shall clearly state which proposed key personnel are currently employed by or under contract with Quoter. Responses must include current resumes for all proposed key personnel. For proposed key personnel that are not currently under contract or employed with the Quoter, a signed letter of commitment from the proposed key personnel should be included with his/her resume.

Please note, however, that while resumes of all proposed key personnel are required, the resumes by themselves are not sufficient to establish Quoter’s ability to perform the work.

Quoter MUST also submit a separate Phase One Response demonstrating how proposed Key Personnel satisfy the Technical Factor 1: Personnel Qualifications.

Business Requirements:

Quoters’ Phase One response must include a completed Price Template (Attachment 2.).

Quoters are only to fill in the highlighted cells (including the proposed labor rate for the base and each option period); all other cells will then auto-populate. Quoters shall submit the completed price template in Microsoft Excel format (do not convert to PDF) as a separate attachment to the Phase One Response. Quoters shall not combine or embed the price template with other materials.

The Government anticipates annual funding for a minimum of 20 labor hours per consultant and has included an annual not to exceed amount of 780 optional hours (for a total annual ceiling of 800 labor hours). Furthermore, the Government will reimburse the successful Quoter(s) up to $1,200 per year in travel-related expenses that are necessary for performance of the work described in the Statement of Work. This travel amount will be included as an option item in the purchase order award. Funds for travel will be provided only after it is determined by the program manager or Contracting Officer’s Representative that there is a need for travel.

If the Quoter proposes any staff in addition to Key Personnel, Quoter must clearly articulate in a separate Price Narrative the additional staff’s role in performing the work and why it believes the additional staff is/are necessary to fulfill the requirement. The Quoter must also explain how the additional staff’s labor will be charged (e.g. direct hourly rate or included within overhead).

Finally, the Quoter is required to document its rationale in the Price Narrative for any proposed Other Direct Costs (ODCs) entered in the Price Template.

Salary Rate Limitation:

This requirement has a direct salary rate limitation whereby proposed labor rates must adhere to the current Executive Level II Salary Rate. Direct salary is exclusive of indirect costs which may include Overhead, Fringe Benefits and General and Administrative Expenses. An individual's direct salary (or institutional base salary) is the annual compensation that the Quoter pays for the individual consultant’s time, regardless of whether the consultant’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 earn outside of his/her work for this requirement.

Note to Quoters: The Salary Rate Limitation for these consulting services may not exceed the Executive Schedule Level II salary – see https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2022/EX.pdf The Executive Schedule, Level II annual salary rate limitation also applies to proposed key personnel that will be providing these consulting services as subcontractors. All costs associated with any resulting purchase order shall fully comply with the current Executive Schedule Level II salary.

All contractors shall comply with Health and Human Services Acquisition Regulations (HHSAR) clause 352.231-70, Salary Rate Limitation (December 18, 2015) , which shall be incorporated by reference in every purchase order.

Quoters shall certify that quoted labor rates comply with HHSAR 352.231-70 by completing and submitting Attachment 4. Representations and Certifications.

Past Performance:

Phase One responses must include at least two previous or current contracts/orders that Quoter has received from Government agencies and/or commercial customers under which Quoter provided services that demonstrate recent and relevant past performance. Relevant is defined as work similar in complexity and magnitude to the work described in the SOW.

Each contract/order should include the following, if applicable:

• Project title, and description of the project

• Contract number, and if applicable, task order number

• Contract amount

• Government Agency/Organization

• Contracting Officer/Project Manager’s name, address, and phone number

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

• Key personnel (please highlight those individuals who worked on the referenced contract/order and are also being proposed for this effort.)

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

The first page of a quotation submitted in response to this RFQ must include:

• RFQ Number

• Quoter’s full name and address;

• Quoter’s UEI Number;

• Name, Telephone Number, and Email Address of Person Authorized to Provide the

Quote

Response Format:

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

(i) Cover Page, if applicable https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2022/EX.pdf https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2022/EX.pdf

(ii) Executive Summary, if applicable

(iii) Table of Contents, if applicable

(iv) Key Personnel Narrative

(v) Past Performance Examples

(vi) Price Narrative, if applicable

This page limit does NOT include:

(i) Key Personnel Resume

(ii) Letters of Commitment

(iii) Completed Representations and Certifications

(iv) Completed Price Template

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

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

Only responses that receive the highest scores from the TEP will be given the opportunity to submit Phase Two Responses.

Only Quoters that have advanced to Phase Two of the evaluation process will be given the opportunity to clarify, discuss, or revise aspects of their Phase One response (including Technical Factor 1, Price, and Past Performance). Phase Two responses will be evaluated against the evaluation criteria for:

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

• Technical Factor 3: Communication and Oral Presentation Skills

Oral Presentation Requirements:

In addition to a Phase Two written response, Quoters’ proposed Key Personnel (consultants) shall deliver an oral presentation to the TEP in which Key Personnel shall address Technical Factors 1 and 2. All presentations will take place via videoconference.

Oral presentations shall include:

• Background discussion of the work contemplated in the Statement of Work (SOW)

• Key Personnel qualifications and specific areas of expertise relevant to the SOW

• Proposed technical approach for fulfilling the requirements described in the

SOW, including how 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

Written Response Requirements:

Responses must include clear and convincing evidence of proposed key personnel’s ability to fully perform the work described in the SOW. In additional, the response must address all evaluation factors:

Phase Two Instructions http://www.sam.gov/

• Technical Factor 1: Personnel Qualifications;

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

• Technical Factor 3: Communication and Oral Presentation Skills;

• Price; and

• Past Performance.

Phase Two written responses will be evaluated in accordance with the evaluation criteria identified in Attachment 7. Evaluation Criteria.

Phase Two responses shall be no more than four (4) single-sided pages in length.

Applicability of FAR 52.212-2 The provision at FAR 52.212-2, Evaluation – Commercial Products and Commercial Services, applies to this acquisition. Attachment 7. Evaluation Criteria is provided as an addendum.

Applicability of FAR 52.212-3 The provision at FAR 52.212-3, Offeror Representations and Certifications – Commercial Products and Commercial Services, applies to this acquisition.

The applicable representations and certifications are contained in Attachment 4.

Representations and Certification. Quoter must submit a completed and signed version of Attachment 4 a part of its Phase One quote/response.

Applicability of FAR 52.212-4 The clause at FAR 52.212-4, Contract Terms and Conditions – Commercial Products and Commercial Services, Alternate I, applies to this acquisition and is incorporated herein by reference.

Applicability of FAR 52.212-5 The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Products and Commercial Services, applies to this acquisition.

Commercial Provisions Please be advised that the NINDS is an Institute within the National Institutes of Health (NIH), which is a Federal agency. Your mass-market commercial and/or license agreement may include provisions that are customarily found in the commercial sector, which are not appropriate for a contract with a Federal agency. Specifically, NINDS considers any provision in your mass-market commercial and/or license agreement to be inappropriate and unenforceable that:

(1) Contravenes a right granted to NINDS under U.S. copyright law (e.g., fair use, right to archive, copying for interlibrary loan),

(2) Violates the Federal Acquisition Regulation or other Federal law (e.g., Anti-deficiency Act, Principles of Federal Appropriations Law),

(3) Departs from reasonable consumer expectations and was not disclosed by the Licensor prior to agreement, or

(4) Violates fundamental public policy.

The NINDS will assume that you agree with the above Commercial Provisions if you submit a quotation.

If you are unable to submit a quote, please so indicate in a reply email to the above referenced point of contact.

This RFQ does not commit the Government to pay any costs incurred in the preparation of the submission of any quotation or to contract for supplies or services.

If you have questions regarding any part of this Solicitation, please submit them immediately but no later than 9:00 AM Eastern Time on July 21, 2022, to the point of contact listed below.

Marlene Milgram Contract Specialist Marlene.milgram@nih.gov

All questions must be submitted by email to marlene.milgram@nih.gov

Phase One quotes/responses including all required materials specified herein must be submitted by 5:00 PM Eastern Time on July 25, 2022 and must reference Solicitation number 75N95022Q00393.

Phase One responses/quotes shall be submitted via email to Marlene Milgram, Contract Specialist, at marlene.milgram@nih.gov. Responses/quotes submitted by fax or mail will not be accepted.

Attachment 1. Statement of Work (SOW) Attachment 2. Price Template Attachment 3. Additional Terms and Conditions Attachment 4. Representations and Certification Attachment 5. Information and Physical Access Security Requirements Attachment 6a. Electronic Invoice Instructions - Not Transitioned to IPP Attachment 6b. IPP Invoice Instructions - Transitioned to IPP Attachment 7. Evaluation Criteria

Questions

Quotation/Response Submission

Solicitation Attachments mailto:Marlene.milgram@nih.gov mailto:marlene.milgram@nih.gov mailto:marlene.milgram@nih.gov