NIH-NINDS-CSS-20-005290 FINAL.pdf

COMBINED SYNOPSIS / SOLICITATION COMPETITIVE

NIH-NINDS-CSS-20-005290

TITLE: Medical Writing Consultant Support 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 at all as a result of this solicitation.

Solicitation Number and Authority

The solicitation number is NIH-NINDS-CSS-20-005290 and the solicitation is issued as a Request for Quotation (RFQ).

This acquisition is for a commercial item or service and is conducted under the authority of the FAR Part 13—Simplified 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 simplified acquisition threshold.

Applicable Federal Acquisition Circular

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-08, dated 08-13-2020.

NAICS Code and Small Business Standard

The associated NAICS code is 541990 (All Other Professional, Scientific and Technical Services) and the small business size standard is $15.0 million.

This procurement is a total small business set-aside.

Anticipated Contract Type

The Government intends to award a Labor-Hour Purchase Order with Options to Extend the Term of the Contract and Options for Increased Quantity.

Description of Requirement

Statement of Need and Purpose: The National Institutes of Health (NIH) requires a senior-level, industry-experienced drug discovery and development consultant with expertise in Medical Writing and Drug Dossier Development to provide leadership and technical guidance to the following programs:

• The Blueprint Neurotherapeutics Program [BPN] – Medical Writing to support neuroscience-focused drug development programs.

• The Early Phase Pain Investigation Clinical Network (EPPIC-Net) Network – Drug Dossier development

• Other NIH neuroscience-focused research and drug discovery and development programs.

Background Information: The NIH Blueprint for Neuroscience Research, a consortium of 15 NIH Institutes and Centers that support neuroscience research, established the BPN as a pipeline between the typical endpoint of NIH-funded research and the beginning of industry drug development. The BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise.

The program is intended for projects requiring medicinal chemistry optimization and contract research organization (CRO) support through Phase I clinical testing. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by CROs. Bioactivity and efficacy studies are typically funded through an award to the PI; other research services can be provided without cost to the PI through NIH contracts.

EPPIC-Net is a part of the NIH Helping to End Addiction Long-termSM (HEAL) Initiative. The HEAL Initiative is an aggressive, trans-NIH effort to speed scientific solutions to the current opioid crisis by improving prevention and treatment strategies for opioid misuse and addiction and to enhance pain management, via the development of effective, non-addictive treatments.

EPPIC-Net is a sophisticated clinical trial network established to design and execute early phase (focused on Phase 2) clinical trials of promising non-addictive pain therapies in well-characterized patient cohorts with pain conditions of high unmet need.

Project Requirements: Independently, and not as an agent of the Government, the Quoter shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government needed to perform the requirements outlined in the Statement of Work (SOW).

The Quoter shall provide this support while serving on NIH BPN LDTs. LDTs meet for approximately two hours via teleconference every one to two weeks; each LDT project may require between three and ten hours weekly, inclusive of meeting and preparation time.

The Quoter is expected to provide support services in a collaborative way. LDTs that the Quoter is assigned to may work on several projects in the exploratory through preclinical safety stages.

Some of these projects may proceed to investigational new drug (IND) and clinical trial stages.

For EPPIC-Net, the Quoter will work with invited applicants at the second stage of the application process to prepare a dossier document based on a template provided by NIH. The dossier will include detailed information on the asset, such as drug pharmacology, device specifications, and preclinical and clinical safety/efficacy data, as applicable, based on information provided by the asset holder and gathered by the Quoter independently as needed.

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: September 14, 2020 – September 13, 2021 Option Period One: September 14, 2021 – September 13, 2022 Option Period Two: September 14, 2022 – September 13, 2023

Place of Performance: The primary place of performance shall be the Quoter’s site. Conference calls and email shall be the primary mode of communication; however, the Quoter may be required to work at Government facilities in the continental United States, primarily Bethesda, MD, on an as-needed basis.

Applicability of FAR clause 52.212-1

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

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

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

Personnel Qualifications and for conformance to the solicitation instructions. Therefore, Quoter 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 Quoter’s capability of fulfilling the requirement as it relates to the following evaluation factors:

• Technical Factor 1: Personnel Qualifications;

• Price; and

• Past Performance.

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

Phase One Instructions

Technical Requirements:

Phase One responses must include clear and convincing evidence of the Quoter’s capability of fulfilling 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 Quoter. Finally, Quoter must address how it will ensure compliance with FAR clause 52.219-14 Limitations on Subcontracting if the proposed key personnel is not an employee of the Quoter.

Please note, however, that while resumes of all proposed key personnel are required, they are NOT, by themselves, sufficient. Quoter 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:

Quoter shall complete Attachment #4 – Price Template. Quoter is only to fill out the highlighted cells; all other cells will then auto-populate. Quoter shall complete and return the Excel pricing template in Excel (do not PDF). The pricing template shall not be combined or embedded with other materials.

Quoter will note that the Government anticipates annual funding in the estimated amount of 20 hours for consultant support and that it has included an annual not to exceed amount of 1,080 optional hours (for a total annual ceiling of 1,100 hours). It should also be noted that the Government will reimburse the successful Quoter for up to $1,200.00 in travel-related expenses that are necessary for performance of this requirement. These funds shall be provided only after it is determined there is a need for travel. Furthermore, all travel requests require advance approval by the Government.

In recognition of these facts, Quoter should include the following statement in its response:

“It is anticipated that the Government will fund an estimated amount of 20 hours and that a maximum of up to 1,080 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 of $1,200 may be funded and exercised during each contract period and may only be used with advance approval.” Any billable travel expenses must follow Federal Travel Regulations.

If the Quoter proposes the involvement of any additional staff besides the Key Personnel, it must clearly articulate how their role will be fulfilled and why it believes additional personnel are necessary. The Quoter must also specify how this time will be charged (e.g. direct hourly rate or included within overhead). Finally, the Quoter 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 Quoter shall complete the appropriate cells in the Price Template and include a Price Narrative in its response.

Salary Rate Limitation:

Quoter is 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 Quoter 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 Quoter.

This does not preclude the Quoter 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 EXECUTIVESCHEDULE 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 Quoters: Quoter 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.

Quoter is instructed to certify that its 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:

Quoter 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.

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

Response:

Quoter’s response 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 Certifications

(iv) Completed Price Template

Additional Required Information:

In addition to the previously discussed requirements, Quoter must include the following in its response:

1) Company’s Full Name and Address

2) Dun & Bradstreet (DUNS) Number, Commercial And Government Entity (CAGE) Code, and Taxpayer Identification Number (TIN)

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

Please note that, to be considered for award, Quoter 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, Quoter must submit all required materials by 11:59 PM Eastern Daylight Time on August 24, 2020 and reference solicitation number NIH-NINDS-CSS-20-005290. Responses must be submitted electronically to Evan Feely, Contract Specialist, at evan.feely@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 Quoters will be evaluated by the Technical Evaluation Panel (TEP).

Only the highest-rated Quoters will be given the opportunity to submit materials pertaining to Phase Two. These Quoters will also be required to give an oral presentation to the Contracting Officer, Contract Specialist, and members of the requiring office. The format for these presentations is described in the following section.

All Quoters that have advanced to Phase Two will be given the opportunity to clarify, discuss, or revise aspects of their Phase One response (including Technical Factor 1, Price, and Past Performance). Additionally, they will be evaluated by using the criteria for the following factors:

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

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

• Technical Factor 3: Communication and Oral Presentation Skills.

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

Please also note that all presentations will take place via virtual conferences. The Contract Specialist will provide eligible Quoters with the information necessary to join 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 that would perform the work described in the SOW conduct or participate in the Quoter’s presentation. Quoter shall discuss its response to Phase One and present its proposed technical approach and understanding of the requirement during the oral presentation, which will include, at a minimum:

• Background discussion of the work contemplated under this project

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

• Proposed technical approach for fulfilling 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 Quoter 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 the Quoter’s capability of fulfilling the requirement as it relates to all evaluation factors:

• 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.

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

Quoter’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 Certifications

(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, 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 Certifications – Commercial Items, applies to this acquisition.

The provision and representations and certifications is included in full text at Attachment #3 – Representations and Certifications. Quoter 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, Alternate I (JAN 2017) 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 (AUG 2020) apply 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 05:00 PM Eastern Daylight Time on August 21, 2020. Fax responses will NOT be accepted.

Questions Regarding Solicitation mailto:evan.feely@nih.gov

Attachment #1 – Statement of Work (SOW) Attachment #2 – Additional Terms and Conditions Attachment #3 – Representations and Certifications Attachment #4 – Price Template Attachment #5 – Evaluation Criteria Attachment #6 – Interim (Electronic) Invoicing Instructions Attachment #7 – Standard Invoice and Payment Instructions Attachment #8 – Information/Physical Access Security Requirements

RFQ Attachments