SAM # 7571PSQ00007

Senior pharmaceutical development and pain advisor for NIH HEAL Initiative

HHS is seeking an experienced pharmaceutical-development and pain advisor to support the NIH HEAL Initiative’s Pain Therapeutics Development Program. - Government buyer: Department of Health and Human Services (HHS), through the National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS). - Requested service: One senior subject-matter expert to advise NIH leadership and serve on the HEAL Pain Therapeutics Development Program External Oversight Committee. - Provide expertise in drug discovery and development, pharmacology, pain, and nervous-system conditions. - Advise on project milestones, pharmacology opportunities and challenges, program operations, and future project opportunities; help resolve program challenges and mentor program leaders. - Participate in monthly and ad hoc virtual meetings and attend at least one annual in-person NIH meeting. - Workload and term: Approximately 20–50 hours of support annually, with 50 hours per year anticipated and an option for up to 50 additional hours per year. The contemplated term is one base year plus two option years. - Expert qualifications: PhD in a pharmacology- or drug-development-related discipline with pain expertise; senior drug-development experience; at least 15 years of executive-level pharmacology guidance experience and 10 years directing collaborative research; and knowledge of global regulatory requirements, including relevant investigational new drug application experience. - Deliverables and costs: Meeting notes are due within three business days after scheduled oversight committee meetings, and quarterly reports within ten business days after each quarter. Necessary travel may be reimbursed up to $2,000 per year, or $6,000 across the base and two option periods, subject to advance government approval. The HHS salary rate limitation applies. - OEMs and vendors: No product manufacturers, OEMs, or commercial vendors are identified; this is an expert advisory service rather than a product purchase.

Description

COMBINED SYNOPSIS / SOLICITATION (COMPETITIVE) Title: Senior Advisor Subject Matter Expert (SME) with Pharmaceutical Development and Pain Expertise for the NINDS Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative for the Pain Therapeutics Development Program (PTDP)

(i) Solicitation Information This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with RFO Part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued. The solicitation number is 7571PSQ00007, issued as a Request for Quote for a Senior Advisor to act as a Subject Matter Expert (SME) with Pharmaceutical Development and Pain Expertise. The Government reserves the right to make one award, multiple awards, or no awards as a result of this solicitation. This acquisition is set aside for small business concerns. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at www.acquisition.gov. The Defense Priorities and Allocations System (DPAS) is not applicable to this requirement.

(ii) Services Required NINDS is seeking to procure a highly experienced executive-level, drug discovery and development Senior Advisor 2 with extensive expertise in drug discovery and development, in support of the NIH HEAL Initiative, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis.

(iii) Description of Requirement The NIH is seeking to procure a highly experienced executive-level Senior Advisor 2, drug discovery and development subject matter expert with experience in the area of Pharmacology and Pain to provide feedback to the NIH program leadership and technical guidance on drug discovery and development projects within the NINDS HEAL portfolio. The Contractor will serve as a member of the HEAL External Oversight Committee, which will provide strategic guidance on HEAL projects and on occasion other NIH drug discovery and development programs. See Attachment #1 - Statement of Work (SOW) for more information.

(iv) Contract Type and Period of Performance The Government anticipates award of a Fixed Price purchase order for this acquisition. The anticipated base period of performance is: Base: 11/5/2026 – 11/4/2027 Option Year 1: 11/5/2027 – 11/4/2028 Option Year 2: 11/5/2028 – 11/4/2029

(v) Solicitation Provisions The provisions at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), apply to this acquisition. 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 these addresses: https://www.acquisition.gov/far-overhaul https://www.hhs.gov/contract-policies-regulations/hhsar-overhaul (End of provision)

a) FAR Provisions Required by FAR 12.2025(a) and Incorporated by Reference FAR 52.212-1 (Nov 2025) (RFO Deviation), Instructions to Offerors—Commercial Products and Commercial Services.

b) FAR Provisions Applicable to This Requirement and Incorporated by Reference See Attachment 2 for (Table #12-2) under FAR 12.205(a)(3).

c) HHSAR Provisions Applicable to This Requirement and Incorporated by Reference (Available Upon Request) HHSAR 352.239.78 – Information and Communication Technology Accessibility Notice (FEB 2024) (Deviation)

(vi) Contract Clauses The clauses at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), apply to this acquisition. 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 these addresses: https://www.acquisition.gov/far-overhaul https://www.hhs.gov/contract-policies-regulations/hhsar-overhaul (End of clause)

a) FAR Clauses Required by FAR 12.205(b)(1) for All Solicitations and Incorporated by Reference FAR 52.212-4 (Nov 2025) (RFO Deviation), Terms and Conditions—Commercial Products and Commercial Services.

b) FAR Clauses Applicable to This Requirement and Incorporated by Reference See Attachment 3: Table #12-3. FAR 52.232-39, Unenforceability of Unauthorized Obligations (Jun 2013).

HHSAR Clauses Applicable to This Requirement and Incorporated by Reference HHSAR 352.204-71, Information and Information System Security (FEB 2024) (Deviation). HSHAR 352-204-73 – Contractor Personnel Security and Agency Access (FEB 2024) (Deviation). HHSAR 352-239-79 – Information and Communication Technology Accessibility (Feb 2024) (Deviation).

FAR/HHSAR PROVISIONS/CLAUSES – FULL TEXT—ADDITIONAL TERMS AND CONDITIONS The following provisions/clauses and additional terms and conditions apply to this acquisition and are provided in full text:

a) HHSAR 352-237-75 Key Personnel (Oct 2026) (RFO Deviation) Key personnel specified in this contract are essential to work performance under the contract. The Contractor must obtain the written consent of the Contracting Officer prior to diverting, replacing, or announcing any key personnel substitutions. At least 30 days prior to the Contractor voluntarily diverting any of the specified individuals to other programs or contracts, the Contractor must submit requests for changes in key personnel to the Contracting Officer in writing. The request must identify the circumstances, proposed replacement, a resume and explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. When advance notice is not practicable because of termination for cause, other voluntary separation or another circumstance outside the Contractor's reasonable control, the Contractor must notify the Contracting Officer as soon as practicable. (End of clause)

b) FAR 52.217-7, Option for Increased Quantity—Separately Priced Line Item (Mar 1989) The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within the period of performance of the contract. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree. (End of clause)

c) 52.217-9 Option to Extend the Term of the Contract The Government may extend the term of this contract by written notice to the Contractor within 15 days of contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend within the period of performance of the contract. The preliminary notice does not commit the Government to an extension. If the Government exercises this option, the extended contract shall be considered to include this option clause. The total duration of this contract, including the exercise of any options under this clause, shall not exceed 3 years. (End of clause)

TECHNICAL EVALUATION AND INSTRUCTIONS The Government will evaluate quotations or offers in accordance with RFO FAR 12.203 and award a purchase order from this solicitation to the responsible vendor whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The factors included in Attachment 5 – Evaluation Factor—shall be used to evaluate quotes: Technical capability of the item offered to meet the Government requirement; Price; and Past performance [see RFO FAR 12.203(a)(2)].

Technical Requirements Instructions 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. Please note that all proposed key personnel must be employed by the Quoter 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. Quoters 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 Instructions Quoters are required to complete Attachment 4 – Price Template. Quoters 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. Quoters 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. Quoters will note that the Government anticipates estimated 50 labor hours per year, with an option for up to an additional 50 hours per year. It should also be noted that the Government may reimburse the successful Quoter(s) for up to $2,000 in annual travel-related expenses, per consultant, that are necessary for performance of this requirement. These funds shall be provided only after it is determined there is a need for travel. Additionally, all travel requests require advance approval by the Government. If the Quoter proposes the involvement of any additional staff besides the Key Personnel, it must clearly articulate their role and why it believes additional personnel are necessary to fulfill the requirement. 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 add rows for the additional costs to the Price Template and include a Price Narrative in its response.

Salary Rate Limitation Quoters 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 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 Quoters 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.)

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

Response Format Quoter responses shall be no more than ten (10) single-sided pages in length. This page limit includes the following: Cover Page, if applicable Executive Summary, if applicable Table of Contents, if applicable Key Personnel Narrative (no more than two pages) Price Narrative, if applicable Past Performance Examples This page limit does not include: Key Personnel Resume(s) Letter(s) of Commitment Representations and Certifications Completed Price Template

Additional Required Information In addition to the previously discussed requirements, Quoters must include the following in their response: Company's Full Name and Address Unique Entity ID (UEI) Name, Telephone Number, and Email Address of Person Authorized to Provide Quote 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.

(a) Options The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. The evaluation of options does not obligate the Government to exercise the option(s).

(b) Notice of Award A written notice of award or acceptance of an offer furnished to the successful Offeror within the time for acceptance specified in the offer shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (End of provision)

Invoice Instructions The following invoice instruction is included and will be incorporated in the final award: Agency Invoicing Instructions (Attachment 6, Invoice Instructions).

(vii) Submission Deadline and Questions Quoter must submit all required materials by 1:00 PM Eastern Time on October 30, 2026, and reference solicitation number 7571PSQ00007. Responses must be submitted electronically to Michelle Cecilia, Contracting Officer, at michelle.cecilia@hhs.gov. All questions must be received by October 27, 2026, at 1:00 p.m. EST, and reference Solicitation Number 7571PSQ00007.

(viii) Additional Contract Requirements and Terms The following additional contract requirement(s) or terms and conditions, as determined by the contracting officer, are necessary for this acquisition and consistent with customary commercial practices. The associated NAICS code is 541690 and the small business size standard is $19 million.

FAR Deviation Statement “System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in this solicitation. Contracting officers will rely on representations from offers based on provisions in the solicitation. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.”

Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal/quote must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate for each labor category, breakdown and rationale for other direct costs or materials, and the total amount. The Unique Entity ID (UEI) from SAM.gov, the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM), www.sam.gov.

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