Attch 1_SOW.pdf

FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SOW) SERVICES

Senior Advisor Subject Matter Expert (SME) with Patient Advocay Expertise for the NINDS

Ultra-rare Gene-based Therapy (URGenT) Network External Oversight Committee (EOC) Subject Matter Expert (SME) Services

GENERAL INFORMATION

Title of Project:

Senior Advisor Subject Matter Expert (SME) for Ultra-rare Gene-based Therapy Network to act as External Oversight Committee (EOC) Subject Matter Expert (SME) with experience in Patient Advocacy.

Statement of Need, Purpose, and/or Objective:

The purpose of this requirement is to procure Senior Advisor 2 [subject matter expert (SME) services] in support of the National Institute of Neurological Disorders and Stroke (NINDS) Ultra-rare Gene-based Therapy (URGenT) Network to accelerate development of drugs for rare diseases. The NINDS is seeking to procure a highly experienced executive-level, drug discovery and development Senior Advisor 2 with experience in the area of Patient Advocacy to provide feedback to the NINDS program leadership and technical guidance on drug discovery and development projects within the URGenT portfolio. The Contractor will serve as a member of the URGenT External Counselor Board (ECB), which provides strategic guidance on URGenT projects and on occasion other NINDS drug discovery and development programs.

Background Information:

The URGenT Network supports the development of state-of-the-art gene-based therapies for ultra-rare neurological diseases, which affect approximately one in fifty thousand people. Altogether, around 7,000 known rare and ultra-rare diseases affect 30 million people in the US. Many are life-threatening and few have FDA-approved treatments. About 45% of rare diseases, including ultra-rare diseases, are neurological disorders, and 90% of rare childhood disorders have major neurological effects. 85% of rare and ultra-rare diseases are single gene disorders, making them excellent candidates for gene-based therapy. The URGenT program provides funding and resources to advance gene-based therapies for ultra-rare neurological diseases from late-stage pre-clinical development into clinical testing. The goals of the URGenT program are to:

1. Accelerate advancement of discoveries into the clinic.

2. Provide resources and expertise not currently available to applicants.

3. Deliver therapeutics to patients with ultra-rare neurological diseases.

4. Standardize and harmonize best practices and protocols for the development of gene-based therapies for ultra-rare diseases.

The NINDS oversees the URGenT External Counselor Board (ECB). The ECB typically convenes up to 8 times yearly via web-enabled virtual meetings and teleconference calls. Additionally, the ECB may meet once per year at NIH for a day long face-to-face meeting on an ad hoc basis. The ECB will be provided appropriate information about new projects entering URGenT program and also evaluate URGenT project specific milestones. Face-to-face meetings of the ECB will be scheduled around ECB member availability.

Period of Performance:

The required period of performance is a one-year base period and 2 subsequent Option years as follows:

Base Year: 11/06/2026 – 11/05/2027 Option Year 1: 11/06/2027 – 11/05/2028 Option Year 2: 11/06/2028 – 11/05/2029

Options to extend the term and labor hours may be requested if continued services are needed.

Place of Performance:

The primary place of performance shall be Contractor site. Conference calls and email shall be the primary mode of communication; however, the Contractor may be required to work at Government facilities in the continental United States, primarily Bethesda / Rockville, MD area.

Type of Contract Contemplated:

A Fixed Price Purchase Order with Options to Extend the Term of the Contract is contemplated.

The order shall be 100% set aside for small businesses.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

The Contractor shall provide this support while serving for URGenT ECB. The ECB may meet up to 8 times/year for approximately one - two hours and on an ad-hoc basis for milestone and/or introductory calls of URGenT projects via teleconference. ECB members may be requested to attend one on site visit to the NIH campus yearly for ECB meetings.

Specific Requirements:

The Contractor shall provide drug discovery and development Senior Advisor 2 Subject Matter Expert support services as members of URGenT ECB to NINDS Leadership programs as follows:

Provide recommendations regarding:

• advancing gene-based and transcript directed therapy-related trials,

• collaborative research among multiple institutions or teams, and

• biologic drug discovery for nervous system conditions

Advise regarding suitability and relevance of proposed URGenT program product development milestones and evaluate project progress relative to established milestones.

Analyze potential opportunities and concerns for future URGenT program projects under consideration.

Recommend potential solutions and assist in implementation of selected strategies to resolve programmatic challenges related to gene-based and/or transcript directed therapy for drug discovery and development as they arise.

Provide feedback to assist in successful work towards scientific and business goals and aspirations of program projects.

LEVEL OF EFFORT

The estimated level of effort for this requirement is one (1) contractor employees on a part-time basis.

The required level of effort varies depending on the quantity and complexity of URGenT projects at any given time. It is anticipated that a minimum of 20 hours of support is required annually.

GOVERNMENT RESPONSIBILITIES

No Government furnished property shall be provided. Project related data will be provided to the Contractor for performance of work efforts. All data provided to the Contractor must be treated as confidential and not be disclosed to any third party. The Contractor must not store, process, or transmit project related data on non-Government equipment.

Project data will be collected and stored by NINDS. NINDS will provide data as needed to the Contractor each time it requests service.

OTHER CONSIDERATIONS

Travel:

The consultant may be required to travel within the contiguous United States to provide the services described in this statement of work for the URGenT program. Travel under this requirement will NOT involve sponsored meetings and conferences which would require prior approval based on the latest HHS and NIH guidelines. Travel reimbursement will be provided for such required travel. All travel arrangements must be made in accordance with Federal Travel Regulations and must be approved by the Contracting Officer’s Representative prior to being finalized or invoiced. Contracting Officer’s Representative-authorized travel shall not exceed $1,400.00 annually. Please note that travel time may not be billed to the Government, in accordance with the Federal Travel Regulation.

Key Personnel:

The Contractor employee providing services for this effort shall be considered key personnel. Key Personnel requirements are as follows:

A PhD or MD equivalent in a Biological Science or Drug Development-related discipline, specializing in patient advocacy.

Senior director level or executive level experience in managing biotherapeutic discovery and development projects in biopharmaceutical industry or academia.

At least 10 years of executive-level experience providing product development guidance related to biopharmaceutical endeavors to government agencies, academic institutions, and/or start-up companies at the executive level. Experience must include responsibility for operations and budgets.

At least 8 years of experience directing collaborative research efforts that involves multiple institutions and/or teams

Knowledge and understanding of global regulatory regulations and guidelines.

The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 (OCT 2026) (RFO Deviation) Key Personnel as follows:

The key personnel specified in this contract are essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts, the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty (30) days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

Information Systems Security:

The following definitions and clauses are required for Information Systems Security:

1. FAR 52.240-90 (Nov 2025) (RFO Deviation) Security Prohibitions and Exclusions Representations and Certifications

2. FAR 52.240-91, (Nov 2025) (RFO Deviation) Security Prohibitions and Exclusions

3. HHSAR Clause 352.224-71 (Feb 2024) (RFO Deviation) (Section 2.A.2.e.)

4. FAR 11.002(g) (Section 2.A.7.)

5. FAR Subpart 4.205 (April 2026) (RFO Deviation) (Section 2.F)

6. FAR Subpart 52.204-9 (Section 2.F)

The Contractor must ensure that any computer system used in the course of this contract shall include the following features:

1. Any computer used in relation to this contract must be patched with most updated IT Security Patches.

2. Any Contractor computer used in relation this contract must have virus protection loaded and running with definition files that are updated on at least a daily basis.

3. Hard drives and portable media used for this contract must be encrypted using the FIPS 140-2 standard.

4. Contractors are required to take NIH Security and Privacy Training annually http://irtsectraining.nih.gov/

5. Contractors are required to sign the NIH non-disclosure agreement http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf

6. Contractors are required to report any lost or stolen NIH data to the NINDS ISSO within one hour of knowing of the lost or theft even if the data is on a Contractor furnished computer.

7. Contractors are required to adhere to the NIH IT rules of behavior which can be found at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx

8. Any computers used in reference to this contract must be assessed for vulnerabilities.

9. Any computers used in reference to this contract must be backed up on an external hard drive which is password protected.

10. Any computers used in reference to this contract must have auditing enabled such that if an incident occurred then that event could be reconstructed.

11. Any computers that are used in reference to this contract must employ at a minimum user name and password authentication or if possible two factor authentication.

12. Any computer used in relation to this contract must be password protected. All Password must meet the NIH standard such that users must choose passwords that have at least eight characters and at least three of the following types of characters:

a. capital letters

b. lower case letters

c. numeric characters

d. special characters (!@#$%^&*()_+|~-=\`{}[]:";'<>?,./)

Data Rights:

The National Institute of Neurological Disorders and Stroke (NINDS) shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations and all other deliverables. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General,” shall be incorporated into any resulting award by reference.

Section 508—Electronic and Information Technology Standards:

Section 508 of the Rehabilitation Act of 1973 requires that Federal agencies’ electronic and information technology (EIT) is accessible to people with disabilities. The Federal Acquisition Regulations (FAR) Final Rule for Section 508 (EIT Accessibility) can be found at www.section508.gov and at the Access Board’s Web site at https://www.access-board.gov/508.htm. Unless it is an “undue burden” or compliant products or services do not exist, the products must conform to Section 508. The contractor must state that they will comply with the requirements of Section 508 or cite a justifiable reason for an exception.

Confidentiality of Information:

Confidential Information means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

Confidential Information or records shall not be disclosed by the Contractor without written authorization from the Contracting Officer. Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should discuss with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

Collaboration Requirements:

It is required that all contractors involved with the NIH community work collaboratively with federal staff and other contractors towards the NIH mission and other affected organizations and follow the direction of the Contracting Officer’s Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer and creating and sharing documentation when required.

Non-Personal Service Statement

Contract employee performing services will be controlled, directed and supervised at all times by management personnel of the contractor. Actions of contractor employees may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulations

(FAR).

Deliverables

1. Meeting Notes. The Contractor shall submit written meeting notes to the COR within three

(3) business days following each scheduled EOC meeting.

2. Quarterly Report. The Contractor shall submit a quarterly report to the COR within ten (10) business days after the end of each quarter, summarizing the consultant’s feedback and recommendations provided during the reporting period. The COR will review and approve the report, or return it with comments, within ten (10) business days of receipt. If the report is returned with comments, the Contractor shall submit a revised report within five (5) business days. Invoices for each quarter shall be submitted only after the COR has approved the corresponding quarterly report; payment is contingent upon COR approval.