Attachment 5.docx

Attachment 5: FY25 BAA Volume I Technical Proposal Template Volume I Technical Proposal, content shall adhere to Page Size: 8 ½ x 11 inches; Spacing – single; Margins – 1 inch; Font – Arial; Font Size – 12. Tables, charts, references, and figures can use Font – Arial; Font Size – 10. Usage of color needs to be 508 compliant. If the submission exceeds the number of pages specified, only the pages up to the limit will be reviewed. For additional details, visit Regulatory Science Extramural Research and Development Projects | FDA.

Volume I – Technical Proposal Checklist *section included in 50-page limit ^section included in 30-page limit

A. Volume I – Technical Proposal (Fifty [50] page limit for items 4 to 11)

1. Cover page:

a. BAA number (if provided by the FDA BAA Team), Charge Area, Regulatory Science Topic Area of Interest, FDA Regulated Areas, and/or Demographic and Populations (as described in Part I of this announcement)

b. Title of proposal

c. Primary Offeror and complete list of subcontractors and/or affiliations, if applicable

d. Technical contact (name, address, phone/fax, electronic mail address)

e. Administrative and/or business contact (name, address, phone/fax, electronic mail address)

2. Official Transmittal letter: This is an official transmittal letter with authorizing official signature

3. Table of contents: An alphabetical/numerical listing of the sections within the proposal, including corresponding page numbers.

4. Executive Summary: Provide a synopsis of the proposal to include research rationale, hypotheses to be tested; short description of the research design, method, and/or approach; primary and secondary objectives; primary and secondary outcomes; duration of the proposed study; importance of the study; regulatory research impact of the proposed study as perceived by the applicant

5. Research and Development justification: Broad Agency Announcements, as described in the Federal Acquisition Regulations (FAR), may only be issued for the procurement of Research and Development (R&D). The following are FAR definitions for Basic and Applied research and Development. All acquisitions resulting from this announcement must meet one or more of the FAR definitions below. All offerors shall write a justification describing why and how the proposal being submitted falls under one or more of the definitions for basic research, applied research and development. The justification shall be no longer than one (1) page in length. Include a clear justification describing how the project falls under the FAR requirements (announcement must meet one or more of the FAR definitions for basic research ̶ See FAR 2.101(b)(2)), applied research ̶ See FAR 35.001, and development ̶ See FAR 35.001) for Research and Development work.

a. Basic research - Research directed toward increasing knowledge in science. The primary aim of basic research is a fuller knowledge or understanding of the subject under study, rather than any practical application of that knowledge (FAR 2.101(b)(2))

b. Applied research - The effort that (a) normally follows basic research, but may not be severable from the related basic research; (b) attempts to determine and exploit the potential of scientific discoveries or improvements in technology, materials, processes, methods, devices, or techniques; and (c) attempts to advance the state of the art. When being used by contractors in cost principle applications, this term does not include efforts whose principal aim is the design, development, or testing of specific items or services to be considered for sale; these efforts are within the definition of “development,” given below (FAR 35.001).

c. Development - The systematic use of scientific and technical knowledge in the design, development, testing, or evaluation of a potential new product or service (or of an improvement in an existing product or service) to meet specific performance requirements or objectives. It includes the functions of design engineering, prototyping, and engineering testing; it excludes subcontracted technical effort that is for the sole purpose of developing an additional source for an existing product and the development of a specific system or hardware procurement (See FAR 35.001).

6. Scientific and Technical Information:

a. Overview of the proposal

i. Introduction and background to discuss (with reference citations) relevant literature to address rationale for research and/or issues or controversies, concise up-to-date status of the field, relevant current context of the study and gaps in current knowledge, significance of the study.

ii. State all aims, goals, objectives, and proposed outcomes. Discuss hypothesis to be tested and/or research questions to be addressed.

iii. Degree of innovation of the approach and potential to offer a revolutionary increase in capability after implementation.

b. Research Methods and Approach: Provide clear and detailed description of overall research method, approach, and/or design, include scientific justification or rationale for the research design, method, and/or approach with reference citations, discuss the PD/PI’s preliminary studies, data, and/or experience pertinent to this proposal. Provide clear information and attach supporting material as Appendix for:

i. Proposed Population, Biospecimens, and/or data such as study population; type and source; exclusion and inclusion criteria; time points for exposure and measurements; endpoints; dosing and administration with justification; recruitment, retention, and follow-up strategies; screening procedures; details for preparation, handling, storage, accountability, formulation, packaging, storage, and/or stability.

ii. Proposed assessments, evaluations, and/or procedures such as statistical considerations (sample size and determination rationale, hypotheses, statistical analysis plan); measures for bias minimization; validation; quality control; data collection; safety assessments

iii. Proposed regulatory, operational, and/or safety considerations such as informed consent; confidentiality and privacy; safety oversight; quality assurance, control, and monitoring; specimens and/or data management (collection, storage, access, sharing, handling, disposition, record keeping); plan for seeking approvals (e.g., IRB, PRA); compliance statements (GMP, GCP, GLP)

7. Regulatory Science Impact:

a. Relevance to the BAA program regulatory research areas of interest indicated in Table 1: Explain research alignment with the priorities and relevant scientific initiatives at FDA, benefits of proposed technology and challenges.

b. Impact: Describe regulatory impact of research proposed. How does this research address an unmet need or fill a critical knowledge gap to advance FDA regulatory science? How might FDA apply the research findings towards advancement of regulatory research?

8. Resources Proposed:

a. Personnel with role, responsibilities, field of expertise, expectations, experience overview, and efforts. Provide list of key personnel. Attach resumes and CV as appendix for “Biographic sketches”

b. Licensure and agreements with sub-contractors, collaborators, and/affiliations proposed to work on the project, nature of agreements (Service Level Agreements, Letter of Intent, and/or any other formal agreements showing commitment for research participation). Provide details in appendix for “Contractual Agreements”.

c. Requirement for any regulatory or compliance approvals (IRB, PRA, MTA, etc.). Provide details in appendix for “Regulatory or Compliance Approvals”.

d. Communication management plan with ways of communication, frequency of communication, stakeholders identified for communication, extent of collaboration intended with FDA subject matter experts, research dissemination and information sharing, publications.

9. Gantt Chart, Work Breakdown Structure and Milestones: A detailed Gantt Chart with associated Work Breakdown Structure (WBS) (Level 3) and program Milestones must be provided as part of the technical submission.

10. Deliverable Schedule: A detailed description of the results and products to be delivered inclusive of the timeframe in which they will be delivered. Specific due dates for deliverables must be established at the time of award. If applicable, Offerors shall clearly identify points of severability in their proposed deliverable schedule.

11. Risk mitigation plan: Identify and list of known potential risks and a mitigation plan to address risks.

12. Security Planning: The work to be performed under this contract may involve access to sensitive program information. Therefore, the Offeror shall develop and submit a written Draft Security Plan that describes their procedures and policies to defend against theft, tampering, or destruction of product-related material, equipment, documents, information, and data. The Offeror is invited to submit a request for waiver if he or she believes the proposed work is exempt from some or all the security requirements or if the Offeror can demonstrate that commensurate protective measures have been applied that afford an equal level of protection. Requests for waivers should be submitted to the Contracting Officer, Ian Weiss at Ian.Weiss@fda.hhs.gov.

13. Intellectual Property: For issued patents or published patent applications that will be used in the performance of the contract, provide the patent number or patent application publication number, a summary of the patent or invention title, and indicate whether the Offeror is the patent or invention owner.

14. Bibliography/References: Applicants should follow scholarly practices in providing citations for source materials relied upon when preparing any section of the application.

15. Table of acronyms: Applicants should include a table for all abbreviations used in the application.

B. Volume I – Technical Proposal Appendices Appendices to Volume I shall contain supplemental data that shall accompany the technical proposal. The combined page total of Appendices in Volume I is thirty (30) pages. Note that biographical sketches/resumes, security, and statement of work are not included in this page limitation. Additional specific information to be included is referenced below. If a particular item is not relevant to the proposed effort, state that it is not applicable along with any supporting justification.

1. Biographical sketches/ Resumes/Roles and Responsibilities

a. Required: Yes

b. This Section shall contain the biographical sketches for only the key personnel from both the contractor and subcontractor(s): The Full Proposal must list the names and proposed duties of the professional personnel, consultants, and key subcontractor employees assigned to the project. Resumes shall be included in the appendices in Volume I of the Full Proposal. The resumes should contain information on education, background, recent experience, and specific or technical accomplishments as they pertain to their ability to support the objectives of this project.

c. The Offeror shall provide a list of the last three (3) related contracts of similar size and scope during the past three (3) years and all contracts currently being performed that are similar in nature to the BAA scope. Contracts listed may include those entered by the Federal Government, agencies of state and local governments and commercial concerns. Offerors may also submit past performance information regarding predecessor companies, key personnel who have relevant experience or subcontractors that will perform major or critical aspects of the requirement when such information is relevant to the proposed project. For the purposes of this BAA, a "major subcontract" is defined as a subcontract that exceeds $25,000. Include the following information for each contract or subcontract listed: 1. Name of Contracting Organization 2. Contract Number (for subcontracts, provide the prime contract number and the subcontract number) 3. Contract Type 4. Total Contract Value 5. Description of Requirement 6. Contracting Officer's Name and Telephone Number 7. Program Manager's Name and Telephone Number 8. North American Industry Classification System (NAICS) Code. The Offeror may provide information on problems encountered on the identified contracts and the Offeror's corrective actions.

2. Security

a. Required: If applicable. If not Applicable, provide justification. Provide additional information related to this section under Appendix 8.

3. Statement of Work (SOW)

a. Required: Yes

b. The SOW should clearly detail the scope and objectives of the effort and the technical approach. The SOW shall clearly identify the specific tasks/aims necessary to complete the scope and objectives of the technical approach. Not included in the 30-page limit.

c. The Offeror shall identify whether or not the proposed effort constitutes a non-severable, single, indivisible undertaking, or if the tasks/aims can be separated into severable/stand-alone deliverables (i.e. pilot study, proof of concept, “go/no-go” decision points in the research, etc.) that meet a need of the Government. If the proposal can be separated into severable deliverables, the Offeror shall identify these points of severability in their SOW and in their budget proposal (see Section C below) as options to be exercised at the discretion of the Government. For example, if Aim 1 can be completed separate and distinct from Aim 2, Aim 1 and its associated tasks shall be proposed as Base Period Tasks, and Aim 2 and its associated tasks would be identified as Option 1 Tasks. Each severable task within the proposal will have its own period of performance and may exceed 12 months if necessary.

d. It is anticipated that the proposed SOW will be incorporated as an attachment to the resultant award instrument. To that end, the proposal must include a severable, self-standing SOW, without any proprietary restrictions which can be attached to the contract award (See attachment 6).

e. The SOW must be organized by task and subtask with a detailed description of the work that will occur in each task. Tasks should have a deliverable or deliverables associated to them. Offerors must include in the SOW, standards for assessing the acceptability of any proposed deliverable.

f. Offerors are encouraged to structure their proposals with severable deliverables to the extent it is practicable with the research being proposed as doing so provides the Government with greater flexibility regarding technical needs and funding constraints. Encourage inclusion of detailed justification of costs that are tied to the milestones or deliverables (especially if a multi-year proposal).

g. See Attachment 6

4. Intellectual Property

a. Required: Yes

b. https://www.acquisition.gov/far/52.227-11; https://www.acquisition.gov/far/52.227-14; https://www.acquisition.gov/far/52.227-17

5. Contractual Agreements

a. Required: If applicable. If not Applicable, provide justification.

b. Sub-contractor agreements, letter of intent, etc.

6. Protection of Human subjects

a. Required: If applicable. If not Applicable, provide justification.

b. If Applicable, Offerors must submit confirmation of an Office for Human Research Protections (OHRP) Approved Federal-wide Assurance (FWA) as well as Approved Institutional Review Board (IRB) with proposal. Please note, the Prime contractor in any partnership must have an approved FWA and cannot rely upon the subcontractor’s FWA. http://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf

c. See Part III, Section 6 of announcement for details

7. Animal Use

a. Required: If applicable. If not Applicable, provide justification.

b. See Part III, Section 7 of announcement for details

8. Use of Select Agents

a. Required: If applicable. If not Applicable, provide justification.

b. See Part III, Section 9 of announcement for details

c. https://www.selectagents.gov/

9. Experiments relevant to the United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential Policy.

a. Required: If applicable. If not Applicable, provide justification.

b. See Part III, Section 9.1 of announcement for details c.

i. https://www.phe.gov/s3/dualuse/Pages/default.aspx

ii. https://www.whitehouse.gov/wp-content/uploads/2024/05/USG-Policy-for-Oversight-of-DURC-and-PEPP.pdf

iii. https://www.whitehouse.gov/wp-content/uploads/2024/04/Nucleic-Acid_Synthesis_Screening_Framework.pdf

10. Laboratory License Requirements

a. Required: If applicable. If not Applicable, provide justification.

b. See Part III, Section 10 of announcement for details

11. Good Laboratory Practice (GLP) Compliance

a. Required: If applicable. If not Applicable, provide justification.

12. Good Manufacturing Practice (GMP) Compliance

a. Required: If applicable. If not Applicable, provide justification.

13. Good Clinical Practice (GCP) Compliance

a. Required: If applicable. If not Applicable, provide justification.

14. Paperwork Reduction Act (PRA) (if applicable)

a. Required: If applicable. If not Applicable, provide justification.

b. Recommend inclusion of 9-12 months in the proposal timeline to account for PRA approval

c. Exemption of PRA approval is dependent on proposal's objectives and methods. PRA for each proposal will be handled on a case-by-case basis.