HR001118S0023-Amendment-02.pdf

The purpose of Amendment 2 to HR001118S0023, the Epigenetic CHaracterization and Observation (ECHO) Broad Agency Announcement, is to revise Sections 1.4, 4.2.2, and 4.3 as described below:

1.4 CONTROLLED UNCLASSIFIED INFORMATION STATEMENT

To prevent the release of sensitive technical information, certain aspects of proposals may be considered Controlled Unclassified Information (CUI) and may require safeguarding or dissemination controls, pursuant to and consistent with applicable law, regulations, and Government-wide policies.

The following applied military technical information could be considered Controlled Technical Information (CTI) by DARPA:

Potential procedure to evade ECHO Signature Panel identification: Any known techniques for rendering the exposure-specific signature undetectable.

Epigenetic Signature Variances: Any known variances between populations that could lead to bias towards race, gender, geographic region, or inherited traits that cannot be controlled through careful clinical sampling design.

Genetic or epigenetic data generated from military personnel, even if de-identified.

Any exposure-specific signatures that are deemed by DARPA to have national security relevance and DARPA reserves the right to identify such exposure-specific signatures on a case-by-base basis.

Proposals that produce any such information must deliver a detailed risk mitigation plan to DARPA (see 4.2.2. Proposal Format Section II: I). Proposers must partition potentially sensitive tasks from non-sensitive research efforts. All proposers (prime contractor and subcontractor) desiring public release of project information that may contain CTI, as defined above, must submit a request for public release to DARPA's Public Release Center (DARPA/PRC) in accordance with their contractual requirements.

4.2.2. Proposal Format

All full proposals must be in the format given below. Proposals shall consist of two volumes: 1) Volume I, Technical and Management Proposal, and 2) Volume II, Cost Proposal. All pages shall be printed on 8-1/2 by 11 inch paper with type not smaller than 12 point. Smaller font (not smaller than 9 point) may be used for figures, tables and charts. The page limitation for full proposals includes all figures, tables, and charts. Volume I, Technical and Management Proposal, may include an attached bibliography of relevant technical papers or research notes (published and unpublished), which document the technical ideas and approach upon which the proposal is based. Copies of not more than three (3) relevant papers may be included with the submission. The bibliography and attached papers are not included in the page counts given below. The submission of other supporting materials along with the proposals is strongly

HR001118S0023, ECHO

discouraged and will not be considered for review. The maximum page count for Volume 1 is 25 pages. A submission letter is optional and is not included in the page count. Volume I should include the following components:

NOTE: Non-conforming submissions that do not follow the instructions herein may be rejected without further review.

a. Volume I, Technical and Management Proposal

Section I. Administrative

A. Cover Sheet (LABELED “PROPOSAL: VOLUME I”):

1. BAA number (HR001118S0023);

2. Technical area;

3. Lead organization submitting proposal (prime contractor);

4. Type of organization, selected from among the following categories: “LARGE

BUSINESS,” “SMALL DISADVANTAGED BUSINESS,” “OTHER SMALL

BUSINESS,” “HBCU,” “MI,” “OTHER EDUCATIONAL,” OR “OTHER

NONPROFIT”;

5. Proposer’s reference number (if any);

6. Other team members (if applicable) and type of business for each;

7. Proposal title;

8. Technical point of contact (Program Manager or Principle Investigator) to include:

salutation, last name, first name, street address, city, state, zip code, telephone, fax, e-mail;

9. Administrative point of contact (Contracting Officer or Grant Officer) to include:

salutation, last name, first name, street address, city, state, zip code, telephone, fax, e-mail;

10. Award instrument requested: cost-plus-fixed-free (CPFF), cost-contract—no fee, firm-fixed-price, grant, cooperative agreement, other transaction, or other type (specify);

11. Place(s) and period(s) of performance ;

12. Proposal validity period;

13. Total funds requested from DARPA, and the amount of cost share (if any); AND

14. Date proposal was submitted.

Information on award instruments is available at http://www.darpa.mil/work-with-us/contract-management.

B. Official Transmittal Letter.

Section II. Detailed Proposal Information http://www.darpa.mil/work-with-us/contract-management http://www.darpa.mil/work-with-us/contract-management

A. Executive Summary (1-2 pages): Provide a synopsis of the proposed project, including answers to the following questions:

What is the proposed work attempting to accomplish or do?

How is it done today, and what are the limitations?

What is innovative in your approach?

What are the key technical challenges in your approach and how do you plan to overcome these?

Who or what will be affected and what will be the impact if the work is successful?

How much will it cost, and how long will it take?

B. Goals and Impact (1-2 pages): Clearly describe what the team is trying to achieve and the difference it will make (qualitatively and quantitatively) if successful. Describe the innovative aspects of the project in the context of existing capabilities and approaches, clearly delineating the uniqueness and benefits of this project in the context of the state of the art, alternative approaches, and other projects from the past and present.

Describe how the proposed project is revolutionary and how it significantly rises above the current state of the art. Describe the deliverables associated with the proposed project and any plans to commercialize the technology, transition it to a customer, or further the work.

C. Technical Plan (7-10 pages): Outline and address technical challenges inherent in the approach and possible solutions for overcoming potential problems. This section should provide appropriate measurable milestones (qualitative and quantitative) and program metrics (see Section 1.3) at intermediate stages of the program to demonstrate progress, and a plan for achieving the milestones. The technical plan should demonstrate a deep understanding of the technical challenges and present a credible (even if risky) plan to achieve the program goal. Discuss mitigation of technical risk.

The technical plan should address the TA1 and TA2 proposal content requirements detailed in Sections 1.2 and 1.3.

A complete technical plan must address the following:

Proposed (7) candidate signatures for Phase I and (14) candidate signatures for Phase II.

Please provide rationale for why all proposed exposure types are relevant to

WMD precursor or agent exposures.

Proposed human sample types (buccal, nasal, or blood); and the proposed cell types (e.g., T-cells, B-cells, keratinocytes, etc.) your team plans to use. Any animal models and tissue chip technologies that are to be supplemented should be identified as well as the cohort or vender providing the samples.

All molecular epigenetic analysis methods to be utilized in both TA1 and TA2 must be identified.

Rationale should be provided for the molecular approaches that are selected in TA1, and how they are to be evaluated for inclusion into the final signature.

generation process to maximize specificity, sensitivity, and temporal resolution.

Anticipated components or modules in the platform system and any anticipated off-the-shelf technologies

Any data from other funded or internal efforts that support your approach.

Any examples of past experience demonstrating capability of developing platform technologies

D. Management Plan (1-2 pages): Provide a summary of expertise of the team, including any subcontractors, and key personnel who will be doing the work. Resumes count against the proposal page count. Identify a principal investigator for the project.

Provide a clear description of the team’s organization including an organization chart that includes, as applicable: the programmatic relationship of team members; the unique capabilities of team members; the task responsibilities of team members, the teaming strategy among the team members; and key personnel with the amount of effort to be expended by each person during each year. Provide a detailed plan for coordination including explicit guidelines for interaction among collaborators/subcontractors of the proposed effort. Include risk management approaches. Describe any formal teaming agreements that are required to execute this program.

E. Capabilities (2-3 pages): Describe organizational experience in relevant subject area(s), existing intellectual property, specialized facilities, and any Government-furnished materials or information. Discuss any work in closely related research areas and previous accomplishments. Describe experience with the proposed exposure-specific agents or compounds.

F. Statement of Work (SOW) (2-3 pages): The SOW should provide a detailed task breakdown, citing specific tasks and their connection to the interim milestones and program metrics. Each phase of the program (Phase I base and Phase II option) should be separately defined in the SOW and each task should be identified by TA (1 or 2). The SOW must not include proprietary information.

For each task/subtask, provide:

A detailed description of the approach to be taken to accomplish each defined task/subtask.

Identification of the primary organization responsible for task execution (prime contractor, subcontractor(s), consultant(s), by name).

A measurable milestone, i.e., a deliverable, demonstration, or other event/activity that marks task completion. Include quantitative metrics.

A definition of all deliverables (e.g., data, reports, software) to be provided to the Government in support of the proposed tasks/subtasks.

G. Schedule and Milestones (1-2 pages): Provide a detailed schedule showing tasks (task name, duration, work breakdown structure element as applicable, performing organization), milestones, and the interrelationships among tasks. The task structure must be consistent with that in the SOW. Measurable milestones should be clearly articulated and defined in time relative to the start of the project.

H. Transition Plan (.5-1- page): As this program is expecting a prototype system at the end of 48 months; proposals must address plan to complete, beta-test, and market the deployable platform to the military and commercial partners. Proposals should include a rough order of magnitude of the prototype system and disposables cost. If off-the-shelf technologies were proposed, proposals should address IP licensing and associated risks.

I. CUI Risk Mitigation Plan (.5 page) (Required for proposers who anticipate generating work that may be considered CUI in accordance with Section 1.4 “Controlled Unclassified Information”): Provide a detailed plan for how the organization and its subcontractors will meet CUI safeguarding requirements. The plan should provide a detailed strategy to protect CUI without unnecessarily compartmentalizing information flow within or among performer teams. This plan must describe safeguard procedures for generating any sensitive program deliverables.

Section III. Additional Information (Note: Does not count towards page limit)

A brief bibliography of relevant technical papers and research notes (published and unpublished) which document the technical ideas upon which the proposal is based. Copies of not more than three (3) relevant papers can be included in the submission.

Sample/Data tables must be included to provide details on the following:

For human samples sourced from WRAIR or ACESO, the proposer should provide a table describing the required sample type (blood, buccal swab, etc.), exposure type, numbers, volumes, and required formats of samples (PAX tubes, etc.).

For team-sourced samples, proposers need to provide a table that includes the species (including human, mouse, etc.), sample type (blood, buccal swab, etc.), exposure type, and a justification of sample size to achieve desired statistical power.

The proposer team will need to provide data requirements for storage of molecular epigenetic datasets in the DARPA database including: storage amount per year (GB/TB), total node hours for a given computing type (CPU/HPU/CPG), software stack description and any other computing infrastructure needs.

4.3 FUNDING RESTRICTIONS

There will be limitations on direct costs of equipment purchases. These limitations include any individual piece of equipment greater than $500,000.00. DARPA is selecting performers who have a proven track record with technologies specific to this solicitation. If equipment is limited due to high internal demand, leasing and external vendors are optional solutions.