W911SR-22-R-CBRND BAA 11 Jun 22.pdf

ARMY CONTRACTING COMMAND-ABERDEEN PROVING GROUND

EDGEWOOD CONTRACTING DIVISION

FT. DETRICK BRANCH

BROAD AGENCY ANNOUNCEMENT (BAA)

RESEARCH AND DEVELOPMENT

IN SUPPORT OF

THE JOINT PROGRAM EXECUTIVE OFFICE FOR

CHEMICAL, BIOLOGICAL, RADIOLOGICAL AND

NUCLEAR DEFENSE (JPEO-CBRND), JOINT PROJECT

MANAGER MEDICAL (JPM MEDICAL) AND JOINT

PRODUCT LEAD ENABLING BIOTECHNOLOGIES

(JPL CBRND EB)

FOR

EFFORTS UNDER PROCUREMENT CONTRACTS,

GRANTS, COOPERATIVE AGREEMENTS, AND OTHER

TRANSACTION AGREEMENTS

CBRND-BAA-22-01

W911SR-22-R-CBRN

Table of Contents:

I. INTRODUCTION:

II. ACRONYMS / DEFINITIONS:

III. GENERAL INFORMATION:

A. AWARDS

B. CONFLICT OF INTEREST:

C. DISCLOSURE OF INFORMATION OUTSIDE THE U.S. GOVERNMENT:

D. U.S. GOVERNMENT OBLIGATION:

E. INFORMATION SERVICE:

F. PREPROPOSALS:

G. FULL PROPOSALS:

IV. APPLICATION INSTRUCTIONS:

A. GENERAL FORMATTING GUIDELINES: 17

B. CONTRACTS:

C. GRANTS, COOPERATIVE AGREEMENTS, and TECHNOLOGY INVESTMENT

AGREEMENTS (TIA):

V. EVALUATION AND SELECTION:

A. EVALUATION FACTORS:

B. SELECTION:

VI. AWARD ADMINISTRATION:

A. PAYMENT:

B. INFORMATION RELEASE:

C. FREEDOM OF INFORMATION ACT REQUESTS:

D. SITE VISITS:

E. REPORTS / MEETINGS / KNOWLEDGE DISSEMINATION:

F. AUDITS AND COST PRINCIPLES:

VII. JPMO MISSION STATEMENTS AND AREAS OF INTEREST:

A. SCOPE OF PROPOSALS SOUGHT:

B. JPMO JOINT DEPUTY PRODUCT MANAGERS, ORGANIZATIONAL MISSION

STATEMENTS AND BAA TECHNICAL POINTS OF CONTACT:

C. MISSION AREAS:

VIII. OTHER TRANSACTION AGREEMENTS…………………………………………….36

IX. ATTACHMENTS AND APPENDICES:

I. INTRODUCTION:

The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) is organized into five Joint Project Management Offices (JPMO), each responsible for specific commodity areas. General information on the JPEO-CBRND and subordinate JPMOs can be obtained from the JPEO-CBD website at http://www.jpeocbd.osd.mil/. Mission areas and technical points of contact for the product management offices are shown in Section VII of this BAA. As the purpose of this BAA is to identify the best available science in the identified areas of research interest, proposals are sought from all eligible sources as specified herein, including educational institutions, nonprofit organizations, and private industry. This Broad Agency Announcement (BAA) provides general information, proposal preparation instructions, evaluation and selection criteria, and award administration.

Offerors may submit unsolicited proposals (preproposals) for consideration under the general requirements of this BAA at any time, as long as the announcement is active, in support of research and development within the mission areas identified in Section VII of this announcement. Studies related to novel solutions and improved methods to develop medical countermeasures more rapidly and with increased efficiency through enabling technologies, life cycle bioinformatics, and improved logistics tracking are of specific interest to the Government.

This announcement will also be available on the Grants.gov web portal (http://www.grants.gov/), the Contract Opportunities section of SAM.gov website (https://sam.gov) and the JPEO-CBD website (http://www.jpeocbd.osd.mil/).

From time to time, special announcements or calls for proposals referencing this BAA may be issued for specific requirements in addition to any requirements announced in Sections VII and VIII. Additionally, the application process may be amended as other electronic application processes are implemented. All amendments to this BAA will be announced respectively. To facilitate communication on both scientific and administrative matters relating to this BAA, a single email address may be used for all communication with the Government. Please send all technical and administrative questions and inquiries to usarmy.detrick.mcs.mbx.baa@mail.mil.

Potential Offerors are encouraged to discuss their proposal ideas with the JPMO technical contacts listed in Section VII (B).

Administrative questions concerning the preparation of preproposals or proposals should be addressed to U.S. Army Contracting Command Edgewood Contracting Division/ Grants Officer. They should be emailed to usarmy.detrick.mcs.mbx.baa@mail.mil, ATTN:

CBRND BAA 22-01.

This BAA is intended to solicit pre-proposals for:

1. Procurement Contracts,: Awarded Procurement Contracts shall apply to those parts of development not related to the development of a specific system or hardware procurement based on the Technical Readiness Level limitations described herein. As to any resultant procurement contracts, this BAA is issued under the provisions of the Competition in Contracting Act of 1984 (P.L. 98-369), as implemented in the Federal Acquisition Regulation (FAR) Part 6.102 (d)(2) and in accordance with FAR 35.016(a). The purpose of Procurement Contracts for research and/or development placed under this BAA is to identify the best available science, and as such, there are no set-asides associated with any awards resulting from this BAA

2. Grants and Cooperative Agreements: Consistent with the regulatory authority in Code of Federal Regulation (CFR), Title 2.A, Chapter II, Part 200, funds may be awarded to stimulate or support a public purpose consistent with objectives to develop, approve, and field medical CBRN countermeasures and enabling biotechnologies, or, as defined in 31 U.S.C. 6305, to transfer a thing of value to a recipient to carry out a public purpose of support or stimulation authorized by a law of the United States instead of acquiring (by purchase, lease, or barter) property or services for the direct benefit or use of the United States Government. These efforts should be intended for scientific study and experimentation directed toward advancing the state-of-the- art or increasing knowledge or understanding, rather than focusing on a specific system, product, or medical countermeasure. The purpose of grants and cooperative agreements placed under this BAA is to identify the best available science, and as such, there are no set-asides associated with any awards resulting from this BAA. This BAA operates as a competitive procedure for the award of grants and cooperative agreements.

3. Other Transactions (OTs) for Research: As prescribed in 10 U.S. Code 4021, OTs for Research are non-FAR based agreements for use in carrying out basic, applied and advanced research. The intent of an OT for Research is to spur dual-use research and development (R&D) between the Government and Industry. An OT for Research requires cost sharing between the awardee and the Government, and to the maximum extent practicable, OTs for Research should not duplicate research being undertaken under other agreements, grants, or procurement contracts. OTs for Research may only be used for a research project when the use of a standard contract, grant, or cooperative agreement for such project is not feasible or appropriate.

4. Prototype Project Other Transactions (OTs): The award of Prototype OTAs shall be for the development of prototypes in accordance with 10 USC 4022 The resultant award of any OTA using the procedures of this BAA either announced in Section VII or for a requirement announced in section VIII are NOT made or issued under the provisions of the Competition in Contracting Act of 1984 (P.L. 98-369), FAR Part 6 or any other FAR based regulation.

However, solely as a matter of convenience to meet the requirement for maximum practicable competition, the mechanics of the competitive BAA process detailed in this BAA otherwise not applicable to OTAs are, as supplemented herein, adopted as the competitive procedure for entering into OTAs.

5. Technology Investment Agreements (TIAs): As prescribed in 32 CFR Part 37, TIAs are defined as a special class of assistance instruments used to support or stimulate research. A TIA may be either a kind of cooperative agreement or a type of assistance transaction other than a grant or cooperative agreement. TIAs allow for involvement of commercial firms in defense research programs and for other purposes (described in 32 CFR 37 appendix A) related to integrating the commercial and defense sectors of the nation's technology and industrial base.

A TIA may be a cooperative agreement with provisions tailored for involving commercial firms (as distinct from a cooperative agreement subject to all of the requirements in 32 CFR part 34), or another kind of assistance transaction described in 32 CFR 37 Appendix B. TIAs are more flexible than traditional Government funding instruments allowing for negotiation of provisions in areas such as audits and intellectual property rights.

6. To the maximum extent practicable, the non-Federal parties carrying out a research project under a TIA are to provide at least half of the costs of the project in accordance with 32 CFR § 37.215(b) to demonstrate its strong commitment to and self-interest in the project’s success.

7. Generally, this announcement is continuously open; preliminary proposals (preproposals) may be submitted and will be evaluated for the general requirements of this BAA at any time throughout the year. The availability of funds may limit the ability of the U.S. Government to make awards in specific areas, nevertheless preproposals are sought under this BAA announcement for areas consistent with the mission areas identified in Section VII of this announcement. Medical/EB are not interested in proposals that are based on data from experiments using specific CBRN warfare agents, not surrogates, to demonstrate safety, efficacy or mode of action. (Please note that CBRN warfare agents may not be provided by the DoD for these efforts.) We are interested in studies on new and better ways to develop medical countermeasures more rapidly and with increased efficiency through enabling technologies, life cycle bioinformatics, and improved logistics tracking.

8. JPM Medical/JPL EB are not interested in Science and Technology (S&T) basic research proposals; however, we are interested in efforts directed toward the development of enabling technologies that speed up the advanced development process leading to FDA approval of countermeasures. All developmental efforts nominated to be considered by this BAA should be evaluated against the Quality Technology Readiness Levels (Q-TRL) (Attachments 1 and 2). Typically, for advanced development, the scope of work proposed under this BAA, except as proposed under Section VIII, must be limited to TRL 4 levels described at 4-M1, 4- D1 and 4-E1 for Medical Products and 4-DAM1, 4-DAS1, 4-DCS1 for Diagnostics.

9. From time to time, special announcements or calls for proposals referencing this BAA may be issued for specific requirements in addition to any requirements announced in Sections VII and VIII. Additionally, the application process may be amended as other electronic application processes are implemented. All amendments to this BAA will be announced on the websites shown above. To facilitate communication on both scientific and administrative matters relating to this BAA, a single email address may be used for all communications.

Please send all technical and administrative questions and inquiries to usarmy.detrick.mcs.mbx.baa@mail.mil. Potential applicants are encouraged to discuss their proposal ideas with the Technical contacts listed in Section VII (B).

10. Administrative questions concerning the preparation of preproposals or proposals should be addressed to U.S. Army Contracting Command Edgewood Contracting Division. They should be emailed to usarmy.detrick.mcs.mbx.baa@mail.mil, ATTN: BAA W911SR-22-R-0001

11. Issues with submitting applications through the Grants.gov web portal should be directed to the Grants.gov help desk at 1-800-518-4726 or email support@grants.gov. The Contact Center hours of operation are Monday-Friday, 7 AM to 9 PM Eastern Standard Time. The Catalog of Federal Domestic Assistance (CFDA) can be accessed online at https://www.cfda.gov. The online CFDA provides access to a database of all Federal programs available to the grant community, including state, local and tribal Governments, academia and research institutions, commercial firms and not-for-profits. Included on the web site are contact information for the office that administers each program, instructions on how to apply for assistance, and several proposal writing guides. The CFDA number for this announcement is 12.360.

II. ACRONYMS / DEFINITIONS:

ACRONYMS:

ACC-APG-NCD

Army Contracting Command-Aberdeen Proving Ground-Edgewood Contracting Division ACO Administrative Contracting Officer

ACURO

Animal Care and Use Review Office

AAO

Administrative Agreements Officer ALINs Agreement Line Item Numbers

AOR

Authorized Organizational Representative

BAA

Broad Agency Announcement

BLA

Biologics License Application

BWA

Biological Warfare Agent

CBDP

Chemical Biological Defense Program

CBRN

Chemical, Biological, Radiological, and Nuclear

CDRL

Contract Data Requirements List

CFDA

Catalog of Federal Domestic Assistance

CFR

Code of Federal Regulations CLINs Contract Line Item Numbers cGMP Current Good Manufacturing Processes

CWA

Chemical Warfare Agent

CWBS

Contract Work Breakdown Structure

DCAA

Defense Contract Audit Agency

DCMA

Defense Contract Management Agency

DFARS

Department of Defense Federal Acquisition Regulation Supplement DoD Department of Defense D-U-N-S Data Universal Number System

JPM-EB

Joint Program Management -Enabling Biotechnologies

EPLS

Excluded Parties List System

EFT

Electronic Funds Transfer

FAR

Federal Acquisition Regulation

FDA

U.S. Food and Drug Administration

FCCM

Facilities Capital Cost of Money

FOIA

Freedom of Information Act

FY

U.S. Government Fiscal Year, which begins October 1

GCP

Good Clinical Practices

GLP

Good Laboratory Practices

HRPO

Human Research Protection Office

IMS

Integrated Master Schedule

IND

Investigational New Drug

IAE

Integrated Acquisition Environment

JPEO-CBD

Joint Program Executive Office for Chemical and Biological Defense

JPM-CBRN MEDICAL

Joint Project Management Chemical, Biological, Radioactive and Nuclear, Medical

NDA

New Drug Application

NIOSH

National Institute of Occupational Safety and Health

OMB

Office of Management and Budget

OSD

Office of the Secretary of Defense P.L.

Public Law

POC

Point of Contact

Q-TRL

Quantitative Technological Readiness Level

RDT&E

Research, Development, Test, and Evaluation

RFFP

Request for Full Proposal

RPP

Request for Project Proposal R&R Research and Related

SAM

System for Award Management

SF

Standard Form

SOW

Statement of Work

TRL

Technology Readiness Level

USC

U.S. Code

WAWF

Wide-Area Work Flow

WBS

Work Breakdown Structure

DEFINITIONS:

AGENCY: Agency means any of the military departments or defense agencies with authority to award OTAs for prototype projects.

AGREEMENTS OFFICER: An Agreements Officer has authority to enter into, administer, or terminate OTs for prototype projects and make related determinations and findings.

DEVELOPMENT: The systematic use of scientific and technical knowledge in the design, development, testing, or evaluation of potential new products, processes, or services to meet specific performance requirements or objectives. It includes the functions of design engineering, prototyping, and engineering testing. Advanced development consists of activities that plan, produce and deliver information outputs (documents, data, and records) from discovery all the way through Phase 4 post-marketing studies and surveillance.

ENABLING TECHNOLOGIES: Technologies that are not countermeasure products or systems themselves but facilitate or accelerate the development of countermeasure products or systems. Examples of enabling technologies include combinatorial chemistry, high-throughput screening, microarrays, bioinformatics and computational biology, nanotechnologies, imaging (including biosensors and biomarkers), animal models, assays, and other product development tools.

HEALTH SURVEILLANCE: The ongoing, systematic collection, analysis, and interpretation of health-related data to detect and assess CBRN warfare risks in order to plan, implement, and evaluate prevention and intervention/response programs. Included are computational models, such as expert systems and predictive models.

IMPROVED LOGISTICS TRACKING: Technologies which facilitate tracking and monitoring individual product items throughout shipping, storage, delivery to, and use by the end user (factory to foxhole). Examples include technologies which facilitate or simplify supply chain management and/or shelf life extension, such as Time Temperature Indicators (TTI), Item Unique Identification (IUID), and Radio-Frequency Identification (RFID).

JOINT PROJECT MANAGER (JPM): The designated individual with responsibility for and authority to accomplish program objectives for development, production, and sustainment to meet the user's operational needs. The JPM is accountable for credible cost, schedule, and performance reporting to the Milestone Decision Authority (MDA).

LIFE CYCLE BIOINFORMATICS: The systematic collection and analysis of data from all phases of research, development, manufacturing, and test and evaluation to enable informed decision making. Included are data obtained from preclinical studies, ensuring compliance with 21 Code of Federal Regulations (CFR) part 11.

MILESTONE DECISION AUTHORITY (MDA) (JPEO-CBD): The designated individual with overall responsibility for the Chemical and Biological Defense Program. The MDA has the authority to approve entry of an acquisition program into the next phase of the acquisition process and shall be accountable for cost, schedule, and performance reporting to higher authority, including Congressional reporting.

OTHER TRANSACTIONS FOR PROTOTYPES: The Department currently has authority under Section 4022, of title 10, U.S.C., to award “other transactions” (OTs) in certain circumstances for prototype projects that are directly relevant to enhancing the mission effectiveness of military personnel and the supporting platforms, systems, components, or materials proposed to be acquired or developed by the Department of Defense, or to improvement of platforms, systems, components, or materials in use by the Armed Forces.

"OTHER TRANSACTIONS AGREEMENTS (OTA) for prototype projects”: are acquisition instruments that generally are not subject to the federal laws and regulations governing procurement contracts. As such, they are not required to comply with the Federal Acquisition Regulation (FAR), its supplements, or laws limited in their applicability to procurement contracts. A prototype can generally be described as “a physical or virtual model used to evaluate the technical or manufacturing feasibility or military utility of a particular technology or process, concept, end item, or system.” OSD, OTA Prototype Guide. While prototype’s are not limited to FDA approved vaccines/therapeutics, a single vial/dose of FDA approved medical counter measure material (e.g., vaccine/therapeutic) is an end item that has been tested and evaluated as to feasibility (technical, manufacturability, and regulatory) and as to military utility

TECHNOLOGY INVESTMENT AGREEMENTS (TIAs): A TIA is a special type of assistance instrument used to increase involvement of commercial firms in DoD research, development and demonstration (RD&D) programs. A TIA, like a cooperative agreement, requires substantial Federal involvement in the technical or management aspects of the project. A TIA may be either a type of cooperative agreement or a type of assistance transaction other than a cooperative agreement, depending on the intellectual property provisions.

III. GENERAL INFORMATION:

A. AWARDS

1. TYPE OF AWARDS: This BAA contemplates the award of procurement Contracts, Grants, Cooperative Agreements, TIAs, and OTAs under this BAA in support of its mission to foster and/or conduct the advanced development of FDA approved medical CBRN countermeasures and to expand, and/or accelerate domestic manufacturing related to Medical Chemical and Biological Countermeasures. For awards involving research and/or development, the purpose of this BAA is to identify the best available science, and as such, there are no set-asides associated with any awards resulting from this BAA due to the impracticality of reserving discrete or severable areas/elements of development in the cited areas of interest or to inapplicability

i. Procurement Contracts: Procurement contracts will be utilized to fund development activities that, while directly supporting a U.S. Government requirement, can include basic research, applied research, advanced technology development or advanced component development and prototypes. Examples of the use of a procurement contract include a Good Laboratory Practices (GLP)-compliant animal toxicology study or a Phase 1 clinical safety study.

ii. Grants/Cooperative Agreements: Consistent with statutory authority, funds may be awarded by the requiring office to stimulate or support a public purpose consistent with the broad DoD objectives to develop, approve, and field medical CBRN countermeasures. Any of these efforts that involve research should be intended for scientific study and experimentation directed toward advancing the state-of-the- art or increasing knowledge or understanding, rather than focusing on a specific system, product, or medical countermeasure. By submitting a proposal and accepting an award, the recipient organization is certifying that the Project Manager and other investigators’ credentials have been examined and verified to ensure that the investigators are qualified to conduct the proposed study, and if applicable, to use humans or animals as research subjects in accordance with all federal and institutional guidelines and regulations. A Cooperative Agreement is used to enter into the same kind of relationship as a grant, except that substantial involvement is expected between the DoD and the recipient when carrying out the activity contemplated by the cooperative agreement. See 31 U.S.C. 6305. Cooperative Agreements awarded to expand, and/or accelerate domestic manufacturing related to Medical Chemical and Biological Countermeasures may include substantial involvement by the Federal Government in the form of coordination of a variety of factors associated with domestic manufacturing expansion (e.g., size and location of expanded manufacturing capability and future government access to the expanded capacity). The term “Cooperative Agreement” does not include “Cooperative Research and Development Agreements” as defined in 15 U.S.C. 3710a. No fee or profit to a recipient and/or subrecipient is allowed on Grants or Cooperative

Agreements awarded by the Department of Defense.

The type of instrument used to reflect the business relationship between the recipient and the U.S. Government will be determined by the Grants, Agreements, or Contracting Officer supporting the JPMO prior to award. For the purposes of this BAA, The U.S. Army Contracting Command Aberdeen Proving Ground Edgewood Contracting Division, Fort Detrick (ACC-APG Edgewood), provides contracting support and will process proposals selected for funding. Applicants may propose the type of instrument for the proposed effort. However, the applicant’s suggestion regarding suitable type of instrument does not obligate the government to employ the suggested instrument. Applicants proposing a COST type procurement contract, must have an adequate accounting system for determining costs on a government contract IAW FAR subpart 16.301-3. This is determined by the Defense Contract Audit Agency (DCAA) assigned to the applicant’s business location and may take thirty (30) to forty (40) days for completion. For OTAs, TIAs and Grants/Cooperative Agreements, the determination will be made by a warranted agreements officer.

iii. Other Transactions Agreements – Prototype: The award of Prototype OTAs shall be for the development of prototypes in accordance with Section 2371b of title 10.

U.S.C. The resultant award of any OTA using the procedures of this BAA either announced in Section VII or for a requirement announced in section VIII are NOT made or issued under the provisions of the Competition in Contracting Act of 1984 (P.L. 98-369), FAR Part 6 or any other FAR based regulation. However, solely as a matter of convenience to meet the requirement for maximum practicable competition, the mechanics of the competitive BAA process detailed in this BAA otherwise not applicable to OTAs are, as supplemented herein, adopted as the competitive procedure for entering into OTAs.

• Section VII contains areas of interest to be competed hereunder for Prototype OTA awards. Section VIII contains instructions specific to the development of, and evaluation of proposals, for prototypes.

• In general, OTA Offeror’s may submit a pre-proposal (1) qualifying under Section VII.A of this BAA for one or more of the Mission Areas or

(2) for prototype requirements identified in Section VIII or in a separate Request for Project Proposals (RPP) issued under this BAA. If two or more Prototype OTA Offerors submit for the same requirement, the field of competition will be narrowed by the evaluations called for under this BAA for pre-proposals used to conduct phased evaluations using one or more of the evaluation factors.

iv. Technology Investment Agreements: As prescribed in 32 CFR Part 37, TIAs are defined as a special class of assistance instruments used to support or stimulate research. A TIA may be either a kind of cooperative agreement or a type of assistance transaction other than a grant or cooperative agreement. TIAs allow for involvement of commercial firms in defense research programs and for other purposes (described in 32 CFR 37 appendix A) related to integrating the commercial and defense sectors of the nation's technology and industrial base. A technology investment agreement may be a cooperative agreement with provisions tailored for involving commercial firms (as distinct from a cooperative agreement subject to all of the requirements in 32 CFR part 34), or another kind of assistance transaction described in 32 CFR 37 Appendix B. TIAs are more flexible than traditional Government funding instruments allowing for negotiation of provisions in areas such as audits and intellectual property rights.

v. To the maximum extent practicable, the non-Federal parties carrying out a research project under a TIA are to provide at least half of the costs of the project in accordance with 32 CFR § 37.215(b) to demonstrate its strong commitment to and self-interest in the project's success.

2. CONTRACTOR MANPOWER REPORTING:

IAW AFARS 5137.91, all procurement contracts awarded under this BAA may include the requirement to report contract manpower in the Enterprise-wide Contractor Manpower Reporting Application (eCMRA). Contracts subject to manpower reporting will include a separate line item in Section B. Reporting period will be the period of performance not to exceed 12 months ending 30 September of each government fiscal year and must be reported by 31 October of each calendar year.

3. BASIC AWARD PROCEDURES:

i. To protect the public interest, the Federal Government ensures the integrity of

Federal programs by only conducting business with responsible recipients. The ACC-APG Edgewood Contracting Division uses the System for Award Management (SAM) to exclude recipients ineligible to receive federal awards.

ii. Applicants should meet certain minimum standards pertaining to institutional support, financial resources, prior records of performance, integrity, organization, experience, operational controls, facilities and conformance with safety and environmental statutes and regulations in accordance with CFR Title 2, Part 200 or FAR subpart 9.1.

iii. Investigators are cautioned that awards are made to organizations, not individuals. A Project Manager must submit a proposal through, and be employed by, an organization in order to receive support. Should the Project Manager of a funded project leave the recipient institution, both the Project Manager and institution must contact ACC-APG Edgewood Contracting/Grants Officer as soon as possible to discuss options for continued support of the project. Every effort should be made to notify ACC-APG Edgewood prior to the Project Manager leaving the institution. By submitting a proposal and accepting an award, the recipient organization is certifying that the Project Manager and other investigators’ credentials have been examined and verified to ensure that the investigators are qualified to conduct the proposed study, and if applicable, to use humans or animals as research subjects in accordance with all federal and institutional guidelines and regulations.

iv. Applicants located outside of the U.S. may submit in response to the BAA, however, it is the organizations’ responsibility to ensure that the project staff is able to complete the work without intercession by the DoD for a J-1 Visa Waiver on behalf of a foreign national in the United States. In addition, the U.S.

Government will not provide funds to support scientists from countries which support terrorism, or otherwise determined not acceptable.

v. Funding may be provided incrementally during the life of the award. Under cost-reimbursement type awards, payments are made in response to monthly vouchers or invoices submitted by the awardee. Grants/cooperative agreement funds are generally awarded via cost-reimbursement or periodic scheduled payments, in accordance with the negotiated payment schedule included in the award document.

vi. The primary basis for the selection of proposals is based upon evaluation of technical merit, programmatic relevance, and the availability of funds.

vii. Detailed information on proposal evaluation and selection is located in section V, “Evaluation and Selection.”

B. CONFLICT OF INTEREST:

There are certain post-employment restrictions on former Federal officers and employees as defined in 18 USC 207 and FAR 3.104-4(c). If a submitter believes a post-employment restriction or conflict of interest exists, the situation should be discussed with the JPMO legal staff (telephone 301-619-8444) prior to expending time and effort in preparation of a proposal.

C. DISCLOSURE OF INFORMATION OUTSIDE THE U.S. GOVERNMENT:

Proposals may be disclosed to U.S. Government contractor support personnel deemed subject matter experts for the sole purpose of technical and programmatic evaluation as part of the determination to fund a proposal. The Government obtains a written agreement from the contractor evaluators that information in the proposal will only be used for evaluation purposes and will not be further disclosed. Proposals for funded projects will be subject to public release under the Freedom of Information Act to the extent that they are incorporated into an award document; proposals that are not selected for funding will not be subject to public release. Any information considered proprietary or otherwise not available for disclosure to other than a warranted contracting officer should be marked accordingly.

D. U.S. GOVERNMENT OBLIGATION:

Only a warranted Contracting, Grants, or Agreements Officer may obligate the U.S.

Government to the expenditure of funds for awards under this BAA. The U.S.

Government does not fund preparation of proposals or support work efforts or tasks that are inferred from discussions with technical project officers.

E. INFORMATION SERVICE:

Applicants should use the technical reference facilities of the Defense Technical Information Center (DTIC) to acquire information of U.S. Government funded projects to avoid duplication of scientific and engineering effort. DTIC is responsible for collecting all scientific or technological observations, findings, recommendations, and results derived from Department of Defense endeavors. Requests for eligibility and registration information should be addressed to DTIC Registration, 8725 John J.

Kingman Road, Ft. Belvoir, VA 22060-6218, or may be obtained at http://www.dtic.mil/dtic.

F. PREPROPOSALS:

1. Organizations are strongly encouraged to explore the JPMO’s interests by submitting a preliminary proposal (preproposal). Preproposals may be submitted at any time describing a specific idea or project pertaining to any of the areas of interest outlined in this BAA. Preproposals should be no longer than eleven (11) pages, and include a description of the relevant technology including supporting data, the scope of the proposed effort including a high-level Work Breakdown Structure (WBS), and a description of the applicant’s research, development, manufacturing, past performance, or other special qualifications, in addition to any IP restrictions. The preproposal should include an anticipated cost for the efforts described in the preproposal. Preproposals may be submitted to the following email address:

usarmy.detrick.mcs.mbx.baa@mail.mil.

Brochures or other descriptions of general organizational or individual capabilities will not be accepted as a preproposal. All preproposals will be assigned and an email will acknowledge receipt of a preproposal. Usually, the applicant’s Project Manager should receive a decision letter or email regarding the preproposal within 60-90 days of submission.

2. In accordance with the United States Government Policy for Oversight of Life

Sciences Dual Use Research of Concern (DURC) released 29 March 2012, research being proposed which falls under the definition of DURC, “life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety agricultural crops and other plants, animals, the environment, materiel, or national security”, must be identified in the applicant’s preproposal. If a full proposal is then requested by the Government, risk mitigation of this concern shall be included as part of the Risk Management Plan of the Technical proposal section (see section V.B.3.e) of this document.

For research involving animals, the JPMO requires a second tier review for the use of animals prior to implementation. Therefore, the applicant’s Project Manager must address all pertinent issues relating to the use of animals in the proposed work effort.

The preproposal should include the required assurances, approvals, forms and description in the proposal addenda entitled “Research Involving Animals,” as specified on the Animal Care and Use Review Office (ACURO) website https://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.acuro.

Projects funded under this BAA that generate preclinical safety data intended to support a research or marketing permit for products regulated by the FDA must be in conformance with GLP. Full proposals may be submitted without protocols for animal use; however, protocols and required institution approvals must be submitted not later than 60 days after award to ensure continuation of payments. The contracting office may grant exceptions in situations where animal use is not expected to occur until after the first year of the project.

G. FULL PROPOSALS:

1. If the preproposal for a procurement contract is accepted, ACC-APG Edgewood Contracting Division will send a Request For Full Proposal (RFFP) and any additional requirements, including suggested Contract Line Item Numbers (CLINs), a Contract Data Requirements List (CDRL), clauses, terms, and conditions. Full proposals shall be submitted within 45 days after being requested. The U.S. Government reserves the right to reject submissions received more than 45 days after the request for a full proposal from the U.S. Government. Receipt of full proposals will be acknowledged by email.

2. If the preproposal for a grant/cooperative agreement is accepted, ACC-APG Edgewood Contracting Division will send a RFFP to the applicant. Full proposals for grants and cooperative agreements must be submitted through grants.gov. The forms will be available under the announcement, and, must be completed and included as part of the submission for a full proposal. Full proposals may be submitted without protocols for human and animal use. However, protocols with required institutional approvals must be submitted not later than 60 days after award to demonstrate continued progress and ensure continuation of payment. The contracting office may make exceptions in situations where human and/or animal use is not expected to begin until after the first year of the award. In such cases, a time frame for submission of the appropriate protocols should be established during discussions/negotiations, prior to award.

3. There are no specified funding limitations identified for the proposals submitted under this BAA. The applicant’s proposed budget should be commensurate with the nature and complexity of the proposed effort. An award decision should be forwarded by the U.S. Government within 180 days after submission. Be advised that at the time of publication of this BAA there are no funds identified for award, and any award(s) are predicated on the availability of funds.

4. Intructions for full proposal submissions for potential OTA’s are provided in Section VIII of this announcement.

IV. FULL PROPOSAL APPLICATION INSTRUCTIONS:

A. GENERAL FORMATTING GUIDELINES:

Unless otherwise specified, full proposal submissions shall be submitted electronically.

All applications must be clear, legible, and conform to the following general formatting guidelines:

a. Elaborate proposals with high-gloss paper, vivid colors, detailed artwork, or other embellishments are unnecessary and not desired.

b. Pages shall be 8.5 x 11 inches, single sided, with each page numbered “X of Y pages.”

c. Margins: Minimum of 1 inch on all sides.

d. Type Font: 12 point Times New Roman, single spaced.

e. Contract Work Breakdown Structure (CWBS) and Integrated Master Schedule (IMS)/Gantt Charts: The minimum CWBS expected is Level 4. The IMS shall document the critical path and predecessor tasks. In addition to a high level presentation in PDF format as part of the Program Management submission, the applicant shall submit an electronic copy with schedule data in Microsoft Project file that shows all formulas and links, compatible with MS Project 13. The files shall be virus and malware free. All passwords shall be removed.

f. Acronyms: Spell out all acronyms the first time they are used. One page of the proposal body is allocated to spell out acronyms, abbreviations and symbols.

g. Language: English.

h. Electronic file format: PDF, compatible with Adobe Acrobat Reader v. 11.0.

File size less than 20 MB.

B. SPECIFIC INSTRUCTIONS FOR CONTRACTS:

1. If a RFFP for a contract is sent to the organization submitting the preproposal, applicants shall use the following guidance as to the scope of the proposal response.

2. The applicant’s proposal shall be submitted electronically. The proposal shall conform to the general formatting guidelines, see above section (IV) (a). The proposal shall include the following sections, which shall conform to the following page limits:

a. Cover Page (1 page):

i. BAA number

ii. Name of Lead Organization submitting proposal including their Unique Entity Identifier.

iii. Type of business, selected among the following categories: “Large Business,” “Small Disadvantaged Business,” “Other Small Business,” “HBCU,” “MI,” “Other Educational,” or “Other Nonprofit”

iv. Contractor’s reference number (if any)

v. Proposal Title

vi. Technical point of contract to include: salutation, last name, first name, street address, city, state, zip code, telephone, fax (if available), and electronic mail address (if available)

vii. Administrative point of contact to include: salutation, last name, first name,

viii. Date proposal was prepared

b. Technical Section (20 pages):

i. Acronyms, Abbreviations, and Symbols

ii. Project objective. Describe what will be accomplished if the U.S.

Government funds the proposal. Describe how it fulfils an area of interest described by this BAA.

iii. Background data. Include, for example, data supporting the safety and efficacy of the proposed technology, the validity of models used to test and evaluate the technology, and Applicant compliance with GLP, current Good Manufacturing Practices (cGMP), and/or Good Clinical Practices (GCP) compliance, as appropriate.

iv. Proposed technical approach. Describe in a comprehensive manner the technical approach proposed to accomplish the project objective. Describe the proposed technical approach in sufficient detail so that the U.S.

Government may determine that the proposed approach is of acceptable risk.

c. Project Management Section (20 pages):

i. Statement of Work (SOW). The Applicant shall submit a SOW which shall describe the work to be performed by the applicant (and any subcontractors).

The final proposed SOW, when accepted by the U.S. Government, shall be incorporated into the contract or Prototype OT at the time of award. For this reason, the SOW shall be a stand-alone document. Applicants should use the

DoD Handbook for Preparation of Statement of Work (MIL-HDBK-245D) as a guide found at: https://assist.daps.dla.mil/quicksearch/

ii. CWBS and CWBS dictionary. The applicant shall submit a CWBS and CWBS dictionary using MIL-HDBK-881 as a guide (http://quicksearch.dla.mil/qsDocDetails.aspx?ident_number=36026). The minimum CWBS expected is Level 4. However, the Applicant shall extend CWBS elements as needed to obtain the depth and breadth required to define the contract scope and to accurately describe the proposed effort. The CWBS shall correlate with the SOW and CLINs. The CWBS shall conform to instructions regarding font size.

iii. IMS. The IMS shall document the critical path, major milestones, tasks/activities, duration, lead/lag/slack time, and schedule relationships. The IMS shall be directly traceable to the SOW, CLINs, and the CWBS. The IMS is intended to be used as a tool for day to day tracking of the program/project. Tasks/activities should roll-up to increasingly higher summary levels. All tasks/activities in the IMS should be logically linked together showing predecessor/successor relationships. The tasks/activities shall be sufficient to account for the entire program/project under contract.

Dates delineated in the IMS and Section F shall become contractually binding, and will be adjusted accordingly, based on actual contract award date. The applicant shall also submit an electronic copy of the schedule for submission of schedule data in “Read Only” format that shows all formulas and links for review. The data file shall be in the Microsoft Project 2013 format.

iv. Project Management Approach. The approach to managing and integrating the various aspects of the required work shall be described in sufficient detail so that the U.S. Government may assess associated risks. The applicant shall identify significant milestones, decision points, and the processes that will be used to evaluate program status and progress. The applicant shall include a description of any functional oversight. The applicant shall present mechanisms for interactions/communications between Program Management and the U.S. Government, to include how processes will be updated (e.g., managing and interfacing with key Subcontractors and the U.S.

Government). The applicant shall include a description of management relationships or techniques that will be used to supplement day-to-day processes and procedures.

v. Risk Management Plan. The Applicant shall identify potential risks and describe the implementation of an integrated and proactive risk management plan as part of an overall management scheme (e.g., risk planning, risk assessment, risk handling, risk monitoring and documentation). The risk management plan shall discuss integrated methods for identifying, analyzing, prioritizing, and tracking risk drivers and include plans for adequate resources for risk mitigation. The Applicant shall describe tools or methodologies used in the integrated risk management and risk assessment processes.

d. Past Performance Section (10 pages):

Information shall be provided for the Applicant as well as all proposed first-tier subcontractors. The Applicant shall list ongoing and previous U.S. Government contracts held during the past three years, which are relevant and demonstrate ability to perform the effort required by the proposal. The Applicant shall explain the relevance of previous efforts with respect to the effort described in the proposal. If the Applicant has limited U.S. Government contracting experience, a description of similar contracts with commercial entities, local and/or state governments should be included, if relevant. Information furnished concerning these efforts shall be similar to that requested of U.S. Government contracts. The Government may send Past Performance questionnaires to any Reference(s) listed, whether for U.S. Government contracts or for contracts with other entities.

For that reason, the applicant must provide current contact information of all References listed in this section, to include: POC name, address, phone number, fax number, email address, Unique Entity Identifier (UEI) number. Past performance information should be a separate document to allow the Government to restrict evaluation to Government personnel only.

e. Cost Section:

The Cost Proposal shall be an integrated and comprehensive estimate with descriptions of estimating techniques and allocation methods that correlate in sufficient depth with the SOO, SOW, CWBS, IMS and CLINs when applicable.

Estimating technique(s) (basis of estimate) used to create the proposal shall be clearly identified. Reasonable and supportable allocation techniques may be used to spread hours and/or cost to lower levels of the CWBS.

While it is intended that Applicants shall use their own format for providing the information requested in these instructions, failure to submit all information requested may result in rejection of a proposal. It is highly suggested that the Cost Proposal Spreadsheet be used by Applicants. The Cost Proposal Spreadsheet can be requested from the BAA POC. Instructions for completion have been embedded into the spreadsheet. Spreadsheet submission must include all formulas and be free from any protection.

Any proposed options that are identified in the Technical Proposal but are not fully priced out in the Cost Proposal Spreadsheet will not be included in any resulting contract or other transaction. If proposing options, they must be separately priced.

For proposed subcontracts, Applicants must provide a separate fully completed Cost Proposal Spreadsheet in support of the proposed costs. This spreadsheet, along with supporting documentation, must be emailed directly to the Business

Point of Contact at the same time the prime proposal is submitted. The e-mail shall identify the proposal title, the prime Applicant and that the attached proposal is a subcontract. Applicants should also familiarize themselves with the subcontract reporting requirements set forth in Federal Acquisition Regulation (FAR) clause 52.204-10, Reporting Executive Compensation and First-Tier Subcontracts Awards. Any newly awarded subcontract must be reported if the prime contract award amount was $25,000 or more.

Fee for travel, direct costs for equipment, Government entities, or cost share contracts is not allowed. In addition, fee applied to Other Direct Costs will be considered based on the application of overhead and the types/quantities of Other Direct Costs, and the Applicant’s demonstrated savings in negotiating competitive pricing.

f. Representations, Certifications, and other Statements of Applicants:

Prospective applicants shall complete electronic annual representations and certifications at SAM accessed via https://www.acquisition.gov as a part of required registration (see FAR 4.1102). Prospective applicants shall update the representations and certifications submitted to SAM as necessary, but at least annually, to ensure they are kept current, accurate, and complete. The representations and certifications are effective until one year from date of submission or update to SAM.

g. Appendices: (no page limit)

h. Key Personnel Qualifications:

The proposal shall include a Curriculum Vitae (CV) and bibliographic data for the Program Manager and other Key Personnel such as Directors (or equivalent) of Regulatory Affairs, Quality Assurance/Quality Control (QA/QC), Manufacturing, and Risk Management detailing their qualifications to perform the work. If the Applicant does not presently employ Personnel in the positions identified as Key, the Applicant must present a description of the terms of the commitment(s). The Applicant shall provide technical, regulatory, and management staffing plans, specifically addressing vacancies and maintaining Key Personnel. The Applicant shall also provide the CVs and/or resumes and list proposed duties of key subcontractor personnel and consultants (if any) who are proposed for this effort. The Applicant shall provide specific details of all assigned personnel explaining their appropriateness, scientific qualifications, depth and breadth of expertise and credentials relative to the projects. The Applicant shall describe the proposed labor hours and labor categories relating to the performance of the SOW of Key Personnel.

i. Other documentation that may be requested by the U.S. Government in the

RFFP:

Subcontracting Plans (if applicable): Pursuant to Section 8(d) of the Small Business Act (15 U.S.C. 637(d)), it is the policy of the Government to enable small business and small disadvantaged business concerns to be considered fairly as subcontractors to contractors performing work or rendering services as prime contractors or subcontractors under Government contracts, and to ensure that prime contractors and subcontractors carry out this policy.

Applicants, other than small businesses, seeking an award of greater than $700,000, who submit a contract proposal including subcontractors are required…