BAA_-_DSBD_and_Diving_Equipment_FY18_Encl_2_-_Full_Proposal_Format_(Final).pdf

DEEP SUBMERGENCE BIOMEDICAL

DEVELOPMENT PROGRAM

AND

DIVING EQUIPMENT

Full - Proposal Format

INSTRUCTIONS

1. PROPOSAL LENGTH – Offerors should strive to keep the length of proposals under 20 pages excluding Section G documents.

2. PROPOSAL COVER SHEET - See example on page 5.

- DATE: Date prepared.

- PROPOSAL NUMBER: Leave blank. NAVSEA 00C3 will assign this number.

- TITLE: The title of the proposal should not exceed 240 characters and spaces; it should be informative and indicative of Navy/Marine Corps relevance if possible; and it should avoid the inclusion of symbols, acronyms, and mathematical or scientific notation.

- PRINCIPAL INVESTIGATOR: Provide the name of the principal investigator, rank, corps, service, and degree(s).

- MAILING ADDRESS: Provide the mailing address of the principal investigator including laboratory, department and subdivision designations.

- E-MAIL ADDRESS: Include the E-mail address for the principal investigator.

- TELEPHONE NUMBER: Provide the telephone number of the principal investigator.

Include commercial and DSN telephone numbers for office and facsimile phones.

- BUSINESS OFFICE POINT OF CONTACT: Provide proposal business and/or financial point of contact and telephone number. This is not necessary for Navy proposals.

- GOVERNMENT AUDITOR POINT OF CONTACT: Provide government auditor (i.e., DHHS, DCAA) point of contact and telephone number. This is not necessary for Navy proposals.

- USE OF HUMAN SUBJECTS: If the work plan in any year involves using human volunteers (including human-derived materials or data that contain personal identifiers), indicate “YES” and provide the estimated number of subjects to be used and appropriate

Assurance (e.g., Navy Assurance, Federal-wide Assurance). If human subjects or personally identifiable material or data are not to be used, indicate “None”. The IRB approved protocol is required but ONLY if the proposal is accepted.

- USE OF ANIMALS: If animal work is planned, indicate “Yes” and list each animal species to be used by common name, such as mice, rats, rabbits, etc., and provide the estimated number of each species to be used. If animal work is not planned, indicate

“None”.

- INVESTIGATIONAL DRUGS, DEVICES, OR BIOLOGICS: If human volunteer studies are planned that use an investigational drug, device, or biologic, indicate “Yes” and provide the drug, device, or biologic’s name, and manufacturer or supplier. If no investigational drugs, devices, or biologics are used, indicate “None”.

- PERSONNEL/ENVIRONMENTAL HAZARDS: If the proposed studies involve any procedures, materials, chemicals, microbiological organisms, or situations that produce personnel or environmental hazards beyond potential routine laboratory exposures (and, therefore, require special precautions) indicate “Yes” and note the specific hazard. If unusual hazards are not evident, indicate “None”.

- PROPOSED BUDGET: Summarize the direct and indirect costs of the proposed research for each year of the project. Proposal submissions generally are for one to three years.

- SIGNATURES AND DATES: The cover sheet must be signed and dated by the principal investigator and also by the laboratory Commanding Officer for military laboratories.

These signatures must follow the statement:

“I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports and agreed upon products to NAVAL SEA SYSTEMS COMMAND

(NAVSEASYSCOM).

- PROPOSAL VALIDITY PERIOD: 270 days from date of Full Proposal submission

3. TABLE OF CONTENTS. - See example on page 6.

4. BODY OF PROPOSAL. The body of the proposal has the following sections.

Section A: PROJECT SUMMARY

Section B: PROJECT DESCRIPTION

Section C: LITERATURE SEARCHED

Section D: RESOURCES REQUIRED

Section E: OTHER SUPPORT

Section F: ENVIRONMENT

Section G: APPENDIX

5. ATTACHMENT 1. Cost Element Breakdown Exhibit

DATE: PROPOSAL NUMBER:

TITLE: Enhanced Submarine Escape and Rescue

PRINCIPAL INVESTIGATOR: John J. Researcher, LCDR, MSC, USN

MAILING ADDRESS: Naval Submarine Medical Research Laboratory

Biomedical Sciences Department

Box 900

Groton, CT 06349-5900

E-MAIL ADDRESS: Researcher@navy.mil

TELEPHONE NUMBER: Office: (860) 694-1234 DSN 694-1234

Facsimile: (860) 694-1111 DSN 694-1111

BUSINESS OFFICE POINT OF CONTACT:

Mrs. J. Comptroller, PHONE: (860) 694-1234, E-MAIL: compJ@contracts.com.

*To expedite contract award, please provide Tax Identification Number (TIN#), CAGE CODE, and confirm that the Central Contractor Registration (CCR) is correct and matches the information for the CAGE CODE used. www.CCR.gov

GOVERNMENT AUDITOR POINT OF CONTACT (i.e. DHHS, DCAA):

Mr. A. Careful, PHONE: (860) 694-1234, E-MAIL: careA@audit.com.

USE OF HUMAN SUBJECTS: Yes Number: 18

USE OF ANIMALS: None

INVESTIGATIONAL DRUGS, DEVICES, OR BIOLOGICS: None

PERSONNEL/ENVIRONMENTAL HAZARDS: None Hazard: NA

PROPOSED BUDGET: Year 1 Year 2 Year 3 Total

Direct Costs:

Overhead Costs:

Total Costs:

I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports and agreed upon products to NAVAL SEA SYSTEMS COMMAND

(NAVSEASYSCOM).

SIGNATURES AND DATES:

John J. Researcher Date Commanding Officer Date

Proposal Validity Period –________________(270 days from date of submission)

$0.00 $0.00 $0.00 = $0.00

$0.00 $0.00 $0.00 = $0.00

$0.00 $0.00 $0.00 = $0.00 mailto:compJ@contracts.com http://www.ccr.gov/ mailto:careA@audit.com

TABLE OF CONTENTS Page

Proposal Cover Sheet ...................................................................................... i

Table of Contents ............................................................................................ ii

Section A: PROJECT SUMMARY

Abstract

Key Personnel Summary ..............................................................................…x

Budget Summary ..............................................................................................x

Section B: PROJECT DESCRIPTION

Aims/Objectives ............................................................................................…x

Background and Significance ......................................................................…..x

Navy/Marine Corps Relevance/Operational Use Scenario ........................…...x

Preliminary Work ........................................................................................…..x

Experimental Design and Methods .............................................................…..x

Deliverables …………………………………………………………………...x

Milestones .................................................................................................……x

Research Transition Plan .................................................................................. x

Patent Disclosures and Inventions ................................................................….x

Section C: LITERATURE SEARCHED

Bibliography ....................................................................................…..............x

DTIC and Civilian Databases ...........................................................….............x

Keywords .........................................................................................….........….x

Section D: RESOURCES REQUIRED

Detailed Budget ………………… ...................................................…..............x

Equipment Purchase and Maintenance ...........................................................…x

Personnel and Organization ......................................................................…......x

Contracts, Consultants, Collaborators, Consortia ..................................….........x

Section E: OTHER SUPPORT .....................................................…….......x

Section F: ENVIRONMENT

Facilities .....................................................................................................…….x

Personnel and Environmental Hazards/Precautions ...........................….........…x

Section G: APPENDIX

Curricula Vitae (required) ........................................................................……...x

Other (optional) ............................................................................................…...x

SECTION A: PROJECT SUMMARY

ABSTRACT

- The abstract should provide a complete, succinct, and accurate description of the proposed work. It should stand-alone and be separable from the rest of the proposal. The abstract should be the only entry on page 1 of the proposal.

- Use layman’s language.

- Avoid summaries of past accomplishments and the use of the first person (I, we).

- Briefly describe:

o The problem or issue addressed by the proposal;

o The broad, long-term objective(s);

o The hypothesis(es) or specific aim(s);

o The experimental design and methods for accomplishing the goal(s) of the study

(for multi-year projects, succinctly identify what portion of the study will be completed in each year);

o The product(s) to be delivered upon completion of the R&D effort;

o The contribution of the product to science at large;

o The contribution of the product to mitigating a Navy need or deficiency.

KEY PERSONNEL SUMMARY

POSITION TITLE DEPARTMENT or

NAME, RANK/DEGREE or ROLE* ORGANIZATION**

* PI = Principal Investigator; CPI = Co-Principal Investigator (if PI is from another facility);

AI = Associate Investigator

**Indicate if any key individual is a post-doctoral fellow, an IPA, a visiting scientist, etc.

BUDGET SUMMARY*

BUDGET ITEM 1st Yr $ 2nd Yr $ 3rd Yr $ Total

Use 12-month period (FY 2014) (FY 2015) (FY 2016)

In-House Personnel (direct labor) =

Equipment and Maintenance =

Expendable Supplies =

Animal Purchase and Per Diem =

Travel (# of people –estimate # of days - how often – purpose)

Miscellaneous =

Subcontractors/Consultants =

TOTAL DIRECT COST: =

Overhead Cost: =

G&A Cost =

________Cost =

TOTAL INDIRECT COSTS =

FIXED FEE (%____) =

GRAND TOTAL =

*Attachment 1 shall be utilized to show the grand total cost build-up in unprotected Excel format with clearly visible formulas, links, and tracking information for each cell.

SECTION B: PROJECT DESCRIPTION

AIMS/OBJECTIVES

- Provide a concise statement of the problem or issue addressed by the proposal and the major objective(s) of the proposal.

- Describe the hypothesis(es) to be tested, and each specific aim of the proposal.

- Clearly define the product(s) to be delivered upon completion of the R&D effort.

BACKGROUND AND SIGNIFICANCE

- Demonstrate a comprehensive understanding of the literature by ensuring adequate citation of references regarding key scientific points (use the citation format specified in

Section C).

- Describe previous research endeavors that led to the proposed aims and scientific questions.

- Critically evaluate existing knowledge noting any major discrepancies, inaccuracies, and controversies in the literature to demonstrate your comprehensive view of the subject.

- Clearly identify knowledge gaps that the proposed effort is intended to address.

- Include specific points that demonstrate the originality and innovativeness of the proposed research.

- State the importance of the proposed work by relating the specific aims of the project to longer-term research objectives and clinical applications to which the proposed research could lead.

- Clearly indicate whether the research is likely to produce new data, techniques, concepts, products, or confirmation of an existing hypothesis(es).

NAVY/MARINE CORPS RELEVANCE/OPERATIONAL USE SCENARIO

- Describe the specific Navy/Marine Corps relevance for the proposed work or its potential product outcome.

- Discuss the technical or clinical significance of the proposed work in terms of demonstrating improvement of existing procedures or standards for specific operational scenarios, needs, or difficulties.

- Cite tasking letters or relevant requirements documents. Copies may be included in the

Appendix.

PRELIMINARY WORK

- Provide information on any preliminary, relevant studies conducted primarily by the principal investigator demonstrating the investigator’s experience and competence in the proposed area of study; preliminary study data should be discussed to demonstrate the feasibility of the proposed research effort, and the importance of the new data, concepts, or techniques evident in the preliminary studies.

- Submit any figures or diagrams depicting relevant preliminary study data, here or in the

- Include titles and complete reference citations for relevant completed work by the involved investigators directly supporting the proposed research; copies of relevant preliminary manuscripts or papers submitted for publication should be included in the

- Use this section to report any progress or accomplishments in related research previously funded by this office that may serve as support documentation for continued research funding in the new proposed area.

EXPERIMENTAL DESIGN AND METHODS

- Disciplined up-front thought should be given to planning the entire research and development effort from beginning to product delivery.

- The narrative must provide the planned experimental design for each year the proposal is to be funded. Each year’s discussion should be introduced under a heading:

- “Detailed Work Plans for Year 1”

- “Detailed Work Plans for Year 2”

- “Detailed Work Plans for Year 3”, etc.

- Describe the experimental design, methods, and procedures to be used to accomplish each specific aim of the proposed research study.

- Include the means by which the data will be collected, analyzed, and interpreted.

- Outline any new methodology to be used and its advantage over existing methodologies.

- Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the specific aims.

- In general, planned procedures should be demonstrated to be feasible, adequate, appropriate, and as innovative as possible for the proposed research.

- If the experimental design involves special protocols (involving the use of human subjects, vertebrate animals, or investigational drugs, devices, or biologics; or unusual personnel/environmental hazards), sufficient information must be included in the proposal to convince the technical reviewer of the appropriateness of the work plan.

Issues would include the kind and number of animals/volunteers, sex, weight, age range;

the need to use the specific species and alternatives considered; the statistical methods used to determine that the numbers of animals/volunteers to be used are necessary to achieve scientific validity of the data (e.g., sample and power size calculations).

DELIVERABLES

- Provide a Work Plan for each year, include a description of the deliverables, delivery dates, and form, e.g. report, prototype, etc.

MILESTONES

- Provide a milestone chart that shows quarterly milestones, for each year the proposal is to be funded. The chart should convey the flow of the work over time, showing any dependencies that exist among sub-efforts. Products projected for delivery at specific time points should be identified.

- The milestone chart should be “read along” with the work plan narratives and should reflect a level of effort consistent with the level of funding requested for each year.

- The following page shows the milestone chart format:

MILESTONE DESCRIPTION

st Yr 2 nd Yr 3 rd Year

1 2 3 4 1 2 3 4 1 2 3 4

A. Subproject A. Short Title:

1) Milestone A.1. description S C

2) Milestone A.2. description S C

3) Milestone A.3. description S C

4) etc. C

B. Subproject B. Short Title:

1) Milestone B.1. description S C

2) Milestone B.2. description S C

3) Milestone B.3. description S C

4) etc.

C. Subproject C. Short Title:

1) Milestone C.1. description S R

LEGEND: Planned Milestones S = Start C = Complete R = Report

RESEARCH TRANSITION PLAN

- New research information, technical capabilities, and preliminary products are often not optimally presented or configured as development products for transition to operational Navy and Marine Corps forces or medical support units;

therefore, describe as clearly and realistically as possible the relevant next steps that should be followed, pending successful achievement of your research aims, to proceed along a pathway for eventual research information and product transition to the operational forces.

- Describe your contact with specific Navy/Marine Corps operational units that demonstrates your ongoing awareness of operational needs and your ability to be involved in eventual transition, support, and testing of your new research information, technical capability, or developmental product in an operational environment.

PATENT DISCLOSURES AND INVENTIONS

- Describe any patent disclosures or inventions that already exist which may bear on the ultimate licensing or delivery of technology or products developed under this proposed research project in accordance with FAR 52.227-11 or

DFARS252.227-7038.

- Briefly outline any potential patent or invention opportunities that may be anticipated with successful completion of this proposed research.

SECTION C: LITERATURE SEARCHED

BIBLIOGRAPHY

- List all references cited in the proposal, in order of appearance in text. Provide the complete citation for each reference. In the body of the text use reference numbers only. Examples (in text): “Several research studies have shown that no deleterious effects from the procedures have occurred (2, 8, 17, 19).”

- Make a judicious attempt to compile a relevant and current list of literature citations; it need not be exhaustive. A complete citation for each reference is required and includes the names of all authors, the title of the article or chapter, the name of the journal or book, volume number, page number, and year of publication (and for books, the city and publisher). Use a consistent format throughout.

- Information in the body of the proposal should be appropriately referenced as in any journal article; uncited references should not be included in this section.

Example of Journal:

#. Author(s). Title. Journal, year; volume number (number):pages.

4. Cockburn WC, Drozdov SC. Poliomyelitis in the World. Military Medicine, 1970;

42(3):405-17.

Example of Book Chapter:

#. Author(s). Title. In: Editors (Eds.), Title of book, publisher’s city & state: name of publisher, year:pages.

5. Cockburn, WC. Poliomyelitis in the World. In: Poon LW (Ed.), Medicine in the

World. Washington, DC: Alcott & Barnes, 1970:215-33.

Example of Technical Report:

#. Author(s). Title, City/State: publisher; year, Report No.

3. Birney AJ, Hall MM. Early Identification of Children with Written Language

Disabilities, San Diego (CA): Naval Health Research Center, 1961, Report No.81-15.

- Be sure to cite any related work at other NAVSEA 00C funded activities or in the NAVSEA 00C contract program and to describe any links and collaborations.

DTIC AND CIVILIAN DATABASES

- Perform a Defense Technical Information Center (DTIC) search and civilian literature search (e.g., Medline) to identify any related research previously performed or ongoing within the DoD.

- Complete and include this statement: “A DTIC search(es) was performed, dated

_________. The proposed work will not result in any undue duplication of technical effort previously performed by other organizations. There were _(#)_ finds.

- If the DTIC search did find related work within the DoD, describe how the finds relate to the proposed work and why the proposed work still should be done.

- Abstracts of such finds should be included in the Appendix; if the DTIC search produced no finds, the search documents should not be submitted with the proposal, but should be retained by the investigator.

KEYWORDS

- Scientific/Technical: List approximately 10 scientific or technical keywords that best support the search for similar and related research work through standard scientific publication databases; examples: diving; submarine escape;

CO2 scrubbing; decompression sickness; bends.

SECTION D: RESOURCES REQUIRED

DETAILED BUDGET

DIRECT COST YEAR 1 (Example below for UNIVERSITY/ INSTITUTE):

Direct Labor (In-House Personnel)

PROFESSIONAL TITLE

PROPOSED

HOURLY RATE

NUMBER OF

HOURS

TOTAL LABOR

Ms. Joan E. Doe PI $58.50 678 = $39,663

Dr. Edward C. Davis, M.D. Co-PI $47.00 456 = $21,432

DIRECT LABOR = $61,095.00

Note: Full supporting rationale for the proposed estimate shall be provided for each of the cost elements (e.g. direct labor rates, indirect rates, Other Direct Costs, material/equipment, travel, etc.). Examples of supporting back up documentation may include, but not limited to the following: Forward Pricing Rate Agreement (FPRA), approved provisional billing rate letter, quotes, purchase orders, and/or historical data.

DIRECT COST YEAR 1 (Example below for FEDERAL

GOVERNMENT/MILITARY*):

Direct Labor (In-House Personnel)

PROFESSIONAL TITLE

EFFORT

(% Man-Yr)

ACCELERATED

SALARY

COST PER

YEAR

LCDR John J. Researcher, MSC, USN PI 0.5 = $0.0

Mr. John C. Doe, USN Co-PI 0.4 $95,000 = $38,000

DIRECT LABOR $95,000 = $38,000

* For those personnel who will not be paid directly via this proposal (e.g., military), enter “0” in the “Cost/Yr” columns. Accelerated Salary includes actual salary plus fringe benefits.

NOTE: OTHER DIRECT COSTS (ODC)

EQUIPMENT PURCHASE AND MAINTENANCE OR FACILITIES -

Equipment and facilities generally must be furnished by the contractor/recipient

(justifications must be provided when Government funding for such items is sought). Include a description of the proposer’s procurement method to be used

(competition, engineering estimate, market survey, etc.) which provides justification of price reasonableness.

TRAVEL – Destination, duration, number of trips, per diem, and airfare.

SUBCONTRACT - A cost proposal with the same level of detail as the proposer’s cost proposal is required to be submitted by the subcontractor. The subcontractor’s cost proposal can be provided in a sealed envelope with the proposer’s cost proposal.

CONSULTANT - Provide consultant agreement or other document that verifies the proposed loaded daily/hourly rate. Include a description of the nature and the need for any consultant’s participation. Strong justification must be provided, and consultants are to be used only under exceptional circumstances where no equivalent expertise can be found at a participating university.

OTHER DIRECT COST (ODC) YEAR 1:

(Example below)

EQUIPMENT PURCHASE AND MAINTENANCE ($): $33,000

Centrifuge $20,000

Maintenance $11,000

Describe Item $2,000

EXPENDABLE SUPPLIES ($): $0.00

Major Item Group 1 $0.00

Major Item Group 2 $0.00

ANIMAL PURCHASE AND PER DIEM ($): $0.00

Purchase 200 rats $0.00

House 25 rabbits $0.00

Describe Item $0.00

TRAVEL (include airfare, per diem, # of trips, duration) ($): $0.00

American Society Annual Meeting $0.00

Describe Item

SUBCONTRACTS/CONSULTANTS/COLLABORATORS ($): $0.00

Jackson Foundation Grant $0.00

University of Texas Contract $0.00

George Washington University IPA $0.00

MISCELLANEOUS ($): $0.00

Hyperbaric Chamber Support $0.00

Machine Shop Support $0.00

OTHER DIRECT COST = $0.00

INDIRECT COSTS YEAR 1:

(Example below)

INDIRECT CATEGORY

RATE

COST

Overhead 30% $24,000

G&A 0% $0

Material & Handling % $

TOTAL INDIRECT COSTS % $

Provide a description of the indirect costs, including which costs each of the indirect rates are applied to and describe the formulation of the percentage.

- Include a statement on the effect of a 20% increase or decrease in funding in the execution year. This section should discuss how additional funds would be used, and what additional milestones would be reached. In the case of funding cuts, list the specific milestones that would slip, and whether personnel reductions would be necessary.

YEAR TWO/ THREE

Same as above

EQUIPMENT PURCHASE and MAINTENANCE

- Provide a justification for all equipment requested and detailed information regarding competition and other purchasing details to fully describe price reasonableness.

PERSONNEL and ORGANIZATION

- Describe the research expertise and the specific research role of each investigator named in the proposed effort.

- Briefly outline the coordination plan for bringing together the various investigators from different disciplines or departments within the laboratory or from different institutions, and discuss any formal plans or arrangements that have been made for coordinating the research efforts and ensuring that appropriate time, direction, and research focus is brought to bear on the project over the projected course of the research.

CONTRACTS, CONSULTANTS, COLLABORATORS, CONSORTIA

- Describe the role and provide justification for all on-site contractors, including all on-site contract professional and support personnel requested.

- Describe the research efforts to be performed by off-site contractors in support the overall project goals.

- Describe the role of off-site co-investigators/collaborators involved in the project. Indicate if, and how, these co-investigators/collaborators will be paid from the requested funds (e.g. No Cost, Purchase Order, Contract, MIPR, etc.).

For large joint ventures between two or more organizations, provide a separate detailed budget exhibit for each organization showing the biomedical RDT&E funds specifically requested from NAVSEA 00C3 and the supporting funds requested/expected from other sponsors. Provide letter for supporting organization(s) agreeing to the joint venture.

- List any individuals, including addresses and phone numbers, expected to provide scientific consultation, outside expert advice, or other consultative support to the project.

SECTION E: OTHER SUPPORT

- Describe any current, pending, or planned research funding support that specifically contributes to the proposed research effort.

- For each item of support, list the title of the research proposal, the principal investigator, the funding amount received or anticipated, and program element/project/task numbers if available.

SECTION F: ENVIRONMENT

FACILITIES

- Describe any special facilities and equipment other than standard laboratory facilities and equipment necessary for performing the proposed research.

- Describe any equipment or facilities necessary for the research but unavailable at the in-house laboratory, and plans to meet these needs using facilities and equipment at other laboratories.

- List all performance sites for the planned research including collaborations, contracts, and sites that may be included only for animal care facilities.

PERSONNEL AND ENVIRONMENTAL HAZARDS/PRECAUTIONS

- Describe any proposed procedures, materials, chemicals, infectious organisms, or situations that produce personnel or environmental hazards beyond potential routine laboratory exposures and require special precautions.

- Describe the precautions being taken to prevent any personnel and environmental hazards that may potentially occur.

SECTION G: APPENDIX

CURRICULUM VITAE

- Include an abbreviated current curriculum vitae (no longer than 5 pages) for each principal, co-principal, or associate investigator participating in the research.

OTHER

- Include abstracts, publications, preprints, and graphic data to support preliminary research findings or related research work performed by the investigators listed in the proposal.

- Include any information or address any issues not covered in the various proposal sections that the investigators feel NAVSEA 00CM or 00C3 should be aware of during the evaluation of the proposal submission.