2ndcallappendices.doc

BAA 08-2

06 March 07

HQ AF/SGR

BAA 08-2

APPENDICES

3APPENDIX 1 – WHITE PAPER INSTRUCTIONS

3APPENDIX 2 – WHITE PAPER FORM

3APPENDIX 3—PROPOSAL INSTRUCTIONS

3A. FORMATTING

3B. TECHNICAL PROPOSAL

31.

COVER PAGE AND ABSTRACT

32. PROPOSAL TABLE OF CONTENTS.

33. STATEMENT OF WORK

34. BODY OF PROPOSAL

3C. COST PROPOSAL

3D. ADDENDA

3E. REGULATIONS AND FORMS

3APPENDIX 4--TECHNICAL PROPOSAL COVER PAGE

3APPENDIX 5 – PROPOSAL ABSTRACT

3APPENDIX 7 – DETAILED COST ESTIMATE

3APPENDIX 8 – BIOGRAPHICAL SKETCH

3APPENDIX 9 – CERTIFICATE OF ENVIRONMENTAL COMPLIANCE

3APPENDIX 10 – MONTHLY TECHNICAL PROGRESS REPORT

3APPENDIX 11 – FINAL REPORT

3APPENDIX 12 – HIPAA AGREEMENT

3APPENDIX 13—ORGANIZATIONAL CONFLICT OF INTEREST

3APPENDIX 14—PROCESS FLOW CHART

APPENDIX 1 – WHITE PAPER INSTRUCTIONS

GENERAL INFORMATION: White Papers should be in the format provided in Appendix 2 and six (6) copies and one (1) CD should be mailed to:

MSgt Barry Snyder Contracting Officer

AFDW/A7KM

5201 Leesburg Pike

STE 15001

Falls Church, VA 22041 Offerors will receive confirmation once the white paper is received and should receive a decision regarding their white paper within 30 days after close-out of the submission period.

Offerors must follow the format provided in Appendix 2 and the instructions in this Appendix (1). Failure to submit a complete White Paper will result in the White Paper not being evaluated by the Government. Any questions regarding the White Paper format should be directed to Mr. Tonico Beope via email at tonico.beople@bolling.af.mil or to MSgt Barry Snyder via email at barry.snyder@bolling.af.mil.

INSTRUCTIONS FOR COMPLETING THE WHITE PAPER FORM:

Section 1: PI Information: Provide complete information for the Principal Investigator (PI).

· Block B: Provide the highest degree held by the PI.

· Block C: Provide the name of the facility/organization the PI is associated with (educational institution or company name). Any resulting contract will be written with an organization (non-profit, educational institution, private industry, or military organization) and not an individual PI.

Section 2: Proposed Title: Provide the complete title for the proposed research.

Section 3: BAA Research Area of Interest: Refer to BAA 08-1 2nd call, general information, pages 1 through 4 for research areas of interest. Select the research area of interest which best matches your proposed research. If your proposed research matches more than one area of interest, select the area of interest that best matches your proposed research. All proposed research must match at least one of the Research Areas of Interest to be considered under this BAA. All Congressionally-directed proposals must select “Special Programs” as their area of interest, but must also meet the requirements of at least one other Research Area.

Section 4: Organization Information: Provide complete information for the facility/organization listed in Block 1C.

· Block B: Select the type of facility/organization (i.e. non-profit, educational institution, private industry, military organization). If DoD labs would like to participate, the funds will be in the form of a Military Interdepartmental Purchase Request (MIPR). Federally Funded Research and Development Centers are not eligible for awards in accordance with FAR 35.017.

· Block E: Provide the organization’s Commercial and Government Entity (CAGE) code. The CAGE Code is a five-position code that identifies contractors doing business with the Federal Government, NATO member nations, and other foreign governments. The CAGE Code is used to support a variety of mechanized systems throughout the government and provides for a standardized method of identifying a given facility at a specific location. Organizations within the U.S. can receive a CAGE code by being registered in the Central Contractor Registration (CCR) database. Organizations within the U.S. may register online at https://www.bpn.gov/ccr or can call 1-888-227-2423 for assistance. Companies outside the U.S. can obtain a CAGE code by going to http://www.dlis.dla.mil/Forms/Form_AC135.asp. Organizations must be registered in the CCR prior to any awards.

· Block F: Provide the organization’s Data Universal Numbering System (DUNS) number. The DUNS number is a unique nine-character identification number provided by Dun & Bradstreet. Organizations can obtain a DUNS number by calling 1-866-705-5711. More information is provided at http://www.ccr.gov/pdfs/DUNSGuideGovVendors.pdf.

Section 5: Description of Problem to be Studied: Provide a concise description of the problem to be studied to include the military relevance of your proposed effort.

Section 6: Significance and/or Uniqueness of the Proposed Effort: Provide assurance that this work is not being undertaken by or with another organization. Also explain the potential importance of the proposed effort to the military and/or civilian communities.

Section 7: Duration of Project to be Studied: Provide the total estimated number of years and/or months required to complete the effort. Generally proposals are awarded for one (1) to three (3) years, and in no case should the proposed period of performance exceed five (5) years. Proposed efforts less than three (3) years are acceptable.

Section 8: Estimated Total Cost of Project: Provide total estimated cost of entire project, to include break-out per year (e.g. Year 1 - $750,000; Year 2 - $1,000,000; Year 3 - $1,250,000; TOTAL - $3,000,000)

Section 9: Key Personnel: List all key personnel that will be supporting the proposed effort. Information must include individual’s name, title, role, and the percent of their time that will be spent on the effort.

(e.g., Joe Smith Microbiologist

Project Manager 100%)

Section 10: Major Equipment and Subcontracts:

· List all anticipated major equipment expected to exceed $10,000 and all subcontracts expected to exceed $100,000.

· List an estimated cost for each item listed.

Section 11: Brief Description of Animal and Human Use: Provide a brief description of any anticipated animal or human use. Institutional Review Board (IRB) approval is not required prior to submittal of your white paper. However, in accordance with Air Force Instruction 40-402 for human use and Air Force Manual 40-401 for animal use, IRB approval is required prior to any award decisions. Indicate whether your proposed protocols have been approved by an IRB, if so list the applicable IRB.

Section 12: FDA Approval: Provide a brief description of any Food and Drug Administration (FDA) approvals that are needed, and the status.

Section 13: Conclusions: Briefly provide expected outcomes or conclusions to proposed research effort.

Section 14: Brief Curriculum Vitae for PI and Key Personnel: Complete for all personnel listed in Block 9.

Section 15: List of Relevant Publications to Support Proposed Effort: List publications; do not include a copy of the actual publications. The list of publications is not included in the white paper page limit of five (5) pages.

APPENDIX 2 – WHITE PAPER FORM

AFDW and HQ AF/SG

BROAD AGENCY ANNOUNCEMENT (BAA)

Date Submitted: _____________________

1-PI Information

2- Proposed Title:

3- BAA Research Area of Interest (Check one block only)

A: HEALTH SURVEILLANCE

B: HUMAN PERFORMANCE AND SYSTEMS INTEGRATION

C: OPERATIONAL MEDICINE / INVESTIGATIONS

D: DIRECTED ENERGY

E: ADVANCED HEALTHCARE INFORMATICS

F: SPECIAL PROGRAMS

4- Organization Information

Organization POC Fax

5- Description of Problem to be Studied:

6- Significance and/or Uniqueness of the Proposed Effort:

7- Duration of Proposed Effort: years, months

8- Estimated Total Cost of the Proposed Effort: $

9- Key Personnel

(List all key personnel that will be supporting the proposed project)

Name

Title

Role

% of Efforts

10- Anticipated Major Capital Equipment Exceeding $10K and Anticipated Subcontracts Exceeding $100K

Estimated Cost of Each Item (required)

11- Brief Description of Animal and Human Use, if applicable

12 – Brief Description of FDA Approval Status, if applicable

13- Conclusions

14- Brief Curriculum Vitae for PI and Key Personnel (Complete for all personnel listed in Section 9)

15- List Titles of Relevant Publications to Support Proposed Effort (do not include a copy of publications. List of publication is not included in the page limit)

APPENDIX 3—PROPOSAL INSTRUCTIONS

Link to instructions:

A.

FORMATTING

B.

TECHNICAL PROPOSAL

C. COST PROPOSAL

D. ADDENDA

E. REGULATIONS AND FORMS

A. FORMATTING

Full proposals should be submitted within 30 days after requested, unless otherwise instructed and an award decision should be rendered by the Government within 90 days after proposal submission. Forms and information supporting the submission of a full proposal are included in the BAA Appendices.

Six (6) copies of both the Technical and Cost proposals must be submitted via post mail. The proposals shall be sent to:

MSgt Barry Snyder Contracting Officer

AFDW/A7KM

5201 Leesburg Pike

Suite 1500 Falls Church, VA 22041

The proposal must be clear and legible, and conform to the following guidelines:

1. Type Font: 12 point.

2. Spacing: Single-spaced between lines of text, no more than five lines of type within a vertical inch.

3. Margins: Minimum of 0.5-inch top, bottom, right, and 1-inch left.

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

5. Language: English.

6. Print Area: 7.0 x 10.0 inches (approximately 18 cm x 25.5 cm).

7. Page Limitation: Body of proposal shall be no more than 20 pages. Total document shall be no more than 100 pages.

B. TECHNICAL PROPOSAL

1.

COVER PAGE AND ABSTRACT

Each proposal must include a completed Research Proposal Cover Page (Appendix 4) and Abstract (Appendix 5). These completed forms must be included with the proposal so the Cover Page and Abstract are foremost, as indicated in the Table of Contents (Appendix 6).

a.

The Research Proposal Cover Page has been designed to request information that is not required on other forms. A block for identifying the Area of Interest (i.e. Military Operational Medicine) has been added to facilitate processing proposals.

b.

The abstract is vitally important to both the peer and programmatic review process. The programmatic review includes an evaluation of the abstract as part of the peer review summary statement; therefore, it is paramount that the investigator submits an abstract that fully describes the proposed work. The abstract must contain the title of the proposal and the name of the PI. Do not include figures or tables in the abstract. Spell out all Greek or other non-English letters. Abstracts of all funded proposals may be posted; therefore, proprietary or confidential information should not be included in the abstract.

The structured technical abstract should provide a clear and concise overview of the proposed work, including the background, objective/hypothesis and its supporting rationale, significance of the proposed work to the program’s goals, specific aims of the study, and the study design.

An outline is provided below for preparing the structured technical abstract.

(1) Background: Provide a brief statement of the ideas and reasoning behind the proposed work.

(2) Objective/Hypothesis: State the objective/hypothesis to be tested. Provide evidence or rationale that supports the objective/hypothesis.

(3) Specific Aims: State concisely the specific aims of the study.

(4) Study Design: Briefly describe the study design.

(5) Relevance: Provide a brief statement explaining the potential relevance of the proposed work to the specific topic area being addressed and its impact on health outcomes.

2. PROPOSAL TABLE OF CONTENTS.

A table of contents (Appendix 6) should be included to show location of:

a.

Technical Proposal b.

Cost Proposal c.

Addenda

3. STATEMENT OF WORK

The STATEMENT OF WORK (SOW) is the section of a research award that outlines and establishes the PI and an organization’s performance expectations for which HQ AF/SGR may provide support. The contract SOW sets rather specific goals and conditions for each year of the contracted project. The PI and contractor are expected to meet the provisions and milestones of the SOW. (The SOW shall be incorporated into the award document and, as such, is subject to release under FOIA.)

A series of relatively short statements should be included which comprise the approach to each of the major goals or objectives of the proposed research. The statements should outline the specific tasks, systems, and materials that are reasonable estimates for testing the proposed hypotheses of the study. An outline should be included which shows the work statements, timelines, and milestones to be accomplished in each year of the award. The SOW shall not exceed ten pages of single-spaced typing, and must include a completed milestone and deliverable table, similar to the example below:

4. BODY OF PROPOSAL

A detailed description of the research to be undertaken should be submitted. This will include background, hypothesis, objectives, approach, methods, and their relationship to the state of knowledge in the field and to comparable work in progress elsewhere. This information shall not exceed 20 pages. Pages exceeding the 20 page limitation will not be reviewed. Evaluation of the proposed research will be influenced by the adequacy of this information. Literature references and curriculum vitae will be shown in separate addenda entries. The following general outline should be followed:

a.

Background. Provide a brief statement of ideas and reasoning behind the proposed study. Describe previous experience most pertinent to this proposal. Cite relevant literature references.

b.

Hypothesis. State the hypothesis to be tested and the expected results.

c.

Technical Objectives. State concisely the question to be answered by each research objective.

d.

Project Milestones. Identify time-lines for critical events that must be accomplished in order for the project to be successful in terms of cost, schedule, and performance.

e.

Military Significance. State precisely the estimates as to the immediate and/or long-range usefulness of this study to the Armed Forces, as distinguished from general advancement of knowledge in medicine.

f.

Public Purpose. If appropriate, provide a concise, detailed description of how this research project will benefit the general public.

g.

Methods. Give details about the experimental design and methodology. If the methodology is new or unusual, describe in sufficient detail for evaluation. For example, for synthetic chemistry proposals include a clear statement of the rationale for the proposed syntheses. Outline and document the routes to the syntheses.

h.

Principal Investigator's Qualifications. By submitting a proposal and accepting an award, the organization is certifying that the PI's credentials have been examined and is verifying that the PI is qualified to conduct the proposed study and to use humans or animals as research subjects, if proposed.

C. COST PROPOSAL

1.

DETAILED COST ESTIMATE

An estimate of the total research project cost, with a breakdown of direct and indirect costs by category and year, must accompany each formal proposal (Appendix 7). All costs must be entered in U.S. dollars. Recipients performing outside of the U.S. should include the cost in local currency, the rate used for converting to U.S dollars, and justification/basis for the conversion rate used. Multiple year proposals shall cover the total estimated duration of the project. Incremental funds may be provided by HQ AF/SGR for effort performed during each Government fiscal year. Costs proposed must conform to the following regulations and principles:

a. Commercial Firms: Federal Acquisition Regulations (FAR) Part 31 and Defense FAR Supplement Part 31, (http://farsite.hill.af.mil) Contract Cost Principles and Procedures.

b. Educational Institutions: OMB Circular A-21, Cost Principles for Educational Institutions.

c. Nonprofit Organizations: OMB Circular A-122, Cost Principles for Nonprofit Organizations. OMB Circular A-133, Audits of Institutions of Higher Education and Other Nonprofit Organizations.

d. State, Local, and Tribal Governments: OMB Circular A-87, Cost Principles for State, Local and Indian Tribal Governments.

The cost of preparing proposals in response to this BAA is not considered an allowable direct charge to any resultant contract, grant, or cooperative agreement. It is, however, an allowable expense to the bid and proposal indirect cost specified in FAR 31.205-18, and OMB Circulars A-21 and A-122.

2.

COST JUSTIFICATION

Organizations must provide sufficient detail and justification so that the Government can determine the proposed costs to be allocable and reasonable for the proposed research effort. Clearly justify the need and cost for each item in the budget under the “Cost Justification” section of the Cost Proposal. Failure to provide this information will result in the proposal not being evaluated. Address the need for personnel requiring background investigations and/or security clearances, as required.

a.

Personnel:

(1) Name: Starting with the PI, list the names of all participants who will be involved in the project during the proposed budget period, regardless of whether salaries are requested. Include all collaborating investigators, research associates, individuals in training, and support staff.

(2) Role on Project: Identify the role of each individual listed on the project. Describe each individual’s specific functions as related to this proposal in the “Justification” section of the Detailed Cost Estimate form.

(3) Type of Appointment (Months): List the number of months per year reflected in an individual’s contractual appointment with the applicant organization for this proposed effort. The DoD staff assumes that appointments at the applicant organization are full time for each individual. If an appointment is less than full time, e.g., 50%, note this with an asterisk (*) and provide a full explanation in the “Justification” section of the Detailed Cost Estimate form. Individuals may have split appointments (e.g., for an academic period and a summer period). For each type of appointment, identify and enter the number of months on separate lines.

(4) Annual Base Salary: Enter the annual base salary for each individual listed for the project. The basis for labor costs should be predicated upon actual labor rates or salaries. Budget estimates may be adjusted upward to forecast salary or wage cost-of-living increases that will occur during the period-of-performance. The proposal should separately identify and explain the ratio applied to base salary/wage for cost-of-living adjustments and merit increases. NOTE: Annual base salary should not include vacation/holidays/sick if this is included with fringe benefits.

(5) Percentage of Effort on Project: The qualifications of the PI and the amount of time that they and other professional personnel will devote to the research are important factors in selecting research proposals for funding. For each key staff member identified on the budget form, list the percentage of each appointment to be spent on this project.

(6) Salaries Requested: Enter the salaries in whole dollar figures for each position for which funds are requested. The salary requested is calculated by multiplying an individual’s base salary by the percentage of effort on the project. This number will normally equal the Annual Base Salary x Percentage Effort on Project.

(7) Fringe Benefits: Fringe benefits may be requested in accordance with institutional guidelines for each position, provided the costs are treated consistently by the applicant organization for all sponsors. Provide documentation to support the fringe benefits in the “Justification” section of the Detailed Cost Estimate form.

(8) Totals: Calculate the totals for each position and enter these as subtotals in the columns indicated. This number should be the total of the Annual Base Salary x Percentage of Effort + Fringe Benefits.

b.

Consultant Costs: Regardless of whether funds are requested, provide the names and organizational affiliations of all consultants. In the “Justification” section of the Detailed Cost Estimate form, state the daily consultant fee, estimated travel expenses, nature of the consulting effort, and why consultants are required for the proposed effort.

c.

Major Equipment:

(1) It is the policy of the DoD that all commercial and non-profit recipients provide the equipment needed to support proposed research. In those rare cases where specific additional equipment is approved for commercial and non-profit organizations, such approved cost elements shall be separately negotiated.

(2) Normally title to equipment or other property purchased with contract funds vests with nonprofit institutions of higher education or with nonprofit research organizations if vesting will facilitate scientific research performed for the Government. Commercial organizations are expected to possess the necessary plant and equipment to conduct the proposed research and therefore equipment and other property purchased with contract funds will vest with the government at the end of the research effort. Deviations shall be made on a case-by-case basis.

(3) An itemized list of permanent equipment required to be purchased in support of this effort is required, showing the cost for each item. Permanent equipment is any article of nonexpendable tangible property having a useful life of more than two years and an acquisition cost of $10,000 or more per unit. The basis for the cost of each item of permanent equipment included in the budget must be disclosed.

a. Vendor Quote: Show name of vendor and number of quotes received and justification if intended award is to other than the lowest bidder.

b. Historical Cost: Identify vendor, date of purchase, and whether or not the cost represented lowest bid.

c. Estimate: Include rationale for estimate and reasons for not soliciting current quotes.

d. Special test equipment to be fabricated by the contractor for specific research purposes and its cost.

e. Standard equipment to be acquired and modified to meet specific requirements, including acquisition and modification costs, listed separately.

f. Existing equipment to be modified to meet specific research requirements, including modification costs. Do not include as special test equipment those items of equipment that, if purchased by the contractor with contractor funds, would be capitalized for Federal income tax purposes.

g. Unless stated otherwise in the award document, title of equipment or other tangible property purchased with Government funds shall belong to the Government and disposition shall be the Government’s responsibility at the completion of the contract period of performance. Commercial organizations are expected to possess the necessary plant and equipment to conduct the proposed research. Equipment purchases for commercial organizations will be supported only in exceptional circumstances.

d.

Materials, Supplies, and Consumables: A general description and total estimated cost of expendable equipment and supplies are required. Itemize supplies in separate categories (e.g., glassware, chemicals, and radioisotopes). Categories in amounts less than $1,000 do not need to be itemized. If animals are to be purchased, state the species, strain (if applicable), and the number to be used. If human cell lines are to be purchased, state the source and the description.

e.

Travel Costs: List the number of trips, name(s) of traveler(s), destinations, and the purpose for all proposed travel annually. Estimate round trip fare and use approved per diem rates for each trip. Travel to scientific meetings requires identification of the specific meeting and purpose. Usually, no more than one trip to a scientific meeting for one person (usually the PI) is funded. Offeror is expected to follow the defense travel regulations for transportation and per diem (lodging, meals, and incidental expenses). Use the travel expense spreadsheet to calculate the travel expenses and include the spreadsheet as part of the proposal submission. The spreadsheet will be supplied to the offeror at the time of request for full proposal.

f.

Research-Related Subject Costs: Itemize costs of subject participation in the research study. These costs are strictly limited to expenses specifically associated with the proposed study. The HQ AF/SGR will not provide funds for ongoing medical care costs that are not related to a subject’s participation in the research study.

g.

Other Direct Cost: Itemize other anticipated direct costs such as publication and report costs, rental for computers and other equipment (provide hours and rates), and communication costs. Unusual or expensive items over $1,000 should be fully explained and justified. Estimate the costs of publishing and reporting research results, including direct charges for clerical preparation, illustrations, reprints and distribution, and conference fees.

h.

Subcontracting Costs: A description of services or materials that are to be awarded by subcontract is required. The following information must be provided on subawards totaling $100,000 or more:

(1) Identification of the type of award to be used (e.g., cost reimbursement, fixed price);

(2) Identification of the proposed subcontractor, if known, and an explanation of why and how the subcontractor was selected or will be selected;

(3) Whether the award will be competitive and, if noncompetitive, rationale to justify the absence of competition;

(4) The proposed acquisition price; and

(5) The offeror's cost or price analysis for the subcontract proposed price (applicable only if the award exceeds $550,000).

If the resultant award is a contract that exceeds $100,000 and the offeror is a large business or an educational institution (other than Historical Black Colleges and Universities (HBCU), the contractor is required to submit a subcontracting plan for small business and small disadvantaged business concerns, in accordance with FAR 19.7. A mutually agreeable plan will be incorporated as part of the resultant contract.

i.

Indirect Costs (overhead, general and administrative, and other): The most recent rates, dates of negotiation, base(s) and periods to which the rates apply should be disclosed along with a statement identifying whether the proposed rates are provisional or fixed. A copy of the negotiated rate agreement should be provided with the proposal. If negotiated forecast rates do not exist, provide sufficient detail regarding a determination that the costs included in the forecast rate are allocable according to applicable FAR/DFARS or OMB Circular provisions (see above). Commercial firms can also visit www.dcaa.mil for additional information on indirect rates. Disclosure should be sufficient to permit a full understanding of the content of the rate(s) and how it was established.

At a minimum, submission should identify:

(1) All individual cost elements included in the forecast rate(s);

(2) The basis used to prorate indirect expenses to cost pools, if any;

(3) How the rate(s) was calculated; and

(4) The distribution basis of the developed rate(s).

j.

Total Costs for the Entire Proposed Period of Support (second page of the Detailed Cost Estimate form): Enter the totals under each budget category for all additional years of support requested and itemize these totals in the “Justification” section of the Detailed Cost Estimate form. Note with an asterisk (*) and explain any significant increases or decreases from the initial year budget. All amounts should be in U.S. dollars. Total costs for the entire proposed period of support should equal the amount entered on the Proposal Cover Page.

k.

Fixed Fee: Any fixed fee applied to the research project must be listed and a claimed Facilities Capital Cost of Money submitted with the full proposal supported by DD Form 1861 www.dtic.mil/whs/directives/infomgt/forms/ddforms1500-1999.htm.

D. ADDENDA

Include items appropriate to the proposal. Incomplete proposals will significantly delay both the review and any subsequent actions in processing the award.

1.

Acronyms and Symbol Definition. Provide a glossary of acronyms and symbols that might not be familiar to reviewers who are not current in the proposal and research area.

2.

Bibliography. List the references in the order they appear in the proposal narrative. Use a reference format, which gives the title of the citation. Do not send or attach copies of articles in print.

3.

Biographical Sketch (Appendix 8). Provide a biographical sketch for key personnel involved with the project and limited to three pages each.

a. Principal Investigator and senior investigators. The qualifications of the PI and other senior professional key personnel are important factors affecting the selection of research proposals. Contracts, grants, and cooperative agreements may be terminated when the PI severs connections with the organization or is unable to continue active participation in the research.

b. Other Personnel. List the names, titles, and participation of other scientific and technical personnel who will be directly associated with the project.

4.

Existing/Pending Support. List the title, time commitments, supporting agency, and level of funding for all existing and pending research projects involving the PI and key personnel. Provide justification for HQ AF/SGR support and interest where the projects overlap or parallel. In order to enable a proper determination of the offeror's past performance, either for use in a technical evaluation or for determination of the necessary level of preaward survey, it is requested that synopsis of awards be prepared on similar or related effort for the past three years, including:

a.

Specifics on each award, including types and dates of performance;

b.

The name and address of the Procuring Contracting/Grants Officer; and c.

The negotiated price, and the final cost to the Government, with reasons for any variance.

5.

Collaboration and Joint Sponsorship. Provide letter(s) supporting stated collaborative efforts that are provided at no cost, but which are necessary for the project's success. Describe present or prospective joint sponsorship of any portion of the program outlined in the proposal. In the absence of agreements among sponsors for joint support, the proposal should be structured so that the research can be carried out without the resources of any other sponsor. If, however, it is desirable to request partial support from another agency, the proposed plan should be stated and the reasons documented. If the plan cannot be formulated at the time the proposal is submitted, information should be sent later as an addendum to the proposal. Prior approval from both agencies must be secured for research to be undertaken under joint sponsorship.

6.

Facilities/Equipment Description. Describe the facilities available for performance of the proposed request and any additional facilities or equipment proposed for acquisition at no cost to HQ AF/SGR. Indicate if Government-owned facility or equipment is proposed for use and if the company or the government will retain title to equipment, software, or other purchased items at the end of the contract period. Reference should be made to the original or present contract under which the facilities or equipment items are now accountable. For work to be performed in any facility other than vendor facility, acknowledge facility safety and environmental rules for that facility.

7.

Certificate of Environmental Compliance. Information regarding environmental compliance must be provided with the full proposal (Appendix 9).

8.

Research Involving Human Subjects. The PI must address all pertinent issues relating to the use of human subjects in the proposed research. Include the required approvals, forms, and information required by Air Force Instruction (AFI) 40-402, Research Involving Human Subjects In Biomedical and Behavioral Research. The contracting office may grant exceptions in situations where human use is not expected to occur until after the first year of the research project. In such cases, a time frame for submission of the appropriate protocols should be established during discussion/negotiations. If human subjects and/or anatomical substances are not proposed, then so state.

9.

Research Involving Animals. The PI must address all pertinent issues relating to the use of animals in the proposed research. Include the required assurances, approvals, forms, and description in the proposal required by Air Force Manual (AFMAN) 40-401, The Care and Use of Animals in Laboratory DoD Programs. The contracting officer may grant exceptions in situations where animal use is not expected to occur until after the first year of the research project. In such cases, a time frame for submission of the appropriate protocols should be established during discussion/negotiations. If animal research is not proposed, then so state.

10.

FDA Status. If the offeror is developing a medical product that requires FDA approval, they must address and adhere to all appropriate FDA laws, regulations, and guidance, consistent with the development of the proposed medical product, e.g. drug, medical device, biologic, or combination product. Address adherence in this addendum.

For appropriate medical products, the offeror/vendor/sponsor shall describe how they will achieve the necessary regulatory approvals, such as medical device 510(k)s, Pre Market Approvals (PMAs), New Drug Applications (NDAs), Biologic product licenses, Combination Product Approvals, CLIA waiver, etc.

11.

Facility Safety Plan. As appropriate for research proposed and in compliance with the Federal and State Laws. (This should not be longer than three pages, does not apply to strictly office environments.)

12.

Monthly Technical Report. The recipient shall submit a Monthly Technical Progress Report covering work accomplished during each calendar month of performance. It shall be brief, factual, and informal, and shall be prepared in accordance with Appendix 10.

13. Final Report. The recipient shall submit a Final Report at the end of the Period of Performance summarizing the entire research effort, citing data in the annual reports (if any) and appended publications, and providing a complete reporting of the research findings in accordance with Appendix 11.

13.

HIPAA Agreement. The offeror must comply with the provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 45 C.F.R. 164-504(e), and to sign a Business Associate Agreement at Appendix 12. If access to government Protected Health Information (PHI), as defined by HIPAA, is not required then so state. If PHI from some other participant is required, then negotiate the HIPAA agreement with that organization. Onsite personnel will be required to show proof of HIPAA training.

14.

Representations and Certifications. The form is located at http://orca.bpn.gov. Online Representations and Certifications Application (ORCA) is an e-Government initiative that was designed by the Integrated Acquisition Environment (IAE) to replace the paper based Representations and Certifications process.

15.

Multimedia Objects, Photographs, Illustrations, Graphs, etc. Proposals may include color, high resolution, or multimedia objects (e.g., MPEG, WAV, or AVI files) embedded in the PDF files; however, these objects must not exceed 15 seconds in length and a size of 10 megabytes (MB). Since some reviewers work from black and white printed copies, applicants may wish to include text in the proposal directing the reviewer to the electronic file for parts of the proposal that may be difficult to interpret when printed in black and white. Photographs and illustrations, graphs etc. must be submitted in Microsoft Office or JPEG format only (no bitmaps or TIFF).

16.

Other. Include in this section, any other documentation not specified elsewhere, that supports the research proposed and could influence the evaluation and selection process.

E. REGULATIONS AND FORMS

1.

Copies of the Federal Acquisition Regulation (FAR) and Defense FAR Supplement referenced in this BAA may be purchased from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 or located at website http://farsite.hill.af.mil.

2.

Office of Management and Budget Circulars referenced in this BAA may be obtained from:

EOP Publication Office

Telephone: 202-395-7332

New Executive Office Building Website www.whitehouse.gov/omb/index.html

725 17th Street, NW, Room 2200

Washington DC 20503

3.

Code of Federal Regulations can be found at www.gpoaccess.gov/cfr.

APPENDIX 4--TECHNICAL PROPOSAL COVER PAGE

PROPOSAL COVER PAGE

1.

Log No.:

Date Submitted___________

2.

Name and Address of Offeror:

3. Proposal Title:

4. BAA Area(s) of Interest or Title of BAA Supplement

5. Total estimated Cost:

6.

Proposed Start Date:

7. Proposed Duration

8. Proposal Valid Until:

9. Principal Investigator’s Organization:

10.

Principal Investigator’s Name and Address:

11.

Admin. Representative Name and Address:

Email:

Email:

Phone No.:

Phone No.:

Fax No:

Fax No:

12. Alternate’s Name:

13. Alternate’s Name:

Alternate’s Phone No:

Alternate’s Phone No:

Alternate’s Email:

Alternate’s Email:

14.

Authorized Representative:

Typed Name:

Signature:

Title:

Date Signed:

NOTHING ON THIS PAGE IS PROPRIETARY INFORMATION

APPENDIX 5 – PROPOSAL ABSTRACT

A completed Abstract must be the second page of each copy of the proposal. A sample technical abstract follows at the end of this section.

The Abstract must include the information listed below. A suggested format is also provided.

1.

Proposal Title (120 characters maximum).

2.

Keywords (6-8 words).

3.

Abstract (approximately 200 words).

NOTHING ON THIS PAGE IS PROPRIETARY INFORMATION

SAMPLE

Technical Abstract:

Blood-Brain Barrier Transport of Uranium

Background: Recent studies of Gulf War veterans with depleted uranium (DU) embedded fragments in their soft tissues point to DU-induced effects on neurobehavioral and cognitive function (McDiarid et al., 2000). These observations are corroborated by electrophysiological changes in hippocampal slices isolated from rats embedded with DU fragments (Pellmar et al., 1999a; Pellmar et al., 1999b). Notably studies from the same group also suggest, for the first time, that uranium accumulates within brain tissue (Pellmar et al., 1999a). It is presently unknown how uranium is transported into the brain, and there are no pharmacological modalities to reduce its accumulation within the central nervous system (CNS).

Objective/Hypothesis: The proposal will assess the substrate specificity of uranium transport into the CNS, testing the hypothesis that the divalent metalcation, 1 (DMT1), which has an unusually broad substrate range that includes Fe 2+, Zn 2+, Mn 2+, Co 2+, Cd 2+, Cu 2+, Ni 2+ and Pb 2+ is also mediating uranium transport into the CNS.

Study Design: As a first step in testing this hypothesis, we will characterize uranium transport in cultured bovine and rat brain endothelium models of the blood-brain barrier (BBB) (Technical Objective 1.0). Correlative in vivo microdialysis studies will delineate the pharmacokinetics of uranium transport across the BBB in rats embedded with DU fragments (Technical Objective 2.0).

Relevance: The studies will test the hypothesis that a relationship exists between blood and brain uranium concentrations, determining whether rats with the highest blood uranium concentrations also accumulate the highest uranium concentrations in the CNS. As such, the studies will facilitate risk assessment in Gulf War veterans, and will determine whether veterans with high uranium blood levels are more prone to accumulate uranium in the CNS compared to veterans with low blood uranium levels.

Proposal Title: (120 Characters Maximum)

Keywords: (6-8 words)

Technical Abstract Blood-Brain Barrier Transport of Uranium

Background: Recent studies of Gulf War veterans with depleted uranium (DU) embedded fragments in their soft tissues point to DU-induced effects on neurobehavioral and cognitive function (McDiarid et al., 2000). These observations are corroborated by electrophysiological changes in hippocampal slices isolated from rats embedded with DU fragments (Pellmar et al., 1999a; Pellmar et al., 1999b). Notably studies from the same group also suggest, for the first time, that uranium accumulates within brain tissue (Pellmar et al., 1999a). It is presently unknown how uranium is transported into the brain, and there are no pharmacological modalities to reduce its accumulation within the central nervous system (CNS).

Objective/Hypothesis: The proposal will asses the substrate specificity of uranium transport into the CNS, testing the hypothesis that the divalent metalcation, 1 (DMT1), which has an unusually broad substrate range that includes Fe 2+, Zn 2+, Mn 2+, Co 2+, Cd 2+, Cu 2+, Ni 2+ and Pb 2+ is also mediating uranium transport into the CNS.

Study Design: As a first step in testing this hypothesis, we will characterize uranium transport in cultured bovine and rat brain endothelium models of the blood-brain barrier (BBB) (Technical Objective 1.0). Correlative in vivo microdialysis studies will delineate the pharmacokinetics of uranium transport across the BBB in rats embedded with DU fragments (Technical Objective 2.0).

Relevance: The studies will test the hypothesis that a relationship exists between blood and brain uranium concentrations, determining whether rats with the highest blood uranium concentrations also accumulate the highest uranium concentrations in the CNS. As such, the studies will facilitate risk assessment in Gulf War veterans, and will determine whether veterans with high uranium blood levels are more prone to accumulate uranium in the CNS compared to veterans with low blood uranium levels.

APPENDIX 6 – PROPOSAL TABLE OF CONTENTS

A.

Technical Proposal

1.

Research Proposal Cover Page

2.

Proposal Abstract

3.

Table of Contents (with pagination)

4.

Statement of Work

5.

Body of Proposal

B.

Cost Proposal 1.

Detailed Cost Estimate 2.

Cost Justification C.

Addenda

1.

Acronym/Symbol Definition

Bibliography

3.

Biographical Sketch (Use Appendix 8 format)

4.

Existing/Pending Support

5.

Letter Confirming Collaboration and/or Joint Sponsorship

6.

Facilities/Equipment Description

7.

Certificate of Environmental Compliance (Use Appendix 9 format)

8.

Research Involving Human Subjects a.

Optional Form 310, Protection of Human Subjects b.

Human use documentation (32CFR 219 and 45 CFR 46) c.

Copy of all protocols and consent forms d.

Documentation of local Institutional Review Board (IRB) review and approval

If not applicable to the proposed research, state so in proposal.

9.

Research Involving Animal a.

Justification for animal/species use b.

Association for Assessment and Accreditation of Laboratory Animal Care International approval or compliance with Public Health Service and Federal Regulations c.

Current approval letter/minutes from local Institutional Animal Care and Use Committee d.

Assurance signed by the Principal Investigator

If not applicable to the proposed research, state so in proposal.

10. FDA Medical Product Approval

a. Intended conduct and structure of pre-clinical safety trials

b. Clinical trials (including trial strategy (ies)).

c. Institutional Review Board (IRB) considerations (if necessary).

d. Investigational Device Exemptions (IDE) and Pre-IDE meetings with FDA.

e. Description of cGMP/QMS compliant facility (ies).

f. Software Validation (if necessary).

g. Information Management / Information Technology / Information Assurance needs including connectivity (if necessary).

h. Other appropriate related items, that will lead to successful FDA and AF program outcomes.

i. If not applicable to the proposed research, state so in proposal.

11.

Facility Safety Plan

12.

Monthly Technical Report (Insert Appendix 10 Boilerplate)

13.

Final Report (Insert Appendix 11 Boilerplate)

14.

HIPAA Agreement (Use Appendix 12)

15.

Representations & Certifications: http://orca.bpn.gov 16.

Multimedia Objects, Photographs, Illustrations, Graphs, etc.

17.

Other

APPENDIX 7 – DETAILED COST ESTIMATE & COST JUSTIFICATION

DETAILED COST ESTIMATE:

cost justification:

NOTE: Itemize all budget categories for each year in this section. Follow Section C.2, Cost Justification of Appendix 3, Proposal Instructions for preparing the justification. Use additional pages as needed to ensure all costs included on the Detailed Cost Estimate forms are fully justified and explained. Failure to submit this section will result in the proposal not being evaluated.

Example Justification:

Cholestech LDX: $13,104 is budgeted for this system that combines enzymatic methodology and solid-hase technology to measure total cholesterols, HDL cholesterol, triglycerides and glucose. This will be done three times to 400 subjects.

If attachments are used to justify equipment costs, label each attachment (e.g. Attachment A) and cross-reference the attachment to the item in the proposal.

APPENDIX 8 – BIOGRAPHICAL SKETCH

Provide the following information for the key personnel listed on the budget page.

name position title

Education/training (Begin with baccalaureate or other initial professional education, such as nursing, and include post-doctoral training).

(if applicable)

Research and professional experience: Concluding with present position, list in chronological order, previous employment, experience, and honors. Include present membership on any Federal Government public advisory committee. List in chronological order, the titles, all authors, and complete references to all publications during the past 3 years and to representative earlier publication pertinent to this application. If the list of publications in the last 3 years exceeds 2 pages, select the most pertinent publications. page limitations apply. do not exceed 3 pages for the entire biographical sketch per investigator.

APPENDIX 9 – CERTIFICATE OF ENVIRONMENTAL COMPLIANCE

Certificate of Environmental Compliance (CEC)

This Certificate of Environmental Compliance shall be executed by the institution’s official responsible for environmental compliance. The Council on Environmental Quality (CEQ) regulations (40 CFR, 1500-1508) that implement the National Environmental Policy Act (Public Law 91-190, as amended) requires all federal agencies to examine possible environmental consequences of their proposed and ongoing actions.

1. One CEC (this form) must be submitted for each site conducting research under the submitted research proposal. This includes all subcontractors.

2.

If you have any questions concerning the generation or applicability of a CEC, please contact Ms. Jeanette Snyder at jeanette.snyder@bolling.af.mil or (202) 404-6686.

The offeror currently __ IS __ IS NOT (check appropriate category) in compliance with applicable national, state, and local environmental laws and regulations. (If not in compliance, attach details and evidence of approved mitigation measures.) The offeror has examined the activities encompassed within the proposed action for compliance with environmental laws and regulations. (Enter title)“_ ” principal investigator: _______________________________

The offeror states that the conduct of the proposed action:

1.

WILL NOT violate any applicable national, state, or local environmental law or regulation, and

WILL NOT have a significant impact on the environment.

The offeror agrees that if the work required under the proposed action at any time results in a significant impact on the environment or a violation of any applicable environmental law or regulation, the offeror will immediately take appropriate action, to include notifying and/or coordinating with the appropriate regulatory agencies as required by law and notifying the Contracting Officer.

Name and Title of Official Responsible for Environmental Compliance (Printed)

Signature

Date

Name of Organization (Printed)

APPENDIX 10 – MONTHLY TECHNICAL PROGRESS REPORT

U.S. AIR FORCE SURGEON GENERAL (SG) REPORTING REQUIREMENTS

USAF SG reporting requirements for contract partners include monthly and final reports. An explanation of requirements for each section follows. The template for the monthly report follows the explanations below:

A.

MONTHLY TECHNICAL PROGRESS REPORT: The recipient shall submit a Monthly Technical Progress Report covering work accomplished during each calendar month of contract performance. It shall be brief, factual, and informal, and shall be prepared in accordance with the sample report format that follows. It shall contain the following:

Section I - Recipient and award information. This generally will not change during the period of performance.

Section II - A brief introduction covering the purpose and scope of the project at this stage and its relevance to the overall effort.