"National Heart, Lung, and Blood Institute
Proteomics Initiative"

BAA-HL-02-04

Broad Agency Announcement (BAA):	BAA-HL-02-04
Issue Date:	September 17, 2001
Issued By:	Joanne Deshler, Contracting Officer National Heart, Lung, and Blood Institute Contracts Operations Branch Rockledge II, Room 6100 6701 ROCKLEDGE DR MSC 7902 BETHESDA MD 20892-7902
Telephone Number:	(301) 435-0340
Fax Number:	(301) 480-3338
E-Mail:	deshlerj@nhlbi.nih.gov
Purchase Authority:	45USC201, Public Health Service Act of 1944
Small Business Set-Aside:	No; NAICS 541710
Pre-Proposal Conference:	November 2, 2001, 11:00 am to 1:00 pm
Proposal Intent Due Date:	December 15, 2001 (See Proposal Instructions and Information)
Proposal Due Date:	February 27, 2002, 4:30 pm (Eastern Time)

COMBINED SOLICITATION FORM AND COVER LETTER

Ladies and Gentlemen:

The National Heart, Lung, and Blood Institute (NHLBI) is soliciting proposals to establish local, highly interactive, multi-disciplinary Centers to enhance and develop innovative proteomic technologies and apply them to relevant biological questions that will advance knowledge of heart, lung, blood, and sleep health and disease.

Pre-proposal Conference: Prospective offerors are invited to attend a pre-proposal conference on November 2, 2001 at the Natcher Building on the NIH Campus in Bethesda, Maryland. NHLBI staff will explain the purpose of the Proteomics Initiative, provide instructions about the proposal process, and answer questions. Questions provided prior to the conference will be answered at the meeting. Please provide such questions by October 26 to the above contact point. Questions asked at the meeting may have to be researched and answered after the meeting. Offeror institutions are urged to send a representative to this conference, both to gather information and to exchange ideas with other potential offerors. All attendees, as well as anyone who cannot attend the pre-proposal conference, will be given access to any distributed materials, questions and answers, and a summary of the discussion. These materials will be posted with the BAA through the NHLBI Research Funding web site. Attendance at the pre-proposal conference is recommended; however, attendance is not a prerequisite for proposal submission and will not be considered a factor in proposal evaluation.

This Broad Agency Announcement (BAA) consists of this combined solicitation form and cover letter, and the components identified in the Table of Contents below. This BAA contains sufficient information for you or your organization to submit a proposal.

If you intend to submit a proposal in response to this BAA, it is important that you notify Joanne Deshler, Contracting Officer. If you do not notify the contracting office of your intent to submit a proposal, you will not receive an individual notice of any amendments to the BAA, if any are issued. However, all amendments will be posted on the NHLBI web site.

Proposals must be received by the Contracting Office no later than February 27, 2002, 4:30 P.M. (Eastern Time) at the address listed in the item entitled "Packaging and Delivery of the Proposal". Also, please complete the form entitled "Proposal Intent Response Sheet" and submit as specified on or before December 15, 2002. This will allow us to prepare for the review of proposals. Your proposal must be organized and submitted in accordance with the "Proposal Format." These items are found under the "Proposal Instructions and Information" portion of this BAA, which follows the technical evaluation criteria section. Note that submission of proposals using facsimile or electronic mail is not authorized.

Please contact me if you have any additional questions regarding this BAA.

Sincerely yours,

/s/
Joanne C. Deshler
Contracting Officer

TABLE OF CONTENTS
	INTRODUCTION
	BACKGROUND AND TECHNICAL OBJECTIVES
		Overview
		Background
		Technical Objectives
		Requirements—Proteomics Center
		Requirements—Administrative Center
	EVALUATION FACTORS FOR AWARD
		General
		Technical Evaluation Criteria—Proteomics Center
		Technical Evaluation Criteria—Administrative Center
	PROPOSAL INSTRUCTIONS AND INFORMATION
		NAICS Code and Size Standard
		Proposals Must be in Two Parts
		Proprietary Data
		Progress Review Panel
		Programmatic and Progress Review Meetings
		Administrative Center
		Reporting Requirements
		Salary Rate Limitations on Contracts, Grants and Cooperative Agreements
		Proposal Format
			Technical Proposal (Separate Volume)
			Business Proposal (Separate Volume)
	ADDITIONAL INFORMATION, INSTRUCTIONS, PROVISIONS, AND CLAUSES
		Proposal Intent Response Sheet
		Packaging and Delivery of the Proposal
		Late Proposals, Modifications of Proposal, and Withdrawals of Proposals
		Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data
		Service of Protest
		Notice of Price Evaluation Adjustments for Small Disadvantaged Business Concerns
		Uniform Resource Locators (URLs) in Contract Proposals
		Sample Contract Format—General

INTRODUCTION

BAAs are used by agencies to fulfill their requirements 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 or hardware solution. Proposals received as a result of the BAA will be evaluated in accordance with evaluation criteria specified herein through a peer review process. Proposals will not be evaluated against a specific Government need, as in the case of a conventional RFP, as they are not submitted in accordance with a common work statement.

It is anticipated that multiple awards will result from this announcement. The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. The maximum period acceptable for a research proposal is seven (7) years. Awards are expected to be made on or about September 30, 2002. The NHLBI anticipates awarding approximately 10 contracts, based on technical merit, available funds, and programmatic balance. Program staff estimates the average total annual cost (direct and indirect costs) for these contracts to be $2,100,000 per year per award. It is anticipated that the individual award total costs for each award will vary depending upon the scope and capacity of the technical objectives of the award. One Proteomics Center will also be selected to serve as the Administrative Center. This Center will facilitate and be responsible for the study meetings, common web site, and other activities involving all 10 Proteomics Centers.

This BAA is open to all domestic sources; however, subcontracts to foreign institutions will be considered, but only in exceptional circumstances.

Award documents will be tailored to the final negotiations with the selected offeror(s) and modified, as necessary, for the type of organization, cost or price arrangements, and other elements as negotiated prior to award.

This Proteomics Initiative will be funding proposals at the cutting edge of science. Thus, it is important that the funded Proteomic Centers interact to share information on technical objectives, progress and impediments, as well as exchange ideas, and, where appropriate, establish collaborations. In addition, as the proteomics and related fields are advancing quickly, the NHLBI will rely on a Proteomics Progress Review Panel to help advise the Institute on the progress and goals of the funded Proteomic Centers. More information about Programmatic Meetings and the Progress Review Panel Meetings is provided in Proposal Instructions and Information.

BACKGROUND AND TECHNICAL OBJECTIVES

This section presents the background for this announcement and the technical objectives that the Government seeks to achieve through this BAA. Proposals should explain how the offeror will contribute to these overall objectives. In contracts awarded as a result of this BAA, the Statement of Work will be the Statement of Work proposed by the offeror and negotiated and accepted by the Government.

Overview
This BAA will establish local, highly interactive, multi-disciplinary Centers to enhance and develop innovative proteomic technologies and apply them to relevant biological questions in a manner that will advance our knowledge of heart, lung, blood, and sleep health and disease. This BAA is intended to complement and enhance the NHLBI's ongoing research programs, which involve a substantial investment in clinical research, genomic research, basic biology, and training and education programs.

Background
The accelerating science of genomics has made a major impact on the practice of biomedical research. New genomic tools, particularly DNA microarrays, provide a previously unattainable global view of how gene expression patterns respond to various physiological stimuli, to mutations, and in disease states. Such knowledge provides a basis for insights into cellular metabolism that were not possible by studies of a few selected genes at a time. However, a DNA microarray, or any nucleic acid-based methodology, is blind to many events that occur at the protein level. Therefore, they provide an indirect and incomplete picture of cellular function and hence additional information is needed for advancing human medicine and health care. The field of proteomics seeks to supply this knowledge by revealing the levels, activities, regulation, and interactions of every protein in the cell and how these quantities respond to a particular stimulus (e.g. drug, food, infection) or disease state or DNA alteration. In essence, proteomics builds on and complements the knowledge gained from genomics.

This significant effort in proteomics will provide discoveries about the cells' protein machinery that will likely yield important clinical applications. Such knowledge could provide an understanding of the molecular basis of the cause and progression of heart, lung, blood, and sleep disorders, identify targets for new therapeutic interventions, and lead to new methods for early detection and diagnosis. For example, analyzing patterns of protein expression from tissues or fluids over the course of disease progression could reveal proteome-level "biosignatures" indicative of specific disease status. Such "biosignatures" may be used extensively in 21^st century medical diagnostics. Similarly, analyses of protein profiles before and after pharmacological treatments could provide vital clues regarding drug effectiveness and toxicity. In addition, particular "biosignatures" may be used to customize therapeutic strategies for individual patients.

Proteomics is much more complex than genomics, not only because there are so many possible interactions among proteins, but because there are so many more proteins than genes. Current estimates are that organisms have over an order of magnitude more proteins than genes. In addition, expressed proteins are typically modified in a variety of ways by post translational modifications (PTM), such as phosphorylation and glycosylation. Furthermore, the proteome is highly dynamic, responding to the cellular microenvironment and the physiological state of the animal.

There are many areas of proteomics that are in need of technological and methodological advances. These areas include, but are not limited to the following.

1. Protein profiling, the simultaneous quantification of many proteins in cells or tissues, offers exceptional promise for clarifying complex molecular pathways and elucidating their involvement in health and disease. These measurements can potentially aid clinical decision- making regarding detection, diagnosis, and treatment. However, no current technology allows both comprehensive identification and sensitive quantification of proteins. Other technical challenges include the quantification of membrane-bound proteins and very low-abundance proteins.

2. Post-Translation Modifications (PTMs) have an enormous effect on the properties of many proteins, modulating their interactions with other factors, sub-cellular localizations, and catalytic activities. A striking example is in signal transduction, where complex cascades of protein phosphorylation and other modification events communicate signals from the cell membrane to the nucleus. Quantitative information about protein modifications will enhance understanding of the altered biological processes associated with development and progression of heart, lung, blood, and sleep diseases. Sensitive, efficient, and reproducible technologies are needed that can provide a global view of protein post-translational modification events.

3. Delineation of Protein interactions is critical, as most proteins function in concert with other factors as members of protein machines. It is important to identify and characterize protein interaction networks of relevance to heart, lung, blood, and sleep biology. Innovative platform technologies are needed to facilitate massively parallel functional proteomic studies, such as arrays that will identify functionally important binding partners of a protein of interest. In addition, investigations of the dynamic nature of protein expression and interaction is a key area requiring technological breakthrough.

4. The ability to manipulate the activity and PTM state of proteins is needed to take full advantage of the potential of proteomics. For example, if a specific protein PTM event is identified as a critical feature of a heart, lung, blood, or sleep disease, it would be worthwhile to block this event and analyze the effect in cell culture or in a living organism. Although this can be done easily in yeast or other simple model organisms by mutating the amino acid that becomes phosphorylated, it is difficult, tedious, and expensive to do so in mammalian systems. One possible solution would be a cell-permeable synthetic molecule or an expressible biomolecule that blocks the specific event of interest. This area of emphasis is important for translation of fundamental knowledge at the proteomic level to therapeutic strategies.

In order to overcome technological barriers and promote biological discoveries with clinical benefit, an environment is needed in which innovative approaches are developed in concert with studies of important biological problems. Hence, this BAA will establish local, highly interactive, multi-disciplinary groups (possibly with expertise in medicine, biological sciences, chemistry, physics, engineering, proteomics, bioinformatics, and statistics) to enhance and develop innovative proteomic technologies and apply them to critical biological questions. In order to develop truly innovative technologies and apply them to biological issues, the BAA provides for a sustained period of substantial, uninterrupted support. It is recognized that proposed approaches may very well be outdated within a few years, thus flexibility allowing updating approaches are part of this BAA and any subsequent contract. In order to insure maximum benefit from this investment, the products (reagents, techniques, methods, documentation, information, etc.) of this effort will be made readily available to the scientific community.

Technical Objectives
The NHLBI Proteomics Program is seeking proposals to establish local, highly interactive, multi-disciplinary groups bringing together scientific expertise from diverse areas such as heart, lung, blood, sleep, chemistry, physics, engineering, proteomics, bioinformatics, and statistics, to enhance and develop innovative proteomic technologies and apply them to biological questions relevant to heart, lung, blood, and sleep. Proteomics Centers funded through this announcement will be expected to accomplish major research and development objectives in this field. The ultimate long term goal of all Centers should be the development of new approaches to understanding heart, lung, blood, and/or sleep disease through basic scientific discovery and the development of new means to influence protein states and function. Examples of areas of proteomic research that might be appropriate for support through this initiative include, but are not limited to, the development and application of:

1. Techniques that substantially increase the sensitivity or capacity of existing approaches with regard to throughput, quantitation, temporal resolution, reliability, and/or informatics;
2. New technologies for resolution of complex protein mixtures based on alternative methods of protein separation or measurement;
3. New methods for characterizing protein characteristics related to their cellular functions (e.g. post-translational modifications, protein-molecule interactions, protein profiling);
4. Novel approaches for characterization of protein-protein, protein-DNA, or other protein-molecule interactions;
5. Novel applications of proteomic methodologies to the study of specific cellular processes (e.g. fast signal transduction pathways in cardiac myocytes, protein expression patterns);
6. Development of new informatics methods appropriate for specific applications (e.g. for management of time-series proteomics data obtained in sleep research, kinetics of complex protein system interactions—such as blood coagulation);
7. Application of proteomic methods to biological systems that involve special technical considerations (e.g. specific cell types within the lung, protein expression in blood cells stored in different conditions), and
8. Use of proteomic approaches in the development and proof-of-concept testing of therapeutics (e.g. anti-platelet and anti-inflammatory agents).

Each Proteomics Center is expected to focus on a specific, physiologically relevant area of heart, lung, blood, and/or sleep research. Technology development in the absence of biology is not responsive to this BAA. Technological developments made within the Center should be coupled to studies that involve application to the Center's stated area of biological focus. For instance, a proposal having as its central theme a specific pathophysiological condition and proposing to develop novel methods for characterizing protein-protein interactions might include specific studies of the processing, subcellular localization, and physiological functions of key proteins and their functional partners in cells, tissues and/or organs in animal models and in humans with this pathophysiological condition. Other organizational and scientific structures are also appropriate.

A distinctive feature of this program is that the work of each Center should involve innovation and continual improvements. Offerors are encouraged to propose both 1) feasible objectives, possibly involving adaptation or augmentation of existing approaches and 2) "far-sighted; high-risk" such as the creation of entirely new approaches or technologies, that has the potential of advancing the field substantially beyond its current status. A mixture of innovative science within each Center of "approachable" and "high-risk" endeavors is desired.

Requirements—Proteomics Center
Innovative Technology and Biology
The objectives of this Program are to support proposed plans that include innovative work that is both 1) feasible by adaptation or augmentation of existing approaches, and 2) "far-sighted; high-risk" such as the creation of entirely new approaches or technologies that has the potential of advancing the field substantially beyond its current status. Proposals that can be accomplished through the standard investigator initiated review process will receive lower programmatic priority. Innovative technology development should be conceived and developed with the goal of a biological application. Proposed study plans should be concisely presented. As technology and scientific advances are expected over the next several years, a discussion of study objectives and evaluation of those study objectives will be important. Thought should be given to how plans and approaches will be re-evaluated as technologies advance over the seven year funding period.

Synergy
The proposed Centers should be local, highly interactive, multi-disciplinary groups (heart, lung, blood, and/or sleep, chemistry, physics, engineering, proteomics, bioinformatics, statistics, etc.) with the purpose to enhance and develop innovative proteomic technologies and apply them to relevant heart, lung, blood, and sleep biological questions. Synergy among the investigators and the proposed science is critical. It is anticipated that all the expertise will be local and highly interactive. If the offeror finds that critical expertise needed for the success of the Center must be found outside the local geographic area, a thoughtful and detailed discussion must be presented.

Quality Control
In order for new technologies, approaches, and applications to be broadly useful and portable to other applications, detailed quality control and quality assurance is required. The technical proposal should include a description of quality control and quality assurance methods and applications. Where relevant, system and design controls, including calibration, validation, and fabrication specifications, should be discussed.

Dissemination Plans
As the NHLBI plans to make a significant investment of time and funds in the Proteomics Program so that truly innovative technologies can be developed and applied to biological areas of interest to NHLBI, the products (reagents, techniques, methods, documentation, information, etc.) of this effort must be made readily available to the scientific community in order to insure maximum benefit from this investment. The proposed plan should include a discussion of intellectual property and patenting and specific plans for dissemination of the products of the Center, which should include a time line. A separate spreadsheet or table is acceptable.

Milestones
The technical proposal should include scientific milestones and time-line for implementation of those milestones for each aim, goal, objective, and study proposed.

Special Requirements
Awards under this solicitation will be made only to offerors located in the continental United States, Alaska, and Hawaii.

Requirements—Administrative Center
In addition to the Proteomic Center proposal, the offeror may also submit a proposal for an Administrative Center. One Proteomics Center will be selected to serve as the Administrative Center. This Center will facilitate and be responsible for the study meetings, common web site, and other administrative activities involving all 10 Proteomics Centers. It is anticipated that the Proteomics Centers will likely be in geographically diverse locations, therefore, effective communication is an important component of this Initiative. Administrative Center staff should demonstrate experience coordinating the administrative functions for a multi-center program and have experience working with multiple investigators with varying experiences. More information about Administrative Center functions is provided in Proposal Instructions and Information.

EVALUATION FACTORS FOR AWARD

General
The Government will make awards to the responsible offeror(s) whose proposals provide the best value to the Government. For this solicitation, the technical proposal shall receive paramount consideration in the selection of the contractor(s). However, cost realism and reasonableness shall also be considered to the extent appropriate.

The evaluation will be based on the demonstrated capabilities of the prospective offerors in relation to the evaluation criteria as set forth herein. Each proposal must document the feasibility of successful implementation of the requirements of the BAA. The estimated cost of an offer must be reasonable for the tasks to be performed, and, in accordance with FAR 15.305, will be subject to a cost realism analysis by the Government.

All technical proposals will undergo evaluation by a peer review group also known as the Technical Evaluation Panel (TEP). It is anticipated that following this, discussions will be held with any offeror whose proposal remains under consideration. Questions arising from the TEP will be sent to offerors for response. Cost negotiations may be necessary as well.

Final selection of awards will depend upon scientific merit, the proposed costs in relation to availability of funds, and program balance within the NHLBI at the time of award selection. The NHLBI reserves the right to select a variety of technical approaches. Please note that no award will be made solely for the Administrative Center. That award would only go to an otherwise successful offeror.

TECHNICAL EVALUATION CRITERIA PROTEOMICS CENTERS
The evaluation criteria are used by the Technical Evaluation Panel when reviewing the technical proposals. The criteria below are listed in relative importance with weights assigned for evaluation purposes.

Evaluation Factors	Weight
INNOVATION	30 Points
Extent to which novel and innovative concepts, approaches, methods, and technologies are employed. Extent to which existing paradigms are challenged, or new methodologies or technologies are developed.
SCIENTIFIC AND TECHNICAL APPROACH	30 Points
Extent to which proposed plans accomplish the scientific goals of the Center. Merit of the technical plan within the context of the goals of the Proteomics Program. Appropriateness of the milestones, time lines, and products of the Proteomics Center. Suitability of proposed plan for data, resources, and tool dissemination to the broader scientific community. Suitability of the quality control and quality assurance plans.
SIGNIFICANCE	20 Points
Adequacy of plans to advance the state of proteomic science. Extent to which the proposal effectively ties in significant biological queries with technological application and advances. Extent to which the proposed Proteomics Center advances, or paves the way to advance, approaches to diagnosis, detection, and/or new therapeutic interventions in heart, lung, blood, and sleep diseases.
OFFEROR'S CAPABILITIES	20 Points
Documented training, experience, expertise, and availability of the Principal Investigator for planning and directing the proposed Proteomics Center. Adequacy of plans describing the synergy of the proposed team of researchers. Documented training, experience, and availability of all personnel in conducting the proposed technical procedures. Adequacy of the organizational and administrative structure of the proposed Proteomics Center. Availability and adequacy of the facilities and resources necessary to meet the objective of the proposed Proteomics Center, including institutional commitment to the Center.

TECHNICAL EVALUATION CRITERIA ADMINISTRATIVE CENTER
The evaluation criteria are used by the technical evaluation committee when reviewing the technical proposals. Only proposals offering to be the Administrative Center will be evaluated against these criteria. The criteria below are listed in the order of relative importance with weights assigned for evaluation purposes:

Evaluation Factors	Weight
TECHNICAL APPROACH	35 Points
Merit of the proposed plan to support the administrative activities of the Proteomics Initiative. Merit of the proposed plan of the Proteomics Administrative Center to facilitate interactions among the Proteomics Centers.
OFFEROR'S CAPABILITIES	35 Points
Documented experience, expertise, and availability of staff in conducting the proposed Proteomics Administrative Center.
INSTITUTIONAL EXPERIENCE AND FACILITIES	30 Points
Adequacy of the organizational and administrative structure of the proposed Proteomics Administrative Center. Availability and adequacy of the facilities and resources necessary to meet the objective of the proposed Proteomics Administrative Center, including institutional commitment to the Center.

PROPOSAL INSTRUCTIONS AND INFORMATION

The proposal must be signed by an individual authorized to bind the organization to a Government contract.

NAICS Code and Size Standard
This requirement is not set-aside for small business. However, the FAR requires in every solicitation (except for foreign acquisitions) the inclusion of the NAICS code and corresponding size standard which best describes the nature of the requirement in the solicitation.

1. The North American Industry Classification System (NAICS) code for this acquisition is 541710.
2. The small business size standard is 500 employees.

This information is to be used by the offeror in preparing its Representations and Certifications, specifically in completing the provision entitled, SMALL BUSINESS PROGRAM REPRESENTATION, FAR Clause 52.219-1.

Proposals Must be in Two Parts
The proposal must be prepared in two parts: a "Technical Proposal" and a "Business Proposal." Each part shall be separate and complete in itself so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the other. The technical proposal should disclose your technical approach in as much detail as possible, including, but not limited to, the requirements of the technical proposal instructions. Offerors should realize that the clarity of the presentation is important in communicating their project ideas to reviewers, and that a concise and well formulated proposal is usually more effective in that respect than a voluminous proposal that lacks effective distillation of ideas.

Proprietary Data

1. Offerors that include in their proposals data that they do not want disclosed to the public for any purpose, or used by the Government except for evaluation purposes, shall mark the title page with the following legend:

   This proposal includes data that shall not be disclosed outside the Government and shall not be duplicated, used, or disclosed—in whole or in part—for any purpose other than to evaluate this proposal. If, however, a contract is awarded to this offeror as a result of, or in connection with, the submission of this data, the Government shall have the right to duplicate, use, or disclose the data to the extent provided in the resulting award. This restriction does not limit the Government's right to use information contained in this data if it is obtained from another source without restriction. The data subject to this restriction are contained in sheets (on pages) [insert numbers or other identification of sheets/pages].

2. Mark each sheet of data you wish to restrict with the following legend:

   Use or disclosure of data contained on this sheet is subject to the restriction on the title page of this proposal.

NOTE: THE FOLLOWING ARE UNIFORM ASSUMPTIONS TO ASSIST IN PREPARATION OF YOUR PROPOSED BUDGET

Progress Review Panel
The NHLBI will establish a scientific Progress Review Panel to monitor progress, review study findings/data and safety, and advise the NHLBI when changes should be made to the Initiative. The panel will be composed of a Chairman and additional members appointed by the NHLBI. Additional panel members or consultants may be appointed if deemed necessary by the NHLBI or in response to recommendations made by panel members.

Programmatic and Progress Review Meetings
In performance of the work, investigators will be expected to attend two programmatic meetings per year. At these meetings each Proteomics Center shall present information on technical objectives, progress, and impediments. The participants at these semi-annual meetings will include Center investigators, Government program officials, and Government contracting officials. For the purposes of estimating costs, offerors should assume two, two-day meetings per year will be conducted in the Washington metropolitan area with attendance by the Principal Investigator as well as the senior investigators on each component project. Post-doctoral and pre-doctoral fellows are encouraged to attend and present, but not as a replacement for key investigators. The purpose of these meetings will be to present information on technical objectives, progress, and impediments, exchange ideas, and, where appropriate, establish collaborations.

In addition to the Programmatic Meetings described above, there will be three Progress Review Meetings with the Progress Review Panel convened by the NHLBI. The Progress Review Panel will meet with the Center investigators, Government program officials, and Government contracting officials. This Progress Review Panel will meet during years 2, 4, and 6 of the Initiative. The purpose of these meetings is to discuss progress and re-evaluate goals.

Administrative Center
In addition to the Proteomic Center proposal, the offeror may also submit a proposal for an Administrative Center. One Proteomics Center will be selected to serve as the Administrative Center. This Center will facilitate and be responsible for certain administrative activities involving all 10 Proteomics Centers. Effective communication is an important component of this Initiative, since it is anticipated that the Proteomics Centers will likely be in geographically diverse locations. Administrative Center staff should demonstrate experience coordinating the administrative functions for a multi-center program and have experience working with multiple investigators with varying experiences.

Meetings of the Proteomics Centers and Progress Review Panel will be a key part of the communication network. This Center would coordinate the twice yearly meetings of the Proteomics Centers and meetings of the Progress Review Panel in years 2, 4, and 6. Meetings require the completion of a number of logistical tasks; such as, selection of dates and scheduling; preparation of meeting agendas; collection, organization, and dissemination of materials needed for the meeting; provisions of supporting materials for each agenda topic so that associated issues are articulated and discussions are focused; coordinating travel arrangements; preparation and distribution of correspondence and minutes related to the meetings; when appropriate, use of slides and presentations to help guide meetings, and, completing arrangements with the hotels regarding sleeping rooms and meeting facilities, coffee breaks, luncheons, acquisition of meeting equipment, i.e., overhead and slide projectors, etc.

In addition, other types of communication will also be needed. Working groups may need to meet in person or more likely, via conference telephone calls. The Administrative Center will prepare and distribute program documents, develop and maintain a unified directory of telephone numbers, fax numbers, and e-mail addresses for all Proteomic Center investigators, Progress Review Panel members, NHLBI Program and Contracts staff. In addition, it is expected that the products (reagents, techniques, methods, documentation, information, etc.) from this initiative will be made readily available to the scientific community. In order to insure maximum benefit from this investment offerors should give consideration to the most effective means of making this information available, i.e. via the internet. Maintenance and enhancements of the proposed system will be a part of the Administrative Center's responsibilities. It will be important for the Administrative Center to establish predictable channels for distribution of memos to all Proteomics Centers. Distribution lists and mailing lists will be maintained as part of the functions of the Administrative Center.

The Administrative Center will be responsible for taking and distributing minutes of meetings and conference calls.

If an offeror wishes to propose as an Administrative Center, technical and business proposals should be provided as a separate part of the overall proposal. For the purposes of estimating costs there will be two 2-day programmatic meetings per year (assume 75 attendees) and one 2-day Progress Review Panel meeting in years 2, 4, and 6 (assume 40 attendees). Meetings will take place in the Washington metropolitan area. Center investigators will pay their own travel costs out of their contracts; Progress Review Panel members (assume 10) will have their travel and honorarium ($200/meeting) paid by the Administrative Center.

Reporting Requirements
In performance of the work, the following reporting requirements should be assumed:

Program Plan
A Program Plan shall be submitted 30 days after contract award for review and approval. The plan shall identify technical risks and critical decision points that are expected to result, and include a one page graphic that reflects, task-by-task, when the key milestones of the Center will be met. All revisions to the approved plan shall be submitted to the NHLBI for review and approval.

Abstracts and Manuscripts
Abstracts and Manuscripts in progress and proposed for publication shall be provided to the NHLBI for review and comment 30 days prior to submission for publication. Copies of manuscripts (published or unpublished) derived from research under the contract and copies of all abstracts, manuscripts, reprints and publications that resulted from work conducted or any protocol or method developed specifically under this contract during the performance period. Manuscripts and publications will only be judged as resulting from this work if they cite the support received from this award.

Quarterly Reports
This report shall document and summarize all work results for the period covered. This report shall be in sufficient detail to explain comprehensively the results achieved. The report should be in letter form (2-3 pages) to both the Contracting and Project Officers. The report should include progress for the quarter, problems encountered during the quarter, a discussion of milestones met or missed, a summary of activities planned for the next quarter, manuscripts in progress, submitted or published, and disclosure of intent to file patent applications.

The first reporting period consists of the first full three months of performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of three full calendar months. A Quarterly Progress report is not required for periods in which an annual or final report is due.

Annual Technical Reports—This report shall document and summarize all work results for the period covered. Specifically, the report shall include:

1. Face page to include contract number, title, period of performance being reported, Contractor's name and address, telephone and telefax numbers, and date of submission.
2. An executive summary, to include:
   1. A statement of intended work for the reporting period;
   2. A brief overview of the work that was completed for the reporting period;
   3. A brief overview of any problems (technical or financial) that occurred during the current reporting period and their resolution or status;
   4. The advancements made in relation to any of the technical tasks and/or milestones set forth in the Statement of Work;
   5. An update to the Program Plan;
   6. A summary of activities planned for the next reporting period;
   7. A full description of data pertaining to:
      1. The work performed during the reporting period;
      2. The materials and methods pertaining to the work; and
      3. The relationship between the accomplishments made relative to the goals, objectives, and milestones of the Statement of Work
      4. Problems encountered and their resolution.
   8. An update of all Abstracts and Manuscripts submitted for publication or in process.
   9. An update of the Dissemination Plan, including time line and discussion of dissemination made to date.
   10. Full disclosure of intent to file patent applications in the U.S. or outside of the U.S. on materials, reagents, animal models or procedures derived or established by the work supported under this contract; full disclosure of patent applications filed in the U.S. or outside of the U.S. as well as copies of patent applications.
   11. Full disclosure of any efforts to transfer the technology or receipt of support from outside entities interested in future access, partnering, or license to the developing technologies.
3. The initial report will be submitted for the first full twelve months of the contract performance including any fractional part of the initial month. Annual reports thereafter shall be submitted at 12 month intervals. An annual report shall not be required for the period when the final report is due.

Progress Review Panel Reports
A report will be required one month prior to the Progress Review Panel meeting. This report will be an update to the Annual Report and should be in the same format as the Annual Report. The Project Officer may request, on an as needed basis, additional information not included in the Annual Report or the Progress Review Panel Report.

Final Report
This report shall consist of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved, and the final Dissemination Plan including dissemination to date. The final report shall be submitted on or before the last day of the contract performance period.

Salary Rate Limitations on Contracts, Grants and Cooperative Agreements
Pursuant to Public Law, no NIH extramural funds may be used to pay the direct salary of an individual through this contract at a rate in excess the salary rate ceiling established in DHHS appropriation acts. Currently this rate is $161,200. Updates of this rate may be found at: http://ocm.od.nih.gov/contracts/rfps/MAINPAGE.HTM

Proposal Format
Your proposal should be organized according to the following outline.

Technical Proposal (Separate Volume)
This volume provides the detailed discussion of the proposed work necessary to enable an in-depth review of the specific technical and managerial issues. Specific attention must be given to addressing both risk and payoff of the proposed work and relevance to the specific technical objectives of the NHLBI Proteomics Initiative as outlined in the BACKGROUND AND TECHNICAL OBJECTIVES section.

The technical proposal should be organized as follows: (Number each page of text. Type density and size must be 10-12 points. If constant spacing is used, there should be no more than 15 cpi, whereas proportional spacing should provide an average of no more than 15 cpi. There must be no more than six lines of text within a vertical inch.)

TECHNICAL PROPOSAL COVER SHEET		Page 1
	The Technical Proposal Cover Sheet is a form that must be completed in full detail and used as the cover sheet for each copy of your technical proposal. It may be accessed at http://ocm.od.nih.gov/contracts/rfps/FORMS1.HTM. The information contained in the form will be used to insure that there will be no conflicts of interest when selecting review committee members.
TECHNICAL PROPOSAL TABLE OF CONTENTS		Page 2
ABSTRACT		Page 3
	Identify the BAA Number, Institution and Principal Investigator on the abstract. State the proposal's broad, long-term objectives and specific aims. Briefly and concisely describe the research design and methods for achieving these goals. DO NOT EXCEED one page in providing the abstract. Also indicate in the abstract whether you are proposing to perform as the Administrative Center.
MILESTONE PLAN		Page 4
	This plan should include scientific milestones and time-line for implementation of those milestones for each aim, goal, objective, and study proposed. The plan should include a one page graphic that reflects, task-by-task, when the key milestones of the Center will be met.
TECHNICAL PLAN (LIMIT 50 double spaced pages of text)		Page #
	Refer to the Sections below and the BACKGROUND AND TECHNICAL OBJECTIVES above for further details. Section One—Detailed Technical Plan and Proposed Statement of Work This section should include a detailed description of the specific technical steps to be taken, rationale, technical challenges likely to be encountered, alternative approaches that might be considered, and justification of approach. Describe the proposed innovative science as "approachable" or as "high risk". Given the level of innovation sought in this BAA, it is anticipated that proposals may carry substantial technical risk. Areas of highest technical risk should be identified and discussed, as well as potential alternative approaches and methods to be used to evaluate study objectives over time. A discussion describing the application of the innovative technology to biological questions is critical. Proposals should outline a technical plan with clearly defined quantifiable milestones of progress and key decision points. This section should also discuss and reference ongoing or previous research by the offeror, and the research team, related to the proposed program. This section should address the project's potential for contribution to the technological objectives of the NHLBI Proteomics Initiative. The following items should be addressed; the ultimate anticipated utility of the technology; the general applicability of the technology; and the ultimate dissemination of the technology and its application. A description of the quality control and quality assurance measures used in both the development/enhancement of the proposed technology and the application of that technology to the chosen biological question(s). In addition, the detailed technical plan will result in the Statement of Work to be used in the contract. Specific technical tasks to be undertaken, specific decision point, and any deliverables to be provided, in addition to the reporting requirements specified in this BAA, will be part of the Statement of Work. The contract Statement of Work will include language that recognizes the proposed approaches may need to be updated to keep pace with state-of-the-art changes that are anticipated under this initiative. The relevance of the proposal to this Initiative will be judged on the basis of the justification provided in the proposal. Section Two—Offeror's Qualifications, Project Team, and Management Plan This section should present a discussion of offeror's qualifications for leading the research effort proposed, including record of innovation. It is anticipated that the complexity of the fundamental technologies targeted as the final products of the NHLBI Proteomics Program will require that expertise from a variety of disciplines be engaged in the development process. Proposals should address the breadth of expertise required for completion of the project, capabilities of the team, and plans for recruiting additional expertise. Local, multidisciplinary teams are strongly encouraged. Proposed management structure for the team and choice of project team leader should be discussed. This section should include a discussion of the composition of the project team with regard to breadth of required expertise, the synergy among the team, and a management plan that details the interactions of the team. This section should also address the programmatic relationship of team members; the scientific and technical expertise of team members as it relates to the proposed project; the task responsibilities of team members; the teaming strategy among the team members; and the key personnel along with the amount of effort to be expended by each person during each year. Any agreements that enable the collaboration of participating individuals or institutions should be detailed in this section. Letters of commitment for such agreements should be included as part of the Appendices. The proposal should include an organizational chart detailing the roles and responsibilities of the individuals proposed under the project. Include a detailed listing of the time commitments of the Principal Investigator(s), Co-Investigator(s) and other Key Personnel using the form Summary of Related and Proposed Activities found at: http://ocm.od.nih.gov/contracts/rfps/summact.htm Section Three—Facilities This section should include a detailed description and documented availability of the facilities, equipment, and other resources that would be used for the proposed effort. Section Four—Dissemination and Use of Results This section should address the plans for disseminating the resulting technology and/or its application, including any plans for engaging commercial partners and support. A plan which identifies the products (reagents, techniques, information, etc.) to be disseminated and a time line for their dissemination should be included. Plans or milestones for the recruitment of external support or commercial interest in the technology and products to be developed should be discussed. A discussion of intellectual property and patenting should be included. For technologies very early in the research phase, a discussion of routes for future technology dissemination should be included. Section Five—Administrative Center If proposing as the Administrative Center, an additional 10 pages are allotted for discussion of the above items as they relate to carrying out that function.
LITERATURE CITED		Page #
	The proposal may contain a brief bibliography of relevant technical papers and research notes (published and unpublished) which document the technical ideas upon which the proposal is based. Proposals may include copies of not more than three (3) relevant papers in the proposal.
APPENDICES		Page #
	List each Appendix and identify the number of pages for each one. Appendices must be clear and legible, and easily located. Include biosketches here. Include Animal Assurances/Human Subjects Assurances: If animals are proposed, include, in the appendices, a detailed plan for maintaining the animals under the contract in accordance to the requirements of NIH, PHS and AALAC. Provide the date of the last AALAC review and your Animal Assurance number. Provide a copy of the DHHS Human Subjects Assurance Number if the proposed work involves Human Subjects. Address the timeline for approval by the Institutional Review Board of your organization. Provide a detailed description of the proposed costs using the Technical Proposal Cost Information form found at: http://ocm.od.nih.gov/contracts/rfps/techcst5.htm. This information will be used by the technical reviewers to assess your understanding of the project. Provide, in the appendices, letters of commitment for proposed consultants.

Business Proposal (Separate Volume)

PROPOSAL SUMMARY AND DATA RECORD, NIH-2043		Page 1
	Form located at: http://ocm.od.nih.gov/contracts/rfps/FORMS1.HTM
BUSINESS PROPOSAL COVER SHEET		Page 2
	The cover sheet shall provide the following information: A statement indicating that the offeror is/is not proposing to serve as the Administrative Center for the Initiative; A statement specifying the extent of agreement with all terms, conditions, and provisions included in the BAA and agreement to furnish any or all items upon which prices are offered at the price set opposite each item; Facsimile numbers and electronic addresses of the principal investigator and of persons authorized to negotiate on the offeror's behalf with the Government in connection with this BAA, and The total proposed cost broken out by year (if proposing to serve as the Administrative Center these costs should be broken out separately).
BUSINESS PROPOSAL TABLE OF CONTENTS		Page 3
	Section One—Budget Proposal Section Two—Budget Justification and Documentation Section Three—Additional Business Data Section Four—Small Disadvantaged Business Participation Plan Section Five—Representations and Certifications Section One—Budget Proposal The budget proposal must contain sufficient information to allow the Government to perform an analysis of the proposed cost or price of the work. This information shall include the amounts of the basic elements of the proposed cost or price. The budget spreadsheets should be in Microsoft Excel using the format located at: http://ocm.od.nih.gov/contracts/rfps/buscost.htm A diskette or CD Rom containing the Microsoft Excel spreadsheets should be attached to the original proposal. As an alternative to submitting the file on diskette, you may send the Microsoft Excel file by electronic mail to: deshlerj@nhlbi.nih.gov In preparing your budget proposal, the following should be considered: The NHLBI views the funding of these contracts as high-risk, high-potential, similar to venture capital investments in the private sector with the contractor potentially receiving a substantial financial benefit for successful projects. Accordingly, the NHLBI does not consider the inclusion of Fee or Profit appropriate for these contracts. If your proposal includes cost sharing, describe the cost sharing, the method of allocating funds, and the source of the shared funds. Section Two—Budget Justification and Documentation Provide justifications and explanations of the proposed costs included in the Microsoft Excel spreadsheets. This includes explanation of the processes by which future year costs are derived. Also, explain the basis for why the proposed costs should be considered reasonable for the work proposed. Provide the following supporting documentation: Verified salary documentation. Acceptable documentation includes any one of the following: 1) personnel action forms, 2) most recent payroll register showing name, pay rate, and percent of effort if applicable, or 3) copy of pay stub. If the proposed positions have not been filled or are to be named or hired, then acceptable documentation includes the following: 1) letter of intent to hire including salary rate and title, 2) position descriptions and salary scales or organizational wage table showing salary range and a copy of hiring policy, or 3) a comparable employee's payroll document. An explanation of when employees receive salary increases and the methodology for determining the salary increase rate(s) and the salary rates for proposed new employees. Vendor quotations, catalog prices, etc., that document the proposed material and supply costs. Supporting documentation of the reasonableness of proposed consulting costs, including documentation from the consultant that the proposed rate is the established consultant rate which the particular consultant normally bills for the work to be performed. Provide documentation which compares the rate proposed with rates for other consultants for similar work. Please DO NOT intermix subcontract and prime contract costs. Prepare each subcontract budget in a separate spreadsheet. The same cost documentation specified for the prime contract is needed for any subcontract. Subcontractors may submit the cost documentation directly to the Contracting Officer. Copies of negotiated indirect cost (IDC) rate agreements. If no current IDC rate agreement is in effect, provide specific of the methodology for determining the proposed IDC costs. Include a description of the cost components of both base and pool costs. Additional guidance on indirect costs is available from the Division of Financial Services, Office of Contracts Management, NIH, at http://ocm.od.nih.gov/dfas/idcsubmission.htm. Section Three—Additional Business Data Submission of Electronic Funds Transfer Information with Offer, FAR Clause 52.232-38 (MAY 1999) The offeror shall provide, with its offer, the following information that is required to make payment by electronic funds transfer (EFT) under any contract that results from this solicitation. This submission satisfies the requirement to provide EFT information under paragraphs (b)(1) and (j) of the clause at 52.232-34, Payment by Electronic Funds Transfer—Other than Central Contractor Registration. The solicitation number (or other procurement identification number). The offeror's name and remittance address, as stated in the offer. The signature (manual or electronic, as appropriate), title, and telephone number of the offeror's official authorized to provide this information. The name, address, and 9-digit Routing Transit Number of the offeror's financial agent. The offeror's account number and the type of account (checking, savings, or lockbox). If applicable, the Fedwire Transfer System telegraphic abbreviation of the offeror's financial agent. If applicable, the offeror shall also provide the name, address, telegraphic abbreviation, and 9-digit Routing Transit Number of the correspondent financial institution receiving the wire transfer payment if the offeror's financial agent is not directly on-line to the Fedwire and, therefore, not the receiver of the wire transfer payment. Financial Capacity The offeror shall indicate if it has the necessary financial capacity, working capital, and other resources to perform the contract without assistance from any outside source. If not, indicate the amount required and the anticipated source. Annual Report Include in this section of the ORIGINAL PROPOSAL ONLY, a copy of the organization's most recent annual report. Travel Policy Include in this section of the ORIGINAL PROPOSAL ONLY, a copy of the your (and any proposed subcontractor's) written travel policy. If an you, or any proposed subcontractor, does not have a written travel policy, provide a statement to that effect. Small Business Subcontracting Plan Since the proposed contract is expected to exceed a total estimated cost of $500,000 for the entire period of performance, a subcontracting plan will be required in accordance with the terms of the clause entitled "Small Business Subcontracting Plan," FAR Clause No. 52.219-9, incorporated herein by reference in the BAA. However, the offeror's Small Business Subcontracting Plan shall not be submitted with the initial business proposal. Only those offerors whose proposal remains under consideration will be required to submit an acceptable subcontracting plan. For information purposes, the DHHS Model Plan may be accessed at: http://sbo.od.nih.gov/forms.htm THIS PROVISION DOES NOT APPLY TO SMALL BUSINESS CONCERNS. For more information about Subcontracting Plans see: http://ocm.od.nih.gov/contracts/rfps/INSTOPT.HTM#Optional H Facilities Capital Cost of Money See http://ocm.od.nih.gov/contracts/rfps/INSTOPT.HTM#Optional N Total Compensation Plan—Instructions and Evaluation See http://ocm.od.nih.gov/contracts/rfps/INSTOPT.HTM#Optional K Note: An offeror shall not submit a Total Compensation Plan with the initial business proposal. Only those offerors those offerors whose proposal remains under consideration will be required to submit an acceptable Total Compensation Plan. Section Four—Small Disadvantaged Business Participation Plan Evaluation of Small Disadvantaged Business (SDB) Participation Plans will be made based on a consideration of all relevant facts and circumstances. It will not be based on absolute standards of acceptable performance. The Government is seeking to determine whether the offeror has demonstrated their commitment and capability to use SDB concerns for the work that it intends to perform as the prime contractor. Evaluation of the Plan will be performed only on those offerors being considered for award. SDB participation will not be scored, but the Government's conclusions about overall commitment and realism of the offeror's SDB Participation Plan will be considered in determining the relative merits of the offeror's proposal. The SDB Participation Plan should address the extent of participation of SDB concerns in performance of the contract. Participation in performance of the contract includes the work expected to be performed by SDB concern(s). This can include SDB (as prime contractor), joint ventures, teaming arrangements, and subcontracts. Include the following information in your SDB participation plan: The extent of an offerors commitment to use SDB concerns. Commitment should be as specific as possible, e.g., are subcontract arrangements already in place; are letters of commitment in place. Enforceable commitments will be weighted more heavily than non-enforceable ones; Specifically identify the SDB concerns with point of contact and telephone number; The complexity and variety of the work SDB concerns are to perform; Realism for the use of SDB in the proposal; Past performance of the offeror in complying with subcontracting plans for SDB concerns; Targets expressed as dollars and percentage of total contract value, in each of the applicable authorized SIC Major Group(s). A total target for SDB participation by the prime contractor that includes any joint ventures and team members* shall be provided, as well as a total target for SDB participation by subcontractors. Targets may be incorporated into and become part of any resulting contract; and The extent of participation of SDB concerns in terms of the value of the total acquisition. NOTE: The SDB Participation Plan is a separate requirement from the Small, Small Disadvantaged and Women-Owned Small Business Subcontracting Plan described in Section 3, item 5. above. Section Five—Representations and Certifications Include in this section of the ORIGINAL PROPOSAL ONLY, the Representations and Certifications required by this particular acquisition. The Representations and Certifications can be accessed electronically from the INTERNET at the following address: http://ocm.od.nih.gov/contracts/rfps/mainpage.htm

ADDITIONAL INFORMATION, INSTRUCTIONS, PROVISIONS, AND REQUIRED CLAUSES

1. Proposal Intent Response Sheet

   Furnish the information requested below and return this page by December 15, 2001. Your expression of intent is not binding but will assist us in planning for proposal evaluation.

   BAA No.: BAA-HL-02-04

   TITLE OF BAA: National Heart, Lung, and Blood Institute Proteomics Initiative
   
   
   I INTEND TO SUBMIT A PROPOSAL

   ---

   COMPANY/INSTITUTION NAME:
   
   
   ADDRESS:
   
   
   
   
   
   PROJECT DIRECTOR'S NAME:

   TITLE:

   TELEPHONE NUMBER:

   NAMES OF COLLABORATING INSTITUTIONS AND INVESTIGATORS
   (include Subcontractors and Consultants):
   
   
   
   
   

   ---

   RETURN TO: Review Branch Attention: Dr. Valerie Prenger Scientific Review Administrator Review Branch, Division of Extramural Affairs NIH, NHLBI 6701 ROCKLEDGE DR MSC 7924 BETHESDA MD 20892-7924

   or fax to: or e-mail to:

   Dr. Valerie Prenger at (301) 480-4755 PrengerV@nhlbi.nih.gov

2. Packaging and Delivery of the Proposal

   Shipment and marking shall be as follows:

   EXTERNAL PACKAGE MARKING
   In addition to the address cited below, mark each package as follows:

   "BAA NO.: BAA-HL-02-04
   TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"

   The number of copies required of each part of your proposal are:
   TECHNICAL PROPOSAL:     ORIGINAL* AND Forty-Five (45) COPIES
   BUSINESS PROPOSAL:     ORIGINAL* AND Six (6) COPIES
   An electronic version of:
   Budget Proposal Spread Sheet (Microsoft EXCEL Spread Sheet)

   DELIVER PROPOSAL TO:

   If hand delivered or delivery service:
   Review Branch
   Division of Extramural Affairs
   National Heart, Lung, and Blood Institute
   Rockledge Building, Room 7091
   6701 ROCKLEDGE DRIVE MSC 7924
   BETHESDA, MD 20817-7924

   If using U.S. Postal Service:
   Review Branch, Division of Extramural Affairs
   National Institutes of Health
   National Heart, Lung, and Blood Institute
   6701 ROCKLEDGE DRIVE MSC 7924
   BETHESDA, MD 20892-7924

   *THE ORIGINAL PROPOSAL MUST BE READILY ACCESSIBLE FOR DATE STAMPING.

3. Late Proposals, Modifications of Proposal, and Withdrawals of Proposals, PHS 352.215-70
   Notwithstanding the procedures contained in the provision of this solicitation entitled Late Submissions, Modifications, and Withdrawals of Proposals, a proposal received after the date specified for receipt may be considered if it offers significant cost or technical advantages to the Government, and it was received before proposals were distributed for evaluation, or within five calendar days after the exact time specified for receipt, whichever is earlier. (End of provision)

4. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data [FAR Clause 52.215-20 (October 1997)]
   
   1. Exceptions from cost or pricing data.
      1. In lieu of submitting cost or pricing data, offerors may submit a written request for exception by submitting the information described in the following subparagraphs. The Contracting Officer may require additional supporting information, but only to the extent necessary to determine whether an exception should be granted, and whether the price is fair and reasonable.
         1. Identification of the law or regulation establishing the price offered. If the price is controlled under law by periodic rulings, reviews, or similar actions of a governmental body, attach a copy of the controlling document, unless it was previously submitted to the contracting office.

         2. Commercial item exception. For a commercial item exception, the offeror shall submit, at a minimum, information on prices at which the same item or similar items have previously been sold in the commercial market that is adequate for evaluating the reasonableness of the price for this acquisition. Such information may include-
            1. For catalog items, a copy of or identification of the catalog and its date, or the appropriate pages for the offered items, or a statement that the catalog is on file in the buying office to which the proposal is being submitted. Provide a copy or describe current discount policies and price lists (published or unpublished), e.g., wholesale, original equipment manufacturer, or reseller. Also explain the basis of each offered price and its relationship to the established catalog price, including how the proposed price relates to the price of recent sales in quantities similar to the proposed quantities;

            2. For market-priced items, the source and date or period of the market quotation or other basis for market price, the base amount, and applicable discounts. In addition, describe the nature of the market;

            3. For items included on an active Federal Supply Service Multiple Award Schedule contract, proof that an exception has been granted for the schedule item.

      2. The offeror grants the Contracting Officer or an authorized representative the right to examine, at any time before award, books, records, documents, or other directly pertinent records to verify any request for an exception under this provision, and the reasonableness of price. For items priced using catalog or market prices, or law or regulation, access does not extend to cost or profit information or other data relevant solely to the offeror's determination of the prices to be offered in the catalog or marketplace.

   2. Requirements for cost or pricing data. If the offeror is not granted an exception from the requirement to submit cost or pricing data, the following applies:
      1. The offeror shall prepare and submit cost or pricing data and supporting attachments in accordance with Table 15-2 of FAR 15.408.

      2. As soon as practicable after agreement on price, but before contract award (except for unpriced actions such as letter contracts), the offeror shall submit a Certificate of Current Cost or Pricing Data, as prescribed by FAR 15.406-2.

      Alternate I (October 1997). As prescribed in 15.408(l), substitute the following paragraph (b)(1) for paragraph (b)(1) of the basic provision:
      (b)(1) The offeror shall submit cost or pricing data and supporting attachments using an Excel spreadsheet. Please submit using the guidance set forth under Sections One and Two of the Business Proposal (Separate Volume), above, and in this clause, Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data.

5. Service of Protest (August 1996)—FAR 52.233-2
   
   1. Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the General Accounting Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:

      Joanne Deshler
      Contracting Officer
      Contracts Operations Branch
      Division of Extramural Affairs
      National Heart, Lung, and Blood Institute
      Rockledge II, Room 6100
      6701 ROCKLEDGE DRIVE, MSC 7902
      BETHESDA MD 20892-7902

   2. The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

6. Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns
   In accordance with FAR Clause 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns, incorporated in Section I.3., offerors will be evaluated by adding a factor of 10 percent to the price of all offers, except offers from small disadvantaged business concerns that have not waived the adjustment. (Note: A listing of other offerors who are excepted and will not have this evaluation factor added to their offer may be found in subparagraph (b) of FAR Clause 52.219-23.

   A small disadvantaged business concern may elect to waive the adjustment, in which case the factor will be added to its offer for evaluation purposes. The agreements in paragraph (d) of FAR Clause 52.219-23 do not apply to offerors that waive the adjustment.

   AN OFFEROR WHO ELECTS TO WAIVE THIS EVALUATION ADJUSTMENT MUST SPECIFICALLY INDICATE WITH A STATEMENT TO THIS EFFECT ON THE COVER PAGE OF ITS BUSINESS PROPOSAL

7. Uniform Resource Locators (URLs) in Contract Proposals
   All proposals must be self-contained within the specific page limitations cited elsewhere in this solicitation. Unless otherwise specified, URLs/Internet addresses shall not be used to provide information necessary to the review because reviewers are under no obligation to review the Internet sites.

8. Sample Contract Format-General
   The sample contract format-general, which is applicable to this BAA, is located at: http://ocm.od.nih.gov/contracts/rfps/SAMPKT.HTM. Selected clauses to be included in the contract will be determined during discussions.