"Re-Engineering the Clinical Research Enterprise: Feasibility of Integrating and Expanding Clinical Research Networks"

(Archive Edition)

Broad Agency Announcement (BAA) No.: BAA-RM-04-23
Issue Date: December 02, 2003
Issued By: John Taylor, Contracting Officer
National Heart, Lung, and Blood Institute
Contracts Operations Branch
Rockledge II Room 6126
BETHESDA MD 20892-7902
Telephone Number: (301) 435-0345
FAX Number: (301) 480-3430
E-Mail: taylorjc@nhlbi.nih.gov
Purchase Authority: 42USC201, Public Health Service Act of 1944
Small Business Set-Aside: No; NAICS 541710
Proposal Intent Due Date: January 30, 2004 (See Proposal Instructions and Information
Proposal Due Date: March 05, 2004 4:30 PM (Eastern Time)

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Potential Offerors:

This initiative is part of the "Re-Engineering the Clinical Research Enterprise" component of the National Institutes of Health (NIH) Roadmap for Accelerating Medical Discovery to Improve Health, described at http://nihroadmap.nih.gov/. This initiative relates closely to a separate solicitation for an inventory of clinical research networks. Information on that solicitation is available from the Contracting Officer.

One long range goal of Re-Engineering the Clinical Research Enterprise is to make the sharing of data among a broad community of clinical researchers a standard practice, by fostering clinical research networks that are based on common or inter-operable infrastructure elements (e.g., informatics, governance, common language, training activities) and that conduct research both in academic and clinical care settings. This will broaden the kinds of research questions that can be addressed and enhance the efficiency of conducting clinical research. Please note that the NIH is not seeking the development of a new network in this feasibility phase. Only existing networks are eligible for this solicitation.

For the purposes of this solicitation, a clinical research network is defined as an organization of clinical field sites and investigators that conducts multiple research protocols, often concurrently. An eligible network may entail varying levels of formality in its organizational structure and linkages provided that the network's collaborative accomplishments can be shown. Observational and outcomes research are included in this definition of clinical research.

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 the Contracting Officer. If you do not notify the Contracting Officer 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 no later than March 5, 2004, 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 January 30, 2004. 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,

John Taylor
Contracting Officer

Technical Objectives
Technical Evaluation Criteria
NAICS Code and Size Standard
Proposals must be in Two Parts
Proprietary Data
Programmatic and Progress Review Meetings
Reporting Requirements
Salary Rate Limitations on Contracts, Grants and Cooperative Agreements
Proposal Format
Technical Proposal (Separate Volume)
Business Proposal (Separate Volume)
  1. Proposal Intent Response Sheet
  2. Packaging and Delivery of the Proposal
  3. Late Proposals, Modifications of Proposal, and Withdrawals of Proposals
  4. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data
  5. Service of Protest
  6. Notice of Price Evaluation Adjustments for Small Disadvantaged Business Concerns
  7. Uniform Resource Locators (URLs) in Contract Proposals
  8. Sample Contract Format General

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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 an approach specified in detail by the Government. Proposals received as a result of the BAA will be evaluated using the peer review process in accordance with evaluation criteria specified below. 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.

The length of time for which funding is requested should be consistent with the nature and complexity of the proposed feasibility study, but the maximum period that will be awarded for a proposal under this solicitation is three years. Funding will be made in increments, with funding for the proposed phases of the project dependent on progress. Awards are expected to be made on or about September 30, 2004. The NIH anticipates awarding approximately 10-12 contracts, based on technical merit, available funds, and importance to NIH programs. Cost realism and reasonableness will be considered to the extent appropriate. Program staff estimates the average total annual cost (direct and indirect costs) for these contracts to be approximately $1,000,000 per year per award. It is anticipated that the amount per award will vary depending upon the scope and capacity of the technical objectives of the award.

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

This initiative will be funding innovative proposals. Thus, it is important that contractors interact to share information on technical objectives, progress and impediments, as well as exchange ideas, and, where appropriate, establish collaborations. Such exchanges will take place, at minimum, during bi-annual meetings and will involve making available tools, platforms, organizational structures and other products developed under the support of this BAA.

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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.

As noted above, one of the long range goals of the clinical research component of the NIH Roadmap is to foster clinical research networks that are based on common or inter-operable infrastructure elements and that conduct research both in academic and clinical care settings. Integrating and expanding clinical research networks will broaden the kinds of research questions that can be addressed and enhance the efficiency of conducting clinical research.

The NIH is soliciting feasibility study proposals that will test methods for achieving these long range goals. Successful models should be developed that can be used by other networks and for dissemination to the clinical research community. Activities that expand, broaden, and optimize existing approaches and can be generalized to the greater clinical research community are essential. These approaches might include, but are not limited to the following:

Projects are needed that show how networks can jointly conduct clinical trials and other multicenter clinical research studies. That is, organizations must show how they can work together to overcome challenges presented by differences in network governance, study management, investigator interests, disease definitions, reporting procedures, core patient data, data and specimen sharing policies, and informatics tools. Sharing of network resources, research forms, and training methods is an important element of becoming truly inter-operable. Many questions need to be addressed. For example, how will networks deal with requirements of the Health Insurance and Portability and Accountability Act (HIPAA) Privacy Rule, the Privacy Act, human subjects protections including coordinated IRB review and approval, and other privacy and confidentiality issues, from the perspective of their impact on network scientific collaborations and objectives? How will intellectual property rights and data sharing goals be advanced simultaneously? How will system security issues, if applicable, be handled? Can existing networks that were formed to answer questions in one medical field examine questions in possibly related, but different medical fields, so that entirely new research network structures need not be established?

Additional issues these feasibility projects may address include training in core competencies for research teams not part of the original network organization, as well as issues of communication, organizational stakeholders and responsibilities, scientific and administrative leadership, methods of setting priorities including opportunity for incorporating minority viewpoints, and problem identification and resolution.

Offerors are expected to be creative in their approaches and to address at least some of the above issues and questions. Offerors also are expected to discuss how they will involve diverse study populations in re-engineering the clinical research enterprise.

The current system of clinical research must change if it is to respond to the scientific and health care needs of the 21st century. Reasons include:

  1. a rapidly increasing rate of growth of health care services and related expenditures;
  2. need for approaches that yield clinically relevant results sooner and with greater consideration of resources needed to implement findings and adapt the results to diverse clinical settings and communities;
  3. need for greater ease in moving from basic science to clinical research (and back).

To address these demands, the clinical research enterprise requires accelerated rates of discovery and clinical validation, find new and more efficient approaches, and identify and explore the advantages of an enhanced infrastructure and multidisciplinary teams.

Possible approaches include creating inter-operable clinical research and clinical trial networks, enhancing informatics tools, and improving training so that clinical research studies may be conducted more efficiently. Clinical research needs to be conducted in settings that lead to better translation of research findings into clinical practice. For the purposes of this solicitation, a clinical research network is defined as an organization of clinical field sites and investigators that conducts multiple research protocols, often concurrently. Not all members of the network need to participate in all protocols to be considered a network. However, a group of investigators that is brought together to conduct a single protocol and is then disbanded, would not be considered a network.

Many networks designed to conduct clinical research exist. These are supported by the NIH and other government agencies, private organizations and industry, and medical practice organizations. They conduct various kinds of clinical research in many medical disciplines, and may be national or international in scope. Because of differences among networks, both in the factors noted above and in others identified by the community of investigators, the current system of conducting clinical research and translating the results into clinical practice is less efficient than it needs to be.

There are a number of barriers to creating successful networks, which can include fundamental differences in informatics infrastructure and communication tools used at various research sites. To the extent that commonalities can be implemented and data and tools shared, studies can be initiated more quickly. If existing networks can broaden their scopes to conduct studies in new areas, the cost and time necessary to establish new research networks can be reduced.

This solicitation is a companion to a contract that is designed to conduct an inventory of existing clinical research networks, assessing their characteristics and evaluating best practices. The results of the inventory will be combined with successful feasibility projects from this BAA in the future development of a National Electronics Clinical Trials and Research (NECTAR) network. The sharing of information and exchange of ideas on technical objectives, progress and impediments that is expected to occur throughout these feasibility projects, and the collaborations that will be established, will be important elements in the development of NECTAR.

Briefly, NECTAR is anticipated to provide the informatics infrastructure that will serve as the backbone for increasingly interconnected and inter-operable research networks. Initially, NECTAR will focus on acquiring an understanding of the hardware and software requirements necessary to achieve connectivity and functionality among systems. It will also explore existing systems that have proven successful and can serve as models for future efforts. This assessment will entail:

  1. selecting the data standards and vocabularies that will form the basis of the system
  2. identifying applications and tools useful to the clinical research community and evaluating their suitability for employment in NECTAR, and
  3. defining the informatics infrastructures and architectures necessary to support the sharing of data and tools across medical disciplines and study types.

Technical Objectives

This BAA will support feasibility projects to enhance clinical research infrastructure in any of several ways. Existing clinical research networks [i.e., both formal and informal associations of investigators, sites, and patient populations] doing clinical research are invited to demonstrate how they can:

  1. increase the scope of network activities to include new scientific questions, disciplines, and or tools and approaches; and/or
  2. increase participation, including appropriate training, within the network to include new sites, new patient populations and/or new investigators; and/or
  3. facilitate the communication and cooperation of one network with one or more additional networks.

These items are only examples for the objectives; variations on these themes are acceptable. Offerors may suggest other areas that might be addressed. Detailed examples are intentionally not provided in this BAA in order to stimulate creativity on the part of the offerors. However, in every case the offeror is required to show how the proposed approach addresses issues such as standardization of patient data collection and storage; information handling and informatics; communication, confidentiality, and data security and data sharing; and technical analysis.

Included within the scope of the BAA is limited funding for demonstration projects designed to show that the approaches described above enhance the conduct and success of clinical research, if this can be done within the time and resources of this feasibility project. Within the technical evaluation criteria below, and in the final selection of offerors, proposals will be considered not only for their technical merit and programmatic interest, but for their ability to illustrate the applications of the enhancements in infrastructure.

Offerors must describe the clinical research networks that will participate. This description must include the kinds of research conducted, the number of participating sites and investigators, the proportion of under-represented minority investigators and populations, the number of protocols conducted, the key policies under which the network operates, and any other relevant information.

A critical component associated with the capacity to extend or join clinical research networks is the information technology used to support the activity. As such, offerors must describe the informatics system underlying their network. Specifically, they must describe the system architecture, software components, and hardware platforms that comprise the information system underlying their clinical network. The proposal should include description of the design methodologies employed to develop the platform and the management strategies associated with maintaining and extending the informatics infrastructure. The proposal should include the systems use of or inter-operability with Department of Health and Human Services (DHHS) information standards (e.g., LIONC, SNOMED, see http://www.aspe.hhs.gov/sp/nhii/Standards.html). As extensibility and/or scalability are critical to the success of this endeavor, the offeror should describe how its informatics platform would need to be altered to accommodate these goals.

A strategic goal of the re-engineering of the clinical research enterprise is assessment of the feasibility of joining of disparate networks. The offeror should describe strategies for opening its information system so that it might interoperate with others. This description could include how the system might exploit computer interfaces and/or how the group would codify and communicate information exchange specifications for its system.

Each feasibility project may be for up to three years for approximately $1,000,000 total costs each year. Funding will be provided in increments, with funding for each year of the project dependent upon successful progress and continued need for the work, as judged by milestones that are established and based on annual assessments by the NIH. Respondents should describe phases and propose milestones appropriate to their projects. When appropriate and possible within the framework of a feasibility project, the proposed project should include an actual clinical research study and/or actual data.

NIH requires the results of the funded feasibility projects to be widely shared. This will occur in part at two meetings that will be held each year with key staff from the NIH and the clinical network inventory contractors. It is anticipated that one of these annual meetings will be open to the public to ensure open access to these results.

It is anticipated that the results from this solicitation, the inventory, and other elements of the Roadmap will be used to develop a follow-up solicitation to obtain new and expanded projects in network connectivity and inter-operability, broader, more generalizable approaches, and dissemination and training in a manner that implements recognized solutions.


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

Program Plan
Each offeror must describe, as a minimum:

  1. the objective(s) being addressed
  2. which areas and questions will be addressed within the objective(s)
  3. which network(s) are participating, and/or which areas of expansion are being included
  4. the approaches by which the questions will be addressed
  5. the criteria by which project progress will be evaluated
  6. how the results of the project will be disseminated
  7. how the results of the project will be integrated into the overall goals of this solicitation.

The offeror must provide sufficient detail, including descriptions of the participating networks and evidence of collaboration from them, to allow for evaluation of the feasibility and merit of the proposal.

It is required that offerors agree to produce structured data utilizing accepted information standards.

Special Requirements


Development of this initiative has been on a fast track as part of the NIH Roadmap effort. Part of the overall structure for accomplishing the goals and objectives of the re-engineering of the clinical research enterprise will be to establish an ongoing, coordinated means of involving NIH staff in the monitoring of the contract work. In addition, it is recognized that the innovative and complex problem-solving that is expected in response to this initiative will require ongoing modification and adjustments to contractors' plans and approaches, and that the Government's monitoring of, and response to these modifications and adjustments will need to be informed and timely. Therefore, the NIH plans to put in place a Program Office Monitoring Committee (POMC) comprised of representatives from various Institutes at NIH. Contractors should plan to include POMC representation and input in their overall approach. For example, it would be appropriate for the POMC to review and comment on progress reports and proposed changes in the Program Plan, and to attend the twice yearly meetings.

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All proposals received on time will be submitted for peer review. This review will be arranged and conducted by the Review Branch, DEA, NHLBI. Following peer review, all proposals and peer review summaries will be subjected to a second review by NIH staff to advise the Contracting Officer on the proposals that should be considered further. Questions arising from the review process will be sent to those offerors being considered further. Cost negotiations may be necessary with those offerors as well.

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). The evaluation will be based on the demonstrated capabilities of the prospective offerors in relation to the evaluation criteria as set forth below. Each proposal must document the feasibility of successful implementation of the requirements of the BAA Importance to agency programs and fund availability shall be considered in the selection decision as well.

In addition, cost realism and reasonableness shall also be considered to the extent appropriate. All evaluation factors other than cost/price, when combined, are significantly more important than cost/price.

Evaluation of Small Disadvantaged Business (SDB) Participation Plans will be made based on a consideration of all relevant facts and circumstances, not on absolute standards of acceptable performance. Past performance will not be evaluated as a "stand-alone factor" independent of the technical evaluation. Instead, past performance is considered to be a part of the technical evaluation criteria shown below, and in determining an offeror's responsibility in accordance with FAR 9.104-3(b).

Final selection of awards will depend upon scientific merit, the proposed costs in relation to availability of funds, and program importance within the NIH at the time of award selection. The NIH reserves the right to select a variety of technical approaches.

The evaluation criteria are used by the Technical Evaluation Panel when reviewing the technical proposals. The criteria below are listed in relative order of importance with weights assigned for evaluation purposes.

Evaluation Factors
50 Points
    Importance of the questions and barriers being addressed to the overall objectives of this solicitation, including relevance to the United States clinical research enterprise; innovation and feasibility of the proposed project, including approaches and ability to illustrate the applications of the enhancements in infrastructure; ability to increase network effectiveness and efficiency; evidence of necessary collaboration from networks and other organizations; innovation and integration of the informatics elements with the scientific issues; adequacy of time frame, milestones, and Program Plan.
25 Points
    Qualifications, experience, and availability of proposed key personnel for all collaborating organizations. Does the proposal provide documentation of competence and experience of professional, administrative, and technical staff pertinent to the objectives being addressed? Is the proposed effort reasonable and appropriate to the technical approach?
25 Points
    Evidence of organizational capabilities and necessary collaboration among networks and other organizations. Are the institutional experience, proposed administrative structures and responsibilities, and management plan appropriate and supportive of the proposed work? Is the organizational commitment to the project evident and appropriate for all participating organizations? Is involvement of under-represented minority populations and investigators adequate? Are the facilities, resources and equipment adequate? Are there plans for efficient and effective use of available resources? Are the informatics components in place and clearly described?

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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 (See Section 5 of the Business Proposal instructions of this BAA), 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.


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 contractor will present information on technical objectives, progress, and impediments. The participants at these semi-annual meetings will include investigators, key network participants, clinical network inventory participants, 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 and other senior investigators.

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

Program Plan and Milestones
An updated Program Plan, with milestones, shall be submitted 30 days after contract award for review and approval. The plan shall identify the objective(s) being addressed, areas and questions within that objective being addressed, participating networks and/or areas of expansion, approaches to be used, and any technical risks and critical decision points. It shall include a one page graphic that reflects, task-by-task, when the key milestones will be met. All revisions to the approved plan shall be submitted to the NHLBI for review and approval.

Quarterly Progress 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 narrative form (3-5 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, and manuscripts in progress, submitted or published.

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 Reports

  1. 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.
  2. 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.
  3. An executive summary, to include:
  4. A statement of intended work for the reporting period;
  5. A brief overview of the work that was completed for the reporting period;
  6. A brief overview of any problems (technical or financial) that occurred during the current reporting period and their resolution or status;
  7. The advancements made in relation to any of the technical tasks and/or milestones set forth in the Statement of Work;
  8. An update to the Program Plan;
  9. A summary of activities planned for the next reporting period;
  10. Copies of manuscripts (published or unpublished) derived from research under the contract and copies of all abstracts, manuscripts, preprints 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;
  11. An update of plans for dissemination, including time line and discussion of dissemination made to date; and
  12. Full disclosure of any efforts to transfer any technology or receipt of support from outside entities interested in future access, partnering, or license to the developing technologies.

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 $171,900. 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 clearly identifying the technical objective(s) being addressed, the specific areas being targeted, and the Program Plan and milestones to be followed in accomplishing the objectives 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. Margins must be set to one inch all around.)

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.
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 which technical objective(s) you are proposing to research.
The proposal should include milestones and time-line for implementation of those milestones for each objective. The milestones should be presented as a one page graphic that reflects, task-by-task, when the key milestones of the pilot will be met.
PROGRAM (TECHNICAL) PLAN (LIMIT 30 single-sided or 15 double-sided, single 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. Proposals should outline a technical plan with clearly defined milestones of progress and key decision points. This section should also discuss and reference ongoing or previous work by the offeror, and the participating networks and/or areas of expansion, that would be relevant to the proposed program.

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 points, 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 changes in other areas of the NIH Roadmap, and otherwise, that are anticipated in relation to this initiative.

Section Two–Offeror's Qualifications, Qualifications of Network Participants and/or Areas of Expansion, and Management Plan
This section should present a discussion of offeror's qualifications for leading the effort proposed, including record of participation in research networks and leadership roles carried out. It is anticipated that the complexity of the areas to be addressed within the technical objectives will require that expertise from a variety of disciplines be engaged in the process. Proposals should address the breadth of expertise required for completion of the project, capabilities and responsibilities of all network participants, and plans for recruiting additional expertise and/or expanding the areas of interest. Multidisciplinary teams are strongly encouraged and appear essential to accomplishing the overall goals. Proposed management structure and choice of key network leaders should be discussed. This section should include a discussion of the composition of and the synergy among the participating groups, and a management plan that details their interactions. This section should also address the programmatic relationship of participating members; their scientific and technical expertise as it relates to the proposed project; task responsibilities assigned to each; the teaming strategy among the participating 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 provided. 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 and Resources
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 any resulting technology and/or its application, including any plans for engaging commercial partners and support. A plan which identifies any products (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, if relevant.
The proposal may contain a brief bibliography of relevant papers and research notes (published and unpublished) which document the ideas upon which the proposal is based. Proposals may include copies of not more than three (3) relevant papers in the proposal.
List each Appendix and identify the number of pages for each one. Appendices must be clear and legible, and easily located. Include biosketches here. Limit Appendices to 100 single-sided or 50 double-sided pages.

Include Human Subjects Assurances: 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 participating network members and consultants.

Business Proposal (Separate Volume)
Form located at: http://ocm.od.nih.gov/contracts/rfps/FORMS1.HTM
The cover sheet shall provide the following information:
  • 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.
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
  1. 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:


    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 the Contracting Officer.

  2. In preparing your budget proposal, the following should be considered:
    1. The NIH views the funding of these contracts as high-visibility, high-potential, with the contractor potentially receiving a substantial benefit for successful projects. Accordingly, the NIH does not consider the inclusion of Fee or Profit appropriate for these contracts.
    2. 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.

  1. Provide the following supporting documentation:
    1. 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.
    2. 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.
    3. Vendor quotations, catalog prices, etc., that document the proposed material and supply costs.
    4. 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.
    5. Travel and meeting costs in direct performance of the contract. Identify locations, dates, number and identity (or roles/responsibilities) of attendees, purpose of proposed meetings, and basis for estimated costs.
    6. 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.
    7. Copies of negotiated indirect cost (IDC) rate agreements. If no current IDC rate agreement is in effect, provide specific documentation 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
  1. 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.

    1. The solicitation number (or other procurement identification number).
    2. The offeror's name and remittance address, as stated in the offer.
    3. The signature (manual or electronic, as appropriate), title, and telephone number of the offeror's official authorized to provide this information.
    4. The name, address, and 9-digit Routing Transit Number of the offeror's financial agent.
    5. The offeror's account number and the type of account (checking, savings, or lockbox).
    6. If applicable, the Fedwire Transfer System telegraphic abbreviation of the offeror's financial agent.
    7. 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.

  2. 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.

  3. Annual Report
    Include in this section of the ORIGINAL PROPOSAL ONLY, a copy of the organization's most recent annual report.

  4. 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.

  5. 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/ [select FORMS]

    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

  6. Facilities Capital Cost of Money
    See http://ocm.od.nih.gov/contracts/rfps/INSTOPT.HTM#Optional N

  7. 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:

  1. 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;
  2. Specifically identify the SDB concerns with point of contact and telephone number;
  3. The complexity and variety of the work SDB concerns are to perform;
  4. Realism for the use of SDB in the proposal;
  5. Past performance of the offeror in complying with subcontracting plans for SDB concerns;
  6. 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
  7. 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 elsewhere in this solicitation.

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:


If you are unable to access this document electronically, you may request a copy from the Contracting Officer.

Table of Contents (hyperlink back to Table of Contents)


  1. Proposal Intent Response Sheet

    Furnish the information requested below and return this page by January 30, 2004. Your expression of intent is not binding but will assist us in planning for proposal evaluation.

    BAA No.: BAA-RM-04-23

    TITLE OF BAA: Re-Engineering the Clinical Research Enterprise: Feasibility of Integrating and Expanding Clinical Research Networks







    (include Participating Networks, Subcontractors and Consultants–Use additional pages as necessary):

    Review Branch
    Attention: Anne Clark
    Scientific Review Administrator
    Review Branch, Room 7214
    Division of Extramural Affairs
    6701 ROCKLEDGE DR MSC 7924
    BETHESDA MD 20892-7924
    or fax to: 301-480-0730
    or e-mail to: ac42y@nih.gov

  1. Packaging and Delivery of the Proposal

    Shipment and marking shall be as follows:

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

    "BAA NO.: BAA-RM-04-23


    The number of copies required of each part of your proposal are:
    An electronic version of:
    Budget Proposal Spread Sheet (Microsoft EXCEL Spread Sheet)


    If hand delivered or delivery service:
    Review Branch
    Division of Extramural Affairs
    National Heart, Lung, and Blood Institute
    Rockledge Building, Room 7091
    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
    BETHESDA, MD 20892-7924


  1. 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)

  1. 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.

  1. 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:

      John Taylor
      Contracting Officer
      Contracts Operations Branch
      Division of Extramural Affairs
      National Heart, Lung, and Blood Institute
      Rockledge II, Room 6126
      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.

  1. 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.


  1. 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.

  1. 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.

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