| 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 6701 ROCKLEDGE DR MSC 7902 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) |
Home :: NHLBI
RFP Directory :: NIH
RFP Directory
COMBINED SOLICITATION FORM AND COVER LETTER
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
Table of Contents (hyperlink back to Table of Contents)
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.
Table of Contents (hyperlink back to Table of Contents)
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
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.
Background
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:
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:
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:
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.
Milestones
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:
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
NIH PROGRAM OFFICE MONITORING COMMITTEEDevelopment 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.
Table of Contents (hyperlink back to Table of Contents)
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.
TECHNICAL EVALUATION CRITERIA
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 |
Weight | |
|---|---|---|
|
50 Points | |
|
||
|
25 Points | |
|
||
|
25 Points | |
|
||
Table of Contents (hyperlink back to Table of Contents)
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.
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.
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].
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
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
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.)
| 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 which technical objective(s) you are proposing to research. |
||
| MILESTONES | Page 4 | |
| 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. |
||
| LITERATURE CITED | Page # | |
| 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. |
||
| 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. 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) | ||
| 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:
|
||
| 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
|
||
| 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.
|
||
Section Three–Additional Business Data
|
||
| 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:
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: http://ocm.od.nih.gov/contracts/rfps/mainpage.htm 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)
ADDITIONAL INFORMATION, INSTRUCTIONS, PROVISIONS, AND REQUIRED CLAUSES
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
I INTEND TO SUBMIT A PROPOSAL
COMPANY/INSTITUTION NAME:
ADDRESS:
PROJECT DIRECTOR'S NAME:
TITLE:
TELEPHONE NUMBER:
NAMES OF COLLABORATING INSTITUTIONS AND INVESTIGATORS
(include Participating Networks, Subcontractors and Consultants–Use additional pages as necessary):
| RETURN TO: | ||
| Review Branch Attention: Anne Clark Scientific Review Administrator Review Branch, Room 7214 Division of Extramural Affairs NIH, NHLBI 6701 ROCKLEDGE DR MSC 7924 BETHESDA MD 20892-7924 |
or fax to: | 301-480-0730 |
| or e-mail to: | ac42y@nih.gov |
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-RM-04-23
TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"
The number of copies required of each part of your proposal are:
TECHNICAL PROPOSAL: ORIGINAL* AND THIRTY (30) 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.
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.
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
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
Top | NIH RFP Directory | NHLBI RFP Directory
RFP References | NIH Home | NHLBI Home