"Translational Behavioral Science Research Consortia"

BAA-HC-02-07

Broad Agency Announcement (BAA): BAA-HC-02-07
Issue Date: October 31, 2001
Issued By: Eve Schaefer, Contracting Officer
National Heart, Lung, and Blood Institute (NHLBI)
Contracts Operations Branch
Rockledge II, Room 6100
6701 ROCKLEDGE DR MSC 7902
BETHESDA MD 20892-7902
Telephone Number: (301) 402-3670
Fax Number: (301) 480-3430
E-Mail: es204n@nih.gov
Purchase Authority: 42USC201, Public Health Service Act of 1944
Small Business Set-Aside: No; NAICS 541710
Proposal Intent Due Date: January 15, 2002 (See Proposal Instructions and Information)
Proposal Due Date: March 04, 2002, 4:30 PM (Eastern Time)


COMBINED SOLICITATION FORM AND COVER LETTER

Ladies and Gentlemen:

The National Heart, Lung, and Blood Institute (NHLBI) is issuing this solicitation to stimulate the application of basic behavioral sciences to the development of novel approaches for changing behavioral risk factors for heart, lung, blood, and sleep diseases and disorders. It is intended to encourage the formation of research consortia in which interdisciplinary teams of basic and applied social scientists conduct independent but coordinated studies pursuing common objectives. In some cases these teams will involve basic behavioral scientists who have not previously applied their findings to a particular disease or disorder. The studies within each set of coordinated projects, or consortia, will involve: 1) basic research aimed at developing and testing evidence-based theories from the behavioral or social sciences concerning cognitive, affective, motivational, developmental and other factors and processes underlying human behavior, and 2) applied, clinical research in which the knowledge gained from the applicable basic behavioral science studies would be used to develop and test methods to encourage adoption and maintenance of healthy lifestyle, manage behavioral risk factors for heart, lung, and blood diseases and sleep disorders, or other applications in preventive or clinical medicine. It is expected that proposals with a wide variety of technical and scientific approaches will be submitted and that multiple awards will be made.

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 Eve Schaefer, NHLBI Contracting Officer. If you do not notify the contracting office of your intent to submit a proposal, you will not receive an individual notice of any amendments to the BAA, if any are issued. However, all amendments will be posted on the NHLBI web site.

Proposals must be received no later than March 4, 2002, 4:30 P.M. (Eastern Time) at the address listed in the attachment 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 15, 2002. This will allow us to prepare for the review of proposals. Your proposal must be organized and submitted in accordance with the "Proposal Format." These attachments are located 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,


Eve Schaefer
Eve Schaefer
NHLBI Contracting Officer


TABLE OF CONTENTS
 
INTRODUCTION
 
BACKGROUND AND TECHNICAL OBJECTIVES
Background
Technical Objectives
Requirements
 
EVALUATION FACTORS FOR AWARD
General
Technical Evaluation Criteria
 
PROPOSAL INFORMATION AND INSTRUCTIONS
NAICS Code and Size Standard
Proposals must be in Two Parts
Proprietary Data
Reporting Requirements
Salary Rate Limitations on Contracts, Grants and Cooperative Agreements
Proposal Format
Technical Proposal (Separate Volume)
Business Proposal (Separate Volume)
 
ADDITIONAL INFORMATION, INSTRUCTIONS, PROVISIONS, AND CLAUSES
  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


Table of Contents
INTRODUCTION

BAAs are used by agencies to fulfill their requirements for scientific study and experimentation directed toward advancing the state-of-the-art or increasing knowledge or understanding rather than focusing on a specific system or hardware solution. Proposals received as a result of the BAA will be evaluated in accordance with evaluation criteria specified herein through a peer review process. Proposals will not be evaluated against a specific Government need, as in the case of a conventional RFP, because they are not submitted in accordance with a common statement of work.

It is anticipated that multiple awards will result from this solicitation. The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. The maximum period acceptable for a proposal under this solicitation is five years. Awards are expected to be made on or about September 30, 2002. The NHLBI anticipates awarding approximately three or four contracts, based on technical merit, available funds, and programmatic balance. Annual costs (direct and indirect costs) for these awards is estimated to be approximately $1,250,000 per contract. The amount of each contract will vary depending on the scope of the technical objectives proposed.

Contracts 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 proposals at the cutting edge of science. Thus, it is important that the funded consortia interact to share information on technical objectives, progress and impediments, as well as exchange ideas, and, where appropriate, establish collaborations.

Table of Contents
BACKGROUND AND TECHNICAL OBJECTIVES

This section presents the background for this solicitation 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. Contracts awarded as a result of this BAA will incorporate the statement of work proposed by the offeror and negotiated and accepted by the Government.

Background

Adoption and maintenance of healthy lifestyles and management of risk factors are critical elements in preventing and treating heart, lung, blood and sleep diseases and disorders, but implementing behavioral change and successfully maintaining change over time are very difficult for most individuals. Much of what is known about promoting healthy lifestyles is based on findings from the behavioral sciences. However, while theories from the behavioral sciences have been used successfully to understand and change health-related behavior (e.g., Brownlee, Leventhal & Leventhal, 2000; Glanz & Rimer, 1995; Leventhal & Cameron, 1987), much greater potential exists in the behavioral sciences than currently is being realized.

Review of the psychological literature shows that a large research effort has been underway to uncover the principles which govern how human beings perceive the environment, process information, make decisions, form and change attitudes, beliefs and values, and become and remain motivated to change behavior. However, diffusion of new concepts and discoveries from the basic behavioral and social sciences to address major issues facing physical health and illness could be more rapid. Many innovative, cutting-edge findings from basic behavioral research could be relevant and advance the prevention and treatment of heart, lung, blood diseases and sleep disorders.

For example, cognitive psychologists have investigated "cognitive biases," or patterns in the way people typically view the world based on individuals' needs to organize and make sense of the environment. Studies show that people tend to categorize objects as starkly black and white, as dangerous or healthy, with inadequate consideration of exposure or dose (Redelmeier, Rozin & Kahneman, 1993). Research on presentation of information has shown that when information on operative procedures is framed in terms of mortality rather than survival, patients are more anxious and less likely to elect surgery, even if other available choices result in less favorable outcomes (McNeil et al., 1982). These findings may explain why patients sometimes seem to act against their own self-interests, as when they exhibit poor adherence to medical and lifestyle recommendations. They may also suggest why health care providers often fail to implement evidence-based practice guidelines, because cognitive and affective processes could also be expected to influence providers' perceptions of a patient's degree of risk and decisions regarding the appropriate course of treatment.

Technical Objectives

The objective of this solicitation is to promote translation of innovative, cutting-edge findings from basic behavioral research to the prevention and treatment of heart, lung, blood, and sleep diseases or disorders. Proposals responsive to this solicitation will involve a set of linked, interactive research projects (with each set of projects referred to as a consortium) from a single institution or from different institutions, involving collaboration between basic behavioral scientists and clinical researchers pursuing a common objective. Although individual research projects within each consortium will be expected to stand on their own merits, hypotheses and specific aims of basic and applied research projects must be coordinated to address significant problems in the prevention of heart, lung, and blood diseases and sleep disorders.

Each set of coordinated translation research projects, or consortium, should include both basic and applied research. For example, one or more projects within a particular consortium may involve laboratory research that tests predictions based on some specific, evidence-based model of human behavior—for example, social cognitive theory, classical conditioning models, decision-making, or information-processing models. Findings from this study or studies might be tested in a clinical setting in order to examine their applicability to disease prevention, including change and long-term maintenance of health-related behaviors over time or adherence to medical treatment regimens. In turn, findings from the clinical research could be used to refine the theoretical model. Thus, laboratory-based studies seeking to develop and refine models of human behavior relevant to preventing and treating disease, larger clinical studies testing the models within a specific health context, and small, focused studies to further refine aspects of the model or models are expected to coexist in the group of coordinated projects. Proposals must provide for a structure for systematic review of progress and cross-fostering of information between basic and applied studies.

Three or four consortia are anticipated to be funded, with each consortium consisting of three to four separate studies or projects and two to four cores that involve coordination/oversight of key elements of the individual projects' implementation, such as recruitment, dissemination, biostatistics, and training. Each consortium must have an administrative core. A recruitment core is recommended, but not required.

The studies or projects within each consortium may start or terminate at any time during the contract period, but at least two (and not more than four) must be active at all times. The decision regarding the number of studies/projects to propose should be based on the ability to provide adequate funding to program activities. The Principal Investigator of the consortium must be a Principal Investigator on one of the component studies, and each component study must have a different Principal Investigator.

The administrative core is central to each consortium. Activities of this core should include: 1) providing administrative advice and guidance on possible applications that arise from the research projects, and materially assisting the application of these results; 2) facilitating collaborative work across the projects by coordinating data collection and providing technical support and guidance to the individual projects as needed; 3) monitoring individual component projects; and 4) assessing the progress and reassigning resources as needed during the course of the award (major changes must be approved by the NHLBI). The day to day running of the administrative core will be coordinated by the Principal Investigator of the consortium.

Because this BAA involves translational research, conventional methods of recruiting and testing participants may not always be appropriate. Therefore, offerors may choose to establish a recruitment core. The roles of this core would be to 1) function as the liaison with community groups who can assist in recruitment and retention; 2) consult community groups about planned studies; 3) recruit and maintain contact with participants; 4) assist in making assessment arrangements either in the laboratory or at test sites; 5) collect standardized demographic information or general performance batteries from participants; 6) assist in collecting information about participants from public records; and 7) support modest payments for participation and transportation to facilitate recruitment and retention of hard to reach groups.

Each set of projects should focus on a single organizing theme, rather than cover the spectrum of problems that may be addressed related to behavioral risk for heart, lung, blood, and sleep disorders. For example, a consortium might focus on basic and applied research related to framing and presentation of health-related messages, or address individuals' motivation to engage in various behaviors, including healthy and unhealthy behaviors.

The following are examples of research relevant to this solicitation it is important to note that these examples are provided only for purposes of illustration, and are not intended to imply either limitations or priorities:

  1. Application of principles and findings from social psychological theory and research on attitude change, from cognitive psychology on how people perceive and process information, and from marketing theory to develop innovative methods to better frame public messages to encourage people to engage in health-promoting behaviors.

  2. Investigations of cognitive biases that lead to sub-optimal decisions concerning behavioral and medical risks, as in "categorical" thinking, time discounting, and perception of risk.

  3. Applications of models from social, developmental and cross-cultural psychology, and from other relevant disciplines, such as anthropology and sociology, to design novel regimens of primary and secondary behavior change programs for individuals from various ethnic, socioeconomic, and age groups.

  4. Examination of the conditions under which an individual's emotional responses to a perceived health threat become counterproductive, resulting in a minimization or denial of a medical condition and subsequent inaction rather than engagement in behaviors designed to treat the condition or prevent disease progression.

  5. Investigations of the psychological underpinnings of individuals' choices among competing goals, needs, and demands (e.g., time or money costs; losses of pleasurable experiences; status effects of undertaking lifestyle changes or following medical recommendations).

Requirements

Program Plan
A preliminary program plan must be submitted in the offeror's proposal. In addition, a program plan shall be submitted 30 days after contract award for review and approval. The plan shall identify technical risks and critical decision points that are expected to result, and include a one-page graphic that reflects, task by task, when the key milestones of the consortium will be met.

Dissemination Plan
The proposed plan should include a discussion of intellectual property and patenting, if any, specific plans for dissemination of the results of the consortium, and a timeline. A separate spreadsheet or table is acceptable.

Human Subjects
This research includes human subjects. Offerors must make every effort to seek out and include, where feasible and appropriate, (a) women of all age groups, and (b) U.S. racial/ethnic minority populations (American Indian or Alaskan Natives, Asian or Pacific Islanders, Blacks, Hispanics) in the study population. Where inclusion of minority populations is not feasible, the offeror must submit with the technical proposal a brief but clear rationale for exclusion of one or both groups from the study population. Demonstration of an adequate subject number must also contain documentation of the inclusion of women and minorities. Human Subject Certification by the local institution's IRB must be obtained prior to participant contact.

OMB Clearance
Clearance of all forms used for any proposed participant recruitment, interim contact, and clinic examinations and scans that represent a burden of time to the participant must be cleared by the Office of Management and Budget (OMB) prior to use in the study, unless the study is determined to be appropriate for a clinical exemption.

Table of Contents
EVALUATION FACTORS FOR AWARD

General
The Government will make awards to the responsible offeror(s) whose proposals provide the best value to the Government. For this solicitation, all evaluation factors other than cost or price, when combined, are significantly more important than cost or price. However, cost realism and reasonableness also shall be considered to the extent appropriate.

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

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

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

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

Evaluation Factors
 
Weight
 
TECHNICAL MERIT 40 Points
Overall technical feasibility of the proposed project and adequacy and relevance of the proposed research plan. Are the designs of the studies proposed adequate and appropriate for the question(s) being asked? Are the eligibility criteria, target population, and outcomes well specified and appropriate to the study? Is the ability to recruit the study participants needed to achieve the required sample size well documented for each study proposed? Are appropriate response or outcome measures selected and are they measured in a valid and reliable manner? Are interventions well specified and appropriate to achieve the desired results? Is compliance to the protocol monitored for each study proposed? Is an appropriate sample size, power, and statistical/analytic approach proposed for each study? Are the data management and quality control procedures adequate to maintain the quality of the studies proposed? Are the investigators aware of the scientific, ethical, and practical issues underlying the proposed studies and are appropriate plans in place to deal with them?
 
OFFEROR'S CAPABILITIES 30 Points
Qualifications, capabilities, experience, and availability of proposed key personnel. Does the proposal provide documentation of specific competence and experience, as well as availability, of professional, administrative, and technical staff pertinent to the research being proposed that is, knowledge of theories and techniques of cognitive, motivational, development, social, or other basic behavioral/social science areas; knowledge of the design and conduct of basic experimental and/or laboratory research; experience in conducting laboratory experiments using human subjects in the disciplines of cognitive psychology, social psychology, or related areas of social science and psychology; design, recruitment, screening and randomization of participants in clinical trials and other clinical research; delivery of interventions; measurement of treatment efficacy; and collaboration with other investigators?

Does this proposal document availability of scientific and administrative staff with expertise in areas such as clinical cardiology, psychology, psychiatry, patient recruitment and data collection, survey research, biostatistics, and management of clinical research suitable for the proposed research?
 

SIGNIFICANCE OF QUESTION(S) AND APPROACH 15 Points
Does the proposal address important questions regarding behavioral or psychological risk factors for heart, lung, blood and/or sleep diseases and disorders? Does the approach proposed include studies designed to address basic behavioral/social processes (e.g., cognitive, motivational, emotional, social, developmental) that are hypothesized to underlie the question(s) being addressed, as well as application of this basic research to prevention or treatment of heart, lung, blood, and/or sleep diseases and disorders?
 
INSTITUTIONAL EXPERIENCE AND FACILITIES 15 Points
Are the institutional experience and facilities adequate, including prior experience in basic and clinical research and the availability and adequacy of proposed facilities and equipment? Are the administrative structure and ability to coordinate multiple studies adequately developed and appropriate? Is there evidence of institutional commitment to the project?
 
TOTAL: 100 Points

Table of Contents
PROPOSAL INFORMATION AND INSTRUCTIONS

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.

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

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

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

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

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

COORDINATING COMMITTEE
There will be a Coordinating Committee for this project, composed of the Principal Investigators (PIs) and the NHLBI Project Officers. The Coordinating Committee will have primary responsibility for coordinating efforts across the consortia. The Chair of the Coordinating Committee will be appointed by the NHLBI. Contractor progress will be monitored by the NHLBI using progress reports, Coordinating Committee meetings, conference calls, and site visits as necessary. Other committees may be formed regarding recruitment, publications, etc.

In performance of the work, PIs will be expected to attend two Coordinating Committee meetings per year. For the purposes of estimating costs, offerors should assume two, two-day meetings per year will be held in the Washington, DC, metropolitan area with attendance by the PI and up to two other investigators.

Contractor progress will be evaluated by recruitment reports, site visits, and periodic progress reports detailing technical and financial progress on an annual basis (as detailed above).

DATA SAFETY AND MONITORING BOARD
A Data and Safety Monitoring Board (DSMB) will be established to monitor data and oversee patient safety in clinical trials. The DSMB will review the proposed clinical trial protocol prior to implementation. The protocol will define study background, design, measurement, intervention, outcomes, quality control procedures, safety monitoring, analysis approach, and rules regarding access to data, type of data entry system, and publication process. Progression from protocol development to participant enrollment in clinical trials is dependent upon the favorable recommendation of the DSMB and approval of NHLBI. The DSMB will review progress at least annually and report to the NHLBI. Their charge is to monitor baseline data, adverse effects, and response variable data, and to evaluate progress. It has the responsibility to recommend whether the study should continue, whether the protocol should be modified, or whether to take other actions. Their judgements concerning the ethical conduct of research and the scientific integrity of the study are of paramount importance to the NHLBI. The DSMB will provide reports to the Institute through the DSMB chair.

Reporting Requirements

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

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

Abstracts and Manuscripts
Abstracts and Manuscripts in progress and proposed for publication shall be provided to the NHLBI for review and comment 30 days prior to submission for publication.

Monthly Recruitment Reports
This report shall describe progress in achieving recruitment goals in terms of overall recruitment and in recruitment of specific subgroups, such as minorities and women.

Interim Progress Reports
This semi-annual report shall document and summarize all work results for the previous six-month period. This report shall be in sufficient detail to explain comprehensively the results achieved. The report should be in letter form (2-3 pages) to both the Contracting and Project Officers. The report should include progress for the elapsed six months, problems encountered during the period, a discussion of milestones met or missed, a summary of activities planned for the next six months, and manuscripts in progress, submitted, or published.

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

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

  1. Face page to include contract number, title, period of performance being reported, Contractor's name and address, telephone and facsimile numbers, and date of submission.

  2. An executive summary, to include:
    1. A statement of intended work for the reporting period;
    2. A brief overview of the work that was completed for the reporting period;
    3. A brief overview of any problems (technical or financial) that occurred during the reporting period and their resolution or status;
    4. The advancements made in relation to any of the technical tasks and/or milestones set forth in the statement of work;
    5. An update to the Program Plan;
    6. A summary of activities planned for the next reporting period;
    7. A full description of data pertaining to:
      1. The work performed during the reporting period;
      2. The materials and methods pertaining to the work; and
      3. The relationship between the accomplishments made relative to the goals, objectives, and milestones of the statement of work
      4. Problems encountered and their resolution.
    8. 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 resulting from this work must cite the support received from this award
    9. An update of the Dissemination Plan, including time line and discussion of dissemination made to date.
    10. Full disclosure of intent to file patent applications in the U.S. or outside of the U.S. on materials, animal models, or procedures derived or established by the work supported under this contract; full disclosure of patent applications filed in the U.S. or outside of the U.S. as well as copies of patent applications.
    11. Full disclosure of any efforts to transfer the technology or receipt of support from outside entities interested in future access, partnering, or license to the developing technologies.
  3. The initial report will be submitted for the first full 12 months of 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.

Data and Safety Monitoring Board (DSMB) Reports
This report shall be submitted one month prior to DSMB meetings. The report shall be an update to the Annual Technical Report and shall be in the same format as the Annual Technical Report. The Project Officer may request, on an as needed basis, additional information not included in the Annual Technical Report or Data and Safety Monitoring Board Report.

Final Technical 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 ceiling is $161,200. Updates of this ceiling may be found at: http://ocm.od.nih.gov/contracts/rfps/MAINPAGE.HTM

Proposal Format

Your proposal should be organized according to the following outline.

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

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

TECHNICAL PROPOSAL COVER SHEET Page 1
The Technical Proposal Cover Sheet is a form that must be completed in full detail and used as the cover sheet for each copy of your technical proposal. It may be accessed at http://ocm.od.nih.gov/contracts/rfps/FORMS1.HTM. The information contained in the form will be used to insure that there will be no conflicts of interest when selecting review committee members.
 
TECHNICAL PROPOSAL TABLE OF CONTENTS
 
Page 2
 
ABSTRACT Page 3
Identify the BAA Number, Institution, and Principal Investigator of the Consortium 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.
 
MILESTONE PLAN Page 4
This plan should include scientific milestones and time-line for implementation of those milestones for each aim, goal, objective, and study proposed. The plan should include a one page graphic that reflects, task-by-task, when the key milestones of the consortium will be met.
 
TECHNICAL PLAN Page #
Section One—Detailed Technical Plan and
Proposed Statement of Work This section should include a detailed description of the research to be conducted within a given consortium, with an overall description of each consortium and a separate description for each component project and core.

The overall consortium description should consist of an abstract, the specific aims for the overall consortium, background and preliminary studies, significance of research, and a listing of the component projects and cores. Include a detailed description of the specific technical steps to be taken, rationale, technical challenges likely to be encountered, alternative approaches that might be considered and justification of approach. Describe the proposed innovative science as "approachable" or "high risk." Given the level of innovation sought in this BAA, it is anticipated that proposals may carry substantial technical risk. Areas of highest technical risk should be identified and discussed, as well as potential alternative approaches and methods to be used to evaluate study objectives over time. Proposals should outline a technical plan with clearly defined quantifiable milestones or progress and key decision points. This section should also discuss and reference ongoing or previous research by the offeror, and the research team, related to the proposed program. THE DESCRIPTION OF THE OVERALL CONSORTIUM SHALL NOT EXCEED 25 PAGES.

Each consortium is expected to consist of three to four separate studies or projects and two to four cores that involve coordination/oversight of key elements of the individual projects' implementation, such as administrative, recruitment, dissemination, biostatistics, and training components. The proposal should describe in detail the nature of each component project and core. The description should include, for each project, the specific aims, research design and methods to include description of population, procedures, and timeline—human subjects issues and personnel. THE DESCRIPTION OF EACH COMPONENT PROJECT SHALL NOT EXCEED 25 PAGES PER PROJECT. The plan for each core should detail the specific aims, methods, and personnel for that core. THE DESCRIPTION OF EACH CORE SHALL NOT EXCEED 10 PAGES PER CORE.

While individual research projects within each consortium will be expected to stand on their own merits, hypotheses and specific aims of basic and applied research projects must be coordinated to address significant problems in the prevention of heart, lung, and blood diseases and sleep disorders. Details of how the projects are coordinated should be contained in the overall research plan.

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 relevance of the proposal to this solicitation will be judged on the basis of the justification provided in the proposal.
 

Section Two—Offeror's Qualifications, Project Team, and Management Plan
This section should present a discussion of offeror's qualifications for leading the research effort proposed for each component project and core. Proposals should address the breadth of expertise required for completion of the projects, capabilities of the team, and plans for recruiting additional expertise. Local, multidisciplinary teams are strongly encouraged. Proposed management structure for the team and choice of project team leader should be discussed. This section should include a discussion of the composition of the project team with regard to breadth of required expertise, the synergy among the team, and a management plan that details the interactions of the team. This section should also address the programmatic relationship between team members; the scientific and technical expertise of team members as it relates to the proposed project; the task responsibilities of team members; the teaming strategy among the team members; and the key personnel along with the amount of effort to be expended by each person during each year. Any agreements that enable the collaboration of participating individuals or institutions should be detailed in this section. Letters of commitment for such agreements should be 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
This section should include a detailed description and documented availability of the facilities, equipment, and other resources that would be used for the proposed effort.
 
Section Four—Dissemination and Use of Results
This section should address the plans for disseminating the resulting findings, including any plans for engaging commercial partners and support. A plan which identifies the products (e.g. behavioral treatments or therapies, materials, information) 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 products to be developed should be discussed. A discussion of intellectual property and patenting should be included.
 
LITERATURE CITED Page #
The proposal may contain a brief bibliography of relevant technical papers and research notes (published and unpublished) which document the technical ideas upon which the proposal is based. Proposals may include copies of not more than three (3) relevant papers in the proposal.
 
APPENDICES Page #
List each Appendix and identify the number of pages for each one. Appendices must be clear and legible, and easily located. Include biosketches here.

Provide a detailed description of the proposed DIRECT costs using the Technical Proposal Cost Information form found at: http://ocm.od.nih.gov/contracts/rfps/techcst5.htm. This information will be used by the technical reviewers to assess your understanding of the project.

Provide, in the appendices, letters of commitment for proposed consultants.
 

Business Proposal (Separate Volume)
PROPOSAL SUMMARY AND DATA RECORD, NIH-2043 Page 1
Form located at: http://ocm.od.nih.gov/contracts/rfps/FORMS1.HTM
 
BUSINESS PROPOSAL COVER SHEET Page 2
The cover sheet shall provide the following information:
  • Proposed costs, total and broken out by year, for each component project and core. You should also provide a cost summary for the entire consortium, total and broken out by year;
  • 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; and
  • 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.
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

  1. A separate budget spreadsheet should be provided for each component project and core. The budget proposal must contain sufficient information to allow the Government to perform an analysis of the proposed costs. This shall include the amounts of all the elements of the proposed cost. The budget spreadsheets shall be in Microsoft Excel using the format located at:

    http://ocm.od.nih.gov/contracts/rfps/buscost.htm

    A diskette containing the Microsoft Excel spreadsheets shall 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: Eve Schaefer, Contracting Officer, at es204n@nih.gov

  2. In preparing your budget proposal, the following should be considered:
    1. 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

For each component project and core, provide justifications and explanations of all proposed costs as included in the Microsoft Excel spreadsheets. This includes explanation of the processes by which future year costs are derived. Also, explain the basis on which 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 that the proposed consulting costs are reasonable, including documentation from the consultant that the proposed rate is the established 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. 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.
    6. 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 whether 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, your Small Business Subcontracting Plan shall not be submitted with the initial business proposal. Only those offerors whose proposal remains under consideration will be required to submit an acceptable subcontracting plan.

    For information purposes, the DHHS Model Plan may be accessed at: http://sbo.od.nih.gov/forms.htm

    THIS PROVISION DOES NOT APPLY TO SMALL BUSINESS CONCERNS. For more information about Subcontracting Plans see: http://ocm.od.nih.gov/contracts/rfps/INSTOPT.HTM#Optional H

  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, as applicable.

Section Four—Small Disadvantaged Business Participation Plan

Offerors must submit a Small Disadvantaged Business Participation Plan as part of the business proposal. The evaluation 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:

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
ADDITIONAL INFORMATION, INSTRUCTIONS, PROVISIONS, AND REQUIRED CLAUSES

  1. Proposal Intent Response Sheet

    Furnish the information requested below and return this page by January 15, 2002. Your expression of intent is not binding but will assist us in planning for proposal evaluation.

    BAA No.: BAA-HC-02-07

    TITLE OF BAA: Translational Behavioral Science Research Consortia


    I INTEND TO SUBMIT A PROPOSAL


    COMPANY/INSTITUTION NAME:


    ADDRESS:





    PROJECT DIRECTOR'S NAME:

    TITLE:

    TELEPHONE NUMBER:

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










    RETURN TO:
    Review Branch
    Attention: Dr. Zoe Huang
    Scientific Review Administrator
    Review Branch, Division of Extramural Affairs
    NIH, NHLBI
    6701 ROCKLEDGE DR MSC 7924
    BETHESDA MD 20892-7924
    or fax to: Dr. Zoe Huang at (301) 480-3541

  2. Packaging and Delivery of the Proposal

    Shipment and marking shall be as follows:

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

    "BAA NO.: BAA-HC-02-07
    TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"

    The number of copies required of each part of your proposal are:
    TECHNICAL PROPOSAL: ORIGINAL* AND Twenty-Five (25) COPIES
    BUSINESS PROPOSAL: ORIGINAL* AND Six (6) COPIES
    An electronic version of:
    Budget Proposal Spread Sheet (Microsoft EXCEL Spread Sheet)

    DELIVER PROPOSAL TO:

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

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

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

  3. Late Proposals, Modifications of Proposal, and Withdrawals of Proposals, HHSAR 352.215-70

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

  4. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data [FAR Clause 52.215-20 (October 1997)] (a) 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.

    (i) 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.

    (ii) 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-

    (A) 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;

    (B) 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;

    (C) 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.

    (b) Requirements for cost or pricing data. If the offeror is not granted an exception from the requirement to submit cost or pricing data, the following applies:

    (1) The offeror shall prepare and submit cost or pricing data and supporting attachments in accordance with Table 15-2 of FAR 15.408.

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

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

  5. Service of Protest (August 1996)—FAR 52.233-2

    (a) 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:

    Eve Schaefer
    Contracting Officer
    Contracts Operations Branch
    Division of Extramural Affairs
    National Heart, Lung, and Blood Institute
    Rockledge II, Room 6100
    6701 Rockledge Drive, MSC 7902
    Bethesda, MD 20892-7902

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

  6. Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns

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

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

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

  7. Uniform Resource Locators (URLs) in Contract Proposals

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

  8. Sample Contract Format-General

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




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