National Heart, Lung, and Blood Institute

Proteomics Initiative

Frequently Asked Questions and Answers

Updated January 18, 2002

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PRE-CONFERENCE QUESTIONS AND ANSWERS (1-24)

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1. I notice that these are called "contracts" instead of "grants", what kind of terms does a contract stipulate?

Grants and cooperative agreements are financial assistance mechanisms whereby money and/or direct assistance is provided to carry out approved activities. A grant is used when the awarding office anticipates no substantial programmatic involvement with the recipient. A cooperative agreement would be used when substantial Federal programmatic involvement is anticipated during performance. A contract is a acquisition mechanism that is used whenever the principal purpose of the transaction is to acquire goods or services for the Government.

The Proteomics Initiative is a form of acquisition (contract) called a Broad Agency Announcement (BAA). The government uses a BAA when the requirement is for scientific study and experimentation directed toward advancing the state-of-the-art or increasing knowledge or understanding. The aims and implementation of the study are proposed by the offerors in their proposals. The resulting contract's workscope (the aims and implementation plan to which the contractor is held) is that proposed by the offeror and accepted by the Government.

The solicitation will provide guidance to prospective offerors regarding the requirement and include instructions for preparing a proposal. A contract can be awarded to an individual or an institution/organization. It is anticipated that contracts awarded under this BAA will be with educational institutions, non-profit institutions and/or commercial organizations. It is doubtful that an individual (sole proprietor) would have the necessary facilities, resources or capacity to carry-out the requirements of this solicitation. Contracts awarded under this solicitation will be between the offeror and the National Heart, Lung, and Blood Institute. Contracts awarded to an institution remain with that institution, regardless of the relocation of the Principal Investigator, though subcontract or other arrangements are possible to continue the contributions of the investigator in some situations.

Staff estimates that the average cost (direct and indirect costs) for these contracts to be $2,100,000 per year, per award. It is anticipated that the total costs for each award will vary depending upon the scope and capacity of the technical objectives. The budget should reflect the science and resources required to carry out the statement of work proposed.

Federal Regulations (FAR 45.102) require Contractors to provide all equipment and facilities necessary for performance of contracts. However, given the high dollar value of equipment required to accomplish the objectives of this BAA, exception may be granted to authorize equipment purchases with contract funds. The proposal must include a comprehensive justification for equipment purchases. The description must include an explanation that it is for a special use essential to the direct performance of the contract and indicate if the item will be used exclusively for contract performance. All proposed equipment costs should be based on current vendor quotes. It is anticipated that discussions will be held with offerors following peer review for those proposals that remain under consideration. These discussions may include clarification of the offeror's cost proposal, especially as related to cost, use, and maintenance of equipment to be purchased through the contract.

Yes, funds may be re-allocated among most categories of cost, though some items such as equipment purchases will require prior approval. Re-allocation of funds that involve a change of scope also require prior approval. However, it is recognized that proposed approaches may very well be outdated within a few years, thus flexibility allowing updating approaches are part of this BAA and any subsequent contract.

The escalation factor currently projected for the performance period is 2.5% per year.

No, the aims, goals, objectives, and/or studies proposed can be for different durations up to a maximum of seven (7) years from the start of funding. However, if there are plans to phase out some activities and build in new ones during the 7 year period, these plans should be clearly outlined, to the extent possible, in the technical proposal.

There is no requirement that all investigators be located at the same institution. It is anticipated that centers will be comprised of highly interactive, multi-disciplinary groups (cardiovascular, pulmonary, blood, and/or sleep, chemistry, physics, engineering, proteomics, bioinformatics, statistics, etc.) with the purpose to enhance and develop innovative proteomic technologies and apply them to relevant heart, lung, blood, and sleep biological questions. Synergy among the investigators and the proposed science is critical. If critical expertise needed for the success of the center must be found outside the local geographic area, a thoughtful and detailed discussion must be presented. It is incumbent upon the offeror to demonstrate that the Center is responsive, effective, synergistic and well coordinated.

The NHLBI is making a significant investment of time and funds in the Proteomics Program so that truly innovative technologies can be developed and applied to biological areas of interest to NHLBI. Therefore, the products (reagents, techniques, information) of this effort must be made readily available to the scientific community. It is anticipated that the timing of data and resource sharing will fall within weeks and months, not years. However, it is acknowledged that some data, tools, and resources have shorter or longer development and testing periods. In special circumstances, i.e. patents, a 60 day delay in release of these data is appropriate; however, the default sharing plan should be immediate. Each offeror must provide in their proposal a detailed plan for release of data and sharing of resources.

Yes, this program operates under the Bayh-Dole Act in which recipients must maximize the use of their research findings by making them available to the research community and the public, and through the timely transfer to industry for commercialization. The over-riding goal of this program is to provide data, tools, and resources to the scientific community. Thus, all patents and licences must be timely and freely accessible to the scientific community to conduct future related and unrelated research.

Yes. The goal of this BAA is to enhance and develop innovative proteomic technologies and apply them to biological questions relevant to heart, lung, blood, and sleep. In order to insure maximum benefit, the products (reagents, techniques, methods, documentation, information, etc.) will be made available to the scientific community in a timely and freely accessible manner. It is important that all industrial collaborators understand this goal. All third party agreements must be approved by the NHLBI prior to implementation.

The objectives of the BAA are to establish local, highly interactive, multi-disciplinary Centers to enhance and develop innovative proteomic technologies and apply them to one or more relevant biological question(s) that will advance knowledge of heart, lung, blood, and sleep health and disease. Centers funded will be expected to accomplish major research and development objectives in the proteomics field. There are no specific disorders recommended for research by this BAA.

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

A proposal to exclusively provide a "Proteomic Resource Center" would not be responsive to the BAA. The NHLBI Proteomic Centers must not only develop innovative proteomic technologies, but also apply them to relevant biological questions. Technology development in the absence of biological application is not responsive.

There are no minimum time requirements for investigators. However, the effort must be appropriate for the scope of work proposed and for the coordination involved in such a Center. A minimum of 20–25% effort would not be unrealistic for the Director of the Center.

Yes, provided that the Center's stated areas of technical development and biological focus do not overlap. If the proposed research overlaps, then the NHLBI will work with the offeror to reduce or eliminate the redundancy of work, and structure the most cost effective program prior to award.

Yes. It is possible that a given investigator may have expertise or resources that are of value to more than one Center. However, this investigator must have the time, interest, and motivation to be involved in more than one Center. Each Center will have a highly organized administrative structure, as well as the over arching commitment of collaboration, that require time and attention by all investigators in a Center. Although an investigator may participate in more than one Center, a Center's Principal Investigator may not.

A foreign Institution can not apply; however, subcontracts to foreign institutions will be considered, but only in exceptional circumstances. The foreign component must be well justified.

No, it is not possible for the NHLBI staff to visit all Institutions, thus no staff visits will occur. However, we encourage participation in the Pre-proposal Conference scheduled on November 2, 2001.

The Conference is on November 2, 2001 in the Natcher Building on the campus of NIH from 11:00 am to 1:00 pm in Balcony A. A variety of information will be included at this meeting. Senior Staff of the NHLBI will be present. It is highly recommended that all potential offerors attend this meeting. Registration is not necessary, but it is helpful. Please contact Joanne Deshler, Contracting Officer by telephone at 301-435-0340 or by e-mail at deshlerj@nhlbi.nih.gov

All attendees, as well as anyone who cannot attend the pre-proposal conference, will be given access to any distributed and presented materials and any new questions and answers developed as a result of the pre-proposal conference. These materials will be posted with the BAA on the NHLBI web site.

A map of the NIH campus can be found at http://des.od.nih.gov/eWeb/parking/html/parking.htm Taxis and hotel shuttles will drop you off at the NIH metro stop. Take the steps near the top of the Metro escalators to the Natcher Building (Bldg 45). Please bring photo identification. We will provide a list of names to NIH security of those participants who have informed us ahead of time that they will be attending the Pre-Proposal Conference. If you have not registered with Ms. Deshler, you may still attend the Pre-Proposal Conference.

The Technical Proposal instructions indicate that an offeror's proposal must not exceed 6 lines per inch. This instruction applies to the entire Technical Proposal including: Technical Proposal Cover Sheet, Technical Proposal Table of Contents, Abstract, and Milestone Plan. The instruction not to exceed 50 pages double spaced is applicable to the Technical Plan section only.

No, this BAA is a one time solicitation.

 

It is important that NHLBI be aware of findings being disseminated from this program. In addition, it is anticipated that findings from this initiative may be used for future program planning within the NHLBI. It is therefore important that the NHLBI be kept informed of proposed publications and presentations at scientific meetings. Program staff input into the review process is intended as an aid. Program staff do not recommend approval or disapproval of proposed publications and presentations. As indicated in the BAA abstracts or manuscripts may be submitted to the Program Office for comment while still in process. Early submission to the Program Office should avoid any delays in publications produced by the centers.

Yes. The BAA does not prohibit the submission of proposals from centers that do not have a proteomics infrastructure currently in place. The BAA is seeking proposals to establish local, highly interactive, multi-disciplinary Centers to enhance and develop innovative proteomic technologies and apply them to relevant biological questions in a manner that will advance our knowledge of heart, lung, blood, and sleep health and disease.

No. The BAA does not require a center awarded a contract to serve as a core center or a service center. Each center awarded a contract will be a stand alone center. There will, however, be investigator discussions at programmatic meetings. The purpose of these meetings will be for each Proteomic Center to present information on technical objectives, progress, and impediments, exchange ideas, and, where appropriate, establish collaborations.

The average cost (direct and indirect costs) for these contracts is estimated at $2,100,000 per year, per award. It is anticipated that the total costs for each award will vary depending upon the scope and capacity of the technical objectives proposed. The budget submitted should take the above items into consideration and should reflect the science and resources required to carry out the statement of work proposed.

It will be up to the offeror to select investigators with appropriate scientific expertise including the Principal Investigator/Project Director. The Principal Investigator/Project Director should have experience in directing highly interactive, multi-disciplinary groups of investigators. Synergy among the investigators and the proposed science is critical. It is incumbent upon the offeror to demonstrate that the Center is responsive, effective, synergistic and well coordinated. The technical proposal 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.

The proposed management structure for the team and choice of project team leader is to be determined by the offeror. Proposals should document training, experience, expertise, and availability of the Principal Investigator for planning and directing the proposed Proteomics Center. The technical proposal should also address the programmatic relationship of team members; the scientific and technical expertise of team members as it relates to the proposed project; the task responsibilities of team members; the teaming strategy among the team members; and the key personnel with the amount of effort to be expended by each person during each year.

Synergy among the investigators and the proposed science is critical. In order to achieve synergy it is anticipated that all the expertise will be local and highly interactive. If the offeror finds that critical expertise needed for the success of the Center must be found outside the local geographic area, a thoughtful and detailed discussion must be presented. The proposal should address the programmatic relationship of team members; the scientific and technical expertise of team members as it relates to the proposed project; the task responsibilities of team members; and the teaming strategy among the team members.

An objective of the NHLBI Proteomics Initiative is to enhance and develop innovative proteomic technologies and apply them to biological questions relevant to heart, lung, blood, and sleep. Advances in technology that will allow a Center to provide answers to important biological questions, open new directions, and provide new information in relevant clinical and diseases areas is desirable. The purpose of this BAA is to stimulate the development of proteomics technologies, thus having more than one technical approach is within the scope. However, the technical approach needs to be developed in conjunction with application to a biological question or theme.

A central theme/focus is important. The purpose of the Center should be to assemble the expertise so that a major question can be answered with greater speed and accuracy than a fragmented approach. A Center could, for example, focus on technology development with 2 or 3 specific relevant biological applications that push the technology further than any one would alone, or a Center could focus on a biological/clinical question with one or more than one technical approach that is developed to address the specific need.

Offerors can choose to focus on the development of single or multiple technologies. However, offerors are encouraged to propose both 1) feasible objectives, possibly involving adaptation or augmentation of existing approaches and 2) "far-sighted; high-risk" objectives such as the creation of entirely new approaches or technologies, that has the potential of advancing the field substantially beyond its current status. A mixture of innovative science within each Center of "approachable" and "high-risk" endeavors is desired.

The NHLBI is not suggesting or recommending a specific organizational model for an NHLBI Proteomics Center. Each center must chose an organizational and operational style that fits the proposed project and personnel.

The NHLBI is making a significant investment of time and funds in the Proteomics Program so that truly innovative technologies can be developed and applied to biological areas of interest to NHLBI. Therefore, the products (reagents, techniques, information) of this effort must be made readily available to the scientific community. Dissemination can be accomplished in a number of ways (publication in scientific literature, presentation at national meetings, education programs, internet, etc). Offerors are required to address plans for dissemination of all their products in their proposal. Each Proteomics Center may maintain a web site for dissemination of information about their Center and the resources available. The Administrative Center may also coordinate and maintain a common web site for the entire Proteomics Program.

Given that a goal of the NHLBI Proteomics Initiative is to make the products readily available to the general scientific community, your dissemination plan should address any training and education activities that might be required, or beneficial to the broader scientific community in order to access the products of your Center (reagents, techniques, information).

The NIH is dedicated to the advancement of health through science. As a sponsor of biomedical research, NIH has a dual interest in accelerating scientific discovery and facilitating product development. It is important that delays in dissemination not occur due to disagreements between the offeror and industry regarding patent issues. The BAA requires offerors to detail any agreements that enable the collaboration of individuals or institutions. Letters of commitment for such agreements should be provided to NHLBI for review. The NHLBI reserves the right to review and comment on any proposed agreement with industry.

Further guidance on the "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources" can be found on the web at: http://ott.od.nih.gov/newpages/rtguide_final.html

The study of protein classes, such as post-translationally modified proteins, or the global study of proteins would each be appropriate definitions for Proteomics for the purposes of this Initiative. The offeror must propose novel and innovative technologies to address relevant questions and significantly advance the state of the art .

Significant oversight and coordination efforts will be needed to manage and conduct a Proteomics Center. The BAA requires coordinating activities within the center, reporting activities to the NHLBI and the external advisory group, dissemination activities to the scientific community, and interactions with other Proteomics Centers.

No. There is not a requirement or advantage for the investigators to have prior or current funding from the NHLBI. The NHLBI welcomes investigators new to heart, lung, blood, and sleep health and disease to apply their knowledge and expertise to the areas of interest to NHLBI.

It may be possible to study multiple pathophysiological conditions if there is a strong unifying theme, such as the development of a novel and innovation technological approach, as the focal point of a proposal. (See question 32 for additional information)

The newly formed Human Proteome Organization (HUPO) and the proposed Human Proteome Project are entirely independent of this BAA.

The development of informatics tools for streamlining data collection, analysis, and dissemination may be innovative; however, the main thrust must be technology development and biological application, and not the manipulation of existing data.

The NHLBI recognizes that industry plays an important role in the advancement of health through science. This initiative neither encourages nor discourages agreements with industry. Given the significant investment of the NHLBI in this area, it is important that delays in dissemination of products resulting from this program not occur due to disagreements or misunderstandings between the offeror and industry. The BAA requires offerors to detail any agreements for collaboration of individuals or institutions with other entities. The NHLBI will review agreements with industry. (Also, see question 36.)

The ultimate goal of all research supported by the NHLBI is to transfer knowledge gained to the improvement of health and the treatment and prevention of disease. The development of proteomic technologies that will facilitate this goal are part of this initiative. Emphasis on a clinical application is not a requirement, nor will it yield special consideration. Projects dealing solely with the transfer of existing technology to the clinic would not address the requirements of the BAA.

Offerors are encouraged to propose both "approachable" and "high risk" proteomic technology development with application to biological questions. "Approachable" studies should have feasible objectives. "High risk" studies should have a sound theoretical basis; however, these latter studies do not have a requirement for demonstrated feasibility at the time of the proposal.

The NHLBI realizes that a seven year research plan in the quickly evolving field of proteomics is difficult. For this reason, there is flexibility in the BAA to modify the work scope over time. However, the offeror must demonstrate a track record of scientific achievement, a firm theoretical basis for the proposed work, and sufficient proof of concept to indicate a reasonable likelihood of achieving the aims within the allotted timeframe. Clearly there is not the requirement for preliminary data that would be expected of a "typical" R01.

The TEP will be instructed to use the review criteria and the associated weights as stated in the BAA Announcement. Additional review criteria will NOT be used. The TEP will be provided with a copy of the complete BAA Announcement and will be instructed to expect nontraditional (i.e., not hypothesis-driven), high-risk proposals.

Six to eight weeks have been allotted in the schedule for negotiations with offerors being considered for an award.

The NHLBI anticipates awarding up to 10 contracts. We cannot anticipate at this time how many proposals will make it to the negotiation phase.

Offerors will be notified by the Contracts Operations Branch if their proposal was selected or not selected for further consideration. Those not selected for further consideration will not be reconsidered even if negotiations with one or more offerors do not result in awards.

Under normal circumstances a proposal that has gone through the negotiation process is not re-reviewed by members of a TEP. Instead, institute program staff will evaluate changes made in the proposals during the negotiation process. In the event that there is a specific issue or an aspect of the revised proposal for which the institute program staff require an outside opinion, appropriate members of the TEP will be recontacted and asked to comment.

The proportionally lower contribution reflects the broader emphasis on technological development rather than a decreased importance of the specific biological questions being addressed. The 20% level is roughly equivalent to the weight of significance used in review of the traditional unsolicited application.

Either hypothesis-driven or ‘descriptive' approaches will be considered, provided they meet the other guidelines described within the BAA.

Yes. A proposal must have both technological development and biological application.

The NHLBI is not specifying priorities with regard to any particular disease areas. However, the final contracts to be awarded will be selected, in part, on the basis of programmatic considerations.

Expansion of current research in one disease area to another disease area would not address the requirements of the BAA. However, substantial adaptation of an existing approach to allow its broader applicability might be appropriate if significant technological development were required and relevant biological questions addressed.

No. Cancer is not part the mission of the NHLBI.

There are any number of proteomic approaches to human studies which would be of value to NHLBI. These include, among many others, technologies to define and measure biomarkers and the use of proteomics to identify and evaluate new therapeutic agents. Clinical trials are beyond the scope of this initiative.

Yes, studies of animal models may be proposed, provided that other requirements (e.g., technological development) are met.

We do not require that the proteomics center have expertise in any particular area, rather, they must demonstrate sufficient expertise to perform the work proposed. If a center is proposing work focusing on basic pulmonary function then a strong track record in "lung biology" is appropriate. If the center is proposing to study asthma, then an expertise in asthma should be documented.

The contracts to be funded as part of the proteomics initiative should propose work that is unachievable by today's technology and, as such, would have little probability of success through the traditional funding mechanisms. In addition, the work proposed need not be hypothesis-driven, a factor usually considered in the review for the R01 mechanism.

The relative distribution of the budget is left to the offeror and should be sufficient to accomplish the goals of the proposal. It is likely that the relative contributions may change year to year, but substantial efforts are expected in both areas.

The synergy between the investigators and the proposed science is critical. In order to achieve synergy, it is anticipated that most of the expertise will be local and highly interactive. A thoughtful and detailed discussion of all consortium arrangements must be presented in your technical proposal. The proposal should address the programmatic relationships of team members; the scientific and technical expertise of team members as it relates to the proposed project; the task responsibilities of team members; and the teaming strategy among the team members. Under certain circumstances, a prospective contractor may find it necessary to delegate portions of the effort contemplated under the project to another organization. Although the contractor has primary responsibility for monitoring progress and cost under a resulting subcontract, the government retains stewardship responsibilities over the entire contract award. (Also, see question 31.)

The BAA does require that the products (reagents, techniques, information) from this initiative be made freely and readily available to the scientific community. However, the BAA does not require that resources be made available free of charge. The dissemination plan should include a discussion of disseminating the resulting technology and/or its application, including any plans for engaging commercial partners. The plan should identify products and a time line for their dissemination.

The balance between "feasible" and "high-risk" is left to the individual offeror, but both must be present as required by the BAA. Work that can be performed with only today's technology does not met this requirement. One of the objectives of this program is to advance technology so that investigations of the important biological questions are not restricted by current technological limitations.

An offeror's proposal should document the training, experience, and availability of all key personnel participating in the proposed technical approach. The NHLBI anticipates that the complexity of the fundamental technologies will require expertise from a variety of disciplines. Proposals should address the breadth of expertise required for completion of the project, capabilities of the team, and plans for recruiting additional expertise. To-be-named individuals may be listed but proposals that contain a number of to-be-named positions are less likely to receive a high score than those proposals that have identified staff with appropriate expertise.

The NHLBI does not anticipate site visits prior to award. Staff visits, and possibly site visits, may occur during the course of the award.

The list of attendees present at the pre-proposal conference has been posted at: http://www.nhlbi.nih.gov/meetings/proteomics.htm. Attendees were not required to indicate if they are interested in serving as the Administrative Center. Therefore, such a list does not exist.

Investigators will have an opportunity to meet twice a year and present information on technical objectives, progress, and impediments; exchange ideas; and, where appropriate, establish collaborations. In order to insure maximum benefit and product dissemination, offerors should give consideration to the most effective means of making this information available. The proposal should include what you believe would be the most effective means of doing this. In addition, the Administrative Center will facilitate and be responsible for coordinating certain activities involving all Proteomics Centers.

The center selected to serve as the Administrative Center will be provided with additional support for Administrative Center activities, but these funds will come out of the overall allocation to the Proteomics Initiative. The role and anticipated responsibilities of the Administrative Center are outlined in the BAA.

As addressed in the BAA, the dissemination plan should address plans for disseminating the resulting technologies, products, and/or their application, including any plans for engaging commercial partners and support. The plan should identify the products (reagents, techniques, information, etc.) to be disseminated and a time line for their dissemination. Plans or milestones for the recruitment of external support or commercial interest in the technology and products to be developed should be discussed. A discussion of intellectual property and patenting should be included. For technologies very early in the research phase, a discussion of routes for future technology dissemination should be addressed in the proposal.

Yes. If a proposal from another government agency is selected for an award, the transfer of funds will be accomplished through an inter-agency agreement. The offeror's business proposal must identify the legal authority to enter into such an agreement. In addition, teaming arrangements with industry must be detailed in the proposal submitted. The NHLBI will review proposed agreements with industry.

73. Can funds be budgeted for alterations or renovation of physical space to be used for equipment or investigators under the contract?

Yes. Costs for alterations and renovations required to physically convert or adapt facilities may be an allowable direct cost under the contract. Any direct costs proposed for alterations and renovations should be consistent with the allocation of such costs within your organization.

74. Do you expect an institutional commitment, either quantitative ($) or qualitative? If so, can you provide examples?

The DHHS encourages cost sharing when there is a probability that the contractor will receive present or future benefits from participation, such as, increased technical know-how, training of employees, acquisition of equipment, or use of background knowledge in future contracts. Your proposal should include a discussion of any cost sharing proposed, describe the method of allocating funds, and the source of the shared funds.

75. Are you looking for institutional matching funds?

Cost sharing/cost contributions are always encouraged, but the program is not dependent on receiving these.

76. Is the $2.1 million estimate for direct or direct and indirect costs?

Both direct and indirect costs are covered by the $2.1 million average per year per contract. (Also, see question 3.)

77. How much flexibility is there in the total costs, given the wide range in an indirect cost rate between institutions?

As indicated in the BAA, the estimated cost total (direct and indirect) for each award is $2.1 million per year, per award. The NHLBI anticipates that each award will vary depending upon the scope and capacity of the technical objectives proposed. The offeror should submit a budget that reflects the science and resources required to carry out the statement of work proposed regardless of the indirect costs at its institution or at other institutions. (Also, see question 28.)

78. Can funds be distributed to more than one institution if participating investigators are from differing institutions?

Funds are awarded to the prime contractor. That contractor may then award subcontracts to other participating institutions. Under certain circumstances, portions of the work scope proposed or effort outlined in a proposal may require expertise outside the offerors organization. Such effort may be acquired through a subcontract or consulting agreements.

79. How should cost associated with an investigator outside of the institution be documented? Subcontract, etc.?

Offerors who may find it necessary to award portions of the work scope or effort to another organization will want to discuss funding options with their grants and contracts office. The appropriate funding mechanism selected for use is determined by the offeror. It should be noted that although the contractor will have primary responsibility for monitoring progress and cost under a resulting subcontract, the government retains stewardship responsibilities over the entire contract award. Offerors should consult with experienced staff within their organization regarding the appropriate funding instrument. (Also, see question 78.)

80. Many of us have experience preparing budgets for grants but no experience with contract budgets. Is there a difference? Is there the possibility of assistance with budget preparation by NHLBI?

The BAA contains instructions for technical and cost proposal preparation and submission. In addition, most educational and non-profit organizations have experienced personnel in research administration that can assist you. Offerors should seek advice from these experienced personnel when preparing the cost proposal. Offerors are also encouraged to contact the NHLBI Contracting Officer, Ms. Deshler with questions regarding proposal preparation. The budgets for contracts should be very similar to those prepared for grants in that all major elements of costs, e.g., salaries and wages, fringe benefits, equipment, material and supplies, travel, consultants, subcontracts, other direct costs and indirect costs are addressed in both.

81. Does the Principal Investigator have to be the Center Director? Can the Principal Investigator provide management and administrative oversight with the Director providing scientific and technical oversight of the Center's operations?

The BAA requires offerors to document training, experience, expertise, and availability of the Principal Investigator for planning and directing the proposed Proteomics Center. The peer reviewers will identify the strengths and weaknesses of an offeror's organizational and administrative structure of the proposed Proteomics Center, including the management structure for the team and choice of key investigators and their roles. The proposal should detail the roles and responsibilities of the individuals proposed under the project. Proposals that offeror two individuals serving in the role of Principal Investigator are less likely to receive a high score as those proposals that have identified a single individual to serve in this position.

82. Is there a cut-off date after which discussion with NHLBI staff will not be possible?

Although offerors may ask question up until the proposal due date, the NHLBI reserves the right to only clarify previously addressed questions within three weeks of the receipt date. All substantially new questions are placed on the NHLBI web site in order that all potential offerors receive the same information, thus time must be available for all potential offerors to read the web site updates.

83. Can the Principal Investigator be from a for-profit (industry) company with other investigators from universities?

Yes. A for-profit organization can submit a proposal that includes collaborations with academic institutions.

84. If contract funds are used to purchase equipment, is NHLBI expecting the equipment be returned to NHLBI at the termination of the contract?

The NHLBI will consider the acquisition or lease of equipment during discussions with those offerors under consideration. There are numerous options that can be considered with respect to title vesting. Title to equipment acquired under a commercial contract will always vest with the government, though there are loan options available to continue work begun under the contract.

85. What is meant by the statement the institute can "buy a portion of the contract?"

A proposal may offer an approach or element that is not available elsewhere. If the NHLBI does not have enough funds to afford the entire proposal, then we might seek your agreement to fund only that portion that we can afford. It is not considered likely that this would occur, but it is mentioned to make offerors aware that the BAA mechanism offers NHLBI this possibility.

86. If you decide to buy a portion of a proposal which is not dependant upon the originally proposed Principal Investigator (e.g., one subproject) would the subproject Principal Investigator become the Principal Investigator for the portion you would buy?

If only a portion of a proposal is funded, this does not necessarily mean that the investigator in charge of that project would assume the role of Principal Investigator. The Principal Investigator will be responsible for planning and directing the proposed Proteomics Center. The qualifications for leading the Center are essential and would need to exist within the project being considered for funding by the NHLBI. The decision about who would lead the project would need to be addressed with the institution and the original Principal Investigator.

The margins for the Technical Proposal are to be set as follows:
Top margin no less one (1) inch exclusive of headers or footers.
Bottom margin no less than one-half (½) inch exclusive of headers or footers. Right and left margin no less than one-half (½) inch.

88. What is meant by a "quantifiable milestone of progress?"

Milestones are significant events that occur during the history of the contract. These milestones are determined by the PI in consideration of the work that is proposed.

89. Should there be a section for each aim detailing potential alternative approaches?

Potential alternative approaches should be clearly associated with each methodology. Whether a separate section should be constructed is a decision best made by the Offeror.

90. Should risk be categorized (e.g., low, medium, high, very high)?

Yes, offerors are encouraged to propose both "approachable" and "high risk" proteomic technology development with application to biological questions. "Approachable" studies should have feasible objectives and "high risk" studies should have a sound theoretical basis.

91. What is meant by quality assurance and quality control? Within this context, how does my role relate to other project members?

Quality assurance and quality control refers to the standards and documentation to assure both accuracy and precision of the resources and data generated by the program. The PI is responsible for ensuring that members of the program are aware of and carry out quality assurance and quality control procedures.

92. What is meant by a "key decision point?"

A key decision point is a critical juncture when an assessment is made to determine if a particular approach is justified. For example, many scientists make comparisons using a variety of protocols to see which one works best for a particular problem to be solved. Based on the comparison results, the selection of one protocol over another would be a key decision point made by the scientist.

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