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Frequently Asked Questions for BAA No. NHLBI-HV-09-12 and RFP No. NHLBI-HV-09-13 Global Health Activities in Developing Countries to Combat Non-Communicable Chronic Cardiovascular and Pulmonary Diseases (CVPD)

Last update: November 04, 2008

  1. We have some partners from developed countries, should we consider them as (subcontractors or consultants) or as key personnel (co-investigators)?

Your developed country partners should be proposed as either subcontractors or consultants. This should be discussed with the business office of your developed country partner.

  1. With respect to OFFEROR'S POINTS OF CONTACT, can the principal investigator also be the Business Representative with whom daily contact is required?

Yes.

  1. Can we associate our partners from developed countries in the negotiations team?

Yes, your developed country partners may be a part of your negotiations team.

  1. In case we will hire some research assistants for specific tasks but we don't know already their names, how should we list them among the staff? or should we just specify their profiles and salaries without names?

You should list them as "To Be Named (TBN)" in addition to the Position Title. Also include their estimated salary and proposed duties on the project.

  1. As we will send the proposal package from {country} and we don’t know how much time this may require, how can we be sure that the package will reach you before the deadline? or should we submit in the same time a copy by e-mail to the Review Branch DERA at NHLBI to be sure that the proposal has reached in time the NHLBI?

In order to guarantee delivery of your proposal by the due date, it is strongly suggested that you use an expedited delivery service (such as Federal Express or UPS).  Proposals sent by e-mail will not be accepted.

  1. Does the developed country partner have to be the same as the US Partner from the Fogarty International Clinical Research Scholars/Fellows Site Center Program?

No. You may choose any institution from any developed country as your partner for this project.

  1. Where can I see the list of pre-approved Fogarty International Clinical Research Scholars/Fellows Site Centers that are eligible to compete on the BAA?

http://www.fogartyscholars.org/articles/nhlbi-centers

  1. How do I apply to be on the list of pre-approved Fogarty International Clinical Research Scholars/Fellows Site Centers?

It is too late to apply to be on the list of pre-approved Fogarty International Clinical Research Scholars/Fellows Site Centers. You must already be on the list in order to be eligible to compete under this BAA.

  1. Who is required to complete Section K: REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS of the BAA? Are collaborators/subcontractors required to complete Section K?

Only the offeror submitting the proposal and any subcontractors from the U.S. are required to complete Section K. Collaborators/subcontractors from foreign (non-U.S.) countries are NOT required to complete Section K.

  1. Can you provide some guidance on how to complete Section K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS of the BAA? I don’t have a DUNS number or MPIN that are needed to register in the Online Representations and Certifications Application (ORCA).

In order to complete Section K of the BAA/RFP you must: (1) have a Data Universal Numbering System (DUNS) number, (2) have a North Atlantic Treaty Organization (NATO) Commercial and Governmental Entity (NCAGE) code, (3) be registered in Central Contractor Registration (CCR), and (4) be registered in the Online Representations and Certifications Application (ORCA). Please follow the instructions below to complete this process:

Step 1: Obtain a DUNS Number if you don't already have one. Go to the following website to request one:

http://fedgov.dnb.com/webform/displayHomePage.do;jsessionid=B1FE9D2DAF04F16F4CDCDEAC392BA2BA

Step 2: Obtain an NCAGE code. Go to the following website to request one:

http://www.dlis.dla.mil/Forms/Form_AC135.asp

Step 3: Register in CCR. Go to the following website to register and click "start registration" at the end of the instructions.

http://www.ccr.gov/international.aspx

Step 4: Register in ORCA. You will need your DUNS number and Marketing Partner ID Number (MPIN) to register. Your MPIN is obtained from registering in CCR.

https://orca.bpn.gov/

After registering in ORCA, you will be able to complete Section K of the BAA/RFP which reads as follows:

  1. Go to the Online Representations and Certifications Application (ORCA) at: https://orca.bpn.gov/ and complete the Representations and Certifications;

  2. Complete, and include as part of your BUSINESS PROPOSAL, SECTION K which can be accessed electronically from the INTERNET at the following address: http://rcb.cancer.gov/rcb-internet/wkf/sectionk.pdf
  1. In reference to the “Required Education in the Protection of Human Research Participants” located on page 40 of the BAA, do investigators on foreign awards or on foreign subcontracts (collaborators) have to comply with the education requirement?

Yes. The education requirement applies to ALL investigators and other individuals involved in the design or conduct of research involving human subjects, including the offeror submitting the proposal and any collaborators, subcontractors, or consultants.

  1. Do the biosketches/resumes have to be in any specific format?

No.

  1. Case Report Forms (CRFs) are not specifically mentioned in the RFP. What role, if any, will the ACC have in developing, reviewing, and/or collecting CRFs?

The ACC will have no role as it relates to CRFs. The Centers of Excellence will take care of the development, review and collection of CRFs.

  1. Will the ACC database house individual patient data?

No.

  1. Will the ACC database house aggregate patient data provided by the COEs?

Yes, the ACC database will house aggregate patient data provided by the COEs.

  1. In the RFP Statement of Work, page 6, #9 it states that the ACC will “Manage unanticipated problems and study related Adverse Events.” Does this include review and assessment of the investigator’s report content by a Medical Safety Monitor at the ACC?

Yes.

  1. Does the Principal Investigator have to be the same as the contact identified on the list of pre-approved Fogarty International Clinical Research Scholars/Fellows Site Centers?

No, but the Principal Investigator must be from institution identified on the list of pre-approved Fogarty International Clinical Research Scholars/Fellows Site Centers.

  1. Does the Administrative Coordinating Center (ACC) need to propose names of potential members of the Scientific Advisory Board which is described on page 4 of the Statement of Work?

No, the NHLBI will select the members of the Scientific Advisory Board after the contracts are awarded.

  1. With respect to the business proposal, what are “fringe benefits”? Is it applicable just for labor or all the rubrics?

The following website provides an example of what is included in a fringe benefit rate: http://oamp.od.nih.gov/dfas/IDCTwoTierExample2.xls

Some fringe benefit costs include vacation, sick leave, insurance, payroll taxes, and pension plans. These are the costs that an organization pays for the employee. The base for fringe benefits is just direct labor, not all the rubrics. You should use the fringe benefit rate applicable to your organization. You should be able to obtain this information from your business and or finance/accounting office.

  1. For materials, it is specified in the Excel spreadsheet calculator to “use current catalog, historical documentation, or vendor quotes.” What kind of catalog or historical documentation should we use?

The best documentation for materials is current paid invoices. If this is not available, you can call a vendor and obtain quotes for the materials. Also, the internet can be used as alternative source. Historical documentation would be used to determine an average that is typical for other grants or contracts for similar work that you have performed. What we are looking for is documentation to show how you determined your cost estimates for materials.

  1. Given that the scope of work emphasizes administrative and management services, is it necessary for the project lead (Principal Investigator or Project Director) to have experience overseeing clinical cardiovascular and pulmonary research studies in developing countries? Would it be acceptable for the project lead (Principal Investigator or Project Director) to have experience operating an ACC for multi-center research studies in developing countries as long as other team members had experience overseeing clinical cardiovascular and pulmonary research studies in developing countries?

The criteria for personnel experience represent what your proposal will be evaluated against. I cannot tell you what kind of team is appropriate or if your proposed team is acceptable. It’s up to you to propose the best team you see fit to perform the project.

  1. According to the Statement of Work, “To avoid conflicts of interest, the same institution may not submit proposals for a Center of Excellence and the Administrative Coordinating Center.” Would it be a conflict of interest for different institutions within one university to submit separate proposals for a Center of Excellence and the Administrative Coordinating Center?

No, it would not be a conflict of interest for different schools/departments within a university to submit proposals for both a COE and the ACC.

  1. In the RFP on page 41 it states that “the page limitation does not include the cover sheet, abstract, table of contents, personnel, facilities, equipment and resources, other considerations, schedule, other support, cost information, and literature cited.”

    1. Does “personnel” refer to the personnel section described on page 46 of the RFP?

    Yes.

    1. Do the above referenced sections that do not count toward the 30 page limitation for the technical plan count toward the 50 page limitation for appendices?

    No.

    1. Is the “Institutional Experience and Facilities” section included in the 30 page limitation for the technical plan?

    Yes.

  2. What is the estimated timeframe for OMB approval?

OMB Clearance is not applicable to foreign institutions, therefore this requirement is being deleted from the BAA and the RFP in Amendment 1. Amendment 1 to the BAA can be found on the FedBizOpps website at the following link:

https://www.fbo.gov/index?s=opportunity&mode=form&id=e3a267b75087f151e43e3ce3751e3e38&tab=core&_cview=1

Amendment 1 to the RFP can be found at the following link:

https://www.fbo.gov/index?s=opportunity&mode=form&id=a18462dd1d7061d0848493fca53bea06&tab=core&_cview=1

  1. What is the estimated timeframe for IRB approval?

IRB approval will occur at the local IRBs of each developing country’s institution, therefore, the estimated timeframe for approval will vary by institution.

  1. Is there an NIH or NHLBI IRB, or just the country IRB?

There is no NIH or NHLBI IRB. There will be IRBs for each developing country’s institution and the Administrative Coordinating Center will also have an IRB.

  1. Can the contact person be in the developed country partner’s institution?

There must be a contact person from the developing country institution. You may also have a contact person from the developed country partner.

  1. Does contract reimbursement mean the COE needs to have funds to carry out the activities and then submit receipts for reimbursement?

Yes. Under cost-reimbursement type contracts, which this contract will be, the institution will be reimbursed for expenses after they occur, through the submission of monthly invoices. However, exceptions might be made, which will be worked out during negotiations.

  1. Using a cost-reimbursement strategy means that we are always at least one month behind in our reimbursement. Is this format necessary, or is it possible to have a grant payment strategy?

See response to question 28 above.

  1. The BAA requires a substantial amount of travel for steering committee meetings – up to 5 people traveling from each centre. This is very costly – amounts to ~10% of direct costs. Can this be reviewed?

Steering committee meetings will be held monthly by conference call, and travel will only be required twice a year for face-to-face meetings. Travel expenses will be reimbursed under the contract. You should follow your institution’s travel policies and also try to obtain the lowest airfare quotes for coach class.

  1. How do we develop our budget with a widely fluctuating exchange rate, to ensure that we have sufficient money to perform the contract?

When submitting your proposal, use the current exchange rate when converting to U.S. dollars. The contract will be awarded in U.S. dollars. Every time you submit an invoice for payment, which should be in US currency, it will be paid using the conversion rate at the time of payment. You are required to stay within the total amount of the contract. If, due to fluctuating exchange rates, you anticipate running out of funds, you are required to notify the Contracting Officer. We will then decide to either scale back the work or add additional funds. In addition, the Government is requesting that offerors incorporate a uniform escalation factor of 8% per year for all direct costs (excluding labor) to account for inflation and fluctuating exchange rates. Offerors should propose an annual labor escalation rate based on their organization’s salary increase policy. This revision is addressed in Amendment 1, which may downloaded from the FedBizOpps website, found at the following link:

https://www.fbo.gov/index?s=opportunity&mode=form&id=e3a267b75087f151e43e3ce3751e3e38&tab=core&_cview=1

  1. Can you please give more clarification on the signing of Section K? If we have made the online representation and certification (ORCA), why should we sign again this section?

This certification must be signed and included with the proposal because it is certifying specific information just for this project, whereas the information in ORCA is general for any project.

  1. What is the CCR and how does a Center of Excellence register?

CCR is the Central Contractor Registration. You must have a DUNS number and NCAGE code in order to register. Please see the instructions and website provided in the response to Question 10 above.

  1. What is accountable Government property and research funding referenced in Section B, Article B.3.?

Accountable Government Property refers to items with an acquisition cost of $1,000 or more and a life expectancy of 2 or more years. It is typically equipment such as computers, printers, copy machines, etc. It also includes items such as cameras, video cameras, microscopes, etc. The items listed in Article B.3. are only allowable with Contracting Officer approval. These items may be proposed in your budget, but are negotiable. Research funding refers to research that your institution is conducting outside of the project you are proposing for this contract.

  1. Would you please post the application package templates for the ACC and the COEs on the website where the questions are answered?

There are no application package templates for contract proposals. Please refer to the instructions in Section L for guidance on the technical and business proposal preparation instructions.

  1. Can ACC hire people from small companies in developing countries who would work as contractors/consultants and are stationed in the developing countries? Would you consider those people from small disadvantaged companies? Can ACC hire people from small companies in developed countries who would work as contractors/consultants and are stationed in the developed countries? Would you consider those people from small disadvantaged companies?

Yes, you can hire people from small companies in developing countries or developed countries who would work as contractors/consultants. If you propose to hire an individual from a small business in a developing or developed country, you would be hiring the individual (as a contractor/consultant) NOT the company. Therefore, the individual would not be considered a small disadvantaged company.

  1. Will those consultants/contractors from foreign countries hired by the ACC be allowed to have the same salary and fringe rate as the contractors/consultants working in the U.S.?

Foreign contractors/consultants should be proposed at an annual salary or hourly rate that the ACC determines to be appropriate for the work to be performed.

  1. What is the maximum basic salary each year for each of the full time contractors in the ACC?

The maximum salary level as of January 1, 2008 is $191,300 (NOT $191,800 as mentioned in the Pre-Proposal conference on October 14, 2008). This salary limitation also applies to the Centers of Excellence.

  1. How detailed should the budget be? Should we use only the categories in the budget template or should we add our own sub-categories/items?

The budget should provide appropriate detail in order for the NHLBI to gain an understanding of what is being proposed. For all proposed costs (excluding labor) provide unit costs and number of units for each cost category, as appropriate. For direct labor, provide the annual salary and the percent of effort for each proposed individual. However, if it is your organization’s policy to charge and record labor time by number of hours, use the hourly worksheet in the template. For the fringe benefit and overhead rates, show the rate(s) and the base(s) used to calculate the cost.

The budget template may be modified. You should only propose the cost categories/cost elements which you determine necessary to perform the work for your proposed project. You may add cost categories/cost elements and delete others not being proposed.

  1. Will the same peer review group/scientific evaluation panel evaluate the ACC proposals as evaluates the COE proposals? If not, who will evaluate the ACC proposals?

The ACC and COE proposals will be reviewed by separate peer review panels. The two panels probably will have some overlapping membership.

  1. Many study sections assume that considerable work will have been done in preparation for a submission. How much prior work will be assumed in reviewing the proposals?

This question seems relevant to the review of COE proposals. The proposed staff's general experience and accomplishments relevant to the proposed work would be factored into the Personnel criterion. The review panel may view any preliminary data directly relevant to proposed research as supportive of the scientific merit of the proposal and thus factor such data into the scoring of the Technical Approach criterion.

  1. Having seen in previous NIH experience a focus on original and innovative research, can you say something about the weight to be given to the 3 components: infrastructure, training, and researcher.

In the evaluation of COE proposals: 1) Infrastructure would be factored into the Institutional Experience and Facilities criterion (15 points maximum assigned to this criterion). 2) The merit of the training component of a proposal could impact all three criteria. The weight of the training component relative to the other components of a Center program is not defined in the BAA. 3) The merit of the research personnel would be factored into the Personnel criterion (40 points maximum assigned to this criterion).

  1. It is not clear how many copies of the proposal need to be sent, could you clarify please?

Please see Attachment 1 of the Broad Agency Announcement, entitled “Packaging and Delivery of Proposal” for the number of copies to be submitted for the technical and business proposals.

  1. In many countries the only type of paper found is A4, no “letter” size paper is available. Would A4 be acceptable?

Yes.

  1. While preparing a package for urgent delivery, how do you suggest the labeling is made on the carrier usual envelope?

Please use the address provided in Attachment 1 of the Broad Agency Announcement, entitled “Packaging and Delivery of Proposal.” You should also contact the courier service that you are using for specific instructions.

  1. In what detail do we need to describe our current centre of excellence and it’s links to other organizations and funders?

You should give enough information so that the reviewers can determine your institutional experience, which is part of the evaluation criteria on page 64. You should also describe your experience in the business proposal as it relates to “Qualifications of the Offeror” found in the business proposal instructions on page 58.

  1. Is there a format for the draft protocol that is required to be submitted for the Centers of Excellence?

There was no format included in the Broad Agency Announcement, however, we have decided to incorporate a Protocol format. A Protocol Summary Sheet is being incorporated in Amendment 1. Amendment 1 may be downloaded from the FedBizOpps website, found at the following link:

https://www.fbo.gov/index?s=opportunity&mode=form&id=e3a267b75087f151e43e3ce3751e3e38&tab=core&_cview=1

  1. Does the Administrative Coordinating Center have to be located in the United States?

The RFP does not restrict the competition to institutions located in the US, however, there is a mandatory criterion that requires the staff of the ACC to be available during the hours of 10:00 am to 4:00 pm EST in order to communicate with the NHLBI.

  1. Are there Federal Acquisition Regulations (FAR) related to the fluctuation of exchanges rates or inflation rates?

Yes, however, I don’t think that they apply to this situation. They would only apply if we were receiving proposals in foreign currencies or if the contract was going to be fixed price. For this project, budgets must be submitted in U.S. currency and the resulting contracts will be cost-reimbursement. When submitting your proposal, use the current exchange rate when converting to U.S. dollars. The contract will be awarded in U.S. dollars. Every time you submit an invoice for payment, which should be in US currency, it will be paid using the conversion rate applicable at the time of payment. Under a cost-reimbursement type contract, you will be reimbursed for actual expenses. You are required to stay within the total amount of the contract. If, due to fluctuating exchange rates, you anticipate running out of funds, you are required to notify the Contracting Officer. We will then decide to either scale back the work or add additional funds.

  1. What are responsibilities of the ACC and what are the administrative responsibilities of the COE?

The responsibilities for the ACC are described in the RFP for the Administrative Coordinating Center. For a general description, please refer to the Statement of Work (Attachment 3), page 1, "General Description of the Required Objectives and Desired Results", second paragraph. For a more detailed description of the technical requirements, please refer to pages 2-6 of the Statement of Work.

The administrative responsibilities of the COE are described in the BAA for the Centers of Excellence. Please refer to the Statement of Work (Attachment 3), section d. Program Requirements and Tasks, pages 4-7.

  1. Can there be more than one developed country partner?

Yes.

  1. What are roles and responsibilities of the developed country partner?

The developed country partner will provide on-going technical and research support to facilitate growth of COE research capabilities.

  1. Does the developed country partner also need to be a Fogarty center?

No.

  1. The Statement of Work, page 6, item 12 states the ACC will design and implement a plan for study close-out, analysis, and dissemination of program information including final data collection, data verification, analytical support for scientific writing groups, and publication of study results. Please confirm that the ACC will not be responsible for managing COE study data. Its responsibility will be to see that the COE has appropriate data collection and verification procedures.

The COEs will be responsible for their own data collection and management. However, in the event that an integrative data management approach is needed, the ACC is expected to have the appropriate data management capabilities.

  1. Could NHLBI estimate the number of studies that will require ACC analytical support for scientific writing groups? Depending on the number of studies requiring analytical support, this could absorb most of the estimated level of effort for the ACC.

Most of the analytical analysis will be done at the COEs, although the ACC may be asked to perform some integrative analytical analysis. We cannot estimate the number of studies that might require ACC analytical services.

  1. Statement of Work, page 6 of attachment 3, item 14 asks the ACC to create a public use dataset and implement a plan for data sharing. Please confirm that the ACC will not manage or have regular access to the COE research study datasets.

The ACC will not manage nor have regular access to the COE research study datasets.

  1. Is it essential to use the template that you will be providing for the draft protocol? For consistency purposes, we ask that you use the template for the draft protocol. The template is being provided in Amendment 1 to the BAA. Amendment 1 may be downloaded from the FedBizOpps website at the following link:

https://www.fbo.gov/index?s=opportunity&mode=form&id=e3a267b75087f151e43e3ce3751e3e38&tab=core&_cview=1

  1. Is this a "multiple PI" available program so that more than one of the investigators could get full credit as a PI?

No, a single PI must be proposed for this project. However, co-investigators may be proposed.

  1. Where can I view the videocast of the Pre-Proposal Conference that took place on October 14, 2008?

The videocast may be viewed at the following link. There is also an “audio only” version if your computer does not have the ability to support the videocast.

http://videocast.nih.gov/Summary.asp?File=14694

  1. Where can I access the Amendment(s) to the solicitations?

The Amendment(s) to the BAA for the Centers of Excellence can be accessed at the FedBizOpps website at the following link:

https://www.fbo.gov/index?s=opportunity&mode=form&id=e3a267b75087f151e43e3ce3751e3e38&tab=core&_cview=1&cck=1&au=&ck=

The Amendment(s) to the RFP for the Administrative Coordinating Center can be accessed at the FedBizOpps website at the following link:

https://www.fbo.gov/index?s=opportunity&mode=form&id=a18462dd1d7061d0848493fca53bea06&tab=core&_cview=1

  1. Please note that there are some scientific restrictions on what you can propose under the BAA. Specifically, prospective efficacy evaluations of novel drugs, devices or biologic therapies will be considered non-responsive. Research proposals on lung cancer or respiratory infectious diseases will be considered non-responsive. And finally, animal studies and/or training with a focus on animal studies will not be supported through this mechanism.

  2. In Section L, Item 6. Required Education in the Protection of Human Research Participants on page 40, it states that “Curricula that are readily available and meet the educational requirement include the NIH on-line tutorial, titled "Protection of Human Research Subjects: Computer-Based Training for Researchers," available at http://ohsr.od.nih.gov/cbt/.” This web site accepts only NIH personnel to log in, how can we follow this computer based training program without being NIH personnel?

A similar course that non-NIH personnel may take is located at the following website. It will satisfy the required training. You will need to register in order to create an account with a username and password.

http://phrp.nihtraining.com/users/login.php

  1. We have a question regarding the manual style that we should use for literature cited. Does the NHLBI have a required style (Chicago, APA, MLA, etc)? Also, do you require a minimum or maximum number of literatures cited?

There is no required style or required number of citations for the literature cited.

  1. Is it acceptable for 2 different developing countries to partner with a developed country institution?

Yes, it is fine for a developed country institution to partner with more than 1 developing country institution.

  1. Do we need to submit separate Protocol summary sheets for each individual study proposed?

Yes. As stated in the Protocol Summary Sheet, incorporated in Amendment 1, please submit separate protocol summary sheets for each study you propose.

  1. Do page limits apply to these protocol summary sheets and if so where do they fit in?

As stated in the Protocol Summary Sheet, the summary should be limited to 2-4 pages for each study. They should be considered part of the Appendices Section, which is limited to 50 pages overall.

  1. Since we are proposing two separate studies, what would be your advice to avoid repetition of the sections which will be common to both studies and confine to the page limits of the Technical proposal?

I would address all sections for the first study, and then when writing the sections for the 2nd study, refer back to the sections of the 1st study that would be the same for both. For example: “See Section x, on page x of the 1st study, for a description of x, which will be the same for this study."

  1. We have a question on exactly what is included in the 30 pages for the Technical Proposal. On page 32 there are specifics on what is not included (cover page, abstract, table of contents, personnel etc.) but on page 37 it says that there needs to be a separate section entitled "Human Subjects". It appears that this section should be included in the 30 page limit. Can you please confirm this?

The Human Subjects section is NOT included in the 30 page limit.

  1. Is there a standard table of content page (like used in the PHS 398 submissions or 424 that include the breakdown)?

There is no standard table of contents page for contract proposals. The forms you referred to are for grants only.

  1. In the FAQ, #19 and #39 respectively state "You should use the fringe benefit rate applicable to your organization." and "For the fringe benefit and overhead rates, show the rate(s) and the base(s) used to calculate the cost." However, the BAA, in Section L.2.c.10.b. on page 59, states "For proposal preparation purposes, offerors who do not have an approved indirect costs rate agreement with the Department of Health and Human Services should estimate 25% for fringe benefits..." Can we use our institution's fringe rate without an agreement with DHHS, as long as the rate and base calculation is provided?

Yes, offerors can use the fringe benefit rate of their institution. Offerors can also use the overhead rate of their institution. The estimates of 25% for fringe benefits and 8% for overhead should be only be used if the offeor’s institution does not have a fringe benefit or overhead rate. If the proposal is selected for negotiations, the offeror will need to provide documentation to support their proposed rates, and, after award, negotiate an indirect cost rate agreement with DHHS. This clarification is addressed in Amendment 2 to the BAA, which can be found at the following link:

https://www.fbo.gov/index?s=opportunity&mode=form&id=e3a267b75087f151e43e3ce3751e3e38&tab=core&_cview=1&cck=1&au=&ck=

  1. Are fringe benefit costs considered direct costs, and therefore included in the direct cost ceiling of $2 million for the 5-year period of performance (which is referenced in Section L.1.d. on page 29)?

Yes.

  1. In the BAA, Attachment 3, Statement of Work, #19 on page 6 it states "Also assume that 3 trainees from the COE will attend the in-person steering committee meeting." However, there are 2 in-person steering committee meetings. Should we budget to send 3 trainees to one meeting or two?

The budget should reflect travel for 3 trainees from the COE to attend only ONE of the 2 in-person meetings per year. The meeting they will attend should be the one held in the Fall in Bethesda, Maryland. This clarification is addressed in Amendment 2 to the BAA, which can be found at the following link:

https://www.fbo.gov/index?s=opportunity&mode=form&id=e3a267b75087f151e43e3ce3751e3e38&tab=core&_cview=1&cck=1&au=&ck=

  1. When "assume" is used in the BAA/RFP does that mean something is "required"?

Yes, the cost assumptions are required, for budget estimating purposes, so that all of the proposals will be consistent.

  1. For travel costing purposes, can we assume that the DSMB and SAB members reside in the United States? [NOTE: This question applies to the Administrative Coordinating Center.]

Please assume that the DSMB members will be from the United States and the SAB members will be a mixture, 50% from the U.S. and 50% from foreign countries. This information is included in Amendment 2 to the RFP, which can be found at the following link:

https://www.fbo.gov/index?s=opportunity&mode=form&id=a18462dd1d7061d0848493fca53bea06&tab=core&_cview=1&cck=1&au=&ck=

  1. For database costing purposes, does the NHLBI have a preference regarding electronic format and platform? [NOTE: This question applies to the Administrative Coordinating Center.]

No. As stated in the Statement of Work, the NHLBI will specify the required electronic format and platform for the database after award.

  1. Are the Technical Proposal Attachments identified in Section J included in the 50 page limit for Appendices?

Yes.

  1. Is there a page limit for the individual biosketches? Are the biosketches included in the 50 page limit for Appendices?

There is no page limit for the individual biosketches, but they are included in the 50 page limit for Appendices.

  1. I have a question about the Center of Excellence direct cost limit. Will the indirect costs from subcontracts count towards the $2 million limit on direct costs (which is referenced in Section L.1.d. on page 29)?

No, the indirect costs of any proposed subcontractors will not count towards the $2 million ceiling on direct costs.

  1. Would it be allowable to have a subcontract to a subcontract for this solicitation? For example, can the developed country partner, which would be a subcontract to the Center of Excellence, have it’s own subcontract to another institution? Or would that institution have to be a direct subcontract to the Center of Excellence?

There is no restriction on second tier subcontracts. Subcontractors to the Center of Excellence are free to propose their own subcontracts in their budgets.

  1. Regarding the SOW: In the approach section: "Discuss phasing of research and, if appropriate, include experimental designs, probable outcomes...", and in the methods section, "describe in detail the methodologies you will use..." I understood that it meant to describe, for example, the technical approach and methods involved in the design and analysis of the proposed research study or teaching approach methods involved in the research training program. But now, I am not that sure. I see in the FAQ # 66, that we should include our research proposal within the protocol summary sheet in the appendices section. Therefore, it is not quite clear to me what exactly to include in the approach and methods section of the SOW regarding the research proposal and the training program. Should we describe the research study in more detail in the appendices but concepts should be included in the body of the SOW? Please, clarify to me on this issue.

The approach and methods sections of the Technical Proposal should be in more detail than the Protocol Summary Sheet. The Protocol Summary Sheet should only summarize what is already described in the technical proposal. As noted in the page limitations, the Technical Plan (objectives, approach, methods, and procedures) of the technical proposal shall not exceed 30 pages while the Protocol Summary Sheet is limited to 2-4 pages.

  1. Regarding the protocol summary sheet: As it is stated, it is formatted for intervention studies but it does not fully apply for observational studies. In this last case, should we keep tight to the proposed format you sent? (assuming we will not exceed 2-4 pages per study). If the whole study has 2 phases very much integrated, should we submit them separately in 2 protocol summary sheets?

For observational studies you should revise/delete the headings as appropriate for your particular study, still keeping to the 2-4 page limit. Regarding the 2 phases, and if you should do one or two Protocol Summary Sheets, it really depends on how separate and distinct the 2 phases are. Please do what you think makes the most sense for your study. If the 2 phases are very integrated and it makes more sense to do one Protocol Summary Sheet, then just do one. Or if splitting the phases into 2 separate Protocol Summary Sheets is more appropriate, then do 2.

  1. Are studies related to asthma considered responsive to the BAA?

Yes.

  1. Do we have to send the Excel spreadsheet file with the business proposal in a Compact Disk in addition to the requested 10 copies of business proposal?

No, a compact disk is not required for the excel spreadsheet or business proposal. As stated in Attachment 1, a compact disk is only required for the technical proposal.

  1. Do the proposal and all of the required copies have to be mailed from the developing country, or can the developed country partner mail it?

It doesn’t matter where the proposals are mailed from as long as they include all of the required signatures of the offeror.

  1. Some of our institutional partners are proposing to finish their sections in 2 years instead of 5 years. So, the PI will have a work plan for 5 years, but some of the partners may contribute with specific tasks to be achieved in less time. Is it permitted to project their budget for two years only (as an instance)?

    Your partners/collaborators/subcontractors/consultants may be proposed for any length of time that you determine necessary. They do not have to be proposed for the entire 5-year period of performance.

  2. Can we budget more funds in the beginning of the project, or do the funds need to be spread evenly over the 5-year period of performance?

    There are no restrictions regarding how the $2 million ceiling for direct costs (referenced on page 29 of the BAA) should be distributed among the 5-year period of performance. However, the budget should correspond with the technical plan.

  3. There are, on our interpretation of the BAA, 3 different instructions on how to proceed in the formulation of the Technical Proposal: Statement of Work (p. 34), Attachment 3: Statement of Work, and Protocol Summary Sheet. What is the proper format that we should follow?

    The format for the technical proposal should follow the Technical Proposal Instructions that begin on page 34. Attachment 3 is the Government's Statement of Work, which is the list of Government requirements. These requirements must be addressed when writing your technical proposal. It's up to you to determine where these requirements fit in to your technical proposal. The Protocol Summary Sheet should be completed for the research study(s) you are proposing. It should be a brief summary of the information that is already included in your technical proposal.

  4. Where in the proposal should we include the personnel section?

    The personnel section is part of the technical proposal.

    • Should it be incorporated in the Technical section?

    The personnel section is not a part of the technical plan of the technical proposal, but is another section in the technical proposal.

    • Will it count as part of the 30 pages limiting the technical section, the 50 limiting the attachment section, or the Business section with unlimited page number?

    • The personnel section will not count towards any of the sections referenced above. There is no page limit to the personnel section.

    • Should the resumes be included in this section, or should they be included as attachments?

    • They should be included as attachments.

  1. Where in the proposal should we include the institutional experience section (referenced on page 64)?

    It should be included as another section of the technical proposal (you may include it under "Other Considerations" (p. 37))

    • Should they be incorporated in the Technical section?

    • This section would not be a part of the technical plan of the technical proposal, but would be another section in the technical proposal.

    • Will they count as part of the 30 pages limiting the technical section, the 50 limiting the attachment section, or the Business section with unlimited page number?

    • The institutional experience section will not count towards any of the sections referenced above. There is no page limit to this section.

    • Are you expecting a section for each individual institution?

    • All institutions participating in the research project should be included, as appropriate.

  2. If our project is not intended to do any clinical trials based strictly on the scientific method, should we include research questions and a hypothesis?

    Even if the proposal does not include a clinical trial, research questions and hypothesis are encouraged.

  3. I’m using the Excel spreadsheet referenced in Attachment 11, second link, (http://oamp.od.nih.gov/Division/DFAS/spshexcl.xls) to prepare my budget. Do I also need to send the “Breakdown of proposed estimated cost (plus fee) and labor hours” form which is referenced in the first link of Attachment 11 (http://oamp.od.nih.gov/contracts/BUSCOST.HTM)? Or is the Excel spreadsheet enough?

    The Excel spreadsheet already covers this information, so it is not necessary to submit the form: "Breakdown of Proposed Estimated Cost (Plus Fee) and Labor Hours.”

  4. In the BAA on page 59, line 2- (d), details on the cognizant audit office of the developed country partner is required in the letter of commitment. Could you tell us more about it? Specifically what needs to be indicated regarding this in the letter of commitment?

    The cognizant audit office is the office that negotiates the institution's indirect cost rate agreement. The developed country partner can either give you a copy of their indirect cost rate agreement, which has the audit office listed on it, or just give you the name of their audit office if they don’t want to provide their rate agreement.

  5. Is it sufficient if the main collaborator from the developed country partner signs the letter of commitment or do we need a contracting official to sign this?

    Your developed country partner should know who in their institution is authorized to sign their letter of commitment.

  6. Could you please clarify from whom we need letters of support/commitment? Only the collaborating sites or also the members of the steering committee and the advisory board?

    Letters of commitment should be submitted by any subcontractors and/or consultants that you are proposing. At a minimum they would be required from your developed country partner and any collaborating sites. Members of the Steering Committee (aside from your developed country partner) would be from your own organization and would not require a letter of commitment. The Scientific Advisory Board members are selected by the Government, you should not be proposing any members.

  7. Is it ok to submit scanned letters of commitment or does the original copy need to include original letters and signatures?

    Scanned letters of commitment are acceptable.

  8. If we have addressed the Program Requirements and Tasks listed in Attachment 3 in various places within the Technical Proposal, do we also need to address them as a separate section of the Technical Proposal?

    No, as long as they are addressed somewhere, that is fine.

  9. Do the Appendices need to be in a particular order?

    No.

  10. Page 50 of the BAA states "A. You must provide the following information on the first page of your pricing proposal". Is the "first page" the "cover page"?

    No, it's the first page after the cover page.

  11. Is the "pricing proposal" the "Business Proposal"?

    Yes

  12. In the BAA, page 25 has instructions for the cover sheet for the entire proposal and page 50-51 has instructions for the cover sheet for the Business Proposal. Are there instructions for the cover page for the Technical Proposal?

    The instructions for the cover page of the business and technical proposal are on page 31. The instructions on page 50-51 are for the first page after the cover sheet of the business proposal.

  13. On Form NIH-2043, which is Business Proposal Attachment 10 of the BAA, please explain on what basis we fill out the section asking for Name, Address and Phone Number of Cognizant Government Audit Agency?

    The Cognizant Government Audit Agency is the agency that negotiates indirect cost rate agreements for Government contracts. If your institution does not have a rate agreement, then this would not be applicable, and you can leave it blank.

  14. Are Letters of Commitment to be submitted with both Technical and Business Proposals?

    Yes, please submit the letters of commitment in both the technical and business proposal.

  15. In Attachment no. 7 (SUMMARY OF RELATED ACTIVITIES), please clarify whether the Offeror need to list ONLY those contracts/cooperative agreements/grants and commercial agreements with NIH and US government or should list all such relationships with other non-US government and non-US funding agencies?

    You should list all projects, not just those funded by the U.S. Government.

  16. How do we express in-kind salary? Should we include it on the Excel spreadsheet? (if so, where?)

    Please include in-kind effort in the direct labor Excel spreadsheet. Show the name, title, effort/hours, and then $0 for the salary. You should also state somewhere in the proposal that the labor is being provided at no charge.

  17. Regarding cost accounting standards (CAS) for completion of Section K, can we claim exemption if we have never been part of a federal contract or received a CAS cover contract of $50 million or more, or can the section on CAS be indicated as not applicable (because we are a foreign institution)?

    CAS is not applicable to foreign institutions.

  18. Do Technical Proposal Attachments 4 and 5 have to be submitted now with the initial proposal? May the forms be modified to add a racial category?

    Attachment 4 must be submitted with your proposal, but Attachment 5 is not needed now. You may add a racial category if you don't think the existing categories are sufficient.

  19. Does Business Proposal Attachment 13 have to be submitted with the business proposal now? It seems that this is not necessary now, but until the negotiations are concluded. Please confirm.

    You are correct, it does not need to be submitted with your initial proposal. It will be required later, at the conclusion of negotiations.

  20. Regarding the Form NIH-2043 for the business proposal, what should we put for the errata number?

    The errata number is the number of each amendment that has been issued to the RFP/BAA. Two amendments to the BAA and the RFP have been issued. Please fill in each Amendment no. and the date of each amendment. The amendments are located on at this site for the BAA:

    https://www.fbo.gov/index?s=opportunity&mode=form&id=e3a267b75087f151e43e3ce3751e3e38&tab=core&_cview=1&cck=1&au=&ck=

    and this site for the RFP:

    https://www.fbo.gov/index?s=opportunity&mode=form&id=a18462dd1d7061d0848493fca53bea06&tab=core&_cview=1&cck=1&au=&ck=

Point of Contact:

Lynn M. Furtaw
Contracting Officer
BDR Contracts Branch, OA, DERA
National Heart, Lung, and Blood Institute, NIH
Rockledge II, Room 6134
6701 Rockledge Drive, MSC 7902
Bethesda, Maryland 20892-7902
(Use 20817 for express service)

Phone: 301-435-0357
Fax: 301-480-3432
Email: lynn.furtaw@nih.gov

 


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