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 10,
2008
- 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.
- With respect to OFFEROR'S POINTS OF CONTACT,
can the principal investigator also
be the Business Representative with
whom daily contact is required?
Yes.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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:
- Go to the Online Representations and Certifications
Application (ORCA) at: https://orca.bpn.gov/ and
complete the Representations and Certifications;
- 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
- 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.
- Do the biosketches/resumes have to be in any specific
format?
No.
- 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.
- Will the ACC database house individual patient
data?
No.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.”
- Does “personnel” refer to the
personnel section described on
page 46 of the RFP?
Yes.
- 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.
- Is the “Institutional Experience and
Facilities” section included in the 30 page
limitation for the technical plan?
Yes.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- In many countries
the only type of paper found is A4, no “letter” size
paper is available. Would A4 be acceptable?
Yes.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- Can there
be more than one developed country partner?
Yes.
- 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.
- Does the developed
country partner also need to be a Fogarty
center?
No.
- 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.
- 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.
- 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.
- 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
- 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.
- 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
- 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
-
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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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."
- 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.
- 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.
- 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=
- 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.
- 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=
- 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.
- 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=
- 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.
- Are the Technical Proposal Attachments identified
in Section J included in the 50 page
limit for Appendices?
Yes.
- 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.
- 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.
- 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.
- 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.
- 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.
- Are studies related to asthma considered
responsive to the BAA?
Yes.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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?
- 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.
- 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.
- 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.
- 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.”
- 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.
- 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.
-
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.
-
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.
-
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.
-
Do the Appendices need to be in a particular order?
No.
-
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.
-
Is the "pricing proposal" the "Business Proposal"?
Yes.
-
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.
-
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.
-
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.
-
In Attachment no. 7 (SUMMARY OF RELATED ACTIVITIES), p lease 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.
-
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.
-
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.
-
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.
-
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.
-
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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