CFF/NIH R01-Unfunded Award

Overview

About the Cystic Fibrosis Foundation

The mission of the Cystic Fibrosis Foundation is to cure cystic fibrosis and to provide all people with CF the opportunity to lead long, fulfilling lives by funding research and drug development, partnering with the CF community, and advancing high-quality, specialized care. To achieve this mission, various types of grants and awards are offered to support meritorious research in CF.

CFF/NIH R01-Unfunded Award

Program and Award Overview

CFF has developed its research program to complement work at the National Institutes of Health (NIH). Support from CFF, through various mechanisms, is intended to provide support for the development of sufficient preliminary data to make CF-related applications highly competitive in the NIH review process. However, as a result of funding constraints on the NIH, coupled with the growing interest in CF research, occasions arise in which highly meritorious grants are submitted to the NIH but not funded.

In an effort to assure that all meritorious CF-relevant research is supported, CFF has developed the CFF/NIH R01 - Unfunded Award mechanism to provide bridge funding. The objective of this Request for Applications (RFA) is to support excellent CF-relevant research projects that have been submitted to and approved by the NIH (or governmental funding agencies in other countries) but cannot be supported by available funds. In order to be eligible for this program, applications must fall within the upper 40th percentile. The CFF/NIH R01-Unfunded Award offers a temporary mechanism for continuing highly meritorious projects until support can be obtained.

The maximum award amount is $125,000 per year for up to two years(Direct Costs Only); indirect costs are notallowable.

Eligibility

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Application Details

For application technical support, please contact jchan@cff.org
Program Name: 2025 CFF/NIH R01-Unfunded Award
Brief Program Overview/Description: In an effort to assure that all meritorious CF-related research is
supported, CFF has developed the CFF/NIH R01 -Unfunded Award mechanism to provide bridge funding. The
objective of this Request for Applications (RFA) is to support excellent CF-related research projects that have
been submitted to and approved by the NIH (or governmental funding agencies in other countries) but cannot
be supported by available funds. In order to be eligible for this program, applications must fall within the
upper 40th percentile (1%-40%). (Please note that unfunded R21 projects are no longer accepted through this
mechanism. Investigators should consider revising and submitting these projects through the Research
Grant/Path to a Cure Research Grant funding mechanisms that are accepted May and December each year.)
Funding Amount: The maximum award amount is $125,000 per year for up to two years (Direct Costs
Only); indirect costs are not allowable. Note: the level of funding will be determined by CFF following
review by the designated medical/scientific advisors.
Eligibility:
• The application must have been reviewed by an NIH study section and presented to an institute council
within 12 months of applying for CFF support.
• Applications must have been submitted to NIH as an R01 and fall within the upper 40th percentile (1-
40%). If an application has been submitted to NIH multiple times, the most recent submission must have
been scored in the upper 40th percentile to be considered.
• Unfunded resubmitted applications (A1 or other) may be submitted through this mechanism, however,
may be subject to additional scrutiny.
• A project may only receive funding through the CFF/NIH-Unfunded mechanism one time. If a project has
received funding through this mechanism previously, it cannot be resubmitted, even if it has gone back
to the NIH (or other governmental funding agency).
• Additional eligibility requirements can be found in Section IV below.
Key Dates:
Published February 11, 2025
Full Application Deadline Rolling through December 1, 2025
Review Ad-hoc basis (typically 8-10 weeks after submission)
Full Application Notification Ad-hoc basis (typically 2-4 weeks after review is complete)
Project Start Date As determined by applicant (at least 120 days after the submission)
*The project start date should be the 1st of the month, and the end date should be the last day of the month.
If you are unable to start on the 1st of the month, please contact the GCMA contact listed on the top of page 1.
Table of Contents:
I. About the Cystic Fibrosis Foundation
II. Program and Award Overview VII. Review and Award
III. Funding Amounts VIII. Submission Information
IV. Eligibility IX. Letter of Intent Guidelines
V. Mentorship Requirements X. Full Application Guidelines
VI. Goals of Research Currently of Interest to XI. Resources and Other Information
CFF/Priority Areas XII. Contact Information

I. About the Cystic Fibrosis Foundation
The mission of the Cystic Fibrosis Foundation is to cure cystic fibrosis and to provide all people with CF
the opportunity to lead long, fulfilling lives by funding research and drug development, partnering with
the CF community, and advancing high-quality, specialized care.
To achieve this mission, various types of grants and awards are offered to support meritorious research in CF.
II. Program and Award Overview
CFF has developed its research program to complement work at the National Institutes of Health (NIH).
Support from CFF, through various mechanisms, is intended to provide support for the development of
sufficient preliminary data to make CF-related applications highly competitive in the NIH review process.
However, as a result of funding constraints on the NIH, coupled with the growing interest in CF research,
occasions arise in which highly meritorious grants are submitted to the NIH but not funded. In an effort to
assure that all meritorious CF-relevant research is supported, CFF has developed the CFF/NIH R01 -
Unfunded Award mechanism to provide bridge funding. The objective of this Request for Applications
(RFA) is to support excellent CF-relevant research projects that have been submitted to and approved by
the NIH (or governmental funding agencies in other countries) but cannot be supported by available funds.
In order to be eligible for this program, applications must fall within the upper 40th percentile. (Please
note that unfunded R21 projects are no longer accepted through this mechanism. Investigators should
consider revising and submitting these projects through the Research Grant/Path to a Cure Research Grant
funding mechanisms that are accepted May and December each year.)
CFF does not intend to assume the role of the NIH or other governmental funding agencies, but instead
wishes to ensure that the momentum in CF research is not irreversibly slowed due to budget constraints.
The CFF/NIH R01-Unfunded Award offers a temporary mechanism for continuing highly meritorious
projects until support can be obtained. The CFF will continue to vigorously encourage the NIH to assume
support of meritorious CF-related projects.
III. Funding Amounts
The maximum award amount is $125,000 per year for up to two years (Direct Costs Only); indirect costs are
not allowable. Note: the level of funding will be determined by CFF following review by the designated
medical/scientific advisors.
IV. Eligibility
• The application must have been reviewed by an NIH study section and presented to an institute
council within 12 months of applying for CFF support.
• Applications must have been submitted to NIH as an R01 and fall within the upper 40th percentile (1-
40%). If an application has been submitted to NIH multiple times, the most recent submission must
have been scored in the upper 40th percentile to be considered.
• For applications submitted to governmental funding agencies in other countries, in order to be
considered for this program, the application must have been submitted in the previous 12 months to
an NIH R01 equivalent funding program, provide reviewer critiques, provide a report indicating the
scores in the upper 40th percentile, and be able to resubmit to the funding agency for funding for this
project.
• Unfunded resubmitted applications (A1) may be submitted through this mechanism, however, may be
subject to additional scrutiny.
• A project may only receive funding through the CFF/NIH-Unfunded mechanism one time. If a project
has received funding through this mechanism previously, it cannot be resubmitted, even if it has gone
back to the NIH (or other governmental funding agency).
• The original NIH application must be clearly relevant to advancing the CFF mission.
• The investigator should not be receiving other funding for this work. If other funding is obtained
CFF/NIH R01 -Unfunded Policies and Guidelines 2025 2
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(through NIH or other funding bodies) for this work or the resubmission of the NIH (or other
funding body) application is approved for funding, the CFF award must be relinquished.
• If awarded, a revised application must be submitted to the funding agency within one (1) year of
receiving the CFF award. Failure to do so will result in the loss of support. Documentation showing
resubmission must be provided to CFF as part of the renewal progress report and/or final scientific
report.
• Applicants must be from a non-profit or academic institution; for-profit entities are not eligible to apply.
For-profit entities should visit Industry Funding Opportunities for more information.
V. Mentorship Requirements
Not applicable to this RFA
VI. Goals of Research Currently of Interest to CFF/Priority Areas
The landscape of CF has changed significantly over the past 30+ years since the identification of the CFTR
gene. The introduction of CFTR modulators, small molecule drugs that target the basic CFTR defect, has
led to unprecedented improvement in health for many people with CF. However, there is still a
significant unmet need for people with CFTR mutations that either do not respond to modulators, do not
generate sufficient quantities of protein for correction, or block protein synthesis (i.e. premature stop
codon mutations, splice mutations, insertion/deletion mutations etc.). In addition to correcting the basic
defect, CFF realizes the needs of the community and places a high priority on supporting efforts that
improve our understanding of disease pathogenesis, such as defects in airway defense, microbial adaption
to the CF lung, mucociliary clearance and airway hydration, and extrapulmonary manifestations of the
disease that may not be completely corrected by CFTR modulators. We therefore encourage investigators
to review the list below for basic and translational science areas of interest to the CFF.
Investigators working in the following areas are particularly encouraged to submit an application for
consideration:
• Developing novel means for repairing and/or replacing the mutant CFTR.
• Evaluating outcomes of inserting a CFTR “superexon” or cDNA into the native locus with particular
emphasis on gene regulation, expression, and transcription termination.
• Developing and optimizing the chemistry and formulation of nucleic acid delivery vehicles, both viral and
non-viral, that can target disease relevant cells and tissues.
• Characterization of cellular targets for CFTR correction, including airway progenitor cells and other
affected epithelial tissues (biliary tract, GI tract, pancreas).
• Characterizing and validating potential targets that regulate CFTR mRNA stability and translation, which
includes understanding the pathways and mechanisms that regulate nonsense mediated decay (NMD),
premature termination codon (PTC) recognition, splicing, and translation termination.
• Evaluating codon optimization strategies to enhance CFTR protein longevity, stability, and function.
• Understanding of how modulators impact disease pathogenesis across all stages of life as well as the
cellular and molecular changes that cannot be reversed by modulators, which may include direct and
indirect influences of CFTR modulation on the airway milieu, including resident pathogens, inflammation
and inflammatory cell function, mucin structure (tethered and secreted), airway surface liquid (ASL), and
mucociliary clearance (MCC), as well as extrapulmonary manifestations.
• Biological mechanisms involved in chronic lung allograft dysfunction (CLAD), rejection and transplant
immunology.
• Improved understanding of acquisition, detection, pathogenesis, host-pathogen interactions, and
treatment approaches for difficult to treat CF infections (i.e. MDR Pseudomonas, Burkholderia,
Stenotrophomonas). *
• Approaches to understand and treat nutritional deficiencies and CF-related GI complications, including
intestinal, pancreatic, and hepatobiliary disease across the lifespan.
CFF/NIH R01 -Unfunded Policies and Guidelines 2025 3
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• Effects of endocrine system dysfunction in CF, especially projects focused on biological underpinnings of
Cystic Fibrosis Related Diabetes (CFRD), CF bone disease, and sexual & reproductive health.
Projects that focus on strategies and methods with the potential to inform or ultimately translate into
novel therapies to restore CFTR protein function or fix/replace the defective CFTR gene as well as those
that improve our understanding of disease mechanisms and pathophysiology in a manner that will lead to
development of new prevention and treatment strategies may be prioritized for funding.
*Projects focused on individual pathogens not listed above or that solely explore basic biology of pathogens
that will not have direct applicability to the development of new treatment strategies or improve outcomes for
people with CF may be deprioritized for funding. Infection/microbiology-focused applications should utilize
clinically relevant strains and specimens or address host responses to the organism as part of the application.
VII. Review and Award
Since applications to this program have already been reviewed and scored by an NIH (or other
governmental agency) study section, CFF medical/scientific advisors will focus on the following points:
• Relevance of the proposed study to issues in CF
• Adequacy of the budget
• Potential for future support by the NIH (or other governmental funding agencies)
Note that A1 applications (or those applications that have previously been through one round of review at
the NIH (or other governmental agency) may be subject to additional scrutiny to ensure that the proposed
bridge funding will improve the applicant’s chances of success on the next resubmission.
All awards are subject to observance of CFF policies and Terms and Conditions in addition to applicable
Federal regulations or equivalent regulations in the Awardee Institution’s country, based on the type of
research involved. All awards and ongoing support are also contingent upon the availability of CFF funds.
VIII. Submission Information
Application Deadline: Rolling through December 1, 2025
Submit online through http://awards.cff.org
(Refer to Section X of these guidelines for specific submission instructions)
An application will be considered incomplete if it fails to comply with the instructions, or if the submitted
material is insufficient to permit adequate review. CFF reviews applications electronically, and only
documents submitted online at http://awards.cff.org will be reviewed.
General Timeline:
Full Application Deadline Rolling through December 1, 2025
Review Ad-hoc basis Ad-hoc basis (typically 8-10 weeks after submission)
Full Application Notification Ad-hoc basis (typically 2-4 weeks after review is complete Project Start
Date As determined by applicant (at least 120 days after the submission)
The project start date should be the 1st of the month, and the end date should be the last day of the month.
If you are unable to start on the 1st of the month, , please contact the GCMA contact listed on the top of page 1.
IX. Letter of Intent Guidelines
Not applicable to this RFA
CFF/NIH R01 -Unfunded Policies and Guidelines 2025 4
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X. Full Application Guidelines
Applications must be submitted online at https://awards.cff.org
Documents should be typed using:
• Font: Times New Roman 12 or Arial 11
• Margins: No less than a half inch on each side
Note: When all the documents have been uploaded to awards.cff.org, the system will compile them into a
single PDF file. You may preview this file by selecting “Application Full Print”, as well as exporting the
compiled PDF file.
To login, please visit: https://awards.cff.org
For all first-time applicants in the new Grants Management System, we ask that you pre-register to create
a username and password for “http://awards.cff.org” and complete a profile prior to submitting an
application. We also request that as you begin your application, you enter the title of your project, if
available. If you are registered and cannot remember your password, click on the “Forgot Password?” link
below the “Login” fields.
Once logged in, the award opportunities, including this Request for Applications (RFA), will be listed in the
Funding Opportunities tab on the opening screen.
Locate the listing for the “2025 CFF/NIH R01 -Unfunded Award” program. Click on the “Apply” button in
the column on the far right to open the application form.
Applicants may stop at any point but must click the “Save” button at the bottom of each page before
exiting in order to save their progress. When you wish to return to your draft application, please do not
go through the “Funding Opportunities” tab. Instead, go to the “My Applications” tab in the right corner
of the main page. When you are in the “My Applications” tab you will be able to find all your draft
applications by clicking on the “Draft Applications” module.
The following sections are displayed as tabs across the application screen. Click on each section and follow the
directions. Click “Save” as you complete each section.
Please note: Only select the “Sign & Submit to AIO” button after the application has been fully
completed. This will trigger validation on all required fields and send the application to your Authorized
Institutional Official “AIO” for review and signature through Adobe Sign.
GENERAL
Enter the title of your project, enter the project start and end dates, and complete any additional questions.
*Please ensure that you review and comply with the Organizational Assurances and Certifications as cited
below.
CONTACT PROFILE
Please note: The INSTITUTION tab must be completed prior to adding internal contacts to ensure that the
contacts are properly associated with the applicant institution.
If a profile was completed upon registration, the fields in this section will already be populated with
the information entered in your Professional Profile. If you need to make any changes, you may
update your profile in this section. Once updated you must “Save and Validate” prior to returning to
CFF/NIH R01 -Unfunded Policies and Guidelines 2025 5
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continue your submission.
INSTITUTION
If a profile was completed upon registration, the applicant’s/principal investigator’s institution will be
preloaded as the Lead Institution. Domestic applicants must verify their institution by entering the
Employer Identification Number (EIN) or Tax Identification Number (TIN) to search the system for the
correct institution. If the EIN/TIN is not located, you may add the legal institution. Please also confirm if
the project site is the same as the legal institution.
Note: When choosing an institution, please select the institution where the applicant will plan to complete
their project.
Verification of Applicant Institution’s Tax Status (upload as PDF documents):
The CFF Grants & Contracts Management and Administration (GCMA) Office must have a copy of the
applicant institution’s current W-9 and 501(c)3 letter, or other documentation verifying its Federal tax
status and will not issue Award Letters to Awardees if these documents are not received and on file.
• Applicants from for-profit organizations must submit a copy of the applicant institution’s W-9 and
IRS documentation verifying the organization’s Federal tax status. Awards are not issued prior to
having these documents on file with the CFF GCMA Office.
• Non-U.S. applicants must provide a copy of the W-8BEN-E form (required). In addition, a tax
equivalency letter should be uploaded, if available. If a tax equivalency letter is not available,
applicants must upload a letter stating this documentation is not available.
International Applicants (if applicable):
For international applicants, you will need to answer an eligibility question specifying if you are an
independent investigator. If answering yes, CFF may require an additional letter of support to be added to
the application to verify eligibility.
Applicants whose institution is not a United States based-entity will be required to provide additional
information and complete the CFF International Institution Form as part of the Full Application stage. Refer
to International Institution Form section below.
CONTACTS
Please note: The INSTITUTION tab must be completed prior to adding internal contacts to ensure that the
contacts are properly associated with the applicant institution.
Complete the required contact fields by searching by name for existing contacts at your institution for each
role. If the desired institutional contact is not available in the system, you may select “Add Internal Contact”
to create a basic contact profile in order to add the individual to your application.
Additional contacts not associated with the applicant institution may also be added. These contacts are
considered additional contributors involved in the proposed research plan. These may include consultants,
collaborators, or subcontractors. In order to add contacts external to the applicant institution, please select
the appropriate “Add Subcontractors” or “Add Consultants/Collaborators” button(s) and add the contacts in
the table, then click “Save”.
ABSTRACTS/RELEVANCE
In the space provided online for abstracts, provide a statement of no more than 2,000 characters (including
spaces) explaining the subject of the research proposal and its relationship to CF. Two different abstracts are
required, as follows:
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• Lay Abstract: This statement will be used to inform the non-scientific departments of CFF and the general
public of the nature of this work. Applicants should not include any confidential or proprietary
information, including intellectual property, in the lay abstract.
• Scientific Abstract: This statement will be used to inform the scientific community.
• Summary of Relevance to CFF mission: All applications are reviewed and scored not only on
scientific merit but also on relevance to CFF’s mission:
The mission of the Cystic Fibrosis Foundation is to cure cystic fibrosis and to provide all people
with CF the opportunity to lead long, fulfilling lives by funding research and drug development,
partnering with the CF community, and advancing high-quality, specialized care.
Provide a statement of no more than 3,000 characters (including spaces) summarizing the relevance
of the proposed research to the health and well-being of CF patients, for a scientific audience who
may or may not have a background in the subspecialty of the proposed research.
BUDGET
Select the “Edit Budget” button under Application Budget, to enter and begin completion of the
application’s budget detail for each year of funding being requested. CFF/NIH-Unfunded Awards approved
through this RFA are for a maximum of two (2) years. The total budget request cannot exceed $125,000
per year (indirect costs are not allowable). *Budget Justification upload(s) should be provided
individually for each year of funding support being requested. These can be uploaded as a single PDF or
separate PDF uploads for each year.
The following budget categories are offered under this program:
Salaries & Benefits - List the names and positions of all professional and non-professional personnel
involved in the project, whether or not salaries are requested. Indicate the percent effort on the project
for all personnel. For each individual, be sure to complete all fields on the Budget Detail in full on the
template provided. In accordance with National Institutes of Health (NIH) policy, salary requests may not
use an institutional base salary in excess of the current federal salary cap of $225,700 (FY2025). Fringe
benefits may be requested if they are treated consistently by the applicant institution as a direct cost to
all funding agencies and foundations.
Consultant Expenses - Give the name and institutional affiliation of any consultant who has agreed to
serve in this capacity, including statisticians and physicians in connection with acquiring patient samples if
they are not listed under personnel. In the budget justification, briefly describe services to be
performed, the number of days, rate of compensation, per diem and any other associated costs.
Travel - Describe the purpose of any CF-relevant travel. Please note: expenses for travel outside the North
American continent, including travel to Hawaii, Puerto Rico, and other U.S. territories are not allowable
expenses without prior written approval from the CFF GCMA Office. Travel expenses may not exceed
$1,500 per person, per year. Registration fees associated with conferences should be listed under “Other
Expenses.” Applicants are encouraged to attend the North American CF Conference each year to present
their work.
Consumable Supplies – Itemize supplies e.g. glassware, chemicals, animals, in separate categories and
give the estimated cost of each category. If animals are involved, state the number, unit purchase cost,
and unit care cost.
Major Equipment - List all items of equipment greater than $5,000 requested and the cost of each item. If
funds are requested to purchase equipment that is equivalent to items listed under “Facilities Available”,
justify the duplication. Justify any item of equipment for which the need may not be obvious.
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Other Expenses - Itemize other expenses by major categories, such as subcontracts, duplication costs,
publication costs, computer charges, conference registration fees, etc. Tuition costs may be requested for
personnel supported through this study but may not exceed $10,000 per person per year.
Subcontractors Summary – If applicable, detailed budgets and budget justifications for each subcontract,
including indirects, must be provided for each year of support. Subcontractors are added in the prior section
entitled CONTACTS. The lead/prime applicant (PI) and/or Grants Officer can initiate/complete the
subcontract budget. After adding Subcontractor(s), in order to access the subcontract budget activity,
please select the “BUDGET” tab of the application and click the “Open” button next to each listed
subcontractor. After completing the subcontract budget activity, please select “Pending PI Acceptance”, as
well as “Submit” to ensure the subcontractor budget is included as part of the main application budget.
Budget Detail – Indirect Costs
Indirect costs are not allowable.
FULL APPLICATION UPLOADS
Download the available templates applicable to the project, upload the completed templates, as well as the
additional application components as outlined below. All documents must be uploaded in PDF format to the
corresponding attachment types within this section. Templates available for download include:
• Budget Justification
• Response to NIH Summary Statement
• Research Plan – Revised
• Other Support
• Results of Past and Current CFF/CFFT Support
• International Institution Form
BUDGET JUSTIFICATION
Describe costs listed in the Budget Detail. Use major categories, such as Salary & Benefits, Consultant
Costs, Major Equipment, etc. Justify all items and make sure amounts and figures listed in the narrative are
consistent with those listed in the Budget Detail(s). *Budget Justification upload(s) should be provided
individually for each year of funding support being requested. These can be uploaded as a single PDF or
separate PDF uploads for each year.
COPY OF NIH (OR OTHER GOVERNMENTAL FUNDING AGENCY) UNFUNDED APPLICATION
A PDF copy of the entire unfunded grant application should be uploaded to the application.
COPY OF NIH SUMMARY STATEMENT (OR EQUIVALENT)
A PDF copy of the entire NIH Summary Statement associated with the unfunded grant application must be
uploaded to the application. Applications that were submitted to governmental funding agencies in other
countries should submit the reviewer critiques provided by the funding agency.
RESPONSES TO NIH SUMMARY STATEMENT
Please provide a point-by-point response to the critiques noted in the NIH Summary Statement (or
reviewer critiques provided by the funding agency) and specific plans to address identified weaknesses.
There is no page limit to the responses; however, be as concise and succinct as possible.
REVISED RESEARCH PLAN
Page limit: Ten (10) single-sided pages, not including the Literature Cited. Applications exceeding this
page limit will not be reviewed. Include sufficient information to permit effective review without
reference to previous applications. Information should be presented in a clear and concise manner,
CFF/NIH R01 -Unfunded Policies and Guidelines 2025 8
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while being specific and informative.
• Key figures and legends must be included in the Research Plan and should be of sufficient quality and
size to be evaluated by the reviewer(s). If uploaded as Appendices, they will NOT be reviewed.
• Type the PI’s name in the space available in the header of the document. The template available will
track page numbers at the bottom.
The Revised Research plan should not be a copy of the submitted NIH (or other governmental funding
agency in another country) unfunded application. Instead, this section should highlight the scope of work
and experiments that will be completed using the funds from CFF if the award is funded. This section
should specifically address weaknesses noted in the NIH Summary Statement (or reviewer critiques
provided by the funding agency) as well as the reduced CFF budget. The Revised Research Plan must also
include a clear strategy for resubmission of the original application to the funding agency. The plan may
include the following components:
a. Hypothesis and Specific Aims: State concisely and realistically the intent of the proposed research
and the hypothesis to be tested. The specific aims should be relevant to the mission of the Cystic
Fibrosis Foundation. Do not exceed one page.
b. Background and Significance: Briefly describe the background. Critically evaluate existing knowledge
and specifically identify the gaps that the project is intended to fill. Concisely state the importance
and rationale of this research by relating the specific aims to longer-term objectives. This section
should also show the potential importance of the proposed work to CF. In addition, describe the
relationship of the proposed work to your long-term career goals. Preference will be given to
applicants who express an interest in a long-term career in CF-related research.
c. Preliminary Results: If applicable, provide a detailed discussion of any preliminary results.
d. Experimental Design and Methods: Discuss the experimental design and methods to be used to
accomplish the specific aims. Describe the protocols, including methods for new techniques, and
explain potential advantages over existing methodologies. Discuss the data expected to be obtained
and the means by which the data will be analyzed and interpreted. If human subjects are involved,
provide details of the methods for patient selection and care. Discuss potential difficulties and/or
limitations of the proposed procedures and alternative approaches to achieve aims. Point out any
procedures, situations or materials that may be hazardous to personnel or patients and the
precautions to be exercised. Applications that include methodologies requiring sampling of materials
from human subjects will only be considered under this mechanism if the sampling method
constitutes minimal patient risk (e.g., venipuncture, nasal brushing) and patient samples or data are
anonymous. Describe the level of risk and measures taken to assure patient anonymity to the PI and
other professional personnel, unless the PI or other professional personnel are care providers.
e. Consultant Arrangements: If the proposed project includes consultant arrangements and/or
collaboration with other individuals outside the applicant's group, describe the working relationships
and support this description by letter(s) of intent signed by collaborating individual(s). If clinical
material required by this award is to be furnished by other individuals, include a letter from these
individuals agreeing to their participation and precautions taken to ensure anonymity of patients.
f. Literature Cited: References should be numbered in the sequence that they appear in the text and
listed at the end of the Research Plan. Each citation must include the names of all authors, title, the
name of the journal or book, volume number, page number and year of publication (titles are
optional).
OTHER SUPPORT
Complete and upload the Other Support form for all key project personnel, beginning with the
Applicant/Principal Investigator. There is no page limitation. Information on other support assists CFF in the
identification and resolution of potential sources of overlap. Scientific and budgetary overlap should be
minimized. Commitment of an individual’s effort greater than 100 percent, is not permitted.
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RESULTS OF PAST AND CURRENT CFF/CFFT SUPPORT
The Principal Investigator (PI) and any Co-Principal Investigator(s), if applicable, are requested to identify
the results of past and current CFF/CFFT support (e.g., subsequent funding from other sources, journal
articles, and invited presentations) and the CFF/CFFT award from which they resulted for the past five (5)
years.
Please note that the following information must be included with each research project identified:
• CFF/CFFT Award #
• Principal Investigator (PI)
• CFF/CFFT Project Title
• Applicant’s Title on Project
• Project Start/End Dates
• Total CFF/CFFT Award Amount
• Results of Support
INTERNATIONAL INSTUTTION FORM (IF APPLICABLE)
Applicants whose institution is not a United States based-entity must complete the CFF International
Institution Form.
• Please attach a current copy of the following documents to your completed form and cite to the relevant
page(s) or paragraph(s) in the supporting documentation:
• A Form W-BEN-E or W-8EXP signed by the authorized institutional official within the last three years.
• An anti-terrorism certification signed by an institutional official indicating that all award funds, including
but not limited to CFF funds, will be used in compliance with applicable U.S. anti-terrorist financing,
privacy and asset control statutes, regulations and executive orders, resulting in funds never being used
to support terrorist networks, organizations and/or activities. Please see the CFF template provided in
Appendix A;
• Names and Addresses of all Institutional Officers and Directors (Appendix B);
• Institution’s Current Sources of Support, including grants, private endowments, commercial activities,
etc. (Appendix C).
Applicants who have provided these documents within the past one (1) year are not required to resubmit
them. However, if any of the above documents have been updated since they were previously submitted,
please upload any updated documents. The CF Foundation GCMA Office will contact applicants if documents
are outdated or missing.
*Applicants must provide English translations for all non-English documents, including material provided in
support of the Research Plan.
APPENDICES
Appendices are restricted to the following categories:
• Up to three (3) reprints of the applicant’s work relating to the general area of research in the proposal
may be uploaded in PDF format.
• Additional NIH (or equivalent) Biographical Sketches, that are not already included in the original
application, should be completed/uploaded for any new key personnel named in the CFF
application. Note: CFF defines “key personnel” as any individual with an advanced degree that will
plan an instrumental role in the accomplishment of the research project.
*Organization Assurances & Certifications
CFF requires, as applicable, that all U.S.-based awardees obtain Institutional Review Board (IRB) approvals
for human subject research, Institutional Biosafety Committee (IBC) approval for recombinant or synthetic
nucleic acid research, and Institutional Animal Care and Use Committee (IACUC) approval for animal
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research, (see additional information regarding these approvals below). Copies of these approvals, if
available at the time the application is submitted, must be uploaded with the application as appendices.
CFF will not release payments to awardee institutions until these documents are received and on file with
the CFF GCMA Office.
Awardees based outside of the U.S. must comply with the applicable equivalent regulations in their
respective countries and provide copies of approvals as soon as they are available. CFF will not
release payments until these documents are received and on file with the CFF GCMA Office.
Research Involving Human Subjects: CFF policy pertaining to the protection of individuals as research
subjects requires that for each proposal awarded, the awardee institution certify in writing that an
Institutional Review Board (IRB) has reviewed and approved the procedures for the use of human
subjects, or human organs, tissues and body fluids, in the proposed research, in accordance with the
Department of Health and Human Services policies found at https://www.hhs.gov/ohrp/regulations-and-
policy/index.html. In the event the IRB has determined a study is exempt, documentation demonstrating
the exempt status must also be submitted to the CFF GCMA Office.
Research Involving Recombinant or Synthetic Nucleic Acid Molecules: All research involving recombinant
or synthetic nucleic acid and human gene transfer studies supported by CFF must meet the requirements
contained in the document NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid
Molecules (updated April 2024). This publication and announcements of modifications and changes to the
NIH Guidelines are available from the Office of Science and Policy, National Institutes of Health, 6705
Rockledge Drive, Ste 750, MSC 7985, Bethesda, MD, 20892-7985 or online at https://osp.od.nih.gov/wp-
content/uploads/NIH_Guidelines.pdf.
Research Involving Animals: Applications submitted to CFF involving the use of animals must meet the
guidelines of the National Institutes of Health found at https://grants.nih.gov/grants/olaw/olaw.htm,
which require that all proposed studies be reviewed and approved by an Institutional Animal Care and Use
Committee (IACUC). In addition, CFF awardee institutions and laboratories must be accredited by the
American Association for Accreditation of Laboratory Animal Care (AAALAC) and/or have other verifiable
assurances that the institution and laboratory meet appropriate standards.
Validation and Submission
Prior to selecting “Sign & Submit to AIO”, please complete a thorough review of the entire application.
The “Sign & Submit to AIO” button will trigger validation on all required fields and identify any errors.
Upon submission the ability to edit the application will be locked pending review and approval by your AIO.
After selecting Sign & Submit to AIO, the applicant will receive an email asking them to sign the
application FacePage electronically using Adobe Sign. Once signed by the PI, the FacePage will then be
routed to the AIO contact that is listed on the application for review and signature to complete the
submission.
XI. Resources and Other Information
• CFF Funding Opportunities Newsletter
• Grants Management System – How to User Guides
XII. Contact Information
For technical and Grants Management System support:
Primary CFF GCMA Office contact Jodie Chan at jchan@cff.org or 301-841-2614
For scientific/programmatic questions:
Program Officer: Katherine L. Tuggle, Ph.D. ktuggle@cff.org
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