For application technical support, please contact: aminucci@cff.org

Program Name: 2024 Fall Clinical Pilot and Feasibility Award with LOI

Brief Program Overview/Description: Clinical Pilot and Feasibility Awards are offered to support projects involving

human subjects (see 45 CFR§46.102(f)) that will develop and test new hypotheses and/or new methods (or those

being applied to the problems of cystic fibrosis for the first time), and to support promising new investigators as they

establish themselves in research areas relevant to cystic fibrosis. The intent of these awards is to enable investigators

to collect sufficient preliminary data to determine the best strategies and methods for approaching a major question

Supplemental Funding to Address High Priority Area – Please refer to Section III. Funding Amounts below for

detailed information regarding Remote Collection and Health Equity Supplements.

Eligibility:

• United States residents and applicants from outside the United States are welcome to apply.

• Applicants must be independent investigators. An independent investigator is an individual who is out of

fellowship training and whose institution allows them to submit applications for research funding as a Principal

Investigator.

• Additional eligibility requirements can be found in Section IV below.

Notification to Applicants May 2025

Earliest Project Start Date July 1, 2025

Table of Contents:

I. About the Cystic Fibrosis Foundation

II. Program and Award Overview

III. Funding Amounts

IV. Eligibility

V. Mentorship Requirements

XI. Resources and Other Information

XII. Contact Information

XIII. Electronic Application Checklist

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.

people of color within the CF community – including those in the CF research workforce – and addressing health

disparities that exist within individuals who identify in these groups is critical to the Foundation’s mission of

serving all people with CF. Making clinical trial design and engagement more inclusive of people of color with CF

will be critical for improving treatment options and health outcomes for individuals who identify in these groups.

In the U.S., Black and Hispanic people with CF account for a disproportionate number of individuals with

rare/understudied CFTR mutations (variants) that are not amenable to (not responsive) or are not currently

approved for treatments that address the underlying cause of the disease. As PIs prepare application materials,

we strongly encourage the consideration of how to support inclusion of diverse participants, including plans for

community engagement to improve trust and enhance recruitment with people with CF who are

underrepresented in CF research.

visit: https://www.cff.org/for-researchers

• CFF Patient Registry Data

• CFF Biorepository

• Community Voice – Getting Community Input

• National Resource Centers

• Whole Genome Sequencing Project Data Requests

II. Program and Award Overview

Program Overview

The CF Foundation funds investigator-initiated clinical research through the Idea Development Award (IDA), the

Clinical Pilot and Feasibility Award (CP&FA), the Clinical Research Award (CRA), and the Clinical Research Award

Plus (CRA+), and other various targeted funding opportunities that occur throughout the year.

Funding for most investigator-initiated clinical research awards is a two-tier process. The CF Foundation requires

CP&FA, CRA, and CRA+ to submit either a Letter of Intent (LOI) or Concept Proposal in advance of a full

application. Full applications are accepted on an invite-only basis; however, applicants may be able to by-pass the

LOI with prior approval from the Program Officer. The Idea Development Award does not contain a Letter of

Intent component.

On average, the Foundation invites about 50% of the investigators to submit full applications and funds roughly

30% of full applications.

collect sufficient preliminary data to determine the best strategies and methods for approaching a major

question that ultimately will require assessment through a larger-scale research and/or multi-center,

collaborative trial. Special consideration will be given to those projects that pursue new approaches, study under-

researched topics, or investigate more creative avenues of research to address the problems of CF. Applications

for continued funding of existing projects, or for long-term support of an investigator, will not be considered.

Note: Preliminary data is not required; however, applicants must provide sufficient background information and

rationale to support moving this work into human subjects research.

III. Funding Amount

Health Equity Supplement: Applicants may request an additional $50,000 (plus twelve (12) percent indirect

costs) over the entire project period to EITHER advance our knowledge of health disparities in cystic fibrosis

OR enhance the diversity, equity, and inclusion in the biomedical workforce.

• Applicants may request funding of up to $50,000 over the course of the entire project period, plus twelve

(12) percent indirect costs to support sub-aims or salary to address high priority areas in remote collection

and health equity.

• Awards may be approved for up to a two (2) year period. Funding for Year 2 is contingent upon submission

and approval of a renewal progress report and the availability of funds.

• Support for multidisciplinary collaborations, including travel

• Travel costs for scientific/technical meeting(s)

• Tuition (proper justification required prior to approval)

Indirect Costs up to twelve (12) percent may be requested from CFF.

• Applicants may request indirect costs on the first $25,000 of each subcontract for the project period.

Indirect costs may be requested for all expenses except for the following:

• Equipment (items over $5,000 in value)

• Computer software

ANTIMICROBIAL MANAGEMENT: Research related to the optimization of current antimicrobial therapies (e.g.,

when antimicrobial therapy is needed, maximally effective treatment, long-term toxicity or side effects,

antimicrobial stewardship, and eradication) with consideration of changes that may occur with current post-

modulator use.

The quality of grantsmanship, including grant writing, level of description, accuracy, and general

organization

Funding of awards is approved by the CFF Board of Directors and is based on the availability of funds, priority

• inadequate analytic methods, or experimental plan that does not address hypothesis

• Failure of the applicant to describe potential relevance of the proposed study to address issues or knowledge

• Failure of the applicant to document the necessary skills, training, or collaborate with individuals with the

relevant expertise to accomplish the goals of the proposal

• Failure of the applicant to demonstrate adequate level of support/expertise and appropriate plan for data

acquisition, management and statistical analyses

• Failure of the applicant to meet all the criteria described in these guidelines

CFF may withdraw applications receiving low scores, and/or those deemed nonresponsive to the program

be accepted for further consideration by CFF. Applicants must address reviewer critiques in order to resubmit

their applications during future application cycles.

VIII. Submission Information

(Refer to Section IX and 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 https://awards.cff.org

will be reviewed.

Specific requests regarding a deviation from these guidelines must be submitted to the Program Officer Dara

Riva ([email protected]

) for approval prior to submitting their application.

Committee Review Date May 2025

Notification to Applicants May 2025

Earliest Project Start Date July 1, 2025

*We highly encourage that you pre-register your profile, institution, contacts, and Title of your Application by

this date. This will confirm that your submission at the Application Deadline, is without any system-related issue.

It will also allow us to assist you on system-related queries before the Application Deadline. This pre-registration

is for new applicants to the system and will only need to be completed once.

IX. Letter of Intent Guidelines

Investigators with a previously approved LOI who did not submit a full application, and/or investigators

submitting a revised application may request to bypass the LOI stage. These requests must be e-mailed to

with “Clinical P&F LOI Bypass Request” in the subject line. LOI bypasses are granted on a case-by-

case basis and the CF Foundation Grants & Contracts Management and Administration (GCMA) Office will send a

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 https://awards.cff.org

, the system will compile them into a

single PDF file. You may preview this file by selecting “LOI Application Full Print”, as well as exporting the

compiled PDF file.

To login, please visit: https://awards.cff.org

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 Spring Clinical Pilot and Feasibility Award with LOI” 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

GENERAL

Enter the title of your project, enter the project start and end dates, select the number of periods being

requested, and complete any additional questions. Also, please complete the organizational assurances

indications (i.e. IRB, IACUC, and/or IBC/rDNA approval letter and status at the time of submitting the

application) in this section.

INSTITUTION

If a profile was completed upon registration, the applicant’s/principal investigator’s institution will be pre-loaded

as the Lead Institution. Domestic applicants must verify their institution by selecting their Employer Identification

Number (EIN) or Tax Identification Number (TIN) that will be pre-loaded based on the institution linked to your

CONTACT PROFILE. You may find your EIN by referencing the Institutional W-9 or equivalent documentation. If

the EIN/TIN is not located in our system, you have the option to add the legal institution. Please also confirm if

the project site is the same as the legal institution.

Verification of Applicant Institution’s Tax Status (upload as PDF documents):

• 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

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 spaces provided online, provide a statement of no more than 2,000 characters (including spaces)

• 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

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.

FULL APPLICATION UPLOADS

Download the available templates applicable to the project, upload the completed templates in PDF format to

the corresponding attachment types within this section. Templates available for download include:

relevant literature, as well as details related to the relevant experience of the study team can

enhance the likelihood of success of the application.

ii. Experimental Design and Methods: Provide a detailed discussion of the experimental design

and methods to be used to accomplish the specific aims, and to test the stated hypothesis.

Protocol Synopsis, Schedule of Events, and Subject Reimbursement (template available for download)

Complete the information required in the available protocol synopsis template for each aspect of the study

For new applications: Provide a point-by-point response to the limitations noted in the critiques of the LOI, using

the template provided. Maximum three (3) pages

For resubmissions: Provide a point-by-point response to the prior reviews. Beginning in 2018, applicant’s will only

be allowed to revise and resubmit their full application for a specific project one time unless granted permission

from the CFF Program Officer. Maximum three (3) pages

Provide a statement of no more than 500 characters (including spaces) summarizing the proposed work

completed under this planning grant that will involve patient engagement. Specifically, please provide

descriptions about what type of support you are requesting from the CFF’s Community Partnerships

department, including survey develop and dissemination, focus groups, or patient partnership identification.

Please provide a timeline on when patient engagement will occur during this planning grant. To learn more

about Community Engagement and CFF’s Community Voice, visit

Budget Justification (template available for download)

Describe costs listed in the Budget Detail. Use major categories, such as Salaries & 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. *Budget Justification upload(s) should be provided individually for each

Complete and upload the Other Support form for all key project personnel, beginning with the

Applicant/Principal Investigator. Make sure all other support is listed not only CF Foundation funded projects

(pending, current, and previous support). 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.

Facilities Available (template available for download)

Describe the facilities and equipment available at the applicant’s institution that will be used for this project, such

as laboratory, clinical, animal, computer, office, etc. Provide any additional information about the environment,

including any support services available that will be utilized. Describe their pertinent capabilities, proximity and

anticipated extent of use. If facilities or equipment at a consultant’s or collaborative site will be used, they should

monitoring of study data to assess whether or not an early termination is necessary for safety or efficacy reasons.

The extent of monitoring required for a study is dependent on the level of risk involved for the subjects, as well

as the size and complexity of the study. Large, multi-center CFF-funded interventional clinical trials may be

required to utilize a Data Safety and Monitoring Board (DSMB). In addition, because its members are CF clinicians

and clinical trial experts, CFF strongly encourages and may require that investigators utilize the CFF DSMB for any

other interventional CF clinical trial that meets one or more of the following criteria:

• Multi-center;

• Randomized;

• Conducted in an emergency setting;

Address the following areas in the DSMP:

• Minimal Risk

• Low Risk

• Clinicaltrials.gov (United States):

• EudraCT Registration (European Union): For interventional clinical trials with medicinal products

conducted in the European Union, the Institution must provide documentation to CFF confirming

registration of the clinical trial when applicable.

Requests/

from the system indicating receipt of the application must be uploaded to the submission. Funding is contingent

upon approval to access registry data.

CFF Biorepository Clinical Specimen Confirmation Letter (if applicable)

To request clinical samples from the CFF Biorepository to use in the proposed study, please follow the following

steps:

receive documentation confirming receipt of your request and that the sample request is feasible from the

Sr. Clinical Research Development Specialist. This should be submitted with your LOI.

Development Specialist and finalize your sample request no less than 6 weeks prior to the Full Application

deadline (2 January 2024, 2 July 2024). ***Late requests may not be processed in time for submission of

A letter documenting available sample counts and other pertinent biorepository details and confirming

access to samples pending CFF funding will be provided by the Sr. Clinical Research Development Specialist

Note: Applicants must upload the confirmation letter provided by the CFF Sr. Clinical Research Development

Specialist to the application. Funding is contingent upon approval and availability to access clinical specimens.

International Institution Form (template available for download, if applicable)

Applicants whose institution is not a United States based-entity must complete the CFF International Institution

Form. The completion of this form also includes submission of the following documentation:

nonprofit status, if available, as well as governing documents (such as a Charter, Statute, or By-Laws)

detailing the funding and expenditures related to activities outlined in the Mission Statement of the

Institution compared to activities outside of the mission of the Institution

• If the Institution is a for-profit organization, provide a complete list of key employees, members of the

governing board, and/or other senior management as well as any governing documents (such as an Articles

of Association or Organization) detailing the funding and expenditures of the Institution

• A complete and accurate Form W-8 signed by the institutional official within the last three years. While CFF

issues grant funding to 501(c)(3) and nonprofit institutions, CFF also issues contract award funding to other

kinds of institutions.

• A description of external sources of support, including the names of individuals and organizations providing

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

institution does not have this policy, CFF can provide an Anti-Terrorism Certification Form to be signed by the

institutional official).

Applicants who have provided these documents within the past one (1) year is 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 (upload as PDF documents)

and how he/she will assist the investigator new to CF research.

Note: Junior investigators must provide such letters by contacting referees via section #6 of the navigation

bar.

• 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.

*No other types of Appendices will be reviewed.

*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

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 CF Foundation 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

determined a study is exempt, documentation demonstrating the exempt status must also be submitted to the

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 upload errors or incomplete

fields. Upon selecting Sign & Submit to AIO, the ability to edit the application will be locked pending review and

approval by your AIO.

Face Page (upload) which includes: