Participating Organization(s)	U.S. Food and Drug Administration (FDA) The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Peer Review Process.
Components of Participating Organizations	Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of New Drug Quality Assessment (OND QA)
Funding Opportunity Title	Predictive Methods for Characterizing Product Performance in Pediatric Patients, Case Study: Furosemide (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
Funding Opportunity Announcement (FOA) Number	RFA-FD-13-035
Companion Funding Opportunity	None
Number of Applications	Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.103
Funding Opportunity Purpose	This project follows after earlier CDER research projects in which in vitro furosemide dissolution and/or solubility data were collected in various dissolution media such as simulated gastric and intestinal fluids. In two different studies with different approaches and dissolution testing apparatus, furosemide dissolution was higher in medium containing milk and baby formula than that in standard buffer medium. This research project will allow collecting in vivo data when furosemide (the model drug) will be given with milk, baby formula and Ensure Plus to healthy adults. The suitability of the in vitro methods using dissolution media containing milk, baby formula and Ensure Plus for predicting in vivo performance of furosemide (a poorly soluble and poorly permeable drug), classified as BCS (Biopharmaceutic Classification System) Class IV drug will be determined.

Posted Date	July 19, 2013
Open Date (Earliest Submission Date)	August 1, 2013
Letter of Intent Due Date(s)	August 8, 2013
Application Due Date(s)	August 15, 2013 by 11:59PM Eastern time. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	August, 2013
Advisory Council Review	Not Applicable
Earliest Start Date	September 2013
Expiration Date	August 16, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the HHS Grants Policy Statement). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Background

This grant is for exploring results observed from in vitro studies showing the importance of assessing in vivo dissolution characteristics of poorly soluble drugs in dissolution media containing milk and baby formula. If the in vitro results coupled with the results from the healthy adult study support that the bioavailability of a poorly soluble drug (furosemide is the model drug) may be highly enhanced due to presence of milk or baby formula, these results could lead to reassessment of furosemide dosing in neonates and infants, and possibly to additional studies and a change in the current dosing practice.

Project Description:

This project follows after earlier CDER research projects in which in vitro furosemide dissolution and/or solubility data were collected in various dissolution media such as simulated gastric and intestinal fluids. In two different studies with different approaches and dissolution testing apparatus, furosemide dissolution was higher in the medium containing milk and baby formula than that in standard buffer medium.

This project will allow collecting in vivo data when furosemide (the model drug) will be given with milk, baby formula and Ensure Plus and also allow assessment of suitability of the in vitro methods using dissolution media containing milk, baby formula and Ensure Plus for predicting in vivo performance of furosemide (a poorly soluble and poorly permeable drug), classified as BCS (Biopharmaceutic Classification System) Class IV drug.

Data and results obtained from this project will be publicly disseminated.

Project Goals:

1. Developing and advancing in vitro predictive methods for assessing in vivo drug performance in pediatric patients.

This effort which complements pediatric formulation development efforts may lead to development of a standard in vitro test for predicting in vivo performance of drug products in pediatric patients. Improving in vitro methods such as dissolution testing as a method for predicting in vivo drug product performance and for linking product quality attributes such as in vitro dissolution with in vivo product performance can ultimately create greater understanding of in vivo performance of poorly soluble drugs in pediatric patients.

2. Exploring in vivo delivery (bioavailability) of furosemide from furosemide tablets when given with water, milk, baby formula and Ensure Plus under fasted conditions to healthy adult volunteers (four-way cross-over).

Because the in vivo exploratory pharmacokinetic studies can not be conducted in pediatric patients, the proposed in vivo study is in healthy adult volunteers under conditions that may be similar to those in younger (two years old or less) pediatric patients. In addition, in vivo furosemide concentrations will be obtained from a small group of pediatric patients (n=3), receiving furosemide for therapeutic purposes, as supportive information. Based on the results of this work, additional pediatric studies may be conducted to collect confirmatory data.

Statement of Work

A. Data generation

• In vitro simulated gastric and intestinal "Biorelevant (patented)" blank media with additional components such as milk, baby formula and Ensure Plus in 1:1 ratio will be used for in vitro dissolution testing of 20-mg furosemide tablets.

The dissolution testing apparatus will be: Modified USP Apparatus 1, 2 and 4. Modification will be in reduction of the volume of the dissolution test medium (such as to 40-mL, 80-mL and 120-mL). Historical compendial dissolution data with compendial methods will be used as available.

1. Method development and standardization (in vitro)

• There is already some information on furosemide dissolution in media containing milk. Additional studies will explore the effects of varying pH range (pH 4 to 5.5) and the varying constituents of the non-compendial "biorelevant" dissolution media.

2. The in vivo assessment of the effect of milk and other media on furosemide bioavailability

The in vivo study will be conducted in healthy adult volunteers (n=6). To mimic conditions similar to that in pediatric patients, the furosemide dosing will be after an overnight fast, first a 6 oz. of water, or milk or baby formula or Ensure Plus will be given and 10 min later, furosemide dose (20-mg tablet) will be given with 6 oz. of water, or milk or baby formula or Ensure Plus according to a 4-way cross-over design. On each occasion, according to a randomized cross-over design, each subject will consume 6 oz. of either water or milk or baby formula or Ensure Plus before the furosemide dosing and again, 6 oz. of the same vehicle with the furosemide dose.

In addition, furosemide plasma concentration-time data will be obtained from pediatric patients (n=3) as supportive data from patients who are receiving furosemide as part of their therapy. Dosing and plasma sample collection from pediatric patients will be according to a protocol developed separately outside this proposal with collaboration with a Children's Hospital. The pediatric data obtained accordingly will supplement the results in this proposal.

B. Sample and data analyses:

Established methods will be used for quantitation of furosemide in samples collected from the dissolution media and plasma samples.

Similarly, established PK and statistical methods will be utilized for data analyses and for biopharmaceutic in vitro and in vivo product performance assessments in media containing milk and other media described above.

The impact of the critical factors and their interactions on in vitro dissolution results as well as in vivo PK parameters (such as partial Area Under Curve (AUC)) will be determined using ANOVA.

Other statistical methods for correlations and trends will be explored as deemed appropriate for the collected data.

C. Task/work and justification

1. Task: Clinical furosemide study (dosing healthy subjects (n=6), taking blood samples and shipping plasma samples to the analytical site)

Justification: Clinical study will be conducted for generating plasma samples.

2. Task: Dissolution method set-up for furosemide in multiple media and in vitro characterization of furosemide dissolution in "blank" simulated gastric and intestinal media containing 1:1 ratio of either milk or baby formula or Ensure Plus

Justification: Provide in vitro product performance data

3. Task: Development and validation of furosemide assay in plasma and analysis of 240 plasma samples for furosemide concentration.

Justification: Provide plasma drug concentration-time data and carry out data analyses

Funding Instrument	Grant: A support mechanism providing money to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. FDA intends to fund an estimate of 3 awards, corresponding to a total of $250,000. The budget for first year is limited to $100,000. Future year amounts will depend on annual appropriations and performance. The second and third year awards may be $100,000 and $50,000, respectively.
Award Budget	Application budgets are limited to $100,000 (direct and indirect costs) for the first year, $100,000 (direct and indirect costs) the second year and $50,000 (direct and indirect costs) the third year and need to reflect actual needs of the proposed project.
Award Project Period	The total project period for an application requesting support may not exceed three years. It will be completed within 3 year.

• Public/State Controlled Institutions of Higher Education

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The HHS Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

Only one application per institution (normally identified by having a unique DUNS number) is allowed.

FDA will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. FDA will not accept any application that is essentially the same as one already reviewed.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to: [email protected] and [email protected].

All page limitations described in the SF424 Application Guide and must be followed, with the following exceptions or additional requirements:

• For this specific FOA, the Research Strategy section is limited to 10 pages.

The forms package associated with this FOA includes all applicable components, required and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed..

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: None

Research Strategy: None

Letters of Support: None

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign (non-U.S.) institutions must follow policies described in the HHS Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA’s electronic system for grants administration. FDA and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the deadline in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

Allowable costs include:

Employee salaries, wages and fringe benefits

Rental, purchasing, calibration, and maintenance of supplies and equipment

Indirect costs

Recruitment costs for hiring new employees

Registration fees to scientific meetings for presentation of results

Purchase or development of IT equipment, software, and support

Shipping and mailing of equipment and supplies

Travel

Non-allowable costs:

Equipment purchases are not permitted.

Please also refer to the HHS Grants Policy Statement for additional information regarding costs.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Office of Acquisition and Grants (OAGS) and responsiveness by the FDA Center for Drug Evaluation and Research (CDER). Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115, with the following modifications:

Acceptable post submission materials include:

• Revised budget pages
• Biographical sketches
• Letters of support or collaboration resulting from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator.
• Copy and/or news of a pertinent article accepted for publication

Only the review criteria described below will be considered in the review process. All applications submitted to the FDA in support of this announcement are evaluated for scientific and technical merit through the FDA peer review system.

"1. The scientific expertise for developing and conducting the listed studies for achieving the goals and project milestones (weight = 40%)

2. Demonstration of past experience and effectiveness in completing projects similar to those described in this project (weight = 30%)

3. Demonstration of effectiveness in working with regulatory research partners and other appropriate organizations to implement the goals of the project (weight = 20%)

4. Demonstration of adequate program resources (including staff) and infrastructure, or the ability to obtain the resources necessary, to complete the project needs (weight = 10%)

Note: Only the Scored Review Criteria (criteria 1-4) will be used for scoring during the review of applications for this announcement. Reviewers may consider additional criteria described in the "Overall Impact" and Additional Review Considerations sections, as they relate to the criteria described above. Separate scores will not be given for the additional criteria. "

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

This grant will be exploring results observed from in vitro studies showing the importance of assessing in vivo dissolution characteristics of poorly soluble drugs in dissolution media containing milk and baby formula. If the results support that the bioavailability of a poorly soluble drug (furosemide is the model drug) may be highly enhanced due to presence of milk or baby formula, the results could lead to reassessment of furosemide dosing in neonates and infants, possibly to additional studies and a change in the current dosing practice.

The Specific Goals are:

1. Developing and advancing in vitro predictive methods for assessing in vivo drug performance in pediatric patients.

This effort which complements pediatric formulation development efforts may lead to development of a standard in vitro test for predicting in vivo performance of drug products in pediatric patients. Improving in vitro methods such as dissolution testing as a method for predicting in vivo drug product performance and for linking product quality attribute such as in vitro dissolution with in vivo product performance can ultimately create greater understanding of in vivo performance of poorly soluble drugs in pediatric patients.

2. Exploring in vivo delivery (bioavailability) of furosemide from furosemide tablets when given with water, milk, baby formula and Ensure Plus under fasted conditions to healthy adult volunteers. (4-way cross-over.)

Because the in vivo exploratory pharmacokinetic studies can not be conducted in pediatric patients, the proposed in vivo study is in healthy adult volunteers under conditions that may be similar to those in younger (two years old or less) pediatric patients. In addition, in vivo furosemide concentrations will be obtained from a small group of pediatric patients (n=3) as supportive information. Based on the results of this work, additional pediatric studies may be conducted to collect confirmatory data.

Milestones

Total project time: 3 years

1) Project Set-up: Write and finalize study protocol (completed by the end of the 3rd month)

2) Obtain the necessary approvals for in vivo studies (completed by the end of the 6th month)

3) In parallel to #2 above, after the set up is established, in vitro method development and product characterization in multiple media will take place (6 months, completed by the 10th month from start of the project)

4) Clinical study: volunteer selection, enrollment of healthy adults and study conduct (4-way cross-over) (start on the 10th month of the project and complete after 2 months i.e. at the end of the 12th month from start of the project)

5) Plasma drug sample analyses (including method validation will take 6 months, completed by the end of 18th month from the project initiation)

6) Data analyses and reviews (will take 6 months)

7) Finalizing the study report from in vitro and in vivo studies, and preparation of the manuscript (will take 6 months)

8) Information will be disseminated as publications and presentations upon completion of the project.

Status meetings will be monthly.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Not Applicable

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

Not Applicable

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Following periodic review of results, additional approaches may be considered.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Not Applicable

Resource Sharing Plans

Not Applicable

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group, using the stated review criteria.

As part of the scientific peer review, all applications:

• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate FDA Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the review of the application is completed, the PD/PI will receive his or her Summary Statement (written critique) via email.

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted in the HHS Grants Policy Statement.

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NOA. For these terms of award, see the HHS Grants Policy Statement.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement.

A final progress report and Financial Status Report are required when an award is relinquished, when a recipient changes institutions or when an award is terminated.

An annual Financial Status Report (FSR) (SF-269) must be sent to FDA's grants management specialist within 90 days of the budget period end date of each twelve month cooperative agreement. Failure to file the annual FSR in a timely fashion will be grounds for suspension or termination of the cooperative agreement.

For continuing cooperative agreements, mid-year reports and an annual program progress report are also required. For such cooperative agreements, the Non-Competing Continuation Progress Report (PHS-2590) will be considered the program progress report for the fourth quarter of the budget period.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act) includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the HHS Grants Policy Statement for additional information on this reporting requirement.

The recipient must file a final program progress report, and FSR, within 90 days after the end date of the project period as noted on the notice of the cooperative agreement award.

The final program progress report must provide full written documentation of the project and summaries of accomplishments and goals, as described in the grant application. The documentation must be in a form and contain sufficient detail such that other entities could reproduce the final project.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding HHS grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Arzu Selen, Ph.D.
FDA/CDER/OPS/Office of New Dug Quality Assessment (ONDQA)
Telephone: 301-796 1603
Email: [email protected]

David Morley
FDA/CDER/OPS/Office of New Dug Quality Assessment (ONDQA)
Telephone: 301-796-1719
Email: [email protected]

Oluyemisi Akinneye
Grants Management Specialist
Food and Drug Administration
Office of Acquisition Support and Grants
Telephone: 301-827-0079
Email: [email protected]

Oluyemisi Akinneye
Grants Management Specialist
Food and Drug Administration
Office of Acquisition Support and Grants
Telephone: 301-827-0079
Email: [email protected]

Recently issued trans-FDA policy notices may affect your application submission. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Awards are made under the authorization of Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.