and Human Services (HHS)
Participating Organization(s) |
U.S. Food and Drug Administration (FDA) NOTE: The policies,
guidelines, terms, and conditions stated in this Notice of Funding
Opportunity (NOFO) may differ from those used by the NIH. Where this NOFO provides specific written
guidance that may differ from the general guidance provided in the grant
application form, please follow the instructions given in this NOFO. The FDA does not follow the NIH Page Limitation Guidelines or the NIH Review 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 |
Center for Food Safety and Applied Nutrition (CFSAN) |
Funding Opportunity Title |
Single Source
Cooperative Agreement to Support HPAI H5N1 Research at
Cornell University (U18) - Clinical Trails Not Allowed |
Activity Code |
U18 Research Demonstration Cooperative Agreements |
Announcement Type |
New |
Related Notices |
None |
Funding Opportunity Number (FON) |
RFA-FD-24-042 |
Companion Notice of Funding Opportunity
|
None |
Number of Applications |
See Part 2, Section III. 3. Additional Information on
Eligibility. |
Assistance Listing Number(s) |
93.103 |
Funding Opportunity Purpose |
The Food and Drug Administration's (FDA) Center for Food and Safety and Applied Nutrition (CFSAN) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2024 to Cornell University to support the Center for Veterinary Medicine and the College of Agricultural and Life Sciences. The purpose of this support is to: 1. Carry out multidisciplinary applied research projects on raw milk cheese aging to examine factors that affect Highly Pathogenic H5N1 Avian Influenza (HPAI H5N1) virus inactivation, to include pH and water activity. 2. Carry out multidisciplinary applied research projects on commonly used acidification methods for treatment of waste milk to be fed to calves, or for disposal, to understand effects on HPAI H5N1. 3. Carry out multidisciplinary applied research projects to characterize the thermal inactivation kinetics of HPAI H5N1 in a wide variety of dairy products. 4. Provide additional capabilities and capacity for HPAI H5N1 testing as needed to help meet the needs of FDA's research agenda. 5. Engage with academic and industry stakeholders to help ensure work is complementary of other ongoing research in these research spaces and to facilitate the use of the information produced by the research program. |
Posted Date |
July 26, 2024 |
Open Date (Earliest Submission Date) |
July 30, 2024 |
Letter of Intent Due Date(s)
|
Not applicable. |
Application Due Date(s) |
August 30, 2024 |
AIDS Application Due Date(s) |
Not applicable. |
Scientific Merit Review |
September 2024 |
Advisory Council Review |
Not Applicable |
Earliest Start Date
|
September 2024 |
Expiration Date |
August 31, 2024 |
Due Dates for E.O. 12372 |
Not Applicable |
It is critical that applicants
follow the Research (R) Instructions in How to Apply -
Application Guide, except where instructed to do otherwise (in this NOFO
or in a Notice from the HHS
Grants Policy Statement). Conformance to all requirements (both in the
How to
Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants
must read and follow all application instructions in the How to
Apply - Application Guide as well as any program-specific instructions
noted in Section IV. When the
program-specific instructions deviate from those in the How to
Apply - Application Guide , follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
Part
1. Overview Information
Part 2. Full Text of the Announcement
Section
I. Notice of 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
While pasteurization is designed to reduce potential bacterial and viral pathogens in milk, and pasteurization studies are ongoing, there is little work to date on survivability of viable HPAI in raw milk products like cheese. Research into survival of the virus in cheeses and other products made with raw milk is critical.
In addition, while heat treatment is the recommended mechanism to treat waste milk prior to disposal or feeding to calves, some waste milk is used on some farms to feed to calves after being acidified. Given that the efficacy of commonly used acidification agents against HPAI H5N1 is unknown, this could pose a concern for further spread of the virus, both to calves and to wildlife and the environment. Practical alternative treatments beyond heat treatment for treatment of waste milk for disposal are also lacking.
These research gaps have been identified by FDA and a single source cooperative agreement with Cornell University to help begin to address these gaps is a critical investment for an effective HPAI response. Cornell performed preliminary benchtop studies of thermal inactivation of HPAI in milk and has early studies with raw milk cheese in process. Cornell's multi-disciplinary team of investigators, supporting these early studies, have leading virology expertise, along with the necessary facilities, as well as access to other scientists, with expertise in dairy processing, quality, and safety, and on-farm feeding practices and biosecurity.
This agreement would fund further research include assessing the survival of HPAI H5N1 in raw milk cheeses and defining the efficacy of chemical mitigants in reducing HPAI H5N1 infectious virus load in raw milk waste. These studies are critical to demonstrate whether processing and aging of raw milk cheeses is sufficient to inactivate HPAI and to identify mitigation strategies that will allow safe disposal of waste milk from affected herds.
A proposal is being solicited for meeting these needs as well as FDA's strategic goal to protect and promote the public health. This cooperative agreement will provide support so the following objectives can be meet:
1. Carry out multidisciplinary applied research projects on raw milk cheese aging to examine factors that affect HPAI H5N1 virus inactivation, to include pH and water activity.
2. Carry out multidisciplinary applied research projects on commonly used acidification methods for treatment of waste milk to be fed to calves, or for disposal, to understand effects on HPAI H5N1.
3. Carry out multidisciplinary applied research projects to characterize the thermal inactivation kinetics of HPAI H5N1 in a wide variety of dairy products.
4. Provide additional capabilities and capacity for HPAI H5N1 testing as needed to help meet the needs of FDA's research agenda.
5. Engage with academic and industry stakeholders to help ensure work is complementary of other ongoing research in these research spaces and to facilitate the use of the information produced by the research program.
See Section VIII. Other Information for award authorities and regulations.
Funding Instrument |
Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO. |
Application Types Allowed |
New The OER Glossary and the How to
Apply - Application Guide provide details on these application types. Only
those application types listed here are allowed for this NOFO. |
Clinical Trial?
|
Not applicable. |
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/CFSAN intends to commit up to $1,150,000.00 in FY 2024 to fund one (1) award in support of this grant program. |
Award Budget |
YR 01: $1,150,000.00 |
Award Project Period |
The maximum project period is one (1) year. |
FDA grants policies as described in the HHS
Grants Policy Statement will apply to the applications submitted and
awards made from this NOFO.
Competition is limited to Cornell University.
Non-domestic (non-U.S.) Entities
(Foreign Organizations) are not
eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in
the HHS Grants Policy Statement, are not allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference HHS Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.
System for Award Management (SAM) 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.
eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. 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 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. PD(s)/PI(s) should work with their
organizational officials to either create a new account or to affiliate their
existing account with the applicant organization in eRA Commons. 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.
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 How to
Apply - Application Guide.
This NOFO does not require cost sharing as defined in the HHS Grants Policy Statement Section 1.2 Definition of Terms.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the FDA will not accept:
A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
An application that has substantial overlap with another application pending appeal of initial peer review (see Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the Research (R) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Not applicable.
For this specific NOFO, the Research Strategy section is limited to 30 pages.
All page limitations described in the How to Apply Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the How to Apply Application Guide and should be used for preparing an application to this NOFO.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission. This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'
If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed. MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract. MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply -
Application Guide must be followed.
Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the How to
Apply - Application Guide , with the following modification:
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by FDA) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
A Data Management and Sharing Plan is not applicable for this NOFO.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide .
When involving human subjects research, clinical research, and/or FDA-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide , with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study
Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply - Application Guide must be followed.
Delayed
Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
Not applicable.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the FDA Policy on Late Application Submission.
Applicants are responsible for viewing their application before
the due date 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 How to Apply
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 Section 7.9.1 Selected Items of Cost.
Applications must be submitted electronically following the instructions
described in the How to
Apply - 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 How to Apply - Application Guide.
If you encounter a system issue beyond your control that threatens your ability
to complete the submission process on-time, you must follow the Dealing
with System Issues guidance. For
assistance with application submission, contact the Application Submission
Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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. See Section III of this NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.
See more tips for avoiding common errors.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and HHS Grants Policy Statement.
Send written disclosures to the FDA Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Post-submission materials are those submitted after submission of the grant application but prior to objective review. They are not intended to correct oversights or errors discovered after submission of the application. FDA accepts limited information between the time of initial submission of the application and the time of objective review. Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials. Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA. Any inquiries regarding post submission materials should be directed to the assigned Grants Management Specialist.
Only the review criteria described below will be considered
in the review process.
Applications submitted to the FDA in support of the FDA mission are evaluated for scientific and technical merit through an Objective Review.
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).
Reviewers will consider each of the review criteria below in the
determination of scientific merit and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to
progress in the field? Is the prior research that serves as the key support for
the proposed project rigorous? If the aims of the project are achieved, how
will scientific knowledge, technical capability, and/or clinical practice be
improved? How will successful completion of the aims change the concepts,
methods, technologies, treatments, services, or preventative interventions that
drive this field? Has this
project been identified as an area for potential research and related
activities by FDA? Is the project relevant to the mission of FDA and support a
relevant topic area? Are results of the project going to be shared (as
publications, protocols, websites, etc.)?
Are the PD(s)/PI(s), collaborators, and other researchers well suited
to the project? If Early Stage Investigators or those in the early stages of independent
careers, do they have appropriate experience and training? If established, have
they demonstrated an ongoing record of accomplishments that have advanced their
field(s)? If the project is collaborative or multi-PD/PI, do the investigators
have complementary and integrated expertise; are their leadership approach,
governance, and organizational structure appropriate for the project? For methods applications: Have the
collaborators been identified and support of collaborations been adequately
defined?
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Have the investigators presented strategies to ensure a robust and unbiased
approach, as appropriate for the work proposed? Are potential problems,
alternative strategies, and benchmarks for success presented? If the project is
in the early stages of development, will the strategy establish feasibility and
will particularly risky aspects be managed? Is the relevance/impact of the proposed
budget toward achieving the goals/aims of the cooperative agreement? Is the
work part of a well-reasoned and focused project? Can it be achieved in the
proposed timeline?
Will the scientific environment in which the work will be done
contribute to the probability of success? Are the institutional support, equipment,
and other physical resources available to the investigators adequate for the
project proposed? Will the project benefit from unique features of the
scientific environment, subject populations, or collaborative arrangements?
For research that involves human subjects but does not involve one of
the 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 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 Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or FDA-defined
clinical research, the committee will evaluate the proposed plans for the
inclusion (or exclusion) of individuals on the basis of sex/gender, race, and
ethnicity, as well as the inclusion (or exclusion) of individuals of all ages
(including children and older adults) to determine if it is justified in terms
of the scientific goals and research strategy proposed. For additional
information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical
Research.
The committee will evaluate the involvement of live vertebrate
animals as part of the scientific assessment according to the following three
points: (1) a complete description of all proposed procedures including the
species, strains, ages, sex, and total numbers of animals to be used; (2)
justifications that the species is appropriate for the proposed research and
why the research goals cannot be accomplished using an alternative non-animal
model; and (3) interventions including analgesia, anesthesia, sedation,
palliative care, and humane endpoints that will be used to limit any
unavoidable discomfort, distress, pain and injury in the conduct of
scientifically valuable research.
Methods of euthanasia and justification for selected methods, if NOT
consistent with the AVMA Guidelines for the Euthanasia of Animals, is also
required but is found in a separate section of the application. For additional information on review of the Vertebrate
Animals Section, please refer to the Worksheet
for Review of the Vertebrate Animals Section.
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.
Not applicable.
Not applicable.
Not applicable.
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.
Not applicable.
Reviewers will assess the information provided in this section of the application,
including 1) the Select Agent(s) to be used in the proposed research, 2) the
registration status of all entities where Select Agent(s) will be used, 3) the
procedures that will be used to monitor possession use and transfer of Select
Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security
of the Select Agent(s).
Reviewers
will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the
resources, is reasonable.
For projects involving key biological and/or
chemical resources, reviewers will comment on the brief plans proposed for
identifying and ensuring the validity of those resources.
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 Objective Review Committee convened by the FDA, using
the stated review criteria. Assignment to an Objective Review Committee will be
shown in the eRA Commons.
As part of the objective review, all applications:
Will receive a written critique.
Appeals of objective peer review will not be accepted for applications submitted in response to this NOFO.
Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. The following will be considered in making funding decisions:
Scientific and technical merit of the proposed project as determined by objective review.
Availability of funds.
Relevance of the proposed project to program priorities.
Successful applicants will be notified of additional
information that may be required or other actions leading to an award. The
decision not to award a grant, or to award a grant at a particular funding
level, is discretionary and is not subject to appeal to any FDA or HHS official
or board.
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.
In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients must comply with any funding restrictions described in the Terms and Conditions, Cost Principles and the Grants Policy Statement.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in FDA-funded studies, the recipient must provide FDA copies of documents related to all major changes in the status of ongoing protocols.
The following Federal wide and HHS-specific policy requirements apply to awards funded through FDA:
The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the HHS Grants Policy Statement Part II: Terms and Conditions of FDA Grant Awards, Subpart A: General and Part II: Terms and Conditions of FDA Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
HHS
recognizes that FDA research projects are often limited in scope for many
reasons that are nondiscriminatory, such as the principal investigator s
scientific interest, funding limitations, recruitment requirements, and other
considerations. Thus, criteria in research protocols that target or exclude
certain populations are warranted where nondiscriminatory justifications
establish that such criteria are appropriate with respect to the health or
safety of the subjects, the scientific study design, or the purpose of the
research. For additional guidance
regarding how the provisions apply to FDA grant programs, please contact the
Scientific/Research Contact that is identified in Section VII under Agency
Contacts of this NOFO.
All federal statutes and regulations
relevant to federal financial assistance, including those highlighted in HHS Grants Policy Statement.
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. FDA may terminate awards under certain circumstances. See the HHS Grants Policy Statement.
Cooperative Agreement Terms and Conditions of Award
The following
special terms of award are in addition to, and not in lieu of, otherwise
applicable U.S. Office of Management and Budget (OMB) administrative
guidelines, U.S. Department of Health and Human Services (HHS) grant
administration regulations at 2 CFR Part 200, and other HHS, PHS, and FDA grant
administration policies.
The administrative
and funding instrument used for this program will be the cooperative agreement,
an "assistance" mechanism (rather than an "acquisition"
mechanism), in which substantial FDA programmatic involvement with the recipients
is anticipated during the performance of the activities. Under the cooperative
agreement, FDA’s purpose is to support and stimulate the recipient’s activities
by involvement in and otherwise working jointly with the recipients in a
partnership role; it is not to assume direction, prime responsibility, or a
dominant role in the activities. Consistent with this concept, the dominant
role and prime responsibility resides with the recipients for the project as a
whole, although specific tasks and activities may be shared among the
recipients and the FDA as defined below.
a. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for and dominant role in planning, directing, and executing the proposed program, with the FDA staff being substantially involved as a partner with the PI.
The Principal Investigator will have primary responsibility for the financial management of program funds to adhere to the mission of the program as determined by the bilateral partnership.
Awardees will retain custody of and have primary rights to the data and software developed under this award, subject to Government rights of access consistent with current HHS, PHS, and FDA policies.
b. FDA Responsibilities
An FDA Project Officer will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The program project officer will monitor the grantee periodically. The monitoring may be in the form of telephone conversations, emails, or written correspondence between the project officer/grants management officer and the Principal Investigator. Periodic site visits with officials of the grantee organization may also occur. The results of these monitoring activities will be recorded in the official grant file and will be available to the grantee upon request, consistent with applicable disclosure statutes and with FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the grant, including those that state that future funding will depend on recommendations from the project officer. In addition,
a. FDA will be directly involved in the guidance and development of the program and the collaborative structure for the program.
b. FDA scientists will participate, with the grantee, in determining and carrying out scientific and technical activities.
Consistent with the 2023 HHS Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the HHS Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the HHS Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the HHS Grants & Funding website, see Post-Award Monitoring and Reporting.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement Section 8.6 Closeout. HHS NOFOs outline intended research goals and objectives. Post award, HHS will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301 and 45 CFR Part 75.301.
We encourage inquiries concerning this funding
opportunity and welcome the opportunity to answer questions from potential
applicants.
eRA Service Desk (Questions regarding ASSIST, eRA
Commons, application errors and warnings, documenting system problems that
threaten submission by the due date,
and post-submission issues)
Finding Help Online: https://www.era.nih.gov/need-help (preferred method
of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
There must be a contact for all participating ICs.
Kristin Butler
Center for Food Safety and Applied Nutrition (CFSAN)
Food
and Drug Administration
Email: Kristin.Butler@fda.hhs.gov
There must be a contact for all participating ICs.
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: Terrin.Brown@fda.hhs.gov
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 2 CFR Part 200 and 45 CFR Part 75..
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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Department of Health and Human Services (HHS) |
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NIH... Turning Discovery Into Health® |
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