This Notice has been Rescinded on March 13, 2019.

RESCINDED

RESCINDED - NIAID, NIDA, and ORIP Interest in Administrative Supplements to Address the Research and Resources Needed to Develop Vaccines Targeting Opioids

Notice Number: NOT-AI-18-055

Key Dates
Release Date:October 2, 2018 - RESCINDED

Related Announcements
PA-18-591

Issued by
National Institute of Allergy and Infectious Diseases ( NIAID)
National Institute on Drug Abuse ( NIDA)
Office of Research Infrastructure Programs (ORIP)

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute on Drug Abuse (NIDA), and the Office of Research Infrastructure Programs (ORIP) announces the opportunity for investigators with relevant active research project grants and cooperative agreements to submit administrative supplements according to PA-18-591, Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional), for funded projects that could accelerate scientific progress towards the development of vaccines targeting opioids (e.g. heroin, fentanyl, etc.).  Parent projects do not need to have an opioid element to submit a supplement request.

Examples of potential research and resource areas include, but are not limited to:

  • Design and optimization of immunogens, including:
    • Structural analysis of antibody / immunogen binding for immunogen optimization
    • Discovery of opioid B cell epitopes
    • Development of carrier platforms to improve immunogenicity (e.g. high-density presentation of immunogens allowing for BCR crosslinking)
    • Exploration of novel haptenation strategies
  • Development of adjuvants for use in opioid vaccines
  • IND enabling studies
  • Determination of mechanism of vaccine-induced protection/neutralization/clearance and safety in animal models
  • Role of mucosal immunity in vaccine efficacy
  • Characterization of immune responses in individuals abusing opioids and how this may affect vaccination strategies
  • Social and behavioral impact of an opioid vaccine
  • Use of an opioid vaccine in conjunction with existing therapy
  • Development and expansion of animal models for preclinical testing of immunogens, adjuvants, and vaccines targeting opioids

Per NIH policy, proposed supplements must be within the scope of the research that is already being supported.  This includes:

  • Parent projects not using vertebrate animal may not propose the use of vertebrate animal in the supplement project.
  • Parent projects not conducting human subjects research may not include human subjects research in the supplement project.

All applicants are strongly encouraged to discuss potential requests with their program official and the contacts named below to discuss if a project idea falls within the scope of the parent project.

Budget:

Requests must reflect the actual needs of the proposed projects.  Administrative supplements will be awarded for FY19 funding only and the project and budget periods must be within the currently approved project period for the existing parent award. 

Submitting Applications:

For administrative supplement to grants and cooperative agreements, supplement requests must be submitted in accordance with the parent program announcement:  Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) PA-18-591

Applicants should begin the supplement application abstract by stating “This application is being submitted in response to NOT-AI-18-055”

Parent grant award must receive funds in FY19 (Oct. 1, 2018 – Sept. 30, 2019) and not be in a no-cost extension.

Page Limits:  The Research Strategy should be approximately 3 pages, not including the abstract.

Supplement requests for grants and cooperative agreements should be submitted electronically if allowed by the parent mechanism.  Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

Scientific Review Process:

Requests received by November 30th, 2018 are anticipated to be reviewed starting the week of December 10th.  Requests received after November 30th will be reviewed on a rolling basis.

Applications will be reviewed by the following criteria:

  • Does the work proposed have scientific merit?
  • Is the work likely to advance the development of vaccines to treat opioid use disorder?

Matching Requirement:

Supplement awards made to grants or cooperative agreements awarded to for-profit recipients are subject to a matching requirement, detailed below.  Subcontracts made to for-profit recipients by the parent awardee are not subject to a matching requirement by the for-profit subcontractor.

The instructions below apply to PA-18-591.

Part 2, Section I, Funding Opportunity Description

Background

Additional language:

This study is part of the of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at:  https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.

Public Law 115-141, the Consolidated Appropriations Act of 2018 (signed March 23, 2018) includes a requirement that for-profit applicant organizations must provide a 50% match and/or in-kind contribution of all federally awarded dollars under the award (direct costs, as well as facilities and administrative costs) for research related to opioid addiction, development of opioid alternatives, pain management, and addiction treatment.


Matching Requirement: A grantee from a for-profit organization funded under this funding opportunity announcement must match funds or provide documented in-kind contributions at a rate of not less than 50% of the total-Federally awarded amount, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.The applicant will be required to demonstrate that matching funds and/or in-kind contributions are committed or available at the time of, and for the duration of, the award. Applications must identify the source and amount of funds proposed to meet the matching requirement and how the value for in-kind contributions was determined. All matching funds and/or in-kind contributions must be used for the portion of allowable project costs not paid by Federal funds under the grant award.  NIH will not be the recipient, nor serve as a pass-through entity, of any such matching funds and/or in-kind contributions required under this announcement.  See  45 CFR 75.306 for additional details.

Part 2, Section III, Cost Sharing

Current language:

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

Revised language:

For grantees from a for-profit organization, this FOA does require cost sharing, as defined in the NIH Grants Policy Statement.  More information on cost matching requirements is in Section IV.2 R&R or Modular Budget

Part 2, Section IV, R&R Budget

Current language:

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

Revised language:

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

Cost Matching Requirement for For-profit Applicants

Cost matching or documented in-kind contributions is required for for-profit organizations responding to this FOA.  The for-profit awardee is required to match funds or provide at least a 50% matching of funds or documented in-kind contributions at a rate of not less than 50% of the for the total-Federally awarded amount (direct costs, as well as facilities and administrative costs), as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.   

Federal funds may not be used as a source of matching funds. Generally, cost matching requirements may not be met from the following sources:

a) Costs borne by another Federal grant or sub award;

b) Costs or contributions toward cost sharing on another Federal grant, a Federal procurement contract, or any other award of Federal funds;

c) Cost of services or property financed by income earned by contractors under a contract from the recipient (or sub recipient);

d) Program income; and

e) Patient incentives.

The for-profit organization will be required to demonstrate that matching funds and/or in-kind contributions are committed or available at the time of, and for the duration of, the award. Applicants must submit budgets that clearly document the total costs, the source and amount of matching funds, and how valuation was determined in the case of in-kind contributions, as well as the Federal and Institutional (non-Federal) components of the budget. All matching funds and/or in-kind contributions must be used for the portion of allowable project costs not paid by Federal funds under the grant award.  NIH will not be the recipient, nor serve as a pass-through entity, of any such matching funds and/or in-kind contributions required under this announcement.  See 45 CFR 75.306  for additional details.

Budget Justification: All for-profit applicants must document the matching (non-Federal) component and the federal (non-matching) component in the total project budget. That is, the requested budget plus the cost-matching budget must be detailed in tabular format to document the cost-matching (non-Federal) component and the federal (non-cost matching) component. The amount of matching is subject to adjustment based on total allowable costs incurred.  All costs and contributions used to satisfy the matching requirement must be documented by the recipient, including how the value for in-kind contributions was determined, and are subject to audit. The cost matching requirement is not negotiable for for-profit organizations.

Part 2, Section IV, Letters of Support

Additional language:

Letters of Support

For-profit applicants must include a letter(s) of support confirming that the required secured cost matching (cash; in-kind commitments such as salary, consultant costs, equipment) is available and confirm that the essential personnel have the authority within the organization to allocate resources. 

Part 2, Section V, Budget and Period of Support

Budget and Period of Support

Additional language:

Specific to this FOA:

How likely is it that the plans for cost matching will be adequate?

Part 2, Section VI, Award Administration Information, Award Notices

Additional language:

Special award condition specific to this FOA: A grantee from a for-profit organization funded under this announcement must match funds or provide documented in-kind contributions at a rate of not less than 50% of the total-Federally awarded amount, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.  See 45 CFR 75.306 for additional details.   Matching funds must be non-Federal funds set aside for this project and are available from the source(s) identified in the application, as committed to by the recipient. Cost matching will be evaluated by the awarding office to ensure that this requirement is being met. Compliance with the matching requirement must be verified on an annual basis and must be documented in the annual and final FFR.

Part 2, Section VI, Reporting

Current language:

When multiple years are involved, awardees will be required to submit the  Research Performance Progress Report (RPPR) annually and financial statements as required in the  NIH Grants Policy Statement

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  NIH Grants Policy Statement.

Revised language:

When multiple years are involved, awardees will be required to submit the  Research Performance Progress Report (RPPR) annually and financial statements as required in the  NIH Grants Policy Statement.

A final Research Performance Progress Report (F-RPPR), invention statement, and the expenditure data portion of the Federal Financial Report, including Federal and non-Federal share for cost matching, are required for closeout of an award, as described in the NIH Grants Policy Statement.

Inquiries

Please direct all inquiries to:

Kentner Singleton, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5499
Email: singletonkl@niaid.nih.gov

Iván Montoya, M.D., M.P.H.
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-5936
Email: imontoya@mail.nih.gov

Harold Watson, Ph.D.
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0884
Email:  watsonh@mail.nih.gov