National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
HIV Pre-exposure Prophylaxis (PrEP) Implementation Science in CDC-funded Public Health Demonstration Projects (Admin Supp)
Additional funds may be awarded as supplements to parent awards using the following Activity Code(s):
Administrative supplement requests must be submitted on paper for the following activity codes:
P30 Center Core Grants
Administrative supplement requests may be submitted electronically for the following activity codes:
NIMH calls for FY16 administrative supplements that would conduct implementation science research related to a Centers for Disease Control and Prevention (CDC)-funded public health initiative to reduce HIV infections in men who have sex with men (MSM) and transgender individuals through improved HIV pre-exposure prophylaxis (PrEP) planning, outreach, and delivery. Applicants are required to establish collaborative partnerships with Public Health Departments conducting PrEP demonstration projects funded through CDC Funding Opportunity Announcement CDC-RFA-PS15-1506 (CDC Project PrIDE). Applications must propose implementation science research that is non-duplicative with any existing program evaluation plans on the demonstration projects, and which is consistent with the aims of the parent NIH grant.
April 18, 2016
May 15, 2016
June 15, 2016, by 5:00 PM local time of applicant organization.
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.
June 16, 2016
Required Application Instructions
It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide or PHS 398 Application Guide, as appropriate) except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). 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
The CDC FOA CDC-RFA-PS15-1506 called for demonstration projects to reduce HIV infections and improve engagement in HIV medical care among MSM and transgender persons. State and local health departments funded under this CDC FOA have proposed activities to strengthen the identification of MSM and transgender persons who would most benefit from PrEP, refer appropriate candidates to local PrEP providers, and increase the number of providers knowledgeable and capable of offering PrEP.
These CDC-funded demonstration projects represent an important effort to advance real-world approaches to PrEP provision in key populations. Administrative supplements to NIH grants could enhance program evaluations of these demonstration projects and advance implementation science designed to improve PrEP delivery.
The CDC website for CDC-RFA-PS15-1506 (CDC Project PrIDE) provides information on the health departments funded under this initiative. Interested applicants should contact Michael Stirratt [firstname.lastname@example.org, 240-627-3875] to obtain name and contact information for CDC-RFA-PS15-1506 (CDC Project PrIDE) grantees in their jurisdiction.
The goal of these administrative supplement applications is to address a research gap and ultimately inform and improve PrEP delivery.
This funding announcement corresponds to the HIV prevention priorities and goals of the Trans-NIH Plan for HIV Research, the US National HIV/AIDS Strategy, and the HHS Secretary's Minority AIDS Initiative by advancing research designed to improve PrEP access and use among key populations.
Another goal is for these supplements to help create collaborative partnerships between researchers and Public Health Departments funded through the CDC Funding Opportunity Announcement CDC-RFA-PS15-1506 to conduct PrEP demonstration projects (CDC Project PrIDE). Local, state, or regional collaborations between applicant organizations and eligible Public Health Departments are allowable. Lastly, another goal is to, after the awards have been made, create a Steering Committee to foster coordination and collaboration among awardees.
These administrative supplements will support implementation science designed to improve our understanding of real world approaches to increasing PrEP provision and use among MSM and transgender persons who are at substantial risk for HIV infection. Applicants are encouraged to use a scientific theory or conceptual/logic model to guide their research. A variety of research designs and scientific methodologies may be used, including mixed-methods approaches.
Applicants are encouraged to consult with the Scientific/Research Contact to discuss the potential supplement request prior to submission. Research foci include but are not limited to:
Applicants are required to establish collaborative partnerships with Public Health Departments funded through the CDC Funding Opportunity Announcement CDC-RFA-PS15-1506 to conduct PrEP demonstration projects (CDC Project PrIDE). Local, state, or regional collaborations between applicant organizations and eligible Public Health Departments are allowable. Letters of support are required from partnering Health Departments. Supplemental awards must leverage Category 1 PrEP-related activities supported under CDC funding announcement PS15-1506; Category 2 “data-to-care” activities are not eligible.
The proposed project must be relevant to the scope and aims of the parent NIH grant. There should also be clear differentiation between the proposed supplemental project and existing program evaluation activities supported under the relevant CDC demonstration project award.
All PDs/PIs will be required to join a Steering Committee after award to foster coordination and collaboration among awardees.
The funding instrument will be the same as the parent award.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Non-competing Administrative Supplements
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets are limited to no more than $175,000 direct costs per year, and must reflect the actual needs of the proposed studies.
The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives, as long as the research objectives are within the original scope of the peer reviewed and approved project, or the cost increases are for unanticipated expenses within the original scope of the project. Any cost increases need to result from making modifications to the project that would increase or preserve the overall impact of the project consistent with its originally approved objectives and purposes.
The project and budget periods must be within the currently approved project period for the existing parent award. The proposed project period for the Administrative Supplement may be up to 24 months. Any second year activities should build on year one activities in discrete and separable ways. More than one year of supplemental funding will only be considered with very strong justification. Funding for a second year supplement is highly contingent upon budget availability, as well as satisfactory progress under the year one supplemental award.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
All organizations administering an eligible parent award may apply for a supplement under this announcement.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.
IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.
Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 NIH Grants Policy Statement, are not allowed.
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. Since administrative supplements are made against active grants and cooperative agreements, many of these registrations may already be in place. 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 NIH 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.
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.
Individual(s) must hold an active grant or cooperative
agreement, and the research proposed in the supplement must be accomplished
within the competitive segment of the active award. Individuals are encouraged to
work with their organizations to develop applications for support.
For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award. Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute or Center.
Applicants must prepare applications using current forms in accordance with the Application Guide.
For electronic submissions, applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this announcement, or use the eRA Commons streamlined submission process.
All forms must be completed for the supplemental activities only and must not reflect funding or activities for the previously awarded parent award.
It is critical that applicants follow the instructions for their submission option (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide or PHS 398 Application Guide, as appropriate) including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to documented requirements 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.
All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:
Administrative supplement requests for most single-project activity codes can be submitted using either paper or electronic submission processes. Administrative supplement requests for multi-project activity codes must be submitted using the paper submission process. See Activity Code section in Part 1 to determine if electronic submission is an option for your activity code.
Applicants submitting paper applications must use the PHS 398 Application Forms and the PHS 398 Application Guide.
Instructions for Electronic Application Submission through Grants.gov
Use the “Apply” button(s) in Part I of this announcement to access the application forms package posted at Grants.gov. If presented with more than one form package, use the Competition ID and Competition Titles provided to determine the most appropriate application forms package for your situation.
Prepare applications using the SF424 (R&R) forms associated with the chosen package. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms, with the following additional guidance:
Special Instructions for Streamlined Submissions using the eRA Commons for electronic-based submissions
NIH offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request. A User’s Guide for submitting through this system is available, with the following additional guidance:
Budget information should be entered for the grantee institution in the tabs provided for each selected budget period. Budget should include travel cost for PIs to attend the annual Steering Committee meeting in Bethesda, MD.
Instructions for Paper-based Submissions using the PHS 398 Application Forms
Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application, with the following additional guidance:
The grantee institution, on behalf of the PD/PI of the parent award, must submit the request for supplemental funds directly to the awarding component that supports the parent award. Submit a signed, typewritten original of the application, including the checklist, to:
NIMH Referral Office
ATTN: HIV PrEP Implementation Science Administrative Supplements Program
Division of Extramural Activities
6001 Executive Boulevard
Bethesda, MD 20892 MSC 9607
Rockville, MD 20852 (FedEx)
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 electronic 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.
Applicants are responsible for viewing their electronic application before the due date in the eRA Commons to ensure accurate and successful submission.
For electronic application submission, information on the submission process and a definition of on-time submission are provided in the SF424(R&R) Application Guide.
For paper-based application submission, information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted using the instructions specified above.
Applicants must complete all required registrations prior to submission. 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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission contact the Application Submission Contacts in Section VII.
For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form of the SF 424(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 NIH.
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 (SAM). Additional information may be found in the Application Guide.
See more tips for avoiding common errors.
Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.
The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:
Budget and Period of Support
NIH staff will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award:
In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.
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, NIH staff 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, NIH staff 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 NIH-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 children 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.
NIH staff will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
NIH staff 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.
Administrative supplement requests will undergo an
administrative evaluation by NIH staff, but not a full peer review. Applications
submitted for this funding opportunity will be assigned to the awarding
component for the parent award and will be administratively evaluated using the
criteria shown above.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. 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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website. When calculating the award for additional funds, NIH will 1) prorate funding if the requested budget period is adjusted at the time of award, and 2) use the institution’s current F&A rate; i.e., the rate in effect when the new funding is provided.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that 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 NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
Cooperative Agreement Terms and Conditions of Award
Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.
Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the Research Performance Progress Report (RPPR) and financial statements as required in the NIH Grants Policy Statement.
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 NIH 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 NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Desk (Questions regarding ASSIST, eRA Commons registration, submitting and
tracking an application, documenting system problems that threaten submission
by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Michael J. Stirratt PhD
National Institute of Mental Health (NIMH)
Jane Z. Lin
National Institute of Mental Health (NIMH)
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
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