Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)
National Center for Complementary and Integrative Health (NCCIH)

National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)

Funding Opportunity Title

Administrative Supplements for Research on HIV/AIDS and Aging (Admin Supp)

Activity Code

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:

P01 Research Program Projects
P20 Exploratory Grants
P30 Center Core Grants
P40 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Material Resource Grants
P50 Specialized Center
P60 Comprehensive Center
P2C Resource-Related Research Multi-Component Projects and Centers
PM1 Program Project or Center with Complex Structure
PN2 Research Development Center
U10 Cooperative Clinical Research – Cooperative Agreements
U19 Research Program – Cooperative Agreements
U54 Specialized Center- Cooperative Agreements
U56 Exploratory Grants – Cooperative Agreements
UM1 Multi-Component Research Project Cooperative Agreements
UL1 Linked Specialized Center Cooperative Agreement

Administrative supplement requests may be submitted electronically for the following activity codes:

DP1 NIH Director’s Pioneer Award (NDPA)
DP2 NIH Director’s New Innovator Awards
DP4 NIH Director’s Pathfinder Award- Multi-Yr Funding
DP5 Early Independence Award
DP7 NIH Director’s Workforce Innovation Award
F05 International Research Fellowships
F30 Individual Predoctoral NRSA for MD/PhD Fellowships
F31 Predoctoral Individual National Research Service Grant Award
F32 Postdoctoral Individual National Research Service Award
F33 National Research Service Awards for Senior Fellows
K01 Research Scientist Development Award - Research & Training
K02 Research Scientist Development Award – Research
K05 Research Scientist Award
K06 Research Career Awards
K07 Academic/Teacher Award (ATA)
K08 Clinical Investigator Award (CIA)
K12 Physician Scientist Award (Program) (PSA)
K18 Career Enhancement Award
K22 Career Transition Award
K23 Mentored Patient-Oriented Research Career Development Award
K24 Midcareer Investigator Award in Patient-Oriented Research
K25 Mentored Quantitative Research Career Development Award
K26 Midcareer Investigator Award in Biomedical and Behavioral Research
K99/R00 Career Transition Award/Research Transition Award
KL2 Mentored Career Development Award
KM1 Institutional Career Enhancement Awards
R01 Research Project Grant
R03 Small Grant Program
R13 Support for Conferences and Scientific Meetings
R13/U13 Support for Conferences and Scientific Meetings
R15 Academic Research Enhancement Award (AREA)
R21 Exploratory/Developmental Research Grant Award
R21/R33 Phased Innovation Award
R24 Resource-Related Research Projects
R25 Education Projects
R33 Exploratory/Developmental Grants Phase II
R34 Clinical Trial Planning Grant Program
R36 Dissertation Award
R37 Method to Extend Research in Time (MERIT) Award
R41 Small Business Technology Transfer (STTR) Grant - Phase I only
R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I, Phase II, and Fast-Track
R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I and Phase II
R42 Small Business Technology Transfer (STTR) Grant - Phase II only
R43 Small Business Innovation Research (SBIR) Grant - Phase I only
R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and Fast-Track
R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I and Phase II
R44 Small Business Innovation Research (SBIR) Grant - Phase II only
RM1 Research Project with Complex Structure
T32 Institutional National Research Service Award (NRSA)
T35 National Research Service Award (NRSA) Short -Term Research Training
TL1 Linked Training Award
U01 Research Project – Cooperative Agreements
U13 Conferences Cooperative Agreements
U24 Resource-Related Research Projects – Cooperative Agreements U34 Clinical Planning Grant Cooperative Agreement
U44 Small Business Innovation Research (SBIR) Cooperative Agreements - Phase II
UC4 High Impact Research and Research Infrastructure - Cooperative Agreement Programs
UH2 Exploratory/Developmental Cooperative Agreement Phase I
UH2/UH3 Phase Innovation Awards Cooperative Agreement
UH3 Exploratory/Developmental Cooperative Agreement Phase II

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PA-15-137

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.866, 93.213, 93.361, 93.393, 93.394, 93.395, 93.396, 93.399, 93.855, 93.856, 93.279, 93.242, 93.853, 93.273

Funding Opportunity Purpose

The Office of AIDS Research, in collaboration with the NIH Institutes and Centers (ICs) named above, encourages applications for administrative supplements to fund innovative research on HIV and aging through clinical, translational, observational, or interventional studies in domestic or international settings. The specific types of NIH awards that can be supplemented are listed above. Supplemental projects must be within the scope of the parent grant. Topics of interest include HIV infection, HIV-associated conditions, HIV treatment, and/or biobehavioral or social factors associated with HIV/AIDS in the context of aging and/or in older adults.

Key Dates
Posted Date

March 12, 2015

Open Date (Earliest Submission Date)

April 15, 2015

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

May 15, 2015, 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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Not Applicable

Advisory Council Review

Not Applicable

Earliest Start Date

September 2015

Expiration Date

May 16, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application 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.

Table of Contents

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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Background

The number of older individuals living with HIV/AIDS has risen dramatically over the last decade. In 2010, 19% or 217,300 of the Americans living with HIV infection were older than 55 years of age. More than one-quarter of new AIDS diagnoses in 2011 in the United States were in individuals who were aged 50 years or older (1). The majority of HIV prevalence among older adults is attributable to improved survival as a result of modern antiretroviral therapy. Understanding the impact of HIV infection and its treatment in older age, and conversely, the effects of aging on prevention, diagnosis, and management of HIV infection in older adults continue to be important knowledge gaps.

In recognition of the importance of enhanced research on HIV in aging populations, in 2011, the NIH Office of AIDS Research (OAR) established the Working Group on HIV and Aging, a panel of academic and community experts charged with identifying current and high priority research opportunities in HIV and aging. A report and recommendations from this Working Group were published in July, 2012 in the Journal of Acquired Immune Deficiency Syndromes (JAIDS). To stimulate research in recommended areas, in 2012 NIH also published three Funding Opportunity Announcements (FOAs) encouraging multidisciplinary studies of HIV/AIDS and aging, PAR-12-174 (R21), PAR-12-175 (R01) and PAR-12-176 (R03). This FOA builds on the successes of grants funded under those announcements, in addition to HIV and Aging research currently funded through other NIH-funding opportunities.

Objectives and Scope

The intent of this Funding Opportunity Announcement (FOA) is to encourage supplemental research projects in the fields of HIV infection, HIV-associated conditions, HIV treatment, and/or biobehavioral or social factors associated with HIV/AIDS in the context of aging and/or in older adults. Research approaches for this administrative supplement opportunity include clinical, translational, observational and interventional studies in domestic and international settings. Applications must propose work that 1) exploits an unexpected opportunity, and 2) fits within the existing scientific scope of the parent award. Applications may not involve new foreign components; however, existing foreign components in the current grant or cooperative agreement are eligible.

Priority will be given to applications with one or more of the following characteristics:

  • Establishment of new collaborations or expertise that are well-suited for the proposed supplemental work
  • Evidence that the proposed work will form the basis of future research applications to NIH or other funding sources
  • Leveraging of existing NIH-supported resources, such as Centers, Clinical and Translational Science Awards (CTSAs), large cohort studies, or other substantial NIH investments

Applicants are strongly encouraged to contact the program officer for the parent grant and/or the Scientific/Research contact below to ensure conformity to eligibility requirements and compliance with IC-specific policies.

IC-Specific Guidance

In addition to the general guidance above, individual ICs may have specific priorities, limitations, or other guidance for their particular research awards as follows:

NCI

NCI encourages supplements that will help to understand how aging in the presence of chronic HIV infection affects the risk, spectrum and biology of cancer (AIDS-defining and non-AIDS-defining cancers).  In particular, it encourages new collaborative projects that aid in the understanding of the interplay between host factors and immune perturbations that occur in aging and how these interactions affect cancers that are otherwise mostly seen in older people (e.g., Kaposi’s sarcoma and Merkel cell carcinoma). 

NCCIH

NCCIH has an interest in examination of mind/body interventions including:

  • Evaluation of "geriatric" complementary health interventions, such as movement-based interventions (e.g., tai chi).
  • Development and evaluation of complementary health strategies to maintain or improve cognition in older adults with HIV.
  • Comparative effectiveness studies of combined pharmacological/non-pharmacological (Complementary and Integrative Health approaches) interventions, particularly incorporating patient and family preferences and evaluating cost effectiveness.
  • Interventions to promote subjective well-being and resilience, and to reduce symptom burden in older adults with HIV, including examination of the impact of individual differences (e.g. personality, sense of control, self-efficacy) on their effectiveness.

NIAAA

Alcohol use persists throughout the life course of many HIV+ individuals and has a substantial impact on multiple health outcomes.  NIAAA is interested in applications that focus on effective interventions, translational research that addresses the synergism of HIV, alcohol, and other physiological, psychological, or social factors (e.g., HCV, neurocognitive impairment, other substance use, affective disorders, care delivery, and polypharmacy) in older HIV-infected individuals.

NIAID

NIAID encourages applications on any topic within the scope of this FOA and the mission of NIAID.  Career Development Awards (K awards), Training Grants and grants in the first or last year of the competitive segments are not eligible for administrative supplements.  Applicants are encouraged to contact their NIAID Program Officers to ensure compliance with NIAID policies.

NIDA

NIDA strongly encourages new interdisciplinary collaborations on studies within the original scope of the NIDA-funded parent grant on a wide range of issues focused on HIV in aging high-risk substance abusing populations including those with multiple infections (e.g., HIV and HCV).

NIMH

Overarching Angle in HIV and Aging

Interdisciplinary, conceptually-grounded HIV research studies in behavioral/clinical science research and basic/clinical neuroscience research of older adults

Major NIMH/DAR Research Program Themes in HIV and Aging

  • Sociobehavioral Influences and Neuropsychiatric Comorbidities  
  • Characterize some major aging phenotypes (e.g., accelerated aging, neurocognitive aging, successful aging)
  • HIV Care Continuum Research
  • HIV CNS Pathophysiology and Neurotherapeutics  
  • Mentoring and Training of Diverse Research Workforce

NINDS

NINDS strongly encourages new interdisciplinary collaborations on studies within the original scope of the NINDS-supported grant project. 

NINR

The aging population with and without HIV infection continues to grow. Basic, clinical, and interventional research related to the intersection of HIV and aging is essential for translation and sustainability. NINR is interested in applications that relate to:

  • Interventions addressing prevention and management of symptoms occurring in older individuals with HIV infection;
  • Unique solutions of caregivers and systems infrastructure – social/behavioral issues and isolation of persons aging with HIV infection;
  • Symptom clusters in the intersection of HIV infection and aging;
  • Symptom science approach to comorbidities related to aging and HIV infection;
  • Predictive modeling related to the comorbid nature of HIV infection and aging that could lead to primary and secondary symptom prevention.
References

(1) CDC Fact Sheet:HIV Among Older Americans, December 20, 2013 http://www.cdc.gov/hiv/risk/age/olderamericans/index.html?s_cid=drmermin-00340

Section II. Award Information
Funding Instrument

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.

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

Non-competing Administrative Supplements

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

The Office of AIDS Research (OAR), through the NIH ICs, intends to commit a total of $2 million in FY15 to fund approximately 10-15 awards.

Award Budget

Application budgets are limited to no more than $100,000 in direct costs, and must reflect the actual needs of the proposed project.

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.

Award Project Period

The project and budget periods must be within the currently approved project period for the existing parent award.and may not exceed one year in duration.

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.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

All organizations administering an eligible parent award may apply for a supplement under this announcement.

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

    • Hispanic-serving Institutions
    • Historically Black Colleges and Universities (HBCUs)
    • Tribally Controlled Colleges and Universities (TCCUs)
    • Alaska Native and Native Hawaiian Serving Institutions
    • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions), provided that the foreign institution is already involved in the parent application. New foreign components will not be allowed.

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.

Foreign Institutions

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.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

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 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.
  • 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.
  • 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.  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.

Eligible Individuals (Program Director/Principal Investigator)

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.

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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.  

Section IV. Application and Submission Information
1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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 in the Application Guide (SF424 (R&R) Application 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 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.

Page Limitations

All page limitations described in the Application Guide and the Table of Page Limits must be followed, .

Application Submission

Electronic submission of request for administrative supplements is only available for single-project activity codes for which competing applications are submitted electronically. Visit the list of single-project Activity Codes Processed Electronically by eRA to determine if the single-project activity code of the parent award has transitioned to electronic submission.  Submission of requests for administrative supplements for all other activity codes must use paper.

If the administrative supplement may be submitted electronically, then you may either (A) submit using the SF424 (R&R) Application Forms and Grants.gov/Apply, (B) submit using the streamlined submission process of eRA Commons, or (C) submit using the paper-based PHS 398 Application forms and the PHS 398 Application Guide.

Instructions for Submissions using Grants.gov/Apply for electronic-based submissions

For single project grants with activity codes that have transitioned to electronic submission using the SF424 (R&R) application forms, administrative supplement requests may be submitted electronically as a Revision application type on the R&R Cover Form. Prepare applications using the SF424 (R&R) application forms associated with this announcement. 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.

Special Instructions for Streamlined Submissions using the eRA Commons for electronic-based submissions

NIH now 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.

Include the Research Strategy and any other required documentation (described below) as a PDF file using the “Add Other Attachments” function.  Budget information should be entered for the grantee institution in the fields provided. There is no template or form available for subaward information; instead, all subaward information should be included as a separate attachment showing the funds requested (by budget period) using the same categories provided for the grantee institution. Also include a budget justification for the subawardee institution in the same file.

Instructions for Submissions using the PHS 398 Application Forms (for paper-based submissions)

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. 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:

The Scientific/Research contact listed in Section VII below.

On the face page of the application form, note that your application is in response to a specific program announcement, and enter the title and number of this announcement.

PHS 398 Research Plan (Research Plan)

All instructions in the Application Guide must be followed for all Research Plan sections applicable to the proposed supplement activities. At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities.

Project/Performance Site Locations (Project/Performance Sites)

All instructions in the Application Guide must be followed, with the following additional instructions:

  • Include the primary site where the proposed supplement activities will be performed.
  • If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
Senior/Key Personnel Form

All instructions in the Application Guide must be followed, with the following additional instructions:

  • List the PD/PI as the first person (regardless of their role on the supplement activities).
  • List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.
R&R Detailed Budget Form (for use with electronic submissions)

All budgets should be submitted using the R&R Detailed Budget form, regardless of the form used for the parent award, and should only include funds requested for the additional supplement activities.

Budget for the Entire Proposed Period of Support (for use with paper-based submissions)

A proposed budget should be submitted using the PHS 398 budget forms, in accordance with the PHS 398 Application Guide, and should only include funds requested for the additional supplement activities.

Other Project Information (for use with electronic submissions); Appendix (use with paper-based submissions)

All instructions in the Application Guide must be followed, with the following additional instructions:

IACUC Documentation and IRB Documentation (Uploaded via the Other Attachments Section for electronic submissions)

If applicable, include documentation that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects’ involvement is planned for the supplement component.

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing the Planned Enrollment Report as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing the Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Foreign Institutions

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

3. Submission Dates and Times

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 as described above. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

Applications must be submitted using the instructions specified above.

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. 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.

Important reminders:
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.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions. Applications that are incomplete or non-compliant will not be reviewed

Post Submission Materials

Not Applicable

Section V. Application Review Information
1. Criteria

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.

Overall Impact

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:

  • For Research and Research Center Awards Only: Will the administrative supplement increase or preserve the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved?
  • For Fellowship Awards Only: Will the administrative supplement increase or preserve the likelihood that the fellowship will enhance the candidate's potential for, and commitment to, a productive, independent scientific research career in a health-related field?
  • For Career Development Awards Only: Will the administrative supplement increase or preserve the likelihood for the candidate to maintain a strong research program?
  • For Institutional Training and Institutional Career Development Awards (including R25) Only: Will the administrative supplement increase or preserve the likelihood for the program to exert a sustained, powerful influence on the research field(s) involved?
  • For Shared Instrumentation and Research Awards Only: Will the administrative supplement increase or preserve the potential benefit of the instrument requested for the overall research community and its potential impact on NIH-funded research?

In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

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, 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.

Inclusion of Women, Minorities, and Children

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.

Vertebrate Animals

NIH staff will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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.

2. Review and Selection Process

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.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information
1. Award Notices

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.

2. Administrative and National Policy Requirements

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.

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.

3. Reporting

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.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-435-0714

Scientific/Research Contact(s)

Geraldina Dominguez, PhD
National Cancer Institute (NCI)
Telephone: 301-496-3204
Email: domingug@mail.nih.gov  

Emmeline Edwards, PhD
National Center for Complementary and Integrative Health (NCCIH)
Telephone:  301-594-7102
Email: edwardse@mail.nih.gov

Basil A. Eldadah, MD, PhD
National Institute on Aging (NIA)
Telephone: 301-496-6761
Email: basil.eldadah@nih.gov

Kendall J. Bryant, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-0332
Email: NIAAA-HIV-Initiatives@mail.nih.gov  

Robin Huebner, PhD, MPH
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3216
Email: rhuebner@niaid.nih.gov

Jag Khalsa, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-2159
Email: jkhalsa@nida.nih.gov

David M. Stoff, PhD
National Institute of Mental Health (NIMH)
Telephone: 240-627-3876
Email:  dstoff@mail.nih.gov

May Wong, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1431
Email: wongm@ninds.nih.gov

Lynda Hardy, Ph.D, RN
National Institute of Nursing Research (NINR)
Telephone: 301-594-5976
Email: hardylr@mail.nih.gov

Peer Review Contact(s)

Not Applicable

Financial/Grants Management Contact(s)

Shane Woodward
National Cancer Institute (NCI)
Telephone: 301-496-8791
Email: woodwars@mail.nih.gov

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: CarowS@mail.nih.gov 

Lesa McQueen
National Institute on Aging (NIA)
Telephone: 301-402-7738
Email: mcqueenl@nia.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-5601
Email: adevine@niaid.nih.gov

Carol Alderson
National Institute on Drug Abuse (NIDA)
Telephone: 301-933-6196
Email:  aldersoc@nida.nih.gov

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: siscor@mail.nih.gov

Tijuanna DeCoster, MPA 
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@ninds.nih.gov

Judy Sint
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959 
Email: sintj@mail.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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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