Participating Organization(s)
National Institutes of Health (NIH)
Components
of Participating Organizations
National Cancer Institute (NCI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Center for Complementary and Integrative Health (NCCIH)
All applications to this funding opportunity announcement
should fall within the mission of the Institutes/Centers. The following NIH
Offices may co-fund applications assigned to those Institutes/Centers.
Office of Strategic Coordination (Common Fund)
Division of Program Coordination,
Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
Division of Program Coordination, Planning and Strategic
Initiatives, Office of AIDS Research (OAR)
Office of Research on Women's Health (ORWH))
Funding Opportunity Title
Administrative Supplements for Research
on Sexual and Gender Minority (SGM) Populations (Admin Supp Clinical Trial
Optional)
Activity Code
Administrative Supplement
Additional funds may be awarded as supplements to parent
awards using the following Activity Code(s):
Administrative supplement requests may be submitted
electronically for the following activity codes:
C06 Research Facilities Construction Grant
D43 International Training Grants in Epidemiology
D71 International Training Program Planning Grant
DP1 NIH Director's Pioneer Award (NDPA)
DP2 NIH Director's New Innovator Awards
DP3 Type 1 Diabetes Targeted Research Award
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
F37 Medical Informatics Fellowships
F38 Applied Medical Informatics Fellowships
F99/K00 Pre-doc to Post-doc Transition Award/
Post-doctoral Transition Award
FI2 Intramural Postdoctoral Research Associate
G08 Resources Project Grant (NLM)
G11 Extramural Associate Research Development Award
(EARDA)
G13 Health Sciences Publication Support Awards (NLM)
G20 Grants for Repair, Renovation and Modernization of
Existing Research Facilities
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
K43 International Research Career Development Award
K76 Emerging Leaders Career Development Award
K99/R00 Career Transition Award/Research Transition Award
KL1 Linked Research Career Development Award
KL2 Mentored Career Development Award
KM1 Institutional Career Enhancement Awards
OT1 Pre-Application for another Transaction Award
OT2 Research Project - Other Transaction Award
RC2 High Impact Research and Research Infrastructure
Programs
RC3 Biomedical Research, Development, and Growth to Spur
the Acceleration of New Technologies (BRDG-SPAN) Program
RC4 High Impact Research and Research Infrastructure
Programs Multi-Yr Funding
RM1 Research Project with Complex Structure
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)
R18 Research Demonstration and Disseminations Projects
R21 Exploratory/Developmental Research Grant Award
R21/R33 Phased Innovation Award
R24 Resource-Related Research Projects
R25 Education Projects
R28 Resource-Related Research Projects
R33 Exploratory/Developmental Grants Phase II
R34 Clinical Trial Planning Grant Program
R35 Outstanding Investigator Award
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
R50 Research Specialist Award
R61/R33 Exploratory/Developmental Phased Award
RC1 NIH Challenge Grants and Partnerships Program Phase
I
RC2 High Impact Research and Research Infrastructure
Programs
RC3 Biomedical Research, Development, and Growth to Spur
the Acceleration of New Technologies (BRDG-SPAN) Program
RC4 High Impact Research and Research Infrastructure
Programs Multi-Yr Funding
RF1 Multi-Year Funded Research Project Grant
RL1 Linked Research project Grant
RL2 Linked Exploratory/Development Grant
RL5 Linked Education Project
RL9 Linked Research Training Award
RM1 Research Project with Complex Structure
S07 Biomedical Research Support Grants
S10 Biomedical Research Support Shared Instrumentation
Grants
S11 Minority Biomedical Research Support Thematic Project
Grants
S21 Research and Institutional Resources Health
Disparities Endowment Grants Capacity Building
SB1 Commercialization Readiness Program
SC1 Research-Enhancement Award
SC2 Pilot Research Project
SC3 Research Continuance Award
T14 Conferences
T15 Continuing Education Training Grants
T32 Institutional National Research Service Award (NRSA)
T34 MARC Undergraduate NRSA Institutional Grants
T35 National Research Service Award (NRSA) Short -Term
Research Training
T36 MARC Ancillary Training Activities Grant
T37 Minority International Research Training Grants
T42 Educational Resource Center Training Grants
T90/R90 Interdisciplinary Research Training
Award/Interdisciplinary Regular Research Training Award
TL1 Linked Training Award
TL4 Undergraduate NRSA Institutional Research Training
Grants
TU2 Institutional National Research Service Award with
Involvement of NIH Intramural Faculty
U01 Research Project Cooperative Agreements
U13 Conferences Cooperative Agreements
U18 Research Demonstration Cooperative Agreements
U2R International Training Cooperative Agreement
U24 Resource-Related Research Projects Cooperative
Agreements U34 Clinical Planning Grant Cooperative Agreement
U44 Small Business Innovation Research (SBIR) Cooperative
Agreements - Phase II
UA5 Academic Research Enhancement Award (AREA) Cooperative
Agreements
UB1 Commercialization Readiness Program - Cooperative
Agreement
UC4 High Impact Research and Research Infrastructure -
Cooperative Agreement Programs
UFI Multi-Year Funded Research Project Cooperative
Agreement UG1 Clinical Research Cooperative Agreements - Single Project
UG3/UH3 Exploratory/Developmental Phased Award Cooperative
Agreement
UH2 Exploratory/Developmental Cooperative Agreement Phase
I
UH2/UH3 Phase Innovation Awards Cooperative Agreement
UH3 Exploratory/Developmental Cooperative Agreement Phase
II
UM1 Multi-Component Research Project Cooperative
Agreements
UP5 Cooperative Agreement
Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.121, 93.172, 93.173, 93.213, 93.393, 93.394, 93.395, 93.396,
93.399, 93.846, 93.847, 93.855, 93.866, 93.279, 93.847, 93.855
Funding Opportunity Purpose
The National Institutes of
Health (NIH) Office of the Director announces the availability of
administrative supplements to expand existing research to focus on Sexual and
Gender Minority (SGM) health. Program Directors/Principal Investigators
holding specific types of NIH research grants, listed in this Funding
Opportunity Announcement (FOA) are notified that funds may be available for
administrative supplements to meet increased costs that are within the scope
of the approved award, but that were unforeseen when the new or renewal
application or grant progress report for non-competing continuation support
was submitted.
Applications for administrative supplements are considered
prior approval requests (as described in Section 8.1.2.11 of the NIH Grants
Policy Statement) and will be routed directly to the Grants Management
Officer of the parent award. Although requests for administrative supplements
may be submitted through this FOA, there is no guarantee that funds are
available from the awarding IC or for any specific grant. All applicants are
encouraged to discuss potential requests with the awarding IC.
SGM populations include, but are not limited to, lesbian,
gay, bisexual, and transgender people, and individuals with differences or
disorders of sexual development (sometimes referred to as "intersex" or as
specific diagnoses). This trans-NIH effort, which involves multiple
Institutes, Centers and Offices from across NIH, is intended to encourage
investigation in this growing, field of research. To increase our collective
understanding of the broad range of research needed to address the unique health
issues of SGM populations, the supplement will focus on areas of research
interest, including, but not limited to: studies on increased disease risk;
mental, behavioral and social health; approaches to personalized medicine;
access to care; reproductive and sexual development; neurological and
cognitive development; and resilience.
Key Dates
Open Date (Earliest Submission Date)
Letter of Intent Due Date(s)
Application Due Date(s)
May 7, 2018, 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)
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, 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
The mission of the NIH is to seek fundamental knowledge
about the nature and behavior of living systems, and the application of that
knowledge to enhance health, lengthen life, and reduce illness and disability.
The NIH is committed to supporting research that will increase scientific
understanding of the health and wellbeing of various population and
subpopulation groups and study the effectiveness of evidence-based health
interventions and services for individuals within those groups. NIH places
high priority on research with populations that appear to have distinctive
health risk profiles but have received insufficient attention from
investigators. This Supplement provides administrative support to expanding
existing research to focus on sexual and gender minority (SGM) populations,
which include (but are not limited to) lesbian, gay, bisexual, and transgender
people, and individuals with differences or disorders of sex development (DSD)
(sometimes referred to as "intersex"). Basic, social, behavioral, clinical,
translational, and health services research relevant to the missions of the
sponsoring Institutes, Centers and Offices may be proposed. Potential
applicants are also encouraged to review recent portfolio analyses of
NIH-funded SGM research (found at https://dpcpsi.nih.gov/sgmro/reports)
to identify gaps in research that may be relevant to this Funding Opportunity
Announcement (FOA).
Background
The Institute of Medicine (IOM), (now the National Academy
of Medicine) report issued in March 2011 (http://www.nationalacademies.org/hmd/Reports/2011/The-Health-of-Lesbian-Gay-Bisexual-and-Transgender-People.aspx stated, in reference to SGM health, that the "existing body of evidence is
sparse, and that substantial research is needed." This situation has improved,
but there is still a need for further research on a range of health-related
issues. NIH encourages potential applicants to read the IOM report, as a
number of specific issues are raised and discussed therein; however, readers
should note that this IOM report addresses most, but not all, of the
populations within NIH's SGM definition. Recent data from national health
surveys and targeted studies suggest that prevalence rates for some health
conditions are significantly higher among SGM populations than for the general
population.
"Sexual and gender minority" is an umbrella phrase that
encompasses lesbian, gay, bisexual, and transgender populations as well as
those whose sexual orientation, gender identity and expressions, or
reproductive development varies from traditional, societal, cultural, or
physiological norms.
NIH uses the term SGM for these populations as well as for
individuals within them. However, applicants may study subpopulations, and/or
adopt other classification frameworks and terminologies as appropriate for
proposed research in such understudied populations.
Specific Areas of Research Interest
This FOA calls for research that will enrich scientific
understanding of how sexual orientation, gender identity, and/or being born
with DSD/Intersex conditions relate to health and health risks, perceptions and
expectations about health, health behaviors, and barriers and access to
health-related services.
Appropriate topics/studies for these supplements include,
but are not limited to, those listed below:
- Addition of SGM individuals to a study which either originally
excluded them or has not enrolled enough SGM participants to make any
meaningful comparisons between groups; studies need to have sufficient power to
allow for meaningful comparisons
- Expansion of an ongoing SGM study focused on one group to add
another; sample sizes need to be powered to allow for meaningful comparisons
- Expansion of questionnaires administered in any setting where it
is relevant to address issues of sexual attraction, sexual behavior, sexual
orientation, gender identity, and/or gender expression
- Assessment of reliability and validity of measures relevant to sexual
attraction, sexual behavior, sexual orientation, gender identity, and/or gender
expression
- Methodological innovations to improve the recruitment and
retention of SGM individuals in any research initiative
- Ethical, legal, or social science research on the implications of
genetic and other research findings on SGM populations.
Scope of Support
Administrative supplements can be used to meet increased
costs that are within the scope of the approved award, but that were unforeseen
when the new or renewal application or grant progress report for non-competing
continuation support was submitted. Applicants should propose research that,
if successful, would contribute to a greater understanding of the health and
wellbeing of sexual and gender minority communities.
IC-Specific Considerations
Applicants are strongly encouraged to discuss their proposed
supplement project with the IC Program Official of the approved award prior to
submission of a supplement application in order to ensure that the proposed
activity fits with the scientific priorities of the IC and is within the scope
of the approved award. Please
note that NIDDK will only support applications that pertain to benign conditions
of lower urinary tract or bladder in response to this FOA. In addition to contact with the IC
Program Official for the approved award, applicants are strongly encouraged to
include the Scientific/Research Contact listed in Section
VII. Agency Contacts in
these communications.
See Section VIII. Other
Information for award authorities and regulations.
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.
See Section VI.2 for additional information about the substantial involvement
for this FOA.
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 NIH Office of the Director and partner ICOs intend
to commit up to $1 Million in FY 2018 to fund approximately 10 awards.
Award Budget
Application budgets are limited to no more than the amount
of the current parent award and must reflect the actual needs of the proposed
project but must not exceed $100,000 in total costs.
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. All awards
are for a one-year period.
NIH grants policies as
described in the NIH Grants
Policy Statement will apply
to the applications submitted and awards made from 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:
o Hispanic-serving Institutions
o Historically Black Colleges and Universities (HBCUs)
o Tribally Controlled Colleges and Universities (TCCUs)
o Alaska Native and Native Hawaiian Serving Institutions
o 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)
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. 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.
- Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.
- System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.
- NATO
Commercial and Government Entity (NCAGE) Code Foreign organizations must
obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
- eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.
- Grants.gov Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration. Grants.gov registration is only required if you plan
to submit using the 'Electronic Application Submission through Grants.gov'
option.
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.
Since applications
in response to this announcement will only receive administrative review by the
awarding Institute or Center, and will not receive a peer review, the NIH
policy on resubmissions will not apply.
Only active awards with at least 18 months remaining at the
time of submission will be considered. Awards in no-cost extension periods are
not allowed to submit an application in response to this FOA.
The administrative funds are not to be used for constructions,
renovations and alterations, purchase of research equipment and/or
instrumentation for enhancement of laboratories or facilities.
Section IV. Application and
Submission Information
1. Requesting an
Application Package
Applicants must prepare applications using current forms in
accordance with the Application Guide.
Buttons to access the online ASSIST system or to download
application forms are available in Part
1 of this FOA. See your administrative office for instructions if you plan
to use an institutional system-to-system solution.
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 for
their submission option (SF424
(R&R) Application Guide, eRA Commons Administrative
Supplement User Guide) 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.
Page Limitations
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:
The Research Strategy section of the administrative
supplement may not exceed 6 pages.
Application Submission
Administrative supplement requests for most single-project
activity codes can be submitted using 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.
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:
- R&R Cover form: Select "Revision" in the "Type of
Application" field.
- Research Plan form: 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 Location form: 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.
- Sr/Key Personnel form: 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.
- Budget forms (e.g., R&R Budget, PHS 398 Training Budget):
Only include funds requested for the additional supplement activities.
- R&R Other Project Information form: If applicable, attach PDF
documents in the "Other Attachments" field indicating 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. Name the documents "IACUC Documentation.pdf" and/or "IRB
Documentation.pdf". 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.
- PHS Human Subjects and Clinical Trial Information: This form
is optional. Given that the proposed supplement should not change the scope of
the awarded parent project, it will typically not be needed. If new recruitment
or use of an additional existing dataset or resource is proposed in the
supplement application, Section 2.4 should be revised and new Inclusion
Enrollment Reports created, as appropriate.
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:
- udget information should be entered for the grantee institution
in the tabs provided for each selected budget period.
- Since there is no template or form available for subaward budget
information, all subaward information must be included as a PDF attachment in
the Subrecipient Budgets section showing the funds requested (by budget period)
and using the same categories provided for the grantee institution. The
attachment must also include any related budget justification information.
- Use the "Add Other Attachments" function to include the following
PDF documents:
- Research
Strategy including a summary or abstract of the funded parent award or project.
- If
applicable, attach documents indicating 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.
- PHS Human
Subjects and Clinical Trial Information: This form is optional. Given that
the proposed supplement should not change the scope of the awarded parent
project, it will typically not be needed. If new recruitment or use of an
additional existing dataset or resource is proposed in the supplement
application, Section 2.4 should be revised and new Inclusion Enrollment Reports
created, as appropriate.
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. Unique Entity Identifier
and System for Award Management (SAM)
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.
4. Submission Dates and
Times
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.
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.
5. Intergovernmental Review
(E.O. 12372)
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.
7. Other Submission
Requirements and Information
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.
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.
Post Submission Materials
Not Applicable
Section V. Application Review Information
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:
- Will the administrative supplement increase or preserve the
likelihood for the project to exert a sustained, powerful influence on the
research field(s) involved?
In
addition, for applications proposing clinical trials
Does the design/research plan include innovative
elements, as appropriate, that enhance its sensitivity, potential for
information or potential to advance scientific knowledge or clinical practice?
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) 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.
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.
Individual awards are based on the application submitted
to, and as approved by, the NIH and are subject to the IC-specific terms and
conditions identified in the NoA. ClinicalTrials.gov: If an award provides for
one or more clinical trials. By law (Title VIII, Section 801 of Public Law
110-85), the "responsible party" must register and submit results
information for certain "applicable clinical trials" on the ClinicalTrials.gov
Protocol Registration and Results System Information Website
(https://register.clinicaltrials.gov). NIH expects registration of all trials
whether required under the law or not. For more information, see
http://grants.nih.gov/ClinicalTrials_fdaaa/
Institutional Review Board or Independent Ethics Committee
Approval: Grantee institutions must ensure that the application as well as all
protocols are reviewed by their IRB or IEC. To help ensure the safety of
participants enrolled in NIH-funded studies, the awardee must provide NIH
copies of documents related to all major changes in the status of ongoing
protocols. Data and Safety Monitoring Requirements: The NIH policy for data
and safety monitoring requires oversight and monitoring of all NIH-conducted or
-supported human biomedical and behavioral intervention studies (clinical
trials) to ensure the safety of participants and the validity and integrity of
the data. Further information concerning these requirements is found at
http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application
instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption
Requirements: Consistent with federal regulations, clinical research projects
involving the use of investigational therapeutics, vaccines, or other medical
interventions (including licensed products and devices for a purpose other than
that for which they were licensed) in humans under a research protocol must be
performed under a Food and Drug Administration (FDA) investigational new drug
(IND) or investigational device exemption (IDE).
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.
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.
In accordance with the statutory
provisions contained in Section 872 of the Duncan Hunter National Defense
Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be
subject to the Federal Awardee Performance and Integrity Information System
(FAPIIS) requirements. FAPIIS requires Federal award making officials to
review and consider information about an applicant in the designated integrity
and performance system (currently FAPIIS) prior to making an award. An
applicant, at its option, may review information in the designated integrity
and performance systems accessible through FAPIIS and comment on any
information about itself that a Federal agency previously entered and is
currently in FAPIIS. The Federal awarding agency will consider any comments by
the applicant, in addition to other information in FAPIIS, in making a
judgement about the applicant's integrity, business ethics, and record of
performance under Federal awards when completing the review of risk posed by
applicants as described in 45 CFR Part 75.205 "Federal awarding agency review
of risk posed by applicants." This provision will apply to all NIH grants and
cooperative agreements except fellowships.
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.
In accordance with the regulatory requirements provided at
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
currently active Federal grants, cooperative agreements, and procurement
contracts from all Federal awarding agencies with a cumulative total value
greater than $10,000,000 for any period of time during the period of
performance of a Federal award, must report and maintain the currency of information
reported in the System for Award Management (SAM) about civil, criminal,
and administrative proceedings in connection with the award or performance of a
Federal award that reached final disposition within the most recent five-year
period. The recipient must also make semiannual disclosures regarding
such proceedings. Proceedings information will be made publicly available
in the designated integrity and performance system (currently FAPIIS). This is
a statutory requirement under section 872 of Public Law 110-417, as amended (41
U.S.C. 2313). As required by section 3010 of Public Law 111-212, all
information posted in the designated integrity and performance system on or
after April 15, 2011, except past performance reviews required for Federal procurement
contracts, will be publicly available. Full reporting requirements and
procedures are found in Appendix XII to 45 CFR Part 75 Award Term and
Conditions for Recipient Integrity and Performance Matters.
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 Service
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: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Grants.gov
Customer Support (Questions regarding Grants.gov registration and submission,
downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573
Scientific/Research Contact(s)
Liz Perruccio
National Cancer Institute (NCI)
Telephone: 240 276-6178
Email: liz.perruccio@nih.gov
Tina Gatlin
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-2851
Email: gatlincl@mail.nih.gov
Melissa Gerald
National Institute on Aging (NIA)
Telephone: 301-451-4503
Email: geraldmel@mail.nih.gov
Phillip Renzullo
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3041
Email: prenzullo@mail.nih.gov
Carl C. Baker
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5032
Email: bakerc@mail.nih.gov
Alberto Rivera-Rentas
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-6251
Email: riverara@nidcd.nih.gov
Melissa Riddle
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-451-3888
Email: riddleme@nidcr.nih.gov
Jeffrey Schulden
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1526
Email: schuldenj@nida.nih.gov
Tamara Bavendam, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4733
Email: tamara.bavendam@nih.gov
Susannah Allison
National Institute of Mental Health (NIMH)
Telephone: 240-627-3861
Email: allisonsu@mail.nih.gov
Rebecca Henry, PhD, BSN, RN
National Institute of Nursing Research (NINR)
Telephone: 301-594-5976
Email: rebecca.henry@nih.gov
Jennifer Alvidrez
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9567
Email: jennifer.alvidrez@nih.gov
Lanay Mudd, Ph.D.
National Center for Complementary and Integrative Health NCCIH)
Telephone: 301-594-9346
lanay.mudd@nih.gov
Kate Winseck
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
Telephone: 301-827-5583
Email: winseckk@mail.nih.gov
Vanessa A. White
Office of AIDS Research (OAR)
Telephone: 301-594-4668
Email: vanessa.white@nih.gov
Victoria Cargill
Office of Research on Women's Health (ORWH)
Telephone: 301-402-1770
Email: CargillV@od.nih.gov
Karen Parker
Sexual & Gender Minority Research Office (SGMRO)
Telephone:301-402-9852
Email: KLParker@mail.nih.gov
Peer Review Contact(s)
Not Applicable
Financial/Grants Management Contact(s)
Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov
John Bladen
National Institute on Aging (NIA)
Telephone: 301-402-7730
Email: bladenj@mail.nih.gov
Deanna Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: (301) 402-0733
Email: ingersolld@mail.nih.gov
Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov
Tseday Girma
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5896
Email: Tseday.Girma@nih.gov
Melinda Nelson
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telehone: 301-435-5278
Email: nelsonm@exchange.nih.gov
Lora Kutkat
DPCPSI
Telehone: 301-402-9852
Email: Lora.Kutkat@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.
Department of Health
and Human Services (HHS)
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