Participating Organization(s)
National Institutes of Health (NIH)
Components
of Participating Organizations
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver
National Institute of Child Health and Human Development (NICHD)
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 Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Library of Medicine (NLM)
Fogarty International Center (FIC)
National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)
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.
Division of Program Coordination, Planning and Strategic
Initiatives, Office of Research Infrastructure Programs (ORIP)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women's Health (ORWH)
Office of Strategic Coordination (Common
Fund)
Funding Opportunity Title
Successor-in-Interest (Type 6 Parent Clinical Trial Optional)
Activity Code
Successor-in-Interest
Successor-in-Interest applications must be submitted on
paper for the following activity codes:
G12 Research Centers in Minority Institutions Award
P01 Research Program Projects
P20 Exploratory Grants
P30 Center Core Grants
P40 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Material
Resource Grants
P41 Biotechnology Resource Grants
P50 Specialized Center
P51 Primate Research Center Grants
P60 Comprehensive Center
P2C Resource-Related Research Multi-Component Projects and Centers
PM1 Program Project or Center with Complex Structure
PN2 Research Development Center
S06 Research-Related Programs
U10 Cooperative Clinical Research Cooperative Agreements
U19 Research Program Cooperative Agreements
U2C Resource-Related Research Multi-Component Projects & Centers
Cooperative Agreements
U41 Biotechnology Resource Cooperative Agreements
U42 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological
Materials Resource Cooperative Agreements
U45 Hazardous Waste Worker Health and Safety Training Cooperative Agreements
U54 Specialized Center- Cooperative Agreements
U56 Exploratory Grants Cooperative Agreements
UC2 High Impact Research and Research Infrastructure Cooperative Agreement
Programs
UC3 Biomedical Research, Development, and Growth to Spur the Acceleration of New
Technologies (BRDG-SPAN) Cooperative Agreement Program
UC7 National Biocontainment Laboratory Operation Cooperative Agreement
UG4 National Network of Libraries of Medicine
UH4 Hazmat Training at DOE Nuclear Weapons Complex
UL1 Linked Specialized Center Cooperative Agreement
UM2 Program Project or Center with Complex Structure Cooperative Agreement
Successor-in-Interest applications 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
F99/K00 Pre-doc to Post-doc Transition Award/ Post-doctoral Transition Award
G08 Resources Project Grant (NLM)
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
K38 Early Stage Mentored Research and Career Development
K43 International Research Career Development Award
K76 Emerging Leaders Career Development Award
K99/R00 Career Transition Award/Research Transition Award
KL2 Mentored Career Development Award
KM1 Institutional Career Enhancement Awards
OT1 Pre-Application for an Other Transaction Award
OT2 Research Project - Other Transaction Award
OT3 Other Transaction Multiple-Component Research 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
R00 Research Transition Award
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
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
R38 Mentored Research Pathway in Residency
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
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
R44 Small Business Innovation Research (SBIR) Grant - Phase II only
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
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
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
UB1 Commercialization Readiness Program - Cooperative Agreement
UC4 High Impact Research and Research Infrastructure - Cooperative Agreement
Programs
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
Related Notices
-
October 01, 2020 - This PA has been reissued as PA-20-275.
- May 21, 2020 - Reissue of Parent Announcements (PA-18-589, PA-18-590, PA-18-591, and PA-18-592) and the Urgent (PA-18-935) and Emergency (PA-20-135) Competitive Revision FOAs is Underway - Continue to use the Current Announcements and Forms Packages Until Reissuance. See Notice NOT-OD-20-110.
- August 23, 2019 -
Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice
NOT-OD-19-137.
- July 26, 2019 -
Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128.
- May 13, 2019 - NIGMS-Managed HIV/AIDS Research Portfolio Transitioning to NIAID. See Notice NOT-GM-19-039.
Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.077, 93.113, 93.121, 93.142, 93.143,
93.172, 93.173, 93.213, 93.233, 93.242, 93.273, 93.279, 93.281, 93.282,
93.286, 93.307, 93.310, 93.350, 93.351, 93.352, 93.361, 93.389, 93.393,
93.394, 93.395, 93.396, 93.397, 93.398, 93.399, 93.701, 93.702, 93.837,
93.838, 93.839, 93.846, 93.847, 93.853, 93.855, 93.856, 93.859, 93.865;
93.866, 93.867, 93.879, 93.989, 93.840, 93.313.
Funding Opportunity Purpose
The National Institutes of
Health (NIH) hereby notify grantee organizations holding specific types of
NIH grants, listed in the full Funding Opportunity Announcement (FOA), that
applications for change of grantee organization status, often referred to in
this announcement as Successor-In-Interest, may be submitted to this FOA.
Applications for change of grantee organization status are considered prior
approval requests (as described in Section
8.1.2.8 of the NIH Grants Policy Statement) and will be routed for
consideration directly to the Grants Management Specialist named in the
current award.
Although successor-in-interest requests may be submitted
through this FOA, there is no guarantee that an award will be transferred to
the new organization. All
applicants are encouraged to discuss potential requests with the awarding IC
before submission.
Key Dates
Open Date (Earliest Submission Date)
Letter of Intent Due Date(s)
Application Due Date(s)
A successor-in-interest request must be made before the anticipated
start date at the new organization and preferably several months in advance.
AIDS Application Due Date(s)
Earliest Start Date
Earliest start dates may vary by awarding IC. Contact awarding
IC for further guidance.
Expiration Date
New Date October 01, 2020 per issuance of PA-20-275. (Original Expiration Date: January 26, 2021)
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
Successor-in-Interest requests for
single-project activity codes can be submitted using either paper or electronic
submission processes. Successor-in-Interest 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.
Successor-in-Interest actions generally require the submission
of multiple applications and can involve awards from numerous NIH ICs.
Therefore, the grantee should contact lead NIH awarding IC before submitting
applications through this FOA.
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 original 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.
Other: A mechanism that is not a grant or cooperative
agreement. Examples include access to research resources or pre-applications
Application Types Allowed
Funds Available and Anticipated Number of Awards
The amount of an award is contingent upon the submission
of an acceptable application and, unless otherwise instructed by the awarding
IC, the direct costs relinquished by the original grantee institution.
Award Budget
Unless otherwise instructed by the awarding IC,
application budgets are limited to the direct costs relinquished by the
original grantee institution, plus applicable F&A costs for the new
institution. Budgets must reflect actual needs of the proposed project. .
Award Project Period
The project period should not exceed the amount of time
remaining in the original project 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
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)
If the original funding opportunity announcement under which
an awardwas funded includes special requirements for applicant eligibility,
those may need to be maintained by the new organization. Prospective grantees
should contact the awarding IC to discuss any special applicant eligibility
requirements that may exist.
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.
- o 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)
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program
Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with
his/her organization to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs,
visit the Multiple Program Director/Principal Investigator Policy and
submission details in the Senior/Key Person Profile (Expanded) Form of the
Application Guide.
Generally a Successor-in-Interest request should include the
same PD/PI(s) as on the currently funded award. Individual(s) must hold an
active award and the research proposed should not exceed the amount of time
remaining in the original project period. Individuals are encouraged to work
with the awarding IC of the current award for further guidance and with their
organization to develop applications for support.
For awards that include multiple PD(s)/PI(s), the Successor-in-Interest request
may be submitted by any or all of the PDs/PIs (in accordance with the existing
leadership plan) and submitted by the awardee institution of the original
award. Do not use this Successor-in-Interest application to add, delete, or
change the PD(s)/PI(s) listed on the current award. Visit the Multiple Program
Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
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 must submit one application for each
active award for which a Successor-in-Interest is being requested.
Section IV. Application and
Submission Information
1. Requesting an
Application Package
Applicants must prepare applications using current forms in
accordance with the Application Guide.
You must use one of the submission options listed above the
Table of Contents in Part 1 of this FOA to access the application forms needed
to apply to this opportunity.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions for
their submission option (SF424
(R&R) Application Guide or PHS 398
Application Guide, as appropriate) 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 original award as
described in the Application Guide and the Table of
Page Limits must be followed.
Application Submission
Prior to submission, grantees are required to contact the
GMO of the lead NIH awarding IC to explain the nature of the change in
organizational status and receive guidance on whether it will be treated as a
name change or Successor-in-Interest. The lead awarding IC ordinarily will be
the IC with which the organization has the most NIH grants. Applications must
only be submitted at the direction of the lead awarding IC.
Successor-in-Interest requests for all single-project
activity codes can be submitted using either paper or electronic submission
processes. Successor-in-Interest requests for multi-project activity codes must
be submitted using the paper submission process. See Activity Code section in
Part 1 to determine if electronic submission is an option for your activity
code.
Applicants submitting paper applications must use the PHS
398 Application Forms and the PHS 398 Application Guide.
Instructions for Electronic
Application Submission through the NIH ASSIST system, an
institutional system-to-system (S2S) solution, or Grants.gov Workspace
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:
SF
424 (R&R) Cover Form:
Successor-in-Interest applications submitted
electronically must include the institute and serial number of the grant number
(e.g. CA987654) of the current award entered in field 4 (Federal Identifier).
In field 8 (Type of Application), select "Revision" and then mark "E.
Other" and insert "Successor-in-Interest" in the corresponding
text field.
Senior/Key
Personnel Profile Form:
Include updated biographical sketches for the PD/PI
and existing senior/key personnel, and biographical sketches for any proposed
new senior/key personnel.
R&R
Budget Form:
Provide budget forms only if instructed to do so by
NIH.
Instructions for Paper-based Submissions using the PHS 398 Application Forms
Applications must be prepared using the PHS 398 research
grant application forms and instructions.
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.
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. 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
Successor-in-Interest applications do not receive peer
review. Instead, the administrative criteria described below will be considered
in the administrative evaluation process.
NIH may request additional information necessary to
accomplish its administrative review of the Successor-in-Interest request. The
following general criteria will be used:
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, program 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, the committee will evaluate: 1) the justification for the
exemption, 2) human subjects involvement and characteristics, and 3) sources of
materials.
Inclusion of Women, Minorities, and Children
When the proposed project involves human subjects and/or
NIH-defined clinical research, program staff 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..
Vertebrate Animals
Program staff will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following criteria: (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. Staff will assess the use of chimpanzees as they would any other
application proposing the use of vertebrate animals.
Biohazards
Program 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.
Select Agent Research
Program staff will assess the information provided in this
section of the application, including 1) the Select Agent(s) to be used in the
proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Program staff will comment on whether the following Resource
Sharing Plans, or the rationale for not sharing the following types of
resources, are reasonable: (1) Data
Sharing Plan; (2) Sharing
Model Organisms; and (3) Genomic
Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical
Resources:
For projects involving key biological and/or chemical
resources, program staff will comment on the brief plans proposed for
identifying and ensuring the validity of those resources.
Budget and Period of Support
Program staff will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.
2. Review and Selection
Process
Successor-in-Interest 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 lead NIH
awarding IC 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
NIH will issue formal notification of a
Successor-in-Interest in the form of a revised Notice of Award (NoA) to show
the transferee as the grantee of record. 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.
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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.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 https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/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 https://www.hhs.gov/ocr/about-us/contact-us/index.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 Successor-in-Interest to Cooperative Agreements will be
subject to the same Cooperative Agreement terms and conditions as the original award.
3. Reporting
When multiple years are involved, awardees will be required
to submit the Research
Performance Progress Report (RPPR) annually and financial statements as
required in the NIH Grants
Policy Statement.
A final RPPR, invention statement, and the expenditure data
portion of the Federal Financial Report are required for closeout of an award,
as described in the NIH
Grants Policy Statement.
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: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Scientific/Research Contact(s)
For any scientific or research-related questions on this Successor-in-Interest
announcement please contact the Program Officer listed on the NoA of the most
recent award.
Peer Review Contact(s)
Not Applicable
Financial/Grants Management Contact(s)
For any financial or grants management questions on this Successor-in-Interest
announcement, please contact the Grants Management Specialist or Grants
Management Officer listed on the NoA of the most recent award.
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
Successor-in-Interest awards are made under appropriate
authorities as referenced in a specific Notice of Award. For reference to
specific authorities, refer to the original funding opportunity announcement
used for the last competing application and/or the most recent Notice of Award.
Department of Health
and Human Services (HHS)
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