Current Issues at NIH
presented at the
SRP Annual Meeting 2015
by
Michelle Victalino
Grants Management Specialist
Lisa A. Edwards
Lead, Grants Management Specialist
George Tucker
Chief, Grants Management Officer
San Juan, PR
November 19, 2015
1
National Institutes of Health • U.S. Department of Health and Human Services
Continuing Resolution
•
NIH is currently funded under the Continuing Appropriations
Act, 2016 (H.R. 719 ) signed by President Obama on September
30, 2015 which funds the government until 12/11/15.
•
Funding is continued at 99.79 percent of the FY2015 level. All
legislative mandates associated with FY2015 remain in effect.
•
Stay tuned for additional guidance
See NOT-OD-16-002
2
National Institutes of Health
U.S. Department of Health and Human Services
Continuing Resolution Fiscal Policy
• Salary Cap – Limited to Executive Level II – set at $183,300.
See NOT-OD-15-049
• NRSA awards -
– Stipends, tuition, fees, and training related expenses will
remain at FY 2015 levels for undergraduate, graduate students
and post-doctorals.
See NOT-OD-15-048
3
National Institutes of Health
U.S. Department of Health and Human Services
Policy Updates
4
National Institutes of Health • U.S. Department of Health and Human Services
NIH Grants Policy Statement
• In keeping with NIH’s annual update of the NIH Grants Policy
Statement, the next revision is scheduled to be issued late
October.
• An out of cycle revision was issued on 3/31/2015 to reflect
NIH’s implementation of HHS regulations implementing
Uniform Guidance.
• The October 2015 NIH Grants Policy Statement incorporates
new and modified requirements, clarifies policies, and
implements changes in statutes, regulations and policies that
have taken place since 3/31/2015.
• The October 2015 will supersede, in its entirety, the 3/31/2015
version as a standard term of award.
5
National Institutes of Health
U.S. Department of Health and Human Services
PMS Subaccounts –Implementation Timeline FY2016
• October 1, 2015 – September 30, 2016
– Competing Awards
• NIH will continue to award all new funding to subaccounts
– Type 3 Awards
• Beginning October 1, 2015, supplements will be awarded to subaccounts.
– Type 5 Awards
• Beginning October 1, 2015, NIH will use an administrative process to
transition all non-competing awards to P subaccounts
• September 30, 2016 – All awards transitioned to subaccounts.
6
National Institutes of Health
U.S. Department of Health and Human Services
PMS Subaccounts – Implementation Requirements
• There will be no change to the due dates, submission, or review
of progress reports for domestic awards for FY 2016.
• NIH will award type 4s to transition funding to subaccounts
• Subaccount Transitional Federal Financial Reports (FFRs)
•Due no later than 90 days after the end of the calendar
quarter in which the budget period ended
•Non-SNAP awards - Equivalent to annual FFR
•SNAP awards – report expenditure data that covers the
project period from the original start date of the competitive
segment through the new project period end date.
•May include unliquidated obligations
•See NOT-OD-15-105
7
National Institutes of Health
U.S. Department of Health and Human Services
Research Training Data Table Formats
• NIH anticipates adopting new research training data table
formats in FY 2016 for use with:
– Institutional training grant applications and;
– Research Performance Progress Reports (RPPRs)
• NIH anticipates releasing the new training table formats by the
end of September 2015, for inclusion in RPPRs submitted
December 1, 2015, or later and applications submitted for the
May 25, 2016, due date and after.
• See NOT-OD-15-112 for more details.
8
National Institutes of Health
U.S. Department of Health and Human Services
Deadline for Final Reports Required for Grant Closeout
• HHS policy requires NIH to initiate unilateral closeout procedures—i.e.,
closeout without receipt of acceptable reports—within 180 days of the
period of performance end date if the grantee has not submitted an
acceptable report for each required final report.
– Final Progress Report (FPR)
– Final Invention Statement and Certification (FIS)
– Final Federal Financial Report (FFR) – must ensure that there are no
discrepancies between the final FFR expenditure data (in eRA
Commons) and the FCTR in the PMS.
• For any grants with a period of performance end date on or after
October 1, 2014, recipients must submit the following documents
within 120 calendar days of the end of the period of performance;
9
National Institutes of Health
U.S. Department of Health and Human Services
Deadline for Final Reports Required for Grant Closeout
• For any grants with a period of performance (project period) end
date prior to October 1, 2014, the reporting deadline will be 90
days of the end of the period of performance.
**Grantees are strongly encouraged to submit other closeout
reports through the Commons**
See NOT-OD-15-111 and NOT-OD-15-136 for more details.
10
National Institutes of Health
U.S. Department of Health and Human Services
OMB Federal Awardee Performance and Integrity
Information System (FAPIIS) Requirement
• FAPIIS is a database for performance data on grantees and
contractors
• FAPIIS is effective:
– For grant awards issued on or after January 1, 2016
– For grant awards that are terminated on or after January 1,
2016
• Applicants and recipients must disclose information.
• Federal awarding agencies must report performance
information and must review FAPIIS before making an award.
• HHS will provide details to NIH.
• Stay tuned for guidance.
11
National Institutes of Health
U.S. Department of Health and Human Services
Clinicaltrials.gov Requirements
• Title VIII of the Food and Drug Administration Amendments Act
of 2007 (FDAAA) requires mandatory registration and reporting
for NIH-funded clinical trials classified as “applicable clinical
trials” ACT.
• NIH is drafting policy to promote broad and responsible
dissemination of information on all clinical trials funded by the
NIH through registration and submission of summary results
information to ClinicalTrials.gov. This Policy is intended to
complement the statutory mandate under (FDAAA).
– See NOT-OD-15-018 and NOT-OD-15-019 for more
information.
12
National Institutes of Health
U.S. Department of Health and Human Services
Memorandum of Understanding (MOU) between NIH
and NSF Concerning Laboratory Animal Welfare
• NIH and NSF operate under a MOU in an effort to:
•
ensures consistent and effective oversight of the welfare of animals used in
activities funded by the NSF;
•
provides a framework to enhance communication and harmonize the agencies'
efforts;
•
reduces regulatory burden to supported institutions
• OLAW will:
•
Negotiate new Assurances for institutions with pending NSF awards;
•
Review and evaluate noncompliance reports and the actions taken involving NSFsupported activities; and
•
Report findings to NSF.
• See NOT-OD-15-139 for more information.
13
National Institutes of Health
U.S. Department of Health and Human Services
Guidance on Qualifications of IACUC Nonscientific and
Nonaffiliated Members
• PHS Policy requires diverse perspectives in the membership of
the IACUC committee. The no fewer than 5 member committee
should include:
– one Doctor of Veterinary Medicine;
– one practicing scientist experienced in research involving
animals;
– one member whose primary concerns are in a nonscientific
area; and
– one individual who is not affiliated with the institution in any
way
• An individual can meet the requirement for both a nonaffiliated
and a nonscientific member as long as they meet the
requirements for each position.
14
National Institutes of Health
U.S. Department of Health and Human Services
Guidance on Qualifications of IACUC Nonscientific and
Nonaffiliated Members
• To meet the intent of this Policy, the:
– nonscientific member - a person without scientific
training.
• (e.g., ethicist, lawyer, and member of the clergy)
– nonaffiliated member must not be:
• a laboratory animal user or former user;
• affiliated with the institution, or;
• an immediate family member of an individual
affiliated with the institution.
See NOT-OD-15-109 for more details.
15
National Institutes of Health
U.S. Department of Health and Human Services
Simplifying/Reinventing NIH’s Grant Application
Instructions
• NIH gathered input from our stakeholders on restructuring of NIH
grant application instructions. RFI closed on September 25, 2015.
• NIH requested comments on streamlined ways for
communicating NIH grant application instructions to applicants in
a more concise, helpful way.
• The goal is reduce administrative burden.
• Stay tuned on details derived from RFI.
16
National Institutes of Health
U.S. Department of Health and Human Services
Enhancing Reproducibility through Rigor and
Transparency
• Scientific rigor - strict application of the scientific method to ensure robust and unbiased experimental
design, methodology, analysis, interpretation and reporting of results that others may reproduce and
extend the findings.
• To ensure that NIH is funding the best science and to enhance reproducibility of research findings
through increased scientific rigor and transparency, NIH plans to:
–
clarify and revise application instructions and review criteria;
• the scientific premise of the proposed research,
• rigorous experimental design for robust and unbiased results,
• consideration of relevant biological variables,
• authentication of key biological and/or chemical resources (not a scored criteria).
–
highlight the need for applicants to describe these previously overlooked details;
–
highlight the need for reviewers to consider these details during the review process;
–
minimize additional burden.
• Updates pending OMB approval will take effect for applications submitted for the January 25, 2016, due date and
beyond.
See NOT-OD-15-103.
17
National Institutes of Health
U.S. Department of Health and Human Services
Informed Consent for Research on Dried Blood Spots
Obtained Through Newborn Screening
• NIH funded research (competing and continuing) using newborn
dried blood spots collected on or after March 18, 2015:
– Will be considered non-exempt human subjects research and must follow the HHS
protection of human subjects regulations at 45 CFR part 46.
– Will have a specific term and condition added to ensure compliance with the new
legislation.
– Must obtain Parental permission. Waiver of parental permission is not permitted.
• This Legislation does not apply to:
– Non-identifiable newborn dried blood spots collected prior to March 18, 2015.
– Research funded solely by state or private entities.
• The HHS Office for Human Research Protections will be issuing
additional guidance on this law in the near future.
• See NOT-OD-15-127
18
National Institutes of Health
U.S. Department of Health and Human Services
Updates to iEdison Regarding Reporting Requirements
and Compliance Messages
• This update to iEdison is intended to alleviate confusion and to assist the
user by ensuring that inventions and patents are not mistakenly
understood to be waived prior to the resolution of outstanding
notification messages.
• iEdison will no longer permit a user to waive title to an invention or patent until all
outstanding compliance issues and notification messages are resolved.
• Examples of actions that need to be taken and Compliance Notification Messages that
an iEdison user may encounter:
• No written description of this invention (Disclosure) has been uploaded into
iEdison;
• A Government Support Clause is missing (or not accepted) for a non-provisional
patent filing;
• The submitted Confirmatory License is missing (or not accepted) for a nonprovisional patent filing;
• Grantees must report inventions electronically through iEdison
• See NOT-OD-15-080 and NOT-OD-15-119 for more details.
19
National Institutes of Health
U.S. Department of Health and Human Services
NIH Requirement for Federal Recognition of Same-Sex
Spouses/Marriages by Grant and Research and
Development Contract Recipients
• In light of the United States v. Windsor (June 26, 2013) ruling, all NIH grant
programs and research and development (R&D) contract programs now
interpret the terms “spouse” and “marriage” to include same-sex
spouses/marriages.
• Under this policy, a same-sex relationship between two individuals is
recognized as a marriage if:
– (1) the state or other jurisdiction, whether foreign or domestic, where the
couple was married recognizes the marriage under its laws or;
– (2) the state or other jurisdiction where the couple currently resides
recognizes the relationship as a legally valid marriage.
See NOT-OD-15-051.
20
National Institutes of Health
U.S. Department of Health and Human Services
Policy Reminders
21
National Institutes of Health • U.S. Department of Health and Human Services
Progress Reports
• Progress report due dates: Failure to submit complete and timely
progress reports may affect future funding to the organization
– Non-SNAP annual progress reports are due the 1st of the month preceding the month in
which the budget period ends
– SNAP progress reports are due the 15th of the month preceding the month in which the
budget ends
– Multi-year funded progress reports due on the anniversary of the budget/project period
start date of the award (electronic submission RPPR only)
• Annual progress reports submitted in any format other than the RPPR
will not be processed by the NIH and will require resubmission through
the RPPR
• Searchable list to determine which progress reports are due:
https://public.era.nih.gov/chl/public/search/progressReportByIpf.era
• More informaiton at NOT-OD-15-014
22
National Institutes of Health
U.S. Department of Health and Human Services
NIH/AHRQ Policy for Application Submission
• NIH and AHRQ announced a change in policy on application submissions.
• Following an unsuccessful resubmission (A1) application, applicants may
submit the same idea as a new (A0) application for the next appropriate due
date.
• The NIH and AHRQ will not assess the similarity of the science in the new (A0)
application to any previously reviewed submission when accepting an
application for review.
• Although a new (A0) application does not allow an introduction or responses
to the previous reviews, the NIH and AHRQ encourage applicants to refine and
strengthen all application submissions.
• A New Application that does not conform to the rules for a New Application
will not be reviewed and will not be considered for funding.
More at NOT-OD-15-059
23
National Institutes of Health
U.S. Department of Health and Human Services
Biographical Sketch
• NIH, in collaboration with AHRQ, requires the use of the new format for
applications submitted for due dates on or after May 25, 2015.
• The revised forms and instructions are available and adjustments have been
made to improve their usability. The following are some of the features of the
new format;
• Extends the page limit from four to five pages
• Investigators can outline the central findings of prior work and the influence
of those findings on the investigator’s field work
• Investigators involved in Team Science are provided the opportunity to
describe their specific role(s) in the work
See NOT-OD-15-085 for additional information
24
National Institutes of Health
U.S. Department of Health and Human Services
Publication Reporting Instructions for RPPRs and
Renewal Applications
• In order to reduce the burden of unnecessary reporting, NIH has clarified that
trainee, scholar, and participant publications must be reported in section C.1
of the RPPR if:
– the publication was accepted for publication or published during the
reporting period; and
– the publication resulted from work conducted while the individual was
supported by the award (i.e., receiving a stipend or salary from the
award).
• Publications resulting from work conducted while not actively supported by
the institutional training, career development, or related award should not be
reported in section C.1.
See NOT-OD-15-091 for details
25
National Institutes of Health
U.S. Department of Health and Human Services
NIH Implementation of Dual Use Research of Concern
(DURC)
• Policy for Institutional Oversight of Life Sciences Dual Use
Research of Concern issued on September 24, 2014
– Applied to all New and Renewal awards issued on
applications submitted on or after January 25, 2015, and to
all non-competing continuation awards issued on or after
January 25, 2015.
– Institutions had one year (until September 24, 2015) to
establish the necessary infrastructure to come into full
compliance with this policy.
• See NOT-OD-15-017 for more information.
26
National Institutes of Health
U.S. Department of Health and Human Services
Genomic Data Sharing Policy
• Reminder that the NIH Genomic Data Sharing Policy became
effective with NIH grant applications submitted for January 25,
2015, due dates and thereafter.
• The new GDS Policy promotes sharing of large scale genomic
data generated by NIH research.
– Includes human, non-human, and model organism data
See NOT-OD-15-027 for reminder.
27
National Institutes of Health
U.S. Department of Health and Human Services
SBIR/STTR Due Dates
• NIH’s standard due dates for SBIR and STTR programs
changed in response to small business community feedback,
congressional mandates, and recommendations from the NIH
Scientific Management Review Board to decrease delays
between submission and award funding.
• Standard due dates: September 5, January 5, and April 5.
See NOT-OD-15-038 for additional information.
28
National Institutes of Health
U.S. Department of Health and Human Services
Audit Requirements
• NIH Recipients (excluding For-Profit) that expend $750,000 or
more within a year in Federal awards are subject to an audit
requirement.
• Applicable to Non-Federal Entity Fiscal Years Beginning
on or after 12/26/2014
• For-profit organizations that expend $750,000 or more within
a year in HHS awards (as a direct recipient and/or under a
consortium participant) are subject to an audit requirement.
• Audits are due within the earlier of 30 days after receipt of the
auditor’s report(s) or 9 months after the end of the grantee’s
audit period.
• Grantees delinquent in submitting audits risk the imposition of
sanctions and potential loss of Federal funds
29
National Institutes of Health
U.S. Department of Health and Human Services
Summary of Uniform Guidance Audit Requirement Changes
.
Recipient
Type
Summary of Audit Requirements
Source of Audit
Source of Audit
Requirement (NonRequirement (NonFederal Entity Fiscal Years Federal Entity Fiscal Years
Beginning Prior to
Beginning On/After
12/26/2014)
12/26/2014)
Where to Submit Audit
Reports
State & Local
Governments
OMB Circular A-133
45 CFR 75.501
Federal Audit Clearinghouse
(See contact information in NIH GPS Part
III)
Institutions of Higher
Education
OMB Circular A-133
45 CFR 75.501
Federal Audit Clearinghouse
(See contact information in NIH GPS Part
III)
Non-Profits, including
non-profit hospitals
OMB Circular A-133
45 CFR 75.501
Federal Audit Clearinghouse
(See contact information in NIH GPS Part
III)
For-Profits, including
for-profit hospitals
45 CFR 74.26(d)
45 CFR 75.501(h) through
75.501(k) and 45 CFR 75.215
National External Audit Review Center
(See contact information in NIH GPS Part
III)
Foreign Organizations
NIH Grants Policy Statement
(same as For-Profits)
NIH Grants Policy
Statement (same as For-Profits)
National External Audit Review Center
(same as For-Profits, see contact
National Institutes of Health
information
in NIH GPS
Part III)
U.S. Department of Health and Human Services
30
Delays in Grant Application Submission due to Severe
Weather and Natural Disasters
• NIH will consider accepting late applications, on a case-by-case
basis, under the following circumstances:
– Applications must be submitted as soon as possible after the applicant
organization/institution re-opens, not to exceed the number of days the
applicant organization was officially closed.
– A cover letter must be submitted with the application, with enough detail
about the delay so that NIH staff can make a determination whether
circumstances justify accepting the application late.
• See NOT-OD-15-108 for additional information.
31
National Institutes of Health
U.S. Department of Health and Human Services
Requirements and
Compliance Assistance
for OHRP and OLAW
32
National Institutes of Health • U.S. Department of Health and Human Services
News from the Office for Human Research
Protections
• International Compilation of Human Research Standards
– Office for Human Research Protections International Activities:
• Ensure that human subjects outside of the United States who participate
in research projects conducted or funded by DHHS receive the same level
of protections as research participants inside the United States.
• Offer consultation services
• Disseminate pertinent reports
• Provide research ethics training
Now Available at http://www.hhs.gov/ohrp/international/index.html
More at: http://www.hhs.gov/ohrp/newsroom/index.html
33
National Institutes of Health
U.S. Department of Health and Human Services
Office of Laboratory Animal Welfare (OLAW) http://
•
OLAW’s mission is to ensure the humane care and use of
animals in PHS-supported research, testing, and training,
thereby contributing to the quality of research
OLAW provides
• Guidance & interpretation of the PHS Policy
• Support of educational programs
• Monitoring of compliance with the PHS Policy
by Assured institutions and PHS funding components
•
34
National Institutes of Health
U.S. Department of Health and Human Services
Update to the PHS Policy
• The FY 15 Revised PHS Policy on Humane Care and Use of
Laboratory Animals has been updated to reflect:
• Implementation of the 2013 Edition of the AVMA Guidelines
for the Euthanasia of Animals
• Adoption of the 8th Edition of the Guide
• Modification to footnotes requiring
compliance with USDA regulations
as applicable
• Minor editorial changes
• Changes in OLAW’s contact information
• See NOT-OD-15-079
35
National Institutes of Health
U.S. Department of Health and Human Services
OLAW Educational Outreach
•
•
36
OLAW free quarterly webinars series
http://grants.nih.gov/grants/olaw/e-seminars.htm
• Recordings of past webinars
http://grants.nih.gov/grants/olaw/educational_resources
.htm
Disaster planning resources
http://grants.nih.gov/grants/olaw/disaster_planning.htm
• Disaster planning webinar & FAQ
National Institutes of Health
U.S. Department of Health and Human Services
OLAW-supported Workshops, Conferences and
Educational Outreach
• IACUC 101 Series Workshops
• March 30, 2016 – Bellevue, WA
• SCAW Workshops & Conferences
• December 7-8, 2015 – San Antonio, TX
• December 5-6, 2016 – San Antonio, TX
• USDA AWIC Workshops
• October 28-29, 2015 – Beltsville, MD
• March 9-10, 2016 – Beltsville, MD
http://grants.nih.gov/grants/olaw/workshop.htm
37
National Institutes of Health
U.S. Department of Health and Human Services
Electronic Post Award
Administration
38
National Institutes of Health • U.S. Department of Health and Human Services
My NCBI
• My NCBI ensures compliance with NIH Public Access Policy
– On-line portal linked to Commons account
– Maintains list of all authored papers
39
National Institutes of Health
U.S. Department of Health and Human Services
Electronic Submission
& eRA Commons
40
National Institutes of Health • U.S. Department of Health and Human Services
Application Submission System & Interface for
Submission Tracking (ASSIST)
• NIH’s solution to submitting multi-project grants electronically.
• NIH’s ASSIST available as a submission option
– Available for all multi-project programs
– Support has expanded to single-project programs and will be available for
all single-project programs by the end of December 2015
• Use of ASSIST -- optional
– Grants.gov downloadable forms and institutional system-to-system
solutions remain viable options for application preparation and
submission to NIH
See NOT-OD-15-156 for more information.
41
National Institutes of Health
U.S. Department of Health and Human Services
Tips for E-submission Success
• Register Early!
– Registration with both Grants.gov (organizations only) and eRA
Commons (organizations & PD/PIs); must be completed before
the submission deadline
– Allow at least 6 weeks to complete new registrations (Foreign
organizations at least 8 weeks)
42
National Institutes of Health
U.S. Department of Health and Human Services
Tips for E-submission Success
• Update Update Update
– System for Award Management (SAM) information must be
updated at least every 12 months to remain active.
https://www.sam.gov/portal/public/SAM
43
National Institutes of Health
U.S. Department of Health and Human Services
Tips for e-Submission Success
• Remember to use the latest forms and application guide available
for your Funding Opportunity Announcement (FOA).
– Identify form version by Competition ID
– Revised Forms-C Application Guide posted 11/25/2014
– Forms-C+ Application Guide will be posted 11/2015 for use
with January 25th, 2016 deadlines.
– Instructions in the FOA supersede those in the Application
Guide
– March 2016 NIH plans to transition to FORMS D.
• Learn more about choosing the correct forms packages at:
http://grants.nih.gov/grants/ElectronicReceipt/files/right_forms.pdf
44
National Institutes of Health
U.S. Department of Health and Human Services
Tips for E-submission Success
• Check the application for common errors before submitting
– http://grants.nih.gov/grants/ElectronicReceipt/avoiding_erro
rs.htm
• Correct any errors before the application due date
– If errors are found, a changed/corrected application must be
submitted before the due date
• Submit early!
– Think days, not hours or minutes before deadline
45
National Institutes of Health
U.S. Department of Health and Human Services
Tips for E-submission Success
• View your application in Commons
– Verify that the error-free application is viewable in the eRA
Commons and correctly reflects the intended submission
– If you can’t VIEW it, NIH can’t REVIEW it!
46
National Institutes of Health
U.S. Department of Health and Human Services
Helpful NIH Resources
47
National Institutes of Health • U.S. Department of Health and Human Services
RPPR Resources
 RPPR Webpage: http://grants.nih.gov/grants/rppr/
 Includes links to
RPPR Application Guide
RPPR Guide Notices
Frequently Asked Questions
Training
Contacts
48
National Institutes of Health
U.S. Department of Health and Human Services
Webinars for New Applicants and Grant Administrators:
What you need to know about NIH Application
Submission and Review
Webinar Focus
Date
University Research Administrators
November 5, 2015
Research Project Grants (R01)
November 6, 2016
Viewers Will See Presentations by Five CSR/NIH Experts
• The Review of Your NIH Grant Application Begins Here
• What You Need to Know about Application Receipt and Referral
• How Your Application Is Reviewed
• Key Things to Know About the NIH Grants Program
• Jumpstart Your Career with CSR’s Early Career Reviewer
Program (R01 webinar only)
See NOT-OD-15-154
49
National Institutes of Health
U.S. Department of Health and Human Services
eRA Training: Video Tutorials
• The following categories of video tutorials are offered by eRA:
– eRA Commons: Features and Functions You Need to Know
– Institution Registration and Account Creation
– Understanding Status
– For Reviewers: Navigating Internet Assisted Review (IAR)
http://era.nih.gov/era_training/era_videos.cfm
50
National Institutes of Health
U.S. Department of Health and Human Services
Frequently Asked Questions
•
FAQs –searchable websites for:
•Application/progress report preparation, funding initiatives,
policies, human subjects, animals, disaster response, PMS
Subaccounts, Core Facilities, etc…
•http://grants.nih.gov/grants/frequent_questions.htm
51
National Institutes of Health
U.S. Department of Health and Human Services
Search NIH Funding
• Research Portfolio Online Reporting Tools (RePORT)
http://report.nih.gov
•Access to reports, data and analysis of NIH research activities
•Quick links to “Frequently Requested Reports,” FAQs.
• RePORT EXPENDITURES & RESULTS (RePORTER)
http://projectreporter.nih.gov/reporter.cfm
•Search information from NIH project databases and funding
records, PubMed abstracts and full-text articles, and
invention reporting (iEdison, Interagency Edison);
52
National Institutes of Health
U.S. Department of Health and Human Services
Summary of Helpful NIH Web Pages
• Office of Extramural Research (OER) Web Page
http://grants.nih.gov/grants/oer.htm
• NIH Grants Policy Statement (Rev. 10/15)
• http://grants.nih.gov/grants/policy/nihgps/
• NIH Extramural Nexus – newsletter for the extramural
community
http://nexus.od.nih.gov/all/nexus-by-date/
• Grant Application Basics
http://grants.nih.gov/grants/grant_basics.htm
53
National Institutes of Health
U.S. Department of Health and Human Services
Summary of Helpful NIH Web Pages
• Applying Electronically
http://grants.nih.gov/grants/ElectronicReceipt/index.htm
• Annotated SF424 (R&R) Application Forms (General and Small
Business and Multi-project)
• http://grants.nih.gov/grants/ElectronicReceipt/communication.ht
m#forms
• Ten Checks to Help Avoid Common Application Errors
http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm
#10checks
• Do I have the right electronic forms for my NIH application?
http://grants.nih.gov/grants/ElectronicReceipt/files/right_forms.pdf
54
National Institutes of Health
U.S. Department of Health and Human Services
Summary of Helpful NIH Web Pages
• NIH Extramural Response to Natural Disasters:
http://grants.nih.gov/grants/natural_disasters.htm
• eRA Commons Web pages: http://era.nih.gov/
• eRA Commons User Guides:
http://era.nih.gov/commons/user_guide.cfm
• Updated (7-15-2015) Commons User Guide:
http://era.nih.gov/Docs/COM_UGV2630.pdf
• Self Help Resources page:
http://grants.nih.gov/support/index.html
• Intellectual Property Policy: http://grants.nih.gov/grants/intellproperty.htm
55
National Institutes of Health
U.S. Department of Health and Human Services
NIH OER Listservs
• NIH Guide for Grants and Contracts:
– Official publication for NIH Grant Policies, Guidelines & Funding
Opportunities
– http://grants.nih.gov/grants/guide/listserv.htm
• Office for Human Research Protections (OHRP):
– Office for Human Research Protections (OHRP)
• Office of Laboratory Animal Welfare (OLAW):
– http://grants.nih.gov/grants/olaw/references/list.htm
• eSubmission:
– Separate listservs available for scientists and administrators
– http://grants.nih.gov/grants/ElectronicReceipt/listserv.htm
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National Institutes of Health
U.S. Department of Health and Human Services
Grants Information: Who to Contact!
• General Application Questions:
• E-Mail: GrantsInfo@nih.gov
• Phone: 301-435-0714
• Grants.gov Customer Support:
• E-Mail: support@grants.gov
• Webpage: http://grants.gov/
• Phone: 800-518-4726
• eRA Service Desk (formerly eRA Commons Helpdesk):
• Web: http://era.nih.gov/help/
• Toll-free: 1-866-504-9552
• Phone: 301-402-7469
• Hours: Mon-Fri, 7a.m. to 8 p.m. Eastern Time
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National Institutes of Health
U.S. Department of Health and Human Services
Grants Information: Who to Contact (cont’d)
• Division of Grants Policy:
• E-Mail: GrantsPolicy@mail.nih.gov
• Phone: 301-435-0949
• Division of Grants Compliance & Oversight:
• E-Mail: GrantsCompliance@mail.nih.gov
• Phone: 301-435-0949
• Division of Extramural Inventions and Technology Resources
• E-Mail: Edison@nih.gov
• Phone: 301-435-0679
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National Institutes of Health
U.S. Department of Health and Human Services
Questions ??
59
National Institutes of Health • U.S. Department of Health and Human Services
Carryover Requests
National Institutes of Health • U.S. Department of Health and Human Services
What is Carryover?
Carryover is forwarding an unobligated balance of funds from the prior budget
period to cover allowable costs in the current budget year. A carryover must be
requested in support of activities aligned with a grantee’s existing project goals
and objectives to cover costs not already incurred by the recipient.
Unobligated Balance is the amount indicated on the Federal Financial Report
(FFR) that represents funds the grantee institution was awarded but has not
obligated (spent).
– The amount listed as “unobligated funds” on the FFR should include any
funds that remain restricted from use in prior years/budget periods. This is
a cumulative amount and should never decrease unless there has been an
authorized carryover or partial payment (offset).
National Institutes of Health
U.S. Department of Health and Human Services
Due Dates for SRP Program
• April 1
• BUDGET START DATE
• June 30
• FFR Due - 90 days following the calendar
quarter end of the previous budget end date
• August 15
• Carryover Requests due – by August 15 to
streamline our review of carryover
submissions.
• Oct. 1
• NIH next fiscal year begins
• February 1
• RPPR Progress Report Due - 60 days prior to
Budget End Date
• March 31
• BUDGET END DATE
National Institutes of Health
U.S. Department of Health and Human Services
Prior Approval for Carryover of Unobligated Balances
The Superfund Research Program P42 grants do not have automatic carryover
authority. Therefore, grantees are required to submit a written prior approval
request for authorization to carryover unobligated funds.
A Federal Financial Report must be received and approved by NIH (Office of
Financial Management) prior to a request for Carryover of unobligated funds
and before SRP Grants Management and Program Staff can begin to process
your carryover request.
A Federal Financial Report (FFR) is a statement of expenditures associated with
a grant. Recipients of federal funds are required to report the status of funds
for grants or assistance agreements to the sponsor of the grant using the
Federal Financial Report expenditure data. Your Federal Financial Report (FFR)
is due by your institutional business office to NIH (via eRA Commons) on or
before June 30.
NIH Grants Policy - 8.1.2.4 Carryover of Unobligated Balances
http://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.1_changes_in_project_and
National Institutes of Health
_budget.htm#Carryove
U.S. Department of Health and Human Services
Carryover Requests should include:
A Grant Number.
The total amount of funds requested for carryover.
The exact total of the Direct Costs requested.
The exact total of the Indirect Costs requested. The F&A rate utilized is the
rate that was in effect when we first awarded funds for the year to which
you would like to carryover funds. For example, if we approve carryover
from year 1 to year 2, the F&A rate we use to calculate the revised year 2
award is the one we used to initially calculate year 2 funds. Indicate base
exclusions.
The detailed budget should include personnel names and calendar month
effort.
Authorized Organization Representative name, title and email address. The
carryover request should be submitted via the AOR.
National Institutes of Health
U.S. Department of Health and Human Services
Carryover Requests should include:
A cover letter including the reason that the funds requested for carryover
were not expended in the year they were awarded and a plan for the use of
the carryover funds, including a description of activities and materials to be
supported, countersigned by the institutional business official.
Submit the budget and budget justification in the following format:
Table 1: “Unobligated Balance Analysis” and Table 2 “Proposed Budget
for Carryover of Unobligated Balance”.
http://www.niehs.nih.gov/research/supported/dert/programs/srp/resou
rces/index.cfm
Or
A detailed budget and budget justification pages in a format such as that
found in the PHS398 or SF424. A separate budget and budget
justification should be provided for any requested consortium expenses.
Provide a Composite Budget page.
National Institutes of Health
U.S. Department of Health and Human Services
Carryover Justification
Grantees should answer the following questions when preparing a justification for
a carryover request.
Why were the funds not spent in the past year?
Is the carryover request essential? Are costs reasonable, allowable, necessary
and in line with the existing budget? How will the work be impacted if the funds
are not carried over?
What additional work will be done during the current grant year that is not
possible with the budget currently allotted to this year? How will the work be
accelerated? Will more staff be hired, effort increased?
Did we provide detailed information in our request for carryover per
project/core/category?
National Institutes of Health
U.S. Department of Health and Human Services
Why are Carryover Requests Rejected?
o The prior year Federal Financial Report (FFR) must be received and approved by
NIH, to verify that funds are available to carryover. Any delay in the FFR may
cause a delay in the carryover request.
o The request was not signed by an Authorized Organization Representative.
o The requested costs duplicate costs in the current year’s award (i.e. requesting
salary for personnel already at 12 months effort in the current award).
o Questionable costs and insufficient justification.
o Requests that are submitted late in a budget period may be rejected if it is
unreasonable to expect that you can expend those funds before the budget
period ends (i.e. requests for travel to meetings that occur in a future budget
period).
o All carryover requests must be within the currently approved scope. For
example, adding a project that includes animals for a grant that never had
animal subjects previously is an unallowable use of carryover funds.
National Institutes of Health
U.S. Department of Health and Human Services
Tips for a Successful Carryover Request
 Work with your business offices to get the FFR in and approved quickly.
Write a thorough justification (e.g. – “travel for conferences”- who’s going
where and how is this different from your current budget?)
 Any budget requests for items that were previously requested in the current
year’s application will be considered unallowable. Check your request against
the budget in your last progress report, to avoid duplication (e.g. – effort levels
shouldn’t add up to 14 months in a year).
Carryover requests should only reflect immediate needs. The justification
should explain why this is an immediate need and why this cannot be
rebudgeted out of your current year’s award. For example, requesting salary for
a “TBN” position is typically seen as not addressing an immediate need because
you have not identified who will be filling those slots. The justification should
address how these positions will be filled.
 Carryover funds are intended to cover only prospective costs, not costs already
incurred by the recipient.
 Send it in earlier! It’s harder to justify that you can spend funds in the current
budget period when there’s only a month left.
National Institutes of Health
U.S. Department of Health and Human Services