Current Issues at NIH

Shellie WilburnDivision Director for Grants Policy

Offi ce of Policy for Extramural Research Administration

NIH Regionals October 14-16, 2015

1

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

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

Policy Updates

4

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

PMS Subaccounts –Implementation Timeline

FY2016October 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

PMS Subaccounts – Implementation Requirements

• There will be no change to the due dates, submission, or review of progress reports for domestic awards for FY 2015.

• 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

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

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;

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.

9

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.

10

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.

11

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 NSF-supported activities; and

• Report findings to NSF.

See NOT-OD-15-139 for more information.

12

Guidance on Qualifications of IACUCNonscientific and Nonaffiliated

MembersPHS 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.

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.

13

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.

14

Enhancing Reproducibility through Rigor and

TransparencyScientific 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.

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See NOT-OD-15-103.

INFORMED CONSENT FOR RESEARCH ON DRIED BLOOD SPOTS OBTAINED THROUGH NEWBORN

SCREENINGNIH 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

16

Updates to iEdison Regarding Reporting Requirements and

Compliance MessagesThis 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 non-provisional patent filing;

Grantees must report inventions electronically through iEdisonSee NOT-OD-15-080 and NOT-OD-15-119 for more details.

17

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.

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Policy Reminders

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Progress ReportsProgress 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

20

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

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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

22

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

23

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.

24

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.

25

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.

26

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

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Summary of Uniform Guidance Audit Requirement Changes

Summary of Audit Requirements

Recipient Type

Source of Audit Requirement (Non-

Federal Entity Fiscal Years Beginning Prior

to 12/26/2014)

Source of Audit Requirement (Non-

Federal Entity Fiscal Years Beginning

On/After 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 information in NIH GPS Part III)

.

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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.

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Requirements and Compliance Assistance

for OHRP and OLAW

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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

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• 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

Office of Laboratory Animal Welfare (OLAW) HTTP://

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Update to the PHS PolicyThe 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

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• OLAW free quarterly webinars serieshttp://grants.nih.gov/grants/olaw/e-seminars.htm

• Recordings of past webinarshttp://grants.nih.gov/grants/olaw/educational_resources.htm

• Disaster planning resourceshttp://grants.nih.gov/grants/olaw/disaster_planning.htm

• Disaster planning webinar & FAQ

OLAW Educational Outreach

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http://grants.nih.gov/grants/olaw/workshop.htm

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

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Electronic Post Award Administration

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My NCBIMy NCBI ensures compliance with NIH Public Access Policy

•On-line portal linked to Commons account•Maintains list of all authored papers

 

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Electronic Submission & eRA Commons

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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.

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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)

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•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

Tips for E-submission Success

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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.    

42

Tips for E-submission Success

•Check the application for common errors before submitting

• http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.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 43

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!

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Helpful NIH Resources

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RPPR RESOURCES

RPPR Webpage: http://grants.nih.gov/grants/rppr/ Includes links to

RPPR Application Guide RPPR Guide Notices Frequently Asked Questions Training Contacts

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WEBINARS FOR NEW APPLICANTS AND GRANT ADMINISTRATORS:

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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

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

eRA Training: Video Tutorials

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• 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

Frequently Asked Questions

49

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);

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Summary of Helpful NIH Web Pages

•Office of Extramural Research (OER) Web Pagehttp://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 communityhttp://nexus.od.nih.gov/all/nexus-by-date/

•Grant Application Basics http://grants.nih.gov/grants/grant_basics.htm

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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.htm#forms

• Ten Checks to Help Avoid Common Application Errorshttp://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

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Summary of Helpful NIH Web Pages

• NIH Extramural Response to Natural Disastershttp://grants.nih.gov/grants/natural_disasters.htm

• eRA Commons Web pageshttp://era.nih.gov/

• eRA Commons User Guideshttp://era.nih.gov/commons/user_guide.cfm

• Updated (7-15-2015) Commons User Guidehttp://era.nih.gov/Docs/COM_UGV2630.pdf

• Self Help Resources page:http://grants.nih.gov/support/index.html

• Intellectual Property Policyhttp://grants.nih.gov/grants/intell-property.htm

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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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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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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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Questions ??

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