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March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health

March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

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Page 1: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

March 31, 2015Crystal Wolfrey

Director, Office of Grants AdministrationNational Cancer Institute

Nat

iona

l Can

cer

Inst

itut

e

US DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Page 2: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National
Page 3: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

OGA Organization

Page 4: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

Institution Grants SpecialistALBERT EINSTEIN COL OF MED YESHIVA UNIV Debra SowellBAYLOR COLLEGE OF MEDICINE Bryann BentonCASE WESTERN RESERVE UNIVERSITY Amy KnightCITY OF HOPE/BECKMAN RESEARCH INSTITUTE Silvia TorresCOLD SPRING HARBOR LABORATORY Renee CarruthersCOLUMBIA UNIVERSITY HEALTH SCIENCES Jackie BoudjedaDANA-FARBER CANCER INSTITUTE Becky Brightful

DARTMOUTH COLLEGE Kimery Griffin

DUKE UNIVERSITY Rosemary Ward

EMORY UNIVERSITY Maricela TrujilloFRED HUTCHINSON CANCER RESEARCH CENTER Samantha Farrell

GEORGETOWN UNIVERSITYMartinson OwusuH. LEE MOFFITT CANCER CTR & RES INST Nick MitranoINDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS Esther Young

JACKSON LABORATORY Sarah LeeJOHNS HOPKINS UNIVERSITY Jackie BoudjedaMASSACHUSETTS INSTITUTE OF TECHNOLOGY Joy Kearse

MAYO CLINIC Arina KramerMEDICAL UNIVERSITY OF SOUTH CAROLINA Tracie McGraw

Institution Grants SpecialistNEW YORK UNIVERSITY SCHOOL OF MEDICINE Amy KnightNORTHWESTERN UNIVERSITY AT CHICAGO Barbara Liesenfeld

OHIO STATE UNIVERSITY Martinson OwusuOREGON HEALTH AND SCIENCE UNIVERSITY Barbara LiesenfeldPURDUE UNIVERSITY WEST LAFAYETTE Renee CarruthersRBHS - CANCER INSTITUTE OF NEW JERSEY Jennifer EdwardsRESEARCH INST OF FOX CHASE CAN CTR Emily TranROSWELL PARK CANCER INSTITUTE CORP Jennifer MeiningerSALK INSTITUTE FOR BIOLOGICAL STUDIES Jackie BoudjedaSANFORD-BURNHAM MEDICAL RESEARCH INSTIT Barbara FisherSLOAN-KETTERING INSTITUTE FOR CANCER RES Funmi ElesinmogunST. JUDE CHILDREN'S RESEARCH HOSPITAL Esther Young

STANFORD UNIVERSITY Aida VasquezTHOMAS JEFFERSON UNIVERSITY Joy Kearse

UNIV OF TX HSC, SA Funmi ElesinmogunUNIVERSITY OF ALABAMA AT BIRMINGHAM Esther Young

UNIVERSITY OF ARIZONA Aida VasquezUNIVERSITY OF CALIFORNIA San Diego Connie MurphyUNIVERSITY OF CALIFORNIA DAVIS Kelly Fritz

Page 5: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

Institution Grants SpecialistUNIVERSITY OF CALIFORNIA IRVINE Silvia Torres

UNIVERSITY OF CALIFORNIA LOS ANGELESKelly Fritz

UNIVERSITY OF CALIFORNIA SAN FRANCISCO Jennifer Meininger

UNIVERSITY OF CHICAGO Debra Sowell

UNIVERSITY OF COLORADO DENVER Debra Sowell

UNIVERSITY OF HAWAII AT MANOA Becky Brightful

UNIVERSITY OF IOWA Joy Kearse

UNIVERSITY OF KANSAS MEDICAL CENTER Amy Knight

UNIVERSITY OF KENTUCKY Romy Reis

UNIVERSITY OF MARYLAND BALTIMORE Rosemary Ward

UNIVERSITY OF MICHIGAN AT ANN ARBOR Emily TranUNIVERSITY OF MINNESOTA Renee Carruthers

UNIVERSITY OF NEBRASKA MEDICAL CENTER Brian Iglesias

UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR Kelly Fritz

UNIVERSITY OF NORTH CAROLINA CHAPEL HILL Barbara Fritz

Institution Grants SpecialistUNIVERSITY OF PENNSYLVANIA Kimery Griffin

UNIVERSITY OF PITTSBURGH AT PITTSBURGH Samantha Farrell

UNIVERSITY OF SOUTHERN CALIFORNIA Tracie McGraw

UNIVERSITY OF TEXAS SW MED CTR Alice Wong

UNIVERSITY OF UTAH Joy Kearse

UNIVERSITY OF VIRGINIA Kimery Griffin

UNIVERSITY OF WISCONSIN MADISON Leslie Hickman

UT MD ANDERSON CANCER CTR Leslie Hickman

VANDERBILT UNIVERSITY Romy Reis

VIRGINIA COMMONWEALTH UNIVERSITY Rosemary Ward

WAKE FOREST UNIVERSITY HEALTH SCIENCES Becky Brightful

WASHINGTON UNIVERSITY Silvia Torres

WAYNE STATE UNIVERSITY Connie Murphy

WISTAR INSTITUTE Bryann Benton

YALE UNIVERSITY Arina Kramer

Page 6: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National
Page 7: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

Mechanism AmountResearch Project Grants 2,012,560R&D Contracts 652,283Buildings and Facilities 8,000Groups 271,635Other Research 158,411Training 69,217Intramural 845,075Research Management & Support 371,350Centers 543,839

Total$4,932,37

0

Page 8: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

P30 CORE GRANTS BY DOLLARS (FY14)

Run Date: Mar 23rd, 2015

Rank by

$ Center Institution

Total

Count by

NCI (P30)

Total

Awarded

by NCI

(P30)

Total

Count by

NCI (All

Grants)

Total

Awarded by

NCI (All

Grants)

1 SLOAN-KETTERING INST CAN RESEARCH 1 12,543,138 127 72,740,502

2 DANA-FARBER CANCER INST 1 11,033,991 127 78,451,654

3 UNIVERSITY OF TX MD ANDERSON CAN CTR 1 10,481,108 173 90,804,059

4 FRED HUTCHINSON CANCER RESEARCH CENTER 1 10,313,826 118 91,445,883

5 UNIVERSITY OF PENNSYLVANIA 1 7,814,026 147 59,601,131

6 JOHNS HOPKINS UNIVERSITY 1 7,575,009 144 69,814,718

7 UNIVERSITY OF CALIFORNIA, SAN FRANCISCO 1 7,565,595 166 72,879,755

8 UNIV OF NORTH CAROLINA CHAPEL HILL 1 7,191,236 120 52,306,352

9 UNIVERSITY OF MICHIGAN 1 6,349,946 117 54,650,446

10 UNIVERSITY OF SOUTHERN CALIFORNIA 1 6,289,895 55 32,870,894

11 VANDERBILT UNIVERSITY 1 6,196,112 137 63,411,306

12 ST. JUDE CHILDREN'S RESEARCH HOSPITAL 1 5,840,603 28 21,377,684

13 DUKE UNIVERSITY 1 5,836,521 82 34,466,685

14 MAYO CLINIC ROCHESTER 1 5,613,500 96 58,786,566

15 UNIVERSITY OF ALABAMA AT BIRMINGHAM 1 5,541,279 53 24,602,090

16 CASE WESTERN RESERVE UNIVERSITY 1 5,204,824 48 22,298,010

17 UNIVERSITY OF PITTSBURGH AT PITTSBURGH 1 5,168,310 96 49,684,170

18 UNIVERSITY OF CALIFORNIA LOS ANGELES 1 4,996,042 73 43,455,017

19 OHIO STATE UNIVERSITY 1 4,929,906 88 45,033,755

20 NORTHWESTERN UNIVERSITY AT CHICAGO 1 4,909,844 71 26,722,103

21 UNIVERSITY OF WISCONSIN-MADISON 1 4,768,387 65 25,484,368

22 COLD SPRING HARBOR LABORATORY 1 4,608,416 17 14,237,490

23 UNIVERSITY OF CHICAGO 1 4,491,307 58 23,467,902

24 RESEARCH INST OF FOX CHASE CAN CTR 1 4,443,687 29 14,605,013

25 WASHINGTON UNIVERSITY 1 4,374,022 97 41,491,411

26 UNIVERSITY OF CALIFORNIA SAN DIEGO 1 4,334,009 73 32,073,900

27 ROSWELL PARK CANCER INSTITUTE CORP 1 4,221,135 41 21,468,771

28 COLUMBIA UNIVERSITY HEALTH SCIENCES 1 4,166,904 72 35,592,740

29 SANFORD-BURNHAM MEDICAL RESEARCH INSTIT 1 3,990,822 37 18,692,547

30 UNIVERSITY OF ARIZONA 1 3,960,199 34 17,153,598

31 ALBERT EINSTEIN COLLEGE OF MEDICINE 1 3,808,748 43 21,672,159

32 UNIVERSITY OF COLORADO DENVER 1 3,761,683 67 23,159,114

33 MASSACHUSETTS INSTITUTE OF TECHNOLOGY 1 3,738,697 41 22,421,972

34 UNIVERSITY OF CALIFORNIA AT DAVIS 1 3,428,938 46 18,413,289

35 STANFORD UNIVERSITY 1 3,396,915 126 55,049,282

36 UNIVERSITY OF MINNESOTA 1 3,366,367 83 31,248,600

37 YALE UNIVERSITY 1 3,280,007 74 27,609,332

38 BAYLOR COLLEGE OF MEDICINE 1 3,222,022 67 31,842,999

39 H. LEE MOFFITT CANCER CTR & RES INST 1 3,189,785 57 26,578,249

40 DARTMOUTH COLLEGE 1 3,183,736 40 17,750,933

Total 40 219,130,497 3,233 1,585,416,449

Page 9: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

P30 CORE GRANTS BY DOLLARS (FY14)Run Date: Mar 23rd, 2015

Rank by

$ Center Institution

Total

Count by

NCI (P30)

Total

Awarded by

NCI (P30)

Total

Count by

NCI (All

Grants)

Total

Awarded by

NCI (All

Grants)41 RBHS -CANCER INSTITUTE OF NEW JERSEY 1 3,049,445 21 9,749,67942 SALK INSTITUTE FOR BIOLOGICAL STUDIES 1 2,909,796 10 6,676,59843 THOMAS JEFFERSON UNIVERSITY 1 2,796,731 39 11,207,05544 UNIVERSITY OF IOWA 1 2,651,000 28 11,651,06845 WISTAR INSTITUTE 1 2,609,010 35 20,190,79746 UNIVERSITY OF VIRGINIA 1 2,580,037 41 17,175,70247 NEW YORK UNIVERSITY SCHOOL OF MEDICINE 1 2,562,445 42 17,583,99548 WAYNE STATE UNIVERSITY 1 2,534,346 40 14,492,15349 CITY OF HOPE/BECKMAN RESEARCH INSTITUTE 1 2,443,863 49 26,644,46350 GEORGETOWN UNIVERSITY 1 2,325,000 36 15,875,90351 UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR 1 2,239,331 14 8,773,99552 JACKSON LABORATORY 1 2,023,677 8 5,187,99253 UT SOUTHWESTERN MEDICAL CENTER 1 1,983,000 59 22,736,84354 UNIVERSITY OF MARYLAND BALTIMORE 1 1,890,196 28 9,691,17855 UNIVERSITY OF TEXAS HLTH SCIENCE CENTER 1 1,875,000 32 13,310,66756 EMORY UNIVERSITY 1 1,870,809 73 22,747,58857 UNIVERSITY OF UTAH 1 1,761,512 44 20,264,40258 OREGON HEALTH & SCIENCE UNIVERSITY 1 1,740,000 43 36,957,92459 UNIVERSITY OF KENTUCKY 1 1,725,000 32 11,223,67660 VIRGINIA COMMONWEALTH UNIVERSITY 1 1,722,857 36 11,491,40061 MEDICAL UNIVERSITY OF SOUTH CAROLINA 1 1,710,467 42 11,386,36762 UNIVERSITY OF HAWAII AT MANOA 1 1,694,380 13 15,196,65763 INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS 1 1,634,792 42 15,045,87564 PURDUE UNIVERSITY WEST LAFAYETTE 1 1,628,292 17 5,375,49165 WAKE FOREST UNIVERSITY HEALTH SCIENCES 1 1,603,998 26 11,925,52366 UNIVERSITY OF KANSAS MEDICAL CENTER 1 1,585,000 23 9,125,07967 UNIVERSITY OF NEBRASKA MEDICAL CENTER 1 1,533,718 33 12,595,00568 UNIVERSITY OF CALIFORNIA-IRVINE 1 1,285,288 30 6,816,951

Total 28 57,968,990 936 401,100,026

Center Institution Consortia69* UNIVERSITY OF WASHINGTON 0 455,194 70 28,502,63970* HARVARD MEDICAL SCHOOL 0 383,271 40 7,717,56771* MIRIAM HOSPITAL 0 219,841 3 1,266,86672* UNIVERSITY OF ROCHESTER 0 197,997 31 13,540,21773* UNIVERSITY OF MIAMI SCHOOL OF MEDICINE 0 195,300 33 10,538,50274* GEORGE WASHINGTON UNIVERSITY 0 91,303 10 3,163,77475* RUSH UNIVERSITY MEDICAL CENTER 0 24,045 2 381,370

Total 0 1,566,951 189 65,110,935

Grand Total 68 278,666,438 4,358 2,051,627,410

Page 10: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National
Page 11: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

NIH funded under the Consolidated Appropriations Act, 2015 (Public Law 113-235) signed into law on December 16, 2014, provides funding to NIH for the fiscal year ending September 30, 2015.

$30.31 billion FY2015 budget $240 million increase over FY2014 budget Information on the FY 2015 appropriation

can be found on the NIH Office of Budget website: http://officeofbudget.od.nih.gov/cy.html

Page 12: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

Salary Cap Limited to Executive Level II which was increased

to $183,300 effective 1/11/2015  See NOT-OD-15-049 for additional information

New Investigators – The support of new investigators is still one of

NIH’s top priorities, and will continue to provide targeted support for these individuals.

NIH will aim for a new investigator success rate on new (type 1) R01 equivalent grants comparable to that of established investigators.

Page 13: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

NRSA awards

Stipends increased for undergraduate, graduate students and postdoctorals

No changes in tuition, fees, and training related expenses

See NOT-OD-15-048.html for details

Page 14: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

NOT-OD-15-054 provides information on the statutory provisions that limit the use of funds on NIH grant and cooperative agreements for FY 2015.

Compliance with Guidance on the Spread of the Ebola Virus for Applicable Grants - funds made available under Title VI - Ebola Response and Preparedness of the HHS appropriation may be made conditional on agreement by the awardee to comply with existing and future guidance from the Secretary regarding control of the spread of the Ebola virus, as well as potential modifications to existing administrative or reporting requirements

Page 15: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

NCI’s Fiscal Year (FY) 2015 appropriation of approximately $4.95 billion

Reflects an approximate .6% increase over FY 2014.

Page 16: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

Non-Competing RPG Funding Policy – fund at the FY 2015 committed level

Competing RPG Funding Policy Modular R01 Awards

New awards - generally will sustain an 8.5% reduction from adjusted requested

Competing Renewal awards – generally will be funded at a 5% reduction from the Type 2 capped level

All Other Awards New awards - generally will sustain 17% reduction

from adjusted requested Competing Renewal awards – generally will be

funded at a 10% reduction from the Type 2 capped level

Page 17: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National
Page 18: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

NIH has revised its definition of “clinical trial” for the following reasons:

To make the distinction between clinical trials and clinical research studies clearer, and

To enhance the precision of the information NIH collects, tracks, and reports on clinical trials

The revised definition applies to competing grant applications submitted for the January 25, 2015 and subsequent due dates

See NOT-OD-15-015 for details

Page 19: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

HHS issued a Notice of Proposed Rulemaking regarding the submission of registration and summary results information, including adverse event information, for specified "applicable clinical

trials" to ClinicalTrials.gov. See NOT-OD-15-018 for

details. NIH is drafting policy to promote broad and

responsible dissemination of information on clinical trials funded by the NIH through registration and submission of summary results information to

ClinicalTrials.gov. See NOT-OD-15-019 for more information

Page 20: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

The National Cancer Institute (NCI) announced its new policy aimed at ensuring public availability of results from NCI-supported clinical trials.  This policy, referred to as the NCI Clinical Trial Access Policy, applies to all NCI funded research grant, cooperative agreements, and/or contracts that support covered interventional clinical trials. NOT-CA-15-011

When the final NIH Policy on Dissemination of NIH-Funded Clinical Trial Information is implemented, all NIH-funded investigators including NCI investigators will be subject to the NIH policy.

Page 21: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

New Inclusion Management System was released on October 17, 2014.For reporting sex/gender, race and ethnicity

information on applications and progress reports

Details at NOT-OD-15-005 NIH grantees completing their RPPR will be

prompted in Section G.4.b to access and update inclusion records directly in IMS.

Inclusion data records (IDRs) included in RPPRs submitted on/after 3/5/2015, must be updated into the enrollment format in supported by IMS – even if no new enrollment has occurred in the past year

Additional information at NOT-OD-15-078

Page 22: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

NOT-OD-14-124 details new GDS PolicyPromotes sharing of large scale genomic data

generated by NIH research Includes human, non-human and model organism

data

NOT-OD-14-111 details GDS implementation for applications and awardsBecomes effective with the 1/25/15

application due date NOT-OD-15-083 additional reminders

regarding cover letters and the need for sharing policies

Page 23: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

NIH and AHRQ encourage applicants to use the newly published biosketch format for all grant and cooperative agreement applications submitted for due dates on or after January 25, 2015, and will require use of the new format for applications submitted for due dates on or after May 25, 2015.

The revised forms and instructions are now 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

Page 24: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

Requirement of Grantees to Submit Invention Disclosures, Related Reports and Documents via iEdison NOT OD-15-080

Reinforcing Service to the Biomedical Research Community NOT OD-15-035

Simplifying the NIH Policy for Late Applications NOT-OD-15-039

Page 25: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National
Page 26: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

Final OMB Uniform Guidance issued 12/26/13 - see https://cfo.gov/cofar/

2 CFR 200Combines eight previously separate sets

of OMB guidance into one - Uniform Administrative Requirements, Audit Requirements and Cost Principles

Co-locates all related OMB guidance into Title 2 of the Code of Federal Regulations

Page 27: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

On December 19, 2014, HHS published in the Federal Register, an interim final rule adapting OMB’s final guidance with certain amendments, based on existing HHS regulations, to supplement the guidance as needed for the Department. 45 CFR Part 75

HHS made this interim final rule effective on December 26, 2014. However, HHS acknowledged that it would

consider and address comments that were received within 60 days of the date the interim final rule was published in the Federal Register.

Page 28: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

Family-friendly policies allowing grantees more flexibility to address temporary dependent-care costs

Updated rules on charging administrative and clerical costs to grants as direct costs

Institutions of higher education (IHEs) or nonprofit organizations that have never received a negotiated indirect cost rate may choose to use a de minimis rate of 10% of modified total direct costs (MTDC) which may be used indefinitely

Clarification on how to treat costs of computing devices that are necessary and support the work of, but are not solely dedicated to, a Federal award

Page 29: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

NIH is working with other Federal Research Agencies to develop a Research Terms and Conditions Overlay documentOverlay will serve as a companion

document to provide additional clarity for select provisions consistent with government-wide research policy

Until the Overlay document is complete, Federal Research Agencies have been encouraged to develop their own Interim Terms and Conditions

Page 30: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

On February 5, 2015, NIH published interim general conditions of NIH grant awards aligned with HHS’ regulation implementing OMB’s Uniform Guidance at 45 CFR Part 75.

The Interim Grant General Conditions document was issued in order to serve as the applicable terms and conditions for recipients of NIH awards, until such time as revised Research Terms and Conditions become effective. The conditions are effective for Notices of Award (NoA)

issued on or after December 26, 2014, that obligate new or supplemental funds.

NoAs issued on or after December 26, 2014 that do not involve obligation of new or supplemental funds remain subject to 45 CFR Part 74 or Part 92, as applicable, until such time that new funds are obligated.

See NOT-OD-15-065 for more information.

Page 31: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

Frequently Asked Questions – will be updated on a continuous basis

Archived presentation available on The NIH Grants YouTube Channel

An archived PowerPoint Presentation Updated NIH Grants Policy Statement

anticipated by March 31 will incorporate the General Grant Conditions Any changes that come from the HHS Final

Rule on 45 CFR Part 75 will be incorporated as further revisions

Page 32: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

New requirements being implemented for all grants with project end dates of 10/1/2014 and later

Closeout reports remain the same:– Final Federal Financial Report (FFR)

SF-425 Expenditure Data (submitted through eRA Commons);

– Final Inventions Statement & Certification;

– Final Progress Report NIH has extended the submission

requirement to 120 days as part of the research terms and conditions of award

Page 33: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

Grantees are strongly encouraged to submit close-out documents electronically through the eRA Commons

NOTE: Grantees must ensure there are no discrepancies between the final FFR expenditure data (in eRA Commons) and the FFR cash transaction data in the Payment Management System.

Page 34: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

Notable changes:• Shorter timeframe to complete process• New requirements for NIH to initiate

“unilateral” closeout if reports are missing or unacceptable

• New requirements which may result in a debt obligation to the grantee

For details see NOT-OD-14-084 and Closeout FAQs

Check Grants Pending Closeout at this link: https://public.era.nih.gov/chl/public/search/gpc.era

Page 35: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National
Page 36: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

IDPs not required, grantees are encouraged to develop as part of training program

As of October 1, 2014 grantees are required to report on the use of IDPs with RPPR submissions Grantees must include a report on the use of IDPs in

Accomplishments, Question B.4. for all grad students and postdocs reported in Section D. List of Participants

Do not include the actual IDP; instead report whether or not IDPs are used to help manage the training for these individuals NOT-OD-14-113

Page 37: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

NOT-OD-13-097 Commons ID for undergraduate and Graduate Students required with RPPR submissions as of October 17, 2014 Applies to students with one person month of effort

or more RPPR will not be accepted without Commons ID

NOT-OD-14-129 eRA Commons Username Required for Sponsor in Individual Fellowship Grant applications to NIH and AHRQ Notice details application requirements for

sponsor role Lack of sponsor ID can prevent successful

application submission

Page 38: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

October 1, 2014 – September 30, 2015Competing Awards

New funding will continue to be awarded to P subaccounts

Type 3 Awards Will continue to be awarded to the same type of

account as the parent awardType 5 Awards

Will continue to be awarded to the same type of account as the previous budget period

Page 39: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

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 all type 3 funding will

be awarded to subaccounts regardless of parent award account type

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

Page 40: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

Beginning October 1, 2015 No change in grantee progress report

submission NIH will award type 4s to transition

funding to subaccounts Grantees will submit Subaccount

Transitional Federal Financial Reports (FFRs) Subaccount Transitional FFRs may include

unliquidated obligations See NOT-OD-14-103 for detailed

transition steps

Page 41: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

Reminder that the basic requirements for allowable applications have not changed with the updated NIH/AHRQ policy on application submission.

Investigators now may submit a New Application, following an unsuccessful application, without concern for scientific overlap with previously reviewed applications.

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

Page 42: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

FAQs (continually updating) NIH Guide NOT-OD-14-081 Announces Changes

affecting FCOI Reporting in eRA Commons NIH Proactive FCOI Compliance Oversight

Program - NIH Guide NOT-OD-12-159 Assess institutional compliance with the 2011

revised FCOI regulation (42 CFR Part 50 Subpart F) and policy development

Results of the pilot program will be shared with the grantee community for educational purposes to enhance and improve FCOI compliance.

Expand the FCOI Compliance Program during FY 2015

Page 43: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

• Mailbox for [email protected]

• OER FCOI Web Site http://grants.nih.gov/grants/policy/coi/

FCOI FAQs

http://grants.nih.gov/grants/policy/coi/coi_faqs.htm

Page 44: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

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 (http://grants.nih.gov/grants/policy/myf.htm

Searchable list to determine which progress reports are due: http://era.nih.gov/userreports/pr_due.cfm

ALL Progress Reports require electronic submission

Page 45: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

NIH will delay processing award if publications arising from it are not in compliance

Electronically associated on RPPRs My NCBI ensures compliance with

NIH Public Access PolicyOn-line portal linked to Commons accountMaintains list of all authored papers

See Notice NOT-OD-13-042

Page 46: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

Public Access Compliance Monitor

A web-based tool that institutions can use to track compliance of publications that fall under the NIH Public Access Policy.

Multiple search options support the efforts of grantee organizations to ensure their awards are compliant.

see NOT-OD-13-020

Page 47: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

http://publicaccess.nih.gov/ for information about how to comply with the policy.

http://publicaccess.nih.gov/address_copyright.htm

http://publicaccess.nih.gov/communications.htm - training materials for My NCBI

http://publicaccess.nih.gov/contact.htm- help desk for questions

Page 48: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National
Page 49: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

2014 Update to the International Compilation of Human Research Standards – Now Available at OHRP International

More at: http://www.hhs.gov/ohrp/newsroom/index.html

Page 50: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

The 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

See NOT-OD-15-079

Page 51: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

Policy on Shared Animal Welfare Concerns NOT-OD-15-028 Explains how self-reports of serious

animal welfare concerns involving USDA-regulated species are shared with Animal Care.

Guidance on Significant Changes to Ongoing Animal Activities NOT-OD-14-126 Provides guidance on what is

considered a significant change to an ongoing animal activity that requires IACUC review.

Change in Criteria for Renewal of Domestic Animal Welfare Assurances NOT-OD-14-099 As of December 1, 2014, OLAW will

not renew a Domestic Assurance if an institution does not have current PHS funding.

Page 52: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

• 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• What Investigators Need to Know About the Use of

Animals• ILAR Journal, Vol. 54(3)

http://grants.nih.gov/grants/olaw/references/ilar_2014_54.pdf

Page 53: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National
Page 54: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

RPPR required for ALL type 5 progress reports (SNAP and non-SNAP) submitted on or after October 17, 2014 NOT-OD-14-092

RPPR Webpage: http://grants.nih.gov/grants/rppr/

Includes links to RPPR Application Guide RPPR Guide Notices Frequently Asked Questions Training Contacts

Page 55: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

NIH Announced the immediate availability of ASSIST as a submission option for the following NIH Programs

Small Research Grants (R03) and, Exploratory/Development Grants (R21) More information at - NOT-15-062

Use of ASSIST is Optional Grants.gov downloadable forms and institutional

system-to-system solutions remain viable options for application preparation and submission to NIH.

Page 56: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

NIH is pilot testing a mobile-friendly FOA format

Basic FOA structure and order stays the same

Will adjust to any screen size Check it out here

Coming soon: Mobile Friendly grants.nih.gov

Page 57: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National
Page 58: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

Administrative SupplementsOptional Grants.gov and Commons

submissionsDetails at NOT-OD-12-024 and PA-14-077

Change of Grantee InstitutionAvailable if activity code has transitioned to

eSubmissionDetails at NOT OD-12-134 and PA-14-078

Relinquishing StatementsAvailable to all grants (does not require

activity code transition to eSubmission)Details at NOT OD-12-132

Page 59: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

Re-entry (PA-12-150) and Diversity (PA-12-149) Supplement FOAs now use the Forms C application New supplement requests

Use Forms C and Forms C application guideIn-process supplement requests Applicants may submit using Forms B until

current FOAs expire

Administrative supplements Electronic submission is only available for single-

project activity codes

See NOT-OD-14-118 for details

Page 60: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National
Page 61: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

New Online EditionFormatted as web pages so the content is

searchable Provides links to additional resources on

Cancer.gov, NIH and HHS sitesEasier to edit and keep current with new

policies and changing guidelines New Print Edition

PDF may be printed from the webSmall batch printing for bi-annual updatesNew design for easier & faster printing

Page 62: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National
Page 63: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National
Page 64: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National
Page 65: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National
Page 66: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National
Page 67: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

OGA’s Internet siteOffice of Grants Administration

Current NCI Grants Process BookNCI Grants Process

OGA Institution Points of ContactSpecialist Institutional Assignments

Revamping our external site to provide better information and FAQs

Page 68: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National
Page 69: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National
Page 70: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

The NIH Regional Seminars offer an unparalleled opportunity to:Gain a better perspective of NIH/HHS

policies and programs;Network with peers;Gather helpful contacts; and Obtain useful resources and tools related

to obtaining and managing NIH awards. Baltimore, Maryland on May 6-8. See NOT-OD-15-063 for more

information

Page 71: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

• The following four tutorials have been added to the eRA Tutorials page http://era.nih.gov/era_training/era_videos.cfm

• Accessing the Notice of Award (SO & PD/PI)

• Accessing Just In Time (SO & PD/PI)• No Cost Extension (SO Only)• Change of Institution (SO & PD/PI)

Page 72: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

FAQs include information about: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

Page 73: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

Research Portfolio Online Reporting Tools (RePORT) http://report.nih.gov Provides access to reports, data and analysis of

NIH research activities, including ARRA-specific data queries, and more;

Quick links to “Frequently Requested Reports,” FAQs

RePORT EXPENDITURES & RESULTS (RePORTER) http://projectreporter.nih.gov/reporter.cfm Tool used to search information from NIH project

databases and funding records, PubMed abstracts and full-text articles, and invention reporting (iEdison, Interagency Edison);

Replaces CRISP.

Page 74: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

Office of Extramural Research (OER) Web Page http://grants.nih.gov/grants/oer.htm

NIH Grants Policy Statement (Rev. 10/13)http://grants.nih.gov/grants/policy/nihgps_2013/

index.htm NIH Extramural Nexus – newsletter for the

extramural communityhttp://nexus.od.nih.gov/all/nexus-by-date/ Grant Application Basicshttp://grants.nih.gov/grants/grant_basics.htm Rock Talkhttp://nexus.od.nih.gov/all/rock-talk/

Page 75: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

• 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 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

Page 76: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

• 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://era.nih.gov/ElectronicReceipt/listserv.htm

Page 77: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

• General Application Questions:E-Mail: [email protected]: 301-435-0714

• Grants.gov Customer Support: E-Mail: [email protected]: http://grants.gov/ Phone: 800-518-4726

• eRA Commons Helpdesk:Web: http://era.nih.gov/help/ Toll-free: 1-866-504-9552 Phone: 301-402-7469 TTY: 301-451-5939 Hours: Mon-Fri, 7a.m. to 8 p.m. Eastern Time

Page 78: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National

• Division of Grants Policy:E-Mail: [email protected]: 301-435-0949

• Division of Grants Compliance & Oversight:E-Mail: [email protected]: 301-435-0949

Page 79: March 31, 2015 Crystal Wolfrey Director, Office of Grants Administration National Cancer Institute US DEPARTMENT OF HEALTH AND HUMAN SERVICES National