Crystal Wolfrey - Markey Cancer Center

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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
OGA Organization
Institution
ALBERT EINSTEIN COL OF
MED YESHIVA UNIV
BAYLOR COLLEGE OF
MEDICINE
CASE WESTERN RESERVE
UNIVERSITY
CITY OF HOPE/BECKMAN
RESEARCH INSTITUTE
COLD SPRING HARBOR
LABORATORY
COLUMBIA UNIVERSITY
HEALTH SCIENCES
DANA-FARBER CANCER
INSTITUTE
Grants Specialist
Debra Sowell
Bryann Benton
Amy Knight
Silvia Torres
Renee Carruthers
Jackie Boudjeda
Becky Brightful
DARTMOUTH COLLEGE
Kimery Griffin
DUKE UNIVERSITY
Rosemary Ward
EMORY UNIVERSITY
FRED HUTCHINSON
CANCER RESEARCH
CENTER
Maricela Trujillo
Samantha Farrell
GEORGETOWN UNIVERSITY Martinson Owusu
H. LEE MOFFITT CANCER
CTR & RES INST
Nick Mitrano
INDIANA UNIV-PURDUE
UNIV AT INDIANAPOLIS
Esther Young
JACKSON LABORATORY
JOHNS HOPKINS
UNIVERSITY
MASSACHUSETTS
INSTITUTE OF
TECHNOLOGY
Sarah Lee
MAYO CLINIC
MEDICAL UNIVERSITY OF
SOUTH CAROLINA
Arina Kramer
Jackie Boudjeda
Joy Kearse
Tracie McGraw
Institution
NEW YORK UNIVERSITY
SCHOOL OF MEDICINE
NORTHWESTERN
UNIVERSITY AT CHICAGO
Grants Specialist
Amy Knight
Barbara Liesenfeld
OHIO STATE UNIVERSITY
Martinson Owusu
OREGON HEALTH AND
SCIENCE UNIVERSITY
Barbara Liesenfeld
PURDUE UNIVERSITY WEST
LAFAYETTE
Renee Carruthers
RBHS - CANCER INSTITUTE
OF NEW JERSEY
Jennifer Edwards
RESEARCH INST OF FOX
CHASE CAN CTR
Emily Tran
ROSWELL PARK CANCER
INSTITUTE CORP
Jennifer Meininger
SALK INSTITUTE FOR
BIOLOGICAL STUDIES
Jackie Boudjeda
SANFORD-BURNHAM
MEDICAL RESEARCH INSTIT Barbara Fisher
SLOAN-KETTERING
INSTITUTE FOR CANCER
RES
Funmi Elesinmogun
ST. JUDE CHILDREN'S
RESEARCH HOSPITAL
Esther Young
STANFORD UNIVERSITY
THOMAS JEFFERSON
UNIVERSITY
Aida Vasquez
UNIV OF TX HSC, SA
UNIVERSITY OF ALABAMA
AT BIRMINGHAM
Funmi Elesinmogun
UNIVERSITY OF ARIZONA
UNIVERSITY OF
CALIFORNIA San Diego
UNIVERSITY OF
CALIFORNIA DAVIS
Aida Vasquez
Joy Kearse
Esther Young
Connie Murphy
Kelly Fritz
Institution
Grants Specialist
UNIVERSITY OF
CALIFORNIA IRVINE
Silvia Torres
UNIVERSITY OF
CALIFORNIA LOS ANGELES Kelly 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 Tran
UNIVERSITY 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
UNIVERSITY OF
PENNSYLVANIA
Grants Specialist
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
Mechanism
Research Project Grants
R&D Contracts
Buildings and Facilities
Groups
Other Research
Training
Intramural
Research Management &
Support
Centers
Total
Amount
2,012,560
652,283
8,000
271,635
158,411
69,217
845,075
371,350
543,839
$4,932,37
0
P30 CORE GRANTS BY DOLLARS (FY14)
Run Date: Mar 23rd, 2015
Rank by
$
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
Center Institution
SLOAN-KETTERING INST CAN RESEARCH
DANA-FARBER CANCER INST
UNIVERSITY OF TX MD ANDERSON CAN CTR
FRED HUTCHINSON CANCER RESEARCH CENTER
UNIVERSITY OF PENNSYLVANIA
JOHNS HOPKINS UNIVERSITY
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
UNIV OF NORTH CAROLINA CHAPEL HILL
UNIVERSITY OF MICHIGAN
UNIVERSITY OF SOUTHERN CALIFORNIA
VANDERBILT UNIVERSITY
ST. JUDE CHILDREN'S RESEARCH HOSPITAL
DUKE UNIVERSITY
MAYO CLINIC ROCHESTER
UNIVERSITY OF ALABAMA AT BIRMINGHAM
CASE WESTERN RESERVE UNIVERSITY
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
UNIVERSITY OF CALIFORNIA LOS ANGELES
OHIO STATE UNIVERSITY
NORTHWESTERN UNIVERSITY AT CHICAGO
UNIVERSITY OF WISCONSIN-MADISON
COLD SPRING HARBOR LABORATORY
UNIVERSITY OF CHICAGO
RESEARCH INST OF FOX CHASE CAN CTR
WASHINGTON UNIVERSITY
UNIVERSITY OF CALIFORNIA SAN DIEGO
ROSWELL PARK CANCER INSTITUTE CORP
COLUMBIA UNIVERSITY HEALTH SCIENCES
SANFORD-BURNHAM MEDICAL RESEARCH INSTIT
UNIVERSITY OF ARIZONA
ALBERT EINSTEIN COLLEGE OF MEDICINE
UNIVERSITY OF COLORADO DENVER
MASSACHUSETTS INSTITUTE OF TECHNOLOGY
UNIVERSITY OF CALIFORNIA AT DAVIS
STANFORD UNIVERSITY
UNIVERSITY OF MINNESOTA
YALE UNIVERSITY
BAYLOR COLLEGE OF MEDICINE
H. LEE MOFFITT CANCER CTR & RES INST
DARTMOUTH COLLEGE
Total
Total
Total
Total
Total
Awarded Count by Awarded by
Count by
by NCI
NCI (All
NCI (All
NCI (P30)
(P30)
Grants)
Grants)
1 12,543,138
127
72,740,502
1 11,033,991
127
78,451,654
1 10,481,108
173
90,804,059
1 10,313,826
118
91,445,883
1
7,814,026
147
59,601,131
1
7,575,009
144
69,814,718
1
7,565,595
166
72,879,755
1
7,191,236
120
52,306,352
1
6,349,946
117
54,650,446
1
6,289,895
55
32,870,894
1
6,196,112
137
63,411,306
1
5,840,603
28
21,377,684
1
5,836,521
82
34,466,685
1
5,613,500
96
58,786,566
1
5,541,279
53
24,602,090
1
5,204,824
48
22,298,010
1
5,168,310
96
49,684,170
1
4,996,042
73
43,455,017
1
4,929,906
88
45,033,755
1
4,909,844
71
26,722,103
1
4,768,387
65
25,484,368
1
4,608,416
17
14,237,490
1
4,491,307
58
23,467,902
1
4,443,687
29
14,605,013
1
4,374,022
97
41,491,411
1
4,334,009
73
32,073,900
1
4,221,135
41
21,468,771
1
4,166,904
72
35,592,740
1
3,990,822
37
18,692,547
1
3,960,199
34
17,153,598
1
3,808,748
43
21,672,159
1
3,761,683
67
23,159,114
1
3,738,697
41
22,421,972
1
3,428,938
46
18,413,289
1
3,396,915
126
55,049,282
1
3,366,367
83
31,248,600
1
3,280,007
74
27,609,332
1
3,222,022
67
31,842,999
1
3,189,785
57
26,578,249
1
3,183,736
40
17,750,933
40 219,130,497
3,233 1,585,416,449
P30 CORE GRANTS BY DOLLARS (FY14)
Run Date: Mar 23rd, 2015
Rank by
$
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69*
70*
71*
72*
73*
74*
75*
Center Institution
RBHS -CANCER INSTITUTE OF NEW JERSEY
SALK INSTITUTE FOR BIOLOGICAL STUDIES
THOMAS JEFFERSON UNIVERSITY
UNIVERSITY OF IOWA
WISTAR INSTITUTE
UNIVERSITY OF VIRGINIA
NEW YORK UNIVERSITY SCHOOL OF MEDICINE
WAYNE STATE UNIVERSITY
CITY OF HOPE/BECKMAN RESEARCH INSTITUTE
GEORGETOWN UNIVERSITY
UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR
JACKSON LABORATORY
UT SOUTHWESTERN MEDICAL CENTER
UNIVERSITY OF MARYLAND BALTIMORE
UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
EMORY UNIVERSITY
UNIVERSITY OF UTAH
OREGON HEALTH & SCIENCE UNIVERSITY
UNIVERSITY OF KENTUCKY
VIRGINIA COMMONWEALTH UNIVERSITY
MEDICAL UNIVERSITY OF SOUTH CAROLINA
UNIVERSITY OF HAWAII AT MANOA
INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
PURDUE UNIVERSITY WEST LAFAYETTE
WAKE FOREST UNIVERSITY HEALTH SCIENCES
UNIVERSITY OF KANSAS MEDICAL CENTER
UNIVERSITY OF NEBRASKA MEDICAL CENTER
UNIVERSITY OF CALIFORNIA-IRVINE
Total
Center Institution Consortia
UNIVERSITY OF WASHINGTON
HARVARD MEDICAL SCHOOL
MIRIAM HOSPITAL
UNIVERSITY OF ROCHESTER
UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
GEORGE WASHINGTON UNIVERSITY
RUSH UNIVERSITY MEDICAL CENTER
Total
Grand Total
Total
Total
Total
Total
Count by Awarded by
Count by Awarded by NCI (All
NCI (All
NCI (P30) NCI (P30) Grants)
Grants)
1
3,049,445
21
9,749,679
1
2,909,796
10
6,676,598
1
2,796,731
39
11,207,055
1
2,651,000
28
11,651,068
1
2,609,010
35
20,190,797
1
2,580,037
41
17,175,702
1
2,562,445
42
17,583,995
1
2,534,346
40
14,492,153
1
2,443,863
49
26,644,463
1
2,325,000
36
15,875,903
1
2,239,331
14
8,773,995
1
2,023,677
8
5,187,992
1
1,983,000
59
22,736,843
1
1,890,196
28
9,691,178
1
1,875,000
32
13,310,667
1
1,870,809
73
22,747,588
1
1,761,512
44
20,264,402
1
1,740,000
43
36,957,924
1
1,725,000
32
11,223,676
1
1,722,857
36
11,491,400
1
1,710,467
42
11,386,367
1
1,694,380
13
15,196,657
1
1,634,792
42
15,045,875
1
1,628,292
17
5,375,491
1
1,603,998
26
11,925,523
1
1,585,000
23
9,125,079
1
1,533,718
33
12,595,005
1
1,285,288
30
6,816,951
28 57,968,990
936
401,100,026
0
455,194
0
383,271
0
219,841
0
197,997
0
195,300
0
91,303
0
24,045
0
1,566,951
68 278,666,438
70
28,502,639
40
7,717,567
3
1,266,866
31
13,540,217
33
10,538,502
10
3,163,774
2
381,370
189
65,110,935
4,358 2,051,627,410
 NIH
funded under the Consolidated
Appropriations Act, 2015 (Public Law 113235) 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
 Salary


Limited to Executive Level II which was increased to
$183,300 effective 1/11/2015
See NOT-OD-15-049 for additional information
 New


Cap
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.
 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
 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
NCI’s Fiscal Year (FY) 2015 appropriation of
approximately $4.95 billion
 Reflects an approximate .6% increase over FY
2014.

 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
 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

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
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.


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

NOT-OD-14-124 details new GDS Policy
 Promotes 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 awards


Becomes effective with the 1/25/15 application
due date
NOT-OD-15-083 additional reminders
regarding cover letters and the need for
sharing policies


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
 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
Final OMB Uniform Guidance issued 12/26/13 see https://cfo.gov/cofar/
 2 CFR 200
 Combines 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
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.




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
 NIH
is working with other Federal Research
Agencies to develop a Research Terms and
Conditions Overlay document

Overlay 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

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.
 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
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

 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.

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
 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-14113

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


October 1, 2014 – September 30, 2015
 Competing Awards


Type 3 Awards


New funding will continue to be awarded to P
subaccounts
Will continue to be awarded to the same type of
account as the parent award
Type 5 Awards

Will continue to be awarded to the same type of
account as the previous budget period

October 1, 2015 – September 30, 2016

Competing Awards


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


NIH will continue to award all new funding to
subaccounts
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
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
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




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
•
Mailbox for inquiries

•
FCOICompliance@mail.nih.gov
OER FCOI Web Site

http://grants.nih.gov/grants/policy/coi/
FCOI FAQs
http://grants.nih.gov/grants/policy/coi/coi_faqs
.htm






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
 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 Policy


On-line portal linked to Commons account
Maintains list of all authored papers
 See
Notice NOT-OD-13-042
 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
 http://publicaccess.nih.gov/
for
information about how to comply with the
policy.
 http://publicaccess.nih.gov/address_copy
right.htm
 http://publicaccess.nih.gov/communicati
ons.htm - training materials for My NCBI
 http://publicaccess.nih.gov/contact.htmhelp desk for questions
 2014
Update to the International Compilation
of Human Research Standards – Now Available
at OHRP International
More
at:
http://www.hhs.gov/ohrp/newsroom/in
dex.html
 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

Policy on Shared Animal Welfare Concerns


Guidance on Significant Changes to Ongoing
Animal Activities


NOT-OD-15-028 Explains how self-reports of serious
animal welfare concerns involving USDA-regulated
species are shared with Animal Care.
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.
•
•
•
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_5
4.pdf

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

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.
 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
 Administrative


Optional Grants.gov and Commons submissions
Details at NOT-OD-12-024 and PA-14-077
 Change


of Grantee Institution
Available if activity code has transitioned to
eSubmission
Details at NOT OD-12-134 and PA-14-078
 Relinquishing


Supplements
Statements
Available to all grants (does not require
activity code transition to eSubmission)
Details at NOT OD-12-132

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 guide
In-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
 New



Formatted as web pages so the content is
searchable
Provides links to additional resources on
Cancer.gov, NIH and HHS sites
Easier to edit and keep current with new policies
and changing guidelines
 New



Online Edition
Print Edition
PDF may be printed from the web
Small batch printing for bi-annual updates
New design for easier & faster printing
 OGA’s

Internet site
Office of Grants Administration
 Current

NCI Grants Process
 OGA

NCI Grants Process Book
Institution Points of Contact
Specialist Institutional Assignments
 Revamping
our external site to provide
better information and FAQs
 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
•
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)
•
 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_questio
ns.htm


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.
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
community
http://nexus.od.nih.gov/all/nexus-by-date/
 Grant Application Basics
http://grants.nih.gov/grants/grant_basics.htm
 Rock Talk
http://nexus.od.nih.gov/all/rock-talk/

•
•
•
•
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
•
NIH Guide for Grants and Contracts:


•
Office for Human Research Protections (OHRP):

•
Office for Human Research Protections (OHRP)
Office of Laboratory Animal Welfare (OLAW):

•
Official publication for NIH Grant Policies, Guidelines &
Funding Opportunities
http://grants.nih.gov/grants/guide/listserv.htm
http://grants.nih.gov/grants/olaw/references/list.htm
eSubmission:


Separate listservs available for scientists and
administrators
http://era.nih.gov/ElectronicReceipt/listserv.htm
•
General Application Questions:


•
Grants.gov Customer Support:



•
E-Mail: GrantsInfo@nih.gov
Phone: 301-435-0714
E-Mail: support@grants.gov
Webpage: 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
•
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
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