November 2011

Alison Yeung and Jeff Warner
Grace Park
Nancy Lewis
Chris Abernethy and Beverly Esparza
Barbara Inderwiesche and Allison Ramos
Nancy Lewis
Bruce Morgan
 Federal Update
 PHS Conflict of Interest Policy Update
 NIH Genomic Array Policy-
UCI’s Implementation
 Determination of Human Subjects
Research
 Gift/Grant Distinctions
 Subaward Reminders
 Patent Acknowledgement Amendment
November 2011 QRAM

Sponsored Projects
Administration Update
Alison Yeung
Contract and Grant Officer,
Sponsored Projects Administration
Alison.Yeung@research.uci.edu
949.824.2644
Jeff Warner
Contract and Grant Officer,
Sponsored Projects Administration warnerj@uci.edu
949.824.4781
 Federal Update
November 2011 QRAM

Significant Changes and Clarifications to the NSF Agency Specific
Requirements to the Research Terms and Conditions, dated 02/12
• Travel, Article 14, has been updated to incorporate revised circumstances under which use of a foreign-flag air carrier is permissible. The Article provides information on recent modifications to the “Open Skies” Agreement with the
European Union.
• Expenditure Reports, Article 9, has been modified to reflect that all Federal Financial Reports must now be submitted through Research.gov.

Significant Changes and Clarifications to the NSF Agency Specific
Requirements to the Research Terms and Conditions, dated 02/12
• Indirect Costs, Article 11, is a new Article reminding awardees subject to OMB Circular A-21 that they must use the indirect cost (F&A) rate(s) approved by the cognizant Federal negotiating agency that are in effect at the time of the initial award, throughout the life of the award, unless otherwise specified in the award notice.
• Grantee Responsibilities and Federal Requirements, Article
12, has been supplemented with a weblink to a listing of the
National Policy Requirements. http://www.nsf.gov/bfa/dias/policy/rtc/appc_june11.pdf

NIH eRA Commons User Guides New and
Updated
• The eRA Commons User Guide provides extensive information on how to use the Commons and was updated on October 7 th .
The updated eRA Commons User Guide can be found at http://era.nih.gov/docs/COM_UGV2630.pdf
and the updated
User Guide FAQ can be found at http://era.nih.gov/commons/faq_commons.cfm
.
• The Account Management tool has replaced the eRA Commons
Admin module. The Account Management (AMS) User Guide can be found at http://era.nih.gov/files/AMS_user_guide.pdf
.

DHHS ACF Submissions
• The DHHS’ Administration of Children and Families announced in the Federal Register that effective January 2012 it will require electronic submissions through Grants.gov or
GrantSolutions.gov for its discretionary programs. With the implementation of electronic submission of discretionary grant applications via Grants.gov, ACF will extend the timeframe for application receipt from 4:30 p.m., E.T., to 11:59 p.m., E.T.
• See the notice at http://www.gpo.gov/fdsys/pkg/FR-2011-10-
27/pdf/2011-27878.pdf

• New focus at all NIH Institutes on progress and final reports.
Failure to submit complete and timely reports may affect future funding to the organization.
• NOT-OD-12-004 - NIH is operating under a Continuing
Resolution (CR) that was enacted on October 4, 2011. The CR continues NIH’s operations at the FY 2011 level minus 1.5%.
Until FY 2012 appropriations are enacted, NIH will issue noncompeting research grant awards at a level below (generally up to 90% of the previously committed level) that indicated on the Notice of Grant Award. NIH will consider providing upward adjustments to those awarded levels after the FY 2012 appropriation is enacted.

Significant Changes to the NIH GPS for October
2011 Version
• Section 1.2 – Definitions of Terms - In response to user input:
This revision provides consistent terminology in referring to funding mechanisms and peer review, aligning definitions with other policy source documents as appropriate.
• Section 2.3.4 – NOT-OD-10-140 - NIH will not accept a
Resubmission that is submitted later than thirty-seven months after the date of receipt ("receipt date") of the initial New,
Renewal, or Revision application.

Significant Changes to the NIH GPS for October
2011 Version
• Section 2.3.9.4 – New Section - Submissions of identical applications to one or more components of the PHS are not allowed, and the NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. Reflects consistent policy with relevant section of the SF424 (R&R) Application Guide.
• Section 2.3.11.2.2 – Confidentiality of Information – The
Freedom of Information Act: Edited by NIH FOIA officer for clarity in response to user input.

Significant Changes to the NIH GPS for October
2011 Version
• Section 2.4.2 – NOT-OD-1106 – NOT-OD-11-101 – Revises NIH policy on Appeals of Initial Scientific Review. Appeals must be based on one of the following: evidence of bias on the part of one or more peer reviewers; conflict of interest, on the part of one or more non-Federal peer reviewers; lack of appropriate expertise within the
SRG; factual error(s) made by one or more reviewers that could have altered the outcome of review substantially.
• Section 4.1.3 (Not 4.1.6) – Clinical Trials.gov Requirement – Section edited by OGC in response to user input and current status of the rulemaking process. In particular, grantees should be aware that if an applicable clinical trial is funded in whole or in part by an NIH grant or cooperative agreement, any application or progress report shall include a certification that the Responsible Party has made all required submissions to ClinicalTrials.gov.

Significant Changes to the NIH GPS for October
2011 Version
• Section 4.1.10 – NOT-OD-11-109 – Implements new Financial
Conflict of Interest policies. Summary of major changes can be found here: http://grants.nih.gov/grants/policy/coi/summary_of_major_ch anges.doc
.
• Section 4.1.11 – Fly America Act – Revised text to reflect updated GSA guidance related to Open Skies.

Significant Changes to the NIH GPS for October
2011 Version
• Section 8.1.1.3 – NOT-OD-11-098 - Notifications may not be submitted via e-mail or fax. Upon receipt of the notification, the GMO will process and acknowledge the extension. If the no-cost extension notification is submitted late, the extension notification automatically becomes a request and requires the approval of the IC Chief GMO.
• Section 8.1.2.4 – Carryover of Unobligated Balance - In general, carryover action requiring prior approval will be approved using the F&A rate that was in effect at the time the initial funds were awarded. However, actual expenditures will still be based on the rate applicable when the cost is incurred.

Significant Changes to the NIH GPS for October
2011 Version
• Section 8.1.2.6 – NOT-OD-11-118 - The grantee is required to submit a prior approval request to the GMO if: There is a change from a multiple PD/PI model to a single PD/PI model.
There is a change from a single PD/PI model to a multiple
PD/PI model. There is a change in the number or makeup of the PD/PIs on a multiple PD/PI award.
• Section 8.1.2.7 – Change of Grantee Organization – The list of required documents for this request was edited for clarity in response to user input.

Significant Changes to the NIH GPS for October
2011 Version
• Section 8.4.2.1 – Streamlined Progress Reports Reductions are cumulative, i.e., the 25% threshold may be reached by two or more successive reductions that total 25% or more. Once agency approval has been given for a significant change in the level of effort, then all subsequent reductions are measured against the approved adjusted level.
• Section 8.4.1.3 - New Section - Progress Reports for Multiyear
Funded Awards: A limited number of NIH grant awards are multi-year funded, i.e., not funded in budget years but funded in full at the start of the project period from a single fiscal year appropriation. The project period and the budget period are the same in a multi-year funded (MYF) award, and are longer than one year. Progress reports for MYF awards are due annually on or before the anniversary of the budget/project period start date of the award.

Financial Expenditure Reports
• Implements the use of the Federal Financial Report
(FFR) system located in eRA Commons for reporting expenditure data
– including new reporting dates for annual FFRs, and reporting of cumulative data only.
• See the notice at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-
11-017.html
Section 8.4.1.5.2 & 8.4.1.4.3
NOT-OD-11-017

Special Award Conditions & Enforcement
Actions
• Special Award Conditions & Enforcement Actions
(Section 8.5)
– If you do not comply with Terms & Conditions of the award:
• NIH may place special conditions on awards; prevent you from obtaining future awards for a specified period, or more closely monitor the award
• Modification of the Terms of Award (Section 8.5.1)
– Grants management officer may include special conditions during the grant performance – which would result in a modification of the award

Special Award Conditions & Enforcement Actions
• Suspension, Termination, and
Withholding of Support (8.5.2)
• Other Enforcement Actions (8.5.3)
• Recovery of funds (8.5.4)

Application Requirements
• Implements revised multiple PI/PD policy (previous slide)
• Also includes clarification of “new investigator status”,
“multiple PI” and “Lead Researcher
New investigator:
Not previously a
PD/PI for
*substantial NIH independent research award
ESI:
10 yrs after
PhD or medical
Residency
Sections 9.3 and 9.4
Notice NOT-OD-11-118
•See the notice at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-
118.html

Kirchstein National Research Service Awards
(NRSA):
F-32 eligibility
Grad student institution
Postdoctoral training
*should be at site other than graduate institution
*See notice and text for detail
Section 11.2.2.5
NOT-OD-11-097

Section 11.2.2.4
Unless in process of becoming permanent resident and expected to be admitted by the earliest possible award date.

Written Agreement with Consortium participants (subawards)
• Grantees must enter into a formal written agreement with subawards that addresses arrangements for meeting scientific, administrative, financial and reporting requirements of the grant
Subrecipient
Commitment Forms must be submitted at the proposal stage
Section 15.2.1

Consortium Agreements:
Allowable and Unallowable Cost
• Clarification of NIH policy on third party F&A in the
absence of a rate agreement:
Grantee must include in consortium agreements the applicable government-wide cost principles and NIH cost policies and requirements related to allowable/unallowable costs described in the Cost
Considerations Chapter of NIH GPS.
Section 15.2.3

Domestic Grants with Foreign Components
Foreign component: performance of a significant part of the project outside the
US by the grantee or by another researcher at a foreign institution (regardless of whether $$ are expended)
Section 16.2

New Conference Costs and
Reporting Requirements

Effective immediately,
NO OJP funding can be used for food and/or beverages at conference, meeting, training, any other event
*Exceptions require prior approval from DOJ

For events for which you have entered into a contract prior to 10/21/2011, the contract should be renegotiated to the extent possible to avoid food and/or beverages expenditures
Regardless, only ONE refreshment break a day is allowable to be charged.

Grantees funded through cooperative agreements or contracts may not enter into any contract for services without prior approval from the Office of
Justice.
For events for which you have entered into a contract prior to 10/21/2011, the contract should be renegotiated to avoid food and/or beverages expenditures
Regardless, only ONE refreshment break a day is allowable.

• DOJ has identified conference planning costs as an area for further review
• Avoid situations where conference planning costs are not critical or exceed necessary levels

Stay tuned…

• Effective 10/21/2011
• New grants will specify the award effective date and anticipated “final” expiration date
• If an award includes additional incremental funding in the out-years, the time associated with the increment will be included in the final expiration date
• No more “incremental time”; only incremental funds

Conflict of Interest
Update
Grace Park
Conflict of Interest Administrator parkgj@uci.edu
949.824.7218
 Sneak Preview:
The Revised PHS
Financial Conflict of
Interest Regulations
August 2011 QRAM

Sponsored Projects
Update
Nancy Lewis
Director, Sponsored Projects
Administration nancy.lewis@research.uci.edu
949.824.2897
 NIH Genomic Array
Policy- UCI’s
Implementation
November 2011 QRAM

NOT-OD-10-097 : Budgeting for Genomic
Arrays in NIH Grants, Cooperative,
Agreements and Contracts
– Places a cap on indirect cost assessment under
NIH grants, cooperative agreements, and contracts.
– Costing limitation is incorporated into UCI’s
F&A
November 2011 QRAM

• Indirect Cost may be assessed on the first
$75,000 of external genomic array purchases per budget year.
• Funds in excess of the first $75,000 per
budget year will be exempt from indirect cost assessment.
November 2011 QRAM

• Annual external genomic array costs that do not exceed $50,000 per year should be budgeted as supplies.
• Annual external genomic array costs in excess of
$50,000 per year should be budgeted as follows:
• (Example: Purchase of $140k genomic arrays per year.)
Supplies
Subcontract w/ F&A
Year 1
Direct
$50,000
$25,000
F&A
$26,500
$13,250
Year 2
Direct
$50,000
$25,000
F&A
$26,500
$13,250
Subcontract w/ F&A excluded
65,000 0 65,000 0
November 2011 QRAM

New Object Codes created for use when charging external genomic array purchases to NIH awards:
• Object Code 7010:
– Use on NIH awards only. Genomic Array expenditures in excess of $75,000 per year from external sources are exempt from F&A in the MTDC base.
• Object Code 7011:
– Use on NIH awards only. Genomic Array expenditures form external sources less than $75,000 per year to be charged to F&A in the MTDC base.
November 2011 QRAM

Human Research
Protections/Sponsored
Projects Administration
Update
Beverly Esparza,
Assistant Director, Human
Research Protections besparza@uci.edu
(949) 824-5746
 Determination of Human
Subjects Research
Chris Abernethy,
Principal Contract and Grant
Officer
Chris.Abernethy.uci.edu
(949) 824-1749
November 2011 QRAM

Sponsored Projects
Administration Update
Barbara Inderwiesche
Senior Contract and Grant Officer
Sponsored Projects Administration barbarai@uci.edu
949.824.7697
Allison Ramos
Principal Contract and Grant Officer
Sponsored Projects Administration acramos@uci.edu
949.824.3428
 Gift/Grant Distinctions
November 2011 QRAM

Sponsored Projects
Subaward Update
Nancy Lewis
Director, Sponsored Projects
Administration nancy.lewis@research.uci.edu
949.824.2897
 Subaward Reminders
November 2011 QRAM

 Effective, October 1 st , form is required for all proposals that include subawards and after-the-fact subawards proposal submissions.
 Provides SPA with data and assurances that we need to meet federal reporting and compliance requirements (FFATA, ARRA etc.)
 Must be submitted at the proposal stage as part of the proposal package submitted to the Sponsored Projects
Officers for review.
 SPA is seeking clarification from the NIH policy office regarding the need for a letter of commitment/intent the proposal.
Clarification will be disseminated via the SPA list serve .
 SPA staff may ask for that it be completed for proposals submitted prior to October 1 st as a means to collect data or assurances needed for the prime proposal.

Sponsored Projects
Subaward Update
Bruce Morgan
Assistant Vice Chancellor for
Research/Research Administration
Bruce.Morgan@uci.edu
949.824.5677
 Patent
Acknowledgement
Amendment
November 2011 QRAM

November 2011 QRAM