Post Award Administration

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Post Award Administration

• Mary Kirker
• Chief, Grants Management Officer
• National Institute of Allergy Infectious
  Diseases
• July 22, 2007
• Sydney, Australia

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Discussion

• Notice of Grant Award (NoA)
• Yearly Progress Report (2590)
• Prior Approvals

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Notice of Grant Award
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What Is a Notice of Award?

• The Notice of Award (NoA) is the legal document
  issued to notify the grantee that an award has
  been made.
• The NoA is issued for a budget period of up to 12
  months.
• A new NoA will be issued for each year of the
  project.

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What Is a Notice of Award?

• The NoA is provided in letter format
• One copy of the NoA is provided by e-mail or by
  mail to the grantee institution listed on the
  application.
• It is forwarded to the business office that signs
  the application. The business official provides
  the principal investigator with a complete copy
  of the NoA.
• The Latest NoA can be seen in the eRA Commons.

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Principle Investigators eRA Commons View
Here is the link to the latest NoA

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Example
Grant number

Budget period
Project period
Award amount
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Notice of Award

• A grantee organization indicates acceptance of an
  NIH award and its associated terms and
  conditions, including restrictions, by spending
  1 U.S. of the awarded funds.

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Notice of Award

• YOUR OBLIGATION
• AS A GRANTEE
• IS TO READ AND ABIDE BY
• THE TERMS OF YOUR
• NOTICE OF AWARD

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Terms of AwardNotice of Award Sections III IV

• Terms of Award are legally binding.
• Terms of Award accompany every NoA issued by the
  U.S. government.
• They can either be informational, or restrictive.
• They are often applied to clarify any funding,
  human subjects, or animal welfare issues.

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NIH Grants Policy Statement

• The NIH Grants Policy Statement is a term of
  award and summarizes all policy requirements that
  serve as terms and conditions of NIH grant
  awards.
• The NIH Grants Policy Statement is available on
  the World Wide Web at
• http//grants.nih.gov/grants/policy/nihgps_2003/i
  ndex.htm

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NIH Grants Policy Statement
Starting on page 228 is a section devoted to
Grants to Foreign Institutions, International
Organizations, and Domestic Grants with Foreign
Components.
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Notice of AwardRestrictive Terms

• There are two types of restrictive terms
• One which restricts the use of funds for a
  purpose (Example for purchasing a specific piece
  of equipment),
• OR
• A Temporary Restriction of all or a specified
  amount of funds until issues or assurances have
  been resolved.
• Restrictions are only lifted by a Revised Notice
  of Award.

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Notice of AwardAdministrative Terms Conditions
of Award

• Administrative terms and conditions on the NGA
  may include
• Issues related to funding, including funding
  restrictions
• Human subject or animal welfare issues
• NIAID required clinical terms
• Special Requirement of the Institute (identified
  Key Personnel accrual requirements for future
  funding). Often these requirements are in the
  solicitation (RFA).

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Temporarily restricted use of funds for Human
Subject research until FWA approved
Addressed the need for Financial Status Reports
Referenced the NIAID rules on Human Subject
Research
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Programmatic Terms of Award

• Programmatic Terms of Award are a part of all
  Cooperative Agreements awards
• They are specific to the grant solicitation
  (RFA/FOA) and/or award.
• They are organized in the following sections
• Applicability
• Awardee Rights and Responsibilities
• NIAID Staff Responsibilities
• Collaborative Responsibilities
• Arbitration

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Programmatic Terms of Award
Programmatic term referencing the Cooperative
agreement terms
The Cooperative Agreement Terms of Award
Incorporated by reference
These are additional terms of award that must
also be followed
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Yearly Progress Report
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Public Health Service (PHS 2590)

• Public Health Service (PHS 2590), or
  Non-Competing
• Grant Progress Report
• http//grants.nih.gov/grants/funding/2590/2590.htm
  
• What is a PHS 2590?
• A progress report for the year ending
• A budget for the next year
• Other required information.
• When is my PHS 2590 due to NIH?
• Two months before the next budget period. For
  example, with a budget start date of April 1st,
  the report would be due to NIH on February 1st.

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Public Health Service (PHS 2590)

• Send your NIAID PHS 2590 application to
• Division of Extramural Activities Support
• Office of Extramural Research
• National Institutes of Health
• 6705 Rockledge Drive
• Room 2207, MSC 7987
• Bethesda, MD 20892-7987
• (for regular or US Postal Service Express
  mail) OR
  
• Bethesda, MD 20817
• (for other courier/express mail delivery only)
  
• NIH Guide Notice http//grants.nih.gov/grants/gui
  de/index.html
• 
  

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PHS 2590 What does NIAID staff review?

• Is progress satisfactory? Are there changes in
  the scope, goals, or objectives
  of the project?
• Are there any changes in key personnel or their
  level of effort?
• Is there evidence of scientific overlap?
• Are there changes or concerns regarding human
  subjects research?
• Is gender and minority information provided?
• Is recruitment and retention appropriate and on
  schedule?
• Are there changes in other support?
• Are there changes or concerns regarding animal
  care and use?
• Are there inventions?
• Are there large unobligated balances?
• If applicable, have enrollment tables been
  included?
• Any other issues which arise.

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PHS 2590 Tips for Preparing your
Non-Competing Budget

• FOREIGN APPLICATIONS NEED TO SUBMIT BUDGETS IN
  THE NON-COMPETING APPLICATION
• Budget instructions for Foreign Institutions
  NOT-OD-06-096
• http//grants.nih.gov/grants/guide/notice-files/N
  OT-OD-06-096.html
• For instructions forms http//grants.nih.gov/g
  rants/funding/2590/2590.htm
• Budget should not exceed total costs as reflected
  on the previous years Notice of Award (NOA).
• Itemize categories such as Personnel, Supplies
  and Other expenses.
• Consortium Partners are also required to submit
  categorical budgets and justifications.

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Prior Approval
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What is..

• Prior Approval
• Expanded Authority
• Carryover Request

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What Requires Prior Approval?

• No-Cost Extensions beyond the first extension
• Change in Principal Investigator
• Change of Grantee Institution
• Pre-Award costs more than 90 days
• Carryover of restricted funds or as designated in
  the Notice of Award
• Rebudgeting over 25 of Total Cost Awarded
• Undertaking activities disapproved or restricted
  as a term of award
• Change in Scope or Research Objectives
• Actions needing additional funding

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Prior Approval for Foreign Grants

• Prior Approval specifically for foreign grants is
• required for
• Change in performance site within a foreign
  country other than that specified in the approved
  application
• Transfer of work by a domestic grantee to a
  foreign component
• Transfer of a grant from a foreign organization
  to a domestic organization

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Change in Scope

• Actions likely to be considered a change in scope
  include
• Change in specific aims
• Substitution of one animal model for another
• Any change from the approved use of animals of
  human subjects
• Shift of the research emphasis from one disease
  area to another
• A clinical hold by FDA under a study involving an
  IND or IDE

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Change in Scope

• Actions likely to be considered a change in scope
  include
• Application of a new technology
• Transferring the performance of substantive
  programmatic work
• Change in key personnel
• Significant rebudgeting
• The purchase of equipment exceeding 25,000

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Requests for Prior Approval

• Submitted in writing via letter or email
  include complete grant number, PI name and
  contact information, grantee name.
• Signed or sent by the Authorizing Official.
• Submitted to the awarding Institute/Center (IC)
  Grants Management Specialist no later than 30
  days before the proposed change.
• Only responses to prior approval requests signed
  by the Grants Management Officer are valid.

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What Is Expanded Authority?

• Cost-related and other prior-approval
  requirements for activities and expenditures
  waived by NIH.
• Expanded Authority provides grantees flexibility
  to make some changes in their approved project or
  budget without prior approval.
• Foreign Grants ARE included under Expanded
  Authorities unless excluded on the Notice of
  Award.

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Example
Grant under Expanded Authorities
Term and condition of award excluding this grant
from automatic carryover of unobligated funds
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What Is Expanded Authority?

• With Expanded Authority, grantees are not
  required to request prior approval to
• Extend a project period for up to 12 months
  beyond the original expiration date IF
• Additional funds are not required
• Original approved scope will not change
• Any of the following applies
• Additional time required for adequate completion
• Continuity of support while competing
  continuation is reviewed
• Necessary for orderly phase out
• The fact that funds are remaining is not
  sufficient justification.

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What Is Expanded Authority?

• With Expanded Authority, grantees are not
  required to request prior approval to
• Transfer work to a third party through consortium
  agreement IF
• It does not constitute a change of scope
• Not a foreign subcontract

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What Is Expanded Authority?

• With Expanded Authority, grantees are not
  required to request prior approval to
• Make cost-related changes, including rebudgeting
  of funds, up to 25 of the Total Cost Awarded,
  for all categories unless these changes
  constitute a change in scope.
• Carryover unobligated/unspent balances certain
  mechanisms are excluded.
• You will need to pay close attention to the
  Notice of Award (NoA) to see if the Terms of
  Award include specific actions not allowed.

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Requests to Carryover Unobligated/Unspent Funds

• A carryover of unobligated/unspent funds from one
  budget period to the next requires prior written
  approval in the form of a Revised NoA for certain
  mechanisms.
• NIAID will only approve a request to carryover
  funds if the current award can not cover all
  requested expenses.

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Requests to Carryover Unobligated/Unspent Funds

• To request a carryover of unobligated/unspent
  funds, the grantee must
• Have submitted current Financial Status Report
  (FSR).
• Submit a written request to the NIAID grants
  management and program officers.

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Rule of Thumb

• Whenever Principal Investigators are
  contemplating post-award changes and are
  uncertain about the need for prior approval,
  consult, in advance, with
• Grants Management Specialist listed on the Notice
  of Award (NoA)
• Written policies and regulations
• (e.g. NIH Grants Policy Statement)

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NIH Websites

• NIH Grants Policy Statement http//grants2.nih.go
  v/grants/policy/nihgps_2003/index.htm
• NIH Guide Notice NOT-OD-00-09, Process for E-Mail
  Submissions of Prior Approvals for NIH Grants and
  Cooperative Agreements http//grants.nih.gov/grant
  s/guide/notice-files/NOT-OD-00-009.html
• NIH Guide Notice NOT-OD-06-054, NIH Announces
  Change in Business Process Replacing Principal
  Investigator Signature on Grant Applications,
  Progress Reports, and Prior Approval Requests
  with an Institutional Compliance Requirement
  http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-06-054.html

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NIAID Websites

• NIAID Division of Extramural Activities--Standard
  Operating Procedures for Carryover Requests
  http//www.niaid.nih.gov/ncn/sop/carryover.htm
• NIAID Division of Extramural ActivitiesStandard
  Operating Procedure for Expanded Authorities or
  Federal Demonstration Partnership
  http//www.niaid.nih.gov/ncn/sop/ea.htm
• NIAID Division of Extramural ActivitiesStandard
  Operating Procedure for Prior Approvals for
  Post-Award Grant Actions SOP http//www.niaid.nih.
  gov/ncn/sop/priorapproval.htm