NIAAA Guidelines – Administrative Supplements and Extensions

Administrative supplement applications submitted in response to the NIH Notice of Funding Opportunity (NOFO) PA-20-272, Administrative Supplements to Existing NIH Grants and Cooperative Agreements (parent administrative supplement NOFO).

NIAAA may accept unsolicited administrative supplement applications submitted through PA-20-272, or linked to a notice of special interests (NOSI), which must be indicated in Box4B of the application.

Timeline

Unless otherwise specified (i.e., in the linked NOSI), NIAAA’s receipt dates for administrative supplement applications submitted in response to PA-20-272 are on a rolling basis. However, funding considerations will be processed by NIAAA only twice a year: for administrative supplement applications received on or before January 31^st, and for those received on or before July 15^th. Applications received after July 15^thwill be considered for funding during the next fiscal year.

Procedure

Discussion with Program Officer (PO).

As soon as it is apparent that a grant may need additional funds, NIAAA recommends that the Principal Investigators (PI) contact the PO named on the parent grant Notice of Award to discuss the possible funding options available.

Submission

If the PO deems that an Administrative Supplement may be considered, the grantee may submit an administrative supplement electronically (ASSIST or eRA Commons) through the parent administrative supplement NOFO PA-20-272, directly or through an appropriate NOSI.

IMPORTANT: Project Summary/Abstract of the administrative supplement application must include a brief description of purpose and scope of the supplement. If description of purpose and scope of the supplement is missing in the Project Summary/Abstract, the application will be rejected.

During electronic submission, if prompted, applicants must also complete “Introduction to the Supplement”. For funding consideration, if applicable, all applicants must designate “NOT-IC-XX-XXX” (without quotation marks) in the Agency Routing Identifier field (Box 4b) of the SF424 (R&R). Grants Management Branch may refuse incomplete or non-compliant applications. Grantees are encouraged to check updates in the eRA Commons Accounts.

Inform NIAAA Office of Extramural Activities

Grantees may alert the NIAAA Office of Extramural Activities (OEA) at niaaaoea@mail.nih.gov, as soon as the administrative supplement application is submitted.

Considerations for acceptable Administrative Supplements

NIAAA awards well-justified administrative supplements only when necessary to the successful conduct of a funded project and only if funds are available. Administrative supplement requests must be within the original Council-approved scope of the research. Increased funding above study section-recommended levels or outside the fiscal year funding policies generally is for items resulting from events unanticipated when the parent application originally was submitted that cannot be paid for by re-budgeting funds or from utilization of unobligated balances from prior year awards and must not represent changes in the basic goals or intent of the project.

NIAAA may fund administrative supplements to cover unanticipated costs of a project and may include the following examples:

• Preservation of a unique research material or resource that may otherwise be lost, such as maintaining a unique knockout mouse model.
• Addition of patients, populations, or other items related to a protocol due to enrollment issues, a need for statistically significant data, or responses to protocol and Data and Safety Monitoring Board (DSMB) reviews.
• Provision for an orderly termination or temporary continuation of support to prevent loss of research resources or hardship of personnel, which includes taking advantage of a rare event with an immediate need, such as salvaging a rare animal model.
• Replacement of equipment, supplies, and time lost due to a natural disaster or loss of equipment originally available to the project from other sources.
• Increased cost of equipment and related services, e.g., data analysis, animal purchase and care costs.
• Hardships caused by the COVID-19 pandemic, e.g., well-documented lab closure, absence of research staff, disruption in the recruitment of study population.

Extension with funds

NIAAA may support administrative supplements made for the purpose of extending the period of support to assure orderly termination of a project or to support a project for a limited time pending a decision or action to continue or discontinue support (for example, when there is an IRG or Council deferral and support would terminate before completion of review).  Extensions of projects made for this purpose should be for short periods, not to exceed one (1) year.

NIAAA may fund administrative extension of investigator-initiated clinical trial grants or cooperative agreements that may not be completed on time due to the following:

• Difficulties in obtaining suitable study subject and/or agent.
• Difficulties meeting enrollment schedule.
• Difficulties obtaining assurances and certifications.
• Difficulties with access to suitable facilities
• External hold ups at regulatory funding agencies (not related to safety)
• Litigation involving any of the above
• Changes in public health policy or standards of care.

Procedure

Discussion with Program Officer (PO).

As soon as it is apparent that a grant may need an extension to complete the project, NIAAA recommends that the Principal Investigators (PI) contact the PO named on the parent grant Notice of Award to discuss the possible funding options available.

Inform NIAAA Office of Extramural Activities

Applicants are encouraged to send a letter of intent (LOI) to submit an administrative supplement application to extend an active grant with funds. LOIs are sent to niaaaoea@mail.nih.gov.

Submission

Instructions on how to submit an Extension with Costs application will be provided by PO and/or by NIAAA OEA.

IMPORTANT:

• Extension with Costs applications must be submitted through PA-20-272.
• If planning to submit an Extension with Costs application, do not initiate NCE.

Unacceptable Administrative Supplement and Extension Applications:

• Funding consideration during the first year of the parent grant (new and competing renewals). Exceptions are: unavoidable circumstances due to natural disasters), or emergencies, such as failure of scientific instruments for the exclusive use of the grantee, and not departmental shared appliances.
• Request for support of parent grants that are in no cost extension or going into no cost extension.
• Support to pay for a PI to move in a new scientific direction; obtain preliminary data for another contemplated research effort; use a new technology or an animal model not specified in the original application; or to accomplish new specific aims that are not part of the original Council-approved grant application.
• Support of a parent conference grants (R13/U13). Grantees may consider submitting new or revision (competitive supplement) application if the goals of the supplement are to include new symposia, workshops and/or to participate in other scientific meetings that are not originally proposed in the funded grant. Exceptions may be considered for R13/U13 administrative supplement applications responding to specific NIH-issued notices of funding opportunity (excluding PA-21-151 (R13/U13 FOA,), and/or instances that will compromise the success of the parent conference grants, such as unexpected increases in costs due to natural disasters and other emergencies.

Evaluation of Administrative Supplements and Extensions

Administrative supplements and extensions are evaluated by Program Staff for scientific merit. A Grants Management Officer reviews the appropriateness of the budget requests and ensures requests adhere to regulatory and all other requirements described in the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/nihgps.pdf.

Administrative supplement requests that exceed $100,000 AND more than 25% of the direct costs of the active year of the parent grant will undergo a second level of review and recommendation of approval/disapproval by the National Advisory Council on Alcohol Abuse and Alcoholism and the Director, NIAAA.

The parent grant must be active for at least another 12 months at the time of submission. Exceptions may be granted after discussion with the Program Officer, Chief of the Grants Management Branch, and Director of the Office of Extramural Activities in rare circumstances.

Awarded or active administrative/revision supplements are not transferrable to a new institution.

Non-compliant administrative supplement applications may be rejected.

Diversity Supplements

See: NIAAA Research Supplements to Promote Diversity in Health-Related Research | National Institute on Alcohol Abuse and Alcoholism (NIAAA) (nih.gov)

Contacts:

Ms. Judy Fox
Chief, Grants Management Branch
Office of Extramural Activities, NIAAA
301-443-4704
jfox@mail.nih.gov

Philippe Marmillot, Ph.D.
Director
Office of Extramural Activities, NIAAA
301-443-2861
niaaaoea@mail.nih.gov