Skip to main content
HHS Logo U.S. Department of Health & Human Services NIH Logo National Institutes of Health

General Council Operating Procedures

Contact

Anna L. Ramsey-Ewing, Ph.D.

B. Duane Price, Ph.D.

Advisory Councils at the National Institutes of Health (NIH) provide second-level review of all grant applications under consideration for institute or center funding. Each Council is required to establish general operating procedures for the review of grant applications. These procedures must be in writing and should be reviewed once a year.

The sections below explain the operating procedures associated with the National Center for Advancing Translational Sciences Advisory Council (hereafter referred to as Council) for the following activities:

  • Council may vote in either en bloc or individual actions.
  • Council will give special consideration to well-funded Investigators.
  • Council will give special consideration to foreign applications and applications with international collaborations.
  • Council may conduct expedited reviews as well as early concurrence voting.
  • Council may delegate selected activities to staff.
  • Council has the ability to form subcommittees to perform its duties.

Second-Level Review of Grant Applications

En Bloc and Special-Action Voting

Prior to a Council meeting, Council members review an electronic summary of the peer review results for grant applications assigned to NCATS for funding consideration. Council members consider the adequacy of the review and are asked to concur with the review. Most of the concurrence voting occurs through en bloc actions.

En bloc voting occurs for applications with the following attributes:

  • Have an overall impact score, are deemed competitive but not discussed or otherwise fall within the fundable range for a specific group of applications;
  • Neither from a foreign institution nor that include a foreign collaboration;
  • No unresolved human subject, animal or biohazard concern identified by the study section or NCATS staff;
  • No unresolved issues regarding the recruitment of women, minorities, or children or data monitoring identified by the study section or NCATS staff; and
  • No unresolved appeal letters or other issues requiring attention of the full Council.

Specific Council consideration is required for special issues that include, but are not limited to, applications that meet the following criteria:

  • Human Subjects. Applications proposed for award with unresolved concerns about protection of human subjects (Code 48).
  • Inclusion of Women and Minorities as Subjects in Clinical Research. Applications a Division/Office (DO) plans to award with an unresolved inclusion issue ("U" code).
  • Inclusion Across the Lifespan in Clinical Research. Applications a DO plans to award with an unresolved inclusion issue ("U" code).
  • Use of Animals in Research. Applications proposed for award with unresolved concerns about protection of animals in research (Code 44).
  • Biohazards. Applications proposed for award with unresolved concerns about biohazards.
  • Select Agents. Applications proposed for award with unresolved concerns about use of select agents.
  • Authentication of Key Biological and/or Chemical Resources. Applications proposed for award with unresolved concerns about authentication plans.
  • Resource Sharing Plans. Applications proposed for award with unresolved concerns about resource sharing plans.
  • Training in the Responsible Conduct of Research. Applications proposed for award with unresolved concerns about plans for training in the responsible conduct of research.
  • Discretionary. Applications program staff present to Council for items such as adding substantial funds or years when obtaining Council's advice for public health, political, or scientific reasons is important.

Specific Council discussion and consideration are required for special actions that include, but are not limited to, applications that meet the following criteria:

  • Special Council Review of Well-Funded Investigators. Principal Investigator (PI) covered under NIH’s Special Council Review Requirement (PI currently awarded $2.0 million or more in total costs through certain NIH research mechanisms);
  • Special Council Review of Pending Foreign Applications and Applications with International Collaborations. Foreign applications and domestic or foreign primary applications that include foreign projects; foreign projects must be funded as primary awards, not sub-awards.
  • Reinstatement of Research Aims. Applications for which the DO is requesting to reinstate Specific Aims or research not recommended for support by the study section;
  • Restoration of Budget. Applications for which the DO is requesting to reinstate some or all of the budget not recommended by the study section;
  • Not Discussed Applications. Any "Not discussed" applications a DO proposes to award;
  • Non-Peer-Reviewed Applications. Used in some circumstances, for example, type 4 MERIT awards. Council performs both initial peer review and second-level review functions;
  • Deferred Applications. All applications deferred from the previous Council, independent of review results and/or
  • Appeals. Formerly called rebuttals. Applicants may appeal the results of peer review for flaws in the review process.

In addition to the applications identified above, the NCATS director or any Council member may ask that any individual application or group of applications be discussed.

Options Available to Council

Voting options include:

  1. Concurrence — Concurrence with initial review recommendation.
    A Council may not change the outcome of initial peer review, that is, numeric overall impact scores, criterion scores or designation as competitive but not discussed. Other — An unusual action that cannot be identified as Concurrence, such as changes in recommended budget and/or duration of support. Use of this code is optional at the IC’s discretion.
  2. Deferred — This action could be taken if additional information is required prior to voting or if an error requires the re-review of an application.
  3. Not Recommended by Council — Non-concurrence with initial review.

Special Council Review of Pending Applications from Well-Funded Investigators

In an effort to continue responsible stewardship of public funds and to support meritorious and innovative research, NIH has instituted a policy of Special Council Review (SCR) of applications from well-funded investigators.

Applications before Council from Program Directors/Principal Investigators (PD/PI) who have more than $2.0 million in total costs from active NIH Research Project Grants (RPGs) grants will be subject to additional consideration. Council members will receive a list of those PIs and their applications that fall under this requirement. It is important to recognize that this is a threshold for special review only: investigators who have research support greater than $2.0 M in total costs may continue to receive additional awards as warranted.

When making funding recommendations, staff and Council members will consider factors such as: how innovative and distinct the pending project is from the PD/PI’s other grants; the type of research (since cost requirements differ substantially by field); the public health priority of the research; and how the absence of an award impacts other collaborative or translational research efforts.

Special Council Review of Pending Foreign Applications and Applications with International Collaborations

In an effort to address the need for reporting and oversight and to support meritorious and innovative research, NIH has instituted a new policy for grants requesting NIH funding for one or more foreign components. NIH requires that foreign applications be submitted to a Notice of Funding Opportunity (NOFO) that allows foreign applications and that domestic applications that include international collaborations (“foreign projects”) be submitted to a NOFO that supports appropriate activity codes, that is, that support the International Project component type.

Foreign applications and applications with international collaborations before Council will be subject to additional consideration. Council members will receive a list of those PIs and their applications that fall under this requirement. It is important to recognize that foreign components other than those previously supported by subawards or consortia agreements (e.g., foreign consultants, international travel) may continue to be supported through other activity codes unless otherwise specified in the NOFO.

When making funding recommendations, staff and Council members will consider factors such as: how innovative and distinct the pending project is from the PD/PI’s other grants; the public health priority of the research; whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources, whether the proposed project has specific relevance to the mission and objectives of the IC and has the potential for significantly advancing the health sciences in the United States, and how the absence of an award impacts other collaborative or translational research efforts.

Expedited Review

Staff may request expedited electronic review for eligible applications.
All Council members will be asked to participate in the expedited review, will be notified of the applications under consideration, and will have secure access to the summary statements.
Expedited electronic review may be designated for, but not limited to:

  • Applications that require the immediate availability of time-limited, unique resources;
  • Applications that were administratively deferred or re-reviewed due to a successful appeal; and
  • Applications received in response to Request for Applications (RFAs).

Early Concurrence

The Chair of Council will select two members or more of Council to provide the en bloc early concurrence on behalf of the full Council for a specified group of applications.

The Executive Secretary of Council will determine which applications, meeting the following criteria, are eligible for the en bloc early concurrence voting process:

  • Have an overall impact score, are deemed competitive but not discussed or otherwise fall within the fundable range for a specific group of applications;
  • From neither a foreign institution nor that include a foreign collaboration;
  • No unresolved human subject, animal or biohazard concern identified by the study section or NCATS staff;
  • No unresolved issues regarding the recruitment of women, minorities, or children or data monitoring identified by the study section or NCATS staff; and/or
  • No unresolved appeal letters or other issues requiring attention of the full Council.

All Council members will be provided with a list of the names, institutions, project titles, requested dollars and priority scores/percentile ranks proposed for the en bloc early concurrence. If any Council member determines an application should come to the full Council for discussion or should not be expedited for any reason, he or she needs to notify only the Executive Secretary by the response date, and the application will be removed from the early concurrence en bloc list.

Two or more designated Council members will receive and review the list of the names, institutions, project titles, requested dollars, and priority scores/percentile ranks for all eligible early concurrence en bloc applications, as well as summary statements. The selected Council members will notify the Executive Secretary of the results of their review by the requested response date. Concurrence by the majority of selected members is required for approval. Any single vote for non-concurrence will result in that application going before the Council for full consideration at its upcoming meeting.

A report of the Early Concurrence en bloc recommendations will be presented at each Council meeting.

Applications receiving early concurrence will be eligible for funding as soon as the Executive Secretary of Council has certified that the review is complete.

Concept Review

As the Center continues to address its mission through the support of the most current relevant research and research training, it may be necessary to develop specific research initiatives to solicit applications on a given topic. Descriptions of planned research initiatives are presented to Council in the form of Concept Clearances for proposed Funding Opportunity Announcements (FOAs) or contract solicitations. These documents present the objectives and rationale for the concept, and the current scientific needs and opportunities.

Two or more Council members are asked to serve as reviewers (“discussants”) of each concept.

Following discussion of the concept, Council members may take one of the following actions:

  • Approval with or without modifications;
  • Disapproval; or
  • Deferral for further development and discussion.

Delegations of Authority

The Council delegates the following authority to the NCATS staff for the administrative actions described below. 

Program staff, in consultation with Grants Management staff, may take administrative action without prior Council approval to award funds greater than the amount recommended by Council for research and training grants and cooperative agreements to support increased operational costs not anticipated at the time the Council recommended approval of the project.

Administrative increases and extensions should be provided only when necessary for the successful conduct of the project and must not represent changes in the basic goals or intent of the project. Generally, these administrative increases will be no more than 25 percent of the current year’s awarded direct costs. A list of all administrative supplements will be provided to Council members for informational purposes only. These increases may cover unanticipated costs of a project and can include, but are not limited to:

  • Cost increases due to state, university or labor union stipulated salary increases in fringe benefits;
  • Increased federally negotiated facilities and administrative cost rates or loss of equipment originally available to the project from other sources;
  • Increased cost of equipment and related services (e.g., data analysis);
  • Making minor modifications for the purpose of taking advantage of serendipitous and other unanticipated opportunities to increase the value of the project consistent with the originally approved objectives and purposes of the project;
  • Preparing and disseminating materials concerning the project and for the purpose of ensuring that important findings from the project are made widely available in a timely and effective manner;
  • Orderly termination of a project;
  • Bridge funding; and/or
  • Administrative correction to correct an error in the submission of an application.

Consistent with NIH policy, administrative supplements and extensions may be made for the purpose of extending the period of support to ensure orderly termination of a project or to support a project for a limited time, pending a decision or action to continue or discontinue support (e.g., when there is an Initial Review Group or Council deferral) where support would terminate before completion of review. Extensions of projects made for this purpose should be for periods as brief as possible, but usually should not exceed one year.

All administrative supplements must be endorsed by the NCATS director. In addition, the Council will be informed of all such administrative actions at the January meeting.

Subcommittees

As necessary, subcommittees may be established by the executive secretary or other designated government official within the Council’s jurisdiction. The advice/recommendations of a subcommittee must be deliberated by the parent advisory committee. A subcommittee may not report directly to a federal official unless there is statutory authority to do so.

A member of a standing subcommittee may serve as a voting member of another standing subcommittee but may not be counted toward determining a quorum. The quorum for a standing or ad hoc subcommittee is three.

Exceptional Circumstances

As circumstances require, based on programmatic considerations, the Director of NCATS, after consultation with Council, may make exceptions to these guidelines.

Exceptions to these procedures should be extremely rare because there needs to be consistent application of these procedures across extramural divisions. Nonetheless, circumstances may require deviation from the prescribed procedure in order to achieve the mission of the NCATS. By NCATS Advisory Council (NCATSAC) delegated procedures, the Director, NCATS has authority to act upon unusual or extenuating circumstances. These actions are usually discussed by a subset of Council members selected by the Director and Executive Secretary of NCATSAC. Any actions of this exceptional nature must be appropriately documented as necessary for the official record and should be reported to Council at its next scheduled meeting.

Anna L. Ramsey-Ewing, Ph.D.
Executive Secretary
National Center for Advancing Translational Sciences Advisory Council

Jan. 29, 2026

References

Last updated on February 9, 2026