The National Institute of Diabetes & Digestive & Kidney Diseases

Implementation of Expedited Concurrence of En Bloc Actions

This documents policy for the expedited concurrence of en bloc actions of all grant and cooperative agreement mechanisms. The purpose is to provide the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) staff with the opportunity to make awards meeting specific circumstances in a more timely, responsive and responsible manner.

The application review and award process currently takes a minimum of nine months from application submission to potential award, and in many cases, the period can be approximately a full year or longer. Over the years, the number of applications reviewed and the addition of new requirements has increased the steps and time necessary to issue an award.

Applications are reviewed three times per year, and the award start dates cluster around the earliest project start dates of December, April, and July. Because awards are often not made during the months of October and November, the preponderance of award activity falls from December through September. Due to other mitigating circumstances, the bulk of activity falls within the last quarter. One of the many factors that limit a smoother award process is that the Advisory Council must conduct second level review of applications prior to award. The National Institutes of Health (NIH), in an effort to improve the efficiency of making awards, has authorized the use of an expedited review process by initiating OER Policy Announcement 1999-01 entitled "Council Operating Procedure for Expedited En Bloc Concurrence," dated February 17, 1999.

The trend in RPG growth during recent years, combined with the number of noncompeting awards, required the implementation of expedited concurrence of en bloc actions during FY2002. In 2002, the National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC) implemented expedited en bloc concurrence procedures for R01 and R03 applications meeting specific criteria. For FY2002, because of this new authority, NIDDK received concurrence for early award of 245 applications and of these, a significant number received earlier start dates than would have been possible prior to implementation of early concurrence. During FY2003, NIDDK staff extended the early concurrence activity to all grant and cooperative agreement applications, including those competing for RFA funds. This was particularly advantageous in 2003 because of the disproportionately high number of RFA's combined with the extremely short amount of time available between the Council meeting and the end of the fiscal year.

For all grant and cooperative agreement applications which have no concerns noted that would represent an administrative bar to award (e.g., for human subjects, animal welfare, biohazards or inclusion of women, children and appropriate minority distribution), excluding those from foreign organizations, a process of expedited concurrence will be used whereby the power to review applications is delegated by the Chairman of the Advisory Council to specifically designated Council members acting on behalf of the Advisory Council as a whole. The concurrence committee shall consist of the Council Executive Secretary and six members of the NDDKAC. Two members will be selected from each subcommittee of the NDDKAC.

The Executive Secretary will alert the concurrence committee members with responsibility for expedited concurrence when review outcomes for eligible applications are available in the Electronic Council Book. The Executive Secretary will provide the following information electronically to the members: Application Number, Principal Investigator, Project Title and Percentile/Priority Score.

Electronic or written concurrence by a minimum of two members with no votes for nonconcurrence within seven days of notification of posting is required for expedited concurrence approval. Any member may bring an application to full NDDKAC consideration without the need for justification. Any single vote for non-concurrence within the allotted time period will result in that application going for regular consideration to the NDDKAC under its normal procedures for concurrence. Members not acting upon an application within the allotted time period after posting will be considered to have abstained from a vote on that application. Expedited listings lacking enough votes for final action will be presented to the regular NDDKAC meeting for review.

The full NDDKAC will be provided with a list of all applications eligible for expedited concurrence, as well as the outcome of the vote by the concurrence committee members on those applications. The Executive Secretary will report the expedited concurrence recommendations during the closed session of the full Advisory Council meeting when reviewed applications are discussed. The NDDKAC may reconsider the parameters for expedited eligibility at the first Council meeting of each calendar year.

Public Health Service Act (Sec. 492 [289a])

42 CFR Part 52h – Public Health

OER Policy Announcement 1999-01 – Council Operating Procedure for Expedited En Bloc Concurrence