The NIH booklet Setting Research Priorities has fairly full discussions of priority-setting criteria and their complexity, descriptions of the various mechanisms used to solicit advice, and lists of the types of individuals, groups, and organizations that are routinely consulted, but it contains little about the planning and budgeting processes that result in the annual budgets and the expanded and new initiatives that those budgets typically contain. The best description was probably provided by NIH Director Harold Varmus to the House appropriations subcommittee in 1997 (U.S. House of Representatives, 1997a:73-76).
In those hearings, the NIH director described priority setting as continuous and occurring at two pivotal levels: at the level of the institute directors and at the level of the director of NIH. The central element of the NIH planning process is the annual meeting of the NIH Leadership Forum, composed of the NIH director, the institute directors, and NIH administrators responsible for major trans-NIH research and management issues (e.g., women's health, rare diseases, and alternative medicine).
The actual dollar amount allocated to NIH is the result of a complex process of negotiations among OMB, DHHS, the NIH director, and Congress. Because of NIH's commitments to infrastructure and multiyear grants (its commitment base), each year it can realign only a fraction of its budget.1 More specifically, the NIH director can set new priorities only with additional funds received beyond the commitment base.
Historically, an expansion of research in one area has resulted in a decrease in another area. Only in times of real growth have significant realignments been made. A further constraint on change comes from the fact that each of the institutes receives a separate appropriation from Congress, as do the Office of the Director, the Office of AIDS Research, and buildings and facilities. Budgets are put together from the bottom up (from the institutes and centers and through the NIH director) and are reconciled with budget limits and programmatic priorities imposed at higher levels within NIH, DHHS, and OMB in a long, complex, and interactive process. The institute budget proposals are negotiated with DHHS and OMB through the NIH director, who submits an NIH budget overview to the appropriations committees along with the individual institutes' budgets and, most importantly, works with the appropriations committees on how to distrib-
In addition, it is important to note that NIH has several mandated activities requiring collaboration with other federal agencies, such as the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Environmental Protection Agency, the U.S. Department of Defense, and NSF.