2. Remarks of the Director, NIAID

Anthony S. Fauci, M.D.

Dr. Fauci opened the Monday afternoon, January 25, session of Council by welcoming visitors to the 131^st meeting.

He announced the appointment of five new Council members: Dr. Kim Bottomly; Dr. Raif Geha; Dr. Ellen Goldberg; Dr. Barton Haynes; and Marie Saint-Cyr.

Dr. Fauci welcomed the ad hoc Council members: Dr. Douglas Fearon, Director, Wellcome Trust Immunology Centre, Cambridge UK; and Dr. Giorgio Trinchieri, Professor, The Wistar Institute, Philadelphia, Pennsylvania.

The minutes of the September 24-25, 1998 meeting were considered and approved as written.

Dr. Fauci announced Dr. Daniel Rotrosen's appointment as Director, Division of Allergy, Immunology, and Transplantation (DAIT). Within the Office of the Director, NIAID, Dr. Jane Kinsel has been appointed Director of the Office of Policy Analysis; and, Laurie Doepel has been appointed Acting Director, Office of Communications and Public Liaison.

Operating procedures had been sent to Council members for review. No modifications were suggested and they were approved.

In his budget update, Dr. Fauci informed Council that NIAID had received a budget allocation of $1,570,102,000, a 16.4 percent increase over FY 1998. This increase compares favorably to the NIH average of 14.6 percent. He also addressed the $30 million additional dollars Congress placed in the NIAID budget for autoimmunity research. NIAID will transfer some of the money to other institutes to support initiatives in this high-priority area.

Dr. Fauci reviewed the Institute's Financial Management Plan, which sets the payline at 20.0 for all research project grants, institutes programmatic adjustments at an average of 7 percent according to percentile ranking, caps recompeting grants at 20 percent more than the previous award, and includes a selective pay pool of $9 million.

He also discussed the rationale for NIAID's management of its budget.

• New Terms of Award for Clinical Studies
  
  For some clinical research grants, NIAID is revamping the terms of award, which are part of the notice of grant award. The new mandatory terms will help the Institute make sure patients are protected and grantees comply with government regulations. The terms will stipulate information NIAID needs before we can authorize the initiation of a clinical trial and will also define reporting during the study. During the course of the study, grantees must notify NIAID of changes in status, for example, changes to the protocol, accrual, or IRB approval.

• Hyperaccelerated Review of Clinical Immunology Applications
  
  Last fall, the institute developed the initiative "Hyper-Accelerated Award Mechanisms in Immune Disease Trials" to address important and often missed opportunities to use patient samples from clinical trials. The latter are used to study mechanisms of immunomodulatory interventions and the pathogenic mechanisms of immunological diseases, such as asthma, rejection of transplanted organs and tissues, and autoimmune diseases.
  
  To be compatible with timelines of industry-supported trials, NIAID and the Center for Scientific Review developed new procedures that complete the entire review and award process within 13 weeks of receipt of an application. Elements that contribute to the shorter time line include the elimination of NIH assignment processes, electronic review, expedited Council review, monthly receipt dates, and monthly scientific review group meetings via teleconferences. In addition, NIH established a new scientific review group with expertise in immunology, immune system disorders, and clinical trials.
  
  Since the first receipt date in October, NIH has received 10 applications; eight have been reviewed and two funded with all aspects of the hyper-accelerated process accomplished within the timeline. Participating institutes are co-funding applications within their mission, reinforcing the trans-NIH and cooperative nature of this of this initiative.

• Autoimmunity
  
  Dr. Varmus asked Dr. Fauci to coordinate the development of trans-NIH research initiatives to be supported in part by the additional $30 million appropriated by Congress. In December 1998, representatives from many NIH institutes, centers, and offices drew up initiatives to maximize cross-cutting research relevant to diseases and components of NIH. As a result, ten new initiatives are being published in the next few weeks after Council.
  
  The initiatives support a broad spectrum of research spanning pathogenesis, genetics, environmental factors, translation and clinical research. They will accelerate the clinical application of advances, focusing on the best disease models to advance knowledge.

• Bioterrorism
  
  With administration and Congress committed to preparing for possible bioterrorist attacks, NIAID is slated to play a major role in a two-prong effort to counter cyberterrorism and biological threats. As part of a multi-agency effort, NIAID has developed a research plan for bioterrorism, proposing to fund basic and applied research of agents such as anthrax, plague, and smallpox toward the development of diagnostics, treatments and vaccines.
  
  Dr. Fauci told Council at the January meeting that genomics will play a big part in this effort. Measures to protect the nation's computer resources will be developed by the private sector.

• NIAID Policy for Release of Microbial Sequencing Data
  
  Agreeing with a new policy proposed by Dr. Fauci for releasing pathogen sequencing data, Council approved an approach that strives to balance grantees' rights to pursue their research goals with the rights of the research community to access new data. According to the new regulation, PIs have one month after achieving 3X coverage in which to publish new sequence information. (See http://grants.nih.gov/grants/guide/notice-files/not99-040.html).
  Disseminating data expeditiously is important because, in contrast to human sequencing, even short stretches of microbial sequences can contain valuable information. While rapid data dissemination benefits the research community, it can hurt the individual grantee because the goals of these investigator-initiated R01s are usually more than just sequencing. Thus, early release of data may interfere with a grantee's intellectual property rights and the opportunity not only to publish the data but to conduct further research.
  
  The Institute is now requiring sequencing applications to have a data release plan providing for timely data release together with information on the reliability of the data. Awards will not be made before an approved plan is in place and incorporated into the terms of award.

• Committee Report - NAAIDC Liaison to OAR Advisory Committee — Jerrold Ellner, M.D.
  
  Dr. Ellner reported that the committee discussed the recruitment of the new chief of the Vaccine Research Center and also the design of the facility, which is scheduled for completion by May of 2000. The OARAC members unanimously agreed to two recommendations to the Director of NIH. The first was that the search committee remove any institutional impediments to seeking the candidate who demonstrates the best mix of qualities to provide leadership, and the second was that the next director review intended reporting lines.

• Council Materials
  
  Copies of the Legislative Update, which describes hearings and bills of interest to the Institute, were distributed. In addition, the NIAID Office of Communications provided Council members with several publications and press releases.