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Executive Summary

The Center for Drug Evaluation and Research is establishing a "Recruitment Crisis Task Force" in response to delays in filling 40 vacant full-time equivalent (FTE) positions and the prospect of adding 300 more slots as user fees are implemented. The concept of a Recruitment Crisis Task Force arose out of a CDER "management retreat" in Warrenton, Va. May 23-26. The task force, which has yet to be formed, is one of six initiatives outlined in a June 3 memo on the retreat sent to all CDER employees by director Carl Peck. As a first step to prepare for the new hires, a "tentative allocation" of the first 100 FTEs has been made and a recruitment staff is being hired. These steps come as the Senate Appropriations Committee is encouraging the Clinton Administration to increase FDA staffing allowances to permit the agency to expand to the levels stipulated in the user fee act (see preceding story). The initial 100 slots include chemists, statisticians, toxicologists, consumer safety officers, microbiologists, computer specialists, pharmacokineticists, pharmacologists and medical officers. The center has prepared a recruitment package describing the positions and encouraging candidates to "join the organization that safeguards the drugs we take." The CDER director's June 3 memo calls on the task force to prepare a report "1) identifying division, center, and agency recruitment bottlenecks and short-term and long-term recommendations to eliminate them; 2) describing a clear well- defined recruitment procedure with responsibility and accountability defined and measures to evaluate the success of the process; and 3) recommending recruitment strategies for hard-to- recruit disciplines." Peck has set a tight deadline of June 30 for the report. The memo calls on the task force to coordinate its efforts with the Center for Biologics Evaluation and Research and the User Fee Working Group and sets an Aug. 1 deadline for a decision by CDER and Senior Advisor to the Commissioner Mary Jo Veverka on the implementation of recommendations. The impetus for the task force come at least in part from CDER's difficulties in complying swiftly with Office of Personnel Management guidelines on hiring procedures. Virtually no new hires were made between September and February as a result. A General Accounting Office report submitted in August 1990 detailed widespread non-compliance among various agencies with federal law governing hiring procedures. OPM responded to the study by issuing more specific instructions on documenting compliance. These instructions, FDAers said, have led to increased paperwork for CDER, causing the center to slip below its FTE ceiling. As CDER attempts to resolve its staffing problems, user fee working groups continue to explore a range of implementation issues. The agency hopes to release its policy statement on combining market applications, or "bundling," and the definition of clinical data at the same time it sends out invoices, since these issues have a direct bearing on fees. FDAers have been predicting the imminent release of this guidance since February ("The Pink Sheet," May 24, p. 12). Five other initiatives came out of the CDER management retreat and are outlined in the Peck memo: "Create Reviewer Affairs Committee to serve as a forum to communicate reviewers' concerns to upper management"; "Improve administrative/computer support at the reviewer level by charging a working group to make recommendations on what improvements should be made"; "Develop a Good Review Practices Document for clinical/statistical reviews"; "Create a broad-based project management implementation group . . . that will assist in the integration of project management techniques in the review divisions to enable the divisions to achieve the user fee performance goals"; and "Re-examine relationships between the center and the field, addressing how to work together more constructively in improving integration of the review and inspection processes, communicating concerns, and resolving differences and misunderstandings."

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