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This article was originally published in The Tan Sheet

Executive Summary

FDA HALTS HIRING OF NEW PERSONNEL AFTER PHS-WIDE EMPLOYMENT FREEZE is imposed by HHS Assistant Secretary for Health Philip Lee, MD. As of Dec. 10, the personnel office at FDA is making no employment offers to prospective personnel; however, other recruitment activities, including clearance requests, are continuing. Lee announced the freeze in a Dec. 8 memo distributed to all agency heads within the Public Health Service. Lee explained that "no accession of staff to PHS will occur except for an existing firm offer made by a personnel officer or his/her designee and a firm acceptance by a prospective employee" as of Dec. 8. In addition, "no promotions to the GS-14 level will be processed during the freeze period," Lee instructed. Notice of the freeze was disseminated to FDA senior staff Dec. 16 along with a memo from Deputy Commissioner for Management and Systems Mary Jo Veverka that notes that Lee's staff has indicated that "active recruitment should continue, but that written offers should be held pending release from the freeze." In addition, Veverka noted that she, Commissioner David Kessler and Deputy Commissioner for Operations Jane Henney all "feel very strongly that every effort should be made to continue recruitment activity to meet our critical programmatic needs." The PHS employment freeze comes as FDA is working to hire the additional staff it needs for its user fee program. If the employment increases mandated by the implementing user fee legislation are not reached, FDAers worry that the agency may not be able to meet its goals for drug approval times. FDA is already facing obstacles in user fee hiring from senior staffing reductions mandated throughout PHS by a presidential executive order. In response to the PHS plan for reductions, FDA submitted its own proposal to PHS, which would have set the target number for senior staff somewhat higher. FDA's proposal was apparently rejected. The delay in broadly notifying FDA senior staff about the freeze may be due to the agency's attempts to negotiate an exemption. FDA is "in active discussions with PHS regarding FDA's hiring status," Veverka indicated in the Dec. 16 memo, "and [has] been assured that this action relative to us is temporary and could last for a very short duration." The administration, however, seems likely to hold firm on the reductions it is seeking. Congressional intervention may be the one course of redress that remains available to FDA and the companies that are making user fee payments. In imposing the temporary employment freeze, Lee cited a "recently completed" review of PHS staffing showing "increasing employment, notwithstanding targets for reduced full-time equivalent (FTE) staffing for FY 1994 and FY 1995." If the increases are not reversed, Lee warned, they may "compromise our ability to achieve FTE targets." The impetus for the freeze apparently came from the top levels of HHS -- Lee's memo notes that "the Secretary and Deputy Secretary have both spoken to me personally on these employment increases." Lee explained that the freeze "will enable PHS to restrict hiring pending final FY 1994 and FY 1995 FTE levels and to assess total employment in light of the Vice President's National Performance Review (NPR) and the President's Executive Order to reduce federal employment." In addition, Lee noted, the freeze also will allow his office to "focus on the viability" of the agency heads" plans to meet employment goals. During the freeze period, the assistant secretary for health will meet with agency heads to discuss the development of their plans, which Lee said must address: progress toward 1994 and 1995 targets for overall FTEs and senior level staff; restructuring and streamlining; past personnel growth in several areas; reductions in the ratio of managers and supervisors to other personnel; and achievement of a 12% staffing reduction by FY 1999. Any requests for "necessary exceptions" to the freeze must be directed to Lee for consideration, the memo states. However, Lee said he expects that "any exception request to be of the highest priority and to be fully justified based on the programmatic urgency of the request." Despite the restraints that have been placed on FDA hiring, the Center for Drug Evaluation & Research has made a concerted effort to improve its hiring procedures and get the personnel it needs for user fee reviews. A few months ago, CDER put together a recruitment strategic plan that implements many of the recommendations made in a Sept. 16 report by the center's Recruitment Crisis Task Force. The task force was charged with identifying recruitment bottlenecks and finding ways to eliminate them, developing a clear and well- defined recruitment procedure, and recommending strategies for hard-to-recruit disciplines ("The Tan Sheet" June 14, p. 14). The strategic plan mentions the Presidential Order to reduce Senior Executive Service levels -- "the grade levels of the majority of planned hires under the provisions of our user fee legislative hiring mandate." The plan suggests that FDA "consider such alternatives as hiring fewer physicians and consider other mixes of professional staff to perform initial reviews." CDER has allocated a total of 175 user fee positions to the review divisions to meet its FY 1993-1994 total allocation of 125 user fee FTEs, the plan says. The user fee recruitment goal mentioned in the plan is "to ensure that the entire recruitment process from receipt of [curriculum vitae] to actual firm offer of a job position to a candidate should require no more than eight weeks." The strategic plan also describes a Model Recruitment Process that was suggested by the task force and became effective on Oct. 29. One of the short-term actions called for in the plan is that "for each division director affected by user fee performance goals, his/her performance appraisal . . . for FY 94 shall contain a 15% critical job element entitled 'Recruitment'". Performance standards for recruitment efforts and outcomes also will be applied to performance plans for office and center directors and deputies, and to personnel dedicated to recruitment. Under the plan, each division director must appoint a person to be the division's administrative recruitment assistant.

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