all its property, we believe several weaknesses in its property management system have contributed to the difficulties in completing the physical inventory. For example, (1) transfers of property between NCTR operating groups were either not documented or not reported to NCTR property management personnel, (2) newly purchased property was not always recorded in NCTR's property records, and (3) property custodians had been appointed for only 13 of the 56 NCTR operating groups. QUESTIONABLE LONG DISTANCE TELEPHONE CALLS A number of long distance telephone calls that appeared to us to be personal in nature were charged to Government credit cards. Our analysis of NCTR's monthly long distance telephone statements for November 1975, March 1976, and March, April, and June 1977, showed that NCTR employees made calls to private residences, a real estate broker, a hair stylist, and a personal accountant. Such calls were certified as official calls by NCTR officials and were paid for by the Government. NCTR employees made long distance calls totalling about $1,625 on the five monthly credit card statements we reviewed and about $375 of these calls appeared questionable. Regarding one of the telephone statements reviewed, an NCTR official told us that he knew some of the calls listed on the statement were personal in nature, but he certified them as official since they had already been billed. As a result of this problem, an FDA official told us that the number of telephone credit cards in use at NCTR was being reduced from 20 to 10; and until an investigation of this matter is completed, FDA headquarters would review long distance calls charged to NCTR credit cards. CONCLUSIONS AND RECOMMENDATIONS Generally, the deficiencies found were the result of management's inattention to or failure to follow prescribed regulations and procedures. Since our review was limited to specific allegations, the problems we noted may be indicative of more widespread problems at NCTR. We recommend that the Secretary of HEW direct HEW's Inspector General to conduct a comprehensive audit of NCTR's administrative practices. This audit should be directed to identiying: --The extent to which additional administrative problems may exist at NCTR, and changes needed to strengthen administrative controls. --The amounts owed to the Government as a result of improper payments by NCTR under circumstances discussed in this report, so that appropriate collection action can be taken. ACTIONS TAKEN BY FDA After we briefed FDA officials in October 1977 on the results of our review at NCTR, the Commissioner of FDA took the following action: --Issued a series of administrative directives to NCTR management concerning, among other matters, the authorization of travel, use of personal and rental vehicles, use of long distance telephone calls, hiring and reimbursement practices, training assignments, and procurement of property and services. --Requested that the Inspector General investigate our The Inspector General has initiated an investigation of the matters we referred to the Department of Justice, but as of January 1, 1978, had not initiated a comprehensive audit of administrative matters. NCTR REVIEW BY NATIONAL ACADEMY OF SCIENCES QUESTION: In September, the National Academy of Sciences (NAS) issued a somewhat critical review of the National Center for Toxicological Research. I will print the principal conclusions and recommendations in the record at this point, along with FDA's letter to the Committee regarding them. Please discuss the findings of the NAS in general, the FDA view on them and any actions or changes made subsequent to your letter to the Committee of February 10, 1978, regarding this report. ANSWER: The FDA views on the NAS report are contained in the February 10, 1978 letter sent to Senator Eagleton by Dr. Kennedy. No additional actions or changes have been made subsequent to this letter. (The information follows:) In September 1977, the National Academy of Sciences completed an evaluation,df the National Center for Toxicological Research (NCTR): This evaluation was done under contract with the Food and Drug Administration (FDA) at the request of House Committee Report No. 93-1120 accompanying the 1975 Appropriation Bill for the FDA. During the past four months, my staff and I have carefully reviewed the Academy's recommendations. I now want to share with you my findings. Before I begin, let me say that I am most appreciative of the Committee's interest in CTR, and your continuing interest in FDA. As you know, the four major regulatory agencies concerned with health (Environmental Protection Agency, Food and Drug Administration, Occupational Safety and Health Administration and Consumer Product Safety Commission) have formed a strong bond of mutual cooperation. In discussing our respective responsibilities, the present agency heads agree that toxicology represents an area of neglect and great possibilities. It is of utmost importance to our missions that we have strong well-integrated-toxicology programs. The National Center for Toxicological Research will undoubtedly play a large future role. Consequently, while I agree with the Academy that BCTR ́s role-needs. a contemporary evaluation-and-definition, Iwant to await the outcome of an ongoing and more broadly based effort to focus Government toxicology, before specifying-NCTR's role too narrowly. I do, however, fully agree with the Academy's-findings-that any secondary mission be abolished. Agency needs must be of paramount importance to the Center. In structuring the Center's programs to accomplish these missions, I do recognize the scientific necessity for some discretion in problem solving. Consequently, I favor the provision of a small amount of discretionary funding for projects directed in a long-term-way at the goals of the Center. The Academy-believes that the MR should engage in the safety evaluation-of selected chemicals (Recommendation #2). I agree, and would add only, that the criteria for chemical selection should include the likelihood that the chemicals selected will help us to elaborate basic principles, and not be substances only submitted for routine bio-assay screening. In recommendation #4 and #5, the Academy suggests improvements in both the Policy Board and the Science Advisory: Board of NCTR I an troubled that the Academy fails to distinguish adequately between these two boards. In my view, the Policy Board should consist of very senior officials in the regulatory agencies, who have the authority to commit agency resources. I do not believe that this group needs to be filled exclusively by scientists, although I willingly accept the view that the Chairman of the Science Advisory Board should be an ex officio member of the Policy Board. The Policy Board should primarily concern itself with direction of the Center's program to ensure that the program is relevant to Agency regulatory decisions. The Science Advisory Board, composed of top-flight scientists outside the NCTR, should exercise oversight to determine whether the research activities of the Center are of the right nature and quality to meet the demands of the Policy Board I agree that these Boards have not functioned well in the past, and Recommendations #3, #6, and #8, concerning the planning and review of NCTR programs, are linked together. I fully support the findings.. of the report that call for more comprehensive program planning. The Agency is currently restructuring the organization of scientific activities at NCTR, and is developing the mechanisms for adequate planning. The Policy Board and Science Advisory Board will participate in this initial planning, as well as in the system that will periodically update the plan. In light of our determination to carefully guide NCTR from both the policy and science perspectives, I do not believe that the external science review recommended by the Academy will be necessary. I concur with the Academy's findings that an Associate Director and Chief Scientist be appointed to guarantee a high quality of science, although it will take careful planning to distinguish this role from that of the responsible official for supporting activities, the Deputy Director. With regard to the recommendation concerning aninal care facilities I do not concur with the Academy's findings regarding contracts and the Centers pathology functions (Recommendations #12 and #13).. I do not believe that the direct-employment of 300-500 additional full-time personnel will improve the quality of support at the Center I have instructed the Center's Acting Director to review the contractors' performance and report any deficiencies. I concur with the Academy about the importance of pathology and I want to emphasize my belief, that the current group of seven pathologists constitutes a functioning unit of scientists that is capable of continuing screening, diagnosis and research related to the Center's mission. In order to implement the spirit of the Academy's recommendation, I will instruct the Acting Director to recruit an experimental pathologist as a member of the full time Government staff. This person will serve as project officer in the pathology contract, and guarantee quality control. No inhalation toxicology program is currently active at NCTR. The Science Advisory Board, the Policy Board, and myself will be involved in any decision to redevelop this area. I agree with the Academy that outside scientific evaluation is necessary for the 2-AAF study. The Science Advisory Board and its subcommittees have the competence to undertake this review. I have left my findings regarding the science environment at NCTR> for last (Recommendations 19, #10, #14 and #15). The Academy made |