Volume 3
Interagency coordination in drug research and regulation : hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, United States Senate, Eighty-eighth Congress, first session. Agency coordination study, pursuant to S. Res. 27, 88th Cong. Review of cooperation on drug policies among Food and Drug Administration, National Institutes of Health, Veterans' Administration, and other agencies. Mar. 20-June 26, 1963.
- United States. Congress. Senate. Committee on Government Operations
- Date:
- 1963
Licence: Public Domain Mark
Credit: Interagency coordination in drug research and regulation : hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, United States Senate, Eighty-eighth Congress, first session. Agency coordination study, pursuant to S. Res. 27, 88th Cong. Review of cooperation on drug policies among Food and Drug Administration, National Institutes of Health, Veterans' Administration, and other agencies. Mar. 20-June 26, 1963. Source: Wellcome Collection.
469/504 page 1235
![Phasing and cost.—It is recommended that the above contract be entered into during the current fiscal year and that it be phased over a 2-year period. It would appear that a contract of the type proposed concentrates the cost of such an undertaking within a limited period of time, whereas an effort to make im- provements on a process-by-process basis would stretch out the total cost. How- ever, it has the significant advantage of minimizing the burden which such an undertaking will have on the limited FDA manpower and skills that would be needed to participate in such an undertaking. This plan places the major man- power and skills burden on the contractor. It also represents, in the opinion of the Committee, the most efficient method of bringing the necessary technical skills to bear on a problem which FDA is not prepared to solve for itself. The Committee suggests that the contract be phased as follows: Fiscal year 19638 1. Reconnaissance study to determine feasibility and to identify pro- gram requirements. Fiscal year 1964 1. Planning and analysis. 2. Systems design, equipment procurement, installation, and testing. Attempts by the Committee to develop detailed cost estimates for such a con- tract were generally unsuccessful. However, it is believed that a contract would cost between $250,000 to $300,000. Phased over a 2-year period, this would re- sult in an annual budget of $125,000 to $150,000 a year. The Committee recommends that the 1964 budget, now pending before the Bureau of the Budget, be modified to include specific funds to finance the 1964 portion of the proposed contract. It is further suggested that the necessary funds for reconnaissance during 1963 be funded by reprograming regular 1963 appro- priations for this purpose. Potential contractors.—The Committee believes that the development of such a contract is possible and practical. A number of potential contractors with ex- perience which would qualify them for this assignment appear to be available. EH. Basis for Recommendations—NBS Study The above recommendations are based on the conclusions enumerated earlier in the report and also take into consideration the fact that the National Bureau of Standards study indicated that it would be possible to systematize much of FDA’s scientific data processing. As indicated, the recommendations having to do with personnel assignments also take into account the experiences of the National Bureau of Standards. However, the recommendations depart somewhat from the suggestions of the National Bureau of Standards in that the FDA Com- mittee is recommending that the total problem be attacked on an agency-wide basis rather than on a process-by-process basis. It is suggested that the views of the National Bureau of Standards be solicited in the development of the proposed contract. iI. EXCHANGE OF SCIENTIFIC INFORMATION WITH OUTSIDE ORGANIZATIONS A. FDA Participation in the Program of Science Information Hachange , (Smithsonian Institution) Based on recommendations of this Committee, on November 6, 1962, Deputy _ Commissioner Harvey addressed a letter to Dr. Monroe E. Freeman, Director of the Science Information Exchange, indicating that FDA will begin on or about January 1, 1963, to register individual FDA research projects with the Px- change [See appendix B]. The FDA proposal calls for the registration of food, food ingredient, nutritional, chemical and biological research projects conducted by the Bureau of Biological and Physical Sciences. Deputy Commissioner Harvey also made a commitment in the November 6 letter to expand, at a later date, FDA registration to include human and veterinary drug studies conducted by the Bureau of Biological and Physical Sciences and the Bureau of Medicine. The letter designated Dr. Daniel Banes, Deputy Director of the Bureau of Biological and Physical Sciences to represent FDA and to work with the Science Information Exchange to complete arrangements for FDA participa- tion. The Science Information Exchange has acknowledged FDA’s offer to partici- pate and Dr. Banes has had followup discussions with representatives of the](https://iiif.wellcomecollection.org/image/b32183148_0003_0469.jp2/full/800%2C/0/default.jpg)
