Department of Health and Human Services
Public Health Service
Food and Drug Administration
Dear President/CEO/Blood Establishment Director:
The purpose of this letter is to request your assistance in assuring the Agency and the American public that your firm has addressed the year 2000 (Y2K) problem as it affects the adequate supply of safe and effective biological products to Americans.
The Y2K problem can cause a variety of errors in how dates are expressed or computed that could adversely affect automated process controls and clinical and non-clinical data integrity. Y2K is an issue that, if not addressed by you, could adversely affect the safety and health of the American public. It is also important that suppliers to your firm have Y2K compliant systems because a disruption in the flow of components, packaging materials, and equipment, for example, could halt or slow the production of biological products, even if your firm has Y2K well under control. I therefore urge you to work with your suppliers to ensure there will be a minimum of disruption. Of special concern are manufacturing processes, which if disrupted by Y2K could result in severe shortages of needed biological products. An additional concern is the possibility of increased production demands because of distributor and consumer stockpiling of critical products.
It is the agency's expectation that manufacturers will do all they can to ensure that their systems are Y2K compliant and give the highest priority to addressing this issue. Manufacturers should thoroughly review and test all computer systems and have appropriate contingency plans in place before January 1, 2000. All procedures to achieve this goal should be appropriately tested and validated prior to implementation. Manufacturers should also establish policies and procedures to monitor consumer demand and to ensure that unwarranted stockpiling beyond normal levels that taxes production capacity does not compromise product availability to all customers.
We request that you complete the attached survey concerning the status of actions taken to address the year 2000 problem. Documentation regarding the steps you have taken to prepare for the year 2000, including this survey, should be available for FDA review during inspections. This special Year 2000 data gathering request is being made pursuant to section 4(f) of the Year 2000 Information and Readiness Disclosure Act. We will use the information you provide to inform the American public about the Year 2000 readiness of the pharmaceutical and blood establishment industries. Therefore, your answers to questions 1, 1a, 7, and 8 of the attached survey may be made available to the public via FDA’s Internet site (www.fda.gov). Answers to questions 2 through 6 in the survey will be protected under section 4(f) of the Year 2000 Information and Readiness Disclosure Act. However, aggregate data may be made available to the public.
In order to provide the best service to the industry and public, as well as recognizing the limited time available before the Year 2000, we ask that all manufacturers respond to the attached Y2K Assessment survey within 15 days of the receipt of this letter to:
FDA Y2K Survey
1101 Olivette Executive Pkwy.
St. Louis, MO 63132 - 9709
In addition, we ask that you provide us with timely updates on any pertinent Y2K compliance issues that might surface after completion of the attached survey.
Licensed manufacturers that make changes to their manufacturing processes to become Y2K compliant should report these changes to CBER in the appropriate format (supplement or annual report), according to current regulations and guidance. If a manufacturer files a supplement to an approved application for manufacturing changes made for the purpose of making manufacturing processes Y2K compliant, the supplement should be labeled as Y2K-related. If possible, supplements for Y2K-related changes should be submitted separately from supplements for other changes, unless the changes are related such that they cannot be submitted independently.
On a personal note, I know that you share our commitment to the uninterrupted provision of our nation’s vital drug supply. If you have further questions, you may contact Jennifer Thomas, CBER, OCBQ Associate Director for Policy, at (301) 827-6190. Thank you for your cooperation.
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Jane E. Henney, M.D.
Food and Drug Administration