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Statement of Need: The present system has been shown to be burdensome to both licenseholders and to FDA in that licenseholders must submit supplements for every proposed change, and FDA must review them. The present system is also time-consuming--manufacturers may wait from 6 to 12 months for approval of supplements--and unnecessarily rigid. FDA estimates that the proposed system would reduce by 50 percent--from 1,000 to 500--the number of supplements submitted annually for biologics and reviewed by FDA, allowing for more expeditious agency review of supplements that are submitted.

Summary of the Legal Basis: The Public Health Service Act (42 USC 216 et seq.) and the Federal Food, Drug, and Cosmetic Act (21 USC 321 et seq.) authorize FDA to regulate the distribution of biological products so that the products are safe, pure, potent, and effective. These acts authorize FDA to promulgate regulations designed to ensure that the public is not exposed to biological products that may not be safe, pure, or potent for their intended uses. In order to carry out the public health protection purposes of the FD&C Act, FDA (a) reviews and approves applications for licenses to manufacture biological products; (b) inspects establishments involved in manufacturing activities; and (c) reviews and approves important changes that have the potential to adversely affect the biological product.

Alternatives: FDA considered two alternatives. The first alternative was allowing license holders to submit summary data and a certification of validation and lack of adverse effect on the product's safety, purity, potency, or efficacy. FDA believes this alternative is appropriate for some changes, but not adequate or sufficient for changes with substantial potential to have an adverse effect. ^PThe second alternative would have required license holders to keep validation data and certification of lack of adverse effect, and allowed them to report changes to FDA in annual report. FDA believes this alternative is appropriate for changes that have only a minimal potential for adverse effect on the product. It is incorporated into the proposed revision for such changes.

Anticipated Costs and Benefits: FDA is specifically requesting comment and information that can be used to calculate the costs and benefits to licenseholders. In general, the proposed revision is expected to reduce significantly the burden of preparing supplements for proposed changes by eliminating this requirement for a number of changes. The proposed revision will accordingly reduce the number of supplements requiring FDA review and allow for more expeditious handling of supplements that are submitted. Licenseholders are expected to incur no additional costs as a result of the proposal; on the other hand it will allow for more timely implementation of changes by licenseholders--for example, streamlining and updating manufacturing facilities.

Risks: FDA believes the risks posed by the proposed new reporting system are minimal. In addition to stating in the proposed revision which changes are considered to have substantial, moderate, and minimal potential for adverse effects, FDA will provide thorough supplementary guidance to manufacturers to help assure adequate assessment of the potential for adverse effects.