Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972
other · Food and Drug Administration · Rule · Published 2016-02-12 · Effective 2016-03-14 · 81 FR 7445
Document
Document number
2016-02884
Federal Register citation
81 FR 7445
CFR reference
21 CFR 601
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2016-02-12
Effective date
2016-03-14
HHS docket
Docket No. FDA-2015-N-2103
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is removing two regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. FDA is taking this action because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972, which allow FDA to evaluate and monitor the safety and effectiveness of all biological products. In addition, other statutory and regulatory authorities authorize FDA to revoke a license for biological products because they are not safe and effective, or are misbranded. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation.