§10.80. Dissemination of draft Federal Register notices and regulations. — Inbound Citations

(a) FDA regulations are issued in the Federal Register under § 10.40 or § 10.50 and codified in the Code of Federal Regulations. Regulations may contain provisions that will be enforced as legal requirements, or which are intended only as guidance documents and recommendations, or both. The dissemination of draft notices and regulations is subject to § 10.80.