§660.6. Samples; protocols; official release. — Inbound Citations

(1) Biological product samples and/or protocols, other than radioactive biological product samples and protocols, required under §§ 600.13, 600.22, 601.15, 610.2, 660.6, 660.36, or 660.46 of this chapter must be sent by courier service to: Food and Drug Administration, Center for Biologics Evaluation and Research, ATTN: Sample Custodian, 10903 New Hampshire Ave., Bldg. 75, Rm. G707, Silver Spring, MD 20993-0002. The protocol(s) may be placed in the box used to ship the samples to CBER. A cover letter should not be included when submitting the protocol with the sample unless it contains pertinent information affecting the release of the lot.