Federal Register Notice: FDA’s proposed collection of information, “Request for Samples and Protocols,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. Under 21 CFR 610.2 CBER or CDER may at any time require manufacturers of licensed biological products to submit to FDA samples of any lot along with the protocols showing the results of applicable tests prior to distributing the lot of the product. In addition to Sec. 610.2, there are other regulations that require the submission of samples and protocols for specific licensed biological products. To view this notice, click here.