FDA is extending the period for public comments on its proposed new tobacco product manufacturing practice requirements for manufacturers of finished and bulk tobacco products, it said in a notice. The proposed regulations, which would include requirements for manufacture, preproduction design validation, packing and storage, also would apply to foreign manufacturers' and importers' finished and bulk tobacco products. Comments are now due by 11:59 p.m. EDT on Oct. 6.
On Aug. 24, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 23, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 21, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 18, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 17, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 16, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 15, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Aug. 14, FDA posted new and revised versions of the following Import Alerts on the detention without physical examination of:
Comments are due Sept. 5 to the Office of Management and Budget on information collected through FDA's prior notice requirements for imported food, FDA said in a notice. The agency submitted its proposed extension of approval for prior notice requirements to OMB, it said. FDA estimates 10 minutes per new prior notice submission through the Automated Broker Interface and 23 minutes for each new submission via the FDA Prior Notice System Interface, 15 minutes for each cancellation of a prior notice in both systems, and one to eight hours for prior notice requests for review and post-hold submissions, for a total of 3,677,494 burden hours, an increase in burden hours attributed to an increase in the number of responses.