Daily Rules, Proposed Rules, and Notices of the Federal Government
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Section 701(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)) authorizes the Secretary of Health and Human Services (the Secretary) to develop guidance documents with public participation presenting the views of the Secretary on matters under the jurisdiction of FDA.
Therefore, FDA intends to establish and maintain a list identifying U.S. manufacturers/processors that have expressed interest to FDA in exporting dairy products to Chile, are subject to FDA jurisdiction, and are not the subject of a pending judicial enforcement action (i.e. an injunction or seizure) or an unresolved warning letter. Under this guidance, FDA recommends that U.S. firms that want to be placed on the list send information to FDA (i.e., name and address of the firm and the manufacturing plant; name, telephone number, and e-mail address (if available) of contact person; list of products presently shipped and expected to be shipped in the next 3 years; identities of agencies that inspect the plant and date of last inspection plant number and copy of last inspection notice; and, if other than an FDA inspection, copy of last inspection report. The term “dairy products,” for purposes of this list, is not intended to cover the raw agricultural commodity raw milk. The guidance can be found at
The burden estimates presented in the following paragraphs considered the number of U.S. firms that FDA believes produce dairy products and that will be interested in exporting to Chile, which is estimated to total 75. After the first year, FDA believes that approximately eight new firms each year will be interested in exporting dairy products to Chile, and thus, being placed on the list. In the
Those comments were answered in the 60-day notice.
FDA estimates the burden for this collection of information as follows:
The estimate of the number of firms is based on the actual number of U.S. firms that applied to be placed on the list as a result of the