(a) Any Foreign Seller(s) designated in a SIP Proposal must be registered with FDA before FDA will authorize the SIP Proposal.
(b) To register, a Foreign Seller must provide the following information:
(1) Name of the owner or operator; if a partnership, the name of each partner; if a corporation, the name of each corporate officer and director, and the place of incorporation;
(2) All names of the Foreign Seller, including names under which the Foreign Seller conducts business or names by which the Foreign Seller is known;
(3) Physical address and telephone number(s) of the Foreign Seller;
(4) Registration number, if previously assigned by FDA;
(5) A unique facility identifier in accordance with the system specified under section 510 of the Federal Food, Drug, and Cosmetic Act;
(6) All types of operations performed by the Foreign Seller;
(7) Name, mailing address, telephone number, and email address of the official contact for the establishment; and
(8) Name, mailing address, telephone number, and email address of:
(i) The U.S. agent;
(ii) The Importer to which the Foreign Seller plans to sell eligible prescription drugs; and
(iii) Each SIP Sponsor with which the Foreign Seller works.