Proposed SEC 507.7(b)(2) would provide an option to submit documentation by mail. A qualified facility would have the option to submit documents in a paper format or in an electronic format on a CD-ROM, by mail to the U.S. Food and Drug Administration, ATTN: Qualified Facility Coordinator, 10903 New Hampshire Ave., Silver Spring, MD 20993. "Mail" would include the U.S. mail and businesses that can deliver documents to the address provided. The Agency would recommend that an owner, operator or agent in charge of a qualified facility submit by mail only if the qualified facility does not have reasonable access to the Internet. It is not efficient for FDA to receive such documents by mail.
The Agency is not proposing to provide for submission by fax. The Agency expects that there may be technical difficulties or loss or mix-up of some submitted information if the Agency were to allow for submission by fax.
4. Proposed SEC 507.7(c)--Frequency of Submission
Proposed SEC 507.7(c)(1) would require that the documentation that would be required by section SEC 507.7(a) be submitted to FDA initially within 90 days of the applicable compliance date of the rule. As discussed in section VI, the compliance date for a small business would be 2 years after the date of publication of the final rule and the compliance date for a very small business would be 3 years after the date of publication of the final rule.
Proposed SEC 507.7(c)(2) would require that the documentation that would be required by proposed SEC 507.7(a) also must be resubmitted to FDA at least every 2 years, or whenever there is a material change to the information that would be described in proposed SEC 507.7(a). For the purposes of proposed SEC 507.7, a material change would be one that changes whether or not a facility is a "qualified facility." The status of a facility as a qualified facility has the potential to change materially on an annual basis. For example, if a facility reports that it is a very small business (i.e., under one option identified in proposed SEC 507.3, has less than $500,000 in total annual sales of animal food, adjusted for inflation), its total annual sales of animal food likely would change on an annual basis, and could change so as to exceed $500,000. Likewise, if a facility reports that it otherwise satisfies the definition of a qualified facility, its total annual sales of animal food and value of animal food sold to qualified end users as compared to other purchasers likely would change on an annual basis, and could change so as to no longer satisfy the definition of a qualified facility.
5. Information That Would Be Submitted
Consistent with section 418(l)(2)(B)(ii) of the FD&C Act, the Agency intends to issue guidance regarding documentation that would be submitted under proposed SEC 507.7(a)(1) to demonstrate that a facility is a qualified facility. As discussed in sections VIII.D.2.a and VIII.D.2.b, the Agency tentatively concludes that certified statements from the owner, operator, or agent in charge of a qualified facility would be acceptable for the purposes of satisfying the requirements that would be established in proposed SEC 507.7(a)(1) and (a)(2).