§ 730.4 - Information requested.

(a) Form FD-2704 (Cosmetic Product Experience Report) requests the following information:

(1) The name of the person (manufacturer, packer, or distributor) designated on the label of the cosmetic product.

(2) Time period covered by the report.

(3) The complete name of the cosmetic product exactly as it appears on the label of the product.

(4) The cosmetic product category, as set forth in § 720.4(c) of this chapter and on the form, which best describes the product's intended use.

(5) Total number of reportable experiences during this reporting period and number of these experiences requiring professional medical attention.

(6) Total number of product units of the cosmetic product estimated to have been distributed to consumers during this reporting period.

(7)-(8) [Reserved]

(9) The cosmetic product ingredient statement number (CPIS No.) assigned to the product under § 720.7 of this chapter, if known. If a number is pending, but has not been assigned, the firm should so indicate. Where the firm submitting the report knows that a cosmetic product ingredient statement pursuant to part 720 of this chapter has not been filed, it should so indicate.

(10) Any additional evaluation of the experiences or other pertinent data or information as the person filing wishes to provide to assist the Food and Drug Administration in evaluating the report.

(b) [Reserved]

(c) Form FD-2706 (Summary Report of Cosmetic Product Experience by Product Categories) requests the following information:

(1) The name and address (include country, if other than the United States), including post office ZIP code of the person (manufacturer, packer, or distributor) designated on the label of the cosmetic products.

(2) Time period covered by the report.

(3) Total number of product units within each product category, as set forth in § 720.4(c) of this chapter and on the form, estimated to have been distributed to consumers during this reporting period.

(4) Total number of reportable experiences within each product category during this reporting period, if any.

(d) The person filing a Form FD-2704 (Cosmetic Product Experience Report)or Form FD-2706 (Summary Report of Product Experience by Product Categories) should:

(1) Provide the information requested in paragraphs (a) and (c) of this section, as appropriate.

(2) Provide the screening procedure in conformance with § 700.3(p) when a screening procedure is used in connection with the reports requested by this part and is not already on file with the Food and Drug Administration.

(3) Provide the name, title, and signature of the individual authorized to submit the report(s), and the name and address of the firm which he represents if it differs from that provided in paragraph (a) or (c) of this section.

(e) The information requested under paragraph (a) of this section should be filed separately for each cosmetic product, except that a single report may be filed for two or more shades, flavors, or fragrances of a cosmetic product where only the proportions of these ingredients are varied, and such product is covered by a single cosmetic product ingredient statement under § 720.4(e) of this chapter.

(f) On the basis of a review of individual reports or patterns of experience disclosed as a result of a number of reports, the Commissioner of Food and Drugs may request as much additional information from persons submitting reports as the Commissioner deems appropriate. For this reason, every person participating in this program should retain for three years all correspondence and records pertaining to alleged cosmetic product injuries.