The applicant for each new animal drug product approved under section 512 of the Federal Food, Drug, and Cosmetic Act, or conditionally approved under section 571 of the Federal Food, Drug, and Cosmetic Act, and containing an antimicrobial active ingredient, must submit an annual report to FDA on the amount of each such antimicrobial active ingredient in the drug that is sold or distributed in the reporting year for use in food-producing animal species, including information on any distributor-labeled product.

This report must identify the approved or conditionally approved application and must include the following information for each new animal drug product described in paragraph (a) of this section:

A listing of each antimicrobial active ingredient contained in the product;

A description of each product sold or distributed by unit, including the container size, strength, and dosage form of such product units;

For each such product, a listing of the target animal species, indications, and production classes that are specified on the approved label;

For each such product, the number of units sold or distributed in the United States (i.e., domestic sales) for each month of the reporting year; and

For each such product, the number of units sold or distributed outside the United States (i.e., quantities exported) for each month of the reporting year.

Each report must also provide a species-specific estimate of the percentage of each product described in paragraph (b)(2) of this section that was sold or distributed domestically in the reporting year for use in any of the following animal species categories, but only for such species that appear on the approved label: Cattle, swine, chickens, turkeys. The total of the species-specific percentages reported for each product must account for 100 percent of its sales and distribution; therefore, a fifth category of “other species/unknown” must also be reported.

Each report must:

Be submitted not later than March 31 each year;

Cover the period of the preceding calendar year; and

Be submitted using Form FDA 3744, “Antimicrobial Animal Drug Distribution Report.”

Sales and distribution data and information reported under this section will be considered to fall within the exemption for confidential commercial information established in § 20.61 of this chapter and will not be publicly disclosed, except that summary reports of such information aggregated in such a way that does not reveal information that is not available for public disclosure under this provision will be prepared by FDA and made available to the public as provided in paragraph (f) of this section.

FDA will publish an annual summary report of the data and information it receives under this section for each calendar year by December 31 of the following year. Such annual reports must include a summary of sales and distribution data and information by antimicrobial drug class and may include additional summary data and information as determined by FDA. In order to protect confidential commercial information, each individual datum appearing in the summary report must:

Reflect combined product sales and distribution data and information obtained from three or more distinct sponsors of approved products that were actively sold or distributed that reporting year, and

Be reported in a manner consistent with protecting both national security and confidential commercial information.