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In addition, we are proposing to revise paragraph (c)(2)(vi) to reflect current practice for microbiology specimens

Physical and Chemical Lesions of the oral mucosa

of this proposed rule)

Although the buying manufacturer is required by the MDRP to report for the new NDC-9 the base date AMP associated with the earliest NDC-9 of the dosage form and strength, and to report the first marketed date associated with the earliest NDC-9 of the dosage form and strength as the first marketed date for the new NDC-9, [584] the buying manufacturer is not required to report which NDC-9 was used to determine the base date AMP and first marketed date