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of tobacco use (Z87.891) tobacco dependence (F17.-) tobacco use (Z72.0) C03.0 Malignant neoplasm of upper gum C03.1 Malignant neoplasm of lower gum C03.9 Malignant neoplasm of gum, unspecified C04 Malignant neoplasm of floor of mouth Use additional code to identify: alcohol abuse and dependence (F10.-) history of tobacco use (Z87.891) tobacco dependence (F17.-) tobacco use (Z72.0) C04.0 Malignant neoplasm of anterior floor of mouth Malignant neoplasm of anterior to the premolar-canine junction C04.1 Malignant neoplasm of lateral floor of mouth C04.8 Malignant neoplasm of overlapping sites of floor of mouth C04.9 Malignant neoplasm of floor of mouth, unspecified C05 Malignant neoplasm of palate Excludes1: Kaposi's sarcoma of palate (C46.2) Use additional code to identify: alcohol abuse and dependence (F10.-) history of tobacco use (Z87.891) tobacco dependence (F17.-) tobacco use (Z72.0) C05.0 Malignant neoplasm of hard palate C05.1 Malignant neoplasm of soft palate Excludes2: malignant neoplasm of nasopharyngeal surface of soft palate (C11.3) C05.2 Malignant neoplasm of uvula C05.8 Malignant neoplasm of overlapping sites of palate C05.9 Malignant neoplasm of palate, unspecified Malignant neoplasm of roof of mouth C06 Malignant neoplasm of other and unspecified parts of mouth Use additional code to identify: alcohol abuse and dependence (F10.-) history of tobacco use (Z87.891) tobacco dependence (F17.-) tobacco use (Z72.0) C06.0 Malignant neoplasm of cheek mucosa Malignant neoplasm of buccal mucosa NOS Malignant neoplasm of internal cheek C06.1 Malignant neoplasm of vestibule of mouth Malignant neoplasm of buccal sulcus (upper) (lower) Malignant

Concerns included lack of adequate guidance and transparency regarding CTP expectations, lack of clarity regarding review standards, [and] an unsustainable process of requiring a complete PMTA filing for each product

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