§ 1107.20. Amendments.

141 words·~1 min read·/us/cfr/t21/s§ 1107.20·

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(a)Except as provided in paragraphs

(b)and

(c)of this section, the applicant may submit an amendment to an SE Report in accordance with subpart C of this part. If an applicant chose to submit a health information summary with its SE Report under § 1107.18(j)(1), the applicant must submit with the amendment a redacted copy of the amendment that excludes research subject identifiers and trade secret and confidential commercial information as defined in §§ 20.61 and 20.63 of this chapter.

(b)An applicant may not amend an SE Report to change the predicate tobacco product.

(c)An applicant may not amend an SE Report after FDA has closed the SE Report under § 1107.44 or it has been withdrawn under § 1107.22.

(d)In general, amendments will be reviewed in the next review cycle as described in § 1107.42.

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§ 1107.20

Amendments.

Fed. Reg.×2

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