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As an example of how CMS would identify the payment amount benchmark period as proposed under 428.202(c)(3), if a Part D rebatable drug that was first approved or licensed by the FDA on July 7, 2021, and has a first marketed date of September 15, 2021, does not have AMP reported in the period beginning January 1, 2021 and ending September 30, 2021, but does have AMP reported for the second calendar quarter of 2022, CMS would identify the payment amount benchmark period for such drug as calendar year 2022 (that is, January 1, 2022, through December 31, 2022)

Moreover, even though three metabolites related to TCA cycle were significantly decreased in nicotine-exposed testes, other metabolites didnt exhibit abnormality