; (iv) the standardization of the concentration or dose of a specific finalized ingredient within a particular finalized monograph; (v) a change to ingredient nomenclature to align with nomenclature of a standards-setting organization; or (vi) addition of an interchangeable term in accordance with part 330.1 of title 21, Code of Federal Regulations. (B) The Secretary may, based on program implementation experience or other factors found appropriate by the Secretary, characterize any monograph drug order request as a Tier 2 monograph drug order request (including recategorizing a request from Tier 1 to Tier 2) and publish such determination in a proposed order issued pursuant to section 505G(c). 744L–1. Authority to assess and use monograph drug fees (a) Types of fees Beginning with fiscal year 2018, the Secretary shall assess and collect fees in accordance with this section as follows: (1) Facility fee (A) In general Except as provided in subparagraph (B), each person that owns a facility identified as a monograph drug facility on December 31 of the fiscal year or at any time during the preceding 12-month period shall be assessed an annual fee for each such facility as determined under subsection (c). (B) Exception (i) In general A fee shall not be assessed under subparagraph (A) if the identified monograph drug facility has ceased all activities related to monograph drug products prior to the publication of the Notice under subparagraph C and has updated its registration to reflect such change under the requirements for drug establishment registration set forth in section 510. (ii) Fee amount The amount of the fee for a contract manufacturing organization facility shall be equal to two-thirds the amount of the fee for a monograph drug facility that is not a contract manufacturing organization facility. (C) Due date For each fiscal year, the facility fees required under subparagraph (A) shall be due on the later of— (i) the first business day of April of such year