S. 1844 — what changed
Animal Drug and Animal Generic Drug User Fee Amendments of 2023
From Introduced in Senate to Reported in Senate. 1 section amended and 1 added between Introduced in Senate and Reported in Senate.
Sec. 202 Authority to assess and use generic new animal drug fees
Generic Investigational New Animal Drug File Fee— Section 741(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(a)) is amended by adding at the end the following:
“(4) Generic investigational new animal drug file fee
“(A) In general
“(i) New file request—Each person that submits a request to establish a generic investigational new animal drug file on or after October 1, 2023, shall be assessed a fee as established under subsection (c).
“(ii) New submission to established file—Each person that makes a submission to a generic investigational new animal drug file on or after October 1, 2023, where such file was established prior to October 1, 2023, shall be assessed a fee for the first submission on or after October 1, 2023, as established under subsection (c).
“(B) Payment
“(i) New file request—The fee required by subparagraph (A)(i) shall be due upon submission of the request to establish the generic investigational new animal drug file.
“(ii) New submission to established file—The fee required by subparagraph (A)(ii) shall be due upon the first submission to the generic investigational new animal drug file.
“(C) Exceptions
“(i) Terminating an existing generic investigational new animal drug file—If a person makes a submission to the generic investigational new animal drug file to terminate that file, the person shall not be subject to a fee under subparagraph (A)(ii) for that submission.
“(ii) Transferring an existing generic investigational new animal drug file—If a person makes a submission to the generic investigational new animal drug file to transfer that file to a different generic new animal drug sponsor, the person shall not be subject to a fee under subparagraph (A)(ii) for that submission.”
Fee revenue amounts— Section 741(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(b)) is amended—
in paragraph (1)—
by striking “2019 through 2023” and inserting “2024 through 2028”; and
by striking “$18,336,340” and inserting “$25,000,000”; and
in paragraph (2)—
in subparagraph (A)—
by striking “25 percent” and inserting “20 percent”; and
by inserting before the semicolon at the end the following: “and fees under subsection (a)(4) (relating to generic investigational new animal drug files)”;
in subparagraph (B), by striking “37.5 percent” and inserting “40 percent”; and
in subparagraph (C), by striking “37.5 percent” and inserting “40 percent”.
Annual fee setting; adjustments—
Annual fee setting— Section 741(c)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(c)(1)) is amended to read as follows:
“(1) Annual fee setting—The Secretary shall establish, not later than 60 days before the start of each fiscal year beginning after September 30, 2023, for that fiscal year—
“(A) abbreviated application fees that are based on the revenue amounts established under subsection (b), the adjustments provided under this subsection, and the amount of fees anticipated to be collected under subsection (a)(4) during that fiscal year;
“(B) generic new animal drug sponsor fees, and generic new animal drug product fees, based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and
“(C) a generic investigational new animal drug file fee of $50,000 for each request or submission described in subsection (a)(4)(A).”
Inflation adjustment— Section 741(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(c)(2)) is amended—
in subparagraph (A)—
in the matter preceding clause (i), by striking “2020” and inserting “2025”; and
in clause (iii), by striking “Baltimore” and inserting “Arlington-Alexandria”; and
in subparagraph (B), by striking “2020” and inserting “2025”.
Workload adjustment— Section 741(c)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(c)(3)) is amended—
in subparagraph (A)—
in the matter preceding clause (i), by striking “2020” and inserting “2025”;
in clause (i)—
by striking “and investigational generic new animal drug protocol submissions” and inserting “investigational generic new animal drug protocol submissions, requests to establish a generic investigational new animal drug file, and generic investigational new animal drug meeting requests”; and
by striking “; and” and inserting a semicolon;
by redesignating clause (ii) as clause (iii); and
by inserting after clause (i) the following:
“(ii) if the workload adjustment calculated by the Secretary under clause (i) exceeds 25 percent, the Secretary shall use 25 percent for the adjustment; and”
in subparagraph (B), by striking “2021 through 2023” and inserting “2026 through 2028”.
Final year adjustment— Section 741(c)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(c)(4)) is amended—
by striking “2023” each place it appears and inserting “2028”; and
by striking “2024” and inserting “2029”.
Fee waiver or reduction; exemption from fees— Subsection (d) of section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) is amended to read as follows:
“(d) Fee waiver or reduction—The Secretary shall grant a waiver from, or a reduction of, one or more fees assessed under subsection (a) where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication.”
Effect of failure To pay fees— Section 741(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(e)) is amended by striking “The Secretary may discontinue” and inserting “A request to establish a generic investigational new animal drug file that is submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for action by the Secretary until all fees owed by such person have been paid. The Secretary may discontinue”.
Assessment of fees— Section 741(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(f)(2)) is amended by striking “sponsors, and generic new animal drug products at any time” and inserting “products, generic new animal drug sponsors, and generic investigational new animal drug files at any time”.
Crediting and availability of fees— Section 741(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(g)) is amended—
in paragraph (3), by striking “2019 through 2023” and inserting “2024 through 2028”;
by striking the second paragraph (4) (relating to Offset), as added by section 202 of the Animal Generic Drug User Fee Amendments of 2013 (Public Law 113–14); and
by adding at the end the following:
“(5) Recovery of collection shortfalls—The amount of fees otherwise authorized to be collected under this section shall be increased—
“(A) for fiscal year 2026, by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2024 falls below the amount of fees authorized for fiscal year 2024 under paragraph (3);
“(B) for fiscal year 2027, by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2025 falls below the amount of fees authorized for fiscal year 2025 under paragraph (3); and
“(C) for fiscal year 2028, by the amount, if any, by which the amount collected under this section and appropriated for fiscal years 2026 and 2027 (including estimated collections for fiscal year 2027) falls below the amount of fees authorized for such fiscal years under paragraph (3).”
Definitions— Section 741(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(k)) is amended—
by redesignating paragraphs (8), (9), (10), and (11) as paragraphs (9), (10), (11), and (13), respectively;
by inserting after paragraph (7) the following:
changed
“(8) Generic investigational new animal drug meeting request—The term “generic generic investigational new animal drug meeting request” request means a request submitted by a generic new animal drug sponsor to meet with the Secretary to discuss an investigational submission for a generic new animal drug.”
in paragraph (11) (as so redesignated), by adding at the end the following:
“(I) The activities necessary for exploration and implementation of the United States and European Union Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections, and the United States and United Kingdom Mutual Recognition Agreement Sectoral Annex for Pharmaceutical Good Manufacturing Practices, and other mutual recognition agreements, with respect to generic new animal drug products subject to review, including implementation activities prior to and following product approval.”
by inserting after paragraph (11) (as so redesignated) the following:
changed
“(12) Request to establish a generic investigational new animal drug file—The term “request request to establish a generic investigational new animal drug file” file means the submission to the Secretary of a request to establish a generic investigational new animal drug file to contain investigational submissions for a generic new animal drug.”
Sec. 304 Regulation of zootechnical animal food substances
added
added
Definition— Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following:
added “(tt)
added “(1) The term zootechnical animal food substance means a substance that—
added “(A) is added to the food or drinking water of animals;
added “(B) is intended to—
added “(i) affect the byproducts of the digestive process of an animal;
added “(ii) reduce the presence of foodborne pathogens of human health significance in an animal intended to be used for food; or
added “(iii) affect the structure or function of the body of the animal, other than by providing nutritive value, by altering the animal’s gastrointestinal microbiome; and
added “(C) achieves its intended effect by acting solely within the gastrointestinal tract of the animal.
added “(2) Such term does not include a substance that—
added “(A) is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in an animal;
added “(B) is a hormone;
added “(C) is an active moiety in an animal drug, which, prior to the filing of a petition under section 409 was approved under section 512, conditionally approved under section 571, or indexed under section 572, or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public;
added “(D) is an ionophore; or
added “(E) is otherwise excluded from the definition based on criteria established by the Secretary through notice and comment rulemaking.
added “(3) A zootechnical animal food substance shall be deemed to be a food additive within the meaning of paragraph (s) and its introduction into interstate commerce shall be in accordance with a regulation issued under section 409. A zootechnical animal food substance shall not be considered a drug under paragraph (g)(1)(C) solely because the substance has an intended effect described in subparagraph (1).”
added
Food additives— Section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348) is amended—
added
in subsection (b)—
added
by redesignating paragraphs (3) through (5) as paragraphs (4) through (6), respectively; and
added
by inserting after paragraph (2) the following:
added “(3) In the case of a zootechnical animal food substance, such petition shall, in addition to any explanatory or supporting data, contain—
added “(A) all relevant data bearing on the effect the zootechnical animal food substance is intended to have and the quantity of such substance required to produce the intended effect; and
added “(B) full reports of investigations made with respect to the intended use of such substance, including full information as to the methods and controls used in conducting such investigations.”
added
in subsection (c)—
added
by amending subparagraph (A) of paragraph (1) to read as follows:
added “(A)
added “(i) by order establish a regulation (whether or not in accord with that proposed by the petitioner) prescribing—
added “(I) with respect to one or more proposed uses of the food additive involved, the conditions under which such additive may be safely used (including specifications as to the particular food or classes of food in or on which such additive may be used, the maximum quantity which may be used or permitted to remain in or on such food, the manner in which such additive may be added to or used in or on such food, and any directions or other labeling or packaging requirements for such additive as the Secretary determines necessary to assure the safety of such use); and
added “(II) in the case of a zootechnical animal food substance, the conditions under which such substance may be used to achieve the intended effect; and
added “(ii) notify the petitioner of such order and the reasons for such action; or”
added
in paragraph (3)—
added
in subparagraph (A), by striking “; or” and inserting a semicolon;
added
in subparagraph (B), by striking the period and inserting “; or”; and
added
by adding at the end the following:
added “(C) in the case of a zootechnical animal food substance, fails to establish that the proposed use of the substance, under the conditions of use to be specified in the regulation, will achieve the intended effect.”
added
by adding at the end the following:
added “(l) Zootechnical animal food substances—The labeling of a zootechnical animal food substance—
added “(1) shall include the statement: “Not for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals.”; and
added “(2) may include statements regarding the intended effect of the substance on the structure or function of the body of animals, as set forth in section 201(tt)(1).”
added
Misbranded food— Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the following:
added “(z) If it is a zootechnical animal food substance and the labeling of the food does not include the statement required by section 409(l)(1).”
added
Rule of construction— Nothing in this section, or the amendments made by this section, shall be construed to authorize the Secretary of Health and Human Services to require the use of any zootechnical food substance or food additive (as those terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (a)).