US Codex
Pub. L.
Notes

Title III — Miscellaneous Provisions

115th Congress · Approved Aug 14, 2018 · 132 Stat. 2427

TITLE III Miscellaneous Provisions

SEC. 301. Electronic Submissions.

(a)
New Animal Drug Applications and Abbreviated Applications for a Generic New Animal Drug.— Section 512(b) (21 U.S.C. 360b(b)) is amended by adding at the end the following:

“(4) Beginning on October 1, 2018, all applications or submissions pursuant to this subsection shall be submitted by electronic means in such format as the Secretary may require.”

(b)
Conditional Approval of New Animal Drugs for Minor Use and Minor Species.— Section 571(a) (21 U.S.C. 360ccc(a)) is amended by adding at the end the following:

“(4) Beginning on October 1, 2018, all applications or submissions pursuant to this subsection shall be submitted by electronic means in such format as the Secretary may require.”

SEC. 302. Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.

Effective on October 1, 2018, section 572(h) (21 U.S.C. 360ccc–1(h)) is amended—
(1)
by amending paragraph (1) to read as follows:

“(1) ‘LEGAL STATUS—In order to be legally marketed, a new animal drug intended for a minor species must be Approved, Conditionally Approved, or Indexed by the Food and Drug Administration. THIS PRODUCT IS INDEXED—MIF #’ (followed by the applicable minor species index file number and a period) ‘Extra-label use is prohibited.’;”

; and

(2)
in paragraph (2), by striking “ other animals” and inserting “ food-producing animals”.

SEC. 303. Misbranded Drugs and Devices.

(a)
In General.— Section 502(w) (21 U.S.C. 352(w)) is amended—
(1)
in subparagraph (1), by striking “ ; or” and inserting “ ;”;
(2)
in subparagraph (2), by striking the period and inserting “ ; or”; and
(3)
by adding at the end the following:

“(3) for which an application has been approved under section 512 and the labeling of such drug does not include the application number in the format: ‘Approved by FDA under (A)NADA # xxx–xxx’, except that this subparagraph shall not apply to representative labeling required under section 514.1(b)(3)(v)(b) of title 21, Code of Federal Regulations (or any successor regulation) for animal feed bearing or containing a new animal drug.”

(b)
Applicability.— Section 502(w)(3) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall apply beginning on September 30, 2023.

SEC. 304. Conditional Approval of New Animal Drugs.

(a)
In General.— Section 571 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc) is amended—
(1)
in the section heading, by striking “ species” and inserting “ species and certain new animal drugs”;
(2)
in subsection (a)—
(A)
by amending paragraph (1) to read as follows:

“(1)

(A) Except as provided in paragraph (3), any person may file with the Secretary an application for conditional approval of—

“(i) a new animal drug intended for a minor use or a minor species; or

“(ii) a new animal drug not intended for a minor use or minor species—

“(I) that is intended to treat a serious or life-threatening disease or condition or addresses an unmet animal or human health need; and

“(II) for which the Secretary determines that a demonstration of effectiveness would require a complex or particularly difficult study or studies.

“(B) The Secretary shall, not later than September 30, 2019, issue guidance or regulations further clarifying the criteria specified in subparagraph (A)(ii).

“(C) An application under this paragraph shall comply in all respects with the provisions of section 512 except for subsections (a)(4), (b)(2), (c)(1), (c)(2), (c)(3), (d)(1), (e), (h), and (n) of such section unless otherwise stated in this section, and any additional provisions of this section.

“(D) New animal drugs for which conditional approval is sought under this section are subject to the same safety standards that would be applied to new animal drugs under section 512(d) (including, for antimicrobial new animal drugs, with respect to antimicrobial resistance).”

; and

(B)
in paragraph (3)—
(i)
in subparagraph (B), by striking “ , or” and inserting “ ; or”;
(ii)
by redesignating subparagraphs (A), (B), and (C) as clauses (i), (ii), and (iii), respectively;
(iii)
by striking “ A person may not file” and inserting “ (A) A person may not file”; and
(iv)
by adding at the end the following new subparagraph:

“(B) A person may not file an application under paragraph (1)(A)(ii) if the application seeks conditional approval of a new animal drug that contains an antimicrobial active ingredient.”

(3)
in subsection (f)—
(A)
in paragraph (1), in the matter preceding subparagraph (A), by inserting “ for the conditionally approved use” after “ shall”; and
(B)
in paragraph (2)—
(i)
by striking “ An intended use” and inserting “ The Secretary shall, through regulation or guidance, determine under what conditions an intended use”; and
(ii)
by striking “ shall not” and inserting “ may”; and
(4)
by adding at the end the following new subsection:

“(k) Sunset.—

“(1) The Secretary’s authority to grant conditional approval of new animal drugs not intended for a minor use or minor species pursuant to subsection (a)(1)(A)(ii) terminates on October 1, 2028.

“(2) The Secretary—

“(A) may not accept any new applications for such conditional approval pursuant to subsection (a)(1)(A)(ii) on or after such date; and

“(B) may continue all activities under this section with respect to drugs that were conditionally approved pursuant to (a)(1)(A)(ii) prior to such date.

“(3) The Secretary may, until October 1, 2032, accept applications for approval under 512 of drugs conditionally approved pursuant to (a)(1)(A)(ii).”

(b)
Exception From Fees in Case of Certain Previously Submitted Applications for Conditional Approval.— Section 740(a)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(a)(1)(C)) is amended—
(1)
in the caption by striking “ Exception” and inserting “ Exceptions”;
(2)
by striking “ If an animal drug” and inserting the following:

“(i) If an animal drug”

; and

(3)
by inserting after clause (i), as so designated, the following new clause:

“(ii) Beginning with fiscal year 2019, in the case of an animal drug application submitted by a person under section 512(b)(1), where such person (or their licensor, assignor, or predecessor-in-interest) previously submitted an application for conditional approval under section 571 for the same product and paid the applicable fee under subparagraph (A), the application under section 512(b)(1) shall not be subject to a fee under subparagraph (A) if submitted within the timeframe specified in section 571(h).”

(c)
Report on Incorporating Veterinary Oversight.— Not later than September 30, 2019, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate identifying how the Food and Drug Administration will incorporate veterinary oversight for all approved medically important antimicrobial drugs administered to animals that are not yet subject to veterinary oversight. Such report shall address requirements related to revisions of labeling to reflect that medically important antimicrobial drugs administered to animals shall be subject to veterinary oversight.
(d)
GAO Study of Conditional Approval Programs.—
(1)
Study.— The Comptroller General of the United States (referred to in this section as the “Comptroller General”) shall conduct a study on the effectiveness and overall impact of the conditional approval pathway under section 571 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc).
(2)
Issuance of report.— Not later than January 1, 2026, the Comptroller General shall submit to the Committee on Health, Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report containing the results of the study under paragraph (1).
(3)
Contents of reports.— The report submitted under paragraph (2) shall address—
(A)
for each drug for which a conditional approval has been awarded since October 1, 2018—
(i)
whether the drug was granted conditional approval pursuant to clause (i) or (ii) of section 571(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (a);
(ii)
whether the drug was dual labeled during its conditional approval;
(iii)
the indications for which the drug was granted conditional approval under section 571 of such Act (21 U.S.C. 360ccc) and whether the drug was approved or not approved under section 512 of such Act (21 U.S.C. 360b);
(iv)
the number of years the drug was so conditionally approved and a description of the complexity of the investigation to demonstrate the drug’s effectiveness;
(v)
whether, and to what extent, the conditional approval pathway under such section 571 (21 U.S.C. 360ccc) impacted the sponsor’s decision to develop the drug or seek approval of the drug under section 512 of such Act (21 U.S.C. 360b);
(vi)
whether, and to what extent, conditional approval pursuant to clause (ii) of section 571(a)(1)(A) of such Act (21 U.S.C. 360b(a)(1)(A)) addressed a serious or life-threatening condition; and
(vii)
whether, and to what extent, conditional approval pursuant to clause (ii) of section 571(a)(1)(A) of such Act (21 U.S.C. 360b(a)(1)(A)) addressed an unmet animal or human health need, and whether before such conditional approval there were available therapies for the disease or condition involved;
(B)
an analysis of the conditional approval program under section 571 of such Act (21 U.S.C. 360ccc), including—
(i)
the resources used by the Food and Drug Administration in reviewing applications for conditional approval of drugs pursuant to such program and renewal of such conditional approval, including the effects of the program on the Food and Drug Administration’s review of animal drugs for which conditional approval is not used;
(ii)
whether any improvements to the program under section 512 of such Act (21 U.S.C. 360b) are necessary to incentivize the development of animal drugs that would likely not otherwise be developed, or developed in as timely a manner, to address—
(I)
serious or life-threatening conditions; and
(II)
an unmet animal or human health need; and
(iii)
whether the conditional approval pathway has resulted in a greater number of animal drugs approved under section 512 of such Act (21 U.S.C. 360b) for serious or life-threatening conditions or unmet animal or human health needs than would have otherwise come to market under the practices and commitments of the Center for Veterinary Medicine of the Food and Drug Administration as such practices and commitments existed as of the day before the date of enactment of this Act; and
(C)
how the Center for Veterinary Medicine of the Food and Drug Administration has utilized complex adaptive or other novel investigation designs, data from foreign countries, real-world evidence (including ongoing surveillance activities, observational studies, and registry data), biomarkers, or surrogate endpoints—
(i)
to support the approval of products under section 512 of such Act (21 U.S.C. 360b), including how many such products have been approved since October 1, 2018; and
(ii)
to support the approval of products under section 512 of such Act (21 U.S.C. 360b) that received conditional approval under section 571 of such Act (21 U.S.C. 360ccc), including how many such products have been approved since October 1, 2018.

SEC. 305. Guidance Addressing Investigation Designs.

(a)
In General.— For purposes of assisting sponsors in incorporating complex adaptive and other novel investigation designs, data from foreign countries, real world evidence (including ongoing surveillance activities, observational studies, and registry data), biomarkers, and surrogate endpoints (referred to in this section as “elements of investigations”) into proposed clinical investigation protocols and applications for new animal drugs under sections 512 and 571 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b; 360ccc), the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall issue guidance addressing the use of such elements of investigations in the development and regulatory review of such new animal drugs.
(b)
Contents.— The guidance under subsection (a) shall address how the Secretary will evaluate the elements of investigations proposed or submitted pursuant to section 512(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act or to meet the commitment under section 571(a)(2)(F) of such Act, and how sponsors of such applications may obtain feedback from the Secretary on technical issues related to such investigations prior to the submission of an application to the Secretary.
(c)
Meeting.— Prior to issuing the guidance under subsection (a), the Secretary shall consult with stakeholders, including representatives of regulated industry, consumer groups, academia, veterinarians, and food producers, through a public meeting to be held not later than 1 year after the date of enactment of this Act.
(d)
Timing.— The Secretary shall issue a draft guidance under subsection (a) not later than 1 year after the date of the public meeting under subsection (c), and shall finalize such guidance not later than 1 year after the date on which the public comment period on such draft guidance ends.

SEC. 306. Food Additives Intended for Use in Animal Food.

(a)
Food Additive Petitions for Animal Food.— Section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348) is amended by adding at the end the following:

“(k) Food Additives Intended for Use in Animal Food.—

(1) In taking action on a petition under subsection (c) for, or for recognition of, a food additive intended for use in animal food, the Secretary shall review reports of investigations conducted in foreign countries, provided by the petitioner.

“(2) Not later than 12 months after the date of enactment of the Animal Drug and Animal Generic Drug Use Fee Amendments of 2018, the Secretary shall post on the internet website of the Food and Drug Administration—

“(A) the number of petitions for food additives intended for use in animal food filed under subsection (b) that are pending;

“(B) how long each such petition submitted under subsection (b) has been pending, including such petitions the Secretary has extended under subsection (c)(2); and

“(C) the number of study protocols that have been pending review for over 50 days, and the number that have received an extension.

“(3) In the case of a food additive petition intended for use in animal food, the Secretary shall provide information to the petitioner on the required contents of such petition. If the Secretary requires additional studies beyond what the petitioner proposed, the Secretary shall provide the scientific rationale for such requirement.”

(b)
Ensuring the Safety of Pet Food.— Section 1002(a) of the Food and Drug Administration Amendments Act of 2007 (21 U.S.C. 2102(a)) is amended—
(1)
by striking paragraph (1); and
(2)
by redesignating paragraphs (2) and (3) as paragraphs (1) and (2), respectively.
(c)
Guidance on Pre-Petition Consultation Process for Animal Food Additives.—
(1)
In general.— Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the “Secretary”) shall publish draft guidance relating to the voluntary pre-petition consultation process for food additives intended for use in animal food.
(2)
Contents.— The guidance under paragraph (1) shall include—
(A)
the recommended format to submit to the Food and Drug Administration existing data, including any applicable foreign data, for assessment prior to submission of a food additive petition for animal food under section 409(b) of the Federal Food, Drug, and Cosmetic Act;
(B)
the manner and the number of days by which the Food and Drug Administration intends to review and respond to such existing data, including with respect to providing a scientific rationale for any additional data request;
(C)
circumstances under which the submission of study protocols is recommended prior to submission of a food additive petition under such section 409(b);
(D)
the manner in which the Secretary intends to inform the person submitting a study protocol for a food additive if the review of such study protocol will take longer than 50 days; and
(E)
best practices for communication between the Food and Drug Administration and industry on the development of pre-petition submissions of study protocols and existing data for food additives.
(3)
Final guidance.— The guidance under paragraph (1) shall be finalized, withdrawn, or reissued not later than 1 year after the close of the comment period on the draft guidance.