21 U.S.C. § 356l — Untitled legal text

Page 295 TITLE 21—FOOD AND DRUGS § 356l tion 355(b) of this title or section 351(a) of the Public Health Service Act or a request for emer- gency use authorization under section 360bbb–3 of this title, in order to support approval, licen- sure, or authorization, to reference or rely upon data and information within an application or request for a drug or biological product that in- corporates or utilizes the same platform tech- nology designated under subsection (d), provided that— (1) such data and information was submitted by the same sponsor, pursuant to the applica- tion for the drug with respect to which des- ignation of the designated platform tech- nology under subsection (d) was granted; or (2) the sponsor relying on such data and in- formation received a right of reference to such data and information from the sponsor de- scribed in paragraph (1). (g) Changes to a designated platform technology A sponsor of more than one application ap- proved under section 355(b) of this title or sec- tion 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for drugs that incorporate or uti- lize a designated platform technology may sub- mit a single supplemental application for pro- posed changes to the designated platform tech- nology that may be applicable to more than one such drug that incorporates or utilizes the same designated platform technology. Such supple- mental application may cross-reference data and information submitted in other applications and may include one or more comparability proto- cols regarding how such changes to the platform technology would be made for each applicable drug or biological product. (h) Definitions For purposes of this section: (1) The term ‘‘platform technology’’ means a well-understood and reproducible technology, which may include a nucleic acid sequence, molecular structure, mechanism of action, de- livery method, vector, or a combination of any such technologies that the Secretary deter- mines to be appropriate, that the sponsor dem- onstrates— (A) is incorporated in or utilized by a drug or biological product and is essential to the structure or function of such drug or biologi- cal product; (B) can be adapted for, incorporated into, or utilized by, more than one drug or bio- logical product sharing common structural elements; and (C) facilitates the manufacture or develop- ment of more than one drug or biological product through a standardized production or manufacturing process or processes. (2) The term ‘‘designated platform tech- nology’’ means a platform technology that is designated as a platform technology under subsection (d). (i) Rule of construction Nothing in this section shall be construed to— (1) alter the authority of the Secretary to approve drugs pursuant to section 505 of this Act [21 U.S.C. 355] or license biological prod- ucts pursuant to section 351 of the Public Health Service Act [42 U.S.C. 262], including standards of evidence and applicable condi- tions for approval or licensure under the appli- cable Act; or (2) confer any new rights with respect to the permissibility of a sponsor of an application for a drug product or biological product ref- erencing information contained in another ap- plication submitted by the holder of an ap- proved application under section 355(c) of this title or of a license under section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)]. (June 25, 1938, ch. 675, § 506K, as added Pub. L. 117–328, div. FF, title II, § 2503(a), Dec. 29, 2022, 136 Stat. 5798.) Editorial Notes REFERENCES IN TEXT The Public Health Service Act, referred to in subsec. (d)(5), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classi- fication of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables. Statutory Notes and Related Subsidiaries GUIDANCE Pub. L. 117–328, div. FF, title II, § 2503(b), Dec. 29, 2022, 136 Stat. 5801, provided that: ‘‘Not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], the Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall issue draft guidance on the implementation of this section. Such guidance shall include examples of drugs that can be manufactured using platform technologies, including drugs that contain or consist of vectors and nucleic acids, information about the Secretary’s review of plat- form technologies, information regarding submitting for designation, considerations for persons submitting a request for designation who have been granted a right of reference, the implementation of the designated platform technology designation program, efficiencies that may be achieved in the development and review of products that incorporate or utilize designated plat- form technologies, and recommendations and require- ments for making and reporting manufacturing changes to a designated platform technology in accord- ance with section 506K(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356k(g)] (as added by sub- section (a)) and section 506A of such Act (21 U.S.C. 356a), as applicable.’’ § 356l. Advanced manufacturing technologies designation program (a) In general Not later than 1 year after December 29, 2022, the Secretary shall initiate a program under which persons may request designation of an ad- vanced manufacturing technology as described in subsection (b). (b) Designation process The Secretary shall establish a process for the designation under this section of methods of manufacturing drugs, including biological prod- ucts, and active pharmaceutical ingredients of such drugs, as advanced manufacturing tech- nologies. A method of manufacturing, or a com- bination of manufacturing methods, is eligible for designation as an advanced manufacturing technology if such method or combination of methods incorporates a novel technology, or uses an established technique or technology in a Page 296 TITLE 21—FOOD AND DRUGS § 356l novel way, that will substantially improve the manufacturing process for a drug while main- taining equivalent, or providing superior, drug quality, including by— (1) reducing development time for a drug using the designated manufacturing method; or (2) increasing or maintaining the supply of— (A) a drug that is life-supporting, life-sus- taining, or of critical importance to pro- viding health care; or (B) a drug that is on the drug shortage list under section 356e of this title. (c) Evaluation and designation of an advanced manufacturing technology (1) Submission A person who requests designation of a method of manufacturing as an advanced man- ufacturing technology under this section shall submit to the Secretary data or information demonstrating that the method of manufac- turing meets the criteria described in sub- section (b) in a particular context of use. The Secretary may facilitate the development and review of such data or information by— (A) providing timely advice to, and inter- active communication with, such person re- garding the development of the method of manufacturing; and (B) involving senior managers and experi- enced staff of the Food and Drug Adminis- tration, as appropriate, in a collaborative, cross-disciplinary review of the method of manufacturing, as applicable. (2) Evaluation and designation Not later than 180 calendar days after the re- ceipt of a request under paragraph (1), the Sec- retary shall determine whether to designate such method of manufacturing as an advanced manufacturing technology, in a particular context of use, based on the data and informa- tion submitted under paragraph (1) and the criteria described in subsection (b). (d) Review of advanced manufacturing tech- nologies If the Secretary designates a method of manu- facturing as an advanced manufacturing tech- nology, the Secretary shall— (1) expedite the development and review of an application submitted under section 355 of this title or section 262 of title 42, including supplemental applications, for drugs that are manufactured using a designated advanced manufacturing technology; and (2) allow the holder of an advanced tech- nology designation, or a person authorized by the advanced manufacturing technology des- ignation holder, to reference or rely upon, in an application submitted under section 355 of this title or section 262 of title 42, including a supplemental application, data and informa- tion about the designated advanced manufac- turing technology for use in manufacturing drugs in the same context of use for which the designation was granted. (e) Implementation and evaluation of advanced manufacturing technologies program (1) Public meeting The Secretary shall publish in the Federal Register a notice of a public meeting, to be held not later than 180 days after December 29, 2022, to discuss, and obtain input and rec- ommendations from relevant stakeholders re- garding— (A) the goals and scope of the program under this section, and the framework, pro- cedures, and requirements suitable for such program; and (B) ways in which the Food and Drug Ad- ministration will support the use of ad- vanced manufacturing technologies and other innovative manufacturing approaches for drugs. (2) Program guidance (A) In general The Secretary shall— (i) not later than 180 days after the pub- lic meeting under paragraph (1), issue draft guidance regarding the goals and im- plementation of the program under this section; and (ii) not later than 2 years after December 29, 2022, issue final guidance regarding the implementation of such program. (B) Content The guidance described in subparagraph (A) shall address— (i) the process by which a person may re- quest a designation under subsection (b); (ii) the data and information that a per- son requesting such a designation is re- quired to submit under subsection (c), and how the Secretary intends to evaluate such submissions; (iii) the process to expedite the develop- ment and review of applications under sub- section (d); and (iv) the criteria described in subsection (b) for eligibility for such a designation. (3) Report Not later than 3 years after December 29, 2022, and annually thereafter, the Secretary shall publish on the website of the Food and Drug Administration and submit to the Com- mittee on Health, Education, Labor, and Pen- sions of the Senate and the Committee on En- ergy and Commerce of the House of Represent- atives a report containing a description and evaluation of the program being conducted under this section, including the types of inno- vative manufacturing approaches supported under the program. Such report shall include the following: (A) The number of persons that have re- quested designations and that have been granted designations. (B) The number of methods of manufac- turing that have been the subject of designa- tion requests and that have been granted designations. (C) The average number of calendar days for completion of evaluations under sub- section (c)(2). (D) An analysis of the factors in data sub- missions that result in determinations to designate and not to designate after evalua- tion under subsection (c)(2). (E) The number of applications received under section 355 of this title or section 262 Page 297 TITLE 21—FOOD AND DRUGS § 357 of title 42, including supplemental applica- tions, that have included an advanced manu- facturing technology designated under this section, and the number of such applications approved. (f) Sunset The Secretary— (1) may not consider any requests for des- ignation submitted under subsection (c) after October 1, 2032; and (2) may continue all activities under this section with respect to advanced manufac- turing technologies that were designated pur- suant to subsection (b) prior to such date, if the Secretary determines such activities are in the interest of the public health. (June 25, 1938, ch. 675, § 506L, as added Pub. L. 117–328, div. FF, title III, § 3213, Dec. 29, 2022, 136 Stat. 5826.) § 357. Qualification of drug development tools (a) Process for qualification (1) In general The Secretary shall establish a process for the qualification of drug development tools for a proposed context of use under which— (A)(i) a requestor initiates such process by submitting a letter of intent to the Sec- retary; and (ii) the Secretary accepts or declines to ac- cept such letter of intent; (B)(i) if the Secretary accepts the letter of intent, a requestor submits a qualification plan to the Secretary; and (ii) the Secretary accepts or declines to ac- cept the qualification plan; and (C)(i) if the Secretary accepts the quali- fication plan, the requestor submits to the Secretary a full qualification package; (ii) the Secretary determines whether to accept such qualification package for re- view; and (iii) if the Secretary accepts such quali- fication package for review, the Secretary conducts such review in accordance with this section. (2) Acceptance and review of submissions (A) In general Subparagraphs (B), (C), and (D) shall apply with respect to the treatment of a letter of intent, a qualification plan, or a full quali- fication package submitted under paragraph (1) (referred to in this paragraph as ‘‘quali- fication submissions’’). (B) Acceptance factors; nonacceptance The Secretary shall determine whether to accept a qualification submission based on factors which may include the scientific merit of the qualification submission. A de- termination not to accept a submission under paragraph (1) shall not be construed as a final determination by the Secretary under this section regarding the qualifica- tion of a drug development tool for its pro- posed context of use. (C) Prioritization of qualification review The Secretary may prioritize the review of a full qualification package submitted under paragraph (1) with respect to a drug develop- ment tool, based on factors determined ap- propriate by the Secretary, including— (i) as applicable, the severity, rarity, or prevalence of the disease or condition tar- geted by the drug development tool and the availability or lack of alternative treatments for such disease or condition; and (ii) the identification, by the Secretary or by biomedical research consortia and other expert stakeholders, of such a drug development tool and its proposed context of use as a public health priority. (D) Engagement of external experts The Secretary may, for purposes of the re- view of qualification submissions, through the use of cooperative agreements, grants, or other appropriate mechanisms, consult with biomedical research consortia and may consider the recommendations of such con- sortia with respect to the review of any qualification plan submitted under para- graph (1) or the review of any full qualifica- tion package under paragraph (3). (3) Review of full qualification package The Secretary shall— (A) conduct a comprehensive review of a full qualification package accepted under paragraph (1)(C); and (B) determine whether the drug develop- ment tool at issue is qualified for its pro- posed context of use. (4) Qualification The Secretary shall determine whether a drug development tool is qualified for a pro- posed context of use based on the scientific merit of a full qualification package reviewed under paragraph (3). (b) Effect of qualification (1) In general A drug development tool determined to be qualified under subsection (a)(4) for a proposed context of use specified by the requestor may be used by any person in such context of use for the purposes described in paragraph (2). (2) Use of a drug development tool Subject to paragraph (3), a drug development tool qualified under this section may be used for— (A) supporting or obtaining approval or li- censure (as applicable) of a drug or biologi- cal product (including in accordance with section 356(c) of this title) under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262]; or (B) supporting the investigational use of a drug or biological product under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [42 U.S.C. 262(a)(3)]. (3) Rescission or modification (A) In general The Secretary may rescind or modify a de- termination under this section to qualify a drug development tool if the Secretary de-