21 U.S.C. § 356k — Platform technologies

Page 294 TITLE 21—FOOD AND DRUGS § 356k interruption in the manufacture of a device for which such notification is received. The Secretary shall issue final guidance not later than 1 year after the close of the comment period for the draft guidance.’’ GUIDANCE ON DEVICE SHORTAGE NOTIFICATION REQUIREMENT Pub. L. 117–328, div. FF, title II, § 2514(c), Dec. 29, 2022, 136 Stat. 5806, provided that: ‘‘Not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], the Secretary shall issue or revise draft guidance re- garding requirements under section 506J of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356j). Such guidance shall include a list of each device product code for which a manufacturer of such device is re- quired to notify the Secretary in accordance with sec- tion 506J.’’ § 356k. Platform technologies (a) In general The Secretary shall establish a program for the designation of platform technologies that meet the criteria described in subsection (b). (b) Criteria A platform technology incorporated within or utilized by a drug or biological product is eligi- ble for designation as a designated platform technology under this section if— (1) the platform technology is incorporated in, or utilized by, a drug approved under sec- tion 355 of this title or a biological product li- censed under section 351 of the Public Health Service Act [42 U.S.C. 262]; (2) preliminary evidence submitted by the sponsor of the approved or licensed drug de- scribed in paragraph (1), or a sponsor that has been granted a right of reference to data sub- mitted in the application for such drug, dem- onstrates that the platform technology has the potential to be incorporated in, or utilized by, more than one drug without an adverse ef- fect on quality, manufacturing, or safety; and (3) data or information submitted by the ap- plicable person under paragraph (2) indicates that incorporation or utilization of the plat- form technology has a reasonable likelihood to bring significant efficiencies to the drug de- velopment or manufacturing process and to the review process. (c) Request for designation A person may request the Secretary designate a platform technology as a designated platform technology concurrently with, or at any time after, submission 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)] for the inves- tigation of a drug that incorporates or utilizes the platform technology that is the subject of the request. (d) Designation (1) In general Not later than 90 calendar days after the re- ceipt of a request under subsection (c), the Secretary shall determine whether the plat- form technology that is the subject of the re- quest meets the criteria described in sub- section (b). (2) Designation If the Secretary determines that the plat- form technology meets the criteria described in subsection (b), the Secretary shall des- ignate the platform technology as a des- ignated platform technology and may expedite the development and review of any subsequent application submitted under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for a drug that uses or incorporates the platform technology pursuant to subsection (e), as appropriate. (3) Determination not to designate If the Secretary determines that the plat- form technology does not meet the criteria under subsection (b), the Secretary shall in- clude with the determination not to designate the technology a written description of the ra- tionale for such determination. (4) Revocation of designation The Secretary may revoke a designation made under paragraph (2), if the Secretary de- termines that the designated platform tech- nology no longer meets the criteria described in subsection (b). The Secretary shall commu- nicate the determination to revoke a designa- tion to the requesting sponsor in writing, in- cluding a description of the rationale for such determination. (5) Applicability Nothing in this section shall prevent a prod- uct that uses or incorporates a designated platform technology from being eligible for expedited approval pathways if it is otherwise eligible under this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.]. (e) Actions The Secretary may take actions to expedite the development and review of an application for a drug that incorporates or utilizes a des- ignated platform technology, including— (1) engaging in early interactions with the sponsor to discuss the use of the designated platform technology and what is known about such technology, including data previously submitted that is relevant to establishing, as applicable, safety or efficacy under section 355(b) of this title or safety, purity, or potency under section 351(a) of the Public Health Serv- ice Act [42 U.S.C. 262(a)]; (2) providing timely advice to, and inter- active communication with, the sponsor re- garding the development of the drug that pro- poses to use the designated platform tech- nology to ensure that the development pro- gram designed to gather data necessary for ap- proval or licensure is as efficient as prac- ticable, which may include holding meetings with the sponsor and the review team through- out the development of the drug; and (3) considering inspectional findings, includ- ing prior findings, related to the manufacture of a drug that incorporates or utilizes the des- ignated platform technology. (f) Leveraging data from designated platform technologies The Secretary shall, consistent with applica- ble standards for approval, authorization, or li- censure under this chapter and section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)], allow the sponsor of an application under sec- 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