Browse Arkansas Code titles and sections

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

Federal law — U.S. Code and appendices · legal_authorities

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

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 356k

Stored review status: release_metadata_unconfirmed. A text match is a research starting point; applicability is not established.

Original supplied file — preserved unchanged

Download original Markdown file

File SHA-256: 99d8044e8434dfa8016ca7ad46429ae63e350d907582de4f8017448fe39f8dea. The original may include catalog metadata, neighboring provisions, or embedded records outside this collection's scope. Search shows only the selected federal record. Historical editions and unverified snapshots are not a statement of current law.

Authority boundary: historical or unconfirmed source not current law verified.

Open the recorded source website ↗

Record provenance

Stable record: federal_law:legal_authorities:record_usc_f7d6299ff64cdfb0af47c3be
Source file: Laws/federal/codes/united-states-code/title-21/section-356k-platform-technologies--3f7852a9e9.md
Pages: Not recorded – Not recorded
Passage SHA-256: ea8e550e46b042644c585899b19a12d68dc717e11edc4c9774416dd64f1f3ec2

Source location: Title 21, Chapter 9, § 356k; chapter-009-federal-food-drug-and-cosmetic-act.md

Stored source content

**(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 eligible 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 [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or a biological product licensed under section 351 of the Public Health Service Act [[42 U.S.C. 262](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim)]; (2) preliminary evidence submitted by the sponsor of the approved or licensed drug described in paragraph (1), or a sponsor that has been granted a right of reference to data submitted in the application for such drug, demonstrates that the platform technology has the potential to be incorporated in, or utilized by, more than one drug without an adverse effect on quality, manufacturing, or safety; and (3) data or information submitted by the applicable person under paragraph (2) indicates that incorporation or utilization of the platform technology has a reasonable likelihood to bring significant efficiencies to the drug development 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/i&num=0&edition=prelim) or section 351(a)(3) of the Public Health Service Act [[42 U.S.C. 262(a)(3)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a/3&num=0&edition=prelim)] for the investigation 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 receipt of a request under subsection (c), the Secretary shall determine whether the platform technology that is the subject of the request meets the criteria described in subsection (b). (2) **Designation** — If the Secretary determines that the platform technology meets the criteria described in subsection (b), the Secretary shall designate the platform technology as a designated platform technology and may expedite the development and review of any subsequent application submitted under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) or section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a&num=0&edition=prelim)] 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 platform technology does not meet the criteria under subsection (b), the Secretary shall include with the determination not to designate the technology a written description of the rationale for such determination. (4) **Revocation of designation** — The Secretary may revoke a designation made under paragraph (2), if the Secretary determines that the designated platform technology no longer meets the criteria described in subsection (b). The Secretary shall communicate the determination to revoke a designation to the requesting sponsor in writing, including a description of the rationale for such determination. (5) **Applicability** — Nothing in this section shall prevent a product 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section201&num=0&edition=prelim) 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 designated 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) or safety, purity, or potency under section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a&num=0&edition=prelim)]; (2) providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug that proposes to use the designated platform technology to ensure that the development program designed to gather data necessary for approval or licensure is as efficient as practicable, which may include holding meetings with the sponsor and the review team throughout the development of the drug; and (3) considering inspectional findings, including prior findings, related to the manufacture of a drug that incorporates or utilizes the designated platform technology. **(f) Leveraging data from designated platform technologies** The Secretary shall, consistent with applicable standards for approval, authorization, or licensure under this chapter and section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a&num=0&edition=prelim)], allow the sponsor of an application under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) or section 351(a) of the Public Health Service Act or a request for emergency use authorization under [section 360bbb–3 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb-3&num=0&edition=prelim), in order to support approval, licensure, or authorization, to reference or rely upon data and information within an application or request for a drug or biological product that incorporates or utilizes the same platform technology designated under subsection (d), provided that— (1) such data and information was submitted by the same sponsor, pursuant to the application for the drug with respect to which designation of the designated platform technology under subsection (d) was granted; or (2) the sponsor relying on such data and information received a right of reference to such data and information from the sponsor described in paragraph (1). **(g) Changes to a designated platform technology** A sponsor of more than one application approved under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) or section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a&num=0&edition=prelim)] for drugs that incorporate or utilize a designated platform technology may submit a single supplemental application for proposed changes to the designated platform technology that may be applicable to more than one such drug that incorporates or utilizes the same designated platform technology. Such supplemental application may cross-reference data and information submitted in other applications and may include one or more comparability protocols 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, delivery method, vector, or a combination of any such technologies that the Secretary determines to be appropriate, that the sponsor demonstrates— (A) is incorporated in or utilized by a drug or biological product and is essential to the structure or function of such drug or biological product; (B) can be adapted for, incorporated into, or utilized by, more than one drug or biological product sharing common structural elements; and (C) facilitates the manufacture or development of more than one drug or biological product through a standardized production or manufacturing process or processes. (2) The term “designated platform technology” 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim)] or license biological products pursuant to section 351 of the Public Health Service Act [[42 U.S.C. 262](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim)], including standards of evidence and applicable conditions for approval or licensure under the applicable 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 referencing information contained in another application submitted by the holder of an approved application under [section 355(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/c&num=0&edition=prelim) or of a license under section 351(a) of the Public Health Service Act [[42 U.S.C. 262(a)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a&num=0&edition=prelim)].

Cross-references

Connections may be documented source relationships, shared citations or nearby passages. Each explains its basis; a connection alone does not establish applicability to your situation.

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 355 — New drugs

**(a) Necessity of effective approval of application** No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug. **(b) Filing application; contents** (1) (A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application— (i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use; (ii) a full list of the articles used as components of such drug; (iii) a full statement of the composition of such drug; (iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (v) such samples of such drug and of the articles used as components thereof as the Secretary may require; (vi) specimens of the labeling proposed to be used for such drug; (vii) any assessments required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); and (viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that— (I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or (II) claims a method of using such drug for which approv

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355

Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 356a — Manufacturing changes

**(a) In general** With respect to a drug for which there is in effect an approved application under section 355 or 360b of this title or a license under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), a change from the manufacturing process approved pursuant to such application or license may be made, and the drug as made with the change may be distributed, if— (1) the holder of the approved application or license (referred to in this section as a “holder”) has validated the effects of the change in accordance with subsection (b); and (2) (A) in the case of a major manufacturing change, the holder has complied with the requirements of subsection (c); or (B) in the case of a change that is not a major manufacturing change, the holder complies with the applicable requirements of subsection (d). **(b) Validation of effects of changes** For purposes of subsection (a)(1), a drug made with a manufacturing change (whether a major manufacturing change or otherwise) may be distributed only if, before distribution of the drug as so made, the holder involved validates the effects of the change on the identity, strength, quality, purity, and potency of the drug as the identity, strength, quality, purity, and potency may relate to the safety or effectiveness of the drug. **(c) Major manufacturing changes** (1) **Requirement of supplemental application** — For purposes of subsection (a)(2)(A), a drug made with a major manufacturing change may be distributed only if, before the distribution of the drug as so made, the holder involved submits to the Secretary a supplemental application for such change and the Secretary approves the application. The application shall contain such information as

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 356a

Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.

Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 201 — Funding

Beginning with fiscal year 2010, the Secretary shall transfer from the Public Health and Social Services Emergency Fund such sums as may be necessary to carry out this part.

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 201

Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.

Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 262 — Regulation of biological products

**(a) Biologics license** (1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless— (A) a biologics license under this subsection or subsection (k) is in effect for the biological product; and (B) each package of the biological product is plainly marked with— (i) the proper name of the biological product contained in the package; (ii) the name, address, and applicable license number of the manufacturer of the biological product; and (iii) the expiration date of the biological product. (2) (A) The Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses. (B) *Pediatric studies.—* — A person that submits an application for a license under this paragraph shall submit to the Secretary as part of the application any assessments required under section 505B of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 355c](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim)]. (C) The Secretary shall approve a biologics license application— (i) on the basis of a demonstration that— (I) the biological product that is the subject of the application is safe, pure, and potent; and (II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and (ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c). (D) *Postmarket studies and clinical trials; labeling; risk evaluation and mitigation strategy.—* — A person that sub

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 262

Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 355 — New drugs

Page 186 TITLE 21—FOOD AND DRUGS § 355 § 355. New drugs (a) Necessity of effective approval of application No person shall introduce or deliver for intro- duction into interstate commerce any new drug, unless an approval of an application filed pursu- ant to subsection (b) or (j) is effective with re- spect to such drug. (b) Filing application; contents (1)(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the ap- plication— (i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use; (ii) a full list of the articles used as compo- nents of such drug; (iii) a full statement of the composition of such drug; (iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (v) such samples of such drug and of the arti- cles used as components thereof as the Sec- retary may require; (vi) specimens of the labeling proposed to be used for such drug; (vii) any assessments required under section 355c of this title; and (viii) the patent number and expiration date of each patent for which a claim of patent in- fringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that— (I) claims the drug for which the applicant submitted the application and is a drug sub- stance (active ingredient) patent or a drug product (formulation or composition) pat- ent; or (II) claims a method of using such drug for which approval is sought or has been granted in the application. (B) If an a

Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 355

Stored review status: historical_2024_not_currentness_verified. The source passage cites 21 U.S.C. § 355. This identifies an authority to review, not proof of applicability.

Federal law — U.S. Code and appendices · legal_authorities

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 o

Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 356k

Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.

Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 201 — Definitions

Page 35 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 201 1 See References in Text note below. Sec. 300jj–34. Competitive grants to States and Indian tribes for the development of loan pro- grams to facilitate the widespread adoption of certified EHR technology. 300jj–35. Demonstration program to integrate in- formation technology into clinical education. 300jj–36. Information technology professionals in health care. 300jj–37. General grant and loan provisions. 300jj–38. Authorization for appropriations. PART C—OTHER PROVISIONS 300jj–51. Health information technology enroll- ment standards and protocols. 300jj–52. Information blocking. SUBCHAPTER XXIX—DATA COLLECTION, ANALYSIS, AND QUALITY 300kk. Data collection, analysis, and quality. SUBCHAPTER XXX—COMMUNITY LIVING ASSISTANCE SERVICES AND SUPPORTS 300ll to 300ll–9. Repealed. SUBCHAPTER XXXI—WORLD TRADE CENTER HEALTH PROGRAM PART A—ESTABLISHMENT OF PROGRAM; ADVISORY COMMITTEE 300mm. Establishment of World Trade Center Health Program. 300mm–1. WTC Health Program Scientific/Tech- nical Advisory Committee; WTC Health Program Steering Committees. 300mm–2. Education and outreach. 300mm–3. Uniform data collection and analysis. 300mm–4. Clinical Centers of Excellence and Data Centers. 300mm–5. Definitions. PART B—PROGRAM OF MONITORING, INITIAL HEALTH EVALUATIONS, AND TREATMENT SUBPART 1—WTC RESPONDERS 300mm–21. Identification of WTC responders and provision of WTC-related monitoring services. 300mm–22. Treatment of enrolled WTC responders for WTC-related health conditions. 300mm–23. National arrangement for benefits for el- igible individuals outside New York. SUBPART 2—WTC SURVIVORS 300mm–31. Identification and initial health evalua- tion of screening-eligible and

Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 201

Stored review status: historical_2024_not_currentness_verified. The source passage cites 42 U.S.C. § 201. This identifies an authority to review, not proof of applicability.

Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 262 — Regulation of biological products

Page 456 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 258a § 258a. Transferred Editorial Notes CODIFICATION Section, act July 8, 1947, ch. 210, title II, § 201, 61 Stat. 269, which related to transfer of balances in working capital fund, narcotic hospitals, to surplus fund, was transferred and is set out as a note under section 290aa of this title. §§ 259 to 261a. Repealed. Pub. L. 106–310, div. B, title XXXIV, § 3405(a), Oct. 17, 2000, 114 Stat. 1221, as amended by Pub. L. 114–198, title I, § 110(b), July 22, 2016, 130 Stat. 710 Section 259, acts July 1, 1944, ch. 373, title III, § 343, 58 Stat. 699; Pub. L. 91–513, title I, § 2(a)(2)(A), (3), (4), Oct. 27, 1970, 84 Stat. 1240; Pub. L. 92–293, § 3, May 11, 1972, 86 Stat. 136; Pub. L. 98–473, title II, § 232(b), Oct. 12, 1984, 98 Stat. 2031, related to convict addicts or other persons with drug abuse or drug dependence problems. Section 260, acts July 1, 1944, ch. 373, title III, § 344, 58 Stat. 701; June 25, 1948, ch. 654, § 5, 62 Stat. 1018; July 24, 1956, ch. 676, title III, § 302(b), 70 Stat. 622; Pub. L. 91–513, title I, § 2(a)(2)(A), (3), (4), Oct. 27, 1970, 84 Stat. 1240, re- lated to addicts and persons with drug abuse or drug dependence problems. Section 260a, act July 1, 1944, ch. 373, title III, § 345, as added May 8, 1954, ch. 195, § 2, 68 Stat. 79; amended July 24, 1956, ch. 676, title III, § 302(c), 70 Stat. 622; Pub. L. 91–358, title I, § 155(c)(32), July 29, 1970, 84 Stat. 572, re- lated to admission of addicts committed from District of Columbia. Section 261, acts July 1, 1944, ch. 373, title III, § 346, formerly § 345, 58 Stat. 701; renumbered § 346, May 8, 1954, ch. 195, § 2, 68 Stat. 79; amended Pub. L. 91–513, title I, § 2(a)(2)(A), (5), Oct. 27, 1970, 84 Stat. 1240, relate

Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 262

Stored review status: historical_2024_not_currentness_verified. The source passage cites 42 U.S.C. § 262. This identifies an authority to review, not proof of applicability.