Biosimilar User Fee Act of 2012

Pub. L. 112–144

Also known as: Generic Drug User Fee Amendments of 2012, Medical Device User Fee Amendments of 2012, Synthetic Drug Abuse Prevention Act of 2012, Prescription Drug User Fee Amendments of 2012, Food and Drug Administration Safety and Innovation Act

US Codex doesn’t hold the enacted text of this law — the public-law corpus runs from the 113th Congress (2013) onward. What it changed in the U.S. Code, reconstructed from the credit notes, is listed below.

111 sections of the Code credited to this law, found between Public Law 112-90 and Public Law 112-283.

• 18 U.S.C. § 2320 — Trafficking in counterfeit goods or services
• 21 U.S.C. § 331 — Prohibited acts
• 21 U.S.C. § 333 — Penalties
• 21 U.S.C. § 334 — Seizure
• 21 U.S.C. § 337a — Extraterritorial jurisdiction
• 21 U.S.C. § 351 — Adulterated drugs and devices
• 21 U.S.C. § 352 — Misbranded drugs and devices
• 21 U.S.C. § 355 — New drugs
• 21 U.S.C. § 355-1 — 355–1. Risk evaluation and mitigation strategies
• 21 U.S.C. § 355a — Pediatric studies of drugs
• 21 U.S.C. § 355c — Research into pediatric uses for drugs and biological products
• 21 U.S.C. § 355c-1 — 355c–1. Report
• 21 U.S.C. § 355d — Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
• 21 U.S.C. § 355f — Extension of exclusivity period for new qualified infectious disease products
• 21 U.S.C. § 356 — Expedited approval of drugs for serious or life-threatening diseases or conditions
• 21 U.S.C. § 356b — Reports of postmarketing studies
• 21 U.S.C. § 356c — Discontinuance or interruption in the production of life-saving drugs
• 21 U.S.C. § 356c-1 — 356c–1. Annual reporting on drug shortages
• 21 U.S.C. § 356d — Coordination; task force and strategic plan
• 21 U.S.C. § 356e — Drug shortage list
• 21 U.S.C. § 356f — Hospital repackaging of drugs in shortage
• 21 U.S.C. § 360 — Registration of producers of drugs or devices
• 21 U.S.C. § 360a-1 — 360a–1. Clinical trials
• 21 U.S.C. § 360c — Classification of devices intended for human use
• 21 U.S.C. § 360c-1 — 360c–1. Reporting
• 21 U.S.C. § 360d — Performance standards
• 21 U.S.C. § 360e — Premarket approval
• 21 U.S.C. § 360g — Judicial review
• 21 U.S.C. § 360g-1 — 360g–1. Agency documentation and review of significant decisions regarding devices
• 21 U.S.C. § 360h-1 — 360h–1. Program to improve the device recall system
• 21 U.S.C. § 360i — Records and reports on devices
• 21 U.S.C. § 360j — General provisions respecting control of devices intended for human use
• 21 U.S.C. § 360l — Postmarket surveillance
• 21 U.S.C. § 360m — Accredited persons
• 21 U.S.C. § 360n-1 — 360n–1. Priority review for qualified infectious disease products
• 21 U.S.C. § 360ee — Grants and contracts for development of drugs for rare diseases and conditions
• 21 U.S.C. § 360ff — Priority review to encourage treatments for rare pediatric diseases
• 21 U.S.C. § 360bbb-5 — 360bbb–5. Critical Path Public-Private Partnerships
• 21 U.S.C. § 360bbb-7 — 360bbb–7. Notification
• 21 U.S.C. § 360bbb-8 — 360bbb–8. Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments
• 21 U.S.C. § 360bbb-8a — 360bbb–8a. Optimizing global clinical trials
• 21 U.S.C. § 360bbb-8b — 360bbb–8b. Use of clinical investigation data from outside the United States
• 21 U.S.C. § 360bbb-8c — 360bbb–8c. Patient participation in medical product discussion
• 21 U.S.C. § 360ddd — Definitions
• 21 U.S.C. § 360ddd-1 — 360ddd–1. Regulation of medical gases
• 21 U.S.C. § 360ddd-2 — 360ddd–2. Inapplicability of drug fees to designated medical gases
• 21 U.S.C. § 371 — Regulations and hearings
• 21 U.S.C. § 374 — Inspection
• 21 U.S.C. § 379 — Confidential information
• 21 U.S.C. § 379d-1 — 379d–1. Conflicts of interest
• 21 U.S.C. § 379d-3 — 379d–3. Streamlined hiring authority
• 21 U.S.C. § 379d-4 — 379d–4. Reporting requirements
• 21 U.S.C. § 379d-5 — 379d–5. Guidance document regarding product promotion using the Internet
• 21 U.S.C. § 379g — Definitions
• 21 U.S.C. § 379h — Authority to assess and use drug fees
• 21 U.S.C. § 379h-2 — 379h–2. Reauthorization; reporting requirements
• 21 U.S.C. § 379i — Definitions
• 21 U.S.C. § 379j — Authority to assess and use device fees
• 21 U.S.C. § 379j-1 — 379j–1. Reauthorization; reporting requirements
• 21 U.S.C. § 379j-41 — 379j–41. Definitions
• 21 U.S.C. § 379j-42 — 379j–42. Authority to assess and use human generic drug fees
• 21 U.S.C. § 379j-43 — 379j–43. Reauthorization; reporting requirements
• 21 U.S.C. § 379j-51 — 379j–51. Definitions
• 21 U.S.C. § 379j-52 — 379j–52. Authority to assess and use biosimilar biological product fees
• 21 U.S.C. § 379j-53 — 379j–53. Reauthorization; reporting requirements
• 21 U.S.C. § 379k-1 — 379k–1. Electronic format for submissions
• 21 U.S.C. § 381 — Imports and exports
• 21 U.S.C. § 383 — Office of International Relations
• 21 U.S.C. § 384e — Recognition of foreign government inspections
• 21 U.S.C. § 393a — Office of Pediatric Therapeutics
• 21 U.S.C. § 399e — Nanotechnology
• 21 U.S.C. § 399f — Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups
• 21 U.S.C. § 811 — Authority and criteria for classification of substances
• 21 U.S.C. § 812 — Schedules of controlled substances
• 21 U.S.C. § 826 — Production quotas for controlled substances
• 21 U.S.C. § 826a — Attorney General report on drug shortages
• 42 U.S.C. § 213a — Rights, benefits, privileges, and immunities for commissioned officers or beneficiaries; exercise of authority by Secretary or designee
• 42 U.S.C. § 262 — Regulation of biological products
• 42 U.S.C. § 284m — Program for pediatric studies of drugs
• 42 U.S.C. § 284m-1 — 284m–1. Pediatric Advisory Committee
• 42 U.S.C. § 290b — Establishment and duties of Foundation
• 21 U.S.C. § 355–1 — Risk evaluation and mitigation strategies
• 21 U.S.C. § 355c–1 — Report
• 21 U.S.C. § 356c–1 — Annual reporting on drug shortages
• 21 U.S.C. § 360a–1 — Clinical trials
• 21 U.S.C. § 360c–1 — Reporting
• 21 U.S.C. § 360g–1 — Agency documentation and review of significant decisions regarding devices
• 21 U.S.C. § 360h–1 — Program to improve the device recall system
• 21 U.S.C. § 360n–1 — Priority review for qualified infectious disease products
• 21 U.S.C. § 360bbb–5 — Critical Path Public-Private Partnerships
• 21 U.S.C. § 360bbb–7 — Notification
• 21 U.S.C. § 360bbb–8 — Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments
• 21 U.S.C. § 360bbb–8a — Optimizing global clinical trials
• 21 U.S.C. § 360bbb–8b — Use of clinical investigation data from outside the United States
• 21 U.S.C. § 360bbb–8c — Patient participation in medical product discussion
• 21 U.S.C. § 360ddd–1 — Regulation of medical gases
• 21 U.S.C. § 360ddd–2 — Inapplicability of drug fees to designated medical gases
• 21 U.S.C. § 379d–1 — Conflicts of interest
• 21 U.S.C. § 379d–3 — Streamlined hiring authority
• 21 U.S.C. § 379d–4 — Reporting requirements
• 21 U.S.C. § 379d–5 — Guidance document regarding product promotion using the Internet
• 21 U.S.C. § 379h–2 — Reauthorization; reporting requirements
• 21 U.S.C. § 379j–1 — Reauthorization; reporting requirements
• 21 U.S.C. § 379j–41 — Definitions
• 21 U.S.C. § 379j–42 — Authority to assess and use human generic drug fees
• 21 U.S.C. § 379j–43 — Reauthorization; reporting requirements
• 21 U.S.C. § 379j–51 — Definitions
• 21 U.S.C. § 379j–52 — Authority to assess and use biosimilar biological product fees
• 21 U.S.C. § 379j–53 — Reauthorization; reporting requirements
• 21 U.S.C. § 379k–1 — Electronic format for submissions
• 42 U.S.C. § 284m–1 — Pediatric Advisory Committee