Sec. 2. Table of contents
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The table of contents for this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents. Title I—Fees relating to drugs Sec. 101. Short title; finding. Sec. 102. Authority to assess and use drug fees. Sec. 103. Reauthorization; reporting requirements. Sec. 104. Sunset dates. Sec. 105. Effective date. Sec. 106. Savings clause. Title II—Fees relating to devices Sec. 201. Short title; findings. Sec. 202. Definitions. Sec. 203. Authority to assess and use device fees. Sec. 204.
Reauthorization; reporting requirements. Sec. 205. Conformity assessment pilot program. Sec. 206. Reauthorization of review. Sec. 207. Electronic format for submissions. Sec. 208. Savings clause. Sec. 209. Effective date. Sec. 210. Sunset clause. Title III—Fees relating to generic drugs Sec. 301. Short title; finding. Sec. 302. Definitions. Sec. 303. Authority to assess and use human generic drug fees. Sec. 304. Reauthorization; reporting requirements. Sec. 305. Sunset dates.
Sec. 306. Effective date. Sec. 307. Savings clause. Title IV—Fees relating to biosimilar biological products Sec. 401. Short title; finding. Sec. 402. Definitions. Sec. 403. Authority to assess and use biosimilar fees. Sec. 404. Reauthorization; reporting requirements. Sec. 405. Sunset dates. Sec. 406. Effective date. Sec. 407. Savings clause. Title V—Reauthorizations and improvements related to drugs Sec. 501. Reauthorization of provision relating to exclusivity of certain drugs containing single enantiomers.
Sec. 502. Reauthorization of orphan grants program. Sec. 503. Reauthorization of pediatric study of drugs. Sec. 504. Protecting and strengthening the drug supply chain. Sec. 505. Sense of Congress on lowering the cost of prescription drugs. Title VI—Device Inspection and regulatory improvements Subtitle A—Improving the process for inspections of device establishments Sec. 601. Risk-based inspections for devices. Sec. 602. Recognition of foreign government inspections. Sec. 603.
Improvements to inspections process for device establishments. Sec. 604. Certificates to foreign governments for devices. Sec. 605. Facilitating international harmonization. Sec. 606. Reauthorization of inspection program. Subtitle B—Other provisions Sec. 611. Reauthorization of pediatric humanitarian device exceptions. Sec. 612. Reauthorization of pediatric device consortia. Sec. 613. Regulation of over-the-counter hearing aids. Sec. 614. Report on ensuring quality, safety, and continued effectiveness of devices that have been serviced.
Sec. 615. Device pilot projects to generate reliable and timely safety and active surveillance data. Sec. 616. Risk-based classification of accessories. Title VII—Generic Drug Access and Competition Sec. 701. Competitive Generic Therapies. Sec. 702. Enhancing regulatory transparency To enhance generic competition. Sec. 703. Incentivizing competitive generic therapy development. Sec. 704. Tropical disease product application. Sec. 705. G AO study of issues regarding first cycle approvals of generic medicines.
Title VIII—Fostering Innovation in Medical Imaging Sec. 801. Approval of applications for certain diagnostic medical imaging devices. Sec. 802. Applications for approval of contrast agents intended for use with certain diagnostic medical imaging devices. Title IX—Additional Provisions Sec. 901. Technical corrections. Sec. 902. Reauthorization of the critical path public-private partnerships.