Page:United States Statutes at Large Volume 111 Part 3.djvu/209

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PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2297 Sec. 128. Reauthorization of clinical pharmacology program. Sec. 129. Regulations for sunscreen products. Sec. 130. Reports of postmarketing approval studies. Sec. 131. Notification of discontinuance of a life saving product. TITLE II—IMPROVING REGULATION OF DEVICES Sec. 201. Investigational device exemptions. Sec. 202. Special review for certain devices. Sec. 203. Expanding humanitarian use of devices. Sec. 204. Device standards. Sec. 205. Scope of review; collaborative determinations of device data requirements. Sec. 206. Premarket notification. Sec. 207. Evaluation of automatic class III designation. Sec. 208. Classification panels. Sec. 209. Certainty of review timeframes; collaborative review process. Sec. 210. Accreditation of persons for review of premarket notification reports. Sec. 211. Device tracking. Sec. 212. Postmarket surveillance. Sec. 213. Reports. Sec. 214. Practice of medicine. Sec. 215. Noninvasive blood glucose meter. Sec. 216. Use of data relating to premarket approval; product development protocol. Sec. 217. Clarification of the number of required clinical investigations for approval. TITLE III—IMPROVING REGULATION OF FOOD Sec. 301. Flexibility for regulations regarding claims. Sec. 302. Petitions for claims. Sec. 303. Health claims for food products. Sec. 304. Nutrient content claims. Sec. 305. Referral statements. Sec. 306. Disclosure of irradiation. Sec. 307. Irradiation petition. Sec. 308. Glass and ceramic ware. Sec. 309. Food contact substances. TITLE rV—GENERAL PROVISIONS Sec. 401. Dissemination of information on new uses. Sec. 402. Expanded access to investigational therapies and diagnostics. Sec. 403. Approval of supplemental applications for approved products. Sec. 404. Dispute resolution. Sec. 405. Informal agency statements. Sec. 406. Food and Drug Administration mission and annual report. Sec. 407. Information system. Sec. 408. Education and training. Sec. 409. Centers for education and research on therapeutics. Sec. 410. Mutual recognition agreements and global harmonization. Sec. 411. Environmental impact review. Sec. 412. National uniformity for nonprescription drugs and cosmetics. Sec. 413. Food and Drug Administration study of mercury compounds in drugs and food. Sec. 414. Interagency collaboration. Sec. 415. Contracts for expert review. Sec. 416. Product classification. Sec. 417. Registration of foreign establishments. Sec. 418. Clarification of seizure authority. Sec. 419. Interstate commerce. Sec. 420. Safety report disclaimers. Sec. 421. Labeling and advertising regarding compliance with statutory requirements. Sec. 422. Rule of construction. TITLE V—EFFECTIVE DATE Sec. 501. Effective date. SEC. 2. DEFINrriONS. 21 USC 321 note. In this Act, the terms "drug", "device", "food", and "dietary supplement" have the meaning given such terms in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).