SUBCHAPTER A—GENERAL Part Page 1 General enforcement regulations 5 2 General administrative rulings and decisions 61 3 Product jurisdiction 67 5 Organization 72 7 Enforcement policy 78 10 Administrative practices and procedures 87 11 Electronic records; electronic signatures 122 12 Formal evidentiary public hearing 125 13 Public hearing before a public board of inquiry 143 14 Public hearing before a public advisory committee 148 15 Public hearing before the Commissioner 175 16 Regulatory hearing before the Food and Drug Administration 177 17 Civil money penalties hearings 183 19 Standards of conduct and conflicts of interest 197 20 Public information 199 21 Protection of privacy 230 25 Environmental impact considerations 247 26 Mutual recognition of pharmaceutical good manufacturing practice reports, medical device quality system audit reports, and certain medical device product evaluation reports: United States and The European Community 258 50 Protection of human subjects 291 54 Financial disclosure by clinical investigators 303 56 Institutional Review Boards 306 58 Good laboratory practice for nonclinical laboratory studies 316 60 Patent term restoration 329 70 Color additives 337 71 Color additive petitions 344 73 Listing of color additives exempt from certification 351 74 Listing of color additives subject to certification 401 80 Color additive certification 441 81 General specifications and general restrictions for provisional color additives for use in foods, drugs, and cosmetics 447 82 Listing of certified provisionally listed colors and specifications 454 83-98 [Reserved] 99 Dissemination of information on unapproved/new uses for marketed drugs, biologics, and devices 459