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1、 56.122 21 CFR Ch. I 4102 Edition addition the agency may elect to pub- ment agency for any action that that lish a notice of its action in the FED- agency determines to be appropriate. ERAL REGISTER. d The Food and Drug Administra- PART 58GOOD LABORATORY tion will not approve an application for PRA
2、CTICE FOR NONCLINICAL a research permit for a clinical inves- LABORATORY STUDIES tigation that is to be under the review of a disqualified IRB or that is to be Subpart AGeneral Provisions conducted at a disqualified institution and it may refuse to consider in sup- Sec. port of a marketing permit th
3、e data 58.1 Scope. 58.3 Definitions. from a clinical investigation that was 58.10 Applicability to studies performed reviewed by a disqualified IRB as con- under grants and contracts. ducted at a disqualified institution un- 58.15 Inspection of a testing facility. less the IRB or the parent institut
4、ion is reinstated as provided in 56.123. Subpart BOrganization and Personnel 58.29 Personnel. 56.122 Public disclosure of informa- 58.31 Testing facility management. tion regarding revocation. 58.33 Study director. A determination that the Food and 58.35 Quality assurance unit. Drug Administration h
5、as disqualified an institution and the administrative Subpart CFacilities record regarding that determination 58.41 General. are disclosable to the public under part 58.43 Animal care facilities. 20. 58.45 Animal supply facilities. 58.47 Facilities for handling test and con- 56.123 Reinstatement of
6、an IRB or an trol articles. institution. 58.49 Laboratory operation areas. 58.51 Specimen and data storage facilities. An IRB or an institution may be re- instated if the Commissioner deter- Subpart DEquipment mines upon an evaluation of a written 58.61 Equipment design. submission from the IRB or i
7、nstitution 58.63 Maintenance and calibration of equip- that explains the corrective action ment. that the institution or IRB plans to take that the IRB or institution has Subpart ETesting Facilities Operation provided adequate assurance that it 58.81 Standard operating procedures. will operate in co
8、mpliance with the 58.83 Reagents and solutions. standards set forth in this part. Notifi- 58.90 Animal care. cation of reinstatement shall be pro- vided to all persons notified under Subpart FTest and Control Articles 56.121c. 58.105 Test and control article characteriza- 56.124 Actions alternative
9、or addi- tion. tional to disqualification. 58.107 Test and control article handling. 58.113 Mixture of articles with carriers. Disqualification of an IRB or of an institution is independent of and nei- Subpart GProtocol for and Conduct of a ther in lieu of nor a precondition to Nonclinical Laborator
10、y Study other proceedings or actions authorized 58.120 Protocol. by the act. The Food and Drug Admin- 58.130 Conduct of a nonclinical laboratory istration may at any time through study. the Department of Justice institute any appropriate judicial proceedings Subparts HI Reserved civil or criminal an
11、d any other appro- priate regulatory action in addition to Subpart JRecords and Reports or in lieu of and before at the time of 58.185 Reporting of nonclinical laboratory or after disqualification. The agency study results. may also refer pertinent matters to an- 58.190 Storage and retrieval of reco
12、rds and other Federal State or local govern- data. 308VerDate Aprlt24gt2002 15:16 May 02 2002 Jkt 197062 PO 00000 Frm 00308 Fmt 8010 Sfmt 8010 Y:SGML197062T.XXX pfrm13 PsN: 197062T Food and Drug Administration HHS 58.3 58.195 Retention of records. secs. 201902 52 Stat. 1040 et seq. as amended 21 U.S
13、.C. 321392. Subpart KDisqualification of Testing b Test article means any food addi- Facilities tive color additive drug biological 58.200 Purpose. product electronic product medical 58.202 Grounds for disqualification. device for human use or any other ar- 58.204 Notice of and opportunity for heari
14、ng ticle subject to regulation under the on proposed disqualification. act or under sections 351 and 354360F 58.206 Final order on disqualification. of the Public Health Service Act. 58.210 Actions upon disqualification. 58.213 Public disclosure of information re- c Control article means any food ad
15、- garding disqualification. ditive color additive drug biological 58.215 Alternative or additional actions to product electronic product medical disqualification. device for human use or any article 58.217 Suspension or termination of a test- other than a test article feed or water ing facility by a
16、 sponsor. that is administered to the test system 58.219 Reinstatement of a disqualified test- in the course of a nonclinical labora- ing facility. tory study for the purpose of estab- AUTHORITY: 21 U.S.C. 342 346 346a 348 351 lishing a basis for comparison with the 352 353 355 360 360b360f 360h360j
17、 371 379e test article. 381 42 U.S.C. 216 262 263b263n. d Nonclinical laboratory study means SOURCE: 43 FR 60013 Dec. 22 1978 unless in vivo or in vitro experiments in otherwise noted. which test articles are studied prospec- tively in test systems under laboratory Subpart AGeneral Provisions condit
18、ions to determine their safety. The term does not include studies uti- 58.1 Scope. lizing human subjects or clinical stud- a This part prescribes good labora- ies or field trials in animals. The term tory practices for conducting nonclin- does not include basic exploratory ical laboratory studies th
19、at support or studies carried out to determine are intended to support applications whether a test article has any poten- for research or marketing permits for tial utility or to determine physical or products regulated by the Food and chemical characteristics of a test arti- Drug Administration inc
20、luding food cle. and color additives animal food addi- e Application for research or mar- tives human and animal drugs med- keting permit includes: ical devices for human use biological 1 A color additive petition de- products and electronic products. scribed in part 71. Compliance with this part is
21、 intended 2 A food additive petition described to assure the quality and integrity of in parts 171 and 571. the safety data filed pursuant to sec- 3 Data and information regarding a tions 406 408 409 502 503 505 506 510 substance submitted as part of the pro- 512516 518520 721 and 801 of the Fed- ce
22、dures for establishing that a sub- eral Food Drug and Cosmetic Act and stance is generally recognized as safe sections 351 and 354360F of the Public for use which use results or may rea- Health Service Act. sonably be expected to result directly b References in this part to regu- or indirectly in it
23、s becoming a compo- latory sections of the Code of Federal nent or otherwise affecting the charac- Regulations are to chapter I of title 21 teristics of any food described in unless otherwise noted. 170.35 and 570.35. 43 FR 60013 Dec. 22 1978 as amended at 52 4 Data and information regarding a FR 33
24、779 Sept. 4 1987 64 FR 399 Jan. 5 1999 food additive submitted as part of the procedures regarding food additives 58.3 Definitions. permitted to be used on an interim As used in this part the following basis pending additional study de- terms shall have the meanings speci- scribed in 180.1. fied: 5
25、An investigational new drug appli- a Act means the Federal Food cation described in part 312 of this Drug and Cosmetic Act as amended chapter. 309VerDate Aprlt24gt2002 15:16 May 02 2002 Jkt 197062 PO 00000 Frm 00309 Fmt 8010 Sfmt 8010 Y:SGML197062T.XXX pfrm13 PsN: 197062T 58.3 21 CFR Ch. I 4102 Edit
26、ion 6 A new drug application described such product described in section 358 in part 314. of the Public Health Service Act. 7 Data and information regarding 21 Data and information regarding an over-the-counter drug for human an electronic product submitted as use submitted as part of the proce- part of the procedures for obtaining a dures for classifying such drugs as gen- variance from any electronic product erally recognized as safe and effective performance standard as described in and not misbranded described in part.
