Source: https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&mc=true&n=pt21.1.58&r=PART&ty=HTML
Timestamp: 2020-08-10 18:20:46
Document Index: 145319360

Matched Legal Cases: ['art 58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§170', '§180', '§1010', '§1010', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', '§58', 'art 20']

Title 21 → Chapter I → Subchapter A → Part 58
§58.1 Scope.
§58.3 Definitions.
§58.10 Applicability to studies performed under grants and contracts.
§58.15 Inspection of a testing facility.
§58.29 Personnel.
§58.31 Testing facility management.
§58.33 Study director.
§58.35 Quality assurance unit.
§58.41 General.
§58.43 Animal care facilities.
§58.45 Animal supply facilities.
§58.47 Facilities for handling test and control articles.
§58.49 Laboratory operation areas.
§58.51 Specimen and data storage facilities.
§58.61 Equipment design.
§58.63 Maintenance and calibration of equipment.
§58.81 Standard operating procedures.
§58.83 Reagents and solutions.
§58.90 Animal care.
Subpart F—Test and Control Articles
§58.105 Test and control article characterization.
§58.107 Test and control article handling.
§58.113 Mixtures of articles with carriers.
Subpart G—Protocol for and Conduct of a Nonclinical Laboratory Study
§58.120 Protocol.
§58.130 Conduct of a nonclinical laboratory study.
§58.185 Reporting of nonclinical laboratory study results.
§58.190 Storage and retrieval of records and data.
§58.195 Retention of records.
Subpart K—Disqualification of Testing Facilities
§58.200 Purpose.
§58.202 Grounds for disqualification.
§58.204 Notice of and opportunity for hearing on proposed disqualification.
§58.206 Final order on disqualification.
§58.210 Actions upon disqualification.
§58.213 Public disclosure of information regarding disqualification.
§58.215 Alternative or additional actions to disqualification.
§58.217 Suspension or termination of a testing facility by a sponsor.
§58.219 Reinstatement of a disqualified testing facility.
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987; 64 FR 399, Jan. 5, 1999]
(3) Data and information regarding a substance submitted as part of the procedures for establishing that a substance is generally recognized as safe for use, which use results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, described in §§170.35 and 570.35.
(4) Data and information regarding a food additive submitted as part of the procedures regarding food additives permitted to be used on an interim basis pending additional study, described in §180.1.
(21) Data and information regarding an electronic product submitted as part of the procedures for obtaining a variance from any electronic product performance standard as described in §1010.4.
(22) Data and information regarding an electronic product submitted as part of the procedures for granting, amending, or extending an exemption from any electronic product performance standard, as described in §1010.5.
(n) Batch means a specific quantity or lot of a test or control article that has been characterized according to §58.105(a).
(p) Study completion date means the date the final report is signed by the study director.
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987; 54 FR 9039, Mar. 3, 1989; 64 FR 56448, Oct. 20, 1999; 67 FR 35729, May 21, 2002]
(a) Designate a study director as described in §58.33, before the study is initiated.
(c) Assure that there is a quality assurance unit as described in §58.35.
(a) The protocol, including any change, is approved as provided by §58.120 and is followed.
[43 FR 60013, Dec. 22, 1978; 44 FR 17657, Mar. 23, 1979]
(1) Maintain a copy of a master schedule sheet of all nonclinical laboratory studies conducted at the testing facility indexed by test article and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director.
(2) Maintain copies of all protocols pertaining to all nonclinical laboratory studies for which the unit is responsible.
(6) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the nonclinical laboratory study.
(d) A designated representative of the Food and Drug Administration shall have access to the written procedures established for the inspection and may request testing facility management to certify that inspections are being implemented, performed, documented, and followed-up in accordance with this paragraph.
[52 FR 33780, Sept. 4, 1987]
(1) Receipt and storage of the test and control articles.
(2) Mixing of the test and control articles with a carrier, e.g., feed.
(3) Storage of the test and control article mixtures.
(b) The written standard operating procedures required under §58.81(b)(11) shall set forth in sufficient detail the methods, materials, and schedules to be used in the routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment, and shall specify, when appropriate, remedial action to be taken in the event of failure or malfunction of equipment. The written standard operating procedures shall designate the person responsible for the performance of each operation.
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987; 54 FR 15924, Apr. 20, 1989; 56 FR 32088, July 15, 1991; 67 FR 9585, Mar. 4, 2002]
(d) For studies of more than 4 weeks' duration, reserve samples from each batch of test and control articles shall be retained for the period of time provided by §58.195.
(14) The statement prepared and signed by the quality assurance unit as described in §58.35(b)(7).
(d) The master schedule sheet, copies of protocols, and records of quality assurance inspections, as required by §58.35(c) shall be maintained by the quality assurance unit as an easily accessible system of records for the period of time specified in paragraphs (a) and (b) of this section.
(e) Summaries of training and experience and job descriptions required to be maintained by §58.29(b) may be retained along with all other testing facility employment records for the length of time specified in paragraphs (a) and (b) of this section.
(f) Records and reports of the maintenance and calibration and inspection of equipment, as required by §58.63(b) and (c), shall be retained for the length of time specified in paragraph (b) of this section.
(a) Whenever the Commissioner has information indicating that grounds exist under §58.202 which in his opinion justify disqualification of a testing facility, he may issue to the testing facility a written notice proposing that the facility be disqualified.
(a) If the Commissioner, after the regulatory hearing, or after the time for requesting a hearing expires without a request being made, upon an evaluation of the administrative record of the disqualification proceeding, makes the findings required in §58.202, he shall issue a final order disqualifying the facility. Such order shall include a statement of the basis for that determination. Upon issuing a final order, the Commissioner shall notify (with a copy of the order) the testing facility of the action.
(b) If the Commissioner, after a regulatory hearing or after the time for requesting a hearing expires without a request being made, upon an evaluation of the administrative record of the disqualification proceeding, does not make the findings required in §58.202, he shall issue a final order terminating the disqualification proceeding. Such order shall include a statement of the basis for that determination. Upon issuing a final order the Commissioner shall notify the testing facility and provide a copy of the order.
(b) No nonclinical laboratory study begun by a testing facility after the date of the facility's disqualification shall be considered in support of any application for a research or marketing permit, unless the facility has been reinstated under §58.219. The determination that a study may not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any other applicable regulation to submit the results of the study to the Food and Drug Administration.
(a) Upon issuance of a final order disqualifying a testing facility under §58.206(a), the Commissioner may notify all or any interested persons. Such notice may be given at the discretion of the Commissioner whenever he believes that such disclosure would further the public interest or would promote compliance with the good laboratory practice regulations set forth in this part. Such notice, if given, shall include a copy of the final order issued under §58.206(a) and shall state that the disqualification constitutes a determination by the Food and Drug Administration that nonclinical laboratory studies performed by the facility will not be considered by the Food and Drug Administration in support of any application for a research or marketing permit. If such notice is sent to another Federal Government agency, the Food and Drug Administration will recommend that the agency also consider whether or not it should accept nonclinical laboratory studies performed by the testing facility. If such notice is sent to any other person, it shall state that it is given because of the relationship between the testing facility and the person being notified and that the Food and Drug Administration is not advising or recommending that any action be taken by the person notified.
A testing facility that has been disqualified may be reinstated as an acceptable source of nonclinical laboratory studies to be submitted to the Food and Drug Administration if the Commissioner determines, upon an evaluation of the submission of the testing facility, that the facility can adequately assure that it will conduct future nonclinical laboratory studies in compliance with the good laboratory practice regulations set forth in this part and, if any studies are currently being conducted, that the quality and integrity of such studies have not been seriously compromised. A disqualified testing facility that wishes to be so reinstated shall present in writing to the Commissioner reasons why it believes it should be reinstated and a detailed description of the corrective actions it has taken or intends to take to assure that the acts or omissions which led to its disqualification will not recur. The Commissioner may condition reinstatement upon the testing facility being found in compliance with the good laboratory practice regulations upon an inspection. If a testing facility is reinstated, the Commissioner shall so notify the testing facility and all organizations and persons who were notified, under §58.213 of the disqualification of the testing facility. A determination that a testing facility has been reinstated is disclosable to the public under part 20 of this chapter.