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order?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.393","label":"§ 1.393 What information must FDA include in the detention order?","label_level":"§ 1.393","label_description":"What information must FDA include in the detention order?","reserved":false,"type":"section","volumes":["1"],"received_on":"2020-03-25T22:30:08-0400"}],"descendant_range":"1.391 – 1.393"},{"generated_id":true,"identifier":"ECFR9b3ad29133d95d0","label":"What Is the Appeal Process for a Detention Order?","label_level":"What Is the Appeal Process for a Detention Order?","label_description":"What Is the Appeal Process for a Detention Order?","reserved":false,"type":"subject_group","children":[{"identifier":"1.401","label":"§ 1.401 Who is entitled to appeal?","label_level":"§ 1.401","label_description":"Who is entitled to appeal?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.402","label":"§ 1.402 What are the requirements for submitting an appeal?","label_level":"§ 1.402","label_description":"What are the requirements for submitting an appeal?","reserved":false,"type":"section","volumes":["1"],"received_on":"2020-03-25T22:30:08-0400"},{"identifier":"1.403","label":"§ 1.403 What requirements apply to an informal hearing?","label_level":"§ 1.403","label_description":"What requirements apply to an informal hearing?","reserved":false,"type":"section","volumes":["1"],"received_on":"2020-03-25T22:30:08-0400"},{"identifier":"1.404","label":"§ 1.404 Who serves as the presiding officer for an appeal and for an informal hearing?","label_level":"§ 1.404","label_description":"Who serves as the presiding officer for an appeal and for an informal hearing?","reserved":false,"type":"section","volumes":["1"],"received_on":"2020-03-25T22:30:08-0400"},{"identifier":"1.405","label":"§ 1.405 When does FDA have to issue a decision on an appeal?","label_level":"§ 1.405","label_description":"When does FDA have to issue a decision on an appeal?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.406","label":"§ 1.406 How will FDA handle classified information in an informal hearing?","label_level":"§ 1.406","label_description":"How will FDA handle classified information in an informal hearing?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"1.401 – 1.406"}],"descendant_range":"1.377 – 1.406"},{"identifier":"L","label":"Subpart L - Foreign Supplier Verification Programs for Food Importers","label_level":"Subpart L","label_description":"Foreign Supplier Verification Programs for Food Importers","reserved":false,"type":"subpart","volumes":["1"],"children":[{"identifier":"1.500","label":"§ 1.500 What definitions apply to this subpart?","label_level":"§ 1.500","label_description":"What definitions apply to this subpart?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.501","label":"§ 1.501 To what foods do the requirements in this subpart apply?","label_level":"§ 1.501","label_description":"To what foods do the requirements in this subpart apply?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.502","label":"§ 1.502 What foreign supplier verification program (FSVP) must I have?","label_level":"§ 1.502","label_description":"What foreign supplier verification program (FSVP) must I have?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.503","label":"§ 1.503 Who must develop my FSVP and perform FSVP activities?","label_level":"§ 1.503","label_description":"Who must develop my FSVP and perform FSVP activities?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.504","label":"§ 1.504 What hazard analysis must I conduct?","label_level":"§ 1.504","label_description":"What hazard analysis must I conduct?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.505","label":"§ 1.505 What evaluation for foreign supplier approval and verification must I conduct?","label_level":"§ 1.505","label_description":"What evaluation for foreign supplier approval and verification must I conduct?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.506","label":"§ 1.506 What foreign supplier verification and related activities must I conduct?","label_level":"§ 1.506","label_description":"What foreign supplier verification and related activities must I conduct?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.507","label":"§ 1.507 What requirements apply when I import a food that cannot be consumed without the hazards being controlled or for which the hazards are controlled after importation?","label_level":"§ 1.507","label_description":"What requirements apply when I import a food that cannot be consumed without the hazards being controlled or for which the hazards are controlled after importation?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.508","label":"§ 1.508 What corrective actions must I take under my FSVP?","label_level":"§ 1.508","label_description":"What corrective actions must I take under my FSVP?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.509","label":"§ 1.509 How must the importer be identified at entry?","label_level":"§ 1.509","label_description":"How must the importer be identified at entry?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.510","label":"§ 1.510 How must I maintain records of my FSVP?","label_level":"§ 1.510","label_description":"How must I maintain records of my FSVP?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.511","label":"§ 1.511 What FSVP must I have if I am importing a food subject to certain requirements in the dietary supplement current good manufacturing practice regulation?","label_level":"§ 1.511","label_description":"What FSVP must I have if I am importing a food subject to certain requirements in the dietary supplement current good manufacturing practice regulation?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.512","label":"§ 1.512 What FSVP may I have if I am a very small importer or I am importing certain food from certain small foreign suppliers?","label_level":"§ 1.512","label_description":"What FSVP may I have if I am a very small importer or I am importing certain food from certain small foreign suppliers?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.513","label":"§ 1.513 What FSVP may I have if I am importing certain food from a country with an officially recognized or equivalent food safety system?","label_level":"§ 1.513","label_description":"What FSVP may I have if I am importing certain food from a country with an officially recognized or equivalent food safety system?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.514","label":"§ 1.514 What are some consequences of failing to comply with the requirements of this subpart?","label_level":"§ 1.514","label_description":"What are some consequences of failing to comply with the requirements of this subpart?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"1.500 – 1.514"},{"identifier":"M","label":"Subpart M - Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications","label_level":"Subpart M","label_description":"Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications","reserved":false,"type":"subpart","volumes":["1"],"children":[{"identifier":"1.600","label":"§ 1.600 What definitions apply to this subpart?","label_level":"§ 1.600","label_description":"What definitions apply to this subpart?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.601","label":"§ 1.601 Who is subject to this subpart?","label_level":"§ 1.601","label_description":"Who is subject to this subpart?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"generated_id":true,"identifier":"ECFRf65d3d87da8b12a","label":"Recognition of Accreditation Bodies Under This Subpart","label_level":"Recognition of Accreditation Bodies Under This Subpart","label_description":"Recognition of Accreditation Bodies Under This Subpart","reserved":false,"type":"subject_group","children":[{"identifier":"1.610","label":"§ 1.610 Who is eligible to seek recognition?","label_level":"§ 1.610","label_description":"Who is eligible to seek recognition?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.611","label":"§ 1.611 What legal authority must an accreditation body have to qualify for recognition?","label_level":"§ 1.611","label_description":"What legal authority must an accreditation body have to qualify for 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Subpart","reserved":false,"type":"subject_group","children":[{"identifier":"1.620","label":"§ 1.620 How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation?","label_level":"§ 1.620","label_description":"How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.621","label":"§ 1.621 How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited?","label_level":"§ 1.621","label_description":"How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.622","label":"§ 1.622 How must a recognized accreditation body monitor its own performance?","label_level":"§ 1.622","label_description":"How must a recognized accreditation body monitor its own performance?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.623","label":"§ 1.623 What reports and notifications must a recognized accreditation body submit to FDA?","label_level":"§ 1.623","label_description":"What reports and notifications must a recognized accreditation body submit to FDA?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.624","label":"§ 1.624 How must a recognized accreditation body protect against conflicts of interest?","label_level":"§ 1.624","label_description":"How must a recognized accreditation body protect against conflicts of interest?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.625","label":"§ 1.625 What records requirements must an accreditation body that has been recognized meet?","label_level":"§ 1.625","label_description":"What records requirements must an accreditation body that has been recognized meet?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"1.620 – 1.625"},{"generated_id":true,"identifier":"ECFR6b8dfd0174182e8","label":"Procedures for Recognition of Accreditation Bodies Under This Subpart","label_level":"Procedures for Recognition of Accreditation Bodies Under This Subpart","label_description":"Procedures for Recognition of Accreditation Bodies Under This Subpart","reserved":false,"type":"subject_group","children":[{"identifier":"1.630","label":"§ 1.630 How do I apply to FDA for recognition or renewal of recognition?","label_level":"§ 1.630","label_description":"How do I apply to FDA for recognition or renewal of recognition?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.631","label":"§ 1.631 How will FDA review my application for recognition or renewal of recognition and what happens once FDA decides on my application?","label_level":"§ 1.631","label_description":"How will FDA review my application for recognition or renewal of recognition and what happens once FDA decides on my application?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.632","label":"§ 1.632 What is the duration of recognition?","label_level":"§ 1.632","label_description":"What is the duration of recognition?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.633","label":"§ 1.633 How will FDA monitor recognized accreditation bodies?","label_level":"§ 1.633","label_description":"How will FDA monitor recognized accreditation bodies?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.634","label":"§ 1.634 When will FDA revoke 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must an accredited third-party certification body ensure its audit agents are competent and objective?","label_level":"§ 1.650","label_description":"How must an accredited third-party certification body ensure its audit agents are competent and objective?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.651","label":"§ 1.651 How must an accredited third-party certification body conduct a food safety audit of an eligible entity?","label_level":"§ 1.651","label_description":"How must an accredited third-party certification body conduct a food safety audit of an eligible entity?","reserved":false,"type":"section","volumes":["1"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1.652","label":"§ 1.652 What must an accredited third-party certification body include in food safety audit reports?","label_level":"§ 1.652","label_description":"What must an accredited third-party certification body include in food safety audit 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collect?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.83","label":"§ 111.83 What are the requirements for reserve samples?","label_level":"§ 111.83","label_description":"What are the requirements for reserve samples?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.87","label":"§ 111.87 Who conducts a material review and makes a disposition decision?","label_level":"§ 111.87","label_description":"Who conducts a material review and makes a disposition decision?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.90","label":"§ 111.90 What requirements apply to treatments, in-process adjustments, and reprocessing when there is a deviation or unanticipated occurrence or when a specification established in accordance with § 111.70 is not met?","label_level":"§ 111.90","label_description":"What requirements apply to treatments, in-process adjustments, and reprocessing when there is a deviation or unanticipated occurrence or when a specification established in accordance with § 111.70 is not met?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.95","label":"§ 111.95 Under this subpart E, what records must you make and keep?","label_level":"§ 111.95","label_description":"Under this subpart E, what records must you make and keep?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"111.55 – 111.95"},{"identifier":"F","label":"Subpart F - Production and Process Control System: Requirements for Quality Control","label_level":"Subpart F","label_description":"Production and Process Control System: Requirements for Quality Control","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"111.103","label":"§ 111.103 What are the requirements under this subpart F for written procedures?","label_level":"§ 111.103","label_description":"What are the requirements under this subpart F for written procedures?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.105","label":"§ 111.105 What must quality control personnel do?","label_level":"§ 111.105","label_description":"What must quality control personnel do?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.110","label":"§ 111.110 What quality control operations are required for laboratory operations associated with the production and process control system?","label_level":"§ 111.110","label_description":"What quality control operations are required for laboratory operations associated with the production and process control system?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.113","label":"§ 111.113 What quality control operations are required for a material review and disposition decision?","label_level":"§ 111.113","label_description":"What quality control operations are required for a material review and disposition decision?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.117","label":"§ 111.117 What quality control operations are required for equipment, instruments, and controls?","label_level":"§ 111.117","label_description":"What quality control operations are required for equipment, instruments, and controls?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.120","label":"§ 111.120 What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?","label_level":"§ 111.120","label_description":"What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.123","label":"§ 111.123 What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?","label_level":"§ 111.123","label_description":"What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.127","label":"§ 111.127 What quality control operations are required for packaging and labeling operations?","label_level":"§ 111.127","label_description":"What quality control operations are required for packaging and labeling operations?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.130","label":"§ 111.130 What quality control operations are required for returned dietary supplements?","label_level":"§ 111.130","label_description":"What quality control operations are required for returned dietary supplements?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.135","label":"§ 111.135 What quality control operations are required for product complaints?","label_level":"§ 111.135","label_description":"What quality control operations are required for product complaints?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.140","label":"§ 111.140 Under this subpart F, what records must you make and keep?","label_level":"§ 111.140","label_description":"Under this subpart F, what records must you make and keep?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"111.103 – 111.140"},{"identifier":"G","label":"Subpart G - Production and Process Control System: Requirements for Components, Packaging, and Labels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement","label_level":"Subpart G","label_description":"Production and Process Control System: Requirements for Components, Packaging, and Labels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"111.153","label":"§ 111.153 What are the requirements under this subpart G for written procedures?","label_level":"§ 111.153","label_description":"What are the requirements under this subpart G for written procedures?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.155","label":"§ 111.155 What requirements apply to components of dietary supplements?","label_level":"§ 111.155","label_description":"What requirements apply to components of dietary supplements?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.160","label":"§ 111.160 What requirements apply to packaging and labels received?","label_level":"§ 111.160","label_description":"What requirements apply to packaging and labels received?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.165","label":"§ 111.165 What requirements apply to a product received for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier)?","label_level":"§ 111.165","label_description":"What requirements apply to a product received for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier)?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.170","label":"§ 111.170 What requirements apply to rejected components, packaging, and labels, and to rejected products that are received for packaging or labeling as a dietary supplement?","label_level":"§ 111.170","label_description":"What requirements apply to rejected components, packaging, and labels, and to rejected products that are received for packaging or labeling as a dietary supplement?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.180","label":"§ 111.180 Under this subpart G, what records must you make and keep?","label_level":"§ 111.180","label_description":"Under this subpart G, what records must you make and keep?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"111.153 – 111.180"},{"identifier":"H","label":"Subpart H - Production and Process Control System: Requirements for the Master Manufacturing Record","label_level":"Subpart H","label_description":"Production and Process Control System: Requirements for the Master Manufacturing Record","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"111.205","label":"§ 111.205 What is the requirement to establish a master manufacturing record?","label_level":"§ 111.205","label_description":"What is the requirement to establish a master manufacturing record?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.210","label":"§ 111.210 What must the master manufacturing record include?","label_level":"§ 111.210","label_description":"What must the master manufacturing record include?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"111.205 – 111.210"},{"identifier":"I","label":"Subpart I - Production and Process Control System: Requirements for the Batch Production Record","label_level":"Subpart I","label_description":"Production and Process Control System: Requirements for the Batch Production Record","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"111.255","label":"§ 111.255 What is the requirement to establish a batch production record?","label_level":"§ 111.255","label_description":"What is the requirement to establish a batch production record?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.260","label":"§ 111.260 What must the batch record include?","label_level":"§ 111.260","label_description":"What must the batch record include?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"111.255 – 111.260"},{"identifier":"J","label":"Subpart J - Production and Process Control System: Requirements for Laboratory Operations","label_level":"Subpart J","label_description":"Production and Process Control System: Requirements for Laboratory Operations","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"111.303","label":"§ 111.303 What are the requirements under this subpart J for written procedures?","label_level":"§ 111.303","label_description":"What are the requirements under this subpart J for written procedures?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.310","label":"§ 111.310 What are the requirements for the laboratory facilities that you use?","label_level":"§ 111.310","label_description":"What are the requirements for the laboratory facilities that you use?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.315","label":"§ 111.315 What are the requirements for laboratory control processes?","label_level":"§ 111.315","label_description":"What are the requirements for laboratory control processes?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.320","label":"§ 111.320 What requirements apply to laboratory methods for testing and examination?","label_level":"§ 111.320","label_description":"What requirements apply to laboratory methods for testing and examination?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.325","label":"§ 111.325 Under this subpart J, what records must you make and keep?","label_level":"§ 111.325","label_description":"Under this subpart J, what records must you make and keep?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"111.303 – 111.325"},{"identifier":"K","label":"Subpart K - Production and Process Control System: Requirements for Manufacturing Operations","label_level":"Subpart K","label_description":"Production and Process Control System: Requirements for Manufacturing Operations","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"111.353","label":"§ 111.353 What are the requirements under this subpart K for written procedures?","label_level":"§ 111.353","label_description":"What are the requirements under this subpart K for written procedures?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.355","label":"§ 111.355 What are the design requirements for manufacturing operations?","label_level":"§ 111.355","label_description":"What are the design requirements for manufacturing operations?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.360","label":"§ 111.360 What are the requirements for sanitation?","label_level":"§ 111.360","label_description":"What are the requirements for sanitation?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.365","label":"§ 111.365 What precautions must you take to prevent contamination?","label_level":"§ 111.365","label_description":"What precautions must you take to prevent contamination?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.370","label":"§ 111.370 What requirements apply to rejected dietary supplements?","label_level":"§ 111.370","label_description":"What requirements apply to rejected dietary supplements?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.375","label":"§ 111.375 Under this subpart K, what records must you make and keep?","label_level":"§ 111.375","label_description":"Under this subpart K, what records must you make and keep?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"111.353 – 111.375"},{"identifier":"L","label":"Subpart L - Production and Process Control System: Requirements for Packaging and Labeling Operations","label_level":"Subpart L","label_description":"Production and Process Control System: Requirements for Packaging and Labeling Operations","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"111.403","label":"§ 111.403 What are the requirements under this subpart L for written procedures?","label_level":"§ 111.403","label_description":"What are the requirements under this subpart L for written procedures?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.410","label":"§ 111.410 What requirements apply to packaging and labels?","label_level":"§ 111.410","label_description":"What requirements apply to packaging and labels?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.415","label":"§ 111.415 What requirements apply to filling, assembling, packaging, labeling, and related operations?","label_level":"§ 111.415","label_description":"What requirements apply to filling, assembling, packaging, labeling, and related operations?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.420","label":"§ 111.420 What requirements apply to repackaging and relabeling?","label_level":"§ 111.420","label_description":"What requirements apply to repackaging and relabeling?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.425","label":"§ 111.425 What requirements apply to a packaged and labeled dietary supplement that is rejected for distribution?","label_level":"§ 111.425","label_description":"What requirements apply to a packaged and labeled dietary supplement that is rejected for distribution?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.430","label":"§ 111.430 Under this subpart L, what records must you make and keep?","label_level":"§ 111.430","label_description":"Under this subpart L, what records must you make and keep?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"111.403 – 111.430"},{"identifier":"M","label":"Subpart M - Holding and Distributing","label_level":"Subpart M","label_description":"Holding and Distributing","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"111.453","label":"§ 111.453 What are the requirements under this subpart for M written procedures?","label_level":"§ 111.453","label_description":"What are the requirements under this subpart for M written procedures?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.455","label":"§ 111.455 What requirements apply to holding components, dietary supplements, packaging, and labels?","label_level":"§ 111.455","label_description":"What requirements apply to holding components, dietary supplements, packaging, and labels?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.460","label":"§ 111.460 What requirements apply to holding in-process material?","label_level":"§ 111.460","label_description":"What requirements apply to holding in-process material?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.465","label":"§ 111.465 What requirements apply to holding reserve samples of dietary supplements?","label_level":"§ 111.465","label_description":"What requirements apply to holding reserve samples of dietary supplements?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.470","label":"§ 111.470 What requirements apply to distributing dietary supplements?","label_level":"§ 111.470","label_description":"What requirements apply to distributing dietary supplements?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.475","label":"§ 111.475 Under this subpart M, what records must you make and keep?","label_level":"§ 111.475","label_description":"Under this subpart M, what records must you make and keep?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"111.453 – 111.475"},{"identifier":"N","label":"Subpart N - Returned Dietary Supplements","label_level":"Subpart N","label_description":"Returned Dietary Supplements","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"111.503","label":"§ 111.503 What are the requirements under this subpart N for written procedures?","label_level":"§ 111.503","label_description":"What are the requirements under this subpart N for written procedures?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.510","label":"§ 111.510 What requirements apply when a returned dietary supplement is received?","label_level":"§ 111.510","label_description":"What requirements apply when a returned dietary supplement is received?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.515","label":"§ 111.515 When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?","label_level":"§ 111.515","label_description":"When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.520","label":"§ 111.520 When may a returned dietary supplement be salvaged?","label_level":"§ 111.520","label_description":"When may a returned dietary supplement be salvaged?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.525","label":"§ 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing?","label_level":"§ 111.525","label_description":"What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.530","label":"§ 111.530 When must an investigation be conducted of your manufacturing processes and other batches?","label_level":"§ 111.530","label_description":"When must an investigation be conducted of your manufacturing processes and other batches?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.535","label":"§ 111.535 Under this subpart N, what records must you make and keep?","label_level":"§ 111.535","label_description":"Under this subpart N, what records must you make and keep?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"111.503 – 111.535"},{"identifier":"O","label":"Subpart O - Product Complaints","label_level":"Subpart O","label_description":"Product Complaints","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"111.553","label":"§ 111.553 What are the requirements under this subpart O for written procedures?","label_level":"§ 111.553","label_description":"What are the requirements under this subpart O for written procedures?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.560","label":"§ 111.560 What requirements apply to the review and investigation of a product complaint?","label_level":"§ 111.560","label_description":"What requirements apply to the review and investigation of a product complaint?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.570","label":"§ 111.570 Under this subpart O, what records must you make and keep?","label_level":"§ 111.570","label_description":"Under this subpart O, what records must you make and keep?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"111.553 – 111.570"},{"identifier":"P","label":"Subpart P - Records and Recordkeeping","label_level":"Subpart P","label_description":"Records and Recordkeeping","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"111.605","label":"§ 111.605 What requirements apply to the records that you make and keep?","label_level":"§ 111.605","label_description":"What requirements apply to the records that you make and keep?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"111.610","label":"§ 111.610 What records must be made available to FDA?","label_level":"§ 111.610","label_description":"What records must be made available to FDA?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"111.605 – 111.610"}],"descendant_range":"111.1 – 111.610"},{"identifier":"112","label":"Part 112 - Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption","label_level":"Part 112","label_description":"Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption","reserved":false,"type":"part","volumes":["2"],"children":[{"identifier":"A","label":"Subpart A - General Provisions","label_level":"Subpart A","label_description":"General Provisions","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"112.1","label":"§ 112.1 What food is covered by this part?","label_level":"§ 112.1","label_description":"What food is covered by this part?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.2","label":"§ 112.2 What produce is not covered by this part?","label_level":"§ 112.2","label_description":"What produce is not covered by this part?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.3","label":"§ 112.3 What definitions apply to this part?","label_level":"§ 112.3","label_description":"What definitions apply to this part?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.4","label":"§ 112.4 Which farms are subject to the requirements of this part?","label_level":"§ 112.4","label_description":"Which farms are subject to the requirements of this part?","reserved":false,"type":"section","volumes":["2"],"received_on":"2019-04-03T20:00:10-0400"},{"identifier":"112.5","label":"§ 112.5 Which farms are eligible for a qualified exemption and associated modified requirements based on average monetary value of all food sold and direct farm marketing?","label_level":"§ 112.5","label_description":"Which farms are eligible for a qualified exemption and associated modified requirements based on average monetary value of all food sold and direct farm marketing?","reserved":false,"type":"section","volumes":["2"],"received_on":"2019-04-03T20:00:10-0400"},{"identifier":"112.6","label":"§ 112.6 What modified requirements apply to me if my farm is eligible for a qualified exemption in accordance with § 112.5?","label_level":"§ 112.6","label_description":"What modified requirements apply to me if my farm is eligible for a qualified exemption in accordance with § 112.5?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.7","label":"§ 112.7 What records must I establish and keep if my farm is eligible for a qualified exemption in accordance with § 112.5?","label_level":"§ 112.7","label_description":"What records must I establish and keep if my farm is eligible for a qualified exemption in accordance with § 112.5?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"112.1 – 112.7"},{"identifier":"B","label":"Subpart B - General Requirements","label_level":"Subpart B","label_description":"General Requirements","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"112.11","label":"§ 112.11 What general requirements apply to persons who are subject to this part?","label_level":"§ 112.11","label_description":"What general requirements apply to persons who are subject to this part?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.12","label":"§ 112.12 Are there any alternatives to the requirements established in this part?","label_level":"§ 112.12","label_description":"Are there any alternatives to the requirements established in this part?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"112.11 – 112.12"},{"identifier":"C","label":"Subpart C - Personnel Qualifications and Training","label_level":"Subpart C","label_description":"Personnel Qualifications and Training","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"112.21","label":"§ 112.21 What requirements apply regarding qualifications and training for personnel who handle (contact) covered produce or food contact surfaces?","label_level":"§ 112.21","label_description":"What requirements apply regarding qualifications and training for personnel who handle (contact) covered produce or food contact surfaces?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.22","label":"§ 112.22 What minimum requirements apply for training personnel who conduct a covered activity?","label_level":"§ 112.22","label_description":"What minimum requirements apply for training personnel who conduct a covered activity?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.23","label":"§ 112.23 What requirements apply regarding supervisors?","label_level":"§ 112.23","label_description":"What requirements apply regarding supervisors?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.30","label":"§ 112.30 Under this subpart, what requirements apply regarding records?","label_level":"§ 112.30","label_description":"Under this subpart, what requirements apply regarding records?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"112.21 – 112.30"},{"identifier":"D","label":"Subpart D - Health and Hygiene","label_level":"Subpart D","label_description":"Health and Hygiene","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"112.31","label":"§ 112.31 What measures must I take to prevent ill or infected persons from contaminating covered produce with microorganisms of public health significance?","label_level":"§ 112.31","label_description":"What measures must I take to prevent ill or infected persons from contaminating covered produce with microorganisms of public health significance?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.32","label":"§ 112.32 What hygienic practices must personnel use?","label_level":"§ 112.32","label_description":"What hygienic practices must personnel use?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.33","label":"§ 112.33 What measures must I take to prevent visitors from contaminating covered produce and food contact surfaces with microorganisms of public health significance?","label_level":"§ 112.33","label_description":"What measures must I take to prevent visitors from contaminating covered produce and food contact surfaces with microorganisms of public health significance?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"112.31 – 112.33"},{"identifier":"E","label":"Subpart E - Agricultural Water","label_level":"Subpart E","label_description":"Agricultural Water","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"112.41","label":"§ 112.41 What requirements apply to the quality of agricultural water?","label_level":"§ 112.41","label_description":"What requirements apply to the quality of agricultural water?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.42","label":"§ 112.42 What requirements apply to my agricultural water sources, water distribution system, and pooling of water?","label_level":"§ 112.42","label_description":"What requirements apply to my agricultural water sources, water distribution system, and pooling of water?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.43","label":"§ 112.43 What requirements apply to treating agricultural water?","label_level":"§ 112.43","label_description":"What requirements apply to treating agricultural water?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.44","label":"§ 112.44 What specific microbial quality criteria apply to agricultural water used for certain intended uses?","label_level":"§ 112.44","label_description":"What specific microbial quality criteria apply to agricultural water used for certain intended uses?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.45","label":"§ 112.45 What measures must I take if my agricultural water does not meet the requirements of § 112.41 or § 112.44?","label_level":"§ 112.45","label_description":"What measures must I take if my agricultural water does not meet the requirements of § 112.41 or § 112.44?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.46","label":"§ 112.46 How often must I test agricultural water that is subject to the requirements of § 112.44?","label_level":"§ 112.46","label_description":"How often must I test agricultural water that is subject to the requirements of § 112.44?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.47","label":"§ 112.47 Who must perform the tests required under § 112.46 and what methods must be used?","label_level":"§ 112.47","label_description":"Who must perform the tests required under § 112.46 and what methods must be used?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.48","label":"§ 112.48 What measures must I take for water that I use during harvest, packing, and holding activities for covered produce?","label_level":"§ 112.48","label_description":"What measures must I take for water that I use during harvest, packing, and holding activities for covered produce?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.49","label":"§ 112.49 What alternatives may I establish and use in lieu of the requirements of this subpart?","label_level":"§ 112.49","label_description":"What alternatives may I establish and use in lieu of the requirements of this subpart?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.50","label":"§ 112.50 Under this subpart, what requirements apply regarding records?","label_level":"§ 112.50","label_description":"Under this subpart, what requirements apply regarding records?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"112.41 – 112.50"},{"identifier":"F","label":"Subpart F - Biological Soil Amendments of Animal Origin and Human Waste","label_level":"Subpart F","label_description":"Biological Soil Amendments of Animal Origin and Human Waste","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"112.51","label":"§ 112.51 What requirements apply for determining the status of a biological soil amendment of animal origin?","label_level":"§ 112.51","label_description":"What requirements apply for determining the status of a biological soil amendment of animal origin?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.52","label":"§ 112.52 How must I handle, convey, and store biological soil amendments of animal origin?","label_level":"§ 112.52","label_description":"How must I handle, convey, and store biological soil amendments of animal origin?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.53","label":"§ 112.53 What prohibitions apply regarding use of human waste?","label_level":"§ 112.53","label_description":"What prohibitions apply regarding use of human waste?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.54","label":"§ 112.54 What treatment processes are acceptable for a biological soil amendment of animal origin that I apply in the growing of covered produce?","label_level":"§ 112.54","label_description":"What treatment processes are acceptable for a biological soil amendment of animal origin that I apply in the growing of covered produce?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.55","label":"§ 112.55 What microbial standards apply to the treatment processes in § 112.54?","label_level":"§ 112.55","label_description":"What microbial standards apply to the treatment processes in § 112.54?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.56","label":"§ 112.56 What application requirements and minimum application intervals apply to biological soil amendments of animal origin?","label_level":"§ 112.56","label_description":"What application requirements and minimum application intervals apply to biological soil amendments of animal origin?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.60","label":"§ 112.60 Under this subpart, what requirements apply regarding records?","label_level":"§ 112.60","label_description":"Under this subpart, what requirements apply regarding records?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"112.51 – 112.60"},{"identifier":"G-H","label":"Subpart G-H [Reserved]","label_level":"Subpart G-H","label_description":"Subpart G-H [Reserved]","reserved":true,"type":"subpart","volumes":[],"children":[]},{"identifier":"I","label":"Subpart I - Domesticated and Wild Animals","label_level":"Subpart I","label_description":"Domesticated and Wild Animals","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"112.81","label":"§ 112.81 How do the requirements of this subpart apply to areas where covered activities take place?","label_level":"§ 112.81","label_description":"How do the requirements of this subpart apply to areas where covered activities take place?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.83","label":"§ 112.83 What requirements apply regarding grazing animals, working animals, and animal intrusion?","label_level":"§ 112.83","label_description":"What requirements apply regarding grazing animals, working animals, and animal intrusion?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.84","label":"§ 112.84 Does this regulation require covered farms to take actions that would constitute a “taking” of threatened or endangered species; to take measures to exclude animals from outdoor growing areas; or to destroy animal habitat or otherwise clear farm borders around outdoor growing areas or drainages?","label_level":"§ 112.84","label_description":"Does this regulation require covered farms to take actions that would constitute a “taking” of threatened or endangered species; to take measures to exclude animals from outdoor growing areas; or to destroy animal habitat or otherwise clear farm borders around outdoor growing areas or drainages?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"112.81 – 112.84"},{"identifier":"J","label":"Subpart J [Reserved]","label_level":"Subpart J","label_description":"Subpart J [Reserved]","reserved":true,"type":"subpart","volumes":[],"children":[]},{"identifier":"K","label":"Subpart K - Growing, Harvesting, Packing, and Holding Activities","label_level":"Subpart K","label_description":"Growing, Harvesting, Packing, and Holding Activities","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"112.111","label":"§ 112.111 What measures must I take if I grow, harvest, pack or hold both covered and excluded produce?","label_level":"§ 112.111","label_description":"What measures must I take if I grow, harvest, pack or hold both covered and excluded produce?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.112","label":"§ 112.112 What measures must I take immediately prior to and during harvest activities?","label_level":"§ 112.112","label_description":"What measures must I take immediately prior to and during harvest activities?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.113","label":"§ 112.113 How must I handle harvested covered produce during covered activities?","label_level":"§ 112.113","label_description":"How must I handle harvested covered produce during covered activities?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.114","label":"§ 112.114 What requirements apply to dropped covered produce?","label_level":"§ 112.114","label_description":"What requirements apply to dropped covered produce?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.115","label":"§ 112.115 What measures must I take when packaging covered produce?","label_level":"§ 112.115","label_description":"What measures must I take when packaging covered produce?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.116","label":"§ 112.116 What measures must I take when using food-packing (including food packaging) material?","label_level":"§ 112.116","label_description":"What measures must I take when using food-packing (including food packaging) material?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"112.111 – 112.116"},{"identifier":"L","label":"Subpart L - Equipment, Tools, Buildings, and Sanitation","label_level":"Subpart L","label_description":"Equipment, Tools, Buildings, and Sanitation","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"112.121","label":"§ 112.121 What equipment and tools are subject to the requirements of this subpart?","label_level":"§ 112.121","label_description":"What equipment and tools are subject to the requirements of this subpart?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.122","label":"§ 112.122 What buildings are subject to the requirements of this subpart?","label_level":"§ 112.122","label_description":"What buildings are subject to the requirements of this subpart?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.123","label":"§ 112.123 What general requirements apply regarding equipment and tools subject to this subpart?","label_level":"§ 112.123","label_description":"What general requirements apply regarding equipment and tools subject to this subpart?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.124","label":"§ 112.124 What requirements apply to instruments and controls used to measure, regulate, or record?","label_level":"§ 112.124","label_description":"What requirements apply to instruments and controls used to measure, regulate, or record?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.125","label":"§ 112.125 What requirements apply to equipment that is subject to this subpart used in the transport of covered produce?","label_level":"§ 112.125","label_description":"What requirements apply to equipment that is subject to this subpart used in the transport of covered produce?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.126","label":"§ 112.126 What requirements apply to my buildings?","label_level":"§ 112.126","label_description":"What requirements apply to my buildings?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.127","label":"§ 112.127 What requirements apply regarding domesticated animals in and around a fully-enclosed building?","label_level":"§ 112.127","label_description":"What requirements apply regarding domesticated animals in and around a fully-enclosed building?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.128","label":"§ 112.128 What requirements apply regarding pest control in buildings?","label_level":"§ 112.128","label_description":"What requirements apply regarding pest control in buildings?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.129","label":"§ 112.129 What requirements apply to toilet facilities?","label_level":"§ 112.129","label_description":"What requirements apply to toilet facilities?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.130","label":"§ 112.130 What requirements apply for hand-washing facilities?","label_level":"§ 112.130","label_description":"What requirements apply for hand-washing facilities?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.131","label":"§ 112.131 What must I do to control and dispose of sewage?","label_level":"§ 112.131","label_description":"What must I do to control and dispose of sewage?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.132","label":"§ 112.132 What must I do to control and dispose of trash, litter, and waste in areas used for covered activities?","label_level":"§ 112.132","label_description":"What must I do to control and dispose of trash, litter, and waste in areas used for covered activities?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.133","label":"§ 112.133 What requirements apply to plumbing?","label_level":"§ 112.133","label_description":"What requirements apply to plumbing?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.134","label":"§ 112.134 What must I do to control animal excreta and litter from domesticated animals that are under my control?","label_level":"§ 112.134","label_description":"What must I do to control animal excreta and litter from domesticated animals that are under my control?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.140","label":"§ 112.140 Under this subpart, what requirements apply regarding records?","label_level":"§ 112.140","label_description":"Under this subpart, what requirements apply regarding records?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"112.121 – 112.140"},{"identifier":"M","label":"Subpart M - Sprouts","label_level":"Subpart M","label_description":"Sprouts","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"112.141","label":"§ 112.141 What commodities are subject to this subpart?","label_level":"§ 112.141","label_description":"What commodities are subject to this subpart?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.142","label":"§ 112.142 What requirements apply to seeds or beans used to grow sprouts?","label_level":"§ 112.142","label_description":"What requirements apply to seeds or beans used to grow sprouts?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.143","label":"§ 112.143 What measures must I take for growing, harvesting, packing, and holding sprouts?","label_level":"§ 112.143","label_description":"What measures must I take for growing, harvesting, packing, and holding sprouts?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.144","label":"§ 112.144 What testing must I do during growing, harvesting, packing, and holding sprouts?","label_level":"§ 112.144","label_description":"What testing must I do during growing, harvesting, packing, and holding sprouts?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.145","label":"§ 112.145 What requirements apply to testing the environment for Listeria species or L. monocytogenes?","label_level":"§ 112.145","label_description":"What requirements apply to testing the environment for Listeria species or L. monocytogenes?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.146","label":"§ 112.146 What actions must I take if the growing, harvesting, packing, or holding environment tests positive for Listeria species or L. monocytogenes?","label_level":"§ 112.146","label_description":"What actions must I take if the growing, harvesting, packing, or holding environment tests positive for Listeria species or L. monocytogenes?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.147","label":"§ 112.147 What must I do to collect and test samples of spent sprout irrigation water or sprouts for pathogens?","label_level":"§ 112.147","label_description":"What must I do to collect and test samples of spent sprout irrigation water or sprouts for pathogens?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.148","label":"§ 112.148 What actions must I take if the samples of spent sprout irrigation water or sprouts test positive for a pathogen?","label_level":"§ 112.148","label_description":"What actions must I take if the samples of spent sprout irrigation water or sprouts test positive for a pathogen?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.150","label":"§ 112.150 Under this subpart, what requirements apply regarding records?","label_level":"§ 112.150","label_description":"Under this subpart, what requirements apply regarding records?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"112.141 – 112.150"},{"identifier":"N","label":"Subpart N - Analytical Methods","label_level":"Subpart N","label_description":"Analytical Methods","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"112.151","label":"§ 112.151 What methods must I use to test the quality of water to satisfy the requirements of § 112.46?","label_level":"§ 112.151","label_description":"What methods must I use to test the quality of water to satisfy the requirements of § 112.46?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.152","label":"§ 112.152 What methods must I use to test the growing, harvesting, packing, and holding environment for Listeria species or L. monocytogenes to satisfy the requirements of § 112.144(a)?","label_level":"§ 112.152","label_description":"What methods must I use to test the growing, harvesting, packing, and holding environment for Listeria species or L. monocytogenes to satisfy the requirements of § 112.144(a)?","reserved":false,"type":"section","volumes":["2"],"received_on":"2019-08-09T20:30:11-0400"},{"identifier":"112.153","label":"§ 112.153 What methods must I use to test spent sprout irrigation water (or sprouts) from each production batch of sprouts for pathogens to satisfy the requirements of § 112.144(b) and (c)?","label_level":"§ 112.153","label_description":"What methods must I use to test spent sprout irrigation water (or sprouts) from each production batch of sprouts for pathogens to satisfy the requirements of § 112.144(b) and (c)?","reserved":false,"type":"section","volumes":["2"],"received_on":"2019-08-09T20:30:11-0400"}],"descendant_range":"112.151 – 112.153"},{"identifier":"O","label":"Subpart O - Records","label_level":"Subpart O","label_description":"Records","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"112.161","label":"§ 112.161 What general requirements apply to records required under this part?","label_level":"§ 112.161","label_description":"What general requirements apply to records required under this part?","reserved":false,"type":"section","volumes":["2"],"received_on":"2019-04-03T20:00:10-0400"},{"identifier":"112.162","label":"§ 112.162 Where must I store records?","label_level":"§ 112.162","label_description":"Where must I store records?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.163","label":"§ 112.163 May I use existing records to satisfy the requirements of this part?","label_level":"§ 112.163","label_description":"May I use existing records to satisfy the requirements of this part?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.164","label":"§ 112.164 How long must I keep records?","label_level":"§ 112.164","label_description":"How long must I keep records?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.165","label":"§ 112.165 What formats are acceptable for the records I keep?","label_level":"§ 112.165","label_description":"What formats are acceptable for the records I keep?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.166","label":"§ 112.166 What requirements apply for making records available and accessible to FDA?","label_level":"§ 112.166","label_description":"What requirements apply for making records available and accessible to FDA?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.167","label":"§ 112.167 Can records that I provide to FDA be disclosed to persons outside of FDA?","label_level":"§ 112.167","label_description":"Can records that I provide to FDA be disclosed to persons outside of FDA?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"112.161 – 112.167"},{"identifier":"P","label":"Subpart P - Variances","label_level":"Subpart P","label_description":"Variances","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"112.171","label":"§ 112.171 Who may request a variance from the requirements of this part?","label_level":"§ 112.171","label_description":"Who may request a variance from the requirements of this part?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.172","label":"§ 112.172 How may a State, tribe, or foreign country request a variance from one or more requirements of this part?","label_level":"§ 112.172","label_description":"How may a State, tribe, or foreign country request a variance from one or more requirements of this part?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.173","label":"§ 112.173 What must be included in the Statement of Grounds in a petition requesting a variance?","label_level":"§ 112.173","label_description":"What must be included in the Statement of Grounds in a petition requesting a variance?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.174","label":"§ 112.174 What information submitted in a petition requesting a variance or submitted in comments on such a petition are publicly available?","label_level":"§ 112.174","label_description":"What information submitted in a petition requesting a variance or submitted in comments on such a petition are publicly available?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.175","label":"§ 112.175 Who responds to a petition requesting a variance?","label_level":"§ 112.175","label_description":"Who responds to a petition requesting a variance?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.176","label":"§ 112.176 What process applies to a petition requesting a variance?","label_level":"§ 112.176","label_description":"What process applies to a petition requesting a variance?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.177","label":"§ 112.177 Can an approved variance apply to any person other than those identified in the petition requesting that variance?","label_level":"§ 112.177","label_description":"Can an approved variance apply to any person other than those identified in the petition requesting that variance?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.178","label":"§ 112.178 Under what circumstances may FDA deny a petition requesting a variance?","label_level":"§ 112.178","label_description":"Under what circumstances may FDA deny a petition requesting a variance?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.179","label":"§ 112.179 When does a variance approved by FDA become effective?","label_level":"§ 112.179","label_description":"When does a variance approved by FDA become effective?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.180","label":"§ 112.180 Under what circumstances may FDA modify or revoke an approved variance?","label_level":"§ 112.180","label_description":"Under what circumstances may FDA modify or revoke an approved variance?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.181","label":"§ 112.181 What procedures apply if FDA determines that an approved variance should be modified or revoked?","label_level":"§ 112.181","label_description":"What procedures apply if FDA determines that an approved variance should be modified or revoked?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"112.182","label":"§ 112.182 What are the permissible types of variances that may be granted?","label_level":"§ 112.182","label_description":"What are the permissible types of variances that may be granted?","reserved":false,"type":"section","volumes":["2"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"112.171 – 112.182"},{"identifier":"Q","label":"Subpart Q - Compliance and Enforcement","label_level":"Subpart Q","label_description":"Compliance and Enforcement","reserved":false,"type":"subpart","volumes":["2"],"children":[{"identifier":"112.192","label":"§ 112.192 What is the applicability and status of this part?","label_level":"§ 112.192","label_description":"What is the applicability and status of this 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201.326 Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling.","label_level":"§ 201.326","label_description":"Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling.","reserved":false,"type":"section","volumes":["4"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"201.327","label":"§ 201.327 Over-the-counter sunscreen drug products; required labeling based on effectiveness testing.","label_level":"§ 201.327","label_description":"Over-the-counter sunscreen drug products; required labeling based on effectiveness testing.","reserved":false,"type":"section","volumes":["4"],"received_on":"2019-06-28T20:00:10-0400"},{"identifier":"201.328","label":"§ 201.328 Labeling of medical gas containers.","label_level":"§ 201.328","label_description":"Labeling of medical gas 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Biologics License Application, and Animal Drugs, and the National Drug Code","label_level":"Part 207","label_description":"Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code","reserved":false,"type":"part","volumes":["4"],"children":[{"identifier":"A","label":"Subpart A - General","label_level":"Subpart A","label_description":"General","reserved":false,"type":"subpart","volumes":["4"],"children":[{"identifier":"207.1","label":"§ 207.1 What definitions and interpretations of terms apply to this part?","label_level":"§ 207.1","label_description":"What definitions and interpretations of terms apply to this part?","reserved":false,"type":"section","volumes":["4"],"received_on":"2021-04-02T22:00:09-0400"},{"identifier":"207.3","label":"§ 207.3 Bulk drug substance.","label_level":"§ 207.3","label_description":"Bulk drug 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NDC?","reserved":false,"type":"section","volumes":["4"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"207.37","label":"§ 207.37 What restrictions pertain to the use of the NDC?","label_level":"§ 207.37","label_description":"What restrictions pertain to the use of the NDC?","reserved":false,"type":"section","volumes":["4"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"207.33 – 207.37"},{"identifier":"D","label":"Subpart D - Listing","label_level":"Subpart D","label_description":"Listing","reserved":false,"type":"subpart","volumes":["4"],"children":[{"identifier":"207.41","label":"§ 207.41 Who must list drugs and what drugs must they list?","label_level":"§ 207.41","label_description":"Who must list drugs and what drugs must they list?","reserved":false,"type":"section","volumes":["4"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"207.45","label":"§ 207.45 When, after initial registration of an establishment, must drug listing information be 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207.57"},{"identifier":"E","label":"Subpart E - Electronic Format for Registration and Listing","label_level":"Subpart E","label_description":"Electronic Format for Registration and Listing","reserved":false,"type":"subpart","volumes":["4"],"children":[{"identifier":"207.61","label":"§ 207.61 How is registration and listing information provided to FDA?","label_level":"§ 207.61","label_description":"How is registration and listing information provided to FDA?","reserved":false,"type":"section","volumes":["4"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"207.65","label":"§ 207.65 How can a waiver of the electronic submission requirement be obtained?","label_level":"§ 207.65","label_description":"How can a waiver of the electronic submission requirement be obtained?","reserved":false,"type":"section","volumes":["4"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"207.61 – 207.65"},{"identifier":"F","label":"Subpart F - Miscellaneous","label_level":"Subpart 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other class I ozone-depleting substances.","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"801.60 – 801.63"},{"identifier":"D","label":"Subpart D - Exemptions From Adequate Directions for Use","label_level":"Subpart D","label_description":"Exemptions From Adequate Directions for Use","reserved":false,"type":"subpart","volumes":["8"],"children":[{"identifier":"801.109","label":"§ 801.109 Prescription devices.","label_level":"§ 801.109","label_description":"Prescription devices.","reserved":false,"type":"section","volumes":["8"],"received_on":"2020-06-03T10:03:00-0400"},{"identifier":"801.110","label":"§ 801.110 Retail exemption for prescription devices.","label_level":"§ 801.110","label_description":"Retail exemption for prescription devices.","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"801.116","label":"§ 801.116 Medical devices having commonly known 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me?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"803.18","label":"§ 803.18 What are the requirements for establishing and maintaining MDR files or records that apply to me?","label_level":"§ 803.18","label_description":"What are the requirements for establishing and maintaining MDR files or records that apply to me?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"803.19","label":"§ 803.19 Are there exemptions, variances, or alternative forms of adverse event reporting requirements?","label_level":"§ 803.19","label_description":"Are there exemptions, variances, or alternative forms of adverse event reporting requirements?","reserved":false,"type":"section","volumes":["8"],"received_on":"2020-04-03T20:30:06-0400"}],"descendant_range":"803.1 – 803.19"},{"identifier":"B","label":"Subpart B - Generally Applicable Requirements for Individual Adverse Event 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report?","label_level":"§ 803.22","label_description":"What are the circumstances in which I am not required to file a report?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"803.23","label":"§ 803.23 Where can I find information on how to prepare and submit an MDR in electronic format?","label_level":"§ 803.23","label_description":"Where can I find information on how to prepare and submit an MDR in electronic format?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"803.20 – 803.23"},{"identifier":"C","label":"Subpart C - User Facility Reporting Requirements","label_level":"Subpart C","label_description":"User Facility Reporting Requirements","reserved":false,"type":"subpart","volumes":["8"],"children":[{"identifier":"803.30","label":"§ 803.30 If I am a user facility, what reporting requirements apply to me?","label_level":"§ 803.30","label_description":"If I am 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Plan","reserved":false,"type":"subpart","volumes":["8"],"children":[{"identifier":"822.8","label":"§ 822.8 When, where, and how must I submit my postmarket surveillance plan?","label_level":"§ 822.8","label_description":"When, where, and how must I submit my postmarket surveillance plan?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.9","label":"§ 822.9 What must I include in my submission?","label_level":"§ 822.9","label_description":"What must I include in my submission?","reserved":false,"type":"section","volumes":["8"],"received_on":"2020-04-17T20:00:06-0400"},{"identifier":"822.10","label":"§ 822.10 What must I include in my surveillance plan?","label_level":"§ 822.10","label_description":"What must I include in my surveillance plan?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.11","label":"§ 822.11 What should I consider when designing my plan to conduct postmarket surveillance?","label_level":"§ 822.11","label_description":"What should I consider when designing my plan to conduct postmarket surveillance?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.12","label":"§ 822.12 Do you have any information that will help me prepare my submission or design my postmarket surveillance plan?","label_level":"§ 822.12","label_description":"Do you have any information that will help me prepare my submission or design my postmarket surveillance plan?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.13","label":"§ 822.13 [Reserved]","label_level":"§ 822.13","label_description":"§ 822.13 [Reserved]","reserved":true,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.14","label":"§ 822.14 May I reference information previously submitted instead of submitting it again?","label_level":"§ 822.14","label_description":"May I reference information previously submitted instead of submitting it again?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.15","label":"§ 822.15 How long must I conduct postmarket surveillance of my device?","label_level":"§ 822.15","label_description":"How long must I conduct postmarket surveillance of my device?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"822.8 – 822.15"},{"identifier":"D","label":"Subpart D - FDA Review and Action","label_level":"Subpart D","label_description":"FDA Review and Action","reserved":false,"type":"subpart","volumes":["8"],"children":[{"identifier":"822.16","label":"§ 822.16 What will you consider in the review of my submission?","label_level":"§ 822.16","label_description":"What will you consider in the review of my submission?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.17","label":"§ 822.17 How long will your review of my submission take?","label_level":"§ 822.17","label_description":"How long will your review of my submission take?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.18","label":"§ 822.18 How will I be notified of your decision?","label_level":"§ 822.18","label_description":"How will I be notified of your decision?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.19","label":"§ 822.19 What kinds of decisions may you make?","label_level":"§ 822.19","label_description":"What kinds of decisions may you make?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.20","label":"§ 822.20 What are the consequences if I fail to submit a postmarket surveillance plan, my plan is disapproved and I fail to submit a new plan, or I fail to conduct surveillance in accordance with my approved plan?","label_level":"§ 822.20","label_description":"What are the consequences if I fail to submit a postmarket surveillance plan, my plan is disapproved and I fail to submit a new plan, or I fail to conduct surveillance in accordance with my approved plan?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.21","label":"§ 822.21 What must I do if I want to make changes to my postmarket surveillance plan after you have approved it?","label_level":"§ 822.21","label_description":"What must I do if I want to make changes to my postmarket surveillance plan after you have approved it?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.22","label":"§ 822.22 What recourse do I have if I do not agree with your decision?","label_level":"§ 822.22","label_description":"What recourse do I have if I do not agree with your decision?","reserved":false,"type":"section","volumes":["8"],"received_on":"2020-04-03T20:30:06-0400"},{"identifier":"822.23","label":"§ 822.23 Is the information in my submission considered confidential?","label_level":"§ 822.23","label_description":"Is the information in my submission considered confidential?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"822.16 – 822.23"},{"identifier":"E","label":"Subpart E - Responsibilities of Manufacturers","label_level":"Subpart E","label_description":"Responsibilities of Manufacturers","reserved":false,"type":"subpart","volumes":["8"],"children":[{"identifier":"822.24","label":"§ 822.24 What are my responsibilities once I am notified that I am required to conduct postmarket surveillance?","label_level":"§ 822.24","label_description":"What are my responsibilities once I am notified that I am required to conduct postmarket surveillance?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.25","label":"§ 822.25 What are my responsibilities after my postmarket surveillance plan has been approved?","label_level":"§ 822.25","label_description":"What are my responsibilities after my postmarket surveillance plan has been approved?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.26","label":"§ 822.26 If my company changes ownership, what must I do?","label_level":"§ 822.26","label_description":"If my company changes ownership, what must I do?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.27","label":"§ 822.27 If I go out of business, what must I do?","label_level":"§ 822.27","label_description":"If I go out of business, what must I do?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.28","label":"§ 822.28 If I stop marketing the device subject to postmarket surveillance, what must I do?","label_level":"§ 822.28","label_description":"If I stop marketing the device subject to postmarket surveillance, what must I do?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"822.24 – 822.28"},{"identifier":"F","label":"Subpart F - Waivers and Exemptions","label_level":"Subpart F","label_description":"Waivers and Exemptions","reserved":false,"type":"subpart","volumes":["8"],"children":[{"identifier":"822.29","label":"§ 822.29 May I request a waiver of a specific requirement of this part?","label_level":"§ 822.29","label_description":"May I request a waiver of a specific requirement of this part?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.30","label":"§ 822.30 May I request exemption from the requirement to conduct postmarket surveillance?","label_level":"§ 822.30","label_description":"May I request exemption from the requirement to conduct postmarket surveillance?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"822.29 – 822.30"},{"identifier":"G","label":"Subpart G - Records and Reports","label_level":"Subpart G","label_description":"Records and Reports","reserved":false,"type":"subpart","volumes":["8"],"children":[{"identifier":"822.31","label":"§ 822.31 What records am I required to keep?","label_level":"§ 822.31","label_description":"What records am I required to keep?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.32","label":"§ 822.32 What records are the investigators 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postmarket surveillance plan?","label_level":"§ 822.35","label_description":"Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.36","label":"§ 822.36 Can you inspect and copy the records related to my postmarket surveillance plan?","label_level":"§ 822.36","label_description":"Can you inspect and copy the records related to my postmarket surveillance plan?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.37","label":"§ 822.37 Under what circumstances would you inspect records identifying subjects?","label_level":"§ 822.37","label_description":"Under what circumstances would you inspect records identifying subjects?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"822.38","label":"§ 822.38 What reports must I submit to you?","label_level":"§ 822.38","label_description":"What reports must I submit to you?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"822.31 – 822.38"}],"descendant_range":"822.1 – 822.38"},{"identifier":"830","label":"Part 830 - Unique Device Identification","label_level":"Part 830","label_description":"Unique Device Identification","reserved":false,"type":"part","volumes":["8"],"children":[{"identifier":"A","label":"Subpart A - General Provisions","label_level":"Subpart A","label_description":"General Provisions","reserved":false,"type":"subpart","volumes":["8"],"children":[{"identifier":"830.3","label":"§ 830.3 Definitions.","label_level":"§ 830.3","label_description":"Definitions.","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"830.3"},{"identifier":"B","label":"Subpart B - Requirements for a Unique Device Identifier","label_level":"Subpart 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1271.10 Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?","label_level":"§ 1271.10","label_description":"Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1271.15","label":"§ 1271.15 Are there any exceptions from the requirements of this part?","label_level":"§ 1271.15","label_description":"Are there any exceptions from the requirements of this part?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1271.20","label":"§ 1271.20 If my HCT/P's do not meet the criteria in § 1271.10, and I do not qualify for any of the exceptions in § 1271.15, what regulations apply?","label_level":"§ 1271.20","label_description":"If my HCT/P's do not meet the criteria in § 1271.10, and I do not qualify for any of the exceptions in § 1271.15, what regulations apply?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"1271.1 – 1271.20"},{"identifier":"B","label":"Subpart B - Procedures for Registration and Listing","label_level":"Subpart B","label_description":"Procedures for Registration and Listing","reserved":false,"type":"subpart","volumes":["8"],"children":[{"identifier":"1271.21","label":"§ 1271.21 When do I register, submit an HCT/P list, and submit updates?","label_level":"§ 1271.21","label_description":"When do I register, submit an HCT/P list, and submit updates?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1271.22","label":"§ 1271.22 How do I register and submit an HCT/P list?","label_level":"§ 1271.22","label_description":"How do I register and submit an HCT/P list?","reserved":false,"type":"section","volumes":["8"],"received_on":"2020-06-03T10:03:00-0400"},{"identifier":"1271.23","label":"§ 1271.23 How is a waiver from the electronic format requirements requested?","label_level":"§ 1271.23","label_description":"How is a waiver from the electronic format requirements requested?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1271.25","label":"§ 1271.25 What information is required for establishment registration and HCT/P listing?","label_level":"§ 1271.25","label_description":"What information is required for establishment registration and HCT/P listing?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1271.26","label":"§ 1271.26 When must I amend my establishment registration?","label_level":"§ 1271.26","label_description":"When must I amend my establishment registration?","reserved":false,"type":"section","volumes":["8"],"received_on":"2020-06-03T10:03:00-0400"},{"identifier":"1271.27","label":"§ 1271.27 Will FDA assign me a registration number?","label_level":"§ 1271.27","label_description":"Will FDA assign me a registration number?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1271.37","label":"§ 1271.37 Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings?","label_level":"§ 1271.37","label_description":"Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"1271.21 – 1271.37"},{"identifier":"C","label":"Subpart C - Donor Eligibility","label_level":"Subpart C","label_description":"Donor Eligibility","reserved":false,"type":"subpart","volumes":["8"],"children":[{"identifier":"1271.45","label":"§ 1271.45 What requirements does this subpart contain?","label_level":"§ 1271.45","label_description":"What requirements does this subpart contain?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1271.47","label":"§ 1271.47 What procedures must I establish and maintain?","label_level":"§ 1271.47","label_description":"What procedures must I establish and maintain?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1271.50","label":"§ 1271.50 How do I determine whether a donor is eligible?","label_level":"§ 1271.50","label_description":"How do I determine whether a donor is eligible?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1271.55","label":"§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?","label_level":"§ 1271.55","label_description":"What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1271.60","label":"§ 1271.60 What quarantine and other requirements apply before the donor-eligibility determination is complete?","label_level":"§ 1271.60","label_description":"What quarantine and other requirements apply before the donor-eligibility determination is complete?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1271.65","label":"§ 1271.65 How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?","label_level":"§ 1271.65","label_description":"How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1271.75","label":"§ 1271.75 How do I screen a donor?","label_level":"§ 1271.75","label_description":"How do I screen a donor?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1271.80","label":"§ 1271.80 What are the general requirements for donor testing?","label_level":"§ 1271.80","label_description":"What are the general requirements for donor testing?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1271.85","label":"§ 1271.85 What donor testing is required for different types of cells and tissues?","label_level":"§ 1271.85","label_description":"What donor testing is required for different types of cells and tissues?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"},{"identifier":"1271.90","label":"§ 1271.90 Are there other exceptions and what labeling requirements apply?","label_level":"§ 1271.90","label_description":"Are there other exceptions and what labeling requirements apply?","reserved":false,"type":"section","volumes":["8"],"received_on":"2017-01-05T00:00:00-0500"}],"descendant_range":"1271.45 – 1271.90"},{"identifier":"D","label":"Subpart D - Current Good Tissue Practice","label_level":"Subpart D","label_description":"Current Good Tissue Practice","reserved":false,"type":"subpart","volumes":["8"],"children":[{"identifier":"1271.145","label":"§ 1271.145 Prevention of the introduction, transmission, or spread of communicable diseases.","label_level":"§ 1271.145","label_description":"Prevention of the introduction, transmission, or spread of communicable 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