Section 1308.01 Scope of this part. Note: If you need help accessing information in different file formats, see The most significant changes affected part 21, Certification Procedures for Products, Articles, and Parts, and part 45, Identification and Registration Marking. § 1.509 - How must the importer be identified at entry? Full Text Version (44.99 KB). Waivers § 1.3 - Definitions. § 1.362 - What records are excluded from this subpart? Electronic Code of Federal Regulations (e-CFR) Title 21. § 1.3 - Definitions. § 1.232 - What information is required in the registration? § 1.645 - What records procedures must a third-party certification body have to qualify for accreditation? Title 21 Code of Federal Regulations. Section 1313.05 Requirements for an established business relationship.    § 1.278 - Who is authorized to submit prior notice? Subpart Q - Administrative Detention of Drugs Intended for Human or Animal Use § 1.655 - How must an accredited third-party certification body monitor its own performance? § 1.393 - What information must FDA include in the detention order? § 1.76 - Medical devices. Requirements for Nontransporters To Establish and Maintain Records To Identify the Nontransporter and Transporter Immediate Previous Sources of Food The regulations in this part establish procedures and requirements for implementation of section 206 of the Energy Reorganization Act of 1974. § 1.504 - What hazard analysis must I conduct? § 1.613 - What protections against conflicts of interest must an accreditation body have to qualify for recognition? Authority: 21 U.S.C.    § 1.906 - What requirements apply to vehicles and transportation equipment? Source: 81 FR 20166, Apr. 21.3 Definitions. § 1.90 - Notice of sampling. Records § 1.918 - What must be included in the Statement of Grounds in a petition requesting a waiver? § 1.514 - What are some consequences of failing to comply with the requirements of this subpart? § 1.73 - Food. § 1.508 - What corrective actions must I take under my FSVP? Section 1313.02 Definitions. § 1.327 - Who is excluded from all or part of the regulations in this subpart? PART 1304 — RECORDS AND REPORTS OF REGISTRANTS CONTINUING RECORDS §1304.21 General requirements for continuing records. § 1.662 - How will FDA monitor accredited third-party certification bodies? Subpart I - Prior Notice of Imported Food. How do I check if One-drive and Sharepoint is compliant with 21 CFR Part 11, ICH R2, HIPAA, etc...? § 1.23 - Procedures for requesting variations and exemptions from required label statements. Training § 1.653 - What must an accredited third-party certification body do when issuing food or facility certifications? § 1.97 - Bonds. § 1.233 - Are there optional items included in the registration form? § 1.928 - What process will we follow when waiving a requirement of this subpart on our own initiative? Additional Procedures for Direct Accreditation of Third-Party Certification Bodies Under This Subpart Subpart A - General Provisions § 1.1 - General. § 1.643 - What protections against conflicts of interest must a third-party certification body have to qualify for accreditation? PART 1313 — IMPORTATION AND EXPORTATION OF LIST I AND LIST II CHEMICALS. § 1.705 - What user fees are established under this subpart? § 1.245 - Waiver request.    § 1.914 - Under what circumstances will we waive a requirement of this subpart? § 1.922 - Who will respond to a petition requesting a waiver? § 1.279 - When must prior notice be submitted to FDA? PART 1304 - RECORDS … New Search § 1.391 - Who approves a detention order? § 1.623 - What reports and notifications must a recognized accreditation body submit to FDA? § 1.932 - Under what circumstances may we modify or revoke a waiver? General Requirements The information on this page is current as of April 1 2020. 6, 2016, unless otherwise noted. § 1.363 - What are the consequences of failing to establish or maintain records or make them available to FDA as required by this subpart? Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)). § 1.101 - Notification and recordkeeping. § 1.80 - Cosmetics. This online reference for CFR Title 21 is updated once a year.    § 1.337 - What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate previous sources of food? § 1.666 - How do I request reaccreditation? Recognition of Accreditation Bodies Under This Subpart    § 1.352 - What information must transporters establish and maintain? Source: 69 FR 71651, Dec. 9, 2004, unless otherwise noted. Source: 73 FR 66402 , … § 1.692 - How do I request internal agency review of a denial of an application or waiver request upon reconsideration?    § 1.20 - Presence of mandatory label information. § 1.611 - What legal authority must an accreditation body have to qualify for recognition? § 1.657 - How must an accredited third-party certification body protect against conflicts of interest? § 1.632 - What is the duration of recognition? § 1.21 - Failure to reveal material facts. Practically speaking, Part 11 applies to drug makers, medical device § 1.633 - How will FDA monitor recognized accreditation bodies? § 1.672 - What is the duration of direct accreditation? 21.4 Interpretations. Electronic Code of Federal Regulations (e-CFR) Title 21 - Food and Drugs; CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; SUBCHAPTER A - GENERAL; PART 1 - GENERAL ENFORCEMENT REGULATIONS; Subpart L - Foreign Supplier Verification Programs for Food Importers § 1.500 What definitions apply to this subpart? Title 21 Code of Federal Regulations. Procedures for Registration of Food Facilities For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).. § 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? § 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? 21 CFR Part 11 includes 36 pages out of which only 3 pages constitute the rule itself , the other 33 pages are a preamble with comments from the FDA on feedback from the industry. § 1.285 What happens to food that is imported or offered for import from unregistered facilities that are required to register under subpart H of this part? § 1.642 - What competency and capacity must a third-party certification body have to qualify for accreditation?    § 1.660 - Where do I apply for accreditation or renewal of accreditation by a recognized accreditation body and what happens once the recognized accreditation body decides on my application? This information is current as of April 1, 2020..    § 1.690 - How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public? regulations (21 CFR Part 211), the Quality System regulation (21 CFR Part 820), and the Good Laboratory Practice for Nonclinical Laboratory Studies regulations (21 CFR Part 58). § 1.720 - Are user fees under this subpart refundable? 216, 241, 243, 262, 264, 271; Pub. Consequences Subpart M - Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications. § 1.227 - What definitions apply to this subpart? Part 11 has a total of 19 requirements. § 1.235 - How and when do you cancel your facility's registration information? Subpart L - Foreign Supplier Verification Programs for Food Importers It is divided into 50 titles that represent broad areas subject to Federal regulation. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. § 1.282 - What must you do if information changes after you have received confirmation of a prior notice from FDA? § 1.503 - Who must develop my FSVP and perform FSVP activities? 802, 827(h), 830, 871(b) 890. 6, 2016, unless otherwise noted. § 1.920 - What information submitted in a petition requesting a waiver or submitted in comments on such a petition is publicly available? § 1.361 - What are the record availability requirements? The information on this page is current as of April 1 2020.    § 1.500 - What definitions apply to this subpart? Title 21 PART 1 SUBPART j. CFR › Title 21 › Volume 1 › Chapter I › Subchapter A › Part 1 › Subpart j. Subpart J - Establishment, Maintenance, and Availability of Records. It is divided into three chapters: Chapter I — Food and Drug Administration Chapter II — Drug Enforcement Administration    § 1.283 - What happens to food that is imported or offered for import without adequate prior notice? L. 111-353, 124 Stat. § 1.710 - How will FDA notify the public about the fee schedule? § 1.378 - What criteria does FDA use to order a detention? Requirements To Submit Prior Notice of Imported Food Subpart B - General Labeling Requirements How Does FDA Order a Detention? regulations (21 CFR Part 211), the Quality System regulation (21 CFR Part 820), and the Good Laboratory Practice for Nonclinical Laboratory Studies regulations (21 CFR Part 58). § 1.652 - What must an accredited third-party certification body include in food safety audit reports? § 1.671 - How will FDA review my application for direct accreditation or renewal of direct accreditation and what happens once FDA decides on my application? § 1.904 - What definitions apply to this subpart? General Provisions § 1.284 - What are the other consequences of failing to submit adequate prior notice or otherwise failing to comply with this subpart? § 1.23 - Procedures for requesting variations and exemptions from required label statements. CFR Title 21 Part 11 sets requirements to ensure that electronic records and signatures are trustworthy, reliable, and equivalent substitutes for paper records and handwritten signatures. Source: 54 FR 31665, Aug. 1, 1989, unless otherwise noted.    § 1.225 - Who must register under this subpart? § 1.24 - Exemptions from required label statements. § 1.71 - Definitions. 14 CFR Parts 1, 21, 43, & 45 Amendments Part 21 Briefing Material - 2009 Rule Change.    § 1.83 - Definitions. § 1.281 - What information must be in a prior notice? 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