FDA Unique Facility Identifier / Registration Controls
Facility identification and registration data quality requirements for regulated establishments.
Articles (1104)
§ 1.1360 Under what circumstances will FDA modify the requirements in this subpart that apply to a food or type of entity or exempt a food or type of entity from the requirements of this subpart?§ 17.39 Evidence.§ 58.41 General.§ 74.2317 D&C Red No. 17.§ 1.1365 When will FDA consider whether to adopt modified requirements or grant an exemption from the requirements of this subpart?§ 17.41 The administrative record.§ 58.43 Animal care facilities.§ 74.2321 D&C Red No. 21.§ 1.1370 What must be included in a petition requesting modified requirements or an exemption from the requirements?§ 17.43 Posthearing briefs.§ 58.45 Animal supply facilities.§ 74.2322 D&C Red No. 22.§ 1.1375 What information submitted in a petition requesting modified requirements or an exemption, or information in comments on such a petition, is publicly available?§ 17.45 Initial decision.§ 58.47 Facilities for handling test and control articles.§ 74.2327 D&C Red No. 27.§ 1.1380 What process applies to a petition requesting modified requirements or an exemption?§ 17.47 Appeals.§ 58.49 Laboratory operation areas.§ 74.2328 D&C Red No. 28.§ 1.1385 What process will FDA follow when adopting modified requirements or granting an exemption on our own initiative?§ 17.48 Harmless error.§ 58.51 Specimen and data storage facilities.§ 74.2330 D&C Red No. 30.§ 1.1390 When will modified requirements that we adopt or an exemption that we grant become effective?§ 17.51 Judicial review.§ 58.61 Equipment design.§ 74.2331 D&C Red No. 31.§ 1.1395 Under what circumstances may FDA revise or revoke modified requirements or an exemption?§ 17.54 Deposit in the Treasury of the United States.§ 58.63 Maintenance and calibration of equipment.§ 74.2333 D&C Red No. 33.§ 1.1400 What procedures apply if FDA tentatively determines that modified requirements or an exemption should be revised or revoked?§ 19.1 Scope.§ 58.81 Standard operating procedures.§ 74.2334 D&C Red No. 34.§ 1.1405 Under what circumstances will FDA waive one or more of the requirements of this subpart for an individual entity or a type of entity?§ 19.5 Reference to Department regulations.§ 58.83 Reagents and solutions.§ 74.2336 D&C Red No. 36.§ 1.1410 When will FDA consider whether to waive a requirement of this subpart?§ 19.6 Code of ethics for government service.§ 58.90 Animal care.§ 74.2340 FD&C Red No. 40.§ 1.1415 How may I request a waiver for an individual entity?§ 19.10 Food and Drug Administration Conflict of Interest Review Board.§ 58.105 Test and control article characterization.§ 74.2602 D&C Violet No. 2.§ 1.1420 What process applies to a request for a waiver for an individual entity?§ 19.21 Duty to report violations.§ 58.107 Test and control article handling.§ 74.2602a Ext. D&C Violet No. 2.§ 1.1425 What must be included in a petition requesting a waiver for a type of entity?§ 19.45 Temporary disqualification of former employees.§ 58.113 Mixtures of articles with carriers.§ 74.2705 FD&C Yellow No. 5.§ 1.1430 What information submitted in a petition requesting a waiver for a type of entity, or information in comments on such a petition, is publicly available?§ 19.55 Permanent disqualification of former employees.§ 58.120 Protocol.§ 74.2706 FD&C Yellow No. 6.§ 1.1435 What process applies to a petition requesting a waiver for a type of entity?§ 20.1 Testimony by Food and Drug Administration employees.§ 58.130 Conduct of a nonclinical laboratory study.§ 74.2707 D&C Yellow No. 7.§ 1.1440 What process will FDA follow when waiving a requirement of this subpart on our own initiative?§ 20.2 Production of records by Food and Drug Administration employees.§ 58.185 Reporting of nonclinical laboratory study results.§ 74.2707a Ext. D&C Yellow No. 7.§ 1.1445 Under what circumstances may FDA modify or revoke a waiver?§ 20.3 Certification and authentication of Food and Drug Administration records.§ 58.190 Storage and retrieval of records and data.§ 74.2708 D&C Yellow No. 8.§ 1.1450 What procedures apply if FDA tentatively determines that a waiver should be modified or revoked?§ 20.20 Policy on disclosure of Food and Drug Administration records.§ 58.195 Retention of records.§ 74.2710 D&C Yellow No. 10.§ 1.1455 How must records required by this subpart be maintained and made available?§ 20.21 Uniform access to records.§ 58.200 Purpose.§ 74.2711 D&C Yellow No. 11.§ 1.1460 What consequences could result from failing to comply with the requirements of this subpart?§ 20.22 Partial disclosure of records.§ 58.202 Grounds for disqualification.§ 74.3045 [Phthalocyaninato(2-)] copper.§ 1.1465 How will FDA update the Food Traceability List?§ 20.23 Request for existing records.§ 58.204 Notice of and opportunity for hearing on proposed disqualification.§ 74.3054 D&C Black No. 4.§ 2.5 Imminent hazard to the public health.§ 20.24 Preparation of new records.§ 58.206 Final order on disqualification.§ 74.3102 FD&C Blue No. 2.§ 2.10 Examination and investigation samples.§ 20.25 Retroactive application of regulations.§ 58.210 Actions upon disqualification.§ 74.3106 D&C Blue No. 6.§ 2.19 Methods of analysis.§ 20.26 Electronic availability and indexes of certain records.§ 58.213 Public disclosure of information regarding disqualification.§ 74.3206 D&C Green No. 6.§ 2.25 Grain seed treated with poisonous substances; color identification to prevent adulteration of human and animal food.§ 20.27 Submission of records marked as confidential.§ 58.215 Alternative or additional actions to disqualification.§ 74.3230 D&C Red No. 17.§ 2.35 Use of secondhand containers for the shipment or storage of food and animal feed.§ 20.28 Food and Drug Administration determinations of confidentiality.§ 58.217 Suspension or termination of a testing facility by a sponsor.§ 74.3602 D&C Violet No. 2.§ 1.1 General.§ 2.110 Definition of ammonia under Federal Caustic Poison Act.§ 20.29 Prohibition on withdrawal of records from Food and Drug Administration files.§ 58.219 Reinstatement of a disqualified testing facility.§ 74.3708 D&C Yellow No. 8.§ 1.3 Definitions.§ 2.125 Use of ozone-depleting substances in foods, drugs, devices, or cosmetics.§ 20.30 Food and Drug Administration Division of Freedom of Information.§ 60.1 Scope.§ 74.3710 D&C Yellow No. 10.§ 1.4 Authority citations.§ 3.1 Purpose.§ 20.31 Retention schedule of requests for Food and Drug Administration records.§ 60.2 Purpose.§ 80.10 Fees for certification services.§ 1.20 Presence of mandatory label information.§ 3.2 Definitions.§ 20.32 Disclosure of Food and Drug Administration employee names.§ 60.3 Definitions.§ 80.21 Request for certification.§ 1.21 Failure to reveal material facts.§ 3.3 Scope.§ 20.33 Form or format of response.§ 60.10 FDA assistance on eligibility.§ 80.22 Samples to accompany requests for certification.§ 1.23 Procedures for requesting variations and exemptions from required label statements.§ 3.4 Designated agency component.§ 20.34 Search for records.§ 60.20 FDA action on regulatory review period determinations.§ 80.31 Certification.§ 1.24 Exemptions from required label statements.§ 3.5 Procedures for identifying the designated agency component.§ 20.40 Filing a request for records.§ 60.22 Regulatory review period determinations.§ 80.32 Limitations of certificates.§ 1.70 Scope.§ 3.6 Product jurisdiction officer.§ 20.41 Time limitations.§ 60.24 Revision of regulatory review period determinations.§ 80.34 Authority to refuse certification service.§ 1.71 Definitions.§ 3.7 Request for designation.§ 20.42 Aggregation of certain requests.§ 60.26 Final action on regulatory review period determinations.§ 80.35 Color additive mixtures; certification and exemption from certification.§ 1.72 Data elements that must be submitted in ACE for articles regulated by FDA.§ 3.8 Letter of designation.§ 20.43 Multitrack processing.§ 60.28 Time frame for determining regulatory review periods.§ 80.37 Treatment of batch pending certification.§ 1.73 Food.§ 3.9 Effect of letter of designation.§ 20.44 Expedited processing.§ 60.30 Filing, format, and content of petitions.§ 80.38 Treatment of batch after certification.§ 1.74 Human drugs.§ 3.10 Stay of review time.§ 20.45 Fees to be charged.§ 60.32 Applicant response to petition.§ 80.39 Records of distribution.§ 1.75 Animal drugs and veterinary devices.§ 4.1 What is the scope of this subpart?§ 20.46 Waiver or reduction of fees.§ 60.34 FDA action on petitions.§ 81.1 Provisional lists of color additives.§ 1.76 Medical devices.§ 4.2 How does FDA define key terms and phrases in this subpart?§ 20.47 Situations in which confidentiality is uncertain.§ 60.36 Standard of due diligence.§ 81.10 Termination of provisional listings of color additives.§ 1.77 Radiation-emitting electronic products.§ 4.3 What current good manufacturing practice requirements apply to my combination product?§ 20.48 Judicial review of proposed disclosure.§ 60.40 Request for hearing.§ 81.30 Cancellation of certificates.§ 1.78 Biological products, HCT/Ps, and related drugs and medical devices.§ 4.4 How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product?§ 20.49 Denial of a request for records.§ 60.42 Notice of hearing.§ 82.3 Definitions.§ 1.79 Tobacco products.§ 4.100 What is the scope of this subpart?§ 20.50 Nonspecific and overly burdensome requests.§ 60.44 Hearing procedures.§ 82.5 General specifications for straight colors.§ 1.80 Cosmetics.§ 4.101 How does the FDA define key terms and phrases in this subpart?§ 20.51 Referral to primary source of records.§ 60.46 Administrative decision.§ 82.6 Certifiable mixtures.§ 1.81 Rejection of entry filing.§ 4.102 What reports must you submit to FDA for your combination product or constituent part?§ 20.52 Availability of records at National Technical Information Service.§ 70.3 Definitions.§ 82.50 General.§ 1.83 Definitions.§ 4.103 What information must you share with other constituent part applicants for the combination product?§ 20.53 Use of private contractor for copying.§ 70.5 General restrictions on use of color additives.§ 82.51 Lakes (FD&C).§ 1.90 Notice of sampling.§ 4.104 How and where must you submit postmarketing safety reports for your combination product or constituent part?§ 20.54 Request for review without copying.§ 70.10 Color additives in standardized foods and new drugs.§ 82.101 FD&C Blue No. 1.§ 1.91 Payment for samples.§ 4.105 What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?§ 20.55 Indexing trade secrets and confidential commercial or financial information.§ 70.11 Related substances.§ 82.102 FD&C Blue No. 2.§ 1.94 Hearing on refusal of admission or destruction.§ 5.1100 Headquarters.§ 20.60 Applicability of exemptions.§ 70.19 Fees for listing.§ 82.203 FD&C Green No. 3.§ 1.95 Application for authorization to relabel and recondition.§ 5.1105 Chief Counsel, Food and Drug Administration.§ 20.61 Trade secrets and commercial or financial information which is privileged or confidential.§ 70.20 Packaging requirements for straight colors (other than hair dyes).§ 82.304 FD&C Red No. 4.§ 1.96 Granting of authorization to relabel and recondition.§ 5.1110 FDA public information offices.§ 20.62 Inter- or intra-agency memoranda or letters.§ 70.25 Labeling requirements for color additives (other than hair dyes).§ 82.705 FD&C Yellow No. 5.§ 1.97 Bonds.§ 7.1 Scope.§ 20.63 Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy.§ 70.40 Safety factors to be considered.§ 82.706 FD&C Yellow No. 6.§ 1.99 Costs chargeable in connection with relabeling and reconditioning inadmissible imports.§ 7.3 Definitions.§ 20.64 Records or information compiled for law enforcement purposes.§ 70.42 Criteria for evaluating the safety of color additives.§ 82.1050 General.§ 1.101 Notification and recordkeeping.§ 7.12 Guaranty.§ 20.65 National defense and foreign policy.§ 70.45 Allocation of color additives.§ 82.1051 Lakes (D&C).§ 1.225 Who must register under this subpart?§ 7.13 Suggested forms of guaranty.§ 20.66 Internal personnel rules and practices.§ 70.50 Application of the cancer clause of section 721 of the act.§ 82.1104 D&C Blue No. 4.§ 1.226 Who does not have to register under this subpart?§ 7.40 Recall policy.§ 20.67 Records exempted by other statutes.§ 70.51 Advisory committee on the applicability of the anticancer clause.§ 82.1205 D&C Green No. 5.§ 1.227 What definitions apply to this subpart?§ 7.41 Health hazard evaluation and recall classification.§ 20.80 Applicability of limitations on exemptions.§ 70.55 Request for scientific studies.§ 82.1206 D&C Green No. 6.§ 1.230 When must you register or renew your registration?§ 7.42 Recall strategy.§ 20.81 Data and information previously disclosed to the public.§ 71.1 Petitions.§ 82.1254 D&C Orange No. 4.§ 1.231 How and where do you register or renew your registration?§ 7.45 Food and Drug Administration-requested recall.§ 20.82 Discretionary disclosure by the Commissioner.§ 71.2 Notice of filing of petition.§ 82.1255 D&C Orange No. 5.§ 1.232 What information is required in the registration?§ 7.46 Firm-initiated recall.§ 20.83 Disclosure required by court order.§ 71.4 Samples; additional information.§ 82.1260 D&C Orange No. 10.§ 1.233 Are there optional items included in the registration form?§ 7.49 Recall communications.§ 20.84 Disclosure to consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372(a), and other special government employees.§ 71.6 Extension of time for studying petitions; substantive amendments; withdrawal of petitions without prejudice.§ 82.1261 D&C Orange No. 11.§ 1.234 How and when do you update your facility's registration information?§ 7.50 Public notification of recall.§ 20.85 Disclosure to other Federal Government departments and agencies.§ 71.15 Confidentiality of data and information in color additive petitions.§ 82.1306 D&C Red No. 6.§ 1.235 How and when do you cancel your facility's registration information?§ 7.53 Recall status reports.§ 20.86 Disclosure in administrative or court proceedings.§ 71.18 Petition for exemption from certification.§ 82.1307 D&C Red No. 7.§ 1.240 What other registration requirements apply?§ 7.55 Termination of a recall.§ 20.87 Disclosure to Congress.§ 71.20 Publication of regulation.§ 82.1317 D&C Red No. 17.§ 1.241 What are the consequences of failing to register, update, renew, or cancel your registration?§ 7.59 General industry guidance.§ 20.88 Communications with State and local government officials.§ 71.22 Deception as a basis for refusing to issue regulations; deceptive use of a color additive for which a regulation has issued.§ 82.1321 D&C Red No. 21.§ 1.242 What does assignment of a registration number mean?§ 7.84 Opportunity for presentation of views before report of criminal violation.§ 20.89 Communications with foreign government officials.§ 71.25 Condition for certification.§ 82.1322 D&C Red No. 22.§ 1.243 Is food registration information available to the public?§ 7.85 Conduct of a presentation of views before report of criminal violation.§ 20.90 Disclosure to contractors.§ 71.26 Revocation of exemption from certification.§ 82.1327 D&C Red No. 27.§ 1.245 Waiver request.§ 7.87 Records related to opportunities for presentation of views conducted before report of criminal violation.§ 20.91 Use of data or information for administrative or court enforcement action.§ 71.27 Listing and exemption from certification on the Commissioner's initiative.§ 82.1328 D&C Red No. 28.§ 1.276 What definitions apply to this subpart?§ 10.1 Scope.§ 20.100 Applicability; cross-reference to other regulations.§ 71.30 Procedure for filing objections to regulations.§ 82.1330 D&C Red No. 30.§ 1.277 What is the scope of this subpart?§ 10.3 Definitions.§ 20.101 Administrative enforcement records.§ 71.37 Exemption of color additives for investigational use.§ 82.1331 D&C Red No. 31.§ 1.278 Who is authorized to submit prior notice?§ 10.10 Summaries of administrative practices and procedures.§ 20.102 Court enforcement records.§ 73.1 Diluents in color additive mixtures for food use exempt from certification.§ 82.1333 D&C Red No. 33.§ 1.279 When must prior notice be submitted to FDA?§ 10.19 Waiver, suspension, or modification of procedural requirements.§ 20.103 Correspondence.§ 73.30 Annatto extract.§ 82.1334 D&C Red No. 34.§ 1.280 How must you submit prior notice?§ 10.20 Submission of documents to Dockets Management Staff; computation of time; availability for public disclosure.§ 20.104 Summaries of oral discussions.§ 73.32 Antarctic krill meal.§ 82.1336 D&C Red No. 36.§ 1.281 What information must be in a prior notice?§ 10.25 Initiation of administrative proceedings.§ 20.105 Testing and research conducted by or with funds provided by the Food and Drug Administration.§ 73.35 Astaxanthin.§ 82.1602 D&C Violet No. 2.§ 1.282 What must you do if information changes after you have received confirmation of a prior notice from FDA?§ 10.30 Citizen petition.§ 20.106 Studies and reports prepared by or with funds provided by the Food and Drug Administration.§ 73.37 Astaxanthin dimethyldisuccinate.§ 82.1707 D&C Yellow No. 7.§ 1.283 What happens to food that is imported or offered for import without adequate prior notice?§ 10.31 Citizen petitions and petitions for stay of action related to abbreviated new drug applications, certain new drug applications, or certain biologics license applications.§ 20.107 Food and Drug Administration manuals.§ 73.40 Dehydrated beets (beet powder).§ 82.1708 D&C Yellow No. 8.§ 1.284 What are the other consequences of failing to submit adequate prior notice or otherwise failing to comply with this subpart?§ 10.33 Administrative reconsideration of action.§ 20.108 Agreements between the Food and Drug Administration and other departments, agencies, and organizations.§ 73.50 Ultramarine blue.§ 82.1710 D&C Yellow No. 10.§ 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?§ 10.35 Administrative stay of action.§ 20.109 Data and information obtained by contract.§ 73.69 Butterfly pea flower extract.§ 82.2050 General.§ 1.326 Who is subject to this subpart?§ 10.40 Promulgation of regulations for the efficient enforcement of the law.§ 20.110 Data and information about Food and Drug Administration employees.§ 73.70 Calcium carbonate.§ 82.2051 Lakes (Ext. D&C).§ 1.327 Who is excluded from all or part of the regulations in this subpart?§ 10.45 Court review of final administrative action; exhaustion of administrative remedies.§ 20.111 Data and information submitted voluntarily to the Food and Drug Administration.§ 73.75 Canthaxanthin.§ 82.2707a Ext. D&C Yellow No. 7.§ 1.328 What definitions apply to this subpart?§ 10.50 Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.§ 20.112 Voluntary drug experience reports submitted by physicians and hospitals.§ 73.85 Caramel.§ 99.1 Scope.§ 1.329 Do other statutory provisions and regulations apply?§ 10.55 Separation of functions; ex parte communications.§ 20.113 Voluntary product defect reports.§ 73.90 β-Apo-8′-carotenal.§ 99.3 Definitions.§ 1.330 Can existing records satisfy the requirements of this subpart?§ 10.60 Referral by court.§ 20.114 Data and information submitted pursuant to cooperative quality assurance agreements.§ 73.95 β-Carotene.§ 99.101 Information that may be disseminated.§ 1.337 What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate previous sources of food?§ 10.65 Meetings and correspondence.§ 20.115 Product codes for manufacturing or sales dates.§ 73.100 Cochineal extract; carmine.§ 99.103 Mandatory statements and information.§ 1.345 What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate subsequent recipients of food?§ 10.70 Documentation of significant decisions in administrative file.§ 20.116 Drug and device registration and listing information.§ 73.125 Sodium copper chlorophyllin.§ 99.105 Recipients of information.§ 1.352 What information must transporters establish and maintain?§ 10.75 Internal agency review of decisions.§ 20.117 New drug information.§ 73.140 Toasted partially defatted cooked cottonseed flour.§ 99.201 Manufacturer's submission to the agency.§ 1.360 What are the record retention requirements?§ 10.80 Dissemination of draft Federal Register notices and regulations.§ 20.118 Advisory committee records.§ 73.160 Ferrous gluconate.§ 99.203 Request to extend the time for completing planned studies.§ 1.361 What are the record availability requirements?§ 10.85 Advisory opinions.§ 20.119 Lists of names and addresses.§ 73.165 Ferrous lactate.§ 99.205 Application for exemption from the requirement to file a supplemental application.§ 1.362 What records are excluded from this subpart?§ 10.90 Food and Drug Administration regulations, recommendations, and agreements.§ 20.120 Records available in Food and Drug Administration Public Reading Rooms.§ 73.169 Grape color extract.§ 99.301 Agency action on a submission.§ 1.363 What are the consequences of failing to establish or maintain records or make them available to FDA as required by this subpart?§ 10.95 Participation in outside standard-setting activities.§ 21.1 Scope.§ 73.170 Grape skin extract (enocianina).§ 99.303 Extension of time for completing planned studies.§ 1.368 What are the compliance dates for this subpart?§ 10.100 Public calendar.§ 21.3 Definitions.§ 73.185 Haematococcus algae meal.§ 99.305 Exemption from the requirement to file a supplemental application.§ 1.377 What definitions apply to this subpart?§ 10.105 Representation by an organization.§ 21.10 Policy concerning records about individuals.§ 73.200 Synthetic iron oxide.§ 99.401 Corrective actions and cessation of dissemination of information.§ 1.378 What criteria does FDA use to order a detention?§ 10.110 Settlement proposals.§ 21.20 Procedures for notice of Food and Drug Administration Privacy Act Record Systems.§ 73.225 Jagua (genipin-glycine) blue.§ 99.403 Termination of approvals of applications for exemption.§ 1.379 How long may FDA detain an article of food?§ 10.115 Good guidance practices.§ 21.21 Changes in systems and new systems.§ 73.250 Fruit juice.§ 99.405 Applicability of labeling, adulteration, and misbranding authority.§ 1.380 Where and under what conditions must the detained article of food be held?§ 10.200 Scope.§ 21.30 Records of contractors.§ 73.260 Vegetable juice.§ 99.501 Recordkeeping and reports.§ 1.381 May a detained article of food be delivered to another entity or transferred to another location?§ 10.203 Definitions.§ 21.31 Records stored by the National Archives and Records Administration.§ 73.275 Dried algae meal.§ 100.1 Petitions requesting exemption from preemption for State or local requirements.§ 1.382 What labeling or marking requirements apply to a detained article of food?§ 10.204 General.§ 21.32 Personnel records.§ 73.295 Tagetes (Aztec marigold) meal and extract.§ 100.2 State enforcement of Federal regulations.§ 1.383 What expedited procedures apply when FDA initiates a seizure action against a detained perishable food?§ 10.205 Electronic media coverage of public administrative proceedings.§ 21.33 Medical records.§ 73.300 Carrot oil.§ 100.100 Misleading containers.§ 1.384 When does a detention order terminate?§ 10.206 Procedures for electronic media coverage of agency public administrative proceedings.§ 21.40 Procedures for submitting requests for notification and access.§ 73.315 Corn endosperm oil.§ 100.155 Salt and iodized salt.§ 1.391 Who approves a detention order?§ 11.1 Scope.§ 21.41 Processing of requests.§ 73.340 Paprika.§ 101.1 Principal display panel of package form food.§ 1.392 Who receives a copy of the detention order?§ 11.2 Implementation.§ 21.42 Responses to requests.§ 73.345 Paprika oleoresin.§ 101.2 Information panel of package form food.§ 1.393 What information must FDA include in the detention order?§ 11.3 Definitions.§ 21.43 Access to requested records.§ 73.350 Mica-based pearlescent pigments.§ 101.3 Identity labeling of food in packaged form.§ 1.401 Who is entitled to appeal?§ 11.10 Controls for closed systems.§ 21.44 Verification of identity.§ 73.352 Paracoccus pigment.§ 101.4 Food; designation of ingredients.§ 1.402 What are the requirements for submitting an appeal?§ 11.30 Controls for open systems.§ 21.45 Fees.§ 73.355 Phaffia yeast.§ 101.5 Food; name and place of business of manufacturer, packer, or distributor.§ 1.403 What requirements apply to an informal hearing?§ 11.50 Signature manifestations.§ 21.50 Procedures for submitting requests for amendment of records.§ 73.450 Riboflavin.§ 101.7 Declaration of net quantity of contents.§ 1.404 Who serves as the presiding officer for an appeal and for an informal hearing?§ 11.70 Signature/record linking.§ 21.51 Responses to requests for amendment of records.§ 73.500 Saffron.§ 101.8 Vending machines.§ 1.405 When does FDA have to issue a decision on an appeal?§ 11.100 General requirements.§ 21.52 Administrative appeals of refusals to amend records.§ 73.520 Soy leghemoglobin.§ 1.406 How will FDA handle classified information in an informal hearing?§ 11.200 Electronic signature components and controls.§ 21.53 Notation and disclosure of disputed records.§ 73.530 Spirulina extract.§ 1.500 What definitions apply to this subpart?§ 11.300 Controls for identification codes/passwords.§ 21.54 Amended or disputed records received from other agencies.§ 73.575 Titanium dioxide.§ 1.501 To what foods do the requirements in this subpart apply?§ 12.1 Scope.§ 21.60 Policy.§ 73.585 Tomato lycopene extract; tomato lycopene concentrate.§ 1.502 What foreign supplier verification program (FSVP) must I have?§ 12.20 Initiation of a hearing involving the issuance, amendment, or revocation of a regulation.§ 21.61 Exempt systems.§ 73.600 Turmeric.§ 1.503 Who must develop my FSVP and perform FSVP activities?§ 12.21 Initiation of a hearing involving the issuance, amendment, or revocation of an order.§ 21.65 Access to records in exempt systems.§ 73.615 Turmeric oleoresin.§ 1.504 What hazard analysis must I conduct?§ 12.22 Filing objections and requests for a hearing on a regulation or order.§ 21.70 Disclosure and intra-agency use of records in Privacy Act Record Systems; no accounting required.§ 73.1001 Diluents in color additive mixtures for drug use exempt from certification.§ 1.505 What evaluation for foreign supplier approval and verification must I conduct?§ 12.23 Notice of filing of objections.§ 21.71 Disclosure of records in Privacy Act Record Systems; accounting required.§ 73.1010 Alumina (dried aluminum hydroxide).§ 1.506 What foreign supplier verification and related activities must I conduct?§ 12.24 Ruling on objections and requests for hearing.§ 21.72 Individual consent to disclosure of records to other persons.§ 73.1015 Chromium-cobalt-aluminum oxide.§ 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?§ 12.26 Modification or revocation of regulation or order.§ 21.73 Accuracy, completeness, timeliness, and relevance of records disclosed from Privacy Act Record Systems.§ 73.1025 Ferric ammonium citrate.§ 1.508 What corrective actions must I take under my FSVP?§ 12.28 Denial of hearing in whole or in part.§ 21.74 Providing notice that a record is disputed.§ 73.1030 Annatto extract.§ 1.509 How must the importer be identified at entry?§ 12.30 Judicial review after waiver of hearing on a regulation.§ 21.75 Rights of legal guardians.§ 73.1070 Calcium carbonate.§ 1.510 How must I maintain records of my FSVP?§ 12.32 Request for alternative form of hearing.§ 25.1 Purpose.§ 73.1075 Canthaxanthin.§ 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?§ 12.35 Notice of hearing; stay of action.§ 25.5 Terminology.§ 73.1085 Caramel.§ 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?§ 12.37 Effective date of a regulation.§ 25.10 Policies and NEPA planning.§ 73.1095 β-Carotene.§ 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?§ 12.38 Effective date of an order.§ 25.15 General procedures.§ 73.1100 Cochineal extract; carmine.§ 1.514 What are some consequences of failing to comply with the requirements of this subpart?§ 12.40 Appearance.§ 25.16 Public health and safety emergencies.§ 73.1125 Potassium sodium copper chloropyhllin (chlorophyllin-copper complex).§ 1.600 What definitions apply to this subpart?§ 12.45 Notice of participation.§ 25.20 Actions requiring preparation of an environmental assessment.§ 73.1150 Dihydroxyacetone.§ 1.601 Who is subject to this subpart?§ 12.50 Advice on public participation in hearings.§ 25.21 Extraordinary circumstances.§ 73.1162 Bismuth oxychloride.§ 1.610 Who is eligible to seek recognition?§ 12.60 Presiding officer.§ 25.22 Actions requiring the preparation of an environmental impact statement.§ 73.1200 Synthetic iron oxide.§ 1.611 What legal authority must an accreditation body have to qualify for recognition?§ 12.62 Commencement of functions.§ 25.30 General.§ 73.1298 Ferric ammonium ferrocyanide.§ 1.612 What competency and capacity must an accreditation body have to qualify for recognition?§ 12.70 Authority of presiding officer.§ 25.31 Human drugs and biologics.§ 73.1299 Ferric ferrocyanide.§ 1.613 What protections against conflicts of interest must an accreditation body have to qualify for recognition?§ 12.75 Disqualification of presiding officer.§ 25.32 Foods, food additives, and color additives.§ 73.1326 Chromium hydroxide green.§ 1.614 What quality assurance procedures must an accreditation body have to qualify for recognition?§ 12.78 Unavailability of presiding officer.§ 25.33 Animal drugs.§ 73.1327 Chromium oxide greens.§ 1.615 What records procedures must an accreditation body have to qualify for recognition?§ 12.80 Filing and service of submissions.§ 25.34 Devices and electronic products.§ 73.1329 Guanine.§ 1.620 How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation?§ 12.82 Petition to participate in forma pauperis.§ 25.35 Tobacco product applications.§ 73.1350 Mica-based pearlescent pigments.§ 1.621 How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited?§ 12.83 Advisory opinions.§ 25.40 Environmental assessments.§ 73.1375 Pyrogallol.§ 1.622 How must a recognized accreditation body monitor its own performance?§ 12.85 Disclosure of data and information by the participants.§ 25.41 Findings of no significant impact.§ 73.1400 Pyrophyllite.§ 1.623 What reports and notifications must a recognized accreditation body submit to FDA?§ 12.87 Purpose; oral and written testimony; burden of proof.§ 25.42 Environmental impact statements.§ 73.1410 Logwood extract.§ 1.624 How must a recognized accreditation body protect against conflicts of interest?§ 12.89 Participation of nonparties.§ 25.43 Records of decision.§ 73.1496 Mica.§ 1.625 What records requirements must an accreditation body that has been recognized meet?§ 12.90 Conduct at oral hearings or conferences.§ 25.44 Lead and cooperating agencies.§ 73.1530 Spirulina extract.§ 1.630 How do I apply to FDA for recognition or renewal of recognition?§ 12.91 Time and place of prehearing conference.§ 25.45 Responsible agency official.§ 73.1550 Talc.§ 1.631 How will FDA review my application for recognition or renewal of recognition and what happens once FDA decides on my application?§ 12.92 Prehearing conference procedure.§ 25.50 General information.§ 73.1575 Titanium dioxide.§ 1.632 What is the duration of recognition?§ 12.93 Summary decisions.§ 25.51 Environmental assessments and findings of no significant impact.§ 73.1645 Aluminum powder.§ 1.633 How will FDA monitor recognized accreditation bodies?§ 12.94 Receipt of evidence.§ 25.52 Environmental impact statements.§ 73.1646 Bronze powder.§ 1.634 When will FDA revoke recognition?§ 12.95 Official notice.§ 25.60 Environmental effects abroad of major agency actions.§ 73.1647 Copper powder.§ 1.635 What if I want to voluntarily relinquish recognition or do not want to renew recognition?§ 12.96 Briefs and arguments.§ 26.0 General.§ 73.1991 Zinc oxide.§ 1.636 How do I request reinstatement of recognition?§ 12.97 Interlocutory appeal from ruling of presiding officer.§ 26.1 Definitions.§ 73.2030 Annatto.§ 1.640 Who is eligible to seek accreditation?§ 12.98 Official transcript.§ 26.2 Purpose.§ 73.2085 Caramel.§ 1.641 What legal authority must a third-party certification body have to qualify for accreditation?§ 12.99 Motions.§ 26.3 Scope.§ 73.2087 Carmine.§ 1.642 What competency and capacity must a third-party certification body have to qualify for accreditation?§ 12.100 Administrative record of a hearing.§ 26.4 Product coverage.§ 73.2095 β-Carotene.§ 1.643 What protections against conflicts of interest must a third-party certification body have to qualify for accreditation?§ 12.105 Examination of record.§ 26.5 Length of transition period.§ 73.2110 Bismuth citrate.§ 1.644 What quality assurance procedures must a third-party certification body have to qualify for accreditation?§ 12.120 Initial decision.§ 26.6 Equivalence assessment.§ 73.2120 Disodium EDTA-copper.§ 1.645 What records procedures must a third-party certification body have to qualify for accreditation?§ 12.125 Appeal from or review of initial decision.§ 26.7 Participation in the equivalence assessment and determination.§ 73.2125 Potassium sodium copper chlorophyllin (chlorophyllin-copper complex).§ 1.650 How must an accredited third-party certification body ensure its audit agents are competent and objective?§ 12.130 Decision by Commissioner on appeal or review of initial decision.§ 26.8 Other transition activities.§ 73.2150 Dihydroxyacetone.§ 1.651 How must an accredited third-party certification body conduct a food safety audit of an eligible entity?§ 12.139 Reconsideration and stay of action.§ 26.9 Equivalence determination.§ 73.2162 Bismuth oxychloride.§ 1.652 What must an accredited third-party certification body include in food safety audit reports?§ 12.140 Review by the courts.§ 26.10 Regulatory authorities not listed as currently equivalent.§ 73.2180 Guaiazulene.§ 1.653 What must an accredited third-party certification body do when issuing food or facility certifications?§ 12.159 Copies of petitions for judicial review.§ 26.11 Start of operational period.§ 73.2190 Henna.§ 1.654 When must an accredited third-party certification body monitor an eligible entity that it has issued a food or facility certification?§ 13.1 Scope.§ 26.12 Nature of recognition of inspection reports.§ 73.2250 Iron oxides.§ 1.655 How must an accredited third-party certification body monitor its own performance?§ 13.5 Notice of a hearing before a Board.§ 26.13 Transmission of postapproval inspection reports.§ 73.2298 Ferric ammonium ferrocyanide.§ 1.656 What reports and notifications must an accredited third-party certification body submit?§ 13.10 Members of a Board.§ 26.14 Transmission of preapproval inspection reports.§ 73.2299 Ferric ferrocyanide.§ 1.657 How must an accredited third-party certification body protect against conflicts of interest?§ 13.15 Separation of functions; ex parte communications; administrative support.§ 26.15 Monitoring continued equivalence.§ 73.2326 Chromium hydroxide green.§ 1.658 What records requirements must a third-party certification body that has been accredited meet?§ 13.20 Submissions to a Board.§ 26.16 Suspension.§ 73.2327 Chromium oxide greens.§ 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?§ 13.25 Disclosure of data and information by the participants.§ 26.17 Role and composition of the Joint Sectoral Committee.§ 73.2329 Guanine.§ 1.661 What is the duration of accreditation by a recognized accreditation body?§ 13.30 Proceedings of a Board.§ 26.18 Regulatory collaboration.§ 73.2400 Pyrophyllite.§ 1.662 How will FDA monitor accredited third-party certification bodies?§ 13.40 Administrative record of a Board.§ 26.19 Information relating to quality aspects.§ 73.2496 Mica.§ 1.663 How do I request an FDA waiver or waiver extension for the 13-month limit for audit agents conducting regulatory audits?§ 13.45 Examination of administrative record.§ 26.20 Alert system.§ 73.2500 Silver.§ 1.664 When would FDA withdraw accreditation?§ 13.50 Record for administrative decision.§ 26.21 Safeguard clause.§ 73.2550 Silver nitrate.§ 1.665 What if I want to voluntarily relinquish accreditation or do not want to renew accreditation?§ 14.1 Scope.§ 26.31 Purpose.§ 73.2575 Titanium dioxide.§ 1.666 How do I request reaccreditation?§ 14.5 Purpose of proceedings before an advisory committee.§ 26.32 Scope.§ 73.2645 Aluminum powder.§ 1.670 How do I apply to FDA for direct accreditation or renewal of direct accreditation?§ 14.7 Administrative remedies.§ 26.33 Product coverage.§ 73.2646 Bronze powder.§ 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?§ 14.10 Applicability to Congress.§ 26.34 Regulatory authorities.§ 73.2647 Copper powder.§ 1.672 What is the duration of direct accreditation?§ 14.15 Committees working under a contract with FDA.§ 26.35 Length and purpose of transition period.§ 73.2725 Ultramarines.§ 1.680 How and when will FDA monitor eligible entities?§ 14.20 Notice of hearing before an advisory committee.§ 26.36 Listing of CAB's.§ 73.2775 Manganese violet.§ 1.681 How frequently must eligible entities be recertified?§ 14.22 Meetings of an advisory committee.§ 26.37 Confidence building activities.§ 73.2991 Zinc oxide.§ 1.690 How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public?§ 14.25 Portions of advisory committee meetings.§ 26.38 Other transition period activities.§ 73.2995 Luminescent zinc sulfide.§ 1.691 How do I request reconsideration of a denial by FDA of an application or a waiver request?§ 14.27 Determination to close portions of advisory committee meetings.§ 26.39 Equivalence assessment.§ 73.3100 1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester copolymers.§ 1.692 How do I request internal agency review of a denial of an application or waiver request upon reconsideration?§ 14.29 Conduct of a hearing before an advisory committee.§ 26.40 Start of the operational period.§ 73.3105 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione.§ 1.693 How do I request a regulatory hearing on a revocation of recognition or withdrawal of accreditation?§ 14.30 Chairperson of an advisory committee.§ 26.41 Exchange and endorsement of quality system evaluation reports.§ 73.3106 1,4-Bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone copolymers.§ 1.694 Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?§ 14.31 Consultation by an advisory committee with other persons.§ 26.42 Exchange and endorsement of product evaluation reports.§ 73.3107 Carbazole violet.§ 1.695 Are the records obtained by FDA under this subpart subject to public disclosure?§ 14.33 Compilation of materials for members of an advisory committee.§ 26.43 Transmission of quality system evaluation reports.§ 73.3110 Chlorophyllin-copper complex, oil soluble.§ 1.700 Who is subject to a user fee under this subpart?§ 14.35 Written submissions to an advisory committee.§ 26.44 Transmission of product evaluation reports.§ 73.3110a Chromium-cobalt-aluminum oxide.§ 1.705 What user fees are established under this subpart?§ 14.39 Additional rules for a particular advisory committee.§ 26.45 Monitoring continued equivalence.§ 73.3111 Chromium oxide greens.§ 1.710 How will FDA notify the public about the fee schedule?§ 14.40 Establishment and renewal of advisory committees.§ 26.46 Listing of additional CAB's.§ 73.3112 C.I. Vat Orange 1.§ 1.715 When must a user fee required by this subpart be submitted?§ 14.55 Termination of advisory committees.§ 26.47 Role and composition of the Joint Sectoral Committee.§ 73.3115 2-[[2,5-Diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5-benzenetriol.§ 1.720 Are user fees under this subpart refundable?§ 14.60 Minutes and reports of advisory committee meetings.§ 26.48 Harmonization.§ 73.3117 16,23-Dihydrodinaphtho[2,3-a:2′,3′-i] naphth [2′,3′:6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone.§ 1.725 What are the consequences of not paying a user fee under this subpart on time?§ 14.61 Transcripts of advisory committee meetings.§ 26.49 Regulatory cooperation.§ 73.3118 N,N′-(9,10-Dihydro-9,10-dioxo-1,5-anthracenediyl) bisbenzamide.§ 1.900 Who is subject to this subpart?§ 14.65 Public inquiries and requests for advisory committee records.§ 26.50 Alert system and exchange of postmarket vigilance reports.§ 73.3119 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone.§ 1.902 How do the criteria and definitions in this subpart apply under the Federal Food, Drug, and Cosmetic Act?§ 14.70 Administrative record of a public hearing before an advisory committee.§ 26.60 Definitions.§ 73.3120 16,17-Dimethoxydinaphtho [1,2,3-cd:3′,2′,1′-lm] perylene-5,10-dione.§ 1.904 What definitions apply to this subpart?§ 14.75 Examination of administrative record and other advisory committee records.§ 26.61 Purpose of this part.§ 73.3121 Poly(hydroxyethyl methacrylate)-dye copolymers.§ 1.906 What requirements apply to vehicles and transportation equipment?§ 14.80 Qualifications for members of standing policy and technical advisory committees.§ 26.62 General obligations.§ 73.3122 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one.§ 1.908 What requirements apply to transportation operations?§ 14.82 Nominations of voting members of standing advisory committees.§ 26.63 General coverage of this part.§ 73.3123 6-Ethoxy-2-(6-ethoxy-3-oxobenzo[b]thien-2(3H)-ylidene) benzo[b]thiophen-3 (2H)-one.§ 1.910 What training requirements apply to carriers engaged in transportation operations?§ 14.84 Nominations and selection of nonvoting members of standing technical advisory committees.§ 26.64 Transitional arrangements.§ 73.3124 Phthalocyanine green.§ 1.912 What record retention and other records requirements apply to shippers, receivers, loaders, and carriers engaged in transportation operations?§ 14.86 Rights and responsibilities of nonvoting members of advisory committees.§ 26.65 Designating authorities.§ 73.3125 Iron oxides.§ 1.914 Under what circumstances will we waive a requirement of this subpart?§ 14.90 Ad hoc advisory committee members.§ 26.66 Designation and listing procedures.§ 73.3126 Titanium dioxide.§ 1.916 When will we consider whether to waive a requirement of this subpart?§ 14.95 Compensation of advisory committee members.§ 26.67 Suspension of listed conformity assessment bodies.§ 73.3127 Vinyl alcohol/methyl methacrylate-dye reaction products.§ 1.918 What must be included in the Statement of Grounds in a petition requesting a waiver?§ 14.100 List of standing advisory committees.§ 26.68 Withdrawal of listed conformity assessment bodies.§ 73.3128 Mica-based pearlescent pigments.§ 1.920 What information submitted in a petition requesting a waiver or submitted in comments on such a petition is publicly available?§ 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).§ 26.69 Monitoring of conformity assessment bodies.§ 73.3129 Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulfonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulfonate.§ 1.922 Who will respond to a petition requesting a waiver?§ 14.122 Functions of TEPRSSC.§ 26.70 Conformity assessment bodies.§ 74.101 FD&C Blue No. 1.§ 1.924 What process applies to a petition requesting a waiver?§ 14.125 Procedures of TEPRSSC.§ 26.71 Exchange of information.§ 74.102 FD&C Blue No. 2.§ 1.926 Under what circumstances may we deny a petition requesting a waiver?§ 14.127 Membership of TEPRSSC.§ 26.72 Sectoral contact points.§ 74.203 FD&C Green No. 3.§ 1.928 What process will we follow when waiving a requirement of this subpart on our own initiative?§ 14.130 Conduct of TEPRSSC meeting; availability of TEPRSSC records.§ 26.73 Joint Committee.§ 74.250 Orange B.§ 1.930 When will a waiver that we grant become effective?§ 14.140 Establishment of a color additive advisory committee.§ 26.74 Preservation of regulatory authority.§ 74.302 Citrus Red No. 2.§ 1.932 Under what circumstances may we modify or revoke a waiver?§ 14.142 Functions of a color additive advisory committee.§ 26.75 Suspension of recognition obligations.§ 74.303 FD&C Red No. 3.§ 1.934 What procedures apply if we determine that a waiver should be modified or revoked?§ 14.145 Procedures of a color additive advisory committee.§ 26.76 Confidentiality.§ 74.340 FD&C Red No. 40.§ 1.980 Administrative detention of drugs.§ 14.147 Membership of a color additive advisory committee.§ 26.77 Fees.§ 74.705 FD&C Yellow No. 5.§ 1.1101 What documents are incorporated by reference in this subpart§ 14.155 Fees and compensation pertaining to a color additive advisory committee.§ 26.78 Agreements with other countries.§ 74.706 FD&C Yellow No. 6.§ 1.1102 What definitions apply to this subpart?§ 14.160 Establishment of standing technical advisory committees for human prescription drugs.§ 26.79 Territorial application.§ 74.1101 FD&C Blue No. 1§ 1.1103 Who is subject to this subpart?§ 14.171 Utilization of an advisory committee on the initiative of FDA.§ 26.80 Entry into force, amendment, and termination.§ 74.1102 FD&C Blue No. 2.§ 1.1107 When must food testing be conducted under this subpart?§ 14.172 Utilization of an advisory committee at the request of an interested person.§ 26.81 Final provisions.§ 74.1104 D&C Blue No. 4.§ 1.1108 When and how will FDA issue a directed food laboratory order?§ 14.174 Advice and recommendations in writing.§ 50.1 Scope.§ 74.1109 D&C Blue No. 9.§ 1.1109 How will FDA make information about recognized accreditation bodies and LAAF-accredited laboratories available to the public?§ 15.1 Scope.§ 50.3 Definitions.§ 74.1203 FD&C Green No. 3.§ 1.1110 What are the general requirements for submitting information to FDA under this subpart?§ 15.20 Notice of a public hearing before the Commissioner.§ 50.20 General requirements for informed consent.§ 74.1205 D&C Green No. 5.§ 1.1113 What are the eligibility requirements for a recognized accreditation body?§ 15.21 Notice of participation; schedule for hearing.§ 50.22 Exception from informed consent requirements for minimal risk clinical investigations.§ 74.1206 D&C Green No. 6.§ 1.1114 How does an accreditation body apply to FDA for recognition or renewal of recognition?§ 15.25 Written submissions.§ 50.23 Exception from general requirements.§ 74.1208 D&C Green No. 8.§ 1.1115 How will FDA evaluate applications for recognition and renewal of recognition?§ 15.30 Conduct of a public hearing before the Commissioner.§ 50.24 Exception from informed consent requirements for emergency research.§ 74.1254 D&C Orange No. 4.§ 1.1116 What must a recognized accreditation body do to voluntarily relinquish or not renew its recognition?§ 15.40 Administrative record.§ 50.25 Elements of informed consent.§ 74.1255 D&C Orange No. 5.§ 1.1117 How may an accreditation body request reinstatement of recognition?§ 15.45 Examination of administrative record.§ 50.27 Documentation of informed consent.§ 74.1260 D&C Orange No. 10.§ 1.1119 What are the conflict of interest requirements for a recognized accreditation body?§ 16.1 Scope.§ 50.50 IRB duties.§ 74.1261 D&C Orange No. 11.§ 1.1120 How must a recognized accreditation body assess laboratories seeking LAAF-accreditation and oversee LAAF-accredited laboratories?§ 16.5 Inapplicability and limited applicability.§ 50.51 Clinical investigations not involving greater than minimal risk.§ 74.1303 FD&C Red No. 3.§ 1.1121 When must a recognized accreditation body require corrective action, suspend a LAAF-accredited laboratory, or reduce the scope of or withdraw the LAAF-accreditation of a laboratory?§ 16.22 Initiation of regulatory hearing.§ 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.§ 74.1304 FD&C Red No. 4.§ 1.1122 What procedures must a recognized accreditation body provide for appeals of decisions to suspend, reduce the scope of, withdraw, or deny LAAF-accreditation?§ 16.24 Regulatory hearing required by the act or a regulation.§ 50.53 Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.§ 74.1306 D&C Red No. 6.§ 1.1123 What reports, notifications, and documentation must a recognized accreditation body submit to FDA?§ 16.26 Denial of hearing and summary decision.§ 50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.§ 74.1307 D&C Red No. 7.§ 1.1124 What are the records requirements for a recognized accreditation body?§ 16.40 Commissioner.§ 50.55 Requirements for permission by parents or guardians and for assent by children.§ 74.1317 D&C Red No. 17.§ 1.1125 What are the internal audit requirements for a recognized accreditation body?§ 16.42 Presiding officer.§ 50.56 Wards.§ 74.1321 D&C Red No. 21.§ 1.1130 How will FDA oversee recognized accreditation bodies?§ 16.44 Communication to presiding officer and Commissioner.§ 54.1 Purpose.§ 74.1322 D&C Red No. 22.§ 1.1131 When will FDA require corrective action, put a recognized accreditation body on probation, or revoke the recognition of an accreditation body?§ 16.60 Hearing procedure.§ 54.2 Definitions.§ 74.1327 D&C Red No. 27.§ 1.1138 What are the eligibility requirements for a LAAF-accredited laboratory?§ 16.62 Right to counsel.§ 54.3 Scope.§ 74.1328 D&C Red No. 28.§ 1.1139 How does a laboratory apply for LAAF-accreditation or extend its scope of LAAF-accreditation?§ 16.80 Administrative record of a regulatory hearing.§ 54.4 Certification and disclosure requirements.§ 74.1330 D&C Red No. 30.§ 1.1140 What must a LAAF-accredited laboratory do to voluntarily relinquish its LAAF-accreditation?§ 16.85 Examination of administrative record.§ 54.5 Agency evaluation of financial interests.§ 74.1331 D&C Red No. 31.§ 1.1141 What is the effect on a LAAF-accredited laboratory if its recognized accreditation body is no longer recognized by FDA?§ 16.95 Administrative decision and record for decision.§ 54.6 Recordkeeping and record retention.§ 74.1333 D&C Red No. 33.§ 1.1142 How does a laboratory request reinstatement of LAAF-accreditation?§ 16.119 Reconsideration and stay of action.§ 56.101 Scope.§ 74.1334 D&C Red No. 34.§ 1.1147 What are the impartiality and conflict of interest requirements for a LAAF-accredited laboratory?§ 16.120 Judicial review.§ 56.102 Definitions.§ 74.1336 D&C Red No. 36.§ 1.1149 What oversight standards apply to sampling?§ 17.1 Scope.§ 56.103 Circumstances in which IRB review is required.§ 74.1339 D&C Red No. 39.§ 1.1150 What are the requirements for analysis of samples by a LAAF-accredited laboratory?§ 17.2 Maximum penalty amounts.§ 56.104 Exemptions from IRB requirement.§ 74.1340 FD&C Red No. 40.§ 1.1151 What requirements apply to the methods of analysis a LAAF-accredited laboratory uses to conduct food testing under this subpart?§ 17.3 Definitions.§ 56.105 Waiver of IRB requirement.§ 74.1602 D&C Violet No. 2.§ 1.1152 What notifications, results, reports, and studies must a LAAF-accredited laboratory submit to FDA?§ 17.5 Complaint.§ 56.106 Registration.§ 74.1705 FD&C Yellow No. 5.§ 1.1153 What are the requirements for submitting abridged analytical reports?§ 17.7 Service of complaint.§ 56.107 IRB membership.§ 74.1706 FD&C Yellow No. 6.§ 1.1154 What other records requirements must a LAAF-accredited laboratory meet?§ 17.9 Answer.§ 56.108 IRB functions and operations.§ 74.1707 D&C Yellow No. 7.§ 1.1159 How will FDA oversee LAAF-accredited laboratories?§ 17.11 Default upon failure to file an answer.§ 56.109 IRB review of research.§ 74.1707a Ext. D&C Yellow No. 7.§ 1.1160 How will FDA review test results and analytical reports?§ 17.13 Notice of hearing.§ 56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.§ 74.1708 D&C Yellow No. 8.§ 1.1161 When will FDA require corrective action, put a LAAF-accredited laboratory on probation, or disqualify a LAAF-accredited laboratory from submitting analytical reports?§ 17.15 Parties to the hearing.§ 56.111 Criteria for IRB approval of research.§ 74.1710 D&C Yellow No. 10.§ 1.1162 What are the consequences if FDA puts a LAAF-accredited laboratory on probation or disqualifies a LAAF-accredited laboratory?§ 17.17 Summary decisions.§ 56.112 Review by institution.§ 74.1711 D&C Yellow No. 11.§ 1.1171 How does an accreditation body request reconsideration by FDA of a decision to deny its application for recognition, renewal, or reinstatement?§ 17.18 Interlocutory appeal from ruling of presiding officer.§ 56.113 Suspension or termination of IRB approval of research.§ 74.2052 D&C Black No. 2.§ 1.1173 How does an accreditation body or laboratory request a regulatory hearing on FDA's decision to revoke the accreditation body's recognition or disqualify a LAAF-accredited laboratory?§ 17.19 Authority of the presiding officer.§ 56.114 Cooperative research.§ 74.2053 D&C Black No. 3.§ 1.1174 How does an owner or consignee request a regulatory hearing on a directed food laboratory order?§ 17.20 Ex parte contacts.§ 56.115 IRB records.§ 74.2101 FD&C Blue No. 1.§ 1.1199 Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?§ 17.21 Prehearing conferences.§ 56.120 Lesser administrative actions.§ 74.2104 D&C Blue No. 4.§ 1.1200 Are the records obtained by FDA under this subpart subject to public disclosure?§ 17.23 Discovery.§ 56.121 Disqualification of an IRB or an institution.§ 74.2151 D&C Brown No. 1.§ 1.1300 Who is subject to this subpart?§ 17.25 Exchange of witness lists, witness statements, and exhibits.§ 56.122 Public disclosure of information regarding revocation.§ 74.2203 FD&C Green No. 3.§ 1.1305 What foods and persons are exempt from this subpart?§ 17.27 Hearing subpoenas.§ 56.123 Reinstatement of an IRB or an institution.§ 74.2205 D&C Green No. 5.§ 1.1310 What definitions apply to this subpart?§ 17.28 Protective order.§ 56.124 Actions alternative or additional to disqualification.§ 74.2206 D&C Green No. 6.§ 1.1315 What traceability plan must I have for foods on the Food Traceability List that I manufacture, process, pack, or hold?§ 17.29 Fees.§ 58.1 Scope.§ 74.2208 D&C Green No. 8.§ 1.1320 When must I assign traceability lot codes to foods on the Food Traceability List?§ 17.30 Computation of time.§ 58.3 Definitions.§ 74.2254 D&C Orange No. 4.§ 1.1325 What records must I keep and provide when I harvest or cool a raw agricultural commodity on the Food Traceability List?§ 17.31 Form, filing, and service of papers.§ 58.10 Applicability to studies performed under grants and contracts.§ 74.2255 D&C Orange No. 5.§ 1.1330 What records must I keep when I am performing the initial packing of a raw agricultural commodity (other than a food obtained from a fishing vessel) on the Food Traceability List?§ 17.32 Motions.§ 58.15 Inspection of a testing facility.§ 74.2260 D&C Orange No. 10.§ 1.1335 What records must I keep when I am the first land-based receiver of a food on the Food Traceability List that was obtained from a fishing vessel?§ 17.33 The hearing and burden of proof.§ 58.29 Personnel.§ 74.2261 D&C Orange No. 11.§ 1.1340 What records must I keep and provide when I ship a food on the Food Traceability List?§ 17.34 Determining the amount of penalties and assessments.§ 58.31 Testing facility management.§ 74.2304 FD&C Red No. 4.§ 1.1345 What records must I keep when I receive a food on the Food Traceability List?§ 17.35 Sanctions.§ 58.33 Study director.§ 74.2306 D&C Red No. 6.§ 1.1350 What records must I keep when I transform a food on the Food Traceability List?§ 17.37 Witnesses.§ 58.35 Quality assurance unit.§ 74.2307 D&C Red No. 7