| 1400 |
GENERAL AGENCY |
| 1401.1 |
Policy and Procedures Governing Regulatory and Administrative Delegations of Authority (DOAs) |
| 1405.5 |
Authority To Establish and Maintain Equal Employment Opportunity (EEO) Programs |
| 1410 |
REGULATORY DELEGATIONS OF AUTHORITY |
| 1410.10 |
Delegations of Authority to the Commissioner of Food and Drugs |
| 1410.20 |
General Redelegations of Authority |
| 1410.21 |
General Redelegations of Authority from the Commissioner to Other Officers of the Food and Drug Administration |
| 1410.22 |
Emergency Functions and Delegations for Incident Management Teams |
| 1410.23 |
Certification of True Copies and Use of Department Seal |
| 1410.24 |
Disclosure of Official Records and Authorization of Testimony |
| 1410.25 |
Authority Relating to Technology Transfer |
| 1410.26 |
Research, Investigation, and Testing Programs and Health Promotion Programs |
| 1410.27 |
Service Fellowships (Contact the OHR Policy Office for more information at OO-OHR-PPDT@fda.hhs.gov) |
| 1410.28 |
Patent Term Extensions for Human Drug Products, Medical Devices, and Food and Color Additives; and Authority To Perform Due Diligence Determinations and Informal Hearings |
| 1410.29 |
Hearings |
| 1410.30 |
Petitions under Title 21 Code of Federal Regulations (21 CFR) Part 10 |
| 1410.31 |
Authority To Select Temporary Voting Members for Advisory Committees and Authority To Sign Conflict of Interest Waivers |
| 1410.32 |
Enforcement Activities |
| 1410.33 |
Certification Following Inspections |
| 1410.34 |
Issuance of Reports of Minor Violations |
| 1410.35 |
Issuance of Notices Relating to Proposals and Orders for Debarment and Denial of an Application To Terminate Debarment |
| 1410.36 |
Officials Authorized To Make Certification under 5 U.S.C. 605(b) for Any Proposed and Final Rules |
| 1410.37 |
Issuance of Orders of Decisions Relating to Matters under 21 CFR 10.75 in the Office of the Commissioner |
| 1410.63 |
Ensurance of Compliance of FDA Laboratory Science and Safety and Environmental Health and Safety Programs |
| 1410.64 |
Government Deliberative Process Privilege |
| 1410.65 |
Disclosure of Trade Secret Information to Foreign Governments |
| 1410.66 |
Disclosure of Non-Public Information to Foreign Government Officials or Receipt of Non-Public Information from Foreign Government Officials |
| 1410.100 |
Human Drugs |
| 1410.101 |
Issuance of Notice Implementing the Provisions of the Drug Amendments of 1962 |
| 1410.102 |
Termination of Exemptions for New Drugs for Investigational Use In Human Beings |
| 1410.103 |
Authority To Approve and To Withdraw Approval of a Charge for Investigational New Drugs |
| 1410.104 |
Approval of New Drug Applications and Their Supplements |
| 1410.105 |
Responses to Drug Enforcement Administration Temporary Scheduling Notices |
| 1410.106 |
Issuance of Notices Relating to Proposals To Refuse Approval or To Withdraw Approval of New Drug Applications and Their Supplements |
| 1410.107 |
Submission of and Effective Approval Dates for Abbreviated New Drug Applications and Certain New Drug Applications |
| 1410.108 |
Extensions or Stays of Effective Dates for Compliance with Certain Labeling Requirements for Human Prescriptions Drugs |
| 1410.109 |
Human Drug User Fees |
| 1410.110 |
Issuance of Written Notices Concerning Patent Information, Current Good Manufacturing Practices and False or Misleading Labeling of New Drugs |
| 1410.111 |
Permit or Deny Use of an Investigational Drug for Treatment Use |
| 1410.112 |
Requests for Records or Other Information from Establishments Engaged in Manufacturing, Preparing, Propagating, Compounding, or Processing of Drugs |
| 1410.113 |
Drug and Biological Product Shortages |
| 1410.114 |
Grant or Denial of Requests for Certification of Designated Medical Gases and Amendments to Such Requests; Approval of Supplements; Approval of Supplements; and Other Regulatory Actions |
| 1410.115 |
Terminations of Illegitimate and High Risk of Illegitimacy Product Notifications Pertaining to the Drug Supply Chain Security Act |
| 1410.116 |
Waivers, Exceptions, and Exemptions Pertaining to the Drug Supply Chain Security Act |
| 1410.117 |
Notification, Nondistribution, and Recall of Controlled Substances |
| 1410.118 |
Regulation of Certain Nonprescription Drugs That Are Marketed Without an Approved Drug Application |
| 1410.200 |
Biologics |
| 1410.201 |
Functions Pertaining to Safer Vaccines |
| 1410.202 |
Redelegation of the Center for Biologics Evaluation and Research Director's Program Authorities |
| 1410.203 |
Issuance of Notices of Opportunity for a Hearing on Proposals for Denial of Approval of Applications for Licenses, Suspension of Licenses, or Revocation of Licenses and Certain Notices of Revocation of Licenses |
| 1410.204 |
Issuance and Revocation of Licenses for the Propagation or Manufacture and Preparation of Biological Products |
| 1410.205 |
Notification of Release for Distribution of Biological Products |
| 1410.206 |
Delegations of Authority for Various Issuances Related to Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/Ps) |
| 1410.300 |
Food and Cosmetics |
| 1410.301 |
Food Standards, Food Additives, Generally Recognized As Safe (GRAS) Substances, Color Additives, Nutrient Content Claims, and Health Claims |
| 1410.302 |
Notices of Confirmation of Effective Date of Final Regulations on Food for Human and Animal Consumption |
| 1410.303 |
Detention of Meat, Poultry, Eggs, and Related Products |
| 1410.304 |
Establishing Standards and Approving Accrediting Bodies under the National Laboratory Accreditation Program |
| 1410.305 |
Approval of Schools Providing Food-Processing Instruction |
| 1410.306 |
Determinations Related to Records Access for Human and Animal Food |
| 1410.307 |
Determinations Related to Processes or Treatments Not Meeting the Requirements of the Federal Food, Drug, and Cosmetic Act |
| 1410.308 |
Emergency Permit Control Provisions |
| 1410.309 |
To Issue an Order Under Section 423(b) In The Context of a Mandatory Food Recall |
| 1410.310 |
Issue a Directed Food Laboratory Order |
| 1410.400 |
Medical Devices and Radiological Health |
| 1410.401 |
Issuance of Federal Register Documents To Recognize or To Withdraw Recognition of a Standard To Meet Premarket Submission Requirements |
| 1410.402 |
Issuance of Federal Register Documents Pertaining to Premarket Submission Requirements and Exemption from Premarket Notification |
| 1410.403 |
Detention of Adulterated or Misbranded Medical Devices |
| 1410.404 |
Use of Alternative Evidence for Determination of the Effectiveness of Medical Devices |
| 1410.405 |
Notification to Petitioners of Determinations Made on Petitions for Reclassification of Medical Devices |
| 1410.406 |
Determination of Classification of Medical Devices |
| 1410.407 |
Notification to Sponsors of Deficiencies In Petitions for Reclassification of Medical Devices |
| 1410.408 |
Approval, Disapproval, or Withdrawal of Approval of Product Development Protocols and Applications for Premarket Approval, and Humanitarian Exemptions, for Medical Devices |
| 1410.409 |
Determinations Concerning the Type of Valid Scientific Evidence Submitted in a Premarket Approval Application |
| 1410.410 |
Determinations That Medical Devices Present Unreasonable Risk of Substantial Harm |
| 1410.411 |
Certain Orders Issued Pursuant to Sections 518(b) and 518(c) of the Federal Food, Drug, and Cosmetic Act |
| 1410.412 |
Medical Device Recall Authority |
| 1410.413 |
Temporary Suspension of a Medical Device Application |
| 1410.414 |
Investigational Device Exemptions |
| 1410.415 |
Medical Devices Postmarket Surveillance |
| 1410.416 |
Medical Device Reporting Procedures |
| 1410.417 |
Medical Device Tracking |
| 1410.418 |
Accreditations for Medical Devices |
| 1410.419 |
Medical Device User Fee Authorities |
| 1410.420 |
Requests for Information Concerning Device Classification and Requirements |
| 1410.422 |
Device Shortages |
| 1410.423 |
Unique Device Identifier |
| 1410.500 |
Animal Drugs |
| 1410.501 |
Issuance of Federal Register Documents Pertaining to the Determination of Safe Levels, Notice of Need for Development of an Analytical Method, Notice of Availability of a Developed Analytical Method, and Prohibition of Certain Extralabel Drug Use |
| 1410.502 |
Approval of New Animal Drug Applications, Medicated Feed Mill License Applications, and Their Supplements |
| 1410.503 |
Issuance of Notices, Proposals, and Orders Relating to New Animal Drugs and Medicated Feed Mill License Applications |
| 1410.504 |
Submission of and Effective Approval Dates for Abbreviated New Animal Drug Applications and Certain New Animal Drug Applications |
| 1410.505 |
Issuance of Written Notices Concerning Patent Information, Current Good Manufacturing Practices and False or Misleading Labeling of New Animal Drugs and Feeds Bearing or Containing New Animal Drugs |
| 1410.506 |
Termination of Exemptions for New Drugs for Investigational Use In Animals |
| 1410.507 |
Authority under the Animal Drug User Fee Act (ADUFA) |
| 1410.508 |
Authority under the Minor Use and Minor Species (MUMS) Health Act of 2004 |
| 1410.509 |
Import Tolerances under Section 512(a) of the Federal Food, Drug and Cosmetic Act |
| 1410.600 |
Radiation Control |
| 1410.601 |
Variances from Performance Standards for Electronic Products |
| 1410.602 |
Exemptions of Electronic Products from Performance Standards and Prohibited Acts |
| 1410.603 |
Testing Programs and Methods of Certification and Identification for Electronic Products |
| 1410.604 |
Notification of Defects In, and Repair or Replacement of, Electronic Products |
| 1410.605 |
Manufacturers Requirement To Provide Data to Ultimate Purchasers of Electronic Products |
| 1410.606 |
Dealer and Distributor Direction To Provide Data to Manufacturers of Electronic Products |
| 1410.607 |
Acceptance of Assistance from State and Local Authorities for Enforcement of Radiation Control Legislation and Regulations |
| 1410.700 |
Product Designation |
| 1410.701 |
Authority Relating To Determination of Product Primary Jurisdiction |
| 1410.702 |
Premarket Approval of a Product That Is or Contains a Biologic, a Device, or a Drug |
| 1410.800 |
Imports and Exports |
| 1410.801 |
Imports and Exports |
| 1410.802 |
Export of Unapproved Drugs |
| 1410.803 |
Reject Manufacturer’s Designation of Import Agents |
| 1410.900 |
Orphan Products |
| 1410.901 |
Orphan Products |
| 1410.1000 |
Mammography Facilities |
| 1410.1001 |
Authority To Ensure That Mammography Facilities Meet Quality Standards |
| 1410.1100 |
Tobacco |
| 1410.1101 |
Requests for Tobacco Documents |
| 1410.1102 |
Warning Plans for Cigars, Cigarettes, and Smokeless Tobacco Products |
| 1410.1103 |
Substantial Equivalence and Premarket Review of Tobacco Products |
| 1410.1104 |
Modified Risk Tobacco Products |
| 1410.1105 |
Registration Information |
| 1410.1106 |
Tobacco Product Constituents and Compliance Dates for Small Tobacco Product Manufacturers |
| 1410.1107 |
Tobacco Product Recall Authority |
| 1415 |
GENERAL ADMINISTRATION |
| 1415.5 |
Authority To Approve Organization Structure and Functional Statements |
| 1415.6 |
Authority To Approve Designation of Notaries Public |
| 1425 |
MATERIAL MANAGEMENT |
| 1425.1 |
Authority To Transfer Title to Government-Owned Vehicles |
| 1425.5 |
Authority To Dispose of Government-Owned Unrequired or Excess Personal Property |
| 1425.6 |
Authority To Loan Government-Owned Personal Property |
| 1430 |
PERSONNEL |
| 1430.2 |
Outside Activities |
| 1430.4 |
Authority To Establish Workweeks and Work Schedules |
| 1430.5 |
Authority To Approve Overtime |
| 1430.6 |
Authority for Flexible Workplace Arrangements Program |
| 1430.7 |
Authority To Review and/or Consider Public and Confidential Financial Disclosure Reports |
| 1430.8 |
Authority To Prescribe and Furnish Uniforms and Other Special Wearing Apparel |
| 1430.9 |
Authority for Flexitime and Alternative Work Schedules |
| 1430.10 |
Authority To Establish Official Relationships with Associations of Supervisors and Management Employees |
| 1430.13 |
Authority To Approve Recruitment, Retention, and Relocation Incentives (3Rs) |
| 1430.14 |
Authority To Approve Payment of Supervisory Differentials |
| 1430.15 |
Authority To Make Initial Decisions to Grant or Deny Requests for Waivers of Claims for Erroneous Overpayments of Pay, Allowances, and of Travel, Transportation, and Relocation Expenses |
| 1430.16 |
Authority To Approve A Student Loan Repayment |
| 1430.17 |
Authority To Approve Title 38 Physician and Dentist Pay |
| 1430.18 |
Setting Pay Based on Superior Qualifications and Special Needs |
| 1431.1 |
Authority To Set Rates of Pay for Positions Not Covered by the General Schedule |
| 1431.2a |
Selecting Authority |
| 1431.3 |
Authority To Determine Acceptable Level of Competence for Within-Grade Increases |
| 1431.4 |
Grant and Restore Leave and Excused Absences |
| 1431.6 |
Authority To Effect Trial Retirements and Reemployment of Retirees |
| 1431.8 |
Appointing Authority |
| 1431.9 |
Authority To Approve Details of Personnel |
| 1431.11 |
Authority To Approve Awards |
| 1431.12 |
Authority To Take Adverse Actions for Misconduct and Other Reasons |
| 1431.13 |
Authority To Issue Official Reprimands |
| 1431.14 |
Authority To Issue Grievance Decisions under HHS Personnel Instruction 771-3 |
| 1431.15 |
Authority To Restore Annual Leave |
| 1431.17 |
Authority To Propose, Decide, and Concur on Reduction In Grade and Removal Action Based on Unacceptable Performance |
| 1431.18 |
Authority for Physicians' Comparability Allowance (PCA) |
| 1431.19 |
Authority To Determine When Term Appointments Are Appropriate |
| 1431.22 |
Authority To Approve Details of Civil Service Personnel under the Public Health Service Act |
| 1431.23 |
Authority for Executive Resources Management |
| 1431.24 |
Authority To Approve/Disapprove Inter-Governmental Personnel Act (IPA) Assignments |
| 1431.26 |
Authority for Performance Appraisal Provisions under the Performance Management Appraisal Program (PMAP) |
| 1431.27 |
Authority for Labor Relations Matters |
| 1431.29 |
Authority Regarding Part-Time Employment |
| 1431.30 |
Authority To Administer Availability Pay |
| 1431.31 |
Authority To Waive the Maximum Entry Age for Law Enforcement Officers |
| 1431.32 |
Authority To Determine When Use of Commercial Recruiting Firms Is Appropriate under 5 CFR Part 300 and Applicable FDA Guidance |
| 1431.33 |
Senior Biomedical Research and Biomedical Product Assessment Service |
| 1432.1 |
Approval and Acquisition of Training |
| 1433.1 |
Authority To Approve Details of Commissioned Officers |
| 1433.2 |
Authority To Approve Outside-the-Service Short-Term Training for Commissioned Officers |
| 1433.3 |
Authority To Grant Leave to Commissioned Officers |
| 1433.7 |
Authority To Take Disciplinary Action Against Commissioned Corps Officers |
| 1433.11 |
Authority Regarding the PHS Commissioned Officer Recognition Program |
| 1433.12 |
Authority for Collection of Commissioned Officers Indebtedness |
| 1440 |
PROCUREMENT |
| 1440.1 |
Procurement Authority (Agency-Wide) |
| 1445 |
FACILITIES MANAGEMENT |
| 1445.1 |
Authority Concerning Easements, Revocable Licenses, Rights of Entry, and Use Permits |
| 1445.2 |
Authority under the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970 |
| 1445.3 |
Authority To Perform Real Property Management |
| 1445.4 |
Authority To Approve Work Requests for Repair, Maintenance, and Operation Projects |
| 1445.5 |
Authority To Approve the Use of FDA Facilities for Meetings for Non-Official Purposes |
| 1445.6 |
Authority To Authorize Use of FDA Scientific Research and Study Facilities |
| 1445.8 |
Authority for Field Engineering and Facility Management Services |
| 1445.9 |
Authority To Execute Space Requests with the General Services Administration |
| 1445.15 |
Authority To Operate MOD II, Laurel, MD |
| 1455 |
TRAVEL |
| 1455.1 |
Authority To Authorize and Approve Local and Domestic Travel, Cash or In Kind Travel, Transportation, and Related Allowances--Civil Service Personnel |
| 1455.4 |
PHS Commissioned Officer Travel Authority |
| 1455.5 |
Authority To Approve Attendance at International Meetings |
| 1460 |
COMMITTEE MANAGEMENT |
| 1460.2 |
Advisory Committee Authorities Regarding Reports, Records and Other Papers under the Federal Advisory Committee Act |
| 1460.3 |
Advisory Committee Authorities Regarding the Assembly and Maintenance of Reports, Records and Other Papers under the Federal Advisory Committee Act |
| 1465 |
FINANCIAL MANAGEMENT |
| 1465.1 |
Authority for Designation of Imprest Fund Cashiers |
| 1465.2 |
Authority To Approve Non Expenditure Transfer Authorizations |
| 1465.3 |
Authority To Allocate Funds |
| 1465.4 |
Authority To Issue Allotments, Allowances and Suballowances and Authorize the Establishment of Suballowances |
| 1465.6 |
Authority for Administrative Resolution of Cash or Fund Irregularities |
| 1465.7 |
Authority To Compromise, Terminate, or Suspend Collection of Claims under the Federal Claims Collections Act |
| 1465.8 |
Authority To Approve Resolution of Audit Reports |
| 1465.9 |
Authority To Accept Gifts under Title XXI of the PHS Act |
| 1465.10 |
Authority To Designate Certifying Officers and Travel Advance/Emergency Salary Advance Disbursement Officials |
| 1465.11 |
Authority To Approve Journal Vouchers Not Pre-Authorized |
| 1470 |
COMPETITIVE SOURCING |
| 1470.1 |
Authority for Performance of Commercial Activities |
