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Delegations of Authority, Volume II (1400)

1401.1Policy and Procedures Governing Regulatory and Administrative Delegations of Authority (DOAs)
1405.5Authority To Establish and Maintain Equal Employment Opportunity (EEO) Programs
1410.10Delegations of Authority to the Commissioner of Food and Drugs
1410.20General Redelegations of Authority
1410.21General Redelegations of Authority from the Commissioner to Other Officers of the Food and Drug Administration
1410.22Emergency Functions and Delegations for Incident Management Teams
1410.23Certification of True Copies and Use of Department Seal
1410.24Disclosure of Official Records and Authorization of Testimony
1410.25Authority Relating to Technology Transfer
1410.26Research, Investigation, and Testing Programs and Health Promotion Programs
1410.27Service Fellowships (Contact the OHR Policy Office for more information at OO-OHR-PPDT@fda.hhs.gov)
1410.28Patent Term Extensions for Human Drug Products, Medical Devices, and Food and Color Additives; and Authority To Perform Due Diligence Determinations and Informal Hearings
1410.30Petitions under Title 21, Code of Federal Regulations (21 CFR), Part 10
1410.31Authority To Select Temporary Voting Members for Advisory Committees and Authority To Sign Conflict of Interest Waivers
1410.32Enforcement Activities
1410.33Certification Following Inspections
1410.34Issuance of Reports of Minor Violations
1410.35Issuance of Notices Relating to Proposals and Orders for Debarment and Denial of an Application To Terminate Debarment
1410.36Officials Authorized To Make Certification under 5 U.S.C. 605(b) for Any Proposed and Final Rules
1410.37Issuance of Orders of Decisions Relating to Matters under 21 CFR 10.75 in the Office of the Commissioner
1410.63Ensurance of Compliance of FDA Laboratory Science and Safety and Environmental Health and Safety Programs
1410.64Government Deliberative Process Privilege
1410.100Human Drugs
1410.101Issuance of Notice Implementing the Provisions of the Drug Amendments of 1962
1410.102Termination of Exemptions for New Drugs for Investigational Use In Human Beings
1410.103Authority To Approve and To Withdraw Approval of a Charge for Investigational New Drugs
1410.104Approval of New Drug Applications and Their Supplements
1410.105Responses to Drug Enforcement Administration Temporary Scheduling Notices
1410.106Issuance of Notices Relating to Proposals To Refuse Approval or To Withdraw Approval of New Drug Applications and Their Supplements
1410.107Submission of and Effective Approval Dates for Abbreviated New Drug Applications and Certain New Drug Applications
1410.108Extensions or Stays of Effective Dates for Compliance with Certain Labeling Requirements for Human Prescriptions Drugs
1410.109Prescription Drug User Fees, Generic Drug User Fees, Biosimilar Biological Product User Fees, and Fees Related to the Drug Quality and Security Act
1410.110Issuance of Written Notices Concerning Patent Information, Current Good Manufacturing Practices and False or Misleading Labeling of New Drugs
1410.111Permit or Deny Use of an Investigational Drug for Treatment Use
1410.112Requests for Records or Other Information from Establishments Engaged in Manufacturing, Preparing, Propagating, Compounding, or Processing of Drugs
1410.113Drug and Biological Product Shortages
1410.114Grant 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
1410.115Terminations of Illegitimate and High Risk of Illegitimacy Product Notifications Pertaining to the Drug Supply Chain Security Act
1410.116Waivers, Exceptions, and Exemptions Pertaining to the Drug Supply Chain Security Act
1410.201Functions Pertaining to Safer Vaccines
1410.202Redelegation of the Center for Biologics Evaluation and Research Director's Program Authorities
1410.203Issuance 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
1410.204Issuance and Revocation of Licenses for the Propagation or Manufacture and Preparation of Biological Products
1410.205Notification of Release for Distribution of Biological Products
1410.206Delegations of Authority for Various Issuances Related to Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/Ps)
1410.300Food and Cosmetics
1410.301Food Standards, Food Additives, Generally Recognized As Safe (GRAS) Substances, Color Additives, Nutrient Content Claims, and Health Claims
1410.302Notices of Confirmation of Effective Date of Final Regulations on Food for Human and Animal Consumption
1410.303Detention of Meat, Poultry, Eggs, and Related Products
1410.304Establishing Standards and Approving Accrediting Bodies under the National Laboratory Accreditation Program
1410.305Approval of Schools Providing Food-Processing Instruction
1410.306Determinations Related to Records Access for Human and Animal Foods under Section 414 of the Federal Food, Drug, and Cosmetic Act
1410.307Determinations Related to Processes or Treatments Not Meeting the Requirements of the Federal Food, Drug, and Cosmetic Act
1410.308Emergency Permit Control Provisions
1410.400Medical Devices and Radiological Health
1410.401Issuance of Federal Register Documents To Recognize or To Withdraw Recognition of a Standard To Meet Premarket Submission Requirements
1410.402Issuance of Federal Register Documents Pertaining to Premarket Submission Requirements and Exemption from Premarket Notification
1410.403Detention of Adulterated or Misbranded Medical Devices
1410.404Authorization To Use Alternative Evidence for Determination of the Effectiveness of Medical Devices
1410.405Notification to Petitioners of Determinations Made on Petitions for Reclassification of Medical Devices
1410.406Determination of Classification of Devices
1410.407Notification to Sponsors of Deficiencies In Petitions for Reclassification of Medical Devices
1410.408Approval, Disapproval, or Withdrawal of Approval of Product Development Protocols and Applications for Premarket Approval, and Humanitarian Exemptions for Medical Devices
1410.409Determinations Concerning the Type of Valid Scientific Evidence Submitted In a Premarket Approval Application
1410.410Determinations That Medical Devices Present Unreasonable Risk of Substantial Harm
1410.411Orders To Repair, Replace, or Make Refunds for Medical Devices
1410.412Medical Device Recall Authority
1410.413Temporary Suspension of a Medical Device Application
1410.414Approval, Disapproval, or Withdrawal of Approval of Applications and Entering Into Agreements for Investigational Device Exemptions
1410.415Medical Devices Postmarket Surveillance
1410.416Medical Device Reporting Procedures
1410.417Medical Device Tracking
1410.418Accreditation Functions for Medical Devices
1410.419Medical Device User Fee Authorities
1410.420Requests for Information Concerning Device Classification (If Any) and Requirements
1410.500Animal Drugs
1410.501Issuance 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
1410.502Approval of New Animal Drug Applications, Medicated Feed Mill License Applications, and Their Supplements
1410.503Issuance of Notices, Proposals, and Orders Relating to New Animal Drugs and Medicated Feed Mill License Applications
1410.504Submission of and Effective Approval Dates for Abbreviated New Animal Drug Applications and Certain New Animal Drug Applications
1410.505Issuance 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
1410.506Termination of Exemptions for New Drugs for Investigational Use In Animals
1410.507Authority under the Animal Drug User Fee Act (ADUFA)
1410.508Authority under the Minor Use and Minor Species (MUMS) Health Act of 2004
1410.509Import Tolerances under Section 512(a) of the Federal Food, Drug and Cosmetic Act
1410.600Radiation Control
1410.601Variances from Performance Standards for Electronic Products
1410.602Exemptions of Electronic Products from Performance Standards and Prohibited Acts
1410.603Testing Programs and Methods of Certification and Identification for Electronic Products
1410.604Notification of Defects In, and Repair or Replacement of, Electronic Products
1410.605Manufacturers Requirement To Provide Data to Ultimate Purchasers of Electronic Products
1410.606Dealer and Distributor Direction To Provide Data to Manufacturers of Electronic Products
1410.607Acceptance of Assistance from State and Local Authorities for Enforcement of Radiation Control Legislation and Regulations
1410.700Product Designation
1410.701Authority Relating To Determination of Product Primary Jurisdiction
1410.702Premarket Approval of a Product That Is or Contains a Biologic, a Device, or a Drug
1410.800Imports and Exports
1410.801Imports and Exports
1410.802Export of Unapproved Drugs
1410.803Manufacturer's Resident Import Agents
1410.900Orphan Products
1410.901Orphan Products
1410.1000Mammography Facilities
1410.1001Authority To Ensure That Mammography Facilities Meet Quality Standards
1410.1101Requests for Tobacco Documents
1410.1102Warning Plans for Cigars, Cigarettes, and Smokeless Tobacco Products
1410.1103Substantial Equivalence and Premarket Review of Tobacco Products
1410.1104Modified Risk Tobacco Products
1410.1105Registration Information
1410.1106Tobacco Product Constituents and Compliance Dates for Small Tobacco Product Manufacturers
1410.1107Tobacco Product Recall Authority
1415.5Authority To Approve Organization Structure and Functional Statements
1415.6Authority To Approve Designation of Notaries Public
1425.1Authority To Transfer Title to Government-Owned Vehicles
1425.5Authority To Dispose of Government-Owned Unrequired or Excess Personal Property
1425.6Authority To Loan Government-Owned Personal Property
1430.2Authority To Approve Outside Activities
1430.4Authority To Establish Workweeks and Work Schedules
1430.5Authority To Approve Overtime
1430.6Authority for Flexible Workplace Arrangements Program
1430.7Authority To Review and/or Consider Public and Confidential Financial Disclosure Reports
1430.8Authority To Prescribe and Furnish Uniforms and Other Special Wearing Apparel
1430.9Authority for Flexitime and Alternative Work Schedules
1430.10Authority To Establish Official Relationships with Associations of Supervisors and Management Employees
1430.13Authority To Approve Recruitment, Retention, and Relocation Incentives (3Rs)
1430.14Authority To Approve Payment of Supervisory Differentials
1430.15Authority 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
1430.16Authority To Approve A Student Loan Repayment
1430.17Authority To Approve Title 38 Physician and Dentist Pay
1431.1Authority To Set Rates of Pay for Positions Not Covered by the General Schedule
1431.2aSelecting Authority
1431.3Authority To Determine Acceptable Level of Competence for Within-Grade Increases
1431.4Authority To Grant and Restore Leave and Excuse Absences
1431.6Authority To Effect Trial Retirements and Reemployment of Retirees
1431.8Appointing Authority
1431.9Authority To Approve Details of Personnel
1431.11Authority To Approve Awards
1431.12Authority To Take Adverse Actions for Misconduct and Other Reasons
1431.13Authority To Issue Official Reprimands
1431.14Authority To Issue Grievance Decisions under HHS Personnel Instruction 771-3
1431.15Authority To Restore Annual Leave
1431.17Authority To Propose, Decide, and Concur on Reduction In Grade and Removal Action Based on Unacceptable Performance
1431.18Authority for Physicians' Comparability Allowance (PCA)
1431.19Authority To Determine When Term Appointments Are Appropriate
1431.22Authority To Approve Details of Civil Service Personnel under the Public Health Service Act
1431.23Authority for Executive Resources Management
1431.24Authority To Approve/Disapprove Inter-Governmental Personnel Act (IPA) Assignments
1431.26Authority for Performance Appraisal Provisions under the Performance Management Appraisal Program (PMAP)
1431.27Authority for Labor Relations Matters
1431.29Authority Regarding Part-Time Employment
1431.30Authority To Administer Availability Pay
1431.31Authority To Waive the Maximum Entry Age for Law Enforcement Officers
1431.32Authority To Determine When Use of Commercial Recruiting Firms Is Appropriate under 5 CFR Part 300 and Applicable FDA Guidance
1432.1Approval and Acquisition of Training
1433.1Authority To Approve Details of Commissioned Officers
1433.2Authority To Approve Outside-the-Service Short-Term Training for Commissioned Officers
1433.3Authority To Grant Leave to Commissioned Officers
1433.7Authority To Take Disciplinary Action Against Commissioned Corps Officers
1433.11Authority Regarding the PHS Commissioned Officer Recognition Program
1433.12Authority for Collection of Commissioned Officers Indebtedness
1440.1Procurement Authority (Agency-Wide)
1445.1Authority Concerning Easements, Revocable Licenses, Rights of Entry, and Use Permits
1445.2Authority under the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970
1445.3Authority To Perform Real Property Management
1445.4Authority To Approve Work Requests for Repair, Maintenance, and Operation Projects
1445.5Authority To Approve the Use of FDA Facilities for Meetings for Non-Official Purposes
1445.6Authority To Authorize Use of FDA Scientific Research and Study Facilities
1445.8Authority for Field Engineering and Facility Management Services
1445.9Authority To Execute Space Requests with the General Services Administration
1445.15Authority To Operate MOD II, Laurel, MD
1455.1Authority To Authorize and Approve Local and Domestic Travel, Cash or In Kind Travel, Transportation, and Related Allowances--Civil Service Personnel
1455.4PHS Commissioned Officer Travel Authority
1455.5Authority To Approve Attendance at International Meetings
1460.2Advisory Committee Authorities Regarding Reports, Records and Other Papers under the Federal Advisory Committee Act
1460.3Advisory Committee Authorities Regarding the Assembly and Maintenance of Reports, Records and Other Papers under the Federal Advisory Committee Act
1465.1Authority for Designation of Imprest Fund Cashiers
1465.2Authority To Approve Non Expenditure Transfer Authorizations
1465.3Authority To Allocate Funds
1465.4Authority To Issue Allotments, Allowances and Suballowances and Authorize the Establishment of Suballowances
1465.6Authority for Administrative Resolution of Cash or Fund Irregularities
1465.7Authority To Compromise, Terminate, or Suspend Collection of Claims under the Federal Claims Collections Act
1465.8Authority To Approve Resolution of Audit Reports
1465.9Authority To Accept Gifts under Title XXI of the PHS Act
1465.10Authority To Designate Certifying Officers and Travel Advance/Emergency Salary Advance Disbursement Officials
1465.11Authority To Approve Journal Vouchers Not Pre-Authorized
1470.1Authority for Performance of Commercial Activities


Page Last Updated: 11/19/2018
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