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  5. Delegations of Authority, Volume II (1400)
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Delegations of Authority, Volume II (1400)

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
1410.10 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 Authorization To Use 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 (If Any) 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 Manufacturer's Resident 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
1415.5 Authority To Approve Organization Structure and Functional Statements
1415.6 Authority To Approve Designation of Notaries Public
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
1430.2 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
1440.1 Procurement Authority (Agency-Wide)
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
1455.1 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
1460.2 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
1465.1 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
1470.1 Authority for Performance of Commercial Activities


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