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

Delegations of Authority to the Commissioner of Food and Drugs

General Redelegations of Authority from the Commissioner to Other Officers of the Food and Drug Administration

Emergency Functions

Certification of True Copies & Use of the Department Seal

Disclosure of Official Records and Authorization of Testimony

Authority Relating to Technology Transfer

Research, Investigation, and Testing Programs and Health Promotion Programs

Service Fellowships

Patent Term Extensions for Human Drug Products, Medical Devices, and Food and Color Additives; and Authority to Perform Due Diligence Determinations and Informal Hearings

Hearings

Petitions Under Title 21, Code of Federal Regulations (21 CFR), Part 10

Authority to Select Temporary Voting Members for Advisory Committees and Authority to Sign Conflict Of Interest Waivers

Enforcement Activities

Certification Following Inspection

Issuance of Reports of Minor Violations

Issuance of Notices Relating to Proposals and Orders for Debarment and Denial of an Application to Terminate Debarment

Officials Authorized to Make Certifications Under 5 U.S.C. 605(b) For Any Proposed and Final Rules

Issuance of Notice Implementing the Provisions of the Drug Amendments of 1962

Termination of Exemptions for New Drugs for Investigational Use in Human Beings

Authority to Approve and to Withdraw Approval of a Charge for Investigational New Drugs

Approval of New Drug Applications and Their Supplements

Responses to Drug Enforcement Administration Temporary Scheduling Notices

Issuance of Notices Relating to Proposals to Refuse Approval or to Withdraw Approval of New Drug Applications and Their Supplements

Submission of and Effective Approval Dates for Abbreviated New Drug Applications and Certain New Drug Applications

Extensions or Stays of Effective Dates for Compliance With Certain Labeling Requirements for Human Prescriptions Drugs

Authority Relating to Waivers or Reductions of Prescription Drug User Fees

Issuance of Written Notices Concerning Patent Information, Current Good Manufacturing Practices and False or Misleading Labeling of New Drugs

Permit or Deny Use of an Investigational Drug for Treatment Use

Functions Pertaining to Safer Vaccines

Redelegation of the Center for Biologics Evaluation And Research Director's Program Authorities

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

Issuance and Revocation of Licenses for the Propagation Or Manufacture and Preparation of Biological Products

Notification of Release for Distribution of Biological Products

Delegations of Authority for Various Issuances Related to Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/Ps)

Food Standards, Food Additives, Generally Recognized As Safe (GRAS) Substances, Color Additives, Nutrient Content Claims, and Health Claims

Issuance of Initial Emergency Permit Orders and Notices of Confirmation of Effective Date of Final Regulations of Food for Human and Animal Consumption

Detention of Meat, Poultry, Eggs, and Related Products

Establishing Standards and Approving Accrediting Bodies Under the National Laboratory Accreditation Program

Approval of Schools Providing Food-Processing Instruction

Issuance of Federal Register Documents to Recognize or to Withdraw Recognition of a Standard to Meet Premarket Submission Requirements

Issuance of Federal Register Documents Pertaining to Premarket Submission Requirements and Exemption from Premarket Notification

Detention of Adulterated or Misbranded Medical Devices

Authorization to Use Alternative Evidence for Determination of the Effectiveness of Medical Devices

Notification to Petitioners of Determinations Made on Petitions for Reclassification of Medical Devices

Determination of Classification of Devices

Notification to Sponsors of Deficiencies in Petitions for Reclassification of Medical Devices

Approval, Disapproval, or Withdrawal of Approval of Product Development Protocols and Applications for Premarket Approval, and Humanitarian Device Exemptions for Medical Devices

Determinations Concerning the Type of Valid Scientific Evidence Submitted in a Premarket Approval Application

Determination that Medical Devices Present Unreasonable Risk of Substantial Harm

Orders to Repair or Replace, or Make Refunds for, Medical Devices

Medical Device Recall Authority

Temporary Suspension of a Medical Device Application

Approval, Disapproval, or Withdrawal of Approval of Applications and Entering Into Agreements for Investigational Device Exemptions

Postmarket Surveillance

Authority Relating to Medical Device Reporting Procedures

Medical Device Tracking

Authority Pertaining to Accreditation Functions for Medical Devices

Medical Device User Fee Authorities

Requests for Information Concerning Device Classification (if any) and Requirements

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

Approval of New Animal Drug Applications, Medicated Feed Mill License Applications, and Their Supplements

Issuance of Notices, Proposals, and Orders Relating to New Animal Drugs and Medicated Feed Mill License Applications

Submission of and Effective Approval Dates for Abbreviated New Animal Drug Applications and Certain New Animal Drug Applications

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

Termination of Exemptions for New Drugs for Investigational Use in Animals

Authority Under the Animal Drug User Fee Act (ADUFA)

Authority Under the Minor Use and Minor Species (MUMS) Health Act of 2004

Import Tolerances Under Section 512(a) of the Federal Food, Drug and Cosmetic Act

Variances From Performance Standards for Electronic Products

Exemptions of Electronic Products from Performance Standards and Prohibited Acts

Testing Programs and Methods of Certification and Identification for Electronic Products

Notification of Defects In, and Repair or Replacement of, Electronic Products

Manufacturers Requirement to Provide Data to Ultimate Purchasers of Electronic Products

Dealer and Distributor Direction to Provide Data to Manufacturers of Electronic Products

Acceptance of Assistance from State and Local Authorities for Enforcement of Radiation Control Legislation and Regulations

Authority Relating to Determination of Product Primary Jurisdiction

Premarket Approval of a Product That is or Contains A Biologic, a Device, or a Drug

Imports and Exports

Export of Unapproved Drugs

Manufacturer's Resident Import Agents

Orphan Products

Authority to Ensure that Mammography Facilities Meet Quality Standards

Authority To Approve Organization Structure And Functional Statements

1415.6

Authority To Authorize 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

Authority to Approve 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 and Relocation Bonuses and Retention Allowances (3Rs)

1430.14

Authority to Approve Payment of Supervisory Differentials

1430.15

Authority to Grant or Deny Requests for Waivers of Claims for Erroneous Overpayments of Pay, Allowances, and of Travel, Transportation, and Relocation Expenses Under 5 U.S.C. 5584

1430.16

Authority To Approve A Student Loan Repayment

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

Authority to Grant Leave and Excuse 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

1431.19

Authority to Determine When Term Appointments Are Appropriate

1431.20

Authority to Approve the Use of Physician Special Pay (PSP) Under 38 U.S.C. and USOPM Title 38 Delegation Agreement

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 Intergovernmental Personnel Act (IPA) Assignments

1431.26

Authority for Performance Appraisal Provisions Under the Performance Management System (PMS)

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

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

1433.4

Authority to Issue Identification Cards to Commissioned Officers, their Dependents, and Others

1433.6

Authority to Certify that Adequate Quarters are Not Available for Commissioned Officers

1433.7

Authority to Take Disciplinary Action Against Commissioned Corps Officers.

1433.11

Authority Regarding the PHS Commissioned Officer's Recognition Program

1433.12

Authority for Collection of Commissioned Officers Indebtedness

1440.1

Procurement Authority (Agencywide)

1440.2

Procurement Authority (Field)

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

1445.11

Authority To Operate The Crawford Building Annex And Annex II, Atlanta, Georgia

1445.14

Authority To Operate 12720 Twinpark Building, Rockville, MD

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

PHS Commissioned Officer Travel Authority

1455.5

Authority To Approve Attendance At International Meetings

1460.2

Authority Delegated to the Assistant Commissioner for Public Affairs Under the Federal Advisory Committee Act

1460.3

Authority Delegated To Executive Secretaries Of Advisory Committees 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