Regulatory Procedures Manual

Chapter 2 – FDA Authority

August 2018

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This chapter includes the following sections: 

Section Topic Page

The information in this Chapter is current as of June 1, 2018. For the most up-to-date version of the US 

Code, go to the US Government Publishing Office (GPO).

2-1 THE U.S. FEDERAL JUDICIAL SYSTEM.........................................................................3

2.1.1 District........................................................................................................ 3

2.1.2 U.S. Circuit Court of Appeals ..................................................................... 3

2.1.3. The U.S. Supreme Court ........................................................................... 4

2-2 SELECTED AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT4

2.2.1. Animal Drug User Fee (ADUFA)................................................................ 4

2.2.2. Animal Medicinal Drug Use Clarification Act (AMDUCA)........................... 4

2.2.3. Anti-Drug Abuse Act .................................................................................. 4

2.2.4. Best Pharmaceuticals for Children Act (BPFCA) ....................................... 4

2.2.5. Dietary Supplement and Nonprescription Drug Consumer Protection Act 

(DSNPDCPA)............................................................................................................... 5

2.2.6. Dietary Supplement Health and Education Act (DSHEA) .......................... 5

2.2.1. Drug Price Competition and Patent Term Restoration Act (DPCPTRA) .... 5

2.2.2. Drug Quality and Security Act (DQSA) ...................................................... 5

2.2.3. Electronic Product Radiation Control Act (EPRCA) ................................... 6

2.2.4. Family Smoking Prevention and Tobacco Control Act (Tobacco Control 

Act) ................................................................................................................... 6

2.2.5. Food Allergen Labeling and Consumer Protection Act (FALCPA)............. 6

2.2.6. Food and Drug Administration Amendments Act of 2007 (FDAAA)........... 6

2.2.7. Food and Drug Administration Export Reform and Enhancement Act 

(FDAEREA).................................................................................................................. 7

2.2.8. Food and Drug Administration Modernization Act of 1997 (FDAMA)......... 7
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2.2.9. Food and Drug Administration Safety and Innovation Act (FDASIA) ......... 7

2.2.10. Food Quality Protection Act (FQPA) .......................................................... 7

2.2.11. Food Safety Modernization Act (FSMA)..................................................... 7

2.2.12. Generic Drug Enforcement Act (GDEA)..................................................... 7

2.2.13. Health Promotion and Disease Prevention Amendments (HPDPA) .......... 7

2.2.14. Infant Formula Act (IFA)............................................................................. 7

2.2.15. Medical Device Amendments .................................................................... 8

2.2.16. Medical Device User Fee and Modernization Act (MDUFMA I, II and III) .. 8

2.2.17. Minor Use and Minor Species Animal Health Act (MUMS) ........................ 8

2.2.18. Nutrition Labeling and Education Act (NLEA) ............................................ 8

2.2.19. Orphan Drug Act (ODA)............................................................................. 9

2.2.20. Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA)9

2.2.21. Pediatric Research Equity Act (PREA) ...................................................... 9

2.2.22. Prescription Drug Marketing Act of 1987 (PDMA).................................... 10

2.2.23. Prescription Drug User Fee Act (PDUFA)................................................ 10

2.2.24. Project Bioshield Act................................................................................ 10

2-3 OTHER LAWS ................................................................................................................10

2.3.1. Public Health Service Act - Biological Products (Part F, Subpart 1) ........ 10

2.3.2. Public Health Service Act - Control of Communicable Diseases (Part G) 11

2.3.3. Mammography Quality Standards Act of 1992 ........................................ 12

2.3.4. Federal Anti-Tampering Act – 1983 ......................................................... 12

2.3.5. Freedom of Information Act – 1966 ......................................................... 13

2.3.6. Electronic Freedom of Information Amendments of 1996........................ 14

2.3.7. Sanitary Food Transportation Act of 1990 ............................................... 14

2.3.8. Pesticides Monitoring Improvements Act of 1988 .................................... 14

2.3.9. AIDS Amendments of 1988 ..................................................................... 15

2.3.10. Lead-Based Paint Poisoning Prevention Act – 1971 ............................... 16

2.3.11. Egg Products Inspection Act - 1970......................................................... 16

2.3.12. Fair Packaging and Labeling Act - 1966 .................................................. 17

2.3.13. Federal Import Milk Act............................................................................ 17

2.3.14. Health Insurance Portability and Accountability Act of 1996.................... 18

2.3.15. Equal Access to Justice Act - 1980.......................................................... 19

2.3.16. Sentencing Reform Act of 1984 ............................................................... 19

2.3.17. Crimes And Criminal Procedure .............................................................. 20
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2-1THE U.S. FEDERAL JUDICIAL SYSTEM

2.1.1 District Courts

There are 89 districts in the 50 states, which are listed with their divisions 

in Title 28 of the U.S. Code, Sections 81-144. District courts also exist in 

Puerto Rico, the Virgin Islands, the District of Columbia, Guam, and the 

Northern Mariana Islands. In total there are 94 U.S. district courts. Some 

states, such as Alaska, are composed of a single judicial district. Others, 

such as California, are composed of multiple judicial districts. The number 

of judgeships allotted to each district is set forth in Title 28 of the U.S. 

Code, Section 133. For a list of U.S. district courts and their rules, on the 

Internet go to: List of US District Courts http://www.uscourts.gov/ 

rules/distr-localrules.html.

2.1.2 U.S. Circuit Court of Appeals

There are 13 judicial circuits, each with a court of appeals. The smallest 

court is the First Circuit with six judgeships, and the largest court is in the 

Ninth Circuit, with 28 judgeships. A list of the states that compose each 

circuit is set forth in Title 28 of the U.S. Code, Section 41. The number of 

judgeships in each circuit is set forth in Title 28 of the U.S. Code, Section 

44. Court rules for each circuit court are available on the Internet at Court 

Rules http://www.uscourts.gov/RulesAndPolicies/rules/current-rules.aspx.

U.S. Circuit Court of Appeals
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The U.S. Court of Appeals Federal Circuit and the District of Columbia 

bring the total number of circuit courts to 13. Additional information is 

available at the following Internet site, Guide to Law Online > US Federal

> Judiciary by the Library of Congress.

2.1.3. The U.S. Supreme Court

The United States Supreme Court consists of the Chief Justice of the 

United States and eight associate justices. At its discretion, and within 

certain guidelines established by Congress, the Supreme Court each year 

hears a limited number of the cases it is asked to decide. Those cases 

may begin in the federal or state courts, and they usually involve important 

questions about the Constitution or federal law. For more information 

about the Supreme Court, visit the website for the US Supreme Court.

2-2SELECTED AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC 

ACT

The following is a list of selected Amendments to the Federal Food, Drug, 

and Cosmetic Act (FD&C Act). The amendments are listed in alphabetical 

order with the corresponding enactment date noted.

2.2.1. Animal Drug User Fee (ADUFA)

The FDA User Fee page is at https://www.fda.gov/ForIndustry/UserFees.

Information on ADUFA, Aug 14, 2008, is available on CVM’s ADUFA page

at http://www.fda.gov/ForIndustry/UserFees/AnimalDrug 

UserFeeActADUFA.

2.2.2. Animal Medicinal Drug Use Clarification Act (AMDUCA)

Information on AMDUCA, is available on CVM’s Acts, Rules and 

Regulations page at http://www.fda.gov/AnimalVeterinary/Guidance 

ComplianceEnforcement/ ActsRulesRegulations/.

2.2.3. Anti-Drug Abuse Act

Information on the Controlled Substances Act, Nov 11, 1988, is available 

at http://www.fda.gov/regulatoryinformation/legislation/ucm148726.htm. It 

includes the Anti-Drug Abuse Act, available at 

http://www.gpo.gov/fdsys/pkg/STATUTE-102/pdf/STATUTE-102-

Pg4181.pdf and which is administered by FDA.

2.2.4. Best Pharmaceuticals for Children Act (BPFCA)

The BPFCA, Jan. 4, 2002, reauthorizes the pediatric studies provision of 

the Food and Drug Administration Modernization and Accountability Act 

(FDAMAA) of 1997. Information is available on the Pediatric Product 
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Development page at 

http://www.fda.gov/drugs/developmentapprovalprocess/developmentresou

rces/ ucm049867.htm.

2.2.5. Dietary Supplement and Nonprescription Drug Consumer Protection 

Act (DSNPDCPA)

Information on DSNPDCPA, Dec. 22, 2006, is available on the OTC 

Products and Dietary Supplements page.

2.2.6. Dietary Supplement Health and Education Act (DSHEA)

Information on DSHEA, Oct. 25, 1994, is available on the Dietary 

Supplements page at http://www.fda.gov/food/dietarysupplements. 

NOTE: DSHEA does not apply to products intended for animal use. The 

FDA’s Center for Veterinary Medicine (CVM)

(http://www.fda.gov/AnimalVeterinary), Division of Compliance

(https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ 

ComplianceEnforcement), telephone 240-276-9200, should be consulted 

for appropriate guidance on these products for animal use.

2.2.1. Drug Price Competition and Patent Term Restoration Act (DPCPTRA)

DPCPTRA is available on the following Government’s Printing Office web 

page (http://www.gpo.gov/fdsys/pkg/STATUTE-98/pdf/STATUTE-98-

Pg1585.pdf), Sept. 24, 1984, consists of two titles:

• Title I authorizes the approval of generic drugs under an 

Abbreviated New Drug Application (ANDA) procedure.

• Title II authorizes the extension of patent terms for approved new 

drug products including antibiotics and biological drug products, 

some medical devices, food additives, and color additives.

2.2.2. Drug Quality and Security Act (DQSA)

DQSA, Nov 27, 2013, https://www.congress.gov/bill/113thcongress/house-bill/3204/text contains two titles:

• Title I of DQSA, Compounding Quality Act at 

http://www.fda.gov/drugs/GuidanceComplianceRegulatory 

Information/PharmacyCompounding addresses compounding of 

human drugs. Information is available on the FDA Compounding

page at http://www.fda.gov/drugs/GuidanceCompliance 

RegulatoryInformation/PharmacyCompounding.

• Title II of DQSA, Drug Supply Chain Security Act (DSCSA) at 

http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChain

Security outlines steps for an electronic, interoperable system to 

identify and trace certain prescription drugs as they are distributed 

in the United States.
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Additional information is available on the Drug Supply Chain Integrity page 

at http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityand 

SupplyChainSecurity.

2.2.3. Electronic Product Radiation Control Act (EPRCA)

The EPRCA of 1990, 21 U.S.C. 360hh-360ss, is the new name for the 

Radiation Control for Health and Safety Act

(http://www.gpo.gov/fdsys/pkg/STATUTE-82/pdf/STATUTE-82-

Pg1173.pdf), Oct. 18, 1968 (formerly at 42 U.S.C. 263c-263n). The 

change was made as part of the Safe Medical Devices Act of 1990

(SMDA) (http://www.gpo.gov/fdsys/pkg/STATUTE-104/pdf/STATUTE-104-

Pg4511.pdf) which was itself amended by the FDA Amendments Act at 

http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandco

smeticactfdcact/significantamendmentstothefdcact/foodanddrugadministra

tionamendmentsactof2007/default.htm Additional information is on the 

Summary of the Electronic Product Radiation Control Provisions page at 

http://www.fda.gov/radiation-emittingproducts/electronicproduct 

radiationcontrolprogram/lawsandregulations/ucm118156.htm.

2.2.4. Family Smoking Prevention and Tobacco Control Act (Tobacco 

Control Act)

Information on the Tobacco Control Act

(http://www.accessdata.fda.gov/scripts/tobaccocontrol/index.cfm), June 

22, 2009, is available on the Tobacco Control Act page at 

http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInfor

mation/ucm298595.htm.

2.2.5. Food Allergen Labeling and Consumer Protection Act (FALCPA)

Additional Information on FALCPA

(http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulator

yinformation/allergens/ucm106187.htm), Aug. 2, 2004, is available on the 

Food Allergens Guidance documents and Regulatory Information page at 

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegula

toryInformation/Allergens.

2.2.6. Food and Drug Administration Amendments Act of 2007 (FDAAA)

Information on FDAAA, Sept. 27, 2007, is available at 

http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandco

smeticactfdcact/significantamendmentstothefdcact/foodanddrugadministra

tionamendmentsactof2007.

Information on device-related legislation that FDAAA amended is available 

on the page for the Safe Medical Devices Act of 1990 (SMDA), Nov. 28, 

1990, at http://www.gpo.gov/fdsys/pkg/STATUTE-104/pdf/STATUTE-104-

Pg4511.pdf and on the page for the Medical Devices Amendments of 

1992 (the 1992 Amendments), June 16, 1992, at http://www.gpo.gov/ 

fdsys/pkg/STATUTE-106/pdf/STATUTE-106-Pg238.pdf.
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2.2.7. Food and Drug Administration Export Reform and Enhancement Act

(FDAEREA)

Information on FDAEREA, April 26, 1996, is available at 

http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrug 

andCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/ 

ucm148005.htm.

2.2.8. Food and Drug Administration Modernization Act of 1997 (FDAMA)

Information on FDAMA, Nov. 21, 1997 is available at 

http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandco

smeticactfdcact/significantamendmentstothefdcact/fdama.

2.2.9. Food and Drug Administration Safety and Innovation Act (FDASIA)

Information on FDASIA (http://www.gpo.gov/fdsys/pkg/PLAW112publ144/pdf/PLAW-112publ144.pdf) July 9, 2012, is available on 

FDA’s FDASIA page at http://www.fda.gov/RegulatoryInformation/ 

Legislation/FederalFoodDrugandCosmeticActFDCAct/ 

SignificantAmendmentstotheFDCAct/FDASIA.

2.2.10. Food Quality Protection Act (FQPA)

Information on FQPA, Aug. 3, 1996, is available at http://www.fda.gov/ 

RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDC

Act/SignificantAmendmentstotheFDCAct/ucm148008.htm.

2.2.11. Food Safety Modernization Act (FSMA)

Information on FSMA, Jan. 4, 2011 is available at http://www.fda.gov/ 

RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDC

Act/SignificantAmendmentstotheFDCAct/ucm148008.htm.

2.2.12. Generic Drug Enforcement Act (GDEA)

Additional information on GDEA (http://www.gpo.gov/fdsys/pkg/STATUTE106/pdf/STATUTE-106-Pg149.pdf), May 13, 1992 is available on the FDA

debarment page at http://www.fda.gov/ICECI/EnforcementActions/ 

FDADebarmentList.

2.2.13. Health Promotion and Disease Prevention Amendments

(HPDPA)

Information on HPDPA, Oct. 30, 1984, is available at 

http://www.gpo.gov/fdsys/pkg/STATUTE-98/pdf/STATUTE-98-Pg2815.pdf.

2.2.14. Infant Formula Act (IFA)

The IFA, (http://www.gpo.gov/fdsys/pkg/STATUTE-94/pdf/STATUTE-94-

Pg1190.pdf), Sept. 26, 1980, and subsequent amendments in 1986 

(Section 412) establish nutrient requirements for infant formulas. 

Information is available on the pages for Guidelines Concerning 

Notification and Testing of Infant Formulas

(http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegul
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atoryInformation/InfantFormula/ucm169730.htm) and Briefing Materials for 

the Food Advisory Committee Meeting on Infant Formula

(http://www.fda.gov/ohrms/dockets/ac/02/briefing/3852b1_01.htm).

2.2.15. Medical Device Amendments

Information on the Medical Device Amendments, May 24, 1976, is 

available on the pages for Overview of Device Regulation

(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overv

iew) and Overview of Medical Device Classification and Reclassification

(http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsan

dTobacco/CDRH/CDRHTransparency/ucm378714.htm).

2.2.16. Medical Device User Fee and Modernization Act (MDUFMA I, II 

and III)

The FDA User Fee page is at https://www.fda.gov/ForIndustry/UserFees.

Information on MDUFMA III (http://www.gpo.gov/fdsys/pkg/PLAW112publ144/html/PLAW-112publ144.htm), July 9, 2012, is included in 

FDASIA. Additional information is available on the pages for MDUFMA

(http://www.fda.gov/medicaldevices/deviceregulationandguidance/overvie

w/medicaldeviceuserfeeandmodernizationactmdufma) and MDUFMA III

(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overv

iew/MDUFAIII).

MDUFMA III amended MDUFMA I (http://www.fda.gov/medicaldevices/ 

deviceregulationandguidance/overview/medicaldeviceuserfeeandmoderniz

ationactmdufma/ucm109133.htm), Oct. 26, 2002.

MDUFMA II

http://www.fda.gov/medicaldevices/deviceregulationandguidance/ 

overview/medicaldeviceuserfeeandmodernizationactmdufma/ucm109316.

htm) was included in the Food and Drug Administration Amendments Act 

of 2007 (http://www.fda.gov/RegulatoryInformation/Legislation/Federal 

FoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/F

oodandDrugAdministrationAmendmentsActof2007/FullTextofFDAAALaw)

(FDAAA), Sept. 27, 2007.

2.2.17. Minor Use and Minor Species Animal Health Act (MUMS)

Information on MUMS (http://www.fda.gov/RegulatoryInformation/ 

Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendm

entstotheFDCAct/MinorUseandMinorSpeciesAnimalHealthActof2004), 

Aug. 2, 2004, is available on the MUMS resource page at 

http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/Minor

UseMinorSpecies.

2.2.18. Nutrition Labeling and Education Act (NLEA)

Information on the NLEA (http://www.fda.gov/iceci/inspections/ 

inspectionguides/ucm074948.htm), Nov. 8, 1990, is available on the

pages for Labeling & Nutrition Guidance Documents & Regulatory 
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Information at http://www.fda.gov/Food/GuidanceRegulation/ 

GuidanceDocumentsRegulatoryInformation/LabelingNutrition and for

Inspection Guide to NLEA Requirements at 

http://www.fda.gov/iceci/inspections/inspectionguides/ucm074948.htm.

2.2.19. Orphan Drug Act (ODA)

Information on the ODA (http://www.fda.gov/regulatoryinformation/ 

egislation/federalfooddrugandcosmeticactfdcact/significantamendmentstot

hefdcact/orphandrugact), April 18, 1988, is available on the pages for

regulatory history of Orphan Drugs (http://www.fda.gov/ForIndustry/ 

DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanPro

ductDesignation/ucm356481.htm) and requirements for industry

(http://www.fda.gov/forindustry/DevelopingProductsforrareDiseasesConditi

ons). The ODA of 1988 amended the Orphan Drug Act of 1983

(http://www.gpo.gov/fdsys/pkg/STATUTE-96/pdf/STATUTE-96-

Pg2049.pdf) Jan. 4, 1983.

2.2.20. Pandemic and All-Hazards Preparedness Reauthorization Act

(PAHPRA)

Information on PAHPRA (http://www.gpo.gov/fdsys/pkg/PLAW113publ5/pdf/PLAW-113publ5.pdf), March 13, 2013 is available on the 

MCM-related Legislation page at http://www.fda.gov/Emergency 

Preparedness/Counterterrorism/MedicalCountermeasures/MCMLegalReg

ulatoryandPolicyFramework/ucm2007271.htm#PAHPRA.

PAHPRA updated and reauthorized related provisions of the Pandemic 

and All-Hazards Preparedness Act of 2006 (http://www.gpo.gov/ 

fdsys/pkg/PLAW-109publ417/pdf/PLAW-109publ417.pdf) (PAHPA), Dec. 

19, 2006; the Public Readiness and Emergency Preparedness Act of 2005

(http://www.gpo.gov/fdsys/pkg/PLAW-109publ148/pdf/PLAW109publ148.pdf) (PREP Act), Dec. 30, 2005; and the Public Health 

Security and Bioterrorism Preparedness and Response Act

(http://www.fda.gov/RegulatoryInformation/Legislation/ucm148797.htm)

(the Bioterrorism Act), June 12, 2002. General information about medical 

counter measures (MCM), emergency preparedness and response, and 

the various recent counter-terrorism legislation is available on the MCMrelated Legislation page at http://www.fda.gov/EmergencyPreparedness/ 

Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolic

yFramework/ucm2007271.htm.

2.2.21. Pediatric Research Equity Act (PREA)

PREA (http://www.fda.gov/downloads/Drugs/DevelopmentApproval 

Process/ DevelopmentResources/UCM077853.pdf), Dec. 2, 2003, has 

been amended by subsequent legislation. See the pages for the pediatric 

provisions in FDASIA (http://www.fda.gov/RegulatoryInformation/ 

Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendm

entstotheFDCAct/FDASIA/ucm311038.htm) and for the Food and Drug 
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Administration Amendments Act (FDAAA) (http://www.fda.gov/ 

RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDC

Act/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAme

ndmentsActof2007/FullTextofFDAAALaw), Sept. 27, 2007.

2.2.22. Prescription Drug Marketing Act of 1987 (PDMA)

Information on PDMA, April 22, 1988 is at http://www.fda.gov/Regulatory 

Information/Legislation/FederalFoodDrugandCosmeticActFDCAct/Signific

antAmendmentstotheFDCAct/PrescriptionDrugMarketingActof1987).

2.2.23. Prescription Drug User Fee Act (PDUFA)

The FDA User Fee page is at https://www.fda.gov/ForIndustry/UserFees.

Information on PDUFA (http://www.fda.gov/RegulatoryInformation/ 

Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendm

entstotheFDCAct/PrescriptionDrugAmendmentsof1992PrescriptionDrugUs

erFeeActof1992) Oct. 29, 1992, is available on the PDUFA pages for 

industry (http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrug 

UserFee) and for small business (http://www.fda.gov/Drugs/Development 

ApprovalProcess/SmallBusinessAssistance/ucm069943.htm).

2.2.24. Project Bioshield Act

Information Project Bioshield Act (http://www.gpo.gov/fdsys/pkg/PLAW108publ276/pdf/PLAW-108publ276.pdf), July 21, 2004, FDA’s emergency 

preparedness and response, and the more recent counter-terrorism 

legislation is available on the MCM-related Legislation page at 

http://www.fda.gov/EmergencyPreparedness/Counterterrorism/ 

MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/ 

ucm2007271.htm.

2-3 OTHER LAWS

2.3.1. Public Health Service Act - Biological Products (Part F, Subpart 1)

Biological products are approved for marketing under provisions of the 

Public Health Service Act (PHS Act). However, because most biological 

products also meet the definition of "drugs" under the Federal Food, Drug, 

and Cosmetic Act (FD&C Act), they are also subject to regulation under 

FD&C Act provisions.

A biological product is a virus, therapeutic serum, toxin, antitoxin, vaccine, 

blood, blood component or derivative, allergenic product, or analogous 

product, or arsphenamine or its derivatives (or any other trivalent organic 

arsenic compound), applicable to the prevention, treatment, or cure of a 

disease or condition of human beings. For example, biologics include 

vaccines, various toxoids, skin test antigens, allergenic extracts, blood and 

blood products, and certain in vitro test kits intended for testing of 

biological products. The PHS Act requires individuals or companies who 
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manufacture biologics for introduction into interstate commerce to hold a 

license for the products. These licenses are issued by FDA's Center for 

Biologics Evaluation and Research (CBER). Biological products intended 

for veterinary use are regulated under a separate law, the Virus, Serum, 

and Toxin Act, which is administered by the U.S. Department of 

Agriculture.

In May 1996, FDA amended the biologics regulations to eliminate the 

Establishment License Application (ELA) for certain biotechnology and 

synthetic biological products subject to licensing under the PHS Act. 

Manufacturers of those products are now required to submit only a 

biologics license application (BLA), thereby enabling companies to devote 

more resources to ensuring that manufacturing processes are properly 

validated and fewer resources to submitting documentation to the agency. 

A BLA may be used for submissions for specified biotechnology products 

such as products manufactured by recombinant DNA technology and 

monoclonal antibody products. This regulatory change will reduce 

unnecessary burdens for industry without diminishing public health 

protection.

The PHS Act also provides authority to immediately suspend licenses in 

situations where there exists a danger to public health. This statute also 

allows us to prepare or procure products in the event of shortages and 

critical public health needs and authorizes the creation and enforcement of 

regulations to prevent the introduction, or spread of communicable 

disease in the US and/or between states. This law also provides important 

flexibility in regulation of biotechnology products, which facilitates the 

introduction and development of new medicines.

The PHS Act specifies that manufacturers must plainly label the biological 

products with the proper name of the article, the name, address, and 

license number of the manufacturer, and the appropriate expiration date of 

the product. No person shall falsely label any package containing a 

biological product. The PHS Act authorizes the inspection of biological 

product manufacturers. Section 351 provides for civil money penalties, 

fines and imprisonment for violations, and specifies export requirements 

for biological products.

2.3.2. Public Health Service Act - Control of Communicable Diseases (Part 

G)

Section 361 of the Public Health Service Act (PHS Act) authorizes the 

creation and enforcement of regulations to prevent the introduction, 

transmission, or spread of communicable diseases from foreign countries 

into the U.S. or possessions or between states and possessions. These 

regulations may provide for inspection, fumigation, disinfection, sanitation, 

pest extermination, and destruction of animals or articles found infected or 

contaminated and as sources of dangerous infection to human beings.
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See PHS Act 42 U.S.C. 264-272, 42 U.S.C. 264-272, July 1, 1944, as 

amended 1957, 1958, 1960 and 1976.

2.3.3. Mammography Quality Standards Act of 1992

The Mammography Quality Standards Act (MQSA) was signed into law on 

October 27, 1992, to establish national quality standards for 

mammography. The MQSA required that to provide mammography 

services legally after October 1, 1994, all facilities, except facilities of the 

Department of Veterans Affairs, must be accredited by an approved 

accreditation body and certified by the Secretary of Health and Human 

Services (the Secretary) or by an approved State certification body. The 

authority to approve accreditation bodies, State certification bodies, and to 

certify facilities was delegated by the Secretary to the FDA.

On October 28, 1997, the FDA published regulations to implement the 

MQSA in the Federal Register. The regulations (21 CFR Part 900) 

became effective April 28, 1999. The FDA compiled all final guidance 

related to MQSA into a computerized searchable Policy Guidance Help 

System in November 1998. The Policy Guidance Help System is 

available on the Internet at: http://www.fda.gov/Radiation-Emitting 

Products/MammographyQualityStandardsActandProgram/Guidance/ 

PolicyGuidanceHelpSystem.

Also at: http://www.fda.gov/RegulatoryInformation/Legislation/ 

ucm148794.htm.

2.3.4. Federal Anti-Tampering Act – 1983

On October 13, 1983, the President signed the Federal Anti-Tampering 

Act (P.L. 98-127). This Act amends Title 18 of the United States Code 

(U.S.C.) to establish graduated penalties for tampering with a consumer 

product with intent to cause injury or death. The penalties range from a 

maximum of $25,000 and 10 years imprisonment in the case of an attempt 

to tamper, to a maximum of $100,000 and life imprisonment, in a case 

where death results from the tampering.

In addition, FATA establishes penalties for:

A. Tampering with or mislabeling consumer products with intent to injure 

a business;

B. Knowingly communicating false information about tainting of a 

consumer product, if such tainting occurred, that would create a risk of 

death or bodily injury;

C. Threatening to tamper with a consumer product in a manner to create 

a risk of death or bodily injury; and,

D. Conspiracy to tamper with a consumer product.

A “consumer product” is any article subject to the Act and FDA is the 

designated authority to investigate violations.
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Additional information is available on the FDA Internet at:

http://www.fda.gov/RegulatoryInformation/Legislation/ucm148785.htm.

2.3.5. Freedom of Information Act – 1966

The Freedom of Information Act (FOIA) (P.L. 104-231) was passed by 

Congress in 1966 and amended in 1974 (5 U.S.C. 552). The FOIA created 

procedures by which any member of the public may obtain the records of 

the agencies of the federal government. Section 552 (a) of FOIA directs 

government agencies to disclose certain types of records and describes 

the manner of disclosure required.

The FOIA applies only to federal agencies and does not create a right of 

access to records held by Congress, the courts, or by state or local 

government agencies. Each state has its own public access laws that 

should be consulted for access to state and local records.

Like all federal agencies, the Food and Drug Administration is required 

under the Freedom of Information Act (FOIA) to disclose records 

requested in writing by any person. However, agencies may withhold 

information pursuant to nine exemptions and three exclusions contained in 

the statute.

The FOIA contains six subsections, the first two of which establish certain 

categories of information that must automatically be disclosed by federal 

agencies. Subsection (a)(1) of the FOIA requires disclosure through 

publication in the Federal Register of information such as descriptions of 

agency organization, functions, procedures, substantive rules, and 

statements of general policy. This requirement provides automatic public 

access to very basic information regarding the transaction of agency 

business.

Subsection (a)(2) of the FOIA requires that certain types of records--final 

opinions rendered in the adjudication of cases, specific policy statements, 

certain administrative staff manuals and some records previously 

processed for disclosure under the Act--be routinely made “available for 

public inspection and copying.” At the Food and Drug Administration 

(FDA), this is generally accomplished through FDA’s two “reading rooms,” 

and as a result of the Electronic FOIA Amendments (hereafter referred to 

as (EFOIA”), many of the records in the reading rooms also are located in 

FDA’s “electronic reading room.”

On the FDA Internet at: http://www.fda.gov/foi/foia2.htm, 

http://www.usdoj.gov/oip/ amended-foia-redlined.pdf and 

http://www.fda.gov/RegulatoryInformation/FOI/ ReferenceMaterials. For 

additional information and guidance on the FOIA, see FDA’s Information 

Disclosure Manual on the FDA Intranet.
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2.3.6. Electronic Freedom of Information Amendments of 1996

The Electronic Freedom of Information Act (E-FOIA) Amendments signed 

into law in 1996 amended the Freedom of Information Act (FOIA), adding 

a requirement that agencies had to establish an electronic reading room. 

The reading room must include agency policy manuals, opinions made in 

the adjudication of cases, and an index of records released by FOIA that 

are likely to become the subject of subsequent FOIA requests.

In addition, E-FOIA:

A. Extends from 10 to 20 business days (excluding holidays) the time 

agencies have to respond to requests for information;

B. Requires agencies to make reasonable efforts to make records 

available in the form desired by requesters;

C. Requires agencies to submit an FDA FOIA Report by the fiscal year;

D. Requires agencies to make the reports available to the public by 

computer telecommunications or other electronic means;

E. Requires agencies to list their major information systems record locator 

system and a reference guide or guide for obtaining information; and,

F. Requires that the provisions of the E-FOIA be implemented by specific 

dates.

2.3.7. Sanitary Food Transportation Act of 1990

The Sanitary Food Transportation Act (P.L. 101-500) requires the 

Department of Transportation (DOT), in consultation with the Department 

of Health and Human Services, Environmental Protection Agency, and the 

United States Department of Agriculture, to issue regulations to provide for 

the safe transportation of food, food additives, cosmetics, drugs, and 

medical devices. The requirement includes safe transportation that occurs 

in vehicles used to transport nonfood products or waste, and the use of 

dedicated vehicles to transport hazardous materials such as asbestos or 

municipal waste. SFTA authorizes funding for food transportation 

inspections from funds designated to carry out the motor carrier safety 

assistance program if the Recipient State agrees to assist in enforcement. 

DOT is required to issue regulations.

Codified at: 49 U.S.C. 5701 et. Seq. Additional information is available on 

the FDA Internet at: http://www.fda.gov/RegulatoryInformation/Legislation/ 

ucm148790.htm.

2.3.8. Pesticides Monitoring Improvements Act of 1988

On August 23, 1988, the President signed into law the Omnibus Trade 

and Competitiveness Act (P.L. 100-418). Included in this law is the 

Pesticide Monitoring Improvements Act of 1988 which is intended to 

improve the analytical approaches used by the FDA to determine residues 

of pesticides in foods. Specifically, Subtitle G requires FDA to computerize 
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its pesticide monitoring activities, to compile a summary of the information 

gathered through computerized monitoring activities, and to make its 

summary and report available to Federal and State agencies and other 

interested persons.

The PMIA also requires the Secretary of Health and Human Services

(HHS) to attempt to enter into cooperative agreements with governments 

of foreign countries that are major sources of food imports into the U.S., 

for the purpose of better enabling FDA to assure compliance with 

pesticide tolerances, or otherwise to obtain, information on pesticides 

used on imported foods where such agreements cannot be obtained. 

Finally, the PMIA requires the Secretary of HHS to develop, in 

consultation with the Environmental Protection Agency (EPA), a longrange plan for the development of new and improved methods for 

detecting pesticide residues, and to make a report and recommendations 

to appropriate congressional committees.

The PMIA is codified at 21 U.S.C. Sections 1401-1403 Part 4702, 4703, 

and 4704, included as part of the Omnibus Trade and Competitiveness 

Act.

2.3.9. AIDS Amendments of 1988

The AIDS amendments (P.L. 100-607) set up broad programs for 

research, counseling, testing, education and information programs, and 

health care for acquired immune deficiency syndrome (AIDS) patients. Of 

interest to FDA are provisions that specify requirements of the Secretary.

A. Require the Secretary to encourage manufacturers of drugs with 

potential effectiveness as AIDS treatments to apply for investigational 

exemptions under the Act. The Secretary has authorization to provide 

technical assistance through grants or contracts to manufacturers, 

researchers, and physicians to expedite submission of applications 

and the availability of new drugs under treatment INDS.

B. Require the Secretary to establish a data bank that includes a registry 

of clinical trials and information on AIDS drugs available under INDS, 

including treatment INDS, superseding the confidentiality provisions of 

the Act with respect to these drugs.

C. Authorize the Secretary to add 780 new positions to the Public Health 

Service (PHS) before October 1, 1990, and require the Secretary to 

report to Congress after three months on the allocation among the 

agencies.

D. Require the Office of Personnel Management or the General Services 

Administration (GSA) to respond to priority requests for personnel and 

administrative support from FDA and PHS agencies within 21 days 

after the request.

E. Establish a National Commission on AIDS that would, among other 

things, evaluate the adequacy of clinical trials and make
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recommendations on streamlining regulations relating to FDA approval 

of new drugs and medical devices, including procedures for the 

release of experimental drugs.

F. Require the Secretary to submit an annual report to Congress on all 

expenditures by the Department with respect to AIDS.

G. Require the National Institute of Allergy and Infectious Diseases 

(NIAID), after consulting with FDA, to establish the AIDS Clinical 

Research Review Committee. The Committee is physicians in clinical 

practice. They advise NIAID on appropriate research activities to 

undertake, including research on drugs, with respect to clinical 

treatment of AIDS.

H. Authorize NIH, after consulting with FDA, to provide grants and 

contracts to community- based organizations to conduct clinical trials 

approved by FDA, and require that FDA, among others, approve 

applications for financial assistance.

I. Require the Secretary to establish a program to evaluate the 

effectiveness and risks associated with unapproved drugs in use by 

AIDS patients.

J. Require the Secretary, after consultation with FDA, among others, to 

establish a program of research and education regarding blood 

donations and transfusions.

K. Require that the grant programs for clinical care of AIDS patients must 

provide patients with information and counseling on the availability of 

treatments both approved and not yet approved by FDA.

L. Require the Secretary to expedite the award of grants, contracts, and 

cooperative agreements for research projects relating to AIDS and 

require the submission of a quarterly report to Congress.

M. Require the Secretary to request the National Academy of Science and 

others to report on the potential use of consortia for research and 

development of vaccines and drugs.

2.3.10. Lead-Based Paint Poisoning Prevention Act – 1971

The Lead-Based Paint Poisoning Prevention Act required the Secretary of 

Health and Human Services to take such steps and impose such 

conditions as may be necessary or appropriate to prohibit the application 

of lead-based paint to any cooking utensil, drinking utensil, or eating 

utensil manufactured and distributed after January 13, 1971.

Codified at 42 U.S.C. 4831. Additional information is available at:

http://www.fda.gov/RegulatoryInformation/Legislation/ucm148755.htm .

2.3.11. Egg Products Inspection Act - 1970

The Egg Products Inspection Act enacted in 1970 is administered by the 

U.S. Department of Agriculture and imposes specific inspection 
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requirements for the two categories of eggs—egg products and shell eggs 

to assure wholesome shell eggs and egg products in the marketplace.

The Act gives enforcement authority to the USDA and to the Food and 

Drug Administration. Federal agriculture officials or state officials acting on 

behalf of USDA visit egg packers and hatcheries at least every three 

months to see that they are in compliance with the law. Firms which 

transport, ship or receive shell eggs and egg products may also be 

checked periodically. Under the Egg Products Inspection Act, plants that 

break, dry and process shell eggs into liquid, frozen or dried egg products 

must operate under the continuous inspection program of the USDA. An 

official inspector must be present at all times when eggs are being 

processed. The law applies to all egg-breaking plants, regardless of size, 

and to those selling products locally, across state lines and in foreign 

commerce. Disposition of undesirable shell eggs is controlled to prevent 

their entering consumer food channels.

Egg Products Inspection Act, 21 U.S.C. Sections 1031 et seq., see 

http://www.fda.gov/RegulatoryInformation/Legislation/ucm148752.htm .

2.3.12. Fair Packaging and Labeling Act - 1966

The Fair Packaging and Labeling Act enacted in 1966 and substantially 

amended in 1992, prohibits any person who packages or labels consumer 

commodities, as defined, from distributing commodities that are not 

packaged and labeled as required by this law and its implementing 

regulations. See 15 U.S.C. 1452. The law is designed to ensure that 

consumers receive accurate and usable information about consumer 

commodities from the labeling on their packages. Consumer commodities 

include any food, drug, device or cosmetic, as defined by the Federal 

Food, Drug, and Cosmetics Act, and any other article, product or 

commodity customarily produced or distributed through retail sales 

agencies for use or consumption by individuals. 15 U.S.C. 1459(a). Meat, 

poultry, tobacco products, and specified beverages, drugs, and 

agricultural products regulated under other statutes and programs are 

excluded from the definition of consumer commodity. 15 U.S.C. 

1459(a)(1)-(5).

Codified at 15 U.S.C. 1451 et seq. On the FDA Internet at:

http://www.fda.gov/RegulatoryInformation/Legislation/ucm148722.htm.

2.3.13. Federal Import Milk Act

In addition to being subject to the requirements of the FFD&C Act, milk 

and cream (including sweetened condensed milk) offered for import into 

the U.S. are subject to the Federal Import Milk Act (P.L. 69-625) enforced 

by the FDA. Such products may be imported only under permit after 

certain sanitary and other prerequisites have been fulfilled.
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2.3.14. Health Insurance Portability and Accountability Act of 1996

The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 

Title II (Administration Simplification) requires the Secretary to issue 

several regulations, one of which would protect the privacy of individually 

identifiable health information. The Final “Privacy” Rule published on 

December 20, 2000 and was amended on May 31, 2002 and August 14,

2002. The Privacy Rule provides that a "covered entity" may not use or 

disclose protected health information ("PHI") except as permitted or 

required by the Rule. It permits the continued use of PHI for treatment, 

payment, or operations purposes. There are only two required 

disclosures: (1) to the individual pursuant to the access requirements; and, 

(2) to the Secretary to determine compliance with the Rule. Covered 

entities are defined as health plans, health care clearinghouses, and 

health care providers who engaged in certain electronic transactions. 

FDA is not a covered entity. PHI includes individually identifiable health 

information that is electronically transmitted or maintained by a covered 

entity in any form or medium.

The Privacy Rule permits covered entities to disclose PHI without the 

individual's consent or authorization, to a person or entity subject to FDA 

jurisdiction, for public health purposes related to quality, safety or 

effectiveness of the FDA regulated product or activity. Such purposes 

include the reporting of adverse events or product defects or problems; 

the tracking of FDA regulated products; the ability to effectuate products 

recalls, repairs, replacement or lookback (traceback); and conducting post 

marketing surveillance. The Privacy Rule is not intended to discourage or 

prevent adverse event reporting or otherwise disrupt the flow of essential 

information needed by the FDA to carry out its public health activities.

The Privacy Rule also permits covered entities to disclose PHI to the FDA 

without consent or authorization pursuant to several other exemptions in 

the rule. These include where the use or disclosure is required by law; for 

the purpose of preventing or controlling disease, injury, or disability 

(including, but not limited to the conduct of public health surveillance, 

public health investigations, and public health interventions); for oversight 

activities authorized by law (including audits, civil, administrative or 

criminal investigations, inspections, disciplinary actions, civil, 

administrative, or criminal proceedings or other actions, or other activities 

necessary for appropriate oversight of the health care system); and for law 

enforcement purposes, when certain conditions are met. The information 

disclosed in these instances may only be the minimum amount necessary 

for the purpose. Before disclosing protected health information to their 

"business associate," covered entities must have a contract assuring that 

the business associate will safeguard the information pursuant to the 

Privacy Rule. At times, some covered entities, such as hospitals, 

mistakenly believe that FDA is their business associate and ask FDA to 

sign a confidentiality statement before the hospital gives FDA individually 
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identifiable health information. FDA is not a business associate and is not 

required to sign such a statement. Additional information about 

HIPAA and the Privacy Rule is on the Internet at: 

http://www.hhs.gov/ocr/hipaa .

2.3.15. Equal Access to Justice Act - 1980

The winning party has traditionally been awarded court costs. However, 

these costs do not include fees and expenses for attorneys and expert 

witnesses. The purpose of the EAJA of 1980 (P.L. 96-481) and the 

subsequent 1985 amendments (P.L. 99-80) was to prevent overbearing 

conduct on the part of the government against individuals and small firms 

who might not have the financial resources to oppose improper 

government acts.

Under the EAJA (28 U.S.C. 2412), a "party" is defined as an individual 

whose net worth does not exceed $2,000,000 or the owner of an 

unincorporated business or any partnership, corporation, association, or 

unit of local government whose net worth does not exceed

$7,000,000 and which does not have more than 500 employees. 

Cooperative agricultural associations and tax exempt organizations may 

be parties without regard to these parameters.

A party prevailing against the government is entitled to be reimbursed for 

reasonable attorney fees, expenses for expert witnesses and the cost of 

any study, analysis, engineering report, test, or project which is found by 

the court to be necessary for the preparation of the party's case. The 

EAJA applies to civil litigation but does not include torts (injury claims for a 

civil wrong). The EAJA does not apply to criminal cases.

Pursuant to the EAJA, costs will be awarded to a private party "unless the 

court finds that the position of the United States was substantially justified 

or that special circumstances make an award unjust."

2.3.16. Sentencing Reform Act of 1984

The Sentencing Reform Act of 1984 (Title II of the Comprehensive Crime 

Control Act of 1984) provides for the development of guidelines that will 

further the basic purposes of criminal punishment: deterrence, 

incapacitation, just punishment, and rehabilitation. The Act delegates 

broad authority to the Commission to review and rationalize the federal 

sentencing process.

The Act contains detailed instructions as to how this determination should 

be made, the most important of which directs the Commission to create 

categories of offense behavior and offender characteristics. An offense 

behavior category might consist, for example, of "bank robbery/committed 

with a gun/$2500 taken." An offender characteristic category might be 

"offender with one prior conviction not resulting in imprisonment." The 

Commission is required to prescribe guideline ranges that specify an 

appropriate sentence for each class of convicted persons determined by 
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coordinating the offense behavior categories with the offender

characteristic categories. Where the guidelines call for imprisonment, the 

range must be narrow: the maximum of the range cannot exceed the 

minimum by more than the greater of 25 percent or six months.

Pursuant to the Act, the sentencing court must select a sentence from 

within the guideline range. If, however, a particular case presents atypical 

features, the Act allows the court to depart from the guidelines and 

sentence outside the prescribed range. In that case, the court must 

specify reasons for departure. 18 U.S.C. 3553(b). If the court sentences 

within the guideline range, an appellate court may review the sentence to 

determine whether the guidelines were correctly applied. If the court 

departs from the guideline range, an appellate court may review the 

reasonableness of the departure. 18 U.S.C. 3742. The Act also abolishes 

parole, and substantially reduces and restructures good behavior 

adjustments.

The guidelines took effect on November 1, 1987, and apply to all offenses 

committed on or after that date. The Commission has the authority to 

submit guideline amendments each year to Congress between the 

beginning of a regular Congressional session and May 1. Such 

amendments automatically take effect 180 days after submission unless a 

law is enacted to the contrary. 28 U.S.C. 994(p).

2.3.17. Crimes And Criminal Procedure

A. Sec. 111. - Assaulting, resisting, or impeding certain officers or 

employees

(a) In General - Whoever –

(1) Forcibly assaults, resists, opposes, impedes, intimidates, 

or interferes with any person designated in section 1114 of 

this title while engaged in or on account of the performance 

of official duties; or

(2) Forcibly assaults or intimidates any person who formerly 

served as a person designated in section 1114 on account of 

the performance of official duties during such person's term 

of service, shall, where the acts in violation of this section 

constitute only simple assault, be fined under this title or 

imprisoned not more than one year, or both, and in all other 

cases, be fined under this title or imprisoned not more than 8 

years, or both.

(b) Enhanced Penalty –

Whoever, in the commission of any acts described in subsection 

(a), uses a deadly or dangerous weapon (including a weapon 

intended to cause death or danger but that fails to do so by reason 

of a defective component) or inflicts bodily injury, shall be fined 

under this title or imprisoned not more than 20 years, or both.
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B. Sec. 1114. - Protection of officers and employees of the United States

Whoever kills or attempts to kill any officer or employee of the United 

States or of any agency in any branch of the United States Government 

(including any member of the uniformed services) while such officer or 

employee is engaged in or on account of the performance of official 

duties, or any person assisting such an officer or employee in the 

performance of such duties or on account of that assistance, shall be 

punished...

C. Sec. 371. - Conspiracy to commit offense or to defraud United States

If two or more persons conspire either to commit any offense against the 

United States, or to defraud the United States, or any agency thereof in 

any manner or for any purpose, and one or more of such persons do any 

act to effect the object of the conspiracy, each shall be fined under this 

title or imprisoned not more than five years, or both.

If, however, the offense, the commission of which is the object of the 

conspiracy, is a misdemeanor only, the punishment for such conspiracy 

shall not exceed the maximum punishment provided for such 

misdemeanor.

D. Sec. 1001. - Statements or entries generally

(a) Except as otherwise provided in this section, whoever, in any 

matter within the jurisdiction of the executive, legislative, or judicial 

branch of the Government of the United States, knowingly and 

willfully -

(1) falsifies, conceals, or covers up by any trick, scheme, or 

device a material fact;

(2) makes any materially false, fictitious, or fraudulent 

statement or representation;

or

(3) makes or uses any false writing or document knowing the 

same to contain any materially false, fictitious, or fraudulent 

statement or entry;

shall be fined under this title or imprisoned not more than 5 years, 

or both.

(b) Subsection (a) does not apply to a party to a judicial proceeding, 

or that party's counsel, for statements, representations, writings or 

documents submitted by such party or counsel to a judge or 

magistrate in that proceeding.

(c) With respect to any matter within the jurisdiction of the 

legislative branch, subsection (a) shall apply only to –
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(1) Administrative matters, including a claim for payment, a 

matter related to the procurement of property or services, 

personnel or employment practices, or support services, or a 

document required by law, rule, or regulation to be submitted 

to the Congress or any office or officer within the legislative 

branch; or

(2) Any investigation or review, conducted pursuant to the authority 

of any committee, subcommittee, commission or office of the 

Congress, consistent with applicable rules of the House or Senate.

E. Sec. 1341. - Frauds and swindles

Whoever, having devised or intending to devise any scheme or artifice to 

defraud, or for obtaining money or property by means of false or 

fraudulent pretenses, representations, or promises, or to sell, dispose of, 

loan, exchange, alter, give away, distribute, supply, or furnish or procure 

for unlawful use any counterfeit or spurious coin, obligation, security, or 

other article, or anything represented to be or intimated or held out to be 

such counterfeit or spurious article, for the purpose of executing such 

scheme or artifice or attempting so to do, places in any post office or 

authorized depository for mail matter, any matter or thing whatever to be 

sent or delivered by the Postal Service, or deposits or causes to be 

deposited any matter or thing whatever to be sent or delivered by any 

private or commercial interstate carrier, or takes or receives therefrom, 

any such matter or thing, or knowingly causes to be delivered by mail or 

such carrier according to the direction thereon, or at the place at which it is 

directed to be delivered by the person to whom it is addressed, any such 

matter or thing, shall be fined under this title or imprisoned not more than 

20 years, or both. If the violation affects a financial institution, such person 

shall be fined not more than $1,000,000 or imprisoned not more than 30 

years, or both.

F. Sec. 1343. - Fraud by wire, radio, or television

Whoever, having devised or intending to devise any scheme or artifice to 

defraud, or for obtaining money or property by means of false or 

fraudulent pretenses, representations, or promises, transmits or causes to 

be transmitted by means of wire, radio, or television communication in 

interstate or foreign commerce, any writings, signs, signals, pictures, or 

sounds for the purpose of executing such scheme or artifice, shall be fined 

under this title or imprisoned not more than 20 years, or both. If the 

violation affects a financial institution, such person shall be fined not more 

than $1,000,000 or imprisoned not more than 30 years, or both.

G. Sec. 1505. - Obstruction of proceedings before departments, agencies, 

and committees

Whoever, with intent to avoid, evade, prevent, or obstruct compliance, in 

whole or in part, with any civil investigative demand duly and properly 
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made under the Antitrust Civil Process Act, willfully withholds, 

misrepresents, removes from any place, conceals, covers up, destroys, 

mutilates, alters, or by other means falsifies any documentary material, 

answers to written interrogatories, or oral testimony, which is the subject 

of such demand; or attempts to do so or solicits another to do so; or

Whoever corruptly, or by threats or force, or by any threatening letter or 

communication influences, obstructs, or impedes or endeavors to 

influence, obstruct, or impede the due and proper administration of the law 

under which any pending proceeding is being had before any department 

or agency of the United States, or the due and proper exercise of the 

power of inquiry under which any inquiry or investigation is being had by 

either House, or any committee of either House or any joint committee of 

the Congress -

Shall be fined under this title or imprisoned not more than five years, or 

both.

H. Sec. 1905. - Disclosure of confidential information generally

Whoever, being an officer or employee of the United States or of any 

department or agency thereof, any person acting on behalf of the Office of 

Federal Housing Enterprise Oversight, or agent of the Department of 

Justice as defined in the Antitrust Civil Process Act (15 U.S.C. 1311-

1314), or being an employee of a private sector organization who is or 

was assigned to an agency under chapter 37 of title 5, publishes, divulges, 

discloses, or makes known in any manner or to any extent not authorized 

by law any information coming to him in the course of his employment or 

official duties or by reason of any examination or investigation made by, or 

return, report or record made to or filed with, such department or agency 

or officer or employee thereof, which information concerns or relates to the 

trade secrets, processes, operations, style of work, or apparatus, or to the 

identity, confidential statistical data, amount or source of any income, 

profits, losses, or expenditures of any person, firm, partnership, 

corporation, or association; or permits any income return or copy thereof 

or any book containing any abstract or particulars thereof to be seen or 

examined by any person except as provided by law; shall be fined under 

this title, or imprisoned not more than one year, or both; and shall be 

removed from office or employment.