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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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PART VI - REFERENCES AND CONTACTS

A. REFERENCES

1. FDA laws

Federal Food Drug and Cosmetic Act (FFDCA) – Sections 501(i), 505(i), 505(k)(2), 510(k), 513(f), 515, 520(g), and 520(m)

2. Most Relevant 21 CFR Regulations

Part 50 Protection of Human Subjects Part 56 Institutional Review Boards

Part 312 Investigational New Drug Application Part 511 New Animal Drugs for Investigational Use Part 812 Investigational Device Exemptions

3. Other 21 CFR Regulations

Part 11 Electronic Records; Electronic Signatures, Part 54 Financial Disclosure by Clinical Investigators

Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies (when applicable) Part 314 Applications for FDA Approval to Market a New Drug or Antibiotic Drug

Part 514 New Animal Drug Applications

Part 601 Licensing (Applications for FDA Approval of a Biologic License) Part 807 Premarket Notification Procedures (Subpart E)

Part 814 Premarket Approval of Medical Devices (includes HDE requirements in 814.100)

4. SPECIFIC FORMS

a. Form FDA 1571 – Investigational New Drug Application (See 21 CFR 312.23(a)(1)) (http://www.fda.gov/downloads/
AboutFDA/ReportsManualsForms/Forms/UCM083533.pdf
)

b. Form FDA 1572 – Statement of Investigator (See 21 CFR 312.53(c)(1)) (http://www.fda.gov/downloads/
AboutFDA/ReportsManualsForms/Forms/UCM074728.pdf
)

c. Form FDA 3454 – Certification: Financial Interests and Arrangements of Clinical Investigators (See 21 CFR 54.4(a)(1))
(http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/
Forms/UCM048304.pdf
)

d. Form FDA 3455 – Disclosure: Financial Interests and Arrangements of Clinical Investigators (See 21 CFR 54.4(a)(3))
(http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/
Forms/UCM048310.pdf
)

e. Form FDA 3458 – Notice of Claimed Investigational Exemption for a New Animal Drug (See 21 CFR 511.1(b)(4))
(http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/
Forms/UCM052356.pdf
)

5. FDA Guidelines, Guidances, and Inspection Guides

FDA Information Sheet Guidances for Institutional Review Boards, Clinical Investigators, and Sponsors
(http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/
GuidancesInformationSheetsandNotices/ucm113709.htm
)

Guidance for Industry: International Conference on Harmonization (ICH) E6, Good Clinical Practice: Consolidated Guidance
(http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.pdf
)

Guidance for Industry: Computerized Systems Used in Clinical Investigations (http://www.fda.gov/
downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070266.pdf
)  

Guidance for Industry: Part 11: Electronic Records, Electronic Signatures-- Scope and Application (http://www.fda.gov/
downloads/RegulatoryInformation/Guidances/ucm126953.pdf
)

Guidance for Industry: Financial Disclosure by Clinical Investigators (http://www.fda.gov/RegulatoryInformation/
Guidances/ucm126832.htm
)

General Principles of Software Validation; Final Guidance for Industry and FDA Staff (http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085281.htm
)

Investigations Operations Manual (IOM), Sections 5.3.8.3 (Filmed or Electronic Records) and 5.3.8.4 (Requesting and Working with Computerized Complaint and Data Failure) (http://www.fda.gov/ICECI/Inspections/IOM/ucm122531.htm)

Guidance for Industry: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects
(http://www.fda.gov/downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/UCM187772.pdf
)

Guidance for Industry (Guidance 85): Veterinary International Conference on Harmonization (VICH) GL9, Good Clinical Practice, Final Guidance (http://www.fda.gov/downloads/
AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052417.pdf
)  

Compliance Policy Guide # 7150.09: Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities
(http://www.fda.gov/ICECI/ComplianceManuals/
CompliancePolicyGuidanceManual/ucm073837.htm
)

Compliance Policy Guide # 7151.02: FDA Access to Results of Quality Assurance Program Audits and Inspections
(http://www.fda.gov/ICECI/ComplianceManuals/
CompliancePolicyGuidanceManual/ucm073841.htm
)

Guidance for Industry and Food and Drug Administration Staff: The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program
(http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/ucm071557.htm
)

Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff – Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of the Public Health Service Act, Added by Title VIII of the Food and Drug Administration Amendments Act of 2007
(http://www.fda.gov/RegulatoryInformation/
Guidances/ucm125335.htm
)

B. PROGRAM CONTACTS

1. When medical, technical or scientific questions or issues arise about a specific assignment or if additional information is required about a specific assignment, consult the Center contact identified in the assignment.

2. For operational questions, contact:

Office of the Associate Commissioner for Regulatory Affairs
Office of Regional Operations (ORO)
Division of Domestic Field Investigations
301-796-5403, FAX 301-827-4090

or

Division of Foreign Field Investigations
301-796-5521, FAX 301-827-6685

3. For questions about GCP and Compliance program issues, specific to a Center product area, contact:

Center for Drug Evaluation and Research (CDER)
Division of Scientific Investigations:
301-796-3150, FAX 301-847-8748

Center for Biologics Evaluation and Research (CBER)
Bioresearch Monitoring Staff:
301-827-6221, FAX 301-827-6748


Center for Veterinary Medicine (CVM)
Premarket Compliance and Administrative Actions Team
240-276-9200, FAX 240-276-9241

Center for Devices and Radiological Health (CDRH)
Division of Bioresearch Monitoring:
301-796-5490, FAX 301-847-8136

Center for Food Safety and Applied Nutrition (CFSAN)
Division of Petition Review, CFSAN BIMO Program Manager
Catherine Whiteside, Ph.D., HFS-265
301-436-1265, FAX 301-436-2972

4. For crosscutting questions about Good Clinical Practice (GCP) policy and program issues impacting the Agency's BIMO Programs, or suggestions to improve this Compliance Program, contact:

Office of Good Clinical Practice
Office of the Commissioner
301-796-8340, FAX 301-847-8640

5. For information about inspection warrants and final issuance of Notice of Opportunity of Hearing (NOOH) letters for clinical investigator disqualifications, contact:

Office of Regulatory Affairs
Office of Enforcement (OE)
Director, Division of Compliance Management and Operations
301-796-8203, FAX 301-847-8635