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PART VI- REFERENCES AND PROGRAM CONTACTS

REFERENCES

1. 21 CFR *Part 11 Electronic Records; Electronic Signatures*

Part 50 Protection of Human Subjects

Part 56 Institutional Review Boards

Part 312 Investigational New Drug Application

*Part 314 Applications for FDA Approval to Market A New Drug or An Antibiotic Drug*

Part 361 Prescription Drugs for Human Use Generally Recognized As Safe And Effective And Not Misbranded: Drugs Used In Research

Part 511 New Animal Drugs For Investigational Use

Part 514 New Animal Drug Applications, Sections 514.1, 514.8, 514.111

Part 571 Food Additive Petitions

Part 812 Investigational Device Exemptions

*Part 814 Premarket Approval of Medical devices (section 100 - Humanitarian Use Devices) *

2. 45 CFR Part 46 Protection of Human Subjects (NIH Requirements)

3. FD&C Act Secs. 301(e), 501(i), 505(i), 507(d), 510(b),(e),and (i), 512(j), 520(g)

4. Specific Forms

a. Form FDA-1571, Investigational New Drug Application,

21 CFR 312.40

b. Form FDA-1572, Statement of Investigator,

21 CFR 312.53(c)

c. Notice of Claimed Investigational Exemption for a New Animal Drug, 21 CFR 511.1(b)(4)

5. CVM guidance document, May 1997, "Good Target Animal Study Practices: Clinical Investigators and Monitors"

6. Guide for Detecting Fraud in Bioresearch Monitoring Inspections, April 1993

PROGRAM CONTACTS

When technical questions arise on a specific assignment, or when additional information or guidance is required, contact the assigning Center. Operational questions should be addressed to ORO (HFC-132).

Specific Contacts

Office of the Associate Commisioner for Regulatory Affairs

*James F. McCormack, Ph.D.
Bioresearch Monitoring Program Coordinator
Division of Compliance Policy (HFC-230)
Telephone 301-827-0425, FAX 301-827-0482*

Thaddeus Sze, Ph.D.
Bioresearch Program Monitor
*Division of Emergency and
Investigational Operations(HFC-132)*
Telephone 301-827-5649, FAX 301-443-6919.

Center for Drug Evaluation and Research (CDER)

*Bette Barton, Ph.D. M.D.*
Chief, Clinical Investigations Branch (HFD-344)
Telephone 301-594-1032, FAX 301-594-1204.
(or specific contact person named in the assignment)

Center for Biologics Evaluation and Research (CBER)

*Patricia Holobaugh*
Bioresearch Monitoring Team (HFM-650)
Telephone 301-827-6221, FAX 301-594-1944
(or specific contact person named in the assignment)

Center for Veterinary Medicine (CVM)

Dorothy Pocurull
Bioresearch Monitoring Program Staff (HFV-234)
Telephone 301-594-1785, FAX 301-594-1812.

Center for Devices and Radiological Health (CDRH)

*Robert K. Fish*
Division of Bioresearch Monitoring (HFZ-312)
Telephone 301-594-4723, FAX 301-594-4731.

Center for Food Safety and Applied Nutrition (CFSAN)

John J. Welsh, Ph.D.
Division of Product Policy (HFS-207)
Telephone 202-418-3057, FAX 202-418-3126.

*Current Changes *

Hypertext updated August 20,1998 by djv