Regulatory Procedures Manual March 2008 Chapter 1 ENFORCEMENT POLICY DIRECTORY

Compliance References
Regulatory Procedures Manual 2008

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1-8 - ENFORCEMENT POLICY DIRECTORY
     1-8-1 - Office Of Regulatory Affairs (ORA) Headquarters
     1-8-2 - Office Of Regulatory Affairs (Field)
     1-8-3 - FDA Centers

1-8 - ENFORCEMENT POLICY DIRECTORY

The most current version of this directory is available on FDA’s Intranet website.

1-8-1 - Office Of Regulatory Affairs (ORA) Headquarters

1.	Associate Commissioner for Regulatory Affairs (ACRA)
	a.	ACRA (HFC-1)......................................................................		301-827-3101
		i.	Deputy for Field Operations (HFC-1).....................................	301-827-3101
		ii.	Deputy for Compliance Policy (HFC-1)...................................	301-827-3101
2.	Office of Enforcement (OE)
	a.	Director, OE (HFC-200).......................................................... Compliance Policy Council Internet Regulatory Policy and Enforcement		240-632-6800
		i.	Director of Compliance, OE (HFC-201)...................................	240-632-6800
		ii.	Director, Division of Compliance Management and Operations (HFC-210)........................................................
		ii.		240-632-6850
		iii.	Director, Division of Compliance Policy (HFC-230)....................	240-632-6860
		iv.	Director, Division of Compliance Information and Quality Assurance (HFC-240)..............................................
		iv.		240-632-6820
	b.	Division of Compliance Management and Operations (HFC-210)...........................................................................
	b.			240-632-6850
			Case Review and Management Civil Money Penalties (Compliance) Inspection Warrants Recalls Team Biologics (Compliance) Warning Letter Database
	c.	Division of Compliance Policy (HFC-230)....................................		240-632-6860
			Bioresearch Misconduct and Monitoring Good Guidance Practices (GGPs) Good Laboratory Practices (GLPs)/Non-Clinical Information Disclosure (including FOI) Policy (Biologics, Civil Money Penalties, Cosmetics, Drugs, Foods, Medical Devices, Veterinary Medicine, and Radiation Emitting Electronic Products) Publications (Compliance Policy Guides Manual, Enforcement Notes, Enforcement Story, Information Disclosure Manual, Regulatory Procedures Manual), Testimony
	d.	Division of Compliance Information and Quality Assurance (HFC-240) .................................................
	d.			240-632-6820
			Electronic Regulatory Information Assurance FACTS Firm Profiles (COMSTAT) Gold Disk Government-Wide Quality Assurance Program (GWQAP) Quality Management Systems (QMS) Turbo EIR
3.	Office of Regional Operations (ORO)
	a.	Director, ORO (HFC-100) .......................................................		301-443-6230
		i.	Director of Compliance, OE (HFC-201)...................................	240-632-6800
	b.	Director, Division of Field Investigations (HFC-130) ....................		301-827-5653
		i.	Director, Domestic Operations Branch (HFC-130).....................	301-827-5653
		ii.	Director, International Operations Branch (HFC-130) ......................................................................
		ii.		301-827-5653
	c.	Director, Division of Field Science (HFC-140)..............................		301-827-7605
	d.	Director, Division of Federal/State Relations (HFC-150) ...............		301-827-6906
	e.	Director, Division of Import Operations & Policy (HFC-170) ..........................................................................
	e.			301-443-6553
		i.	Director, Operations & Policy Branch (HFC-170) .....................	301-594-3845
		ii.	Director, Systems Branch (HFC-170) ....................................	301-594-1162
		(As of October 18, 2002 Emergency Operations has been organized structurally as Office of Emergency Operations, Office of Crisis Management, Office of the Commissioner)
4.	Office of Resource Management (ORM)
	a.	Director, ORM (HFC-10) ........................................................		301-443-2175
	b.	Deputy Director, ORM (HFC-10) ..............................................		301-443-2175
5.	Office of Criminal Investigations (OCI)
	a.	Director, OCI (HFC-300) ........................................................		240-276-9500

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1-8-2 - Office Of Regulatory Affairs (Field)

1.	Northeast Region
	a.	Regional Food and Drug Director, HFR-NE1 .................................. FAX .................................................................................... Deputy Regional Food and Drug Director, HFR-NE2 ....................... FAX ....................................................................................		718-662-5416
				718-662-5434
				718-662-5610
				718-662-5530
	b.	New York District Office ..........................................................		718-340-7000
		i.	District Director, HFR-100..................................................... FAX .................................................................................	718-662-5447
				781-662-5665
			Director Compliance Branch, HFR-NE340.............................................................. FAX........................................................................
				716-551-4461 Ext 3116
				716-551-4499
	c.	New England District Office .....................................................		781-596-7700
		i.	District Director, HFR-NE200 ................................................. FAX .................................................................................	781-596-7717
				781-596-7758
			Director Compliance Branch, HFR-NE240 ....................... FAX........................................................................	781-596-7795
				781-596-7899
	d.	Winchester Engineering & Analytical Center .................................		781-729-5700
		i.	Director, HFR-NE400 ........................................................... FAX..................................................................................	781-729-5700 Ext 749
				781-729-3593
	e.	Northeast Regional Laboratory
		i.	Director, HFR-NE500 ........................................................... FAX..................................................................................	718-662-5450
				718-340-7061
2.	Central Region
	a.	Regional Food and Drug Director, PHI-FO, HFR-CE1 ...................... FAX.....................................................................................		215-717-3701
				215-597-5798
	b.	Deputy Regional Food and Drug Director, CHI-FO HFR-CE2 .............................................................................. FAX.....................................................................................
				312-596-6520
				312-886-1682
	c.	Baltimore District Office
		i.	District Director, HFR-CE200 .................................................	410-779-5424
			Director Compliance Branch, HFR-CE240........................ FAX........................................................................	410-779-5412
				410-779-5703
	d.	Chicago District Office
		i.	District Director, HFR-CE600 .................................................	312-596-4200
			Director Compliance Branch, HFR-CE640 ....................... FAX........................................................................	312-596-4220
				312-596-4195
	e.	Cincinnati District Office
		i.	District Director, HFR-CE400..................................................	513-679-2700 Ext 116
			Director Compliance Branch HFR-CE440 ............................................................. FAX........................................................................
				513-679-2700 Ext 160
				513-679-2775
	f.	Detroit District Office
		i.	District Director, HFR-CE700 .................................................	313-393-8106
			Director Compliance Branch, HFR-CE740 ....................... FAX........................................................................	313-393-8110
				313-393-8139
	g.	Forensic Chemistry Center
		i.	Director, HFR-CE500 ........................................................... FAX..................................................................................	513-679-2700 Ext 180
				513-679-2761
	h.	Minneapolis District Office
		i.	District Director, HFR-CE800 .................................................	612-758-7124
			Director Compliance Branch, HFR-CE840 ....................... FAX.......................................................................	612-758-7112
				612-334-4134
	i.	New Jersey District Office
		i.	District Director, HFR-CE300 ................................................	973-331-4901
			Director Compliance Branch, HFR-CE340 ....................... FAX........................................................................	973-331-4902
				973-331-4969
	j.	Philadelphia District Office
		i.	District Director, HFR-CE100 .................................................	215-717-3001
			Director Compliance Branch, HFR-CE140.............................................................. FAX........................................................................
				215-717-3071
				215-597-8212
3.	Southeast Region
	a.	Regional Food and Drug Director, HFR-SE1................................... FAX.....................................................................................		404-253-1171
				404-253-1207
	b.	Atlanta District Office
		i.	District Director, HFR-SE100.................................................	404-253-1161
			Director Compliance Branch, HFR-SE140........................ FAX........................................................................	404-253-2239
				404-253-1201
	c.	Florida District Office
		i.	District Director, HFR-SE200 .................................................	407-475-4701
			Director Compliance Branch, HFR-SE240 ....................... FAX........................................................................	407-475-4734
				407-475-4769
	d.	New Orleans District Office
		i.	District Director, HFR-SE400 .................................................	615-781-5388
			Director Compliance Branch, HFR-SE440.............................................................. FAX........................................................................
				504-219-8818 Ext 101
				504-219-8813
	e.	San Juan District Office
		i.	District Director, HFR-SE500 ................................................	787-474-9565
			Director Compliance Branch, HFR-SE540 .............................................................. FAX........................................................................
				787-474-9514
				717-729-6658
	f.	Southeast Regional Laboratory
		i.	Director, HFR-SE600............................................................ FAX..................................................................................	404-253-1176
				404-253-1208
4.	Southwest Region
	a.	Regional Food and Drug Director, HFR-SW1 ................................ FAX.....................................................................................		214-253-4904
				214-253-4965
	b.	Arkansas Regional Laboratory
		i.	Director, HFR-SW500 .......................................................... FAX..................................................................................	870-543-4099
				870-543-4002
	c.	Dallas District Office
		i.	District Director, HFR-SW100 ................................................	214-253-5201
		ii.	Director Compliance Branch, HFR-SW140 ................................ FAX..................................................................................	214-253-5215
				214-253-5313
	d.	Denver District Office
		i.	District Director, HFR-SW200 ................................................	303-236-3016
		ii.	Director Compliance Branch, HFR-SW240 ................................. FAX..................................................................................	303-236-3019
				303-236-3551
	e.	Kansas City District Office
		i.	District Director, HFR-SW300 ................................................	913-752-2144
		ii.	Director Compliance Branch, HFR-SW340 ................................ FAX..................................................................................	913-752-2101
				913-752-2111
	f.	Southwest Import District Office
		i.	Director, HFR-SW600 ..........................................................	214-253-5283
		ii.	Director Compliance Branch, HFR-SW640 ................................. FAX..................................................................................	214-253-5284
				214-253-5316
5.	Pacific Region
	a.	Regional Food and Drug Director, HFR-PA1 .................................. FAX......................................................................................		510-637-3960 Ext 143
				510-637-3976
	b.	Los Angeles District Office
		i.	District Director, HFR-PA200 .................................................	949-608-4414
		ii.	Director Compliance Branch, HFR-PA240 .................................. FAX..................................................................................	949-608-4426
				949-608-4401
	c.	San Francisco District Office
		i.	District Director, HFR-PA100 .................................................	510-337-6783
		ii.	Director Compliance Branch, HFR-PA140 .................................. FAX..................................................................................	510-337-6846
				510-337-6702
	d.	Seattle District Office
		i.	District Director, HFR-PA300 .................................................	425-483-4950
		ii.	Director Compliance Branch, HFR-PA340 ................................. FAX..................................................................................	425-483-4963
				425-483-4760
	e.	Pacific Regional Laboratory Northwest
		i.	Director, HFR-PA360 ........................................................... FAX..................................................................................	425-483-4901
				425-483-4918
	f.	Pacific Regional Laboratory Southwest
		i.	Director, HFR-PA260 ........................................................... FAX..................................................................................	949-608-2907
				949-608-3567

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1-8-3 - FDA Centers

1.	Center For Biologics Evaluation And Research (CBER)
	a.	Director, Office of Compliance and Biologics Quality, HFM-600 ................................................................................
				301-827-6190
	b.	Deputy Director, Office of Compliance and Biologics Quality, HFM-600 .........................................................
				301-827-6190
		i.	Director, Division of Case Management, HFM-610 .......................	301-827-6201
		ii.	Director, Division of Inspections and Surveillance, HFM-650 ...........................................................................
				301-827-6220
		iii.	Director, Division of Manufacturing and Product Quality, HFM-670 .....................................................
				301-827-3031
2.	Center For Drug Evaluation And Research (CDER)
	a.	Director, Office of Compliance, HFD-300 .................................................................................
				301-827-8910
		i.	Associate Director of Scientific & Medical Affairs, HFD-300 ............................................................................
				301-827-8910
		ii.	Deputy Director, Office of Compliance, HFD-301 ............................................................................
				301-827-8910
		iii.	Associate Director, HFD-300 ...................................................	301-827-8910
		iv.	Director, Division of New Drugs and Labeling Compliance, HFD-310 ................................................
				301-827-8930
			Deputy Director, HFD-310 ........................................... Associate Director, HFD-310 ........................................ OTC Drugs Team, HFD-313 .......................................... Internet and Health Fraud Team, HFD-315 ..................... Compounding Team, HFD-317 ...................................... New Drugs and Labeling Team, HFD-318 ........................ Imports and Exports Team, HFD-319 .............................	301-827-8930
				301-827-8930
				301-827-8930
				301-827-8930
				301-827-8930
				301-827-8930
				301-827-8930
		v.	Director, Division of Manufacturing and Product Quality, HFD-320 ......................................................
				301-827-8940
			Deputy Director, HFD-320 ........................................... Recalls, Shortages & Certificates Branch, HFD-321 .......... Manufacturing Assessment & Pre-Approval Compliance Branch, HFD-322 ...................................... New & Generic Drug Manufacturing Team, HFD-323 .................................................................. International Compliance Team, HFD-325 ....................... Biotech Manufacturing Team, HFD-328 ......................... Case Management & Guidance Branch, HFD-326 ............. Case Management Team, HFD-327 ............................... Guidance and Policy Development Team, HFD-329 ..........	301-827-8940
				301-827-9045

				301-827-8942

				301-827-9013
				301-827-9021
				301-827-8942
				301-827-8941
				301-827-9023
				301-827-9046
		vi.	Director, Division of Compliance Risk Management & Surveillance, HFD-330 .....................................
				301-827-8920
			Deputy Director, HFD-330 .......................................... Risk Management and Strategic Problem Solving Team, HFD-331 ................................................................. Surveillance and Data Analysis Branch, HFD-332 ................................................................. Surveillance Programs Team, HFD-333 .......................... Data Analysis & Information Management Team, HFD-335 ................................................................. Drug Registration & Listing Team, HFD-337 ....................	301-827-8920

				301-827-8920

				301-827-8920
				301-827-8920

				301-827-8920
				301-827-8920
		vii.	Director, Division of Scientific Investigations, HFD-45 ........................................................
				240-276-8817
			Deputy Director, HFD-45 ............................................ Good Clinical Practice Branch 1, HFD-46 ........................ Good Clinical Practice Branch 2, HFD-47 ........................ Good Laboratory Practices Bioequivalence Branch, HFD-48 ...................................	240-276-8817
				240-276-8817
				240-276-8817

				240-276-8817
3.	Center For Devices And Radiological Health (CDRH)
	a.	Director, Office of Compliance, HFZ-300 .......................................		240-276-0100
		i.	Deputy Director for Regulatory Affairs, Office of Compliance, HFZ-300 ..............................................
				240-276-0103
		ii.	Deputy Director for Medical Affairs, Office of Compliance, HFZ-300 ..............................................
				240-276-0105
		iii.	Director, Division of Risk Management Operations, HFZ-305 ...........................................................................
				240-276-0130
			Deputy Director, Division of Risk Management Operations, HFZ-305 ................................................. Chief, Risk Management and Analysis Branch, HFZ-305 ................................................................. Chief, Field Operations Branch, HFZ-306 ....................... Chief, Regulatory Policy and Systems Branch, HFZ-307 .................................................................
				240-276-0130

				240-276-0130
				240-276-0186

				240-276-0219
		iv.	Director, Division of Bioresearch Monitoring, HFZ-310 ..........................................................................
				240-276-0125
			Chief, Program Enforcement Branch, HFZ-311 ................................................................. Chief, Special Investigations Branch, HFZ-312 .................................................................
				240-276-0125

				240-276-0125
		v.	Director, Division of Enforcement A, HFZ-320 ...........................	240-276-0165
			Deputy Director, Division of Enforcement A, HFZ-320 ................................................................. Case Expert, HFZ-320 ................................................ GMP/Quality Systems Expert, HFZ-320 .......................... Chief, General Surgical Devices Branch, HFZ-323 .................................................................. Chief, Dental, ENT and Ophthalmic Devices Branch, HFZ-331 .................................................................. Chief, OB/GYN, Gastroenterology and Urology Devices Branch, HFZ-332 ................................. Chief, General Hospital Devices Branch, HFZ-333 ..................................................................
				240-276-0344
				Vacant
				240-276-0354

				240-276-0163

				240-276-0352

				240-276-0356

				240-276-0343
		vi.	Director, Division of Enforcement B, HFZ-340 ............................	240-276-0306
			Deputy Director, Division of Enforcement B, HFZ-340 .................................................................. Case Expert, HFZ-340 ................................................ GMP/Quality Systems Expert, HFZ-340 .......................... Software Expert, HFZ-340 ........................................... Chief, Cardiovascular and Neurological Devices Branch, HFZ-341 ........................... Chief, Orthopedic, Physical Medicine and Anesthesiology Devices Branch, HFZ-342 ....................... Radiology Devices Team ..............................................
				240-276-0147
				Vacant
				240-276-0120
				240-276-0284

				240-276-0295

				240-276-0293
				240-276-0120
	b.	Director, Office of In Vitro Diagnostic Device Evaluation and Safety, HFZ-440 ................................................................
				240-276-0450
		i.	Deputy Director, Patient Safety and Product Quality, Office of In VitroDiagnostic Device Evaluation and Safety, HFZ-440 .................................................................

				240-276-0377
	c.	Director, Office of Communication, Education and Radiation Programs, HFZ-200 ......................................................
				240-276-3200
		i.	Director, Division of Mammography Quality and Radiation Programs, HFZ-240 .................................................
				240-276-3332
			Chief, Electronic Products Branch ................................. Chief, Diagnostic X-Ray Devices Branch ......................... Chief, Inspection and Compliance Branch .......................	240-276-3332
				240-276-3332
				240-276-3332
4.	Center For Food Safety And Applied Nutrition (CFSAN)
	a.	Director, Office of Compliance (OC), HFS-600 ................................		301-436-2359
		i.	Special Assistant (OC), HFS-600 ............................................	301-436-2359
		ii.	Deputy Director (OC), HFS-600 ..............................................	Vacant
		iii.	Division of Enforcement, HFS-605 ...........................................	301-436-1750
			Recall Team, HFS-605................................................. Manufacturing and Storage Adulteration Branch, HFS-607................................................................... Labeling Compliance Team............................................ Product Adulteration Branch, HFS-606 ...........................	301-436-2082

				301-436-1611
				Vacant
				301-436-1742
		iv.	Division of Field Programs and Guidance, HFS-615 ......................	Vacant
			Field Programs Branch................................................. Compliance Information Branch ....................................	Vacant
				Vacant
	b.	Director, Office of Cosmetics and Colors (OCAC), HFS-100 ...............		301-436-1130
		i.	Deputy Director (OCAC) ........................................................	Vacant
		ii.	Cosmetics Staff, HFS-125......................................................	301-436-1124
			Industry Activities Team, HFS-320 ................................	Vacant
		iii.	Division of Color Certification and Technology, HFS-105 ..............	301-436-1108
			Color Technology Team, HFS-106 ................................. Color Certification Branch, HFS-107 ..............................	301-436-1119
				301-436-1136
	c.	Director, Office of Nutrition, Labeling and Dietary Supplements (ONLDS), HFS-800 ....................................................................
				301-436-2373
		i.	Deputy Director (ONLDS), HFS-800 .........................................	301-436-1761
		ii.	Food Labeling and Standards Staff, HFS-820 ............................	301-436-2371
			Product Evaluation and Labeling Team, HFS-820 .................................................................. Labeling Regulations Implementation Team, HFS-820 ..................................................................
				301-436-1802

				301-436-1690
		iii.	Nutrition Programs Staff, HFS-830...........................................	301-436-1450
			Nutrition Assessment and Evaluation Team, HFS-830 .................................................................. Nutrition Science Review Team, HFS-830 .......................
				301-436-1788
				301-436-2579
		iv.	Division of Dietary Supplement Programs, HFS-810 .....................	301-436-1850
			Clinical Evaluation Team.............................................. Dietary Supplement Regulations Implementation Team, HFS-810.......................................................... NDI Review Staff, HFS-810...........................................	Vacant

				301-436-1441
				301-436-1448
		v.	Infant Formula and Medical Foods Staff, HFS-850 ......................	301-436-1459
	d.	Director, Office of Food Safety (OFS), HFS-300 .............................		301-436-1700
		i.	Deputy Director (OFS), HFS-300 ............................................	301-436-2300
		ii.	Chemical Hazard Assessment Team, HFS-301 ............................	301-436-1941
		iii.	Food Processing Evaluation Team, HFS-302 ..............................	301-436-1693
		iv.	Division of Seafood Science and Technology .............................	Vacant
			Chemical Hazards Science Branch, HFS-400 ................. Microbiological Hazards Science Branch .......................	215-690-3368
				Vacant
		v.	Division of Food Processing Science and Technology, HFS-450 ............................................................................
				708-728-4154
			Process Engineering Branch, HFS-450 ............................ Food Technology Branch, HFS-450 ............................... Laboratory Proficiency and Evaluation Team, HFS-450 ..................................................................	708-728-4131
				708-728-4146

				708-728-4115
		vi.	Division of Plant and Dairy Food Safety, HFS-315 ......................	301-436-1488
			Dairy and Egg Branch, HFS-316 .................................... Plant Products Branch, HFS-317 ...................................	301-436-1494
				301-436-2023
		vii.	Retail Food & Cooperative Programs Coordination Staff ...............	Vacant
			Retail Food Protection Team, HFS-320 ...........................	301-436-2150
		viii.	Division of Seafood Safety, HFS-325 .......................................	301-436-1422
			Shellfish & Aquaculture Policy Branch ............................ Seafood Processing and Technology Policy Branch ...........	Vacant
				Vacant
	e.	Director, Office of Regulatory Science (ORS), HFS-700 ...................		301-436-1990
		i.	Deputy Director (ORS), HFS-700 ............................................	301-436-1908
		ii.	Division of Analytical Chemistry, HFS-705 .................................	301-436-1898
			Methods Development Branch ...................................... Spectroscopy & Mass Spectrometry Branch ...................	Vacant
				Vacant
		iii.	Division of Microbiology, HFS-710 ...........................................	301-436-2007
			Microbial Methods Development Branch, HFS-711 ............ Molecular Methods and Subtyping Branch .......................	301-436-2009
				Vacant
		iv.	Division of Bioanalytical Chemistry, HFS-715 .............................	301-436-1786
			Chemical Contaminants Branch, HFS-716 ....................... Bioanalytical Methods Branch .......................................	301-436-2003
				Vacant
5.	Center For Veterinary Medicine (CVM)
	a.	Director, Office of Surveillance and Compliance (OS &C), HFV-200 .................................................................................
				240-453-6830
	b.	Deputy Director, OS&C, HFV-200 .................................................		240-453-6830
		i.	Director, Division of Surveillance, HFV-210 ...............................	240-276-9062
			Team Leader, Marketed Product Information Team, HFV-212 .................................................................. Team Leader, Pharmacovigilance Review Team, HFV-214 .................................................................. Team Leader, Marketed Product Scientific and Regulatory Review, HFV-216 .......................................................
				240-276-9064

				240-453-6844

				240-276-9065
		ii.	Director, Division of Animal Feeds, HFV-220 ..............................	240-453-6864
			Team Leader, Feed Safety Team, HFV-222 .................... Team Leader, Medicated Feeds Team, HFV-226 .................................................................. Team Leader, Nutrition and Labeling Team, HFV-228 ..................................................................	240-453-6851

				240-453-6858

				240-453-6866
		iii.	Director, Division of Compliance, HFV-230 .................................	240-276-9200
			Team Leader, Enforcement and Regulatory Policy Team, HFV-232 ................................................ Team Leader, BIMO and Administrative Actions Team, HFV-234 .............................................. Team Leader, Compliance Information Management Team, HFV-235 .......................................
				240-276-9239

				240-276-9238

				240-276-9209

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