Form 3537 DHHS/FDA-Food Facility Registration Form

Form Approval: OMB No. 0910-xxxx

Expiration Date:

See OMB Statement at end of form

DHHS/FDA - FOOD FACILITY REGISTRATION FORM

FDA USE ONLY

U SE BLUE OR BLACK INK ONLY

Date: (MM/DD/YYYY)
Section 1 - TYPE OF REGISTRATION
1a. O DOMESTIC REGISTRATION	O FOREIGN REGISTRATION
1b. O INITIAL REGISTRATION	O UPDATE OF REGISTRATION INFORMATION
If update, provide the following: Facility Registration Number: _________________________________ PIN___________________________
Check all that apply and further identify changes in the applicable sections.	O United States Agent Change – Foreign facilities only
O Facility Name Change	O Seasonal Facility Dates of Operation Change
O Facility Address Change (see instructions)	O Type of Activity Change
O Preferred Mailing Address Change	O Type of Storage Change
O Parent Company Change	O Human Food Product Category Change
O Emergency Contact Change	O Animal Food Product Category Change
O Trade Name Change	O Operator or Agent in Charge Change
1c. ARE YOU THE NEW OWNER OF A PREVIOUSLY REGISTERED FACILITY? Yes O No O If “yes”, provide the following information, if known.
Previous owner’s name:	Previous owner’s registration number:
Section 2 - FACILITY NAME / ADDRESS INFORMATION
FACILITY NAME:
FACILITY STREET ADDRESS, Line 1:
FACILITY STREET ADDRESS, Line 2:
CITY:	STATE:
ZIP CODE (POSTAL CODE):	PROVINCE/TERRITORY:
COUNTRY:	PHONE NUMBER (Include Area/Country Code):
FAX NUMBER (OPTIONAL; Include Area/ Country Code):	E-MAIL ADDRESS (OPTIONAL):

Section 3 - PREFERRED MAILING ADDRESS INFORMATION complete this section only if different from Section 2, Facility Name/Address Information (OPTIONAL)
NAME:
ADDRESS, Line 1:
ADDRESS, Line 2:
CITY:	STATE:
ZIP CODE (POSTAL CODE):	PROVINCE/TERRITORY:
COUNTRY:	PHONE NUMBER (Include Area/ Country Code):
FAX NUMBER (Include Area/ Country Code):	E-MAIL ADDRESS:

Section 4 - PARENT COMPANY NAME / ADDRESS INFORMATION (IF APPLICABLE AND IF DIFFERENT FROM SECTIONS 2 AND 3). IF INFORMATION IS THE SAME AS ANOTHER SECTION, CHECK WHICH SECTION: SECTION 2 O or SECTION 3 O
NAME OF PARENT COMPANY:
STREET ADDRESS OF PARENT COMPANY, Line 1:
STREET ADDRESS OF PARENT COMPANY, Line 2:
CITY:	STATE:
ZIP CODE (POSTAL CODE):	PROVINCE/TERRITORY:
COUNTRY:	PHONE NUMBER (Include Area/ Country Code):
FAX NUMBER (OPTIONAL; Include Area/Country Code):	E-MAIL ADDRESS (OPTIONAL):
Section 5 - FACILITY EMERGENCY CONTACT INFORMATION (OPTIONAL FOR FOREIGN FACILITIES; FDA WILL USE YOUR U.S. AGENT AS YOUR EMERGENCY CONTACT UNLESS YOU CHOOSE TO DESIGNATE A DIFFERENT CONTACT HERE.)
INDIVIDUAL’S NAME (OPTIONAL):
TITLE (OPTIONAL):	EMERGENCY CONTACT PHONE (Include area/ country code):
E-MAIL ADDRESS (OPTIONAL):

Section 6 – TRADE NAMES (IF THIS FACILITY USES TRADE NAMES OTHER THAN THAT LISTED IN SECTION 2 ABOVE, LIST THEM BELOW (E.G., “ALSO DOING BUSINESS AS,” “FACILITY ALSO KNOWN AS”):
ALTERNATE TRADE NAME #1:
ALTERNATE TRADE NAME #2:
ALTERNATE TRADE NAME #3:
ALTERNATE TRADE NAME #4:
Section 7 - UNITED STATES AGENT (TO BE COMPLETED BY FACILITIES LOCATED OUTSIDE ANY STATE OR TERRITORY OF THE UNITED STATES, THE DISTRICT OF COLUMBIA, OR THE COMMONWEALTH OF PUERTO RICO.)
NAME OF U.S. AGENT:
TITLE (OPTIONAL):
ADDRESS, Line 1:
ADDRESS, Line 2:
CITY:	STATE:	ZIP CODE:
U.S. AGENT PHONE NUMBER (Include Area Code):	EMERGENCY CONTACT PHONE NUMBER (Include Area Code):
FAX NUMBER (OPTIONAL; Include Area Code):	E-MAIL ADDRESS (OPTIONAL):

Section 8 - SEASONAL FACILITY DATES OF OPERATION

(GIVE THE APPROXIMATE DATES THAT YOUR FACILITY IS OPEN FOR BUSINESS, IF ITS OPERATIONS

ARE ON A SEASONAL BASIS) (OPTIONAL)

DATES OF OPERATION:

Section 9 - TYPE OF ACTIVITY CONDUCTED AT THE FACILITY (CHECK ALL TYPES OF OPERATIONS THAT ARE PERFORMED AT THIS FACILITY REGARDING THE MANUFACTURING/PROCESSING, PACKING OR HOLDING OF FOOD) (OPTIONAL)
O Warehouse / Holding Facility (e.g., storage facilities, including storage tanks, grain elevators)
O Acidified / Low Acid Food Processor		O Labeler / Relabeler
O Interstate Conveyance Caterer/Catering Point		O Manufacturer / Processor
O Molluscan Shellfish Establishment		O Repacker / Packer
O Commissary		O Salvage Operator (Reconditioner)
O Contract Sterilizer		O Animal food manufacturer / processor / holder
Section 10 – TYPE OF STORAGE (FOR FACILITIES THAT ARE PRIMARILY HOLDERS) (OPTIONAL)
O Ambient (neither frozen nor refrigerated) Storage	O Refrigerated Storage		O Frozen Storage

Section 11a - GENERAL PRODUCT CATEGORIES - FOOD FOR HUMAN CONSUMPTION To be completed by all food facilities. Please see instructions for further examples. IF NONE OF THE MANDATORY CATEGORIES BELOW APPLY, SELECT BOX 37.
O 1. ALCOHOLIC BEVERAGES [21 CFR 170.3 (n) (2)]	O 7. CHEESE AND CHEESE PRODUCTS [21 CFR 170.3 (n) (5)]
O 2. BABY (INFANT AND JUNIOR) FOOD PRODUCTS Including Infant Formula (Optional Selection)	O 8. CHOCOLATE AND COCOA PRODUCTS [21 CFR 170.3 (n) (3), (9), (38), (43)]
O 3. BAKERY PRODUCTS, DOUGH MIXES, OR ICINGS [21 CFR 170.3 (n) (1), (9)]	O 9. COFFEE AND TEA [21 CFR 170.3 (n) (3), (7)]
O 4. BEVERAGE BASES [21 CFR 170.3 (n) (3), (16), (35)]	O 10. COLOR ADDITIVES FOR FOODS [21 CFR 170.3 (o) (4)]
O 5. CANDY WITHOUT CHOCOLATE, CANDY SPECIALITIES & CHEWING GUM [21 CFR 170.3 (n ) (6), (9), (25), (38)]	O 11. DIETARY CONVENTIONAL FOODS OR MEAL REPLACEMENTS (includes Medical Foods) [21 CFR 170.3 (n ) (31)]
O 6. CEREAL PREPARATIONS, BREAKFAST FOODS, QUICK COOKING/INSTANT CEREALS [21 CFR 170.3 (n) (4)]

Section 11a - GENERAL PRODUCT CATEGORIES - FOOD FOR HUMAN CONSUMPTION (CONTINUED) To be completed by all food facilities. Please see instructions for further examples. IF NONE OF THE MANDATORY CATEGORIES BELOW APPLY, SELECT BOX 37.
12. DIETARY SUPPLEMENTS O Proteins, Amino Acids, Fats and Lipid Substances [21 CFR 170.3 (o) (20)] O Vitamins and Minerals [21 CFR 170.3 (o) (20)] O Animal By-Products and Extracts (Optional Selection) OHerbals and Botanicals (Optional Selection)	O 23. MILK, BUTTER, OR DRIED MILK PRODUCTS [21 CFR 170.3 (n) (12), (30), (31)]
	O 24. MULTIPLE FOOD DINNERS, GRAVIES, SAUCES AND SPECIALTIES [21 CFR 170.3 (n) (11), (14), (17), (18), (23), (24), (29), (34), (40)]
	O 25. NUT AND EDIBLE SEED PRODUCTS [21 CFR 170.3 (n) (26), (32)]
O 13. DRESSINGS AND CONDIMENTS [21 CFR 170.3 (n) (8), (12)]	O 26. PREPARED SALAD PRODUCTS [21 CFR 170.3 (n) (11), (17), (18), (22), (29), (34), (35)]
O 14. FISHERY/SEAFOOD PRODUCTS [21 CFR 170.3 (n) (13), (15), (39), (40)]	O 27. SHELL EGG AND EGG PRODUCTS [21 CFR 170.3 (n) (11), (14)]
O 15. FOOD ADDITIVES, GENERALLY RECOGNIZED AS SAFE (GRAS) INGREDIENTS, OR OTHER INGREDIENTS USED FOR PROCESSING [21 CFR 170.3 (n) (42); 21 CFR 170.3 (o) (1), (2), (3), (5), (6), (7), (8), (9), (10), (11), (12), (13), (14), (15), (16), (17), (18), (19), (22), (23), (24), (25), (26), (27), (28), (29), (30), (31), (32)	O 28. SNACK FOOD ITEMS (FLOUR, MEAL OR VEGETABLE BASE) [21 CFR 170.3 (n) (37)]
O 16. FOOD SWEETENERS (NUTRITIVE) [21 CFR 170.3 (n) (9), (41), 21 CFR 170.3 (o) (21)]	O 29. SPICES, FLAVORS, AND SALTS [21 CFR 170.3 (n) (26)]
	O 30. SOUPS [21 CFR 170.3 (n) (39), (40)]
O 17. FRUITS AND FRUIT PRODUCTS [21 CFR 170.3 (n) (16), (27), (28), (35), (43)]	O 31. SOFT DRINKS AND WATERS [21 CFR 170.3 (n) (3), (35)]
O 18. GELATIN, RENNET, PUDDING MIXES, OR PIE FILLINGS [21 CFR 170.3 (n) (22)]	O 32. VEGETABLES AND VEGETABLE PRODUCTS [21 CFR 170.3 (n) (19), (36)]
O 19. ICE CREAM AND RELATED PRODUCTS [21 CFR 170.3 (n) (20), (21)]	O 33. VEGETABLE OILS (INCLUDES OLIVE OIL) [21 CFR 170.3 (n) (12)]
O 20. IMITATION MILK PRODUCTS [21 CFR 170.3 (n) (10)]	O 34. VEGETABLE PROTEIN PRODUCTS (SIMULATED MEATS) [21 CFR 170.3 (n) (33)]
O 21. MACARONI OR NOODLE PRODUCTS [21 CFR 170.3 (n) (23)]	O 35. WHOLE GRAINS, MILLER GRAIN PRODUCTS (FLOURS),OR STARCH [21 CFR 170.3 (n) (1), (23)]
O 22. MEAT, MEAT PRODUCTS AND POULTRY (FDA REGULATED) [21 CFR 170.3 (n) (17), (18), (29), (34), (39), (40)]	O 36. MOST/ALL HUMAN FOOD PRODUCT CATEGORIES (Optional Selection)
	O 37. NONE OF THE ABOVE MANDATORY CATEGORIES

Section 11b - GENERAL PRODUCT CATEGORIES – FOOD FOR ANIMAL CONSUMPTION (OPTIONAL)
O 1. GRAIN PRODUCTS (E.G., BARLEY, GRAIN SORGHUMS, MAIZE, OAT, RICE, RYE AND WHEAT)	O 14. MILK PRODUCTS
O 2. OILSEED PRODUCTS (E.G., COTTONSEED, SOYBEANS, OTHER OIL SEEDS)	O 15. MINERALS
O 3. ALFALFA AND LESPEDEZA PRODUCTS	O 16. MISCELLANEOUS AND SPECIAL PURPOSE PRODUCTS
O 4. AMINO ACIDS	O 17. MOLASSES
O 5. ANIMAL-DERIVED PRODUCTS	O 18. NON-PROTEIN NITROGEN PRODUCTS
O 6. BREWER PRODUCTS	O 19. PEANUT PRODUCTS
O 7. CHEMICAL PRESERVATIVES	O 20. RECYCLED ANIMAL WASTE PRODUCTS
O 8. CITRUS PRODUCTS	O 21. SCREENINGS
O 9. DISTILLERY PRODUCTS	O 22. VITAMINS
O 10. ENZYMES	O 23. YEAST PRODUCTS
O 11. FATS AND OILS	O 24. MIXED FEED (POULTRY, LIVESTOCK, AND EQUINE)
O 12. FERMENTATION PRODUCTS	O 25. PET FOOD
O 13.MARINE PRODUCTS	O 26. MOST/ALL ANIMAL FOOD PRODUCT CATEGORIES

Section 12 – OWNER, OPERATOR, OR AGENT IN CHARGE INFORMATION
NAME OF ENTITY OR INDIVIDUAL WHO IS THE OWNER, OPERATOR, OR AGENT IN CHARGE
PROVIDE THE FOLLOWING INFORMATION, IF DIFFERENT FROM ALL OTHER SECTIONS ON THE FORM. IF INFORMATION IS THE SAME AS ANOTHER SECTION OF THE FORM, CHECK WHICH SECTION: SECTION 2 O SECTION 3 O SECTION 4 O SECTION 7 O
STREET ADDRESS, Line 1:
STREET ADDRESS, Line 2:
CITY:	STATE:
ZIP CODE (POSTAL CODE):	PROVINCE/TERRITORY:
COUNTRY:	PHONE NUMBER (Include Area/Country Code):
FAX NUMBER (OPTIONAL; Include Area/ Country Code):	E-MAIL ADDRESS (OPTIONAL):

Section 13 - CERTIFICATION STATEMENT
The owner, operator, or agent in charge of the facility, or an individual authorized by the owner, operator, or agent in charge of the facility, must submit this form. By submitting this form to FDA, or by authorizing an individual to submit this form to FDA, the owner, operator, or agent in charge of the facility certifies that the above information is true and accurate. An individual (other than the owner, operator, or agent in charge of the facility) who submits the form to the FDA also certifies that the above information submitted is true and accurate and that he/she is authorized to submit the registration on the facility's behalf. An individual authorized by the owner, operator, or agent in charge must below identify by name the individual who authorized submission of the registration. Under 18 U.S.C. 1001, anyone who makes a materially false, fictitious, or fraudulent statement to the U.S. Government is subject to criminal penalties.
SIGNATURE OF SUBMITTER
PRINT NAME OF THE SUBMITTER
CHECK ONE BOX: O A. OWNER, OPERATOR OR AGENT IN CHARGE (STOP HERE, FORM IS COMPLETED) O B. INDIVIDUAL AUTHORIZED TO SUBMIT THE REGISTRATION (FILL IN BELOW)
IF YOU CHECKED BOX B ABOVE, INDICATE WHO AUTHORIZED YOU TO SUBMIT THE REGISTRATIONFILL IN THE FOLLOWING INFORMATION: O OWNER, OPERATOR, OR AGENT IN CHARGE (STOP HERE, FORM IS COMPLETED) O ____________________________________________________________ NAME OF INDIVIDUAL WHO AUTHORIZED REGISTRATION ON BEHALF OF OWNER, OPERATOR, OR AGENT IN CHARGE, IF DIFFERENT FROM FACILITY INFORMATION ABOVE (FILL IN ADDRESS BELOW)
ADDRESS INFORMATION FOR THE AUTHORIZING INDIVIDUAL, IF DIFFERENT FROM SECTION 12 ABOVE:
AUTHORIZING INDIVIDUALFACILITY STREET ADDRESS, Line 1:
AUTHORIZING INDIVIDUALFACILITY STREET ADDRESS, Line 2:
CITY:	STATE:
ZIP CODE (POSTAL CODE):	PROVINCE/TERRITORY:
COUNTRY:	PHONE NUMBER (Include Area/Country Code):
FAX NUMBER (OPTIONAL; Include Area/ Country Code):	E-MAIL ADDRESS (OPTIONAL):

MAIL COMPLETED FORM TO U.S. FOOD AND DRUG ADMINISTRATION, HFS-681, 5600 FISHERS LANE, ROCKVILLE, MD 20857, OR FAX IT TO (301) 210-0247.

FDA USE ONLY
DATE REGISTRATION FORM RECEIVED	DATE NOTIFICATION SENT TO FACILITY

Public reporting burden for this collection of information is estimated to average between 1 and 12 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:

Department of Health and Human Services An agency may not conduct or sponsor, and a

Food and Drug Administration person is not required to respond to a collection of

CFSAN (HFS-024) information unless it displays a currently valid

5100 Paint Branch Parkway OMB control number

College Park, MD 20740

7

Form 3537 (1/03)