FORM FDA 3537

Status: Original and derived artifacts are available for this document.

Download: pdf

Form Approval: OMB Control No. 0910-0502; Expiration Date: 11/30/2028; See PRA Statement on page 10.

FDA USE ONLY

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

DHHS/FDA FOOD FACILITY REGISTRATION
(If entering by hand, use blue or black ink only.)

Date (mm/dd/yyyy)

Section 1 – TYPE OF REGISTRATION
1a.

DOMESTIC REGISTRATION

FOREIGN REGISTRATION

1b.

INITIAL REGISTRATION

UPDATE OF REGISTRATION INFORMATION

1c.

BIENNIAL REGISTRATION RENEWAL

ABBREVIATED REGISTRATION RENEWAL (Complete Section 12)
By checking this box, you are certifying that no changes have been made
to your registration
Facility Registration Number

If update or registration renewal, provide the
Facility Registration Number and PIN
For update of registration information: Check all that apply
and further identify changes in the applicable sections

United States Agent Change - Foreign facilities only
Seasonal Facility Dates of Operation Change

Facility Address Change (See instructions)

Type of Activity Change

Preferred Mailing Address Change

Human Food Product Category Change

AF
T

Facility Name Change

Parent Company Change

Animal Food Product Category Change

Emergency Contact Change

Operator or Agent in Charge Change

R

Trade Name Change

Previous owner’s name

No

Yes

ARE YOU THE NEW OWNER OF A PREVIOUSLY REGISTERED FACILITY?
If “Yes,” provide the following information, if known.

D

1d.

PIN

Previous owner’s registration number

Section 2 – FACILITY NAME/ADDRESS INFORMATION
Facility Name

Unique Facility Identifier (UFI)

Facility Street Address, Line 1
Facility Street Address, Line 2
City

State (If applicable; if not, skip to Province/Territory)

Province/Territory (If applicable)

ZIP or Postal Code

Country

Phone Number (Include Area/Country Code)

FAX Number (Include Area/Country Code)

Domestic Facility Contact Person E-Mail Address

FORM FDA 3537 (7/26)

Page 1 of 11

PSC Publishing Services (301) 443-6740

EF

DHHS/FDA FOOD FACILITY REGISTRATION
Section 3 – PREFERRED MAILING ADDRESS INFORMATION
– Complete this section only if different from Section 2 Facility Name/Address Information
Is the preferred mailing address the same as the facility address (Section 2)?

Yes

No

Name
Street Address, Line 1
Street Address, Line 2
City

State (If applicable; if not, skip to Province/Territory)

Province/Territory (If applicable)

ZIP or Postal Code

Country

Phone Number (Include Area/Country Code)

FAX Number (Optional; Include Area/Country Code)

E-Mail Address (Optional)

AF
T

Section 4 – PARENT COMPANY NAME/ADDRESS INFORMATION
(If applicable and if different from Sections 2 and 3)
Is the parent company address the same as:
facility address (Section 2)

preferred mailing address (Section 3)

Street Address of Parent Company, Line 2

D

Street Address of Parent Company, Line 1

R

Name of Parent Company

none of the above

City

State (If applicable; if not, skip to Province/Territory)

Province/Territory (If applicable)

ZIP or Postal Code

Country

Phone Number (Include Area/Country Code)

FAX Number (Optional; Include Area/Country Code)

E-Mail Address (Optional)

FORM FDA 3537 (7/26)

Page 2 of 11

DHHS/FDA FOOD FACILITY REGISTRATION
Section 5 – FACILITY EMERGENCY CONTACT INFORMATION
For foreign facilities; FDA will use your U.S. agent as your emergency contact
unless you choose to designate a different contact here.
If information is the same as another section, check which section:
facility address (Section 2)

U.S. Agent Information (Section 7)

none of the above

Individual Name (Optional)
Title (Optional)
E-Mail Address

Emergency Contact Phone Number (Include Area/Country Code)

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”).
Alternative Trade Name #1

Alternative Trade Name #2

AF
T

Alternative Trade Name #3

Alternative Trade Name #4

R

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
U.S. Agent ID

D

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

Section 8 – SEASONAL FACILITY DATES OF OPERATION (OPTIONAL)
Optional - Give the approximate dates that your facility is open for business, if its operations are on a seasonal basis.
Dates of Operation (Optional; mm/dd/yyyy)

FORM FDA 3537 (7/26)

Page 3 of 11

DHHS/FDA FOOD FACILITY REGISTRATION
Section 9a – GENERAL PRODUCT CATEGORIES – FOOD FOR HUMAN CONSUMPTION;
and TYPE OF ACTIVITY CONDUCTED AT THE FACILITY
To be completed by all food
facilities. Please see instructions
for further examples.

IF NONE OF THE MANDATORY
CATEGORIES BELOW APPLY,
GO TO ITEM 37 AND
ENTER CATEGORY OR
CATEGORIES THERE.

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.
Ambient Food
Storage
Refrigerated
Warehouse / Food Storage Frozen Food
Holding
Warehouse/
Storage
AcidiFacility (e.g.,
Holding
Warehouse /
fied
Facility (e.g.
storage
Holding
Food
Storage
Facility (e.g.
Profacilities,
facilities,
storage
cessor
including
including
facilities)
storage
tanks, grain storage tanks)
elevators)

LowInterstate
Acid Conveyance
Contract
Food
Caterer/
Sterilizer
ProCatering
cessor
Point

1. ALCOHOLIC BEVERAGES
[21 CFR 170.3 (n) (2)]
2. BABY (INFANT AND JUNIOR)
FOOD PRODUCT CATEGORIES
a. Infant Formula (Powder)
b. Infant Formula (Liquid)
c. Other Baby Food Products
3. BAKERY PRODUCTS,
DOUGH MIXES, OR ICINGS
[21 CFR 170.3 (n) (1), (9)]

AF
T

4. BEVERAGE BASES [21
CFR 170.3 (n) (3), (35)]

7. CHEESE AND CHEESE
PRODUCT CATEGORIES
[21 CFR 170.3 (n) (5)]
a. Soft, Ripened Cheese

D

6. CEREAL PREPARATIONS,
BREAKFAST FOODS, QUICK
COOKING/INSTANT CEREALS
[21 CFR 170.3 (n) (4)]

R

5. CANDY WITHOUT CHOCOLATE,
CANDY SPECIALTIES AND
CHEWING GUM [21 CFR 170.3 (n)
(6), (9), (25), (38)]

b. Semi-Soft Cheese
c. Hard Cheese
d. Other Cheeses and
Cheese Products
8. CHOCOLATE AND COCOA
PRODUCTS [21 CFR 170.3 (n) (3),
(9), (38), (43)]
9. COFFEE AND TEA
[21 CFR 170.3 (n) (3), (7)]
10. COLOR ADDITIVES FOR
FOODS [21 CFR 170.3 (o) (4)]
11. DIETARY CONVENTIONAL
FOODS OR MEAL
REPLACEMENTS
(Includes Medical Foods)
[21 CFR 170.3 (n) (31)]

FORM FDA 3537 (7/26)

Page 4 of 11

Labeler/
Relabeler

Salvage
ManufacRepacker/ Operator
turer/
Packer
(RecondiProcessor
tioner)

Farm
MixedType
Facility

Other
Activity
Conducted
(Please
specify
Below
Row 37)

DHHS/FDA FOOD FACILITY REGISTRATION
Section 9a – GENERAL PRODUCT CATEGORIES – FOOD FOR HUMAN CONSUMPTION;
and TYPE OF ACTIVITY CONDUCTED AT THE FACILITY (cont.)
To be completed by all food
facilities. Please see instructions
for further examples.

IF NONE OF THE MANDATORY
CATEGORIES BELOW APPLY,
GO TO ITEM 37 AND
ENTER CATEGORY OR
CATEGORIES THERE.

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.
Ambient Food
Storage
Refrigerated
Warehouse / Food Storage Frozen Food
Holding
Warehouse/
Storage
AcidiFacility (e.g.,
Warehouse /
Holding
fied
storage
Facility (e.g.
Holding
Food
Facility (e.g.
Storage
Profacilities,
storage
cessor
facilities,
including
including
facilities)
storage
tanks, grain storage tanks)
elevators)

LowInterstate
Acid Conveyance
Contract
Food
Caterer/
Sterilizer
ProCatering
cessor
Point

12. DIETARY SUPPLEMENT
CATEGORIES
[21 CFR 170.3 (o) (20)]
a. Proteins, Amino Acids,
Fats and Lipid Substances
b. Vitamins and Minerals
c. Animal By-Products and Extracts
d. Herbals and Botanicals
13. DRESSING AND CONDIMENTS
[21 CFR 170.3 (n) (8), (12)]

AF
T

14. FISHERY/SEAFOOD PRODUCT
CATEGORIES [21 CFR 170.3 (n)
(13), (15), (39), (40)]
a. Fin Fish, Whole or Filet
b. Molluscan Shellfish

e. Processed and Other Fishery
Products
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)]

D

d. Ready to Eat (RTE) Fishery
Products

R

c. Other Shellfish

16. FOOD SWEETENERS
(NUTRITIVE) [21 CFR 170.3 (n)
(9) (41), 21 CFR 170.3 (o) (21)]
17. FRUIT AND FRUIT PRODUCTS
[21 CFR 170.3 (n) (16), (27), (28),
(35), (43)]
a. Fresh Cut Produce
b. Raw Agricultural Commodities
c. Other Fruit and Fruit Products
18. FRUIT OR VEGETABLE
JUICE, PULP OR
CONCENTRATE PRODUCTS
[21 CFR 170.3 (n) (3), (16), (35)]
19. GELATIN, RENNET, PUDDING
MIXES, OR PIE FILLINGS
[21 CFR 170.3 (n) (22)]

FORM FDA 3537 (7/26)

Page 5 of 11

Labeler/
Relabeler

Salvage
ManufacRepacker/ Operator
turer/
Packer
(RecondiProcessor
tioner)

Farm
MixedType
Facility

Other
Activity
Conducted
(Please
specify
Below
Row 37)

DHHS/FDA FOOD FACILITY REGISTRATION
Section 9a – GENERAL PRODUCT CATEGORIES – FOOD FOR HUMAN CONSUMPTION;
and TYPE OF ACTIVITY CONDUCTED AT THE FACILITY (cont.)
To be completed by all food
facilities. Please see instructions
for further examples.

IF NONE OF THE MANDATORY
CATEGORIES BELOW APPLY,
GO TO ITEM 37 AND
ENTER CATEGORY OR
CATEGORIES THERE.

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.
Ambient Food
Storage
Refrigerated
Warehouse / Food Storage Frozen Food
Holding
Warehouse/
Storage
AcidiFacility (e.g.,
Warehouse /
Holding
fied
storage
Facility (e.g.
Holding
Food
Facility (e.g.
Storage
Profacilities,
storage
cessor
facilities,
including
including
facilities)
storage
tanks, grain storage tanks)
elevators)

LowInterstate
Acid Conveyance
Contract
Food
Caterer/
Sterilizer
ProCatering
cessor
Point

20. ICE CREAM AND
RELATED PRODUCTS
[21 CFR 170.3 (n) (20), (21)]
21. IMITATION MILK PRODUCTS
[21 CFR 170.3 (n) (10)]
22. MACARONI OR
NOODLE PRODUCTS
[21 CFR 170.3 (n) (23)]
23. MEAT, MEAT PRODUCTS AND
POULTRY (FDA REGULATED)
[21 CFR 170.3 (n) (17), (18), (29),
(34), (39), (40)]

AF
T

24. MILK, BUTTER, OR
DRIED MILK PRODUCTS
[21 CFR 170.3 (n) (12), (30), (31)]

a. Nut and Nut Products
b. Edible Seed and Edible Seed
Products
27. PREPARED SALAD PRODUCTS
[21 CFR 170.3 (n) (11), (17), (18),
(22), (29), (34), (35)]

D

26. NUTS AND EDIBLE SEED
PRODUCT CATEGORIES
[21 CFR 170.3 (n) (26), (32)]

R

25. MULTIPLE FOOD DINNERS,
GRAVIES, SAUCES
AND SPECIALTIES
[21 CFR 170.3 (n) (11) (14), (17),
(18), (23), (24), (29), (34), (40)]

28. SHELL EGG AND EGG PRODUCT
CATEGORIES [21 CFR 170.3 (n)
(11), (14)]
a. Chicken Egg and Egg Products
b. Other Eggs and Egg Products
29. SNACK FOOD ITEMS (FLOUR,
MEAL OR VEGETABLE BASE)
[21 CFR 170.3 (n) (37)]
30. SPICES, FLAVORS, AND SALTS
[21 CFR 170.3 (n) (26)]
31. SOUPS
[21 CFR 170.3 (n) (39), (40)]
32. SOFT DRINKS AND WATERS
[21 CFR 170.3 (n) (3), (35)]
33. VEGETABLE AND VEGETABLE
PRODUCT CATEGORIES
[21 CFR 170.3 (n) (19), (36)]
a. Fresh Cut Products
b. Raw Agricultural Commodities
c. Other Vegetable and Vegetable
Products

FORM FDA 3537 (7/26)

Page 6 of 11

Labeler/
Relabeler

Salvage
ManufacRepacker/ Operator
turer/
Packer
(RecondiProcessor
tioner)

Farm
MixedType
Facility

Other
Activity
Conducted
(Please
specify
Below
Row 37)

DHHS/FDA FOOD FACILITY REGISTRATION
Section 9a – GENERAL PRODUCT CATEGORIES – FOOD FOR HUMAN CONSUMPTION;
and TYPE OF ACTIVITY CONDUCTED AT THE FACILITY (cont.)
To be completed by all food
facilities. Please see instructions
for further examples.

IF NONE OF THE MANDATORY
CATEGORIES BELOW APPLY,
GO TO ITEM 37 AND
ENTER CATEGORY OR
CATEGORIES THERE.

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.
Ambient Food
Storage
Refrigerated
Warehouse / Food Storage Frozen Food
Holding
Warehouse/
Storage
AcidiFacility (e.g.,
Warehouse /
Holding
fied
storage
Facility (e.g.
Holding
Food
Facility (e.g.
Storage
Profacilities,
storage
cessor
facilities,
including
including
facilities)
storage
tanks, grain storage tanks)
elevators)

LowInterstate
Acid Conveyance
Contract
Food
Caterer/
Sterilizer
ProCatering
cessor
Point

34. VEGETABLE OILS (INCLUDES
OLIVE OIL) [21 CFR 170.3 (n) (12)]
35. VEGETABLE PROTEIN
PRODUCTS (SIMULATED
MEATS) [21 CFR 170.3 (n) (33)]
36. WHOLE GRAINS, MILLER
GRAIN PRODUCTS (FLOURS),
OR STARCH
[21 CFR 170.3 (n) (1), (23)]
37. IF NONE OF THE ABOVE FOOD
CATEGORIES APPLY, THEN
ENTER THE APPLICABLE FOOD
CATEGORY OR CATEGORIES
(THAT DOES NOT OR DO NOT
APPEAR ABOVE).

Other Category or Categories

D

R

AF
T

Other Activity Conducted:

FORM FDA 3537 (7/26)

Page 7 of 11

Labeler/
Relabeler

Salvage
ManufacRepacker/ Operator
turer/
Packer
(RecondiProcessor
tioner)

Farm
MixedType
Facility

Other
Activity
Conducted
(Please
specify
Below
Row 37)

DHHS/FDA FOOD FACILITY REGISTRATION
Section 9b – GENERAL PRODUCT CATEGORIES – FOOD FOR ANIMAL CONSUMPTION;
and TYPE OF ACTIVITY CONDUCTED AT THE FACILITY
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.

To be completed by all animal
food facilities. Please see instructions
for further examples.
IF NONE OF THE MANDATORY
CATEGORIES BELOW APPLY, GO TO
ITEM 33 AND ENTER CATEGORY OR
CATEGORIES THERE.

Animal Food
Manufacturer/
Processor

Animal Food
Warehouse/Holding
Facility (e.g., storage
facilities, including
storage tanks, grain
elevators)

Acidified
Food
Processor

Low Acid
Food
Processor

Contract
Sterilizer

1. GRAIN OR GRAIN PRODUCTS (I.E.,
BARLEY, GRAIN SORGHUMS, MAIZE,
OAT, RICE, RYE, WHEAT, OTHER
GRAINS OR GRAIN PRODUCTS)
2. OILSEED OR OILSEED PRODUCTS (I.E.,
COTTONSEED, SOYBEANS, OTHER
OILSEEDS OR OILSEED PRODUCTS)
3. ALFALFA PRODUCTS OR LESPEDEZA
PRODUCTS
4. AMINO ACIDS OR RELATED PRODUCTS
5. ANIMAL PROTEIN PRODUCTS
6. BOTANICALS AND HERBS

AF
T

7. BREWER PRODUCTS
8. CHEMICAL PRESERVATIVES
9. CITRUS PRODUCTS

12. ENZYMES

D

11. DISTILLERY PRODUCTS

R

10. DIRECT FEED MICROBIALS

13. FATS OR OILS
14. FERMENTATION PRODUCTS
15. FORAGE PRODUCTS
16. HUMAN FOOD BY-PRODUCTS NOT
OTHERWISE LISTED
17. MARINE PRODUCTS
18. MILK PRODUCTS
19. MINERALS OR MINERAL PRODUCTS
20. MISCELLANEOUS OR SPECIAL
PURPOSE PRODUCTS
21. MOLASSES OR MOLASSES
PRODUCTS
22. NON-PROTEIN NITROGEN PRODUCTS
23. PEANUT PRODUCTS
24. PROCESSED ANIMAL WASTE
PRODUCTS

FORM FDA 3537 (7/26)

Page 8 of 11

Repacker/
Packer

Labeler/
Relabeler

Salvage
Operator
(Reconditioner)

Farm
Mixed-Type
Facility

Other
Activity
(Please
specify
Below
Row 33)

DHHS/FDA FOOD FACILITY REGISTRATION
Section 9b – GENERAL PRODUCT CATEGORIES – FOOD FOR ANIMAL CONSUMPTION;
and TYPE OF ACTIVITY CONDUCTED AT THE FACILITY (cont.)
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.

To be completed by all animal
food facilities. Please see instructions
for further examples.
IF NONE OF THE MANDATORY
CATEGORIES BELOW APPLY, GO TO
ITEM 33 AND ENTER CATEGORY OR
CATEGORIES THERE.

Animal Food
Manufacturer/
Processor

Animal Food
Warehouse/Holding
Facility (e.g., storage
facilities, including
storage tanks, grain
elevators)

Acidified
Food
Processor

Low Acid
Food
Processor

Contract
Sterilizer

Packer/
Repacker

Labeler/
Relabeler

Salvage
Operator
(Reconditioner)

Farm
Mixed-Type
Facility

Other
Activity
(Please
specify
Below
Row 33)

25. SCREENINGS
26. TECHNICAL ADDITIVES
27. VITAMINS OR VITAMIN PRODUCTS
28. YEAST PRODUCTS
29. MIXED FEED (E.G., POULTRY,
LIVESTOCK, EQUINE)
30. PET FOOD
31. PET TREATS OR PET CHEWS

33. IF NONE OF THE ABOVE FOOD
CATEGORIES APPLY, THEN ENTER THE
APPLICABLE FOOD CATEGORY OR
CATEGORIES (THAT DOES NOT OR DO
NOT APPEAR ABOVE).

AF
T

32. PET NUTRITIONAL SUPPLEMENTS (E.
G., VITAMINS, MINERALS)

Other Category or Categories

R

Other Activity Conducted

Section 10 – OWNER, OPERATOR, OR AGENT-IN-CHARGE INFORMATION

D

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 the information is the same as another section of
the form, check which section.
Section 3
Section 4
Section 2
Street Address, Line 1

Street Address, Line 2

City

State (If applicable; if not, skip to Province/Territory)

Province/Territory (If applicable)

ZIP or Postal Code

Country

Phone Number (Include Area/Country Code)

FAX Number (Optional; Include Area/Country Code)

FORM FDA 3537 (7/26)

E-Mail Address (Required unless FDA has granted a waiver under 21 CFR 1.245)

Page 9 of 11

DHHS/FDA FOOD FACILITY REGISTRATION
Section 11 – INSPECTION STATEMENT
FDA will be permitted to inspect the facility at the time and in the manner permitted
by the Federal Food, Drug, and Cosmetic Act.

Section 12 – 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 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

Printed Name of Submitter

Check One Box
A. OWNER, OPERATOR, OR AGENT IN CHARGE (STOP HERE, FORM IS COMPLETED)
B. INDIVIDUAL AUTHORIZED TO SUBMIT THE REGISTRATION (FILL IN BELOW)
If you checked Box B above, indicate who authorized you to submit the registration.

AF
T

OWNER, OPERATOR, OR AGENT IN CHARGE (STOP HERE, FORM IS COMPLETED)
NAME OF INDIVIDUAL WHO AUTHORIZED REGISTRATION

ON BEHALF OF OWNER, OPERATOR, OR AGENT IN CHARGE (FILL IN ADDRESS BELOW)
Address Information for the Authorizing Individual

D

Authorizing Individual Street Address, Line 2

R

Authorizing Individual Street Address, Line 1

City

State (If applicable; if not, skip to Province/Territory)

Province/Territory (If applicable)

ZIP or Postal Code

Country

Phone Number (Include Area/Country Code)

FAX Number (Optional; Include Area/Country Code)

E-Mail Address (Required unless FDA has granted a waiver under 21 CFR 1.245)

MAIL COMPLETED FORM FDA 3537 TO U.S. FOOD AND DRUG ADMINISTRATION, HFS-681,
5001 CAMPUS DRIVE, COLLEGE PARK, MD 20740, OR FAX IT TO 301-436-2804

FDA USE ONLY
Date Registration Form Received (mm/dd/yyyy)

FORM FDA 3537 (7/26)

Date Notification Sent to Facility (mm/dd/yyyy)

Page 10 of 11

DHHS/FDA FOOD FACILITY REGISTRATION
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average between 1 and 12 hours per response,
including the time to review instructions, search existing data sources, gather and maintain the data needed and
complete and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Operations
Paperwork Reduction Act (PRA) Staff
[email protected]

D

R

AF
T

“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3537 (7/26)

Page 11 of 11