LIMITED OFFERS
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LIMITED OFFER

FOOD
FACILITY
REGISTRATION

$99.00

  • Company Registration
  • U.S. Agent Service
  • Available for additional fee:
    *FSVP
    *Label Review or Update
    *Prior Notice
    *Certificate of Registration
ANNUAL SERVICE FEE

Food Canning Establishment (FCE) Registration requires a separate fee. Click here, first.

LIMITED OFFER
FDA ESTABLISHMENT
REGISTRATION
MEDICAL DEVICES (PPE)
$350.00 | SERVICE FEE
  • Facemasks
  • Surgical Masks
  • N95 Respirators
  • Gowns, Face Shields, Gloves, Goggles
$5,672.00 | USER FEE

FDA Medical Device Establishment registration fee for Fiscal Year (FY) 2022 is $5,672. FY 2022 starts on October 1, 2021 and ends on September 30, 2022. Annual establishment registration fee must be paid between October 1, 2021 and December 31, 2021.

LIMITED OFFER
FDA ESTABLISHMENT
REGISTRATION
OVER-THE-COUNTER (OTC) DRUGS
$350.00 | SERVICE FEE
  • Alcohol Hand Sanitizers
  • Alcohol Wipes
  • Sunscreens
  • Antidandruff shampoo, Toothpaste containing fluoride, Antiperspirant deodorant, Cold and cough products, Skin Protectant, Sleep Aid, Topical Analgesic, Weight Control
$20,322.00 | USER FEE

Over-The-Counter Monograph Drug User Fee Program (OMUFA) (FY 2021). This new fee is additional and required. Manufacturers of hand sanitizers and alcohol wipes are currently exempt.

FDA REGISTRATION FEES: WHAT YOU SHOULD KNOW

There are two types of fees here

  • SERVICE FEES paid to ITB HOLDINGS LLC
  • USER FEES paid to the U.S. Treasury
FDA USER FEES

Personal Protective Equipment (PPE)s (gowns, gloves, face shields, goggles, facemasks and respirators) are Medical Devices.

Therefore, an FDA User Fee of $5,672.00 is required for the annual Establishment Registration (Fiscal Year 2022).

Some medical devices are subject to Premarket Notification 510(k) – Standard Fee: $12,745.00. Small Business Fee: $3,186.00 (Fiscal Year 2022).

In order to register your establishment and list your hand sanitizer, only our annual fee of $350.00 is needed. Hand sanitizers are OTC Drug Products.

$20,322.00 | Over-The-Counter Monograph Drug User Fee Program (OMUFA) ( FY 2021). This new fee does not apply to manufacturers of hand sanitizers, yet.

Below is a list of fees covering Annual Establishment Registration and or filing of an Application:

  • Accredited Third-Party Certification Program User Fees
  • Animal Drug User Fee Act (ADUFA)
  • Animal Generic Drug User Fee Act (AGDUFA)
  • Biosimilar User Fee Amendments
  • Color Additive Certification Fees
  • Export Certificate Fees
  • Freedom of Information Act Fees (FOIA)
  • Generic Drug User Fee Amendments
  • Human Drug Compounding Outsourcing Facility Fees
  • Mammography Facility Fees (MQSA)
  • Medical Device User Fee Amendments (MDUFA)
  • Over-The-Counter Monograph User Fee Program (OMUFA)
  • Prescription Drug User Fee Amendments
  • Voluntary Qualified Importer Program User Fees

These User Fees tend to increase yearly.

When you contact us, have your company’s DUNS NUMBER ready.

Food Facility

$99.00

Dietary Supplements Facility

$99.00

Food Canning Establishment (FCE)

$350.00

OTC Drug Establishment

$350.00

Prescription Drug Establishment

$350.00

Medical Devices Establishment

$350.00

Cosmetics Establishment

$150.00

OTC Cosmetics Establishment

$350.00

Label Review

$99.00

Foreign Supplier Verification Program (FSVP) Importer

$350.00

Prior Notice

$25.00

FDA REGISTRATION requests must include:

  • Full company name
  • Complete physical address
  • First and last name of CEO or Manager
  • Email and telephone of CEO or Manager
  • Product details
  • Company DUNS Number

Data Universal Numbering System, DUNS or D-U-N-S from Dun & Bradstreet Inc. Free in 30 days or for a fee in 15 days.

Keep in mind that all domestic and foreign companies must have a DUNS Number. Therefore, requesting one now or as soon as possible, is in your company’s best interest.

FDA automatically performs a DUNS check during the registration process. So, make sure your company’s name and physical address match D&B’s records.

PAYMENT METHODS ACCEPTED FOR ITB HOLDINGS LLC’S INVOICES

PayPal, Local European Payments
Debit and Credit cards
Bank Wire Transfer.

PAYMENT OF USER FEES

You must first create an account. Click here

U.S. Department of Treasury
TREAS NYC
33 Liberty St
New York, NY 10045
Account Number: 75060099
Routing number: 021030004
SWIFT: FRNYUS33
Beneficiary:
FDA
8455 Colesville Rd, 14th Floor
Silver Spring, MD 20993-0002
FDA’s Tax Identification Number: 53-0196965.

REGISTRATION RENEWAL

■ Annual for Medical and Drug Establishments
■ Biennial for Food Facilities

The preferred payment methods are

  • electronic check (Automated Clearing House – ACH also known as eCheck)
  • credit or debit card (Discover, VISA, MasterCard, American Express).

Payment by credit card is available for balances less than $25,000.

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