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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices
percent of the standard full fee for the submission see 21 U.S.C. 379jd2C.
The annual fee for establishment registration, after adjustment, is set at
$5,672 for FY 2022. There is no small business rate for the annual establishment registration fee; all establishments pay the same fee.

Table 5 summarizes the FY 2022 rates for all medical device fees.

TABLE 5MEDICAL DEVICE FEES FOR FY 2022
Standard fee as a percent of the standard fee for a premarket application
Application fee type
Premarket application a PMA submitted under section 515c1 of the FD&C Act 21 U.S.C. 360ec1, a PDP submitted under section 515f of the FD&C Act, or a BLA submitted under section 351 of the Public Health Service Act the PHS Act 42 U.S.C. 262.
Premarket report submitted under section 515c2 of the FD&C Act
Efficacy supplement to an approved BLA under section 351 of the PHS Act Panel-track supplement
De novo classification request
180-day supplement
Real-time supplement
510k premarket notification submission
30-day notice
513g request for classification information
Annual Fee Type Annual fee for periodic reporting on a class III device
Annual establishment registration fee to be paid by the establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device, as defined by 21 U.S.C. 379i14.

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IV. How To Qualify as a Small Business for Purposes of Medical Device Fees If your business, including your affiliates, has gross receipts or sales of no more than $100 million for the most recent tax year, you may qualify for reduced small business fees. If your business, including your affiliates, has gross sales or receipts of no more than $30 million, you may also qualify for a waiver of the fee for your first premarket application i.e. PMA, PDP, or BLA or premarket report. If you want to pay the small business fee rate for a submission or you want to receive a waiver of the fee for your first premarket application or premarket report, you should submit the materials showing you qualify as a small business at least 60 days before you send your submission to FDA.
Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2022, you should not submit a Small Business Certification Request. FDA will review your information and determine whether you qualify as a small business eligible for the reduced fee and/or fee waiver. If you make a submission before FDA finds that you qualify as a small business, you must pay the standard full fee for that submission.
If your business qualified as a small business for FY 2021, your status as a small business will expire at the close
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$374,858

$93,714

100
100
75
30
15
7
3.40
1.60
1.35

374,858
374,858
281,143
112,457
56,229
26,240
12,745
5,998
5,061

93,714
93,714
70,286
28,114
14,057
6,560
3,186
2,999
2,530

3.50
Base fee specified in statute ..

13,120
5,672

3,280
5,672

A. Domestic U.S. Businesses If you are a domestic U.S. business and wish to qualify as a small business for FY 2022, submit the following to FDA:
1. A completed MDUFA Small Business Certification Request For a Business Headquartered in the United States Form FDA 3602. Form FDA
3602 is provided in the FDA Forms database: https www.fda.gov/
downloads/AboutFDA/Reports ManualsForms/Forms/UCM573420.pdf.
2. A signed copy of your Federal U.S. Income Tax Return for the most recent tax year. The most recent tax year will be 2021, except:
If you submit your MDUFA Small Business Certification Request for FY
2022 before April 15, 2022, and you have not yet filed your return for 2021, you may use tax year 2020.
If you submit your MDUFA Small Business Certification Request for FY
2022 on or after April 15, 2022, and have not yet filed your 2021 return because you obtained an extension, you may submit your most recent return filed prior to the extension.
3. For each of your affiliates, either:
If the affiliate is a domestic U.S.
business, a signed copy of the affiliates Federal U.S. Income Tax Return for the most recent tax year, or
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FY 2022
small business fee
Base fee specified in statute ..

of business on September 30, 2021. You must re-qualify for FY 2022 in order to pay small business fees during FY 2022.

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If the affiliate is a foreign business and cannot submit a Federal U.S.
Income Tax Return, a National Taxing Authority Certification completed by, and bearing the official seal of, the National Taxing Authority of the country in which the firm is headquartered. The National Taxing Authority is the foreign equivalent of the U.S. Internal Revenue Service. This certification must show the amount of gross receipts or sales for the most recent tax year, in both U.S. dollars and the local currency of the country, the exchange rate used in converting the local currency to U.S. dollars, and the dates of the gross receipts or sales collected. The business must also submit a statement signed by the head of the businesss firm or by its chief financial officer that the business has submitted certifications for all of its affiliates, identifying the name of each affiliate, or that the business has no affiliates.
B. Foreign Businesses If you are a foreign business, and wish to qualify as a small business for FY
2022, submit the following:
1. A completed MDUFA Foreign Small Business Certification Request For a Business Headquartered Outside the United States Form FDA 3602A.
Form FDA 3602A is provided in the FDA Forms database: https
www.fda.gov/downloads/AboutFDA/
ReportsManualsForms/Forms/
UCM573423.pdf.

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