90 FR 109 pgs. 24280-24281 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Small Business Qualification and Certification
Type: NOTICEVolume: 90Number: 109Pages: 24280 - 24281
Pages: 24280, 24281Docket number: [Docket No. FDA-2018-D-1873]
FR document: [FR Doc. 2025-10387 Filed 6-6-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-1873]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Small Business Qualification and Certification
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
DATES:
Submit written comments (including recommendations) on the collection of information by July 9, 2025.
ADDRESSES:
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting "Currently under Review-Open for Public Comments" or by using the search function. The OMB control number for this information collection is 0910-0508. Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Medical Device User Fee Small Business Qualification and Certification
OMB Control Number 0910-0508-Revision
This information collection helps support implementation of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250), most recently reauthorized in 2022 from October 1, 2022, until September 30, 2027. To qualify as a "small business," and therefore be eligible for reduced or waived fees, respondents submit information to FDA so we can determine whether the applicant is a small business. Sections 738(d)(2)(A) and (e)(2)(A) of the FD&C Act (21 U.S.C. 379j(d)(2)(A) and (e)(2)(A)) define a "small business" as an entity that reported $100 million or less of gross receipts or sales in its most recent Federal income tax return, including such returns of its affiliates, partners, and parent firms. If a firm's gross receipts or sales are no more than $30 million (including all affiliates, partners, and parent firms), they will also qualify for a waiver of the fee for their first (ever) premarket application (PMA), product development protocol (PDP), biological licensing application (BLA), or premarket report.
[top] In the Federal Register of February 22, 2024 (89 FR 13349), FDA announced the availability of the draft guidance for industry entitled "Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance" (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/select-updates-medical-device-user-fee-small-business-qualification-and-certification-guidance ). The guidance includes select updates to the guidance "Medical Device User Fee Small Business Qualification and Certification" (August 2018), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-small-business-qualification-and-certification ) which describe how FDA plans to determine if a small business is experiencing "financial hardship" that makes them eligible for a waiver of their registration fee. A manufacturer seeking the small business fee waiver may provide evidence of a reported $1 million or less of gross receipts or sales in its most recent Federal income tax return, as well as evidence that they have filed a petition for bankruptcy and that the bankruptcy is currently active. The proposed updates also reflect that firms based in jurisdictions without a National Taxing Authority (NTA) need not submit a
Additionally, FDA intends to consolidate the forms previously known as FDA 3602 and FDA 3602A into a single webform, the "MDUFA Small Business Request" (MDUFA SBR, FDA 3602N) to be completed by foreign as well as U.S. businesses/applicants via FDA's Center for Devices and Radiological Health Customer Collaboration Portal (CDRH Portal). We have also added to the MDUFA SBR a "Registration & Listing Waiver" section which asks if the business/applicant will apply for a registration and listing fee waiver and whether they have applied in the past. Applicants seeking this waiver will be asked to include proof of bankruptcy documentation in the supporting documentation section.
In the Federal Register of February 22, 2024 (89 FR 13349), FDA published a 60-day notice requesting public comment on the proposed collection of information. Three comments were received, but they were not related to the information collection.
FDA estimates the burden of this collection of information as follows:
| FDA form No. | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| MDUFA Small Business Request webform-FDA 3602N | 4,500 | 1 | 4,500 | 1 | 4,500 |
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
As discussed previously in this document, we have proposed updates to the guidance document, "Medical Device User Fee Small Business Qualification and Certification Guidance for Industry, Food and Drug Administration Staff and Foreign Governments," (August 2018) consistent with amendments to section 738(a)(3)(B) of the FD&C Act. Because we assume that current bankruptcy documentation is readily available to applicants, we assume no change to the Average Burden per Response for this information collection.
Aside from the changes already discussed, the total burden estimate remains unchanged from the last OMB approval.
Dated: June 3, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-10387 Filed 6-6-25; 8:45 am]
BILLING CODE 4164-01-P