💰FDA Final Guidance on Medical Device User Fees for Small Businesses
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Medical Device User Fee Small Business Qualification and Determination Guidance." This guidance updates the previous version of the guidance, titled "Medical Device User Fee Small Business Qualification and Certification Guidance", issued on August 1, 2018. The guidance includes updates which describe how FDA plans to determine if a small business is experiencing "financial hardship" which makes them eligible for a waiver of their registration fee. The guidance details what information FDA intends to review and consider in making this determination.
Learn More💼FDA Notice on Medical Device User Fee Small Business Certification
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.
Learn More💰IRS Proposes Reduced User Fee for Estate Tax Closing Letters
In the Rules and Regulations section of this issue of the Federal Register, the Department of the Treasury (Treasury Department) and the IRS are issuing interim final regulations that amend the current regulations to reduce the amount of the user fee imposed on authorized persons requesting the issuance of IRS Letter 627, also referred to as an estate tax closing letter. The text of the interim final regulations also serves as the text of these proposed regulations.
Learn More📄FDA Notice
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with our generic drug user fee program.
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