News & Analysis as of

Department of Health and Human Services (HHS) User Fees

Alston & Bird

Health Care Week in Review: FDA Released Its User Fee Amendments For FY 2023

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Foley & Lardner LLP

What’s Next in Washington? - October 2022 Edition

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The 2022 Midterm Elections are a little over one month away and the races are tightening up. Democrats have seen their fortunes improve with a string of legislative victories and improving poll numbers for President Joe...more

Faegre Drinker Biddle & Reath LLP

Fall 2022 Federal Healthcare Legislative Landscape

With President Biden signing the Inflation Reduction Act (IRA) into law on August 16, the next big question is what the last third of 2022 will bring. Enacting the IRA takes the “will it or won’t it happen” issue of...more

Holland & Knight LLP

Holland & Knight Health Dose: July 19, 2022

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include: ...more

Foley & Lardner LLP

What’s Next in Washington? - July Edition

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With just a few short weeks left until August recess, there is no shortage of items on the congressional to-do list. The latest round of Supreme Court decisions has inspired new action within Congress to pass legislation...more

Akin Gump Strauss Hauer & Feld LLP

FDA User Fee Reauthorization Gains Momentum with Senate HELP Committee Approval

There continues to be no shortage of FDA-related issues in front of Congress this summer. In recent days, the pace of Congressional action on reauthorizing FDA’s user fee programs has significantly picked up with the Senate...more

Holland & Knight LLP

Holland & Knight Health Dose: June 22, 2022

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include ...more

Holland & Knight LLP

Holland & Knight Health Dose: June 14, 2022

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include . . . ...more

Arnall Golden Gregory LLP

This Is Not A Drill . . . FDA Publishes Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021

On March 26, 2021, the Food and Drug Administration (FDA) issued a new Federal Register notice finally announcing the fee rates under the Over-the-Counter (OTC) Monograph Drug User Fee Program for Fiscal Year 2021.  As we...more

Locke Lord LLP

Case Closed: Facilities That Manufactured Hand Sanitizers During the Pandemic Will Not Be Charged User Fees

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On January 12, 2021, the Department of Health and Human Services issued yet another Federal Register notice announcing that Persons that Entered the Over the Counter drug market to supply hand sanitizers during the COVID-19...more

Hogan Lovells

HHS forces FDA to withdraw notice for OTC user fees and creates new exemptions

Hogan Lovells on

On January 6, 2021, the U.S. Department of Health and Human Services (HHS) ordered the Food and Drug Administration (FDA) to “cease further collection efforts” related to the Over-the-Counter (OTC) Drug Monograph User Fee...more

Locke Lord LLP

HHS Withdraws FDA’s “Arbitrary, Surprise” OTC User Fee and ‎Proposals for FY 2021

Locke Lord LLP on

As is typical with the FDA, the Agency chose the end of the year to publish the fees it intended to ‎collect from over-the-counter (OTC) monograph drug manufacturers under the OTC Monograph User ‎Fee Act (OMUFA). In its...more

King & Spalding

FDA Establishes – And HHS Immediately Withdraws – New OTC Drug User Fee Rates

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Last week, on December 29, 2020, the Food and Drug Administration (“FDA”) published a notice setting the amount of new annual facility fees for both for over-the-counter (“OTC”) monograph drug product manufacturers and for...more

Bergeson & Campbell, P.C.

FDA DHHS Announces 2021 Biosimilar User Fee Rates

On August 4, 2020, the U.S. Food and Drug Administration (FDA) Department of Health and Human Services (DHHS) announced the rates for biosimilar user fees for fiscal year (FY) 2021. ...more

Alston & Bird

Alston & Bird Healthcare Week in Review

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Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Mintz - Health Care Viewpoints

Decision Expected Soon in Ongoing Risk Corridors Litigation

Many provisions of the Affordable Care Act (“ACA”) have been the subject of litigation over the last decade, with several high-profile Supreme Court cases including: NFIB v. Sebelius, King v. Burwell, and Burwell v. Hobby...more

Proskauer Rose LLP

ERISA Newsletter - Fourth Quarter 2017

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Editor's Overview - For over two decades, federal law has required covered health plans and insurers to ensure that certain mental health benefits are in parity with offered medical/surgical benefits. The meaning of...more

BakerHostetler

Capitol Hill Healthcare Update

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Senate Republicans face a key procedural vote this week that would allow for debate of their healthcare legislation, but significant uncertainty remains about whether GOP senators can meet that procedural hurdle, what the...more

BakerHostetler

Capitol Hill Healthcare Update

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Delayed Senate Health Vote Boon to GOP or Just Prolonging the Inevitable? Senate Majority Leader Mitch McConnell’s announcement that he would delay a key procedural vote scheduled for this week on the Republicans’...more

BakerHostetler

Capitol Hill Healthcare Update

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Senate Reconvenes but No Health Votes Expected This Week - The Senate reconvenes today following the Fourth of July recess, but senators are at least a week away – and perhaps even longer – from voting on legislation to...more

BakerHostetler

Capitol Hill Healthcare Update

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Senate Republican leaders are expected to make a series of changes to the healthcare legislation released Thursday as they scramble to gain the support of at least 50 lawmakers in a showdown vote scheduled for later this...more

BakerHostetler

Capitol Hill Healthcare Update

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Senate Republicans return to Washington this week after a 10-day recess facing a key inflection point in their effort to repeal and replace the Affordable Care Act (ACA) as GOP leaders will outline policy options they hope...more

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