This part says what the drug agency must report each year about its work on these drugs. It also makes it post notes from its talks with industry. And it asks a watchdog office for a report on supply.
The document says “shall”Who acts: Food and Drug AdministrationHow: statuteSec. 6505 in the PDF
What the document says
“Beginning with fiscal year 2026, the annual report under this subsection shall include--”
The section amends section 744N of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-73). The first item added is the progress of the agency in achieving the goals and its future plans for meeting them. The rest include counts of proposed and final orders issued on each kind of order request, on safety requests and on requests to finalize a finding that a drug is generally recognized as safe and effective. Information subject to withholding under section 552(b)(4) of title 5 is protected.
What the document actually says
“Beginning with fiscal year 2026, the annual report under this subsection shall include--”
That sentence, in plain words
From 2026 the yearly report must hold more than it used to.
What this is about
The fees come with goals, such as how fast work gets done. The report is how Congress checks whether the goals are met.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall”Who acts: Secretary of Health and Human ServicesHow: statuteSec. 6505 in the PDF
What the document says
“The Secretary shall make publicly available, on the public website of the Food and Drug Administration, robust written minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry, not later than 30 days after each such negotiation meeting.”
The minutes have to set out in detail any substantive proposal made by any party, together with significant controversies or differences of opinion and how they were resolved.
What the document actually says
“The Secretary shall make publicly available, on the public website of the Food and Drug Administration, robust written minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry, not later than 30 days after each such negotiation meeting.”
That sentence, in plain words
The agency must put notes from its talks with industry on its website. It has thirty days after each talk.
What this is about
The fee deal is worked out in meetings with the firms that pay. This makes the record of those meetings public.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “shall”Who acts: Comptroller General of the United StatesHow: statuteSec. 6505 in the PDF
What the document says
“Not later than September 30, 2027, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report assessing the supply chain”
The report has to assess how stable the supply chain is, what information the agency collects about it, how that information is used, how the agency works with others to head off disruption, and what further authority it may need.
What the document actually says
“Not later than September 30, 2027, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report assessing the supply chain”
That sentence, in plain words
A watchdog office must report to two committees by September 30, 2027. The report is about how these drugs reach the shelf.
What this is about
The Comptroller General runs an office that checks on the government for Congress. Here it is asked to look at supply.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The added content of the annual performance report, the duty to publish minutes of negotiation meetings, and the report asked of the Comptroller General.
The list of items the annual report has to count is recorded in summary rather than clause by clause, and the edits that move the reauthorization years from 2025 to 2030.
The section works by amending the Federal Food, Drug, and Cosmetic Act. That law is not indexed here, so this file does not say what the existing report contains.
