The Secretary must decide which requirement applies, and the two tracks stay apart
Making further consolidated appropriations for the fiscal year ending September 30, 2026, and for other purposes, section 6601, Sec. 6601.
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The Secretary must decide which requirement applies, and the two tracks stay apart
The document says “shall”Who acts: Secretary of Health and Human ServicesHow: statuteSec. 6601 in the PDF
What the document says
“``The Secretary shall determine whether subparagraph (A) or (B) of subsection (a)(1) applies with respect to an application before the date on which the applicant is required to submit the initial pediatric study plan under paragraph (2)(A).''.”
Section 6601 requires the Secretary to decide which of the two requirements in section 505B(a)(1) applies to an application before the initial pediatric study plan is due. It also adds a rule of construction: an application subject to one of those subparagraphs is not subject to the other. The Secretary may require the results of completed preclinical studies relevant to the plan to be submitted at the same time.
What the document actually says
“``The Secretary shall determine whether subparagraph (A) or (B) of subsection (a)(1) applies with respect to an application before the date on which the applicant is required to submit the initial pediatric study plan under paragraph (2)(A).''.”
That sentence, in plain words
The health chief must decide which of two rules covers an application. That must happen before the first study plan is due.
What this is about
A maker cannot plan a study without knowing the rule. Deciding first saves wasted work. An application falls under one rule, not both.
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.
Consolidated Appropriations Act, 2026, Public Law 119-75, sec. 6601, 140 Stat. 695 (2026). https://www.govinfo.gov/content/pkg/PLAW-119publ75/html/PLAW-119publ75.htm
This page
“The Secretary must decide which requirement applies, and the two tracks stay apart,” Consolidated Appropriations Act, 2026, section 6601, Sec. 6601. Read the Mandate, https://readthemandate.org/consolidated-appropriations-act-2026/proposal/sec6601-determination-and-rule/ (retrieved August 26, 2026).
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