References to Opioid Overdose Reversal Agents in HHS Grant Programs
Section 210 · Sec. 210 ·
What this chapter is about
This part is about words used in federal grant papers. Many name one drug that stops an overdose. The Secretary must make those words cover any approved drug of that kind. Old papers must be fixed within a year.
The document says “shall”Who acts: Secretary of Health and Human ServicesHow: statuteSec. 210 in the PDF
What the document says
“The Secretary of Health and Human Services shall ensure that, as appropriate, whenever the Department of Health and Human Services issues a regulation or guidance for any grant program addressing opioid misuse and use disorders, any reference to an opioid overdose reversal drug (such as a reference to naloxone) is inclusive of any opioid overdose reversal drug that has been approved under section 505 of the Federal Food, Drug, and Cosmetic Act”
The section requires the Secretary to ensure that, in new regulations or guidance for any grant program addressing opioid misuse and use disorders, a reference to an overdose reversal drug such as naloxone covers any approved overdose reversal drug for emergency treatment of a known or suspected opioid overdose.
What the document actually says
“The Secretary of Health and Human Services shall ensure that, as appropriate, whenever the Department of Health and Human Services issues a regulation or guidance for any grant program addressing opioid misuse and use disorders, any reference to an opioid overdose reversal drug (such as a reference to naloxone) is inclusive of any opioid overdose reversal drug that has been approved under section 505 of the Federal Food, Drug, and Cosmetic Act”
That sentence, in plain words
New rules and advice must not name only one drug. If they name naloxone, they must cover the others too. Any approved reversal drug counts.
What this is about
Naloxone was the first drug to reverse an opioid overdose. Others have since been approved. Naming only the first can leave the newer ones out.
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. 210 in the PDF
What the document says
“Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall update all references described in paragraph (2) to be inclusive of any opioid overdose reversal drug that has been approved or otherwise authorized for use by the Food and Drug Administration.”
The section requires the Secretary to update, within one year of enactment, references to an overdose reversal drug in regulations and guidance issued before enactment under the State and Tribal Opioid Response grant program and under the grant program for priority substance use disorder prevention needs of regional and national significance.
What the document actually says
“Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall update all references described in paragraph (2) to be inclusive of any opioid overdose reversal drug that has been approved or otherwise authorized for use by the Food and Drug Administration.”
That sentence, in plain words
Papers written before this law must be fixed. The fix is due within one year. The words must cover any approved reversal drug.
What this is about
This reaches two named grant programs. One sends money to States and Tribes. The other funds prevention work of national reach.
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 two duties the section creates: the forward-looking duty on new regulations and guidance, and the duty to update references already in place in two named grant programs.
Nothing. The section has two subsections and both are recorded here.
The section refers to section 1003 of the 21st Century Cures Act, section 516 of the Public Health Service Act, and section 505 of the Federal Food, Drug, and Cosmetic Act. None is indexed here, so nothing is recorded about those programs or about how a drug is approved.
