Establishment of Abraham Accords Office Within Food and Drug Administration
Section 6611 · Sec. 6611 ·
What this chapter is about
This part sets up an office inside the drug agency, placed in an Abraham Accords country. It must be established within two years. The office helps those countries with drug oversight rules and helps their firms deal with the agency. A report is due in three years.
The document says “shall”Who acts: Secretary of Health and Human Services, Commissioner of Food and DrugsHow: statuteSec. 6611 in the PDF
What the document says
“The Secretary, acting through the Commissioner of Food and Drugs, shall establish within the Food and Drug Administration an office, to be known as the Abraham Accords Office, to be headed by a director.”
Section 6611 adds a new section 1015 to chapter X of the Federal Food, Drug, and Cosmetic Act. The Secretary, acting through the Commissioner of Food and Drugs, must set up an office in the Food and Drug Administration, called the Abraham Accords Office, headed by a director.
What the document actually says
“The Secretary, acting through the Commissioner of Food and Drugs, shall establish within the Food and Drug Administration an office, to be known as the Abraham Accords Office, to be headed by a director.”
That sentence, in plain words
The health chief must set up an office inside the drug agency. It is called the Abraham Accords Office. A director runs it.
What this is about
The Abraham Accords are deals between Israel and some Arab states. The office is a link to the states that signed.
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. 6611 in the PDF
What the document says
“select the location of the Abraham Accords Office in an Abraham Accords country; and”
Within two years of enactment the Secretary must, in consultation with the governments of Abraham Accords countries and appropriate United States diplomatic and security personnel, pick the office's location in such a country, establish it, and assign to it the Food and Drug Administration personnel the Secretary finds necessary.
What the document actually says
“select the location of the Abraham Accords Office in an Abraham Accords country; and”
That sentence, in plain words
Pick where the office will sit. It must be in a country that signed the Abraham Accords.
What this is about
The choice is made with those governments and with United States diplomats. The office must be up within two years. Staff go with it.
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: Director of the Abraham Accords OfficeHow: statuteSec. 6611 in the PDF
What the document says
“provide technical assistance to regulatory partners in Abraham Accords countries on strengthening regulatory oversight and converging regulatory requirements for the oversight of regulated products, including good manufacturing practices”
Once established, the office must provide technical assistance to regulatory partners in those countries on strengthening oversight and bringing requirements closer together, including good manufacturing practices and other issues relevant to making medical products. It must also make it easier for interested parties there to deal with the agency, including by sharing information on United States regulatory pathways and gathering feedback on research, development and manufacturing. It carries out other functions the Secretary finds necessary.
What the document actually says
“provide technical assistance to regulatory partners in Abraham Accords countries on strengthening regulatory oversight and converging regulatory requirements for the oversight of regulated products, including good manufacturing practices”
That sentence, in plain words
The office helps the drug watchdogs in those countries. It works on stronger oversight and on rules that line up with each other.
What this is about
Good manufacturing practice is the way medicine must be made. Rules that match make trade and checks easier for both sides.
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 “means”Who acts: Department of StateHow: statuteSec. 6611 in the PDF
What the document says
“the term `Abraham Accords country' means a country identified by the Department of State as having signed the Abraham Accords Declaration.”
The new section defines an Abraham Accords country as one the Department of State identifies as having signed the Abraham Accords Declaration. It also provides that nothing in the section requires any action inconsistent with a national security recommendation from the federal government.
What the document actually says
“the term `Abraham Accords country' means a country identified by the Department of State as having signed the Abraham Accords Declaration.”
That sentence, in plain words
The words name a country. The State Department says which ones signed the deal.
What this is about
The list is not written into the law. The State Department keeps it. Nothing here beats a warning about safety.
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. 6611 in the PDF
What the document says
“Not later than 3 years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Congress a report on the Abraham Accords Office, including--”
Subsection (b) of section 6611 requires the Secretary to report to Congress within three years of enactment on the office. The report must evaluate how the office has advanced progress toward conformance with the agency's requirements by manufacturers in those countries, count the parties it helped, summarize the technical assistance given, and recommend ways to improve coordination.
What the document actually says
“Not later than 3 years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Congress a report on the Abraham Accords Office, including--”
That sentence, in plain words
Within three years the health chief must send Congress a report on the office. It must hold the things listed next.
What this is about
The report asks whether the office made a difference. It counts who it helped. It says what should change.
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 main things the section does: establish the office and its director, set the two year deadline and the way the location is chosen, set the office's duties, define Abraham Accords country, state that nothing requires action against a national security recommendation, and require a report to Congress with its four contents.
Nothing else in the section.
The section adds a new section to the Federal Food, Drug, and Cosmetic Act, which is not indexed here. The Abraham Accords Declaration is identified by the Department of State and is not indexed here either.
