Which research the expedited procedures cover
What the document says“``(2) Research subject to expedited procedures.--Research described in this paragraph is research that-- ``(A) is with respect to a drug that is the subject of an investigational use exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)); or ``(B) is-- ``(i) conducted by the Department of Health and Human Services, the Department of Defense, or the Department of Veterans Affairs; or”
The research that qualifies for the new subsection. It is research on a drug that is the subject of an investigational use exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act, or research conducted by the Department of Health and Human Services, the Department of Defense or the Department of Veterans Affairs. Clause (ii), not quoted here, adds research funded partly or entirely by a grant, contract, cooperative agreement or other transaction from one of those three departments.
What the document actually says“``(2) Research subject to expedited procedures.--Research described in this paragraph is research that-- ``(A) is with respect to a drug that is the subject of an investigational use exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)); or ``(B) is-- ``(i) conducted by the Department of Health and Human Services, the Department of Defense, or the Department of Veterans Affairs; or”
Only some work counts here. It counts if the drug is being tested as a new medicine. It also counts if one of three federal departments does the work.
The three are Health and Human Services, Defense, and Veterans Affairs. Work they pay for counts too. Other work must use the older route.
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.