-CITE-

    45 CFR Sec. 46.121

-EXPCITE-

    Title 45
    SUBTITLE A
    PART 46
    Subpart A

-HEAD-

    Sec. 46.121 Investigational new drug or device 30-day delay
        requirement.

-TEXT-

      When an institution is required to prepare or to submit a
    certification with an application or proposal under these
    regulations, and the application or proposal involves an
    investigational new drug (within the meaning of 21 U.S.C. 355(i) or
    357(d)) or a significant risk device (as defined in 21 CFR
    812.3(m)), the institution shall identify the drug or device in the
    certification.  The institution shall also state whether the 30-day
    interval required for investigational new drugs by 21 CFR 312.1(a)
    and for significant risk devices by 21 CFR 812.30 has elapsed, or
    whether the Food and Drug Administration has waived that
    requirement.  If the 30-day interval has expired, the institution
    shall state whether the Food and Drug Administration has requested
    that the sponsor continue to withhold or restrict the use of the
    drug or device in human subjects.  If the 30-day interval has not
    expired, and a waiver has not been received, the institution shall
    send a statement to the Department upon expiration of the
    interval.  The Department will not consider a certification
    acceptable until the institution has submitted a statement that the
    30-day interval has elapsed, and the Food and Drug Administration
    has not requested it to limit the use of the drug or device, or
    that the Food and Drug Administration has waived the 30-day
    interval.