
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360aaa-4]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
             Part D--Dissemination of Treatment Information
 
Sec. 360aaa-4. Corrective actions; cessation of dissemination


(a) Postdissemination data regarding safety and effectiveness

                       (1) Corrective actions

        With respect to data received by the Secretary after the 
    dissemination of information under section 360aaa of this title by a 
    manufacturer has begun (whether received pursuant to paragraph (2) 
    or otherwise), if the Secretary determines that the data indicate 
    that the new use involved may not be effective or may present a 
    significant risk to public health, the Secretary shall, after 
    consultation with the manufacturer, take such action regarding the 
    dissemination of the information as the Secretary determines to be 
    appropriate for the protection of the public health, which may 
    include ordering that the manufacturer cease the dissemination of 
    the information.

        (2) Responsibilities of manufacturers to submit data

        After a manufacturer disseminates information under section 
    360aaa of this title, the manufacturer shall submit to the Secretary 
    a notification of any additional knowledge of the manufacturer on 
    clinical research or other data that relate to the safety or 
    effectiveness of the new use involved. If the manufacturer is in 
    possession of the data, the notification shall include the data. The 
    Secretary shall by regulation establish the scope of the 
    responsibilities of manufacturers under this paragraph, including 
    such limits on the responsibilities as the Secretary determines to 
    be appropriate.

(b) Cessation of dissemination

       (1) Failure of manufacturer to comply with requirements

        The Secretary may order a manufacturer to cease the 
    dissemination of information pursuant to section 360aaa of this 
    title if the Secretary determines that the information being 
    disseminated does not comply with the requirements established in 
    this part. Such an order may be issued only after the Secretary has 
    provided notice to the manufacturer of the intent of the Secretary 
    to issue the order and (unless paragraph (2)(B) applies) has 
    provided an opportunity for a meeting with respect to such intent. 
    If the failure of the manufacturer constitutes a minor violation of 
    this part, the Secretary shall delay issuing the order and provide 
    to the manufacturer an opportunity to correct the violation.

                    (2) Supplemental applications

        The Secretary may order a manufacturer to cease the 
    dissemination of information pursuant to section 360aaa of this 
    title if--
            (A) in the case of a manufacturer that has submitted a 
        supplemental application for a new use pursuant to section 
        360aaa-3(a)(1) of this title, the Secretary determines that the 
        supplemental application does not contain adequate information 
        for approval of the new use for which the application was 
        submitted;
            (B) in the case of a manufacturer that has submitted a 
        certification under section 360aaa-3(b) of this title, the 
        manufacturer has not, within the 6-month period involved, 
        submitted the supplemental application referred to in the 
        certification; or
            (C) in the case of a manufacturer that has submitted a 
        certification under section 360aaa-3(c) of this title but has 
        not yet submitted the supplemental application referred to in 
        the certification, the Secretary determines, after an informal 
        hearing, that the manufacturer is not acting with due diligence 
        to complete the studies involved.

     (3) Termination of deemed approval of exemption regarding 
                          supplemental applications

        If under section 360aaa-3(d)(3) of this title the Secretary 
    terminates a deemed approval of an exemption, the Secretary may 
    order the manufacturer involved to cease disseminating the 
    information. A manufacturer shall comply with an order under the 
    preceding sentence not later than 60 days after the receipt of the 
    order.

(c) Corrective actions by manufacturers

                           (1) In general

        In any case in which under this section the Secretary orders a 
    manufacturer to cease disseminating information, the Secretary may 
    order the manufacturer to take action to correct the information 
    that has been disseminated, except as provided in paragraph (2).

     (2) Termination of deemed approval of exemption regarding 
                          supplemental applications

        In the case of an order under subsection (b)(3) of this section 
    to cease disseminating information, the Secretary may not order the 
    manufacturer involved to take action to correct the information that 
    has been disseminated unless the Secretary determines that the new 
    use described in the information would pose a significant risk to 
    the public health.

(June 25, 1938, ch. 675, Sec. 555, as added Pub. L. 105-115, title IV, 
Sec. 401(a), Nov. 21, 1997, 111 Stat. 2361.)

                         Termination of Section

        For termination of section by section 401(e) of Pub. L. 105-115, 
    see Effective and Termination Dates note set out under section 
    360aaa of this title.

                  Section Referred to in Other Sections

    This section is referred to in sections 360aaa-2, 360aaa-3 of this 
title.
