
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[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-3]

 
                        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-3. Requirement regarding submission of supplemental 
        application for new use; exemption from requirement
        

(a) In general

    A manufacturer may disseminate information under section 360aaa of 
this title on a new use only if--
        (1)(A) the manufacturer has submitted to the Secretary a 
    supplemental application for such use; or
        (B) the manufacturer meets the condition described in subsection 
    (b) or (c) of this section (relating to a certification that the 
    manufacturer will submit such an application); or
        (2) there is in effect for the manufacturer an exemption under 
    subsection (d) of this section from the requirement of paragraph 
    (1).

(b) Certification on supplemental application; condition in case of 
        completed studies

    For purposes of subsection (a)(1)(B) of this section, a manufacturer 
may disseminate information on a new use if the manufacturer has 
submitted to the Secretary an application containing a certification 
that--
        (1) the studies needed for the submission of a supplemental 
    application for the new use have been completed; and
        (2) the supplemental application will be submitted to the 
    Secretary not later than 6 months after the date of the initial 
    dissemination of information under section 360aaa of this title.

(c) Certification on supplemental application; condition in case of 
        planned studies

                           (1) In general

        For purposes of subsection (a)(1)(B) of this section, a 
    manufacturer may disseminate information on a new use if--
            (A) the manufacturer has submitted to the Secretary an 
        application containing--
                (i) a proposed protocol and schedule for conducting the 
            studies needed for the submission of a supplemental 
            application for the new use; and
                (ii) a certification that the supplemental application 
            will be submitted to the Secretary not later than 36 months 
            after the date of the initial dissemination of information 
            under section 360aaa of this title (or, as applicable, not 
            later than such date as the Secretary may specify pursuant 
            to an extension under paragraph (3)); and

            (B) the Secretary has determined that the proposed protocol 
        is adequate and that the schedule for completing such studies is 
        reasonable.

                   (2) Progress reports on studies

        A manufacturer that submits to the Secretary an application 
    under paragraph (1) shall submit to the Secretary periodic reports 
    describing the status of the studies involved.

           (3) Extension of time regarding planned studies

        The period of 36 months authorized in paragraph (1)(A)(ii) for 
    the completion of studies may be extended by the Secretary if--
            (A) the Secretary determines that the studies needed to 
        submit such an application cannot be completed and submitted 
        within 36 months; or
            (B) the manufacturer involved submits to the Secretary a 
        written request for the extension and the Secretary determines 
        that the manufacturer has acted with due diligence to conduct 
        the studies in a timely manner, except that an extension under 
        this subparagraph may not be provided for more than 24 
        additional months.

(d) Exemption from requirement of supplemental application

                           (1) In general

        For purposes of subsection (a)(2) of this section, a 
    manufacturer may disseminate information on a new use if--
            (A) the manufacturer has submitted to the Secretary an 
        application for an exemption from meeting the requirement of 
        subsection (a)(1) of this section; and
            (B)(i) the Secretary has approved the application in 
        accordance with paragraph (2); or
            (ii) the application is deemed under paragraph (3)(A) to 
        have been approved (unless such approval is terminated pursuant 
        to paragraph (3)(B)).

                     (2) Conditions for approval

        The Secretary may approve an application under paragraph (1) for 
    an exemption if the Secretary makes a determination described in 
    subparagraph (A) or (B), as follows:
            (A) The Secretary makes a determination that, for reasons 
        defined by the Secretary, it would be economically prohibitive 
        with respect to such drug or device for the manufacturer to 
        incur the costs necessary for the submission of a supplemental 
        application. In making such determination, the Secretary shall 
        consider (in addition to any other considerations the Secretary 
        finds appropriate)--
                (i) the lack of the availability under law of any period 
            during which the manufacturer would have exclusive marketing 
            rights with respect to the new use involved; and
                (ii) the size of the population expected to benefit from 
            approval of the supplemental application.

            (B) The Secretary makes a determination that, for reasons 
        defined by the Secretary, it would be unethical to conduct the 
        studies necessary for the supplemental application. In making 
        such determination, the Secretary shall consider (in addition to 
        any other considerations the Secretary finds appropriate) 
        whether the new use involved is the standard of medical care for 
        a health condition.

     (3) Time for consideration of application; deemed approval

        (A) In general

            The Secretary shall approve or deny an application under 
        paragraph (1) for an exemption not later than 60 days after the 
        receipt of the application. If the Secretary does not comply 
        with the preceding sentence, the application is deemed to be 
        approved.

        (B) Termination of deemed approval

            If pursuant to a deemed approval under subparagraph (A) a 
        manufacturer disseminates written information under section 
        360aaa of this title on a new use, the Secretary may at any time 
        terminate such approval and under section 360aaa-4(b)(3) of this 
        title order the manufacturer to cease disseminating the 
        information.

(e) Requirements regarding applications

    Applications under this section shall be submitted in the form and 
manner prescribed by the Secretary.

(June 25, 1938, ch. 675, Sec. 554, as added Pub. L. 105-115, title IV, 
Sec. 401(a), Nov. 21, 1997, 111 Stat. 2359.)

                         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, 360aaa-4 of this 
title.
