§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, §554, as added Pub. L. 105–115, title IV, §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.