(1) In the case of a new drug with respect to which the Secretary has made a determination described in subsection (a) of this section and with respect to which an exemption is in effect for purposes of section
355 (i) of title
21, the Secretary shall
(A) as appropriate, encourage the sponsor of the investigation of the new drug to submit to the Secretary, in accordance with regulations issued under such section, an application to use the drug in the treatment of individuals
(i) who are infected with the etiologic agent for acquired immune deficiency syndrome; and
(ii) who are not participating in the clinical trials conducted pursuant to such exemption; and
(B) if such an application is approved, encourage, as appropriate, licensed medical practitioners to obtain, in accordance with such regulations, the new drug from such sponsor for the purpose of treating such individuals.