Page:United States Statutes at Large Volume 102 Part 4.djvu/97

 PUBLIC LAW 100-607—NOV. 4, 1988

102 STAT. 3067

deficiency syndrome, the Secretary shall, through statements published in the Federal Roister— "(A) announce the fact of such determination; and "(B) with respect to the new drug involved, encourage an application for an exemption for investigational use of the new drug under r^ulations issued under section 505(i) of the Federal Food, Drug, and Cosmetic Act. "(2)(A) The AIDS Clinical Research Review Committee established pursuant to section 2304 shall msdce recommendations to the Secretary with respect to new drugs appropriate for determinations described in paragraph (1). "(B) The Secretary shall, as soon as is practicable, determine the merits of recommendations received by the Secretary pursuant to subparagraph (A). "(b) ENCOURAGEMENT OP APPLICATIONS WITH RESPECT TO TREATMENT USE IN CIRCUMSTANCES OTHER THAN CLINICAL TRIALS.—

"(1) In the case of a new drug with respect to which the Secretary has made a determination described in subsection (a) and with respect to which an exemption is in effect for purposes of section 505(i) of the Federal Food, Drug, and Cosmetic Act, 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. "(2) If the sponsor of the investigation of a new drug described Federal in paragraph (1) does not submit to the Secretary an application Register, described in such paragraph (relating to treatment use), the publication. Secretary shall, through statements published in the Federal Register, encourage, as appropriate, licensed medical practitioners to submit to the Secretary such applications in accordance with regulations described in such paragraph. "(c) TECHNICAL ASSISTANCE WITH RESPECT TO TREATMENT USE.—In Grants. the case of a new drug with respect to which the Secretary has made Contracts.

a determination described in subsection (a), the Secretary may, directly or through grants or contracts, provide technical assistance with respect to the process of— "(1) submitting to the Secretary applications for exemptions described in paragraph (I)(B) of such subsection; "(2) submitting to the Secretary applications described in subsection (b); and "(3) with respect to sponsors of investigations of new drugs, facilitoting the transfer of new drugs from such sponsors to licensed medical practitioners. "(d) DEFINITION.—For purposes of this section, the term "new drug" has the meaning given such term in section 201 of the Federal Food, Drug, and Cosmetic Act.

19-194 a-91—Part -

i:QL3

�