PUBLIC LAW 100-607—NOV. 4, 1988 102 STAT. 3069

information as the Secretary determines to be necessary to
carry out this section.
"(e) AUTHORIZATION OF APPKOPEIATIONS.-—

"(1) For the purpose of carrying out subsection (bXD, there are
authorized to be appropriated such sums as may be necessary
for each of the fiscal years 1989 through 1991.

"(2) For the purpose of carrying out subsection (bX2), there are
authorized to be appropriated such sums as may be necessary
for each of the fiscal years 1989 through 1991.

"SEC. 2314. EVALUATION OF CERTAIN TREATMENTS. 42 USC

"(a) ESTABLISHMENT OF PROGRAM.— 300cc~14'

"(1) After consultation with the Clinical Research Review
Committee established pursuant to section 2304, the Secretary
shall establish a program for the evaluation of drugs that—
"(A) are not approved by the Commissioner of Food and
Drugs for the purpose of treatments with respect to ac-
quired immune deficiency syndrome; and

"(B) are being utilized for such purpose by individuals
infected with the etiologlc agent for such syndrome.
"(2) The program established under paragraph (1) shall in-
clude evaluations of the effectiveness and the risks of the
treatment involved, including the risks of foregoing treatments
with respect to acquired immune deficiency syndrome that are
approved by the Commissioner of Food and Drugs.
"(b) AUTHORITY WITH RESPECT TO GRANTS AND CONTRACTS.—

"(1) For the purpose of conducting evaluations required in
subsection (a), the Secretary may make grants to, and enter into
cooperative agreements and contracts with, public and non-
profit private entities.

"(2) Nonprofit private entities under paragraph (1) may
include nonprofit private organizations that—

"(A) are established for the purpose of evaluating treat-
ments with respect to acquired immune deficiency syn-
drome; and

"(B) consist primarily of individuals infected with the
etiologic agent for such syndrome.
"(c) SCIENTIFIC AND ETHICAL Guromcmss.—

"(1) The Secretary shall establish appropriate scientific and
ethical guidelines for the conduct of evaluations carried out
pursuant to this section. The Secretary may not provide finan-
cial assistance under subsection (bXD unless the applicant for
such assistance agrees to comply with such guidelines.

"(2) The Secretary may establish the guidelines described in
paragraph (1) only after consulting with—

"(A) physicians whose clinical practice includes a signifi-
cant number of individuals with acquired immune defi-
ciency syndrome;

"(B) individuals who are infected with the etiologic agent
for such syndrome; and

"(Q oilier individuals with appropriate expertise or
experience.

"(d) AUTHORIZATION OF ApnoraiATiQNS.—For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as may be necessary.