PUBLIC LAW 100-607—NOV. 4, 1988 102 STAT. 3073

"(2) Information pertaining to experimental treatments for
acquired immune deficiency syndrome that may be available
under a treatment investigational new drug application that
has been submitted to the Food and Drug Administration pursu-
ant to part 312 of title 21, Code of Federal Regulations. The
Data Bank shall also include information pertaining to the
results of clinical trials of such treatments, with the consent of
the sponsor, of such experimental treatments, including
information concerning potential toxicities or adverse effects
associated with the use or administration of such experimental
treatment.

"SEC. 2318. DEVELOPMENT OF MODEL PROTOCOLS FOR CLINICAL CARE 42 USC
OF INFECTED INDIVIDUALS. 300cc-18.

"(a) IN GENERAL.—

"(1) The Secretary may make grants to public and nonprofit Grants.
private entities for the establishment of projects to develop
model protocols for the clinical care of individuals infected with
the etiologic agent for acquired immune deficiency syndrome.
"(2) The Secretary may not make a grant under paragraph (1)
unless—

"(A) the applicant for the grant is a provider of com-
prehensive primary care; or

"(B) the applicant for the grant agrees, with respect to
the project carried out pursuant to paragraph (1), to enter
into a cooperative arrangement with an entity that is a
provider of comprehensive primary care.

"(b) REQUIREMENT OF PROVISION OF CERTAIN SERVICES.—The Sec-
retary may not make a grant under subsection (a) unless the
applicant for the grant agrees that, with respect to patients partici-
pating in the project carried out with the grant, services provided
pursuant to the grant will include—

"(1) monitoring, in clinical laboratories, of the condition of
such patients;

"(2) clinical intervention for infection with the etiologic agent
for acquired immune deficiency syndrome, including measures
for the prevention of conditions arising from the infection;
"(3) information and counseling on the availability of treat-
ments for such infection approved by the Commissioner of Food
and Drugs, on the availability of treatments for such infection
not yet approved by the Commissioner, and on the reports
issued by the Clinical Research Review Committee under sec-
tion 2304(cX2XB);

"(4) support groups; and

"(5) information on, and referrals to, entities providing appro-
priate social support services.

"(c) LIMITATION ON IMPOSITION OF CHARGES FOR SERVICES.—The
Secretary may not make a grant under subsection (a) unless the
applicant for the grant agrees that, if the applicant will routinely
impose a charge for providing services pursuant to the grant, the
applicant will not impose the charge on any individual seeking such
services who is unable to pay the charge.
"(d) EVALUATION AND REPORTS.—

"(1) The Secretary may not make a grant under subsection (a)
unless the applicant for the grant agrees, with respect to the
project carried out pursuant to subsection (a), to submit to the
Secretary—