Page:United States Statutes at Large Volume 102 Part 4.djvu/103

 PUBLIC LAW 100-607—NOV. 4, 1988

102 STAT. 3073

"(2) Information pertaining to experimental treatments for acquired immune deficiency sjmdrome that may be available under a treatment investigational new drug application that has been submitted to the Food and Drug Administration pursuant 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 OF INFECTED INDIVIDUALS.

42 USC

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 s)mdrome. "(2) The Secretary may not make a grant under paragraph (1) unless— "(A) the applicant for the grant is a provider of comprehensive 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 Secretary may not make a grant under subsection (a) unless the applicant for the grant agrees that, with respect to patients participating 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 treatments 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 section 2304(c)(2)(B); "(4) support groups; and "(5) information on, and referrals to, entities providing appropriate 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 grsuit, 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—

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