ISSUANCE OF RULE ON ANIMAL TRIALS.

SEC. 123. ISSUANCE OF RULE ON ANIMAL TRIALS. Not later than 90 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall complete the process of rulemaking that was commenced under authority of section 505 of the Federal Food, Drug, and Cosmetic Act and section 351 of the Public Health Service Act with the issuance of the proposed rule entitled “New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot be Conducted” published in the Federal Register on October 5, 1999 (64 Fed. Reg. 53960), and shall promulgate a final rule.