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HHS/FDA

RIN: 0910-AA61

Publication ID: Fall 1995

Title: ●Export Requirements for Drugs for Investigational Use in Other Countries
Abstract: FDA is considering whether to amend its regulations on investigational new drugs to streamline requirements for exports of unapproved drugs for investigational use in other countries. FDA is considering whether to exempt, or reduce requirements for exports of such drugs to highly developed countries such as Australia, Canada, Japan, and countries that are members of the European Union or the European Free Trade Area. The proposal carries out the President's and Vice President's "National Performance Review" for drugs and devices and is consistent with recent Congressional initiatives.
Agency: Department of Health and Human Services(HHS)	Priority: Substantive, Nonsignificant
RIN Status: First time published in the Unified Agenda	Agenda Stage of Rulemaking: Long-Term Actions
CFR Citation: 21 CFR 312.110
Legal Authority: 21 USC 331    21 USC 351 to 352    21 USC 355 to 357    21 USC 360    21 USC 360b    21 USC 360aa to 360dd    21 USC 371 to 372    21 USC 374    21 USC 379e    21 USC 379g    21 USC 381 to 382    21 USC 393    42 USC 216    42 USC 241    42 USC 242l

Timetable: Action Date FR Cite NPRM  To Be Determined

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Included in the Regulatory Plan: No
Agency Contact: Linda Horton Director, International Policy Staff, Office of Policy (HF-23) Department of Health and Human Services Food and Drug Administration 5600 Fishers Lane, Rockville, MD 20857 Phone:301 827-3344 Email: lhorton@bangate.fda.gov