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HHS/FDA RIN: 0910-AA61 Publication ID: Fall 1996 
Title: Export Requirements for Drugs for Investigational Use in Other Countries 
Abstract: FDA is proposing to amend its regulations on investigational new drug products to streamline requirements for exports of unapproved drugs for investigational use to foreign countries. The proposal would permit an unapproved new drug product to be exported without prior FDA approval if the product is to be exported for use in a clinical investigation in any country. Persons exporting such products to countries not on the list of 25 countries in the recent Export Reform Act would be required to report to FDA at the time of export. Thus, the proposal would eliminate the need to submit a written request to FDA and to obtain FDA approval before exporting an unapproved new drug product for use in a clinical investigation in a foreign country. The proposal is relevant to the President's and Vice-President's "National Performance Review" for drugs and is consistent with recent Congressional initiatives. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
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