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HHS/FDA RIN: 0910-AA61 Publication ID: Spring 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 in other 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 would be required to report to FDA the country receiving the unapproved new drug product, the consignee in the foreign country, the name of the drug product, and the quantity being exported. 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 carries out 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: Proposed Rule Stage 
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  07/00/1996    
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