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HHS/CDC RIN: 0920-AA37 Publication ID: Spring 2011 
Title: Control of Communicable Diseases: Foreign and Possessions; Proposed Revision of CDC Etiological Agents Importation Regulations 
Abstract: By statute, CDC implements regulations found at 42 CFR 71.54 restricting the importation and transportation of etiologic agents. Importers are required to complete an application for permit. Under its current regulatory framework, policies and procedures, the EAIPP does not perform on-site inspections at these facilities prior to the issuance of an import permit. Permits are issued based on a review of safety information provided by a potential importer in support of an import permit application. Rule-making is needed with the aim of improving CDC's ability to prevent importation of communicable diseases into the United States. CDC is considering whether to adopt a program similar to the U.S. Department of Agriculture/Animal and Plant Health Inspection Service Program such as conducting inspections on importer facilities prior to issuance of a permit for etiologic agents such as Mycobacterium tuberculosis and Hantavirus, providing an appeal process for denied applications. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 42 CFR 71.54   
Legal Authority: PHA as amended (42 USC 216, 264 to 272)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  08/00/2011    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Dr. Dan Sosin
Acting Director, Division of Select Agents and Toxins
Department of Health and Human Services
Centers for Disease Control and Prevention
1600 Clifton Road NE., MS A-46,
Atlanta, GA 30329
Phone:404 718-2000
Email: dms8@cdc.gov