Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Food and Drug Administration 

          - [Docket No. 97N-0314] 

# AGENCY:

Food and Drug Administration, HHS. 

# ACTION:

Notice; extension of compliance date. 

# SUMMARY:

                        The Food and Drug Administration (FDA) is announcing that manufacturers who were marketing orally administered drug products containing levothyroxine sodium on or before August 14, 1997, may continue to market these products without approved applications until August 14, 2001. FDA is extending by 1 year the compliance date given in the notice published in the                         **Federal Register**                         of August 14, 1997 (62 FR 43535). The agency is taking this action to give manufacturers additional                               ( print page 24489)                            time to conduct studies and to prepare applications.                     

# EFFECTIVE DATE:

April 26, 2000. 

# FOR FURTHER INFORMATION CONTACT:

Christine F. Rogers, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. 

# SUPPLEMENTARY INFORMATION:

                    In the                     **Federal Register**                     of August 14, 1997 (62 FR 43535), FDA announced that orally administered drug products containing levothyroxine sodium are new drugs and required manufacturers to have approved applications as a condition of marketing. The notice advised that manufacturers who were marketing levothyroxine sodium drug products on or before August 14, 1997, may continue to market their products until August 14, 2000.[1]                                          The notice stated that a manufacturer who marketed a levothyroxine sodium drug product without an approved application after that date would be subject to regulatory action.                 

                    FDA permitted this period of continued marketing because it regards levothyroxine sodium products as medically necessary and, therefore, wanted to allow sufficient time for manufacturers to conduct the required studies and to prepare and submit applications, as well as to allow the agency sufficient time to review these applications. FDA has now concluded that manufacturers may need additional time to conduct studies and to prepare applications. Therefore, the agency extends by 1 year the compliance date given in the                     **Federal Register**                     notice of August 14, 1997, to permit continued marketing of these products until August 14, 2001.                 

This notice is issued under the Federal Food, Drug, and Cosmetic Act (secs. 502, 505 (21 U.S.C. 352, 355)) and under authority delegated to the Associate Commissioner for Regulatory Affairs (21 CFR 5.20). 

Dated: April 18, 2000. 

Margaret M. Dotzel, 

Acting Associate Commissioner for Policy. 

# Footnotes

1.                             After August 14, 1997, a new levothyroxine drug product may not be introduced into the market unless FDA has approved an application for that product.                    
        Back to Citation      

[FR Doc. 00-10322 Filed 4-25-00; 8:45 am] 

BILLING CODE 4160-01-F