[Federal Register Volume 63, Number 86 (Tuesday, May 5, 1998)]
[Notices]
[Page 24813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11841]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0149]


Guidance for Industry on National Uniformity for Nonprescription 
Drugs--Ingredient Listing for OTC Drugs; Availability; Clarification

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; clarification.

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SUMMARY: The Food and Drug Administration (FDA) is clarifying an 
administrative error relating to a notice that appeared in the Federal 
Register of April 9, 1998 (63 FR 17429). The notice announced the 
availability of a guidance for industry entitled ``National Uniformity 
for Nonprescription Drugs--Ingredient Listing for OTC Drugs.'' The 
agency displayed the incorrect draft of the guidance. This document 
clarifies that error.

FOR FURTHER INFORMATION CONTACT: Thomas C. Kuchenberg, 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 April 9, 1998 (63 
FR 17429), FDA published a notice announcing the availability of a 
guidance for industry entitled ``National Uniformity for 
Nonprescription Drugs--Ingredient Listing for OTC Drugs.'' The agency, 
however, inadvertently put on display a working draft of the guidance 
dated February 1998, rather than the version the agency intends to 
implement, which is dated April 1998. This notice clarifies that error 
by announcing the availability of the April 1998 version of the 
guidance document and by withdrawing the February 1998 draft. 
Additionally, on February 19, 1998, FDA inadvertently put the working 
draft dated February 1998 on the Internet at http://www.fda.gov/cder/
guidance/index.htm. The agency intends to replace the working draft 
that is on the Internet with the April 1998 version in the near future.

    Dated: April 27, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-11841 Filed 5-4-98; 8:45 am]
BILLING CODE 4160-01-F