95-10542. Topical Drug Products for Over-the-Counter Human Use; Products for the Prevention of Swimmer's Ear and for the Drying of Water-Clogged Ears; Final Rule; Correction

[Federal Register Volume 60, Number 82 (Friday, April 28, 1995)]
[Rules and Regulations]
[Pages 20897-20898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10542]



-----------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 310

[Docket No. 77N-334S]
RIN 0905-AA06


Topical Drug Products for Over-the-Counter Human Use; Products 
for the Prevention of Swimmer's Ear and for the Drying of Water-Clogged 
Ears; Final Rule; Correction

AGENCY: Food and Drug Administration, HHS.

[[Page 20898]] ACTION: Final rule; correction.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
rule that appeared in the Federal Register of February 15, 1995 (60 FR 
8916). The document established that any over-the-counter (OTC) drug 
product for the prevention of swimmer's ear or for the drying of water-
clogged ears is not generally recognized as safe and effective and is 
misbranded. The document was published with a typographical error in 
the codified section. This document corrects that error.

EFFECTIVE DATE: August 15, 1995.

FOR FURTHER INFORMATION CONTACT: William E. Gilbertson, Center for Drug 
Evaluation and Research (HFD-810), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5000.

    In FR Doc. 95-3803, appearing on page 8916, in the Federal Register 
of Wednesday, February 15, 1995, the following correction is made:


Sec. 310.545  [Corrected]

    1. On page 8920, in the third column, under Sec. 310.545, in 
paragraph (d)(1), in lines 2 and 3, ``(a)(1) through (a)(2)(i), (a)(3) 
through (a)(4)'' is corrected to read ``(a)(1) through (a)(4)''.

    Dated: April 24, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-10542 Filed 4-27-95; 8:45 am]
BILLING CODE 4160-01-F