[Federal Register Volume 60, Number 158 (Wednesday, August 16, 1995)]
[Rules and Regulations]
[Pages 42435-42436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20315]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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; Partial Stay of Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; partial stay of regulation.

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SUMMARY: The Food and Drug Administration (FDA) is staying part of a 
final rule that established that any over-the-counter (OTC) topical 
otic drug products 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. This action, which is being taken in 
response to new clinical data and a petition for stay of action, 
applies only to topical otic drug products for the drying of water-
clogged ears. This action is part of the ongoing review of OTC drug 
products conducted by FDA.

EFFECTIVE DATE: June 22, 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.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 8, 1986 (51 FR 28656), the agency 
published a final rule establishing conditions under which OTC topical 
otic drug products are generally recognized as safe and effective. That 
final rule applied only to earwax removal aids. Products for the 
prevention of swimmer's ear and for the drying of water-clogged ears 
were not considered by the agency at that time.
    In the Federal Register of February 15, 1995 (60 FR 8916), the 
agency declared that OTC drug products containing active ingredients 
for the prevention of swimmer's ear or for the drying of water-clogged 
ears were new drugs under section 201(p) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 321(p)). To be marketed, such 
products would require an application or abbreviated application 
approved under section 505 of the act (21 U.S.C. 355) and 21 CFR part 
314. In the absence of an approved application, products for this use 
also would be misbranded under section 502 of the act (21 U.S.C. 352). 
The agency also stated that, in appropriate circumstances, a citizen 
petition to establish a monograph may be submitted under Sec.  10.30 
(21 CFR 10.30) in lieu of an application.
    Subsequently, Buc Levitt & Beardsley, on behalf of Del 
Pharmaceuticals, Inc., filed a citizen petition (Ref. 1) to: (1) Permit 
the marketing of 95 percent isopropyl alcohol in 5 percent anhydrous 
glycerin for the drying of water-clogged ears, and (2) remove glycerin, 
anhydrous glycerin, and isopropyl alcohol from the list of active 
ingredients in Sec.  310.545(a)(15)(ii) (21 CFR 310.545(a)(15)(ii)). 
This petition included the results of a double-blinded, 3-arm parallel 
study to evaluate the efficacy and tolerability of isopropyl alcohol in 
drying water-clogged ears in 90 adult volunteers. Buc Levitt & 
Beardsley, on behalf of Del Pharmaceuticals, Inc., also filed a 
petition (Ref. 2), pursuant to 21 CFR 10.35, requesting a stay of the 
August 15, 1995, effective date of the final rule to allow time for the 
agency to review the results of the new study.
    The agency reviewed the results of this study and determined that 
95 percent isopropyl alcohol in a 5 percent anhydrous glycerin base is 
safe and effective for OTC use for drying water-clogged ears. The 
agency's detailed comments and evaluations of this study are on file in 
the Dockets Management Branch (Ref. 3).
    On June 22, 1995, FDA agreed to stay the effective date of the 
final rule for OTC swimmer's ear and the drying of water-clogged ear 
drug products (Ref. 4). The agency intends to propose to amend the 
final monograph for OTC topical otic drug products to include 
conditions under which drug products for the drying of water-clogged 
ears are generally recognized as safe and effective and not misbranded.
    The agency has determined that the stay of action applies only to 
topical otic drug products for the drying of water-clogged ears. The 
new study did not involve the prevention of swimmer's ear. Therefore, 
the August 15, 1995, effective date for Sec.  310.545(a)(15)(ii) 
remains in effect for topical otic drug products for the prevention of 
swimmer's ear. The August 15, 1995, effective date is stayed only for 
topical otic drug products for the drying of water-clogged ears.

[[Page 42436]]


II. References

    The following references are on display in the Dockets Management 
Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 
Parklawn Dr., Rockville, MD 20857, and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday.
    (1) Citizen's Petition, Buc Levitt & Beardsley, filed on behalf 
of Del Pharmaceuticals, Inc., coded CP1, Docket No. 77N-334S, 
Dockets Management Branch.

    (2) Citizen's Petition to Stay Action, Buc Levitt & Beardsley, 
filed on behalf of Del Pharmaceuticals, Inc., coded PSA 1, Docket 
No. 77N-334S, Dockets Management Branch.
    (3) Letter from W. E. Gilbertson, FDA, to Buc Levitt & 
Beardsley, attorneys for Del Pharmaceuticals, Inc., coded LET 12, 
Docket No. 77N-334S, Dockets Management Branch.
    (4) Letter from W. E. Gilbertson, FDA to Buc Levitt & Beardsley, 
attorneys for Del Pharmaceuticals, Inc., coded LET 13, Docket No. 
77N-334S, Dockets Management Branch.

List of Subjects in 21 CFR Part 310

    Administrative practice and procedure, Drugs, Labeling, Medical 
devices, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
310 is amended as follows:

PART 310--NEW DRUGS

    1. The authority citation for 21 CFR part 310 continues to read as 
follows:

    Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 512-16, 
520, 601(a), 701, 704, 705, 721 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 
360b-360f, 360j, 361(a), 371, 374, 375, 379e; secs. 215, 301, 302(a) 
351, 354-360F of the Public Health Service Act (42 U.S.C. 216, 241, 
242(a), 262, 263b-263n).


Sec.  310.545   [Partial stay]

    2. Section 310.545 Drug products containing certain active 
ingredients offered over-the-counter (OTC) for certain uses is stayed 
in paragraph (a)(15)(ii) only for topical otic drug products for the 
drying of water-clogged ears.

    Dated: August 7, 1995.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 95-20315 Filed 8-15-95; 8:45 am]
BILLING CODE 4160-01-F