[Federal Register Volume 65, Number 46 (Wednesday, March 8, 2000)]
[Notices]
[Pages 12272-12273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5525]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-0357]


Draft Guidance for Industry on OTC Treatment of Herpes Labialis 
With Antiviral Agents; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``OTC Treatment 
of Herpes Labialis with Antiviral Agents.'' Recent interest in 
marketing antiviral agents over-the-counter (OTC) to treat herpes 
labialis has raised public health concerns. This draft guidance 
summarizes the agency's current thinking on why it does not favor the 
OTC treatment of herpes labialis with antiherpes agents at this time. 
The guidance also describes issues that sponsors should consider before 
submitting a marketing application for an OTC antiviral product to 
treat herpes labialis.

DATES: Submit written comments on the draft guidance by May 8, 2000. 
General comments on agency guidance documents are welcome at any time.

ADDRESSES: Copies of this draft guidance for industry are available on 
the Internet at hppt://www.fda.gov/cder/guidance/index.htm. Submit 
written requests for single copies of the draft guidance to the Drug 
Information Branch (HFD-210), Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. Submit written comments on the draft guidance 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Joseph G. Toerner, Center for Drug 
Evaluation and Research (HFD-530), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2330.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``OTC Treatment of Herpes Labialis 
with Antiviral Agents.'' This draft guidance summarizes the agency's 
current thinking on the OTC use of antiviral agents to treat herpes 
labialis. The agency believes that, until other safe

[[Page 12273]]

antiherpes agents that lack cross-resistance to the currently available 
class become available, issues relating to misuse and resistance will 
need to be thoroughly evaluated in an actual use setting of an 
antiviral agent for recurrent herpes labialis, particularly if OTC 
marketing is proposed sometime in the future. At present, based on a 
public health-based risk/benefit assessment with respect to treatment 
of herpes labialis, the agency concludes that antiherpes agents should 
not be made available OTC.
    This draft guidance is being issued consistent with FDA's good 
practices (62 FR 8961, February 27, 1997). The draft guidance 
represents the agency's current thinking on OTC treatment of herpes 
labialis with antiviral agents. Its does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such an approach 
satisfies the requirements of the applicable statute, regulations, or 
both.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance. Two copies of 
any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The draft guidance and 
received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 17, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-5525 Filed 3-7-00; 8:45 am]
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