[Federal Register: March 8, 2000 (Volume 65, Number 46)]
[Notices]
[Page 12272-12273]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08mr00-76]

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

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Draft Guidance for Industry on OTC Treatment of Herpes Labialis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.

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

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availability of a draft guidance for industry entitled ``OTC Treatment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 This draft guidance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DATES: Submit written comments on the draft guidance by May 8, 2000.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ADDRESSES: Copies of this draft guidance for industry are available on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written requests for single copies of the draft guidance to the Drug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 Submit written comments on the draft guidance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draft guidance for industry entitled ``OTC Treatment of Herpes Labialis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 This draft guidance summarizes the agency's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]
BILLING CODE 4160-01-F