[Federal Register Volume 67, Number 98 (Tuesday, May 21, 2002)]
[Notices]
[Page 35827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12666]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0200]


Sunlamp Product Performance Standard and UVA Tanning Products; 
Revocation of Compliance Policy Guide 7133.16

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is revoking the 
compliance policy guide (CPG) entitled "Sec. 396.100 
Applicability of the Sunlamp Performance Standard to UVA Tanning 
Products (CPG 7133.16)." This CPG is no longer necessary because 
the agency has amended the sunlamp product performance standard (21 CFR 
1040.20) to include sunlamp products and ultraviolet lamps that emit 
only ultraviolet A (UVA) radiation.

DATES: The revocation is effective June 20, 2002.

ADDRESSES: Submit written requests for single copies of the CPG to the 
Division of Compliance Policy (HFC-230), Office of Enforcement, 
Office of Regulatory Affairs, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-0411 or FAX your 
request to 301-827-0482.
    A copy of the CPG may be seen in the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through 
Friday.

FOR FURTHER INFORMATION CONTACT: Jeffrey B. Governale, Division of 
Compliance Policy (HFC-230), Office of Enforcement, Office of 
Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-0411.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA issued the CPG entitled "Sec. 396.100 Applicability of 
the Sunlamp Performance Standard to UVA Tanning Products (CPG 
7133.16)" on October 1, 1980. This CPG describes how the sunlamp 
product performance standard ( 1040.20 (21 CFR 1040.20)), 
that became effective on May 7, 1980, applied to: (1) Any sunlamp 
product designed to incorporate one or more ultraviolet lamps and 
intended for irradiation of any part of the living human body by 
ultraviolet radiation with wavelengths, in air, between 180 and 320 
nanometers (nm) to induce skin tanning and (2) any ultraviolet lamp 
that produces radiation in the wavelength interval of 180 to 320 nm, in 
air, and is intended for use in any sunlamp product. Sunlamp products, 
that emit only UVA radiation (320 to 400 nm), were not subject to the 
1980 performance standard.
    In the Federal Register of September 6, 1985 (50 FR 36548 at 
36550), FDA amended the sunlamp product performance standard to 
accommodate new products and designs that were significantly different 
from those for which the original standard was developed. This revised 
performance standard, which became effective on September 8, 1986, 
applies to sunlamp products and ultraviolet lamps that emit ultraviolet 
radiation with wavelengths, in air, between 200 and 400 nm and are 
intended for skin tanning ( 1040.20(b)(9) and (b)(11)). 
Accordingly, sunlamp products and ultraviolet lamps which emit only UVA 
radiation are now subject to the performance standard.
    Given the current sunlamp product performance standard, FDA is 
revoking CPG 7133.16, in its entirety.

II. Electronic Access

    Prior to June 20, 2002, a copy of the CPG may also be downloaded to 
a personal computer with access to the Internet. The Office of 
Regulatory Affairs home page includes the referenced document that may 
be accessed at http://www.fda.gov/ora/compliance_ref/cpg/cpgdev/cpg396-100.html.

    Dated: May 14, 2002.
John Marzilli,
Deputy Associate Commissioner for Regulatory Affairs.
[FR Doc. 02-12666 Filed 5-20-02; 8:45 am]
BILLING CODE 4160-01-S