[Federal Register Volume 64, Number 85 (Tuesday, May 4, 1999)]
[Proposed Rules]
[Page 23811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-11121]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1020

[Docket No. 98N-1170]


Medical Devices; Sunlamp Products Performance Standard; Request 
for Comments and Information; Extension of Comment Period

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Advance notice of proposed rulemaking; extension of comment 
period.

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SUMMARY:  The Food and Drug Administration (FDA) is extending to July 
9, 1999, the comment period for the advance notice of proposed 
rulemaking (ANPRM) that appeared in the Federal Register of February 9, 
1999 (64 FR 6288). That ANPRM announced FDA's intention to propose 
amendments to the performance standard for sunlamp products. The agency 
is taking this action in response to a request for extension of the 
comment period. This extension of the comment period is intended to 
allow interested persons additional time to submit comments on the 
ANPRM.

DATES:  Written comments by July 9, 1999.

ADDRESSES:  Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Individuals or organizations wishing to receive 
copies of draft amendments or related documents distributed for review 
during the development of these amendments may have their names placed 
on a mailing list by writing to the Office of Science and Technology 
(HFZ-114), Center for Devices and Radiological Health, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, FAX 301-594-
6775, e-mail ``[email protected]''.

FOR FURTHER INFORMATION CONTACT:  W. Howard Cyr, Center for Devices and 
Radiological Health (HFZ-114), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-7179.

SUPPLEMENTARY INFORMATION:

I. Extension of Comment Period

    In the Federal Register of February 9, 1999 (64 FR 6288), FDA 
published an ANPRM to propose amendments to the performance standard 
for sunlamp products. FDA is soliciting comments and information from 
interested persons concerning the adequacy of the warnings on sunlamp 
products, current recommended exposure schedule to minimize risk to 
customers who choose to produce and maintain a tan, current labeling 
for replacement lamps, and current health warnings which do not reflect 
recent advances in photobiological research.
    FDA received a request from an association of tanning facilities 
owners to extend the comment period an additional 90 days to allow 
adequate time to respond. In response to the letter, FDA is extending 
the comment period for 60 additional days.

II. Comments

    Interested persons may, on or before July 9, 1999, submit to the 
Dockets Management Branch (address above) written comments regarding 
this ANPRM. 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. 
Received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: April 26, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-11121 Filed 5-3-99; 8:45 am]
BILLING CODE 4160-01-F