Medical devices: Sunlamp products performance standard; recommended exposure schedule and health warnings requirements,

[Federal Register: May 4, 1999 (Volume 64, Number 85)]

[Proposed Rules]

[Page 23811]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr04my99-24]

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.

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 ``HWC@CDRH.FDA.GOV''.

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:

1. 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.

2. 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. 99-11121Filed5-3-99; 8:45 am]

   BILLING CODE 4160-01-F