[Federal Register Volume 65, Number 38 (Friday, February 25, 2000)]
[Rules and Regulations]
[Page 10012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4404]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 801

[Docket No. 99N-2550]


Medical Devices; Hearing Aids; Technical Data Amendments; 
Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA) is confirming the 
effective date of March 17, 2000, for the final rule that appeared in 
the Federal Register of November 3, 1999 (64 FR 59618). The direct 
final rule amends regulations governing hearing aid labeling to 
reference the most recent version of the consensus standard used to 
determine technical data to be included in labeling for hearing aids. 
This amendment allows manufacturers to use state-of-the-art methods to 
address technical data in labeling for hearing aids. This document 
confirms the effective date of the direct final rule.

DATES: Effective date confirmed: March 17, 2000.

FOR FURTHER INFORMATION CONTACT: David A. Segerson, Center for Devices 
and Radiological Health (HFZ-460), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2080.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 3, 1999 
(64 FR 59618), FDA solicited comments concerning the direct final rule 
for a 75-day period ending January 17, 2000. FDA stated that the 
effective date of the direct final rule would be on March 17, 2000, 60 
days after the end of the comment period, unless any significant 
adverse comment was submitted to FDA during the comment period. FDA did 
not receive any significant adverse comments.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, notice is 
given that no objections or requests for a hearing were filed in 
response to the November 3, 1999, direct final rule. Accordingly, the 
amendments issued thereby are effective.

    Dated: February 17, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-4404 Filed 2-24-00; 8:45 am]
BILLING CODE 4160-01-F