[Federal Register Volume 72, Number 81 (Friday, April 27, 2007)]
[Rules and Regulations]
[Page 20942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8043]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 2

[Docket No. 2006N-0416]


Use of Ozone-Depleting Substances; Removal of Essential Use 
Designations; 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 April 23, 2007, for the direct final rule that 
appeared in the Federal Register of December 7, 2006 (71 FR 70870). The 
direct final rule amends the regulation to remove beclomethasone, 
dexamethasone, fluticasone, bitolterol, salmeterol, ergotamine 
tartrate, and ipratropium bromide, used in oral pressurized metered-
dose inhalers, from the list of essential uses of ozone-depleting 
substances. None of these products is currently being marketed. This 
document confirms the effective date of the direct final rule.

DATES: Effective date confirmed: April 23, 2007, except for the removal 
of Sec.  2.125(e)(4)(v) (21 CFR 2.125(e)(4)(v)), which is effective 
August 1, 2007.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen or Wayne H. Mitchell, 
Center for Drug Evaluation and Research (HFD-7), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 7, 2006 
(71 FR 70870), FDA solicited comments concerning the direct final rule 
for a 75-day period ending February 20, 2007. FDA stated that the 
effective date of the direct final rule would be on April 23, 2007, 60 
days after the end of the comment period, unless any significant 
adverse comment was submitted to FDA during the comment period.
    FDA received no significant adverse comments within the comment 
period. Therefore, under the Federal Food, Drug, and Cosmetic Act, the 
Clean Air Act, and under authority delegated to the Commissioner of 
Food and Drugs, after consultation with the Administrator of the 
Environmental Protection Agency, notice is given that no objections or 
requests for a hearing were filed in response to the December 7, 2006, 
direct final rule. Accordingly, FDA is confirming that the amendment 
issued thereby is effective April 23, 2007, except for the removal of 
Sec.  2.125(e)(4)(v), which is effective August 1, 2007.

    Dated: April 17, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-8043 Filed 4-26-07; 8:45 am]
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