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Use of Ozone-Depleting Substances; Removal of Essential Use Designations; Confirmation of Effective Date

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

  
[Federal Register: April 27, 2007 (Volume 72, Number 81)]
[Rules and Regulations]
[Page 20942]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27ap07-3]

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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]
BILLING CODE 4160-01-S

 
 

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