This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.
The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.
The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.
Food and Drug Administration, HHS.
Direct final rule; confirmation of effective date.
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.
Effective date confirmed: April 23, 2007, except for the removal of § 2.125(e)(4)(v) (21 CFR 2.125(e)(4)(v)), which is effective August 1, 2007.Start Further Info
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.End Further Info End Preamble Start Supplemental 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 § 2.125(e)(4)(v), which is effective August 1, 2007.Start Signature
Dated: April 17, 2007.
Assistant Commissioner for Policy.
[FR Doc. E7-8043 Filed 4-26-07; 8:45 am]
BILLING CODE 4160-01-S