Revision of the Requirements for Publication of License Revocation; Confirmation of Effective Date, 42175 [E9-20119]

Download as PDF Federal Register / Vol. 74, No. 161 / Friday, August 21, 2009 / Rules and Regulations Issued in Washington, DC, on August 17, 2009. Pamela Hamilton-Powell, Director, Office of Rulemaking. [FR Doc. E9–20059 Filed 8–20–09; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Authority: Therefore, under the biological products provisions under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 601 is amended. Accordingly, the amendments issued thereby are effective. 21 CFR Part 601 [Docket No. FDA–2009–N–0100] Revision of the Requirements for Publication of License Revocation; Confirmation of Effective Date AGENCY: Food and Drug Administration, HHS. ACTION: Direct final rule; confirmation of effective date. The Food and Drug Administration (FDA) is confirming the effective date of September 17, 2009, for the direct final rule that appeared in the Federal Register of May 5, 2009 (74 FR 20583). The direct final rule amends the biologics regulations to clarify the regulatory procedures for notifying the public about the revocation of a biologics license. The rule provides that FDA will publish a notice in the Federal Register following revocation of a biologics license under FDA regulations and will include a statement of the specific grounds for the revocation. This document confirms the effective date of the direct final rule. DATES: Effective date confirmed: September 17, 2009. FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: In the Federal Register of May 5, 2009 (74 FR 20583), FDA issued a direct final rule amending the biologics regulations for notifying the public about the revocation of a biologics license by clarifying that FDA will publish a notice of license revocation in cases where the Commissioner has made a finding that reasonable grounds for revocation exist under 21 CFR 601.5(b). The rule, as amended, does not affect other regulations or procedures for notification of license revocation. The rule, as amended, also does not affect existing FDA practices for publishing notices of voluntary withdrawal, CPrice-Sewell on DSKGBLS3C1PROD with RULES SUMMARY: VerDate Nov<24>2008 15:08 Aug 20, 2009 Jkt 217001 including notices of voluntary withdrawal of new drug applications. FDA solicited comments concerning the direct final rule for a 75-day period ending July 20, 2009. FDA stated that the effective date of the direct final rule would be on September 17, 2009, 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. Dated: August 14, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–20119 Filed 8–20–09; 8:45 am] BILLING CODE 4160–01–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 55 [OAR–2004–0091; FRL–8941–3] Outer Continental Shelf Air Regulations; Consistency Update for California AGENCY: Environmental Protection Agency (‘‘EPA’’). ACTION: Final rule. EPA is finalizing the update of the Outer Continental Shelf (‘‘OCS’’) Air Regulations proposed in the Federal Register on April 20, 2009. Requirements applying to OCS sources located within 25 miles of states’ seaward boundaries must be updated periodically to remain consistent with the requirements of the corresponding onshore area (‘‘COA’’), as mandated by section 328(a)(1) of the Clean Air Act Amendments of 1990 (‘‘the Act’’). The portion of the OCS air regulations that is being updated pertains to the requirements for OCS sources for which the Santa Barbara County Air Pollution Control District (Santa Barbara County APCD) is the designated COA. The intended effect of approving the requirements contained in the ‘‘Santa Barbara County Air Pollution Control District Requirements Applicable to OCS Sources’’ (June 2009) is to regulate emissions from OCS sources in accordance with the requirements onshore. SUMMARY: PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 42175 DATES: Effective Date: This rule is effective on September 21, 2009. The incorporation by reference of certain publications listed in this rule is approved by the Director of the Federal Register as of September 21, 2009. ADDRESSES: EPA has established docket number OAR–2004–0091 for this action. The index to the docket is available electronically at https:// www.regulations.gov and in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available in either location (e.g., CBI). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed in the FOR FURTHER INFORMATION CONTACT section. FOR FURTHER INFORMATION CONTACT: Cynthia G. Allen, Air Division, U.S. EPA Region IX, (415) 947–4120, allen.cynthia@epa.gov. SUPPLEMENTARY INFORMATION: Throughout this document, the terms ‘‘we,’’ ‘‘us,’’ or ‘‘our’’ refer to U.S. EPA. Organization of this document: The following outline is provided to aid in locating information in this preamble. Table of Contents I. Background II. Public Comment III. EPA Action IV. Statutory and Executive Order Reviews I. Background On April 20, 2009 (74 FR 17934), EPA proposed to approve requirements into the OCS Air Regulations pertaining to Santa Barbara County APCD. These requirements are being promulgated in response to the submittal of rules from this California air pollution control agency. EPA has evaluated the proposed requirements to ensure that they are rationally related to the attainment or maintenance of federal or state ambient air quality standards or Part C of title I of the Act, that they are not designed expressly to prevent exploration and development of the OCS and that they are applicable to OCS sources. 40 CFR 55.1. EPA has also evaluated the rules to ensure that they are not arbitrary or capricious. 40 CFR 55.12(e). In addition, EPA has excluded administrative or procedural rules. Section 328(a) of the Act requires that EPA establish requirements to control air pollution from OCS sources located within 25 miles of states’ seaward boundaries that are the same as onshore requirements. To comply with this E:\FR\FM\21AUR1.SGM 21AUR1

Agencies

[Federal Register Volume 74, Number 161 (Friday, August 21, 2009)]
[Rules and Regulations]
[Page 42175]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20119]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 601

[Docket No. FDA-2009-N-0100]


Revision of the Requirements for Publication of License 
Revocation; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; confirmation of effective date.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is confirming the 
effective date of September 17, 2009, for the direct final rule that 
appeared in the Federal Register of May 5, 2009 (74 FR 20583). The 
direct final rule amends the biologics regulations to clarify the 
regulatory procedures for notifying the public about the revocation of 
a biologics license. The rule provides that FDA will publish a notice 
in the Federal Register following revocation of a biologics license 
under FDA regulations and will include a statement of the specific 
grounds for the revocation. This document confirms the effective date 
of the direct final rule.

DATES: Effective date confirmed: September 17, 2009.

FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 5, 2009 (74 
FR 20583), FDA issued a direct final rule amending the biologics 
regulations for notifying the public about the revocation of a 
biologics license by clarifying that FDA will publish a notice of 
license revocation in cases where the Commissioner has made a finding 
that reasonable grounds for revocation exist under 21 CFR 601.5(b). The 
rule, as amended, does not affect other regulations or procedures for 
notification of license revocation. The rule, as amended, also does not 
affect existing FDA practices for publishing notices of voluntary 
withdrawal, including notices of voluntary withdrawal of new drug 
applications.
    FDA solicited comments concerning the direct final rule for a 75-
day period ending July 20, 2009. FDA stated that the effective date of 
the direct final rule would be on September 17, 2009, 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.

    Authority: Therefore, under the biological products provisions 
under the Federal Food, Drug, and Cosmetic Act and the Public Health 
Service Act, and under authority delegated to the Commissioner of 
Food and Drugs, 21 CFR part 601 is amended. Accordingly, the 
amendments issued thereby are effective.

    Dated: August 14, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20119 Filed 8-20-09; 8:45 am]
BILLING CODE 4160-01-S

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.