Current Good Manufacturing Practice Requirements for Combination Products; Correction, 51099 [E9-23899]

Download as PDF Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Proposed Rules Is not a ‘‘significant regulatory action’’ under Executive Order 12866; (2) is not a ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. The FAA’s authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency’s authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would revise Colored Federal Airways in Alaska. Environmental Review This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1E, ‘‘Environmental Impacts: Policies and Procedures,’’ prior to any FAA final regulatory action. List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (air). The Proposed Amendment In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows: cprice-sewell on DSK2BSOYB1PROD with PROPOSALS PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 1963 Comp., p. 389. § 71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9T, Airspace Designations and Reporting Points, signed August 27, 2009, and VerDate Nov<24>2008 13:51 Oct 02, 2009 Jkt 220001 effective September 15, 2009, is to be amended as follows: Paragraph 6009(a) * * * Green Federal Airways. * * G–16 [Revised] From Point Lay, AK, NDB; Wainwright Village, AK, NDB; Browerville, AK, NDB; Nuiqsut Village, AK, NDB; to Put River, AK, NDB. * * * * Paragraph 6009(d) * * * * Blue Federal Airways. * * * * 2. On page 48423, in the third column, in the ADDRESSES section, beginning in the second line, ‘‘[Docket No. FDA–2008–D–0409] (formerly Docket No. 2004D–0431)’’ is corrected to read ‘‘[Docket No. FDA–2009–N– 0435]’’. Dated: September 28, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–23899 Filed 10–2–09; 8:45 am] BILLING CODE 4160–01–S * B–26 [Revised] From Chena, AK, NDB, to Yukon River, AK, NDB. * 51099 * Issued in Washington, DC, September 28, 2009. Edith V. Parish, Manager, Airspace and Rules Group. [FR Doc. E9–23884 Filed 10–2–09; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF THE INTERIOR National Park Service 36 CFR Part 7 RIN 1024–AD75 Special Regulations, Areas of the National Park System, Grand Teton National Park National Park Service, Interior. Proposed rule. AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 4 [Docket No. FDA–2009–N–0435] Current Good Manufacturing Practice Requirements for Combination Products; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of September 23, 2009 (74 FR 48423). The document proposed to codify the current good manufacturing practice requirements applicable to combination products. The document published with an incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy (HF–27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–7010. SUPPLEMENTARY INFORMATION: In FR Doc. E9–22850, appearing on page 48423, in the Federal Register of Wednesday, September 23, 2009, the following corrections are made: 1. On page 48423, in the third column, in the Docket No. heading, ‘‘[Docket No. FDA–2008–D–0409]’’ is corrected to read ‘‘[Docket No. FDA– 2009–N–0435]’’. PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 ACTION: SUMMARY: The National Park Service (NPS) proposes to designate certain multi-use pathways in Grand Teton National Park as routes for bicycle use; NPS regulations require issuance of a special regulation to designate routes for bicycle use when it will be off park roads and outside developed areas. Several segments of multi-use pathways have been constructed, or are planned for construction, and are located parallel to and generally within about 50 feet of existing park roads. Moving bicycle traffic off the lanes of motor vehicle travel will reduce real and perceived safety hazards, which will enhance opportunities for non-motorized enjoyment of the park, and encourage the use of alternate transportation by park employees and visitors. In addition, the NPS is proposing revisions to its regulations regarding fishing and boating in certain park waters of Grand Teton National Park to reflect current operating practices and management objectives. DATES: Comments must be received by December 4, 2009. ADDRESSES: You may submit your comments, identified by Regulatory Information Number 1024–AD75 (RIN), by any of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • Mail: Grand Teton National Park, P.O. Drawer 170, Moose, WY 83012. • Hand Deliver to: Superintendent’s Office, Moose, Wyoming. E:\FR\FM\05OCP1.SGM 05OCP1

Agencies

[Federal Register Volume 74, Number 191 (Monday, October 5, 2009)]
[Proposed Rules]
[Page 51099]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23899]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 4

[Docket No. FDA-2009-N-0435]


Current Good Manufacturing Practice Requirements for Combination 
Products; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a 
proposed rule that appeared in the Federal Register of September 23, 
2009 (74 FR 48423). The document proposed to codify the current good 
manufacturing practice requirements applicable to combination products. 
The document published with an incorrect docket number. This document 
corrects that error.

FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy (HF-
27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-7010.

SUPPLEMENTARY INFORMATION: In FR Doc. E9-22850, appearing on page 
48423, in the Federal Register of Wednesday, September 23, 2009, the 
following corrections are made:
    1. On page 48423, in the third column, in the Docket No. heading, 
``[Docket No. FDA-2008-D-0409]'' is corrected to read ``[Docket No. 
FDA-2009-N-0435]''.
    2. On page 48423, in the third column, in the ADDRESSES section, 
beginning in the second line, ``[Docket No. FDA-2008-D-0409] (formerly 
Docket No. 2004D-0431)'' is corrected to read ``[Docket No. FDA-2009-N-
0435]''.

    Dated: September 28, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-23899 Filed 10-2-09; 8:45 am]
BILLING CODE 4160-01-S
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.