Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications; Correction, 53670 [2014-21481]

Download as PDF tkelley on DSK3SPTVN1PROD with PROPOSALS 53670 Federal Register / Vol. 79, No. 175 / Wednesday, September 10, 2014 / Proposed Rules 6005 respectively, of FAA Order 7400.9X, dated August 7, 2013, and effective September 15, 2013, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order. The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (1) 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, would 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 proposed 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 use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This proposed regulation is within the scope of that authority as it would establish Class D and amend existing Class E airspace at Paulding Northwest Atlanta Airport, Dallas, GA. 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. It is anticipated that this environmental analysis will be incorporated into the environmental document described in more detail at 79 FR 22177 (May 21, 2014). proposes to amend 14 CFR part 71 as follows: DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS Food and Drug Administration 1. The authority citation for Part 71 will continue to read as follows: 21 CFR Parts 610 and 680 [Docket No. FDA–2014–N–1110] ■ Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 1963 Comp., p. 389. Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications; Correction § 71.1 AGENCY: [Amended] 2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.9X, Airspace Designations and Reporting Points, dated August 7, 2013, and effective September 15, 2013, is amended as follows: ■ Paragraph 5000 Class D Airspace * * * ASO GA D * * Dallas, GA [New] Paulding Northwest Atlanta Airport, GA (Lat. 33°54′43″ N., long. 84°56′26″ W.) That airspace extending upward from the surface up to and including 2,500 feet MSL within a 4.2-mile radius of Paulding Northwest Atlanta Airport. This Class D airspace area is effective during specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory. Paragraph 6005. Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. * * * ASO GA E5 * ACTION: Proposed rule; correction. The Food and Drug Administration is correcting a proposed rule entitled ‘‘Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biological License Applications’’ that appeared in the Federal Register of August, 22, 2014. The document proposed to amend the biologics regulations by removing the general safety test requirements for biological products. The document published with the incorrect title. This document corrects that error. SUMMARY: Lori J. Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. FOR FURTHER INFORMATION CONTACT: In the Federal Register of August 22, 2014, in FR Doc. 2014–19888, on page 49727, the following correction is made: 1. On page 49727, in the third column, in the heading of the document, ‘‘Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biological License Applications’’ is corrected to read ‘‘Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications’’. SUPPLEMENTARY INFORMATION: * Dallas, GA [Amended] Paulding Northwest Atlanta Airport, GA (Lat. 33°54′43″ N., long. 84°56′26″ W.) That airspace extending upward from 700 feet above the surface within a 6.7-mile radius of. Paulding Northwest Atlanta Airport. Issued in College Park, Georgia, on September 2, 2014. Myron A. Jenkins, Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization. [FR Doc. 2014–21582 Filed 9–9–14; 8:45 am] BILLING CODE 4910–13–P Food and Drug Administration, HHS. Dated: September 3, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–21481 Filed 9–9–14; 8:45 am] Lists of Subjects in 14 CFR Part 71: Airspace, Incorporation by reference, Navigation (Air). BILLING CODE 4164–01–P The Proposed Amendment In consideration of the foregoing, the Federal Aviation Administration VerDate Mar<15>2010 16:29 Sep 09, 2014 Jkt 232001 PO 00000 Frm 00038 Fmt 4702 Sfmt 9990 E:\FR\FM\10SEP1.SGM 10SEP1

Agencies

[Federal Register Volume 79, Number 175 (Wednesday, September 10, 2014)]
[Proposed Rules]
[Page 53670]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21481]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 610 and 680

[Docket No. FDA-2014-N-1110]


Revocation of General Safety Test Regulations That Are 
Duplicative of Requirements in Biologics License Applications; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; correction.

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SUMMARY: The Food and Drug Administration is correcting a proposed rule 
entitled ``Revocation of General Safety Test Regulations That Are 
Duplicative of Requirements in Biological License Applications'' that 
appeared in the Federal Register of August, 22, 2014. The document 
proposed to amend the biologics regulations by removing the general 
safety test requirements for biological products. The document 
published with the incorrect title. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Lori J. Churchyard, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 22, 2014, 
in FR Doc. 2014-19888, on page 49727, the following correction is made:
    1. On page 49727, in the third column, in the heading of the 
document, ``Revocation of General Safety Test Regulations That Are 
Duplicative of Requirements in Biological License Applications'' is 
corrected to read ``Revocation of General Safety Test Regulations That 
Are Duplicative of Requirements in Biologics License Applications''.

    Dated: September 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21481 Filed 9-9-14; 8:45 am]
BILLING CODE 4164-01-P
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