41148 Federal Register / Vol. 79, No. 135 / Tuesday, July 15, 2014 / Proposed Rules 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2014–0305; Airspace 

Docket No. 14–AWP–2] 

Proposed Establishment and 

Amendment of Class D and E 

Airspace; Santa Rosa, CA 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: This action proposes to 

establish Class E airspace and modify 

Class D and E airspace at Charles M. 

Shultz-Sonoma County Airport, Santa 

Rosa, CA. This action, initiated by the 

FAAs biennial review of the airspace 

area, would enhance the safety and 

management of instrument flight rules 

(IFR) operations at the airport. Class D 

airspace would be amended to reflect 

the airport’s name change. 

DATES: Comments must be received on 

or before August 29, 2014. 

ADDRESSES: Send comments on this 

proposal to the U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC 20590; telephone (202) 

366–9826. You must identify FAA 

Docket No. FAA–2014–0305; Airspace 

Docket No. 14–AWP–2, at the beginning 

of your comments. You may also submit 

comments through the Internet at http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Richard Roberts, Federal Aviation 

Administration, Operations Support 

Group, Western Service Center, 1601 

Lind Avenue SW., Renton, WA 98057; 

telephone (425) 203–4517. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

Interested parties are invited to 

participate in this proposed rulemaking 

by submitting such written data, views, 

or arguments, as they may desire. 

Comments that provide the factual basis 

supporting the views and suggestions 

presented are particularly helpful in 

developing reasoned regulatory 

decisions on the proposal. Comments 

are specifically invited on the overall 

regulatory, aeronautical, economic, 

environmental, and energy-related 

aspects of the proposal. 

Communications should identify both 

docket numbers (FAA Docket No. FAA– 

2014–0305 and Airspace Docket No. 14– 

AWP–2) and be submitted in triplicate 

to the Docket Management System (see 

‘‘ADDRESSES’’ section for address and 

phone number). You may also submit 

comments through the Internet at 

http://www.regulations.gov. 

Commenters wishing the FAA to 

acknowledge receipt of their comments 

on this action must submit with those 

comments a self-addressed stamped 

postcard on which the following 

statement is made: ‘‘Comments to FAA 

Docket No. FAA–2014–0305 and 

Airspace Docket No. 14–AWP–2’’. The 

postcard will be date/time stamped and 

returned to the commenter. 

All communications received on or 

before the specified closing date for 

comments will be considered before 

taking action on the proposed rule. The 

proposal contained in this action may 

be changed in light of comments 

received. All comments submitted will 

be available for examination in the 

public docket both before and after the 

closing date for comments. A report 

summarizing each substantive public 

contact with FAA personnel concerned 

with this rulemaking will be filed in the 

docket. 

Availability of NPRMs 

An electronic copy of this document 

may be downloaded through the 

Internet at http://www.regulations.gov. 

Recently published rulemaking 

documents can also be accessed through 

the FAA’s Web page at http://

www.faa.gov/airports_airtraffic/air_

traffic/publications/airspace_

amendments/. 

You may review the public docket 

containing the proposal, any comments 

received, and any final disposition in 

person in the Dockets Office (see the 

‘‘ADDRESSES’’ section for the address 

and phone number) between 9:00 a.m. 

and 5:00 p.m., Monday through Friday, 

except federal holidays. An informal 

docket may also be examined during 

normal business hours at the Northwest 

Mountain Regional Office of the Federal 

Aviation Administration, Air Traffic 

Organization, Western Service Center, 

Operations Support Group, 1601 Lind 

Avenue SW., Renton, WA 98057. 

Persons interested in being placed on 

a mailing list for future NPRMs should 

contact the FAA’s Office of Rulemaking, 

(202) 267–9677, for a copy of Advisory 

Circular No. 11–2A, Notice of Proposed 

Rulemaking Distribution System, which 

describes the application procedure. 

The Proposal 

The FAA is proposing an amendment 

to Title 14 Code of Federal Regulations 

(14 CFR) Part 71 by establishing Class E 

airspace designated as an extension and 

modifying Class E airspace extending 

upward from 700 feet above the surface 

at Charles M. Schultz-Sonoma County 

Airport, Santa Rosa, CA. After a biennial 

review of the airspace, the FAA found 

modification of the airspace necessary 

for the safety and management of 

aircraft departing and arriving under 

IFR operations at the airport. Class E 

airspace designated as an extension to 

the Class D and Class E surface area 

would be established from the 4.3-mile 

radius of the airport to 14 miles 

northwest of the airport. Class E 

airspace extending upward from 700 

feet above the surface would be 

modified with segments extending 23 

miles northwest, 28 miles southeast, 

and 13 miles southwest of the airport. 

The description for the Class D airspace 

would reflect the airport name change 

from Santa Rosa/Sonoma County 

Airport to Charles M. Schultz-Sonoma 

County Airport. 

Class D and E airspace designations 

are published in paragraph 5000, 6004, 

and 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 this 

Order. 

The FAA has determined this 

proposed regulation only involves an 

established body of technical 

regulations for which frequent and 

routine amendments are necessary to 

keep them operationally current. 

Therefore, this proposed regulation; (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 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 U.S. Code. Subtitle 1, 

Section 106, describes the authority for 

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 


sroberts on DSK5SPTVN1PROD with PROPOSALS
Federal Register / Vol. 79, No. 135 / Tuesday, July 15, 2014 / Proposed Rules 41149 

prescribing regulations to assign the use 

of 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 

amend controlled airspace at Charles M. 

Schultz-Sonoma County Airport, Santa 

Rosa, CA. 

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 

Accordingly, pursuant to the 

authority delegated to me, the Federal 

Aviation Administration proposes to 

amend 14 CFR Part 71 as follows: 

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 14 CFR 

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 the 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 

* * * * * 

AWP CA D Santa Rosa, CA [Amended] 

Charles M. Schultz-Sonoma County Airport, 

CA 

(Lat. 38°30′33′′ N., long. 122°48′46′′ W.) 

That airspace extending upward from the 

surface to and including 2,600 feet MSL 

within a 4.3-mile radius of Santa Rosa/

Sonoma County Airport. This Class D 

airspace area is effective during the 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 6004 Class E Airspace Areas 

Designated As An Extension to Class D or 

Class E Surface Area 

* * * * * 

AWP CA E4 Santa Rosa, CA [New] 

Charles M. Shultz-Sonoma County Airport, 

CA 

(Lat. 38°30′33′′ N., long. 122°48′46′′ W.) 

That airspace extending upward from the 

surface within 2 miles either side of the 342° 

bearing from the Charles M. Shultz-Sonoma 

County Airport, CA, extending from the 4.3 

mile radius of the airport to 14 miles 

northwest of the airport. 

Paragraph 6005 Class E Airspace Areas 

Extending Upward From 700 Feet or More 

Above the Surface of the Earth 

* * * * * 

AWP CA E5 Santa Rosa, CA [Modified] 

Charles M. Shultz-Sonoma County Airport, 

CA 

(Lat. 38°30′33′′ N., long. 122°48′46′′ W.) 

That airspace extending upward from 700 

feet above the surface bounded by a line 

beginning at lat. 38°53′25′′ N., long. 

122°52′34′′ W.; to lat. 38°37′07′′ N., long. 122° 

46′02.00′′ W.; to 38°22′08′′ N., long. 

122°38′28′′ W.; lat. 38°06′41′′ N., long. 

122°29′59′′ W.; lat. 38°02′10′′ N., long. 

122°44′09′′ W.; lat. 38°17′57′′ N., long. 

122°54′37′′ W.; lat. 38°22′58′′ N., long. 

123°02′34′′ W.; lat. 38°29′12′′ N., long. 

122°56′32′′ W.; lat. 38°33′48′′ N., long. 

123°00′47′′ W.; lat. 38°50′14′′ N., long. 

123°07′20′′ W. thence to the point of origin; 

that airspace extending upward from 1,200 

feet above the surface bounded by a line 

beginning at lat. 45°49′00′′ N., long. 

118°00′00′′ W.; to lat. 45°49′00′′ N., long. 

119°45′00′′ W.; to lat. 47°00′00′′ N., long. 

119°45′00′′ W., to lat. 47°00′00′′ N., long. 

118°00′00′′ W.; thence to the point of origin. 

Issued in Seattle, Washington, on July 2, 

2014. 

Clark Desing, 

Manager, Operations Support Group, Western 

Service Center. 

[FR Doc. 2014–16636 Filed 7–14–14; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 15 

[Docket No. FDA–2014–N–0824] 

Confidentiality of Interim Results in 

Cardiovascular Outcome Safety Trials; 

Public Hearing; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of public hearing; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public hearing that will provide a forum 

to discuss confidentiality of interim 

results for certain cardiovascular 

outcomes trials (CVOTs) submitted to 

the Agency while the trials are still 

ongoing. The purpose of the public 

hearing is to initiate constructive 

discussion among regulators, 

researchers, health care providers, 

representatives from the pharmaceutical 

industry and health care organizations, 

and the general public, about 

appropriate handling of interim analysis 

results of these ongoing CVOTs. FDA is 

also opening a public docket to receive 

comments on this topic. 

DATES: The public hearing will be held 

on August 11, 2014, from 8 a.m. to 5 

p.m. Individuals who wish to present at 

the public hearing must register by July 

28, 2014. Section IV provides 

attendance and registration information. 

To ensure consideration, submit 

comments by July 28, 2014. Electronic 

or written comments will be accepted 

after the public hearing until October 

10, 2014. 

ADDRESSES: The public hearing will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (rm. 

1503), Silver Spring, MD 20993–0002. 

Entrance for the public hearing 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to http://www.

fda.gov/AboutFDA/WorkingatFDA/

BuildingsandFacilities/WhiteOak

CampusInformation/ucm241740.htm. 

Submit electronic comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Indira Hills, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, 10903 New 

Hampshire Ave., Bldg. 21, rm. 4508, 

Silver Spring, MD 20993, 301–796– 

9686, FAX: 301–796–9907, email: 

indira.hills@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. The Requirement for Postmarketing 

Studies To Assess the Risk of a New 

Drug 

In some cases, studies submitted to 

FDA as part of a new drug application 

or biologics license application will 

demonstrate that a drug is safe and 

effective for its intended use (i.e., that 

its benefits outweigh its identified 

risks), but the Agency will nevertheless 

require a sponsor to conduct additional 

postmarketing studies or trials under 

section 505(o)(3) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 


sroberts on DSK5SPTVN1PROD with PROPOSALS