Federal Register / Vol. 77, No. 121 / Friday, June 22, 2012 / Rules and Regulations 37569 

Dated: June 14, 2012. 

Richard Cordray, 

Director, Bureau of Consumer Financial 

Protection. 

[FR Doc. 2012–15163 Filed 6–21–12; 8:45 am] 

BILLING CODE 4810–AM–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2012–0217; Airspace 

Docket No. 12–AEA–2] 

Establishment of Class D Airspace and 

Amendment of Class E Airspace; East 

Hampton, NY 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This action establishes Class 

D airspace and amends existing Class E 

airspace at East Hampton, NY, to 

accommodate the new mobile airport 

traffic control tower (ATCT) at East 

Hampton Airport. Controlled airspace 

enhances the safety and management of 

Instrument Flight Rules (IFR) operations 

at the airport. This action also updates 

the geographic coordinates of the 

airport’s existing Class E airspace and 

eliminates Class E extensions that are no 

longer required. 

DATES: Effective 0901 UTC, July 26, 

2012. The Director of the Federal 

Register approves this incorporation by 

reference action under title 1, Code of 

Federal Regulations, part 51, subject to 

the annual revision of FAA Order 

7400.9 and publication of conforming 

amendments 

FOR FURTHER INFORMATION CONTACT: John 

Fornito, Operations Support Group, 

Eastern Service Center, Federal Aviation 

Administration, P.O. Box 20636, 

Atlanta, Georgia 30320; telephone (404) 

305–6364. 

SUPPLEMENTARY INFORMATION: 

History 

On March 15, 2012, the FAA 

published in the Federal Register a 

Notice of Proposed Rulemaking (NPRM) 

to establish Class D and E airspace and 

amend existing Class E airspace at East 

Hampton, NY, to accommodate a new 

air traffic control tower at East Hampton 

Airport (77 FR 15297). Interested parties 

were invited to participate in this 

rulemaking effort by submitting written 

comments on the proposal to the FAA. 

Two positive comments were received 

in support of the airspace. One negative 

comment letter was received. 

One positive response was received 

from the Town of East Hampton. The 

other positive commenter, the East 

Hampton Aviation Association, 

observed that establishment of Class D 

airspace would provide greater safety to 

IFR operations during bad weather 

conditions. The FAA agrees with this 

observation. 

The negative response comment was 

received from the Eastern Region 

Helicopter Council, Inc. (ERHC). ERHC 

made several observations in its 

comment letter. The FAA does not agree 

with this commenter’s observations or 

conclusion. Each of the commenter’s 

observations are outlined and addressed 

below. 

The ERHC observed that the purpose 

of Class D airspace is to protect IFR 

operations; that the East Hampton tower 

will not have radar capabilities; that the 

tower will not have the authority to 

require helicopters to fly specific 

arrival/departure flight paths; and that 

most helicopter operations already 

comply with the voluntary noise 

abatement procedures; therefore, the 

commenter concludes that the airspace 

changes are not needed. 

The FAA does not agree. The 

protection provided by Class D airspace 

to IFR operations is not based on the 

tower’s ability to use radar to provide 

separation. Rather, the airspace 

establishes higher weather minima for 

VFR flights, thus restricting access of 

VFR flights to the airspace while IFR 

operations are in progress. 

The ERHC commented that an 

unintended consequence of establishing 

Class D airspace would be increased 

noise impact from helicopters that are 

forced to wait outside the Class D 

airspace during adverse weather 

conditions. 

While the FAA agrees that one-at-atime Special VFR operations may have 

the potential for creating adverse effects, 

separation rules for Special VFR 

operations in Class D airspace allow for 

multiple helicopters to operate in Class 

D airspace at the same time, as long as 

they operate at a safe distance from IFR 

operations. Use of these rules requires 

the helicopter operators to enter into a 

Letter of Agreement (LOA) with the 

FAA. Use of these rules will allow the 

helicopter operators to minimize any 

delays they may experience due to the 

airspace, as well as provide a higher 

level of safety to all operations in 

adverse weather conditions. 

The ERHC observed that one purpose 

of establishing a tower at East Hampton 

Airport is for helicopter noise mitigation 

purposes. 

The FAA does not agree. The purpose 

of control towers and Class D airspace 

is the safe and efficient use of airspace. 

Class D airspace provides controlled 

airspace to contain IFR arrival and 

departure operations. Further, Class D 

enhances safety by setting VFR weather 

minima specified in 14 CFR § 91.155 

and the communications and other 

operating requirements in 14 CFR 

91.129. 

The Proposed Rule included a Class E 

surface area to be in effect when the 

control tower is closed. One prerequisite 

for the establishment of controlled 

airspace at the surface of an airport is 

the availability of hourly and special 

weather observations. Currently this 

prerequisite is only met during the dates 

and times when the tower will be 

operating. Therefore, the Class E surface 

area has been removed from this rule 

action. 

The current Class E5 Airspace Areas 

Extending Upward from 700 feet or 

More Above the Surface of the Earth 

(E5) includes two extensions for the 

support of IFR approach procedures. 

The approaches published for East 

Hampton Airport have been modified 

since this airspace was established and 

these extensions are no longer required 

for safe IFR operations. Therefore, they 

are being removed as part of the rule. 

Class D and E airspace designations 

are published in Paragraphs 5000 and 

6005, respectively, of FAA Order 

7400.9V dated August 9, 2011, and 

effective September 15, 2011, 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 Rule 

This amendment to Title 14, Code of 

Federal Regulations (14 CFR) part 71 

establishes Class D airspace extending 

upward from the surface to and 

including 2,500 feet MSL within a 4.8- 

mile radius of East Hampton Airport, 

East Hampton, NY. Controlled airspace 

supports the new airport traffic control 

tower for continued safety and 

management of IFR operations at East 

Hampton Airport. This action also 

amends Class E airspace extending 

upward from 700 feet above the surface 

within a 7.3-mile radius of the airport. 

The geographic coordinates of the 

airport are adjusted to be in concert 

with the FAA’s current aeronautical 

database. 

The FAA has determined that this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current. Therefore, this regulation: (1) Is 

not a ‘‘significant regulatory action’’ 


wreier-aviles on DSK7SPTVN1PROD with RULES
37570 Federal Register / Vol. 77, No. 121 / Friday, June 22, 2012 / Rules and Regulations 

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 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 use of 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 establishes and amends controlled 

airspace at East Hampton Airport, East 

Hampton, NY. 

Environmental Review 

The FAA has determined that this 

action qualifies for categorical exclusion 

under the National Environmental 

Policy Act in accordance with FAA 

Order 1050.1E, ‘‘Environmental 

Impacts: Policies and Procedures,’’ 

paragraph 311a. This airspace action is 

not expected to cause any potentially 

significant environmental impacts, and 

no extraordinary circumstances exist 

that warrant preparation of an 

environmental assessment. 

Lists of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

Adoption of the Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends 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 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 Federal Aviation 

Administration Order 7400.9V, Airspace 

Designations and Reporting Points, 

dated August 9, 2011, and effective 

September 15, 2011, is amended as 

follows: 

Paragraph 5000 Class D airspace. 

* * * * * 

AEA NY D East Hampton, NY [NEW] 

East Hampton Airport, NY 

(Lat. 40°57′34′′ N., long. 72°15′06′′ W.) 

That airspace extending upward from the 

surface up to and including 2,500 feet MSL 

within a 4.8-mile radius of East Hampton 

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. 

* * * * * 

AEA NY E5 East Hampton, NY 

[AMENDED] 

East Hampton Airport, NY 

(Lat. 40°57′34′′ N., long. 72°15′06′′ W.) 

That airspace extending upward from 700 

feet above the surface within a 7.3-mile 

radius of East Hampton Airport. 

Issued in College Park, Georgia, on June 14, 

2012. 

Barry A. Knight, 

Manager, Operations Support Group, Eastern 

Service Center, Air Traffic Organization. 

[FR Doc. 2012–15279 Filed 6–21–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 870 

[Docket No. FDA–2011–N–0526] 

Effective Date of Requirement for 

Premarket Approval for a Pacemaker 

Programmer 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing a final 

rule to require the filing of a premarket 

approval application (PMA) or a notice 

of completion of a product development 

protocol (PDP) for pacemaker 

programmers. The Agency has 

summarized its findings regarding the 

degree of risk of illness or injury 

designed to be eliminated or reduced by 

requiring this device to meet the 

statute’s approval requirements and the 

benefits to the public from the use of the 

devices. This action implements certain 

statutory requirements. 

DATES: This rule is effective September 

20, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Burns, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1646, Silver Spring, 

MD 20993–0002, 301–796–5616. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act), as amended by the 

Medical Device Amendments of 1976 

(the 1976 amendments) (Pub. L. 94– 

295), the Safe Medical Devices Act of 

1990 (SMDA) (Pub. L. 101–629), the 

Food and Drug Administration 

Modernization Act of 1997 (Pub. L. 105– 

115), the Medical Device User Fee and 

Modernization Act of 2002 (Pub. L. 107– 

250), and the Food and Drug 

Administration Amendments Act of 

2007 (Pub. L. 110–85), among other 

amendments, established a 

comprehensive system for the regulation 

of medical devices intended for human 

use. Section 513 of the FD&C Act 

(21 U.S.C. 360c) established three 

categories (classes) of devices, 

depending on the regulatory controls 

needed to provide reasonable assurance 

of their safety and effectiveness. The 

three categories of devices are class I 

(general controls), class II (special 

controls), and class III (premarket 

approval). 

Under section 513 of the FD&C Act, 

devices that were in commercial 

distribution before the enactment of the 

1976 amendments, May 28, 1976 

(generally referred to as preamendments 

devices), are classified after FDA has: 

(1) Received a recommendation from a 

device classification panel (an FDA 

advisory committee); (2) published the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) published 

a final regulation classifying the device. 

FDA has classified most 

preamendments devices under these 

procedures. 

Devices that were not in commercial 

distribution prior to May 28, 1976 

(generally referred to as 

postamendments devices), are 

automatically classified by section 

513(f) of the FD&C Act into class III 

without any FDA rulemaking process. 

Those devices remain in class III and 


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