Federal Register / Vol. 78, No. 188 / Friday, September 27, 2013 / Rules and Regulations 59623 

U.S. Code. Subtitle 1, Section 106 

discusses 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 

controlled airspace at the Akutan 

Airport, Akutan, AK. 

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. 

List 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 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 6005 Class E airspace areas 

extending upward from 700 feet or more 

above the surface of the earth. 

* * * * * 

AAL AK E5 Akutan, AK [New] 

Akutan Airport, AK 

(Lat. 54°08′41′′ N., long. 165°36′15′′ W.) 

That airspace extending upward from 700 

feet above the surface within a 3.5-mile 

radius of the Akutan Airport and within 1- 

mile each side of the 311° bearing extending 

from the 3.5-mile radius to 5.5-miles 

northwest of the airport. 

Issued in Seattle, Washington, on 

September 16, 2013. 

Clark Desing, 

Manager, Operations Support Group, Western 

Service Center. 

[FR Doc. 2013–23221 Filed 9–26–13; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Parts 121 and 135 

[Docket No. FAA–2000–7119] 

RIN 2120–AG89 

Emergency Medical Equipment 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule; notice of policy 

change and availability. 

SUMMARY: This action supplements the 

preamble published in the Federal 

Register on April 12, 2001 (66 FR 

19028). The FAA has reviewed data for 

automated external defibrillators and 

enhanced emergency medical kits to 

amend the ‘‘no go’’ provision. Data 

show that allowing these items to be 

incomplete, missing, or inoperative for 

one flight in accordance with the FAA 

master minimum equipment list does 

not adversely affect aviation safety. This 

action provides notice of the data 

finding and makes available the 

corresponding policy change for the 

one-flight relief for use of emergency 

medical equipment. 

DATES: This action becomes effective 

September 27, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Gregory J. Janosik, New Program 

Implementation and International 

Support Branch, Air Transportation 

Division, Flight Standards Service, 

Federal Aviation Administration, 800 

Independence Avenue SW., 

Washington, DC 20591; telephone: 202– 

267–8166; facsimile: 202–267–5229; 

email: Gregory.Janosik@faa.gov. 

SUPPLEMENTARY INFORMATION: In the 

final rule entitled, ‘‘Emergency Medical 

Equipment,’’ published on April 12, 

2001 (66 FR 19028), the preamble states 

that automated external defibrillators 

(AED) should be, and enhanced 

emergency medical kits (EMK) should 

remain, ‘‘no-go’’ items. See 66 FR 19033. 

That final rule’s preamble also states 

that the current provision under 

§ 121.279(a), with adoption of 

§ 121.803(a) without the words ‘‘unless 

authorized by the Administrator’’ would 

remain until the FAA developed more 

experience with the enhanced EMKs 

and AEDs. Id. 

As described in the background 

section, the FAA has data obtained from 

the airline industry to demonstrate that 

use of the emergency medical 

equipment required by § 121.803(a) 

would rarely be used on back-to-back 

flights and therefore has allowed relief 

for one flight with an incomplete, 

missing, or inoperative Emergency 

Medical Kit (EMK) or automated 

external defibrillator (AED). A copy of 

Master Minimum Equipment List 

(MMEL) Policy Letter (PL) 73, Revision 

5, Relief for Emergency Medical 

Equipment, is available for review on 

the Flight Standards Information 

Management System found on the 

FAA’s Web site at: http:// 

fsims.faa.gov/. A copy will also be 

posted to the docket for this action. 

Background 

FAA PL–73, MMEL Relief for 

Emergency Medical Equipment, was 

originally issued on March 4, 1994. The 

PL was created to provide standardized 

MMEL requirements for the deferral of 

approved emergency medical 

equipment, including EMK, First Aid 

Kits (FAK), and AEDs required by 14 

CFR § 121.803. The purpose of the PL 

has remained consistent throughout its 

five revisions, although the relief 

specifics have been further defined. 

Revision 1 reformatted the PL to 

conform to PL standardization 

requirements. Revision 2 expanded the 

relief for FAKs to include relief for all 

emergency medical equipment. Revision 

3 clarified that emergency medical 

equipment in excess of the regulatory 

requirements can be inoperative. 

Revision 4 provided three-flight limited 

dispatch authority for all incomplete, 

missing, or inoperative EMKs, FAKs, 

and AEDs that do not meet the 

minimum regulatory requirements. 

Revision 5 reduced the limited dispatch 

authority available from three flights to 

one flight in all situations. 

On April 6, 2001, the FAA issued the 

final rule requiring certain aircraft 

operating under part 121 to carry EMKs, 

FAKs, and AEDs. See 66 FR 19028. The 

final rule’s preamble reflected the FAA’s 

long-standing position that emergency 

medical equipment items are ‘‘no-go’’ 

items and AEDs should also be 

considered ‘‘no-go’’ items meaning that 

if they are not operating pursuant to the 

regulatory standard then the flight 

should not be permitted to takeoff. In 

that final rule, the FAA also indicated 


pmangrum on DSK3VPTVN1PROD with RULES
59624 Federal Register / Vol. 78, No. 188 / Friday, September 27, 2013 / Rules and Regulations 

that the ‘‘no go’’ policy would remain in 

effect until the agency develops more 

experience with the equipment. 

Consistent with the regulation, the FAA 

issued Advisory Circular (AC) 121–33B 

which restated the policy that ‘‘EMKs 

and AEDs are ‘no-go’ items and must be 

carried as indicated on the’’ MEL on 

January 12, 2006. The AC indicated that 

the air carrier may elect to carry 

redundant equipment to ensure that 

after use of the equipment in flight, the 

minimum required equipment is still on 

board the aircraft. 

However, on April 12, 2006, the FAA 

issued Notice 8000.320, which allowed 

MMEL relief for EMKs and AEDs, 

despite the contrary statements in the 

rule and AC discussed earlier. The FAA 

allowed the MMEL relief based on data 

collected from major air carriers, 

beginning in 1998 that showed using an 

EMK on back-to-back flights was rare. 

The notice also determined that ‘‘a large 

number of passengers may be at more 

risk at a diversion airport than they 

would be if MMEL relief’’ was available 

allowing the aircraft to be dispatched to 

its intended destination. This notice, 

which reversed previous FAA policy as 

stated in the preamble to the 2001 final 

rule, was not published for public 

comment before its issuance. It was 

eventually cancelled after 12 months on 

April 12, 2007. 

On April 18, 2006, soon after the 

release of Notice 8000.320, the FAA 

released PL–73, Revision 4, MMEL 

Relief for Emergency Medical 

Equipment. Consistent with Notice 

8000.320, this revision granted limited 

dispatch authority for aircraft with 

EMKs, FAKs, and AEDs that did not 

meet the minimum requirements of 14 

CFR § 121.803. PL–73, Revision 4 

authorized an air carrier to complete up 

to three flight cycles (3 flights) without 

the required equipment allowing time 

for the air carrier to repair or replace 

emergency medical equipment. PL–73, 

Revision 4 remained in effect until June 

15, 2011. 

PL–73, Revision 5 was released on 

June 15, 2011. Revision 5 resulted from 

a review conducted by FAA Flight 

Standards Service, which concluded 

that the MMEL relief offered by revision 

4 was not consistent with regulation and 

was counter to the FAA’s established 

position that EMKs and AEDs are ‘‘nogo’’ items. Revision 5 allows only one 

flight cycle (1 flight), in any situation, 

for an air carrier to obtain the minimum 

required emergency medical equipment 

on board the aircraft. However, upon 

review of the policy, the FAA 

concluded that revision 5, though more 

restrictive than revision 4, is still not 

consistent with the regulation nor does 

it comply with the intent of the 

regulation as expressed in the preamble. 

Because revision 5 was a shift in the 

FAA’s stated policy, the public should 

have been notified and provided 

opportunity for comment before 

adopting the new policy. 

The FAA’s position is that although 

the preamble to the rule is clear that 

EMKs and AEDs are ‘‘no go’’ items, as 

contemplated by that final rule. Our 

experience has led us to conclude that 

relief should be allowed in limited 

circumstances. However, it is 

foreseeable that required medical 

equipment may be used during a flight, 

and the pilot will divert the aircraft to 

a location where the utilized medical 

equipment cannot be replenished or 

replaced. Therefore, the FAA has 

determined that allowing the air carrier 

to conduct one flight so that the aircraft 

can fly to a location where supplies are 

available would allow passengers on 

such a flight to reach their destinations 

without adversely affecting safety. As 

discussed earlier, air carriers have 

presented statistical information about 

EMK usage on aircraft to the FAA, 

which indicates that once an EMK or 

AED is used during a flight, there is 

only a remote possibility that it would 

need to be used on the next flight. 

Airlines for America (A4A) recently 

resubmitted that data along with an 

analysis of EMK use to support its 

position that three-flight relief would be 

acceptable. A4A’s analysis was based on 

the likelihood of using an EMK on the 

first successive flight and extrapolated 

that data to conclude the likelihood of 

using an EMK on three consecutive 

flights would be 1: 3.8 × 10¥13. The 

FAA evaluated A4A’s analysis and 

determined that the conclusion 

regarding use on three consecutive 

flights was not statistically valid. The 

FAA notes that A4A’s analysis failed to 

consider that the likelihood of needing 

to use an EMK on any of the three 

successive flights would be the same as 

needing it on the first flight. A4A’s letter 

has been placed in the docket associated 

with this notice. 

The probability of needing an EMK 

does not decrease because an EMK was 

opened on the first flight. We believe, 

therefore, that the probability of needing 

the EMK on subsequent flights would be 

5.5 x 10¥5 to 7.8 × 10¥5 (3 times as high 

as the one-flight case). Therefore, 

because there is a relatively low 

probability of needing the EMK on any 

particular flight, we are allowing oneflight relief to air carriers with an 

inoperative EMK or AED so that if the 

flight lands at a location where the 

equipment cannot be repaired or 

replenished, the airplane can move to a 

location where such services are 

available. However, because the 

probability of needing to use an EMK on 

subsequent flights does not diminish, 

we do not believe that three-flight relief 

would be acceptable. 

Issued in Washington, DC, on September 

18, 2013. 

John S. Duncan, 

Director, FAA Flight Standards Service. 

[FR Doc. 2013–23522 Filed 9–26–13; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 501 

[Docket No. FDA–2013–D–1088] 

Guidance for Industry #223: Small 

Entity Compliance Guide—Declaring 

Color Additives in Animal Foods; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availabilty. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

#223 entitled ‘‘Small Entity Compliance 

Guide—Declaring Color Additives in 

Animal Foods.’’ This small entity 

compliance guide (SECG) aids industry 

in complying with the requirements of 

the final rule that published in the 

Federal Register of November 17, 2011. 

FDA issued the regulation in response 

to the Nutrition Labeling and Education 

Act of 1990 (the 1990 amendments), 

which amended the Federal Food, Drug, 

and Cosmetic Act (FD&C Act). 

Specifically, FDA amended its 

regulations regarding the declaration of 

certified color additives on the labels of 

animal food including animal feeds and 

pet foods. 

DATES: The guidance is effective 

September 27, 2013. Submit either 

electronic or written comments on the 

SECG at any time. 

ADDRESSES: Submit requests for single 

copies of the SECG to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the SECG. 

Submit electronic comments on the 

SECG to http://www.regulations.gov. 

Submit written comments to the 


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