56526 Federal Register / Vol. 79, No. 183 / Monday, September 22, 2014 / Proposed Rules 

submissions at http://

www.regulations.gov as well as enter the 

comment submissions into ADAMS. 

The NRC does not routinely edit 

comment submissions to remove 

identifying or contact information. 

If you are requesting or aggregating 

comments from other persons for 

submission to the NRC, then you should 

inform those persons not to include 

identifying or contact information that 

they do not want to be publicly 

disclosed in their comment submission. 

Your request should state that the NRC 

does not routinely edit comment 

submissions to remove such information 

before making the comment 

submissions available to the public or 

entering the comment submissions into 

ADAMS. 

II. The Petition 

Anthony R. Pietrangelo, Vice 

President, and Chief Nuclear Officer, 

NEI, submitted a PRM dated June 12, 

2014 (ADAMS Accession No. 

ML14184B120), requesting that the NRC 

revise its cyber security requirements. 

Specifically, the petitioner requests that 

the NRC revise 10 CFR 73.54(a) to 

ensure the regulation is not overly 

burdensome for NRC licensees, and 

adequately protects the public health 

and safety and common defense and 

security. The petitioner requests that the 

NRC promptly initiate rulemaking to 

resolve this matter. The NRC has 

determined that the petition meets the 

threshold sufficiency requirements for a 

petition for rulemaking under 10 CFR 

2.802 ‘‘Petition for rulemaking,’’ and the 

petition has been docketed as PRM–73– 

18. The NRC is requesting public 

comment on the petition for rulemaking. 

III. The Petitioner 

The petition states that NEI ‘‘is 

responsible for establishing a unified 

industry position on matters affecting 

the nuclear energy industry, including 

the regulatory aspects of generic 

operational and technical issues.’’ The 

petition further states that ‘‘NEI member 

companies are specifically affected by 

the NRC’s cyber security regulations.’’ 

The NEI claims it provides a ‘‘principal 

interface between power reactor 

licensees and the NRC on matters of 

policy, including cyber security-related 

policy.’’ 

IV. Discussion of the Petition 

The petitioner states that power 

reactor licensees are required to 

establish and maintain a physical 

protection program to protect against 

the design basis threat of radiological 

sabotage, and summarizes the physical 

protection program and the attributes of 

the design basis threat of radiological 

sabotage described in 10 CFR 73.1, 

which include: (1) An external physical 

assault, (2) an internal threat, (3) a land 

vehicle bomb assault, (4) a waterborne 

vehicle bomb assault, and (5) a cyber 

attack. The petitioner asserts that to 

prevent radiological sabotage, licensees 

have well-established programs to 

identify the set of personnel systems, 

and equipment that must be protected 

against the design basis threat in order 

to prevent significant core damage and 

spent fuel sabotage. 

The petitioner noted that NRC’s cyber 

security requirements, found in 10 CFR 

73.54, provide the programmatic 

requirements to defend against the 

design basis threat of radiological 

sabotage through a cyber attack, and that 

Section 73.54(a)(1) requires licensees to 

protect certain digital assets against 

cyber attack even though those digital 

assets, if compromised, would not 

adversely impact the systems and 

equipment necessary to prevent 

significant core damage and spent fuel 

sabotage. The petitioner asserts that the 

current regulations require NRC 

licensees to protect one set of systems 

and equipment against the effects of 

four of the attributes of the design basis 

threat (physical assault; internal threat; 

land vehicle bomb assault; waterborne 

vehicle bomb assault), and a 

substantially broader set of assets 

against the fifth design basis threat 

attribute, cyber attack. Further, the 

petitioner contends that this regulatory 

language is inconsistent with both the 

agency’s intent in promulgating the 

cyber security requirements and the 

NRC’s programmatic requirements to 

defend against other attributes of the 

radiological sabotage design basis threat. 

The petitioner argues that the 

language in 10 CFR 73.54(a)(1) 

unnecessarily diverts NRC licensee 

attention and resources away from the 

protection of assets that have a nexus to 

radiological safety. The petitioner 

asserts that this provision burdens NRC 

reactor licensees without providing a 

commensurate enhancement in the 

protection of the public health and 

safety, or plant security. Furthermore, 

the petitioner claims that for digital 

assets that do not reasonably require 

protection against radiological sabotage, 

the considerable time, resources, and 

cost needed to protect them against 

cyber attack is unjustified. In this 

regard, the petitioner asserts that the 

current cyber security regulations fail to 

comply with the Commission’s 

Principles of Good Regulation. 

The petitioner states that the industry 

has brought to the attention of the NRC 

staff the significant problems created by 

the current scoping language in 10 CFR 

73.54(a), and has determined that 

revisions to NRC regulations are needed 

to address this problem. The petitioner 

further states that implementing the 

revisions proposed herein will not 

adversely affect NRC licensees’ ability to 

ensure that public health, safety, and 

security are being adequately protected. 

NEI contends that the change 

proposed in its petition is the single 

most important near-term regulatory 

improvement that can be made in the 

area of cyber security. The petitioner 

claims that it would provide a 

substantial benefit to regulatory clarity 

and stability by assuring that licensees 

have protected those assets that, if 

compromised by a cyber attack, would 

be inimical to the health and safety of 

the public. 

The complete text of the petition is 

available for review as described in 

Section I.A. of this document. 

Because the petitioner has satisfied 

the docketing criteria in 10 CFR 2.802, 

‘‘Petition for rulemaking,’’ the NRC has 

docketed this petition as PRM–73–18. 

The NRC is reviewing the issues raised 

by the petitioner to determine whether 

they should be considered in the NRC’s 

rulemaking process. 

Dated at Rockville, Maryland, this 15th day 

of September, 2014. 

For the Nuclear Regulatory Commission. 

Annette L. Vietti-Cook, 

Secretary of the Commission. 

[FR Doc. 2014–22523 Filed 9–19–14; 8:45 am] 

BILLING CODE 7590–01–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2014–0648; Directorate 

Identifier 2013–NM–136–AD] 

RIN 2120–AA64 

Airworthiness Directives; Airbus 

Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: We propose to supersede 

Airworthiness Directive (AD) 2010–06– 

04, for certain Airbus Model A300 B2– 

1C, B2–203, B2K–3C, B4–103, B4–203, 

B4–2C airplanes; Model A310 series 

airplanes; Model A300 B4–600 series 

airplanes; and Model A300 B4–600R 

series airplanes. AD 2010–06–04 

currently requires repetitive inspections 

to detect cracks of the pylon side panels 


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(upper section) at rib 8; and corrective 

actions if necessary. Since we issued AD 

2010–06–04, fleet survey and updated 

fatigue and damage tolerance analyses 

were done. We have determined that 

reduced compliance times are 

necessary. This proposed AD would 

continue to require repetitive 

inspections for cracking of the pylons 1 

and 2 side panels (upper section) at rib 

8 with reduced compliance times, and 

corrective actions if necessary. This 

proposed AD would also require 

repetitive post-repair and postmodification inspections and repair if 

necessary. This proposed AD would 

also remove certain airplanes having a 

certain modification from the 

applicability. We are proposing this AD 

to detect and correct cracking of pylon 

side panels (upper section) at rib 8, 

which could lead to reduced structural 

integrity of the pylon primary structure, 

which could cause detachment of the 

engine from the fuselage. 

DATES: We must receive comments on 

this proposed AD by November 6, 2014. 

ADDRESSES: You may send comments by 

any of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: (202) 493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC 20590. 

• Hand Delivery: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. 

For service information identified in 

this proposed AD, contact Airbus SAS, 

Airworthiness Office—EAW, 1 Rond 

Point Maurice Bellonte, 31707 Blagnac 

Cedex, France; telephone +33 5 61 93 36 

96; fax +33 5 61 93 44 51; email 

account.airworth-eas@airbus.com; 

Internet http://www.airbus.com. You 

may view this referenced service 

information at the FAA, Transport 

Airplane Directorate, 1601 Lind Avenue 

SW., Renton, WA. For information on 

the availability of this material at the 

FAA, call 425–227–1221. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http://

www.regulations.gov; or in person at the 

Docket Management Facility between 9 

a.m. and 5 p.m., Monday through 

Friday, except Federal holidays. The AD 

docket contains this proposed AD, the 

regulatory evaluation, any comments 

received, and other information. The 

street address for the Docket Office 

(telephone (800) 647–5527) is in the 

ADDRESSES section. Comments will be 

available in the AD docket shortly after 

receipt. 

FOR FURTHER INFORMATION CONTACT: Dan 

Rodina, Aerospace Engineer, 

International Branch, ANM–116, 

Transport Airplane Directorate, FAA, 

1601 Lind Avenue SW., Renton, WA 

98057–3356; telephone (425) 227–2125; 

fax (425) 227–1149. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

We invite you to send any written 

relevant data, views, or arguments about 

this proposed AD. Send your comments 

to an address listed under the 

ADDRESSES section. Include ‘‘Docket No. 

FAA–2014–0648; Directorate Identifier 

2013–NM–136–AD’’ at the beginning of 

your comments. We specifically invite 

comments on the overall regulatory, 

economic, environmental, and energy 

aspects of this proposed AD. We will 

consider all comments received by the 

closing date and may amend this 

proposed AD based on those comments. 

We will post all comments we 

receive, without change, to http://

www.regulations.gov, including any 

personal information you provide. We 

will also post a report summarizing each 

substantive verbal contact we receive 

about this proposed AD. 

Discussion 

On March 4, 2010, we issued AD 

2010–06–04, Amendment 39–16228 (75 

FR 11428, March 11, 2010); corrected 

May 4, 2010 (75 FR 23572). AD 2010– 

06–04 requires actions intended to 

address an unsafe condition on Airbus 

Model A300 B2–1C, B2–203, B2K–3C, 

B4–103, B4–203, B4–2C airplanes; 

Model A310 series airplanes; Model 

A300 B4–600 series airplanes; and 

Model A300 B4–600R series airplanes. 

Since we issued AD 2010–06–04, fleet 

survey and updated fatigue and damage 

tolerance analyses were done. We have 

determined that reduced compliance 

times are necessary. The European 

Aviation Safety Agency (EASA), which 

is the Technical Agent for the Member 

States of the European Community, has 

issued EASA Airworthiness Directive 

2013–0136R1, dated July 30, 2013 

(referred to after this as the Mandatory 

Continuing Airworthiness Information, 

or ‘‘the MCAI’’), to correct an unsafe 

condition for the specified products. 

The MCAI states: 

Cracks were found on pylon side panels 

(upper section) at rib 8 on Airbus A300, A310 

and A300–600 aeroplanes equipped with 

General Electric engines. Investigation of 

these findings indicated that this problem 

was likely to also affect aeroplanes of this 

type design with other engine installations. 

This condition, if not detected and 

corrected, could lead to reduced strength of 

the pylon primary structure, possibly 

resulting in pylon structural failure and inflight loss of an engine. 

Prompted by these findings, EASA issued 

AD 2008–0181 [http://www.regulations.gov/

#!documentDetail;D=FAA-2009-0789-0002] 

[which corresponds to FAA AD 2010–06–04, 

Amendment 39–16228 (75 FR 11428, March 

11, 2010); corrected May 4, 2010 (75 FR 

23572)] to require repetitive detailed visual 

inspections [of the pylon side panels (upper 

section) at rib 8] and, depending on 

aeroplane configuration and/or findings, the 

accomplishment of applicable corrective 

action(s). 

Since that [EASA] AD was issued, a fleet 

survey and updated Fatigue and Damage 

Tolerance analyses have been performed in 

order to substantiate the second A300–600 

Extended Service Goal (ESG2) exercise. The 

results of these analyses have shown that the 

risk for these aeroplanes is higher than 

initially determined and consequently, the 

threshold and interval must be reduced to 

allow timely detection of these cracks and 

the accomplishment of applicable correction 

action(s). 

EASA issued AD 2013–0136 [http://

ad.easa.europa.eu/ad/2013-0136R1] which 

retained the requirements of EASA AD 2008– 

0181, which was superseded, and required 

the inspections to be accomplished within 

reduced thresholds and intervals. 

After publication of EASA AD 2013–0136, 

it appeared that Airbus Mod 03599 had no 

influence on the aeroplane configuration 

affected by this AD. At the same time Airbus 

Service Bulletin (SB) A300–54–6015 

Revision 3 was not integrally taken into 

account as this revision no longer identifies 

configuration 3 aeroplanes. 

For the reasons described above, EASA 

2013–0136 is revised to exclude Airbus Mod 

03599 from the applicability and to delete the 

reference to the configuration 3 for A300–600 

aeroplanes. 

Corrective actions include doing a 

repair. This proposed AD also provides 

an optional modification (installing a 

doubler), which would terminate the 

repetitive inspections. Required actions 

also include repetitive post-repair and 

post-modification inspections and 

repair if necessary. 

Depending on airplane configuration: 

Initial compliance times range from 

4,800 flight cycles or 24,100 flight 

hours, and 9,700 flight cycles or 19,400 

flight hours. Initial post-modification 

and post-repair inspection compliance 

times range from 7,200 flight cycles or 

36,400 flight hours, and 10,400 flight 

cycles or 50,800 flight hours, depending 

on inspection type. Repetitive intervals 

range from 2,600 flight cycles or 13,000 

flight hours, and 6,700 flight cycles or 

18,700 flight hours. You may examine 


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the MCAI in the AD docket on the 

Internet at http://www.regulations.gov 

by searching for and locating it in 

Docket No. FAA–2014–0648. 

Relevant Service Information 

Airbus has issued the Service 

Bulletins listed below. The actions 

described in this service information are 

intended to correct the unsafe condition 

identified in the MCAI. 

• Airbus Service Bulletin A300–54– 

0075, Revision 03, dated March 27, 

2013. 

• Airbus Service Bulletin A300–54– 

6015, Revision 03, dated April 11, 2013. 

• Airbus Service Bulletin A310–54– 

2018, Revision 03, dated April 11, 2013. 

• Airbus Service Bulletin A300–54– 

0081, dated August 11, 1993. 

• Airbus Service Bulletin A300–54– 

6021, Revision 02, dated May 21, 2008. 

• Airbus Service Bulletin A310–54– 

2024, dated August 11, 1993. 

FAA’s Determination and Requirements 

of This Proposed AD 

This product has been approved by 

the aviation authority of another 

country, and is approved for operation 

in the United States. Pursuant to our 

bilateral agreement with the State of 

Design Authority, we have been notified 

of the unsafe condition described in the 

MCAI and service information 

referenced above. We are proposing this 

AD because we evaluated all pertinent 

information and determined an unsafe 

condition exists and is likely to exist or 

develop on other products of the same 

type design. 

Differences Between This Proposed AD 

and the MCAI or Service Information 

Although the MCAI or service 

information allows further flight after 

cracks are found during compliance 

with the required actions of this 

proposed AD, this proposed AD would 

require that you repair any cracking 

before further flight. 

Changes to This NPRM 

Table 2, ‘‘Service Bulletins,’’ in AD 

2010–06–04, Amendment 39–16228 (75 

FR 11428, March 11, 2010), has been 

converted to text in paragraph (g)(9) of 

this AD. 

Table 3, ‘‘Previous Service 

Information,’’ in AD 2010–06–04, 

Amendment 39–16228 (75 FR 11428, 

March 11, 2010), has been converted to 

text in paragraph (m)(1) of this AD. 

Costs of Compliance 

We estimate that this proposed AD 

affects 156 airplanes of U.S. registry. We 

estimate the following costs to comply 

with this proposed AD: 

ESTIMATED COSTS

Action Labor cost Parts cost Cost per product Cost on U.S. operators 

Inspection [retained actions from AD 2010–06– 

04, Amendment 39–16228 (75 FR 11428, 

March 11, 2010); corrected May 4, 2010 (75 

FR 23572)].

4 work-hours × $85 per 

hour = $340.

$0 $340 ............................. $53,040. 

Inspection [new proposed actions] ..................... 24 work-hours × $85 

per hour = $2,040 

per inspection cycle.

0 $2,040 per inspection 

cycle.

$318,240 per inspection 

cycle. 

We estimate the following costs to do 

any necessary repairs that would be 

required based on the results of the 

proposed inspection. We have no way of 

determining the number of aircraft that 

might need these repairs: 

ON-CONDITION COSTS

Action Labor cost Parts cost Cost per product 

Repair ........................................................................ 58 work-hours × $85 per hour = $4,930 ................... $3,910 .............. $8,840. 

Optional Modification ................................................. Up to 48 work-hours × $85 per hour = $4,080 ......... Up to $1,026 ..... Up to $5,106. 

Authority for This Rulemaking 

Title 49 of the United States Code 

specifies the FAA’s authority to issue 

rules on aviation safety. 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. 

We are issuing this rulemaking under 

the authority described in ‘‘Subtitle VII, 

Part A, Subpart III, Section 44701: 

General requirements.’’ Under that 

section, Congress charges the FAA with 

promoting safe flight of civil aircraft in 

air commerce by prescribing regulations 

for practices, methods, and procedures 

the Administrator finds necessary for 

safety in air commerce. This regulation 

is within the scope of that authority 

because it addresses an unsafe condition 

that is likely to exist or develop on 

products identified in this rulemaking 

action. 

Regulatory Findings 

We determined that this proposed AD 

would not have federalism implications 

under Executive Order 13132. This 

proposed AD would not have a 

substantial direct effect on the States, on 

the relationship between the national 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. 

For the reasons discussed above, I 

certify this proposed regulation: 

1. Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866; 

2. Is not a ‘‘significant rule’’ under the 

DOT Regulatory Policies and Procedures 

(44 FR 11034, February 26, 1979); 

3. Will not affect intrastate aviation in 

Alaska; and 

4. Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 14 CFR part 

39 as follows: 


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Federal Register / Vol. 79, No. 183 / Monday, September 22, 2014 / Proposed Rules 56529 

PART 39—AIRWORTHINESS 

DIRECTIVES 

■ 1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

■ 2. Amend § 39.13 by removing 

Airworthiness Directive (AD) 2010–06– 

04, Amendment 39–16228 (75 FR 

11428, March 11, 2010); corrected May 

4, 2010 (75 FR 23572), and adding the 

following new AD: 

Airbus: Docket No. FAA–2014–0648; 

Directorate Identifier 2013–NM–136–AD. 

(a) Comments Due Date 

We must receive comments by November 

6, 2014. 

(b) Affected ADs 

This AD replaces AD 2010–06–04, 

Amendment 39–16228 (75 FR 11428, March 

11, 2010); corrected May 4, 2010 (75 FR 

23572). 

(c) Applicability 

This AD applies to the airplanes identified 

in paragraphs (c)(1), (c)(2), and (c)(3) of this 

AD, certificated in any category. 

(1) Airbus Model A300 B2–1C, B2–203, 

B2K–3C, B4–103, B4–203, and B4–2C 

airplanes, on which Airbus Modification 

02434 has been embodied in production. 

(2) Airbus Model A310–203, –204, –221, 

–222, –304, –322, –324, and –325 airplanes, 

except those on which Airbus Modification 

10432 has been embodied in production. 

(3) Airbus Model A300 B4–601, B4–603, 

B4–605R, B4–620, B4–622, and B4–622R 

airplanes, except those on which Airbus 

Modification 10432 has been embodied in 

production. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 54, Nacelles/Pylons. 

(e) Reason 

This AD was prompted by reports of cracks 

found on pylon side panels at rib 8 and a 

fleet survey and updated fatigue and damage 

tolerance analyses. We are issuing this AD to 

detect and correct cracking of pylon side 

panels (upper section) at rib 8, which could 

lead to reduced structural integrity of the 

pylon primary structure, which could cause 

detachment of the engine from the fuselage. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Retained Actions and Compliance With 

Revised Service Information 

This paragraph restates the requirements of 

paragraph (f) of AD 2010–06–04, Amendment 

39–16228 (75 FR 11428, March 11, 2010); 

corrected May 4, 2010 (75 FR 23572), with 

revised service information. Accomplishing 

the initial inspection required by paragraph 

(h) of this AD terminates the requirements of 

this paragraph. 

(1) For Configuration 01 airplanes as 

identified in the applicable service bulletin 

identified in paragraph (g)(9) of this AD: At 

the applicable time specified in table 1 to 

paragraph (g) of this AD, except as required 

by paragraphs (g)(2) and (g)(3) of this AD, 

perform a detailed visual inspection of the 

pylons 1 and 2 side panels (upper section) at 

rib 8, in accordance with paragraph 3.B. of 

the Accomplishment Instructions of the 

applicable service bulletin identified in 

paragraph (g)(9)(i) through (g)(9)(iii) of this 

AD or paragraphs (k)(1), (k)(2), or (k)(3) of 

this AD. Repeat the inspection at the time 

specified in table 1 to paragraph (g) of this 

AD. 

TABLE 1—TO PARAGRAPH (G) OF THIS AD—COMPLIANCE TIMES FOR CONFIGURATION 1 AIRPLANES

For Model— That have accumulated— Inspect before the 

accumulation of— 

Or within— And repeat the inspection 

at intervals not to 

exceed— 

Whichever occurs later 

A300 B2–1C, B2–203, and 

B2K–3C airplanes.

≤17,500 total flight cycles 1 5,350 total flight cycles ..... 2,500 flight cycles 2 ........... 4,300 flight cycles. 

A300 B2–1C, B2–203, and 

B2K–3C airplanes.

>17,500 total flight cycles 1 20,000 total flight cycles or 

40,000 total flight hours, 

whichever occurs first.

250 flight cycles 2 .............. 4,300 flight cycles. 

A300 B4–103, B4–203, 

and B4–2C airplanes.

≤18,000 total flight cycles 1 5,350 total flight cycles ..... 2,000 flight cycles 2 ........... 4,300 flight cycles. 

A300 B4–103, B4–203, 

and B4–2C airplanes.

>18,000 total flight cycles 1 20,000 total flight cycles or 

40,000 total flight hours, 

whichever occurs first.

250 flight cycles 2 .............. 4,300 flight cycles. 

A300 B4–601, B4–603, 

B4–605R, B4–620, B4– 

622, and B4–622R airplanes.

≤18,000 total flight cycles 1 4,200 total flight cycles ..... 2,000 flight cycles 2 ........... 3,600 flight cycles. 

A300 B4–601, B4–603, 

B4–605R, B4–620, B4– 

622, and B4–622R airplanes.

>18,000 total flight cycles 1 20,000 total flight cycles or 

40,000 total flight hours, 

whichever occurs first.

250 flight cycles 2 .............. 3,600 flight cycles. 

A310–200 airplanes with 

GE CF6–80A3 or Pratt & 

Whitney engines.

≤18,000 total flight cycles 1 9,700 total flight cycles or 

19,400 total flight hours, 

whichever occurs first.

1,500 flight cycles 2 ........... 6,700 flight cycles or 

13,400 flight hours, 

whichever occurs first. 

A310–200 airplanes with 

GE CF6–80A3 or Pratt & 

Whitney engines.

>18,000 total flight cycles 1 19,500 total flight cycles or 

55,500 total flight hours, 

whichever occurs first.

250 flight cycles 2 .............. 6,700 flight cycles or 

13,400 flight hours, 

whichever occurs first. 

A310–200 airplanes with 

GE CF6–80C2 engines.

≤18,000 total flight cycles 1 7,800 total flight cycles or 

15,600 total flight hours, 

whichever occurs first.

1,500 flight cycles 2 ........... 5,800 flight cycles or 

11,600 flight hours, 

whichever occurs first. 

A310–200 airplanes with 

GE CF6–80C2 engines.

>18,000 total flight cycles 1 19,500 total flight cycles or 

55,500 total flight hours, 

whichever occurs first.

250 flight cycles 2 .............. 5,800 flight cycles or 

11,600 flight hours, 

whichever occurs first. 

A310–300 SR 3 airplanes 

with Pratt & Whitney 

JT9D engines.

≤18,000 total flight cycles 1 8,600 total flight cycles or 

24,000 total flight hours, 

whichever occurs first.

1,500 flight cycles 2 ........... 6,700 flight cycles or 

18,700 flight hours, 

whichever occurs first. 


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TABLE 1—TO PARAGRAPH (G) OF THIS AD—COMPLIANCE TIMES FOR CONFIGURATION 1 AIRPLANES—Continued 

A310–300 SR 3 airplanes 

with Pratt & Whitney 

JT9D engines.

>18,000 total flight cycles 1 19,500 total flight cycles or 

55,500 total flight hours, 

whichever occurs first.

250 flight cycles 2 .............. 6,700 flight cycles or 

18,700 flight hours, 

whichever occurs first. 

A310–300 SR 3 airplanes 

with GE engines.

≤18,000 total flight cycles 1 7,000 total flight cycles or 

19,600 total flight hours, 

whichever occurs first.

1,500 flight cycles 2 ........... 5,700 flight cycles or 

15,900 flight hours, 

whichever occurs first. 

A310–300 SR 3 airplanes 

with GE engines.

>18,000 total flight cycles 1 19,500 total flight cycles or 

55,500 total flight hours, 

whichever occurs first.

250 flight cycles 2 .............. 5,700 flight cycles or 

15,900 flight hours, 

whichever occurs first. 

A310–300 SR 3 airplanes 

with Pratt & Whitney 

4000 engines.

≤18,000 total flight cycles 1 7,000 total flight cycles or 

19,600 total flight hours, 

whichever occurs first.

1,500 flight cycles 2 ........... 5,800 flight cycles or 

16,200 flight hours, 

whichever occurs first. 

A310–300 SR 3 airplanes 

with Pratt & Whitney 

4000 engines.

>18,000 total flight cycles 1 19,500 total flight cycles or 

55,500 total flight hours, 

whichever occurs first.

250 flight cycles 2 .............. 5,800 flight cycles or 

16,200 flight hours, 

whichever occurs first. 

A310–300 LR 4 airplanes 

with Pratt & Whitney 

JT9D engines.

≤18,000 total flight cycles 1 5,900 total flight cycles or 

29,500 total flight hours, 

whichever occurs first.

1,500 flight cycles 2 ........... 6,000 flight cycles or 

30,300 flight hours, 

whichever occurs first. 

A310–300 LR 4 airplanes 

with Pratt & Whitney 

JT9D engines.

>18,000 total flight cycles 1 19,500 total flight cycles or 

55,500 total flight hours, 

whichever occurs first.

250 flight cycles 2 .............. 6,000 flight cycles or 

30,300 flight hours, 

whichever occurs first. 

A310–300 LR 4 airplanes 

with GE engines.

≤18,000 total flight cycles 1 4,800 total flight cycles or 

24,100 total flight hours, 

whichever occurs first.

1,500 flight cycles 2 ........... 5,100 flight cycles or 

25,500 flight hours, 

whichever occurs first. 

A310–300 LR 4 airplanes 

with GE engines.

>18,000 total flight cycles 1 19,500 total flight cycles or 

55,500 total flight hours, 

whichever occurs first.

250 flight cycles 2 .............. 5,100 flight cycles or 

25,500 flight hours, 

whichever occurs first. 

A310–300 LR 4 airplanes 

with Pratt & Whitney 

4000 engines.

≤18,000 total flight cycles 1 4,800 total flight cycles or 

24,000 total flight hours, 

whichever occurs first.

1,500 flight cycles 2 ........... 5,200 flight cycles or 

26,300 flight hours, 

whichever occurs first. 

A310–300 LR 4 airplanes 

with Pratt & Whitney 

4000 engines.

>18,000 total flight cycles 1 19,500 total flight cycles or 

55,500 total flight hours, 

whichever occurs first.

250 flight cycles 2 .............. 5,200 flight cycles or 

26,300 flight hours, 

whichever occurs first. 

1As of April 15, 2010 (the effective date of AD 2010–06–04, Amendment 39–16228 (75 FR 11428, March 11, 2010)). 

2After April 15, 2010 (the effective date of AD 2010–06–04, Amendment 39–16228 (75 FR 11428, March 11, 2010)). 

3 ‘‘SR’’ applies to airplanes with average flights less than 4 flight hours. 

4 ‘‘LR’’ refers to airplanes with average flights of 4 or more flight hours. 

(2) For Model A300 and A300–600 

airplanes that have accumulated more than 

40,000 total flight hours as of April 15, 2010 

(the effective date of AD 2010–06–04, 

Amendment 39–16228 (75 FR 11428, March 

11, 2010)): Within 250 flight cycles after 

April 15, 2010, do the actions specified in 

paragraph (g)(1) of this AD. 

(3) For Model A310 airplanes that have 

accumulated more than 55,500 total flight 

hours as of April 15, 2010 (the effective date 

of AD 2010–06–04, Amendment 39–16228 

(75 FR 11428, March 11, 2010)): Within 250 

flight cycles after April 15, 2010, do the 

actions specified in paragraph (g)(1) of this 

AD. 

(4) For Configuration 01 airplanes, as 

identified in the applicable service bulletin 

identified in paragraph (g)(9) of this AD: If a 

crack is found during any inspection 

required by paragraph (g)(1) of this AD, 

before further flight, install a doubler, in 

accordance with paragraph 3.C. of the 

Accomplishment Instructions of the 

applicable service bulletin identified in 

paragraph (g)(9) of this AD. 

(5) For Configuration 02 airplanes, as 

identified in the applicable service bulletin 

identified in paragraph (g)(9) of this AD: At 

the applicable time specified in paragraph 

1.E.(2) of the applicable service bulletin 

identified in paragraphs (g)(9)(i) through 

(g)(9)(iii) of this AD, or within 250 flight 

cycles after April 15, 2010 (the effective date 

of AD 2010–06–04, Amendment 39–16228 

(75 FR 11428, March 11, 2010)), whichever 

occurs later, perform a detailed visual 

inspection of the pylons 1 and 2 side panels 

(upper section) at rib 8, in accordance with 

paragraph 3.B. of the Accomplishment 

Instructions of the applicable service bulletin 

identified in paragraph (g)(9) of this AD. 

(6) For Configuration 03 airplanes, as 

identified in the applicable service bulletin 

identified in paragraph (g)(9) of this AD: At 

the applicable time specified in paragraph 

1.E.(2) of the applicable service bulletin 

identified in paragraphs (g)(9)(i) through 

(g)(9)(iii) of this AD, or within 250 flight 

cycles after April 15, 2010 (the effective date 

of AD 2010–06–04, Amendment 39–16228 

(75 FR 11428, March 11, 2010)), whichever 

occurs later, perform a detailed visual 

inspection, and a high frequency eddy 

current inspection as applicable, of the 

pylons 1 and 2 side panels (upper section) at 

rib 8, in accordance with paragraph 3.B. of 

the Accomplishment Instructions of the 

applicable service bulletin identified in 

paragraph (g)(9) of this AD. 

(7) For Configuration 02 and 03 airplanes, 

as identified in the applicable service 

bulletin identified in paragraph (g)(9) of this 

AD: If a crack is found during any inspection 

required by paragraph (g)(1), (g)(5), or (g)(6) 

of this AD, before further flight, repair in 

accordance with paragraph 3.C. of the 

Accomplishment Instructions of the 

applicable service bulletin identified in 

paragraph (g)(9) of this AD. 

(8) For all airplanes, except those in 

Configuration 01, as identified in the 

applicable service bulletin identified in 

paragraph (g)(9) of this AD: Repeat the 

inspection specified in paragraph (g)(1), 

(g)(5), or (g)(6) of this AD, as applicable, at 

the intervals specified in paragraph 1.E.(2) of 

the applicable service bulletin identified in 

paragraph (g)(9)(i) through (g)(9)(iii) of this 

AD. 

(9) For the actions specified in paragraph 

(g) of this AD, use the applicable service 

bulletin identified in paragraphs (g)(9)(i) 

through (g)(9)(iii) of this AD, or paragraph 

(k)(1), (k)(2), or (k)(3) of this AD. 

(i) Airbus Mandatory Service Bulletin 

A300–54–0075, excluding Appendices 1, 2, 

and 3, Revision 02, dated June 26, 2008 (For 

Model A300 B2–1C, B2–203, B2K–3C, B4– 

103, B4–203, and B4–2C airplanes). 

(ii) Airbus Mandatory Service Bulletin 

A300–54–6015, excluding Appendices 1, 2, 

and 3, Revision 02, dated June 26, 2008 (For 

Model A300 B4–601, B4–603, B4–605R, B4– 

620, B4–622, and B4–622R airplanes). 

(iii) Airbus Mandatory Service Bulletin 

A310–54–2018, excluding Appendices 1, 2, 

and 3, Revision 02, dated June 26, 2008 (for 

Model A310 series airplanes). 

(h) New Repetitive Inspections and Repair 

Except as required by paragraphs (l)(1) and 

(l)(2) of this AD, at the applicable times 

specified in paragraph 1.E., ‘‘Compliance,’’ of 

the applicable service bulletin identified in 


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Federal Register / Vol. 79, No. 183 / Monday, September 22, 2014 / Proposed Rules 56531 

paragraph (k) of this AD: Do a detailed 

inspection for cracking of the pylons 1 and 

2 side panels (upper section) at rib 8, in 

accordance with the Accomplishment 

Instructions of the applicable service bulletin 

identified in paragraph (k) of this AD. 

Accomplishing the inspection required by 

this paragraph terminates the requirements of 

paragraph (g)(1) through (g)(9) of this AD. 

(1) If any cracking is found, before further 

flight, do a high frequency eddy current 

(HFEC) inspection to confirm the crack, in 

accordance with the Accomplishment 

Instructions of the applicable service bulletin 

identified in paragraph (k) of this AD. 

(i) If any crack indication is confirmed 

during the HFEC inspection specified in 

paragraph (h)(1) of this AD, and the crack is 

less than 20 mm, before further flight, repair, 

in accordance with the Accomplishment 

Instructions of the applicable service bulletin 

identified in paragraph (k) of this AD. 

(ii) If any crack indication is confirmed 

during the HFEC inspection specified in 

paragraph (h)(1) of this AD and the crack is 

greater than or equal to 20 mm, before further 

flight, repair using a method approved by the 

Manager, International Branch, ANM–116, 

Transport Airplane Directorate, FAA; or the 

European Aviation Safety Agency (EASA); or 

Airbus’s EASA Design Organization 

Approval (DOA). 

(2) If no cracking is found, or if crack 

indication is not confirmed during the HFEC 

inspection required by paragraph (h)(1) of 

this AD, at the applicable interval specified 

in paragraph 1.E., ‘‘Compliance,’’ of the 

applicable service bulletin identified in 

paragraph (k) of this AD, repeat the 

inspection specified in paragraph (h) of this 

AD, in accordance with the Accomplishment 

Instructions of the applicable service bulletin 

identified in paragraph (k) of this AD until 

the modification specified in paragraph (i) is 

done. 

(i) Optional Modification 

Modifying by installing a doubler on the 

left hand (LH) pylon 1 and right hand (RH) 

pylon 2, on pylon side panels (upper 

section), at rib 8, in accordance with the 

Accomplishment Instructions of Airbus 

Service Bulletin A300–54–0081, dated 

August 11, 1993; A310–54–2024, dated 

August 11, 1993; or A300–54–6021, Revision 

02, dated May 21, 2008; as applicable, 

terminates the repetitive inspections 

specified in paragraph (h)(2) of this AD. 

(j) Post-Modification and Post-Repair 

Repetitive Inspections and Corrective 

Actions 

For airplanes on which the modification 

has been done as specified in paragraph (i) 

of this AD, and airplanes on which the repair 

has been done as specified in paragraph (h) 

of this AD: At the applicable compliance 

time specified in paragraph 1.E., 

Compliance,’’ of the applicable service 

bulletin identified in paragraph (k) of this 

AD, do the post-modification and post-repair 

detailed inspections for cracking, as 

applicable, of the LH and RH side panels of 

pylons 1 and 2, in accordance with the 

applicable service bulletins identified in 

paragraph (k) of this AD. Repeat the 

inspections thereafter at the times specified 

in paragraph 1.E., ‘‘Compliance’’ of the 

applicable service bulletin specified in 

paragraph (k) of this AD. If any cracking is 

found, before further flight, repair using a 

method approved by the Manager, 

International Branch, ANM–116, Transport 

Airplane Directorate, FAA; or EASA; or 

Airbus’s EASA Design Organization 

Approval (DOA). This repair is not a 

terminating action for the repetitive 

inspections required by this paragraph. 

(k) New Service Information 

Use the applicable service bulletin 

identified in paragraphs (k)(1) through (k)(3) 

of this AD to accomplish the inspections 

required by paragraphs (h) and (j) of this AD. 

(1) Airbus Mandatory Service Bulletin 

A300–54–0075, Revision 03, dated March 27, 

2013 (for Model A300 B2–1C, B2–203, B2K– 

3C, B4–103, B4–203, and B4–2C airplanes). 

(2) Airbus Mandatory Service Bulletin 

A310–54–2018, Revision 03, dated April 11, 

2013 (for Model A310–203, –204, –221, –222, 

–304, –322, –324, and –325 airplanes). 

(3) Airbus Mandatory Service Bulletin 

A300–54–6015, Revision 03, dated April 11, 

2013 (for Model A300 B4–601, B4–603, B4– 

605R, B4–620, B4–622, and B4–622R 

airplanes). 

(l) Exceptions 

(1) Where the compliance time column in 

the tables in paragraph 1.E., ‘‘Compliance,’’ 

of the applicable service bulletin identified 

in paragraph (k) of this AD specifies a 

‘‘threshold’’ in FC or FH, and does not 

specify from repair or service bulletin 

embodiment, those compliance times are 

total flight cycles and total flight hours. 

(2) Where the tables in paragraph 1.E., 

‘‘Compliance,’’ of the applicable service 

bulletin specified in paragraph (k) of this AD 

specifies ‘‘grace period after the receipt of the 

service bulletin,’’ this AD requires 

compliance within the corresponding 

compliance time after the effective date of 

this AD. 

(m) Credit for Previous Actions 

(1) This paragraph restates the credit 

provided by paragraph (f)(9) of AD 2010–06– 

04, Amendment 39–16228 (75 FR 11428, 

March 11, 2010) with no changes. This 

paragraph provides credit for initial 

inspections required by paragraph (g) of this 

AD, if those actions were performed prior to 

April 15, 2010 (the effective date of AD 

2010–06–04) using the applicable service 

bulletins specified in paragraphs (m)(1)(i) 

through (m)(1)(vi) of this AD, which are not 

incorporated by reference in this AD. 

(i) Airbus Service Bulletin A300–54–0075, 

dated August 11, 1993. 

(ii) Airbus Service Bulletin A300–54–0075, 

Revision 01, dated November 9, 2007. 

(iii) Airbus Service Bulletin A300–54– 

6015, dated August 11, 1993. 

(iv) Airbus Service Bulletin A300–54– 

6015, Revision 01, dated November 9, 2007. 

(v) Airbus Service Bulletin A310–54–2018, 

dated August 11, 1993. 

(vi) Airbus Service Bulletin A310–54– 

2018, Revision 01, dated November 16, 2007. 

(2) This paragraph provides credit for 

initial inspections required by paragraph (h) 

of this AD, if those actions were performed 

before the effective date of this AD using the 

applicable service bulletins specified in 

paragraphs (m)(2)(i) through (m)(2)(vi) of this 

AD. 

(i) Airbus Service Bulletin A300–54–0075, 

dated August 11, 1993, which is not 

incorporated by reference in this AD. 

(ii) Airbus Service Bulletin A300–54–0075, 

Revision 01, dated November 9, 2007, which 

is not incorporated by reference in this AD. 

(iii) Airbus Service Bulletin A300–54– 

0075, Revision 02, dated June 26, 2008, 

which is incorporated by reference in this 

AD. 

(iv) Airbus Service Bulletin A300–54– 

6015, dated August 11, 1993, which is not 

incorporated by reference in this AD. 

(v) Airbus Service Bulletin A300–54–6015, 

Revision 01, dated November 9, 2007, which 

is not incorporated by reference in this AD. 

(vi) Airbus Service Bulletin A300–54– 

6015, Revision 02, dated June 26, 2008, 

which is incorporated by reference in this 

AD. 

(vii) Airbus Service Bulletin A310–54– 

2018, dated August 11, 1993, which is not 

incorporated by reference in this AD. 

(viii) Airbus Service Bulletin A310–54– 

2018, Revision 01, dated November 16, 2007, 

which is not incorporated by reference in this 

AD. 

(ix) Airbus Service Bulletin A310–54– 

2018, Revision 02, dated June 26, 2008, 

which is incorporated by reference in this 

AD. 

(3) This paragraph provides credit for 

initial inspections required by paragraph (i) 

of this AD, if those actions were performed 

before the effective date of this AD using the 

applicable service bulletins specified in 

paragraphs (m)(3)(i) and (m)(3)(ii) of this AD. 

(i) Airbus Service Bulletin A300–54–6021, 

dated August 11, 1993. 

(ii) Airbus Service Bulletin A300–54–6021, 

Revision 01, dated November 16, 2007. 

(n) Other FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, International 

Branch, ANM–116, FAA, has the authority to 

approve AMOCs for this AD, if requested 

using the procedures found in 14 CFR 39.19. 

In accordance with 14 CFR 39.19, send your 

request to your principal inspector or local 

Flight Standards District Office, as 

appropriate. If sending information directly 

to the International Branch, send it to ATTN: 

Dan Rodina, Aerospace Engineer, 

International Branch, ANM–116, Transport 

Airplane Directorate, FAA, 1601 Lind 

Avenue SW., Renton, WA 98057–3356; 

telephone (425) 227–2125; fax (425) 227– 

1149. Information may be emailed to: 9- 

ANM-116-AMOC-REQUESTS@faa.gov. 

(i) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/

certificate holding district office. The AMOC 

approval letter must specifically reference 

this AD. 

(ii) AMOCs approved previously for AD 

2010–06–04, Amendment 39–16228 (75 FR 


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56532 Federal Register / Vol. 79, No. 183 / Monday, September 22, 2014 / Proposed Rules 

11428, March 11, 2010); corrected May 4, 

2010 (75 FR 23572); are approved as AMOCs 

for the corresponding provisions of this AD. 

(2) Contacting the Manufacturer: As of the 

effective date of this AD, for any requirement 

in this AD to obtain corrective actions from 

a manufacturer, the action must be 

accomplished using a method approved by 

the Manager, International Branch, ANM– 

116, Transport Airplane Directorate, FAA; or 

EASA; or Airbus’s EASA Design 

Organization Approval (DOA). If approved by 

the DOA, the approval must include the 

DOA-authorized signature. 

(o) Related Information 

(1) Refer to Mandatory Continuing 

Airworthiness Information (MCAI) EASA 

Airworthiness Directive 2013–0136R1, dated 

July 30, 2013, for related information. This 

MCAI may be found in the AD docket on the 

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

searching for and locating it in Docket No. 

FAA–2014–0648. 

(2) For service information identified in 

this AD, contact Airbus SAS, Airworthiness 

Office—EAW, 1 Rond Point Maurice 

Bellonte, 31707 Blagnac Cedex, France; 

telephone +33 5 61 93 36 96; fax +33 5 61 

93 44 51; email account.airworth-eas@

airbus.com; Internet http://www.airbus.com. 

You may view this referenced service 

information at the FAA, Transport Airplane 

Directorate, 1601 Lind Avenue SW., Renton, 

WA. For information on the availability of 

this material at the FAA, call 425–227–1221. 

Issued in Renton, Washington, on 

September 12, 2014. 

Jeffrey E. Duven, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2014–22467 Filed 9–19–14; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 890 

[Docket No. FDA–2000–N–0158] 

Reclassification of Iontophoresis 

Devices Intended for Any Other 

Purposes 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed order. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

reclassify iontophoresis devices 

intended for any other purposes, a 

preamendments class III device, into 

class II (special controls), and to amend 

the device identification. FDA is 

proposing this reclassification on its 

own initiative based on new 

information. This action implements 

certain statutory requirements. 

DATES: Submit either electronic or 

written comments by December 22, 

2014. See section XII for the proposed 

effective date of a final order based on 

this proposed order. 

ADDRESSES: You may submit comments 

by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include the Docket No. (FDA– 

2000–N–0158) for this rulemaking. All 

comments received may be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Michael Ryan, Center for Devices and 

Radiological Health, Food and Drug 

Administration,10903 New Hampshire 

Ave., Bldg. 66, Rm. 1615, Silver Spring, 

MD 20993–0002, 301–796–6283. 

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 (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), the Medical 

Devices Technical Corrections Act (Pub. 

L. 108–214), the Food and Drug 

Administration Amendments Act of 

2007 (Pub. L. 110–85), and the Food and 

Drug Administration Safety and 

Innovation Act (FDASIA) (Pub. L. 112– 

144), 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, reflecting 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). 

Section 513(a)(1) of the FD&C Act 

defines class II devices as those devices 

for which the general controls by 

themselves are insufficient to provide 

reasonable assurance of safety and 

effectiveness, but for which there is 

sufficient information to establish 

special controls to provide such 

assurance. 

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 

require premarket approval unless, and 

until, the device is reclassified into class 

I or II or FDA issues an administrative 

order finding the device to be 

substantially equivalent, in accordance 

with section 513(i) of the FD&C Act, to 

a predicate device that does not require 

premarket approval. The Agency 

determines whether new devices are 

substantially equivalent to predicate 

devices by means of premarket 

notification procedures in section 510(k) 

of the FD&C Act (21 U.S.C. 360(k)) and 

part 807 (21 CFR part 807). 

On July 9, 2012, FDASIA was enacted. 

Section 608(a) of FDASIA amended 

section 513(e) of the FD&C Act, 

changing the process for reclassifying a 

device from rulemaking to an 

administrative order. Section 513(e) of 

the FD&C Act governs reclassification of 

classified preamendments devices. This 


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