This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

22009 

Vol. 79, No. 76 

Monday, April 21, 2014 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Parts 91, 120, and 135 

[Docket No.: FAA–2010–0982; Amdt. Nos. 

91–330, 120–2; 135–129] 

RIN 2120–AK47 

Extension of Effective Date for the 

Helicopter Air Ambulance, Commercial 

Helicopter, and Part 91 Helicopter 

Operations Final Rule 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule; delay of effective 

date and request for comments. 

SUMMARY: The FAA is delaying the 

effective date of the Helicopter Air 

Ambulance, Commercial Helicopter, 

and Part 91 Helicopter Operations final 

rule published on February 21, 2014. In 

that rule, the FAA amended its 

regulations to revise the helicopter air 

ambulance, commercial helicopter, and 

general aviation helicopter operating 

requirements. The April 22, 2014 

effective date does not provide an 

adequate amount of time for the affected 

certificate holders to implement the new 

requirements. By extending the effective 

date to April 22, 2015, the affected 

certificate holders will have sufficient 

time to implement the new 

requirements. This action will only 

affect the effective date of the provisions 

of the rule scheduled to take effect April 

22, 2014. Other provisions in the rule 

with specified compliance dates will 

not be affected. 

DATES: The effective date of the rule 

amending 14 CFR Parts 91, 120, and 135 

published February 21, 2014 (79 FR 

9932), is delayed until April 22, 2015. 

The amendment to § 135.293 in this 

document is effective April 22, 2015. 

Submit comments on or before May 

21, 2014. 

ADDRESSES: Send comments identified 

by docket number FAA–2010–0982 

using any of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov and follow 

the online instructions for sending your 

comments electronically. 

• Mail: Send comments to Docket 

Operations, M–30; U.S. Department of 

Transportation (DOT), 1200 New Jersey 

Avenue SE., Room W12–140, West 

Building Ground Floor, Washington, DC 

20590–0001. 

• Hand Delivery or Courier: Take 

comments to Docket Operations in 

Room W12–140 of the West Building 

Ground Floor at 1200 New Jersey 

Avenue SE., Washington, DC, between 9 

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

Friday, except Federal holidays. 

• Fax: Fax comments to Docket 

Operations at 202–493–2251. 

Privacy: In accordance with 5 U.S.C. 

553(c), DOT solicits comments from the 

public to better inform its rulemaking 

process. DOT posts these comments, 

without edit, including any personal 

information the commenter provides, to 

www.regulations.gov, as described in 

the system of records notice (DOT/ALL– 

14 FDMS), which can be reviewed at 

www.dot.gov/privacy. 

Docket: Background documents or 

comments received may be read at 

http://www.regulations.gov at any time. 

Follow the online instructions for 

accessing the docket or Docket 

Operations in Room W12–140 of the 

West Building Ground Floor at 1200 

New Jersey Avenue SE., Washington, 

DC, between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: For 

technical questions concerning this 

action, contact Andy Pierce, Air 

Transportation Division, AFS–200, 

Federal Aviation Administration, 800 

Independence Avenue SW., 

Washington, DC 20591; telephone (202) 

267–8238; email andy.pierce@faa.gov. 

For legal questions concerning this 

action, contact Dean E. Griffith, Office of 

Chief Counsel, AGC–220, Federal 

Aviation Administration, 800 

Independence Avenue SW., 

Washington, DC 20591; telephone (202) 

267–3073; email dean.griffith@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Good Cause for Dispensing With Notice 

and Comment and for Immediate 

Adoption 

Section 553(b)(3)(B) of Title 5, United 

States Code, (the Administrative 

Procedure Act) authorizes agencies to 

dispense with notice and comment 

procedures for rules when the agency 

for ‘‘good cause’’ finds that those 

procedures are ‘‘impracticable, 

unnecessary, or contrary to the public 

interest.’’ Under this section, an agency, 

upon finding good cause, may issue a 

final rule without seeking comment 

prior to the rulemaking. 

The FAA finds that prior notice and 

public comment to this final rule are 

contrary to the public interest. This final 

rule extends the effective date for the 

Helicopter Air Ambulance, Commercial 

Helicopter, and Part 91 Helicopter 

Operations final rule from April 22, 

2014 to April 22, 2015. By extending the 

effective date, affected entities will have 

sufficient time to implement the new 

requirements. Without the extension of 

the effective date, regulated entities 

would not have sufficient time to 

prepare to meet the new requirements 

that were scheduled to take effect April 

22, 2014. If these entities are not 

prepared to meet the new requirements 

then, beginning April 23, 2014, they 

would not be able to continue 

conducting part 135 operations and 

would not be able to meet the new part 

91 requirements. Therefore, the FAA 

has determined that prior notice and 

public comment are contrary to the 

public interest. 

The Administrative Procedure Act 

also allows agencies to dispense with 

the 30-day delayed effective date 

requirement for ‘‘good cause found and 

published with the rule.’’ 5 U.S.C. 

553(d)(3). The FAA has determined that 

good cause exists to make this rule 

immediately effective upon publication. 

As discussed above the Helicopter Air 

Ambulance, Commercial Helicopter, 

and Part 91 Helicopter Operations final 

rule takes effect April 22, 2014. If the 

delay of the effective date is not made 

immediately effective there would be a 

period of time under which certificate 

holders would be in jeopardy of not 

being able to continue part 135 

operations because of inability to satisfy 

the new requirements and part 91 

operators would not be able to meet new 

requirements applicable to them. The 

delayed effective date must take effect 

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22010 Federal Register / Vol. 79, No. 76 / Monday, April 21, 2014 / Rules and Regulations 

before April 22, 2014 to ensure 

certificate holders can continue to 

operate. 

Comments Invited 

The FAA is adopting this final rule 

without prior notice and public 

comment because delaying the 

amendment could result in a negative 

impact to certificate holders conducting 

part 135 rotorcraft operations, part 91 

rotorcraft operators, and the public that 

relies on those certificate holders. The 

Regulatory Policies and Procedures of 

the Department of Transportation (DOT) 

(44 FR 11034; Feb. 26, 1979), provide 

that to the maximum extent possible, 

operating administrations for the DOT 

should provide an opportunity for 

public comment on regulations issued 

without prior notice. All comments will 

be considered by the Administrator and 

this amendment may be changed in 

light of the comments received. We note 

that, although the FAA will consider 

comments, this rule will be effective 

upon publication of this document in 

the Federal Register. 

Authority for This Rulemaking 

The FAA’s authority to issue rules on 

aviation safety is found in Title 49 of the 

United States Code. Subtitle I, Section 

106(f) 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 III, Section 

44701. Under that section, the FAA is 

charged with prescribing regulations 

and minimum standards 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 safety of rotorcraft 

operations. 

I. Overview of Final Rule With Request 

for Comments 

This final rule with request for 

comments extends the effective date for 

the Helicopter Air Ambulance, 

Commercial Helicopter, and Part 91 

Helicopter Operations final rule 

published on February 21, 2014 (79 FR 

9932). In that rule, the FAA established 

several operational rules for part 91 

rotorcraft operators and part 135 

rotorcraft operators which are scheduled 

to take effect April 22, 2014. This final 

rule extends the effective date to April 

22, 2015 to provide a sufficient amount 

of time for the affected operators and 

certificate holders to implement the new 

requirements. This action does not 

affect the provisions of the rule with a 

specific compliance date that are 

discussed later in this document. 

II. Background 

A. Statement of the Problem 

There are approximately 5,465 

rotorcraft pilots and 496 certificate 

holders conducting part 135 rotorcraft 

operations that are affected by the new 

requirements established in the 

February 21 rule. Moreover, all part 91 

operations in class G airspace under 

visual flight rules will be affected by 

this rule. Multiple steps are required by 

the FAA and the regulated community 

for operators to implement the new 

requirements. However, it is not feasible 

for the FAA or rotorcraft operators to 

complete all the necessary steps by 

April 22, 2014. Consequently, operators 

will not be able to meet the operational 

requirements and thus will not be able 

to conduct part 135 operations or follow 

the new part 91 requirements beginning 

April 23, 2014. Therefore, the FAA is 

extending the rule’s effective date to 

April 22, 2015 to provide a sufficient 

amount of time for the affected entities 

to complete all the necessary steps to 

implement the new requirements. 

III. Discussion of Final Rule With 

Request for Comments 

As stated above, the current effective 

date of the Helicopter Air Ambulance, 

Commercial Helicopter, and Part 91 

Helicopter Operations final rule is April 

22, 2014. Since the publication of the 

rule, it has become evident that this 

effective date does not allow certificate 

holders sufficient time to complete all 

the necessary steps to implement the 

new rule. 

As one example, pilots are currently 

required to complete written or oral 

knowledge testing and a flight 

competency check every 12 calendar 

months. New § 135.293(a)(9) requires 

rotorcraft pilots to complete knowledge 

testing on ‘‘procedures for aircraft 

handling in flat-light, whiteout, and 

brownout conditions, including 

methods for recognizing and avoiding 

those conditions’’ during their next 

written or oral test after April 22, 2014. 

New § 135.293(c) requires rotorcraft 

pilots to complete ‘‘a demonstration of 

the pilot’s ability to maneuver the 

rotorcraft solely by reference to 

instruments’’ during their next 

competency check after April 22, 2014. 

In order to implement these new 

requirements, certificate holders must 

complete several steps, such as 

developing the procedures for testing 

aircraft handling in flat-light, whiteout, 

and brownout conditions, revising the 

approved training program to address 

the new requirements, and training 

instructors and check pilots prior to 

beginning the training, testing, and 

checking of rotorcraft pilots. The April 

22, 2014 compliance date does not 

provide adequate time for certificate 

holders to complete these necessary 

steps and therefore the compliance date 

will be delayed to April 22, 2015. We 

note that this is the only provision 

requiring a specific change of rule text. 

In addition, we are revising the rule text 

to clarify the compliance date for this 

section. 

In addition, the FAA has determined 

that the April 22, 2014 effective date 

does not provide sufficient time for the 

FAA or the regulated community to 

implement the other operational rules 

which are currently scheduled to take 

effect on that date. However, the FAA 

has determined that provisions with 

delayed compliance dates in the 

Helicopter Air Ambulance, Commercial 

Helicopter, and Part 91 Helicopter 

Operations final rule do not need to be 

extended under this action. This is 

because the FAA will have sufficient 

time to prepare guidance for regulated 

entities in advance of the compliance 

dates for these provisions. The FAA is 

not extending the compliance dates of 

the following provisions: 

• 135.160, Radio altimeters for 

rotorcraft operations—compliance date 

April 24, 2017. 

• 135.168, Emergency equipment: 

Overwater rotorcraft operations (406 

MHz emergency locator transmitter)— 

compliance date April 24, 2017. 

• 135.603, Pilot-in-command 

instrument qualifications—compliance 

date April 24, 2017. 

• 135.605, Helicopter terrain 

awareness and warning system 

(HTAWS)—compliance date April 24, 

2017. 

• 135.607, Flight Data Monitoring 

System—compliance date April 23, 

2018. 

• 135.619, Operations control 

centers—compliance date April 22, 

2016. 

IV. Regulatory Notices and Analyses 

A. Regulatory Evaluation 

Changes to Federal regulations must 

undergo several economic analyses. 

First, Executive Order 12866 and 

Executive Order 13563 direct that each 

Federal agency shall propose or adopt a 

regulation only upon a reasoned 

determination that the benefits of the 

intended regulation justify its costs. 

Second, the Regulatory Flexibility Act 

of 1980 (Pub. L. 96–354) requires 

agencies to analyze the economic 

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Federal Register / Vol. 79, No. 76 / Monday, April 21, 2014 / Rules and Regulations 22011 

impact of regulatory changes on small 

entities. Third, the Trade Agreements 

Act (Pub. L. 96–39) prohibits agencies 

from setting standards that create 

unnecessary obstacles to the foreign 

commerce of the United States. In 

developing U.S. standards, the Trade 

Act requires agencies to consider 

international standards and, where 

appropriate, that they be the basis of 

U.S. standards. Fourth, the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4) requires agencies to prepare a 

written assessment of the costs, benefits, 

and other effects of proposed or final 

rules that include a Federal mandate 

likely to result in the expenditure by 

State, local, or tribal governments, in the 

aggregate, or by the private sector, of 

$100 million or more annually (adjusted 

for inflation with base year of 1995). 

This portion of the preamble 

summarizes the FAA’s analysis of the 

economic impacts of this final rule. 

Department of Transportation Order 

DOT 2100.5 prescribes policies and 

procedures for simplification, analysis, 

and review of regulations. If the 

expected cost impact is so minimal that 

a proposed or final rule does not 

warrant a full evaluation, this order 

permits that a statement to that effect 

and the basis for it to be included in the 

preamble if a full regulatory evaluation 

of the cost and benefits is not prepared. 

Such a determination has been made for 

this final rule. The reasoning for this 

determination follows. 

The FAA is extending the effective 

date for the rules published in the 

Helicopter Air Ambulance, Commercial 

Helicopter, and Part 91 Helicopter 

Operations final rule on February 21, 

2014 that are scheduled to take effect on 

April 22, 2014. The effective date of 

April 22, 2014 does not provide an 

adequate amount of time for the affected 

certificate holders to implement the new 

requirements. By extending the effective 

date to April 22, 2015, the affected 

certificate holders will have sufficient 

time to implement the new 

requirements. 

The expected outcome will be cost 

relieving for certificate holders 

operating rotorcraft under part 135 and 

part 91 operators, and therefore a 

regulatory evaluation was not prepared. 

The FAA requests comments with 

supporting justification about the FAA 

determination of minimal impact. 

The FAA has, therefore, determined 

that this final rule is not a ‘‘significant 

regulatory action’’ as defined in section 

3(f) of Executive Order 12866, and is not 

‘‘significant’’ as defined in DOT’s 

Regulatory Policies and Procedures. 

B. Regulatory Flexibility Determination 

The Regulatory Flexibility Act of 1980 

(Pub. L. 96–354) (RFA) establishes ‘‘as a 

principle of regulatory issuance that 

agencies shall endeavor, consistent with 

the objectives of the rule and of 

applicable statutes, to fit regulatory and 

informational requirements to the scale 

of the businesses, organizations, and 

governmental jurisdictions subject to 

regulation. To achieve this principle, 

agencies are required to solicit and 

consider flexible regulatory proposals 

and to explain the rationale for their 

actions to assure that such proposals are 

given serious consideration.’’ The RFA 

covers a wide-range of small entities, 

including small businesses, not-forprofit organizations, and small 

governmental jurisdictions. 

Agencies must perform a review to 

determine whether a rule will have a 

significant economic impact on a 

substantial number of small entities. If 

the agency determines that it will, the 

agency must prepare a regulatory 

flexibility analysis as described in the 

RFA. 

However, if an agency determines that 

a rule is not expected to have a 

significant economic impact on a 

substantial number of small entities, 

section 605(b) of the RFA provides that 

the head of the agency may so certify 

and a regulatory flexibility analysis is 

not required. The certification must 

include a statement providing the 

factual basis for this determination, and 

the reasoning should be clear. 

This final rule does not impose any 

additional costs on affected entities. 

Therefore, as provided in section 605(b), 

the FAA certifies that this rulemaking 

will not result in a significant economic 

impact on a substantial number of small 

entities. 

C. International Trade Impact 

Assessment 

The Trade Agreements Act of 1979 

(Pub. L. 96–39), as amended by the 

Uruguay Round Agreements Act (Pub. 

L. 103–465), prohibits Federal agencies 

from establishing standards or engaging 

in related activities that create 

unnecessary obstacles to the foreign 

commerce of the United States. 

Pursuant to these Acts, the 

establishment of standards is not 

considered an unnecessary obstacle to 

the foreign commerce of the United 

States, so long as the standard has a 

legitimate domestic objective, such as 

the protection of safety, and does not 

operate in a manner that excludes 

imports that meet this objective. The 

statute also requires consideration of 

international standards and, where 

appropriate, that they be the basis for 

U.S. standards. The FAA has assessed 

the potential effect of this final rule and 

determined that it will have only a 

domestic impact and therefore no effect 

on international trade. 

D. Unfunded Mandates Assessment 

Title II of the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4) 

requires each Federal agency to prepare 

a written statement assessing the effects 

of any Federal mandate in a proposed or 

final agency rule that may result in an 

expenditure of $100 million or more (in 

1995 dollars) in any one year by State, 

local, and tribal governments, in the 

aggregate, or by the private sector; such 

a mandate is deemed to be a ‘‘significant 

regulatory action.’’ The FAA currently 

uses an inflation-adjusted value of $151 

million in lieu of $100 million. This 

final rule does not contain such a 

mandate; therefore, the requirements of 

Title II of the Act do not apply. 

E. Paperwork Reduction Act 

The Paperwork Reduction Act of 1995 

(44 U.S.C. 3507(d)) requires that the 

FAA consider the impact of paperwork 

and other information collection 

burdens imposed on the public. The 

FAA has determined that there is no 

new requirement for information 

collection associated with this 

immediately adopted final rule. 

F. International Compatibility and 

Cooperation 

In keeping with U.S. obligations 

under the Convention on International 

Civil Aviation, it is FAA policy to 

conform to International Civil Aviation 

Organization (ICAO) Standards and 

Recommended Practices to the 

maximum extent practicable. The FAA 

has reviewed the corresponding ICAO 

Standards and Recommended Practices 

and has identified no differences with 

these proposed regulations. 

Executive Order 13609, Promoting 

International Regulatory Cooperation, 

promotes international regulatory 

cooperation to meet shared challenges 

involving health, safety, labor, security, 

environmental, and other issues and to 

reduce, eliminate, or prevent 

unnecessary differences in regulatory 

requirements. The FAA has analyzed 

this action under the policies and 

agency responsibilities of Executive 

Order 13609, and has determined that 

this action would have no effect on 

international regulatory cooperation. 

G. Environmental Analysis 

FAA Order 1050.1E identifies FAA 

actions that are categorically excluded 

from preparation of an environmental 

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22012 Federal Register / Vol. 79, No. 76 / Monday, April 21, 2014 / Rules and Regulations 

assessment or environmental impact 

statement under the National 

Environmental Policy Act in the 

absence of extraordinary circumstances. 

The FAA has determined this 

rulemaking action qualifies for the 

categorical exclusion identified in 

paragraph 312f and involves no 

extraordinary circumstances. 

H. Regulations Affecting Intrastate 

Aviation in Alaska 

Section 1205 of the FAA 

Reauthorization Act of 1996 (110 Stat. 

3213) requires the FAA, when 

modifying its regulations in a manner 

affecting intrastate aviation in Alaska, to 

consider the extent to which Alaska is 

not served by transportation modes 

other than aviation, and to establish 

appropriate regulatory distinctions. As 

discussed in the Helicopter Air 

Ambulance, Commercial Helicopter, 

and Part 91 Helicopter Operations final 

rule which instituted the requirements 

being delayed by this action, the FAA 

finds that there is no need to make any 

regulatory distinctions in the provisions 

of this rule. See 79 FR 9932, 9971–72. 

V. Executive Order Determinations 

A. Executive Order 13132, Federalism 

The FAA has analyzed this 

immediately adopted final rule under 

the principles and criteria of Executive 

Order 13132, Federalism. The agency 

determined that this action will not 

have a substantial direct effect on the 

States, or the relationship between the 

Federal Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government, and, therefore, 

does not have Federalism implications. 

B. Executive Order 13211, Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use 

The FAA analyzed this final rule with 

request for comments under Executive 

Order 13211, Actions Concerning 

Regulations that Significantly Affect 

Energy Supply, Distribution, or Use 

(May 18, 2001). The agency has 

determined that it is not a ‘‘significant 

energy action’’ under the executive 

order and it is not likely to have a 

significant adverse effect on the supply, 

distribution, or use of energy. 

VI. How To Obtain Additional 

Information 

A. Rulemaking Documents 

An electronic copy of a rulemaking 

document my be obtained by using the 

Internet— 

1. Search the Federal eRulemaking 

Portal (http://www.regulations.gov); 

2. Visit the FAA’s Regulations and 

Policies Web page at http://

www.faa.gov/regulations_policies/ or 

3. Access the Government Printing 

Office’s Web page at: http://

www.gpo.gov/fdsys/. 

Copies may also be obtained by 

sending a request (identified by notice, 

amendment, or docket number of this 

rulemaking) to the Federal Aviation 

Administration, Office of Rulemaking, 

ARM–1, 800 Independence Avenue 

SW., Washington, DC 20591, or by 

calling (202) 267–9680. 

B. Comments Submitted to the Docket 

Comments received may be viewed by 

going to http://www.regulations.gov and 

following the online instructions to 

search the docket number for this 

action. Anyone is able to search the 

electronic form of all comments 

received into any of the FAA’s dockets 

by the name of the individual 

submitting the comment (or signing the 

comment, if submitted on behalf of an 

association, business, labor union, etc.). 

C. Small Business Regulatory 

Enforcement Fairness Act 

The Small Business Regulatory 

Enforcement Fairness Act (SBREFA) of 

1996 requires FAA to comply with 

small entity requests for information or 

advice about compliance with statutes 

and regulations within its jurisdiction. 

A small entity with questions regarding 

this document, may contact its local 

FAA official, or the person listed under 

the FOR FURTHER INFORMATION CONTACT

heading at the beginning of the 

preamble. To find out more about 

SBREFA on the Internet, visit http://

www.faa.gov/regulations_policies/

rulemaking/sbre_act/. 

List of Subjects in 14 CFR Parts 91, 120, 

and 135 

Air taxis, Aircraft, Airmen, Aviation 

safety, Reporting and recordkeeping 

requirements. 

The Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends chapter I of title 14, Code of 

Federal Regulations as follows: 

PART 135—OPERATING 

REQUIREMENTS: COMMUTER AND 

ON DEMAND OPERATIONS AND 

RULES GOVERNING PERSONS ON 

BOARD SUCH AIRCRAFT 

■ 1. The authority citation for part 135 

continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g), 41706, 

40113, 44701–44702, 44705, 44709, 44711– 

44713, 44715–44717, 44722, 44730, 45101– 

45105, Pub. L. 112–95, 126 Stat. 58 (49 U.S.C. 

44730). 

■ 2. Amend § 135.293 by removing the 

phrase ‘‘After the next scheduled 

competency check after April 22, 2014’’ 

from the beginning of paragraph (a)(9) 

and adding paragraph (h) to read as 

follows: 

§ 135.293 Initial and recurrent pilot testing 

requirements. 

* * * * * 

(h) Rotorcraft pilots must be tested on 

the subjects in paragraph (a)(9) of this 

section when taking a written or oral 

knowledge test after April 22, 2015. 

Rotorcraft pilots must be checked on the 

maneuvers and procedures in paragraph 

(c) of this section when taking a 

competency check after April 22, 2015. 

Issued under authority provided by 49 

U.S.C. 106(f), 44701(a), and 44703 in 

Washington, DC, on April 15, 2014. 

Michael G. Whitaker, 

Deputy Administrator, Federal Aviation 

Administration. 

[FR Doc. 2014–09034 Filed 4–17–14; 11:15 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 886 

[Docket No. FDA–2013–N–0069] 

Medical Devices; Ophthalmic Devices; 

Classification of the Eyelid Weight 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

classifying the eyelid weight into class 

II (special controls). The Agency is 

exempting the external eyelid weight 

from premarket notification, but 

continuing to require premarket 

notification for implantable eyelid 

weights in order to provide a reasonable 

assurance of safety and effectiveness of 

the device. Both external and 

implantable eyelid weight devices are 

subject to special controls. The eyelid 

weight may be adhered to the outer skin 

of the upper eyelid (external eyelid 

weight) or implanted into the upper 

eyelid (implantable eyelid weight), and 

is intended for the gravity assisted 

treatment of lagophthalmos (incomplete 

eyelid closure). 

DATES: Effective Date: July 21, 2014. 

Compliance Dates: Premarket 

notification submissions (510(k)s) for 

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