Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations 46867 

allocated Operating Authorization must 

be submitted to the FAA Slot 

Administration Office, facsimile (202) 

267–7277 or email 7-AWA-Slotadmin@

faa.gov, and must come from a 

designated representative of the carrier. 

If the FAA cannot approve a carrier’s 

request to move a scheduled arrival or 

departure, the carrier may then apply 

for a trade in accordance with paragraph 

7. 

7. For the duration of this Order, a 

carrier may enter into a lease or trade of 

an Operating Authorization to another 

carrier for any consideration. Notice of 

a trade or lease under this paragraph 

must be submitted in writing to the FAA 

Slot Administration Office, facsimile 

(202) 267–7277 or email 7-AWASlotadmin@faa.gov, and must come 

from a designated representative of each 

carrier. The FAA must confirm and 

approve these transactions in writing 

prior to the effective date of the 

transaction. The FAA will approve 

transfers between carriers under the 

same marketing control up to five 

business days after the actual operation, 

but only to accommodate operational 

disruptions that occur on the same day 

of the scheduled operation. The FAA’s 

approval of a trade or lease does not 

constitute a commitment by the FAA to 

grant the associated historical rights to 

any operator in the event that slot 

controls continue at JFK after this order 

expires. 

8. A carrier may not buy, sell, trade, 

or transfer an Operating Authorization, 

except as described in paragraph 7. 

9. Historical rights to Operating 

Authorizations and withdrawal of those 

rights due to insufficient usage will be 

determined on a seasonal basis and in 

accordance with the schedule approved 

by the FAA prior to the commencement 

of the applicable season. 

a. For each day of the week that the 

FAA has approved an operating 

schedule, any Operating Authorization 

not used at least 80% of the time over 

the time-frame authorized by the FAA 

under this paragraph will be withdrawn 

by the FAA for the next applicable 

season except: 

i. The FAA will treat as used any 

Operating Authorization held by a 

carrier on Thanksgiving Day, the Friday 

following Thanksgiving Day, and the 

period from December 24 through the 

first Saturday in January. 

ii. The Administrator of the FAA may 

waive the 80% usage requirement in the 

event of a highly unusual and 

unpredictable condition which is 

beyond the control of the carrier and 

which affects carrier operations for a 

period of five consecutive days or more. 

b. Each carrier holding an Operating 

Authorization must forward in writing 

to the FAA Slot Administration Office a 

list of all Operating Authorizations held 

by the carrier along with a listing of the 

Operating Authorizations and: 

i. The dates within each applicable 

season it intends to commence and 

complete operations. 

A. For each winter scheduling season, 

the report must be received by the FAA 

no later than August 15 during the 

preceding summer. 

B. For each summer scheduling 

season, the report must be received by 

the FAA no later than January 15 during 

the preceding winter. 

ii. The completed operations for each 

day of the applicable scheduling season: 

A. No later than September 1 for the 

summer scheduling season. 

B. No later than January 15 for the 

winter scheduling season. 

iii. The completed operations for each 

day of the scheduling season within 30 

days after the last day of the applicable 

scheduling season. 

10. In the event that a carrier 

surrenders to the FAA any Operating 

Authorization assigned to it under this 

Order or if there are unallocated 

Operating Authorizations, the FAA will 

determine whether the Operating 

Authorizations should be reallocated. 

The FAA may temporarily allocate an 

Operating Authorization at its 

discretion. Such temporary allocations 

will not be entitled to historical status 

for the next applicable scheduling 

season under paragraph 9. 

11. The FAA considers the following 

factors and priorities in allocating 

Operating Authorizations, which the 

FAA has determined are available for 

reallocation— 

a. Historical requests for allocation of 

an Operating Authorization in the same 

time; 

b. New entrant status; 

c. Retiming of historic Operating 

Authorizations; 

d. Extension of a seasonal Operating 

Authorization to year-round service; 

e. The effective period of operation; 

f. The extent and regularity of 

intended use with priority given to yearround services; 

g. The operational impacts of 

scheduled demand, including the 

hourly and half-hour demand and the 

mix of arrival and departure flights; and 

h. Airport facility constraints. 

Any carrier that is not approved for 

allocation of an Operating Authorization 

by the FAA may request it be placed on 

a waiting list for consideration should 

an Operating Authorization in the 

requested time become available during 

that scheduling season. 

12. If the FAA determines that an 

involuntary reduction in the number of 

allocated Operating Authorizations is 

required to meet operational needs, 

such as reduced airport capacity, the 

FAA will conduct a weighted lottery to 

withdraw Operating Authorizations to 

meet a reduced hourly or half-hourly 

limit for scheduled operations. The FAA 

will provide at least 45 days’ notice 

unless otherwise required by 

operational needs. Any Operating 

Authorization that is withdrawn or 

temporarily suspended will, if 

reallocated, be reallocated to the carrier 

from which it was taken, provided that 

the carrier continues to operate 

scheduled service at JFK. 

13. The FAA may enforce this Order 

through an enforcement action seeking 

a civil penalty under 49 U.S.C. 46301(a). 

The FAA also could file a civil action 

in U.S. District Court, under 49 U.S.C. 

46106, 46107, seeking to enjoin any 

carrier from violating the terms of this 

Order. 

14. The FAA may modify or withdraw 

any provision in this Order on its own 

or on application by any carrier for good 

cause shown. 

Issued in Washington, DC, on September 

11, 2018. 

Jeffrey Planty, 

Deputy Vice President, System Operations 

Services. 

[FR Doc. 2018–20138 Filed 9–14–18; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Office of the Secretary 

14 CFR Parts 295 and 298 

RIN No. 2105–AD66 

[Docket No. DOT–OST–2007–27057] 

Increasing Charter Air Transportation 

Options 

AGENCY: Office of the Secretary (OST), 

Department of Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: The Department of 

Transportation (DOT or Department) is 

issuing a final rule to facilitate 

innovation and growth in the air charter 

industry while strengthening the legal 

protections provided to consumers of 

charter air transportation. First, this rule 

allows ‘‘air charter brokers’’ as 

principals or bona fide agents to provide 

single entity charter air transportation of 

passengers. Second, it requires air 

charter brokers to make certain 

disclosures including those responsive 

to a National Transportation Safety 


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Board (NTSB) recommendation and to 

make other disclosures upon request. 

Third, it enumerates certain practices by 

air charter brokers as prohibited unfair 

or deceptive practices or unfair methods 

of competition. Fourth, this rule 

requires air taxis and commuter air 

carriers that sell charter air 

transportation to make certain 

disclosures including those responsive 

to an NTSB recommendation and other 

disclosures upon request. Fifth, it 

enumerates certain practices by an air 

taxi or commuter air carrier as 

prohibited unfair or deceptive practices 

or unfair methods of competition. At the 

same time, the Department is not 

adopting a proposal to codify exemption 

authority allowing indirect air carriers 

to engage in the sale of air 

transportation related to air ambulance 

services. Nor is it adopting a proposal to 

codify that certain air transportation 

services performed under contract with 

the Federal Government are in common 

carriage. 

DATES: This rule is effective February 

14, 2019. 

FOR FURTHER INFORMATION CONTACT: 

Jonathan Dols, Deputy Assistant General 

Counsel, Office of the Assistant General 

Counsel for Aviation Enforcement and 

Proceedings, Department of 

Transportation, 1200 New Jersey Ave. 

SE, Washington, DC 20590, 202–366– 

9342 (phone), 202–366–7152 (fax), 

jonathan.dols@dot.gov. You may also 

contact Lisa Swafford-Brooks, Chief, 

Aviation Licensing and Compliance 

Branch, Office of the Assistant General 

Counsel for Aviation Enforcement and 

Proceedings, U.S. Department of 

Transportation, 1200 New Jersey Ave. 

SE, Washington, DC 20590, 202–366– 

9342 (phone), 202–366–7152 (fax), 

lisa.swaffordbrooks@dot.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

On September 30, 2013, the 

Department published a notice of 

proposed rulemaking (NPRM) in the 

Federal Register, 78 FR 59880, in which 

it addressed the following areas: (1) An 

NTSB recommendation for air taxis and 

commuter air carriers to make certain 

disclosures and a prohibition on certain 

practices by air taxis and commuter air 

carriers; (2) the creation of a new class 

of indirect air carrier, a requirement for 

these entities to make certain 

disclosures, and a prohibition on certain 

practices by these entities; (3) the 

authority of indirect air carriers to 

engage in sale of air transportation 

related to air ambulance services; and 

(4) a clarification regarding air services 

performed under contract with the 

Federal Government. 

The Department’s proposal to act in 

response to the NTSB recommendation 

built upon an advance notice of 

proposed rulemaking (ANPRM) 

published in the Federal Register on 

January 26, 2007, 72 FR 3773. The 

Department received 23 comments in 

response to the ANPRM, which were 

summarized in the NPRM. 

The Department received 21 

comments in response to the NPRM, 

including one comment representing the 

views of multiple entities. Of these, 18 

comments were from members of the 

industry, including direct and indirect 

air carriers, as well as associations 

representing both direct and indirect air 

carriers and other aviation businesses. 

Specifically, these comments 

represented the views of the Air Charter 

Association, the Air Medical Operators 

Association, Air Methods, the 

Association of Air Medical Services, 

Blue Feather Charter, Chapman 

Freeborn, Corporate Flight Management, 

CSI Aviation, Flex Jet, Flight Options, 

Jet Logistics, Jet Solutions, the National 

Air Carrier Association, the National Air 

Transportation Association (NATA), the 

National Business Aviation Association 

(NBAA), Premier Aviation Charter, 

Public Charters Inc., Sentient Jet, 

Sentient Jet Charter, and Ultimate 

Jetcharters. One comment was from 

Consumers Union, a consumer rights 

organization; one comment was from 

the American Society of Travel Agents 

(ASTA), an association representing 

travel agents; and another comment was 

made anonymously. Three comments 

addressed the NTSB recommendation, 

17 addressed the creation of a new class 

of indirect air carrier, six addressed air 

ambulance services, and one addressed 

air services performed under contract 

with the Federal Government. 

In general, almost all commenters 

supported the proposals regarding the 

NTSB recommendation, the creation of 

a new class of indirect air carrier, and 

codifying the exemption authority for 

air ambulance services. These 

comments also provided suggested 

changes to the Department’s proposals. 

The one comment regarding air services 

performed under contract with the 

Federal Government objected to the 

Department’s proposal on that topic in 

its entirety. The section-by-section 

analysis will describe each provision of 

the final rule and respond to the 

comments received. 

Comments and Responses 

1. New Class of Indirect Air Carrier 

A. Recognition of an ‘‘Air Charter 

Broker’’ Class of Indirect Air Carrier (14 

CFR 295.1, 295.3, 295.5, 295.7, 295.10, 

295.12) 

The NPRM: In the NPRM, the 

Department proposed to recognize a 

class of indirect air carrier to be named 

‘‘air charter brokers’’ that are permitted 

as principals in their own right to 

engage in single entity charter air 

transportation aboard large and small 

aircraft pursuant to exemptions from 

certain provisions of Subtitle VII of Title 

49 of the United States Code. The 

Department proposed allowing this 

class of indirect air carrier to selfidentify, rather than establish a formal 

licensing or registration scheme. The 

Department solicited comment on the 

establishment of such a scheme, 

particularly whether one should apply 

to non-U.S. citizen air charter brokers. 

In addition, the Department sought 

comment on whether ‘‘single entity 

charter’’ should include individuals 

who self-aggregate to form a single 

entity charter and whether including 

self-aggregated groups in this definition 

would require a change to the definition 

of a single entity charter in 14 CFR 

212.2. 

Comments: The comments received 

by DOT demonstrated general support 

for the recognition of a new class of 

indirect air carrier. There was some 

support for expanding the definition of 

‘‘air charter broker’’ to include ‘‘bona 

fide agents.’’ NBAA noted that charter 

customers using the services of an air 

charter broker acting as an agent were 

no less deserving of consumer 

protections than customers of air charter 

brokers acting as indirect air carriers. 

Further, NATA encouraged the 

Department to harmonize the regulatory 

language regarding disclosures required 

by air taxi operators/commuter air 

carriers and by air charter brokers. 

Support for a registration scheme, on 

the other hand was mixed. Entities that 

favored the creation of a registry 

commented that self-identification 

might not adequately protect consumers 

because unscrupulous air charter 

brokers could easily change names, that 

a registry could be used to ensure 

minimum standards among air charter 

brokers (e.g., a certain level of insurance 

or bonding), and that a registry would 

provide consumers and DOT with 

contact information for and basic 

information about the regulated entities. 

Some commenters stated that such a 

registry would be inexpensive to 

maintain, while others stated it would 


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be costly to maintain. Of the comments 

in favor of the establishment of a 

registration scheme, some favored 

requiring only U.S.-citizen air charter 

brokers to register, others favored 

requiring only foreign-citizen air charter 

brokers to register, and still others 

favored requiring all air charter brokers 

to register. 

The Department received over a halfdozen comments regarding the proposed 

definition of ‘‘single entity charter,’’ all 

but one of which supported the 

inclusion of individuals who selfaggregate to form a single entity. NBAA 

proposed making clear that this class of 

indirect air carrier does not include 

‘‘fractional ownership program 

managers’’ and ‘‘in-house corporate 

travel departments,’’ and proposed 

definitions of those two terms. The Air 

Charter Association of North America 

expressed concern that the proposed 

definition was overly broad and 

undermined consumer protections, 

including those found in DOT’s rule 

governing public charters, 14 CFR part 

380. 

DOT Response: The Department is 

finalizing its proposed rule to recognize 

an ‘‘air charter broker’’ class of indirect 

air carrier. Because many commenters 

raised a valid point that charter 

customers deserve the same consumer 

protections whether they use air charter 

brokers who are acting as indirect air 

carriers or as bona fide agents, the 

Department has decided to widen its 

definition of air charter broker to 

include bona fide agents and, further, to 

define that term by regulation. Based on 

the multiple comments received, this is 

a natural outgrowth of the NPRM. The 

Department is also harmonizing, to the 

extent practicable, the regulatory 

language regarding disclosures required 

by air taxi operators/commuter air 

carriers and by air charter brokers. 

The Department has decided not to 

create a registry of air charter brokers, 

either U.S. or non-U.S. citizens. After 

thoroughly reviewing the arguments 

raised in favor of and in opposition to 

such a registry, DOT has determined 

that at this time the potential benefits 

are ill-defined. The Department may 

revisit this issue in the future should the 

need become apparent. The Department 

notes, however, that this rulemaking 

does not preclude voluntary registration 

or ‘‘certification’’ through third parties. 

For example, air charter brokers may 

determine that voluntary membership in 

an association or organization provides 

the same benefits cited in the comments 

favoring the creation of a DOT-run 

registry. 

Finally, recognizing the support of 

most commenters to including selfaggregated individuals within the 

definition of ‘‘single entity charter,’’ 

DOT adopts its proposed definition, but 

limits the ability of individuals to form 

self-aggregated groups only to flights to 

be operated using small aircraft. Thus, 

there is no need to change the definition 

of single entity charter in 14 CFR 212.2, 

since that part is not applicable to any 

flights performed by a commuter air 

carrier, air taxi operator, or certificated 

air carrier operating ‘‘small aircraft’’ 

under Part 298. Further, it 

acknowledges concerns, including those 

of the Air Charter Association of North 

America that the definition as proposed 

in the NPRM unnecessarily broadens 

the definition of a single entity charter 

and could undermine the consumer 

protections in the Department’s rule 

governing public charters, 14 CFR part 

380. In addition, the Department is 

making a non-substantive change by 

removing the word ‘‘passenger’’ from its 

‘‘air charter broker’’ definition so that it 

references ‘‘single entity charter,’’ a term 

defined by regulation, rather than 

‘‘single entity passenger charter.’’ The 

Department has decided not to accept 

NBAA’s proposals regarding ‘‘fractional 

ownership membership program 

managers’’ and ‘‘in-house corporate 

travel departments’’ because those two 

entities do not provide common carriage 

air transportation and are therefore 

already excluded from the scope of this 

rule. 

B. Disclosures (14 CFR 295.20, 295.23, 

295.24, 295.26) 

The NPRM: In the NPRM, the 

Department proposed to require that an 

air charter broker disclose clearly and 

conspicuously in any solicitation 

materials its status and the fact that it 

is not a direct air carrier and will use 

an authorized direct air carrier to 

provide the transportation it offers. The 

Department also proposed requiring 

written disclosure of (1) the corporate 

name of the direct air carrier in 

operational control of the aircraft and 

any other names in which the carrier 

holds itself out to the public (as 

recommended by the NTSB); (2) the 

capacity in which the air charter broker 

is acting; (3) the existence of any 

corporate or business relationships with 

a particular direct air carrier; (4) the 

aircraft type; (5) the total cost of air 

transportation paid to the air charter 

broker; (6) the existence of any other 

amount charged by third parties for 

which the charterer will be responsible 

for paying directly; and (7) the existence 

or absence of liability insurance held by 

the air charter broker covering the 

charterer and passengers and property 

on the charter flight, and the monetary 

limits of such insurance. Further, the 

Department sought public comment on 

whether any additional disclosures 

should be required. 

Under the proposed rule, any required 

disclosure must be made within a 

‘‘reasonable’’ time, defined as enough 

time for the charterer to make an 

informed decision as to whether to 

accept the change. Failure to provide 

notice within a ‘‘reasonable’’ time 

would entitle the consumer the option 

of receiving a full refund. The 

Department sought comment on 

whether to provide a specific time frame 

for the disclosures and whether to 

require some sort of confirmation of 

receipt of the disclosures. In addition, 

DOT solicited comment on whether the 

refund requirements of 14 CFR part 374 

should apply to air charter brokers. 

Comments: The comments received in 

response to the disclosure proposals ran 

the gamut, with some support for and 

some objection to each of the seven 

proposed disclosures. When expressing 

support for a disclosure, commenters 

generally cited a consumer need to 

possess that information. When 

expressing opposition to a disclosure, 

commenters generally asserted that 

consumers would not benefit from that 

information. In particular, many 

commenters noted that consumers need 

not learn the identity of the aircraft’s 

owner so long as they know the name 

of the direct air carrier. In addition, 

some commenters stated that because 

most customers of air charter brokers are 

sophisticated consumers with 

significant bargaining power, the 

proposed disclosures would be better 

handled through a negotiated contract. 

In response to the disclosure of 

insurance (or lack thereof), several 

commenters suggested that DOT not 

only require disclosure, but require that 

air charter brokers maintain a certain 

level of insurance. Finally, NATA 

requested that the Department clarify 

the meaning of ‘‘any corporate or 

business relationship between the air 

charter broker and the direct air 

carrier.’’ The NBAA further requested 

that the disclosure of such relationships 

be limited to those ‘‘which may have a 

substantial bearing upon the air charter 

broker’s selection of a direct air carrier.’’ 

Finally, Chapman Freeborn 

Airchartering questioned at what level 

of detail any required itemization must 

be made. 

Both industry and ASTA provided 

comments against establishing a fixed 

time in which air charter brokers must 

disclose any changes in the air 

transportation arrangements. These 

comments explained that it would be an 

unworkable requirement, as some 


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changes could be very last-minute and 

thus too late to comply with the 

prescribed time frame while others 

could become known far in advance 

thus rendering the time frame 

unnecessarily restrictive. 

Most commenters expressed 

opposition to requiring that air charter 

brokers obtain some form of 

confirmation of the receipt of any 

changes to the required disclosures. 

These commenters stated that obtaining 

confirmation would not be practicable, 

as some consumers may simply decline 

to confirm receipt, and would create an 

undue burden for air charter brokers 

forced to obtain one. 

Comments regarding DOT’s proposal 

to subject air charter brokers to the 

refund requirements of 14 CFR part 374 

indicated general disapproval. Most 

commenters wanted parties to negotiate 

refund provisions in the original 

contract. These commenters noted that 

customers of air charter brokers are 

sophisticated parties with significant 

bargaining power, that Part 374 may 

prove unworkable in the air charter 

broker context, and that DOT should not 

substitute its judgment for that of 

individuals in the marketplace. Several 

suggested that DOT could require 

refund provisions be disclosed in the 

original contract rather than impose Part 

374 by default. The minority of 

commenters who expressed support for 

this portion of the NPRM stated that 

consumers of air charter broker services 

deserve the same protections as 

consumers of other forms of air 

transportation. 

DOT Response: Of the seven proposed 

disclosures, the Department is requiring 

three and making three others required 

upon request. Having considered the 

comments both for and against the 

proposal, the Department believes that 

on the whole consumers, regardless of 

sophistication level, would benefit from 

an increased amount of information. 

The Department is not requiring that the 

type of the aircraft be disclosed since it 

believes that information is already a 

part of most charter negotiations. The 

Department is clarifying what type of 

‘‘corporate or business relationship 

between the air charter broker and the 

direct air carrier’’ must be disclosed 

upon request by adding the example of 

a pre-existing contract between the two 

entities. Further, the Department is 

adopting in part NBAA’s suggestion that 

this definition be further refined by 

adding language that the relationship 

must have a ‘‘bearing’’ on the 

transaction. Finally, the Department is 

changing the language of the disclosure 

upon request relating to costs to make 

clear that detailed itemization is not 

required. 

The Department is not requiring that 

air charter brokers maintain a certain 

level of insurance. The Department is 

aware that most air charter brokers 

already maintain a certain level of 

insurance as a good business practice. 

Establishing a minimum level of 

insurance would therefore not add 

additional protection for consumer 

funds. 

The Department agrees with industry 

and ASTA that regulating the time 

frame in which disclosures must be 

made is impracticable, for the reasons 

provided by those commenters. 

Therefore, the Department adopts the 

‘‘within a reasonable time after such 

information becomes available’’ 

standard as proposed in the NPRM. The 

Department has clarified in the final 

rule that it is within a reasonable time 

of becoming available ‘‘to the air charter 

broker.’’ A ‘‘reasonable’’ time would be 

enough time for the charterer to make an 

informed decision as to whether he or 

she wants to accept the additional 

information or the change. For example, 

should the direct air carrier to operate 

the flight change one week prior to the 

flight date, the Department would find 

it ‘‘reasonable’’ for notice to be given 

within 24 hours after such information 

becomes available to the air charter 

broker. On the other hand, the 

Department would not find it 

‘‘reasonable’’ for notice to be given two 

hours before departure in such a 

circumstance, since that would not give 

the charterer time to make an informed 

decision as to whether to accept the 

change. At that point, the charterer 

would already likely be fully prepared 

for the flight and may in fact already be 

en route to the airport. 

Having reviewed the public 

comments, the Department has decided 

not to add a requirement that air charter 

brokers obtain written confirmation that 

the required disclosures were made or 

that charterers received notice of any 

changes to the information that must be 

disclosed or of any information that was 

not known at the time the contract was 

entered. The Department appreciates the 

burden such a requirement would place 

on air charter brokers and that some 

consumers may simply ignore requests 

for confirmation. Furthermore, such a 

requirement is likely not necessary 

since, as several commenters noted, the 

original signed contract may serve as 

confirmation that the air charter broker 

made, and that the consumer received, 

the required disclosures. The 

Department notes, however, that air 

charter brokers are free to obtain such 

confirmations as a method of guarding 

against claims that they did not make 

the disclosures. 

The Department has considered the 

arguments against applying the refund 

requirements of 14 CFR part 374 to air 

charter brokers. The Department 

nevertheless believes that these 

requirements are not overly burdensome 

on air charter brokers, as their crux is 

establishing a time frame in which 

refunds should be processed, and 

provide consumers with useful 

protections. The Department believes 

that these are important consumer 

protections. As such, the Department is 

adopting the proposed rule on refunds. 

C. Enumerated Unfair and Deceptive 

Practices (14 CFR 295.22 and 295.50) 

The NPRM: In the NPRM, the 

Department proposed to enumerate ten 

prohibited unfair and deceptive 

practices and unfair methods of 

competition by air charter brokers. First, 

air charter brokers may not misrepresent 

themselves as direct air carriers. 

Second, air charter brokers must not use 

their names and slogans in connection 

with the name of the direct air carrier 

in such a manner that may confuse 

consumers as to the status of the air 

charter broker. Third, air charter brokers 

must not misrepresent the service, type 

of aircraft, or itinerary. Fourth, air 

charter brokers must not misrepresent 

the qualifications of pilots or the safety 

record and certification of pilots, 

aircraft, and air carriers. Fifth, air 

charter brokers must not make 

misrepresentations regarding insurance. 

Sixth, air charter brokers must not 

misrepresent the cost of the air 

transportation. Seventh, air charter 

brokers must not misrepresent 

membership in or involvement with 

organizations that audit air charter 

brokers or direct air carriers. Eighth, air 

charter brokers must not represent that 

they possess a contract with a direct air 

carrier until they have received a 

binding commitment from the direct air 

carrier. Ninth, air charter brokers must 

not sell or contract for air transportation 

that they know cannot be legally 

performed by the entity that is to 

operate the air transportation. Tenth, air 

charter brokers must not misrepresent 

the requirements that must be met by 

charterers to qualify for charter flights. 

The Department solicited comments on 

which, if any, of these should be 

enumerated in the final rule. In 

addition, the Department asked the 

public to comment on a potential 

record-keeping requirement to ensure 

compliance with the proposed 

regulations. 

Comments: Members of the public 

expressed widely divergent views on 


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what practices, if any, should be 

enumerated as unfair and deceptive. 

Two commenters stated that DOT 

should enumerate only one unfair and 

deceptive practice and unfair method of 

competition: That air charter brokers 

must not misrepresent themselves as 

direct air carriers. A third commenter 

expressed a view along these lines, 

noting that DOT should merely continue 

its existing enforcement policy of 

finding an unfair or deceptive practice 

or unfair method of competition when 

an air charter broker misrepresents itself 

as a direct air carrier. A fourth mirrored 

these comments but also supported 

enumerating as unfair or deceptive the 

practice of telling consumers that the 

broker maintains a certain level of 

insurance that it does not, in fact, 

maintain. Three commenters supported 

all the proposed enumerated unfair and 

deceptive practices. Another commenter 

opposed this portion of the proposal in 

its entirety. In addition, FlexJet asked 

that the Department clarify that it is not 

unfair or deceptive to advertise a price 

that changes due to circumstances 

beyond the air charter broker’s control. 

The Department received input 

regarding a record retention 

requirement. CSI Aviation expressed 

support for a requirement, noting that 

pursuant to Internal Revenue Service 

requirements, records are maintained 

for seven years following the date of 

transportation. NATA proposed a twoyear retention requirement. The Air 

Charter Association voiced support for a 

retention requirement without 

proposing a time-frame. 

DOT Response: The Department is 

making changes to its proposed rule to 

harmonize language where appropriate 

with the text of the section enumerating 

prohibited unfair and deceptive 

practices by air taxis/commuter air 

carriers, 14 CFR 298.90. The significant 

amount of enforcement activity in this 

area has led the Department to find such 

enumeration necessary. In fact, the 

Department believes that codifying 

certain actions as unfair or deceptive 

will lower the amount of enforcement 

action necessary, as all air charter 

brokers will be fully aware of what 

behavior is prohibited. In turn, this will 

level the playing field for those air 

charter brokers that do not misrepresent 

themselves or any part of their services. 

In response to FlexJet’s query, the 

Department notes that the final rule 

requires that an air charter broker have 

a binding contract with a direct air 

carrier or direct foreign air carrier before 

representing such to the public. As a 

result, the largest portion of the charter 

transportation cost should already be 

established at the point where FlexJet’s 

question arises. The final rule already 

provides air charter brokers with 

flexibility in quoting total costs and 

DOT does not believe greater flexibility 

is needed, despite FlexJet’s request. 

The Department is choosing at this 

time not to require a specific record 

retention period, but may revisit this 

issue if it becomes clear that efforts to 

enforce this part are impeded by a lack 

of such a period, air charter brokers are 

evading their disclosure obligations to 

charterers, or charterers are otherwise 

being harmed. 

2. Air Taxis and Commuter Air Carriers 

A. Disclosures (14 CFR 298.80) 

The NPRM: In the NPRM, the 

Department proposed to amend 14 CFR 

part 298 to prohibit air taxis and 

commuter air carriers from soliciting or 

executing contracts for single entity 

charter air transportation to be 

performed by another carrier without 

first providing clear and conspicuous 

written disclosure to the person or 

entity that contracts for that air 

transportation of: (1) The corporate 

name of the direct air carrier in 

operational control of the aircraft and 

any other names in which the carrier 

holds itself out to the public (as 

recommended by the NTSB) (2) the 

capacity in which the air taxi is acting 

in contracting for the air transportation; 

(3) the existence of any corporate or preexisting business relationship with the 

direct air carrier that will be in 

operational control of the aircraft; (4) 

the make and model of the aircraft to be 

used; (5) the total cost of the air 

transportation, including carrier- and 

government-imposed fees and taxes; and 

(6) the existence of any fees and their 

amounts, if known, charged by third 

parties for which the charterer will be 

responsible for paying directly. In 

addition, should the operating carrier 

change, the Department proposed 

requiring that written notice be 

provided to the charter customer when 

the change becomes known. Should 

reasonable notice not be given, the 

Department proposed that the charter 

customer be entitled to a full refund. 

The Department sought comment on 

whether it should set a specific 

timeframe for such notice and whether 

it should require carriers to obtain 

confirmation of receipt of that notice 

and, if so, what type of confirmation. 

Comments: Of the three comments on 

this topic, those from NATA and NBAA 

generally supported the Department’s 

proposed disclosure requirements, 

albeit with some changes and 

clarifications. For example, both sought 

clarification of what type of ‘‘corporate 

or business relationship’’ must be 

disclosed and NBAA sought 

clarification on whether the parties 

could agree in writing to forgo certain 

disclosures. Furthermore, NATA 

suggested that the Department 

harmonize the disclosure requirements 

imposed on air taxi operators/commuter 

air carriers and on air charter brokers. 

NATA also commented that the 

Department should refine the 

requirement that air taxi operators and 

commuter air carriers disclose the total 

cost. As proposed, the regulation 

indicates that government-imposed 

taxes and fees must be disclosed only as 

they apply to the total cost of air 

transportation but not as they apply to 

any fees (e.g., landing fees and fuel) 

charged by third parties for which the 

charterer will be responsible for paying 

directly. In addition, NATA suggested 

that the Department change its ‘‘make 

and model’’ references to ‘‘type of 

aircraft’’ in order to use an industry 

standard term. 

Neither association advocated for a 

specified time frame in which 

disclosures must be made, noting that 

the fact-specific situations require a 

flexible ‘‘reasonable time’’ standard like 

that originally proposed by the 

Department. Moreover, neither 

advocated for a regulation requiring the 

confirmation of the receipt of the 

proposed disclosures. 

On the other hand, the comment filed 

jointly by Corporate Flight Management, 

Public Charters Inc., and Ultimate 

Jetcharters opposed all the Department’s 

proposed disclosure requirements. They 

asserted that the Department failed to 

provide evidence of objectionable 

practices by air taxis and commuter air 

carriers that would provide a rationale 

for the proposed rule, noting that the 

NTSB had advocated only the limited 

disclosure of the name of the operating 

carrier and the type of aircraft. In the 

absence of a demonstrated need for 

greater regulation, the commenters 

suggested that DOT allow market forces 

to work, particularly in this situation, 

where DOT has acknowledged that the 

consumers are sophisticated entities. 

Moreover, they asserted that the 

Department could rely on its existing 

enforcement mechanisms should 

problems arise. 

DOT Response: The Department is 

amending 14 CFR part 298 to require air 

taxis and commuter air carriers to make 

three disclosures and to make three 

more upon request. The Department 

appreciates the comments it received 

and has incorporated the suggestions of 

NATA and NBAA into the final rule. 

First, the Department harmonizes the 

regulatory language regarding 


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disclosures applicable to air taxi 

operators/commuter air carriers in 14 

CFR 298.80 with those applicable to air 

charter brokers in 14 CFR 295.24. The 

Department clarifies what type of 

‘‘corporate or business relationship 

between the air taxi operator or 

commuter air carrier and the direct air 

carrier’’ must be disclosed upon request. 

The Department adopts in part NBAA’s 

suggestion that the definition of a 

corporate or business relationship be 

further refined by adding language that 

the relationship must have a ‘‘bearing’’ 

on the transaction. The Department 

disagrees with NBAA’s suggestion that 

the rule indicate that parties may agree 

in writing to forgo certain disclosures 

because allowing parties to contract 

away these protections would severely 

limit the benefits of the rule. 

In addition, based on NATA’s 

suggestion, DOT is adding language to 

14 CFR 298.80(a)(5) to clarify that air 

taxi operators and commuter air carriers 

must disclose upon request any 

government-imposed taxes and fees 

levied on expenses collected by third 

parties (e.g., landing fees and fuel) and 

paid directly by the charterer. Further, 

the Department is not requiring the type 

of aircraft to be disclosed since it 

believes that information is already a 

part of most charter negotiations. 

The Department appreciates the 

positive feedback received regarding its 

‘‘reasonable time’’ standard for making 

the required disclosures and, having 

received no alternative suggestions, 

adopts that standard. As the comments 

noted, because each situation is factspecific, it would be difficult to enact a 

workable specific time frame for 

disclosures. The Department clarifies in 

the final rule that it is within a 

reasonable time of becoming available 

‘‘to the air or commuter air carrier.’’ For 

this same reason, the Department 

clarifies in the final rule that in an 

exigent circumstance particular to a 

passenger the required disclosures do 

not have to be made prior to the start of 

the air transportation. In addition, the 

Department is not adding a requirement 

that air taxi operators and commuter air 

carriers obtain written confirmation that 

the required disclosures were made and 

that charterers received notice of any 

changes to the information that must be 

disclosed or of any information that was 

not known at the time the contract was 

entered. The Department notes, 

however, that air taxi operators and 

commuter air carriers are free to obtain 

such confirmations as a method of 

guarding against claims that they did 

not make the disclosures. 

The Department thoroughly 

considered the comments of Corporate 

Flight Management, Public Charters 

Inc., and Ultimate Jetcharters. 

Nevertheless, DOT agrees with NTSB 

that disclosures are necessary to 

enhance consumer protection in charter 

air transportation. Furthermore, DOT 

also believes that there are significant 

benefits regarding additional disclosures 

to charterers when weighing their air 

transportation options to know the 

capacity in which the air taxi or 

commuter air carrier is acting in 

contracting for the air transportation, 

the existence of any corporate or 

business relationship between the air 

taxi or commuter air carrier and the 

direct air carrier that will be in 

operational control of the flight that 

bears on the selection of the direct air 

carrier, the type of aircraft to be used for 

the flight, the total cost of the air 

transportation, and the existence of any 

fees and their amounts that are collected 

by third parties that the charterer will be 

responsible for paying directly. The 

Department firmly believes that within 

this regulatory framework, the market 

will continue to work, allowing parties 

to freely contract with each other. In 

fact, these required disclosures, many of 

which are already made as good 

business practices and/or customer 

service gestures, will provide a more 

level playing field for all air taxis and 

commuter air carriers, thus contributing 

to the correction of any existing market 

failures. 

B. Enumerated Unfair and Deceptive 

Practices (14 CFR 298.90) 

The NPRM: The NPRM proposed to 

prohibit certain practices as unfair or 

deceptive or unfair methods of 

competition by air taxis and commuter 

air carriers. Specifically, these 

misrepresentations involved the entity 

in operational control of the aircraft, the 

quality of the aircraft involved, the 

schedule and itinerary, the insurance 

carried, the fares or charges levied, the 

presence of a contract for a specific air 

carrier or aircraft, and the legal 

impossibility of completing the specific 

flight. 

Comments: Only the NATA and 

NBAA comments addressed the 

Department’s proposal to enumerate for 

air taxis and commuter air carriers 

certain unfair and deceptive practices 

and unfair methods of competition. 

Both associations supported the 

proposal in its entirety. 

DOT Response: The Department is 

adopting the proposed 14 CFR 298.100 

and codifying it as 14 CFR 298.90. 

However, the Department is making 

changes to its proposed rule to 

harmonize language where appropriate 

with the text of the section enumerating 

prohibited unfair or deceptive practices 

by air charter brokers, 14 CFR 295.50. 

This includes enumerating 

misrepresentations as to the 

qualifications and the safety records of 

pilots, aircraft, and air carriers; 

membership in, involvement with, and 

standards set by auditing organizations; 

the requirements that charterers must 

meet to qualify for charter flights; and 

the use of names, trade names or 

slogans. The Department already 

considers such misrepresentations by 

air carriers, including air taxis and 

commuter air carriers, to be prohibited 

under 49 U.S.C. 41712. The Department 

believes that codifying these and other 

actions as unfair or deceptive will 

forestall enforcement action as all air 

taxis and commuter air carriers will be 

fully aware of what behavior is 

prohibited. In addition, the second and 

third enumerated unfair or deceptive 

practices contained significant overlap. 

Thus, these subsections are changed in 

the final rule so that each is a distinct 

unfair or deceptive practice or unfair 

method of competition. 

3. Air Ambulance Services 

The NPRM: Since 1983, the 

Department has authorized entities that 

arrange air ambulance services as 

indirect air carriers to engage in the sale 

of air transportation through a blanket 

exemption granted by the CAB in Order 

81–1–36, 99 C.A.B. 801 (1983). In the 

NPRM, the Department proposed to 

codify that exemption. In addition, 

based upon the number of enforcement 

actions taken for violations of this 

exemption authority, as well as the 

licensing requirements of 49 U.S.C. 

41101 and the statutory prohibition on 

unfair and deceptive practices and 

unfair methods of competition, 49 U.S.C 

41712, the Department proposed in the 

NPRM to apply to indirect air carrier air 

ambulances the same enumerated 

prohibited practices proposed for air 

charter brokers in § 295.50, but not to 

apply to indirect air carrier air 

ambulances the disclosure requirements 

applicable to air charter brokers. DOT 

invited comments on this proposal in 

general, as well as comments regarding 

whether any of the specific provisions 

in section 295.24 should apply to 

indirect air carrier air ambulances. 

Comments: All commenters expressed 

general support for the codification of 

the Department’s long-standing 

exemption. Air Methods addressed the 

application of the enumerated 

prohibited practices in 295.50 to 

indirect air carrier air ambulances by 

proposing that an indirect air medical 

program name or logo on an aircraft not 

be considered misleading, so long as the 


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Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations 46873 

1U.S. Department of Transportation (DOT), Office 

of the Secretary (OST). ‘‘Increasing Charter Air 

Transportation Options. Final Rule. Regulatory 

Impact Analysis (RIA).’’ June 2018. Available in 

Docket DOT–OST–2007–27057 at https://

www.regulations.gov. 

name of the direct air carrier is 

displayed in accordance with 14 CFR 

119.9(b). Many commenters expressed 

opposition to applying to air ambulance 

services the disclosure requirements 

applied to air charter brokers. Among 

the reasons given for excluding air 

ambulance services from these 

requirements, commenters cited a lack 

of passenger need and the possible 

delayed provision of care that could 

result. The Air Charter Association and 

the Association of Air Medical Services, 

on the other hand, disagreed and 

instead commented that air ambulances 

should be subjected to the same 

disclosure requirements as air charter 

brokers. Moreover, the latter group 

commented that it would be beneficial 

for air charter brokers to disclose their 

medical training level to consumers so 

that those consumers can better judge 

the broker’s ability to determine the 

appropriateness of various aspects of 

flight, e.g., aircraft type, medical 

staffing, pressurization, etc. 

DOT Response: The Department 

appreciates the general support 

expressed for the codification of its 

long-standing exemption, but chooses 

not to do so at this time. The 

Department will be studying this area 

further, including reviewing air 

ambulance complaints to determine 

what, if any, disclosure or other 

consumer protection requirements are 

appropriate in this area for direct and 

indirect air carrier air ambulances. Our 

decision here does not in any way alter 

the authority for entities that arrange air 

ambulance services as indirect air 

carriers to engage in the sale of air 

transportation under the blanket 

exemption granted by the CAB in Order 

81–1–36, 99 C.A.B. 801 (1983). 

4. Air Services Provided Under Contract 

With the Federal Government 

The NPRM: The Department proposed 

to codify the longstanding view of its 

Office of Aviation Enforcement and 

Proceedings that contracts with the 

Federal Government arranged under a 

GSA Schedule are in fact in common 

carriage and subject to DOT jurisdiction. 

Comments: CSI Aviation (CSI), the 

sole commenter on this portion of the 

NPRM, disagreed with the Department’s 

proposal in its entirety. CSI stated that 

DOT failed to explain why air charter 

brokers operating under a GSA 

Schedule required economic authority 

from the Department. To the contrary, 

CSI argued that air transportation 

services conducted pursuant to the GSA 

Schedules were not common carriage 

but were, in fact, private carriage. In 

addition, CSI commented that because 

the GSA Schedules are governed by the 

Federal Acquisition Regulations, CSI 

(and similarly situated parties) are 

already subject to a consumer protection 

regime far more comprehensive that the 

regime proposed by DOT. For example, 

the Federal Acquisition Regulations 

subject violators to liquidated damages, 

nonpayment, and even criminal 

prosecution. Moreover, CSI asserted that 

the DOT proposal would interfere with 

GSA’s contracting practices. 

DOT Response: The Department is 

deferring action on this proposal as it is 

not clear that additional action is 

necessary. First, the dearth of feedback 

on this portion of the NPRM makes it 

more difficult for the Department to 

consider the various viewpoints of all 

stakeholders; the views of the only 

stakeholder to comment had previously 

been made clear in Federal court. 

Second, the paucity of feedback 

received from stakeholders in the years 

following the litigation that prompted 

the proposed codification indicates that 

the existing consumer protection regime 

may suffice at this time as asserted by 

CSI. Third, by having only imperfect 

information available to it, the 

Department risks taking action that may 

have unintended consequences. The 

Department stresses, however, that it 

may revisit this issue in the future. It 

may, for example, receive more input 

from stakeholders or see that changes in 

Federal Government procurement 

practices and rules have changed the 

level of protection afforded consumers. 

Regulatory Analyses and Notices 

A. Executive Order 12866 (Regulatory 

Planning and Review) and DOT 

Regulatory Policies and Procedures 

This proposed rule is not a significant 

regulatory action under section 3(f) of 

E.O. 12866 (58 FR 51735, October 4, 

1993), Regulatory Planning and Review, 

as supplemented by E.O. 13563 (76 FR 

3821, January 21, 2011), Improving 

Regulation and Regulatory Review. 

Accordingly, the Office of Management 

and Budget (OMB) has not reviewed it 

under that Order. It is also not 

significant within the meaning of DOT 

regulatory policies and procedures 

(DOT Order 2100.5 dated May 22, 1980; 

44 FR 11034 (February 26, 1979)). 

The final rule is in part an enabling 

regulatory action, which would 

eliminate existing regulatory barriers by 

recognizing air charter brokers as a new 

class of indirect air carrier, and would 

allow air charter brokers as principals to 

provide single entity charter air 

transportation of passengers. By 

removing current regulatory barriers to 

the sale of single entity charters by air 

charter brokers, the rule is expected to 

result in a reduction in the opportunity 

costs currently incurred by those air 

charter brokers that would prefer to act 

as a principal, thereby resulting in a cost 

savings for these air charter brokers. The 

magnitude of these potential costs 

savings cannot be estimated, in part 

because under the rule the decision by 

an air charter broker to act as a principal 

rather than as an agent is discretionary. 

Therefore, the number of air charter 

brokers affected by the enabling aspects 

of rule and that may experience a cost 

savings cannot be estimated. 

The final rule establishes 

requirements for actions and disclosures 

to be made by air charter brokers that 

result in more accurate and transparent 

information about brokered air 

transportation transactions being 

present in the marketplace for 

charterers. This includes disclosures 

that are to be made by air taxi operators 

that may be selling air charter flights 

that are operated by some other direct 

air carrier. The total annual costs of the 

information disclosure provisions of the 

final rule are estimated to range from 

$1.3 million to $2.7 million, with a midrange estimate of $2.0 million expressed 

in 2017 dollars. 

The Department believes that the final 

rule will result in benefits from the 

information disclosure requirements 

and from the enumeration of 

prohibitions on specific types of unfair 

or deceptive practices by air charter 

brokers, air taxis, and commuter air 

carriers. These benefits cannot be 

quantified however. 

Additional details regarding the cost 

savings, costs, and benefits of the final 

rule can be found in the Regulatory 

Impact Analysis (RIA) for the final rule 

which is available in the Docket for this 

rulemaking.1

B. Executive Order 13771 (Reducing 

Regulation and Controlling Regulatory 

Costs) 

This rule is not an E.O. 13771 

regulatory action because this rule is not 

significant under E.O. 12866. 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act of 1980 

(RFA) (5 U.S.C. 601 et seq.) requires 

Federal agencies to consider the effects 

of their regulatory actions on small 

businesses and other small entities, and 

to minimize any significant economic 

impact. When an agency issues a 

rulemaking proposal, the RFA requires 


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2U.S. Department of Transportation (DOT), Office 

of the Secretary (OST). ‘‘Enhanced Consumer 

Protections for Charter Air Transportation. Notice of 

Proposed Rulemaking.’’ 78 FR 59880. September 30, 

2013. Available at: https://www.gpo.gov/fdsys/pkg/ 

FR-2013-09-30/pdf/2013-23142.pdf (accessed May 

21, 2018). 

3Regulatory Impact Analysis for Enhanced 

Consumer Protections for Charter Air 

Transportation. Notice of Proposed Rulemaking. 

Available at: https://www.regulations.gov/content

Streamer?documentId=DOT-OST-2007-27057- 

0028&attachmentNumber=1&contentType=pdf 

(accessed May 21, 2018). 

the agency to ‘‘prepare and make 

available for public comment an initial 

regulatory flexibility analysis’’ which 

will ‘‘describe the impact of the 

proposed rule on small entities’’ (5 

U.S.C. 603(a)). Section 605 of the RFA 

allows an agency to certify a rule, in lieu 

of preparing an analysis, if the proposed 

rulemaking is not expected to have a 

significant economic impact on a 

substantial number of small entities. 

In the NPRM (78 FR 59880), in lieu 

of preparing an Initial Regulatory 

Flexibility Analysis under section 

603(a) of the RFA to assess the impact 

of the rule, the Department performed a 

certification analysis under section 

605(b) of the RFA and certified that the 

rule will not have a significant 

economic impact on a substantial 

number of small entities.2 3 No 

comments were received regarding this 

certification or on the threshold 

economic analysis and its underlying 

assumptions that were presented in the 

NPRM. 

The threshold economic analysis that 

was performed for the certification of 

the proposed rule under section 605(b) 

of the RFA determined that although a 

substantial number of air charter brokers 

would likely be considered small 

entities that would be affected by the 

rule, the economic impact on these 

small entities would not constitute a 

significant economic impact on these 

small entities relative to either gross 

revenues or profit. The primary changes 

made to the final rule from the proposed 

rule include the elimination of 

provisions that in the proposed rule 

would have applied to air ambulance 

services, and to certain air 

transportation services performed under 

contract to the Federal government. The 

elimination of these provisions does not 

substantively alter the economic 

analysis and certification of the rule 

under the RFA as compared to that 

performed for at the proposed rule stage, 

other than to remove one class of 

regulated entity, air ambulance services, 

that under the final rule are no longer 

affected and would no longer be subject 

to disclosure requirements or other 

provisions. The remaining provisions of 

the final rule still affect the same classes 

of regulated entities including air 

charter brokers, air taxis, and commuter 

air carriers, and affect these entities in 

essentially the same manner and to the 

same extent in terms of the costs and 

benefits of the rule. 

Accordingly, the Secretary of 

Transportation certifies that this final 

rule will not have a significant 

economic impact on a substantial 

number of small entities. 

D. Executive Order 13132 (Federalism) 

This final rule has been analyzed in 

accordance with the principles and 

criteria contained in Executive Order 

13132 (‘‘Federalism’’). This final rule 

does not include any provision that: (1) 

Has substantial direct effects on the 

States, the relationship between the 

national government and the States, or 

the distribution of power and 

responsibility among the various levels 

of government; (2) imposes substantial 

direct compliance costs on State and 

local governments; or (3) preempts State 

law. States are already preempted from 

regulating in this area by the Airline 

Deregulation Act, 49 U.S.C. 41713. 

Therefore, the consultation and funding 

requirements of Executive Order 13132 

do not apply. 

E. Executive Order 13084 

This final rule has been analyzed in 

accordance with the principles and 

criteria contained in Executive Order 

13084 (‘‘Consultation and Coordination 

with Indian Tribal Governments’’). 

Because this final rule does not 

significantly or uniquely affect the 

communities of the Indian Tribal 

governments or impose substantial 

direct compliance costs on them, the 

funding and consultation requirements 

of Executive Order 13084 do not apply. 

F. Paperwork Reduction Act 

This rule adopts new information 

collection requirements subject to the 

Paperwork Reduction Act of 1995 (Pub. 

L. 104–13, 49 U.S.C. 3501 et seq.). (PRA) 

The Department will publish a separate 

notice in the Federal Register inviting 

the Office of Management and Budget 

(OMB), the general public, and other 

Federal agencies to comment on the 

new and revised information collection 

requirements contained in this 

document. As prescribed by the PRA, 

the requirements will not go into effect 

until OMB has approved them and the 

Department has published a notice 

announcing the effective date of the 

information collection requirements. 

G. Unfunded Mandates Reform Act 

The Department has determined that 

the requirements of Title II of the 

Unfunded Mandates Reform Act of 1995 

do not apply to this rule. 

H. National Environmental Policy Act 

The DOT has analyzed the 

environmental impacts of this action 

pursuant to the National Environmental 

Policy Act of 1969 (NEPA) (42 U.S.C. 

4321 et seq.) and has determined that it 

is categorically excluded pursuant to 

DOT Order 5610.1C, Procedures for 

Considering Environmental Impacts (44 

FR 56420, Oct. 1, 1979). Categorical 

exclusions are actions identified in an 

agency’s NEPA implementing 

procedures that do not normally have a 

significant impact on the environment 

and therefore do not require either an 

environmental assessment (EA) or 

environmental impact statement (EIS). 

See 40 CFR 1508.4. In analyzing the 

applicability of a categorical exclusion, 

the agency must also consider whether 

extraordinary circumstances are present 

that would warrant the preparation of 

an EA or EIS. Id. Paragraph 3.c.5 of DOT 

Order 5610.1C incorporates by reference 

the categorical exclusions for all DOT 

Operating Administrations. This action 

is covered by the categorical exclusion 

listed in the Federal Highway 

Administration’s implementing 

procedures, ‘‘[p]romulgation of rules, 

regulations, and directives.’’ 23 CFR 

771.117(c)(20). The purpose of this 

rulemaking is to eliminate a regulatory 

barrier to the sale of charter air 

transportation while providing 

consumers with information to make 

informed purchasing decisions. The 

agency does not anticipate any 

environmental impacts, and there are no 

extraordinary circumstances present in 

connection with this rulemaking. 

Issued this 20th day of August 2018, in 

Washington, DC, under authority delegated 

in 49 CFR 1.27(n). 

Steven G. Bradbury, 

General Counsel. 

For the reasons set forth above, 14 

CFR chapter II is amended as follows: 

■ 1. Add Part 295 to read as follows: 

PART 295—AIR CHARTER BROKERS 

Subpart A—General 

Sec. 

295.1 Purpose. 

295.3 Applicability. 

295.5 Definitions. 

295.7 Agency relationships. 

Subpart B—Exemption Authority 

295.10 Grant of economic authority; 

exemption from the Statute. 


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Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations 46875 

295.12 Suspension or revocation of 

exemption authority. 

Subpart C—Consumer Protection 

295.20 Use of duly authorized direct air 

carriers. 

295.22 Prohibited unfair or deceptive 

practices or unfair methods of 

competition. 

295.23 Advertising. 

295.24 Disclosures. 

295.26 Refunds. 

Subpart D—Violations 

295.50 Enumerated unfair or deceptive 

practices or unfair methods of 

competition. 

295.52 Enforcement. 

Authority: 49 U.S.C. Chapters 401, 411, 

413, and 417. 

Subpart A—General 

§ 295.1 Purpose. 

Air charter brokers, defined as an 

indirect air carrier, foreign indirect air 

carrier or a bona fide agent, provide 

indirect air transportation of passengers 

on single entity charters aboard large 

and small aircraft. This part grants 

exemptions to such air charter brokers 

from certain provisions of Subtitle VII of 

Title 49 of the United States Code 

(Transportation), and establishes rules, 

including consumer protection 

provisions, for the provision of such air 

transportation by air charter brokers. 

§ 295.3 Applicability. 

This part applies to any person or 

entity acting as an air charter broker as 

defined in this part with respect to 

single entity charter air transportation 

that the air charter broker, as an indirect 

air carrier, foreign indirect air carrier, or 

a bona fide agent, holds out, sells or 

undertakes to arrange aboard large and 

small aircraft. 

§ 295.5 Definitions. 

For the purposes of this part: 

(a) Air transportation means interstate 

or foreign air transportation, as defined 

in 49 U.S.C. 40102(a)(5), 40102(a)(23), 

and 40102(a)(25). 

(b) Air charter broker means a person 

or entity that, as an indirect air carrier, 

foreign indirect air carrier, or a bona 

fide agent, holds out, sells, or arranges 

single entity charter air transportation 

using a direct air carrier. 

(c) Bona fide agent means a person or 

entity that acts as an agent on behalf of 

a single entity charterer seeking air 

transportation or a direct air carrier 

seeking to provide single entity charter 

air transportation, when such charterer 

or direct air carrier, as principal, has 

appointed or authorized such agent to 

act on the principal’s behalf. 

(d) Charterer means the person or 

entity that contracts with an air charter 

broker, direct air carrier, or foreign 

direct air carrier, for the transportation 

of the passengers flown on a charter 

flight. 

(e) Charter air transportation means 

charter flights in air transportation 

authorized under Part A of Subtitle VII 

of Title 49 of the United States Code. 

(f) Direct air carrier and foreign direct 

air carrier mean a U.S. or foreign air 

carrier that provides or offers to provide 

air transportation and that has control 

over the operational functions 

performed in providing that 

transportation. 

(g) Indirect air carrier and foreign 

indirect air carrier mean a person or 

entity that, as a principal, holds out, 

sells, or arranges air transportation and 

separately contracts with direct air 

carriers and/or foreign direct air 

carriers. 

(h) Single entity charter means a 

charter for the entire capacity of the 

aircraft, the cost of which is borne by 

the charterer and not directly or 

indirectly by individual passengers, 

except when individual passengers selfaggregate to form a single entity for 

flights to be operated using small 

aircraft. 

(i) Statute means Subtitle VII of Title 

49 of the United States Code 

(Transportation). 

(j) Large aircraft means any aircraft 

originally designed to have a maximum 

passenger capacity of more than 60 seats 

or a maximum payload capacity of more 

than 18,000 pounds. 

(k) Small aircraft means any aircraft 

originally designed to have a maximum 

passenger capacity of 60 seats or fewer 

or a maximum payload capacity of 

18,000 pounds or less. 

§ 295.7 Agency relationships. 

An air charter broker acting as an 

indirect air carrier or foreign indirect air 

carrier may choose to act as a bona fide 

agent in individual cases where a 

charterer, direct air carrier, or foreign 

direct air carrier has expressly 

authorized such agency relationship. 

Subpart B—Exemption Authority 

§ 295.10 Grant of economic authority; 

exemption from the statute. 

To the extent necessary to permit air 

charter brokers, acting as indirect air 

carriers or foreign indirect air carriers, 

to hold out, sell, and undertake to 

arrange single entity charter air 

transportation, such air charter brokers 

are exempted from the following 

provisions of Subtitle VII of Title 49 of 

the United States Code, except for the 

provisions noted, only if and so long as 

they comply with the provisions and the 

conditions imposed by this part: 49 

U.S.C. 41101–41113, 49 U.S.C. 41301– 

41313, and 49 U.S.C. 41501–41511. Air 

charter brokers are not exempt from the 

following provision: 49 U.S.C. 41310 

(nondiscrimination) with respect to 

foreign air transportation. 

§ 295.12 Suspension or revocation of 

exemption authority. 

The Department reserves the power to 

alter, suspend, or revoke the exemption 

authority of any air charter broker acting 

as an indirect air carrier, without a 

hearing, if it finds that such action is in 

the public interest or is otherwise 

necessary to protect the traveling public. 

Subpart C—Consumer Protection 

§ 295.20 Use of duly authorized direct air 

carriers. 

Air charter brokers are not authorized 

under this part to hold out, sell, or 

otherwise arrange charter air 

transportation to be operated by a 

person or entity that does not hold the 

requisite form of economic authority 

from the Department and appropriate 

safety authority from the Federal 

Aviation Administration and, if 

applicable, a foreign safety authority. 

Air charter brokers are not authorized 

under this part to hold out, sell, or 

arrange air transportation to be 

performed by a direct air carrier or 

direct foreign air carrier that the direct 

carrier is not authorized in its own right 

to hold out, sell, or operate. Only direct 

air carriers that are citizens of the 

United States as defined in 49 U.S.C. 

40102(a)(15) may provide direct air 

transportation operations in interstate or 

intrastate air transportation. 

§ 295.22 Prohibited unfair or deceptive 

practices or unfair methods of competition. 

An air charter broker shall not engage 

in any unfair or deceptive practice or 

unfair method of competition. 

§ 295.23 Advertising. 

(a) All solicitation materials and 

advertisements, including internet web 

pages, published or caused to be 

published by air charter brokers shall 

clearly and conspicuously state that the 

air charter broker is an air charter 

broker, and that it is not a direct air 

carrier or a direct foreign air carrier in 

operational control of aircraft, and that 

the air service advertised shall be 

provided by a properly licensed direct 

air carrier or direct foreign air carrier. 

(b) Air charter brokers may display 

their name and logo on aircraft provided 

the name of the direct air carrier is 

displayed prominently and clearly on 

the aircraft and consumers are not 

otherwise misled into thinking that the 


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air charter broker is a direct air carrier 

or direct foreign air carrier. 

§ 295.24 Disclosures. 

(a) Before entering a contract for a 

specific flight or series of flights with 

charterers, air charter brokers must 

disclose to the charterer the information 

in paragraphs (a)(1),(2), and (6) of this 

section. Before entering a contract for a 

specific flight or series of flights with 

charterers, air charter brokers must, 

upon request of the charterer, disclose 

to the charterer the information in 

paragraphs (a)(3), (4), and (5) of this 

section. The six disclosures may be 

accomplished through electronic 

transmissions. 

(1) The corporate name of the direct 

air carrier or direct foreign air carrier in 

operational control of the aircraft on 

which the air transportation is to be 

performed and any other names in 

which that direct carrier holds itself out 

to the public. 

(2) The capacity in which the air 

charter broker is acting in contracting 

for the air transportation, i.e., as an 

indirect air carrier, indirect foreign air 

carrier, as an agent of the charterer, or 

as an agent of the direct air carrier or 

direct foreign air carrier that will be in 

operational control of the flight. 

(3) If the air charter broker is acting 

as the agent of the charterer, the air 

charter broker must disclose the 

existence of any corporate or business 

relationship, including a preexisting 

contract, between the air charter broker 

and the direct air carrier or direct 

foreign air carrier that will be in 

operational control of the flight that may 

have a bearing on the air charter 

broker’s selection of the direct carrier 

that will be in operational control of the 

flight. 

(4) The total cost of the air 

transportation paid by the charterer to 

or through the air charter broker, 

including any air charter broker or 

carrier-imposed fees or governmentimposed taxes and fees. Specific 

individual fees, taxes, or costs may, but 

are not required to be itemized. 

(5) The existence of any fees and their 

amounts collected by third-parties, if 

known (or a good faith estimate if not 

known), including fuel, landing fees, 

and aircraft parking or hangar fees, for 

which the charterer will be responsible 

for paying directly. 

(6) The existence or absence of 

liability insurance held by the air 

charter broker covering the charterer 

and passengers and property on the 

charter flight, and the monetary limits of 

any such insurance. 

(b) If any of the information in 

paragraph (a) of this section that is 

required to be disclosed to the charterer 

or requested by the charterer to be 

disclosed is not known at the time the 

contract is entered into or changes 

thereafter, air charter brokers must 

provide the information to the charterer 

within a reasonable time after such 

information becomes available to the air 

charter broker, such that the charterer 

has enough time to make an informed 

decision as to whether to accept the 

additional information or accept the 

change. 

(c) If the information in paragraph (a) 

of this section that is required to be 

disclosed to the charterer or requested 

by the charterer to be disclosed is not 

provided to the charterer within a 

reasonable time after such information 

becomes available to the air charter 

broker, air charter brokers must provide 

the charterer with the opportunity to 

cancel the contract for charter air 

transportation, including any services in 

connection with such contract, and 

receive a full refund of any monies paid 

for the charter air transportation and 

services. 

(d) In all circumstances, air charter 

brokers must disclose prior to the start 

of the air transportation the information 

in paragraph (a) of this section that is 

required to be disclosed or that the 

charterer has requested to be disclosed. 

(e) If the information in paragraph (a) 

of this section that is required to be 

disclosed to the charterer or requested 

by the charterer to be disclosed changes 

after the air transportation covered by 

the contract has begun, air charter 

brokers must provide information 

regarding any such changes to the 

charterer within a reasonable time after 

such information becomes available to 

the air charter broker. 

(f) If the changes in information 

described in paragraph (e) of this 

section are not provided to the charterer 

within a reasonable time after becoming 

available to the air charter broker, air 

charter brokers must provide the 

charterer with the opportunity to cancel 

the remaining portion of the contract for 

charter air transportation, including any 

services paid in connection with such 

contract, and receive a full refund of any 

monies paid for the charter air 

transportation and services not yet 

provided. 

§ 295.26 Refunds. 

Air charter brokers must make prompt 

refunds of all monies paid for charter air 

transportation when such transportation 

cannot be performed or when such 

refunds are otherwise due, as required 

by 14 CFR 374.3 and 12 CFR part 226 

for credit card purchases, and within 20 

days after receiving a complete refund 

request for cash and check purchases. 

Subpart D—Violations 

§ 295.50 Enumerated unfair or deceptive 

practices or unfair methods of competition. 

(a) Violations of this Part shall be 

considered to constitute unfair or 

deceptive practices or unfair methods of 

competition in violation of 49 U.S.C. 

41712. 

(b) In addition to paragraph (a) of this 

section, the following enumerated 

practices, among others, by an air 

charter broker are unfair or deceptive 

practices or unfair methods of 

competition in violation of 49 U.S.C. 

41712: 

(1) Misrepresentations that may 

induce members of the public to 

reasonably believe that the air charter 

broker is a direct air carrier or direct 

foreign air carrier when that is not the 

case. 

(2) Misrepresentations as to the 

quality or kind of service or type of 

aircraft. 

(3) Misrepresentations as to the time 

of departure or arrival, points served, 

route to be flown, stops to be made, or 

total trip-time from point of departure to 

destination. 

(4) Misrepresentations as to the 

qualifications of pilots or safety record 

or certification of pilots, aircraft, or air 

carriers. 

(5) Misrepresentations that passengers 

are directly insured when they are not 

so insured. For example, where the only 

insurance in force is that protecting the 

direct air carrier or air charter broker in 

event of liability. 

(6) Misrepresentations as to fares or 

charges for air transportation or services 

in connection therewith. 

(7) Misrepresentations as to 

membership in or involvement with an 

organization that audits air charter 

brokers, direct air carriers, or direct 

foreign air carriers, or that the air 

charter broker or any direct carriers to 

be used for a particular flight meets a 

standard set by an auditing 

organization. 

(8) Representing that a contract for a 

specified direct air carrier, direct foreign 

air carrier, aircraft, flight, or time has 

been arranged without a binding 

commitment with a direct air carrier or 

direct foreign air carrier for the 

furnishing of such transportation as 

represented. 

(9) Selling or contracting for air 

transportation while knowing or having 

reason to know or believe that such air 

transportation cannot be legally 

performed by the direct air carrier or 

foreign direct air carrier that is to 

perform the air transportation. 


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(10) Misrepresentations as to the 

requirements that must be met by 

charterers to qualify for charter flights. 

(11) Using or displaying or permitting 

or suffering to be used or displayed the 

name, trade name, slogan or any 

abbreviation thereof, of the air charter 

broker in advertisements, on or in 

places of business, or on or in aircraft 

or any other place in connection with 

the name of an air carrier or foreign air 

carrier or with services in connection 

with air transportation, in such manner 

that it may mislead or confuse potential 

consumers with respect to the status of 

the air charter broker. 

§ 295.52 Enforcement. 

In case of any violation of any of the 

provisions of the Statute, or of this part, 

or any other rule, regulation, or order 

issued under the Statute, the violator 

may be subject to a proceeding under 49 

U.S.C. 46101 before the Department, or 

49 U.S.C. 46106–46108 before a U.S. 

District Court, as the case may be, to 

compel compliance. The violator may 

also be subject to civil penalties under 

the provisions of 49 U.S.C. 46301, or 

other lawful sanctions, including 

revocation of the exemption authority 

granted in this part. In the case of a 

willful violation, the violator may be 

subject to criminal penalties under the 

provisions of 49 U.S.C. 46316. 

PART 298—EXEMPTIONS FOR AIR 

TAXI AND COMMUTER AIR CARRIER 

OPERATIONS 

■ 2. The authority citation for Part 298 

is revised to read as follows: 

Authority: 49 U.S.C. 329 and chapters 401, 

411, and 417. 

■ 3. Revise § 298.80 to read as follows: 

§ 298.80 Disclosures. 

(a) Before entering a contract for a 

specific flight or series of flights with 

charterers, air taxi operators and 

commuter air carriers must disclose to 

the charterer the information in 

paragraphs (a)(1) and (2) of this section. 

Before entering a contract for a specific 

flight or series of flights with charterers, 

air taxi operators and commuter air 

carriers must, upon request of the 

charterer, disclose to the charterer the 

information in paragraphs (a)(3), (4), 

and (5) of this section. The disclosures 

may be accomplished through electronic 

transmissions. 

(1) That the flight will be performed 

by another direct air carrier or direct 

foreign air carrier if that is the case. The 

corporate name of the direct air carrier 

or direct foreign air carrier in 

operational control of the aircraft on 

which the air transportation is to be 

performed and any other names in 

which that direct carrier holds itself out 

to the public. 

(2) If the flight is to be performed by 

another direct air carrier or direct 

foreign air carrier, the capacity in which 

the air taxi operator or commuter air 

carrier is acting in contracting for the air 

transportation, i.e., as a principal, as an 

agent of the charterer, or as an agent of 

the direct air carrier that will be in 

operational control of the flight. 

(3) If the flight is to be performed by 

another direct air carrier or foreign 

direct air carrier and the air taxi 

operator or commuter air carrier is 

acting as the agent of the charterer, the 

air taxi operator or commuter air carrier 

must disclose the existence of any 

corporate or business relationship, 

including a preexisting contract, 

between the air taxi operator or 

commuter air carrier and the direct 

carrier that will be in operational 

control of the flight that may have a 

bearing on the air taxi operator’s or 

commuter air carrier’s selection of the 

direct carrier that will be in operational 

control of the flight. 

(4) The total cost of the air 

transportation paid by the charterer to 

or through the air taxi operator or 

commuter air carrier, including any 

carrier-imposed fees or governmentimposed taxes and fees. Specific 

individual fees, taxes, or costs may, but 

are not required to be itemized. 

(5) The existence of any fees and their 

amounts collected by third parties, if 

known (or a good faith estimate if not 

known), including fuel, landing fees, 

and aircraft parking or hangar fees for 

which the charterer will be responsible 

for paying directly. 

(b) If any of the information in 

paragraph (a) of this section that is 

required to be disclosed to the charterer 

or requested by the charterer to be 

disclosed is not known at the time the 

contract is entered into or changes 

thereafter, air taxi operators and 

commuter air carriers must provide the 

information to the charterer within a 

reasonable time after such information 

becomes available to the air taxi 

operator or commuter air carrier, such 

that the charterer has enough time to 

make an informed decision as to 

whether to accept the additional 

information or accept the change. 

(c) If the information in paragraph (a) 

of this section that is required to be 

disclosed to the charterer or requested 

by the charterer to be disclosed is not 

provided to the charterer within a 

reasonable time after such information 

becomes available to the air taxi 

operator or commuter air carrier, air taxi 

operators and commuter air carriers 

must provide the charterer with the 

opportunity to cancel the contract for air 

transportation, including any services in 

connection with such contract, and 

receive a full refund of any monies paid 

for the charter air transportation and 

services. 

(d) Except in exigent circumstances 

particular to a passenger, air taxi 

operators and commuter air carriers 

must disclose prior to the start of the air 

transportation the information in 

paragraph (a) of this section that is 

required or requested to be disclosed. 

(e) If the information in paragraph (a) 

of this section that is required to be 

disclosed to the charterer or requested 

by the charterer to be disclosed changes 

after the air transportation covered by 

the contract has begun, air taxi operators 

and commuter air carriers must provide 

information regarding any such changes 

to the charterer within a reasonable time 

after such information becomes 

available to the air taxi operator or 

commuter air carrier. 

(f) If the changes in information 

described in paragraph (e) of this 

section are not provided to the charterer 

within a reasonable time after becoming 

available to the air taxi operator or 

commuter air carrier, air taxi operators 

and commuter air carriers must provide 

the charterer with the opportunity to 

cancel the remaining portion of the 

contract for charter air transportation, 

including any services paid for in 

connection with such contract, and 

receive a full refund of any monies paid 

for the charter air transportation and 

services not yet provided. 

■ 4. Add Subpart I, consisting of 

§§ 298.90 and 298.92, to read as follows: 

Subpart I—Violations 

§ 298.90 Prohibited unfair or deceptive 

practices or unfair methods of competition. 

(a) Violations of this Part shall be 

considered to constitute unfair or 

deceptive practices or unfair methods of 

competition in violation of 49 U.S.C. 

41712. 

(b) In addition to paragraph (a) of this 

section, the following enumerated 

practices, among others, by an air taxi 

operator or commuter air carrier are 

unfair or deceptive practices or unfair 

methods of competition in violation of 

49 U.S.C. 41712: 

(1) Misrepresentations that may 

induce members of the public to 

reasonably believe that the air taxi 

operator or commuter air carrier will be, 

or is, in operational control of a flight 

when that is not the case. 

(2) Misrepresentations as to the 

quality or kind of service or type of 

aircraft. 


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46878 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Rules and Regulations 

(3) Misrepresentations as to the time 

of departure or arrival, points served, 

route to be flown, stops to be made, or 

total trip-time from point of departure to 

destination. 

(4) Misrepresentations as to the 

qualifications of pilots or safety record 

or certification of pilots, aircraft, or air 

carriers. 

(5) Misrepresentations that passengers 

are directly insured when they are not 

so insured. For example, where the only 

insurance in force is that protecting the 

air taxi operator or commuter air carrier 

in the event of liability. 

(6) Misrepresentations as to fares or 

charges for air transportation or services 

in connection therewith. 

(7) Misrepresentations as to 

membership in or involvement with an 

organization that audits direct air 

carriers or that the direct air carrier to 

be used for a flight meets a standard set 

by an auditing organization. 

(8) Representing that a contract for a 

specified direct air carrier, aircraft, 

flight, or time has been arranged 

without a binding commitment with a 

direct air carrier for the furnishing of 

such transportation as represented. 

(9) Selling or contracting for air 

transportation while knowing or having 

reason to know or believe that such air 

transportation cannot be legally 

performed by the direct air carrier or 

foreign direct air carrier that is to 

perform the air transportation. 

(10) Misrepresentations as to the 

requirements that must be met by 

charterers in order to qualify for charter 

flights. 

(11) Using or displaying or permitting 

or suffering to be used or displayed the 

name, tradename, slogan or any 

abbreviation thereof, of an air charter 

broker in advertisements, on or in 

places of business, or on or in aircraft 

or any other place in connection with 

the name of the air taxi or commuter air 

carrier in such manner that it may 

mislead or confuse potential consumers 

with respect to the status of the air 

charter broker. 

§ 298.92 Enforcement. 

In case of any violation of the 

provisions of the Statute, or this part, or 

any other rule, regulation, or order 

issued under the Statute, the violator 

may be subject to a proceeding pursuant 

to section 46101 of the Statute before 

the Department, or sections 46106 

through 46108 of the Statute before a 

U.S. District Court, as the case may be, 

to compel compliance therewith; or to 

civil penalties pursuant to the 

provisions of section 46301 of the 

Statute; or, in the case of a willful 

violation, to criminal penalties pursuant 

to the provisions of section 46316 of the 

Statute; or other lawful sanctions 

including revocation of operating 

authority. 

[FR Doc. 2018–18345 Filed 9–14–18; 8:45 am] 

BILLING CODE 4910–9X–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 117 and 507 

[Docket No. FDA–2016–D–1164] 

Determination of Status as a Qualified 

Facility Under the Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Human and Animal Food 

Rules; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or Agency) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Determination of Status as a Qualified 

Facility Under Part 117: Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Human Food and Part 507: 

Current Good Manufacturing Practice, 

Hazard Analysis, and Risk-Based 

Preventive Controls for Food for 

Animals; Guidance for Industry.’’ This 

guidance explains our current thinking 

on how to determine whether a facility 

is a ‘‘qualified facility’’ that is subject to 

modified requirements under our rule 

entitled ‘‘Current Good Manufacturing 

Practice, Hazard Analysis, and RiskBased Preventive Controls for Human 

Food’’ (the Preventive Controls for 

Human Food Rule) or under our rule 

entitled ‘‘Current Good Manufacturing 

Practice, Hazard Analysis, and RiskBased Preventive Controls for Food for 

Animals’’ (the Preventive Controls for 

Animal Food Rule). This guidance also 

explains our current thinking on how a 

facility would submit Form FDA 3942a, 

attesting to its status as a qualified 

facility under the Preventive Controls 

for Human Food Rule and how a 

business would submit Form FDA 

3942b, attesting to its status as a 

qualified facility under the Preventive 

Controls for Animal Food Rule. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 17, 2018. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2016–D–1164 for ‘‘Determination of 

Status as a Qualified Facility Under Part 

117: Current Good Manufacturing 

Practice, Hazard Analysis, and RiskBased Preventive Controls for Human 

Food and Part 507: Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Food for Animals; 

Guidance for Industry.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 


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