This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

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

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

26819 

Vol. 80, No. 90 

Monday, May 11, 2015 

1To view the proposed rule and the comments 

we received, go to http://www.regulations.gov/

#!docketDetail;D=APHIS-2011-0048. 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Part 107 

[Docket No. APHIS–2011–0048] 

RIN 0579–AD66 

Viruses, Serums, Toxins, and 

Analogous Products; Exemptions 

From Preparation Pursuant to an 

Unsuspended and Unrevoked License 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Final rule. 

SUMMARY: We are amending the VirusSerum-Toxin Act regulations to require 

that veterinary biologics prepared under 

the veterinary practitioner exemption 

must be prepared at the same facility the 

veterinarian utilizes in conducting the 

day-to-day activities associated with his 

or her practice. This exemption applies 

to veterinary biologics prepared by a 

veterinary practitioner solely for 

administration to animals in the course 

of a State-licensed professional practice 

of veterinary medicine under a 

veterinarian-client-patient relationship. 

This rule is necessary to ensure that 

veterinary biologics are not prepared in 

unlicensed establishments in violation 

of the Virus-Serum-Toxin Act and to 

clarify the regulations regarding the 

preparation of product by a veterinary 

practitioner under a veterinarian-clientpatient relationship. 

DATES: Effective July 10, 2015. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Donna Malloy, Operational Support 

Section, Center for Veterinary Biologics, 

Policy, Evaluation, and Licensing, VS, 

APHIS, 4700 River Road Unit 148, 

Riverdale, MD 20737–1231; phone (301) 

851–3426, fax (301) 734–4314. 

SUPPLEMENTARY INFORMATION: 

Background 

The regulations in Title 9, Code of 

Federal Regulations (9 CFR), parts 101– 

118 (referred to below as the 

regulations) contain provisions 

implementing the Virus-Serum-Toxin 

Act (the Act), as amended (21 U.S.C. 

151–159). These regulations are 

administered by the Animal and Plant 

Health Inspection Service (APHIS) of 

the U.S. Department of Agriculture 

(USDA). The Act prohibits the 

preparation, sale, and shipment of 

veterinary biological products in or from 

the United States unless such products 

have been prepared under and in 

compliance with USDA regulations at 

an establishment holding an 

unsuspended and unrevoked license 

issued by USDA. 

In part 102 of the regulations, §§ 102.1 

and 102.2 require that each 

establishment and every person 

preparing biological products subject to 

the Act must hold an unexpired, 

unsuspended, and unrevoked U.S. 

Veterinary Biologics Establishment 

License issued by the Administrator and 

a U.S. Veterinary Biological Product 

License for each product prepared in 

such establishment. Part 107 of the 

regulations contains exemptions from 

the requirement for preparation 

pursuant to unsuspended and 

unrevoked establishment and product 

licenses. One of those exemptions, 

found in § 107.1(a)(1), allows for 

product to be prepared by a veterinary 

practitioner solely for administration to 

animals in the course of his or her Statelicensed professional practice of 

veterinary medicine under a 

veterinarian-client-patient relationship. 

The regulations in § 107.1(a)(1) also set 

forth the criteria that must be satisfied 

in order to establish the existence of a 

veterinarian-client-patient relationship. 

On July 18, 2012, we published in the 

Federal Register (77 FR 42195–42197, 

Docket No. APHIS–2011–0048) a 

proposal 1 to amend the regulations to 

require that veterinary biologics 

prepared under the veterinary 

practitioner exemption be prepared at 

the same facility the veterinarian 

utilizes in conducting the day-to-day 

activities associated with his or her 

practice. The proposal was intended to 

ensure that veterinary biologics are not 

prepared in unlicensed establishments 

in violation of the Virus-Serum-Toxin 

Act and to clarify the regulations 

regarding the preparation of product by 

a veterinary practitioner under a 

veterinarian-client-patient relationship. 

We solicited comments concerning 

our proposal for 60 days ending 

September 17, 2012. We reopened and 

extended the deadline for comments 

until November 16, 2012, in a document 

published in the Federal Register on 

September 20, 2012 (77 FR 58323, 

Docket No. APHIS–2011–0048). We 

received 55 comments by that date. 

They were from veterinarians and 

veterinary associations, several State 

universities, pork producers’ 

associations, trade organizations, 

veterinary biologics companies, private 

laboratories, aquaculture companies, 

officials from the State of Iowa, and 

individuals. These comments are 

discussed below by topic. 

Some commenters not only supported 

the proposal but recommended that we 

speed the implementation process 

along. 

We are finalizing this rule as 

expeditiously as possible. Given the 

number of comments we received on the 

proposed rule and the substantive 

nature of most of them, however, we 

determined that we needed to carefully 

review and evaluate those comments 

before implementing any regulatory 

changes. 

Several organizations and a number of 

veterinary practitioners raised concerns 

about what they termed the ‘‘forced 

relocation’’ of preparation sites for 

veterinary biologics to the same facility 

in which the veterinarian conducts dayto-day activities connected with his or 

her practice. Commenters stated that a 

veterinary practice is an environment 

poorly suited to the aseptic conditions 

required for biologics production and 

that personnel working in these 

facilities are trained in animal care 

rather than in specialized laboratory 

work. Several commenters 

recommended that APHIS revise the 

rule to require that, regardless of the 

location of the production facility, 

veterinarians that use the facility must 

document regular involvement in the 

management of the facility, provide 

such documentation on request, and 

allow regular on-site inspections, 

presumably by APHIS. 


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26820 Federal Register / Vol. 80, No. 90 / Monday, May 11, 2015 / Rules and Regulations 

APHIS disagrees with the 

commenters’ recommendation. As noted 

in the preamble to the July 2012 

proposed rule, the intent of the 

veterinary practitioner exemption in 

§ 107.1(a)(1) is to allow a practitioner to 

prepare exempt biological products at a 

location not licensed under the Act, 

where the practitioner operates a 

veterinary practice, and to transport 

such products away from that facility 

when necessary for administration to an 

animal or animals under a veterinarianclient-patient relationship without 

violating the Act. The intention behind 

the proposed rule was to clarify the 

relationship between the veterinary 

practitioner and the facility where 

exempt veterinary biological product is 

prepared. No provision in the Act or the 

regulations allows an unlicensed 

commercial laboratory, acting as the 

agent for the practitioner, to prepare, 

produce, sell, and ship the veterinary 

biological product under the exemption 

in § 107.1(a)(1). Such an arrangement 

would violate the Act. Nothing in this 

rule or in the Act, however, prevents 

veterinarians from working with 

establishments with a license to 

produce autogenous products, i.e., 

limited use biologics. 

Commenters expressed concern about 

how this rule would affect practitioners 

who have offices in multiple locations 

in which there are multiple 

practitioners. It was stated that changes 

within the swine industry have led 

many veterinarians to practice in this 

manner. According to the commenters, 

this rule would potentially require that 

a ‘‘brick and mortar’’ location for 

vaccine production would have to be 

the same as the physical location of the 

veterinarian. In the commenters’ view, 

such a requirement could prove 

problematic for a multi-location 

veterinary practice in which there may 

only be one location suitable for the 

preparation of exempt veterinary 

biological product. Commenters 

questioned how we would address the 

issue of multiple locations managed by 

the same veterinarian or practice even 

though the prescribing veterinarian may 

not routinely work out of the office 

where the exempt biological product is 

prepared. 

APHIS acknowledges that it has 

become a common occurrence in the 

swine industry for swine practitioners 

to work in multi-veterinarian, multilocation corporate practices. Nothing in 

this rule, however, prohibits a 

veterinarian from producing an exempt 

biological product in any of the 

locations routinely used in his or her 

day-to-day practice, provided that the 

other conditions in § 107.1 are met. 

Noting that § 107.1(a)(2) of the 

proposed rule stated that a biological 

product may be prepared by a veterinary 

assistant under the veterinarian’s 

‘‘direct supervision,’’ some commenters, 

while generally supportive of the rule, 

requested that we clarify how we define 

that term. 

APHIS interprets ‘‘direct supervision’’ 

to mean that the licensed veterinarian is 

readily available on the premises where 

the product is being prepared and has 

the responsibility for its preparation by 

the assistant working under his or her 

direction. 

Some commenters suggested that the 

emphasis of the rule should be 

redirected away from location of the 

exempt facilities and toward the quality 

and management of the facilities where 

the products are prepared. It was stated 

that the rule focuses too much on 

location and not enough on animal 

health. 

As noted above, the purpose of this 

rule is to clarify who may prepare 

exempted biological products and 

where those exempted products may be 

prepared under the regulations. 

Requirements pertaining to the quality 

and management of veterinary biologics 

establishments are already addressed in 

9 CFR part 108. 

Some commenters maintained that 

unlicensed laboratories should be 

allowed to prepare and ship exempt 

veterinary biological products on behalf 

of veterinary practitioners, that the rule 

may hinder innovative practices, and 

that the relationship between the 

veterinarian and the facility should be 

legal rather than location-based. The 

commenters expressed concern that the 

rule will restrict veterinarians’ access to 

certain customized vaccines that are 

prepared in specialized settings and 

thus prevent practitioners from 

responding rapidly to mutating viruses. 

Several commenters cited the case of an 

Iowa manufacturer, which they viewed 

as an innovative company with 

expertise in new technologies that 

enabled it to prepare vaccines quickly 

and effectively. The commenters stated 

that that company’s activities may be 

restricted under this rule. 

The purpose of this rule is to clarify 

the relationship between the veterinary 

practitioner and the facility where 

exempt veterinary biological products 

are prepared. We do not intend to 

hinder innovation and the development 

of valuable new technologies, nor do we 

anticipate that this rule will have such 

an effect. Any manufacturing 

establishment wishing to provide its 

technology and expertise to 

veterinarians has several licensing 

options that will allow it to market its 

product. To cite one example, in 2012, 

APHIS published guidelines for 

obtaining a conditional veterinary 

biologics license using production 

platform technology. These guidelines, 

which describe the policies and 

procedures regarding the licensure of 

product platforms based on recombinant 

technology, can be viewed at http://

www.aphis.usda.gov/animal_health/

vet_biologics/publications/memo_800_

213.pdf. 

Some commenters expressed concerns 

about how this rule may affect minor 

species, in particular, the aquaculture 

industry. It was stated that the language 

contained in the proposed rule was too 

restrictive, as it was based on an 

erroneous assumption of a homogenous 

type of veterinary practice involving 

mainly major species where there is 

only in-patient or on-the-farm care. 

Veterinary practitioners in the 

aquaculture industry routinely prepare 

autogenous vaccines, which may be 

isolated from a particular school of fish. 

A commenter stated that for minor 

species and minor indications, it is not 

cost-effective to have separate facilities 

for the preparation of existing exempt 

vaccines and autogenous vaccines. The 

commenter recommended that, for 

minor species applications, we add a 

provision to the final rule allowing the 

production of exempt biological 

products in a veterinary establishment 

that has either full or autogenous 

licensure to produce biologics, provided 

that the practitioner can demonstrate 

temporal and sanitary separation 

between exempt and non-exempt 

products. 

We do not agree that adding such a 

provision to the regulations is 

necessary. This rule does not affect the 

preparation of exempt veterinary 

biological product for minor species, 

such as farmed fish; it merely clarifies 

where such products can be prepared. 

Veterinarians who service minor species 

will continue to have the options 

currently available to them of preparing 

an exempt product or working with a 

licensed establishment to produce an 

autogenous vaccine. 

The July 2012 proposed rule included 

some additional changes to § 107.1. 

Specifically, we proposed to replace the 

term ‘‘establishments’’ with ‘‘facilities’’ 

in the introductory text and in 

paragraph (a)(1). One commenter 

favored retaining the original 

terminology. The commenter stated that 

‘‘facilities’’ is too narrow a term and 

that, conversely, ‘‘establishments’’ 

correctly reflects many of the types of 

operations that licensed veterinarians 

are associated with (ambulatory, zoos, 


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Federal Register / Vol. 80, No. 90 / Monday, May 11, 2015 / Rules and Regulations 26821 

aquarium, fish culture facilities, 

feedlots, etc.). 

We do not agree with this comment. 

The reason for the proposed change in 

terminology was to distinguish between 

manufacturers that produce licensed 

biological products in licensed 

establishments and those that produce 

exempt veterinary biological products 

under the conditions described in 

§ 107.1. The introductory text of § 107.1 

contains a reference to establishment 

licenses. Elsewhere in the regulations, 

including § 107.2, only production sites 

that are not exempt from licensing 

requirements are referred to as 

establishments. Drawing a clear 

distinction between establishments, 

where vaccines are prepared in 

accordance with our licensing 

requirements, and facilities, where 

exempt products are produced, helps to 

clarify the regulations and eliminate 

possible confusion. 

Therefore, for the reasons given in the 

proposed rule and in this document, we 

are adopting the proposed rule as a final 

rule, without change. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This final rule has been determined to 

be not significant for the purposes of 

Executive Order 12866 and, therefore, 

has not been reviewed by the Office of 

Management and Budget. 

In accordance with the Regulatory 

Flexibility Act, we have analyzed the 

potential economic effects of this action 

on small entities. The analysis is 

summarized below. Copies of the full 

analysis are available on the 

Regulations.gov Web site (see footnote 1 

in this document for a link to 

Regulations.gov) or by contacting the 

person listed under FOR FURTHER

INFORMATION CONTACT. 

This final rule amends the regulations 

in § 107.1 to clarify that the preparation 

of biological products pursuant to the 

exemption in paragraph (a)(1) of that 

section must take place at the same 

facility that the veterinarian preparing 

the product utilizes in conducting the 

day-to-day activities associated with 

his/her State-licensed professional 

practice of veterinary medicine. 

The exemption applies to veterinary 

biologics prepared by a veterinary 

practitioner solely for administration to 

animals in the course of a State-licensed 

professional practice of veterinary 

medicine under a veterinarian-clientpatient relationship. No provision in the 

Act or the regulations allows a 

veterinary practitioner to take advantage 

of the licensing exemption while at the 

same time consigning the actual 

preparation of the product to a 

commercial laboratory or other 

manufacturing establishment which 

would then exchange or deliver the 

product to a third party. 

The Regulatory Flexibility Act 

requires agencies to consider whether a 

rule will have a significant economic 

impact on a substantial number of small 

entities. 

Some commenters on the July 2012 

proposed rule expressed concerns that 

the rule would adversely affect how 

veterinary practitioners conduct day-today activities connected with their 

practices, prevent veterinarians from 

working with commercial labs or 

manufacturing facilities in preparing 

vaccines, and hinder the development 

of innovative practices. 

For the most part, there should be 

little or no effect on veterinary 

practitioners. Veterinary practitioners 

who are in compliance with the 

regulations do not need to alter the way 

they conduct their veterinarian-clientpatient relationships. This final rule 

will not change the nature of the 

exemption, the number of veterinary 

practitioners eligible to take advantage 

of the exemption, or the criteria that 

must be satisfied in order to establish 

the existence of a veterinarian-clientpatient relationship. Also, this final rule 

will not add any additional reporting or 

recordkeeping burden. 

Under these circumstances, the 

Administrator of the Animal and Plant 

Health Inspection Service has 

determined that this action will not 

have a significant economic impact on 

a substantial number of small entities. 

Executive Order 12372 

This program/activity is listed in the 

Catalog of Federal Domestic Assistance 

under No. 10.025 and is subject to 

Executive Order 12372, which requires 

intergovernmental consultation with 

State and local officials. (See 7 CFR part 

3015, subpart V.) 

Executive Order 12988 

This final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. It is not intended to 

have retroactive effect. This rule will 

not preempt any State or local laws, 

regulations, or policies where they are 

necessary to address local disease 

conditions or eradication programs. 

However, where safety, efficacy, purity, 

and potency of biological products are 

concerned, it is the Agency’s intent to 

occupy the field. This includes, but is 

not limited to, the regulation of labeling. 

Under the Act, Congress clearly 

intended that there be national 

uniformity in the regulation of these 

products. There are no administrative 

proceedings which must be exhausted 

prior to a judicial challenge to the 

regulations under this rule. 

Paperwork Reduction Act 

This final rule contains no new 

information collection or recordkeeping 

requirements under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.). 

List of Subjects in 9 CFR Part 107 

Animal biologics, Reporting and 

recordkeeping requirements. 

Accordingly, we are amending 9 CFR 

part 107 as follows: 

PART 107—EXEMPTIONS FROM 

PREPARATION PURSUANT TO AN 

UNSUSPENDED AND UNREVOKED 

LICENSE 

■ 1. The authority citation for part 107 

continues to read as follows: 

Authority: 21 U.S.C. 151–159; 7 CFR 2.22, 

2.80, and 371.4. 

■ 2. Section 107.1 is amended as 

follows: 

■ a. In the introductory text of the 

section and in paragraph (a)(1), 

introductory text, by removing the word 

‘‘establishments’’ both times it appears 

and adding the word ‘‘facilities’’ in its 

place; and 

■ b. By redesignating paragraph (a)(2) as 

paragraph (a)(3) and adding a new 

paragraph (a)(2). 

The addition reads as follows: 

§ 107.1 Veterinary practitioners and animal 

owners. 

* * * * * 

(a) * * * 

(2) All steps in the preparation of 

product being prepared under the 

exemption in paragraph (a)(1) of this 

section must be performed at the 

facilities that the veterinarian utilizes 

for the day-to-day activities associated 

with the treatment of animals in the 

course of his/her State-licensed 

professional practice of veterinary 

medicine. A veterinary assistant 

employed by the veterinary practitioner 

and working at the veterinary practice’s 

facility under the veterinarian’s direct 

supervision may perform the steps in 

the preparation of product. Such 

preparation may not be consigned to 

any other party or sub-contracted to a 

commercial laboratory/manufacturing 

facility. 

* * * * * 


Lhorne on DSK2VPTVN1PROD with RULES
26822 Federal Register / Vol. 80, No. 90 / Monday, May 11, 2015 / Rules and Regulations 

Done in Washington, DC, this 6th day of 

May 2015. 

Kevin Shea, 

Administrator, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2015–11311 Filed 5–8–15; 8:45 am] 

BILLING CODE 3410–34–P 

FARM CREDIT ADMINISTRATION 

12 CFR Part 620 

RIN 3052–AD02 

Disclosure to Shareholders; Pension 

Benefit Disclosures 

AGENCY: Farm Credit Administration. 

ACTION: Notice of effective date. 

SUMMARY: The Farm Credit 

Administration (FCA or we) adopted a 

final rule related to Farm Credit System 

(System) bank and association 

disclosures to shareholders and 

investors of senior officer compensation 

in the Summary Compensation Table 

(Table). Under the final rule, System 

banks and associations are not required 

to report in the Table the compensation 

of employees who are not senior officers 

and who would not otherwise be 

considered ‘‘highly compensated 

employees’’ but for the payments related 

to, or change(s) in value of, the 

employees’ qualified pension plans, 

provided that the plans were available 

to all employees on the same basis at the 

time the employees joined the plans. In 

accordance with the law, the effective 

date of the rule is 30 days from the date 

of publication in the Federal Register 

during which either or both Houses of 

Congress are in session. 

DATES: Effective Date: Under the 

authority of 12 U.S.C. 2252, the 

regulation amending 12 CFR part 620 

published on February 26, 2015 (80 FR 

10325) is effective April 29, 2015. 

Compliance Date: System banks and 

associations must comply with the final 

rule for compensation reported in the 

Table for the fiscal year ending 2015, 

and may implement the final rule 

retroactively for the fiscal years ended 

2014, 2013, and 2012. However, 

retroactive application is not required, 

and we would expect footnote 

disclosure of the change in calculation 

for the fiscal years to which the final 

rule was applied. 

FOR FURTHER INFORMATION CONTACT: 

Michael T. Wilson, Policy Analyst, 

Office of Regulatory Policy, Farm Credit 

Administration, McLean, VA 22102– 

5090, (703) 883–4124, TTY (703) 883– 

4056, or Jeff Pienta, Senior Attorney, 

Office of General Counsel, Farm Credit 

Administration, McLean, VA 22102– 

5090, (703) 883–4020, TTY (703) 883– 

4056. 

SUPPLEMENTARY INFORMATION: The Farm 

Credit Administration adopted a final 

rule related to System bank and 

association disclosures to shareholders 

and investors of senior officer 

compensation in the Summary 

Compensation Table. Under the final 

rule, System banks and associations are 

not required to report in the Table the 

compensation of employees who are not 

senior officers and who would not 

otherwise be considered ‘‘highly 

compensated employees’’ but for the 

payments related to, or change(s) in 

value of, the employees’ qualified 

pension plans, provided that the plans 

were available to all employees on the 

same basis at the time the employees 

joined the plans. In accordance with 12 

U.S.C. 2252, the effective date of the 

final rule is 30 days from the date of 

publication in the Federal Register 

during which either or both Houses of 

Congress are in session. Based on the 

records of the sessions of Congress, the 

effective date of the regulations is April 

29, 2015. 

(12 U.S.C. 2252(a)(9) and (10)) 

Dated: May 5, 2015. 

Dale L. Aultman, 

Secretary, Farm Credit Administration Board. 

[FR Doc. 2015–11286 Filed 5–8–15; 8:45 am] 

BILLING CODE 6705–01–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 91 

[Docket No. FAA–2003–14766; Amendment 

No. 91–327A; SFAR No. 77] 

RIN 2120–AK60 

Prohibition Against Certain Flights 

Within the Baghdad (ORBB) Flight 

Information Region (FIR) 

AGENCY: Federal Aviation 

Administration (FAA), Department of 

Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: This action amends Special 

Federal Aviation Regulation (SFAR) No. 

77, ‘‘Prohibition Against Certain Flights 

Within the Territory and Airspace of 

Iraq,’’ which prohibits certain flight 

operations in the territory and airspace 

of Iraq by all United States (U.S.) air 

carriers; U.S. commercial operators; 

persons exercising the privileges of a 

U.S. airman certificate, except when 

such persons are operating a U.S.- 

registered civil aircraft for a foreign air 

carrier; and operators of U.S.-registered 

civil aircraft, except when such 

operators are foreign air carriers. On 

August 8, 2014, the FAA issued a Notice 

to Airmen (NOTAM) prohibiting flight 

operations in the ORBB FIR at all 

altitudes, subject to certain limited 

exceptions, due to the armed conflict in 

Iraq. This amendment to SFAR No. 77 

incorporates the flight prohibition set 

forth in the August 8, 2014, NOTAM 

into the rule. The FAA is also revising 

the approval process for this SFAR for 

other U.S. Government departments, 

agencies, and instrumentalities, to align 

with the approval process established 

for other recently published flight 

prohibition SFARs. This final rule will 

remain in effect for two years. 

DATES: This final rule is effective May 

11, 2015 through May 11, 2017. 

FOR FURTHER INFORMATION CONTACT: For 

technical questions about this action, 

contact Will Gonzalez, Air 

Transportation Division, AFS–220, 

Flight Standards Service, Federal 

Aviation Administration, 800 

Independence Avenue SW., 

Washington, DC 20591; telephone: 202– 

267–8166; email: will.gonzalez@faa.gov. 

For legal questions concerning this 

action, contact: Robert Frenzel, Office of 

the Chief Counsel, AGC–200, Federal 

Aviation Administration, 800 

Independence Avenue SW., 

Washington, DC 20591; telephone (202) 

267–7638, email: robert.frenzel@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Good Cause for Immediate Adoption 

Section 553(b)(3)(B) of title 5, U.S. 

Code, authorizes agencies to dispense 

with notice and comment procedures 

for rules when the agency for ‘‘good 

cause’’ finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ In this instance, 

the FAA finds that notice and public 

comment to this immediately adopted 

final rule, as well as any delay in the 

effective date of this rule, are 

impracticable and contrary to the public 

interest due to the immediate need to 

address the potential hazard to civil 

aviation that now exists in the ORBB 

FIR, as described in the Background 

section of this rule. 

Authority for This Rulemaking 

The FAA is responsible for the safety 

of flight in the U.S. and for the safety 

of U.S. civil operators, U.S.-registered 

civil aircraft, and U.S.-certificated 

airmen throughout the world. The 

FAA’s authority to issue rules on 

aviation safety is found in title 49, U.S. 

Code. Subtitle I, section 106(f), 


Lhorne on DSK2VPTVN1PROD with RULES