26948 Federal Register / Vol. 74, No. 107 / Friday, June 5, 2009 / Rules and Regulations 

seats that incorporated non-traditional, 

large, non-metallic panels in lieu of the 

traditional metal covered by fabric. The 

Seattle Aircraft Certification Office and 

Transport Standards Staff reviewed this 

design and determined that it 

represented the kind and quantity of 

material that should be required to pass 

the heat release and smoke emissions 

requirements. We have determined that 

special conditions would be 

promulgated to apply the standards 

defined in § 25.853(d) to seats with large 

non-metallic panels in their design. 

Applicability 

Although smoke testing requirements 

of § 25.853 per Appendix F, parts IV and 

V, are not part of the part 25 

certification basis for the Bombardier 

DHC–8–100 and –301 series airplanes, 

these special conditions are applicable 

if the airplanes were manufactured after 

8/19/1990 and are in 14 CFR part 121 

service. Part 121 requires applicable 

interior panels to comply with § 25.853 

and Appendix F, parts IV and V, 

regardless of the certification basis. It is 

not our intent to require seats with large 

non-metallic panels to meet § 25.853 

and Appendix F, parts IV and V, if they 

are installed in cabins of airplanes that 

are not required to meet these standards. 

Because the heat release and smoke 

testing requirements of § 25.853 are part 

of the type certification basis for the 

DHC–8–200 series, models 311 and 315 

of the –300 series, and DHC–8–400 

series airplanes, these special 

conditions are applicable to the DHC–8– 

200 series, models 311 and 315 of the 

–300 series, and DHC–8–400 series 

airplanes for all types of operations. 

Should Bombardier apply at a later date 

for a change to the type certificate to 

include another model incorporating the 

same novel or unusual design feature, 

the special conditions would apply to 

that model as well. 

Seats do not have to meet these 

special conditions when installed in 

compartments that are not otherwise 

required to meet the test requirements of 

14 CFR part 25 and Appendix F, parts 

IV and V. For example, airplanes that do 

not have § 25.853, Amendment 25–61 or 

later, in their certification basis, and do 

not need to comply with the 

requirements of 14 CFR 121.312, do not 

have to comply with these special 

conditions. 

Conclusion 

This action affects only certain novel 

or unusual design features on 

Bombardier Inc. DHC–8–100, –200, and 

–400 series airplanes and in models 

–311 and –315 in –300 series airplanes. 

It is not a rule of general applicability. 

The substance of these special 

conditions has been subjected to the 

notice and comment period in several 

prior instances and has been derived 

without substantive change from those 

previously issued. It is unlikely that 

prior public comment would result in a 

significant change from the substance 

contained herein. Therefore, the FAA 

has determined that prior public notice 

and comment are unnecessary and good 

cause exists for adopting these special 

conditions upon issuance. The FAA is 

requesting comments to allow interested 

persons to submit views that may not 

have been submitted in response to the 

prior opportunities for comment 

described above. 

List of Subjects in 14 CFR Part 25 

Aircraft, Aviation safety, Reporting 

and recordkeeping requirements. 

Authority Citation 

■ The authority citation for these 

special conditions is as follows: 

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

44702, 44704. 

The Special Conditions 

Accordingly, pursuant to the 

authority delegated to me by the 

Administrator, the following special 

conditions are issued as part of the type 

certification basis for Bombardier Inc. 

DHC–8–100 series, DHC–8–200 series, 

models 311 and 315 of the –300 series, 

and DHC–8–400 series airplanes. 

1. Except as provided in paragraph 3 

of these special conditions, compliance 

with heat release and smoke emission 

testing requirements per 14 CFR part 25, 

and Appendix F, parts IV and V, is 

required for seats that incorporate nontraditional, large non-metallic panels 

that may either be a single component 

or multiple components in a 

concentrated area in their design. 

2. The applicant may designate up to 

and including 1.5 square feet of nontraditional, non-metallic panel material 

per seat place that does not have to 

comply with special condition Number 

1, above. A triple seat assembly may 

have a total of 4.5 square feet excluded 

on any portion of the assembly (e.g., 

outboard seat place 1 square foot, 

middle 1 square foot, and inboard 2.5 

square feet). 

3. Seats do not have to meet the test 

requirements of 14 CFR part 25 and 

Appendix F, parts IV and V, when 

installed in compartments that are not 

otherwise required to meet these 

requirements. Examples include: 

a. Airplanes with passenger capacities 

of 19 or less, 

b. Airplanes that do not have § 25.853, 

Amendment 25–61 or later, in their 

certification basis and do not need to 

comply with the requirements of 14 CFR 

121.312, and 

c. Airplanes exempted from § 25.853, 

Amendment 25–61 or later. 

4. Only airplanes associated with new 

seat certification programs approved 

after the effective date of these special 

conditions will be affected by the 

requirements in these special 

conditions. Previously certificated 

interiors on the existing airplane fleet 

and follow-on deliveries of airplanes 

with previously certificated interiors are 

not affected. 

Issued in Renton, Washington, on May 18, 

2009. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. E9–13187 Filed 6–4–09; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 25 

[Docket No. NM406; Special Conditions No. 

25–384–SC] 

Special Conditions: Bombardier Inc. 

Model CL–600–2B19, –2C10, –2D15 

and –2D24 Airplanes; Passenger Seats 

with Non-Traditional, Large, NonMetallic Panels 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final special conditions; request 

for comments. 

SUMMARY: These special conditions are 

issued for Bombardier Inc. model CL– 

600–2B19, –2C10, –2D15 and –2D24 

airplanes. These airplanes will have a 

novel or unusual design feature(s) 

associated with seats that include nontraditional, large, non-metallic panels 

that would affect survivability during a 

post-crash fire event. The applicable 

airworthiness regulations do not contain 

adequate or appropriate safety standards 

for this design feature. These special 

conditions contain the additional safety 

standards that the Administrator 

considers necessary to establish a level 

of safety equivalent to that established 

by the existing airworthiness standards. 

DATES: The effective date of these 

special conditions is May 18, 2009. 

We must receive your comments by 

July 20, 2009. 

ADDRESSES: You must mail two copies 

of your comments to: Federal Aviation 

Administration, Transport Airplane 

Directorate, Attn: Rules Docket (ANM– 


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Federal Register / Vol. 74, No. 107 / Friday, June 5, 2009 / Rules and Regulations 26949 

113), Docket No. NM406, 1601 Lind 

Avenue, SW., Renton, Washington 

98057–3356. You may deliver two 

copies to the Transport Airplane 

Directorate at the above address. You 

must mark your comments: Docket No. 

NM406 You can inspect comments in 

the Rules Docket weekdays, except 

Federal holidays, between 7:30 a.m. and 

4 p.m. 

FOR FURTHER INFORMATION CONTACT: 

Alan Sinclair, FAA, Airframe/Cabin 

Safety Branch, ANM–115, Transport 

Airplane Directorate, Aircraft 

Certification Service, 1601 Lind 

Avenue, SW., Renton, Washington 

98057–3356; telephone (425) 227–2195; 

facsimile (425) 227–1232; electronic 

mail alan.sinclair@faa.gov. 

SUPPLEMENTARY INFORMATION: The FAA 

has determined that notice and 

opportunity for prior public comment 

hereon are impracticable because these 

procedures would significantly delay 

issuance of the design approval and 

thus delivery of the affected aircraft. In 

addition, the substance of these special 

conditions has been subject to the 

public comment process in several prior 

instances with no substantive comments 

received. The FAA therefore finds that 

good cause exists for making these 

special conditions effective upon 

issuance. 

Comments Invited 

We invite interested people to take 

part in this rulemaking by sending 

written comments, data, or views. The 

most helpful comments reference a 

specific portion of the special 

conditions, explain the reason for any 

recommended change, and include 

supporting data. We ask that you send 

us two copies of written comments. 

We will file in the docket all 

comments we receive, as well as a 

report summarizing each substantive 

public contact with FAA personnel 

about these special conditions. You can 

inspect the docket before and after the 

comment closing date. If you wish to 

review the docket in person, go to the 

address in the ADDRESSES section of this 

preamble between 7:30 a.m. and 4 p.m., 

Monday through Friday, except Federal 

holidays. 

We will consider all comments we 

receive by the closing date for 

comments. We will consider comments 

filed late if it is possible to do so 

without incurring expense or delay. We 

may change these special conditions 

based on the comments we receive. 

If you want us to let you know we 

received your comments on these 

special conditions, send us a preaddressed, stamped postcard on which 

the docket number appears. We will 

stamp the date on the postcard and mail 

it back to you. 

Background 

On July 1, 2008, Bombardier Inc. 400 

Cote Vertu West, Dorval, Quebec, 

Canada H4S 1Y9 applied for a design 

change to Type Certificate No. A21EA 

for installation of seats that include nontraditional, large, non-metallic panels in 

the following Bombardier Inc. airplanes: 

Model CL–600–2B19, Model CL–600– 

2C10, Model CL–600–2D15 and Model 

CL–600–2D24. These airplanes, which 

are currently approved under Type 

Certificate No. A21EA, are swept-wing, 

T-tail, twin-engine, fuselage mounted 

turbofan-powered, single aisle, medium 

sized transport category airplanes. 

The applicable regulations to 

airplanes currently approved under 

Type Certificate No. A21EA do not 

require seats to meet the more stringent 

flammability standards required of 

large, non-metallic panels in the cabin 

interior. At the time the applicable rules 

were written, seats were designed with 

a metal frame covered by fabric, not 

with large, non-metallic panels. Seats 

also met the then recently adopted 

standards for flammability of seat 

cushions. With the seat design being 

mostly fabric and metal, the 

contribution to a fire in the cabin had 

been minimized and was not considered 

a threat. For these reasons, seats did not 

need to be tested to heat release and 

smoke emission requirements. 

Seat designs have now evolved to 

occasionally include non-traditional, 

large, non-metallic panels. Taken in 

total, the surface area of these panels is 

on the same order as the sidewall and 

overhead stowage bin interior panels. 

To provide the level of passenger 

protection intended by the 

airworthiness standards, these nontraditional, large, non-metallic panels in 

the cabin must meet the standards of 

Title 14 Code of Federal Regulations (14 

CFR), part 25, Appendix F, parts IV and 

V, heat release and smoke emission 

requirements. 

Type Certification Basis 

Under the provisions of § 21.101 

Bombardier must show that the 

following model airplanes, CL–600– 

2B19, CL–600–2C10, CL–600–2D15 and 

CL–600–2D24, as changed, continue to 

meet the applicable provisions of the 

regulations incorporated by reference in 

Type Certificate No. A21AE, or the 

applicable regulations in effect on the 

date of application for the change. The 

regulations incorporated by reference in 

the type certificate are commonly 

referred to as the ‘‘original type 

certification basis.’’ 

The regulations incorporated by 

reference in Type Certificate No. A21AE 

are for the following models: 

• CL–600–2B19, regulation 14 CFR 

part 25, effective February 1, 1965, 

including Amendments 25–1 through 

25–62; 

• CL–600–2C10, regulation 14 CFR 

part 25, effective February 1, 1965, 

including Amendments 25–1 through 

25–86: 

• CL–600–2D15, regulation 14 CFR 

part 25, effective February 1, 1965, 

including Amendments 25–1 through 

25–86, Amendments 25–88 through 

Amendments 25–90 and Amendments 

25–92 through Amendments 25–98. 

• CL–600–2D24, regulation 14 CFR 

part 25, effective February 1, 1965, 

including Amendments 25–1 through 

25–86, Amendments 25–88 through 

Amendments 25–90 and Amendments 

25–92 through Amendments 25–98. 

In addition, the certification basis 

includes other regulations and special 

conditions that are not pertinent to 

these special conditions. 

If the Administrator finds that the 

applicable airworthiness regulations 

(i.e., 14 CFR part 25) do not contain 

adequate or appropriate safety standards 

for the Model CL–600 series airplanes 

because of a novel or unusual design 

feature, special conditions are 

prescribed under the provisions of 

§ 21.16. 

In addition to the applicable 

airworthiness regulations and special 

conditions, the Model CL–600 series 

airplanes must comply with the fuel 

vent and exhaust emission requirements 

of 14 CFR part 34 and the noise 

certification requirements of 14 CFR 

part 36. 

The FAA issues special conditions, as 

defined in § 11.19, under § 11.38 and 

they become part of the type 

certification basis under § 21.101. 

Special conditions are initially 

applicable to the model for which they 

are issued. Should the type certificate 

for that model be amended later to 

include any other model that 

incorporates the same novel or unusual 

design feature, or should any other 

model already included on the same 

type certificate be modified to 

incorporate the same novel or unusual 

design feature, the special conditions 

would also apply to the other model. 

Novel or Unusual Design Features 

The Model CL–600 series airplanes 

will incorporate the following novel or 

unusual design features: These models 

offer interior arrangements that include 

passenger seats that incorporate nonVerDate Nov<24>2008 14:04 Jun 04, 2009 Jkt 217001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\FR\FM\05JNR1.SGM 05JNR1

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26950 Federal Register / Vol. 74, No. 107 / Friday, June 5, 2009 / Rules and Regulations 

traditional, large, non-metallic panels in 

lieu of the traditional metal frame 

covered by fabric. The flammability 

properties of these panels have been 

shown to significantly affect the 

survivability of occupants of the cabin 

in the case of fire. These seats are 

considered a novel design for transport 

category airplanes that include 

Amendment 25–61 and Amendment 

25–66 in the certification basis, and 

were not considered when those 

airworthiness standards were 

established. 

The existing regulations do not 

provide adequate or appropriate safety 

standards for seat designs that 

incorporate non-traditional, large, nonmetallic panels. In order to provide a 

level of safety that is equivalent to that 

provided by the balance of the cabin, 

additional airworthiness standards, in 

the form of special conditions, are 

necessary. These special conditions 

supplement § 25.853. The requirements 

contained in these special conditions 

consist of applying the identical test 

conditions required of all other large 

panels in the cabin, to seats with nontraditional, large, non-metallic panels. 

Definition of ‘‘Non-Traditional, Large, 

Non-Metallic Panel’’ 

A non-traditional, large, non-metallic 

panel, in this case, is defined as a panel 

with exposed-surface areas greater than 

1.5 square feet installed per seat place. 

The panel may consist of either a single 

component or multiple components in a 

concentrated area. Examples of parts of 

the seat where these non-traditional 

panels are installed include, but are not 

limited to: seat backs, bottoms and leg/ 

foot rests, kick panels, back shells, 

credenzas and associated furniture. 

Examples of traditional exempted parts 

of the seat include: arm caps, armrest 

close-outs such as end bays and armreststyled center consoles, food trays, video 

monitors and shrouds. 

Clarification of ‘‘Exposed’’ 

‘‘Exposed’’ is considered to include 

those panels directly exposed to the 

passenger cabin in the traditional sense, 

plus those panels enveloped such as by 

a dress cover. Traditional fabrics or 

leathers currently used on seats are 

excluded from these special conditions. 

These materials must still comply with 

§ 25.853(a) and § 25.853(c) if used as a 

covering for a seat cushion, or 

§ 25.853(a) if installed elsewhere on the 

seat. Non-traditional, large, non-metallic 

panels covered with traditional fabrics 

or leathers will be tested without their 

coverings or covering attachments. 

Discussion 

In the early 1980s the FAA conducted 

extensive research on the effects of postcrash flammability in the passenger 

cabin. As a result of this research and 

service experience, we adopted new 

standards for interior surfaces 

associated with large surface area parts. 

Specifically, the rules require 

measurement of heat release and smoke 

emission (part 25, Appendix F, parts IV 

and V) for the affected parts. Heat 

release has been shown to have a direct 

correlation with post-crash fire survival 

time. Materials that comply with the 

standards (i.e., § 25.853 entitled 

‘‘Compartment interiors’’ as amended by 

Amendment 25–61 and Amendment 

25–66) extend survival time by 

approximately 2 minutes, over materials 

that do not comply. 

At the time these standards were 

written, the potential application of the 

requirements of heat release and smoke 

emission to seats was explored. The seat 

frame itself was not a concern because 

it was primarily made of aluminum and 

there were only small amounts of nonmetallic materials. It was determined 

that the overall effect on survivability 

was negligible, whether or not the food 

trays met the heat release and smoke 

requirements. The requirements, 

therefore, did not address seats. The 

preambles to both the Notice of 

Proposed Rule Making (NPRM), Notice 

No. 85–10 (50 FR 15038, April 16, 

1985), and the Final Rule at 

Amendment 25–61 (51 FR 26206, July 

21, 1986), specifically note that seats 

were excluded ‘‘because the recentlyadopted standards for flammability of 

seat cushions will greatly inhibit 

involvement of the seats.’’ 

Subsequently, the Final Rule at 

Amendment 25–83 (60 FR 6615, March 

6, 1995) clarified the definition of 

minimum panel size: ‘‘It is not possible 

to cite a specific size that will apply in 

all installations; however, as a general 

rule, components with exposed-surface 

areas of one square foot or less may be 

considered small enough that they do 

not have to meet the new standards. 

Components with exposed-surface areas 

greater than two square feet may be 

considered large enough that they do 

have to meet the new standards. Those 

with exposed-surface areas greater than 

one square foot, but less than two square 

feet, must be considered in conjunction 

with the areas of the cabin in which 

they are installed before a determination 

could be made.’’ 

In the late 1990s, the FAA issued 

Policy Memorandum 97–112–39, 

‘‘Guidance for Flammability Testing of 

Seat/Console Installations,’’ October 17, 

1997 (http://rgl.faa.gov). That memo 

was issued when it became clear that 

seat designs were evolving to include 

large non-metallic panels with surface 

areas that would impact survivability 

during a cabin fire event, comparable to 

partitions or galleys. The memo noted 

that large surface area panels must 

comply with heat release and smoke 

emission requirements, even if they 

were attached to a seat. If the FAA had 

not issued such policy, seat designs 

could have been viewed as a loophole 

to the airworthiness standards that 

would result in an unacceptable 

decrease in survivability during a cabin 

fire event. 

In October of 2004, an issue was 

raised regarding the appropriate 

flammability standards for passenger 

seats that incorporated non-traditional, 

large, non-metallic panels in lieu of the 

traditional metal covered by fabric. The 

Seattle Aircraft Certification Office and 

Transport Standards Staff reviewed this 

design and determined that it 

represented the kind and quantity of 

material that should be required to pass 

the heat release and smoke emissions 

requirements. We have determined that 

special conditions would be 

promulgated to apply the standards 

defined in § 25.853(d) to seats with large 

non-metallic panels in their design. 

Applicability 

These special conditions are 

applicable to Bombardier model CL– 

600–2B19 airplanes. Because the heat 

release testing requirements of § 25.853 

per Appendix F, part IV are part of the 

type certification basis for model CL– 

600–2B19 airplanes, these special 

conditions are applicable to model CL– 

600–2B19 airplanes. Although smoke 

testing requirements of § 25.853 per 

Appendix F, part V, are not part of the 

part 25 certification basis for 

Bombardier Model CL–600–2B19 

airplanes, these special conditions are 

applicable if the airplanes are in 14 CFR 

part 121 service. Part 121 requires 

applicable interior panels to comply 

with § 25.853 and Appendix F, part V, 

regardless of the certification basis. It is 

not our intent to require seats with large 

non-metallic panels to meet § 25.853 

and Appendix F, parts V, if they are 

installed in cabins of airplanes that 

otherwise are not required to meet these 

standards. Should Bombardier apply at 

a later date for a change to the type 

certificate to include another model 

incorporating the same novel or unusual 

design feature, the special conditions 

would apply to that model as well. 

These special conditions are 

applicable to Bombardier Inc. Model 

CL–600–2C10, –2D15 and –2D24 


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Federal Register / Vol. 74, No. 107 / Friday, June 5, 2009 / Rules and Regulations 26951 

airplanes. Because the heat release and 

smoke testing requirements of § 25.853 

are part of the type certification basis for 

the Model CL–600–2C10, –2D15 and 

–2D24 airplanes, these special 

conditions are applicable to the Model 

CL–600–2C10, –2D15 and –2D24 

airplanes. Should Bombardier apply at a 

later date for a change to the type 

certificate to include another model 

incorporating the same novel or unusual 

design feature, the special conditions 

would apply to that model as well. 

Seats do not have to meet these 

special conditions when installed in 

compartments that are not otherwise 

required to meet the test requirements of 

CFR part 25, Appendix F, parts IV and 

V, for example, airplanes that do not 

have § 25.853, Amendment 25–61 or 

later, in their certification basis and 

those airplanes that do not need to 

comply with the requirements of 14 CFR 

121.312. 

Conclusion 

This action affects only certain novel 

or unusual design features on 

Bombardier Inc. Model CL–600–2B19, 

–2C10, –2D15 and –2D24 series 

airplanes. It is not a rule of general 

applicability. 

The substance of these special 

conditions has been subjected to the 

notice and comment period in several 

prior instances and has been derived 

without substantive change from those 

previously issued. It is unlikely that 

prior public comment would result in a 

significant change from the substance 

contained herein. Therefore, the FAA 

has determined that prior public notice 

and comment are unnecessary and good 

cause exists for adopting these special 

conditions upon issuance. The FAA is 

requesting comments to allow interested 

persons to submit views that may not 

have been submitted in response to the 

prior opportunities for comment 

described above. 

List of Subjects in 14 CFR Part 25 

Aircraft, Aviation safety, Reporting 

and recordkeeping requirements. 

Authority Citation 

■ The authority citation for these 

special conditions is as follows: 

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

44702, 44704. 

The Special Conditions 

Accordingly, pursuant to the 

authority delegated to me by the 

Administrator, the following special 

conditions are issued as part of the type 

certification basis for Bombardier Inc. 

Model CL–600–2B19, –2C10, –2D15 and 

–2D24 series airplanes. 

1. Except as provided in paragraph 3 

of these special conditions, compliance 

with heat release and smoke emission 

testing requirements per 14 CFR part 25 

and Appendix F, parts IV and V, is 

required for seats that incorporate nontraditional, large non-metallic panels 

that may either be a single component 

or multiple components in a 

concentrated area in their design. 

2. The applicant may designate up to 

and including 1.5 square feet of nontraditional, non-metallic panel material 

per seat place that does not have to 

comply with special condition Number 

1, above. A triple seat assembly may 

have a total of 4.5 square feet excluded 

on any portion of the assembly (e.g., 

outboard seat place 1 square foot, 

middle 1 square foot, and inboard 2.5 

square feet). 

3. Seats do not have to meet the test 

requirements of 14 CFR part 25 and 

Appendix F, parts IV and V, when 

installed in compartments that are not 

otherwise required to meet these 

requirements. Examples include: 

a. Airplanes with passenger capacities 

of 19 or less, 

b. Airplanes that do not have § 25.853, 

Amendment 25–61 or later, in their 

certification basis and do not need to 

comply with the requirements of 14 CFR 

121.312, and 

c. Airplanes exempted from § 25.853, 

Amendment 25–61 or later. 

4. Only airplanes associated with new 

seat certification programs approved 

after the effective date of these special 

conditions will be affected by the 

requirements in these special 

conditions. Previously certificated 

interiors on the existing airplane fleet 

and follow-on deliveries of airplanes 

with previously certificated interiors are 

not affected. 

Issued in Renton, Washington, on May 18, 

2009. 

Ali Bahrami, 

Manager, Transport Airplane Directorate 

Aircraft Certification Service. 

[FR Doc. E9–13188 Filed 6–4–09; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 522 

[Docket No. FDA–2009–N–0665] 

New Animal Drugs; Change of 

Sponsor; Fomepizole 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect a 

change of sponsor for a new animal drug 

application (NADA) for fomepizole 

solution for injection from Jazz 

Pharmaceuticals, Inc., to Paladin Labs 

(USA), Inc. 

DATES: This rule is effective June 5, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

David R. Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8307, email: david.newkirk@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Jazz 

Pharmaceuticals, Inc., 3180 Porter Dr., 

Palo Alto, CA 94304, has informed FDA 

that it has transferred ownership of, and 

all rights and interest in, NADA 141– 

075 for ANTIZOL-VET (fomepizole) to 

Paladin Labs (USA), Inc., 160 Greentree 

Dr., suite 101, Dover, DE 19904. 

Accordingly, the agency is amending 

the regulations in 21 CFR 522.1004 to 

reflect the transfer of ownership. 

Following these changes of 

sponsorship, Jazz Pharmaceuticals, Inc., 

is no longer the sponsor of an approved 

application. Accordingly, 21 CFR 

510.600(c) is being amended to remove 

the entries for this sponsor. 

In addition, Paladin Labs (USA), Inc., 

is not currently listed in the animal drug 

regulations as a sponsor of an approved 

application. Accordingly, 21 CFR 

510.600(c) is being amended to add 

entries for this sponsor. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

21 CFR Part 522 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR parts 510 and 522 are amended as 

follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 510 continues to read as follows 


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