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 


erowe on PROD1PC63 with RULES
26952 Federal Register / Vol. 74, No. 107 / Friday, June 5, 2009 / Rules and Regulations 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

■ 2. In § 510.600, in the table in 

paragraph (c)(1) remove the entry for 

‘‘Jazz Pharmaceuticals, Inc.’’ and 

alphabetically add a new entry for 

‘‘Paladin Labs, Inc.’’; and in the table in 

paragraph (c)(2) remove the entry for 

‘‘068727’’ and numerically add a new 

entry for ‘‘046129’’ to read as follows: 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler 

code 

* * * * * 

Paladin Labs (USA), Inc., 

160 Greentree Dr., suite 

101, Dover, DE 19904 

046129 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

046129 Paladin Labs (USA), Inc., 

160 Greentree Dr., suite 

101, Dover, DE 19904 

* * * * * 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 522 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

§ 522.1004 [Amended] 

■ 4. In paragraph (b) of § 522.1004, 

remove ‘‘068727’’ and add in its place 

‘‘046129’’. 

Dated: June 1, 2009. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E9–13126 Filed 6–4–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2009–0385] 

RIN 1625–AA09 

Drawbridge Operation Regulation; 

Sturgeon Bay Ship Canal, Sturgeon 

Bay, WI 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard proposes to 

temporarily revise the operating 

regulations for the Maple-Oregon Bridge 

at Mile 4.17 over the Sturgeon Bay Ship 

Canal in Sturgeon Bay, WI. This action 

was requested by the Wisconsin 

Department of Transportation 

(Wisconsin DOT) to facilitate vehicular 

traffic in downtown Sturgeon Bay 

during the rehabilitation of the 

Michigan Street Bridge at Mile 4.30 over 

the Sturgeon Bay Ship Canal. This final 

rule is expected to reflect the need for 

bridge openings for the Maple-Oregon 

Bridge during the Michigan Street 

Bridge rehabilitation and still provide 

for the reasonable needs of navigation. 

DATES: This temporary final rule is 

effective from 6 a.m. on June 1, 2009 to 

6 p.m. on November 15, 2010. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket, are part of docket USCG–2009– 

0385 and are available by going to 

http://www.regulations.gov, selecting 

the Advanced Docket Search option on 

the right side of the screen, inserting 

USCG–2009–0385 in the Docket ID box, 

pressing Enter, and then clicking on the 

item in the Docket ID column. This 

material is also available for inspection 

or copying at the Docket Management 

Facility (M–30), U.S. Department of 

Transportation, West Building Ground 

Floor, Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590, 

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

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

rule, call or e-mail Blair Stanifer, Bridge 

Management Specialist, Coast Guard 

Ninth District; telephone 216–902–6086, 

e-mail: William.B.Stanifer@uscg.mil. If 

you have questions on viewing the 

docket, call Renee V. Wright, Program 

Manager, Docket Operations, telephone 

202–366–9826. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

The Coast Guard is issuing this 

temporary final rule without prior 

notice and opportunity to comment 

pursuant to authority under section 4(a) 

of the Administrative Procedure Act 

(APA) (5 U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because the 

request to revise the operating schedule 

for this temporary final rule included 

extensive preliminary coordination with 

known affected marine entities, 

Wisconsin DOT, and the City of 

Sturgeon Bay, WI, and resulted in a 

temporary drawbridge schedule that 

would not significantly impact either 

vehicular traffic or known navigation. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective in less than 30 

days after publication in the Federal 

Register. As noted above the Coast 

Guard has conducted extensive 

preliminary coordination with known 

affected marine entities, the Wisconsin 

DOT and the City of Sturgeon Bay, WI 

and determined that the impact on 

navigation will be minimal as the bridge 

will continue to open on demand for 

commercial vessels and public vessels 

and on the hour for recreational vessels 

from March 15 through December 31, 

and from January 1 through March 14, 

for any vessel provided at least notice is 

given at least 12 hours advance. This is 

the same schedule under which the 

Michigan Street Bridge currently 

operates under 33 CFR 117.1101. During 

renovation the Michigan Street Bridge 

will remain in the open position and 

vehicular traffic is expected to use the 

Maple-Oregon Bridge as an alternate 

route. Repeated openings would likely 

cause significant congestion on the 

vehicular approaches to the bridge. 

Hourly openings will allow vehicular 

traffic to plan accordingly and will 

minimally affect recreational vessels. 

Background and Purpose 

Wisconsin DOT requested a 

temporary change to the operating 

schedule of the Maple-Oregon Bridge at 

Mile 4.17 over the Sturgeon Bay Ship 

Canal to facilitate the rehabilitation of 

the Michigan Street Bridge. The MapleOregon Double-Leaf Bascule Bridge 

navigation span provides for a design 

clearance of 25 feet above Mean Low 


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