62468 Federal Register / Vol. 75, No. 196 / Tuesday, October 12, 2010 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

[Docket No. FDA–2010–N–0002] 

Implantation and Injectable Dosage 

Form New Animal Drugs; Ceftiofur 

Crystalline Free Acid 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of a supplemental new animal 

drug application (NADA) filed by 

Pharmacia & Upjohn Co., a Division of 

Pfizer, Inc. The supplemental NADA 

provides for veterinary prescription use 

of ceftiofur crystalline free acid 

suspension in swine, by intramuscular 

injection, for the control of swine 

respiratory disease (SRD) in groups of 

pigs where SRD has been diagnosed. 

DATES: This rule is effective October 12, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Cindy L. Burnsteel, Center for 

Veterinary Medicine (HFV–130), Food 

and Drug Administration, 7500 Standish 

Pl., Rockville, MD 20855, 240–276– 

8341, e-mail: 

cindy.burnsteel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pharmacia 

& Upjohn Co., a Division of Pfizer, Inc., 

235 East 42d St., New York, NY 10017, 

filed a supplement to NADA 141 235 for 

EXCEDE (ceftiofur crystalline free acid) 

for Swine Sterile Suspension. The 

supplemental NADA provides for the 

veterinary prescription use of ceftiofur 

crystalline free acid suspension in 

swine, by intramuscular injection, for 

the control of SRD associated with 

Actinobacillus pleuropneumoniae, 

Pasteurella multocida, Haemophilus 

parasuis, and Streptococcus suis in 

groups of pigs where SRD has been 

diagnosed. The application is approved 

as of September 15, 2010, and the 

regulations are amended in 21 CFR 

522.313a to reflect the approval. In 

addition, the regulations are amended to 

specify which strength of two approved 

formulations is approved for use in 

horses. This is being done to improve 

the accuracy of the regulations. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, between 9 

a.m. and 4 p.m., Monday through 

Friday. 

Under section 512(c)(2)(F)(iii) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(c)(2)(F)(iii)), this 

approval qualifies for 3 years of 

marketing exclusivity beginning on the 

date of approval. 

The agency has determined under 21 

CFR 25.33 that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

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 in 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 part 522 is amended as follows: 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

■ 2. In § 522.313a, add a second 

sentence to paragraph (e)(1)(ii) and 

revise paragraph (e)(3) to read as 

follows: 

§ 522.313a Ceftiofur crystalline free acid. 

* * * * * 

(e) * * * 

(1) * * * 

(ii) * * * For the control of SRD 

associated with A. pleuropneumoniae, 

P. multocida, H. parasuis, and S. suis in 

groups of pigs where SRD has been 

diagnosed. 

* * * * * 

(3) Horses. The formulation described 

in paragraph (a)(2) of this section is 

used as follows: 

(i) Amount. Two intramuscular 

injections, 4 days apart, at a dose of 3.0 

mg/lb (6.6 mg/kg) body weight. 

(ii) Indications for use. For the 

treatment of lower respiratory tract 

infections in horses caused by 

susceptible strains of Streptococcus equi 

ssp. zooepidemicus. 

(iii) Limitations. Do not use in horses 

intended for human consumption. 

Dated: October 5, 2010. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2010–25527 Filed 10–8–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2010–0861] 

Drawbridge Operation Regulations; 

Saugatuck River, Saugatuck, CT 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, First Coast 

Guard District, has issued a temporary 

deviation from the regulation governing 

the operation of the Saga Railroad 

Bridge across the Saugatuck River, mile 

1.1, at Saugatuck, Connecticut. The 

deviation is necessary to facilitate 

scheduled rehabilitation maintenance at 

the bridge. Under this deviation the 

bridge may remain in the closed 

position from October 1, 2010 through 

October 17, 2010. 

DATES: This deviation is effective with 

constructive notice from October 12, 

2010 through October 17, 2010, and for 

enforcement with actual notice from 

October 1, 2010 through October 12, 

2010. 

ADDRESSES: Documents mentioned in 

this preamble as being available in the 

docket are part of docket USCG–2010– 

0861 and are available online at 

http://www.regulations.gov, inserting 

USCG–2010–0861 in the ‘‘Keyword’’ and 

then clicking ‘‘Search.’’ They are 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 rule, call or 

e-mail Ms. Judy K. Leung-Yee, Project 

Officer, First Coast Guard District, 

telephone (212) 668–7165, judy.k.leungyee@uscg.mil. If you have questions on 

viewing the docket, call Renee V. 

Wright, Program Manager, Docket 

Operations, telephone 202–366–9826. 


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1
Federal Register / Vol. 75, No. 196 / Tuesday, October 12, 2010 / Rules and Regulations 62469 

SUPPLEMENTARY INFORMATION: The Saga 

Railroad Bridge across the Saugatuck 

River at mile 1.1, has a vertical 

clearance of 13 feet at mean high water 

and 20 feet at mean low water. The 

drawbridge operation regulations are 

listed at 33 CFR 117.221(b). 

The owner of the bridge, Metro North 

Railroad, requested a temporary 

deviation from the regulations to 

facilitate scheduled maintenance, track 

tie replacement, from October 1, 2010 

through October 17, 2010. 

The normal waterway users are 

predominantly recreational craft of 

various sizes. 

Under this temporary deviation the 

Saga Railroad Bridge may remain in the 

closed position from October 1, 2010 

through October 17, 2010, to facilitate 

rehabilitation maintenance at the bridge. 

Vessels that can pass under the bridge 

in the closed position may do so at any 

time. 

Waterway users were advised of the 

requested bridge and channel closure 

and offered no objection. 

In accordance with 33 CFR 117.35(e), 

the bridge must return to its regular 

operating schedule immediately at the 

end of the designated time period. This 

deviation from the operating regulations 

is authorized under 33 CFR 117.35. 

Dated: September 28, 2010. 

Gary Kassof, 

Bridge Program Manager, First Coast Guard 

District. 

[FR Doc. 2010–25494 Filed 10–8–10; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2010–0847] 

Drawbridge Operation Regulations; 

Charles River, Boston, MA, 

Maintenance 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, First Coast 

Guard District, has issued a temporary 

deviation from the regulation governing 

the operation of the Craigie Bridge 

across the Charles River, mile 1.0, at 

Boston, Massachusetts. The deviation is 

necessary to facilitate scheduled 

rehabilitation maintenance at the bridge. 

Under this deviation the bridge may 

remain in the closed position from 

November 1, 2010 through April 26, 

2011. 

DATES: This deviation is effective from 

November 1, 2010 through April 26, 

2011. 

ADDRESSES: Documents mentioned in 

this preamble as being available in the 

docket are part of docket USCG–2010– 

0847 and are available online at 

www.regulations.gov, inserting USCG– 

2010–0847 in the ‘‘Keyword’’ and then 

clicking ‘‘Search.’’ They are 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 rule, call or 

e-mail Mr. John W. McDonald, Project 

Officer, First Coast Guard District, 

telephone (617) 223–8364, 

john.w.mcdonald@uscg.mil. If you have 

questions on viewing the docket, call 

Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: The 

Craigie Bridge across the Charles River 

at mile 1.0, has a vertical clearance of 

10.25 feet at normal pool elevation. The 

drawbridge operation regulations are 

listed at 33 CFR 117.591(e). 

During the rehabilitation construction 

the Craigie Bridge will provide a vertical 

clearance of 17.41 feet at normal pool 

elevation from November 15, 2010 

through January 19, 2011, and 10.25 feet 

at normal pool elevation from January 

20, 2011 through April 26, 2011. 

The operator of the bridge, the 

Massachusetts Department of 

Transportation, requested a temporary 

deviation from the regulations to 

facilitate scheduled rehabilitation 

maintenance from November 1, 2010 

through April 26, 2011. 

The normal waterway users are 

predominantly recreational craft of 

various sizes and commercial tour boats 

that operate from April through 

November. The waterway is normally 

frozen from late December through 

March each year. 

Under this temporary deviation the 

Craigie Bridge may remain in the closed 

position from November 1, 2010 

through April 26, 2011, to facilitate 

rehabilitation maintenance at the bridge. 

From November 1 through November 

14, 2010, a work barge will be located 

under the bridge blocking the entire 

channel from vessel access while the 

bridge lift spans are removed. 

From November 15, 2010 through 

April 26, 2011, vessels that can pass 

under the bridge in the closed position 

may do so provided they contact the 

contractor, J.F. White, Mr. Greg Labrum, 

via land line at 508–879–4700 or cell 

phone at 617–719–7150, to arrange a 

transit. 

Waterway users were advised of the 

requested bridge and channel closure 

and offered no objection. 

In accordance with 33 CFR 117.35(e), 

the bridge must return to its regular 

operating schedule immediately at the 

end of the designated time period. This 

deviation from the operating regulations 

is authorized under 33 CFR 117.35. 

Dated: September 28, 2010. 

Gary Kassof, 

Bridge Program Manager, First Coast Guard 

District. 

[FR Doc. 2010–25498 Filed 10–8–10; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2010–0907] 

Drawbridge Operation Regulations; 

Newtown Creek, Dutch Kills, English 

Kills, and Their Tributaries, NY, 

Maintenance 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, First Coast 

Guard District, has issued a temporary 

deviation from the regulation governing 

the operation of the Greenpoint Avenue 

Bridge across Newtown Creek, mile 1.3, 

New York. The deviation allows the 

bridge to remain in the closed position 

for seven days to facilitate bridge 

rehabilitation maintenance. 

DATES: This deviation is effective from 

October 26, 2010 through November 1, 

2010. 

ADDRESSES: Documents mentioned in 

this preamble as being available in the 

docket are part of docket USCG–2010– 

0907 and are available online at 

http://www.regulations.gov, inserting 

USCG–2010–0907 in the ‘‘Keyword’’ and 

then clicking ‘‘Search.’’ They are 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 rule, call or 


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1