Drawbridge Operation Regulations; Saugatuck River, Saugatuck, CT, 62468-62469 [2010-25494]

Download as PDF 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. Final rule; technical amendment. ACTION: 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. SUMMARY: 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 wwoods2 on DSK1DXX6B1PROD with RULES_PART 1 SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 14:49 Oct 08, 2010 Jkt 223001 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 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 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 Coast Guard, DHS. Notice of temporary deviation from regulations. AGENCY: ACTION: 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 https://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. SUMMARY: E:\FR\FM\12OCR1.SGM 12OCR1 Federal Register / Vol. 75, No. 196 / Tuesday, October 12, 2010 / Rules and Regulations 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. SUPPLEMENTARY INFORMATION: 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 Coast Guard, DHS. Notice of temporary deviation from regulations. AGENCY: ACTION: 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. wwoods2 on DSK1DXX6B1PROD with RULES_PART 1 SUMMARY: VerDate Mar<15>2010 14:49 Oct 08, 2010 Jkt 223001 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 DATES: PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 62469 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 Coast Guard, DHS. Notice of temporary deviation from regulations. AGENCY: ACTION: 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 https://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 SUMMARY: E:\FR\FM\12OCR1.SGM 12OCR1

Agencies

[Federal Register Volume 75, Number 196 (Tuesday, October 12, 2010)]
[Rules and Regulations]
[Pages 62468-62469]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-25494]


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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.

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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 https://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.leung-yee@uscg.mil. If 
you have questions on viewing the docket, call Renee V. Wright, Program 
Manager, Docket Operations, telephone 202-366-9826.

[[Page 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

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