Federal Register / Vol. 75, No. 198 / Thursday, October 14, 2010 / Rules and Regulations 63085 

following information with respect to 

the swap transaction: 

(i) A copy of the transaction 

confirmation, in electronic form if 

available, or in written form if there is 

no electronic copy; and 

(ii) The time, if available, that the 

transaction was executed; and 

(2) Report to the Commission on 

request, in a form and manner 

prescribed by the Commission, any 

information relating to the swap 

transaction. 

Note to Paragraphs (a)(1) and (a)(2). In 

order to comply with the reporting 

requirements contained in paragraph 

(a)(1) and (a)(2) of this section, each 

counterparty to a pre-enactment 

unexpired swap transaction that may be 

required to report such transaction 

should retain, in its existing format, all 

information and documents, to the 

extent and in such form as they 

presently exist, relating to the terms of 

a swap transaction, including but not 

limited to any information necessary to 

identify and value the transaction; the 

date and time of execution of the 

transaction; information relevant to the 

price of the transaction; whether the 

transaction was accepted for clearing 

and, if so, the identity of such clearing 

organization; any modification(s) to the 

terms of the transaction; and the final 

confirmation of the transaction. 

(b) Reporting party. The 

counterparties to a swap transaction 

shall report the information required 

under paragraph (a) of this section as 

follows: 

(1) Where only one counterparty to a 

swap transaction is a swap dealer or a 

major swap participant, the swap dealer 

or major swap participant shall report 

the transaction; 

(2) Where one counterparty to a swap 

transaction is a swap dealer and the 

other counterparty is a major swap 

participant, the swap dealer shall report 

the transaction; and 

(3) Where neither counterparty to a 

swap transaction is a swap dealer or a 

major swap participant, the 

counterparties to the transaction shall 

select the counterparty who will report 

the transaction. 

By the Commission. 

Dated: October 1, 2010. 

David A. Stawick, 

Secretary. 

[FR Doc. 2010–25325 Filed 10–13–10; 8:45 am] 

BILLING CODE 6351–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 529 

[Docket No. FDA–2010–N–0002] 

Certain Other Dosage Form New 

Animal Drugs; Progesterone 

Intravaginal Inserts 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

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 use of progesterone 

intravaginal inserts and dinoprost 

tromethamine by injection for 

synchronization of estrus in lactating 

dairy cows. 

DATES: This rule is effective October 14, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Suzanne J. Sechen, Center for Veterinary 

Medicine (HFV–126), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8105, 

e-mail: suzanne.sechen@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 141–200 

that provides for use of EAZI–BREED 

CIDR Progesterone Intravaginal Inserts 

and dinoprost tromethamine by 

injection for synchronization of estrus 

in lactating dairy cows. The NADA is 

approved as of July 22, 2010, and the 

regulations are amended in 21 CFR 

529.1940 to reflect the approval. 

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 

supplemental 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 529 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under the 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 529 is amended as follows: 

PART 529—CERTAIN OTHER DOSAGE 

FORM NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 529 continues to read as follows: 

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

■ 2. In § 529.1940, revise paragraphs 

(d)(2) and (e)(1) and remove the last 

sentence in paragraph (e)(2)(iii) to read 

as follows: 

§ 529.1940 Progesterone intravaginal 

inserts. 

* * * * * 

(d) * * * 

(2) Cows. This product is approved 

with the concurrent use of dinoprost 

solution when used for indications 

listed in paragraphs (e)(1)(ii)(A) and 

(e)(1)(ii)(B) of this section. See 

§ 522.690(c) of this chapter. 

(e) * * * 

(1) Cows—(i) Amount. Administer one 

intravaginal insert per animal for 7 days. 

When used for indications listed in 

paragraph (e)(1)(ii)(A) of this section, 

administer 25 milligrams (mg) dinoprost 

(5 milliliters (mL) of 5 mg/mL solution 

as in § 522.690(a) of this chapter) as a 

single intramuscular injection 1 day 

prior to insert removal (Day 6). When 

used for indications listed in paragraph 

(e)(1)(ii)(B) of this section, administer 25 

mg dinoprost as a single intramuscular 

injection on the day of insert removal 

(Day 7). 

(ii) Indications for use—(A) For 

synchronization of estrus in suckled 

beef cows and replacement beef and 

dairy heifers; for advancement of first 

postpartum estrus in suckled beef cows; 

and for advancement of first pubertal 

estrus in replacement beef heifers. 

(B) For synchronization of estrus in 

lactating dairy cows. 

(C) For synchronization of the return 

to estrus in lactating dairy cows 


emcdonald on DSK2BSOYB1PROD with RULES
63086 Federal Register / Vol. 75, No. 198 / Thursday, October 14, 2010 / Rules and Regulations 

inseminated at the immediately 

preceding estrus. 

(iii) Limitations. Do not use in beef or 

dairy heifers of insufficient size or age 

for breeding or in animals with 

abnormal, immature, or infected genital 

tracts. Do not use in beef cows that are 

fewer than 20 days postpartum. Do not 

use an insert more than once. To 

prevent the potential transmission of 

venereal and bloodborne diseases, the 

inserts should be disposed after a single 

use. Administration of vaginal inserts 

for periods greater than 7 days may 

result in reduced fertility. Dinoprost 

solution provided by No. 000009 in 

§ 510.600(c) of this chapter. 

* * * * * 

Dated: October 8, 2010. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–25893 Filed 10–13–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2010–0912] 

Drawbridge Operation Regulations; 

Duluth Ship Canal (Duluth-Superior 

Harbor). 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: Commander, Ninth Coast 

Guard District, has issued a temporary 

deviation from the regulation governing 

the operation of the Duluth Ship Canal 

Aerial Bridge at Mile 0.1 over the 

Duluth Ship Canal, at Duluth, MN, for 

scheduled maintenance. During this 

temporary deviation the bridge will be 

secured to masted navigation. Vessels 

that can pass under the bridge without 

an opening may do so at any time. 

DATES: This deviation is effective from 

6 a.m. on January 14, 2011 to 10 a.m. 

on March 14, 2011. 

ADDRESSES: Documents mentioned in 

this preamble as being available in the 

docket are part of docket USCG–2010– 

0912 and are available online by going 

to http://www.regulations.gov, inserting 

USCG–2010–0912 in the ‘‘Keyword’’ box 

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. Lee D. Soule, Bridge 

Management Specialist, Ninth Coast 

Guard District; telephone 216–902– 

6085, e-mail; lee.d.soule@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 City 

of Duluth, MN, who owns and operates 

this drawbridge, has requested a 

temporary deviation from the current 

operating regulations set forth in 33 CFR 

117.661. The purpose of this request is 

to facilitate structural maintenance of 

the bridge superstructure. The bridge is 

normally required to open if at least 24 

hours advance notice is provided during 

the scheduled maintenance period. 

Vessels that can pass under the bridge 

without an opening may do so at any 

time. The bridge has a horizontal 

clearance of 300 feet and a vertical 

clearance of 15 feet in the closed 

position. Mariners that require passage 

between the harbor and Lake Superior 

with an air draft greater than 15 feet 

may use the Superior Entrance Channel, 

Superior, Wisconsin at any time. Impact 

to masted navigation is mitigated by the 

close proximity of an alternate route and 

the reduced navigational needs in the 

harbor during the winter. The most 

updated and detailed marine 

information for this event, and all bridge 

operations, is found in the Local Notice 

to Mariners and Broadcast Notice to 

Mariners issued by the Coast Guard. 

From 6 a.m. on January 14, 2011 to 10 

a.m. on March 14, 2011 the bridge need 

not open for any vessel. In accordance 

with 33 CFR 117.35(e), the drawbridge 

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. 

Scot M. Striffler, 

Bridge Program Manager, Ninth Coast Guard 

District. 

[FR Doc. 2010–25805 Filed 10–13–10; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2010–0873] 

RIN 1625–AA00 

Great Mississippi Balloon Race and 

Fireworks Safety Zone; Lower 

Mississippi River, Mile Marker 365.5 to 

Mile Marker 363, Natchez, MS 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone for 

all waters of the Lower Mississippi 

River from mile marker 365.5 to 363 

extending the entire width of the river. 

This safety zone is needed to protect 

persons and vessels from the potential 

safety hazards associated with a 

fireworks display and low flying hot air 

balloons transiting across the Lower 

Mississippi River. Entry into this zone 

is prohibited to all vessels, mariners, 

and persons unless specifically 

authorized by the Captain of the Port 

(COTP) Lower Mississippi River or a 

designated representative. The COTP 

Lower Mississippi River or a designated 

representative must authorize vessels 

that desire to operate in this zone. 

DATES: This rule is effective from 7:15 

p.m. on October 15, 2010, until 6 p.m. 

on October 16, 2010. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket USCG–2010– 

0873 and are available online by going 

to http://www.regulations.gov, inserting 

USCG–2010–0873 in the ‘‘Keyword’’ 

box, 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 temporary 

rule, call or e-mail Lieutenant Junior 

Grade Jason Erickson, Coast Guard; 

telephone 901–521–4753, e-mail 

Jason.A.Erickson@uscg.mil. If you have 

questions on viewing the docket, call 

Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: 


emcdonald on DSK2BSOYB1PROD with RULES