Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations 45611 

animal drug regulations to reflect 

approval of a supplemental new animal 

drug application (NADA) filed by 

Phibro Animal Health. The 

supplemental NADA provides for label 

revisions associated with a previous 

change of sponsorship and other minor 

changes for amprolium concentrate 

solution to make medicated drinking 

water for chickens and turkeys for the 

treatment of coccidiosis. The product 

approval is being codified for the first 

time. 

DATES: This rule is effective August 6, 

2008. 

FOR FURTHER INFORMATION CONTACT: 

Donald A. Prater, Center for Veterinary 

Medicine (HFV–130), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8343, 

e-mail: donald.prater@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Phibro 

Animal Health, 65 Challenger Rd., 3d 

floor, Ridgefield Park, NJ 07660, filed a 

supplement to NADA 13–663 that 

provides for the use of COCCIPROL 

(amprolium) 9.6% Oral Solution to 

make medicated drinking water for 

chickens and turkeys for the treatment 

of coccidiosis. The supplemental NADA 

provides for label revisions associated 

with a previous change of sponsorship 

and other minor changes. The 

supplemental NADA is approved as of 

July 8, 2008, and the regulations are 

amended in 21 CFR 520.100 to reflect 

the approval. The product approval is 

being codified for the first time. Also, §

520.100 is revised to reflect current 

pathogen spelling. 

Approval of this supplemental NADA 

did not require review of additional 

safety or effectiveness data or 

information. Therefore, a freedom of 

information summary is not required. 

The agency has determined under 21 

CFR 25.33(a)(1) 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 Subject in 21 CFR Part 520 

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 520 is amended as follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

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

■ 2. In § 520.100, revise paragraph (b), 

remove paragraph (d), redesignate 

paragraph (e) as paragraph (d), and 

revise new paragraphs (d)(2)(i)(A) and 

(d)(2)(i)(B) to read as follows: 

§ 520.100 Amprolium. 

* * * * * 

(b) Sponsors. See sponsors in 

510.600(c) of this chapter. 

(1) No. 016592 for use of products 

described in paragraph (a) of this 

section as in paragraph (d) of this 

section. 

(2) Nos. 051311 and 066104 for use of 

product described in paragraph (a)(1) of 

this section as in paragraph (d)(1) of this 

section. 

(3) No. 059130 for use of product 

described in paragraph (a)(1) of this 

section as in paragraph (d)(2) of this 

section. 

* * * * * 

(d) * * * 

(2) * * * 

(i) * * * (A) As an aid in the 

prevention of coccidiosis caused by 

Eimeria bovis and E. zurnii, administer 

5 mg per kilogram (mg/kg) body weight 

for 21 days during periods of exposure 

or when experience indicates that 

coccidiosis is likely to be a hazard. 

(B) As an aid in the treatment of 

coccidiosis caused by E. bovis and E. 

zurnii, administer 10 mg/kg body weight 

for 5 days. 

* * * * * 

Dated: July 28, 2008. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E8–18093 Filed 8–5–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

[Docket No. FDA–2008–N–0039] 

Implantation or Injectable Dosage 

Form New Animal Drugs; Ceftiofur 

Hydrochloride 

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 new animal drug 

application (NADA) filed by Pharmacia 

and Upjohn Co., a Division of Pfizer, 

Inc. The NADA provides for the 

veterinary prescription use of a ceftiofur 

hydrochloride injectable suspension for 

treatment of various bacterial infections 

in swine and cattle. 

DATES: This rule is effective August 6, 

2008. 

FOR FURTHER INFORMATION CONTACT: 

Donald A. Prater, Center for Veterinary 

Medicine (HFV–130), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8343, 

e-mail: donald.prater@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pharmacia 

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

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

filed NADA 141–288 that provides for 

veterinary prescription use of EXCENEL 

RTU EZ (ceftiofur hydrochloride) Sterile 

Suspension, used for treatment of 

various bacterial infections in swine and 

cattle. The NADA is approved as of July 

1, 2008, and the regulations are 

amended in 21 CFR 522.313b to reflect 

the approval. A swine pathogen is also 

being revised to reflect current scientific 

nomenclature. 

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)(ii) of the 

Federal Food, Drug, and Cosmetic Act 

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

approval qualifies for 3 years of 

marketing exclusivity beginning on the 

date of approval. 

The agency has determined under 

§ 25.33(a)(1) 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 Subject in 21 CFR Part 522 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 


yshivers on PROD1PC62 with RULES
45612 Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations 

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 § 522.313b, revise paragraphs (a), 

(e)(1)(ii), and (e)(2)(i) to read as follows: 

§ 522.313b Ceftiofur hydrochloride. 

(a) Specifications. Each milliliter of 

ceftiofur hydrochloride suspension 

contains 50 milligrams (mg) ceftiofur 

equivalents in either a peanut oil or 

caprylic/capric triglyceride suspension. 

* * * * * 

(e) Conditions of use—

(1) * * * 

(ii) Indications for use. For treatment 

and control of swine bacterial 

respiratory disease (swine bacterial 

pneumonia) associated with 

Actinobacillus pleuropneumoniae, 

Pasteurella multocida, Salmonella 

Choleraesuis, and Streptococcus suis. 

* * * * * 

(2) * * * 

(i) Amount. For bovine respiratory 

disease and acute bovine interdigital 

necrobacillosis, administer 1.1 to 2.2 

mg/kg of body weight at 24-hour 

intervals for 3 to 5 consecutive days. For 

bovine respiratory disease only, 2.2 mg/ 

kg of body weight may be administered 

twice at a 48-hour interval. For acute 

metritis only, administer 2.2 mg/kg of 

body weight at 24-hour intervals for 5 

consecutive days. Product in peanut oil 

suspension may be administered by 

either intramuscular or subcutaneous 

injection. Product in caprylic/capric 

triglyceride suspension may be 

administered by subcutaneous injection 

only. 

* * * * * 

Dated: July 28, 2008. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E8–18094 Filed 8–5–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9415] 

RIN 1545–BB84 

REMIC Residual Interests—Accounting 

for REMIC Net Income (Including Any 

Excess Inclusions) (Foreign Holders) 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Correcting amendment. 

SUMMARY: This document contains a 

correction to final regulations (TD 

9415), that were published in the 

Federal Register on Monday, July 14, 

2008 (73 FR 40171). The final 

regulations relates to income that is 

associated with a residual interest in a 

Real Estate Mortgage Investment 

Conduit (REMIC) and that is allocated 

through certain entities to foreign 

persons who have invested in those 

entities. 

DATES: This correction is effective on 

August 6, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Arturo Estrada, (202) 622–3900 (not a 

toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background 

The final regulations (TD 9415) that is 

the subject of this correction is under 

section 1441 of the Internal Revenue 

Code. 

Need for Correction 

As published, TD 9415 contains an 

error that may prove to be misleading 

and is in need of clarification. 

List of Subjects in 26 CFR Part 1 

Income taxes, Reporting and 

recordkeeping requirements. 

Correction of Publication 

■ Accordingly, 26 CFR part 1 is 

corrected by making the following 

correcting amendment: 

PART 301—PROCEDURE AND 

ADMINISTRATION 

■ Paragraph 1. The authority citation 

for part 1 continues to read in part as 

follows: 

Authority: 26 U.S.C. 7805 * * * 

■ Par. 2. Section 1.1441–2 is amended 

by revising paragraph (f) to read as 

follows: 

§ 1.1441–2 Amounts subject to 

withholding. 

* * * * * 

(f) Effective/applicability date. This 

section applies to payments made after 

December 31, 2000. Paragraphs (b)(5) 

and (d)(4) of this section apply to 

payments made after August 1, 2006. 

Cynthia E. Grigsby, 

Senior Federal Register Liaison Officer, 

Publications and Regulations Branch, Legal 

Processing Division, Associate Chief Counsel, 

(Procedure and Administration). 

[FR Doc. E8–17954 Filed 8–5–08; 8:45 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket No. USCG–2008–0763] 

RIN 1625–AA00 

Special Local Regulation; Chris Craft 

Silver Cup Regatta, St. Clair River, 

Algonac, MI 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary special local 

regulation for an area on the St. Clair 

River, Algonac, Michigan. This 

temporary special local regulation is 

intended to restrict vessels from a 

portion of the St. Clair River during the 

Chris Craft Silver Cup Regatta. This 

temporary special local regulation is 

necessary to protect spectators and 

vessels from the hazards associated with 

boat race operations. 

DATES: This rule is effective from 9 a.m. 

on August 8, 2008 until 8 p.m. on 

August 10, 2008. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket USCG–2008–

0763 and are available online at 

http://www.regulations.gov. 

They are also available for inspection 

or copying at two locations: 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, and at U.S. 

Coast Guard Sector Detroit, 110 Mt. 

Elliot Ave., Detroit, MI 48207 between 

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

Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

rule, call CDR Joseph Snowden, 

Prevention, U.S. Coast Guard Sector 


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