60308 Federal Register / Vol. 69, No. 159 / Friday, October 8, 2004 / Rules and Regulations 

FDA finds that the effective date of the 

final rule that published in the Federal 

Register of July 28, 2004, should be 

confirmed.

List of Subjects in 21 CFR Part 74 

Color additives, Cosmetics, Drugs.

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 321, 

341, 342, 343, 348, 351, 352, 355, 361, 

362, 371, 379e) and under authority 

delegated to the Commissioner of Food 

and Drugs (1410.10 of the FDA Staff 

Manual Guide), notice is given that no 

objections or requests for a hearing were 

filed in response to the July 28, 2004, 

final rule. Accordingly, the amendments 

issued thereby became effective August 

30, 2004.

Dated: September 30, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–22605 Filed 10–7–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 522 and 556

New Animal Drugs; Flunixin

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 

Schering-Plough Animal Health Corp. 

The supplemental NADA provides for 

the veterinary prescription use of 

flunixin meglumine solution by 

intravenous injection in lactating dairy 

cattle for control of pyrexia associated 

with bovine respiratory disease and 

endotoxemia, and for control of 

inflammation in endotoxemia. It also 

provides for the veterinary prescription 

use of flunixin meglumine solution by 

intravenous injection for control of 

pyrexia associated with acute bovine 

mastitis and for the establishment of a 

tolerance for residues of flunixin in 

milk.

DATES: This rule is effective October 8, 

2004.

FOR FURTHER INFORMATION CONTACT: Joan 

C. Gotthardt, Center for Veterinary 

Medicine (HFV–130), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.gov.

SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 1095 

Morris Ave., Union, NJ 07083, filed a 

supplement to NADA 101–479 that 

provides for the veterinary prescription 

use of BANAMINE (flunixin 

meglumine) Injectable Solution by 

intravenous injection in lactating dairy 

cattle for control of pyrexia associated 

with bovine respiratory disease and 

endotoxemia, and for control of 

inflammation in endotoxemia. It also 

provides for the veterinary prescription 

use of flunixin meglumine solution by 

intravenous injection for control of 

pyrexia associated with acute bovine 

mastitis and for the establishment of a 

tolerance for residues of flunixin in 

milk. The supplemental NADA is 

approved as of August 19, 2004, and the 

regulations are amended in 21 CFR 

522.970 and 556.286 to reflect the 

approval. The basis of approval is 

discussed in the freedom of information 

summary.

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 

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

supplemental approval qualifies for 3 

years of marketing exclusivity beginning 

August 19, 2004. The 3 years of 

marketing exclusivity applies only to 

the new indication of control of pyrexia 

associated with acute bovine mastitis.

The agency has determined under 21 

CFR 25.33(d)(5) 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

21 CFR Part 522

Animal drugs. 

21 CFR Part 556

Animal drugs, Foods.

■ 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 522 and 556 are 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. Section 522.970 is amended by 

revising the section heading; by revising 

paragraph (b)(1); by redesignating 

paragraph (b)(2) as paragraph (b)(3); by 

adding new paragraph (b)(2); and by 

revising paragraphs (e)(2) introductory 

text, (e)(2)(i), (e)(2)(ii), and (e)(2)(iii) to 

read as follows:

§ 522.970 Flunixin.

* * * * *

(b) * * *

(1) See No. 000061 for use as in 

paragraph (e) of this section.

(2) See Nos. 055529, 057561, and 

059130 for use as in paragraphs (e)(1), 

(e)(2)(i)(A), (e)(2)(ii)(A), and (e)(2)(iii), of 

this section.

* * * * *

(e) * * *

* * * * *

(2) Cattle—(i) Amount. (A) 1.1 to 2.2 

mg/kilogram (kg) (0.5 to 1.0 mg/lb) of 

body weight per day, as a single dose or 

divided into two doses administered at 

12-hour intervals, intravenously, for up 

to 3 days.

(B) 2.2 mg/kg (1.0 mg/lb) of body 

weight given once by intravenous 

administration.

(ii) Indications for use. (A) For control 

of pyrexia associated with bovine 

respiratory disease and endotoxemia. 

Also indicated for control of 

inflammation in endotoxemia.

(B) For control of pyrexia associated 

with acute bovine mastitis.

(iii) Limitations. Do not slaughter for 

food use within 4 days of last treatment. 

A withdrawal period has not been 

established for use in preruminating 

calves. Do not use in calves to be 

processed for veal. For No. 000061: Do 

not use in dry dairy cows. Milk that has 

been taken during treatment and for 36 

hours after the last treatment must not 

be used for food. For Nos. 055529, 

057561, and 059130: Not for use in 

lactating or dry dairy cows.

Federal Register / Vol. 69, No. 159 / Friday, October 8, 2004 / Rules and Regulations 60309

PART 556—TOLERANCES FOR 

RESIDUES OF NEW ANIMAL DRUGS 

IN FOOD

■ 3. The authority citation for 21 CFR 

part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

■ 4. Section 556.286 is amended by 

revising the section heading; by revising 

paragraph (b); and by adding paragraph 

(c) to read as follows:

§ 556.286 Flunixin.

* * * * *

(b) Tolerances—(1) Cattle. The 

tolerance for flunixin free acid (the 

marker residue) is:

(i) Liver (the target tissue). 125 parts 

per billion (ppb).

(ii) Muscle. 25 ppb.

(iii) Milk. 2 ppb.

(2) [Reserved]

(c) Related conditions of use. See 

§ 522.970 of this chapter.

Dated: September 27, 2004.

Stephen D. Vaughn,

Office of New Animal Drug Evaluation, Center 

for Veterinary Medicine.

[FR Doc. 04–22606 Filed 10–7–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 151

[USCG–2002–14273] 

RIN 1625–AA52

Mandatory Ballast Water Management 

Program for U.S. Waters; Corrections

AGENCY: Coast Guard, DHS.

ACTION: Correcting amendments.

SUMMARY: The Coast Guard is correcting 

a final rule that appeared in the Federal 

Register of July 28, 2004 (69 FR 44952). 

The final rule requires mandatory 

ballast water management practices for 

all vessels equipped with ballast water 

tanks bound for ports or places within 

the U.S. or entering U.S. waters. These 

grammatical corrections clarify the final 

rule.

DATES: This correction is effective on 

July 28, 2004.

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call Mr. 

Bivan Patnaik, Project Manager, 

Environmental Standards Division, 

Coast Guard, telephone 202–267–1744, 

email: bpatnaik@comdt.uscg.mil. If you 

have questions on viewing the docket, 

call Ms. Andrea M. Jenkins, Program 

Manager, Docket Operations, telephone 

202–366–0271.

SUPPLEMENTARY INFORMATION: 

Need for Correction 

As published, the final rule contain 

errors which may prove to be 

misleading and therefore need to be 

clarified.

List of Subjects in 33 CFR Part 151

Administrative practice and 

procedure, Oil pollution, Penalties, 

Reporting and recordkeeping 

requirements, Water pollution control.

■ Accordingly, 33 CFR part 151 is 

corrected by making the following 

correcting amendments:

PART 151—VESSELS CARRYING OIL, 

NOXIOUS LIQUID SUBSTANCES, 

GARBAGE, MUNICIPAL OR 

COMMERCIAL WASTE, AND BALLAST 

WATER

Subpart D—Ballast Water Management 

for Control of Nonindigenous Species 

in Waters of the United States

■ 1. The authority citation for subpart D 

continues to read as follows:

Authority: 16 U.S.C. 4711; Department of 

Homeland Security Delegation No. 0170.1.

§ 151.2035 [Corrected]

■ 2. In § 151.2035(b)(2), add the word 

‘‘or’’ after the semicolon. In paragraph 

(b)(3), replace the semi-colon with a 

period.

Dated: September 28, 2004. 

Joseph J. Angelo, 

Director of Standards, Marine Safety, Security 

& Environmental Protection.

[FR Doc. 04–22721 Filed 10–7–04; 8:45 am] 

BILLING CODE 4910–15–P

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64

[Docket No. FEMA–7849] 

Suspension of Community Eligibility

AGENCY: Federal Emergency 

Management Agency, Emergency 

Preparedness and Response Directorate, 

Department of Homeland Security.

ACTION: Final rule.

SUMMARY: This rule identifies 

communities, where the sale of flood 

insurance has been authorized under 

the National Flood Insurance 

Program(NFIP), that are suspended on 

the effective dates listed within this rule 

because of noncompliance with the 

floodplain management requirements of 

the program. If the Federal Emergency 

Management Agency (FEMA) receives 

documentation that the community has 

adopted the required floodplain 

management measures prior to the 

effective suspension date given in this 

rule, the suspension will be withdrawn 

by publication in the Federal Register.

DATES: The effective date of each 

community’s suspension is the third 

date (‘‘Susp.’’) listed in the third column 

of the following tables.

ADDRESSES: If you wish to determine 

whether a particular community was 

suspended on the suspension date, 

contact the appropriate FEMA 

RegionalOffice or the NFIP servicing 

contractor.

FOR FURTHER INFORMATION CONTACT:

Mike Grimm, Mitigation Division, 500 C 

Street, SW.; Room 412, Washington, DC 

20472, (202) 646–2878.

SUPPLEMENTARY INFORMATION: The NFIP 

enables property owners to purchase 

flood insurance which is generally not 

otherwise available. In return, 

communities agree to adopt and 

administer local floodplain management 

aimed at protecting lives and new 

construction from future flooding. 

Section 1315 of the National Flood 

Insurance Act of 1968, as amended, 42 

U.S.C. 4022, prohibits flood insurance 

coverage as authorized under the 

National Flood Insurance Program, 42 

U.S.C. 4001 et seq.; unless an 

appropriate public body adopts 

adequate floodplain management 

measures with effective enforcement 

measures. The communities listed in 

this document no longer meet that 

statutory requirement for compliance 

with program regulations, 44 CFR part 

59 et seq. Accordingly, the communities 

will be suspended on the effective date 

in the third column. As of that date, 

flood insurance will no longer be 

available in the community. However, 

some of these communities may adopt 

and submit the required documentation 

of legally enforceable floodplain 

management measures after this rule is 

published but prior to the actual 

suspension date. These communities 

will not be suspended and will continue 

their eligibility for the sale of insurance. 

A notice withdrawing the suspension of 

the communities will be published in 

the Federal Register. 

In addition, the Federal Emergency 

Management Agency has identified the 

special flood hazard areas in these 

communities by publishing a Flood 

Insurance Rate Map (FIRM). The date of