Federal Register / Vol. 69, No. 159 / Friday, October 8, 2004 / Rules and Regulations 60307

1 17 CFR 200.30–3(a)(12).

inserted in lieu of the statement of the terms 

of substance. If the proposed rule change 

amends an existing rule, indicate changes in 

the rule by brackets for words to be deleted 

and underlined for words to be added.)

II. Self-Regulatory Organization’s Statement 

of the Purpose of, and Statutory Basis for, 

the Proposed Rule Change 

In its filing with the Commission, the selfregulatory organization included statements 

concerning the purpose of and basis for the 

proposed rule change and discussed any 

comments it received on the proposed rule 

change. The text of these statements may be 

examined at the places specified in Item IV 

below. The self-regulatory organization has 

prepared summaries, set forth in Sections A, 

B, and C below, of the most significant 

aspects of such statements. (Reproduce the 

headings, and summarize briefly the most 

significant aspects of the responses, to Items 

3, 4, and 5 of Form 19b–4, redesignating 

them as A, B, and C, respectively.) 

III. Date of Effectiveness of the Proposed 

Rule Change and Timing for Commission 

Action 

(If the proposed rule change is to be 

considered by the Commission pursuant to 

Section 19(b)(2) of the Act, the following 

paragraph should be used.)Within 35 days of 

the date of publication of this notice in the 

Federal Register or within such longer 

period (i) as the Commission may designate 

up to 90 days of such date if it finds such 

longer period to be appropriate and publishes 

its reasons for so finding or (ii) as to which 

the self-regulatory organization consents, the 

Commission will: 

(A) By order approve such proposed rule 

change, or 

(B) Institute proceedings to determine 

whether the proposed rule change should be 

disapproved. 

(If the proposed rule change is to take, or 

to be put into, effect pursuant to Section 

19(b)(3)(A) of the Act and paragraph (f)(6) of 

Rule 19b–4 thereunder, the following 

paragraph should be used.) 

Because the foregoing proposed rule 

change does not: 

(i) Significantly affect the protection of 

investors or the public interest; 

(ii) Impose any significant burden on 

competition; and 

(iii) Become operative for 30 days from the 

date on which it was filed, or such shorter 

time as the Commission may designate, it has 

become effective pursuant to Section 

19(b)(3)(A) of the Act and Rule 19b–4(f)(6) 

thereunder. 

At any time within 60 days of the filing of 

the proposed rule change, the Commission 

may summarily abrogate such rule change if 

it appears to the Commission that such action 

is necessary or appropriate in the public 

interest, for the protection of investors, or 

otherwise in furtherance of the purposes of 

the Act. 

(If the proposed rule change is to take, or 

to be put into, effect pursuant to Section 

19(b)(3)(A) of the Act and subparagraphs (1)–

(5) of paragraph (f) of Rule 19b–4 thereunder, 

the following paragraph should be used.) 

The foregoing rule change has become 

effective pursuant to Section 19(b)(3)(A) of 

the Act and paragraph (f) of Rule 19b-4 

thereunder. At any time within 60 days of the 

filing of the proposed rule change, the 

Commission may summarily abrogate such 

rule change if it appears to the Commission 

that such action is necessary or appropriate 

in the public interest, for the protection of 

investors, or otherwise in furtherance of the 

purposes of the Act. 

(If the proposed rule change is to be 

considered by the Commission pursuant to 

Section 19(b)(7)(D) of the Act, the following 

paragraph should be used.) 

Within 35 days of the date of publication 

of this notice in the Federal Register or 

within such longer period (i) as the 

Commission may designate up to 90 days of 

such date if it finds such longer period to be 

appropriate and publishes its reasons for so 

finding or (ii) as to which the self-regulatory 

organization consents, the Commission will: 

(A) By order approve such proposed rule 

change, or 

(B) After consultation with the Commodity 

Futures Trading Commission, institute 

proceedings to determine whether the 

proposed rule change should be disapproved. 

IV. Solicitation of Comments 

Interested persons are invited to submit 

written data, views and arguments 

concerning the foregoing, including whether 

the proposed rule change is consistent with 

the Act. Comments may be submitted by any 

of the following methods: 

Electronic Comments 

• Use the Commission’s Internet comment 

form (http://www.sec.gov/rules/sro.shtml); or 

• Send an e-mail to rulecomments@sec.gov. Please include File 

Number XX on the subject line. 

Paper Comments 

• Send paper comments in triplicate to 

Jonathan G. Katz, Secretary, Securities and 

Exchange Commission, 450 Fifth Street, NW., 

Washington, DC 20549–0609. 

All submissions should refer to File 

Number XX. This file number should be 

included on the subject line if e-mail is used. 

To help the Commission process and review 

your comments more efficiently, please use 

only one method. The Commission will post 

all comments on the Commission’s Internet 

Web site (http://www.sec.gov/rules/

sro.shtml). Copies of the submission, all 

subsequent amendments, all written 

statements with respect to the proposed rule 

change that are filed with the Commission, 

and all written communications relating to 

the proposed rule change between the 

Commission and any person, other than 

those that may be withheld from the public 

in accordance with the provisions of 5 U.S.C. 

552, will be available for inspection and 

copying in the Commission’s Public 

Reference Room, 450 Fifth Street, NW., 

Washington, DC 20549. Copies of such filing 

also will be available for inspection and 

copying at the principal office of the 

[exchange]. All comments received will be 

posted without change; the Commission does 

not edit personal identifying information 

from submissions. You should submit only 

information that you wish to make available 

publicly. All submissions should refer to File 

Number XX and should be submitted on or 

before [insert date 21 days from publication 

in the Federal Register].

For the Commission, by the Division of 

Market Regulation, pursuant to delegated 

authority.1

Secretary

[FR Doc. 04–22628 Filed 10–5–04; 9:06 am] 

BILLING CODE 8010–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. 1987C–0023]

Listing of Color Additives Subject to 

Certification; D&C Black No. 2; 

Confirmation of Effective Date

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule; confirmation of 

effective date.

SUMMARY: The Food and Drug 

Administration (FDA) is confirming the 

effective date of August 30, 2004, for the 

final rule that appeared in the Federal 

Register of July 28, 2004 (69 FR 44927). 

The final rule amended the color 

additive regulations to provide for the 

safe use of D&C Black No. 2 (a high 

purity furnace black, subject to FDA 

batch certification) as a color additive in 

the following cosmetics: Eyeliner, 

brush-on-brow, eye shadow, mascara, 

lipstick, blushers and rouge, makeup 

and foundation, and nail enamel.

DATES: Effective date confirmed: August 

30, 2004.

FOR FURTHER INFORMATION CONTACT:

Celeste Johnston, Center for Food Safety 

and Applied Nutrition (HFS–265), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740–

3835, 202–418–3423.

SUPPLEMENTARY INFORMATION: In the 

Federal Register of July 28, 2004 (69 FR 

44927), FDA amended the color additive 

regulations to add § 74.2052 D&C Black 

No. 2 (21 CFR 74.2052) to provide for 

the safe use of D&C Black No. 2 as a 

color additive in the following 

cosmetics: Eyeliner, brush-on-brow, eye 

shadow, mascara, lipstick, blushers and 

rouge, makeup and foundation, and nail 

enamel.

FDA gave interested persons until 

August 27, 2004, to file objections or 

requests for a hearing. The agency 

received no objections or requests for a 

hearing on the final rule. Therefore,

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.