76260 Federal Register / Vol. 75, No. 235 / Wednesday, December 8, 2010 / Rules and Regulations 

Dated: December 2, 2010. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2010–30814 Filed 12–7–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

[Docket No. FDA–2010–N–0002] 

Implantation or Injectable Dosage 

Form 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 abbreviated 

new animal drug application (ANADA) 

filed by Agri Laboratories, Ltd. The 

supplemental ANADA provides for use 

of flunixin meglumine solution by 

intravenous injection in lactating dairy 

cows for control of pyrexia associated 

with acute bovine mastitis. 

DATES: This rule is effective December 8, 

2010. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–104), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8197, 

e-mail: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Agri 

Laboratories, Ltd., P.O. Box 3103, St. 

Joseph, MO 64503, filed a supplement 

to ANADA 200–061 that provides for 

veterinary prescription use of FLU–NIX 

(flunixin meglumine) Injectable 

Solution. The supplemental ANADA 

provides for use of flunixin meglumine 

solution by intravenous injection in 

lactating dairy cows for control of 

pyrexia associated with acute bovine 

mastitis. The supplemental application 

is approved as of September 27, 2010, 

and the regulations are amended in 21 

CFR 522.970 to reflect the approval. 

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. 

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 § 522.970, revise paragraphs (b), 

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

§ 522.970 Flunixin. 

* * * * * 

(b) Sponsors. See sponsors in 

§ 510.600(c) of this chapter for use as in 

paragraph (e) of this section. 

(1) See Nos. 000061, 055529, and 

061623 for use as in paragraph (e) of this 

section. 

(2) See No. 000856 for use as in 

paragraph (e)(1) of this section. 

(3) See Nos. 057561 and 059130 for 

use as in paragraphs (e)(1) and (2) of this 

section. 

* * * * * 

(e) * * * 

(1) * * * 

(iii) Limitations. Do not use in horses 

intended for human consumption. 

(2) Cattle—(i) Amounts and 

indications for use—(A) Administer 1.1 

to 2.2 mg/kilogram (kg) (0.5 to 1.0 mg/ 

lb) of body weight per day 

intravenously, as a single dose or 

divided into two doses administered at 

12-hour intervals, for up to 3 days for 

control of pyrexia associated with 

bovine respiratory disease and 

endotoxemia or for control of 

inflammation in endotoxemia. 

(B) Administer 2.2 mg/kg (1.0 mg/lb) 

of body weight once intravenously for 

control of pyrexia associated with acute 

bovine mastitis. 

(ii) Limitations. Cattle must not be 

slaughtered for human consumption 

within 4 days of last treatment. Milk 

that has been taken during treatment 

and for 36 hours after the last treatment 

must not be used for food. Do not use 

in dry dairy cows. A withdrawal period 

has not been established for use in 

preruminating calves. Do not use in 

calves to be processed for veal. 

* * * * * 

Dated: December 1, 2010. 

Elizabeth Rettie, 

Deputy Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–30769 Filed 12–7–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

24 CFR Parts 5, 84, and 85 

[Docket No. FR–5350–F–02] 

RIN 2501–AD50 

Conforming Changes to Applicant 

Submission Requirements; 

Implementing Federal Financial Report 

and Central Contractor Registration 

Requirements 

AGENCY: Office of the Secretary, HUD. 

ACTION: Final rule. 

SUMMARY: This final rule follows 

publication of a July 15, 2010, interim 

rule that revised HUD regulations to 

reference the new governmentwide 

Federal Financial Report (FFR) 

approved by the Office of Management 

and Budget (OMB). The FFR 

consolidates requirements from the 

OMB-issued Standard Forms SF–269, 

SF–269A, SF–272, and SF–272A into a 

single governmentwide form. In 

incorporating reference to the new FFR 

in its regulations, HUD amended its 

regulations to remove references to old 

and outdated forms that are no longer in 

use. The July 15, 2010, interim rule also 

codified the requirement that applicants 

for HUD assistance possess an active 

Central Contractor Registration (CCR). 

HUD is adopting the interim rule 

without change. 

DATES: Effective Date: January 7, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Barbara Dorf, Director, Office of 

Departmental Grants Management and 

Oversight, Office of Administration, 

Chief Human Capital Officer, 

Department of Housing and Urban 

Development, 451 7th Street, SW., 

Room 3156, Washington, DC 20410– 

0500, telephone number 202–708–0667. 

Persons with hearing or speech 

impairments may access this number 

through TTY by calling the toll-free 

Federal Information Relay Service at 

800–877–8339. 


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