16270 Federal Register / Vol. 72, No. 64 / Wednesday, April 4, 2007 / Rules and Regulations 

Commission, Three Lafayette Centre, 

1155 21st Street, NW., Washington, DC 

20581. Requests for public records 

directed to a regional office of the 

Commission pursuant to § 145.2 should 

be sent to: 

Commodity Futures Trading 

Commission, 140 Broadway, New York, 

New York 10005, Telephone: (646) 746–

9700. 

Commodity Futures Trading 

Commission, 525 West Monroe Street, 

Suite 1100 North, Chicago, Illinois 

60661, Telephone: (312) 596–0700. 

Commodity Futures Trading 

Commission, Two Emanuel Cleaver II 

Blvd., Suite 300, Kansas City, Missouri 

64112, Telephone: (816) 960–7700. 

* * * * * 

Dated: March 29, 2007. 

By the Commission. 

Eileen A. Donovan, 

Acting Secretary of the Commission. 

[FR Doc. E7–6190 Filed 4–3–07; 8:45 am] 

BILLING CODE 6351–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

Oral Dosage Form New Animal Drugs; 

Praziquantel and Pyrantel 

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 an original new animal drug 

application (NADA) filed by Virbac AH, 

Inc. The NADA provides for use of 

chewable tablets containing 

praziquantel and pyrantel pamoate in 

dogs and puppies for the treatment and 

control of various internal parasites. 

DATES: This rule is effective April 4, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Virbac 

AH, Inc., 3200 Meacham Blvd., Ft. 

Worth, TX 76137, filed NADA 141–261 

for WORMXPLUS (praziquantel and 

pyrantel pamoate) Flavored Chewables 

and VIRBANTEL (praziquantel and 

pyrantel pamoate) Flavored Chewables 

that provides for their use in dogs and 

puppies for the treatment and control of 

various internal parasites. The NADA is 

approved as of March 13, 2007, and 21 

CFR 520.1871 is amended 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)(ii) of the 

Federal Food, Drug, and Cosmetic Act 

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

this approval qualifies for 3 years of 

marketing exclusivity beginning March 

13, 2007. 

FDA has determined under 21 CFR 

25.33(d)(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 Subjects 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. Amend § 520.1871 as follows: 

■ a. Revise the section heading and 

paragraphs (a) and (b); 

■ b. Redesignate paragraph (c) as 

paragraph (d) and add new paragraph 

(c); and 

■ c. Revise newly redesignated 

paragraphs (d)(1)(i), (d)(1)(iii), and 

(d)(2). 

The revisions, redesignation, and 

addition read as follows: 

§ 520.1871 Praziquantel and pyrantel. 

(a) Specifications—(1) Each tablet 

contains 18.2 milligrams (mg) 

praziquantel and 72.6 mg pyrantel (as 

pyrantel pamoate). 

(2) Each chewable tablet contains 30 

mg praziquantel and 30 mg pyrantel 

pamoate or 114 mg praziquantel and 

114 mg pyrantel pamoate. 

(b) Sponsors. See sponsors in 

§ 510.600(c) for use as in paragraph (d) 

of this chapter. 

(1) See No. 000859 for use of tablet 

described in paragraph (a)(1) of this 

section for use as in paragraph (d)(1) of 

this section. 

(2) See No. 051311 for use of tablets 

described in paragraph (a)(2) of this 

section for use as in paragraph (d)(2) of 

this section. 

(c) Special considerations. See 

§ 500.25 of this chapter. 

(d) * * * 

(1) * * * 

(i) Dosage. 1.5 to 1.9 pounds, 1/4 

tablet; 2 to 3 pounds, 1/2 tablet; 4 to 8 

pounds, 1 tablet; 9 to 12 pounds, 1 1/ 

2 tablets; 13 to 16 pounds, 2 tablets. If 

reinfection occurs, treatment may be 

repeated. 

* * * * * 

(iii) Limitations. Not for use in kittens 

less than 1 month of age or weighing 

less than 1.5 pounds. May be given 

directly by mouth or in a small amount 

of food. Do not withhold food prior to 

or after treatment. Consult your 

veterinarian before giving to sick or 

pregnant animals. 

(2) Dogs—(i) Amount. Administer a 

minimum dose of 5 mg praziquantel and 

5 mg pyrantel pamoate per kilogram 

body weight (2.27 mg praziquantel and 

2.27 mg pyrantel pamoate per pound 

body weight) according to the dosing 

tables on labeling. 

(ii) Indications for use. For the 

treatment and control of roundworms 

(Toxocara canis and Toxascaris 

leonina), hookworms (Ancylostoma 

caninum, Ancylostoma braziliense, and 

Uncinaria stenocephala), and 

tapeworms (Dipylidium caninum and 

Taenia pisiformis) in dogs and puppies. 

Dated: March 26, 2007. 

Stephen F. Sundlof, 

Director, Center for Veterinary Medicine. 

[FR Doc. E7–6181 Filed 4–3–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

New Animal Drugs for Use in Animal 

Feeds; Melengestrol and Lasalocid 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 


cprice-sewell on PROD1PC61 with RULES
Federal Register / Vol. 72, No. 64 / Wednesday, April 4, 2007 / Rules and Regulations 16271 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of an abbreviated new animal 

drug application (ANADA) filed by Ivy 

Laboratories, Div. of Ivy Animal Health, 

Inc. The ANADA provides for use of 

single-ingredient Type A medicated 

articles containing melengestrol and 

lasalocid to make two-way combination 

drug Type B or Type C medicated feeds 

for heifers fed in confinement for 

slaughter. 

DATES: This rule is effective April 4, 

2007. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–104), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Ivy 

Laboratories, Div. of Ivy Animal Health, 

Inc., 8857 Bond St., Overland Park, KS 

66214, filed ANADA 200–451 for use of 

HEIFERMAX 500 (melengestrol acetate) 

Liquid Premix and BOVATEC (lasalocid 

sodium) single-ingredient Type A 

medicated articles to make dry and 

liquid, two-way combination drug Type 

B or Type C medicated feeds for heifers 

fed in confinement for slaughter. Ivy 

Laboratories’ ANADA 200–451 is 

approved as a generic copy of NADA 

140–288, sponsored by Pharmacia & 

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

combination use of MGA 500 and 

BOVATEC. The application is approved 

as of March 12, 2007, and the 

regulations are amended in 21 CFR 

558.342 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. 

The agency has determined under 21 

CFR 25.33(a)(2) 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 558 

Animal drugs, Animal feeds. 

■ 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 558 is amended as follows: 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 1. The authority citation for 21 CFR 

part 558 continues to read as follows: 

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

§ 558.342 [Amended] 

■ 2. In § 558.342, amend the table in 

paragraph (e)(1)(iii) in the ‘‘Sponsor’’

column by adding in numerical 

sequence ‘‘021641’’. 

Dated: March 26, 2007. 

Stephen F. Sundlof, 

Director, Center for Veterinary Medicine. 

[FR Doc. E7–6180 Filed 4–3–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF JUSTICE 

Bureau of Prisons 

28 CFR Parts 500 and 501 

[BOP–1116; AG Order No. 2878–2007] 

RIN 1120–AB08 

National Security; Prevention of Acts 

of Violence and Terrorism 

AGENCY: Bureau of Prisons, Department 

of Justice. 

ACTION: Final rule. 

SUMMARY: This rule finalizes the interim 

rules on Special Administrative 

Measures that were published on 

October 31, 2001 (66 FR 55062). The 

previously existing regulations 

authorized the Bureau of Prisons 

(Bureau), at the direction of the 

Attorney General, to impose special 

administrative measures with respect to 

specified inmates, based on information 

provided by senior intelligence or law 

enforcement officials, if determined 

necessary to prevent the dissemination 

of either classified information that 

could endanger the national security, or 

of other information that could lead to 

acts of violence and/or terrorism. The 

interim rule extended the period of time 

for which such special administrative 

measures may be imposed from 120 

days to up to one year, and modified the 

standards for approving extensions of 

such special administrative measures. In 

addition, where the Attorney General 

has certified that reasonable suspicion 

exists to believe that an inmate may use 

communications with attorneys (or 

agents traditionally covered by the 

attorney-client privilege) to further or 

facilitate acts of violence and/or 

terrorism, the interim rule amended the 

previously existing regulations to 

provide that the Bureau must provide 

appropriate procedures to monitor or 

review such communications to deter 

such acts, subject to specific procedural 

safeguards, to the extent permitted 

under the Constitution and laws of the 

United States. The interim rule also 

requires the Director of the Bureau of 

Prisons to give written notice to the 

inmate and attorneys and/or agents 

before monitoring or reviewing any 

communications as described in this 

rule. The interim rule also provided that 

the head of each component of the 

Department of Justice that has custody 

of persons for whom special 

administrative measures are determined 

to be necessary may exercise the same 

authority to impose such measures as 

the Director of the Bureau of Prisons. 

DATES: Effective date: June 4, 2007. 

ADDRESSES: Rules Unit, Office of the 

General Counsel, Bureau of Prisons, 320 

First Street, NW., Washington, DC 

20534. 

FOR FURTHER INFORMATION CONTACT: 

Sarah Qureshi, Office of the General 

Counsel, Bureau of Prisons, (202) 307–

2105. 

SUPPLEMENTARY INFORMATION: This rule 

finalizes interim rules on Special 

Administrative Measures that were 

published on October 31, 2001 (66 FR 

55062). These rules are codified at 28 

CFR 501.2 (national security) and 501.3 

(violence and terrorism). We received 

approximately 5000 comments in 

opposition to the rule, which we discuss 

below. 

Section 501.2 

Section 501.2 authorizes the Director 

of the Bureau, at the direction of the 

Attorney General, to impose special 

administrative measures with respect to 

a particular inmate that are reasonably 

necessary to prevent disclosure of 

classified information. These 

procedures may be implemented after 

written certification by the head of a 

United States intelligence agency that 

the unauthorized disclosure of such 

information would pose a threat to the 

national security and that there is a 

danger that the inmate will disclose 

such information. These special 

administrative measures ordinarily may 

include housing the inmate in special 

housing units and/or limiting certain 

privileges, including, but not limited to, 


cprice-sewell on PROD1PC61 with RULES