20942 Federal Register / Vol. 72, No. 81 / Friday April 27, 2007 / Rules and Regulations 

who is accused of criminal activity 

receives due process of law in a 

criminal proceeding under the 

jurisdiction of the judicial branch of the 

Federal government. 

(f) In other circumstances. We may 

disclose information to a court of 

competent jurisdiction in circumstances 

other than those stated in paragraph (e) 

of this section. We will make our 

decision regarding disclosure by 

balancing the needs of a court while 

preserving the confidentiality of 

information. For example, we may 

disclose information under a court order 

that restricts the use and redisclosure of 

the information by the participants in 

the proceeding; we may offer the 

information for inspection by the court 

in camera and under seal; or we may 

arrange for the court to exclude 

information identifying individuals 

from that portion of the record of the 

proceedings that is available to the 

public. We will make these 

determinations in accordance with 

§ 401.140. 

(g) Other regulations on request for 

testimony, subpoenas and production of 

records in legal proceedings. See 20 CFR 

part 403 of this chapter for additional 

rules covering disclosure of information 

and records governed by this part and 

requested in connection with legal 

proceedings. 

[FR Doc. E7–7940 Filed 4–26–07; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 2 

[Docket No. 2006N–0416] 

Use of Ozone-Depleting Substances; 

Removal of Essential Use 

Designations; Confirmation of 

Effective Date 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule; confirmation of 

effective date. 

SUMMARY: The Food and Drug 

Administration (FDA) is confirming the 

effective date of April 23, 2007, for the 

direct final rule that appeared in the 

Federal Register of December 7, 2006 

(71 FR 70870). The direct final rule 

amends the regulation to remove 

beclomethasone, dexamethasone, 

fluticasone, bitolterol, salmeterol, 

ergotamine tartrate, and ipratropium 

bromide, used in oral pressurized 

metered-dose inhalers, from the list of 

essential uses of ozone-depleting 

substances. None of these products is 

currently being marketed. This 

document confirms the effective date of 

the direct final rule. 

DATES: Effective date confirmed: April 

23, 2007, except for the removal of 

§ 2.125(e)(4)(v) (21 CFR 2.125(e)(4)(v)), 

which is effective August 1, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen or Wayne H. Mitchell, 

Center for Drug Evaluation and Research 

(HFD–7), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–594–2041. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of December 7, 2006 

(71 FR 70870), FDA solicited comments 

concerning the direct final rule for a 75- 

day period ending February 20, 2007. 

FDA stated that the effective date of the 

direct final rule would be on April 23, 

2007, 60 days after the end of the 

comment period, unless any significant 

adverse comment was submitted to FDA 

during the comment period. 

FDA received no significant adverse 

comments within the comment period. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act, the Clean Air 

Act, and under authority delegated to 

the Commissioner of Food and Drugs, 

after consultation with the 

Administrator of the Environmental 

Protection Agency, notice is given that 

no objections or requests for a hearing 

were filed in response to the December 

7, 2006, direct final rule. Accordingly, 

FDA is confirming that the amendment 

issued thereby is effective April 23, 

2007, except for the removal of 

§ 2.125(e)(4)(v), which is effective 

August 1, 2007. 

Dated: April 17, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–8043 Filed 4–26–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

Oral Dosage Form New Animal Drugs; 

Diclazuril 

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 ScheringPlough Animal Health Corp. The NADA 

provides for the veterinary prescription 

use of diclazuril oral pellets in horses 

for the treatment of equine protozoal 

myeloencephalitis. 

DATES: This rule is effective April 27, 

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: ScheringPlough Animal Health Corp., 556 Morris 

Ave., Summit, NJ 07901, filed NADA 

141–268 for the veterinary prescription 

use of PROTAZIL (1.56% diclazuril) 

Antiprotozoal Pellets in horses for the 

treatment of equine protozoal 

myeloencephalitis (EPM) caused by 

Sarcocystis neurona. The NADA is 

approved as of March 29, 2007, and the 

regulations in 21 CFR part 520 are 

amended by adding new § 520.606 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 

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

approval qualifies for 3 years of 

marketing exclusivity beginning March 

29, 2007. 

The agency 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 


cprice-sewell on PROD1PC66 with RULES
Federal Register / Vol. 72, No. 81 / Friday April 27, 2007 / Rules and Regulations 20943 

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. Add § 520.606 to read as follows: 

§ 520.606 Diclazuril. 

(a) Specifications. Each 100 grams (g) 

of pellets contain 1.56 g diclazuril. 

(b) Sponsor. See No. 000061 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in horses—(1) 

Amount. Administer 1 milligram (mg) 

per kilogram (0.45 mg per pound) of 

body weight in the daily grain ration for 

28 days. 

(2) Indications for use. For the 

treatment of equine protozoal 

myeloencephalitis (EPM) caused by 

Sarcocystis neurona. 

(3) Limitations. Do not use in horses 

intended for human consumption. 

Federal law restricts this drug to use by 

or on the order of a licensed 

veterinarian. 

Dated: April 13, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–8041 Filed 4–26–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[COTP San Francisco Bay 07–007] 

RIN 1625–AA00 

Safety Zone; Kimmelman’s Wedding 

Party Fireworks Display, San 

Francisco Bay, CA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone in 

the navigable waters of San Francisco 

Bay for the loading, transport, and 

launching of fireworks used during a 

wedding celebration display. This safety 

zone is established to ensure the safety 

of participants and spectators. 

Unauthorized persons or vessels are 

prohibited from entering into, transiting 

through, or remaining in the safety zone 

without permission of the Captain of the 

Port or his designated representative. 

DATES: This rule is effective from 1 p.m. 

to 9:35 p.m. on April 28, 2007. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket, are part of the docket COTP San 

Francisco Bay 07–007 and are available 

for inspection or copying at Coast Guard 

Sector San Francisco, 1 Yerba Buena 

Island, San Francisco, California, 94130, 

between 9 a.m. and 4 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Ensign Sheral Richardson, U.S. Coast 

Guard Sector San Francisco, at (415) 

556–2950 ext. 140. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

We did not publish a notice of 

proposed rulemaking (NPRM) for this 

regulation. Under 5 U.S.C. 553(b)(B), the 

Coast Guard finds that good cause exists 

for not publishing an NPRM. Logistical 

details surrounding the event were not 

finalized and presented to the Coast 

Guard in time to draft and publish an 

NPRM. As such, the event would occur 

before the rulemaking process was 

complete. Because of the dangers posed 

by the pyrotechnics used in this 

fireworks display, safety zones are 

necessary to provide for the safety of 

event participants, spectator craft, and 

other vessels transiting the event area. 

For the safety concerns noted, it is in 

the public interest to have these 

regulations in effect during the event. 

For the same reasons listed in the 

previous paragraph, under 5 U.S.C. 

553(d)(3), the Coast Guard finds that 

good cause exists for making this rule 

effective less than 30 days after 

publication in the Federal Register. Any 

delay in the effective date of this rule 

would expose mariners to the dangers 

posed by the pyrotechnics used in this 

fireworks display. 

Background and Purpose 

Pyro’s Spectacular Incorporated is 

sponsoring a brief fireworks display on 

April 28, 2007 in the waters of San 

Francisco Bay near Angel Island. The 

fireworks display is meant for 

entertainment purposes at the 

Kimmelman’s Wedding. This safety 

zone is being issued to establish a 

temporary regulated area in San 

Francisco around the fireworks launch 

barge during loading of the 

pyrotechnics, during the transit of the 

barge to the display location, and during 

the fireworks display. This safety zone 

around the launch barge is necessary to 

protect spectators, vessels, and other 

property from the hazards associated 

with the pyrotechnics on the fireworks 

barge. The Coast Guard has granted the 

event sponsor a marine event permit for 

the fireworks display. 

Discussion of Rule 

The Coast Guard is establishing a 

temporary safety zone on specified 

waters off of San Francisco Bay near 

Angel Island. During the loading of the 

fireworks barge, while the barge is being 

towed to the display location, and until 

the start of the fireworks display, the 

safety zone will apply to the navigable 

waters around and under the fireworks 

barge within a radius of 100 feet. Fifteen 

minutes prior to and during the 5- 

minute fireworks display, the area to 

which this safety zone applies to will 

increase in size to encompass the 

navigable waters around and under the 

fireworks barge within a radius of 800 

feet. Loading of the pyrotechnics onto 

the fireworks barge is scheduled to 

commence at 1 p.m. on April 28, 2007, 

and will take place at Pier 50 in San 

Francisco. Towing of the barge from Pier 

50 to the display location is scheduled 

to take place between 1 p.m. and 4 p.m. 

on April 28, 2007. During the fireworks 

display, scheduled to commence at 

approximately 9:30 p.m., the fireworks 

barge will be located approximately 800 

feet off of Angel Island in position 37° 

51′20.0′′ N, 122° 26′43.0′′ W. 

The effect of the temporary safety 

zone will be to restrict general 

navigation in the vicinity of the 

fireworks barge while the fireworks are 

loaded at Pier 50, during the transit of 

the fireworks barge, and until the 

conclusion of the scheduled display. 

Except for persons or vessels authorized 

by the Coast Guard Patrol Commander, 

no person or vessel may enter or remain 

in the safety zone. This safety zone is 

needed to keep spectators and vessels a 

safe distance away from the fireworks 

barge to ensure the safety of 

participants, spectators, and transiting 

vessels. 

Regulatory Evaluation 

This rule is not a ‘‘significant 

regulatory action’’ under section 3(f) of 

Executive Order 12866, Regulatory 

Planning and Review, and does not 

require an assessment of potential costs 

and benefits under section 6(a)(3) of that 

Order. The Office of Management and 

Budget has not reviewed it under that 

Order. 

Although this rule restricts access to 

the waters encompassed by the safety 

zone, the effect of this rule will not be 

significant because the local waterway 

users will be notified via public 

broadcast notice to mariners to ensure 

the safety zone will result in minimum 

impact. The entities most likely to be 


cprice-sewell on PROD1PC66 with RULES