Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57173

That airspace extending upward from 700 

feet above the surface within an 8.3-mile 

radius of Cram Field.

* * * * *

Issued in Kansas City, MO, on September 

16, 2004. 

Paul J. Sheridan, 

Manager, Air Traffic Division, Central Region.

[FR Doc. 04–21530 Filed 9–23–04; 8:45 am] 

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs; 

Ivermectin Liquid

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 Merial 

Ltd. The supplemental NADA provides 

revised labeling, including the addition 

of four new species of internal parasites, 

for ivermectin oral liquid used in 

horses.

DATES: This rule is effective September 

24, 2004.

FOR FURTHER INFORMATION CONTACT:

Martine Hartogensis, Center for 

Veterinary Medicine (HFV–216), Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855, 301–827–

7815, e-mail: 

martine.hartogensis@fda.gov.

SUPPLEMENTARY INFORMATION: Merial 

Ltd., 3239 Satellite Blvd., Bldg. 500, 

Duluth, GA 30096–4640, filed a 

supplement to NADA 140–439 for 

EQVALAN (ivermectin) Oral Liquid for 

Horses. The supplemental application 

provides for revisions to the labeled 

indications. Specifically, the 

supplement provides for the use of 

ivermectin oral liquid for the treatment 

and control of Craterostomum 

acuticaudatum, Petrovinema 

poculatum, and Coronocyclus spp., 

including Coronocyclus coronatus and 

Coronocyclus labratus. The label 

descriptions of some currently approved 

parasite genera are also being revised to 

add included species for which data 

already exists in the NADA file and to 

reflect changes in scientific 

nomenclature. In addition, under the 

sub-heading ‘‘Small Strongyles,’’ the 

labeling has been revised to separate the 

listing of adult species from the fourthstage larvae. The supplemental NADA is 

approved as of August 9, 2004, and 21 

CFR 520.1195 is amended 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, 

Room 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 

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

supplemental approval qualifies for 3 

years of marketing exclusivity beginning 

August 9, 2004. This marketing 

exclusivity only applies to the parasites 

for which new data were required.

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 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. Section 520.1195 is amended by 

revising paragraphs (b), (e)(1)(ii), and 

(e)(1)(iii) to read as follows:

§ 520.1195 Ivermectin liquid.

* * * * *

(b) Sponsors. See sponsor numbers in 

§ 510.600(c) of this chapter.

(1) No. 050604 for use of product 

described in paragraph (a)(1) of this 

section as in paragraph (e)(1)(i), 

(e)(1)(ii)(A), and (e)(1)(iii) of this 

section.

(2) Nos. 051259, 058829, and 059130 

for use of product described in 

paragraph (a)(1) of this section as in 

paragraph (e)(1)(i), (e)(1)(ii)(B), and 

(e)(1)(iii) of this section.

(3) Nos. 050604 and 058829 for use of 

product described in paragraph (a)(2) of 

this section as in paragraph (e)(2) of this 

section.

* * * * *

(e) * * *

(1) * * *

(ii) Indications for use. For treatment 

and control of:

(A) Large Strongyles (adults): 

Strongylus vulgaris (also early forms in 

blood vessels), S. edentatus (also tissue 

stages), S. equinus, Triodontophorus

spp. including T. brevicauda and T. 

serratus, and Craterostomum 

acuticaudatum; Small Strongyles 

(adults, including those resistant to 

some benzimidazole class compounds): 

Coronocyclus spp. including C. 

coronatus, C. labiatus, and C. labratus, 

Cyathostomum spp. including C. 

catinatum and C. pateratum, 

Cylicocyclus spp. including C. insigne, 

C. leptostomum, C. nassatus, and C. 

brevicapsulatus, Cylicodontophorus

spp., Cylicostephanus spp. including C. 

calicatus, C. goldi, C. longibursatus, and 

C. minutus, and Petrovinema 

poculatum; Small Strongyles (fourthstage larvae); Pinworms (adults and 

fourth stage larvae): Oxyuris equi; 

Ascarids (adults and third- and fourthstage larvae): Parascaris equorum; 

Hairworms (adults): Trichostrongylus 

axei; Large mouth Stomach Worms 

(adults): Habronema muscae; Bots (oral 

and gastric stages): Gasterophilus spp. 

including G. intestinalis and G. nasalis; 

Lungworms (adults and fourth-stage 

larvae): Dictyocaulus arnfieldi; 

Intestinal Threadworms (adults), 

Strongyloides westeri; Summer Sores 

caused by Habronema and Draschia

spp. cutaneous third-stage larvae; 

Dermatitis caused by neck threadworm 

microfilariae, Onchocerca sp.

(B) Large Strongyles (Strongylus 

equinus (adult), S. vulgaris (adult and 

arterial larval stages), S. endentatus

(adult and migrating tissue stages), 

Triodontophorus spp. (adult)); Small 

Strongyles including those resistant to 

some benzimidazole class compounds 

(Cyathostomum spp. (adult and fourthstage larvae), Cylicocyclus spp., 

Cylicodontophorus spp., 

Cylicostephanus spp.); Pinworms 

(Oxyuris equi (adult and fourth-stage 

larvae)); Ascarids (Parascaris equorum

(adult and third- and fourth-stage 

larvae)); Hairworms (Trichostongylus 

57174 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

axei(adult)); Large mouth Stomach 

Worms (Habronema muscae (adult)); 

Stomach Bots (Gastrophilus spp. (oral 

and gastric stages)); Lungworms 

(Dictyocaulus arnfieldi (adult and 

fourth-stage larvae)); intestinal 

threadworms (Strongyloides westeri

(adult)); Summer Sores caused by 

Habronema and Draschia spp. 

cutaneous third-stage larvae; and 

Dermatitis caused by neck threadworm 

microfilariae (Onchocerca spp.).

(iii) 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: September 14, 2004.

Daniel G. McChesney,

Director, Office of Surveillance and 

Compliance, Center for Veterinary Medicine.

[FR Doc. 04–21415 Filed 9–23–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[CGD05–04–175] 

RIN 1625–AA08 

Special Local Regulations for Marine 

Events; Virginia Beach, VA

AGENCY: Coast Guard, DHS.

ACTION: Notice of implementation of 

regulation. 

SUMMARY: The Coast Guard is 

implementing the special local 

regulations at 33 CFR 100.522 during 

the Neptune Festival Fireworks to be 

held September 25, 2004, in the vicinity 

of the Virginia Beach Fishing Pier, 

Virginia Beach, VA. This action is 

necessary to provide for the safety of life 

on navigable waters during the event. 

The effect will be to restrict general 

navigation in the regulated area for the 

safety of participants and vessels 

transiting the event area.

DATES: 33 CFR 100.522 will be enforced 

from 8:45 p.m. to 10 p.m. on September 

25, 2004.

FOR FURTHER INFORMATION CONTACT:

Michael Bowling, Project Manager, 

Coast Guard Group Hampton Roads, 

VA, at (757) 483–8567.

SUPPLEMENTARY INFORMATION: The 

Virginia Beach Neptune Festival will 

sponsor the fireworks display on 

September 25, 2004 over the coastal 

waters in the vicinity of the Virginia 

Beach Fishing Pier, Virginia Beach, 

Virginia. The pyrotechnic display will 

be launched from the fishing pier 

located within the regulated area. A 

fleet of spectator vessels is expected to 

gather nearby to view the event. 

Therefore, to ensure the safety of 

spectators and transiting vessels, 33 CFR 

100.522 will be enforced for the 

duration of the event. Under provisions 

of 33 CFR 100.522, a vessel may not 

enter the regulated area unless it 

receives permission from the Coast 

Guard Patrol Commander. Spectator 

vessels may anchor outside the 

regulated area but may not block a 

navigable channel. 

In addition to this notice, the 

maritime community will be provided 

extensive advance notification via the 

Local Notice to Mariners, marine 

information broadcasts, and area 

newspapers, so mariners can adjust 

their plans accordingly.

Dated: September 14, 2004. 

Ben R. Thomason, III, 

Captain, U.S. Coast Guard, Acting 

Commander, Fifth Coast Guard District.

[FR Doc. 04–21524 Filed 9–23–04; 8:45 am] 

BILLING CODE 4910–15–P

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[CGD05–04–166] 

RIN 1625–AA–09 

Drawbridge Operation Regulations; 

Delaware River, NJ

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, Fifth Coast 

Guard District, has approved a 

temporary deviation from the 

regulations governing the operation of 

the Delair Railroad Bridge across the 

Delaware River mile 104.5, between 

Philadelphia, PA, and Delair, NJ. This 

deviation allows the drawbridge to 

remain in the closed-to-navigation 

position from 8 a.m. to 4 p.m., on nine 

consecutive Mondays on September 27 

through November 22, 2004, to facilitate 

replacement of bridge timbers.

DATES: This deviation is effective from 

8 a.m. on September 27, 2004, to 4 p.m. 

on November 22, 2004.

FOR FURTHER INFORMATION CONTACT: Bill 

Brazier, Bridge Management Specialist, 

Fifth Coast Guard District, at (757) 398–

6422.

SUPPLEMENTARY INFORMATION: New 

Jersey Transit, who operates their trains 

and controls the signaling system at the 

Delair Railroad Bridge, has requested a 

temporary deviation from the operating 

regulation to facilitate needed 

replacement of bridge timbers. 

To facilitate this replacement, the 

vertical lift-span will be locked in the 

closed-to-navigation position from 8 

a.m. to 4 p.m. on nine consecutive 

Mondays: on September 27; on October 

4, 11, 18, and 25; and on November 1, 

8, 15, and 22, 2004. During these stages, 

the work requires completely 

immobilizing the operation of the 

vertical-lift span in the closed-tonavigation position. At all other times, 

the bridge will operate in accordance 

with the current operating regulations 

outlined in 33 CFR 117.716. 

The Coast Guard has informed the 

known users of the waterway of the 

closure periods for the bridge so that 

these vessels can arrange their transits 

to minimize any impact caused by the 

temporary deviation. 

The District Commander has granted 

temporary deviation from the operating 

requirements listed in 33 CFR 117.35 for 

the purpose of repair completion of the 

drawbridge. The temporary deviation 

allows the Delair Railroad Bridge across 

the Delaware River mile 104.5, between 

Philadelphia, PA and Delair, NJ, to 

remain closed to navigation from 8 a.m. 

to 4 p.m. on nine consecutive Mondays: 

on September 27; on October 4, 11, 18, 

and 25; and on November 1, 8, 15, and 

22, 2004.

Dated: September 20, 2004. 

Waverly W. Gregory, Jr., 

Chief, Bridge Administration Branch, Fifth 

Coast Guard District.

[FR Doc. 04–21526 Filed 9–23–04; 8:45 am] 

BILLING CODE 4910–15–P

DEPARTMENT OF THE INTERIOR

National Park Service 

36 CFR Part 7 

RIN 1024–AD14 

Delaware Water Gap National 

Recreation Area, Pennsylvania and 

New Jersey; U.S. Route 209 

Commercial Vehicle Fees

AGENCY: National Park Service, Interior.

ACTION: Final rule.

SUMMARY: This final rule revises the 

special regulations for Delaware Water 

Gap National Recreation Area. It 

changes the fee schedule for those 

commercial vehicles permitted to travel