70056 Federal Register / Vol. 69, No. 231 / Thursday, December 2, 2004 / Rules and Regulations 

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)(1) that these actions are of 

a type that do 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 the 

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. Section 522.2476 is amended by 

removing paragraph (a); by redesignating 

paragraphs (b), (c), and (d) as paragraphs 

(a), (b), and (c); and by revising newly 

redesignated paragraphs (a)(1), (a)(2), 

(c)(1)(iii), and (c)(2)(iii) to read as 

follows:

§ 522.2476 Trenbolone acetate.

(a) * * *

(1) No. 021641 for use as in paragraph 

(c) of this section.

(2) No. 057926 for use as in 

paragraphs (c)(1)(i)(A), (c)(1)(ii), 

(c)(1)(iii), (c)(2)(i)(A), (c)(2)(ii), and 

(c)(2)(iii) of this section.

* * * * *

(c) * * *

(1) * * *

(iii) Limitations. Implant 

subcutaneously in ear only. Do not use 

in animals intended for subsequent 

breeding or in dairy animals. Safety and 

effectiveness have not been established 

in veal calves. A withdrawal period has 

not been established for this product in 

preruminating calves. Do not use in 

calves to be processed for veal.

(2) * * *

(iii) Limitations. Implant 

subcutaneously in ear only. Do not use 

in animals intended for subsequent 

breeding or in dairy animals. Safety and 

effectiveness have not been established 

in veal calves. A withdrawal period has 

not been established for this product in 

preruminating calves. Do not use in 

calves to be processed for veal.

Dated: November 18, 2004.

Steven D. Vaughn,

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine.

[FR Doc. 04–26552 Filed 12–1–04; 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; Coumaphos

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule; technical 

amendment.

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to remove 

conditions of use in cattle and chickens 

for a coumaphos Type A medicated 

article for which approval was 

withdrawn in July 1996. This action is 

being taken to improve the accuracy of 

the agency’s regulations.

DATES: This rule is effective December 2, 

2004.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary 

Medicine (HFV–6), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 301–827–4567, email: george.haibel@fda.gov.

SUPPLEMENTARY INFORMATION: FDA has 

found that parts 500 to 599 (21 CFR 

parts 500 to 599) of the Code of Federal 

Regulations reflect conditions of use in 

cattle for a coumaphos Type A 

medicated article for which approval 

was withdrawn by FDA, at the sponsors 

request, on July 3, 1996 (61 FR 34727). 

At this time, FDA is amending the 

regulations in § 558.185 to reflect the 

remaining approved uses of coumaphos 

in medicated cattle feeds.

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 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.

■ 2. Section 558.185 is amended by 

redesignating paragraph (d) as paragraph 

(e); by revising paragraphs (a), (b), and 

newly redesignated (e)(1); and by adding 

paragraph (d) to read as follows:

§ 558.185 Coumaphos.

(a) Specifications. Type A medicated 

articles containing 1.12, 2.0, 11.2, or 50 

percent coumaphos.

(b) Approvals. See sponsors in 

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

paragraph (e) of this section.

(1) No. 000859 for use of Type A 

medicated articles containing 1.12, 2.0, 

11.2, or 50 percent coumaphos as in 

paragraphs (e)(2) and (e)(3) of this 

section.

(2) No. 017800 for use of Type A 

medicated articles containing 1.12 or 

11.2 percent coumaphos as in paragraph 

(e)(1) of this section.

* * * * *

(d) Special considerations. Labeling 

shall bear the following caution 

statement: ‘‘The active ingredient 

coumaphos is a cholinesterase inhibitor. 

Do not use this product on animals 

simultaneously or within a few days 

before or after treatment with or 

exposure to cholinesterase-inhibiting 

drugs, pesticides, or chemicals.’’ Also, 

see § 500.25 of this chapter.

(e) Conditions of use—(1) Beef and 

dairy cattle—(i) Amount. 0.0002 lb. 

(0.091 gram) per 100 lb. body weight per 

day for 6 consecutive days. Should 

conditions warrant, repeat treatment at 

30-day intervals.

(ii) Indications for use. Control of 

gastrointestinal roundworms 

(Haemonchus spp., Ostertagia spp., 

Cooperia spp., Nematodirus spp., 

Trichostrongylus spp.).

(iii) Limitations. Feed in the normal 

grain ration to which the animals are 

accustomed, but not in rations 

containing more than 0.1 percent 

coumaphos. Do not feed to animals less 

than 3 months old. Do not feed to sick 

animals or animals under stress, such as 

those just shipped, dehorned, castrated, 

or weaned within the last 3 weeks. Do 

not feed in conjunction with oral 

Federal Register / Vol. 69, No. 231 / Thursday, December 2, 2004 / Rules and Regulations 70057

drenches or with feeds containing 

phenothiazine.

* * * * *

Dated: November 16, 2004.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 04–26529 Filed 12–1–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117

[CGD05–04–117] 

RIN 1625–AA09

Drawbridge Operation Regulation: 

Atlantic Intracoastal Waterway, 

Elizabeth River (Southern Branch), VA

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

SUMMARY: The Coast Guard is changing 

the operating regulations for the Norfolk 

Southern (NS) #7 Railroad Bridge at 

Atlantic Intracoastal Waterway (AICW) 

mile 5.8, in Chesapeake, Virginia. The 

final rule for the NS Railroad Bridge 

will eliminate the need for a bridge 

tender by allowing the bridge to remain 

in the fully open position, to be 

operated from a remote location, and to 

close the bridge for train crossings and 

periodic repairs. The final rule will 

provide for the reasonable needs of 

navigation.

DATES: This rule is effective January 3, 

2005.

ADDRESSES: Comments and material 

received from the public, as well as 

documents indicated in this preamble as 

being available in the docket, are part of 

docket CGD05–04–117 and are available 

for inspection or copying at Commander 

(obr), Fifth Coast Guard District, Federal 

Building, 1st Floor, 431 Crawford Street, 

Portsmouth, Virginia 23704–5004 

between 8 a.m. and 4:30 p.m., Monday 

through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT:

Waverly W. Gregory, Jr., Bridge 

Administrator, Fifth Coast Guard 

District, at (757) 398–6222.

SUPPLEMENTARY INFORMATION: 

Regulatory History 

On August 27, 2004, we published a 

notice of proposed rulemaking (NPRM) 

entitled ‘‘Drawbridge Operation 

Regulations; Atlantic Intracoastal 

Waterway, Elizabeth River (Southern 

Branch), VA’’ in the Federal Register

(69 FR 52617). We received four letters 

commenting on the proposed rule. No 

public hearing was requested nor held. 

Background and Purpose 

Norfolk Southern Corporation (NSC) 

requested a change to the current 

operating regulation set out in 33 CFR 

117.5 that requires the drawbridge to 

open promptly and fully for the passage 

of vessels when a request to open is 

given. 

NSC would remotely control the 

opening and closing of the Norfolk 

Southern (NS) #7 Railroad Bridge across 

the Southern Branch of the Elizabeth 

River at AICW mile 5.8 in Chesapeake, 

Virginia, by the remote operator at the 

NS #5 Railroad Bridge across the 

Eastern Branch of the Elizabeth River, at 

mile 1.1, in Norfolk, Virginia. NSC 

installed a Programmable Logic 

Controller and associated mechanical, 

electrical and signal apparatus on the 

drawbridge. NSC has installed motion 

sensors, laser scanners and highresolution video cameras on the bridge 

to enhance the remote operator’s ability 

to monitor and control the equipment. 

The NS #5 Railroad Bridge office, in 

Norfolk, is also equipped with an 

amplified open-mike from the bridge to 

enable the remote operator to hear boat 

horns that may signal for an opening. 

NS has also installed additional safety 

warning lights to the bridge for the 

remote operation. 

Under this rule, the drawbridge 

would be left in open position to vessels 

and would only close for the passage of 

trains and to perform periodic 

maintenance authorized in accordance 

with subpart A of part 117. 

Before the NS #7 Railroad Bridge 

closes for any reason, the remote 

operator will observe the waterway 

traffic in the area with closed-circuit 

cameras and motion sensors mounted 

on the bridge. The bridge would only be 

closed if the off-site remote operator’s 

visual inspection shows that the 

channel is clear and there are no vessels 

transiting the area.

While the NS #7 Railroad Bridge is 

moving from the full open position to 

the full closed position, the off-site 

remote operator will maintain constant 

surveillance of the navigation channel 

to ensure that no conflict with maritime 

traffic exists. In the event of failure or 

obstruction, the off-site remote operator 

will stop and return the bridge to the 

full open position to vessels. In these 

situations, a bridge tender must be 

called and must be on-site within 30 

minutes to operate the bridge. 

During span movement, the channel 

traffic lights will flash red, the horn 

would sound twice, and an audio voicewarning device will announce bridge 

movement, then two repeat blasts of the 

horn will continue until the bridge is 

seated and locked down. When the 

bridge is seated and locked down to 

vessels, the channel traffic lights will 

flash red. 

When the rail traffic has cleared, the 

horn will automatically sound five 

times to indicate that the draw of the NS 

#7 Railroad Bridge is about to return to 

the full open position to vessels. During 

the open span movement, the channel 

traffic lights will flash red, the horn will 

sound twice, followed by a pause, and 

then five repeat blasts of the horn until 

the bridge is in the full open position to 

vessels. In the full open position to 

vessels, the bridge channel traffic lights 

will flash green then an audio warning 

device will announce bridge movement 

by stating ‘‘Security, security, security, 

the NS #7 Railroad Bridge at mile 5.8 is 

open for river traffic’’. After the train 

has cleared the bridge by leaving the 

track circuit, any delay in opening of the 

draw to vessels shall not exceed ten 

minutes except as provided in 33 CFR 

117.31(b). Operational information will 

be provided 24 hours a day on marine 

channel 13 and via telephone (757) 924–

5320. 

This rule will make the closure 

process of the NS #7 Railroad Bridge be 

more efficient during train crossings and 

periodic maintenance and will save 

operational costs by eliminating bridge 

tenders while providing greater bridge 

operating capabilities. 

Discussion of Comments and Changes 

The Coast Guard received four 

comments on the NPRM. Three 

comments, from commercial vessel 

operators, expressed their concerns with 

the location of the off-site remote 

operation. Their interests centered 

around the limited effectiveness of 

monitoring and communications with 

approaching vessels, their past 

experience with current bridge tenders’

failure to respond to security calls, the 

lowering of the bridge while their 

vessels are transiting, and the loss of onsite bridge tenders controlling the 

operation of the bridge. 

The remaining comment, offered by 

NSC, addressed the commercial vessel 

operators’ concerns. NSC indicated that 

the location of the Norfolk area bridge 

operation center at the NS #5 Railroad 

Bridge office was selected because of the 

better-quality operators’ house and 

facilities, economic considerations for 

relocation and that the communication 

between marine interests and the NS #5 

Railroad Bridge operator will be 

comparable to the communication with 

the NS #7 Railroad Bridge operator. The