74418 Federal Register / Vol. 69, No. 239 / Tuesday, December 14, 2004 / Rules and Regulations 

(c) Bureau of the Census. (1) 13 U.S.C. 

304, Delinquency on Delayed filing of 

Export Documentation, from $1,100 to 

$10,000. 

(2) 13 U.S.C. 305, Collection of 

Foreign Trade Statistics—Violations, 

from $1,100 to $10,000. 

(d) Economics and Statistics 

Administration. 22 U.S.C. 3105(a), 

International Investment and Trade in 

Services Act—Failure to Furnish 

Information, from $27,500 to $27,500. 

(e) International Trade 

Administration. (1) 19 U.S.C. 81s, 

Foreign Trade Zone—Violation, from 

$1,100 to $1,100. 

(2) 16 U.S.C. 1677(f)(4), U.S.-Canada 

FTA Protective Order—Violation, from 

$110,000 to $120,000. 

(f) National Oceanic and Atmospheric 

Administration. (1) 15 U.S.C. 5623(a)(3), 

Land Remote Sensing Policy Act of 

1992, from $11,000 to $11,000. 

(2) 15 U.S.C. 5658(c), Land Remote 

Sensing Policy Act of 1992, from 

$11,000 to $11,000. 

(3) 16 U.S.C. 773f(a), Northern Pacific 

Halibut Act of 1982, from $27,500 to 

$27,500. 

(4) 16 U.S.C. 783, Sponge Act (1914), 

from $550 to $550. 

(5) 16 U.S.C. 957, Tuna Conventions 

Act of 1950 (1962); 

(i) Violation/Subsection a, from 

$27,500 to $27,500. 

(ii) Subsequent Violation/Subsection 

a, from $60,000 to $65,000. 

(iii) Violation/Subsection b, from 

$1,100 to $1,100. 

(iv) Subsequent Violation/Subsection 

b, from $5,500 to $5,500. 

(v) Violation/Subsection c, from 

$120,000 to $130,000. 

(6) 16 U.S.C. 971e(e), Atlantic Tuna 

Convention Act of 1975 (1995), from 

$120,000 to $130,000. 

(7) 16 U.S.C. 972f(b), Eastern Pacific 

Tuna Licensing Act of 1984; 

(i) Violation/Subsections (a)(1)–(3), 

from $27,500 to $27,500. 

(ii) Subsequent Violation/Subsections 

(a)(1)–(3), from $60,000 to $60,000. 

(iii) Violation/Subsections (a)(4)–(5), 

from $5,500 to $5,500. 

(iv) Subsequent Violation/Subsections 

(a)(4)–(5), from $5,500 to $5,500. 

(v) Violation/Subsection (a)(6), from 

$120,000 to $130,000. 

(8) 16 U.S.C. 973f(a), South Pacific 

Tuna Act of 1988, from $300,000 to 

$325,000. 

(9) 16 U.S.C. 1174(b), Fur Seal Act 

Amendments of 1983, from $11,000 to 

$11,000.

(10) 16 U.S.C. 1375(a)(1), Marine 

Mammal Protection Act of 1972 (1981), 

from $11,000 to $11,000. 

(11) 16 U.S.C. 1385(e), Dolphin 

Protection Consumer Information Act 

(1990), from $110,000 to $120,000. 

(12) 16 U.S.C. 1437(d)(1), National 

Marine Sanctuaries Act (1992), from 

$120,000 to $130,000. 

(13) 16 U.S.C. 1540(a)(1), Endangered 

Species Act of 1973; 

(i) Knowing Violations of Section 

1538 (1988), from $27,500 to $27,500. 

(ii) Other Knowing Violations (1988), 

from $13,200 to $13,200. 

(iii) Otherwise Violations (1978), from 

$550 to $550. 

(14) 16 U.S.C. 1858(a), MagnusonStevens Fishery Conservation and 

Management Act (1990), from $120,000 

to $130,000. 

(15) 16 U.S.C. 2437(a)(1), Antarctic 

Marine Living Resources Convention 

Act of 1984; 

(i) Knowing Violation, from $11,000 

to $11,000. 

(ii) Violation, from $5,500 to $5,500. 

(16) 16 U.S.C. 2465(a), Antarctic 

Protection Act of 1990; 

(i) Knowing Violation, from $11,000 

to $11,000. 

(ii) Violation, from $5,500 to $5,500. 

(17) 16 U.S.C. 3373(a), Lacey Act 

Amendments of 1981; 

(i) Sale and Purchase Violation, from 

$11,000 to $11,000. 

(ii) Marking Violation, from $275 to 

$275. 

(iii) False Labeling Violation, from 

$11,000 to $11,000. 

(iv) Other than Marking Violation, 

from $11,000 to $11,000. 

(18) 16 U.S.C. 3606(b)(1), Atlantic 

Salmon Convention Act of 1982 (1990), 

from $120,000 to $130,000. 

(19) 16 U.S.C. 3637(b), Pacific Salmon 

Treaty Act of 1985 (1990), from 

$120,000 to $130,000. 

(20) 16 U.S.C. 4016(b)(1)(B), Fish and 

Seafood Promotion Act of 1986, from 

$5,500 to $5,500. 

(21) 16 U.S.C. 5010(a)(1), North 

Pacific Anadromous Stocks Act of 1992, 

from $110,000 to $120,000. 

(22) 16 U.S.C. 5103(b)(2), Atlantic 

Coastal Fisheries Cooperative 

Management Act (1993), from $120,000 

to $130,000. 

(23) 16 U.S.C. 5154(c)(1), Atlantic 

Striped Bass Conservation Act (1990), 

from $120,000 to $130,000. 

(24) 16 U.S.C. 5507(a)(1), High Seas 

Fishing Compliance Act of 1995, from 

$110,000 to $120,000. 

(25) 16 U.S.C. 5606(b), Northwest 

Atlantic Fisheries Convention Act of 

1995, from $120,000 to $130,000. 

(26) 22 U.S.C. 1978(e), Fishermen’s 

Protective Act of 1967 (1971); 

(i) Violation, from $11,000 to $11,000. 

(ii) Subsequent Violation, from 

$27,500 to $27,500. 

(27) 30 U.S.C. 1462(a), Deep Seabed 

Hard Mineral Resources Act (1980), 

from $27,500 to $27,500. 

(28) 42 U.S.C. 9152(c)(1), Ocean 

Thermal Energy Conversion Act of 1980, 

from $27,500 to $27,500.

■ 3. Section 6.5 is revised to read as 

follows:

§ 6.5 Effective date of adjustments. 

The adjustments made by § 6.4 of this 

part, of the penalties there specified, are 

effective on December 14, 2004, and 

said penalties, as thus adjusted by the 

adjustments made by § 6.4 of this part, 

shall apply only to violations occurring 

after December 14, 2004, and before the 

effective date of any future inflation 

adjustment thereto made subsequent to 

December 14, 2004 as provided in § 6.6 

of this part.

[FR Doc. 04–27314 Filed 12–13–04; 8:45 am] 

BILLING CODE 3510–33–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 10

Administrative Practices and 

Procedures 

CFR Correction 

In Title 21 of the Code of Federal 

Regulations, parts 1 to 99, revised as of 

April 1, 2004, on page 123, § 10.50 is 

corrected by removing paragraph (c)(11).

[FR Doc. 04–55527 Filed 12–13–04; 8:45 am] 

BILLING CODE 1505–01–D

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs; 

Furosemide

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 abbreviated new animal 

drug application (ANADA) filed by 

Phoenix Scientific, Inc. The ANADA 

provides for veterinary prescription use 

of furosemide syrup in dogs by oral 

administration for treatment of edema 

associated with cardiac insufficiency 

and acute noninflammatory tissue 

edema.

DATES: This rule is effective December 

14, 2004.

Federal Register / Vol. 69, No. 239 / Tuesday, December 14, 2004 / Rules and Regulations 74419

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary 

Medicine (HFV–104), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 301–827–8549, email: lonnie.luther@fda.gov.

SUPPLEMENTARY INFORMATION: Phoenix 

Scientific, Inc., 3915 South 48th St. Ter., 

St. Joseph, MO 64503, filed ANADA 

200–382 for veterinary prescription use 

of Furosemide Syrup 1% in dogs by oral 

administration for treatment of edema 

associated with cardiac insufficiency 

and acute noninflammatory tissue 

edema. Phoenix Scientific’s Furosemide 

Syrup 1% is approved as a generic copy 

of Intervet, Inc.’s LASIX (furosemide) 

Syrup 1%, approved under NADA 102–

380. The ANADA is approved as of 

November 18, 2004, and the regulations 

are amended in 21 CFR 520.1010 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, rm. 

1061, Rockville, MD 20852, between 9 

a.m. and 4 p.m., Monday through 

Friday.

FDA has determined under 21 CFR 

25.33(a)(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 520.1010 is amended by 

adding paragraph (b)(4) to read as 

follows:

§ 520.1010 Furosemide.

* * * * *

(b) * * *

(4) No. 059130 for use of syrup in 

paragraph (a)(4) of this section for 

conditions of use in paragraph (d)(2)(i) 

and (d)(2)(ii)(A) of this section.

* * * * *

Dated: December 6, 2004.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 04–27291 Filed 12–13–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF TRANSPORTATION

Federal Highway Administration 

23 CFR Part 650 

[FHWA Docket No. FHWA–2001–8954] 

RIN 2125–AE86 

National Bridge Inspection Standards

AGENCY: Federal Highway 

Administration (FHWA), DOT.

ACTION: Final rule.

SUMMARY: The FHWA is revising its 

regulation on the National Bridge 

Inspection Standards (NBIS). This 

action is necessary to address perceived 

ambiguities in the NBIS that have been 

identified since the last update to the 

regulation in 1988. The changes clarify 

the NBIS language that is vague or 

ambiguous; reorganizes the NBIS into a 

more logical sequence; and makes the 

regulation easier to read and 

understand, not only by the inspector in 

the field, but also by those 

administering the highway bridge 

inspection programs at the State or 

Federal agency level.

DATES: This rule is effective January 13, 

2005. The incorporation by reference of 

the publications listed in this rule is 

approved by the Director of the Federal 

Register as of January 13, 2005.

FOR FURTHER INFORMATION CONTACT: Mr. 

Wade F. Casey, P.E., Federal Lands 

Highway, HFPD–9, (202) 366–9486, or 

Mr. Robert Black, Office of the Chief 

Counsel, HCC–30, (202) 366–1359, 

Federal Highway Administration, 400 

Seventh Street, SW., Washington, DC 

20590–0001. Office hours are from 7:45 

a.m. to 4:15 p.m. e.t., Monday through 

Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION: 

Electronic Access 

An electronic copy of this document 

may also be downloaded by using a 

computer, modem and suitable 

communications software from the 

Government Printing Office’s Electronic 

Bulletin Board Service at (202) 512–

1661. Internet users may also reach the 

Office of the Federal Register’s home 

page at: http://www.archives.gov and the 

Government Printing Office’s Web page 

at: http://www.access.gpo.gov/nara.

Background 

The FHWA bridge inspection program 

regulations were developed as a result 

of the Federal-Aid Highway Act of 1968 

(Pub. L. 90–495, 82 Stat. 815) that 

required the Secretary of Transportation 

to establish NBIS to ensure the safety of 

the traveling public. 

The 1968 Federal-Aid Highway Act 

directed the States to maintain an 

inventory of Federal-aid highway 

system bridges. The Federal-Aid 

Highway Act of 1970 (Pub. L. 91–605, 

84 Stat. 1713) limited the NBIS to 

bridges on the Federal-aid highway 

system. The Surface Transportation 

Assistance Act of 1978 (Pub. L. 95–599, 

92 Stat. 2689) extended NBIS 

requirements to bridges greater than 20 

feet on all public roads. The Surface 

Transportation and Uniform Relocation 

Assistance Act of 1987 (Pub. L. 100–17, 

101 Stat. 132) expanded the scope of 

bridge inspection programs to include 

special inspection procedures for 

fracture critical members and 

underwater inspection. 

The FHWA published an advance 

notice of proposed rulemaking 

(ANPRM) on September 26, 2001, (66 

FR 49154) to solicit comments on 

whether to revise its regulation on the 

NBIS. The majority of commenters to 

the ANPRM recommended that the 

FHWA revise the NBIS regulation. 

Discussion of Comments Received to 

the Notice of Proposed Rulemaking 

(NPRM) 

The FHWA published an NPRM on 

September 9, 2003, at 68 FR 53063, to 

solicit public comments on proposed 

changes to the NBIS. All comments 

received to the NPRM were carefully 

considered in the decision to publish a 

final rule. Commenters included: 

representatives from 1 Federal agency, 

25 States, 44 counties, 9 cities, 1 Indian 

tribal government, 4 consulting firms, 

the American Association of State 

Highway and Transportation Officials 

(AASHTO), the Association of Diving 

Contractors International (ADCI), the 

Illinois Association of County Engineers 

(IACE), the National Association of 

County Engineers (NACE) and 3 private 

citizens. 

Discussion of Rulemaking Text 

The following summarizes the 

comments submitted to the docket by