62406 Federal Register / Vol. 69, No. 206 / Tuesday, October 26, 2004 / Rules and Regulations 

Issued in Kansas City, MO, on October 13, 

2004. 

Paul J. Sheridan, 

Area Director, Western Flight Services 

Operations.

[FR Doc. 04–23868 Filed 10–25–04; 8:45 am] 

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, and 558

New Animal Drugs; Correction of 

Sponsor’s Drug Labeler Codes

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 reflect a 

correction of sponsor’s drug labeler code 

for Pennfield Oil Co.

DATES: This rule is effective October 26, 

2004.

FOR FURTHER INFORMATION CONTACT:

David R. Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.gov.

SUPPLEMENTARY INFORMATION: FDA has 

found that the animal drug regulations 

do not reflect the correct sponsor’s drug 

labeler code for Pennfield Oil Co. 

Accordingly, the agency is amending 

the regulations in 21 CFR 510.600, 

520.445b, 520.1660d, 522.1660a, 558.76, 

558.78, 558.128, 558.140, 558.145, 

558.195, 558.355, 558.450, 558.550, 

558.600, 558.625, and 558.630 to correct 

this error.

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

21 CFR Part 510

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements.

21 CFR Parts 520 and 522

Animal drugs.

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 

parts 510, 520, 522, and 558 are amended 

as follows:

PART 510—NEW ANIMAL DRUGS

■ 1. The authority citation for 21 CFR 

part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e.

■ 2. Section 510.600 is amended in the 

table in paragraph (c)(1) in the entry for 

‘‘Pennfield Oil Co.’’ by removing 

‘‘053389’’ and by adding in its place 

‘‘048164’’; and in the table in paragraph 

(c)(2) by removing the entry for ‘‘053389’’

and by adding in numerical sequence an 

entry for ‘‘048164’’ to read as follows:

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address Drug labeler 

code 

*****

Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 

68144

048164

*****

(2) * * *

Drug labeler 

code Firm name and address 

*****

048164 Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 

68144

*****

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS

■ 3. The authority citation for 21 CFR 

part 520 continues to read as follows:

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

§ 520.445b [Amended]

■ 4. Section 520.445b is amended in 

paragraph (b) by removing ‘‘053389’’ and 

by adding in its place ‘‘048164’’.

§ 520.1660d [Amended]

■ 5. Section 520.1660d is amended in 

paragraph (b)(6) by removing ‘‘053389’’

and by adding in its place ‘‘048164’’.

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS

■ 6. The authority citation for 21 CFR 

part 522 continues to read as follows:

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

§ 522.1660a [Amended]

■ 7. Section 522.1660a is amended in 

paragraph (b) by removing ‘‘053389’’ and 

by adding in its place ‘‘048164’’.

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS

■ 8. The authority citation for 21 CFR 

part 558 continues to read as follows:

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

§ 558.76 [Amended]

■ 9. Section 558.76 is amended in the 

table in paragraph (d)(1)(iv) in the 

‘‘Limitations’’ and ‘‘Sponsor’’ columns 

by removing ‘‘053389’’ and by adding in 

its place ‘‘048164’’.

■ 10. Section 558.78 is amended by 

revising paragraphs (a) and (b); in the 

table in paragraph (d)(1) by redesignating 

paragraphs (d)(1)(ii) through (d)(1)(vi) as 

paragraphs (d)(1)(iii) through (d)(1)(vii); 

and by revising paragraph (d)(1)(i); and 

by adding new paragraph (d)(1)(ii) to 

read as follows:

§ 558.78 Bacitracin zinc.

(a) Specifications. Type A medicated 

articles containing bacitracin zinc 

equivalent to 5, 10, 25, 40, or 50 grams 

per pound bacitracin.

(b) Approvals. See sponsors in 

§ 510.600(c) of this chapter for uses as 

follows:

(1) No. 046573: 10, 25, 40, and 50 

grams per pound for uses as in 

paragraph (d) of this section.

(2) No. 048164: 5 and 50 grams per 

pound for use as in as in paragraph 

(d)(1)(i) of this section.

* * * * *

(d) * * *

(1) * * *

Federal Register / Vol. 69, No. 206 / Tuesday, October 26, 2004 / Rules and Regulations 62407

Bacitracin zinc in 

grams per ton 

Combinations 

in grams per 

ton 

Indications for use Limitations Sponsor 

(i) 4 to 50 ................... .................... Chickens: for increased rate of weight gain 

and improved feed efficiency

Growing chickens 046573

048164

(ii) 4 to 50 .................. .................... Turkeys and pheasants: for increased rate 

of weight gain and improved feed efficiency

Growing turkeys and 

pheasants

046573

*******

* * * * *

§ 558.128 [Amended]

■ 11. Section 558.128 is amended in 

paragraph (b)(1) by removing ‘‘053389’’

and by adding in its place ‘‘048164’’; and 

in the tables in paragraphs (e)(1), (e)(2), 

(e)(3), (e)(4), and (e)(5) in the ‘‘Sponsor’’

column by removing ‘‘053389’’ wherever 

it appears and by adding in its place 

‘‘048164’’.

§ 558.140 [Amended]

■ 12. Section 558.140 is amended in 

paragraph (a) by removing ‘‘053389’’ and 

by adding in its place ‘‘048164’’.

§ 558.145 [Amended]

■ 13. Section 558.145 is amended in 

paragraph (a)(2) by removing ‘‘053389’’

and by adding in its place ‘‘048164’’.

§ 558.195 [Amended]

■ 14. Section 558.195 is amended in the 

table in paragraph (e)(2)(iii) in the 

‘‘Limitations’’ and ‘‘Sponsor’’ columns 

by removing ‘‘053389’’ and by adding in 

its place ‘‘048164’’.

§ 558.355 [Amended]

■ 15. Section 558.355 is amended in 

paragraph (f)(1)(xiv)(b) by removing 

‘‘053389’’ and by adding in its place 

‘‘048164’’.

§ 558.450 [Amended]

■ 16. Section 558.450 is amended in 

paragraph (a)(2) by removing ‘‘053389’’

and by adding in its place ‘‘048164’’; in 

the table in paragraphs (d)(1)(i), (d)(1)(v), 

(d)(1)(vii), and (d)(1)(viii) in the 

‘‘Sponsor’’ column by removing 

‘‘053389’’ wherever it appears and by 

adding in its place ‘‘048164’’; and in the 

table in paragraph (d)(1)(ix) in the 

‘‘Limitations’’ column by removing 

‘‘053389’’ wherever it appears and by 

adding in its place ‘‘048164’’.

■ 17. Section 558.550 is amended in 

paragraphs (d)(1)(xv)(c) and (d)(1)(xvi)(c) 

by removing ‘‘053389’’ and by adding in 

its place ‘‘048164’’; and by revising 

paragraph (a) and adding paragraph (b) to 

read as follows:

§ 558.550 Salinomycin.

(a) Specifications. Type A medicated 

articles containing 30 or 60 grams of 

salinomycin activity per pound (as 

salinomycin sodium biomass).

(b) Approvals. See sponsors in 

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

paragraph (d) of this section:

(1) No. 046573 for use as in paragraph 

(d) of this section.

(2) No. 057926 for use as in 

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

(d)(1)(xvi), (d)(2)(i), and (d)(3)(i) of this 

section.

(3) No. 048164 for use as in 

paragraphs (d)(1)(xv) and (d)(1)(xvi) of 

this section.

* * * * *

§ 558.600 [Amended]

■ 18. Section 558.600 is amended in the 

table in paragraph (e)(1)(iii) in the 

‘‘Limitations’’ and ‘‘Sponsor’’ columns 

by removing ‘‘053389’’ and by adding in 

its place ‘‘048164’’.

§ 558.625 [Amended]

■ 19. Section 558.625 is amended in 

paragraph (b)(89) by removing ‘‘053389’’

and by adding in its place ‘‘048164’’.

§ 558.630 [Amended]

■ 20. Section 558.630 is amended in 

paragraph (b)(10) by removing ‘‘053389’’

and by adding in numerical sequence 

‘‘048164’’.

Dated: October 14, 2004.

Steven D. Vaughn,

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine.

[FR Doc. 04–23854 Filed 10–25–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF DEFENSE

National Security Agency/Central 

Security Services 

32 CFR Part 322

[NSA Regulation 10–35] 

Privacy Act; Implementation

AGENCY: National Security Agency/

Central Security Services.

ACTION: Final rule.

SUMMARY: The National Security 

Agency; Central Security Services 

(NSA/CSS) is adding an exemption rule 

for the system of records GNSA 20, 

entitled ‘NSA Police Operational Files’. 

The exemptions increase the value of 

the system of records for law 

enforcement purposes. 

The proposed rule was published on 

August 9, 2004, at 69 FR 48183. No 

comments were received; therefore, the 

National Security Agency/Central 

Security Services is adopting the rule as 

published below.

EFFECTIVE DATE: October 12, 2004.

FOR FURTHER INFORMATION CONTACT: Ms. 

Anne Hill at (301) 688–6527.

SUPPLEMENTARY INFORMATION: 

Executive Order 12866

It has been determined that this 

Privacy Act rule for the Department of 

Defense does not constitute ‘significant 

regulatory action’. Analysis of the rule 

indicates that it does not have an annual 

effect on the economy of $100 million 

or more; does not create a serious 

inconsistency or otherwise interfere 

with an action taken or planned by 

another agency; does not materially alter 

the budgetary impact of entitlements, 

grants, user fees, or loan programs or the 

rights and obligations of recipients 

thereof; does not raise novel legal or 

policy issues arising out of legal 

mandates, the President’s priorities, or 

the principles set forth in Executive 

Order 12866 (1993).