Federal Register / Vol. 74, No. 198 / Thursday, October 15, 2009 / Rules and Regulations 52885 

PART 774—[AMENDED] 

■ 19. The authority citation for part 774 

continues to read as follows: 

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. 

7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et 

seq., 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); 

42 U.S.C. 2139a; 42 U.S.C. 6212; 43 U.S.C. 

1354; 46 U.S.C. app. 466c; 50 U.S.C. app. 5; 

22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 

13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 

228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 

Comp., p. 783; Notice of August 13, 2009, 74 

FR 41,325 (August 14, 2009). 

■ 20. In Supplement No. 1 to part 774 

(the Commerce Control List), Category 5 

Telecommunications and ‘‘Information 

Security’’, Part 2 Information Security, 

Export Control Classification Number 

(ECCN) 5B002 is amended by revising 

the License Exception section to read as 

follows: 

5B002 Information Security—test, 

inspection and ‘‘production’’ equipment. 

* * * * * 

License Exceptions 

LVS: N/A 

GBS: N/A 

CIV: N/A 

ENC: Yes for certain EI controlled 

equipment, see § 740.17 of the EAR for 

eligibility. 

* * * * * 

■ 21. In Supplement No. 1 to part 774 

(the Commerce Control List), Category 5 

Telecommunications and ‘‘Information 

Security’’, Part 2 Information Security, 

Export Control Classification Number 

(ECCN) 5E002 is amended by revising 

the License Exception section to read as 

follows: 

5E002 ‘‘Technology’’ according to the 

General Technology Note for the 

‘‘development’’, ‘‘production’’ or ‘‘use’’ of 

equipment controlled by 5A002 or 5B002 or 

‘‘software’’ controlled by 5D002. 

* * * * * 

License Exceptions 

CIV: N/A 

TSR: N/A 

ENC: Yes for certain EI controlled 

technology, see § 740.17 of the EAR for 

eligibility. 

* * * * * 

■ 22. In Supplement No. 1 to part 774 

(the Commerce Control List), Category 5 

Telecommunications and ‘‘Information 

Security’’, Part 2 Information Security, 

Export Control Classification Number 

(ECCN) 5E992 is amended by revising 

the Heading to read as follows: 

5E992 ‘‘Information Security’’ 

‘‘technology’’ according to the General 

Technology Note, not controlled by 5E002. 

* * * * * 

Dated: October 7, 2009. 

Matthew S. Borman, 

Acting Assistant Secretary for the Bureau of 

Industry and Security. 

[FR Doc. E9–24697 Filed 10–14–09; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

[Docket No. FDA–2009–N–0665] 

New Animal Drugs for Use in Animal 

Feeds; Monensin; Tylosin 

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 

Elanco Animal Health, A Division of Eli 

Lilly & Co. The supplemental NADA 

revises limitations for liquid Type B 

medicated cattle feeds containing 

tylosin phosphate. 

DATES: This rule is effective October 15, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Cindy L. Burnsteel, Center for 

Veterinary Medicine (HFV–130), Food 

and Drug Administration, 7500 Standish 

Pl., Rockville, MD 20855, 240–276– 

8341, e-mail: 

cindy.burnsteel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Elanco 

Animal Health, A Division of Eli Lilly 

& Co., Lilly Corporate Center, 

Indianapolis, IN 46285, filed a 

supplement to NADA 12–491 for use of 

TYLAN (tylosin phosphate) Type A 

medicated article. For liquid Type B 

medicated cattle feeds containing 

tylosin phosphate, the supplement 

removes the presolubilization 

instructions previously required for 

manufacture and reduces the expiry 

from 8 weeks to 31 days. The 

supplemental NADA is approved as of 

September 8, 2009, and the regulations 

in 21 CFR 558.625 are amended to 

reflect the approval. In addition, the 

limitations for two-way combination 

drug medicated liquid feeds containing 

tylosin and monensin in 21 CFR 

558.355 are amended to reflect the 

revised limitations for tylosin liquid 

feeds. 

Approval of this supplemental NADA 

did not require review of additional 

safety or effectiveness data or 

information. Therefore, a freedom of 

information summary is not required. 

The agency has determined under 21 

CFR 25.33 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 558 

Animal drugs, Animal feeds. 

■ 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 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. In § 558.355, revise paragraph 

(f)(3)(ii)(b) to read as follows: 

§ 558.355 Monensin. 

* * * * * 

(f) * * * 

(3) * * * 

(ii) * * * 

(b) Limitations. Feed only to cattle 

being fed in confinement for slaughter. 

Feed continuously as sole ration at the 

rate of 50 to 480 milligrams of monensin 

and 60 to 90 milligrams of tylosin per 

head per day. Combination drug liquid 

Type B medicated feeds may be used to 

manufacture dry Type C medicated 

feeds as in § 558.625(c) of this chapter. 

* * * * * 

§ 558.625 [Amended] 

■ 3. In § 558.625, remove and reserve 

paragraph (c)(2)(i); and in paragraph 

(c)(3), remove ‘‘8 weeks’’ and in its 

place add ‘‘31 days’’. 

Dated: September 25, 2009. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. E9–24716 Filed 10–14–09; 8:45 am] 

BILLING CODE 4160–01–S 


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