Federal Register / Vol. 75, No. 210 / Monday, November 1, 2010 / Rules and Regulations 67031 

statutory duties, and contrary to the 

public’s national security interests. 

In addition, BIS finds good cause to 

waive the requirement of 5 U.S.C. 

553(d)(3) to delay the effectiveness of 

this regulation, because such a delay is 

contrary to the public’s interest. When 

the U.S. Government has been notified 

of or has identified a material change in 

circumstances that warrants revocation 

or modification of VEU status for an 

end-user or a facility of an end-user, 

there is a need to quickly alert the 

public that the facility is no longer 

authorized as a recipient of items under 

Authorization VEU. Delaying this 

action’s effectiveness could result in 

items that otherwise require licenses 

being exported, reexported or 

transferred (in-country), license-free, to 

an ineligible facility. Accordingly, it 

would be contrary to the public interest 

to delay this rule’s effectiveness. 

No other law requires that a notice of 

proposed rulemaking and an 

opportunity for public comment be 

given for this final rule. Because a 

notice of proposed rulemaking and an 

opportunity for public comment are not 

required to be given for this rule under 

the Administrative Procedure Act or by 

any other law, the analytical 

requirements of the Regulatory 

Flexibility Act (5 U.S.C. 601 et seq.) are 

not applicable and no regulatory 

flexibility analysis has been prepared. 

List of Subjects in 15 CFR Part 748 

Administrative practice and 

procedure, Exports, Reporting and 

recordkeeping requirements. 

■ Accordingly, part 748 of the Export 

Administration Regulations (15 CFR 

parts 730–774) is amended as follows: 

PART 748—[AMENDED] 

■ 1. The authority citation for part 748 

continues to read as follows: 

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

U.S.C. 1701 et seq.; 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 12, 2010 (75 FR 50681) (August 16, 

2010). 

■ 2. Supplement No. 7 to part 748 is 

amended by removing ‘‘Cension 

Semiconductor Manufacturing 

Corporation’’ and its address ‘‘(3/F, 8–1 

Kexin Road, Export Processing Zone 

(West Area), Chengdu, China 611731)’’ 

from the list of ‘‘Eligible Destinations’’ 

for ‘‘Validated End-User’’ 

‘‘Semiconductor Manufacturing 

International Corporation’’ in ‘‘China 

(People’s Republic of)’’. 

Dated: October 26, 2010. 

Kevin J. Wolf, 

Assistant Secretary for Export 

Administration. 

[FR Doc. 2010–27517 Filed 10–29–10; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2010–N–0002] 

Oral Dosage Form New Animal Drugs; 

Domperidone 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect the 

original approval of a new animal drug 

application (NADA) filed by Dechra, 

Ltd. The NADA provides for the 

veterinary prescription use of 

domperidone oral gel for prevention of 

fescue toxicosis in periparturient mares. 

DATES: This rule is effective November 

1, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Amy L. Omer, Center for Veterinary 

Medicine (HFV–114), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8336, 

e-mail: amy.omer@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Dechra, 

Ltd., Dechra House, Jamage Industrial 

Estate, Talke Pits, Stoke-on-Trent, 

Staffordshire, ST7 1XW, United 

Kingdom, filed NADA 141–314 that 

provides for veterinary prescription use 

of EQUIDONE (domperidone) Gel for 

prevention of fescue toxicosis in 

periparturient mares. The NADA is 

approved as of September 9, 2010, and 

the regulations in 21 CFR part 520 are 

amended by adding § 520.766 to reflect 

the approval. 

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. 

Under section 512(c)(2)(F)(i) of the 

Federal Food, Drug, and Cosmetic Act 

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

approval qualifies for 5 years of 

marketing exclusivity beginning on the 

date of approval. 

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 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. Add § 520.766 to read as follows: 

§ 520.766 Domperidone. 

(a) Specifications. Each milliliter of 

gel contains 110 milligrams (mg) 

domperidone. 

(b) Sponsor. See No. 043264 in 

§ 510.600 of this chapter. 

(c) Conditions of use in horses—(1) 

Amount. Administer 0.5 mg per pound 

(mg/lb) (1.1 mg/kilogram (kg)) by mouth 

once daily starting 10 to 15 days prior 

to the expected foaling date. Treatment 

may be continued for up to 5 days after 

foaling if mares are not producing 

adequate milk. 

(2) Indications for use. For prevention 

of fescue toxicosis in periparturient 

mares. 

(3) 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: October 27, 2010. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2010–27524 Filed 10–29–10; 8:45 am] 

BILLING CODE 4160–01–P 

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