15960 Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Rules and Regulations 

have in support of a claim for 

preferential tariff treatment under the 

United States-Korea Free Trade 

Agreement (UKFTA), including a 

UKFTA importer’s certification. 

* * * * * 

■ 10. The appendix to part 163 is 

amended by adding a new listing under 

section IV in numerical order to read as 

follows: 

Appendix to Part 163—Interim (a)(1)(A) 

List 

* * * * * 

IV. * * * 

§ 10.1005 UKFTA records that the importer 

may have in support of a UKFTA claim for 

preferential tariff treatment, including an 

importer’s certification. 

* * * * * 

PART 178—APPROVAL OF 

INFORMATION COLLECTION 

REQUIREMENTS 

■ 11. The authority citation for part 178 

continues to read as follows: 

Authority: 5 U.S.C. 301; 19 U.S.C. 1624; 44 

U.S.C. 3501 et seq. 

■ 12. Section 178.2 is amended by 

adding new listings for ‘‘§§ 10.1003 and 

10.1004’’ to the table in numerical order 

to read as follows: 

§ 178.2 Listing of OMB control numbers. 

19 CFR Section Description OMB Control No. 

*******

§§ 10.1003 and 10.1004 ................ Claim for preferential tariff treatment under the US-Korea Free 

Trade Agreement.

1651–0117 

* * * * * * * 

* * * * * 

David V. Aguilar, 

Acting Commissioner, U.S. Customs and 

Border Protection. 

Approved: March 14, 2012. 

Timothy E. Skud, 

Deputy Assistant Secretary of the Treasury. 

[FR Doc. 2012–6554 Filed 3–15–12; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2011–N–0003] 

Oral Dosage Form New Animal Drugs; 

Pergolide 

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 original new animal drug 

application (NADA) filed by Boehringer 

Ingelheim Vetmedica, Inc. The NADA 

provides for the veterinary prescription 

use of pergolide mesylate tablets in 

horses for the control of clinical signs 

associated with Pituitary Pars 

Intermedia Dysfunction (Equine 

Cushing’s Disease). 

DATES: This rule is effective March 19, 

2012. 

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, 

email: amy.omer@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Boehringer Ingelheim Vetmedica, Inc., 

2621 North Belt Highway, St. Joseph, 

MO 64506–2002, filed NADA 141–331 

for the veterinary prescription use in 

horses of PRASCEND (pergolide 

mesylate) Tablets for the control of 

clinical signs associated with Pituitary 

Pars Intermedia Dysfunction (Equine 

Cushing’s Disease). The NADA is 

approved as of September 7, 2011, and 

21 CFR part 520 is amended 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 § 520.1705 to read as follows: 

§ 520.1705 Pergolide. 

(a) Specifications. Each tablet 

contains 1 milligram (mg) pergolide 

mesylate. 

(b) Sponsor. See No. 000010 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in horses—(1) 

Amount. Administer orally at a starting 

dose of 2 micrograms/kilograms (m/kg) 

once daily. Dosage may be adjusted to 

effect, not to exceed 4 mg/kg daily. 

(2) Indications for use. For the control 

of clinical signs associated with 

Pituitary Pars Intermedia Dysfunction 

(Equine Cushing’s Disease). 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 


emcdonald on DSK29S0YB1PROD with RULES
Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Rules and Regulations 15961 

Dated: March 14, 2012. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2012–6544 Filed 3–16–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2011–N–0003] 

Oral Dosage Form New Animal Drugs; 

Phenylpropanolamine 

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 original new animal drug 

application (NADA) filed by Pegasus 

Laboratories, Inc. The NADA provides 

for the veterinary prescription use of 

phenylpropanolamine hydrochloride 

chewable tablets for the control of 

urinary incontinence due to urethral 

sphincter hypotonus in dogs. 

DATES: This rule is effective March 19, 

2012. 

FOR FURTHER INFORMATION CONTACT: Lisa 

M. Troutman, Center for Veterinary 

Medicine (HFV–116), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8322, 

email: lisa.troutman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pegasus 

Laboratories, Inc., 8809 Ely Rd., 

Pensacola, FL 32514, filed NADA 141– 

324 that provides for the veterinary 

prescription use of PROIN 

(phenylpropanolamine hydrochloride) 

Chewable Tablets for the control of 

urinary incontinence due to urethral 

sphincter hypotonus in dogs. The 

NADA is approved as of August 4, 2011, 

and the regulations are amended in 

21 CFR part 520 to reflect the approval. 

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. 

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. 

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. 

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 § 520.1760 to read as follows: 

§ 520.1760 Phenylpropanolamine. 

(a) Specifications. Each chewable 

tablet contains 25, 50, or 75 milligram 

(mg) phenylpropanolamine 

hydrochloride. 

(b) Sponsors. See No. 055246 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in dogs—(1) 

Amount. Administer 2 mg/kg of body 

weight twice daily. 

(2) Indications for use. For the control 

of urinary incontinence due to urethral 

sphincter hypotonus in dogs. 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

Dated: March 14, 2012. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2012–6553 Filed 3–16–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Chapter I 

[Docket No. FDA–2012–N–0222] 

Revision of Organization and 

Conforming Changes to Regulations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing this 

final rule to amend the regulations to 

reflect organizational change in the 

Agency and to make other conforming 

changes. This action is editorial in 

nature and is intended to improve the 

accuracy of the Agency’s regulations. 

DATES: This rule is effective April 1, 

2012. 

FOR FURTHER INFORMATION CONTACT: 

Vanessa Starks, Human Capital 

Management, Food and Drug 

Administration, 19903 New Hampshire 

Ave., Silver Spring, MD 20903, 301– 

796–8846. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is issuing this final rule to 

amend its regulations by updating the 

organizational information in part 5 

(21 CFR part 5). 

The portion of this final rule updating 

the organizational information in part 5, 

subpart M is a rule of Agency 

organization, procedure, or practice. 

FDA is issuing these provisions as a 

final rule without publishing a general 

notice of proposed rulemaking because 

such notice is not required for rules of 

Agency organization, procedure, or 

practice under 5 U.S.C. 553(b)(3)(A). For 

the conforming changes to the other 

regulations, the Agency finds good 

cause under 5 U.S.C. 553(b)(3)(B) to 

dispense with prior notice and 

comment, and good cause under 5 

U.S.C. 553(d)(3) to make these 

conforming changes effective less than 

30 days after publication because such 

notice and comment and delayed 

effective date are unnecessary and 

contrary to the public interest. These 

conforming changes merely update the 

footnotes in part 5, subpart M. These 

changes do not result in any substantive 

change in the regulations. 

II. Analysis of Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866, 

Executive Order 13563, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). Executive Orders 

12866 and 13563 direct Agencies to 

assess all costs and benefits of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

Agency believes that this final rule is 


emcdonald on DSK29S0YB1PROD with RULES