This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

25181 

Vol. 78, No. 83 

Tuesday, April 30, 2013 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 27 

[Doc. No. AMS–CN–12–0024] 

RIN 0581–AD26 

Revision of Regulations Defining Bona 

Fide Cotton Spot Markets 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Final rule. 

SUMMARY: The Agricultural Marketing 

Service (AMS) is amending the 

regulation that specifies which states 

compose bona fide cotton spot markets 

in order to assure consistency with the 

revised Cotton Research and Promotion 

Act. Updated bona fide spot market 

definitions allow for published spot 

quotes to consider spot prices of cotton 

marketed in Kansas and Virginia. AMS 

is also amending references to the ‘‘New 

York Cotton Exchange’’ to read the 

‘‘Intercontinental Exchange.’’ 

DATES: Effective date: May 30, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Darryl Earnest, Deputy Administrator, 

Cotton & Tobacco Programs, AMS, 

USDA, 3275 Appling Road, Room 11, 

Memphis, TN 38133. Telephone (901) 

384–3060, facsimile (901) 384–3021, or 

email darryl.earnest@ams.usda.gov. 

SUPPLEMENTARY INFORMATION: 

Executive Order 12866 

This final rule has been determined to 

be not significant for purposes of 

Executive Order 12866; and, therefore 

has not been reviewed by the Office of 

Management and Budget (OMB). 

Executive Order 12988 

This final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. It is not intended to 

have retroactive effect. There are no 

administrative procedures that must be 

exhausted prior to any judicial 

challenge to the provisions of this rule. 

Regulatory Flexibility Act and 

Paperwork Reduction Act 

Pursuant to requirements set forth in 

the Regulatory Flexibility Act (RFA) (5 

U.S.C. 601–612), AMS has considered 

the economic impact of this action on 

small entities and has determined that 

its implementation will not have a 

significant economic impact on a 

substantial number of small businesses. 

The purpose of the RFA is to fit 

regulatory actions to the scale of 

businesses subject to such actions so 

that small businesses will not be 

disproportionately burdened. There are 

an estimated 25,000 cotton growers in 

the U.S. who voluntarily use the AMS 

cotton classing services annually, and 

the majority of these cotton growers are 

small businesses under the criteria 

established by the Small Business 

Administration (13 CFR 121.201). 

Revisions to the regulations concerning 

bona fide spot market definitions are 

necessary to assure consistency with the 

revised Cotton Research and Promotion 

Act and to allow for published spot 

quotes to consider spot prices of cotton 

marketed in Kansas and Virginia. 

Changes in spot market definitions as 

stated will not significantly affect small 

businesses as defined in the RFA 

because: 

(1) How spot prices are estimated are 

not expected to be impacted by this 

action; 

(2) Business practices of the U.S. 

cotton industry are not expected to 

change as a result of this action; 

(3) Costs associated with providing 

market news services will not be 

significantly changed by this action; 

(4) Market news services are paid for 

by appropriated funds, therefore users 

are not charged fees for the provision of 

the services. 

In compliance with OMB regulations 

(5 CFR part 1320), which implement the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501), the information collection 

requirements contained in the 

provisions amended by this rule have 

been previously approved by OMB and 

were assigned OMB control number 

0581–0009, Cotton Classification and 

Market New Service. 

Background 

The Secretary of Agriculture is 

authorized under the United States 

Cotton Futures Act (7 U.S.C. 15b) to 

designate at least five bona fide spot 

markets from which cotton price 

information can be collected. A spot 

market—also called the ‘‘cash market’’ 

or ‘‘physical market’’—is a market 

where commodities are sold on the spot 

for cash at current market prices and 

delivered immediately. Designation of 

these bona fide spot markets and the 

determination of which counties and 

states compose each of these spot 

markets was most recently published in 

the Federal Register on August 4, 1988 

(53 FR 29327). For each of these bona 

fide spot markets, the Cotton and 

Tobacco Programs of the Agricultural 

Marketing Service collects market price 

information under the United States 

Cotton Futures Act (7 U.S.C. 15b), the 

Cotton Statistics and Estimates Act (7 

U.S.C. 473b) and the Agricultural 

Marketing Act of 1946 (7 U.S.C. 

1622(g)). This price information is then 

used to calculate price differences for 

cotton futures contracts. 

The Food, Conservation, and Energy 

Act of 2008 (Pub. L. 110–234, 122 Stat. 

923, enacted May 22, 2008, H.R. 2419) 

amended Section 17(f) of the Cotton 

Research and Promotion Act (7 U.S.C. 

2116(f)), designating Kansas, Virginia, 

and Florida as cotton producing states 

for purposes of the Cotton Research and 

Promotion Act. To achieve consistency 

with the revised Cotton Research and 

Promotion Act and to allow for 

published spot quotes to consider spot 

prices of cotton marketed in the 

aforementioned states, § 27.93 is 

amended to add all the counties of 

Virginia to the Southeastern spot 

market, and Kansas to the East Texas 

and Oklahoma spot market. 

On September 14, 2006, New York 

Board of Trade—the parent company of 

the New York Cotton Exchange—agreed 

to become a unit of Intercontinental 

Exchange. This transaction was 

completed on January 12, 2007. To 

reflect this organizational change in the 

regulations, § 27.94 is amended such 

that references to the ‘‘New York Cotton 

Exchange’’ read as the ‘‘Intercontinental 

Exchange.’’ 

Summary of Comments 

A proposed rule was published in the 

Federal Register on February 8, 2013, 


pmangrum on DSK3VPTVN1PROD with RULES
25182 Federal Register / Vol. 78, No. 83 / Tuesday, April 30, 2013 / Rules and Regulations 

with a comment period of February 8, 

2013 through March 11, 2013 (78 FR 

9330). No comments on the proposed 

regulatory amendments were received 

by AMS. The proposed rule may be 

viewed at www.regulations.gov. 

List of Subjects in 7 CFR Part 27 

Commodity futures, Cotton. 

For the reasons set forth in the 

preamble, 7 CFR part 27 is amended as 

follows: 

PART 27—[Amended] 

■ 1. The authority citation for 7 CFR 

part 27 continues to read as follows: 

Authority: 7 U.S.C. 15b, 7 U.S.C. 473b, 7 

U.S.C. 1622(g). 

■ 2. In § 27.93, definitions of the 

Southeastern market and the East Texas 

and Oklahoma market are revised to 

read as follows: 

§ 27.93 Bona fide Spot Markets. 

* * * * * 

Southeastern 

All counties in the states of Alabama, 

Florida, Georgia, North Carolina, South 

Carolina, and Virginia and all counties 

in the state of Tennessee east of and 

including Stewart, Houston, 

Humphreys, Perry, Wayne and Hardin 

counties. 

* * * * * 

East Texas and Oklahoma 

All counties in the states of Kansas 

and Oklahoma and the Texas counties 

east of and including Montague, Wise, 

Parker, Erath, Comanche, Mills, San 

Saba, Mason, Sutton, Edwards, Kinney, 

Maverick, Webb, Zapata, Star and 

Hidalgo counties. 

* * * * * 

■ 3. In § 27.94, paragraph (a) is revised 

to read as follows: 

§ 27.94 Spot Markets for Contract 

Settlement Purposes. 

* * * * * 

(a) For cotton delivered in settlement 

of any No. 2 contract on the 

Intercontinental Exchange (ICE); 

Southeastern, North and South Delta, 

Eastern Texas and Oklahoma, West 

Texas, and Desert Southwest. 

* * * * * 

Dated: April 25, 2013. 

David R. Shipman, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2013–10114 Filed 4–29–13; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 522 and 558 

[Docket No. FDA–2013–N–0002] 

New Animal Drugs; Dexmedetomidine; 

Lasalocid; Melengestrol; Monensin; 

and Tylosin 

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 

approval actions for new animal drug 

applications and abbreviated new 

animal drug applications during March 

2013. FDA is also informing the public 

of the availability of summaries the 

basis of approval and of environmental 

review documents, where applicable. 

DATES: This rule is effective April 30, 

2013. 

FOR FURTHER INFORMATION CONTACT: 

George K. Haibel, Center for Veterinary 

Medicine (HFV–6), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9019, 

george.haibel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

amending the animal drug regulations to 

reflect approval actions for new animal 

drug applications (NADAs) and 

abbreviated new animal drug 

applications (ANADAs) during March 

2013, as listed in table 1. In addition, 

FDA is informing the public of the 

availability, where applicable, of 

documentation of environmental review 

required under the National 

Environmental Policy Act (NEPA) and, 

for actions requiring review of safety or 

effectiveness data, summaries of the 

basis of approval (FOI Summaries) 

under the Freedom of Information Act 

(FOIA). These public documents 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. Persons with access to the 

Internet may obtain these documents at 

the CVM FOIA Electronic Reading 

Room: http://www.fda.gov/AboutFDA/ 

CentersOffices/OfficeofFoods/CVM/ 

CVMFOIAElectronicReadingRoom/ 

default.htm. 

In addition, the animal drug 

regulations are being amended at 21 

CFR 522.558 to add a new strength of 

dexmedetomidine hydrochloride 

injectable solution for use in dogs and 

cats. This change is being made to 

improve the accuracy of the regulations. 

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. 

TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MARCH 2013 

NADA/ 

ANADA Sponsor New animal drug product name Action 21 CFR section 

FOIA 

summary 

NEPA 

review 

200–532 Huvepharma AD, 5th Floor, 3A 

Nikolay Haytov Str., 1113 Sophia, 

Bulgaria.

TYLOVET 100 (tylosin phosphate) 

and MGA (melegestrone acetate) 

Type A medicated articles.

Original approval 

as a generic 

copy of NADA 

139–192.

558.342 yes ...... CE1

200–533 Huvepharma AD, 5th Floor, 3A 

Nikolay Haytov Str., 1113 Sophia, 

Bulgaria.

TYLOVET 100 (tylosin phosphate) 

and RUMENSIN (monensin) and 

DECCOX (decoquinate) Type A 

medicated articles.

Original approval 

as a generic 

copy of NADA 

141–149.

558.195 yes ...... CE1


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