60308 Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Rules and Regulations 

Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Orion 

Corp., Orionintie 1, 02200 Espoo, 

Finland, filed a supplement to NADA 

141–267 for DEXDOMITOR 

(dexmedetomidine hydrochloride). The 

supplemental NADA provides for 

veterinary prescription use of 

dexmedetomidine hydrochloride 

injectable solution as a preanesthetic to 

general anesthesia in cats. The 

supplemental application is approved as 

of August 16, 2010, and the regulations 

in 21 CFR 522.558 are 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), 

summaries of the safety and 

effectiveness data and information 

submitted to support approval of these 

applications 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)(iii) of the 

Federal Food, Drug, and Cosmetic Act 

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

approval qualifies for 3 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 522 

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 522 is amended as follows: 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

■ 2. In § 522.558, revise paragraph 

(c)(2)(ii) to read as follows: 

§ 522.558 Dexmedetomidine. 

* * * * * 

(c) * * * 

(2) * * * 

(ii) Indications for use. For use as a 

sedative and analgesic to facilitate 

clinical examinations, clinical 

procedures, minor surgical procedures, 

and minor dental procedures; and as a 

preanesthetic to general anesthesia. 

* * * * * 

Dated: September 24, 2010. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–24494 Filed 9–29–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

[Docket No. FDA–2010–N–0002] 

New Animal Drugs for Use in Animal 

Feeds; Melengestrol 

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 more 

accurately reflect the recent approval of 

two supplemental new animal drug 

applications (NADAs) filed by 

Pharmacia & Upjohn Co., a Division of 

Pfizer, Inc. The supplemental NADAs 

provided for increased levels of 

monensin in two-way Type C medicated 

feeds containing melengestrol acetate 

and monensin, and in three-way Type C 

medicated feeds containing 

melengestrol acetate, monensin, and 

tylosin phosphate for heifers fed in 

confinement for slaughter. These 

amendments are being made to improve 

the accuracy of the regulations. 

DATES: This rule is effective September 

30, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Suzanne J. Sechen, Center for Veterinary 

Medicine (HFV–126), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8105, 

email: suzanne.sechen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pharmacia 

& Upjohn Co., a Division of Pfizer, Inc., 

235 East 42d St., New York, NY 10017, 

filed supplements to NADA 125–476 for 

use of liquid MGA 500 (melengestrol 

acetate) and RUMENSIN (monensin, 

USP) single-ingredient Type A 

medicated articles to make two-way 

Type C medicated feeds and to NADA 

138–870 for use of liquid MGA 500, 

RUMENSIN, and TYLAN (tylosin 

phosphate) single-ingredient Type A 

medicated articles to make three-way 

Type C medicated feeds for heifers fed 

in confinement for slaughter. The 

supplemental NADAs provided for use 

of increased levels of monensin, 

previously approved for singleingredient monensin Type C medicated 

feeds under NADA 95–735 (72 FR 653, 

January 8, 2007). The supplements were 

approved in October 2009 and the 

regulations were amended in § 558.342 

(21 CFR 558.342) (74 FR 59911, 

November 19, 2009; 74 FR 61029, 

November 23, 2009). 

Labeling submitted with these 

supplements also provided for use of a 

dry MGA 200 Type A medicated article 

in formulating both the two-way and 

three-way combination feeds with 

increased levels of monensin. This was 

consistent with the February 2009 

supplemental approvals under NADA 

125–476 and NADA 138–870 of these 

same two-way and three-way 

combinations using dry MGA 200 for 

conditions of use that had been 

originally approved under Pharmacia & 

Upjohn Co.’s NADA 124–309 and 

NADA 138–792. Approval of these 

supplements in this manner was 

intended, in part, to simplify 

administration of the two-way and 

three-way combinations under a single 

NADA file for each combination and to 

treat Pharmacia & Upjohn’s applications 

in a manner consistent with similar 

applications held by other sponsors. As 

of February 2009, NADA 124–309 and 

NADA 138–792 no longer contained the 

most current approved labeling and 

were administratively considered part of 

NADA 125–476 and NADA 138–870, 

respectively. 

FDA has noticed that the regulations 

in § 558.342 contain entries for use of 

monensin in these two-way and threeway combinations at the lower use 

levels. At this time, the regulations are 

being amended to reflect the conditions 

of use described in labeling approved in 

October 2009 under NADA 125–476 and 

NADA 138–870. These amendments are 

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. 

List of Subjects in 21 CFR Part 558 

Animal drugs, Animal feeds. 


jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Rules and Regulations 60309 

■ 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 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. 

§ 558.342 [Amended] 

■ 2. In § 558.342, in the table in 

paragraphs (e)(1)(v), (e)(1)(vi), and 

(e)(1)(vii), in the ‘‘Sponsor’’ column, 

remove ‘‘000009,’’. 

Dated: September 24, 2010. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–24480 Filed 9–29–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Parts 1 and 602 

[TD 9501] 

RIN 1545–BI28 

Furnishing Identifying Number of Tax 

Return Preparer 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final rule. 

SUMMARY: This document contains final 

regulations under section 6109 of the 

Internal Revenue Code (Code) that 

provide guidance on how the IRS will 

define the identifying number of tax 

return preparers and set forth 

requirements on tax return preparers to 

furnish an identifying number on tax 

returns and claims for refund of tax they 

prepare. Additional provisions of the 

regulations provide that tax return 

preparers must apply for and regularly 

renew their preparer identifying number 

as the IRS may prescribe in forms, 

instructions, or other guidance. 

DATES: Effective Date: These regulations 

are effective on September 30, 2010. 

Applicability Date: For dates of 

applicability, see § 1.6109–2(i). 

FOR FURTHER INFORMATION CONTACT: 

Stuart Murray at (202) 622–4940 (not a 

toll-free number). 

SUPPLEMENTARY INFORMATION: 

Paperwork Reduction Act 

The collection of information 

contained in these final regulations has 

been reviewed and approved by the 

Office of Management and Budget in 

accordance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

3507(d)) under control number 1545– 

2176. The collection of information in 

these final regulations is in § 1.6109– 

2(d) and (e). This information is 

required in order for the IRS to issue 

identifying numbers to tax return 

preparers who are eligible to receive 

them. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless the collection of information 

displays a valid control number. 

Books or records relating to a 

collection of information must be 

retained as long as their contents may 

become material in the administration 

of any internal revenue law. Generally, 

tax returns and tax return information 

are confidential, as required by 26 

U.S.C. 6103. 

Background 

This document contains final 

amendments to regulations under 

section 6109 of the Code relating to 

furnishing a tax return preparer’s 

identifying number on tax returns and 

claims for refund of tax. Section 

6109(a)(4) requires tax return preparers 

to furnish on tax returns and claims for 

refund of tax an identifying number, as 

prescribed, to ensure proper 

identification of the preparer, the 

preparer’s employer, or both. In 

addition, section 6109(c) authorizes the 

Secretary ‘‘to require such information 

as may be necessary to assign an 

identifying number to any person.’’ The 

requirement to furnish an identifying 

number on tax returns and claims for 

refund of tax applies to information 

returns described in § 301.7701–15(b)(4) 

and to electronically filed tax returns. 

In 2009 the IRS conducted a 

comprehensive review of tax return 

preparers, culminating in Publication 

4832, Return Preparer Review (Rev. 12– 

2009) (the Report). The Report 

recommended that tax return preparers 

be required to obtain and use a preparer 

tax identification number (PTIN) as the 

exclusive preparer identifying number. 

The Report also recommended that the 

IRS establish new eligibility standards 

to prepare tax returns—including 

testing, continuing education, and 

Federal tax compliance checks. The 

proposed regulations adopted several of 

the recommendations made in the 

Report. The Treasury Department and 

the IRS conclude that adopting these 

provisions in the final regulations will 

increase tax compliance and help to 

ensure that tax return preparers are 

knowledgeable, skilled, and ethical. 

To implement recommendations 

made in the Report, on March 26, 2010, 

the Treasury Department and the IRS 

published in the Federal Register (75 

FR 14539) a notice of proposed 

rulemaking (REG–134235–08) proposing 

amendments to § 1.6109–2 regarding the 

identifying number that a tax return 

preparer must furnish on tax returns 

and claims for refund of tax. A public 

hearing was held on the proposed 

regulations on May 6, 2010. The IRS 

received written public comments 

responding to the proposed regulations. 

Summary of Comments and 

Explanation of Revisions 

Over 200 written comments were 

received in response to the notice of 

proposed rulemaking. All comments 

were considered and are available for 

public inspection. Most of the 

comments are summarized in this 

preamble. 

1. Requiring the Use of PTINs 

The final regulations adopt the 

proposed amendments to § 1.6109–2, 

which provide that for tax returns or 

refund claims filed after December 31, 

2010, tax return preparers must obtain 

and exclusively use the identifying 

number prescribed by the IRS in forms, 

instructions, or other guidance, rather 

than a social security number (SSN), as 

the identifying number to be included 

with the tax return preparer’s signature 

on a tax return or claim for refund. Prior 

to these final regulations, the identifying 

number of a tax return preparer was the 

tax return preparer’s SSN or an 

alternative number as prescribed by the 

IRS. The alternative number that the IRS 

has prescribed is a PTIN. After 

December 31, 2010, tax return preparers 

can only use a PTIN (or other number 

that the IRS prescribes in the future as 

a replacement to the PTIN) and may not 

use an SSN as a preparer identifying 

number unless the IRS directs 

otherwise. For tax returns or claims for 

refund filed before January 1, 2011, the 

identifying number of a tax return 

preparer will remain the preparer’s SSN 

or PTIN. 

The requirement to use a PTIN will 

allow the IRS to better identify tax 

return preparers, centralize information, 

and effectively administer the rules 

relating to tax return preparers. The 

final regulations will also benefit 

taxpayers and tax return preparers and 

help maintain the confidentiality of 

SSNs. Most of the comments received 


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