69586 Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Rules and Regulations 

CFR 510.600) is being amended to 

remove the entries for this firm. 

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 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

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 parts 510 and 520 are amended as 

follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 510 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

§ 510.600 [Amended] 

■ 2. In § 510.600, in the table in 

paragraph (c)(1) remove the entry for 

‘‘Animal Health Pharmaceuticals, LLC’’; 

and in the table in paragraph (c)(2) 

remove the entry for ‘‘068718’’. 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 520 continues to read as follows: 

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

§ 520.2215 [Amended] 

■ 4. In paragraph (b) of § 520.2215, 

remove ‘‘068718’’ and add in its place 

‘‘055246’’. 

Dated: November 8, 2010. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–28549 Filed 11–12–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 516 

[Docket No. FDA–2010–N–0534] 

New Animal Drugs for Minor Use and 

Minor Species 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulations regarding new animal drugs 

for minor use and minor species to 

update language and to clarify the 

regulations consistent with the 

explanations in the preambles to the 

proposed and final rules establishing 

them. This action is being taken to 

ensure accuracy and clarity in the 

Agency’s regulations. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a 

companion proposed rule, under FDA’s 

usual procedure for notice-andcomment rulemaking, to provide a 

procedural framework to finalize the 

rule in the event the Agency receives 

any significant adverse comments and 

withdraws this direct final rule. The 

companion proposed rule and direct 

final rule are substantively identical. 

DATES: This rule is effective March 30, 

2011. Submit either electronic or 

written comments by January 31, 2011. 

If FDA receives no significant adverse 

comments within the specified 

comment period, the Agency will 

publish a document confirming the 

effective date of the final rule in the 

Federal Register within 30 days after 

the comment period on this direct final 

rule ends. If timely significant adverse 

comments are received, the Agency will 

publish a document in the Federal 

Register withdrawing this direct final 

rule before its effective date. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2010–N– 

0534, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

docket number for this rulemaking. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Request for 

Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Meg 

Oeller, Center for Veterinary Medicine 

(HFV–50), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–9005. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Minor Use and Minor Species 

Animal Health Act of 2004 amended the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) to establish new 

regulatory procedures that provide 

incentives intended to make more drugs 

legally available to veterinarians and 

animal owners for the treatment of 

minor animal species and uncommon 

diseases in major animal species. FDA 

published the final rule to implement 

these regulations (part 516 (21 CFR part 

516)) in the Federal Register of July 26, 

2007 (72 FR 41010). 

FDA is issuing this direct final rule to 

amend its regulations regarding new 

animal drugs for minor use and minor 

species (MUMS) in part 516 to update 

language and clarify the intent of the 

regulations consistent with the 

preambles to the proposed and final 

rules. 

In § 516.3(b), FDA is amending the 

definition of ‘‘Same dosage form’’ to 

make it clearer that the six dosage form 

categories listed in the regulations 

under § 516.3(b)(i) through (b)(vi) are 

the ‘‘categories’’ of dosage forms that the 

preamble to the proposed rule 

referenced as follows: ‘‘The second test 

of sameness which the statute 

establishes to determine eligibility of an 

animal drug for designation is ‘same 

dosage form.’ The agency proposes to 


jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Rules and Regulations 69587 

use the long-established dosage form 

categories listed in Title 21 of the Code 

of Federal Regulations to implement 

this statutory requirement’’ (70 FR 56394 

at 56398, September 27, 2005). To 

accomplish this clarification, the 

amendment will add the word 

‘‘categories’’ after the phrase ‘‘dosage 

forms’’ and remove the ‘‘s’’ from ‘‘forms’’ 

in the first sentence of the definition. 

Section 516.20(b)(2) requires that 

requests for MUMS designation include 

‘‘* * * the generic and trade name, if 

any, of the drug * * *’’ intended to be 

designated and FDA is amending this 

language to replace the terms ‘‘generic’’ 

and ‘‘trade’’ with the terms ‘‘established’’ 

and ‘‘proprietary’’, respectively, because 

the latter are the terms used in the FD&C 

Act (see section 502(e) (21 U.S.C. 

352(e)). FDA is also revising this 

language to clarify that ‘‘drug’’ in the 

context of § 516.20(b)(2) refers to the 

‘‘active pharmaceutical ingredient (API)’’ 

name rather than to a formulated drug 

product name. The purpose of the 

information required in this provision of 

the regulation is to permit the Agency 

to determine whether a drug is eligible 

for designation on the basis that it is not 

the ‘‘same drug’’ as a drug that is already 

designated, conditionally approved, or 

approved (see section 573(a)(2)(B) of the 

FD&C Act (21 U.S.C. 360ccc–2)) and, 

because the definition of ‘‘same drug’’ in 

§ 516.3(b) requires a knowledge of the 

drug’s ‘‘active moiety’’ in order to make 

this determination, a request for MUMS 

designation needs to include the API 

name. This is because the API name 

includes the active moiety and the drug 

product name normally does not. FDA 

is also clarifying the relationship 

between established and proprietary 

names in this context with the use of 

parentheses. 

II. Direct Final Rulemaking 

FDA has determined that the subject 

of this rulemaking is suitable for a direct 

final rule. FDA is revising part 516 by 

updating language and clarifying its 

intent. This rule is intended to make 

noncontroversial changes to existing 

regulations. The Agency does not 

anticipate receiving any significant 

adverse comment on this rule. 

Consistent with FDA’s procedures on 

direct final rulemaking, we are 

publishing elsewhere in this issue of the 

Federal Register a companion proposed 

rule. The companion proposed rule 

provides the procedural framework 

within which the rule may be finalized 

in the event the direct final is 

withdrawn because of any significant 

adverse comment. The comment period 

for this direct final rule runs 

concurrently with the comment period 

of the companion proposed rule. Any 

comments received in response to the 

companion proposed rule will also be 

considered as comments regarding this 

direct rule. 

FDA is providing a comment period 

on the direct final rule of 75 days after 

the date of publication in the Federal 

Register. If FDA receives any significant 

adverse comment, we intend to 

withdraw this direct final rule before its 

effective date by publication of a notice 

in the Federal Register within 30 days 

after the comment period ends. A 

significant adverse comment is one that 

explains why the rule would be 

inappropriate, including challenges to 

the rule’s underlying premise or 

approach, or would be ineffective or 

unacceptable without a change. In 

determining whether an adverse 

comment is significant and warrants 

withdrawing a direct final rule, we will 

consider whether the comment raises an 

issue serious enough to warrant a 

substantive response in a notice-andcomment process in accordance with 

section 553 of the Administrative 

Procedure Act (5 U.S.C. 553). A 

comment recommending a rule change 

in addition to this rule will not be 

considered a significant adverse 

comment unless the comment also 

states why this rule would be ineffective 

without the additional change. 

If FDA does not receive significant 

adverse comment, the Agency will 

publish a document in the Federal 

Register confirming the effective date of 

the final rule. The Agency intends to 

make the direct final rule effective 30 

days after publication of the 

confirmation document in the Federal 

Register. 

A full description of FDA’s policy on 

direct final rule procedures may be 

found in a guidance document 

published in the Federal Register of 

November 21, 1997 (62 FR 62466). The 

guidance document may be accessed at: 

http://www.fda.gov/ 

RegulatoryInformation/Guidances/ 

ucm125166.htm. 

III. Legal Authority 

FDA’s authority to issue this direct 

final rule is provided by section 

512(b)(1) of the FD&C Act (21 U.S.C. 

360b(b)(1)). This section states that any 

person may file with the Secretary of 

Health and Human Services an 

application with respect to any intended 

use or uses of a new animal drug and 

sets forth the specific information that 

must be included in such an 

application. In addition, section 701(a) 

of the FD&C Act (21 U.S.C. 371(a)) gives 

FDA general rulemaking authority to 

issue regulations for the efficient 

enforcement of the FD&C Act. FDA is 

issuing this direct final rule under these 

authorities. 

IV. Environmental Impact 

FDA has determined under 21 CFR 

25.30(h) 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. 

V. Analysis of Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866 

and the Regulatory Flexibility Act 

(5 U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4). Executive Order 12866 directs 

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 

not a significant regulatory action under 

the Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because this direct final rule 

would not impose any compliance costs 

on the sponsors of animal drug products 

that are currently marketed or in 

development, the Agency certifies that 

the direct final rule will not have a 

significant economic impact on a 

substantial number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and Tribal governments, in the 

aggregate, or by the private sector, of 

$100,000,000 or more (adjusted 

annually for inflation) in any one year.’’ 

The current threshold after adjustment 

for inflation is $135 million, using the 

most current (2009) Implicit Price 

Deflator for the Gross Domestic Product. 

FDA does not expect this direct final 

rule to result in any 1-year expenditure 

that would meet or exceed this amount. 

VI. Federalism 

FDA has analyzed this direct final 

rule in accordance with the principles 

set forth in Executive Order 13132. FDA 

has determined that the direct final rule 


jdjones on DSK8KYBLC1PROD with RULES
69588 Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Rules and Regulations 

1Appendix B to PBGC’s regulation on Allocation 

of Assets in Single-Employer Plans (29 CFR Part 

4044) prescribes interest assumptions for valuing 

benefits under terminating covered single-employer 

plans for purposes of allocation of assets under 

ERISA section 4044. Those assumptions are 

updated quarterly. 

does not contain policies that have 

substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

Agency has concluded that the rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

VII. Paperwork Reduction Act of 1995 

This direct final rule contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(the PRA) (44 U.S.C. 3501–3520). The 

collections of information addressed in 

the direct final rule have been approved 

by OMB in accordance with the PRA 

under the regulations governing 

designation of new animal drugs for 

MUMS (part 516, OMB control number 

0910–0605). Thus, § 516.20 as amended, 

does not constitute a new or additional 

paperwork burden requiring OMB 

approval. 

VIII. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

List of Subjects in 21 CFR Part 516 

Administrative practice and 

procedure, Animal drugs, Confidential 

business information, Reporting and 

recordkeeping requirements. 

■ Therefore under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 516 is 

amended as follows: 

PART 516—NEW ANIMAL DRUGS FOR 

MINOR USE AND MINOR SPECIES 

■ 1. The authority citation for 21 CFR 

part 516 continues to read as follows: 

Authority: 21 U.S.C. 360ccc–1, 360ccc–2, 

371. 

■ 2. Amend § 516.3(b) by revising the 

introductory text of the definition of 

‘‘Same dosage form’’ to read as follows: 

§ 516.3 Definitions. 

* * * * * 

(b) * * * 

Same dosage form means the same as 

one of the dosage form categories 

specified in the following parts of this 

chapter: 

* * * * * 

■ 3. Amend § 516.20 by revising 

paragraph (b)(2) to read as follows: 

§ 516.20 Content and format of a request 

for MUMS-drug designation. 

* * * * * 

(b) * * * 

(2) The name and address of the 

sponsor; the name of the sponsor’s 

primary contact person and/or 

permanent-resident U.S. agent including 

title, address, and telephone number; 

the established name (and proprietary 

name, if any) of the active 

pharmaceutical ingredient of the drug; 

and the name and address of the source 

of the active pharmaceutical ingredient 

of the drug. 

* * * * * 

Dated: November 3, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–28550 Filed 11–12–10; 8:45 am] 

BILLING CODE 4160–01–P 

PENSION BENEFIT GUARANTY 

CORPORATION 

29 CFR Part 4022 

Benefits Payable in Terminated SingleEmployer Plans; Interest Assumptions 

for Paying Benefits 

AGENCY: Pension Benefit Guaranty 

Corporation. 

ACTION: Final rule. 

SUMMARY: This final rule amends 

Pension Benefit Guaranty Corporation’s 

regulation on Benefits Payable in 

Terminated Single-Employer Plans to 

prescribe interest assumptions under 

the regulation for valuation dates in 

December 2010. Interest assumptions 

are also published on PBGC’s Web site 

(http://www.pbgc.gov). 

DATES: Effective December 1, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Catherine B. Klion, Manager, Regulatory 

and Policy Division, Legislative and 

Regulatory Department, Pension Benefit 

Guaranty Corporation, 1200 K Street, 

NW., Washington, DC 20005, 202–326– 

4024. (TTY/TDD users may call the 

Federal relay service toll-free at 1–800– 

877–8339 and ask to be connected to 

202–326–4024.) 

SUPPLEMENTARY INFORMATION: PBGC’s 

regulation on Benefits Payable in 

Terminated Single-Employer Plans (29 

CFR part 4022) prescribes actuarial 

assumptions—including interest 

assumptions—for paying plan benefits 

under terminating single-employer 

plans covered by title IV of the 

Employee Retirement Income Security 

Act of 1974. 

PBGC uses the interest assumptions in 

Appendix B to Part 4022 to determine 

whether a benefit is payable as a lump 

sum and to determine the amount to 

pay. Appendix C to Part 4022 contains 

interest assumptions for private-sector 

pension practitioners to refer to if they 

wish to use lump-sum interest rates 

determined using PBGC’s historical 

methodology. Currently, the rates in 

Appendices B and C of the benefit 

payment regulation are the same. 

The interest assumptions are intended 

to reflect current conditions in the 

financial and annuity markets. 

Assumptions under the benefit 

payments regulation are updated 

monthly. This final rule updates the 

benefit payments interest assumptions 

for December 2010.1

The December 2010 interest 

assumptions under the benefit payments 

regulation will be 2.25 percent for the 

period during which a benefit is in pay 

status and 4.00 percent during any years 

preceding the benefit’s placement in pay 

status. In comparison with the interest 

assumptions in effect for November 

2010, these interest assumptions 

represent an increase of 0.50 percent in 

the immediate annuity rate and are 

otherwise unchanged. 

PBGC has determined that notice and 

public comment on this amendment are 

impracticable and contrary to the public 

interest. This finding is based on the 

need to determine and issue new 

interest assumptions promptly so that 

the assumptions can reflect current 

market conditions as accurately as 

possible. 

Because of the need to provide 

immediate guidance for the payment of 

benefits under plans with valuation 

dates during December 2010, PBGC 

finds that good cause exists for making 

the assumptions set forth in this 

amendment effective less than 30 days 

after publication. 

PBGC has determined that this action 

is not a ‘‘significant regulatory action’’ 


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