Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Rules and Regulations 81455 

claims for exemptions are still pending, 

will be revised. 

e. Internal references will be 

corrected. 

These regulations are being published 

as a direct final rule because the 

amendments do not impose any 

requirements on any member of the 

public. These amendments are the most 

efficient means for the Joint Board to 

implement its internal requirements for 

complying with the Privacy Act. 

Accordingly, pursuant to 5 U.S.C. 

553(b)(3)(B), the Joint Board finds good 

cause that prior notice and other public 

procedures with respect to this rule are 

unnecessary, and good cause for making 

this direct final rule effective 90 days 

after publication in the Federal 

Register. 

Pursuant to Executive Order 12866, it 

has been determined that this direct 

final rule is not a significant regulatory 

action, and therefore, does not require a 

regulatory impact analysis. 

Because no notice of proposed 

rulemaking is required, the provisions 

of the Regulatory Flexibility Act, 5 

U.S.C. 601–612, do not apply. 

List of Subjects in 20 CFR Part 903 

Access to Records. 

Adoption of Amendments to the 

Regulations 

■ Accordingly, 20 CFR part 903 is 

amended as follows: 

PART 903—ACCESS TO RECORDS 

■ 1. The authority citation for 20 CFR 

part 903 continues to read as follows: 

Authority: 5 U.S.C. 552a. 

■ 2. Section 903.8, is amended by: 

■ a. Revising paragraph (a); 

■ b. Revising paragraph (b); 

■ c. Revising the last sentence of 

paragraph (c)(2)(i); 

■ d. Revising the last sentence of 

paragraph (c)(2)(ii); 

■ e. Amending paragraph (c)(2)(iii) by 

removing the reference ‘‘the preceding 

subparagraph (2)(B)’’ and by adding in 

its place, the reference ‘‘the preceding 

subsection (2)(ii)’’; 

■ f. Revising the last sentence of 

paragraph (c)(2)(iii); 

■ g. Amending paragraph (c)(2)(iv) by 

removing the reference ‘‘the preceding 

subparagraph (2)(B)’’ and by adding in 

its place the reference ‘‘the preceding 

subsection (2)(ii)’’; 

■ g. Amending paragraph (c)(2)(iv) by 

removing the reference ‘‘afforded by 

subsections (c)(4)(G)’’ and by adding in 

its place the reference ‘‘afforded by 

subsections (e)(4)(G)’’; and 

■ h. Revising the last sentence of 

paragraphs (c)(2)(iv), (c)(2)(v), and 

(c)(2)(vi). 

The revisions read as follows: 

§ 903.8 Exemptions. 

(a) Names of systems: JBEA–2, 

Enrolled Actuary Disciplinary Records; 

and JBEA–4, Enrolled Actuary 

Enrollment Records. 

(b) Provisions from which exempted: 

These systems contain records 

described in section (k)(2) of the Privacy 

Act of 1974, 5 U.S.C. 552a(k)(2). 

Exemptions are claimed for such 

records only where appropriate from the 

following provisions: sections (c)(3); (d); 

(e)(1); (e)(4)(G), (e)(4)(H), and (e)(4)(I); 

and (f) of 5 U.S.C. 552a. 

(c) * * * 

(2) * * * 

(i) * * * For these reasons, the Joint 

Board claims exemption from the 

requirements of subsection (c)(3) of the 

Act. 

(ii) * * * For these reasons, the Joint 

Board claims exemptions from the 

requirements of subsections (d)(1), 

(e)(4)(H), and (f)(2), (3), and (5) of the 

Act. 

(iii) * * * Therefore, the Joint Board 

claims exemptions from the 

requirements of subsections (d)(2), (3), 

and (4), (e)(4)(H), and (f)(4). 

(iv) * * * For these reasons, the Joint 

Board claims exemptions from the 

requirements of subsections (e)(4)(G) 

and (f)(1). 

(v) * * * For these reasons, the Joint 

Board claims exemption from the 

requirements of subsection (e)(1). 

(vi) * * * For these reasons, the Joint 

Board claims exemption from the 

requirements of subsection (e)(4)(I). 

Dated: November 4, 2010. 

Carolyn E. Zimmerman, 

Chair, Joint Board for the Enrollment of 

Actuaries. 

[FR Doc. 2010–32165 Filed 12–27–10; 8:45 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 522 

[Docket No. FDA–2010–N–0002] 

New Animal Drugs; Deslorelin 

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 Thorn 

Bioscience LLC. The NADA provides for 

the use of deslorelin acetate injectable 

suspension in mares for inducing 

ovulation. 

DATES: This rule is effective December 

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

SUPPLEMENTARY INFORMATION: Thorn 

Bioscience LLC, 1044 East Chestnut St., 

Louisville, KY 40204, filed NADA 141– 

319 that provides for use of 

SUCROMATE Equine (deslorelin 

acetate), an injectable suspension, in 

mares for inducing ovulation. The 

NADA is approved as of November 5, 

2010, and the regulations are amended 

in 21 CFR 522.533 to reflect the 

approval. 

In addition, Thorn Bioscience LLC 

has not been previously listed in the 

animal drug regulations as a sponsor of 

an approved application. Accordingly, 

21 CFR 510.600(c) is being amended to 

add entries for this firm. 

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. 

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)(ii) of the 

Federal Food, Drug, and Cosmetic Act 

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

approval qualifies for 3 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 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 


srobinson on DSKHWCL6B1PROD with RULES
81456 Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Rules and Regulations 

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 parts 510 and 522 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. 

■ 2. In § 510.600, in the table in 

paragraph (c)(1) alphabetically add an 

entry for ‘‘Thorn Bioscience LLC’’; and 

in the table in paragraph (c)(2) 

numerically add an entry for ‘‘051330’’ 

to read as follows: 

* * * * * 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler 

code 

* * * * * 

Thorn Bioscience LLC, 1044 

East Chestnut St., Louisville, KY 40204 .................. 051330 

* * * * * 

(2) * * * 

Drug labeler code Firm name 

and address 

.

* * * * * 

051330 .................................. Thorn 

Bioscience 

LLC, 1044 

East Chestnut 

St., Louisville, 

KY 40204 

* * * * * 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

■ 4. Revise § 522.533 to read as follows: 

§ 522.533 Deslorelin. 

(a) Specifications—(1) Each implant 

contains 2.1 milligrams (mg) deslorelin 

acetate. 

(2) Each milliliter (mL) of suspension 

contains 1.8 mg deslorelin acetate. 

(b) Sponsors. See sponsor numbers in 

§ 510.600(c) of this chapter as follows: 

(1) No. 043246 for use of product 

described in paragraph (a)(1) as in 

paragraph (c)(1) of this section. 

(2) No. 051330 for use of product 

described in paragraph (a)(2) as in 

paragraph (c)(2) of this section. 

(c) Conditions of use—(1) Horses and 

ponies—(i) Amount. One implant per 

mare subcutaneously in the neck. 

(ii) Indications for use. For inducing 

ovulation within 48 hours in estrous 

mares with an ovarian follicle greater 

than 30 mL in diameter. 

(iii) Limitations. Do not use in horses 

or ponies intended for human 

consumption. Federal law restricts this 

drug to use by or on the order of a 

licensed veterinarian. 

(2) Horses—(i) Amount. Administer 

1.8 mg (1 mL) by intramuscular 

injection in the neck. 

(ii) Indications for use. For inducing 

ovulation within 48 hours in cyclic 

estrous mares with an ovarian follicle 

between 30 and 40 mL in diameter. 

(iii) 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: December 9, 2010. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2010–32554 Filed 12–27–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9505] 

RIN 1545–BG36 

Hybrid Retirement Plans; Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Correcting amendment. 

SUMMARY: This document contains 

correctioning amendments to correct 

errors resulting from the publication of 

to final regulations (TD 9505) that were 

published in the Federal Register on 

Tuesday, October 19, 2010 (75 FR 

64123) providing guidance relating to 

certain provisions of the Internal 

Revenue Code that apply to hybrid 

defined benefit pension plans. 

DATES: This correcting amendment is 

effective on December 28, 2010, and is 

applicable on October 19, 2010. 

FOR FURTHER INFORMATION CONTACT: Neil 

S. Sandhu, Lauson C. Green, or Linda S. 

F. Marshall at (202) 622–6090 (not a 

toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background 

The final regulations (TD 9505) that 

are the subject of this document are 

under section 411 of the Internal 

Revenue Code. 

Need for Correction 

As published, the final regulations 

(TD 9505) contain errors that may prove 

to be misleading and are in need of 

clarification. 

List of Subject in 26 CFR Part 1 

Income taxes, Reporting and 

recordkeeping requirements. 

Correction of Publication 

■ Accordingly, 26 CFR part 1 is 

corrected by making the following 

correcting amendments: 

PART 1—INCOME TAXES 

■ Paragraph 1. The authority citation 

for part 1 continues to read in part as 

follows: 

Authority: 26 U.S.C. 7805 * * * 

■ Par. 2. Section 1.411(b)(5)–1 is 

amended by: 

■ 1. Revising the paragraph (b)(1)(ii)(A). 

■ 2. Revising the first sentence of 

paragraph (b)(1)(iv) Example 4.(iii). 

■ 3. Revising the first sentence of 

paragraph (c)(5) Example 2.(iv). 

■ 4. Revising the third sentence of 

paragraph (c)(5) Example 3.(i). 

■ 5. Revising the paragraph (d)(1)(iii). 

■ 6. Revising the first sentence of 

paragraph (f)(2)(iii). 

The revisions read as follows: 

§ 1.411(b)(5)–1 Reduction in rate of benefit 

accrual under a defined benefit plan. 

* * * * * 

(b) * * * 

(1) * * * 

(ii) * * * (A) In general. Except as 

provided in paragraphs (b)(1)(ii)(B), (C), 

and (D) of this section, the safe harbor 

provided by section 411(b)(5)(A) and 

paragraph (b)(1)(i) of this section is 

available with respect to an individual 

only if the individual’s accumulated 

benefit under the plan is expressed in 

terms of only one safe-harbor formula 

measure and no similarly situated, 

younger individual who is or could be 

a participant has an accumulated benefit 

that is expressed in terms of any 

measure other than that same safeharbor formula measure. Thus, for 

example, if a plan provides that the 

accumulated benefit of participants who 


srobinson on DSKHWCL6B1PROD with RULES