Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Rules and Regulations 52621 

resulting overpayments. One commenter 

recommended that we clarify that an 

annulment ab initio will not affect the 

eligibility for child’s benefits to 

stepchildren prior to annulments. One 

of these commenters asked us to notify 

families affected by this final rule. 

Response: As we stated above, we are 

not adopting our proposed rules about 

ab initio or prospective marriage 

annulments at this time. 

Regulatory Procedures 

Executive Order 12866 

We have consulted with the Office of 

Management and Budget (OMB) and 

determined that this final rule meets the 

criteria for a significant regulatory 

action under Executive Order 12866. 

Thus, OMB reviewed it. 

Regulatory Flexibility Act 

We certify that this final rule will not 

have a significant economic impact on 

a substantial number of small entities 

because it affects only individual 

persons. Therefore, the Regulatory 

Flexibility Act, as amended, does not 

require us to develop a regulatory 

flexibility analysis. 

Paperwork Reduction Act 

This final rule does not impose 

reporting or recordkeeping requirements 

subject to OMB clearance. 

(Catalog of Federal Domestic Assistance 

Program Nos. 96.001 Social SecurityDisability Insurance; 96.002 Social SecurityRetirement Insurance; 96.004 Social SecuritySurvivors Insurance) 

List of Subjects in 20 CFR Part 404 

Administrative practice and 

procedure; Blind; Disability benefits; 

Old-Age, Survivors and Disability 

Insurance; Reporting and recordkeeping 

requirements; Social Security. 

Dated: June 7, 2010. 

Michael J. Astrue, 

Commissioner of Social Security. 

■ For the reasons stated in the preamble, 

we are amending 20 CFR part 404 

subpart D as set forth below: 

PART 404—FEDERAL OLD-AGE, 

SURVIVORS AND DISABILITY 

INSURANCE (1950– ) 

Subpart D—[Amended] 

■ 1. The authority citation for subpart D 

of part 404 continues to read as follows: 

Authority: Secs. 202, 203(a) and (b), 205(a), 

216, 223, 225, 228(a)–(e), and 702(a)(5) of the 

Social Security Act (42 U.S.C. 402, 403(a) 

and (b), 405(a), 416, 423, 425, 428(a)–(e), and 

902(a)(5)). 

■ 2. Amend § 404.352 by adding 

paragraph (b)(7) to read as follows: 

§ 404.352 When does my entitlement to 

child’s benefits begin and end? 

* * * * * 

(b) * * * 

(7) With the month in which the 

divorce between your parent (including 

an adoptive parent) and the insured 

stepparent becomes final if you are 

entitled to benefits as a stepchild and 

the marriage between your parent 

(including an adoptive parent) and the 

insured stepparent ends in divorce. 

* * * * * 

■ 3. Amend § 404.363 by revising the 

section heading and introductory text to 

read as follows: 

§ 404.363 When is a stepchild dependent? 

If you are the insured’s stepchild, as 

defined in § 404.357, we consider you 

dependent on him or her if you were 

receiving at least one-half of your 

support from him or her at one of these 

times— 

* * * * * 

[FR Doc. 2010–21341 Filed 8–26–10; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510, 520, and 522 

[Docket No. FDA–2010–N–0002] 

New Animal Drugs; Change of 

Sponsor; Withdrawal of Approval of 

New Animal Drug Applications; 

Deslorelin Acetate; Dichlorophene and 

Toluene Capsules; Pyrantel Pamoate 

Suspension 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect a 

change of sponsor for a new animal drug 

application (NADA) from Peptech 

Animal Health Pty, Ltd. to Dechra, Ltd. 

and for an abbreviated new animal drug 

application (ANADA) from Church & 

Dwight Co., Inc., to Pegasus 

Laboratories, Inc. In addition, FDA is 

removing those portions of the 

regulations that reflect approval of two 

other NADAs transferred from Church & 

Dwight Co., Inc., to Pegasus 

Laboratories, Inc., for which voluntary 

withdrawal of approval was requested 

after the change of sponsorship. In a 

notice published elsewhere in this issue 

of the Federal Register, FDA is 

withdrawing approval of these two 

NADAs. 

DATES: This rule is effective: 

1. August 27, 2010 for 21 CFR 

510.600(c), 520.2043, and 522.533. 

2. September 7, 2010 for 21 CFR 

520.580. 

FOR FURTHER INFORMATION CONTACT: 

David R. Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8307, 

e-mail: david.newkirk@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Church & 

Dwight Co., Inc., 469 North Harrison St., 

Princeton, NJ 08543–5297, has informed 

FDA that it has transferred ownership 

of, and all rights and interest in, NADA 

101–497 and NADA 101–498 for oral 

capsules containing dichlorophene and 

toluene, and ANADA 200–028 for an 

oral suspension of pyrantel pamoate to 

Pegasus Laboratories, Inc., 8809 Ely Rd., 

Pensacola, FL 32514. Accordingly, the 

agency is amending the regulations in 

21 CFR 520.2043 to reflect the transfer 

of ownership. 

Peptech Animal Health Pty, Ltd., 19– 

25 Khartoum Rd., Macquarie Park, New 

South Wales 2113, Australia, has 

informed FDA that it has transferred 

ownership of, and all rights and interest 

in, NADA 141–044 for subcutaneous 

implants containing deslorelin acetate 

to Dechra, Ltd., Dechra House, Jamage 

Industrial Estate, Talke Pits, Stoke-onTrent, Staffordshire, ST7 1XW, United 

Kingdom. Accordingly, the agency is 

amending the regulations in 21 CFR 

522.533 to reflect the transfer of 

ownership and a current format. 

Following these changes of 

sponsorship, Pegasus Laboratories, Inc., 

has requested that FDA withdraw 

approval of the two NADAs for 

dichlorophene and toluene capsules 

because they are no longer 

manufactured or marketed. In a notice 

published elsewhere in this issue of the 

Federal Register, FDA gave notice that 

approval of NADA 101–497 and 101– 

498, and all supplements and 

amendments thereto, is withdrawn, 

effective September 7, 2010. As 

provided in the regulatory text of this 

document, the agency is amending the 

regulations in 21 CFR 520.580 to reflect 

these withdrawals of approval. 

Also, following these changes of 

sponsorship, Church & Dwight Co., Inc., 

and Peptech Animal Health Pty, Ltd., 

are no longer sponsors of an approved 

application. Accordingly, 21 CFR 

510.600(c) is being amended to remove 

the entries for these firms. 

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 

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52622 Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Rules and Regulations 

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 Parts 520 and 522 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under the 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR parts 510, 520, 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. 

§ 510.600 [Amended] 

■ 2. In § 510.600, in the table in 

paragraph (c)(1), remove the entries for 

‘‘Church & Dwight Co., Inc.’’ and 

‘‘Peptech Animal Health Pty, Ltd.’’; and 

in the table in paragraph (c)(2), remove 

the entries for ‘‘010237’’ and ‘‘064288’’. 

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. 

§ 520.580 [Amended]. 

■ 4. In paragraph (b)(1) of § 520.580, 

remove ‘‘010237,’’. 

§ 520.2043 [Amended] 

■ 5. In paragraph (b)(2) of § 520.2043, 

remove ‘‘010237’’ and in its place add 

‘‘055246’’. 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 6. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

■ 7. In § 522.533, revise the section 

heading and paragraph (b), add 

paragraph (c), and remove paragraph (d) 

to read as follows: 

§ 522.533 Deslorelin. 

* * * * * 

(b) Sponsor. See No. 043264 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in horses and 

ponies—(1) Amount. One implant per 

mare subcutaneously in the neck. 

(2) Indications for use. For inducing 

ovulation within 48 hours in estrous 

mares with an ovarian follicle greater 

than 30 millimeters in diameter. 

(3) 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. 

Dated: August 23, 2010. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2010–21296 Filed 8–26–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF STATE 

22 CFR Parts 124, 125, 126, and 129 

[Public Notice: 7134] 

RIN 1400–AC62 

Amendment to the International Traffic 

in Arms Regulations: Removing 

Requirement for Prior Approval for 

Certain Proposals to Foreign Persons 

Relating to Significant Military 

Equipment 

AGENCY: Department of State. 

ACTION: Final rule. 

SUMMARY: The Department of State is 

amending the International Traffic in 

Arms Regulations (ITAR) to remove the 

requirements for prior approval or prior 

notification for certain proposals to 

foreign persons relating to significant 

military equipment. 

DATES: Effective Date: This rule is 

effective August 27, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Director Charles Shotwell, Office of 

Defense Trade Controls Policy, 

Department of State, Telephone (202) 

663–2792 or Fax (202) 261–8199; E-mail 

DDTCResponseTeam@state.gov. ATTN: 

Regulatory Change, Section 126.8. 

SUPPLEMENTARY INFORMATION: In 

accordance with the President’s Export 

Control Reform effort, on March 29, 

2010, the Department published a 

Notice of Proposed Rulemaking (NPRM) 

to eliminate the requirements for prior 

approval or prior notification for certain 

proposals to foreign persons relating to 

significant military equipment at § 126.8 

of the ITAR. Effective September 1, 

1977, the Department of State amended 

§ 123.16 to require Department of State 

approval before a proposal or 

presentation is made that is designed to 

constitute the basis for a decision to 

purchase significant combat equipment, 

involving the export of an item on the 

U.S. Munitions List, valued at 

$7,000,000 or more for use by the armed 

forces of a foreign country (42 FR 41631, 

dated August 18, 1977). Also, § 124.06, 

entitled, ‘‘Approval of proposals for 

technical assistance and manufacturing 

license agreements,’’ was amended to 

require similar prior approval with 

respect to proposals and presentations 

for technical assistance and 

manufacturing license agreements 

involving the production or assembly of 

significant combat equipment. 

‘‘Proposals to foreign persons relating 

to significant military equipment’’ 

became § 126.8 in a final rule effective 

January 1, 1985 (49 FR 47682, dated 

December 6, 1984). Section 126.8 did 

not require prior approval of the 

Department of State when the proposed 

sale was to the armed forces of a 

member of the North Atlantic Treaty 

Organization (NATO), Australia, Japan, 

or New Zealand, except with respect to 

manufacturing license agreements or 

technical assistance agreements. 

A prior notification requirement, 

instead of prior approval, was added to 

§ 126.8 in a final rule effective March 

31, 1985 (50 FR 12787, dated April 1, 

1985). Prior notification to the 

Department of State was required 30 

days in advance of a proposal or 

presentation to any foreign person 

where such proposals or presentations 

concerned equipment previously 

approved for export. 

The current § 126.8 requires prior 

approval or prior notification for certain 

proposals and presentations to make a 

determination whether to purchase 

significant military equipment valued at 

$14,000,000 or more (other than a 

member of NATO, Australia, New 

Zealand, Japan, or South Korea), or 

whether to enter into a manufacturing 

license agreement or technical 

assistance agreement for the production 

or assembly of significant military 

equipment, regardless of dollar value. 

These types of proposals and 

presentations usually involve large 

dollar amounts. Before the defense 

industry undertakes the effort involved 

in formulating its proposals and 

presentations, if there is any doubt that 

the corresponding license application or 

proposed agreement would be 

authorized by the Department of State, 

the industry may request an advisory 

opinion (see § 126.9). The written 

advisory opinion, though not binding on 

the Department, helps inform the 

defense industry whether the 

Department would likely grant a license 

application or proposed agreement. 

Currently, the time between submitting 

a license application or proposed 

WReier-Aviles on DSKGBLS3C1PROD with RULES