16532 Federal Register / Vol. 76, No. 57 / Thursday, March 24, 2011 / Rules and Regulations 

Regulatory Procedures 

We follow Administrative Procedure 

Act (APA) rulemaking procedures 

specified in 5 U.S.C. 553 when we 

develop regulations. Section 702(a)(5) of 

the Social Security Act, 42 U.S.C. 

902(a)(5). The APA provides exceptions 

to its notice and public comment 

procedures when an agency finds there 

is good cause for dispensing with such 

procedures because they are 

impracticable, unnecessary, or contrary 

to the public interest. 5 U.S.C. 553(b)(B). 

The change we are making in this rule 

only corrects an error in a crossreference. Because the change we are 

making is only a minor technical 

correction to a rule to correct an 

outdated cross-reference, we have 

determined that the opportunity for 

prior comment is unnecessary. 

Therefore, we are issuing this rule as a 

final rule. 

In addition, we find that there is good 

cause for dispensing with the 30-day 

delay in the effective date of a 

substantive rule provided by 5 U.S.C. 

553(d)(3). For the reasons already 

discussed, because this change is a 

minor technical correction to a rule, a 

delay in the effective date is 

unnecessary. 

Executive Order 12866, as 

Supplemented by Executive Order 

13563 

We consulted with the Office of 

Management and Budget (OMB) and 

determined that this final rule does not 

meet the requirements for a significant 

regulatory action under Executive Order 

12866, as supplemented by Executive 

Order 13563. Therefore, it was not 

subject to OMB review. 

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 individuals. 

Therefore, a regulatory flexibility 

analysis was not required under the 

Regulatory Flexibility Act, as amended. 

Paperwork Reduction Act 

This rule does not create any new or 

affect any existing collections, and 

therefore, does not require Office of 

Management and Budget approval 

under the Paperwork Reduction Act. 

(Catalog of Federal Domestic Assistance 

Program Nos. 96.001, Social Security— 

Disability Insurance; 96.002, Social 

Security—Retirement Insurance; 96.004, 

Social Security—Survivors Insurance; and 

96.006, Supplemental Security Income) 

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. 

Michael J. Astrue, 

Commissioner of Social Security. 

For the reasons set out in the 

preamble, we are amending subpart P of 

part 404 of chapter III of title 20 of the 

Code of Federal Regulations as set forth 

below: 

PART 404—FEDERAL OLD-AGE, 

SURVIVORS AND DISABILITY 

INSURANCE (1950– ) 

■ 1. The authority citation for subpart P 

of part 404 continues to read as follows: 

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

(h), 216(i), 221(a), (i), and (j), 222(c), 223, 

225, and 702(a)(5) of the Social Security Act 

(42 U.S.C. 402, 405(a)–(b), and (d)–(h), 416(i), 

421(a), (i), and (j), 422(c), 423, 425, and 

902(a)(5)); sec. 211(b), Pub. L. 104–193, 110 

Stat. 2105, 2189; sec. 202, Pub. L. 108–203, 

118 Stat. 509 (42 U.S.C. 902 note). 

■ 2. Amend appendix 1 to subpart P of 

part 404 by revising section 111.09C of 

part B to read as follows: 

APPENDIX 1 TO SUBPART P OF PART 

404—LISTING OF IMPAIRMENTS 

* * * * * 

Part B 

* * * * * 

111.00 [Neurological] 

* * * * * 

111.09 * * * 

C. Impairment of hearing as described 

under the criteria in 102.10 or 102.11. 

* * * * * 

[FR Doc. 2011–6983 Filed 3–23–11; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 529 

[Docket No. FDA–2010–N–0002] 

New Animal Drugs; Change of 

Sponsor’s Name and Address; 

Corrections 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Correcting amendments. 

SUMMARY: The Food and Drug 

Administration (FDA) published a 

document in the Federal Register of 

April 20, 2010 (75 FR 20522) amending 

the animal drug regulations to reflect 

changes to a sponsor’s name and 

address. That document contained 

errors in the regulatory text. FDA is 

correcting the tables listing sponsors of 

approved animal drug applications 

(NADAs) by adding a change to the 

sponsor’s drug labeler code (DLC). 

Cross-references to the sponsor’s DLC 

are amended in two sections of the Code 

of Federal Regulations (CFR) containing 

the conditions of use approved animal 

drug products. These corrections are 

being made to improve the accuracy of 

the animal drug regulations. 

DATES: This rule is effective March 24, 

2011. 

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, 

e-mail: george.haibel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The Food 

and Drug Administration (FDA) 

published a document in the Federal 

Register of April 20, 2010 (75 FR 20522) 

amending the animal drug regulations to 

reflect changes to a sponsor’s name and 

address. That document contained 

errors in the regulatory text. FDA is 

correcting the tables listing sponsors of 

approved animal drug applications 

(NADAs) by adding a change to the 

sponsor’s drug labeler code (DLC). 

Cross-references to the sponsor’s DLC 

are amended in two sections of the Code 

of Federal Regulations (CFR) containing 

the conditions of use approved animal 

drug products. These corrections are 

being made to improve the accuracy of 

the animal drug regulations. 

List of Subjects 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and Recordkeeping 

requirements. 

21 CFR Part 529 

Animal drugs. 

Accordingly, 21 CFR parts 510 and 

529 are corrected by making the 

following correcting amendments: 

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), revise the entry for 

‘‘Piramal Critical Care, Inc.’’; and in the 

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


jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 76, No. 57 / Thursday, March 24, 2011 / Rules and Regulations 16533 

entry for ‘‘060307’’ and in numerical 

sequence, add an entry for ‘‘066794’’ 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 

* * * * * 

Piramal Critical Care, Inc., 3850 

Schelden Circle, Bethlehem, 

PA 18017 .............................. 066794 

* * * * * 

(2) * * * 

Drug 

labeler 

code 

Firm name and address 

* * * * * 

066794 .... Piramal Critical Care, Inc., 3850 

Schelden Circle, Bethlehem, 

PA 18017. 

* * * * * 

PART 529—CERTAIN OTHER DOSAGE 

FORM NEW ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 529 continues to read as follows: 

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

§ 529.1186 [Corrected] 

■ 4. In paragraph (b) of § 529.1186, 

remove ‘‘060307, and 065085’’ and in its 

place add ‘‘065085, and 066794’’. 

§ 529.2150 [Corrected] 

■ 5. In paragraph (b) of § 529.2150, 

remove ‘‘060307’’ and in its place add 

‘‘066794’’. 

Dated: March 17, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6795 Filed 3–23–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 529 

[Docket No. FDA–2010–N–0002] 

Certain Other Dosage Form New 

Animal Drugs; Detomidine; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Correcting amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) published a 

document in the Federal Register of 

April 23, 2010 (75 FR 21162), that 

amended the animal drug regulations to 

reflect approval of an original new 

animal drug application (NADA). FDA 

is correcting a paragraph describing 

limitations to the approved conditions 

of use for detomidine hydrochloride 

oromucosal gel in horses. This 

correction is being made to improve the 

accuracy of the animal drug regulations. 

DATES: This rule is effective March 24, 

2011. 

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, email: George.Haibel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA 

published a document in the Federal 

Register of April 23, 2010 (75 FR 

21162), that amended the animal drug 

regulations to reflect approval of an 

original NADA. FDA is correcting a 

paragraph describing limitations to the 

approved conditions of use for 

detomidine hydrochloride oromucosal 

gel in horses. This correction is being 

made to improve the accuracy of the 

animal drug regulations. 

List of Subjects in 21 CFR Part 529 

Animal drugs. 

Accordingly, 21 CFR part 529 is 

corrected by making the following 

correcting amendment: 

PART 529—CERTAIN OTHER DOSAGE 

FORM NEW ANIMAL DRUGS 

■ 1. The authority citation for part 529 

continues to read as follows: 

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

■ 2. In § 529.536, amend paragraph 

(c)(3) by adding a sentence after the first 

sentence to read as follows: 

§ 529.536 Detomidine. 

* * * * * 

(c) * * * 

(3) * * * Do not use in horses 

intended for human consumption. 

Dated: March 17, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6791 Filed 3–23–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

[Docket No. FDA–2010–N–0002] 

Animal Drugs, Feeds, and Related 

Products; Withdrawal of Approval of 

New Animal Drug Applications; 

Aklomide; Levamisole Hydrochloride; 

Nitromide and Sulfanitran; Roxarsone; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Correcting amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) published a 

document in the Federal Register of 

October 26, 2010 (75 FR 65565) 

amending the animal drug regulations. 

The October 26, 2010, final rule 

amended the regulations by removing 

those portions that reflect approval of 

eight new animal drug applications. The 

final rule inadvertently failed to add 

conforming amendments in § 558.530. 

FDA is correcting the animal drug 

regulations by removing cross references 

for use of the withdrawn drugs in 

combination drug medicated feed. This 

correction is being made to improve the 

accuracy of the animal drug regulations. 

DATES: This rule is effective March 24, 

2011. 

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, 

e-mail: george.haibel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The Food 

and Drug Administration (FDA) 

published a document in the Federal 

Register of October 26, 2010 (75 FR 

65565) amending the animal drug 

regulations. The October 26, 2010, final 

rule amended the regulations by 

removing those portions that reflect 

approval of eight new animal drug 

applications. The final rule 

inadvertently failed to add conforming 

amendments in § 558.530. FDA is 

correcting the animal drug regulations 

by removing cross references for use of 

the withdrawn drugs in combination 


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